Acomplia -- Score One for the FDA :: Michael Shulman's Biotech Blitz

Acomplia -- Score One for the FDA

It simply was not worth the risk for the loss of a grand total of fifteen pounds!

Both advocates and neutral parties said it would be one of many tools needed for the nation's healthcare arsenal that's deficient in the tools needed for the current epidemic in obesity. That's a fair point, but would you want to send our troops into battle with hand grenades that could blow up before the pin is pulled?

The rejection of the drug reminds of me of the paucity of products and research, not only in obesity but within Big Pharma pipelines. Acomplia really was not a blockbuster in the wings - and if its creator, Sanofi-Aventis (SNY), were not desperate for a big revenue producer, it would have fine-tuned the drug and/or the trials. But SNY didn't, and instead it rushed the drug, forgetting the FDA is now being doubly careful with drugs and doubly, doubly careful with drugs for non-life threatening maladies.

Let's take that thought one step further when looking at the potential for a drug approval.

The FDA, both its advisory panels and staff, seemingly work within one set of standards for approval of a drug: The drug must be safe and it must be effective, as measured in certain ways too boring to go into here. A life saving treatment is statistically measured the same way as a sleep medication, arthritis pain relief or a diet drug.

The reality is another thing - the terrible staff decision on Dendreon's (DNDN) Provenge notwithstanding - with the FDA clearly aware all drugs are not created equal. Yesterday, the panel was explicitly concerned that many patients would take Acomplia outside of tightly controlled clinical environments found in the trials, and the number of psychiatric side effects would be higher. They are right - yet those who are bulls on the product ignored this problem.

Don't you do the same. When looking at the potential for a drug to get approved, take a look at all the hows, whys and wherefores - and feel free to write me at mshulman@chanegwave.com if you have questions.

Comments

An FDA Advisory panel rejected weight loss drug Acomplia yesterday - a very good thing in my opinion. The drug had marginal benefits, disturbing side effects on some patients in the trial, and while left unsaid, it was a drug with any number of potential problems. It simply was not worth the risk for the loss of a grand total of fifteen pounds! Both advocates and neutral parties said it would be one of many tools needed for the nation's healthcare arsenal that's deficient in the tools needed for the current epidemic in obesity. That's a fair point, but would you want to send our troops into battle with hand grenades that could blow up before the pin is pulled? The rejection of the drug reminds of me of the paucity of products and research, not only in obesity but within Big Pharma pipelines. Acomplia really was not a blockbuster in the wings - and if its creator, Sanofi-Aventis (SNY), were not desperate for a big revenue producer, it would have fine-tuned the drug and/or the trials. But SNY didn't, and instead it rushed the drug, forgetting the FDA is now being doubly careful with drugs and doubly, doubly careful with drugs for non-life threatening maladies. Let's take that thought one step further when looking at the potential for a drug approval. The FDA, both its advisory panels and staff, seemingly work within one set of standards for approval of a drug: The drug must be safe and it must be effective, as measured in certain ways too boring to go into here. A life saving treatment is statistically measured the same way as a sleep medication, arthritis pain relief or a diet drug. The reality is another thing - the terrible staff decision on Dendreon's (DNDN) Provenge notwithstanding - with the FDA clearly aware all drugs are not created equal. Yesterday, the panel was explicitly concerned that many patients would take Acomplia outside of tightly controlled clinical environments found in the trials, and the number of psychiatric side effects would be higher. They are right - yet those who are bulls on the product ignored this problem. Don't you do the same. When looking at the potential for a drug to get approved, take a look at all the hows, whys and wherefores - and feel free to write me at mshulman@chanegwave.com if you have questions.