About-to-be-approved drug could cause fatal hemorrhage
I know I harp on the The FDA a lot, but they just make it so easy… Get this: The FDA is getting close to approving prasugrel, a new drug that, while it could prevent a heart attack, could also cause severe, even fatal, internal bleeding. All because they're speeding through the review process, without fully exploring the safety of the drug, developed by Pharma giant Eli Lilly. Since January 2008, the FDA has been reviewing Lilly's new drug—which, if approved, would be the first real competition for blood-thinner Plavix…Which just happens to be the world's second-best selling drug. Marketed as Effient, prasugrel would be Lilly's first new drug in four years, and could make the company $1 billion a year in sales. Oh, and patents on Lilly's four best-selling drugs will all expire in 2013. So, they're probably pretty anxious for a quick review process. And it's been looking like they could get their wish. But a letter from consumer watchdog group Public Citizen is taking the wind out of their sails. They say this drug may turn out to be a useful new blood-thinning agent, but does not fulfill an "unmet need," and so the FDA needs to slow down and take another look. Public Citizen is calling for another trial using a lower dose of the drug before the FDA makes a decision—of course, another trial could draw out the approval process. Not what Lilly wants to hear. The letter points to a study of 13,000 people, conducted by Eli Lilly itself, prasugrel prevented more heart attacks than Plavix—but it also dramatically increased the risk of internal bleeding. In fact, says the letter from Public Citizen, the risk of FATAL hemmorhage was nearly FOUR TIMES what it is with Plavix. Additionally, an excess of new cancers, especially highly metastatic solid tumors, was detected in the prasugrel group. It may not be a carcinogen, but it could promote cancer due to its excessive antiplatelet activity. Even one of the co-developers of the drug isn't comfortable with the way things are going. The letter is co-signed by Dr. Victor Serebruany, who is listed on a patent application for the drug and worked on the early development. In the letter, Public Citizen expresses concerns over the dose (10 mg daily)—they say in the Phase 2 study, it resulted in complete platelet inhibition in some patients, which would lead to an excess risk of hemorrhage. Serebruany suggested all the way back in 2004 that a much lower dose, more like 3-4 mg per day, should be tested before going ahead with future trials. Serebruany made the same points he makes in the letter when he went before a committee of the FDA's outside advisers, but despite hearing such misgivings from one of the CREATORS of the drug, the committee unanimously recommended approval. While the FDA isn't required to follow the advice of this committee, it usually does. They haven't yet set a deadline for a final decision, but it's expected to come soon. If concerns like this are being raised about a new drug, especially by someone who had a hand in creating said drug, the next step seems obvious. The review process needs to be halted, and the proper clinical trials need to be carried out. And I'd love to know where this committee of "outside advisers" comes from. Sources:
"Letter Urging the FDA to Halt its Review of Prasugrel (HRG Publication #1875)." Public Citizen (www.citizen.org), 6/3/09.
"Consumer group wants halt on review of Lilly drug." Associated Press, 6/3/09. | 
