News article: Scientific Decisions Warped by Politics.

Discussion in 'Fibromyalgia Main Forum' started by tansy, Sep 24, 2005.

  1. tansy

    tansy New Member

    New York Times

    Leader of the F.D.A. Steps Down After a Short, Turbulent Tenure

    By ROBERT PEAR and ANDREW POLLACK
    Published: September 24, 2005

    WASHINGTON, Sept. 23 - Lester M. Crawford, the commissioner of food
    and drugs, resigned abruptly on Friday, causing further upheaval at an
    agency that has been in turmoil for more than a year.

    Dr. Crawford, who was confirmed just two months ago, on July 18, after
    serving as acting commissioner for more than a year, did not say why
    he was stepping down.

    Senior officials at the Food and Drug Administration said they were
    stunned to learn of the resignation in an e-mail message from Dr.
    Crawford, who also sent a letter to President Bush stating that he was
    resigning "effective immediately."

    A government official said the resignation was related to the fact
    that Dr. Crawford had not fully disclosed information about his
    finances to the Senate before his confirmation. The official spoke on
    condition of anonymity, citing Dr. Crawford's privacy.

    Michael O. Leavitt, the secretary of health and human services,
    accepted the resignation and thanked Dr. Crawford for his service.

    Christina Pearson, a spokeswoman for Mr. Leavitt, refused to say
    whether Bush administration officials had asked for the resignation.

    "I can't comment," Ms. Pearson said. "This is a personnel issue."

    In recent weeks, consumer advocates and scientists inside and outside
    the agency had said scientific decisions were being warped by politics.

    On Thursday, a commentary in The New England Journal of Medicine
    titled "A Sad Day for Science at the F.D.A." said that "recent actions
    of the F.D.A. leadership have made a mockery of the process of
    evaluating scientific evidence," disillusioned many scientists,
    "squandered the public trust and tarnished the agency's image."

    Mr. Bush said he intended to name Dr. Andrew C. von Eschenbach,
    director of the National Cancer Institute, to be acting commissioner
    of food and drugs.

    Dr. Crawford, a veterinarian and expert on food safety, was named
    deputy commissioner of the agency in early 2002 before his tenure as
    acting commissioner. In that time the agency has been rocked by
    disputes over many issues, including the safety of painkillers like
    Vioxx, the regulation of heart defibrillators and other devices, and
    delays in deciding whether to allow over-the-counter sales of an
    emergency contraceptive.

    The director of the agency's Office of Women's Health, Dr. Susan F.
    Wood, resigned three weeks ago to protest delays in approving
    over-the-counter sales of the morning-after pill Plan B.

    Critics, including members of Congress from both parties, say the
    agency has not provided the public with enough information about the
    risks of drugs and devices.

    "In recent years the F.D.A. has demonstrated a too-cozy relationship
    with the pharmaceutical industry and an attitude of shielding rather
    than disclosing information," said Senator Charles E. Grassley,
    Republican of Iowa and chairman of the
    Senate Finance Committee.

    Senator Barbara A. Mikulski, Democrat of Maryland, said the agency had been "politicized and
    degraded" under Dr. Crawford, whose leadership she described as "tepid
    and passive."

    Before the Senate confirmed Dr. Crawford, a Senate committee looked
    into accusations that he was having an affair with a woman who worked
    in his office and that he had wasted government money by taking her on
    official trips when she was not needed. An anonymous letter also
    suggested that Dr. Crawford had helped the woman secure a promotion to
    a higher-paying job.

    An inquiry by the inspector general of the Department of Health and
    Human Services found some contradictions in statements by Dr. Crawford
    and the woman. Investigators found a close personal relationship
    between them but no evidence of an extramarital affair.

    The committee chairman, Senator Michael B. Enzi, Republican of Wyoming, said at the time that the inspector
    general had found no merit to the charges leveled at Dr. Crawford. No
    senator wanted to pursue the issue then.

    In his message to colleagues on Friday, Dr. Crawford said that after
    three and a half years in top positions at the agency, "it is time, at
    the age of 67, to step aside."

    Senator Richard J. Durbin, Democrat of Illinois, who voted against Dr. Crawford's
    nomination, said Friday: "The Food and Drug Administration is facing
    nothing short of a crisis in leadership. The controversy surrounding
    Vioxx and other pharmaceuticals has exposed weak oversight, conflict
    of interest and poor management at the F.D.A."

    Ira Loss, senior health analyst at Washington Analysis, which studies
    federal issues for investors, said he had been told by someone in the
    White House that Dr. Crawford had been asked to resign for a reason
    not yet known to the public.

    "Something new has arisen that has led to this," Mr. Loss said. It was
    not the controversy over the morning-after pill, he said, because Dr.
    Crawford "did what they wanted on Plan B."

    Under Dr. Crawford, the agency was buffeted by fierce debates over
    drug safety.

    Critics, including many in Congress, said the agency had tried to
    stifle one of its own scientists who had found evidence that the use
    of antidepressants could cause children and teenagers to become more
    suicidal.

    The agency was also criticized as slow to recognize that Vioxx and
    similar pain medicines could increase the risk of heart attacks and
    strokes. Merck withdrew Vioxx from the market a year ago and is facing
    thousands of lawsuits from people who say they were harmed by the drug.

