From the New York Times (In Pitches to Doctors, Promise of Big Payday)
Using e-mail solicitations that promise high pay, US HIFU (pronounced you es HIGH-foo) is trying to build and train a network of American urologists for its offshore prostate cancer treatments. “The opportunity before F.D.A. approval is very lucrative,” said one message sent by the company…
But some doctors worry that the money could sway doctors to recommend the treatment, even though it is not approved by the Food and Drug Administration…
According to the solicitations, a doctor providing the company’s treatments can receive up to $7,500, which the company says is five times what doctors earn in the United States for performing other types of prostate cancer procedures…
The chairman of the company, Stephen R. Puckett Sr., said that the company believed that financial incentives did not influence medical judgment. About 30 American medical doctors are fully certified to use the equipment, the company says.
I expect that the FDA will determine that this practice is abusive and find a way to crack down. It’s almost funny for a company to call the opportunity “lucrative” and then have the chairman say financial incentives don’t matter.
US HIFU appears to be pursuing an interim strategy to generate revenue from US patients prior to approval in the US, after which it will presumably stop the practice. (At least this is what I infer from the article.) The idea of sending US doctors abroad is unusual and I don’t know of many companies like this.
But this case has broader implications for medical tourism, which might not be obvious at first glance:
Consider the case of a US-based medical device company that decides not to apply for US approval at all, but rather gains approval in one or more medical tourism destinations where approval procedures may be less stringent. That company then encourages –directly or indirectly– US patients to journey abroad for a procedure involving the device, reaping the revenue from US patients who then return to the US. This could happen to J&J for example, which has announced a new, low end line of medical devices for the Indian market. It seems likely that US patients will end up with “Indian” J&J devices, which will cause some problems when those patients need follow-up in the US. Is J&J going to provide information or support in the US for products that aren’t approved here? It won’t make them too popular with the FDA if they do.
It will be exciting to see where this takes us.January 28, 2008