FDA's Prasugrel Machinations Seem Bound to Attract Doubt

UPDATE: Dr. Sanjay Kaul was bounced from the FDA’s prasugrel panel after Eli Lilly called the FDA to question his inclusion on the panel, according to HeartWire. The FDA has admitted it made a “mistake” by axing Kaul. “At every step of the way there were errors by multiple parties,” said Janet Woodcock, director of drugs at FDA.

When is a unanimous vote for approval by an FDA panel not a unanimous vote for approval? When it’s the FDA’s advisory panel on Eli Lilly’s prasugrel blood thinner.

An FDA panel voted 9-0 to approve the drug on Feb. 3. But a handful of doctors have expressed doubt about why Dr. Sanjay Kaul of Cedars-Sinai Medical Center in Los Angeles, an expert in the field of vascular physiology, was asked not to participate, according to MM&M. Kaul has previously said that the data presented on prasugrel does not adequately distinguish between patient groups who should receive the drug and those that should not.

The exclusion threatens to undermine the credibility of the panel, according to Dr. Steven Nissen of the Cleveland Clinic, who was at one point regarded as a possible FDA chief. MM&M:

Dr. William Boden, of Buffalo General Hospital in New York, who was not part of the panel, told HeartWire that the decision raised some obvious red flags. In addition, an FDA panel member publicly questioned why the Drug Safety and Risk Management subcommittee wasn’t involved, while another antiplatelet expert criticized the TRITON-TIMI-38 findings. Other critics have charged that the decision to approve prasugrel appeared predetermined from the start.

Now Sidney Wolfe of Public Citizen claims Kaul’s exclusion was a “last minute removal” from the panel that made the 9-0 recommendation. He writes: “The February 3, 2009 meeting of the Cardiovascular and Renal Drugs Advisory Committee took place in a ‘family picnic’ atmosphere, as described by one participant“:

Even more conspicuous was the absence of Dr. Sanjay Kaul, a cardiologist and regular voting member of the Cardiovascular and Renal Drugs Advisory Committee, who was removed immediately before the meeting without explanation.

Note that Wolfe, in addition to his Public Citizen role is also a member of the FDA’s Drug Safety & Risk Management Advisory Committee — the panel that prasugrel did not go through.

If the FDA follows Europe’s lead and approves prasugrel (brand name Efient), doctors will only want to know two things: Is it better than Bristol-Myers Squibb’s Plavix? Or is it safer?

With the FDA’s process raising so many questions before it is even over, doctors could be left scratching their heads as to whether the FDA is giving them the right answers.

Bonus: CardioBrief has a nice chronology of the prasugrel controversy.

• See BNET’s previous coverage of Eli Lilly and prasugrel:
• Lilly CEO Lechleiter’s Prasugrel Bet Appears to Pay Off
• Odds Improve for Lilly’s Prasugrel-ImClone Gamble
  
• In Light of Prasugrel Delay, Lilly-ImClone Deal Suddenly Makes Sense
  
• A Lilly-ImClone Deal May Offer the Drama that CEO Lechleiter Craves

Hat-tip to Pharmagossip. Image: prasugrel