Fwd: FDA Acknowledges Caving to Influence Peddling

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ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org FYIThe New York Times reported last month that top FDA officials acknowledgedin a report that the agency's approval process of a medical device had beentainted by political pressure--and that the former Commissioner of theagency, Dr. Andrew von Eschenbach, "personally engaged in the details of aprocess usually coordinated" by scientific staff.http://www.nytimes.com/2009/09/25/health/policy/25knee.htmlThe report stated that Dr. von Eschenbach "was demanding not only anexpedited process but also an outcome in favor of ReGen." "Congressional interest in the ReGen matter - and the unusualresponsiveness of the commissioner to that interest - initiated a chaoticnew phase in the agency's handling of the" company's application, thereport said. "The agency's scientific reviewers repeatedly and unanimously overmany years decided that the device, known as Menaflex and manufactured byReGen Biologics Inc., was unsafe because the device often failed,forcing patients to get another operation. But after receiving what an F.D.A. report described as "extreme,""unusual" and persistent pressure from four Democrats from New Jersey -Senators Robert Menendez and Frank R. Lautenberg andRepresentatives Frank Pallone Jr. and Steven R. Rothman - agency managersoverruled the scientists and approved the device for sale inDecember." All four legislators made their inquiries within a few months ofreceiving significant campaign contributions from ReGen, which is based inNew Jersey, but all said they had acted appropriately andwere not influenced by the money." According to OpenSecrets.org, the four representatives received a total of$26,000 from three ReGen executives beginning in October 2007.The Times reported that: "The agency has never before publicly questioned the process behindone of its approvals, never admitted that a regulatory decision wasinfluenced by politics, and never accused a former commissioner ofquestionable conduct." Dr. Joshua Sharfstein, the FDA's principal deputy commissioner,acknowledged: "The message here is that there were problems with theintegrity of F.D.A.'s decision-making process that have solutions." However, Dr. von Eschenbach denied that he did anything wrong, and Gerald E.Bisbee Jr., chairman and chief executive of ReGen, said that Menaflexdefended the company's appeal to lawmakers, stating: "We did what people doall the time in Washington..." Indeed, America's healthcare crisis is in large measure the consequence ofpolitical influence peddling: public officials--of both parties--areshamelessly accepting "fees for service" from the healthcare industry: somebribes buy government licenses to market unsafe drugs and medical devices ofdubious efficacy.Another example of FDA dodging safety issues in response to influencepeddling:Electroshock manufacturers have succeeded in marketing devices that(admittedly) induce grand mal seizures--without ever having conductedpre-marketing safety tests. Indeed, electroshock machines have NEVER undergone clinical trials todetermine whether they are safe--either before or after marketing. Patients who have undergone electroshock, who have suffered profound memoryloss, have tried for decades to persuade the FDA that the machines shouldundergo clinical trials to demonstrate safety. Their efforts have failedbecause the combined lobbying power of electroshock machine manufacturersand organized psychiatry.Thirty years after the FDA first ruled that ECT can cause brain damage,therefore classified the devices to Class III, which require post-marketingsafety trials, the agency was prompted into action by the General AccountingOffice, which issued a report taking it to task for its neglect ofpre-Amendments Class III devices like the ECT device, and mandating that itnow take action. On April 9, the FDA issued a notice calling on themanufacturers of the ECT device to submit all data known to them of ECT'ssafety and efficacy, including information about adverse effects, by August7.Their submissions (if they made any) are not yet publicly available.However, there is no possibility that the two ECT device manufacturers haveconducted any clinical safety trials--as they are on record (currently)claiming that they can't afford to test their devices for safety, and don'tbelieve that it is their responsibility.For decades, an unholy alliance between ECT manufacturers and a group ofpowerful psychiatrists who have financial interests in the business of shockhave ignored the need to test the devices. The FDA designation for ECTdevices is class III--requiring safety tests. However, the tests have neverbeen conducted. What's more, ECT proponents saw a window of opportunity inthe wake of the publicized evidence uncovered demonstrating the seriousrisks posed by antidepressants: "the recent