Date:   2/15/2008 5:35:44 PM ( 16 y ago)
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By Byron J. Richards, CCN

February 15, 2008

NewsWithViews.com

It now appears that the FDA Chief Andrew von Eschenbach, M.D. has committed perjury before Congress. Unlike Roger Clemens, who also seems to be putting his foot in his mouth before Congress, von Eschenbach’s actions appeared to have allowed unnecessary deaths to Americans – hardly the mission of the FDA. By contrast, Roger Clemens is simply causing death to his own reputation. Hopefully Congress can quit wasting taxpayer money on baseball and get to the bottom of what is really going on at the FDA.

The FDA is now ignoring Congressional subpoenas of its records, setting up another showdown between Congress and the Bush Administration. Unlike former showdowns, national security is not involved. Will the Bush administration offer protection for a situation that involves needless deaths to Americans? The Chinese sentenced to death the head of their FDA for far lesser misdoings.

The issue revolves around the fraud-riddled antibiotic Ketek which is made by Aventis, now Paris-based Sanofi-Aventis. Sen. Charles Grassley, R-IA, has been holding the FDA’s feet to the coals on the Ketek issue for the past several years ever since an 18 year old boy from Iowa was killed by the antibiotic when being treated for a routine infection. There are other deaths and many cases of liver failure. The House Oversight and Investigations Subcommittee has been looking into the matter since early last year, shortly after von Eschenbach’s permanent appointment to head the FDA.

The available evidence paints a picture of the FDA turning this deadly drug loose on children even though it knew of safety problems, a trail of evidence von Eschenbach has actively covered up. In the face of Congressional scrutiny the FDA has since scaled back it’s approved use of Ketek, but has left it on the market to treat pneumonia. The FDA blames Aventis for the problems, who is also in hot water with Congress. The FDA is refusing to hand over records showing what it knew and when.

Insider information indicates significant FDA wrongdoing.

We already know that a clinical trial involving the drug was forged by a weight loss clinic in Gadsden, Alabama. The physician in charge, Dr. Maria Anne Kirkman-Campbell, is now serving five years in prison. Congress has been trying to get to the bottom of the matter, seeking to establish what Sanofi-Aventis and the FDA knew. Congress has hit a stone wall. It appears they both knew plenty – and covered their tracks.

The House Subpoenas FDA Records

Congress finally had enough. On January 25, 2008 John Dingell and Bart Stupak of the House Oversight and Investigations Subcommittee sent a memorandum stating they intended to subpoena FDA investigators, a private contractor, and various FDA records, which they followed through on several days later.

On February 12, 2008 the House committee held hearings on the matter. Douglas Loveland, a special agent at the FDA’s criminal-investigation office, told the committee that Aventis should have known there was fraud and there was a “catastrophic failure” of their clinical trial systems. They ignored “red flags” about the bogus data, “they were loud signals…they were bright signals.”

The FDA even admits that it knew there were “serious protocol violations and regulatory noncompliance by multiple clinical investigators” and that it had no knowledge these problems were ever fixed before approving the drug. However, the FDA is not forthcoming about information that may indicate a von Eschenbach cover-up.

Last March von Eschenbach provided written testimony to the committee on events surrounding the Ketek drug approval. The committee subsequently learned from an FDA insider and those familiar with the approval that the testimony was not truthful. The committee had recently subpoenaed the FDA records regarding the preparation of this testimony to learn why it was lied to.

On February 12, 2008 the committee was told by the parent of the FDA, the Health and Human Services Department, that these documents would not be provided because “The department has serious concerns about providing the kind of materials the committee has subpoenaed…such highly confidential and deliberative materials used to prepare witnesses testifying before Congress risks chilling the open exchange of views that is essential to the effective conduct of agency business.” A more skeptical outsider like myself would interpret this to mean “that when people are killed the FDA is above the law and doesn’t need to disclose relevant information.”

Dingell is not taking the matter lying down: “What is in those briefing books that he does not want either my Republican colleagues or our side to see? Is there evidence of perjury? Are there statements embarrassing to the administration?” He went on to say that “Neither Chairman Stupak nor I will tolerate such a perversion of Congressional powers to investigate and probe.” His next step to get the von Eschenbach records may be to hold Michael Leavitt, the HHS Secretary, in contempt of Congress – setting up a major showdown with the Bush Administration.

FDA Whistleblower

Dr. David Ross served as the FDA’s primary safety reviewer on Ketek. He was concerned about liver damage as early as 2000 and was stunned by the fact that the U.S. clinical trial contained blatant fraud. Back in 2003 he wanted to give this information to the FDA advisory panel that was deciding if Ketek was safe to use for the public. FDA management prevented him from doing so and purposefully withheld information from the advisory panel about the ongoing criminal investigation.

Ross buckled to FDA management pressure and omitted the safety risks and his concerns about Ketek from his final report. This all happened prior to von Eschenbach coming to the FDA. Under von Eschenbach’s tenure as temporary head of the FDA the Ketek problems began to hit the fan. Congress started actively looking into the matter and von Eschenbach went into damage control mode. He called a meeting of 40 FDA employees regarding Ketek issues and mysteriously Ross was invited to this meeting (he no longer worked on the Ketek issue).

Ross has reported that during the meeting von Eschenbach likened the workings of the FDA to a football locker room, where differing views can be vented but that once on the field the team speaks with one voice and any FDA staff who speaks differently will be warned the first time, benched the second time, and traded the third time.

In the face of such a blatant effort to suppress the truth of the situation Ross turned whistleblower. He has told Congress that the FDA approved Ketek “despite knowing that it could kill people from liver damage and that tens of millions of people would be exposed to it.”

Grassley Predicted the Unethical Behavior of von Eschenbach

Back in February of 2007 Senator Grassley informed the House committee of the extensive nature of the FDA cover-up on Ketek as well as other issues, including FDA disregard for Congressional investigation.

Von Eschenbach is a cancer-industry insider who took the job at the FDA so he could get quick approval of new biotech drugs while using humans for cruel experiments in the name of “progress.” His nomination as permanent head of the FDA took place during the 2006 lame duck session of Congress and was rubber stamped by Big Pharma friendly Senators. Senator Grassley knew better, as he stated on the floor of the Senate during the confirmation hearings:

“People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.… This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people.”

As Grassley’s warning fell on deaf ears, Orrin Hatch (R-UT), a man whose pockets are lined with Big Pharma money, rose in defense of von Eschenbach:

“To me it is simply unconscionable that the Food and Drug Administration, one of the best little agencies in Government, has gone leaderless for such a period of time…I know Dr. von Eschenbach well. He is a man of integrity….I urge my colleagues--no, I implore my colleagues--to do what is right and vote [for] this nomination….it is what the American people deserve.”

Indeed, as history notes, the American people got von Eschenbach – a drug company sales rep sitting in the hot seat atop the dysfunctional FDA, an organization of unelected bureaucrats who are certain they are above the rule of law and certain they have nice jobs waiting for them in the Big Pharma world.

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