I think that some people are not surprised by this article. I am not surprised as I have had a niggling in the back of my mind about this when well established FDA approved drugs end up in trials without FDA making the request. This article in medscape dot com finally puts this out for doctors and research clinicians to see what happens.
This is one time that Parke-Davis, a subsidiary of Pfizer, got exposed for their unethical practices. If it had not been for litigation against Parke-Davis for illegally marketing gabapentin (Neurontin), this may not have seen the light of day.
Joseph S. Ross, MD, MHS, from Yale University School of Medicine, New Haven, Connecticut, and his colleagues were consultants to the plaintiffs and so had access to emails, memos, depositions, and other documents uncovered during the litigation. In studing these materials, they came to the conclusion that the trial was really being used for marketing purposes.
G. Caleb Alexander, MD, from the University of Chicago, Illinois, commented in an accompanying editorial that seeding trials threaten the integrity of phase 4 clinical trials.
Dr Alexander did offer some tips for physicians and patients so that they can avoid becoming participants in “seeding trials”. He said that clinicians should be on the lookout for the following characteristics of the study.
Does the study investigate a compelling scientific question? If no – red flag up.
Is there a large number of investigators with a small number of patients per investigator? If yes – red flag up.
Do the investigators themselves have limited to no clinical trial experience? If yes – red flag up.
If the clinician asks if the marketing division has a role in the conduct of the trial? If yes – large red flag up - waving.
To this Dr. Ross adds, if the company only wants you to enroll 5 to 10 patients – please be wary. They may not be interested in the drug as they may be more interested in you for future sales.
Dr. Ross says that participating in one of these trials is not illegal, but is unethical. It violates a number of ethical norms and clinical trial conduct rules. The patients are exposed to some risk because they are not aware that the trial is a marketing trial.
These types of studies very seldom see print because they involve deception, but this is interesting from what this trial reveals about the the drug companies and the lengths they will go to for sales.
Read part of accompanying editorial here, and the abstract here.
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