concerns over antidepressantsand depression, whether justified or not, will hopefully draw attention toECT as a powerful remedy for suicidal thinking." [Editorial in the JournalECT, 2005]In point of fact, the evidence against ECT is overwhelming: it causes shortand long-term memory loss (indicating, brain damage) and its benefits areshort-lived. Dr. Harold Sackeim, the recipient of the bulk of millions of dollars infederal (NIMH) funding to study the effect of ECT, the author of 200 journalarticles who had the greatest influence on the American PsychiatricAssociation ECT Guidelines (1990 and 2001)--and who was a paid consultantfor both ECT device manufacturers, Mecta and Somatics, acknowledged in 2000,after decades of denial that:"virtually all patients experience some degree of persistent, and likelypermanent retrograde amnesia. A series of recent studies demonstrates thatretrograde amnesia is persistent and that this long-term memory loss issubstantially greater with bilateral than right unilateral ECT." See: Sackeim, Harold A. Memory and ECT: From Polarization to Reconciliation.Journal of ECT. 16(2):87-96, June 2000. Dr. Sackeim also documented the high relapse rate: "after discontinuation ofECT the relapse rate was 84%." See: Sackeim, A. Haskett, RF; Mulsant, BH; Thase, ME; Mann, JJ; Pettinati,HM; Greenberg, RM; Crowe, RR; Cooper, TB; Prudic, J. Continuationpharmacotherapy in the prevention of relapse following electroconvulsivetherapy: a randomized controlled trial. JAMA, 2001;285:1299-1307.The ECT saga is compellingly chronicled in "Doctors of Deception: What TheyDon't Want You to Know About Shock Treatment" by Linda Andre, a survivor ofECT who suffered permanent memory loss. The book is published by RutgersUniversity Press.See:http://www.amazon.com/Doctors-Deception-About-Shock-Treatment/dp/0813544416/ref=sr_1_1?ie=UTF8 & qid=1249162232 & sr=8-1http://iospress.metapress.com/content/y476p161np607208/fulltext.htmlOn September 10, 2009, the FDA announced in the Federal Register that itopened a new docket for public comments on shock treatment. The docket, #FDA 2009-N-0392, will accept comments for 120 days, untilJanuary 8, 2010. http://www.gpo.gov/fdsys/pkg/FR-2009-09-10/html/E9-21807.htmIt remains to be seen whether the FDA will cave in to the ECT lobby. Thefear is that pressure from the American Psychiatric Association will prevailon the FDA to re-classify Electroshock machines without mandated safetytrials.It is vitally important that individuals, as well as agencies,organizations, and institutions, write in. Only public pressure has kept theFDA from reclassification all these years.Written comments must include the Docket Number and should be sent to:Food and Drug AdministrationDockets Management Branch (HFA-305)5630 Fishers Lane, Room 1061Rockville, MD 20852Re: Docket #FDA 2009-N-0392Electronic comments may be submitted at www.regulations.govAt the site, choose "Notices", and then enter the Docket #FDA 2009-N-0392 orkeyword "electroconvulsive therapy." The contact for further information at the FDA is Victor Krauthammer, 301796-2474.The Committee for Truth in Psychiatry, the national organization of ECTsurvivors, is coordinating the campaign to write in to the FDA; 917642-4625.Contact: Vera Hassner Sharavveracare212-595-8974~~~~~~~~http://www.nytimes.com/2009/09/25/health/policy/25knee.htmlTHE NEW YORK TIMESSeptember 25, 2009F.D.A. Reveals It Fell to a Push by LawmakersBy GARDINER HARRIS and DAVID M. HALBFINGERWASHINGTON - The Food and Drug Administration said Thursday that four NewJersey congressmen and its own former commissioner unduly influenced theprocess that led to its decision last year to approve a patch for injuredknees, an approval it is now revisiting.The agency's scientific reviewers repeatedly and unanimously over many yearsdecided that the device, known as Menaflex and manufactured by ReGenBiologics Inc., was unsafe because the device often failed, forcing patientsto get another operation.But after receiving what an F.D.A. report described as "extreme,unusual"and persistent pressure from four Democrats from New Jersey - SenatorsRobert Menendez and Frank R. Lautenberg and Representatives Frank PalloneJr. and Steven R. Rothman - agency managers overruled the scientists andapproved the device for sale in December.All four legislators made their inquiries within a few months of receivingsignificant campaign contributions from ReGen, which is based in New Jersey,but all said they had acted appropriately and were not influenced by themoney. Dr. Andrew C. von Eschenbach, the former drug agency's commissioner,said he had acted properly.The agency has never before publicly questioned the process behind one ofits approvals, never admitted that a regulatory decision was influenced bypolitics, and never accused a former commissioner of questionable conduct."The message here is that there were problems with the integrity of F.D.A.'sdecision-making process