Drug Company Used Ghostwriters to Write Work Bylined by Academics, Documents Show
According to newly released documents from GlaxoSmithKline, the pharmaceutical company often paid ghostwriters to pen medical studies, editorials and even a textbook that listed physicians as the authors.
The documents—some of which date back to late 1990s—were recently unsealed in litigation over a GlaxoSmithKline product. We saw them after they were attached to a letter released this week by a nonprofit watchdog group urging the National Institutes of Health to crack down on ghostwriting in medical academia. The documents and the letter by Project on Government Oversight together outline several examples of how a major drug company contributed to the funding, writing and approval of material published in medical journals and elsewhere.
The textbook, published in 1999, listed two physician co-authors who at the time were chairs of the psychiatry departments at the medical schools of Stanford University and Emory University, the New York Times reported this week in a piece that focused only on the textbook. According to the Times, it's the first instance where a book has been criticized for the same issues with ghostwriting and drug industry influence that have plagued medical journals.
A GSK spokesman told the Times that the company's role was described in the book's preface, which thanked the UK drugmaker (then known as SmithKline Beecham) for an “unrestricted educational grant” to the ghostwriting company, Scientific Therapeutics Information. Correspondence between a Scientific Therapeutics Information employee and one of the co-authors, however, shows the employee informing the stated author that she had “begun development of the text.” The employee, Sally Laden, also described her co-worker as the “primary technical writer” and manager for the project.
According to the documents, that same ghostwriter, Sally Laden, wrote an editorial published in 2003 in a medical journal with authorship attributed to two more doctors. One, Dwight Evans, is chairman of the psychiatry department of the University of Pennsylvania School of Medicine. His co-author, Dennis Charney, was head of a research program for the National Institute of Mental Health. (We've asked both for comment but have not yet received a response.) While Laden was credited for “editorial support” in the published article, another document seems to suggest she played more than just a supporting role. In an e-mail to a GlaxoSmithKline employee , she inquired about the status of her payment “for writing Dwight Evans' editorial.”
Laden also helped a number of authors write a 2001 study that was funded by GlaxoSmithKline and concluded that a GSK antidepressant, Paxil, is “generally well tolerated and effective for [treating] major depression in adolescents.” Within a few years, problems with the study became apparent, and both UK regulators and the Food and Drug administration issued warnings about Paxil. Glaxo, following the FDA's warning, issued a letter in 2004 informing healthcare providers that Paxil is “not approved for use in the pediatric population, and clinical trials for PAXIL failed to demonstrate efficacy in pediatric depression'.
Of course, just because a ghostwriter is involved doesn't mean a study is flawed. An anonymous medical writer who has ghostwritten articles published in top medical journals gave an interview in October to the executive editor of a blog by the Society for Scholarly Publishing. In it, he argued that he provides “a service to those who need assistance presenting their findings to the scientific community”—in other words, to academics who “ have a great study ” but aren't good writers.
The ghostwriter also acknowledged, however, that writing services are often solicited by a pharmaceutical company first, and a manuscript is sometimes written before an academic “author” is found:
In my experience, the pharmaceutical company would pay a communications/marketing company to write the manuscript, who would then go out and find academics who would be willing to become the “authors” of the manuscript and paid an honorarium. I've worked with some authors who do absolutely nothing on the manuscript, requiring an additional ghostwriter to be hired, and still demand an honorarium for their time. These academics are willing to enter into this relationship because of the importance of authorship to their careers. You can't entirely blame the pharma company. Universities encourage academics to play this game.
Earlier this year, a study in a scientific journal analyzed how medical ghostwriting works. It found that simply acknowledging ghostwriters “does not accurately reflect their authorship role.” It also found that, of the top 50 medical schools, only 10 explicitly ban ghostwriting.
GlaxoSmithKline told the Times that in recent years, the company has tightened its internal guidelines for medical writers. 3.12.10
Andrew Lansley rejects calls for funding ban on homeopathy
Health Secretary Andrew Lansley says the government will not ban homeopathy on the NHS, following calls from the parliamentary Science and Technology committee.
A statement from the Department of Health says:
‘We believe in patients being able to make informed choices about their treatments, and in a clinician being able to make informed choices about their treatments.
‘The local NHS and clinicians, rather than Whitehall, are best placed to make decisions on what treatment is appropriate for their patients – including complementary or alternative treatments such as homeopathy – and provide accordingly for those treatments.' 28.7.10
Ministers pledge £4bn to tackle smoking, drinking and obesity
Health white paper hands responsibility to councils as health experts question 'nudge' tactics and lack of detail. The government today promised ringfenced funding of £4bn to improve the nation's health by tackling issues such as smoking, obesity and excessive drinking.
But the much-heralded white paper on public health, which hands money and responsibility to local authorities, received a cool welcome from some experts, who warned that the government's preferred option of "nudging" people into good habits may not work.
"We agree that 'nudging' people to be healthy may be more effective than only telling them how to live their lives," said Dr Vivienne Nathanson, of the British Medical Association. "However, if people live in an environment where they are surrounded by fast-food advertising and glamorous alcohol marketing, nudging will have a limited effect. We need an environment that helps us make healthy choices and sometimes tougher action is needed to achieve this." She urged decisive action immediately to ban cigarette displays in shops.
Today's document centred on structural change, handing responsibility and power to local authorities, together with the ringfencing of the budget. Under the previous government, public health funds were raided in a frantic attempt to pull cash-strapped hospitals out of deficit.
The money promised, although it is said to be only a baseline, is just a fraction of total NHS spending, which is more than £100bn and expected to rise to £114bn over the next four years. Part will go to local authorities, while the rest will be spent by a new central body, Public Health England , which will organise national programmes such as immunisation and screening.
The money will also fund research into ways of persuading people to take better care of their health. "People's health and wellbeing will be at the heart of everything local councils do," said the health secretary, Andrew Lansley. "It's nonsense to think that health can be tackled on its own. "Directors of public health will be able to champion local co-operation so that health issues are considered alongside housing, transport and education."
Detail on specific interventions will not be available until next year. Plain packaging for cigarettes and minimum pricing for alcohol are subject to consultation, although the Treasury announced a hike in the duty on high-strength beer. Beer stronger than 7.5% alcohol by volume will be subject to the higher duty from next autumn, while tax on low-alcohol beers with a strength of 2.8% or less will be reduced.
Prof Ian Gilmore, chairman of the alcohol committee of the Royal College of Physicians, pointed out on Radio 4's World at One that only 1% of beers had 7.5% alcohol. He called the government's measures "window-dressing", adding that it "looks less like the 'big society' and more like big business".
Five networks, on food, alcohol, physical activity, health at work and behaviour change, where industry is sitting down with health department officials and the voluntary sector to discuss changes in practice, have yet to report. A "public health responsibility deal" will be launched early next year. The white paper says there will be moves on reducing salt in food, better food labelling, and the "promotion of more socially responsible retailing and consumption of alcohol".
The president of the Royal College of Physicians welcomed ringfencing and the attempt "to bring to the field a much-needed strategic focus and coherence". But, said Sir Richard Thompson, the RCP was disappointed by a lack of detail, especially on how to deal with alcohol misuse, obesity and smoking. "We wait keenly to see if the promised subsequent strategies will fill in the gaps."
He warned that voluntary agreements with industry would not necessarily deliver. "On a whole raft of issues it has been clearly demonstrated that a laissez- faire attitude does not work, either in terms of promoting responsible behaviour among the manufacturers and retailers of potentially harmful products or in creating an environment that would allow individuals to make healthier choices." 2.12.10
Happy pills used by thousands 'raise the risk of heart disease'
Powerful anti-depressants taken by hundreds of thousands of people could significantly raise the chances of heart disease, scientists have found. Men and women taking tricyclics are 35 per cent more likely to develop a range of cardiac problems, from heart attacks to strokes. They also have a greater chance of needing bypass surgery and other heart operations than those taking different anti-depressants or none at all.
The drugs, such as Amitriptyline and Lofepramine, are taken by 300,000 to 400,000 Britons. As well as depression, they are given to treat migraines, obsessive compulsive disorder, nerve pain and panic attacks. They fell out of favour after the advent of Prozac and other similar pills, but are becoming increasingly popular again as the newer drugs are not suitable for everyone and have been linked to suicide.
In the first study to look at the effect of the drugs in large numbers of healthy men and women, researchers tracked almost 15,000 people for an average of eight years. Dr Mark Hamer, one of the researchers from University College London, said: ‘Our study is the first to contain a representative sample of the whole community. ‘The majority of previous work in this area has focused on clinical cardiac patients, so studies in healthy participants are very important.
‘Tricyclics have a number of side effects – they are linked to increased blood pressure, weight gain and diabetes and these are all risk factors for cardiovascular disease.'
The linking of tricyclics, but not more modern anti-depressants, to heart problems means the effect cannot be explained by depression itself being bad for the heart. Tricyclics are often given to patients when Prozac and other Selective Serotonin Reuptake Inhibitors do not work. SSRIs have been linked to suicide, suicidal thoughts and self-harm.
This led to advice in 2004 that they should not be routinely prescribed for mild depression. The following year doctors were advised to not prescribe most SSRIs as a ‘first line' remedy for depression in teenagers.
One tricyclic, Lofepramine, is often given to elderly patients and is thought to have fewer side-effects than others. Professor Tim Kendall, of the Royal College of Psychiatrists, said: ‘There is no side effect-free treatment. ‘Before people run off and take drugs there are quite a lot of safe things they can do to help themselves, like exercise, guided self-help programmes, problem-solving therapies and just getting going. ‘This is more evidence that they need to think about medication carefully before just jumping in.'
Dr Hamer, whose research is published in the European Heart Journal, stressed that people should not stop taking the drugs without speaking to their GP. He added: ‘People taking the anti-depressants are also more likely to smoke, be overweight and do little or no physical activity.
‘By giving up smoking, losing weight, and becoming more active they can reduce their risk of cardiovascular disease two to three-fold, which largely outweighs the risks of taking the medications. ‘In addition, physical exercise and weight loss can improve symptoms of depression and anxiety.'
The British Heart Foundation said more research was needed for the link to be confirmed. The charity's spokesman Amy Thompson said: ‘Anti-depressants are beneficial for many people and so it would be unwise for anyone taking them to stop based on the results of this study alone.'
Despite the guidance about SSRIs, it is claimed that the drugs are massively over-prescribed, with many doctors choosing to hand out tablets rather than condemn patients to a long wait for counselling. 1.12.10
Overpaid NHS doctors and too few practitioners 'knocks three years off Britons' lives'
Britons would be far healthier if the NHS paid its doctors less but employed more of them, a shock international report has concluded. UK health spending is on a par with other prosperous countries - but its people are less healthy because too much of the money goes towards GPs' and consultants' pay packets.
At the same time, Britain has fewer doctors per head of population than most countries in the Western World - and owns far less hi-tech equipment such as cancer scanners because it cannot afford them.
The report, by the Organisation for Economic Co-operation and Development, estimates that NHS waste - such as high salaries for its staff - is knocking three and a half years off the average Briton's life. It said that millions of people could benefit from years of extra life if the UK spent its health funding as effectively as the best countries.
And it singles out the fact that British GPs are paid far more than anywhere else in the Western world as a key example of waste. Our family doctors now receive an average of £106,000 - almost double the amount paid to French GPs, even though their health system is among the best in the world.
If the money spent on doctors' wages were spent instead on, for example, more cancer scanners, then fewer people would die prematurely. The appalling conclusion is contained in a study by the OECD, which represents 30 of the world's most industrialised nations.
It found that Britain has more avoidable deaths than our European neighbours, and that the NHS is more inefficient than most health systems. Tackling this inactivity would add three and a half years on the average man's life expectancy, the report found.
Lawrence Speer, of the OECD, said: 'In the UK , healthcare spending is above average, when compared to other OECD countries and the OECD average, but the volume of various health indicators is below average.
'Why is this? It is because doctors' and nurses' salaries are quite high in the UK , compared to the OECD average. In other words, the UK is paying more for less, by putting salaries above volume. 'The UK has fewer acute care beds and high-tech equipment like scanners than other OECD countries. It also has fewer doctors and fewer doctor consultations per capita.'
The OECD report also shows that our infant mortality rates are one of the highest, and our life expectancy - particularly among women - is one of the worst. Britain has one of the highest rates of avoidable deaths. Every year, 74 deaths out of 100,000 could have been prevented. In Western Europe , only Portugal and Denmark have a worse record.
The OECD estimates that these avoidable deaths cut three years off the average life - about two and a half years for women and three and a half years for men. The report also concludes that the NHS is the seventh most inefficient health system in the OECD. If we spent NHS money as wisely as those in other countries, our life expectancy could be up to three and a half years higher.
And the healthier population would in the long run save almost 4 per cent of our national economic output - more than £50billion. Nevertheless, despite our shortcomings on healthcare, we pay our GPs more handsomely in the UK than anywhere else.
When the comparison was made, GPs got an average salary of £110,000. Pay freezes and other actions have since reduced this to £106,000 - although that is 40 per cent more than what they were earning before the signed a lucrative contract in 2003. However, the salary is much higher than the £61,000 average across the OECD - and the £57,000 paid to French GPs.
Our hospital consultants are now the sixth best paid in the OECD. They are on about £110,000, compared to the OECD average of £80,000 and far higher than payments in France and Germany.
Yet, despite this high pay, our chances of seeing a doctor are smaller than almost anywhere else. People see a doctor on average only five times a year in the UK , compared to 14 in Japan. And we only have 25 doctors per 10,000 inhabitants - lower than most of our competitors.
The high spending on staff salaries comes despite the fact that we have fewer hi-tech scanners - such as MRIs for spotting cancer - than most other OECD countries. The report concludes that the UK would have far better healthcare if it paid its doctors less but employed more of them.
It says the British health system is characterised by the 'high relative income level of health professionals' and that efficiency could be improved if contracts were rewritten to give doctors less money. 'Reinforcing competitive pressures on providers could help mitigate price pressures - such as... reforming compensation systems,' it said. 30.11.10
Acupuncture is no placebo and does relieve pain, say scientists
If you're a fan of acupuncture, you might just have a point, scientists said last night. Scans show the careful placing of needles into a body calms brain cells used to process and perceive pain. This suggests that the popular technique relieves pain, the researchers said. The finding will provide a sense of vindication for those who have used acupuncture for bad backs, sprained ankles and other aches and pains.
And it will provide food for thought for detractors of the ancient Chinese art, including many scientists. They claim the benefits of the practice are all in the mind and that patients benefit from the ‘placebo effect' in which care, attention and the simple belief that the treatment will work lead to improvements in health. However other experts said 'the placebo effect is very 'over-stated', any treatment whether it's a drug or a complementary treatment has a minimal placebo effect. When patients take a drug they expect to get better but often don't so the placebo effect is minimal. Usually when a patient tries a complementary therapy they don't expect it to work but it often does. Real world evidence proves complementary treatments help and are beneficial'.
The research team from the University Hospital in Essen, Germany, studied whether giving acupuncture affected how the brain reacted to electric shocks.
Eighteen volunteers underwent sophisticated brain scans at the same time as an electric shock was applied to their left ankle. Acupuncture needles were then placed at three places on the right side – between the toes, below the knee and near the thumb – and the electric current switched back on.
A second set of brain scans showed noticeably less activity in the brain's pain regions. Researcher Dr Nina Theysohn said: ‘Activation of brain areas involved in pain perception was significantly reduced or modulated under acupuncture.'
Other research released earlier this year revealed that the physical act of acupuncture needles and twisting them releases a flood of natural painkillers. Some sceptics remain unconvinced. David Colquhoun, professor of pharmacology at University College London, said those taking part in the study may simply have expected the technique to work but critics said 'professor Colquhoun is bound to say that, he is funded by the pharmaceutical industry and therefore not independent'. 30.11.10
Psychiatric researcher pleads guilty to research fraud
A psychiatrist on the payroll of GlaxoSmithKline has been sentenced to 13 months in prison after pleading guilty to committing research fraud in trials of the company's antidepressant Paxil on children.
Maria Carmen Palazzo is already serving a sentence of 87 months for defrauding Medicare and Medicaid. Palazzo was accused by the FDA of enrolling children in a clinical trial even though she knew they did not actually suffer from major depressive or obsessive compulsive disorder, the conditions being studied. Palazzo then falsified records and psychiatric diagnoses.
GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study.
The case's significance goes beyond simple research fraud, as Glaxo is now defending itself against charges that for 15 years it deliberately concealed evidence that Paxil increases the risk of suicide in children.
Glaxo is also defending itself against accusations that it manipulated data to conceal the risks of its diabetes blockbuster Avandia, and that it failed to warn parents that Paxil may cause birth defects if taken by pregnant women. The company has already agreed to pay more than $1 billion to settle roughly 700 birth defect lawsuits; another 100 or so suits are pending.
Although the FDA eventually required Paxil to carry a warning about the risk of birth defects and an even more prominent "black box" warning about suicide risk, many critics allege that the agency acted too slowly.
"There [had] been hints for many years that antidepressants, such as Paxil, when given to children, can cause serious side effects, including suicide, but the FDA delayed taking any action to prevent these drugs from being prescribed for children," writes Brent Hoadley in Too Profitable to Cure .
Palazzo will not actually serve any additional prison time for potentially placing children's safety at risk; her new term will be served concurrently with her first. Natural News 29.11.10
NHS shamed by third-rate hospitals: Needless deaths and thousands of blunders exposed
Death rates at 19 hospital trusts are alarmingly high and tens of thousands of patients are suffering blunders at the hands of careless and incompetent doctors and nurses, a major report reveals. Many of the substandard hospitals already face investigations that could lead to fines, prosecutions and the closure of wards and units.
The annual snapshot of the state of care in England 's 147 hospital trusts also lays bare huge variations in treatment for strokes and broken hips and in the odds of developing potentially fatal blood clots after surgery.
In the first of two lists of shame, 19 trusts were named as having higher than average death rates, with patients admitted to Buckinghamshire Hospitals NHS Trust almost 50 per cent more likely to die than those treated in the ‘safest' hospitals.
n the second list, four trusts were found to have higher than normal death rates from post-operative complications.
In the first of two lists of shame, 19 trusts were named as having higher than average death rates, with patients admitted to Buckinghamshire Hospitals NHS Trust almost 50 per cent more likely to die than those treated in the ‘safest' hospitals.
In the second list, four trusts were found to have higher than normal death rates from post-operative complications. While such complications can be unavoidable, they often can be put right with vigilance and treatment, the report states.
The figures, in the tenth annual Dr Foster Hospital Guide 2010, are based on information collected by hospitals, the Department of Health and Office for National Statistics, as well as from questionnaires.
But the researchers behind the guide believe the true rates to be much higher, as many mistakes are not reported.
The Care Quality Commission watchdog, which has the power to issue fines and prosecutions and shut sub-standard wards, last night said 13 of the 19 trusts on the first list and two of the four on the second were already ‘on its radar'.
Two trusts, Hull and East Yorkshire Hospitals and University Hospitals Birmingham, had unacceptably high death rates in both categories. A spokesman for Hull and East Yorkshire Hospitals NHS Trust pointed out that it looks after a population with the highest rates of smoking in the country, along with alcohol problems, obesity and heart disease.
Dr Dave Rosser, executive medical director at the University Hospitals Birmingham NHS Foundation Trust, described the report's methodology as ‘flawed and misleading' and said the figures may have been skewed by the high number of patients with liver disease.
