FDA Shields Drug Companies From Lawsuits

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SSRI-Research@ Wed, 01 Mar 2006 18:52:45 -0500[sSRI-Research] OpEd News - [Pringle] FDA Shields DrugCompanies From Lawsuits Evelyn Pringle has become a superstar among our gang memberjournalists. She is in desperate need of your input for a series ofarticles in preparation for the upcoming FDA hearings, March 22-23. One hearing concerns stimulants used for treatment of ADHD The FDA islooking at /_heart problems, liver problems, and suicide issues_/ ofthese substances (Ritalin, and the like). The other is concerned with a product called Provigil (Modafinil)._/T//his is the most off-label prescribed drug/_ that I know of. Ifapproved, it will be marketed as Sparlon for ADHD If you, or anyone you know of, has had experience with either of thesedrugs, please contact Evelyn at evelyn.pringle. If youare a professional concerned about either of these drugs, contact heralso. *Thanks,* V* Oped Newshttp://www.opednews.com/articles/genera_evelyn_p_060301_fda_shields_drug_com.htm FDA Shields Drug Companies From Lawsuits by Evelyn Pringle http://www.opednews.com evieLast month, the FDA revealed its latest protective policy for drugcompanies in a statement that said people who believe they have beeninjured by drugs approved by the FDA should not be allowed to sue drugcompanies in state courts. "We think that if your company complies with the FDA processes, if youbring forward the benefits and risks of your drug, and let yourinformation be judged through a process with highly trained scientists,you should not be second-guessed by state courts that don't have thesame scientific knowledge," said Scott Gottlieb, the FDA's deputycommissioner for medical and scientific affairs. The agency's assertion of "federal preemption" was included as apreamble to its new drug labeling guidelines. ** Evelyn Pringle * *The claim of preemption was quickly attacked by trial lawyers andmembers of Congress as another effort by the Bush administration tolimit the public's ability to bring and win lawsuits, according to theJanuary 19, 2006 Washington Post. "Eliminating the rights of individuals to hold negligent drug companiesaccountable puts patients in even more danger than they already are infrom drug company executives that put profits before safety," said KenSuggs, president of the Association of Trial Lawyers of America. "The fact that the drug industry can get the FDA to rewrite the rules sothat CEOs can escape accountability for putting dangerous and deadlydrugs on the market is the scariest example yet of how much controlthese big corporations have over our political process," Mr Suggs toldthe Post. In response to the FDA's announcement, Senator Kennedy issued astatement that said: "It's a typical abuse by the Bush Administration --take a regulation to improve the information that doctors and patientsreceive about prescription drugs and turn it into a protection againstliability for the drug industry." The National Conference of State Legislatures, a bipartisan group thatrepresents state lawmakers, accused the FDA of trying to seize authoritythat it did not have. Over the past several years, lawmakers have been turning up the heat onboth the FDA and the pharmaceutical industry in response to theircombined failure to reveal problems found during studies conducted ontop selling drugs like Vioxx. At one point, Senator Charles Grassley (R-Iowa), Chairman of the SenateFinance Committee, came right out and accused the FDA of suppressingstudies in order to protect pharmaceutical industry profits and thecareers of certain FDA officials. "The Vioxx example showed that the FDA and Merck were too close forcomfort," Senator Grassely told Health News on March 12, 2005."Testimony and documents at our Finance Committee hearing showed thatthe FDA allowed itself to be manipulated by Merck," he said. Based on a trial that took place in 2000, both the FDA and Merck wereaware that heart attacks were five times more likely in patients takingVioxx than among those taking a similar drug, Sen Grassley pointed out,but the FDA did nothing to change the labeling on the drug for nearlytwo years, while Merck aggressively marketed its product on nightly TV. Back on November 18, 2004, he generated enormous media attention when heheld hearings on Vioxx, and FDA scientist, Dr David Graham, who works inthe FDA Office of Drug Safety, testified that Vioxx may have beenresponsible for tens of thousands of heart attacks and strokes but thathis superiors had pressured him to keep silent about his findings. "The estimates range from 88,000 to 139,000 Americans," Dr Graham toldthe committee. "Of these, 30 to 40 percent probably died," he advised. "For the survivors," he added, "their lives were changed forever." To put this large number of injuries into perspective, Dr Graham toldmembers of the committee that instead of a serious side-effect of aprescription drug, to think of it as if they were talking about jetliners. "If there were an average of 150 to 200 people on an aircraft," he said,"this range of 88,000 to 138,000 would be the rough equivalent of 500 to900 aircraft dropping from the sky.This translates to 2-4 aircraft every week," he noted, "week in andweek out, for the past 5 years.If you were confronted by this situation," Dr Graham asked thecommittee, "what would be your reaction, what would you want to know andwhat would you do about it?" He condemned the FDA's failure to acknowledge the risks that Vioxx posedto millions of people in the 5 years it was allowed to remain on themarket. "I strongly believe that this should have been, and largelycould have been, avoided," Dr Graham told the committee. The Vioxx matter caught the attention of the Senate Finance Committeebasically because of the Vioxx related costs to government programs likeMedicaid and Medicare. The committee is responsible for oversight of thetwo programs. At the November 18, 2004 hearing, Senator Max Baucus said: "In the 5 years that Vioxx