that have solutions," Dr. Joshua Sharfstein, theagency's principal deputy commissioner, said in a conference call withreporters.Dr. Sharfstein said that patients in the United States who had alreadyreceived the $3,000 device should wait for the agency's review of thedevice's approval and urged them "not to panic."Menaflex is a C-shaped pad used to repair a torn or damaged meniscus, thecushion between knee bones. A clinical trial of the device failed to showthat it worked any better than routine surgery.The report, written by top agency officials, said that Dr. von Eschenbach,who resigned as F.D.A. commissioner in January, became as a result ofpolitical pressure "personally engaged in the details of a process usuallycoordinated" by scientific staff. One agency manager concluded that Dr. vonEschenbach "was demanding not only an expedited process but also an outcomein favor of ReGen," the report stated."Congressional interest in the ReGen matter - and the unusual responsivenessof the commissioner to that interest - initiated a chaotic new phase in theagency's handling of the" company's application, the report said.In an interview Thursday, Dr. von Eschenbach defended his actions."My responsibility as that process was coming to a close was to make surethat it was continued in an orderly and appropriate fashion, and that's whatI believe I did," he said.The F.D.A.'s report said that its Office of Legislation began receivingcalls from members of Congress in December 2007 complaining about its reviewof the device, and the office's director "described the pressure from theHill as the most extreme he had seen."All four members of Congress denied that ReGen's political contributions hadplayed any role in their efforts on its behalf with the F.D.A. and said theywere merely doing their jobs by trying to help a constituent company.The four representatives received a total of $26,000 from three ReGenexecutives beginning in October 2007, according to OpenSecrets.org. Thedonations began with $2,000 to a political action committee controlled byMr. Menendez, the New Millennium PAC, on Oct. 28, 2007. Mr. Menendezreceived another $7,100 for his campaign account in March 2008.Afshin Mohamadi, a spokesman for Mr. Menendez, said the senator's "contactwith the F.D.A. was to help to ensure that the agency was communicatingclearly with the company and to help ensure a fair process."Mr. Rothman, who represents Hackensack, where ReGen is based, said in astatement that the company felt it was being "treated unfairly" and that"today's report makes it clear that the F.D.A. made mistakes andcommunicated poorly with ReGen."Mr. Rothman was given a $500 donation on Dec. 4, 2007; on Feb. 14, 2008, hereceived $8,200 for his campaign account and $2,600 for his own politicalaction committee, Renewing Opportunity, Trust & Hope, for a total of $11,300from the ReGen executives.Richard McGrath, a spokesman for Mr. Pallone, said the congressman hadsimply asked that the F.D.A. "follow the law and make its decision based onscience." Mr. Pallone received $2,300 in December 2007 and $1,000 in October2008 from a ReGen executive.Caley Gray, a spokesman for Mr. Lautenberg, emphasized that the senator"never made any calls or contacts" to ReGen Biologics, but did sign a letteralong with other members of the New Jersey delegation. Mr. Lautenbergreceived $2,300 in May 2008 from a ReGen executive.On Wednesday, the agency asked the Institute of Medicine to review theentire process by which the agency approves the vast majority of medicaldevices. The agency report was deeply critical of its device approvalprocess and said that confusion over basic rules and how to resolvedifferences among reviewers was rife. For decades, most medical devices havereceived only cursory reviews of their safety and efficacy from the agency.For equipment like bed pans and shower curtains, experts agree that quickappraisals are appropriate. But the medical device industry is producingmore and more complex machinery like pacemakers and stents.In January, the Government Accountability Office concluded that it was longpast time that the agency demanded that manufacturers prove that all complexdevices are safe and effective before being approved for sale.The agency's report said that ReGen, like many devices, was approved becauseit was supposed to be similar to an earlier device that itself was approvedbecause it was similar to another device. The result is a "predicate creep,"the report said, in which devices are approved based on information fromolder devices that often bear little resemblance to each other.Dr. David R. Schmidt, the knee surgeon for the San Antonio Spurs, said hewas involved in the original clinical trial of ReGen's Menaflex device andconcluded that patients did not benefit. He said he was surprised that theF.D.A. approved it.Copyright 2009 The New York Times Company FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.