Dr Foster, a public-private partnership organisation, said the differences in death rates were too great to be explained away by chance alone.
A patient's age and type of illness is taken into account when compiling the guide in an attempt to make the results as fair as possible.
The guide also highlights large variations in stroke and hip care. Stroke is the leading cause of severe disability in Britain , with more than 300,000 men and women living with problems from muscle weakness and paralysis to loss of coordination caused by an interruption in the blood supply to the brain.
Although some drugs can limit the damage, they must be given within three hours of falling ill. Patients in some parts of the country are 85 times more likely to be promptly treated with clot-busting drugs than others.
The postcode lottery for stroke sufferers also extends to receiving diagnostic brain scans and the likelihood of being back home within two months of being admitted to hospital.
The report also found that men and women who fall and break a hip are almost three times as likely to be operated on within the recommended two days in some parts of England than others.
However, it also found that the number of trusts with high death rates has fallen by almost a third from last year. Nigel Edwards, acting chief executive of the NHS Confederation, said: ‘This report shows we can do better.'
Health Secretary Andrew Lansley said the Coalition was acting to make the NHS more accountable. 29.11.10
Suppression isn't cure
Our love affair with convenience culture extends to a reliance on convenience ‘cures' for minor complaints. In the first article of a new series, the Ecologist's Health Editor Pat Thomas says that self-medication isn't the same as self-help.
Achieving ‘good health' is one of the single biggest preoccupations in modern society. But if pressed, most of us would struggle to define exactly what ‘good health' is. At a pinch, we would probably define it by the absence or of major or even minor debilities. Yet clearly, good health is more than this; for if it was simply a matter of a well-behaved body, how is it that some individuals – for instance those dying of cancer – often report feeling a profound sense of wellbeing?
Nevertheless, most of us now and again experience troublesome symptoms – such as headaches, insomnia, digestive problems, respiratory and skin troubles and being susceptible to every ‘bug' that is going around – that we fight off in a bid to stay healthy. Vague health complaints are becoming increasingly common, and many of us now consider them part of the ‘normal' human condition. Indeed it is clear that in spite of our increased longevity, a growing number of people in their prime report a lack of vitality and a variety of uncomfortable symptoms that they cannot pin down or get rid of.
According to US health expert Jeffrey Bland PhD, such people are suffering from ‘vertical ill health'; not sick enough to take to their beds (and become horizontally ill) but lacking essential vitality and a sense of wellbeing.
While no one can expect to be symptom-free 100 per cent of the time, banishing these health niggles has become the mainstay of the £2 billion over-the-counter (OTC) drugs industry. During the past decade, more and more drugs have come off the prescription list and become available off the shelf to provide quick relief. The government's enthusiasm for self-medication has a single purpose: to relieve the pressure on overworked physicians who have little time for consultations and little to offer those suffering from chronic sub-clinical health complaints.
The trend for self-medication is actively sold to the public as a way of being in control of their own health, yet most people who selfmedicate are just an extension of the GP or the pharmacist, practising the same magic bullet paradigm that causes ongoing health problems in the first place.
At least 95 per cent of illnesses are self-limiting. In other words, they will heal by themselves and do not require any intervention. In many cases, suppressing symptoms by taking an OTC medication can actually make things worse because it never really tackles the cause of the problem.
A more sensible approach recognises that many of the symptoms we often associate with illness are really the body's attempts to get well and to regain a state of homeostasis, or balance. Good examples of this process abound in our experience of common conditions such as fever, coughs and inflammation. For example, fever is uncomfortable but it is not a disease process, it is the body's attempt to kill off invading bacteria and viruses. Coughing is not a disease process. It is the body's attempt to get rid of excess mucus. Inflammation in a joint or around a wound is the body's way of protecting the injured part while the process of repair takes place. Likewise, a skin rash is seldom a disease process but often the body's way of ridding itself of toxins (the skin is the major excretory organ in the body).
Unfortunately, in Western society today, most people get their information about their bodies and about health matters via the mass media, and the mass media has a lot to answer for in terms of the way we define wellness. First of all, our media suffers from an almost incurable disease itself – expert-itis. Whether writing about conventional medicine or alternatives, the media tendency is to ignore context and uncritically reproduce everything that any so-called health expert has to say. This can often led to the passing on of incomplete, contradictory or simply wrong information. It can also reinforce the idea that others know more about your health than you do and that your body is somehow… wrong. Few people are aware of the hidden agenda in most health reporting: of the multi-million-pound PR machinery that drip-feeds the media with self-serving information on the importance of drugs to relieve symptoms. Ecologist's Health Editor Pat Thomas 1.3.07
NHS salaries ‘can't be justified'
THIRD OF NORTH AND NORTH-EAST STAFF EARN MORE THAN PRIME MINISTER – SURVEY
Nearly 800 health board staff in the north and north-east earn more than £100,000 a year, with a third pocketing more than the first minister. Figures released by Labour revealed 772 top wage-earners, with 219 of them earning more than Alex Salmond who currently takes home £135,065 as first minister and MSP for Gordon.
The party said it was impossible to justify “huge salaries” when health boards were looking at laying off thousands of staff, including those on the front line. Across Scotland 's 22 regional and specialist health boards, nearly 3,000 staff are earning £100,000 or more, with 807 topping the first minister.
NHS Grampian has the third highest number, after Glasgow and Lothian, with 300 top earners, of which 88 make more than Mr Salmond. NHS Tayside has 272 staff earning more than £100,000, with 76 taking home more than Mr Salmond. NHS Highland has 160 in the top wage bracket, including 49 making more than the first minister. The islands health boards in Orkney, Shetland and the Western Isles add 40 top earners, of whom six make more than Mr Salmond.
Labour health spokeswoman Jackie Baillie said: “In the current economic climate, it is impossible to justify huge salaries for consultants and senior executives when health boards are planning 4,000 job losses this year, including 1,500 nurses and midwives.
“I would urge every health board to examine whether they can make savings by cutting the number of managers and reducing the salaries of top earners. “This is a far better option than cutting frontline staff, like nurses and midwives.”
NHS Grampian said 296 of the 300 staff were clinicians, with the remaining four in management.
A spokeswoman said: “Our clinicians, who include medical consultants, perform valued work. “NHS Grampian is looking at every aspect of our activities to see where efficiencies can be made, while still maintaining patient safety and quality of care. “This includes working on the reduction of senior manager numbers, as announced by the health secretary in October.”
NHS Highland said while the board strove to obtain best value, it was bound by national pay scales, terms and conditions. “Of the 160 members of staff listed, 157 of these are clinicians,” a spokeswoman said. “These staff are trained, experienced and skilled professionals who deliver an essential clinical role to ensure high-quality care is given to the population of Highland .”
NHS Tayside workforce director Alex Killick said: “The vast majority are remunerated as consultants under terms of national pay and conditions of service. “There is a very small number of managers in the executive cohort who earn over £100,000.” 28.11.10
Media claim HRT 'brain boost' is unproven
“Hormone replacement therapy can make a woman's mind sharper,” according to the Daily Mail. The newspaper says that women taking hormone replacement therapy (HRT) performed better in tasks involving fine motor co-ordination skills than women of a similar age who were not taking HRT.
The story is based on a limited study (as most are) that compared the results of finger-tapping tests in 33 menopausal women taking HRT with those of 26 menopausal women who had not used the therapy. Women not taking HRT showed less asymmetry between the performance of their left and right hands when performing simple tapping with the index finger, but more asymmetry between hands when performing a more complex sequential tapping task. The opposite findings were seen in women on HRT, a pattern that researchers say is normally observed in younger women.
Although these study findings shed some light on the possible effects of hormones upon brain activity, they have limited clinical implications. All of the women of this study were of comparable dexterity, and this single, experimental test of motor function in a small group of women does not provide much insight into whether their everyday lives were affected. Notably, despite what the press coverage has implied, this study has not investigated cognitive ability or intelligence and provides no evidence that HRT will give women “sharper minds” or boost IQ.
So where did the story come from?
The study was carried out by researchers from Durham University and was funded by grants from the Deutsche Forschungsgemeinschaft research foundation who are funded by various pharmaceutical giants. The study was published in the peer-reviewed scientific journal Hormones and Behavior.
The headline featured in the Daily Mail is misleading in saying that HRT makes a woman's mind “sharper” as the study only examined differences in hand tapping in a small sample of women. The body of the Mail's story is representative of the research. The Daily Mirror, however, is completely incorrect; it says that HRT “boosts brain power”. This is not the conclusion of this research.
What kind of research was this?
There is a theory that activity in the right and left sides of the brain is affected by age, and that hormone manipulation can also have an effect. In this study, the researchers were specifically investigating whether HRT therapy affected “functional cerebral asymmetries” (FCAs), i.e. performance differences between the dominant and non-dominant hands when carrying out functional activities such as simple movement tasks. The experimental research was in older women taking HRT (two types were tested) and women not taking HRT.
Results of this type of study are of general scientific interest and shed some light on the possible effects of hormones upon brain activity. However, they have limited clinical application and provide limited information on the cognitive and functional abilities of women on hormone therapy or not.
What did the research involve?
The research recruited 62 postmenopausal women aged 46-71 who were put into three groups: women who had gone through menopause at least one year ago and had not used any HRT (26 women); women using continuous oestrogen HRT (15 women) and women using combined oestrogen and progestogen HRT (21 women). All were right-handed with good sight and normal dexterity. All groups were of the same educational level and there was no difference in the number of years since menopause.
The researchers used saliva samples to measure the participants' oestrogen and progesterone levels. They then performed a finger-tapping task involving an apparatus consisting of four small, movable switches mounted on a metallic plate. The switches were positioned under each participant's index, middle, ring and little finger. In the first test participants had to repeatedly tap the switch with the index finger as quickly as possible, and in the “sequential” test they had to repeatedly press buttons in the sequence of index finger, ring finger, middle finger, little finger. Participants repeated each test five times with each hand, and each 10-second trial was followed by a short break.
The mean tapping rate was calculated as the mean number of correct taps across the five trials. Manual asymmetry was calculated as the ratio of the differences between hands to overall performance (dominant and non-dominant hand).
What were the basic results?
A total of 59 women were included in the analysis after the exclusion of three participants in the HRT groups who had unusually low blood hormone levels. The basic findings were that postmenopausal women who were not taking HRT had little asymmetry between their right and left hands on simple (repetitive) finger-tapping. However, in sequential finger-tapping there was greater asymmetry, with better performance from their dominant hand.
In comparison, women on HRT (both types) demonstrated a lesser degree of asymmetry between hands when performing sequential finger-tapping. However, they demonstrated increased asymmetry when performing simple finger-tapping. Performance was related to oestrogen levels, with participants with higher oestrogen levels having greater asymmetry on simple tapping.
How did the researchers interpret the results?
The researchers conclude that their results suggest that HRT, and oestrogen therapy in particular, has a positive effect on the motor system and counteracts the changes normally seen with increasing age.
The researchers found that older women not taking HRT displayed less asymmetry when performing simple tapping, but asymmetry between hands when performing more complex sequential tapping with fingers. This, they suggest, reflects age-related changes in connectivity between motor areas of the brain. The opposite findings in women on HRT are, as they say, what has normally been observed when testing younger women (notably, no younger women were included in this study).
There are some limitations to this study, such as the small number of participants and the fact that women were not randomly assigned to the HRT or non- HRT groups, meaning that the results may have been affected by differences between the groups other than HRT use.
Although these study findings are of general scientific interest and shed some light on the possible effects of hormones upon brain activity, they have limited clinical implications. All of the women in this study were of comparable dexterity, and this small test of motor function in 33 menopausal women on HRT and 26 women not on HRT provides very limited information on their functional capacity. Despite its misleading news headlines, this study has not investigated cognitive ability and provides no evidence that women on HRT have sharper minds or higher IQ.
Critics say 'the study is a perfect example of how studies are misrepresented in the media to boost sales of a drug and however trivial the results they were still published in peer reviewed journals so later on they can be referred to as 'fact'. The public are constantly being misled by these limited and misleading trials to sell more drugs'. 24.11.10
More than half of West Midlands GPs refer patients to private sector
More than half of GPs in the West Midlands are referring patients to private hospitals for routine operations, according to a survey. A poll of 1,000 GPs showed 56 per cent of those working in the West Midlands Strategic Health Authority area were now more likely to channel patients to the private sector for “low priority” operations due to pressures on NHS budgets and capacity.
The operations include removal of varicose veins, cataracts operations, fertility treatment and hip and knee surgeries.
The annual NHS budget has been ring-fenced by the Government, but BMI chief executive Adrian Fawcett believes that will not be enough to match annual NHS inflation and the result will be a longer wait for treatment. He said: “As a society we are living longer and are less fit and this is only going to place greater strain on NHS resources in the future.
“The combination of this increasing demand and an over-stretched NHS budget means further treatment de-prioritisation is inevitable and waiting lists look set to rise significantly, resulting in more people opting to seek care from private providers. “As GPs take responsibility for commissioning, they will be very aware that they have to make the most of their budgets for the benefit of all patients.
“It is not surprising, therefore, that we will see GPs increasingly referring patients to the private sector if patients want access to timelier treatment. “It is inevitable that, due to the pressures facing the health care market, some people will decide that for treatments which impact their quality of life, they are increasingly prepared to pay for it themselves.”
The NHS is facing a transformational period which will see the responsibility of commissioning and healthcare budgets handed to GPs. 24.11.100
Scientist's eureka moment that found a ‘cure' for Alzheimer's
Scientists at Dundee University have discovered that anti-diabetes drugs can be used to fight Alzheimer's disease, after a researcher had a flash of inspiration during her commute.
Professor Susan Schweiger had a eureka moment while cycling to work and decided to use the diabetes drug metformin to treat dementia patients. After investigating this hunch, a team of researchers found that the drug can not only treat Alzheimer's disease, but prevent it developing in healthy people.
Although it was already known there was a link between diabetes and Alzheimer's, this was the first time the drug has been used to combat the disease. As the drug has already been tested on elderly patients and was found to be safe, it could come on to the market quicker than new drugs, which can take up to 20 years to be approved. Some 400,000 people in Britain currently suffer from Alzheimer's disease and up to one million are expected to develop it within 15 years.
About 50% of all people aged over 85 will develop the disease, so, as the population ages, finding a treatment becomes ever more urgent. Alzheimer's is a degenerative disease that causes people to lose vital cognitive functions. It impairs sufferers' ability to reason, think and remember.
Ms Schweiger, professor of molecular medicine at Dundee University 's Division of Medical Sciences, led the research. She said: “Cycling on my bike from Broughty Ferry to Ninewells Hospital is a quiet time. In the office, I am always busy with clinical and research work, so don't get a lot of time to myself.
“The idea came to me spontaneously. It just came into my mind. This is how a scientist works. The brain is always working on a problem, even during quiet times. Once I had quiet time, it occurred to me that metformin should have the effect we were looking for. “I was able to put together an excellent team here in Dundee, as well as working with international colleagues, and our results strongly suggest that, not only in type II diabetes patients but also in healthy people, metformin would have a brain-protective effect and that, if given in an early stage, would be a promising medication in the treatment of Alzheimer's.”
Patients with diabetes have an increased risk of developing Alzheimer's disease. Metformin, which is used to treat type II diabetes, works by activating an enzyme that can prevent the death of brain cells.
The team at Dundee has successfully tested metformin in mice as well as in cells. It will now apply for funding to carry out more experiments and then a full clinical trial. “It has not only been tested on humans, but on the exact target group we need,” Ms Schweiger added.
“Metformin is already used on elderly people, the group we would have to use it on, so the side effects and any potential problems are well known. “We would envisage this being used after an early-stage diagnosis of Alzheimer's. We are not expecting to revive cells that are already dead, but to protect those not yet damaged by the progression of Alzheimer's.”
A spokeswoman for Alzheimer's Scotland welcomed the discovery, but warned that it did not mean there was a total cure for the disease. She said: “Potential new treatments or preventative measures for Alzheimer's disease and other forms of dementia give hope to people living with the illness and to those worried that they might develop dementia in the future. “There is still a lot we do not know about the changes in the brain that cause dementia but each piece of research helps us build on our knowledge.
“This research from Dundee University looks promising but there is still a long way to go.” The paper has been published in the most recent edition of the journal Proceedings of the National Academy of Sciences of the USA .
But critics said ‘there is long way to go between sensational headlines which claim a ‘cure' and how any drug may actually perform in the real word. The drug hasn't even been tested on Alzheimer's patient's but already it's claimed to be a cure. I fear this has more to do with finding new markets for Metformin than an actual cure for Alzheimer's. Surely, there is already enough elderly patients taking Metformin for diabetes so these patients shouldn't get Alzheimer's? However, no data on this scenario has been presented, only wild claims'. 23.11.10
GP's fear patient revolt as NHS reforms set to end their monopoly and self interest
The government's NHS reforms could lead to disgruntled patients lobbying outside surgeries to get the treatments they want, said the head of Britain 's GPs. Dr Clare Gerada, chair of the Royal College of GPs said the plans to allow doctors to allocate £80bn a year of health funding could cause unrest among patients who have been denied complementary treatments, major surgery or access to life-extending drugs.
She criticized the NHS reforms that will see private health companies become more prominent in the healthcare market to offer patients more ‘choice' rather than limiting their choice to just NHS services which are often inferior. It will also “compromise the sacredness of the consultation and encourage customers to visit several different doctors looking for who will offer them the most treatment”, she argued.
This could then lead to angry demonstrations and questions being raised over the high salaries of GPs.
Health Secretary Andrew Lansley's plans to give GPs the power to decide who gets treatment from the National Institute for Health and Clinical Excellence and PCTs in England from 2013 have also been criticised by Ms Gerada. "At worst, the negative impact for GPs could be patients lobbying outside their front door, saying 'You've got a nice BMW car but you will not allow me to have this cytotoxic drug that will give me three more months of life'," she told the Guardian newspaper.
"I'm concerned that my profession, GPs, will be exposed to lobbying by patients, patient groups and the pharma industry to fund or commission their bit of the service. There could be letters from MPs and patient groups, and begging letters from patients."
The new head of GPs said that making doctors "the new rationers" of NHS care could diminish patient trust and turn them into "customers" who shop around trying to get the best treatment for their ailment. But critics said ‘she was out of touch, patients want choice and access to the best treatments which the NHS does not always provide'.
The 51-year-old, who will represent Britain 's 40,000 family doctors when she takes up the position, added: "Patients might think that the decision made about their healthcare will be based on self-interest – GPs saving money for themselves rather than spending it on patients."
A Department of Health spokeswoman said: "Our reforms will indeed mark a new era for the NHS – one where patients and clinicians are at the heart of the service. "Our reforms aren't an option, they are a necessity in order to sustain and improve our NHS.
"The reforms are far-reaching but they also build upon existing designs. We share a common goal with the RCGP that we all want patients to get the best health and care services." 22.11.10
Why the NHS must provide more care in community - not hospitals
Health boards are beginning to consult on radical changes to the way NHS services have traditionally been provided. Kate Watkins, acting director of the Welsh NHS Confederation, explains why the health service must change.
We are at a defining moment for the NHS. The Assembly Government's draft Budget has shown us that finances are going to be tight for the foreseeable future. If the NHS is to respond to these budgetary constraints it needs to transform – not tinker with – services.
