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NIH officials received drug money ...

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General fitness, health and nutrition
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2 January 2004
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  1. Report: Drug Firms Paying Health Monitors

    Provided by Associated Press on 12/7/2003

    http://healthy.net/scr/news.asp?Id=8055

    LOS ANGELES (AP) - Some of the National Institute of Health's top
    officials have received hundreds of thousands of dollars in consulting
    fees from drug companies whose products they were responsible for
    monitoring, the Los Angeles Times reported Sunday.

    The newspaper, citing records it said it began gathering five years ago,
    reported that in some instances officials of the federal institute
    operated as consultants for companies whose drugs were linked to the
    deaths of patients taking part in NIH studies.

    Dr. Ruth L. Kirschstein, who as deputy director and acting director of
    the agency since 1993 approved many of the consulting arrangements, told
    the newspaper she did not believe the public's interest had been
    compromised.

    ``I think NIH scientists, NIH directors and all the staff are highly
    ethical people with enormous integrity,'' she said. ``And I think we do
    our business in the most remarkable way.''

    She said she would consider making changes in the consulting
    arrangements.

    ``Systems can always be tightened up,'' Kirschstein told the Times
    during an interview in October. ``And perhaps, based on this, we will do
    so.''

    A month after that interview, NIH Director Elias A. Zerhouni told agency
    leaders he would form a committee to study the appropriateness of
    employee consulting work.

    He told the Times he wants the institute ``to manage not just the
    reality, but the perception of conflict of interest.''

    Medical ethicists said the consulting arrangements represent a clear
    conflict of interest.

    ``If I am a scientist working in an NIH lab and I get a lot of money in
    consulting fees, then I'm going to want to make sure that the company
    does very well,'' said Dr. Arnold S. Relman, former editor of the New
    England Journal of Medicine.

    He said the arrangement also raises concerns about patient safety.

    One patient the Times said died was Jamie Ann Jackson, who had been
    listed as ``Subject No. 4'' in an NIH study of the treatment of kidney
    inflammation related to lupus, a disease that attacks the body's immune
    system.

    The cause of death was linked to a complication involving use of a drug
    made by Schering AG, for which Dr. Stephen I. Katz, the senior NIH
    official involved in the study, was a paid consultant.

    Katz didn't stop the study after Jackson's death or warn doctors outside
    the agency, which could have threatened the market potential for the
    drug, the Times said.

    Katz said his connection to Schering AG had no influence on his
    decisions and his work for the company had been approved by top NIH
    officials.

    Katz has been paid between $476,369 and $616,365 in company fees over
    the past decade, the Times said, citing his income-disclosure reports.

    Dr. John I. Gallin, director of the NIH's Clinical Center, the nation's
    largest site of medical experiments on humans, has received $145,000 to
    $322,000 in fees and stock proceeds for consulting work done between
    1997 and 2002, the newspaper said. In one case, the Times said, he
    co-wrote an article on the gene-transfer technology done by a company he
    consulted for.

    Several other NIH officials were cited as receiving hundreds of
    thousands of dollars, including one who received more than $1.4 million.
    Some of them also were paid by companies involved in the agency's
    research or whose products were the subjects of NIH studies.

    Each of them told the newspaper their consulting work was done with the
    approval of top institute officials.

    Uncovering such payments is difficult, the Times said, because the NIH
    allows more than 94 percent of its top-paid employees to keep their
    consulting income confidential.

    The NIH has been at the forefront of medical research for decades,
    leading the government's battles against cancer, AIDS and other
    diseases. More recently, President Bush pressed the institute, part of
    the Department of Health and Human Services, into service in the fight
    against biological terrorism.

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

    www.BreastImplantAwareness.org

  2. "Ilena" <[email hidden]> wrote in message
    news:[email hidden]...

    Quoted message said:

    Report: Drug Firms Paying Health Monitors

    Provided by Associated Press on 12/7/2003

    http://healthy.net/scr/news.asp?Id=8055

    LOS ANGELES (AP) - Some of the National Institute of Health's top
    officials have received hundreds of thousands of dollars in consulting
    fees from drug companies whose products they were responsible for
    monitoring, the Los Angeles Times reported Sunday.


    Unfortuately even university researchers today have to spend most of their
    time dunning for any money they can raise. Most physical scientists and
    many/most medical school teachers have to raise their own salaries.

  3. George Conklin said:


    "Ilena" <[email hidden]> wrote in message
    news:[email hidden]...

    Quoted message said:

    Report: Drug Firms Paying Health Monitors

    Provided by Associated Press on 12/7/2003

    http://healthy.net/scr/news.asp?Id=8055

    LOS ANGELES (AP) - Some of the National Institute of Health's top
    officials have received hundreds of thousands of dollars in consulting
    fees from drug companies whose products they were responsible for
    monitoring, the Los Angeles Times reported Sunday.


    Unfortuately even university researchers today have to spend most of their
    time dunning for any money they can raise. Most physical scientists and
    many/most medical school teachers have to raise their own salaries.

    Nobody questions that. However, there is an ethical question as to
    whether a salaried official should accept a consulting fee from an
    agency he is monitoring. The standard is recusal. Do not accept any
    fee or favour from an entity you are regulating, or with whom there
    may exist a conflict of interest. Let somebody else handle the job.
    The question is always "why did they ask you to do it?" It is the
    essence.

