Evidence: Why you should never trust new wonder drugs

The tobacco industry denied the direct evidence by misapplying government population statistics showing improved health and longevity as “official evidence” to defend the use of tobacco.
http://legacy.library.ucsf.edu/cgi/getdoc?tid=gox02f00&fmt=pdf&ref=results
 
Pharmaceutical companies in collusion with stakeholders it supports—including, organized psychiatry, influential academics, and mental health front groups posing as “patient advocates”– have similarly grasped at aggregate population trends to defend SSRI antidepressants. They deny the evidence obtained in company controlled clinical trials, making dubious assertions of a causal link between increased rates of suicide and decreased use of antidepressants. http://ahrp.blogspot.com/2007/02/pharma-spin-and-child-suicide-rates.html

However, such ecological studies with multiple uncontrolled variables do not qualify as science.

As two recent articles (January 2007) one in JAMA, [1] the other in the BMJ, [2] point out, the evidence from controlled trials, and the scope and magnitude of the prescription drug industry’s corrupt practices are coming to light primarily through litigation AFTER irreversible harm has been done to tens of thousands of consumers.  See: http://www.ahrp.org/cms/content/view/440/94/

A commentary in the Daily Mail, “Why You Should Never Trust New Wonder Drugs,” by David Healy, MD, the psychiatrist who ignited an international debate about the hidden suicide risk of antidepressants, sheds further insight on the fact that the evidence contained in internal pharmaceutical company documents contradict public claims about these drugs’ safety and efficacy:  “Documents pried out of companies by American court cases have become the main way we have of discovering the truth about some of our best-selling drugs.”

Indeed, secret company documents overturn the legitimacy of current prescribing practices in psychiatry. The information contained in company documents reveals that the scientific journal literature about drug efficacy and safety has been manipulated to conform to marketing needs that no longer reflect the scientific evidence. Journals have become dangerous sources of disinformation misleading physicians who trust them to prescribe dangerous ineffective drugs when safe alternative are known.
 
Citing cases in which he was personally able to examine the documents–beginning with Prozac, then Seroxat (Paxil), and other recent cases of concealment, Dr. Healy writes:
 
“Two years ago, the painkiller Vioxx was found to double the risk of heart problems; company documents revealed that the drugs sales team were instructed to keep this information from doctors.

Just before Christmas, internal documents suggested attempts were made to play down the serious health risks associated with the top-selling anti-psychotic drug Zyprexa.

Last week similar boxes formed the background to a Panorama programme showing how the company making Seroxat distorted evidence that the drug raised the risk of suicide in children.”

In a separate Infomail we will address a fierce dubious campaign targeting healthy American girls and adolescents who are sought by manufacturers—Merck and GlaxoSmithKline—as test subjects for their vaccines aimed at the curbing sexually transmitted diseases. Curiously, though boys and men are the transmitters of these diseases, the burden of risk is expected to be borne by girls.
 
The marketing of medicines is an enterprise that is publicly subsidized, operating under a government license.  The public has every right to expect that those whom it licenses and subsidizes are scrupulously forthright in disclosing risks and benefits of prescribed medicines. The public trust has been hugely betrayed at every level risking a return to snake oil peddlers whose products were no more toxic than numerous, currently licensed drugs.
 
References:
1. Aaron S. Kesselheim, MD, JD and Jerry Avorn, MD. The Role of Litigation in Defining Drug Risks, JAMA, January 17, 2007. 297(3) 308-311. http://jama.ama-assn.org/current.dtl

2. Harlan Krumholz ,Harold H Hines, Joseph S Ross, Amos H Presler, David S Egilman. What have we learnt from Vioxx? BMJ 2007;334:120-123 (20 January),   http://www.bmj.com/cgi/content/short/334/7585/120

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
 

http://tinyurl.com/2fhy4y
Daily Mail
Why you should never trust new wonder drugs
David Healy, MD
6th February 2007

[A drug company was last week accused of concealing evidence about the
safety of the antidepressant Seroxat. According to leading psychiatrist
Professor David Healy, this is just the latest in a string of cases where patients
and medical professionals have been misled about a drug's adverse effects.]

