It’s Big Business!

Posted on January 5, 2009. Filed under: medical ethics, Medical marketing, Sexual issues |

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.

 

 

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3 Responses to “It’s Big Business!”

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Hi Dr. Chip,

I have to admit when I changed med. groups/hospitals for our coming baby I did rely upon a famous name and anecdotal internet reviews. Where might I look for more stats?

Thanks,
Jeff

@Jeff:

Outcomes in obstetrics are usually reflected as “infant mortality rates” and “maternal mortality rates”. Here are a couple of web sites I found with those statistics for the Los Angeles area; I’m sure there are others. A call to the administration of the hospitals you are considering may result in their specific results, which you could compare to the overall rate.

http://lapublichealth.org/mch/fhop/fhop98/individ/p81.pdf
http://publichealth.lacounty.gov/mch/ReproductiveHealth/LACMQCC/lacmqcc.htm

The Medical Board of California may be able to give you information about the malpractice or disciplinary records of physicians you are considering.

That said, putting the whole picture together is much more complicated. First, I would avoid teaching hospitals unless your wife is having a complicated pregnancy involving expected protracted special care for the newborn, and even then, many private hospitals have fine neonatal intensive care teams. While Robin Hanson seems to think that people go to teaching hospitals for “status”, those with common problems usually go there because they are on welfare, Medicaid, or Medicare without supplemental insurance. Second, whatever hospital you choose may or may not be used by whatever doctor you choose. Third, whatever doctor you choose, you must consider the entire group with which he/she takes call, since 2/3 of every day is not during “regular business hours”, and unborn babies don’t know that. The odds are relatively slim that any one doctor will actually be the one who handles the labor and delivery, unless it is a scheduled C-section or induction. Most groups have the pregnant woman see all the doctors prenatally so that a relationship is formed to cover this situation.

Once you know your insurance options, I think you would do well to look around for intelligent couples who have already been through the process and get their feedback on doctor groups and hospital experience. Attentive monitoring of the mother’s progress during gestation is the best insurance against labor and delivery complications; previous mothers will know the level of prenatal attention they received. Hospitals (and some doctors) do a lot of marketing (one way or another), but it’s difficult to fake the actual product as experienced by the consumer.

Lastly, remember that throughout most of the world, and for most of the time that modern Homo sapiens has existed, most babies were/are born without any medical intervention. The “advanced” US system, with all its interventional capabilities, ranks somewhere in the 20’s worldwide for mortality results.

Why don’t you keep posting, this is good stuff, and just confirms what I have suspected for years?


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    About

    The director of the Sexual Medicine Center leaves penile implants behind, and launches a quest for knowledge about Artificial Intelligence, extended life, and the issues inside the health-care industry.

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