XTEND-15sec-NEWSt
28th April 2006
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Experts defining mental disorders are linked to drug firms…n1t2
Every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses, a new analysis has found.
Of the 170 experts in all who contributed to the manual that defines disorders from personality problems to drug addiction, more than half had such ties, including 100 percent of the experts who served on work groups on mood disorders and psychotic disorders. The analysis did not reveal the extent of their relationships with industry or whether those ties preceded or followed their work on the manual. More…
Warren Matthews comments: This is a wide spread problem throughout the entire medical industry. These ‘manuals’ are supposed to be technical documents to help health professionals in prescribing drug treatments to patients. However, they are also very important sales tools for the drug companies! This is why they go to so much effort to influence the content. The most effective way to achieve this is a ‘consultancy’ arrangement with the authors of the content.
I am not suggesting that all the authors of these types of documents are either corrupt or publish information which they do not believe, but it should be recognized that the information that is ultimately published is ‘approved’ by the drug companies and may not necessarily include all the possible downsides. Therefore, always do your own independent ‘due diligence’ before using any drug, unless in an emergency situation.
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Outsourcing patients for clinical trials in India!n2t3
India's outsourced call centers are well known, but not its outsourced patients.
By 2010, some estimate there will be two million patients in India on clinical trials.
An entire industry has sprung up, specializing in recruiting patients and managing experiments.
And a BBC investigation into the conduct of these trials has found that some patients are unaware they are being experimented on at all.
Most of the world's largest pharmaceutical companies have a presence in India, but there is concern about how the country achieves its exceptional recruitment rates and questions about fully-informed consent. More…
Warren Matthews comments: Well…I guess that this was inevitable.
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Drugs volunteers' 'living hell'n3t4
One of the men given a dummy drug as part of the clinical trial that left six men seriously ill has said the study was like "Russian roulette".
Raste Khan said that the test ward in north-west London became a "living hell" as the men spasmed in agony.
Two remain critically ill but four have shown signs of improvement.
A solicitor representing one man said it was not clear if successful animal tests had been previously held. More…
Warren Matthews comments: All I can say here is that this news item should serve as a warning for those people who are contemplating participating in a clinical trial for a new drug. If you are tempted, once again follow the principle that you should with all drugs! Do your research first before committing and confirm that there have been a number of animal trials successfully completed. Take the info and discuss it with your own Doctor.
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Important notice: All material provided within XTEND-15sec-NEWS is for informational and educational purposes only, and is not to be construed as medical advice or instruction. No action should be taken solely on the contents of this publication. Consult your physician or a qualified health professional on any matters regarding your health and wellbeing or on any opinions expressed within this newsletter. The information provided in this newsletter is believed to be accurate based on the best judgment of the editor but the reader is responsible for consulting with their own health professional on any matters raised within.
Experts Defining Mental Disorders Are Linked to Drug Firmsm1
By Shankar Vedantam
Washington Post Staff Writer
Thursday, April 20, 2006; A07
Every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses, a new analysis has found.
Of the 170 experts in all who contributed to the manual that defines disorders from personality problems to drug addiction, more than half had such ties, including 100 percent of the experts who served on work groups on mood disorders and psychotic disorders. The analysis did not reveal the extent of their relationships with industry or whether those ties preceded or followed their work on the manual.
"I don't think the public is aware of how egregious the financial ties are in the field of psychiatry," said Lisa Cosgrove, a clinical psychologist at the University of Massachusetts in Boston, who is publishing her analysis today in the peer-reviewed journal Psychotherapy and Psychosomatics.
The analysis comes at a time of growing debate over the rising use of medication as the primary or sole treatment for many psychiatric disorders, a trend driven in part by definitions of mental disorders in the psychiatric manual.
Cosgrove said she began her research after discovering that five of six panel members studying whether certain premenstrual problems are a psychiatric disorder had ties to Eli Lilly & Co., which was seeking to market its drug Prozac to treat those symptoms. The process of defining such disorders is far from scientific, Cosgrove added: "You would be dismayed at how political the process can be."
The American Psychiatric Association, which publishes the guidelines in its bible of disorders, the Diagnostic and Statistical Manual (DSM), said it is planning to require disclosure of the financial ties of experts who write the next edition of the manual -- due around 2011. The manual carries vast influence over the practice of psychiatry in the United States and around the world.
