It’s Big Business!
On his blog, Science-Based Medicine, Dr. David Gorski posted about the pharmaceutical marketing technique of “seeding trials”. I had participated in one such ruse, although I was unaware that it had its own official name. As I commented to Dr. Gorski:
Fascinating article. I had never heard the term, “seed trial”, but the one in which I participated was similar to Merck’s.
My practice was exclusively limited to male sexual dysfunction for over 20 years, so when Pfizer came to me to participate in the VIGOR pre-market “clinical research” on Viagra, I assumed it was related to my expertise. Their final application for FDA approval had already been submitted, but the release date was pending the FDA’s action. By regulation, they could not detail the drug to doctors, nor even discuss it, unless the doctor was conducting “clinical research” in a pre-market trial. I was assigned only 10 patients (”to eliminate biases”), paid $1000 each for my inconvenience and expertise, and assigned an “FDA compliance consultant” who flew to my office several times, supervising every word that my “study director” (my nurse wife) entered into the forms. Both being participants, my wife and I were sent to “The Dolphin” hotel at Disney World to discuss the “research” with the other “investigators”. Airport-to-hotel limo, etc., plus an honorarium for attending. I expected some sort of round-table arrangement for the discussion; in actuality, it was held in the completely-filled grand ballroom. Other “investigator meetings” were being held around the country, and there were many others both before and after the one I attended. The only thing the investigators had in common was an American license to practice medicine. Criteria for patient enrollment were: male under 65, no anti-hypertensives, no diabetes, no hx of CAD or PVD, no physically-detectable penile abnormalities, and no previous evaluation for ED (a more pleasant term the Pfizer CEO commissioned to replace “impotence”). In other words, it was designed for 100% positive response. Before the study actually ended, Viagra was released. I never heard anything further about the study, and I don’t find much when I Google “VIGOR Viagra”, except ads.
At the time (I was told), the marketing branch of Pfizer estimated that the first-year Viagra market was $3 billion (it wasn’t, but that was their best data). That’s $8.2 million per day (counting only work days, it’s $13.6 million). By having a fully-detailed prescription-writing corps of doctors on release day, they could readily afford the costs of the elaborate “pre-market trial”, versus the months of non-productive days by having reps come around and detail “cold” docs after the release. They couldn’t afford not to have the “trials”.
My ethics in the issue are suspect, to be sure. I justified it by saying that I already knew all about the drug, there were no competitors, it filled a necessary niche (previously unaddressed) for my patients, and I was going to prescribe it anyway. Mea culpa.
But I was misled, right? Do I have to give back the money?
This fits right in with economist David J. Balan’s recent post on Overcoming Bias entitled “It is Simply No Longer Possible to Believe”. The basis for his post was this article by Dr. Marcia Angell, fomer editor-in-chief of the New England Journal of Medicine. If you have bothered to read this far, you owe it to yourself to read Dr. Angell’s treatise. I did, and I am so embarrassed for my profession.