    Under pressure, Dr. Crawford and the agency have started to release
    more information about potential safety problems of drugs and devices,
    rather than waiting, as in the past, until they had a fuller picture.

    "I think he started to lift the veil on how the F.D.A. does business,
    which was long overdue," said Peter Pitts, a former associate
    commissioner under Dr. Crawford.

    While many critics say drugs are approved too quickly, the F.D.A. has
    also come under fire from pharmaceutical companies and some patient
    advocates for not approving drugs quickly enough.

    Pharmaceutical and biotechnology companies had generally welcomed Dr.
    Crawford's appointment, partly because of his long experience at the
    agency, but also because they wanted a full-time commissioner. Many
    industry officials say that under an acting commissioner, the agency
    tends to put off difficult decisions.

    The agency has had a full-time commissioner for only about 18 months
    out of the four and a half years that President Bush has been in office.

    The president's first appointee, Dr. Mark B. McClellan, did not take
    office until November 2002 and then left about 16 months later to run
    the Medicare program.

    It now appears that the agency will be without a permanent
    commissioner for some time. Experience shows that it is difficult for
    any nominee to obtain broad support in the Senate, because the agency
    handles so many volatile issues.

    Dr. von Eschenbach has been director of the National Cancer Institute,
    part of the National Institutes of Health, since January 2002. Before
    that, he had a long career as a doctor and executive at the M. D.
    Anderson Cancer Center in Houston.

    James C. Greenwood, president of the Biotechnology Industry
    Organization, which represents biotech companies, described Dr. von
    Eschenbach as an "excellent choice" who would provide strong leadership.

    Mr. Greenwood had no comment on Dr. Crawford's resignation. Nor did
    the Pharmaceutical Research and Manufacturers of America, which
    represents big drug companies.
  2. justlooking

    justlooking New Member

  3. dojomo

    dojomo New Member

    The FDA isn't the only agency with a "leadership crisis". Did this administration just pull everyone's name out of a hat? I hate the direction this country is taking.//DJ
    [This Message was Edited on 09/26/2005]
  4. Bruin63

    Bruin63 Member



    I think this is an intersting article and after reading it, I thought I'd post this, for others to see.

    Hope these changes, work for the Better and not make things worse.
    I am an Opptmist and try to stay that way, with these Syndromes and conditions, it sure isn't easy these day's.

    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


    FDA Chief Wants Transformation in Medicine By JOHN J. LUMPKIN, Associated Press Writer
    Mon Sep 26, 3:56 AM ET



    The incoming head of the Food and Drug Administration says the agency must stay on top of emerging discoveries into the mechanisms of disease that may lead to new treatments that can be tailored to individual patients.

    Dr. Andrew C. von Eschenbach, tapped by President Bush to at least temporarily head the regulatory agency, said Sunday that recent research will lead to a new kind of health care.

    "We are discovering so much about diseases like cancer at the molecular level," von Eschenbach, a urologic surgeon by training, said in an interview with The Associated Press.

    Based on these understandings, physicians will be able to devise treatments more effectively matched to a specific patient and his or her condition, he said. That's a fundamental shift: Doctors now treat illnesses based primarily on how well other people have responded to a given treatment.

    Von Eschenbach has a reputation for optimism. As head of the National Cancer Institute, he outlined an ambitious goal of eliminating suffering and death due to cancer and turning it into a manageable disease by 2015 — an aim regarded by some as unlikely.

    But von Eschenbach has seen cancer from both sides, having survived three diagnoses: melanoma, prostate cancer and basal cell carcinoma.

    Von Eschenbach said he will stay in his post at the institute, which is the government's lead agency in researching cancer treatments, while running the FDA. He gave no indication whether he expected to be nominated as permanent chief of the FDA.

    He replaces Commissioner Lester Crawford, out only two months after the Senate confirmed him for the post. Crawford had functioned as acting head for more than year.

    Crawford's surprise resignation Friday gave no specific reason for his departure. His tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics or benefiting drug companies than in its mission to protect consumers.

    Von Eschenbach declined to discuss in detail specific cases that have led to criticism of the FDA. They include Vioxx, a class of painkiller lately tied to heart problems, and Plan B, an emergency, morning-after contraceptive that the FDA has yet to approve for over-the-counter sales, despite assurances it is safe.

    Von Eschenbach had only praise for his colleagues at the FDA, calling the agency the "gold standard" for food and health care regulation.

    "I have an enormous amount of respect, admiration and appreciation for them," he said, and will continue many of his predecessors' initiatives while looking for ways to improve agency operations.

    Von Eschenbach also discussed the perpetual challenge for the FDA: speeding new treatments to the market while ensuring they are safe. Sometimes those values are in conflict, as pressure from drug companies and patients to make new treatments available run up against incomplete or ambiguous safety data.

    "I believe very strongly that science has to drive and is the driver of our knowledge and our understanding, and therefore of our decisions," he said. "Where science is incomplete, we continue to believe that under any circumstances, do no harm."

    But with new treatments, von Eschenbach said: "I believe it's still important to ask the question, 'How can we accelerate the timeline? How can we make certain we are getting these interventions to the patients as quickly as possible?'"

    The Philadelphia native served as chief academic officer of the University of Texas M.D. Anderson Cancer Center in Houston before taking over the National Cancer Institute in 2002.

    ___

  5. Mikie

    Mikie Moderator

    Ya gotta love it!

    Love, Mikie