Darrel Regier, director of the association's division of research, said that concerns over disclosure are a relatively recent phenomenon, which may be why the last edition, published in 1994, did not note them. Regier and John Kane, an expert on schizophrenia who worked on the last edition, agreed with the need for transparency but said financial ties with industry should not undermine public confidence in the conclusions of its experts. Kane has been a consultant to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer Inc.
"It shouldn't be assumed there is a true conflict of interest," said Kane, who said his panel's conclusions were driven only by science. "To me, a conflict of interest implies that someone's judgment is going to be influenced by this relationship, and that is not necessarily the case. . . ."
The DSM defines disorders in terms of constellations of symptoms. While neuroscience and genetics are revealing biological aspects to many disorders, there has been unease that psychiatry is ignoring social, psychological and cultural factors in its pursuit of biological explanations and treatments.
"As a profession, we have allowed the biopsychosocial model to become the bio-bio-bio model," Steven Sharfstein, president of the American Psychiatric Association, said in an essay last year to his colleagues. He later added, "If we are seen as mere pill pushers and employees of the pharmaceutical industry, our credibility as a profession is compromised."
He stressed that the association has strict guidelines to police the role of the pharmaceutical industry but said the profession as a whole needs to do a better job monitoring ethical conflicts.
Sharfstein added yesterday that the presence of experts with ties to companies on the manual's expert panels is understandable, given that many of the top experts in the field are involved in drug research.
"I am not surprised that the key people who participate have these kinds of relationships," he said. "They are the major researchers in the field, and are very much on the cutting edge, and will have some kind of relationship -- but there should be full disclosure."
At least one psychiatrist who worked on the current manual criticized the analysis. Nancy Andreasen of the University of Iowa, who headed the schizophrenia team, called the new analysis "very flawed" because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward.
Two out of five researchers on her team had had substantial ties to industry, she said. Andreasen said she would have to check her tax statements to know whether she received money from companies at the time she worked on the panel, but said, "What I do know is that I do almost nothing with drug companies. . . . My area of research is neuroimaging, not psychopharmacology."
The analysis could not determine the extent or timing of the financial ties because it relied on disclosures in journal publications and other venues that do not mention many details, said Sheldon Krimsky, a science policy specialist at Tufts University who also was an author of the new study. Whether the researchers received money before, during or after their service on the panel did not remove the ethical concern, he said.
Krimsky, the author of the book "Science in the Private Interest," added that although more transparency is welcome, the psychiatric association should staff its panels with disinterested experts.
"When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions," he said.
http://www.washingtonpost.com/wp-dyn/content/article/2006/04/19/AR2006041902560_pf.html
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India's outsourced call centres are well known, but not its outsourced patients. m2
By 2010, some estimate there will be two million patients in India on clinical trials.
An entire industry has sprung up, specialising in recruiting patients and managing experiments.
And a BBC investigation into the conduct of these trials has found that some patients are unaware they are being experimented on at all.
Most of the world's largest pharmaceutical companies have a presence in India, but there is concern about how the country achieves its exceptional recruitment rates and questions about fully-informed consent.
Medical language
Six years ago, an experimental drug from the US called M4N was injected into cancer patients in India without being properly tested on animals first.
Later it was discovered that several patients had not known they were part of a clinical trial.
"Most of the patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them."
Dr Shashank Joshi
One of the doctors who later blew the whistle, Dr V Narayan Bhattathiri, told the BBC: "I can only say that what they did is something unbelievable or incomprehensible.
"I couldn't find any example of such a thing being done, maybe in the last 50 years or so. Maybe something similar could have happened in say concentration camps."
Giving informed consent to be part of an experiment is the golden rule of all clinical trials which goes all the way back to the Nuremberg Code.
But one doctor at the prestigious Lilavati hospital in Mumbai, Dr Shashank Joshi, says the idea of all patients giving informed consent in India is "a myth according to me... because I do not think it's truly informed in the language the patient understands.
Lack of understanding
Reporter Paul Kenyon tracked down a drug trial being conducted for a major drug company in a psychiatric unit at a hospital in Gujurat.
It was to test an anti-psychotic drug developed by the world's second largest drug pharmaceutical company Johnson and Johnson.
"I didn't know that experiments were being carried out on me."