In addition to the immediate financial pressures, the NHS, along with other health systems around the world, faces a number of challenges over the next few years. These pressures mean we must transform the way we care for patients by providing more care in the community rather than in hospital; reducing the number of patients admitted to hospital; preventing disease; and reducing duplication of services by centralising complex care.
One of the most significant challenges facing all public services, especially the NHS, is the growing older population. Within two decades almost one in three people in Wales will be 60 or over. By 2031, the number of people over 75 will have increased by 75%. Already a third of adults in Wales have at least one chronic condition, such as asthma, diabetes or arthritis. Older people are more likely to have a long-term, chronic illness so a rising elderly population means the numbers living with such conditions will increase.
Older people and those with chronic conditions tend to have more complex care needs, which means they need more joined-up services provided by a range of health and social care professionals. Older people with chronic conditions are also more likely to be admitted to hospital often for reasons that could have been avoided, maybe because of a fall; because they haven't taken their medicines as directed or because of a chest infection.
Living with as many as five chronic diseases is not fun and many patients experience daily misery as a result. The NHS, although seen by many as a large and complex organisation run by faceless bureaucrats, wants to make real differences to these patients' care and improve their quality of life. The better management of chronic conditions would not only make a real difference to people's lives it also makes better use of scarce NHS resources.
Another driver for change is the simple fact that once-fatal diseases are now more manageable and people are living longer but not
in better health. Although this is the great success story of 60 years of the National Health Service and advances in medicine, it also puts increasing pressure on hospital services. Therefore, the more we can reduce unnecessary hospital attendances and admissions the better. Many people admitted to hospital every year don't need to be there. The NHS can help prevent this by providing more care closer to or in their homes.
Caring for people closer to their own homes will enable patients to better manage their conditions – especially chronic conditions – and live more independent lives.
Not only does it make more sense clinically for the patient as they spend less time in hospital and recover more quickly in a home environment but it is also more cost-efficient for the NHS – it costs around £2,000 a week to treat a patient in hospital.
This is not about rationing services. Hospital care will still be there for those who need it and we will make sure community services are in place before we rebalance the way – and where – care is provided.
We already have a strong base on which to increase the amount of care provided in the community, thanks to the network of GP, pharmacy and nursing services in every part of Wales. Patients in Wales come into contact with the NHS some 22 million times every year – eight out of 10 of these contacts already take place outside of hospitals.
Moving more hospital-based services into the community will mean, in time, that there is less demand on hospital beds and services. This is why we need to get away from the perception that the hospital is the main place in which the NHS provides care. People are attached to their local hospital, understandably so given Wales ' fundamental role in the birth of the NHS, but modern healthcare is changing.
Advances in treatment, new drugs and new technology – like telecare and telemedicine – means patients can be cared for in, or closer to, their home reducing the need to travel to hospital. Hospitals are not risk-free environments. Patients should be admitted when hospital is the only place they can be safely cared for and not the default option.
The NHS also needs to continue – and accelerate – the move from being primarily a sickness service, which treats people when they become ill, to a wellness service that helps people stay healthy and prevents sickness. It has been estimated that every year around 5% of the £6bn Welsh health budget is spent on prevention – this is equivalent to about £94 for every person in Wales . The cost of smoking alone to the NHS is £127 per person a year. As treatment becomes more expensive, the need to prevent ill health in the first place becomes even more important.
Improve Services and Reduce Costs
Areas where savings can be made while improving the quality of patient care:
- Prioritise spending. We need to prioritise what, where and when we spend each pound in the areas that have been proven to be most clinically effective;
- Improve long-term care. – Better management of chronic and complex conditions in the community can improve the health of patients, plus prevent complications and reduce the need for hospital treatment;
- Optimise where care is provided.
New treatments and technologies mean many services can move from hospitals to the community.
Often this move means that quality is improved and, without hospitals' overheads, this is cheaper. Equally, services that must be delivered in hospitals can be consolidated into fewer sites;
Focus on prevention.
Reducing the prevalence of costly lifestyle diseases may take years, but many public health interventions produce quicker savings.
Vascular screening, for example, helps prevent heart attacks. Encouraging breastfeeding cuts hospital admissions in young children. Smoking bans have been linked to drops in acute cardiac admissions.
Sharing best practice.
Poor quality healthcare can cause significant errors – about 10% of NHS inpatients experience an adverse event. This is both damaging for patients and expensive for the system.
The recent 1,000 Lives campaign, which saved 1,199 lives over two years, and the current 1,000 Lives Plus programme are ensuring innovation, which is having a positive impact on patient safety, is being shared across the NHS;
Using NHS staff and facilities better.
All frontline clinical services can be streamlined in order to increase utilisation of staff and expensive assets, reduce duplication, increase throughput and capture scale benefits.
Hospitals can decrease length of stay, increase utilisation and optimise the use of staff, operating theatres, diagnostic kits and estates;
Reduce back-office spend.
Back office spending – from procurement to support services – can be significantly reduced. This is happening in Wales , as health boards join forces to make better use of resources.
A number of organisations have achieved savings of 10% to 15%.
Giving patients the means to care for themselves.
Cutting healthcare spending requires a step change in delivery, similar to that seen in other industries.
Because we now pick our own groceries from shelves, shop online and even scan our own items at the checkout, supermarkets have cut prices while boosting their profits.
Healthcare could see a similar change. Remote devices let patients monitor their own conditions and update their medical records and group consultations enable patients to support one another with practical information and advice. Health systems must consider which actions to pursue. 22.11.10
GPs failing to tackle major health issues
UK GPs could be failing to tackle potentially major health problems because of a reluctance to address sensitive issues and significant time constraints, a survey by health insurance group Aviva Health UK has revealed. Now in its fourth year, Aviva's Health of the Workplace report has uncovered "a worrying trend" in primary care, which, it warns, "could exacerbate the UK 's health issues" unless a major shift in attitude is achieved.
The survey showed that, in a significant number of cases (41%), GPs avoid broaching sensitive subjects with patients such as obesity (47%), alcohol misuse (19%) and smoking (13%) for fear of causing upset, and that patients are equally adverse to raising such issues, with 43% saying they never discussed general health concerns with their GP.
In addition, many patients showed an "alarming lack of knowledge" of basic health indicators, Aviva said, with a significant number only 'vaguely aware' of their body weight and 68% completely unaware of their blood pressure level, despite these being important early warning signs for cardiovascular disease and diabetes.
And it seems that time pressures are a major contributing to this lack of communication between doctors and patients as doctors have an on average just seven minutes with patients with (58%) of individuals claiming a lack of time prevents them from raising more general health concerns with their GP and, on the other side of the fence, 97% of GPs saying they would like more patient time than the average seven minutes face-to-face contact that is the current status quo.
"GPs are tremendously busy and under pressure to deal with high numbers of patients and a growing administrative workload. It's therefore important that individuals continue to be encouraged to take more control of their own health," noted Doug Wright, principal clinical consultant at Aviva UK Health, but he also stressed that "continued collaboration between the Government, the health service and key industry leaders is essential if we are to truly address the ongoing public health issues". 19.11.10
NHS reforms are a necessity, not a gamble
As part of the Government's NHS reform plans, GPs will soon become the central commissioning body of the health service. What this means is that GPs, rather than managers, will be responsible for deciding how money for patients is spent. This set-up will also see £80 billion of the NHS's £100 billion budget spent at GPs' and patients discretion.
The process of disbanding the existing management system will happen over the course of the next two years. Health Secretary, Andrew Lansley said these layers of bureaucracy were merely “frustrating the changes GPs could make”. By putting them in charge of the brunt of healthcare decisions, “you have a much better model of healthcare”.
Others argue that this change will put GPs and patients on different sides ofhealthcare; an Alconbury and Brampton GP believes that patients will end up blaming their doctors for cuts that previously would have been attributed to the Government. Many counter that this shift of power to GPs will allow cuts to be made more efficiently and give patients greater choice.
Mr Lansley says in the end, the reforms amount to patients having greater control over their healthcare. Bringing the management of care and management of resources together in one body is not a gamble, he insisted. “It would be a greater gamble not to reform”.
“Shared decision-making between patients and their clinicians is absolutely critical. We have to focus on outcomes, not targets”. 17.11.10
PM urged to act on "Massive" rise in drug prices
An open letter from 20 consultants and a patient group published on bmj.com today, calls on the Prime Minister to take action over a legal loophole that allows drug companies to make easy profits by licensing existing treatments for rare or orphan diseases.
It is argued that the current situation concerning orphan drugs is not in the best interests of patients or the NHS and that the cost to the NHS is likely to be above £10m a year.
The original purpose of this legislation was to encourage drug companies to conduct research into rare diseases and develop new treatments. But, as the rules are currently enacted, many companies simply modify existing drugs and obtain a licence for one or more orphan diseases. This then gives the company sole rights to supply the drugs and to charge what many consider “exorbitant” prices.
One example of the effect of these rules is the drug 3,4-diaminopyridine (3,4-DAP), which doctors have been using for over 20 years to treat two rare muscle diseases at a cost of £800 to £1,000 per patient per year. The company BioMarin has now been issued with a licence to supply the drug (marketed as Firdapse) throughout Europe and charges £40,000 to £70,000 per patient per year - a 50-fold to 70-fold increase.
Oral ibuprofen for analgesia costs £0.08 per gram, but intravenous ibuprofen for patent ductus arteriosus (a congenital heart disorder) costs £6,575 per gram, tens or even hundreds of times more than the cost of producing sterile ibuprofen solution for intravenous injection in an NHS facility.
"In the present economic situation it seems vital to ensure that systems are in place to prevent excessive commercial profits being made at the expense of patients and public spending," say the signatories.
They add: "Legislation on orphan drugs, far from encouraging the develop ment of new treatments for orphan diseases, is severely limiting the availability of existing treatments. We believe that the Medicines and Healthcare Products Regulatory Agency and Department of Health should not just state the rules but should act now to progress the issue of unfairness upwards, so as to instigate change."
Authors Robin Ferner and Dyfrig Hughes believe the NHS “could, and should, make and distribute ‘specials' (unlicensed medicines) for rare diseases” and that the GMC “should allow do ctors to prescribe a drug that meets the individual patient's needs, but is not licensed for the specific indication, even if a licensed medicine exists for the same indication.”
In an accompanying analysis, Timothy Cox and colleagues at the University of Cambridge argue that pricing for orphan drugs hinders access to treatment and may warrant a competition law investigation. They add that current high pricing contravenes the aim of the Orphan Regulation, which states: “Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.” 17.11.10
This reform of NHS drug funding is not a sweet deal for big pharma
Value-based pricing and risk-sharing agreements will provide hard data on efficacy.
Polly Toynbee (Forget patients. Andrew Lansley is the servant of big pharma, 2 November) attacks the reform of the National Institute for Health and Clinical Excellence (Nice) as "offering a health service without limits just when the NHS is to be cut back as never before". This statement is misleading and deserves to be unpacked.
The announcement that Nice will no longer be the sole body deciding on the reimbursement of treatments that are available on the NHS does not mean it is being "stripped of its powers". It means treatments will now be considered not only on the basis of an educated estimate of their prospective cost per unit increase in life expectancy, but also on the desire to adopt a more patient-centric approach.
GPs will now be able to prescribe based primarily on clinical need – a huge improvement to patient care. But that decision will still have to be made within the limits of local health budgets agreed by a local consortium, accountable to the NHS commissioning board. In practice, GPs will also continue to consult Nice guidance as well as its new standards under an expanded remit.
Despite Toynbee's reference to "runaway drug costs" and implying a free-for-all, spending on medicines actually forms only about 10% of overall NHS costs. And according to OECD figures, the growth in UK pharmaceutical spending is actually decreasing as a percentage of GDP (down from 14% in 2000).
Is the NHS really being "cut back as never before"? While the NHS is indeed being asked to find productivity gains and savings due to the current economic crisis, it has nevertheless had a huge increase in its budget over the last decade. In real terms, health spending has doubled since 1999, reaching £103bn in 2010-11, and the coalition government has committed to a continued real-terms increase in the NHS budget.
Arguing that value-based pricing and risk-sharing agreements will undermine the way our public system considers the cost-effectiveness of treatment (tilting it towards the interests of industry) is simply incorrect. A key purpose of such a system is to assess over time whether the drug has achieved its intended goal and justified its cost. This is hardly a sweet deal for industry. Rather it is a commitment by all sides to come up with hard data on efficacy, compliance and so on.
Patient access schemes are an alternative way of trying to ensure British patients can access new innovations while holding the industry accountable for their effectiveness. Stockholm Network research shows that the evidence on these schemes is patchy, although in some cases they do work well. The coalition should therefore look carefully at the outcomes of pilots as they emerge, before it goes ahead with finalising any change to Nice's functions. But it is not fair of commentators such as Toynbee to simply dismiss these schemes.
Ultimately the NHS's legitimacy comes from making decisions based on a combination of patients' needs, budgetary considerations and real-world evidence. Nice still has an important role to play, but that doesn't mean we should not modernise our system just for the sake of preserving the powers of present institutions.17.10.10
More jobs for managers, but fewer for the nurses
THE number of managers in the Welsh NHS has soared as the nursing workforce has shrunk, according to figures released by the Conservatives yesterday.
Figures obtained by shadow health minister Andrew RT Davies revealed the number of managers has risen by a staggering 20% since 2005. In the same period, there has been a 24% reduction in the absolute number of nurses, midwives and health visitors working on Welsh hospital wards and in the community.
The figures come at a time of concern in the public sector about the scale of government cuts, and amid warnings from the Royal College of Nursing in Wales that health boards are introducing recruitment freezes and not replacing senior and experienced nurses.
Last night it urged health boards to protect the front line and consider other efficiencies – including the money lost in equipment costs every year. Mr Davies said: “We accept the need for leadership and direction at all levels of the NHS, but these figures demonstrate that NHS resources are being directed at managerial posts at the expense of hospital medical staff.
“At a time when Welsh ministers are facing financial pressures in the NHS, due in part to their failure to protect the health budget and made worse by their decision to take £435m out of the health budget this year, we must ensure that funding is prioritised at the front line.”
The figures show there were 3,176 managers, including clinical managers, employed in the NHS in 2005 compared to 3,823 in 2009 – an increase of 20%. When comparing the number of whole time equivalents, management increased by 24%.
In nursing, there were 10,000 fewer nurses, health visitors and midwives in 2009 than in 2005 – a reduction of 24%. But when the figures for whole time equivalents are counted, there was a fall of 0.7% in the nursing workforce between 2005 and 2009.
Tina Donnelly, director of RCN Wales, said: “If we are going to have cuts in the NHS budget then we have to conserve frontline staff. We have to look at other areas for efficiency savings. “Some of our members have told us how when a patient attends A&E with a broken limb they are given crutches, a walking stick or zimmer frame to help them get around.
“But nurses have seen a pile of this equipment at a city dump, which must have cost in the region of £20,000. Why can't this equipment be treated like library books? “We can't have another slash-and-burn approach like we had in the early 1990s.”
Kate Watkins, acting director of the Welsh NHS Confederation, said: “Managers make up a very small percentage of the total number of NHS staff, and a large proportion of them are clinical managers. “The NHS is a vast and complex organisation which has responsibility for the health of the entire nation. “Management numbers this low would be unthinkable for private sector companies of a similar scale and complexity.
But critics have said Ms Watkins is out of touch as the proportion of managers, administrators and support staff to nurses in the NHS is 41/2 times greater than in private hospitals.
“The NHS is driving down management costs every year, and we are on course to achieve a £40m reduction in the next three years. “The NHS is heading into the toughest financial challenge it has ever faced, and we need skilled leaders to make the system run efficiently and ensure that frontline staff have the time to do what they do best – treat patients.”
An Assembly Government spokesman said: “Despite the current financial pressures, there are now more health professionals working in the NHS than ever. “Nurses make up 43% of the NHS workforce, thanks to increased investment in nursing in recent years.
“Meanwhile, managers account for less than 4% of the NHS workforce, but have a key role in ensuring frontline staff can focus on patient care.
“The NHS is continually seeking to improve the quality services it provides in Wales . “In order to achieve this, the workforce needs to change, both in the range and mix of skills it possesses and the roles that professionals undertake.
“It is inaccurate to claim that the NHS budget has been cut by £435m this year – this is simply untrue. “This is a planned efficiency saving requirement for 2010-11 for NHS organisations to deliver balanced financial plans.” 13.11.10
Many doctors still in bed with Big Pharma
The cozy relationship between doctors and drug companies has received a lot of attention recently as numerous reports have exposed widespread corruption between the two groups. But a new study has found that, despite making promises to clean up their act, many doctors continue to accept gifts and cash from Big Pharma.
Back in 2009, a study out of Harvard University and Massachusetts General Hospital found that 84 percent of doctors have ties to drug companies, a ten percent drop from five years earlier. But roughly two thirds of doctors still accept drug samples, while 70 percent accept food and beverage incentives from drug companies. And fourteen percent continue to accept cash payments for services.
In October, ProPublica, Consumer Reports, and National Public Radio (NPR), released a report about the $7 billion spent by drug companies over the last three years to settle cases involving such unethical payouts. Even so, Big Pharma continues to spend millions on doctors to influence their prescribing practices.
While the practice has tapered off some, many say the rate of decrease is not enough. Drug companies are still wining and dining doctors, influencing the way they perceive and prescribe drugs. And many doctors accept gifts and cash without disclosing it publicly anyway, which means that many more doctors could be on Big Pharma's payroll than current studies indicate.
Doctors who continue to accept drug company gifts have come out in defense of themselves, claiming that the gifts do not influence their drug prescribing decisions. But not everyone is convinced.
"Cultures to the beginning of time have figured that gifts engender a positive response toward the giver," explained Eric Campbell from Massachusetts General Hospital , author of the study, to Reuters. "What's hysterical is the fact that physicians deny that these happen. It's absolutely ludicrous to think that drug companies would spend all their time and money giving away this stuff if it didn't work." Narural News 10.11.10
'Elite' NHS hospital scandal which left 1,200 dead could happen again, warn campaigners
One of the worst NHS hospital care scandals – in which up to 1,200 patients died – could happen again, campaigners warned yesterday. As a full public inquiry opened into the appalling standards of care at the Mid-Staffordshire NHS Foundation Trust, Julie Bailey said little had changed at the hospital and complaints were still being routinely ignored.
Mrs Bailey, whose mother was one of the hundreds who fell victim to a regime at Stafford Hospital that left patients ‘sobbing and humiliated', said: ‘The hospital needs to close and reopen bit-by-bit until it's fit for purpose.'
A secret inquiry held last year found between 400 and 1,200 patients died after suffering routine neglect by hospital staff between 2005 and 2009. Staff put cost-cutting and Government targets before care, and patients were caused ‘unimaginable suffering', it said in findings published in February. Mrs Bailey has since set up the Cure the NHS campaign group, which has been at the forefront of the campaign for a public inquiry.
Yesterday, Robert Francis QC, chairman of both inquiries, said what he wanted to know was, ‘Why did none of the many organisations charged with the supervision and regulation of our hospitals detect that something so serious was going on and why was nothing done about it?'
He said the main purpose of the public inquiry at Stafford Civic Centre, which is expected to conclude in the middle of next year, was to determine why no action was taken by NHS management before the intervention of the Healthcare Commission and to identify what lessons could be learned.
