Paul Alper points to this horrifying news article by Mary Chris Jaklevic, “how a medical device ‘seeding trial’ disguised marketing as science.”
I’d never heard of “seeding trials” before. Here’s Jaklevic:
As a new line of hip implants was about to be launched in 2000, a stunning email went out from the manufacturer’s marketing department. It described a “clinical research strategy” to pay orthopedic surgeons $400 for each patient they enrolled in a company-sponsored trial. . . . Ostensibly the trial was intended to measure how often liners of the Pinnacle Hip System, made by Johnson & Johnson’s DePuy subsidiary, stayed in place after five years. But according to a newly published review article [by Joan Steffen, Ella Fassler, Kevin Reardon, and David Egilman], the trial was really a scheme to gin up sales momentum under the guise of scientific research.
How did the scam work? Jaklevic explains:
The internal company email outlined a “strategy for collecting survivorship data on PINNACLE while maximizing our impact on the market.” It said the trial would include a large group of 40 surgeons in order to achieve “very fast patient enrollment” that would generate sales of 1,000 implants in a year.
While $345,000 would be paid to doctors, it said, “The sales revenue estimate for this study is $4.2 million.” . . .
“Seeding trials are one method by which drug or device companies can just pay physicians for using their products without calling it an actual bribe,” said Adriane Fugh-Berman MD, a professor of pharmacology and physiology at Georgetown University . . .
According to the paper, the trial generated millions in sales but yielded no valid research findings, although the company heavily manipulated the data it did collect to show a false 99.9% success rate that was used in promotional materials. . . .
Dayum. 99.9% success rate, huh? You usually hear about that level of success; indeed the only examples I can think of offhand are old-time elections in the Soviet Union, and the replication rate as reported by the Harvard psychology department.
Here are some details:
J&J violated its own clinical research guidelines in manipulating data, delaying reports of adverse events and failing to follow parameters established for the study, such as not reporting results until all patients had been enrolled for five years and not retrospectively enrolling patients, it says. In some cases there were no patient consents. One surgeon continued to enroll patients in the trial and submit data even after his hospital’s review board refused to approve his participation in the trial.
Further, the company went to elaborate lengths to show a 99.9% success rate for five years, using sleights-of-hand such as not including certain types of device failures and hiding the fact that just 21 patients had been followed for a full five years.
Wait a minute. If there are only 21 patients, then the success rate could be 21/21 = 100%, or 20/21 = 95.2% . . . How do you get 99.9%?
Eventually, the bogus trial data was used as the “fundamental selling point” in Pinnacle marketing, providing physicians and patients with “a false sense of security,” the article says. The incredible near-perfect track record appeared in ads in medical journals, patient brochures, and ads in consumer publications such as the Ladies’ Home Journal and Golf Digest. . . .
Some of those ads featured an endorsement from Duke University basketball coach and hip implant recipient Mike Krzyzewski, even though Krzyzewski didn’t have Pinnacle implants. Krzyzewski’s osteoarthritis awareness promotions were covered uncritically by USA Today, the Florida Times- Union, and CBS News, only the latter of which mentioned he was paid.
No . . . not Coach K! All my illusions are shattered. Next you’re gonna tell me that Michael Jordan doesn’t really eat at McDonalds?
P.S. Concern with “seeding trials” is not new. Alper wrote about the topic in 2011, citing a Wikipedia article that pointed to a journal article from 1996. But it keeps happening, I guess.
P.P.S. Full disclosure: I’ve been a paid consultant for pharmaceutical companies.
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