"Drug Companies Should Make Their Studies Public" NYT

“Drug Companies Should Make Their Studies Public” NYT

Wed, 13 Aug 2003

Concealed and inaccessible research findings are undermining the integrity of medicine, the advancement of scientific knowledge, and most importantly, secrecy is putting people’s lives in jeopardy because prescribing doctors are ignorant about adverse – even lethal – drug effects.

Recently disclosed evidence – first in the UK, now in the US – demonstrating a suicidal risk linked to the SSRI antidepressant drugs “has sent a wave of anxiety through doctors and depressed patients.” Doctors who have prescribed SSRI drugs widely – if not indiscriminately – for children and even infants – are beginning to take heed. However, officials at the National Institute of Mental Health have remained conspicuously silent.

Dr. Richard Friedman, Director of Psychopharmacology Clinic at Weil Medical School (Cornell University) acknowledges several truths long-known to drug manufacturers, psychopharmacologists, and FDA officials, but truths vigorously denied at public forums. In an Op Ed in The New York Times, he writes:

(1) “It has been known for some years that many types of antidepressants… make some depressed patients more active in the early phase of treatment.”
Known to who? Not to patients nor their prescribing physicians.

(2) “government approval is not a guarantee of safety. New drugs are approved on the basis of relatively short treatment studies in limited number of patients. …a drug’s rare adverse effects may not turn up until well after it has reached the market…”
But the public expects the FDA to ensure that trials are designed to look for rare but severe adverse effects before the drug is approved.

(3) “a drug company can cherry-pick favorable studies for publication and file away studies that show its drug in a negative light.”
Then what is the FDA’s role – to help conceal or to require disclosure?

(4) “Such publication bias has a profound impact on medical practice because doctors can get an incomplete or distorted impression about the safety and efficacy of new medications.”
Indeed, it has put the lives of patients at risk.

AHRP fully endorses both of Dr. Friedman’s recommendations:

(1) FDA should publish on its Web site the results of ALL company sponsored clinical drug trial results.
(2) “Drug companies should be required in their advertisements to list the number of trials that they conducted and published for each and every drug. These advertisements should also tell people how they can find the complete studies.”

Free and open access to scientific information is a movement initiated by Dr. Harold Varmus when he stepped down as director of the National Institutes of Health. Dr. Varmus recognizes the adverse societal consequences of the prevailing culture of secrecy and elitist exclusion within the scientific community .

The Washington Post reports that even the published findings of publicly funded research are inaccessible to the public due to the high cost of many publications:
“the vast majority of the 50,000 to 60,000 research articles published each year as a result of federally funded science ends up in the hands of for-profit publishers… [some] charge as much as $50 to view the results of a single study online. ”

Rick Weiss reported about the Public Library of Science (PLoS), a new initiative “which has begun to make “open access” scientific publication an issue for everyday citizens, emphasizing that taxpayers fund the lion’s share of biomedical research and deserve access to the results.”

Ultimately, it is the public sector that subsidizes the scientific community – Taxpayers provide $45 billion in federal research funding annually. That’s substantial leverage to bring about change.

http://www.washingtonpost.com/ac2/wp-dyn/admin/emailfriend?contentId=A19104-2003Aug4&sent=no&referrer=emailarticle
A Fight for Free Access To Medical Research
By Rick Weiss
August 4, 2003

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http://www.nytimes.com/2003/08/12/opinion/12FRIE.html?pagewanted=print&position=
August 12, 2003
OP-ED CONTRIBUTOR
What You Do Know Can’t Hurt You
By RICHARD A. FRIEDMAN

A recent report that one of the most widely prescribed antidepressants, Paxil, might be linked to an increased risk of suicidal thinking in teenagers and children has sent a wave of anxiety through doctors and depressed patients alike.