  4. In article <[email hidden]>,

    George Conklin said:

    "Ilena" <[email hidden]> wrote in message
    news:[email hidden]...

    Quoted message said:

    Report: Drug Firms Paying Health Monitors

    Quoted message said:
    Quoted message said:

    Provided by Associated Press on 12/7/2003

    Quoted message said:
    Quoted message said:

    http://healthy.net/scr/news.asp?Id=8055

    Quoted message said:
    Quoted message said:

    LOS ANGELES (AP) - Some of the National Institute of Health's top
    officials have received hundreds of thousands of dollars in consulting
    fees from drug companies whose products they were responsible for
    monitoring, the Los Angeles Times reported Sunday.

    Quoted message said:

    Unfortuately even university researchers today have to spend most of their
    time dunning for any money they can raise. Most physical scientists and
    many/most medical school teachers have to raise their own salaries.

    This is because the federal government got into funding
    research, and the universities diverted the funds to
    other uses. The military were the best in deciding to
    support pure research, as they found during WWII that
    pure researchers could come up with solutions to real
    problems which the ones spending their lives in doing
    that could not. But this was taken away from them
    early in the funding of research, and the bureaucrats
    went by the promises in the proposals, which were either
    pie-in-the-sky or work held back so they could demonstrate
    that something could be produced.

    --
    This address is for information only. I do not claim that these views
    are those of the Statistics Department or of Purdue University.
    Herman Rubin, Department of Statistics, Purdue University
    [email hidden] Phone: (765)494-6054 FAX: (765)494-0558

  5. [email hidden] (Ilena) wrote in message news:<[email hidden]>...

    Quoted message said:

    Report: Drug Firms Paying Health Monitors

    Provided by Associated Press on 12/7/2003

    http://healthy.net/scr/news.asp?Id=8055

    Considering that the first paragraph of the article contains a glaring
    error of fact...would you trust the rest?

    Quoted message said:

    LOS ANGELES (AP) - Some of the National Institute of Health's top
    officials have received hundreds of thousands of dollars in consulting
    fees from drug companies whose products they were responsible for
    monitoring, the Los Angeles Times reported Sunday.

    The FDA monitors drugs in the US, not the NIH.

    Quoted message said:

    The newspaper, citing records it said it began gathering five years ago,
    reported that in some instances officials of the federal institute
    operated as consultants for companies whose drugs were linked to the
    deaths of patients taking part in NIH studies.

    Now, for the example.....and just for clarification - patients do die
    and some die while participating in clinical trials...it's part of the
    problem when you are sick.

    Quoted message said:

    One patient the Times said died was Jamie Ann Jackson, who had been
    listed as ``Subject No. 4'' in an NIH study of the treatment of kidney
    inflammation related to lupus, a disease that attacks the body's immune
    system.

    The cause of death was linked to a complication involving use of a drug
    made by Schering AG, for which Dr. Stephen I. Katz, the senior NIH
    official involved in the study, was a paid consultant.

    I'm sure Schering paid Dr. Katz for his services - or would you expect
    the NIH to fund this research with YOUR tax dollars? In either case,
    the argument would be made that Schering was wrong - either because
    they paid the NIH to conduct the research OR it profited (unfairly)
    from NIH paid research. Which way do you want it?

    In reality, the trial was sponsored collaboratively between the NIH
    and Berlex - Katz wasn't the PI.

    In a review of the case, Dr Leitman (head of the NIH Department of
    Transfusion Medicine at the Warren G. Magnuson Clinical Center)
    suggests that based on this single case study, fludarabine may have
    the ability to cause transfusion-associated graft versus host disease
    (TA-GVHD) in patients without haematologic malignancy.

    Quoted message said:

    Katz didn't stop the study after Jackson's death or warn doctors outside
    the agency, which could have threatened the market potential for the
    drug, the Times said.

    Conjecture. Considering the nature of the condition, the known
    dangers of the drug (it's used to treat CANCER) and what most docs
    know about autoimmune disease treatment with purines....give me a
    break. Also, the death was reported to FDA, to NIH, and to the ethics
    committee responsible for the study. Those are your checks and
    balances folks. You want press releases every time a patient at NIH
    dies and happens to be in a clinical trial?

    And most compelling - the potential for this to happen was well known
    AND documented in the products label and in the medical literature.
    In fact, irradiation is recommended any fluradibine receiving patient
    getting a blood transfusion.

    "Transfusion-associated graft-versus-host disease has been observed
    rarely after transfusion of non-irradiated blood in FLUDARA FOR
    INJECTION treated patients. Consideration should, therefore, be given
    to the use of irradiated blood products in those patients requiring
    transfusions while undergoing treatment with FLUDARA FOR INJECTION."

    But the Times alleges that the NIH doctors did not specify that
    transfusions should be irradiated for patients in the lupus study.
    Considering it is in the label it therefore was submitted to the
    ethics committee - I find this extremely difficult to believe. Don't
    you?

    Quoted message said:

    Katz said his connection to Schering AG had no influence on his
    decisions and his work for the company had been approved by top NIH
    officials.

    Quoted message said:

    Katz has been paid between $476,369 and $616,365 in company fees over
    the past decade, the Times said, citing his income-disclosure reports.

    He's a world class expert in the area and therefore his expertise
    should be made accessible to researchers involved in the area. I
    doubt you can get him to work for free, though. What do you propose?

    Rick

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