Conflict of Interest Case Could Change Disclosure Rules
The congressional investigation into an influential psychiatrist’s failure to disclose more than a million dollars in drugmaker payments is the latest in a spate of conflict-of-interest investigations that may force changes in the way financial disclosures are handled.
According to congressional investigators, Dr. Charles Nemeroff of Emory University earned more than $2.8 million from consulting arrangements with pharmaceutical companies between 2000 and 2007, but failed to disclose at least $1.2 million. Last week, Nemeroff stepped down as chair of Emory’s psychiatry and behavioral sciences department until his relationships with drugmakers can be clarified.
Although Nemeroff is the most prominent physician to be accused of failing to disclose pharmaceutical company payments, he’s not the first. A congressional investigation led by Sen. Charles Grassley (R-Iowa) has uncovered several physician-drugmaker conflict-of-interest cases since the inquiry was launched this spring. Experts in the research field say Grassley’s findings highlight major problems in the overall way physician payment disclosures are handled.
The National Institutes of Health (NIH) and several states have enacted disclosure rules in attempts to limit the amount of income physicians earn from drug companies. These efforts, however, at least as evidenced by the Nemeroff incident, still have to be strengthened
“I think the sort of cumulating drip-drip of revelations suggests first that this whole conflict- of-interest situation is broken,” Dr. Ezekiel Emanuel, chair of the department of bioethics at the NIH, told CWWeekly. “The fact of the matter is, we’ve had a lot of emphasis on disclosure and management and prohibitions and yet we know—or we’re learning—that these aren’t working.”
Grassley is using this latest incident to promote his Physician Payment Sunshine Act, a bill that puts the onus of disclosure on pharmaceutical companies rather than physicians or medical schools.
The bill, introduced in 2007, would require drugmakers and medical device manufacturers to disclose all payments over $500 that they make to physicians. The bill has received support from Pharmaceutical Research and Manufacturers of America, the trade group for major pharmaceutical companies.
Regardless of whether Grassley’s bill or another regulation goes through, experts agree changes need to be made to the disclosure process.
“My own personal view is there is going to be a lot of pressure to change, but I don’t know what the alternative is. I think we need to rethink a different kind of relationship between the manufacturers and the academic medical community. It’s not working, it’s just clearly not working, and we need to change it to make it work,” said Emanuel, who did not comment specifically on Grassley’s bill.
Two companies, Merck and Eli Lilly, have already committed to disclosing physician payments next year regardless of whether the Sunshine Act becomes law. Will the publicity surrounding the Nemeroff case be enough to push the bill through or force Congress to look at other solutions? Emanuel said it is hard to tell.
“Who knows? This is a classic case of predictions. I think it probably won’t because it’s in the midst of a presidential campaign, not enough the focus of attention…On the other hand, who would have predicted [Jesse] Gelsinger? You can’t predict these things; they just happen,” Emanuel said.