Massachusetts officials allow huge loophole in new drug payment disclosure regulations

Kudos to The Boston Globe for revealing a big loophole in Massachusetts' new disclosure rules for health professionals: doctors who receive lucrative consulting and research funding from drug companies do not need to disclose these payments under the proposed regulations.

The new rules would require Massachusetts physicians from accepting free meals, gifts and vacation junkets from drug companies and mandate that they report any money they receive to promote drug company products. However, according to a memo from the Health and Human Services' deputy general counsel, the proposed regulations do not cover "bona fide services" for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education.

In other words, the disclosure requirements won't cover the kind of back-room payments to doctors that create the conflicts of interest that health advocates worry about most. As Tufts University professor Jerome Kassirer, author of On the Take: How Medicine's Complicity with Big Business can endanger your Health told The Boston Herald yesterday, "We shouldn't be hiding any kind of personal relationships between pharmaceutical companies and physicians, because of the possibility that any kind of money that goes to physicians could produce some sort of bias."

Not could, does. Research shows that doctors who receive personal payments from drug companies are much more likely to report and promote positive findings about the company's products than doctors who don't have these conflicts.

In a statement, Massachusetts Public Health Commissioner John Auerbach said the state's public health council allowed the loophole to keep clinical trials in the state. In other words, it caved into pressure from the drug and medical device companies.

It looks like we're going to have to wait for passage of the national Physician Payment Sunshine Act to get any kind of meaningful reform. That law, introduced by Sen. Chuck Grassely last year, would require companies to disclose any payment they made to health professionals in excess of $500 per year (back story). Unless, of course, Massachusetts citizens decide they've had enough and make their voices heard at the two public hearings being held on the new regs in January; see press release.

Wouldn't that be a hoot?