There’s nothing like irony, is there? Last September, Peter Smith stood before an FDA advisory committee and attested to the safety and effectiveness of Trasylol, the controversial med that was approved in the US in 1993 to reduce transfusions and bleeding during open-heart surgery, but was later linked to kidney failure and death. Smith, the chief of thoracic and cardiovascular surgery at Duke University Medical Center, was present on behalf of Bayer, which had already weathered a scandal over safety data that wasn’t provided to the FDA and was again defending the drug’s usefulness.

Here’s what Smith had to say: Trasylol “has a favorable risk-benefit profile when used in accordance with the label. It reduces blood loss, transfusion, re-exploration and it may reduce stroke. It is effective in patients with complex and evolving anti-platelet therapies that we have to deal with every day…It is an essential therapeutic option for CABG-surgery patients at increased risk for bleeding and transfusion,” according to the FDA transcript of the meeting (pages 153-154).

At the same time, however, 11 of Smith’s colleagues from Duke’s anesthesiology and surgery departments were wrapping up a review of 10,275 patients at Duke and found that Trasylol posed a 27 percent greater likelihood of death than a rival drug a decade after open-heart surgery. They presented their findings to the New England Journal of Medicine in November, when Bayer suspended sales after a pivotal Canadian trial linked the drug to higher death rates. Bayer promptly dismissed the Duke study.

So we asked Smith if he has since changed his tune and is a little less bullish on Trayslol, especially given that so many of his own colleagues had uncovered reasons to be skeptical of the drug. Smith, however, refused to respond to repeated phone and e-mail messages. A Bayer spokeswoman declined to comment because the drugmaker doesn’t discuss “confidential” agreements with its consultants.

The lead author of the NEJM study, Andrew Shaw, did reply: “Peter Smith is the chief of cardiac surgery at Duke, and he did not take part in this research project. You are correct in that he has been a consultant for the manufacturer, but there was absolutely no pressure - either explicit or implicit - on me either to withhold publication or to report it differently. Duke University is proud of its long track record of impartial clinical research, and we believe this paper is a good example of the value of long term observational studies of clinically relevant endpoints following drug therapy.”

We should add, however, that Smith’s office did respond to one question. Last September, Smith hosted a Medscape CME about Trasylol, which was supported by Bayer. The funding was disclosed, but not Smith’s consulting relationship with the drugmaker. We sent the appropriate links (this and this) to him by e-mail. He never responded directly when asked why the disclosure wasn’t made, but he directed his assistant to contact Medscape to correct what was described as ‘confusion’ over the disclosure. Medscape made the changes. (Another CME speaker, Keyvan Karkouti, also served as a Bayer consultant in 2006, according to the transcript of the FDA meeting, but this remains undisclosed on the Medscape page). If you click on the ‘read more’ link below, you can read their e-mail exchange.

Dear Annette,

As a follow-up to your email, please be advised that we have updated the
disclosure on Medscape’s CME program as they relate to Dr. Smith.

http://www.medscape.com/viewarticle/563449

http://www.medscape.com/viewprogram/7877_authors

I am sorry for any confusion,
Sincerely,
Deborah

Deborah Johnson
Supervising Associate Editor
Medscape LLC
76 Ninth Avenue
Suite 719
New York, NY 10011
212-301-6694
212-301-6711 (fax)
debjohnson@medscape.net

________________________________

From: Annette A Sullivan [mailto:annette.sullivan@duke.edu]
Sent: Thursday, February 28, 2008 8:55 PM
To: Johnson, Deborah
Subject: Fw: Trasylol
Importance: High

Good Evening Deborah,

There appears to be confusion regarding Dr. Smith’s disclosure submitted
to you for the Medscape meeting on September 18 in Atlanta, Georgia.

Please ensure these two web sites are corrected to indicate what he
actually disclosed. For your reference, I have attached his actual
disclosure form.

Thank you,
Annette Sullivan
Assistant to Peter K. Smith, MD
Professor and Division Chief
Cardiothoracic Surgery
Duke University Medical Center
Phone: (919) 668-0440
Fax: (919) 681-7905
Email: sulli039@mc.duke.edu

—– Forwarded by Peter Smith/Thoracic/Surgery/mc/Duke on 02/28/2008
03:39 PM —–