What you don't know can hurt you
From: Zee (zwalanga_at_yahoo.com)
Date: 07/15/04
- Next message: Robert: "Re: Cholesterol Guidelines A Gift For Merck, Pfizer"
- Previous message: Don Kirkman: "Re: Concerned about Beta Blockers"
- Messages sorted by: [ date ] [ thread ]
Date: 15 Jul 2004 13:08:52 -0700
Reporting of negative clinical results is as necessary as the
positives
"Around $1-billion a year is spent on clinical trials in Canada. A
good chunk of that comes from the public purse through research
grants, and even the privately funded research is a business expense
and is, hence, subsidized by the state."
By ANDRE PICARD
Globe and Mail
Thursday, July 15, 2004 - Page A13
The debate over the effectiveness and safety of antidepressants for
children and adolescents is having a welcome side effect: It has
revived efforts to expand and improve clinical trial registries.
The underlying principle of these registries is that the public has a
right to know when medications and other treatments do not work, as
well as when they do.
Right now, access to accurate information about prescription drugs is
severely limited. We get, at best, only half the story, and much of
the data come to light only after they have been through a rose-tinted
corporate filter.
We are far more likely to hear about the beneficial effects of
prescription drugs and medical devices than about their side effects.
And we will almost never hear about monumental flops -- except those
that occur after a drug comes to market.
There are several reasons for this sad state of affairs. The
overwhelming majority of late-stage research projects are sponsored by
pharmaceutical and biotechnology companies. If they get negative
results -- even if participants in clinical trials are injured or
killed -- there is no obligation to reveal that information to the
public. (In some countries, the data must be reported to regulators,
but they are considered proprietary.)
If drug studies don't reflect well on a product, the company can
simply pull the plug on research and try again. In many cases,
contracts with researchers allow the companies to do so, though
increasingly, researchers are demanding the right to publish
regardless of outcomes.
Compounding the problem is the reality that negative findings are not
attractive to editors of highly competitive medical journals. Given a
choice between a study showing, for example, that a drug can lower
blood pressure by 30 points and one that has absolutely no effect on
blood pressure, it is obvious which one the editor will choose.
And even if negative results do get published in the academic
literature, they are unlikely to make their way into the mainstream
press. The same phenomenon is at work: "New pill could curb hunger" is
a much more attractive headline than "Still no luck in finding a drug
to treat obesity." The only exception to this rule is when research
goes wrong, such as: "Diet pill actually makes people fatter."
But that does not mean negative results should be discarded or hidden.
A case in point are the recent reports that children and adolescents
taking a new class of antidepressants called selective serotonin
reuptake inhibitors (SSRIs) have more suicidal thoughts. It turns out
that drug companies knew this from research, but the results had been
suppressed.
This led to widespread condemnation of the practice of selective
release, in particular from editors of major medical journals, who
demanded clinical trial registries. New York State's Attorney-General
went further, accusing the company GlaxoSmithKline of fraud for
concealing the data about one drug, Paxil.
The World Health Organization is also getting in on the act, saying it
wants to create an international registry.
Individual governments have struggled with this issue for years. The
U.S. created a registry in 1997, but a recent report by the U.S. Food
and Drug Administration revealed that many clinical trials funded
privately -- meaning by pharmaceutical companies -- were simply not
being registered. The registry is also inadequate because it does not
include data on side effects.
Health Canada has its own registry, but it is so shrouded in secrecy
-- because the government takes the position that the information is
proprietary -- that it may as well not exist.
Around $1-billion a year is spent on clinical trials in Canada. A good
chunk of that comes from the public purse through research grants, and
even the privately funded research is a business expense and is,
hence, subsidized by the state.
The public also plays a large and essential role in this research. By
one estimate, done by University of Toronto scientists, as many as 1.8
million Canadians participate in clinical trials each year. They do so
because they believe that by agreeing to be part of an experiment,
they will benefit from treatment themselves and provide invaluable aid
to others in the future.
These willing participants rejoice when a clinical trial gives good
results, but they should be proud too when one fails and prevents harm
to others. If negative results are hidden, nothing is learned, and the
promise made to clinical trial participants that they will advance
scientific knowledge is betrayed.
The results of all clinical trials -- good, bad or ugly -- should be
in the public domain, regardless of who pays for the research. Full
disclosure of clinical trial results will make drugs and other
treatments more effective, cheaper and safer. The right to know must
trump commercial concerns.
The old adage was wrong: What you don't know can hurt you.
apicard@globeandmail.ca
- Next message: Robert: "Re: Cholesterol Guidelines A Gift For Merck, Pfizer"
- Previous message: Don Kirkman: "Re: Concerned about Beta Blockers"
- Messages sorted by: [ date ] [ thread ]
Relevant Pages
|
