Guest guest Posted October 12, 2004 Report Share Posted October 12, 2004 " WC Douglass " <realheath Pulling the wool Tue, 12 Oct 2004 09:21:09 -0400 Daily Dose Tuesday October 12, 2004 ************************************************************** The silent treatment, part one Just last week, I told you about Merck & Co.'s " voluntary " yanking of the blockbuster arthritis drug Vioxx from pharmacy shelves because an ongoing clinical trail (studying a currently UNAPPROVED use of the drug, by the way) indicated the medication posed an increased risk for heart attack and stroke among long-term users. One thing about the story I found curious was that the Food and Drug Administration was seemingly nowhere to be seen in the press reports. Usually, drug-makers pull a pill from the market only after pressure from the FDA — which only tends to happen after a lot of people die or a lot of doctors get their pants sued off. But the stories in Reuters, the AP and others mentioned little, if anything, about the FDA's position. So where was the FDA on the Vioxx issue? They were covering up for it. According to an October 8th Associated Press story, the FDA silenced one of their top experts, Dr. David Graham, who raised concerns about Vioxx's safety WEEKS BEFORE Merck yanked the drug from shelves. Testifying before a panel of Senate investigators just days ago, the doctor told of intense pressure, exclusion and intimidation, even thinly-veiled threats by his colleagues at the FDA for raising a red flag about the drug's safety. He further testified to the generally hostile environment at that government agency with regard to ANY evidence of drug safety issues. Graham, the architect of a 40,000+ patient research project on arthritis medications, concluded well before Merck halted its Vioxx trial that high doses of Vioxx over long periods tripled the risk of heart attack and sudden cardiac events. He was scheduled to present his findings at a conference in late August, but when the FDA reviewed the synopsis of his presentation, they put the kibosh on it! Hmm. A 20-year veteran FDA expert sounds an alarm about a popular prescription drug and gets gagged by his superiors. Days later, the Senate launches an investigation with the expert as a key witness. Meanwhile, the manufacturer " voluntarily " pulls the drug, citing its own research and good conscience... Pretty slick, huh? Merck probably smelled a brouhaha coming in the mainstream media when Graham's testimony became public knowledge, so they positioned themselves as not only the source of the information, but also the solution. I wonder: Did the FDA have a hand in formulating this strategy? A fringe benefit of Merck's highly public handling of the situation would have been that it takes some of the accountability pressure off the agency. As scary as all of this is, it isn't the only instance of the FDA sweeping drug safety findings under the rug in recent history. Next Dose, I'll tell you how these bureaucratic bullies smothered another expert whose testimony could've saved the lives of God- knows-how-many young Americans. First, though, more news on the arthritis drug front... ************************************************************** A bad week for arthritis drugs Seems Vioxx isn't the only arthritis drug causing health problems — and Merck isn't the only pharmaceuticals manufacturer engaging in some astute " damage control. " Ironically, the news you're about to read appeared in print on the same day that the Vioxx cover-up story I just told you about broke. Shrewdly timed, as I'm sure you'll agree in a moment. According to a recent Associated Press article, a drug-making subsidiary of Johnson and Johnson named Centocor expanded its warning label on the 28th top-selling drug in the country, Remicade (a rheumatoid arthritis medication), to include language reflecting an INCREASED CANCER RISK. The company's own research concludes that the arthritis drug contributes to a three-fold increase in the incidence of deadly lymphoma (cancer of the lymphatic system). Funny how this conclusion failed to reveal itself in the stacks of research Centocor no doubt submitted back when they applied for their patent… As if this isn't alarming enough, this announcement marks the second time in just a six-week period when Remicade's warning label had to be changed to reflect a risk of death. In late August, Centocor added a caution against fatal blood and nervous system disorders after 12 people died in clinical trials of the medication. Predictably, the FDA claimed those deaths couldn't be definitively linked to the drug. Kind of makes you wonder whose side they're really on… Never doubting whose side I'M on, William Campbell Douglass II, MD ************************************************************** Copyright ©1997-2004 by www.realhealthnews.com, L.L.C. The Daily Dose may not be posted on commercial sites without written permission. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.