Fwd: The Safety Gap: FDA a fundamentally broken agency

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYITwo reports put the spotlight on the FDA--an agency authorized to regulate"more than $1 trillion worth of consumer goods, which amounts to about 25cents of every consumer dollar spent in this country. This includes $466billion in food sales, $275 billion in drugs, $60 billion in cosmetics and$18 billion in vitamin supplements. The agency is responsible for monitoringa third of all imported goods, from eggplant to eyeliner, microwave ovens tomonoclonal antibodies, slaughterhouses to cellphones. But with fewer than500 import inspectors and computer systems so old that repairmen must becalled out of retirement to fix them, the agency is increasingly beset by asense of futility."Writing in the Sunday Magazine, New York Times reporter, Gardiner Harris,reports: "Even the F.D.A.’s staunchest defenders now acknowledge that something isterribly wrong. Among them is Peter Barton Hutt, who served as the agency’sgeneral counsel during the Nixon administration and is widely considered thedean of the F.D.A. bar in Washington. I’ve interviewed Hutt dozens of timesover the years, and he has always defended the F.D.A. No more. “This is afundamentally broken agency,” Hutt told me earlier this year, “and it needsto be repaired.”"The breakdown is not simply about money. This summer 1,442 people aroundthe country were sickened by tainted tomatoes — or possibly jalepeñopeppers. Such scares have become familiar, and the inability to quickly findthe sources of contamination has been one of the agency’s signal failures. A2002 law requires produce processors and distributors to keep track of wherefood goes and comes from, but the government has yet to mandate standardizedrecord-keeping. As a result, in response to a scare, investigators must pourover a blizzard of contradictory packing slips and incompatible computerprograms as they race to save people.""The F.D.A. relies almost entirely on its own inspections of foreign plants.This was not much of a problem 30 years ago, when most medical productsconsumed in the United States were made here and F.D.A. inspectors coulddrive around to plants in their district. Most of those plants have sincemoved abroad, and now decades can pass between inspections. Testifyingbefore Congress in April, Dr. Janet Woodcock, director of the F.D.A.’s drugcenter, spoke with rare frankness about the ability of the agency to do itsjob abroad. “The F.D.A. of the last century is not configured to regulatethis century’s globalized pharmaceutical industry,” she testified."    Furthermore, "The F.D.A.’s apparent inability to keep names straight is notrivial matter. One reason the agency failed to inspect the Changzhou plantthat produced deadly heparin, for instance, was that someone mixed up thefacility’s name and concluded that the plant had already been inspected.Chinese plant names, a vestige of its once strictly controlled economy, areoften very similar, and translations can vary. For instance, there are 57separate drug master files — the basic F.D.A. record of a plant’s name,location and approved product — with “Shanghai” in the name. Some areobvious repeats, like the ones for “Shanghai No. 6 Pharmaceutical Factory”and “Shanghai Number 6 Pharmaceutical Factory.” But others could be separateplants. Or maybe not. It’s just too hard to tell."More mind boggling still--How does the Administration and Congressional leadership explain the factthat the FDA still lacks a rudimentary reliable computer system???????? Gardiner Harris reports:"Compounding the problem is the F.D.A.’s antiquated technology. Its computersystems are so awful that officials have no way of knowing which names, orwhich plants, are real. To determine which factories need to be inspected,agency investigators must consult two incompatible databases, one of whichlists 3,000 foreign drug plants exporting to the United States and the other6,800. Which number is right? Nobody really knows. Officials have told Houseinvestigators that their best guess for the number of foreign drug plantsexporting to the United States is 2,967, while the Government AccountabilityOffice recently guessed 3,249. Neither can the agency tell in many caseswhen the plants were last inspected (or, more important, which have neverbeen inspected), where they are located or what products they make." See: The Safety Gap at:http://www.nytimes.com/2008/11/02/magazine/02fda-t.htmlSurely, the United States of America--a nation that spends $10 billion amonth on a war the public opposes; a nation that coughs up close to atrillion dollars to bail out banks--which , again the public opposes; surelythe US government could afford to provide the FDA with viable computertechnology to protect the public health!!!!!!!!!Jonathan Cantu, of the Government Accountability Project writes (below) thatthe FDA needs some guts, not PR."After the failures of Vioxx, the respiratory drug Ketek, bacteria-ladenspinach and a roster of other safety lapses, it’s obvious why the agency isseeking a reputation boost. But this won’t come about through Madison Avenuespin jobs. This PR debacle is a microcosm of the inherent problem at FDAthat must be