Senior Women Web

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  • More Than Half of FDA’s Debarment Proceedings Take Four or More Years

    At seniorwomen.com, we receive daily reports from GAO (US Goverment Accountability Office)and often pass them on to our viewers. This we missed, until another weekly report about ethics reminded us:

    Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators

    The Food and Drug Administration (FDA) oversees the clinical investigators who conduct research involving new drugs, biologics, and medical devices to ensure that their conduct does not compromise the safety of clinical trial participants or the integrity of clinical trial data. FDA can debar or disqualify investigators who have engaged in misconduct such as submitting fraudulent data. Debarred or disqualified investigators cannot engage in certain activities related to clinical research. GAO was asked to review FDA’s debarment and disqualification processes. GAO examined the length of time debarment and disqualification processes have taken and factors for those time frames, and the statutory and regulatory limitations of debarment and disqualification. GAO reviewed laws, regulations, and FDA files through November 5, 2008, for (1) all investigators, study coordinators, and sub-investigators for whom FDA pursued debarment since receiving debarment authority in 1992; and (2) all clinical investigators for whom FDA pursued disqualification since FDA adopted its current process for initiating proceedings in 1998.

    What GAO Recommends

    To improve its oversight, the Commissioner of FDA should pursue extending FDA’s debarment authority; extend disqualification to include drugs, biologics, and medical devices; and ensure the timely completion of debarment and disqualification proceedings. FDA agreed with GAO’s recommendations.

    More than half of the debarment proceedings in GAO’s review took 4 or more years, and factors contributing to these time frames included internal control weaknesses in the debarment process and competing priorities among responsible staff. FDA has statutory authority to debar individuals who have been convicted of felonies or certain misdemeanors related to the development, approval, or regulation of a drug or biologic. For the 18 proceedings GAO reviewed, the length of time from an individual’s conviction through debarment (or as of November 5, 2008, for pending proceedings) ranged from about 1 year to nearly 11 years. Factors that contributed to delays included that FDA staff faced competing priorities and FDA had not established internal controls, such as time frames for the completion of steps in the debarment process. FDA has made or planned changes that could improve timeliness (e.g., by establishing time frames in March 2009), but the effects of such actions have yet to be seen.

    The time taken for disqualification proceedings varied and proceedings took longer when the investigator contested disqualification. FDA may disqualify investigators who repeatedly or deliberately failed to comply with FDA regulations or submitted false information to FDA or the sponsor of a clinical trial. For the 52 disqualification proceedings GAO reviewed, the length of time from initiation of a disqualification proceeding to its conclusion (or as of November 5, 2008, for pending proceedings) ranged from 26 days to more than a decade, with about one-third taking more than 2 years. In general, the more steps taken by the investigator to contest disqualification, the longer it took to complete the proceeding. Disqualification proceedings initiated in 1998 through 2001 generally took longer than proceedings that were initiated more recently. FDA officials told us that a lack of time frames for these proceedings — an internal control weakness — may have contributed to longer proceedings. FDA made changes to its disqualification process (e.g., by establishing time frames in June 2008 and January 2009) that could further improve timeliness, but the full effect of these changes remains to be seen.

    FDA’s debarment authority does not fully extend to involvement with medical devices, and its regulations do not extend disqualification for drugs and biologics to medical devices and vice versa. As a result, an individual may be debarred from involvement with drugs and biologics, but not from involvement with medical devices, regardless of the kind of misconduct in which the individual engaged. FDA’s disqualification regulations allow an investigator who is disqualified for conduct related to drugs or biologics to serve as an investigator for medical devices; likewise, an individual who FDA disqualified for conduct related to medical devices remains able to serve as a clinical investigator for drugs and biologics.

    The entire report can be read at the GAO site: http://www.gao.gov/new.items/d09807.pdf. The Wall Street Journal’s article on the report can also be read online:

  • Girls in the Juvenile Justice System

    The following are excerpts from Women’s Policy, Inc.

    On October 20, the House Judiciary Subcommittee on Crime, Terrorism, and Homeland Security held a hearing, “Girls in the Juvenile Justice System: Strategies to Help Girls Achieve Their Full Potential.”

