The Wall Street Journal reports that the FDA is starting to police the medical-device industry a little bit more closely. Advanced Neuromodulation Systems, Inc. is a case in point:
U.S. regulators are looking into past promotional practices at Advanced Neuromodulation Systems Inc., which several years ago offered doctors $1,000 if they implanted a pain-management device in certain patients for a five-day trial, according to a person familiar with the situation. Although the scope of the investigation couldn’t be determined, ANS, of Plano, Texas, disclosed in its quarterly earnings report last week that it had been subpoenaed by the inspector general of the Department of Health and Human Services regarding its promotional practices.
Documents recently reviewed by The Wall Street Journal, labeled “ANS Sales Bulletin,” outline how doctors would be encouraged to implant the ANS device in patients who had failed to get better on a competing device made by Medtronic Inc. (Usually patients try the spinal stimulator for five days, and if it alleviates their pain, the device is permanently implanted, in a short surgical procedure.) The documents referred to the initiative as the “Renew ReTrial Program” and said it was an “initiative” intended “to collect data to compare the efficacy” of the competing devices.
The doctors were to collect information about the patient’s condition and response to the ANS device and report back to the company. They would be paid only if they implanted the device in at least five patients. The documents said doctors would be compensated for providing “data collection and management of the trial process” on a one-page form, according to a review of the documents and the person familiar with the matter.
Physicians, or more commonly the universities or hospitals they work for, do get paid for conducting large-scale clinical trials that can involve hundreds or thousands or patients and take months or years to complete. A question that investigators have studied in prior cases has been whether payments to individual doctors constituted compensation for clinical trials, or inducements to use a medical device or drug.