addressed: Officials are more concerned with limiting bad pressand helping corporate friends than with safeguarding public health. There isa clear path to fixing these fatal flaws, but it won’t happen overnight. Anew generation of FDA leadership must provide sustained support fordecisions based on sound science rather than politics or the marketingimperatives of drug companies."We agree, "a new generation of FDA leadership" is essential if the agency isto return to making science-based decisions--rather than helping increasecorporate profitability.Contact: Vera Hassner Sharavveracare212-595-8974http://citizen-times.com/apps/pbcs.dll/article?AID=200881024055The FDA needs some guts, not PRJonathan CantuThe Food and Drug Administration’s (FDA’s) management has it wrong again:The agency’s troubles aren’t due to bad public relations. At least theyweren’t until recently.This has been yet another tormented year for the FDA. February broughtcongressional hearings into the agency’s lax regulation of fatal drugs.March brought a congressional report scorching the FDA for its woefullyinadequate inspection of foreign products entering the United States,shockingly illustrated by that month’s Chinese ingredient-tainted Heparinscandal that involved at least 81 American deaths. The summer months broughtthe FDA’s long struggle to contain a salmonella outbreak that it attributedto tomatoes, but was caused by peppers.What was the FDA’s response to this string of spotlighted failures? To hirea marketing firm to remake the agency’s public image. Comically, the FDAbotched that task, too. Investigative reports show the agency circumventedthe mandated competitive bidding process in order to steer the PR contractto a Washington, D.C.-based consulting firm.After the failures of Vioxx, the respiratory drug Ketek, bacteria-ladenspinach and a roster of other safety lapses, it’s obvious why the agency isseeking a reputation boost. But this won’t come about through Madison Avenuespin jobs. This PR debacle is a microcosm of the inherent problem at FDAthat must be addressed: Officials are more concerned with limiting bad pressand helping corporate friends than with safeguarding public health.There is a clear path to fixing these fatal flaws, but it won’t happenovernight. A new generation of FDA leadership must provide sustained supportfor decisions based on sound science rather than politics or the marketingimperatives of drug companies.It used to be this way. Dr. Frances Kelsey is the signature example of adiligent FDA scientist who safeguarded the public health. In the early1960s, Dr. Kelsey held fast to scientific integrity in the face of industrypressure, and was able to block Thalidomide, which caused horrific birthdefects, from reaching the U.S. market. As a result, she was lauded publiclyand received a major award from President John F. Kennedy in a White Houseceremony. She continued to work for the FDA for another 40 years and, uponher retirement in 2002, the agency named an award in her honor.Tragically, the FDA treats today’s Dr. Kelseys as pariahs or enemies. WhenDr. David Graham sought to warn the public that the painkiller Vioxx wasrelated to tens of thousands of deaths, he needed congressional interventionjust to save his job and keep his findings from being suppressed by FDAbrass. FDA veterinarian Dr. Victoria Hampshire’s investigation, concludingthat a heartworm drug was related to hundreds of dog fatalities, resulted inher removal without explanation from reviewing the drug. The FDA placed herunder criminal investigation, and it took a subsequent Senate investigationto vindicate her of any wrongdoing.Today’s FDA works at cross-purposes, tethered to its industry patrons whenit should be singularly focused on the public good. The FDA’s Office of NewDrugs, tasked with determining whether new drugs are safe, is largely fundedby industry user fees. How are these fees determined? By industry and agencyofficials sitting down behind closed doors and negotiating terms of the drugapproval process (without any consumer or patient representatives). Once theFDA approves a drug and it is on the market, the agency’s Office ofSurveillance and Epidemiology (OSE) is to monitor its safety. But OSE has noindependent authority to take action against unsafe drugs, only the “power”to make a recommendation to the very body that approved the drug in thefirst place.To restore trust in the agency, the FDA must be restructured so that itsdrug approval function is not tainted by industry conflicts, and itsoversight function is not subordinated to its drug approval branch.Drs. Graham and Hampshire are just two of many FDA employees who should bepraised for coming forward. Their diligence in the face of industry pressureand subterfuge are the sort of everyday heroism that safeguards publichealth. Encouraging rather than subverting this type of work will make forcredible, honest and effective PR for the FDA and restore the public’strust. Corrupt PR contracts will not.Jonathan Cantu is Public Health & Safety Associate for the GovernmentAccountability Project, the nation’s leading whistleblower protection andadvocacy organization. www.whistleblower.org. 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