Clinical trial safety committees: the devil's spoon
BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7229.244 (Published 22 January 2000) Cite this as: BMJ 2000;320:244All rapid responses
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In principle I agree with what Dr Tom Oomen says, but it is important
not to get carried away. The British Biotech affair was - I think and hope
- a very rare example of something going wrong. The vast majority of
pharmaceutical companies, and especially the big ones, are very well aware
of the dangers of getting too close to the results of a clinical trial
while it is in progress. I was surprised to find out what had happened with
marimastat, but I thought I should write about it as a warning rather than
as an example of a common occurrence.
There are many checks and balances that protect patients in clinical
trials, and the DSMB becomes essential once the trial starts. Before that,
however, ethical committees (IRBs) have the responsibility to check trial
protocols - and one of their routine checks should be to ensure that a
DSMB has been set up, with clear working rules.
I think we need awareness and education about this potential problem,
not another layer of controlling bureaucracy.
John Hampton
Competing interests: No competing interests
Must the industry be kept at arm's length from the development of its
own drugs? Hampton metaphorically comments that he who dines with the
devil must have a long spoon. The length of the spoon would then have to
be directly proportional to the distance between the devil and the diner,
and if the proximity between the two is less there is a likelihood that
the diner may become the devil's dinner. That is precisely what the devil
wants and he is trying to acheive by letting the industry have its own way
in clinical trials.
Ethics is a small word that means a big thing. It is common knowledge
that one of the most powerful forces that can bind a man is the force of
the purse. The glut for financial gains has undoubtedly caused perversion
of justice and ethical practice. Every business house would certainly like
to see an upward trend in its profits and promotion of its products, but
at what price? Is health for sale? The drug firm that has its own research
and development unit would certainly like to make the fullest use of its
expertise. It might seem to be totally out of place for one drug firm to
request the services of the R&D unit of another firm. That is
precisely where the national government should step in.
Since the days of the thalidomide disaster the medical fraternity has
been strongly voicing and echoing the need for clinical trials safety
committees. In the interest of the drug firms these committees have been
set up by the drug firms themnselves and it is not difficult to procure a
valid licence for manufacturing a drug on the basis of reported clinical
trials. Common sense shows that every drug firm would like to promote its
own product as the best in the world or the safest among alternatives.
And with the FDA openly showing its willingness to licence drugs which
have been declared unfit for consumption the industry has been invited to
dine with the devil himself.
The moot point of the issue would then be whether it is really
possible for the drug enforcing authority to keep the industry at arm's
length from the development of its own drugs. Theoretically, yes. But what
does the ground reality show? Perhaps that by keeping the firm away from
the development and trials of its own drugs a wider nexus is fanned,
involving researchers and scientists frpom other parts of the country, or
even outside. Very few people would decline a foreign trip at company cost
to do this kind of work, and what makes it worse is the very thought that
this would promote a culture of mutual admiration, appreciation and
acceptance.
There is absolutely no doubt that so long as the industry has a
vested interest in its own product (and which industry would not?) it
should be kept not just at arm's length but at a bargepole's distance from
the development of its own drugs. One possible alternative could be to
have an independant government-recognised scientific agency comprising
medical experts of different disciplines and drawn from different parts of
the country; entrust to them the task of evaluating the reports of any
study, the reports being sent by the individual workers in sealed
envelopes, postage to be paid by the drug firm which is responsible for
developing the drug, the costs involved in getting the apex body together
should be borne by the State which in turn collects the revenue from the
drug firms, the payments being proportional to the intended retail price.
This would also encourage the drug firms to reduce the retail costs of
drugs and promote the research of valid, essential and cost-effective
drugs.
It would also show the consumer the transparency of the scientific
community, so that adverse effects of drugs are not printed in a text of
four-point font size and language which is too technical for them to
comprehend. I would give the devil his due, and if he deserves a kick in
the back I would not hesitate to give it to him.
Competing interests: No competing interests
Bottom line: victims pay the ultimate price for "dancing with the devil"
As a co-spokesperson for victims, including myself, and a researcher
of a drug which has been touted in many of the accepted and revered
journals and other publications as a "safe and efficacious" drug, I read
with great interest this article which once again illustrated the critical
need for a mandated distancing between pharmaceutical companies and any
practice which may ultimately adversely affect the lives of those they
profess to be in the business of "helping."