    “From 1995 through 2005, delinquency caseloads for girls in juvenile justice courts nationwide increased 15 percent while boys’ caseloads decreased by 12 percent,” said Ranking Member Louie Gohmert (R-TX). “Also, from 1995 through 2005, the number of girls’ cases nationwide involving detention increased 49 percent, compared to a seven percent increase for boys. This trend in juvenile delinquency has not gone unnoticed by federal, state, and local policymakers. As the number of female juvenile offenders increased, state juvenile justice officials have noted that juvenile female offenders generally had more serious and wide-ranging service needs than their male counterparts. Many of these needs include treatment for substance abuse and mental health conditions. To address these needs, the Department of Justice tells us that over the last 10 to 15 years, at least 25 states have developed new programming for girls in the juvenile justice system.”

    Lawanda Ravoira, director of the National Council on Crime and Delinquency’s Center for Girls and Young Women, provided a profile of the girls in the criminal justice system, saying, “There is an overrepresentation of girls of color in the justice system. Based on the race/ethnic proportion of the general population of youth ages 12-17, overrepresentation is an equity issue affecting both girls and boys…Girls of color are overrepresented among youth in residential placement. Compared to white girls: African American girls are placed over three times as often; Native American girls are placed over four times as often; Hispanic girls are placed at higher rates; [and] Asian Pacific Islanders are underrepresented.” She continued, “Disparity exists regardless of offense type. Compared to white girls: African American girls are detained almost six times as often and committed over four times as often for violent crimes; Native Americans are detained five times as often for public order and nine times as often for status offenses, and committed over five times as often for violent and status offenses; Hispanic girls are detained almost twice as often for violent, public order, and technical violations. Girls of color are placed in adult prisons at far higher rates. Compared to white girls: African American girls are sent to adult prison over five times as often and Native American girls three times as often.”

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  • The Ten Precautions of Cell Phone Use

    Recommendations for cell phone use that affects not just children but all users from the Environmental Health Trust:

    THE TEN PRECAUTIONS

    Given the absence of definitive proof in humans of the carcinogenic effects of electromagnetic fields of cell phones, we cannot speak about the necessity of preventative measures (as for tobacco or asbestos). In anticipation of more definitive data covering prolonged periods of observation, the existing data press us to share important prudent and simple measures of precaution for cell phone users, as have been variously suggested by several national and international reports.

    These measures are also likely to be important for people who are already suffering from cancer and who must avoid any external influence that may contribute to disease progression.

    1. Do not allow children to use a cell phone except for emergencies. The developing organs of a fetus or child are the most likely to be sensitive to any possible effects of exposure to electromagnetic fields.

    2. While communicating using your cell phone, try to keep the cell phone away from the body as much as possible. The amplitude of the electromagnetic field is one fourth the strength at a distance of two inches and fifty times lower at three feet. Whenever possible, use the speaker-phone mode or a wireless Bluetooth headset, which has less than 1/100th of the electromagnetic emission of a normal cell phone. Use of a headset attachment may also reduce exposure.

    3. Avoid using your cell phone in places, like a bus, where you can passively expose others to your phone’s electromagnetic fields.

    4. Avoid carrying your cell phone on your body at all times. Do not keep it near your body at night such as under the pillow or on a bedside table, particularly if pregnant. You can also put it on “flight” or “off-line” mode, which stops electromagnetic emissions.

    5. If you must carry your cell phone on you, it is preferable that the keypad is positioned toward your body and the back is positioned toward the outside of your body. Depending on the thickness of the phone this may provide a minimal reduction of exposure.

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  • PBS’ Close to Home: Chronicling the Recession’s Impact on NYC’s Tony Upper East Side

    We couldn’t resist publicizing this latest Frontline effort, which is summarized in their release:

    As the US unemployment rate hits a 25-year high and the Dow Jones Industrial Average hits a six-year low, award-winning Frontline producer Ofra Bikel (The Hugo Chavez Show, When Kids Get Life) chronicles the recession’s impact on one unlikely American neighborhood – New York’s Upper East Side.

