Guest guest Posted March 24, 2005 Report Share Posted March 24, 2005 " HSI - Jenny Thompson " <HSIResearch HSI e-Alert - Baby, It's Cold Outside Thu, 24 Mar 2005 10:21:37 -0500 HSI e-Alert - Baby, It's Cold Outside Health Sciences Institute e-Alert **************************************************** March 24, 2005 **************************************************** Dear Reader, 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. ----------- Flexing muscle ----------- 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. " ----------- Leader of the pack ----------- In the e-Alert " Cresting the Wave " (10/15/03) 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 e-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. ----------- Doing the math ----------- Okay, here's where it gets good. 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. **************************************************** ....and another thing Remember that " sparkling drop of Retsyn " that Certs breath mints advertisements used to promise? After all these years, the question finally crossed my mind: What the heck is Retsyn? According to the web site for Cadbury Adams (the maker of Certs), Retsyn is " a combination of partially hydrogenated cottonseed oil, copper gluconate and flavoring. " Sharp-eyed HSI members will immediately focus on those two not-so-little words: partially hydrogenated. That means that Retsyn contains trans-fat, arguably the unhealthiest type of fat. (According to a National Academy of Sciences panel that examined the link between trans-fatty acid intake and heart disease risk, " The only safe intake of trans-fat is zero. " ) Of course, the amount of trans-fat contained in a Certs mint is just a sparkling drop in the bucket compared to the amount of trans-fats that the typical American diet is brimming with. Nevertheless, you might be interested in a unique alternative to breath mints - an alternative that may control bad breath by reducing harmful oral bacteria. At a recent session of the International Association for Dental Research, researchers from Japan's Tsurumi University presented the results of a study in which 24 subjects with halitosis ate sugar-free yogurt two times a day for six weeks. Samples collected from the tongue and saliva showed that about 80 percent of the subjects had lower levels of sulfide compounds that contribute to bad breath. More importantly, the lead author of the study, Dr. Kenichi Hojo, told Reuters Health that subjects in the study were found to have a significant reduction in plaque and gingivitis. (And as we saw in yesterday's e-Alert ( " Heart Floss " 3/23/05), the bacteria that causes gingivitis may also contribute to heart disease risk.) But here's an important note: Not just any yogurt will do. The yogurt used in the Tsurumi study was fermented with streptococci and lactobacilli. So before you put a yogurt product in your grocery cart, take a quick look at the ingredients panel to check for these lactic acid bacteria. To Your Good Health, Jenny Thompson Health Sciences Institute **************************************************** Sources: " U.S. Senator Says FDA Too Cozy With Drugmakers " Julie Rovner, Reuters Health, 3/10/05, reutershealth.com " Lotronex and the FDA: A Fatal Erosion of Integrity " Richard Horton, The Lancet, Vol. 357, No. 9268, 5/19/01, thelancet.com " FDA Rejects Crestor Petition " Julie Appleby, USA TODAY, 3/14/05, usatoday.com FDA letter to Public Citizen, Steven K. Galson, M.D., M.P.H., Acting Director, Center for Drug Evaluation and Research, fda.gov " In Refusing to Ban Crestor, FDA Chooses Drug Company Over Safety " Sidney M. Wolfe, M.D., Public Citizen, 3/14/05, citizen.org " Forget the Breath Mints, Eat Yogurt Instead " Charnicia E. Huggins, Reuters Health, 3/15/05, reutershealth.com " Certs " Cadbury Adams, cadburyadams.com ************** Quote Link to comment Share on other sites More sharing options...
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