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Who Should Promote New Drugs and Devices? — The COI Balancing Act and Transparency

William Sacks

Vice President, COI Product Management

01257766_WB_CR_HCCS-Blog-Images-1_The Conflict of Interest Balancing Act

One of the challenges that governmental and institutional authorities face in evaluating the efficacy and cost effectiveness of therapeutics is determining who to rely on for technical and scientific support.  On one hand, who better to explain the relative advantages of a new product than the inventor of a device, or the researcher who has overseen the development of a new and promising drug? On the other hand, who could be more invested in a favorable determination on safety and effectiveness?

Should researchers who have received funds from a drug or device company be prohibited from testifying about products from that company? During the approval process, you would think all the cards are on the table, so to speak. The vested interests of the direct participants are usually known and can be taken into account as benefits and potential costs are weighed. When a product evolves past the approval stage, however, potential conflicts are harder to identify.

Once a drug or device is approved, the tremendous marketing muscle of the relevant industry comes into play. Millions of dollars are spent to cultivate “Key Opinion Leaders” at prestigious institutions to act as consultants, author journal articles, sit on advisory panels, and give talks promoting new products. How should the line be drawn between providing valuable education on important new therapies, and promoting new and more expensive products which add little to existing therapies?

The critical element is trust, and the only way to engender trust is through transparency. The fact that a physician received money from industry should not automatically disqualify them from speaking about a product, but patients and physicians listening to that talk should be able to take into account all the factors which might have influenced that speaker. Several of the COI “scandals” over the last 5 years had as much to do with a lack of transparency as anything else. Failure to disclose potential conflicts implies a desire to hide something.

Next year the “Physician Payment Sunshine” provisions of the Affordable Care Act will make payment information much more readily available. Once the public and the media get past the “shock” of all this new data, perhaps we can have a more informed conversation about expertise, and influence and trust.