Though the article deals with the need for outside safety monitoring,
I would also like to bring to your reader's attention yet another loophole
which some manufacturers questionably slither through in their feverish
attempts to keep their stocks flying high: namely, manufacturer funded
clinical trials, paid honorariums, and the utilization of a number of the
same clinical researchers, investigators and alleged "expert" panelists.
Through my extensive research, I have found that the manufacturer of
the particular drug which I am addressing has seen to it that 27 different
doctors, appearing in different constellations of coraboration, have been
the authors of 23 different studies and trials touting a number of
different advantages of the drug and it's purported superiority to other
drugs within it's classification. These studies cover a span of 15 years,
with one doctor showing up as one of the primary investigators in 14 of
the reports since the drug's introduction onto the market up to and
including this year. These individuals' studies, trials and purported
findings have by in large been funded by the manufacturer. Some have
received honorariums from the manufacturer, a few are engaged in
activities actively promoting the drug.
The studies and trials were conducted at a multitude of different
psychiatric and psychological centers and universities around the country,
with the different individuals working together in different
constellations, many of them appearing together numerous times.
Their findings have been published in a number of different
publications including but not limited to The Journal of Clinical
Psychopharmacology, The Journal of Clinical Psychiatry, The New England
Journal of Medicine, and The British Journal of Psychiatry.
This interesting set of circumstances may be the status quo within
the pharmaceutical industry, but, as a survivor and mother of 4 who now
has an acquired neurological movement disorder, a dependence on an
addictive anticonvulsant, who has realized significant reduction in
physical capacity and who has lived through a nightmare of misdiagnoses
before being definitively diagnosed as sustaining these injuries as
secondary to the drug by a professor of neurology at UCLA and two other
neurologists after being exposed to the drug just under two years ago post
3.5 day exposure, I find these practices just a bit unerving, to say the
least.
Due in no small part to these glowing testimonies spoon fed to the
medical profession at large, our beloved "learned intermediaries" have
been given just enough of a taste of half truths to consider themselves
knowledgeable concerning this drug, exonerating themselves from the time
consuming effort of delving more deeply into the most legally protected
product insert information that comes with the drug listing a myriad of
serious adverse effects within it's two page tiny print, disclaimer laden
content.
Due to the slick promotional pamplets and manufacturer perks, far too
many drugs are prescribed without an MD having a clue as to the possible
physical ramifications of exposing their patients to them. The majority of
those victims whom I represent have experienced the same treatment I did
when I first arrived at ER via 911 two times and endured subsequent Urgent
Care visits and doctor visits for months post exposure. Namely, our
doctors were mystified, were highly reluctant, if not downright adament in
their contentions that our physical conditions had anything to do with the
drug.
My reaction and subsequent disability alone was reported in the
manufacturer's product insert to have been reported to have occured in a
minimum of 1 in 100 people in various clinical trials and reports. Where
is that in any of the revered journals and publications? And what of the
deaths, cardiovascular accidents, cerebrovascular accidents, the
spontaneous abortions, the unexplained deaths, the anaphylactic shock
deaths, the severe psychiatric disturbances, the severe neurological
disorders and other serious FDA MEDWATCH reports that show up time and
again listing the drug as the primary suspect drug, though conveniently
disclaimed as being conclusively the result of the drug?
It has been admitted by the FDA themselves that the MEDWATCH system
reflects anywhere from 1% to 10% of the actual adverse events ocurring
with any given drug. Ergo, the beat goes on in the escalating carnage of
human suffering, right in step with the escalating stock value and
overflowing pockets of noneother than the pharm manufacturer itself. No
one is held accountable, as the buck is passed along all the way down the
line, amassed from the pockets of the trusting, unsuspecting public who
has been relegated to the realm of the insignificant, dusty statistics
hidden away somewhere that keep the replacement theology of day alive and
well (inexcusably unlike it's victims), namely, the almight buck.
I, for one, will never quit in my endeavors to support, inform and
continue to work with those who have been devastated by the drug. I will
work towards exposing the truth about this particular drug, as myself and
another advocate have amassed a database of 400 individuals and counting
daily online alone who have lived through and/or are continuing to
experience living hells in replacement of their former lives. Many of
those have lost loved ones after exposure to the drug. And because of them
and the many others who have and will be harmed by this drug, and far too
many of the drugs on the market today, I will work until this dystonic
body of mine takes it's last breath...
Competing interests: No competing interests