    In Close to Home, airing Tuesday, Oct. 27, at 9 P.M. ET on PBS (check local listings), Bikel decides to set up her cameras in the hair salon she’s patronized for 20 years. It’s an intimate space where she has come to know well the surprisingly diverse clientele – from athletic trainers and housewives to high-end bankers, actors and opera singers. Despite expectations that this neighborhood is a secure bastion of privilege, these days, when clients get in the chair, they offer a window into the country in recession: Some are broke, others don’t have a plan, and they’re all looking to commiserate.


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  • Green Homes and Hemp

    Jo Freeman writes: There are so many products touting how green they are, that it’s hard to distinguish what’s really different from what’s mostly marketing. You would do well to start at the annual Green Festival where they screen their exhibitors for commitment to sustainability, ecological balance and social justice.

  • Edward Burtynsky: “Oil, The Lifecycle of an Energy Source that Shaped the World”

    The Corcoran Museum in Washington is holding a photography exhibit that is distant from the usual core of subjects: the public figures of Avedon, an Ansel Adams landscape, a Robert Frank portfolio of Americans, etc.

    Edward Burtynsky: Oil from Corcoran Gallery of Art on Vimeo

    “This touring exhibition surveys a decade of photographic imagery exploring the subject of oil by artist Edward Burtynsky. The Canadian photographer has traveled internationally to chronicle the production, distribution, and use of this critical fuel. In addition to revealing the rarely-seen mechanics of its manufacture, Burtynksy photographs the effects of oil on our lives, depicting landscapes altered by its extraction from the earth and by the cities and suburban sprawl generated around its use. He also addresses the coming “end of oil,” as we confront its rising cost and dwindling availability. This exhibition, premiering in the capital city of the United States in Fall 2009, represents a look at one of the most important subjects of our time by one of the most respected and recognized contemporary photographers in the world.”

    “Burtynsky’s photographs, printed at large scale, render his subjects with transfixing clarity of detail. His extensive exploration is organized thematically: aerial views of oil fields, the architecture of massive refineries, highway interchanges ribboning across the landscape, and motorculture aficionados at automotive events. In considering the consequences of oil use, the artist has photographed a series of arresting landscapes: derelict oil derricks, vistas of junked vehicles, recycling yards, and mammoth oil-tanker shipbreaking operations. Edward Burtynsky: Oil promises to be the definitive photographic documentation of this much debated subject.”

    “Consisting of approximately 55 color landscapes, Edward Burtynsky: Oil will encompass a kind of modern-day “lifecycle” of the energy source that has shaped the modern world. The project will feature many new works, most never-before-exhibited. A major catalogue, published by acclaimed German publisher Steidl, will accompany the exhibition.”

    The photographs can also be seen at the Hasted, Hunt Kraeutler Gallery at 537 West 24th Street, New York City

    The President of the US, delivered a speech that dovetails with this exhibit, at least in our mind:

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  • The Controversy about Breast and Prostate Screening

    Rethinking Screening for Breast Cancer and Prostate Cancer appeared in the Journal of the American Medical Association

    Laura Esserman, MD, MBA; Yiwey Shieh, AB; Ian Thompson, MD
    JAMA. 2009;302(15):1685-1692.

    “After 20 years of screening for breast and prostate cancer, several observations can be made. First, the incidence of these cancers increased after the introduction of screening but has never returned to prescreening levels. Second, the increase in the relative fraction of early stage cancers has increased. Third, the incidence of regional cancers has not decreased at a commensurate rate. One possible explanation is that screening may be increasing the burden of low-risk cancers without significantly reducing the burden of more aggressively growing cancers and therefore not resulting in the anticipated reduction in cancer mortality. To reduce morbidity and mortality from prostate cancer and breast cancer, new approaches for screening, early detection, and prevention for both diseases should be considered.”

    Although seniorwomen.com not able to run the JAMA article, we are able to run the audio of the NPR program for KQED radio, recorded Oct. 22:

    Early Cancer Screening

    A new study published in the Journal of the American Medical Association finds that aggressive early screening for breast cancer and prostate cancer may do more harm than good. We discusses whether recommendations for healthy people to get screened should be changed.

