Pharma Blog Watch

Torcetrapib Troubles (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses data recently released by Pfizer on its investigational cholesterol drug torcetrapib — "Pfizer's best hope for replacing Lipitor sales when Lipitor goes off patent" — showing the drug caused a rise in systolic blood pressure. "Does this blood pressure finding, 1-2 mm higher than what was seen in Phase II, really change the outlook for approval? Yes and no," he writes. "I think what it does is cement the need for an outcomes study preapproval, but I also think this was likely to be required anyway, and Pfizer was simply being overly optimistic to the public after Phase II."

"Finally, I wouldn't try to transfer the experience of torcetrapib to therapies aimed at increasing HDL-C through mechanisms other than CETP inhibition. The only relevant lesson is that sponsors must expect and plan for an outcomes study preapproval for virtually any chronic-use cardiovascular drug with a new mechanism of action. Plaque reduction studies are nice but aren't going to cut it for most new drugs."

Reevaluating Risk (Health Business Blog)
In his entry, blogger David Williams writes about a talk Biogen Idec's CEO Jim Mullen gave at a conference last week. Mullen spoke about drug risk. "He wants us to regain perspective on risk," Williams writes. "The 'safe and effective' mantra doesn't make sense. Actually drugs are inherently unsafe, even OTC products. Instead we should look at the risk of unforeseen outcomes (i.e., adverse events) versus the risk of forgoing therapy."

"Naturally he offered the example of Biogen's Tysabri, an effective drug against [multiple sclerosis] that can cause a deadly brain infection. From the FDA's perspective, keeping the drug off the market was good because it meant avoiding harm, but patients looked at it differently: many wanted Tysabri back because they were willing to take the risk," he writes.