The first inquiry found dying patients were left unwashed in their own filth for up to a month while wards were covered in blood and needles. It ruled that patients were neglected, bullied and subjected to ‘inhumane treatment', while bullying managers deterred whistleblowers from coming forward.
Senior staff at the Trust – which was at the time officially an ‘elite' NHS institution – were condemned for their fixation on waiting times to hit Labour targets. But despite the catalogue of failings, no action was initially taken against staff.
There are currently six trained nurses suspended pending disciplinary hearing. It is not known if anyone has been fired or has already faced disciplinary action. Mrs Bailey's mother Bella died in November 2007. She had been so concerned for the 86-year-old that she slept in a chair on the ward for eight weeks.
Yesterday, the 47-year-old said: ‘The Trust is still relying on a complicated system of self-assessment where it is up to the hospital to declare complaints. What's happening at the hospital now is still as bad as it was before. I am still hearing complaints about care and treatment.'
Another victim of the scandal was John Moore-Robinson, who bled to death after doctors at Stafford Hospital failed to notice he had ruptured his spleen in a cycling accident.He was sent home with painkillers and later died. But nine months later, chief executive Martin Yeates wrote a letter to the 20-year-old's parents saying they should ‘move on'.
Yesterday, his parents held a banner outside the civic centre where the inquiry was held that simply asked ‘Why?' with a picture of their son and his birth and death dates. ‘The arrogance of it is despicable,' said his father Frank. ‘The letter is an insult. I don't for one minute think that he's truly sorry. It makes my blood boil to think that Martin Yeates has got away with it.'
The public inquiry, announced by Health Secretary Andrew Lansley in June, is designed to build on the work of the first investigation. The previous Labour government rejected calls for a full public investigation into events at the hospital, instead ordering the independent inquiry which published its findings in February.
Launched after a Healthcare Commission report published last year, the previous inquiry found that appalling standards put patients at risk and between 400 and 1,200 more people died than would have been expected in a three-year period from 2005 to 2008.
Yesterday, in his opening statement, Tom Kark QC, counsel to the inquiry, vowed to leave ‘no pebble unturned' to uncover the truth about what had happened. He said he had consulted more than 170 people, individuals and organisations and had received more than a million pages of documentation. He added: ‘In leading this inquiry, I have sought to ensure that we will explore every relevant nook and cranny in the health service.
Mrs Bailey said: ‘We're not going to go away until we can get answers and ensure that this never happens again. It will be a legacy for people who have lost their loved ones unnecessarily in Stafford'. 9.11.10
Government website 'shifts power to the people'
Whitehall "business plans" are to be published on a new website designed to allow greater public scrutiny of government policies, Prime Minister David Cameron has said. The Prime Minister announced that the new government website will contribute towards shifting power from central government to individual members of the public and communities.
"Instead of bureaucratic accountability to the government machine, these business plans bring in a new system of democratic accountability – accountability to the people", Cameron said.
"So reform will be driven not by the short-term political calculations of the government, but by the consistent, long-term pressure of what people want and choose in their public services – and that is the horizon shift we need."
Cameron said that business plans would bring about a "power shift" and would change what government does. He said: "For a long time, government's default position has been to solve problems by hoarding more power to the centre – passing laws, creating regulations, setting up taskforces. The result is that Britain is now one of the most centralised countries in the developed world."
The Prime Minister added: "We will be the first government in a generation to leave office with much less power in Whitehall than we started with. We are going to take power from government and hand it to people, families and communities – and how we will do that is set out right here in these business plans."
The coalition has indicated that the government's plans for transparency and its business plans website are very different to Labour's approach of publishing performance targets.
The website is expected to include business plans for each government department, with timetables for achieving goals. It is expected that Whitehall departments will update the website with progress reports on a monthly basis.
Chief Secretary to the Treasury Danny Alexander said: "All departments in previous governments have had plans for what they are going to do.
"The difference is that we're making our plans public, so that the public can see how we intend to go about our business, what we intend to do in any department, any area that people are interested in."
He told the BBC: "It's about transparency, it's about giving the public the chance to really scrutinise government, not just once every five years at election time but step by step on each of the policies that people care about and want to see, they'll be able to hold us to account." 8.11.10
Statin drugs cause liver damage, kidney failure and cataracts, says BMJ
Cholesterol-lowering statin drugs significantly increase a person's risk of cataracts, muscle weakness, liver dysfunction and kidney failure, according to a study in the British Medical Journal .
The study also confirmed that the drugs lower the risk of heart disease and esophageal cancer, but claims of other health benefits were unsupported.
Researchers from Nottingham University in the United Kingdom examined data on more than 2 million patients between the ages of 30 and 84, seen at 38 different general practices, who had been prescribed the cholesterol-lowering drugs. More than 70 percent were taking simvastatin (Zocor), 22.3 percent were taking atorvastatin (Lipitor), 3.6 percent were taking pravastatin (Pravachol, Selektine), 1.9 percent were taking rosuvastatin (Crestor) and 1.4 percent were taking fluvastatin (Canef, Lescol, Lochol, Vastin).
The researchers confirmed prior data suggesting that statins increase patients' risk of cataracts, liver dysfunction, kidney failure and a form of muscle weakness known as myopathy. They found that for every 10,000 women treated with the drugs, 23 would develop acute kidney (renal) failure, 39 would develop myopathy, 74 would develop liver dysfunction and 309 would develop cataracts. Men suffered an even higher risk of myopathy, but their risks of the other three conditions were similar to those suffered by women.
Putting it in different terms, the researchers found that only 434 people would need to be treated with the drugs for five years for one case of acute renal failure to develop. It would take only 136 treated for each case of liver dysfunction and 33 for each case of cataracts. Among women, 259 would need to be treated for each case of myopathy; among men, the number was only 91.
The risk of developing all conditions was highest during the first year of treatment, but continued throughout the course of the study. Risk of liver and kidney problems increased proportionally with the dose of statins being taken.
All drugs appeared to pose a similar risk of all conditions, with the exception of fluvastatin, which increased the risk of liver dysfunction more than its competitors. Men taking fluvastatin were twice as likely to develop liver dysfunction as those not taking statins, while women's risk increased by 2.5 times.
The researchers did find, however, that the risk of cataracts returned to normal within one year of stopping statin treatment, while the risk of liver and kidney problems returned to normal within one to three years. Additionally, they found no connection between statin use and the risk of dementia, osteoporotic fracture, Parkinson's disease, rheumatoid arthritis or venous thromboembolism.
Examining the purported benefits of the drugs, researchers found that they did in fact lower the risk of heart disease, averting 271 cases for every 10,000 high-risk patients treated. Put another way, 33 high-risk men or 37 high-risk women would need to be treated with the drugs to avert one case of the disease.
Although advocates of the drugs have claimed that they may also reduce the risk cancer, the researchers found almost no data supporting these claims. The study "largely confirmed other studies that reported no clear association between statins and risk of cancers," the researchers wrote.
The only cancer-fighting effect uncovered in the study was a slightly lower risk of esophageal cancer, with eight cases averted for every 10,000 high-risk women treated. In other words, 1,266 high-risk women or 1,082 high-risk men would need to be treated with the drugs to prevent one case of esophageal cancer.
Although sales of the blockbuster drugs are unlikely to be reduced as a result of the study, the researchers encouraged closer monitoring of patients for side effects and said their findings "would tend to support a policy of using lower doses of statins in people at high risk of the adverse event ." Natural New 7.11.10
Higher US drug spending has not improved health
Healthcare spending in the U.S. is higher than that of most other developed nations -- totaling roughly $7,290 per person -- but the added costs have not translated into better care or quality of life. According to two new studies published in the New England Journal of Medicine , higher spending on drugs does not equal better health, and can actually spur doctors to over-prescribe drugs to patients who do not need them.
Yuting Zhang and her colleagues from the University of Pittsburgh Graduate School of Public Health evaluated drug spending and prescribing practices at various care facilities across the country. Though there were observable differences in spending amounts, Zhang and her team did not observe a connection between higher spending and improved care.
"[The study] contradicts the idea that high spending leads to better prescription practices," she explained in a statement. "Higher spending can be justified if it's for drugs that are necessary and appropriate and improve patients' health ." But much of the time, higher spending actually causes more problems.
Zhang and her team found that in places where per capita medical spending was higher -- and particularly in government-funded medical programs like Medicare -- doctors were more prone to prescribe dangerous, high-risk drugs to patients. And in a second study conducted at the University of Michigan Medical School, Dr. Vanakn Shahinian and colleagues found that when Medicare spending was reduced, doctors prescribed drugs less frequently and more carefully.
High drug spending is also a result of fraudulent billing practices used by drug companies. NaturalNews recently covered the story of Louisiana 's lawsuit against 18 different drug companies for robbing the state's Medicaid fund of million of dollars and 27 other states have also had to battle drug company fraud as well. Natural News 8.11.10
Over-prescribing is so rife that millions of us are given drugs we don't even need
Over-prescribing is so rife that millions of us are given drugs we don't even need, worse, they put you at risk of stroke, kidney failure and deadly infection...
When your doctor prescribes a drug it means you really need it, right? Wrong! In fact, every year, millions of Britons are given medicine that's completely unnecessary or inappropriate. Quite apart from the huge waste this represents for the NHS (conservatively estimated at £400 million a year), these drugs can have harmful, even fatal side-effects — something the family of Mary McIlgorm, an 83-year-old from Barrow-in-Furness , in Cumbria , learned too late.
Mary had suffered with mild indigestion for years, recalls her daughter Christine, 54, a Post Office clerk. ‘But Mum had always got by with over-the-counter remedies and it really didn't bother her too much,' she says. ‘Then one day her GP prescribed a drug called lansoprazole.' This is one of the proton pump inhibitor (PPI) drugs, which work by cutting the amount of stomach acid you produce.
PPIs are used for treating stomach ulcers and heartburn and have rapidly become one of the most frequently prescribed groups of drugs. However, studies have shown that up to 70 per cent of prescriptions for them may be unnecessary. Mary knew none of this. ‘Mum was instructed to take a pill every day, but she told me they didn't seem to be very effective and she still suffered from indigestion,' says Christine.
Later that year, when Mary suffered a fall and broke her arm, she was admitted to hospital. There she caught Clostridium difficile, a superbug that causes severe diarrhoea and is potentially fatal. Three weeks later Mary died.
Christine later learned that PPIs are known to dramatically raise the risk of contracting C.difficile — some experts believe they are linked to hundreds of deaths in the UK every year. ‘I was so angry when I found out about this, especially when Mum probably didn't need the drug in the first place,' says Christine. ‘Her death was completely avoidable.'
Mary's experience is far from an isolated case. There are as many as 15 groups of drugs which are overprescribed, according to guidelines just issued by the NHS National Prescribing Centre. These include some of the most commonly used medicines for arthritis, insomnia and asthma.
There's no denying that these drugs, when correctly prescribed, can transform patients' lives for the better. The worry is when they are doled out unthinkingly, says Dr Martin Johnson, a former GP and trustee of the Patients' Association. ‘Unfortunately, patients can sometimes end up on drugs they don't need and these can have side-effects which impact on quality of life and make them feel unwell. ‘They can also cause long-term side-effects such as kidney disease or increased stroke risk. The elderly suffer more because they are more likely to be on multiple prescription drugs and be more susceptible to side-effects.'
Indeed, between 16 and 30 per cent of all hospital admissions in the elderly are caused by inappropriate prescribing, says Dr Mehool Patel, of University Hospital , Lewisham, who is the deputy chairman of the British Geriatric Society's Council. ‘Increasingly, geriatricians are seeing elderly patients on lots of different types of drugs they don't need.
‘Coping with drug side-effects is a big issue for the elderly. For instance, many elderly patients are prescribed a drug called prochlorperazine for dizziness. It's meant to be a short-term treatment, but if patients are left on it long term they develop Parkinsonism — that's Parkinson's disease symptoms caused by drugs.'
Overall GPs in this country are some of the ‘best prescribers' in the world, says Peter Rowe, who runs the Department of Health's team for assessing medicine use and procurement. ‘But we can always do better.'
Part of the problem is patients are often given repeat prescriptions and no one reviews their medication. For instance, patients with long‑term heartburn symptoms are meant to have an annual review of their treatment and helped to reduce or stop it. In fact, many are not reviewed but left on long-term, high doses of PPIs.
There needs to be ‘much more accountability for prescribing', says Dr Johnson. ‘When I was a GP, I would never have put anyone on a repeat prescription unless I'd reviewed them to see how they were getting on and whether the drug was still necessary. That's just one simple step to avoid unnecessary prescribing. ‘I think another is for patients to actually ask their doctors whether they really need a prescription.'
So are your prescription drugs unnecessary and even harmful? Here, with the help of experts, we identify the main drugs causing concern . . .
The most commonly prescribed drugs for heartburn are PPIs. They are also used to treat stomach ulcers and to counter the gastric side-effects of painkilling drugs used to treat arthritis, such as diclofenac.
Last year alone there were 36 million prescriptions written for PPIs, a three-fold increase since 2000.
Not only are these prescriptions often unnecessary, the drugs dramatically increase the risk of catching potentially fatal C.difficile, raising your chances by as much as 80 per cent, according to a review of studies involving 133,000 patients. It seems PPIs destroy the stomach acid barrier which protects ‘friendly' gut flora; this allows harmful bacteria to flourish.
The drugs increase the risk of osteoporosis and fractures, possibly by preventing calcium absorption. PPIs have also been associated with a 30 per cent increased chance of developing pneumonia in intensive care. PPIs may be responsible for hundreds of extra deaths annually, says Dr Richard Cunningham, consultant microbiologist at Derriford Hospital .
‘The risk of patients developing C.difficile is now well-established, but it seems to be taking a long time for that information to be reflected in prescribing practice,' he says. ‘A high proportion of patients admitted to A&E and acute medical units are on PPIs — up to 40 per cent in some areas — and the worrying thing is that when many of these patients are interviewed, most don't even know when or why they were prescribed them.'
In fact, research shows only around a third of patients actually have serious conditions such as peptic and duodenal ulcers that require this powerful treatment. ‘Doctors are prescribing an unnecessarily potent drug for mild indigestion when lifestyle advice or a much simpler drug would be much safer,' adds Dr Cunningham.
‘In the past, patients would have been advised to lose weight, prop up the head of their bed higher (to lessen the chances of acid coming back up from the stomach) and avoid spicy food, or at the very most take an over-the-counter antacid treatment.'
Professor Roger Jones, author of a King's Fund report, Managing Acute Illness, adds that handing out reassuring advice on prevention rather than pills can be far more useful.
‘In some cases prescribing PPIs became almost a knee-jerk reaction for any patients with indigestion,' he says. ‘Doctors often defend their prescribing by arguing they come under pressure from patients to give them a prescription, but there's good research to suggest doctors tend to overestimate this.
‘Many patients may feel better with a good deal of reassurance and advice on preventing their problem reoccurring.'
Another group of drugs doled out too readily are those for arthritis.
The non-steroidal anti inflammatory drugs (NSAIDs) are some of the most commonly prescribed painkillers in general practice. However, recent studies have linked them to a higher risk of ulcers; the drugs stop the body producing chemicals called prostaglandins, which it needs to protect the stomach lining.
Meanwhile, diclofenac — the most popular NSAID — may also raise the risk of stroke. Some experts say the drug is linked to up to 2,000 extra or premature heart attacks and strokes a year. Although prescriptions fell by 5.6 per cent overall between 2005 and 2008, the National Prescribing Centre says the figure remains at a relatively high level.
Doctors are being urged to review all patients currently prescribed NSAIDs, and, if painkillers are still thought to be necessary, to switch patients to less risky forms such as ibuprofen and naproxen.
‘Often other drugs like paracetamol and codeine may be more suitable if taken at the correct dosage,' says Tony Avery, professor of general practice at the University of Nottingham .
‘It is also very important to consider non-drug treatments. For example, in patients with osteoarthritis of the knee there are so many things that can help, including thigh muscle-strengthening exercises, weight reduction and use of shock- absorbing shoes or insoles.
The worry with the overprescription of insomnia drugs is that users can quickly become addicted, which is why doctors are told to prescribe them for just a few weeks at a time.
There are two groups of insomnia drugs: the benzodiazepines, which include diazepam (previously known as Valium) and alprazolam (brand name Xanax); and the newer, so-called ‘Z' drugs — Zolpidem, Zaleplon and Zopiclone. These are all used to treat severe insomnia and severe anxiety.
The risk of addiction from benzodiazepines has been recognised for years, and under official guidelines they're meant to be used only if insomnia is severe, disabling or causing the patient distress. Even then, the lowest possible dose that controls symptoms should be used for a maximum of four weeks, or intermittently if possible.
Although benzodiazepine prescriptions have fallen, an estimated 1.25 million Britons are long-term users; there are around 500,000 people taking a ‘Z' drug long term.
Last month, the Earl of Sandwich spoke in the House of Lords to highlight the dangers of benzodiazepine over-prescription, revealing a member of his family has been suffering from withdrawal symptoms for the past 18 months. He said: ‘These drugs are dangerous. Why do doctors prescribe them so freely if they provide temporary relief for so little time and never cure the problem?'
Other potential side-effects of benzodiazepines include dizziness, memory problems, day time sleepiness and, in some cases, an increase in anxiety levels. Withdrawal symptoms can be severe and disabling.
Antibiotics are still widely being used to treat viral infections —– despite the fact that the drugs have no effect on them at all. They are prescribed for 81 per cent of otitis media (ear infections), 91 per cent of acute sinusitis, 60 per cent of sore throats, 47 per cent of laryngitis and even 26 per cent of influenza cases — even though a high proportion of these illnesses and all cases of flu are caused by viruses.
The concern is largely that the overuse of antibiotics will lead to more superbugs, resistant to treatment. But patients have a more immediate reason to want to avoid having antibiotics, as Professor Avery explains: ‘There's evidence that they can increase the patient's risk of developing resistance to the use of similar antibiotics in the future, when they may need treatment for a more serious infection.
‘There is also a major concern — particularly in older people — that frequent use of broad spectrum antibiotics (which work against a wide number of bacteria) increases the risks of C.difficile, which can be fatal.'
Other side-effects from taking antibiotics include diarrhoea, nausea and vomiting. If you're treated with broad spectrum antibiotics there is a risk of developing a fungal infection afterwards, such as thrush.
High-dose inhaled corticosteroids are often used for asthma, but if taken at high dosage for long periods they can potentially cause glaucoma and cataracts, slow growth in children and adolescents and suppress the adrenal gland (which produces important hormones such as cortisol).
The British Thoracic Society recommends the dose is reviewed every three months, reducing it by 25 to 50 per cent each time.
However, this is not routinely implemented, leaving some patients overtreated, a report found.
The drug ezetimibe works by inhibiting absorption of cholesterol. It cost the NHS £68 million in 2009, £20 million more than two years previously.
Despite the huge increase in prescriptions, the National Prescribing Centre says there's no good evidence the drug reduces the risk of heart attack or stroke compared to a statin alone.
Potential side-effects include dizziness, headache, muscle pain and disorders, constipation and diarrhoea. 2.11.10
Nice to lose powers to decide on new drugs
The government's drug rationing body, Nice, is to be stripped of its power to turn down new medicines for use in the NHS, ending emotive battles with patient groups but raising the spectre of a postcode lottery for care. The health secretary, Andrew Lansley, believes that Nice, the National Institute for Health and Clinical Excellence, should continue to write guidelines for doctors on the best treatments for their patients, but the Guardian understands he will remove its controversial power to ban the use of drugs it considers too expensive for the benefit they offer.