Parshottam Parmar
There is already controversy over what is happening, with some doctors levelling the accusation that patients are being taken off their existing medication as part of the trial, with the potential they could suffer unnecessarily.
Dr Vikram Patel from the British Journal of Psychiatry says: "The most obvious problem is that they won't get better or they will continue to suffer this extremely severe psychiatric illness, much longer than they need to."
But the ethical concerns go deeper when Kenyon finds a patient who took part in the trial.
"I was just told that the drugs were American. They used to give me the tablets and I used to eat them," says Parshottam Parmar.
"We just sign because I believe the doctor takes the signature to help us. That's why I sign it."
He says he had no idea that he was part of a clinical trial.
"I was told that the old drugs were discontinued and were no longer available in the pharmacies. I don't know a lot about all these things. I am poor and I live in a small hut and I don't understand many things. The doctors are intelligent. They write the drugs for me so I have to take them accordingly."
Johnson and Johnson's spokesman Dr Vivek Kusumaker told us: "We have looked at this particular trial and we've got consent from the patient or from a relative in every case.
"If there is any instance brought to our attention that something was not OK we will take that seriously. We have said that we shut down sites if we don't think we are carrying out research to the highest code of ethics in which we believe."
http://news.bbc.co.uk/2/hi/south_asia/4932188.stm
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Drugs volunteers' 'living hell' m3
One of the men given a dummy drug as part of the clinical trial that left six men seriously ill has said the study was like "Russian roulette".
Raste Khan said that the test ward in north-west London became a "living hell" as the men spasmed in agony. Two remain critically ill but four have shown signs of improvement. A solicitor representing one man said it was not clear if successful animal tests had been previously held.
"Some screamed out that their heads felt like they were going to explode."
Raste Khan
Ann Alexander, whose 29-year-old client is on a life support machine, said: "There is confusion about whether the drug had actually been tested successfully and safely on animals before the tests on these volunteers." She said, the "problem" needed to be "investigated urgently". "The other six have obviously gone through a terrible time. I don't know what their families are going through."
Mr Khan from Barry, near Cardiff, was given a placebo, and spoke to the BBC courtesy of the Sun newspaper. He said: "It was Russian roulette. There were eight of us. Two of us were really lucky." He added: "They must be going through a terrible time at the moment. I really hope they're going to get through this. All we can do is hope they're going to be fine." He said that luckily he felt OK after being given his injection but that the others on the trial began falling "like dominos".
'Significant change'
Mr Khan continued..."The gentleman on my left said, 'I've got really bad headache pains.' He said he was hot and then he started hyper-ventilating. Then they tried to calm him down and then he passed out and came back to consciousness, he vomited and then they got a big bin liner from somewhere for him to vomit in".
Then he described how another volunteer became unwell and said he could not control himself and needed the toilet. "Everything was unplugged from him, he stood up, took several steps and he fainted. He was quite a big guy, it took quite a few nurses to help him up."
"I didn't want him to do it, but he said he was helping mankind, helping scientific knowledge."
Myfanwy Marshall
Earlier Mr Khan had told the Sun newspaper: "Some screamed out that their heads felt like they were going to explode."
Clinical Director of Intensive care Ganesh Suntharalingham at Northwick Park Hospital said: "Of the six patients admitted to critical care, the four who are seriously unwell are continuing to show signs of improvement but it is still early days. The other two men remain critical and it could be a while until they show significant change."
One of the critically ill men has been named as student Ryan Wilson, 21, of Highbury, north London. Another who was taken seriously ill has been confirmed as a New Zealander. The New Zealand High Commission said he was "conscious and has spoken to hospital staff".
'No signs of problems'
It was the first time the drug TGN1412, designed to treat conditions such as rheumatoid arthritis and leukaemia, had been tested on humans. American company Parexel, which ran the trial, said it had followed recommended guidelines.
TeGenero, which manufactures the anti-inflammatory drug, said it apologised to the sick men's families and said the medicine had showed no signs of problems in earlier tests.
Chief scientific officer Thomas Hanke added the company's first concern now was making sure the patients got the best treatment possible and to support the families.
Scotland Yard said officers are talking to the Medicines and Healthcare products Regulatory Agency and doctors.
The MHRA is looking at whether the reaction was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side-effect of the drug in humans".
http://news.bbc.co.uk/1/hi/health/4813478.stm
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