was on the market, Medicaid spent more than$1 billion on the drug.And Medicaid bears the cost of any additional medical care necessarywhen drugs cause injury," he pointed out. The hearings followed a study that estimated between 28,000 and 160,000deaths may have been caused by the Vioxx since it gained FDA approval in1999. By far, the Vioxx debacle is the most serious public health failure tooccur since the FDA took on the authority for safety oversight ofmedical products in 1938. On September 3, 2005, Shane Ellison, M.Sc, a former pharmaceuticalchemist turned whistleblower and author of the book, "Health MythsExposed," gave an interview to Crusador Magazine and discussed Vioxx andsome of the problems within the FDA. His book which was published before Vioxx began making headlines,referred to Vioxx as the "silent killer." According to Mr Ellison, the FDA and Merck knew about the dangersassociated with Vioxx for at least 4 years before it was taken off themarket. "Instead of removing the drug immediately," he said, "they keptit on the drug market for matters of wealth not health." Mr Ellison says pharmaceutically compliant politicians have"democratized" the drug industry. "This means that drug approval is amatter of 51% telling the other 49% that deadly drugs are safe andnecessary," he reports. "Science and choice no longer prevail at the FDAor at pharmaceutical companies," he added. "To go against the 51% means losing your career," Mr Ellison said."Therefore, the majority of scientists choose to please drug companies,not the general public." To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, amember of the FDA's drug safety advisory committee. In the wake of the Vioxx revelations, Dr Furberg went public withfindings that Pfizer's drug Bextra also caused heart attacks and strokesand said studies "showed that Bextra is no different than Vioxx, andPfizer is trying to suppress that information," in the British MedicalJournal. "Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred fromserving on the panel that was responsible for considering the safety ofcyclo-oxygenase-2 (COX 2) inhibitors.The end result being more votes in favor of COX 2 inhibitors, the drugcompany wins by votes -- not science," he told Crusador. A little-mentioned fact is that many FDA employees end up working forthe pharmaceutical industry. "The old joke is that the FDA is sort oflike a showcase for a future job in the drug industry," Robert Whitaker,author of Mad In America, said in an August 2005 interview with StreetSpirit. "You go there, you work awhile, then you go off into the drug industry,"he said, "the progression that people make, in essence they're makinggood old boy network connections, so they're not going to be so harsh onthe drug companies." Critic say the passage of the Prescription Drug User Fee Act in 1992contributed to the current problems within the FDA. The Act allows theagency to collect a fee from a drug company seeking approval for a newdrug. In return, the FDA is expected complete the review process within12 months. User fees now account for about 40% of the approval process, which meansthe FDA is dependent on drug companies for nearly half of its funding. This situation is the root of a major conflict of interest according toDr Graham: "This culture (at the FDA) views the pharmaceutical industryit is supposed to regulate as its client. It overvalues the benefits ofthe drugs it approves, and seriously undervalues, disregards anddisrespects drug safety," he told members of Congress. Another problem he cited is that even when the FDA does try to takemeasures to limit harm, the agency lacks the enforcement authority toforce drug companies to comply. In the case of Vioxx, Dr Graham said ittook more than 2 years to get Merck to add the increased risk of heartattack and stroke to its label. Then there are the conflicts of interests involving the FDA panels thatadvise the agency on matters such as which drugs should be approved,what their warning labels should say, and how studies should be conducted. The 300 experts on the 18 committees make decisions that affect billionsof dollars in sales and with few exceptions the FDA follows theirrecommendations. Members of the panels are supposed to be free of conflicts of interestrelating to products they consider. But the FDA can grant a waiver if amember's expertise is deemed to outweigh the risk of a conflict or ifthe financial interest is minimal. Waivers are liberally granted all thetime. For instance, in February 2005, when the highly publicized hearings wereheld to determine whether the COX-2 inhibitors, manufactured by Merckand Pfizer, should be permitted to remain on the market, an advisorycommittee that was mired with conflicts of interest was exposed. Out ofthe 32 advisers voting on the issue, ten had served as consultants toMerck and Pfizer in recent years. This revelation prompted Senator Mike Enzi, (R-WY), the chairman of theHealth, Education, Labor and Pensions Committee, along with Senators,Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the GeneralAccounting Office to look into the FDA's practice of letting scientistsserve on panels when they have conflicts of interest. "We are concerned about the process that supports FDA's decisions towaive conflicts of interest rules for scientists with financial ties tothe manufacturers of the products under consideration, or theircompetitors," said a letter to the GAO, signed by Senators in September2005. "These practices appear to have undermined the public's faith in theobjectivity and fairness of FDA's advisory committees," they wrote. TheSenators specifically noted the conflicts among the panels that studiedthe Cox-2 inhibitors like Vioxx. According to the Associated Press on January 24, 2006, Merck currentlyfaces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and therest in state courts. Without state product liability laws, drugcompanies like Merck will be able to escape liability for injuries anddeaths caused by drugs like Vioxx.