The move will be greeted with enthusiasm by the pharmaceutical industry, which has opposed Nice from the outset, and by certain patient groups, set up to lobby on specific diseases, sometimes with pharma funding, that have joined cause with them in angry denunciations of Nice when drugs found to have limited benefit have been rejected.
But the decision is likely to cause consternation among the supporters of Nice, who warn of a return to the "postcode lottery" days before Nice came into being, when some patients could get the drugs they wanted on the NHS but others could not.
Critics also point out that careful scrutiny of the cost-effectiveness of drugs is essential to keep drug bills down and ensure that NHS money is not spent on medicines with very limited effect – to the detriment of other patients who may not get the care they need. "Real growth in the NHS will be about 0.5% in the next few years," said Alan Maynard, a health economist. "We're going to have rationing. The question is whether we have it at a national level or let 150 primary care trusts or whatever do it their own way."
David Cameron's announcement of a £200m fund for new cancer drugs, made during the election, "drove a coach and horses through Nice", said Maynard. He said he thought Nice was "under considerable assault".
Lansley wants the decision on whether a patient should get a drug to be moved back to the patient's doctor. The local commissioning body will be asked to agree to pay for it. The cost of the drug will be decided through a new "value-based pricing" system. The NHS will negotiate with the manufacturer on a price for each new drug, taking into account not only how clinically effective it is and how it reduces the burden on the patient's carers but also what other treatments are available and how "innovative" the company has been in producing the drug.
The health secretary told the Guardian that reforming the way medicines were paid for would help ensure money was spent wisely. "We need a system that encourages the development of breakthrough drugs addressing areas of significant unmet need. And we need a much closer link between the price the NHS pays and the value that a new medicine delivers, sending a powerful signal about the areas that the pharmaceutical industry should target for development," he said. "Most importantly, using our cancer drugs fund in the interim, and value-based pricing for the longer-term, we will move to an NHS where patients will be confident that where their clinicians believe a particular drug is the right and most effective one for them, then the NHS will be able to provide it for them."
The pharmaceutical and biotech industries have heavily lobbied governments for a long time, arguing that Nice is an obstacle to innovation, delaying the introduction of their new drugs into the NHS and sometimes turning them down or restricting the numbers of patients for whom they can be used. Under the new system, they will be able to argue for a premium price for a drug in a new class, for instance, or for one that has required a greater outlay for research and development.
According to the pharmaceutical press, health minister Lord Howe told a conference this week on the future of innovation and drug research and development that Nice was now "somewhat redundant" when it came to deciding the cost-effectiveness of drugs, although its role in producing guidance would remain very important. Howe said the price to be paid would reflect "everyone's agreed perspective" on its value.
Dr Richard Barker, director general of the Association of the British Pharmaceutical Industry, said he thought it was right that Nice should no longer be able to accept or reject a drug for the NHS. "It should be a clinical decision on what medicine a patient needs, informed by a broader sense of value than the current one that Nice applies," he said.
He envisaged that Nice would continue to look at the effectiveness of a medicine and give advice, but then the drug manufacturer would meet with the NHS to discuss the price. "We believe a more productive way forward based on some kind of broad assessment of value is for the company to sit down and discuss the outcome of that with the department of health and the NHS, rather than have another body set up. We don't think there is a disagreement between us [the industry and the government]," he said.
Value-based pricing would replace the current complicated system known as the PPRS (pharmaceutical price regulation scheme), which reimburses companies for the drugs they supply to the NHS. The industry has defended the PPRS in the past, but Barker said he thought it would support the new system – as long as existing barriers were swept away.
At the moment, there are some regional bodies assessing the usefulness of medicines and PCTs have pharmacy advisers and formularies – lists of drugs they are willing to buy – which the industry hopes will all go. 31.10.10
Many doctors still prescribe drugs instead of effective therapies for chronic back, neck pain
There are many alternative ways to treat back and neck pain apart from drugs that studies have shown to be effective. But many doctors continue to prescribe drug treatments to their patients anyway, according to new research out of Duke University and the University of North Carolina (UNC).
According to Dr. Adam Goode, PT, DPT, and his colleagues from the UNC Cecil G. Sheps Center for Health Services Research, most people with chronic neck or back pain find little relief from conventional treatment options, which most often involve various strengths of pain medications.
And the long-term effectiveness of these treatments is dismal, they concluded, based on systematic reviews published in The Cochrane Library and The Bone and Joint Decade (BJD) 2000 - 2010 Task Force on Neck Pain and Its Associated Disorders: Noninvasive Interventions for Neck Pain.
Certain methods that actually provide demonstrated benefits are often not recommended by doctors, while others that studies have shown to be effective are ignored.
"Rehabilitation conditioning and acupuncture studies have shown to be effective treatments that were less frequently used by patients with chronic neck pain ," explained Goode. Instead, many patients rely on over-the-counter medications like non-steroidal anti-inflammatory drugs (NSAIDS), various other narcotics like oxycodone and codeine.
Another problem is the overuse of imaging tests in assessing neck and back conditions. According to the study, participants received an average of 1.6 diagnostic tests each, which included spinal radiographs, magnetic resonance imaging (MRI), and computed tomography (CT) scans. But these scans appear to do little or nothing for people with persistent pain.
"For patients with such a long disease duration, the likelihood that imaging techniques would offer clinically important inferences may decrease," emphasized Goode. Natural News 29.10.10
Placebo fraud rocks the very foundation of modern medical science; thousands of clinical trials invalidated
We already know about the corruption and unethical practices that are endemic to every step of the pharmaceuticals business. You know all those thousands of clinical trials conducted over the last few decades comparing pharmaceuticals to placebo pills? Well, it turns out all those studies must now be completely thrown out as utterly non-scientific. And why? Because the placebos used in the studies weren't really placebos at all, rendering the studies scientifically invalid and therefore their drugs as unproven.
This is the conclusion from researchers at the University of California who published their findings in the October issue of the Annals of Internal Medicine. They reviewed 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.
Why is this important? Because placebo pills are supposed to be inert. But nothing is inert, it turns out. Even so-called "sugar pills" contain sugar, obviously. And sugar isn't inert. If you're running a clinical trial on diabetics, testing the effectiveness of a diabetes drug versus a placebo then obviously your clinical trial is going to make the diabetes drug look better than placebo if you use sugar pills as your placebo.
Critics say 'drug manufacturers are using placebos which make the drugs been tested look better than they actually are'. Some placebo pills use olive oil which may actually improve heart health. Other placebo pills use partially-hydrogenated oils which harm heart health. Yet only 8 percent of clinical trials bothered to list the placebo ingredients at all!
Stay with me on this placebo issue... because it gets even more bizarre... There are no FDA rules regarding placebos in clinical trials
It turns out there are absolutely no FDA rules regarding the choice or composition of placebos used in clinical trials. Technically, a clinical trial director could use something to
the condition' as placebo and would not even be required to mention such nefarious details in the trial results.
We already know that clinical trials are rife with fraud and 'the widespread practice of 'ghost medicine' means that most studies in the medical literature are marketing dressed up as research'.
Most of the clinical trials used by pharmaceutical companies to win FDA approval of their drugs, for example, are funded by pharmaceutical companies. And it is a verifiable fact that most clinical trials tend to find results that favor the financial interests of whatever organization paid for them. So what's to stop Big Pharma from scheming up the perfect placebo that would harm patients just enough to make their own drugs look good by comparison?
Fact: Placebos are usually provided by the very same company funding the clinical trial! Do you detect any room for fraud in this equation?
How drug companies can fake clinical trials with selected placebo pills
Placebo performance strongly influences whether drugs are approved by the FDA, by the way. As the key piece of information on its regulatory approval decisions, the FDA wants to know whether a drug works better than placebo. That's the primary requirement! If they work even 5% better than placebo, they are said to be "efficacious" (meaning they "work"). This is true even if the placebo was selected and used specifically to make the drug look good by comparison.
You see, if there are no regulations or rules regarding placebo, then none of the placebo-controlled clinical trials are scientifically valid.
It's amazing how medical scientists will get rough and tough when attacking homeopathy, touting how their own medicine is "based on the gold standard of scientific evidence" and yet when it really comes down to it, their scientific evidence is just a jug of quackery mixed with a pinch of wishful thinking and a wisp of pseudoscientific gobbledygook, all framed in the language of scientism by members of the FDA who wouldn't recognize real science if they tripped and fell into a vat full of it.
Big Pharma and the FDA have based their entire system of scientific evidence on a placebo fraud! And if the placebo isn't a placebo, then the scientific evidence isn't scientific.
Oh, but wait. They'll call it science because they wish the placebo to be a placebo. Yep -- the clinical researchers are now psychics, mediums and fortune tellers who simply decree that little pill of olive oil to "be a placebo!" while waving their hands over it in a gesture borrowed from David Copperfield.
James Randi may have never seen a psychic transmute lead into gold, but he's no doubt seen doctors transmute biochemically active substances into totally inert materials merely by wishing them so! It's so amazing! And this brings me to the really interesting "how-to" part of this article...
How to make your own placebo just like clinical researchers do
Are you wondering how to make your own FDA-approved, scientifically validated placebo? It's easier than you think.
Step 1 - Find something shaped like a pill. It could be a pill full of olive oil, white sugar, palm oil, fluoridated water, an agitate, synthetic chemicals or just about anything you can imagine.
Step 2 - Close your eyes and get ready to concentrate.
Step 3 - This is the important part - Repeat out loud five times while turning counter-clockwise, "I am a scientific researcher practicing evidence-based medicine!" You must say this until you really, truly believe it. If you don't believe it strongly enough, the placebo effect will be ruined.
Step 4 - Thrust your palm in the direction of the placebo pills and shout, at the top of your voice, "You are now placebo!" You may feel a shiver of energy coursing through your body. That's the power of placebo reaching out to the pills.
The process is now complete. You may now use these placebo pills in any clinical trial and expect full approval of such use by your colleagues, famous medical journals and FDA regulators. (This is not a joke. This is the state of the art today in conventional medicine).
Hope also has a huge role to place in all this. The more you hope your placebos are really placebos, the better results you'll get. In fact, in reporting on this whole fiasco, the lead researcher of the study uncovering all this, Dr Beatric Golomb, said, "We can only 'hope' that this hasn't seriously systematically affected medical treatment."
But of course it has. (And by the way, no disrespect toward Dr Golomb. She deserves kudos for being willing to tackle this subject which will no doubt make her very unpopular among the cult of Scientism as practiced by conventional medical researchers today.)
How to improve your clinical trial results
For improved results, try to use the most harmful placebo substances you can. For example, in real clinical trials involving AIDS patients -- who tend to be lactose intolerant -- researchers have used pills made of, guess what? Lactose!
That's sort of like running a clinical trial on a cure for heroin addiction and using heroin as the placebo, isn't it? Gee, somehow our drug worked "better than placebo." Funny how that works, isn't it?
And if you still don't get the results you want, just start inventing your own data like other clinical trial researchers do. Remember Dr Scott Reuben? This highly-respected clinical trial researcher faked at least twenty-one clinical trials for Big Pharma (www.naturalnews.com/028194). His fraudulent clinical trials are still being cited to sell prescription medications!
Heck, who needs placebo when you can just invent the data?
Come to think of it, who needs science when you can just use anything you want and call it placebo in the first place?
Conventional medicine operates clinical trials in the same way that banks and securities firms handle mortgage documents. They all just sort of make things up as they go along, committing felony crimes on a daily basis while hoping nobody notices. On that note, check out this amazing story by Greg Hunter called The Perfect No-Prosecution Crime.
Where are the skeptics and pseudoscience quacks when it comes to Big Pharma science fraud? It is also worthy of note that the most fundamental flaw in modern medicine has not been covered in the media, why?
Abstract of the study
Here's some of the text from the abstract of this study published in the Annals of Internal Medicine
What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials
1. Beatrice A. Golomb, MD, PhD;
2. Laura C. Erickson, BS;
3. Sabrina Koperski, BS;
4. Deanna Sack, BS;
5. Murray Enkin, MD; and
6. Jeremy Howick, PhD
Background: No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.
Purpose: To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials.
Data Sources: 4 English-language general and internal medicine journals with high impact factors.
Study Selection: 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009.
Data Extraction: Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus.
Data Synthesis: Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).
Limitation: Journals with high impact factors may not be representative.
Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials. Natural News 29.10.10
Many critics of allopathic drug based medicine were not surprised by the recent disclosures that most studies in the medical literature are marketing dressed up as research. For as many as 90,000 published drug trials, a drug company hired a PR firm—a ‘medical education and communication company' (MECC)—to carry out its clinical trials, engaged a ‘ghost' to write an article with a positive spin, enlisted a prominent academic to put his name to the paper he's had nothing to do with—and then succeeded in getting it published in a peer-reviewed journal.
This widespread practice came to light a few months ago during the discovery process of a class-action lawsuit against drug manufacturer Wyeth by 14,000 women who developed breast cancer after taking HRT. The 1500 documents afford an unprecedented glimpse into the underworld of pharmaceutical marketing. The paper trail reveals how an MECC called DesignWrite, hired by Wyeth, launched a major damage-limitation exercise after a major study demonstrated an unequivocal link between HRT and life-threatening illness.
Wyeth's HRT products had reached annual revenues of $2 billion, but nose-dived by 65 per cent in 2002, when the Women's Health Initiative (WHI) study found that hormone replacement therapy—specifically Wyeth's version—increased the risk of breast cancer, ovarian cancer, stroke and heart disease.
DesignWrite proceeded to flood the professional press with positive reports of Premarin, cast doubt on the WHI, downplayed the cancer-causing potential of HRT and claimed cardiovascular benefits, while promoting unproven uses of HRT such as for preventing dementia.
A few months later, the German Institute for Quality and Efficiency in Health Care, which produces evidence-based consumer-health information, encountered “serious obstacles” in trying to wrest all sponsored published and unpublished studies from Pfizer on its antidepressant reboxetine. Eventually, it emerged that the company had withheld three-quarters of its patient data from unpublished trials. After these hidden data were finally handed over, the Institute concluded that the drug was “overall an ineffective and potentially harmful antidepressant”.
There's no way to determine the full extent of such dirty research, although one review concluded that as much as three-quarters of every journal is ghosted. As Dr Joseph S. Ross of New York 's Mount Sinai School of Medicine put it: “It's almost like steroids and baseball. You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't.”
These disclosures undermine the entire edifice of modern medicine. The BMJ now plans to encourage efforts to “re-evaluate the integrity of the existing base of research evidence”—in other words, virtually the whole of existing medical research needs to be done all over again.
The most insidious aspect of this story is the topic of this month's special report—that the extraordinary disease-fighting power of a simple nutrient like vitamin C has been virtually ignored by the modern medical press. The published medical evidence was promising 70 years ago—long before MECCs were around to tinker with the data. 2.11.10
Also see: Drug Company Used Ghostwriters to Write Work Bylined by Academics, Documents Show
Big Pharma researcher Dr. Scott Reuben, admits to faking dozens of research studies for Pfizer & Merck
It's being called the largest research fraud in medical history. Dr Scott Reuben, a former member of Pfizer's speakers' bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.
Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as "proof" that Celebrex helped reduce pain during post-surgical recovery. There's only one problem with all this: No patients were ever enrolled in the study!
Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.
It wasn't the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.
As a result of Dr. Reuben's faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 "scientific" papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.
After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.
He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years.
Business as usual in Big Pharma
What's notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It's not the fact that so-called "scientific" medical journals published his fabricated studies. It's not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.
The real story here is that this is business as usual in the pharmaceutical industry.
Dr. Reuben's actions really aren't that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.
Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn't operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.
Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben's faked studies even though this journal claims to be a "scientific" medical journal based on peer review. Funny, isn't it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.
Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on "good science." It's all scientific and trustworthy, they claim, while accusing alternative medicine of being "woo woo" wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that's based largely on 'fraudulent research, bribery and corruption'.
You just have to laugh, actually, when you hear pushers of vaccines and pharmaceuticals claim their medicine is "scientific" while natural medicine is "unproven." Sure it's scientific -- about as scientific as the storyline in a Scooby Doo cartoon, or as credible as the medical license of a six-year-old kid who just received a "let's play doctor" gift set for Christmas. Many pharmaceutical researchers would have better careers as writers of fiction novels rather than scientific papers.
For all those people who ignorantly claim that modern pharmaceutical science is based on "scientific evidence," just give them these three words: Doctor Scott Reuben.
Drug companies support fraudulent research
Don't forget that the drug companies openly supported Dr. Scott Reuben's research. They paid him, in fact, to keep on fabricating studies.
The drug companies claim to be innocent in all this, but behind the scenes they had to have known what was going on. Dr. Reuben's research was just too consistently favorable to drug company interests to be scientifically legitimate. If a drug company wanted to "prove" that their drug was good for some new application, all they had to do was ask Dr. Reuben to come up with the research (wink wink). "Here's another fifty thousand dollars to study whether our drug is good for post-surgical pain (wink)."
And before long, Dr. Reuben would magically materialize a brand new study that just happened to "prove" exactly what the sponsoring drug company wanted to prove. Advocates of western medicine claim they don't believe in magic , but when it comes to clinical trials, they actually do: All the results they wish to see just magically appear as long as the right researcher gets paid to materialize the results out of thin air, much like waving a magician's wand and chanting, "Abra cadabra... let there be RESEARCH DATA!"
Shazam! The research data materializes just like that. It all gets written up into a "scientific" paper that also magically gets published in medical journals that fail to ask a single question that might exposed the research fraud.
I guess these people believe in magic after all, huh? Where science is lacking, a little "research magic" conveniently fills the void.
The whole system makes a mockery of real science. It is a system operated by criminals who fabricate whatever "scientific evidence" they need in order to get published in medical journals and win FDA approval for drugs that they fully realize are killing people.
What is "Evidence-Based Medicine?"
The fact that a researcher like Dr. Reuben could so successfully fabricate fraudulent study data, then get it published in peer-reviewed science journals, and get away with it for 13 years sheds all kinds of new light on what's really behind "evidence-based medicine".
The recipe for evidence-based medicine is quite simple: Fabricate the evidence! Get it published in any mainstream medical journal. Then you can quote the fabricated evidence as "fact!"
When pushers of pharmaceuticals and vaccines resort to quoting "evidence-based medicine" as their defense, keep in mind that much of their so-called evidence has been entirely fabricated. When they claim their branch of toxic chemical medicine is based on "real science," what they really mean is that it's based on fraudulent science but they've all secretly agreed to call it "real science." When they claim to have "scientific facts" supporting their position, what they really mean is that those "facts" were fabricated by criminal researchers being paid bribes by the drug companies.
"Evidence-based medicine," it turns out, hardly exists anymore. And even if it does, how do you know which studies are real vs. which ones were fabricated? If a trusted, well-paid researcher can get his falsified papers published for 13 years in top-notch science journals -- without getting caught by his peers -- then what does that say about the credibility of the entire peer-review science paper publishing process?
Here's what is says: "Scientific medicine" is a total fraud.
And this fraud isn't limited to Dr Scott Reuben, either. Remember: he engaged in routine research fraud for 13 years before being caught. There are probably thousands of other scientists engaged in similar research fraud right now who haven't yet been caught in the act. Their fraudulent research papers have no doubt already been published in "scientific" medical journals. They've been quoted in the popular press. They've been relied on by FDA decision makers to approve drugs as "safe and effective" for widespread use.
