Dr. Bruce M. Psaty, a prominent clinical epidemiologist from Seattle, plunges into the topic of Phase IV drug trials in the June 21, 2006 issue of JAMA.
Phase IV trials are post marketing trials that,quotes Psaty, were discussed in a 1994 NEJM article by former FDA head David Kessler as a main technique to promote "me too" drugs.
...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 "seed trials"...[features 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 [and] sponsorship of the studies by the company's sales and marketing division rather than its research department."
Clearly these seed trials are not high quality studies.Psaty talks about what distinguishes high quality studies. Randomization is not enough.
Psaty says that blood pressure drugs are commonly promoted in these trials.
"industry has supported thousands of small short-term randomized trials..."
Most of these seed trials proudly promote themselves as "randomized" and many are but randomization does not equate to a quality trial nor to one that asks a worthwhile scientific question or is otherwise well designed. As Psaty says other features need be present such as blinding,completeness of followup,ascertainment of outcomes to name a few.Randomization is not a sufficient condition for a trial to be worthwhile and/or meaningful and non-trivial.
At times,big pharma and the contract research organizations have taken some of the concepts and rhetoric of EMB and misused them to promote various products by funding and executing these largely bogus seed trials which may have influenced not only the physicians who participate in them but the other physicians who hear from the "thought leaders" how these randomized trials favor one brand over the other. A veneer of evidence based medicine is glued over what is no more than a promotional activity. If big pharma may have corrupted the EBM process, how should the physicians who take part in them be characterized?
Two nouns come to mind; dupes and co-conspirators and I wish I could think of some less pejorative words as alternatives. Some are simply naive and do not understand what is really going on. Some of the academics, however, probably cannot plead ignorance. They either know better or at least in recent years should know better.