FDA Acknowledges Caving to Influence Peddling–ReGen / ECT

The New York Times reported last month that top FDA officials acknowledged in a report that the agency’s approval process of a medical device had been tainted by political pressure–and that the former Commissioner of the agency, Dr. Andrew von Eschenbach, “personally engaged in the details of a process usually coordinated” by scientific staff.

The report stated that Dr. von Eschenbach “was demanding not only an expedited process but also an outcome in favor of ReGen.”

“Congressional interest in the ReGen matter — and the unusual responsiveness of the commissioner to that interest — initiated a chaotic new phase in the agency’s handling of the” company’s application, the report said.

"The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen 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 and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the  device for sale in December."

“Congressional interest in the ReGen matter — and the unusual responsiveness of the commissioner to that interest — initiated a chaotic new phase in the agency’s handling of the” company’s application, the report said.

"The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen 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 and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the  device for sale in December."

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said  they had acted appropriately and were 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 behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct."

Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner, acknowledged:  “The message here is that there were problems with the integrity 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 Menaflex defended the company’s appeal to lawmakers, stating:
“We did what people do all the time in Washington…”

Indeed, America’s healthcare crisis is in large measure the consequence of political influence peddling: public officials–of both parties–are shamelessly accepting "fees for service" from healthcare industry manufacturers who are given government licenses to market unsafe drugs and medical devices of dubious efficacy.

Another example of FDA dodging safety issues in response to influence peddling:
Electroshock manufacturers have succeeded in marketing devices that (admittedly) induce grand mal seizures–without ever having conducted pre-marketing safety tests.

Thirty years ago, the FDA first ruled that ECT can cause brain damage, classifying  the devices as Class III, which require post-marketing safety trials. Despite mandatory safety test requirements for Class III devices, electroshock machines have NEVER undergone clinical trials to determine whether they are safe–either before or after marketing. 

Patients who have been "treated" with electroshock, and have suffered profound memory loss, have tried for decades to persuade the FDA that the machines should undergo clinical trials to demonstrate safety. Their efforts have failed because the combined lobbying power of electroshock machine manufacturers and organized psychiatry.

After 30 years, the agency, issued a notice, on April 9, calling on the manufacturers of the ECT device to submit all data known to them of ECT’s safety and efficacy, including information about adverse effects, by August 7. 

The agency was prompted into action by the General Accounting Office, which issued a report taking the FDA to task for its neglect of pre-Amendments Class III devices like the ECT device, mandating that the FDA now take action.

Manufacturerers’ submissions (if they made any) are not yet publicly available. However, there is no possibility that the two ECT device manufacturers have conducted any clinical safety trials–as they are on record (currently) claiming that they can’t afford to test their devices for safety, and don’t believe that it is their responsibility to do so.

For decades, an unholy alliance between ECT manufacturers and a group of powerful psychiatrists who have financial interests in the business of shock have ignored the need to test the devices. The FDA desgination for ECT devices is class III–requiring safety tests. However, the tests have never been conducted. What’s more, ECT proponents saw a window of opportunity in the wake of the publicized evidence uncovered demonstrating the serious risks posed by antidepressants:  “the recent concerns over antidepressants and depression, whether justified or not, will hopefully draw attention to ECT as a powerful remedy for suicidal thinking.”   [Editorial in the Journal ECT, 2005]

In point of fact, the evidence against ECT is overwhelming: it causes short and long-term memory loss (indicating, brain damage) and its benefits are short-lived.

Dr. Harold Sackeim, the recipient of the bulk of millions of dollars in federal (NIMH) funding to study the effect of ECT, the author of 200 journal articles who had the greatest influence on the American Psychiatric Association ECT Guidelines (1990 and 2001)–and who was a paid consultant for both ECT device manufacturers, Mecta and Somatics, acknowledged in 2000, after decades of denial that:

“virtually all patients experience some degree of persistent, and likely permanent retrograde amnesia. A series of recent studies demonstrates that retrograde amnesia is persistent and that this long-term memory loss is substantially 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 of ECT 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. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA, 2001;285:1299-1307.

The ECT saga is compellingly chronicled in "Doctors of Deception: What They Don’t Want You to Know About Shock Treatment " by Linda Andre, a survivor of ECT who suffered permanent memory loss. The book is published by Rutgers University Press.

On September 10, 2009, the FDA announced in the Federal Register that it opened a new docket for public comments on shock treatment.
The docket, #FDA 2009-N-0392, will accept comments for 120 days, until January 8, 2010.
http://www.gpo.gov/fdsys/pkg/FR-2009-09-10/html/E9-21807.htm

It remains to be seen whether the FDA will cave in to the ECT lobbyThe fear is that pressure from the American Psychiatric Association will prevail on the FDA to re-classify Electroshock machines without mandated safety trials.