After all, millions of depressed patients have been treated with Paxil as well as Prozac, Zoloft and Celexa, which are all selective serotonin reuptake inhibitors – that is, they regulate the activity of the neurotransmitter serotonin in the brain, which improves mood. And while there were several reports in the early 1990’s suggesting a possible link between this class of drugs and an increased risk of suicidal behavior, the Food and Drug Administration cleared S.S.R.I.’s of any association with suicide in 1991.

In an analysis of all available controlled clinical trials in 1991, the agency compared the incidence of suicidal tendencies in research subjects treated with S.S.R.I.’s, older antidepressants and placebos. They found no significant difference in the rate of suicidal thinking or behavior in subjects treated with S.S.R.I.’s compared to the older antidepressants; people treated with either class of drug had a significantly lower risk of suicidal symptoms than those given placebos.

Since then, there have been a handful of cases, some reported in the news media, of depressed patients who made suicide attempts while taking S.S.R.I.’s. But because one of the core symptoms of depression is suicidal thinking and behavior, it is impossible to know from a few case reports whether to blame the illness – or the treatment.

Now a legitimate question has been raised as to whether there might be a small number of depressed patients – in this case children and adolescents – who run the risk of becoming suicidal when treated with Paxil.

It has been known for years that many types of antidepressants – including S.S.R.I.’s and older drugs – can make some depressed patients more active in the early phase of treatment. When this happens, patients may be at increased risk of suicide because they have more energy to act on their suicidal impulses before the real antidepressant effect of the drug has taken hold.

What is disturbing about the recent report is that the purported link between Paxil and suicidal thinking comes from an unpublished study sponsored by the Paxil’s manufacturer, GlaxoSmithKline. In fact, GlaxoSmithKline has published only one of its nine studies of Paxil in children and adolescents to date.

As the public is now becoming aware, drug companies own the data from the clinical trials that they sponsor. While a drug company must report its findings from all clinical trials to the F.D.A., it is generally under no obligation to publish any of them or make them public. Moreover, government approval is not a guarantee of safety. New drugs are approved on the basis of relatively short treatment studies in a limited number of patients. For this reason, a drug’s rare adverse effects may not turn up until well after it has reached the market and large numbers of people have been exposed to it. As a result, a drug company can cherry-pick favorable studies for publication and file away studies that show its drug in a negative light.

Such publication bias has a profound impact on medical practice because doctors can get an incomplete or distorted impression about the safety and efficacy of new medications. For example, publication bias can make a merely mediocre drug look spectacularly effective. And it can erode public trust in research sponsored by drug makers.

This would be unfortunate because Paxil and company are clearly safe and effective drugs that have helped millions of patients with depression. However, all drugs have side effects, and S.S.R.I.’s are no exception.

Even if it proves to be true that there is a small subset of patients who become more suicidal after taking this class of drugs, the risk of treatment is dwarfed by the risk of untreated depression: 5 percent to 10 percent of patients with major depression eventually commit suicide.

Even so, that is no excuse for concealing Paxil’s or any other drug’s adverse effects, no matter how rare they may be. Though these traits don’t necessarily make a drug unsafe, it is crucial for doctors and patients to be aware of all the risks involved.

When potentially bad news about a drug is leaked from unpublished studies, the public is left to speculate about the true risks of the drug. In the case of Paxil, this only confirms the common suspicion that the pharmaceutical industry has placed economic self-interest ahead of patient safety and the integrity of medical research.

Public confidence in the safety and efficacy of S.S.R.I.’s, like all drugs, can be built only on full and representative disclosure of clinical research. To that end, the F.D.A. should publish on its Web site the results of all studies sponsored by drug companies. And for their part, drug companies should be required in their advertisements to list the number of trials that they conducted and published for each and every drug. These advertisements should also tell people how they can find the complete studies. For too long, drug companies have been allowed to tell us only the good news about their products. Now we’re ready for the whole story.

Richard A. Friedman, a psychiatrist, is director of the psychopharmacology clinic at Weill Medical College of Cornell University.

Copyright 2003 The New York Times Company

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