• 08 MAY 09
    • 0

    #1056: FDA’s CDRH asks to consult with the Bioinitiative group

    While in Australia the telco industry dominated Australian Centre for Radiofrequency Bioeffects Research (ACRBR) continues to rubbish the Bioinitiative report (See: http://www.acrbr.org.au/) the U.S. FDA has requested

    From the CHEEMF list:

    The NY Times article below discusses how scientists concerned about FDA approval
    of some imaging devices over objections from the scientists reviewing them for FDA
    (breast cancer imaging, for one) have now triggered an internal FDA meeting
    to discuss serious flaws in the approval process for medical devices. After their concerns were
    ignored by FDA, these scientists went to Congress, got a Congressional Investigation launched,
    and now the FDA is signaling it will listen. Such political interventions on science and public
    health issues shouldn’t have to happen in order for regulatory agencies to do their jobs.
    But, it shows that if serious deficiencies in agency responses to new public health risks
    are ignored, there is another avenue.

    On a related issue, the FDA Center for Devices and Radiological Health requested a meeting
    with representatives from the BioInitiative Working Group to discuss the scientific and public
    health findings of the BioInitiative Report regarding cell phones and other wireless technology
    health risks. The meeting was held April 15th in Rockville, MD. Although there is no indication that FDA intends to make changes in the website it maintains on cell phone issues; nor issue any precautionary warnings for children who use cell phones, nor upgrade its SAR labeling advice or consumer education information, that they asked for a briefing at all is seen as a positive development.

    David O. Carpenter and Cindy Sage, Co-editors of the Report attended and presented
    findings and recommendations. Abiy Desta, Radiation Bio-effects Laboratory
    Division of Biology, Office of Science and Engineering Laboratories coordinated the
    meeting.

    Submitted by Cindy Sage
    22 April 09

    http://www.nytimes.com/2009/04/22/health/policy/22fda.html?_r=1&hpw=&pagewanted=print

    The New York Times

    April 22, 2009
    Rare F.D.A. Meeting to Discuss Complaints on Device Approval
    By GARDINER HARRIS

    An unusual internal meeting scheduled for Wednesday at the Food and Drug Administration may signal how agency officials intend to handle the many controversies swirling around its embattled device division.

    Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, sent an e-mail message on April 10 announcing an “all-hands meeting” to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for years, two agency officials said.

    Nine dissident scientists signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers.

    The scientists have sent numerous e-mail messages to Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, pleading for his intervention.

    On April 15, Dr. Sharfstein replied to one of the scientists that he was “already burning the candle at both ends to keep up with this job,” and he asked the scientists to distill their concerns into a single memorandum.

    A Congressional investigation into the scientists’ concerns has been opened, and in January the Government Accountability Office released a report that was critical of the device center.

    This week, legislation is expected to be proposed in Congress that would ask the Institute of Medicine to investigate concerns surrounding the device division.

    In an extensive memorandum sent to Dr. Sharfstein last week, the dissident scientists charged that the “regulatory review process for medical devices has been severely distorted” and that those who raised concerns about unsafe devices had been retaliated against by agency managers.

    Among the devices the dissidents say the agency has approved inappropriately are imaging equipment used to detect breast cancer and an orthopedic knee device. The agency has also allowed hospitals to wash and reuse surgical devices intended for just one use, they said.

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