Can You Test A Drug And Also Say Negative Things About It? 8

In my last post I raised the possibility that Steve Nissen, a highly influential cardiologist who has been an outspoken critic of industry influence in medicine, might have his own conflict of interest (COI) problem. In response, another cardiologist, James Stein, said that my post was unfair in its treatment of Nissen and failed to consider important distinctions and subtleties in the academic literature about conflict of interest.

Let me first of all confess that Stein– for whom I have the highest possible regard– makes some excellent points. And I further admit that my piece pretty much ignored some of these fine academic distinctions. But I also think it’s likely that we may have a forest and trees situation here and that by focusing on subtle COI distinctions it is possible to lose sight of the larger issue.

A Simple Test

Rather than focus on the subtle distinctions between different types of COI I’d like to propose a much simpler way to think about this problem as it exists in the real world. Here’s the test I would propose: can you imagine Nissen, or indeed anyone in a similar situation (running a large multimillion dollar trial of a drug) publicly saying something decidedly negative or critical about the drug?

Click here to continue reading…


More Sunshine: CMS Wants Companies To Report Payments To Physicians For Medical Education Reply

In a major reversal of policy, CMS wants industry to report payments to physicians for continuing medical education. The move would eliminate from the Physician Payment Sunshine Act the current exemption for CME.

Initially CMS’s  proposal for implementation of the Sunshine Act required industry to report payments to physicians for CME programs. But after considerable debate and lobbying from industry, the final rule included an exemption. As a result, companies are not now required to report payments to speakers at accredited CME events as long as the companies don’t select the speakers or directly pay them.

CMS now appears to have changed its mind. Near the end of its list of proposed changes for next year, CMS is proposing to eliminate the exemption:

Click here to read the full post on Forbes.


A CME Program Begs The Question: Promotion Or Education? Reply

In recent years defenders of commercially-supported continuing medical education (CME) have claimed that the industry has cleaned up its act and that CME programs today are largely free of the abuses that were so common not so long ago. Perhaps. But there are still plenty of examples of programs that violate the fundamental principle that medical education should be completely separate from commercial interests.

A striking example is a recent email I received from TCTMD, the online arm of the Cardiovascular Research Foundation (CRF), which is basically the equivalent of the Vatican for interventional cardiologists. The subject line of the email was nothing out of the ordinary:

Sponsored Message from Volcano: ADAPT-DES Webcast and Investigator Interview

I get lots of these sort of messages from different medical organizations. I’m not crazy about them but I understand that these groups have to pay their bills. But it’s vitally important that these groups maintain a clear separation between commercial messages like these and genuine educational content.

The text of the email makes some astonishing claims. It makes the case– not surprising in a promotional message– that interventional cardiologists should use IVUS more often during their procedures. But the text fails to mention that the numbers mentioned in the text come not from a randomized controlled trial but from an observational study. The findings thus should be considered hypothesis generating. In addition, as is so often the case when medical results are being hyped, the relative differences sound quite impressive– 50% reduction in stent thrombosis and 33% reduction in MI– but the absolute differences are much less impressive: at one year stent thrombosis was reduced from 1.04% to  0.52% and MI was reduced from 3.7% to 2.5%. And remember, since these differences are not the result of a randomized comparison they may be completely illusory.

Click here to read the full post on Forbes.