And yet underneath all this, there's nothing more than fraud and quackery. Sure, there may be some legitimate studies mixed in with all the fraud, but how can we tell the difference?
How are we to trust this system that claims to have a monopoly on scientific truth but in reality is a front for outright scientific fraud?
Keep up the great work, Dr Reuben
Thank you, Dr Scott Reuben, for showing us the truth about the pharmaceutical industry, the research quackery, the laughable "scientific" journals and the bribery and corruption that characterizes the pharmaceutical industry today. You have done more to shed light on the true nature of the drug industry than a thousand articles on NaturalNews.com ever could.
Keep up the good work. After paying your fine and serving a little jail time, I'm sure your services will be in high demand at all the top drug companies that need yet more "scientific" studies to be fabricated and submitted to the medical journals.
You may be a dishonest, disgusting human being to most of the world, but you're a huge asset to the pharmaceutical industry and they need you back! There are more studies that need to be fabricated soon; more false papers that need to be published and more dangerous drugs that need to receive FDA approval. Hurry!
Because if there's one place that extreme dishonesty is richly rewarded, it's in the pharmaceutical industry, where poisons are approved as medicines and fiction is published as the truth. Natural News 18.2.10
Numerous U.S. states sue Big Pharma for Medicaid fraud
Numerous U.S. states have or are in the process of filing lawsuits against drug companies for ripping off their state Medicaid programs, with one of the most recent being Louisiana.
According to a recent Pharmalot report, Louisiana's Attorney General Buddy Caldwell says that 18 drug companies deliberately lied in drug price information filings in order to bilk more money from the system, and he is going after them to recover it.
"This is an egregious abuse of the Medicaid reimbursement system," explained Caldwell in a official statement. "We believe Louisiana has lost hundreds of millions of dollars as a result of these drug companies' fraudulent pricing schemes."
According to the same official statement, Louisiana doled out more than $850 million in taxpayer funds to drug companies to pay for drugs between 1991 and 2009. But a significant portion of this amount was most likely fraudulent because of the billing scheme drug companies utilize to get reimbursed.
The way it works is drug companies report what are called the Average Wholesale Prices (AWPs) for drugs, and are subsequently reimbursed by state Medicaid programs for these amounts. But the lawsuit alleges that drug companies were marking up these costs as high as 6000 percent above actual costs. And since the drug companies themselves declare the AWPs and other wholesale prices, they can literally put whatever amounts they wish, even if those amounts bear no correlation to the actual cost.
In 2008, NaturalNews covered a similar lawsuit in Texas filed by its Attorney General alleging that drug companies had abused the Medicaid system and 24 other states have all been involved in lawsuits against Big Pharma as well. Even the federal government has sued drug companies for reimbursement fraud. Natural News 6.11.10
GlaxoSmithKline whistleblower awarded $96m payout
Whistleblower who exposed contamination problems at Glaxo plant in Puerto Rico receives $96m. A whistleblower who exposed serious contamination problems at GlaxoSmithKline 's (GSK) pharmaceutical manufacturing operations has been awarded $96m (£60m).
Cheryl Eckard's payment is thought to be the biggest ever handed to a US whistleblower. It was awarded after an eight-year fight, which ended yesterday, when GSK agreed to pay the US government $750m to settle civil and criminal charges that it manufactured and sold adulterated drug products.
Speaking outside the federal courthouse in Boston after the award was agreed, Eckard admitted she was "a little emotional". "It's difficult to survive this financially, emotionally, you lose all your friends, because all your friends are people you have at work," she said. "You really do have to understand that it's a very difficult process but very well worth it."
The case centred on a factory in Cidra, Puerto Rico, where GSK made a range of products including an antibiotic ointment for babies, and drugs to treat nausea, depression and diabetes. In August 2002, Eckard, a global quality assurance manager, led a team sent to the plant to investigate manufacturing violations that had been identified by the US Federal Drugs Administration (FDA). Eckard lost her job nine months later after warning that the problems ran deeper than the FDA realised.
Eckard's lawyers, Getnick & Getnick, said she was made redundant against her will in May 2003 after repeatedly complaining to GSK's management that some drugs made at Cidra were being produced in a non-sterile environment, that the factory's water system was contaminated with micro-organisms, and that other medicines were being made in the wrong doses. "Cheryl Eckard is a role model for whistleblowers," said Lesley Ann Skillen, a partner at Getnick.
Carmen Ortiz, US attorney for Massachusetts , said the case should serve as a warning to other pharmaceutical companies. "We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society," Ortiz told a press conference last night.
Eckard tried to alert GSK's management to the situation in Cidra even after she left the company. According to the lawsuit brought by Eckard, she tried to call GSK's chief executive JP Garnier in July 2003, but he declined to speak to her. She took her concerns to the FDA in August 2003 after concluding that GSK's compliance department lacked the authority to address her concerns.
Getnick & Getnick said the case was particularly significant because it was so difficult for patients to spot deficiencies with medicines. "Once the pill is swallowed, it's gone and there may be no way of telling whether someone got sick because the product was bad. As a result of this settlement and guilty plea, drugmakers will now have more reason to live up to their motto that patient safety is their first priority," Skillen said.
The Cidra factory had been GSK's largest manufacturing operation but was closed last year. Drugs made at the plant include Bactroban ointment, a topical antibiotic used to treat skin infections in babies, Kytril, an anti-nausea drug used by cancer patients, anti-depressant treatment Paxil CR and Avandamet, a derivative of the diabetes drug Avandia.
GSK announced in July that it would pay $750m to settle the charges, and the details were finally agreed on Tuesday in Boston. It will pay fines totalling $150m, plus related claims of $600m.
GSK said that it had worked hard to resolve the problems at Cidra, adding that it has not received any warnings from the FDA since 2002. "We regret that we operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice requirements and with GSK's commitment to manufacturing quality," said PD Villarreal, GSK's senior vice-president and head of global litigation.
Eckard's lawsuit was filed under the False Claims Act, legislation that dates back to the days of Abraham Lincoln. It is designed to allow private citizens with knowledge of fraud on the government to sue and share in the proceeds of the recovery. Read Cheryl Eckard's lawsuit in full. 27.10.10
Chemical cosh drugs to be cut by two thirds
Ministers have pledged to cut the number of chemical cosh drugs prescribed to people with dementia by two thirds within a year. Currently, more than 140,000 people with dementia are given antipsychotics in order to keep them quiet.
However research has shown the drugs, which have no benefits in dementia, double the chance of death. It is estimated 1,800 people die early because of the drugs.
At a conference in London , Paul Burstow, health minister, pledged to cut prescriptions of the drugs by two thirds by November next year. The Department of Health has signed up to a new Dementia Action Alliance, along with 44 other organisations, each making their own pledges.
Ruth Sutherland, Acting Chief Executive of the Alzheimer's Society, said: “Nearly 150,000 people with dementia are currently having their lives put at risk because of dangerous antipsychotic medication. “A large scale reduction in the scandalous levels of inappropriate prescription cannot come soon enough and we are delighted to see the government back up its previous assurances by setting a firm deadline. “These drugs have been found to double the risk of death and treble the risk of stroke so ensuring this commitment is met is essential.”
The Alzheimer's Society released a list of questions that dementia patients and their families should ask care home staff, their GP or psychiatric nurse.
The questions are:
- What is the treatment being prescribed for and are the drugs appropriate for this?
- What are the benefits and risks of the treatment?
- How long has the person with dementia already been on the treatment (It should be no longer than 12 weeks)
- What are the alternative non drug and drug treatments?
- Why isn't the person with dementia receiving access to these alternatives?
- Does the person have capacity to give informed consent to continue treatment?
- If the treatment is continued and the person does not have capacity, will there be a best interest meeting to fully discuss all of the options?
- How long will the person with dementia remain on the treatment for and what are the arrangements for monitoring and reviewing the medication? 27.10.10
Patients' anger after they are unable to opt out of swine flu vaccine despite fears of side effects
Patients' groups have expressed anger over this year's seasonal flu jab programme because people are unable to opt out of having the swine flu vaccine. The H1N1 vaccine will be the dominant of three flu strains included in the shot, meaning millions of elderly and vulnerable patients will get it automatically. Yet many people refused to have the swine flu vaccine when it was offered last year because of fears it may cause serious side effects.
The Mail on Sunday revealed last week that Government experts are examining a possible association between the H1N1 swine flu jab and the paralysing nerve disease Guillain-Barre Syndrome. The vaccine has also been linked to fevers in young children, temporary paralysis and narcolepsy.
Katherine Murphy, chief executive of the Patients Association, said: 'We are very disappointed that patients are not being given the opportunity to choose for themselves whether they wish to take the swine flu vaccine as part of their winter flu vaccine. 'Some may not want the swine flu vaccine and this may mean they would also miss out on their winter flu jab. This seems to go completely against the new initiative from the Government which states that in the NHS there will be "No decision about me without me" for patients and that there will be a large emphasis on patient choice. There does not seem to be any patient choice involved here – either patients have both vaccines or no vaccine.'
Each year the World Health Organisation considers which strains of flu will be dominant in winter. This year they ruled H1N1 would be a dominant strain but some critics wonder whether their assessment is impartial.
The annual seasonal flu jab is being offered to about 12 million people. For the first time, pregnant women are included because of the dangers posed by the swine flu virus. However, some patients are fearful of having this year's jab. Mary Harris, 64, from Plymouth, developed breathing problems and spent three days in hospital after having the swine flu vaccine last year. She said: 'I don't know whether to have the seasonal flu jab, even though I know I should. But I don't want a repeat of last year. There really should be a choice.'
The Medicines and Healthcare products Regulatory Agency received nearly 8,600 suspected adverse reactions to the swine flu jab during the pandemic last winter. Most involved pain or swelling at the site of the jab, vomiting and headaches. The MHRA also received 15 reports of patients developing Guillain-Barre Syndrome. It is not known if the cases are linked to the vaccine, although a swine flu jab in the US in 1976 led to 25 deaths from the condition.
The British Medical Association agreed last month that patients should be told the seasonal jab contains the swine flu strain. Dr Peter Holden of the BMA said: 'This is not a Machiavellian plot to vaccinate everyone against swine flu. There isn't enough capacity to produce an alternative vaccine for those worried about swine flu. 'The consequences of flu are a greater risk than any risk posed by the vaccine itself.'
Professor David Salisbury of the Department of Health said: 'Given that we expect the H1N1 virus to be the most common type this year, it would be negligent if we didn't protect people against it. Every year people die in this country from complications caused by getting flu; these are deaths that could be prevented. 'I would encourage anyone who is offered the seasonal flu vaccine to accept it.' 23.10.10
Labours centralised targets means 10,000 hip replacement patients told their operations may need to be reversed after receiving faulty implants as no one measured ‘outcomes’
As long as the targets were achieved no one was checking the quality of the work or measuring patient outcomes. Now pharmaceutical giant Johnson & Johnson is facing a multi-million-pound legal claim after thousands of British patients were told that their hip replacement operations will need to be reversed.
Many patients have been in excruciating pain – with some unable to walk – since having the operation, and now some of those affected are preparing a class action against Johnson & Johnson's orthopaedic branch, DePuy, in a case which could cost the company £350million.
More than 10,000 patients have been recalled to hospital to have their operations reviewed because components used to cushion and fix the artificial joint were causing tumours and depositing toxic metal in the blood.
Patients receiving the faulty ASR hip implant have experienced agonising pain as the metal fittings have worn away, releasing the metals chromium and cobalt into the blood, and causing inflammation and benign tumours to form. Experts said that although the metals are naturally present within the body, tests showed some patients who had received a DePuy implant had levels which were 100 times higher than normal.
In scientific tests, the metals have been linked with cancer, and more than a 1,000 people have had their operations reversed to rid their bodies of the faulty hip replacements. A letter of claim will be sent to DePuy within weeks, according to solicitors Leigh Day & Co, who are representing 78 patients in a group action against the company. Of those, 34 have already undergone painful revision surgery to remove the implant.
Six are awaiting surgery and 38 are having their cases assessed. The total compensation being claimed is £3.5million but, should the case be successful and more patients come forward, the cost to DePuy and Johnson & Johnson could reach £350million given the number of patients affected.
Leigh Day & Co solicitor Bozena Michalowska Howells said: 'We will be sending a letter of claim to DePuy and have instructed top experts. Our clients will claim for compensation for pain and suffering, loss of earnings and other financial losses. 'They will also be looking for compensation for care, the cost of operations and of any additional operations they will need. It's a very strong case. We hope DePuy will settle and it will not go to trial.
This was an accident waiting to happen.' DePuy manufactures and supplies medical implants such as hip and knee joints. The faulty implant, known as an ASR device, was introduced to the UK in July 2003. It was one of a new generation of hip implants made from metal alone, rather than metal and plastic, and was supposed to last longer and prevent patients from losing too much tissue and bone when it was inserted.
However, surgeons began reporting problems with the implant in 2007 when patients started returning to hospitals in pain. A research team at Newcastle University, headed by bioengineer Dr Tom Joyce, found that the metal surfaces wore away, releasing tiny particles of chromium and cobalt into the body. These were then absorbed into the bloodstream and surrounding tissues, causing inflammation, bone and tissue damage around the pelvis and, in severe cases, blood poisoning and benign tumours.
DePuy was alerted to the problems but only announced it was recalling the implants in August. Dr Tom Joyce said: 'These devices were supposed to reduce the wear, and increase the longevity of the joint. What has happened is the opposite. Surfaces that should have shown a perfect mirror finish were becoming very rough and the levels of metals in the blood of patients were high, in some cases 100 times higher than normal.
'Revision surgery for all implants costs the NHS a quarter of a billion a year – so these revisions for the DePuy implant will be costing the taxpayer millions.' This is not the first time DePuy products have been recalled. Leigh Day & Co acted for another group affected by Hylamer hip and shoulder implants, and last summer a knee component was withdrawn because it leaked aluminium.
A spokeswoman for the Department of Health's Medicines and Healthcare products Regulatory Agency said it was monitoring the safety of the ASR implants and in some cases recommended doctors to test for levels of metal in the blood. A spokeswoman for DePuy said: 'We understand patients may be concerned by this recall. Additional testing and treatment may be necessary to ensure patients' hip implants are functioning well. 'DePuy will cover the costs of testing and treatment including revision surgery if it is necessary.' 23.10.10
Codeine painkillers may be 'unsafe, addictive and ineffective'
Experts are calling for a review on the use of codeine in any medication – and even a possible ban – following growing concern over its safety. They say that over-the-counter painkillers and cough mixtures containing codeine used by millions may be unsafe, addictive, ineffective, and should not be used by children.
Some 27million packs of codeine-containing painkillers are sold over the counter each year in the UK alone, with brands including Nurofen Plus, Solpadeine Max, Panadol Ultra and Syndol. Codeine is a narcotic which makes users feel relaxed. Tens of thousands are thought to be hooked on over-the-counter medication containing it, with some taking 70 tablets a day.
Many of the safety concerns surround the unpredictability of the way the body handles codeine, which has no effect on pain until it is broken down by the liver to produce morphine. Some people will produce little morphine and also get little pain relief.
But others will make large amounts of morphine, putting them at risk of overdose, with children particularly vulnerable.
In a recent warning, the Government's Medicines and Healthcare products Regulatory Agency (MHRA) ruled that the risks of codeine-based cough syrups outweigh the benefits for under-18s and their use should be confined to adults.
The drug safety watchdog said there was ‘little evidence' the codeine in mixtures such as Evacode Paediatric Linctus, Galcodine Linctus Paediatric and Terpin & Codeine Linctus, relieves coughs in children and warned that it can cause side-effects from nausea and vomiting to fits, hallucinations and abnormal heart rhythms.
Doctors writing in the recent Canadian Medical Journal have intensified pressure for the drug to be banned completely. An editorial says: ‘Because codeine has been in common use for over 200 years, it was never subjected to the regulatory requirement for the rigorous safety studies that are mandatory for new drugs. ‘Many genetic factors have recently been identified that can substantially influence the rate of metabolism of codeine to morphine and, consequently, its effects.
‘All of these genetic variations can have potentially serious clinical consequences. The wrong combination can result in toxic doses of morphine, even at conventional doses of codeine. ‘For infants and young children in particular, this can be deadly.'
Concerns about codeine have led to warnings about addiction being added to packaging but campaigners believe more could be done. Davie Grieve, of help group Over-Count, estimates that 30,000 Britons, mainly women, are addicted to the drugs, with many bulk-buying on the internet.
The Proprietary Association of Great Britain (PAGB), the trade body for over-the-counter medicine manufacturers, said the safety of medicines was ‘paramount.' Chief executive Sheila Kelly said a recent review of over-the-counter medicines containing codeine concluded that used properly they were ‘very effective and acceptably safe medicines'. 23.10.10
Docs on Pharma Payroll Have Blemished Records, Limited Credentials
The Ohio medical board concluded that pain physician William D. Leak had performed “unnecessary” nerve tests on 20 patients and subjected some to “an excessive number of invasive procedures,” including injections of agents that destroy nerve tissue. Yet the finding, posted on the board's public website, didn't prevent Eli Lilly and Co. from using him as a promotional speaker and adviser. The company has paid him $85,450 since 2009.
In 2001, the U.S. Food and Drug Administration ordered Pennsylvania doctor James I. McMillen to stop “false or misleading” promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses. Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs.
And in Georgia , a state appeals court in 2004 upheld a hospital's decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He'd also been accused of exposing women's breasts during medical procedures. When confronted by a hospital official, Taylor said, “Maybe I am a pervert, I honestly don't know,” according to the appellate court ruling.
Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June. Leak, McMillen and Taylor are part of the pharmaceutical industry's white-coat sales force, doctors paid to promote brand-name drugs to their peers — and if they're convincing enough, get more physicians to prescribe them.
Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of their drugs. But an investigation by ProPublica uncovered hundreds of doctors on company payrolls who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.
This story is the first of several planned by ProPublica examining the high-stakes pursuit of the nation's physicians and their prescription pads. The implications are great for patients, who in the past have been exposed to such heavily marketed drugs as the painkiller Bextra and the diabetes drug Avandia — billion-dollar blockbusters until dangerous side effects emerged.
"Without question the public should care," said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry's influence on physicians. "You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn't displayed good judgment in the past?"
To vet the industry's handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. In addition to Lilly and Cephalon, the companies include AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck & Co. and Pfizer.
Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.
That is something not all companies do.
A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.
More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don't post these actions on their web sites.
In interviews and written statements, five of the seven companies acknowledged that they don't routinely check state board websites for discipline against doctors. Instead, they rely on self-reporting and checks of federal databases. Only Johnson & Johnson and Cephalon said they review the state sites.
ProPublica found 88 Lilly speakers who have been sanctioned and four more who had received FDA warnings. Reporters asked Lilly about several of those, including Leak and McMillen. A spokesman said the company was unaware of the cases and is now investigating them. “They are representatives of the company,” said Dr. Jack Harris, vice president of Lilly's U.S. medical division. “It would be very concerning that one of our speakers was someone who had these other things going on.”
