Wednesday, April 13, 2005

Baby, It's Cold Outside

Here's a recent headline that gave me a chuckle: "U.S. Senator Says FDA Too Cozy With Drugmakers" The word "cozy" conjures an image of the FDA curling up with its favorite drug giants on a comfy couch in front of a fire. Without delving into the intimate moments the FDA shares with drug companies, it's safe to say that Senator Charles Grassley (the one referred to in that Reuters Health headline) is absolutely right. In an unrelated article I discovered a detail that might help explain why the relationship stays so warm 'n' cozy as the years go by. A 2001 editorial in the British medical journal The Lancet noted that over a period of about six years during the 90s, the FDA hired nearly 700 medical officers to review new products. Nothing wrong with that, except that this small army of new hires was apparently made possible by industry funding. "Industry funding." Call me naive, but I always assumed that we taxpayers picked up the tab when regulators punched in and went to work. But no. A stipulation in the 1992 Prescription Drug User Fee Act (PDUFA) allowed the FDA to receive well over $300 million from industry funding between 1992 and 1998. And this industry funding was devoted to the review of new products from the industry. Gee...think that might create a conflict of interest? According to The Lancet, a 1998 survey of FDA medical officers showed that many of the officers blamed the PDUFA arrangement for declining standards in drug approval. Now who could have seen THAT coming? The latest drop in these declining standards concerns an FDA action we'll call "Industry Muscle." In a previous alert I gave you some details about the launch of a new cholesterol-lowering statin drug called Crestor, manufactured by AstraZeneca (AZ). In Crestor's original clinical trials, some of the subjects who took 80 mg developed kidney damage. So the folks at the FDA said, "Try again," and AZ resubmitted Crestor at doses of 40 mg or less. The FDA gave the green light, and in September 2003 Crestor was introduced in the U.S. Meanwhile, representatives of Public Citizen (a consumer advocacy group) sort of spoiled the Crestor party with one word: "rhabdomyolysis." As I've mentioned in previous alerts, statin drugs increase the risk of muscle pain. In more serious cases this prompts rhabdomyolysis: the death of muscle cells, which releases toxins into the blood stream. Extreme cases of rhabdomyolysis result in paralysis and death. So in 2004, Public Citizen petitioned the FDA to remove Crestor from the market. And more recently, PC reps submitted additional statistics showing that, over a period of one year, Crestor had more than SIX TIMES as many reports of muscle problems than ALL OTHER statin products combined. Last week the FDA denied Public Citizen's petition. In support of that decision, the FDA noted that Crestor was the first statin drug to enter the market after the Baycol fiasco. Of course, the FDA didn't use the word "fiasco," but it would be appropriate. In 1987 the FDA approved Baycol, a statin made by Bayer. Within a year, Doctors began reporting that Baycol was producing serious side effects, primarily muscle pain. In 2000, a Bayer analysis showed that Baycol users had five to 10 times greater chance of developing rhabdomyolysis compared to users of other statins. After a number of deaths were attributed to Baycol use, Bayer removed the drug from the market in 2001. According to the New York Times, More than 10,000 Baycol users filed lawsuits against Bayer, and many of the suits were settled out of court with some payouts by Bayer reportedly topping $1 million each. Not a pretty picture. So here we are, about four years later, and the FDA's response to the excessive number of rhabdomyolysis reports linked to Crestor is this: Because Crestor entered the market on the heels of the Baycol mess, that negative publicity "conceivably contributed to the enhanced reporting." Incredible. Or rather, incredibly lame. On the Public Citizen web site, Sidney M. Wolfe, M.D., Director of PC's Health Research Group responded by pointing out that any boost in the number of adverse effects would have logically affected ALL statin drugs, not just one. But logic isn't the guiding principle these days in the world of drug safety. Maybe that's because logic never offset $300 million in operating expenses.

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