July 05, 2011
from PreventDisease Website
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.
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
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)
According to an article published in the
June 27th issue of the Archives of Internal Medicine a clinical
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.
Yet when independent consultants
reviewed the documentation from the trial all kinds of alarm bells
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.