Leak, the pain doctor, and his attorney did not respond to multiple messages. The Ohio medical board voted to revoke Leak's license in 2008. It remains active as he appeals in court, arguing that the evidence against him was old, the witnesses unreliable and the sentence too harsh. In an interview, McMillen denied nearly all of the allegations in the FDA letter and blamed his troubles on a rival firm whose drug he had criticized in his presentations. “I'm more cautious now than I ever was,” said McMillen, who said he also does research. “That's why I think a lot of the companies use me. I'm not taking any risks.”
Taylor said that the allegations against him were “old news” from the 1990s and that regulators had not sanctioned him. “It had nothing to do with my skills as a physician,” said Taylor , noting that he speaks every other week around the country and sometimes abroad. “Even my biggest detractors in that situation lauded my skills as a physician. That's what's most important.”
Disclosures are just the start
Payments to doctors for promotional work are not illegal and can be beneficial. Strong relationships between pharmaceutical companies and physicians are critical to developing new and better treatments.
There is much debate, however, about whether paying doctors to market drugs can inappropriately influence what they prescribe. Studies have shown that even small gifts and payments affect physician attitudes. Such issues have become flashpoints in recent years both in courtrooms and in Congress.
All told, 384 of the approximately 17,700 individuals in ProPublica's database earned more than $100,000 for their promotional and consulting work on behalf of one or more of the seven companies in 2009 and 2010. Nearly all were physicians, but a handful of pharmacists, nurse practitioners and dietitians also made the list. Forty-three physicians made more than $200,000 — including two who topped $300,000.
Physicians also received money from some of the 70-plus drug companies that have not disclosed their payments. Some of those interviewed could not recall all the companies that paid them, and certainly not how much they made. By 2013, the health care reform law requires all drug companies to report this information to the federal government, which will post it on the Web.
The busiest — and best compensated — doctors gave dozens of speeches a year, according to the data and interviews. The work can mean a significant salary boost — enough for the kids' college tuition, a nicer home, a better vacation. Among the top-paid speakers, some had impressive resumes, clearly demonstrating their expertise as researchers or specialists. But others did not –contrary to the standards the companies say they follow.
Forty five who earned in excess of $100,000 did not have board certification in any specialty, suggesting they had not completed advanced training and passed a comprehensive exam. Some of those doctors and others also lacked published research, academic appointments or leadership roles in professional societies.
Experts say the fact that some companies are disclosing their payments is merely a start. The disclosures do not fully explain what the doctors do for the money — and what the companies get in return.
In a raft of federal whistleblower lawsuits, former employees and the government contend that the firms have used fees as rewards for high-prescribing physicians. The companies have each paid hundreds of millions or more to settle the suits.
The disclosures also leave unanswered what impact these payments have on patients or the health care system as a whole. Are dinner talks prompting doctors to prescribe risky drugs when there are safer alternatives? Or are effective generics overlooked in favor of pricey brand-name drugs?
"The pressure is enormous. The investment in these drugs is massive,” said Dr. David A. Kessler, who formerly served as both FDA commissioner and dean of the University of California , San Francisco School of Medicine. “Are any of us surprised they're trying to maximize their markets in almost any way they can?”
From drug reps to doc reps
For years, drug companies bombarded doctors with pens, rulers, sticky notes, even stuffed animals emblazoned with the names of the latest remedies for acid reflux, hypertension or erectile dysfunction. They wooed physicians with fancy dinners, resort vacations and personalized stethoscopes.
Concerns that this pharma-funded bounty amounted to bribery led the industry to ban most gifts voluntarily. Some hospitals and physicians also banned the gift-givers: the legions of drug sales reps who once freely roamed their halls. So the industry has relied more heavily on the people trusted most by doctors — their peers. Today, tens of thousands of U.S. physicians are paid to spread the word about pharma's favored pills and to advise the companies about research and marketing.
Recruited and trained by the drug companies, the physicians — accompanied by drug reps — give talks to doctors over small dinners, lecture during hospital teaching sessions and chat over the Internet. They typically must adhere to company slides and talking points.
These presentations fill an educational gap, especially for geographically isolated primary care doctors charged with treating everything from lung conditions to migraines. For these doctors, poring over a stack of journal articles on the latest treatments may be unrealistic. A pharma-sponsored dinner may be their only exposure to new drugs that are safer and more effective.
Oklahoma pulmonologist James Seebass, for example, earned $218,800 from Glaxo in 2009 and 2010 for lecturing about respiratory diseases “in the boonies,” he said. On a recent trip, he said, he drove to “a little bar 40 miles from Odessa ,” Texas , where physicians and nurse practitioners had come 50 to 60 miles to hear him. Seebass, the former chair of internal medicine at Oklahoma State University College of Osteopathic Medicine, said such talks are “a calling,” and he is booking them for 2011.
The fees paid to speakers are fair compensation for their time away from their practices, and for travel and preparation as well as lecturing, the companies say.
Dr. Samuel Dagogo-Jack has a resume that would burnish any company's sales force: He is chief of the division of endocrinology, diabetes and metabolism at the University of Tennessee Health Science Center. Dagogo-Jack conducts research funded by the National Institutes of Health, has edited medical journals and continues to see patients.
While most people are going home to dinner with their families, he said, he is leaving to hop on a plane to bring news of fresh diabetes treatments to non-specialist physicians “in the trenches” who see the vast majority of cases. Since 2009, Dagogo-Jack has been paid at least $257,000 by Glaxo, Lilly and Merck.
“If you actually prorate that by the hours put in, it is barely more than minimum wage,” he said. (A person earning the federal minimum wage of $7.25 would have to work 24 hours a day, seven days a week for more than four years to earn Dagogo-Jack's fees.)
For the pharmaceutical companies, one effective speaker may not only teach dozens of physicians how to better recognize a condition, but sell them on a drug to treat it. The success of one drug can mean hundreds of millions in profits, or more. Last year, prescription drugs sales in the United States topped $300 billion, according to IMS Health, a healthcare information and consulting company.
Glaxo's drug to treat enlarged prostates, Avodart — locked in a battle with a more popular competitor — is the topic of more lectures than any of the firm's other drugs, a company spokeswoman said. Glaxo's promotional push has helped quadruple Avodart's revenue to $559 million in five years and double its market share, according to IMS. Favored speakers like St. Louis pain doctor Anthony Guarino earn $1,500 to $2,000 for a local dinner talk to a group of physicians.
Guarino, who made $243,457 from Cephalon, Lilly and Johnson & Johnson since 2009, considers himself a valued communicator. A big part of his job, he said, is educating the generalists, family practitioners and internists about diseases like fibromyalgia, which causes chronic, widespread pain — and to let them know that Lilly has a drug to treat it.
“Somebody like myself may be able to give a better understanding of how to recognize it,” Guarino said. Then, he offers them a solution: “And by the way, there is a product that has an on-label indication for treating it.''
Guarino said he is worth the fees pharma pays him on top of his salary as director of a pain clinic affiliated with Washington University. Guarino likened his standing in the pharma industry to that of St. Louis Cardinals first baseman Albert Pujols, named baseball player of the decade last year by Sports Illustrated. Both earn what the market will bear, he said: “I know I get paid really well.”
Is anyone checking out there?
Simple searches of government websites turned up disciplinary actions against many pharma speakers in ProPublica's database.
The Medical Board of California filed a public accusation against psychiatrist Karin Hastik in 2008 and placed her on five years' probation in May for gross negligence in her care of a patient. A monitor must observe her practice.
Kentucky's medical board placed Dr. Van Breeding on probation from 2005 to 2008. In a stipulation filed with the board, Breeding admits unethical and unprofessional conduct. Reviewing 23 patient records, a consultant found Breeding often that gave addictive pain killers without clear justification. He also voluntarily relinquished his Florida license.
New York's medical board put Dr. Tulio Ortega on two years' probation in 2008 after he pleaded no contest to falsifying records to show he had treated four patients when he had not. Louisiana's medical board, acting on the New York discipline, also put him on probation this year.
Yet during 2009 and 2010, Hastik made $168,658 from Lilly, Glaxo and AstraZeneca. Ortega was paid $110,928 from Lilly and AstraZeneca. Breeding took in $37,497 from four of the firms. Hastik declined to comment, and Breeding and Ortega did not respond to messages.
Their disciplinary records raise questions about the companies' vigilance. “Did they not do background checks on these people? Why did they pick them?” said Lisa Bero, a pharmacy professor at University of California, San Francisco who has extensively studied conflicts of interest in medicine and research.
Disciplinary actions, Bero said, reflect on a physician's credibility and willingness to cross ethical boundaries. "If they did things in their background that are questionable, what about the information they're giving me now?” she said.
ProPublica found sanctions ranging from relatively minor misdeeds such as failing to complete medical education courses to the negligent treatment of multiple patients. Some happened long ago; some are ongoing. The sanctioned doctors were paid anywhere from $100 to more than $140,000.
Several doctors were disciplined for misconduct involving drugs made by the companies that paid them to speak. In 2009, Michigan regulators accused one rheumatologist of forging a colleague's name to get prescriptions for Viagra and Cialis. Last year, the doctor was paid $17,721 as a speaker for Pfizer, Viagra's maker.
A California doctor who was paid $950 this year to speak for AstraZeneca was placed on five years' probation by regulators in 2009 after having a breakdown, threatening suicide and spending time in a psychiatric hospital after police used a Taser on him. He said he'd been self-treating with samples of AstraZeneca's anti-psychotic drug Seroquel, medical board records show.
Other paid speakers had been disciplined by their employers or warned by the federal government. At least 15 doctors lost staff privileges at various hospitals, including one New Jersey doctor who had been suspended twice for patient care lapses and inappropriate behavior. Other doctors received FDA warning letters for research misconduct such as failing to get informed consent from patients.
Pharma companies say they rely primarily on a federal database listing those whose behavior in some way disqualifies them from participating in Medicare. This database, however, is notoriously incomplete. The industry's primary trade group says its voluntary code of conduct is silent about what, if any, behavior should disqualify physician speakers.
“We look at it from the affirmative — things that would qualify physicians,” said Diane Bieri, general counsel and executive vice president of the Pharmaceutical Research and Manufacturers of America.
Some physicians with disciplinary records say their past misdeeds do not reflect on their ability to educate their peers.
Family medicine physician Jeffrey Unger was put on probation by California's medical board in 1999 after he misdiagnosed a woman's breast cancer for 2½ years. She received treatment too late to save her life. In 2000, the Nevada medical board revoked Unger's license for not disclosing California's action.
As a result, Unger said, he decided to slow down and start listening to his patients. Since then, he said, he has written more than 130 peer-reviewed articles and book chapters on diabetes, mental illness and pain management. “I think I've more than accomplished what I've needed to make this all right,” he said. During 2009 and the first quarter of 2010, Lilly paid Unger $87,830. He said he also is a paid speaker for Novo Nordisk and Roche, two companies that have not disclosed payments.
The drug firms, Unger said, “apparently looked beyond the record.”
Companies make their own experts
Last summer, as drug giant Glaxo battled efforts to yank its blockbuster diabetes drug Avandia from the market, Nashville cardiologist Hal Roseman worked the front lines.
At an FDA hearing, he borrowed David Letterman's shtick to deliver a “Top Five” list of reasons to keep the drug on the market despite evidence it caused heart problems. He faced off against a renowned Yale cardiologist and Avandia critic on the PBS NewsHour, arguing that the drug's risks had been overblown.
“I still feel very convinced in the drug,” Roseman said with relaxed confidence. The FDA severely restricted access to the drug last month citing its risks. Roseman is not a researcher with published peer-reviewed studies to his name. Nor is he on the staff of a top academic medical center or in a leadership role among his colleagues.
Roseman's public profile comes from his work as one of Glaxo's highest-paid speakers. In 2009 and 2010, he earned $223,250 from the firm — in addition to payouts from other companies. Pharma companies often say their physician salesmen are chosen for their expertise. Glaxo, for example, said it selects “highly qualified experts in their field, well-respected by their peers and, in the case of speakers, good presenters.”
ProPublica found that some top speakers are experts mainly because the companies have deemed them such. Several acknowledge that they are regularly called upon because they are willing to speak when, where and how the companies need them to. “It's sort of like American Idol,” said sociologist Susan Chimonas, who studies doctor-pharma relationships at the Institute on Medicine as a Profession in New York City.
“Nobody will have necessarily heard of you before — but after you've been around the country speaking 100 times a year, people will begin to know your name and think, ‘This guy is important.' It creates an opinion leader who wasn't necessarily an expert before.” To check the qualifications of top-paid doctors, reporters searched for medical research, academic appointments and professional society involvement. They also interviewed national leaders in the physicians' specialties.
In numerous cases, little information turned up.
Las Vegas endocrinologist Firhaad Ismail, for example, is the top earner in the database, making $303,558, yet only his schooling and mostly 20-year-old research articles could be found. An online brochure for a presentation he gave earlier this month listed him as chief of endocrinology at a local hospital, but an official there said he hasn't held that title since 2008.
And several leading pain experts said they'd never heard of Santa Monica pain doctor Gerald Sacks, who was paid $249,822 since 2009.
Neither physician returned multiple calls and letters.
A recently unsealed whistleblower lawsuit against Novartis, the nation's sixth-largest drug maker by sales, alleges that many speakers were chosen “on their prescription potential rather than their true credentials.” Speakers were used and paid as long as they kept their prescription levels up, even though “several speakers had difficulty with English,” according to the amended complaint filed this year in federal court in Philadelphia.
Some physicians were paid for speaking to one another, the lawsuit alleged. Several family practice doctors in Peoria, Ill., “had two programs every week at the same restaurant with the same group of physicians as the audience attendees.”
In September, Novartis agreed to pay the government $422.5 million to resolve civil and criminal allegations in this case and others. The company has said it fixed its practices and now complies with government rules.
Roseman, who has been a pharma speaker for about a decade, acknowledged that his expertise comes by way of the training provided by the companies that pay him. But he says that makes him the best prepared to speak about their products, which he prescribes for his own patients. Asked about Roseman's credentials, a Glaxo spokeswoman said he is an “appropriate” speaker.
Getting paid to speak “doesn't mean that your views have necessarily been tainted,” he said.
Plus pharma needs talent, Roseman said. Top-tier universities such as Harvard have begun banning their staffs from accepting pharma money for speaking, he said. “It irritates me that the debate over bias comes down to a litmus test of money,” Roseman said. “The amount of knowledge that I have is in some regards to be valued.” 22.10.10
More drug companies exposed for paying off doctors to illegally prescribe drugs
A new report conducted by ProPublica, Consumer Reports , and National Public Radio (NPR) digs even deeper down the rabbit hole of drug company fraud, exposing rampant off-label prescribing, drug company-funded speaking engagements, and illegal monetary and gift compensation programs -- all designed to push as many drugs on the public as possible.
According to the report, the drug industry has spent roughly $7 billion in the past three years to pay out settlements for such practices, many of which were brought forth by former drug company sales representatives that witnessed the activity. According to these whistle-blowers, drug companies routinely break the law to increase drug sales, even after they have signed compliance agreements promising to follow the law.
After the U.S. Food and Drug Administration (FDA) approves a drug for a specific use, drug companies often lavish doctors with gifts, fancy dinners, extravagant vacations, and cash to prescribe the drugs for other, non-approved uses. Big Pharma even uses doctors to tell other doctors to do the same thing, often hiring them to speak at seminars.
Angela Maher, a former sales representative for Ortho-McNeil Pharmaceutical, alleged in a lawsuit that the drug giant pushed an anti-seizure drug for 27 different off-label uses. She observed drug company executives paying off physicians to speak glowingly about the drug at conferences. And if the doctors failed to speak often enough about the drug during their speeches, they were nixed from future participation. Ortho-McNeil recently pleaded guilty to misdemeanor charges and settled for $81 million.
Forest Laboratories recently pleaded guilty to felony and misdemeanor charges as well for paying physicians to allow company sales representatives to observe their practices and push them to prescribe Celexa and Lexapro, two antidepressant drugs. Company representatives also continued to pay doctors for prescribing the drugs, as long as increases in sales were enough to make it worthwhile.
Other companies implicated in similar activity include Wyeth Pharmaceuticals, which is now owned by Pfizer, Allergan, maker of Botox, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, and Merck. 21.10.10
To read the entire report, visit: http://www.propublica.org/article/l...
Government promises patients ‘more choice and a louder voice'
The government has launched two new consultations on its proposals for better patient choice and information, designed to give people more control over their own healthcare as per the white paper Equity and excellence: Liberating the NHS .
Under its plans to increase patient choice, the Department of Health is proposing to open up the field by enabling people to choose services from any willing provider, including for diagnosis and treatment, thereby instilling a greater element of competition throughout the National Health Service.
In addition, maternity choice will be extended to include pre-conception, antenatal, and postnatal care, patients will be able to pick their own mental health service providers, and choices for end of life care are also to be improved, the government said.
According to Health Secretary Andrew Lansley, the NHS must embed the patient motto ‘no decision about me, without me' into practice. “Patients should have choice at every stage of the journey – where they register with a GP, where they go for tests, who they see for treatment, and what care or treatment they receive from any willing provider [and], above all, they should be able to change these choices at any stage,” he stressed.
But the principle of ‘no decision about me without me' is reliant on sound information and a culture that enables patients to use it effectively, which, in turn, depends upon accurate and up-to-date health and care records that form the basis of information systems for both patients and service users, the government explained.
To this end, its second consultation lays out plans for an “information revolution” that aims to help NHS patients make better-informed decisions on their own healthcare and give them more control over their care records.
A different culture
Critical to achieving this ‘revolution' is transforming the way information is collected, analysed and used by the NHS and adult social care services and, in line with this, the government has promised to move away from information belonging to the system, away from top-down information collection, and away from a culture in which information has been held close and recorded in forms that are difficult to compare.
In addition, the government will step away from being the main provider of information on service quality to enable a range of separate organisations to offer such data to a variety of audiences, it said.
“The information we have changes our perspective and influences the decisions we make each and every day. The time has come to apply these principles to the delivery of health and care services,” noted Director General for Informatics Christine Connelly. “Building from a base of accurate care records the Information Revolution will deliver more informed patients, more engaged professionals, more efficient organisations and, ultimately, improved outcomes”. The consultations close on January 14 - 2011.
Eczema cream meant to soothe 'makes skin WORSE'
For years people with eczema have been advised by doctors to use a cheap emollient cream to soothe their irritated skin. But researchers have now discovered that aqueous cream BP can make the condition worse. Tests show a detergent contained in the cream thins the skin and actually causes irritation.
Although aqueous cream has been prescribed for millions of sufferers from childhood, it is the first time research has been carried out on an ingredient called sodium lauryl sulphate (SLS). Previously it was thought the ‘stinging' sensation affecting half of users was due to a preservative or antiseptic in the cream.
In a study by Bath University researchers, aqueous cream reduced the thickness of healthy skin in volunteers by more than 10 per cent in just four weeks and water loss was increased. Professor Richard Guy, professor of pharmaceutical sciences at Bath , said the remedy was likely to aggravate the dry, itchy rashes that plague eczema sufferers.
He said: ‘The skin has a protective barrier layer of lipids, around one eighth the thickness of a sheet of paper, that stops chemicals from getting into the body and keeps moisture in. ‘SLS is a detergent used to mix oils into water-based moisturisation creams to give a nice creamy texture. It's also used widely in shower gels and other cosmetics.
'Our study has found that rubbing aqueous cream containing SLS into the skin thins this protective barrier, making the skin more susceptible to irritation by chemicals. So to use this cream on eczemous skin, which is already thin and vulnerable to irritation, is likely to make the condition even worse.'