    Host: Michael Krasny

    Guests:

    George Sledge, professor of oncology and co-director of the breast cancer program at Indiana University

    J. Leonard Lichtenfeld, deputy chief medical officer for the American Cancer Society

    Laura Esserman, director of the Breast Care Center at UCSF and lead author of the new study

    and in mp3 form:
    2009-10-22a-forum.mp3
    http://kqed02.streamguys.us/anon.kqed/radio/forum/2009/10/2009-10-22a-forum.mp3

    For a professional view of the study, Medpage offers: Analysis Questions Breast and Prostate Cancer Screening

    “Two decades after the explosion in cancer screening fueled by reimbursement for mammography and prostate specific antigen (PSA) testing, a new analysis suggests that it is time to rethink the push for early detection of these two cancers.”

    “There is no argument that more cancers are being detected and at a much earlier stage, but that increase has not resulted in a decrease in metastatic disease, according to Laura Esserman, MD, MBA, of the University of California, San Francisco, and colleagues, who made their case in a special communication published in the Oct. 21 issue of the Journal of the American Medical Association.”

    “In broad strokes they painted a picture of increased detection and costly treatment of cancers that pose minimal risk, without making a dent in killer cancers.”

    “The researchers touched a nerve with the commentary, and the American Cancer Society has already gone on record saying that it is reconsidering its position on the risks and benefits of breast and prostate cancer screening.”

    We did come across a MedPage blog critical about a well-known cancer treatment clinic in reference to prostate screenings:

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  • A psychological study about retirement

    The American Psychological Association released a new study into retirees who transition from full-time work into a temporary or part-time jobs. Those who transition “experience fewer major diseases and are able to function better day-to-day than people who stop working altogether, according to a national study. And the findings were significant even after controlling for people’s physical and mental health before retirement.”

    The study’s authors refer to this transition between career and complete retirement as “bridge employment,” which can be a part-time job, self-employment or a temporary job. The findings are reported in the October issue of the Journal of Occupational Health Psychology, published by the American Psychological Association.

    “Given the economic recession, we will probably see more people considering post-retirement employment,” said co-author Mo Wang, PhD, of the University of Maryland. “These findings highlight bridge employment’s potential benefits.”

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  • In Poetry and Film: Bright star! would I were steadfast as thou art

    Bright star! would I were steadfast as thou art —

    Not in lone splendour hung aloft the night

    And watching, with eternal lids apart,

    Like nature’s patient, sleepless Eremite,

    The moving waters at their priestlike task

    Of pure ablution round earth’s human shores,

    Or gazing on the new soft-fallen mask

    Of snow upon the mountains and the moors —

    No — yet still steadfast, still unchangeable,

    Pillowed upon my fair love’s ripening breast,

    To feel for ever its soft swell and fall,

    Awake for ever in a sweet unrest,

    Still, still to hear her tender-taken breath,

    And so live ever — or else swoon to death.

    Recently, we saw the Jane Campion movie, Bright Star, the story about the love affair between the English 19th c poet, John Keats, and the young Fanny Brawne. We can highly recommend the movie (and advise taking along a supply of tissues) as well as the Andrew Motion University of Chicago biography of Keats, which we quote in a paragraph below:

    “Keats finished Bright Star knowing that one kind of steadfastness had gone, and another kind had yet to be confirmed. On 18 October, twelve days before his twenty-fourth birthday, he finally asked Mrs. Dilke to let Fanny know that he was returning to live with Brown. The following day, he told her himself, asking soon afterwards that their ‘understanding’ should now become a formal arrangement, and probably giving her a garnet ring. It was a momentous decision, but they did their best to keep it secret, and agreed that Fanny should not wear the ring in public. They had several reasons. Keats knew that he could not afford to get married in the foreseeable future. He also realised that Mrs. Brawne did not approve. She still liked Keats, but understood that his prospects were dismal, and hoped that the plan would ‘go off’ in due course. Moreover, he distrusted the reaction of his family and friends — rightly, as it turned out.” (more…)

  • Making the Revolution – in one County

    Jo Freeman reviews Bloody Lowndes: Civil Rights and Black Power in Alabama’s Black Belt: This is a very good book. It blends history and contemporary research into a story that both entertains and educates. Those who study social change and those to want to bring it about will learn much from reading about the revolution in bloody Lowndes County.