You have to be crazy to try a new drug

Bonnie - as I have said many teams, I never recommend a client try a new drug until it has been on the market at least a few years. Maybe I have to rethink that advice and make it four or five years based upon the following reports.

1. According to the Government Accountability Office, the Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal. The GAO found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.
   
   The FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.
   
   The GAO did note that the FDA is making progress on other safety initiatives, including:
   • Revamping the computer system used to track and sort reports of drug side effects.
   • Gathering more reports about possible drug safety issues from federal agencies and private medical systems.
   • Developing a system to resolve drug safety disagreements between staffers.
   
   
2. Wall Street Journal: "Premature Ejaculation: Marketing the Condition Before the Drug"
   Folks from Sciele Pharma spoke to WSJ about the company’s potential treatment for premature ejaculation. They were making the rounds at newspapers and magazines in an effort to raise awareness of the condition and their product, even though the company hasn’t asked regulators for approval yet.
   
   The visit was a reminder about how drug makers can try to lay the groundwork for sales well before a new therapy hits the market. That is especially true when the product will be aimed at treating a condition that carries a stigma.
   
   Hence, the effort for Sciele’s treatment, a spray that goes by the moniker PSD502 for the time being. Sciele, which is a unit of Japanese pharma Shionogi, has been pursuing two tracks to raise awareness. For months, it has sought to educate physicians about premature ejaculation, making presentations at medical meetings. Last month, after Phase 3 studies finished, the company launched a Web site for bloggers with information about the condition and scientific milestones in their product’s development. While the Web site is intended for blogger types, anyone searching for information about premature ejaculation can find the material.
   
   Once Sciele asks the FDA to approve the product — it expects to file by the end of March — the company plans on launching a Web site dedicated to explaining the condition. “It’s not well recognized. It’s not well understood. We know we have to spend a tremendous amount of time and effort,” said Donna Gibson Dell, a Sciele official.
   
   All this effort begs the question whether Sciele is acting prematurely. Analysts say the FDA has taken a tougher line on so-called lifestyle drugs. In 2005, the FDA rejected Johnson & Johnson’s request for approval of a premature ejaculation drug called dapoxetine. Sciele officials expressed optimism about the prospects for PSD502, while allowing that they can’t predict what the FDA will do. The experimental treatment combines two local anesthetics, lidocaine and prilocaine. Sciele officials emphasized that it has an entirely different mechanism of action than dapoxetine, which was made from the ingredient in an antidepressant that attracted regulatory scrutiny.