Rx Week in Review #2
Big news week: FDA laid out the problem and its plan around import safety, and Glaxo paid out $40.75 million in further settlements to states for knowingly selling adulterated or potentially-contaminated drugs. Other headlines of note: Supremes strike down VT data-mining law
The U.S. Supreme Court struck down Vermont’s prescription data-mining law yesterday, saying that drug companies’ purchase of physicians’ prescribing records is protected speech under the First Amendment. Kevin Outterson over at the Incidental Economist (and one of the attorneys who filed an amicus brief in support of Vermont on behalf of the New England Journal of Medicine) has a good early take about the decision and what it might mean for future data privacy laws.
“The Vermont statute suffered from self-inflicted wounds, namely some incautious comments in the preamble that the plaintiffs/respondents hammered away at: Vermont said it was intervening in the “marketplace of ideas” by regulating the use of prescriber-identifiable information for pharmaceutical marketing. Bad move.”
The decision is a bad move for patients and physicians, whose prescribing records are sold—often without their permission—to drug companies who use the data to target their individual sales pitches.
Outterson writes that for those concerned that the case could open the door for loosening of restrictions on off-label promotion to docs, “the decision will not calm these fears.” More here.
AMA committee says no to commercial CME
This week, the American Medical Association ethics committee voted to largely do away with commercial funding of continuing medical education, or CME.
Dr. Daniel Carlat, ex-drug rep and CME watchdog points out on his blog that because of the way accreditation is done, the physicians group’s move forces the ACCME to redefine its standards around industry support. Both Carlat and Ed Silverman at Pharmalot point to caveats that could matter much in the interpretation of the committee’s rule. Still, Carlat called the move huge.
“We have finally entered the era of post-deception medical education,” Carlat writes.
COI survey shows risks, rewards of academic-industry ties
And a large survey from 2008 published in Health Affairs this week found that just over half of life sciences researchers (52.8 percent) have relationships with industry, and those who do have industry ties tend to be more academically productive (publishing rate and service activities, for instance).
The authors also asked researchers whether industry support compromised scholarly objectivity. Reporting the survey results at last week’s PharmedOut conference in Washington D.C., co-author Eric Campbell of MGH found that 41 percent of academic researchers said industry ties did threaten objectivity; predictably, perhaps, those who had speaking or consulting relationships were less worried about that risk than those who didn’t.
These findings underscore the need to continue to manage these relationships without stifling important academic-industry collaboration, but also dispel the myth that finding a conflict-free academic to serve on an advisory committee is an impossible task.
–Kate Petersen, PostScript blogger