Ten years ago, I sat faced with boxes and boxes that contained a dirty
secret.  Inside were thousands of confidential internal company documents
about Prozac, an anti-depressant then being prescribed to millions.

The secret they revealed was that public statements about the safety of
the drug were a lie; that the company knew Prozac was responsible for a
raised risk of suicide and was only slightly more effective than a placebo.

Several years later I was faced with the secrets of another antidepressant – Seroxat.

No one outside the two companies, and few within them, knew what those
boxes contained; I saw them because I was an expert witness in a court case.

Unfortunately, such revelations have since become all too common.
Documents pried out of companies by American court cases have become
the main way we have of discovering the truth about some of our best-selling drugs.

As well as Prozac, there have been another four or five other drugs exposed in this way.

Two years ago, the painkiller Vioxx was found to double the risk of heart problems;
company documents revealed that the drugs sales team were instructed to keep this
information from doctors.

Just before Christmas, internal documents suggested attempts were made to play
down the serious health risks associated with the top-selling anti-psychotic drug Zyprexa.

Last week similar boxes formed the background to a Panorama programme showing
how the company making Seroxat distorted evidence that the drug raised the risk of suicide in children.

The effect of these scandals is to show that something has gone badly wrong with
the way our medicines are researched and sold.

The scientific literature, the very place doctors would look for a warning, contained barely a hint of problems.
What's more, no one seems likely ever to have to answer for what appears to be fraud.

And no one in Britain has any means of finding out why their husband or child might have died.

The company boxes show the progressive demolition of a brilliant system
for discovering how well drugs work: the clinical trial. Developed more than
50 years ago, this involves giving a drug to one group of patients and a
dummy pill to another, similar group.

Drugs such as antibiotics, hypertension drugs and the first treatments
for cancer proved their worth in trials.

Until the 1980s, these were run in universities. Independent academics
did the research and published the results. But for the past 20 years
the drug firms themselves have increasingly run trials.

The result has been to undermine the value of the whole system. Now
company employees analyse the data and medical journalists are hired to
write them up for publication. Then Oxbridge and Ivy League professors
are paid several thousand pounds to be credited as the authors of these
articles.

This is something I've come across personally. Articles have been
"ghostwritten" for me by drug companies, and then – when I refused to
put my name to them – the same articles have appeared under someone
else's name.

I have also seen company memos asking who would be the most "useful"
academics to have as the authors of articles already written.

Once published in top medical journals, these confections will deliver
more sales than any number of drug representatives, but all too often
they are not accurate reports of the trial results.

In other organisations when evidence of disregard for public safety
emerges, heads roll. But there have been no resignations following these
drug disasters – barely a flicker of embarrassment.

The distortion and lack of corporate accountability makes me much slower
to hand out new drugs. I even feel apprehensive if someone I know has to
go to the doctor.

And what would I do if a loved one suffered a serious drug reaction?
It's virtually impossible to sue a pharmaceutical company in Britain,
partly because of the difficulty of getting any funding for such actions.

There's no point appealing to the government drugs watchdog – the MHRA.
It is a small outfit entirely funded by the drug industry. It has never taken any
action against the academics who make fraudulent claims in ghostwritten
articles, nor doctors working for the companies who repeat such claims,
even when they have been shown to be untrue.

So the only other body to turn to is the General Medical Council, whose
job it is to investigate the conduct of doctors – but it has shown no
inclination to act.

But there is one simple thing we could all do to reclaim the clinical
trials. People who participate as guinea pigs should insist the consent
form states that the data will be available to all, and without this any
drug tester should refuse to sign.

In doing this, we can change clinical trials back to a tool for
scientific research and stop them being just a marketing exercise.

We will be told Britain will pay a heavy cost in lost jobs and
breakthrough drugs if the industry is more tightly regulated.
But can it be any higher than the price we are paying in the deaths of
husbands from heart attacks and children from suicide?

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