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F.D.A. Failing in Drug Safety, Official AssertsBy GARDINER HARRIS New York TimesWASHINGTON, Nov. 18 - Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at." In testimony before the Senate Finance Committee, Dr. Graham, the reviewer in the Food and Drug Administration's Office of Drug Safety, used fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers. "We are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world," Dr. Graham concluded. Dr. Galson, the director of the F.D.A.'s Center for Drug Evaluation and Research and one of the agency's top civil servants, later said that Dr. Graham's new numbers "constitute junk science" and were "irresponsible." Dr. Graham, with more than 20 years of service at the Food and Drug Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane. Makers of each drug defended the medicines as safe. Dr. Kweder, deputy director of the F.D.A.'s office of new drugs, told the panel that Dr. Graham was not describing "the F.D.A. that I know" and that she did not see the five drugs he cited as "more concerning than any others." The clash was a rare public airing of tensions that have simmered in the agency for decades. It is a fight between those who focus on the potential of drugs to cure the sick and dying and those who see many medicines as high-priced commercial products with potentially risky side effects, between those who view pharmaceutical makers as beneficial partners and those who see the drug makers as antagonists needing to be curbed. "My personal view is that our system works very well," Dr. Kweder said. The exchange came during a hearing called by Senator E. Grassley, a Republican of Iowa and the chairman of the Finance Committee. Using his broad authority over much of the government's budget, Senator Grassley and his staff have been investigating the F.D.A. for months after several controversies swept the agency this year. The hearing focused on the last of these controversies: Merck's decision in September to withdraw Vioxx, a pain pill that became a $2.5 billion seller and one of the most widely advertised drugs in the world. Merck withdrew Vioxx when a study it sponsored found that after 18 months of use the drug doubled the risk of heart attack or stroke. Critics of the F.D.A. have said that studies from as early as 1999 and 2000 showed that Vioxx was a risk to the heart, and many asked why the F.D.A. had not forced the drug's withdrawal earlier. The critics' case has been bolstered by many e-mail messages from Merck and by company documents disclosed in lawsuits by users of Vioxx. In many of the documents, Merck executives and scientists discussed the possible link between Vioxx and heart damage years before the company publicly admitted that the drug could cause harm. Merck executives have said the documents are being taken out of context. V. Gilmartin, Merck's chief executive, testified Thursday that his company followed a "rigorous scientific process" as it examined the risks and benefits of Vioxx. But Dr. Graham and other witnesses severely criticized Merck, saying the company should have acted years earlier to confirm the risks of Vioxx. Dr. Graham raised his estimates of those in the United States who had suffered heart attacks or stroke as result of taking Vioxx to a range of 88,000 to 139,000, up from 28,000. As many as 40 percent of these people, or about 55,000, died as a result, he said. Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford University, said at the hearing that Merck scientists had tried to intimidate him after he publicly raised questions about the effects of Vioxx. Dr. Singh, a rheumatologist and science officer of the Institute of Clinical Outcomes Research and Education in Woodside, Calif., said: "I was warned that if I continued in this fashion there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice president and a former chief of medicine at a medical school, had extensive contacts within academia and could make life very difficult for me at Stanford and outside." Dr. Graham said that in his years at the F.D.A., he had recommended that 12 drugs be withdrawn. Only two are still being sold, he said. His list of the five most worrisome drugs angered pharmaceutical makers, although objections to most of these drugs have long been known. For instance, Accutane, a drug for severe acne, can cause birth defects. The drug's label has warnings about this risk, and the F.D.A. has long been trying to get physicians to confine prescriptions to those women who cannot become pregnant or who are taking birth control. Dr. Graham said that the F.D.A. needed to do a better job restricting the drug's sales. Carolyn Glynn, a spokeswoman for Roche, which makes Accutane, said that her company had worked with the F.D.A. for years to "address the risk of birth defects." Dr. Graham mentioned Crestor because, he said, it was the only cholesterol-lowering drug on the market that caused acute kidney failure. And the drug is more likely to cause a serious muscle-weakening disease than similar drugs, he said. AstraZeneca introduced Crestor last year, but sales have been disappointing largely because of worries about the drug's safety. Public Citizen, a Washington advocacy group, has called for it to be withdrawn. "We are confident in the safety profile of Crestor," said Bloom-Baglin, a spokeswoman for AstraZeneca. "To date, the F.D.A. has not given us any indication of a major concern regarding Crestor." But Dr. Kweder of the F.D.A. told the panel that Crestor's risks are "something that we are in the process of and have been evaluating very, very closely." Studies of the painkiller Bextra, also mentioned by Dr. Graham, have shown that it increases the risks of heart attack in patients undergoing cardiac surgery. In rare cases, the drug can also cause a fatal skin reaction. Despite these risks, Bextra, which is similar to Vioxx, has never been proved to be any more effective at reducing pain or protecting the stomach than older medicines like ibuprofen that are a fraction of the price and pose none of these suggested or proven risks. Bro, a spokeswoman for Pfizer, the maker of Bextra, said that the drug "has been found to be safe and effective when used as indicated to treat osteoarthritis, rheumatoid arthritis and menstrual pain." She said the F.D.A. planned to ask a panel of experts early next year to examine the safety of Bextra and Celebrex, a Pfizer pain drug. Meridia is a weight-loss pill, made by Abbott Laboratories, that can cause substantial increases in blood pressure in some patients. Public Citizen has called for Meridia's withdrawal because it has been associated with 124 reports of serious cardiovascular problems, including 49 deaths, said Dr. Sidney Wolfe, director of Public Citizen's health research group. Dr. Graham testified that few patients were able to withstand Meridia's side effects long enough to benefit from its use. "What's the utility of the drug?" he asked. Laureen Cassidy, a spokeswoman for Abbott, said, "Science continues to support the safe use of Meridia as a treatment for obesity." The fifth drug named by Dr. Graham was Serevent, an asthma medication made by GlaxoKline, which stopped a large trial last year after an interim analysis revealed an increased risk of asthma-related deaths and life-threatening episodes among those given the drug. "We have case reports of people dying clutching their Serevent inhaler," Dr. Graham said. After the study was released, the F.D.A. placed a "black box" warning, its most severe, on the drug's label. The agency concluded that the drug's benefits outweighed its risks. In a statement Thursday, GlaxoKline said that it "stands firmly behind Serevent, which is safe and effective when used appropriately and in accordance with labeling and treatment guidelines." Dr. Galson of the F.D.A. emphasized that the drugs mentioned by Dr. Graham "are all approved and are safe and effective like other drugs that are approved, recognizing that safe does not mean risk-free." Dr. Kweder of the F.D.A. defended the agency's handling of Vioxx and said that Merck had "acted responsibly" when it sold Vioxx. She said that Dr. Graham's estimates of Vioxx's toll were simply mathematical guesses and "not real deaths." And she said that it was not unusual when a drug went on the market "to have ongoing concerns about particular aspects of its safety." In his testimony, Mr. Gilmartin of Merck retraced many of the steps his company had undertaken and noted that while some early studies suggested that the drug might be a risk to the heart other studies found no problems. He said he believed so thoroughly in the drug that his wife took it until the day the company withdrew it.

