Wednesday, June 21, 2006

Are Phase IV trials really "seed" trials-another way to manipulate physician behavior?

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.

Kessler said:
...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.

1 comment:

Victor Santos said...

I´m not a doctor, also I´m a computer engineer (from Portugal) but I have an "hungry mind".
I reach here seeking information about LABA (Long acting beta-agonist) for my asthma treatment. I´ve asthma induced by exercise and after my swimming train I use to take Formeterol (Foradil). Some heart strokes on higher rythms of exercise warning me that something is not going allright. So I decide to leave it, but how could I prevent EIAsthma ? If I take a corticosteroid, and I have for 20 years my colesterol increases and fat body also. What is a fact is that a lot of Olimpyc Gold Medals have EIA. What alternatives could I take ? One thing I could confirm to all of you is that swimming improves your lung function and reduces your asthma crises. But it is not a 100% natural treatment, if you are in a middle of a crises I would advise you to go swimming. What about acunpuncture ? or any other natural treatment ?
My opinion about physician manipulation is that it is a fact, the reason is on your side, but we all know the influence big companies do all over the world. A 100% solution is hard to find but a strong regulation is one of the solutions for controling market predatators.
I´ll be back trying to learn from you.
Good posts.