|
July 05, 2011
from
PreventDisease Website
Spanish version
Seeding trials are primarily designed
with a devious intention to appear as if they answer a specific
scientific question, but all they really do is fulfill marketing
objectives for pharmaceutical companies.
It is this common pseudo-clinical trial
employed by
Big Pharma which allows them to
conduct hundreds of randomized trials every year to get thousands of
doctors to prescribe new drugs.
“This practice - a seeding trial -
is marketing in the guise of science,” write Harold Sox and
Drummond Rennie, in an editorial in
Annals of Internal Medicine.
“The apparent purpose is to test a
hypothesis. The true purpose is to get physicians in the habit
of prescribing a new drug.”
In that journal researchers - led by
Kevin Hill, of McLean Hospital, Belmont - use documents obtained
through litigation to analyze the ADVANTAGE trial of drug
Vioxx and
to show that it was "designed and executed" by Merck's marketing
division.
These documents have previously been the
source of other damaging allegations against Merck (see this
Nature story).
A seeding trial or marketing trial is a form of marketing, conducted
in supposedly the name of research, designed to target product
sampling towards selected victims of the industrial pharmaceutical
complex. The primary objective of these trials is to introduce the
concept of a particular medical intervention - such as a
pharmaceutical drug or medical device - to physicians, rather than
to test a scientific hypothesis.
In the seeding trial, the marketing department of a pharmaceutical
firm recruits physicians to participate in clinical research.
The drug company pays the physicians for
their participation, designs the study, collects and analyzes the
data. The physician has only to prescribe the drug to his or her
patients.
The typical seeding trial, however, is unlike a proper
clinical trial in that,
In such trials, many, many physicians are signed up as
investigators, so that each only has to sign up a few patients, and
the drug company pays them for each patient and provides all the
support necessary for monitoring and paperwork.
Meanwhile the reward for physicians
participating is the prestige of being an investigator for a
clinical trial, coupled with in essence no penalty because the drug
company more than reimburses for the time spent, which isn't all
that much given that each physician only has to sign up a few
patients.
In reality, however, the design of the
trial is very inefficient. For a real scientific question being
tested in a clinical trial, it would be far more efficient to
concentrate the patient accrual in a few large academic centers that
could find patients much more quickly and already have the
infrastructure to do clinical trials. But for seeding trials the
scientific question is almost besides the point, an afterthought.
The real, unstated purpose of such
trials is to expose as many doctors as possible to using the drug
and thereby make them comfortable using it. The real purpose of
seeding studies is to make these physicians advocates for the new
drug.
The real purpose of seeding trials is marketing, not science.
(Respectful
Insolence)
"Why would a drug company go to the
expense and bother of conducting a trial involving hundreds of
practitioners - each recruiting a few patients - when a study
based at a few large medical centers could accomplish the same
scientific purposes much more efficiently?
The main point of the seeding trial
is not to get high-quality scientific information: It is to
change the prescribing habits of large numbers of physicians,"
as stated in the editorial by Sox and Ronnie.
According to an article published in the
June 27th issue of the Archives of Internal Medicine a clinical
trial of
gabapentin, that was supposed to be for studying dosages of
the drug, could actually be nothing more than a seeding trial
designed to expose more docs to the drug and ultimately to dupe them
into writing more prescriptions for the stuff.
Sadly, the questionable gabapentin trial, called “Study of Neurontin
-
Titrate to Effect, Profile of Safety [STEPS],” resulted in not just
one but two articles being published in major medical journals.
Yet when independent consultants
reviewed the documentation from the trial all kinds of alarm bells
went off.
To start with the study was shoddily designed. It was both
uncontrolled and unblinded making the quality of the data coming out
of it dubious at best. But even worse documents from the study
shockingly suggest that Pfizer’s marketing team could have been
involved in data collection!
In fact, the documents appear to suggest that the marketers saw the
trial itself… not just the end results… as an excellent promotional
vehicle for their cash cow gabapentin.
A 1994 article in The New England Journal of Medicine by former FDA
commissioner David Kessler et al. states:
Some company-sponsored trials of
approved drugs appear to serve little or no scientific purpose.
Because they are, in fact, thinly veiled attempts to entice
doctors to prescribe a new drug being marketed by the company,
they are often referred to as "seeding trials."
Features that distinguish such
trials from scientifically rigorous studies include the use of a
design that does not support the stated research goals, the
recruitment of investigators not because they are experts or
leading researchers but because they are frequent prescribers of
competing products in the same therapeutic class,
disproportionately high payments given to "investigators" for
their work (although the only work may be to write prescriptions
for the drug), sponsorship of the studies by the company's sales
and marketing division rather than its research department,
minimal requirements for data, and the collection of data that
are of little or no value to the company.
Typically, these trials involve
introducing a new drug in a crowded therapeutic class. The
success of such a new product may depend on undoing physicians'
comfortable habits of prescribing a competing, more established
product.
(Kessler
et al., 1994)
A bureaucratic solution, such as relying
on institutional review boards, could help to rid us of seeding
trials, but simply shining a bright light on their existence may
have already sown the seeds of their destruction.
The next step would be a societal
consensus that it is wrong to deceive institutional review boards
and participants about the true purpose of a trial.
Another solution is just to
get rid of Big Pharma all together!
|