The study was published in the British Journal of Dermatology. Aqueous cream is the most widely prescribed moisturiser for dry skin conditions.
It costs the NHS £1.86 for a 500g tub and is also available from pharmacies. The principal ingredients are liquid paraffin, white soft paraffin and purified water. Other ingredients may vary, but some have irritant effects including the preservative chlorocresol and the antimicrobial phenoxyethanol.
Margaret Cox, of the National Eczema Society, said the charity did not recommend aqueous cream as a moisturiser. Almost four million Britons have eczema, which is mainly treated with steroid creams. 19.10.10
Yoga 'provides pain relief for chronic muscle ache'
Patients with a common condition that causes pain throughout the body could ease their symptoms by practising yoga, a study has found. Fibromyalgia (FM) is a disorder causing widespread musculoskeletal pain and fatigue that is thought to affect nearly two million adults in the UK.
Patients struggle with aching muscles and drug therapies are only around 30 per cent effective in relieving symptoms.
A team from Oregon Health & Science University studied whether patients taking a 'Yoga Awareness' programme alongside their standard treatment showed more improvement compared to a control group of sufferers. Study leader Dr James Carson, said: 'Although yoga has been practiced for millennia, only recently have researchers begun to demonstrate yoga's effects on people suffering from persistent pain.'
The researchers conducted an all-woman study because 80 per cent of FM patients are women. While 25 participated in the Yoga of Awareness program, 28 received standard care. The yoga was tailored to address pain, fatigue, sleep disturbance, and emotional distress in FM. Each class included gentle stretching poses, mindfulness meditation and breathing techniques.
Both groups were then assessed for fibromyalgia symptoms alongside physical tests. Following treatment, women assigned to the yoga program showed far greater improvements in their symptoms and general mood.
Dr Carson said: 'The findings of this pilot study provide promising preliminary support for the beneficial effects of yoga in patients with FM.' He added: 'The results suggested the yoga intervention led to a beneficial shift in how patients cope with pain, including greater use of adaptive pain coping strategies such as positive reappraisal.'
The study was published in the November issues of the journal Pain. 16.10.10
Poor GP commissioners should lose their contracts, says health chief
GP commissioners should lose their contracts with the NHS if they fail to manage their practice budget, a primary care trust chief has claimed. The proposed healthcare reforms will fail unless GPs are legally responsible for practice budgets, argues a senior doctor in an opinion piece published in this week's BMJ .
Dr Danny Ruta, Joint Director of Public Health at Lewisham Primary Care Trust in London, believes that the real aim of Equity and Excellence: Liberating the NHS , is “to force doctors, once and for all, to consider the opportunity costs of their day to day clinical decisions,” and that this has been the unstated aim of every major health policy initiative since the mid-1970s.
“Only by getting doctors to acknowledge that NHS resources are scarce, that every clinical decision has an opportunity cost, and that they should take financial responsibility for a finite envelope of resources can we shape a state funded healthcare system that reflects the health needs of the population rather than the interests of doctors, primarily hospital doctors, who have always wielded most of the power in the NHS,” he writes.
This White Paper is finally trying to solve the problem at the heart of the NHS by shifting the power from hospital consultants to GPs, he suggests. In effect the white paper's proposals “force the group of doctors whose interests are arguably most closely aligned with the needs of the population to consider the opportunity cost of their clinical decisions so that they can maximise health gain for that population and reduce health inequalities with the resources available to them,” he adds.
He believes that this most radical policy intervention may succeed where all others have failed, but warns that “if the GPs in a consortium fail to manage their practice budget … they must lose their contract with the NHS.”
Competition between consortia “could promote efficiency and deliver better clinical outcomes, but only if GPs take financial responsibility for the budget,” he says. If this is achieved, “the NHS could quickly start to deliver maximum health gain for the resources available and may even do it equitably.” 15.10.10
NHS patients to see medical records online
Patients will be able to view their medical records online, email their GP and compare doctors across Britain under plans for an “information revolution” in the NHS. Those requiring treatment for cancer will be able to study survival rates – and waiting times – for different medical teams and then opt to have treatment where they wish, under the plans to be announced today. Proposals are being drawn up to give patients online access to their medical records.
In an article for today's Daily Telegraph, Martha Lane Fox says that the most useful online services for consumers should be made available to NHS patients over the next few years.
It is hoped this will help drive up hospital standards as patients choose not to use the services of poor doctors, who will then lose funding. Patients will also be asked to rate the service and treatment they receive from different hospitals and medics. They will be able to choose which GP they register with and whether to be treated at an NHS hospital or private or charity-run institution, within certain cost limits.
Miss Lane Fox, the founder of Lastminute.com, says the data could prove invaluable.
The Department of Health is the only major Whitehall department which will not see its spending cut this week. However, Andrew Lansley, the Health Secretary, still has to push ahead with major reforms as the ageing population is causing a sharp rise in health-care costs.
Miss Lane Fox, the Government's digital champion said: “A recent YouGov poll found that 40 per cent of people believe the NHS can learn from the service offered by supermarkets, banks and utility companies. I've always believed in the power of information and technology as an incredibly useful tool.
“There's clearly an appetite for a new approach. The Department of Health is launching a consultation this week into how information and technology can help people take more control of their health and make the best choices for themselves and their families.”
The consultation will study how internal data could be offered to websites like TripAdvisor or Mumsnet, which could “empower patients and families”.
Mr Lansley said: “The first principle of the White Paper is that the NHS should ensure that for patients, 'no decision about me, without me' is the invariable practice. To realise this means patients must have more say and more choice.” 18.10.10
Scandal as greater protection for NHS whistleblowers is needed
NHS staff fear reporting any problem for fear of reprisals but they will have a constitutional obligation to blow the whistle about safety issues, malpractice and other problems in the workplace under plans unveiled by the Department of Health. The DH is consulting on how to make staff more comfortable in raising concerns to help prevent incidents like Mid-Staffordshire.
Health Secretary Andrew Lansley wants to make changes to the NHS Constitution and the Staff Handbook so that NHS trusts can't suppress staff. “A public inquiry into the failings at Mid-Staffordshire is already underway. But it's important that we don't delay making changes to prevent such failures from happening again. The NHS Constitution must be brought up to date to enshrine the rights of staff,” he said.
The DH wants to:
- highlight existing legal rights of all staff to raise concerns about safety, malpractice or other wrongdoing without fear of dismissal or other ramifications;
- introduce an NHS pledge that employers will support all staff in raising such concerns, responding to and where necessary investigating concerns raised; and
- create an expectation that NHS staff will raise concerns about safety, malpractice or wrongdoing at work which may affect patients, the public, other staff or the organisation itself as early as possible.
In addition, the NHS Staff Council has negotiated changes to the terms and conditions of service handbook for NHS staff covered by Agenda for Change, to include a contractual right and duty to raise concerns in the public interest.
“Staff should be working in an environment where they feel able to voice concerns and know that their concerns will be taken seriously. Mr Lansley said. “The changes we are consulting on take that a step further. Staff will be expected to raise concerns and employers must support them and investigate where necessary. That means better patient care and better staff morale.” 13.10.10
Antidepressant reboxetine no better than a placebo, study finds
Scientists accuse Pfizer of holding back studies which reveal drug sold as Edronax to be ineffective and potentially harmful. An antidepressant prescribed in the UK over the last 13 years is ineffective and potentially harmful, according to a damning study published today.
After examining unpublished data on the drug, researchers at the German Institute for Quality and Efficiency in Health Care found that published studies overestimated reboxetine's benefit by 115 percent when compared to a dummy pill and 23 percent compared with other antidepressants, according to a report today in the British Medical Journal.
The drug, reboxetine, which is known in the UK under the trade name Edronax, works no better than a placebo, or dummy pill, say scientists in the British Medical Journal, who accuse the manufacturer, Pfizer, of failing to disclose the results of trials which show its inadequacies.
Although the pill does not work the side effects are considerable: aggression, anxiety, balance issues , blurred vision , brain zaps, concentration impairment, constipation, crying spells, depersonalization, diarrhea, dizziness. electric shock sensations, fatigue, flatulence, flu-like symptoms, hallucinations, hostility, highly emotional, indigestion, irritability, impaired speech, insomnia, jumpy nerves, lack of coordination, lethargy, migraine headaches / increased headaches, nausea, nervousness, over-reacting to situations, paranoia, repetitive thoughts or songs, sensory & sleep disturbances, severe internal restlessness (akathasia), stomach cramps, tremors, tinnitus (ear ringing or buzzing), tingling sensations, troubling thoughts, visual hallucinations / illusions, vivid dreams, speech visual changes and ironically, worsened depression.
The licensing authorities and Nice, the National Institute for Health and Clinical Excellence, will now be forced to look again at the drug. Nice said in guidance on treating adults with depression that reboxetine works as well as other modern antidepressants. The BMJ authors say it does not.
The revelations come from the German Institute for Quality and Efficiency in Health Care. Its independent scientists decided to scrutinise the data on reboxetine because of doubts that have been raised about its effectiveness and the fact that the US licensing authority, the Food and Drugs Administration (FDA) refused it a licence in 2001.
Individual trials that have been published and reviews of the data in the public domain have all shown the drug to be effective. But the German institute's scientists found that eight out of 13 significant trials had not seen the light of day.
The manufacturer, Pfizer, gave them data relating only to 1,600 patients – although sources suggested the drug had been trialled on 4,600. Pfizer stated publicly it had given the institute "those data that from our point of view are suited for a benefit assessment of Edronax", but eventually handed over most of the rest.
The institute accuses the manufacturers of publishing only positive results for the drug. "Data on 74% of the patients included in our analysis was unpublished, indicating that the published evidence on reboxetine so far has been severely affected by publication bias," the authors write.
"Our comparison of published and unpublished trials confirmed this assumption: the positive benefit-risk ratio of reboxetine in the published literature was changed to a negative ratio if unpublished trials were added to the analysis."
Beate Wieseler, deputy head of the institute's department of drug assessment, and colleagues call for changes in European law to make it mandatory for all clinical trial results to be published. They argue that all trial data should be disclosed – even when the trials fail and the drug is not approved. The results should also be disclosed for all older drugs which have a licence and may not be covered by new rules.
In a commentary, Robert Steinbrook from Dartmouth and Yale and Jerome Kassirer from Tufts University schools of medicine in the US point to recent controversies involving the non-disclosure of data from drug trials. Avandia for diabetes and the painkiller Vioxx were both found to have safety problems that published studies had not shown up.
"Companies have financial interests in the outcome of the studies they sponsor; they own the data, and set the rules for access to the data. Unfortunately, they cannot be relied on to consistently provide dispassionate evaluations of their own drugs and medical devices," they say. Scientists and doctors may also have financial links to the companies.
Dr Fiona Godlee, editor of the BMJ, and colleague Dr Elizabeth Loder say that "the medical evidence base is distorted by missing clinical trial data" and call for urgent action to restore trust in existing evidence. "Full information about previously conducted clinical trials involving drugs, devices and other treatments is vital to clinical decision-making," they say. "It is time to demonstrate a shared commitment to set the record straight." 13.10.10
Force drug makers to publish all clinical trials, says study
Current regulations covering publication of clinical trials are insufficient, and drugmakers should be required to publish data on all drugs, even those that never get approved, say researchers.
A review published in the British Medical Journal (BMJ: October 13 issue) by researchers at the German Institute for Quality and Efficiency in Health Care (IQWiG) reports that 74% of the data on patients who took part in trials of Pfizer's antidepressant Edronax (reboxetine) have not been published until now, and that the published data on the drug overestimate its benefits and underestimate the harms.
Edronax has been approved for the treatment of major depressive disorder in many European countries since 1997, but doubts have been raised about its effectiveness on the basis of recent studies and rejection of the US approval application in 2001. Published trials, however, show a favourable risk-benefit profile for the drug, the report notes.
In their study, IQWiG researchers led by Dr Beate Wieseler sought to assess the benefits and harms of Edronax compared with placebo or other selective serotonin reuptake inhibitors (SSRIs) for treating adults with major depression.
They analysed the results of 13 trials, including eight previously-unpublished trials from Pfizer, and found that while the overall quality of the trials was good, data on 74% of patients were unpublished. A further comparison of pubished and unpublished trials showed that the published data had overestimated the benefits of Edronax and underestimated harm.
Their review shows that Edronax is, overall, an ineffective and potentially harmful antidepressant, they conclude, and describe their findings as “a striking example of publication bias” which can affect health policy decisions and the content of clinical guidelines.
Current regulations on the publication of trial results are insufficient, they say, and call for: drugmakers to be required to publicly disclose data for all drugs - even for those which never get approved; public access to trials of older drugs not covered by current law; greater data-sharing between regulatory authorities; re-evaluation of a drug if its approval is declined elsewhere; and a legal obligation on manufacturers to provide all requested data to official bodies without restrictions to publication.
In an accompanying editorial, BMJ editors Dr Fiona Godlee and Dr Elizabeth Loder warn that “the medical evidence base is distorted by missing clinical trial data” and call for “urgent action is needed to restore trust in existing evidence.” It is important to re-evaluate the integrity of the existing base of research evidence and the BMJ will therefore devote a special theme issue to this topic in late 2011, they say.
IQWiG has described publication bias as one of the most important and dangerous sources of error in medicine. “Deception through concealment is no trivial offence - in extreme cases, patients may even receive useless or harmful treatments if information is incomplete,” it says.
It is particularly dangerous that doctors and researchers are often totally unaware that unpublished trials exist, says the Institute and, in order to solve this problem, it reached basic agreement on the transfer of such data with the German Association of Research-based Pharmaceutical Companies (VFA) in 2005. Also, in January that year, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) announced a voluntary commitment to disclose information on clinical trials.
However, IQWiG reported last November that “these announcements from the pharmaceutical industry cannot be relied upon. In recent years, companies have repeatedly refused to provide the Institute with study documents required for the benefit assessment of drugs. Frequently, clinical trial registries, which have been set up in recent years, do not contain these data either,” it said.
Responding to the IQWiG study, Pfizer stated that it discloses the results of its clinical trials to regulatory authorities around the world and that it would provide further comment on the report after reviewing it fully.
One expert said 'this is nothing new, drug companies have been hiding unfavorable data for many years and everyone knows about it. It seems strange that certain people claim this is something new or they didn't know anything about it'. 14.10.10
Also see: clinical trials
Public 'misled' by drug trial claims
Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned. Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings. The review included 13 treatment trials on just over 4,000 patients. "Data on 74% of these patients were unpublished," the experts said.
Experts writing online in the British Medical Journal (BMJ) reviewed findings for the drug versus a placebo and other anti-depressants, known as selective serotonin reuptake inhibitors (SSRIs). They also measured the impact of "publication bias" in clinical trials of reboxetine carried out for predecessors of Pfizer, which makes Edronax.
The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light. Pfizer maintains its drug is effective. Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK. But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.
This is not the first time a large drug company has come under fire about its published drug trial data.
Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat. GSK rejected claims that it improperly withheld drug trial information.
But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes. Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer's antidepressant reboxetine that should be made public because it could change views about the drug.
Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.
They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.
Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.
The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today. "Our findings underline the urgent need for mandatory publication of trial data," they say in the BMJ. They warn that the lack of all information means policy makers are unable to make informed decisions.
In the US , it is already a requirement that all data - both positive and negative - is published. The UK is also striving to achieve this. The UK 's regulator, the MHRA, said: "There is a European initiative to provide public access to the results of clinical trials. The currently planned timeline is that this information could become available in late 2011/early 2012."
A spokeswoman for Pfizer said: "In the UK , Pfizer's reboxetine is licensed for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment. "This medicine presents an effective treatment option to clinicians for the use in patients suffering from these conditions.
"Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling. "Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review."
The authors wrote: "Published data overestimated the benefit of reboxetine versus placebo by up to 115% and reboxetine versus SSRIs by up to 23%, and also underestimated harm. Reboxetine is, overall, an ineffective and potentially harmful anti-depressant. "Published evidence is affected by publication bias, underlining the urgent need for mandatory publication of trial data."
Others lay at least some of the blame with the medical journals that publish drug trial data. In response, the BMJ has promised to devote an entire issue to the topic next year. 13.10.10
Call to abolish NHS pay protection of 'lifetime bonuses' for consultants
Large pay bonuses cannot be taken away from doctors, even if their performance deteriorates, because of a loophole in the system, the BBC has found. It means that more than half of the 36,000 consultants in England now get what are effectively "lifetime" awards worth up to £75,000 on top of their £89,400 basic pay.
The scheme, which is under review, is worth more than £75,000 a year to the best-performing consultants. But doctors defended the system, saying it ensured excellence was rewarded but critics said 'the NHS can no longer afford such extravagance just for doctors to do their jobs properly'.
The bonus scheme dates back to 1948 when the NHS was created. In England , there are 16 different levels, ranging from £2,957 to £75,889 a year. Similar schemes operate elsewhere in the UK , although only a small number of doctors receive the awards.
During the summer, all four governments agreed to a review of the bonuses amid concerns about the costs. In England , the cost of the awards topped £200m last year. But news of the pay protection clause has added weight to calls for the scheme to be scrapped. According to latest figures, 19,892 consultants in England are paid the bonuses.
To apply for an award, consultants nominate themselves and are asked to provide details of excellent performance and innovation in terms of clinical care, research and training. The awards are reassessed every five years, but critics said the loophole had created a culture where that checking process was effectively obsolete.
In fact, evidence to a government review by the Advisory Committee on Clinical Excellence Awards - the body which oversees the top payouts - even acknowledges that reassessments have not always taken place. During the four years between 2006 to 2009, just seven of the top awards worth over £35,484 were withdrawn.
In 2010, the committee chased up those doctors who had not been taking part in the reassessment process. However, because of the pay protection clause all these doctors have continued to get the payouts even though the 'bonuses' have been formally withdrawn from them.
Those who have had their awards withdrawn do not receive annual pay rises so the NHS can start to claw back some of the money, but as pay is currently frozen, that is having little impact. It is not known how many of the local awards have been withdrawn, but according to those who have helped administer the scheme the bonuses come with a virtual "lifetime" guarantee.
Professor Alan Maynard, an expert in health policy at York University , was chairman of a local NHS trust for 12 years during which time he sat on the committee that handed out the awards. He said: "They never get stopped, once they have them they have them for their lifetime. The system needs completely changing. "The applicants provide very little information, but you can't spend the money on anything else as it is earmarked for these awards. I would have preferred to spend it on providing more care."
He said the evidence for performance-related pay was questionable anyway, but if there was to be an incentives scheme it should be much tougher. Professor John Appleby, chief economist at the King's Fund, agreed. "I think they are out of step with how the NHS should be paying staff. They should be abolished."
But Dr Paul Flynn, of the British Medical Association consultants' committee, defended the scheme. "It is an integral part of the pay structure for consultants. It is only right that those who go over and above what is expected and do the best job get their performance rewarded." He said the BMA would be willing to engage with the government to make sure the system was "transparent, fair and responsive".
But he said pay protection was important as doctors needed "security of income" and so that the bonuses "engaged and motivated, but not distracted" them.
A Department of Health spokeswoman said there were "anomalies" in the system and that was why it was being reviewed. She added: "In future we want to see a much tougher approach, including withdrawing them from people who no longer display the quality of work that would merit an award now." The review is being carried out by independent Doctors' and Dentists' Review Body and is due to report next summer. 13.10.10