Last modified: November 19. 2004 12:00AM

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Satire: The top ten things we'd see if the FDA were put in charge ofthe criminal justice system...1. Telephone con artists who scam senior citizens out of their lifesavings would be put in charge of direct-to-consumer drug advertising.(Explanation: Senior citizens are being financially exploited by drugcompanies who use direct-to-consumer advertising to con people intoasking their doctors for drugs they don't even need.)2. All murderers would be set free as long as they carried a largewarning label that said, "Warning: I may kill you." (Explanation: TheFDA allows prescription drugs with fatal side effects to remainperfectly legal as long as they carry warnings that most people simplyignore.)3. Convicted drug dealers would be given medical degrees and allowedto write prescriptions. (Explanation: The FDA and U.S. authoritiesaren't against all drugs, they're only against the drugs they can'tcontrol. Many prescription drugs are far more dangerous to the humanbody than marijuana, for example.)4. Car thieves would be given new jobs stealing phytochemicaldiscoveries from medicinal plants in the Amazon rainforest that couldbe patented and sold as monopoly drugs. (Explanation: Drug companiesfrequently exploit natural medicinal compounds in plants, then modifyand patent them for manufacturing prescription drugs, even whilediscrediting the healing potential of the very same medicinal plants.Lovastatin, for example, was stolen from red yeast rice, a naturalsupplement that lowers LDL cholesterol. Ephedrine, the activeingredient in Sudafed, was copied from ephedra, a medicinal herb thathas now been outlawed by the FDA even while Sudafed remains perfectlylegal.)5. All rapists would be given four years to run free before beingtaken off the streets, even though they were known to be dangerous.(Explanation: The FDA allows dangerous drugs to remain on the marketfor years, with hundreds of thousands of people being injured by them, before issuing a recall. Rezulin and Vioxx are just two of many suchexamples. Antidepressant drugs and statin drugs are probably next inline.)6. Convicted white collar criminals and accounting fraud artistswould be given top jobs at pharmaceutical companies. Unless, of course, they already work there. (No explanation needed.)7. Drug smugglers would be shot on sight, but only if they aresmuggling legal prescription drugs from Canada. (Explanation: The FDAcontinues to try to ban prescription drugs from Canada in the hopes ofprotecting the profits of U.S. drug companies. In one case, a bus loadof American senior citizens was detained and searched by FDA employees for drugs. Not illegal drugs, mind you, but prescription drugs.)8. All felons serving time in prison would be set free. Why? The FDAwould claim that no particular felon could be considered dangerous,since all felons are dangerous. (Explanation: The FDA defends thesafety of obviously dangerous drugs by explaining that all drugs aredangerous. Therefore, the thinking goes, you can't single out anyparticular drug as being especially dangerous, so they should allremain on the market. Bizarre logic, huh?)9. All crimes would be declared legal, but only if committing thosecrimes generated revenues for powerful corporations. (Explanation:Pharmaceutical companies are allowed to commit all sorts of crimesagainst the public in terms of compromising public safety, lying toconsumers in drug ads, and distorting drug trials to achieve a desired outcome. It's all allowed by the FDA, with virtually no regulatoryresponse, as long as profits continue to flow.)10. Free speech about health and medicine would be outlawed in aSenate bill sponsored by Sen. Orrin Hatch. After all, the FDA doesn'twant people to be exposed to any "dangerous" ideas or information that might question the agency's authority. The list you're reading rightnow would be the first item to be outlawed, followed by a China-styleinternet filtering system that would suppress all non-FDA-approvedtext across the entire world wide web.This effort is dedicated to Dr. Graham, a genuine American hero.As a chief drug safety researcher for the FDA, Dr. Graham has shown enormous courage and dedication to his professional responsibilities in standing up against the FDA and telling the truth about dangerous prescription drugs. Dr. Graham, if you ever get blackballed by the FDA and Big Pharma, just talk to Newstarget.com. We have lots of options for you...