It is vitally important that individuals, as well as agencies, organizations, and institutions, write in. Only public pressure has kept the FDA from reclassification all these years.

Written comments must include the Docket Number and should be sent to:
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Docket #FDA 2009-N-0392

Electronic comments may be submitted at www.regulations.gov

At the site, choose “Notices”, and then enter the Docket #FDA 2009-N-0392 or keyword “electroconvulsive therapy.”

The contact for further information at the FDA is Victor Krauthammer, 301 796-2474.

The Committee for Truth in Psychiatry, the national organization of ECT survivors, is coordinating the campaign to write in to the FDA; 917 642-4625.

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THE NEW YORK TIMES
September 25, 2009
F.D.A. Reveals It Fell to a Push by Lawmakers
By GARDINER HARRIS and DAVID M. HALBFINGER

WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen 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 and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. 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 of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.

Dr. Sharfstein said that patients in the United States who had already received the $3,000 device should wait for the agency’s review of the device’s approval and urged them “not to panic.”

Menaflex is a C-shaped pad used to repair a torn or damaged meniscus, the cushion between knee bones. A clinical trial of the device failed to show that 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 of political pressure “personally engaged in the details of a process usually coordinated” by scientific staff. One agency manager concluded that Dr. von Eschenbach “was demanding not only an expedited process but also an outcome in favor of ReGen,” the report stated.

“Congressional interest in the ReGen matter — and the unusual responsiveness of the commissioner to that interest — initiated a chaotic new phase in the agency’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 sure that it was continued in an orderly and appropriate fashion, and that’s what I believe I did,” he said.

The F.D.A.’s report said that its Office of Legislation began receiving calls from members of Congress in December 2007 complaining about its review of the device, and the office’s director “described the pressure from the Hill as the most extreme he had seen.”

All four members of Congress denied that ReGen’s political contributions had played any role in their efforts on its behalf with the F.D.A. and said they were merely doing their jobs by trying to help a constituent company.

The four representatives received a total of $26,000 from three ReGen executives beginning in October 2007, according to OpenSecrets.org. The donations began with $2,000 to a political action committee controlled by Mr. Menendez, the New Millennium PAC, on Oct. 28, 2007. Mr. Menendez received another $7,100 for his campaign account in March 2008.

Afshin Mohamadi, a spokesman for Mr. Menendez, said the senator’s “contact with the F.D.A. was to help to ensure that the agency was communicating clearly with the company and to help ensure a fair process.”

Mr. Rothman, who represents Hackensack, where ReGen is based, said in a statement that the company felt it was being “treated unfairly” and that “today’s report makes it clear that the F.D.A. made mistakes and communicated poorly with ReGen.”

Mr. Rothman was given a $500 donation on Dec. 4, 2007; on Feb. 14, 2008, he received $8,200 for his campaign account and $2,600 for his own political action committee, Renewing Opportunity, Trust & Hope, for a total of $11,300 from the ReGen executives.

Richard McGrath, a spokesman for Mr. Pallone, said the congressman had simply asked that the F.D.A. “follow the law and make its decision based on science.” Mr. Pallone received $2,300 in December 2007 and $1,000 in October 2008 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 letter along with other members of the New Jersey delegation. Mr. Lautenberg received $2,300 in May 2008 from a ReGen executive.

On Wednesday, the agency asked the Institute of Medicine to review the entire process by which the agency approves the vast majority of medical devices. The agency report was deeply critical of its device approval process and said that confusion over basic rules and how to resolve differences among reviewers was rife. For decades, most medical devices have received only cursory reviews of their safety and efficacy from the agency.

For equipment like bed pans and shower curtains, experts agree that quick appraisals are appropriate. But the medical device industry is producing more and more complex machinery like pacemakers and stents.

In January, the Government Accountability Office concluded that it was long past time that the agency demanded that manufacturers prove that all complex devices are safe and effective before being approved for sale.

The agency’s report said that ReGen, like many devices, was approved because it was supposed to be similar to an earlier device that itself was approved because it was similar to another device. The result is a “predicate creep,” the report said, in which devices are approved based on information from older devices that often bear little resemblance to each other.

Dr. David R. Schmidt, the knee surgeon for the San Antonio Spurs, said he was involved in the original clinical trial of ReGen’s Menaflex device and concluded that patients did not benefit. He said he was surprised that the F.D.A. approved it.

Copyright 2009 The New York Times Company

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