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Medical Forum / Diseases and Disorders / Cancer / December 2004Celebrex /cox-2 inhibitors
For those who are taking it.... http://www.canoe.ca/NewsStand/LondonFreePress/News/2004/12/19/789218-sun.html study says the pain reliever increases the risk of heart attacks and strokes. AP 2004-12-19 02:19:43 NEW YORK -- The U.S. Food and Drug Administration is advising doctors to consider alternatives to pain reliever Celebrex in the wake of a study that showed it increased the risk of heart attack and strokes at high doses. Pfizer Inc. said Friday it will leave Celebrex on the market, although the same problems led Merck & Co. to withdraw its painkiller Vioxx from the market in September. "We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," acting FDA commissioner Lester Crawford said. "We do have great concern about this product (Celebrex) and the class of products." Crawford said doctors should think about other types of drugs to help patients relieve pain. Doctors said they were already inundated with calls from nervous patients and were pledging to curtail their use of the drug. The disclosure sent Pfizer's stock tumbling amid fears it would cripple sales of what had been the most-prescribed drug for treating arthritis. Shares of Pfizer, the world's largest pharmaceutical maker, plunged $3.23 US, to close at $25.75 on the New York Stock Exchange. The decline wiped out almost $25 billion of Pfizer's market value. Both Celebrex and Vioxx are a type of drug called cox-2 inhibitors. Vioxx was pulled from the market in September because it doubled patients' risk of heart attack and stroke. "I think the trial concludes the controversy about whether there is a class effect of these drugs. Now there is clear evidence of it," said Dr. Garret FitzGerald, a cardiologist at the University of Pennsylvania. "You would need to believe the earth is flat if you thought this was just a coincidence." National Institutes of Health director Dr. Elias Zerhouni said that he ordered a full review of the more than 40 agency-supported studies involving cox-2 inhibitors. just another drug fiasco, from the makers of the MMR vaccine that is the main culprit behind the autism epidemic. They suppressed this one for over 3 years > For those who are taking it.... http://www.canoe.ca/NewsStand/LondonFreePress/News/2004/12/19/789218-sun.html > study says the pain reliever increases the risk of heart attacks and > strokes. [quoted text clipped - 39 lines] > ordered a full review of the more than 40 agency-supported studies > involving cox-2 inhibitors. > just another drug fiasco, . They suppressed this one for over > 3 years copyrighted by the new york times 2004 www.nytimes.com Lung-Cancer Drug Shows Unfavorable Trial Results By ANDREW POLLACK Published: December 20, 2004 Celebrex, the pain reliever from Pfizer, is not the only once-celebrated drug that now faces an endangered future. The Food and Drug Administration said on Friday that it would consider whether to remove Iressa, a product from AstraZeneca, from the market after the drug failed to prolong the lives of people with advanced lung cancer in a clinical trial. AstraZeneca said that while the drug would remain available to patients for now, the company would not promote it to physicians. Iressa was one of the first cancer drugs created to disrupt a particular molecular mechanism that spurs tumor cells to grow and to avoid some of the most serious side effects of conventional chemotherapy. In May 2003, the F.D.A. approved Iressa as a last-ditch treatment for lung cancer, under rules intended to speed the introduction of drugs for life-threatening diseases. At the time, the agency was under pressure from some patient groups for keeping drugs for serious diseases off the market - not for allowing unsafe drugs to be sold. The drug was approved because it shrank tumors in about 10 percent of patients for whom other treatments had been unsuccessful. But the approval was contingent on the company running a trial to show that the drug actually prolonged lives, the F.D.A.'s preferred benchmark. On Friday, AstraZeneca announced that Iressa had not prolonged lives in the 1,700-patient trial by a meaningful amount. Those taking the drug had a median survival of 5.6 months compared with 5.1 months for those taking a placebo. > The drug was approved because it shrank tumors in about 10 percent of patients > for whom other treatments had been unsuccessful. But the approval was > contingent on the company running a trial to show that the drug actually > prolonged lives, the F.D.A.'s preferred benchmark. Preferred! The FDA is just the criminal tools of the pharma industry http://www.whale.to/vaccine/fda1.html "If you can shrink the tumour 50% or more for 28 days you have got the FDA's definition of an active drug. That is called a response rate, so you have a response..(but) when you look to see if there is any life prolongation from taking this treatment what you find is all kinds of hocus pocus and song and dance about the disease free survival, and this and that. In the end there is no proof that chemotherapy in the vast majority of cases actually extends life, and this is the GREAT LIE about chemotherapy, that somehow there is a correlation between shrinking a tumour and extending the life of the patient."---Ralph Moss > "If you can shrink the tumour 50% or more for 28 days you have got the > FDA's definition of an active drug. That is called a response rate, so you > have a response..(but) when you look to see if there is any life > prolongation from taking this treatment what you find is all kinds of hocus > pocus and song and dance a http://tinyurl.com/4akk6 > > The drug was approved because it shrank tumors in about 10 percent of > patients [quoted text clipped - 14 lines] > somehow there is a correlation between shrinking a tumour and extending the > life of the patient."---Ralph Moss ralph- i read your newletter regularly. i must admit i'm a bit confused about your statement here. i agree that the FDA is not what everyone seems to think it is. i have several problems with the way they go about things. that having been said, it seems to me that quality of life is just as important as quantity of life. as a 38 yr old late stage 4 patient, i am very close to this subject. i know that the chances are overwhelming that i will die in a year or two. my biggest concern is how i live that time. thanks to the treatment i am on, i have had a great deal of tumor shrinkage. what that means in plain terms is i have got my life back; i can walk without assistance, i have less pain, and most of my organ tumors have shrunk to the point where they are barely visible. for how long? who knows. but my point is this: i'm beginning to tire of the FDA and others who state that a treatment has failed, or should not be approved only because it did not extend life. yes, obviously i would like to live as long as possible, but if i'm only going to live 2 or 3 years, i would rather live that time as independently and comfortably as possible. if extending life were the only deciding issue, we would have very few treatments available indeed, as most do not extend life in any significant measure. my treatment may not make it possible to live longer, but it sure makes the time i have significantly better because it has shrunk my tumors to a manageable size. is this failure? i think not. best wishes to you for the holidays and new year. -christina oops - i think i responded to the wrong person in my 1st post. i'm not sure who said what in this post, but my thoughts on the subject remain the same. just thought i'd clarify , if possible. -christina > > The drug was approved because it shrank tumors in about 10 percent of > patients [quoted text clipped - 14 lines] > somehow there is a correlation between shrinking a tumour and extending the > life of the patient."---Ralph Moss |
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