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FDA official: Safety system broken down

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General fitness, health and nutrition
Published
9 June 2005
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10 June 2005
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TC
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  1. http://news.webindia123.com/news/showdetails.asp?id=87128&cat=Science

    FDA official: Safety system broken down:-
    WASHINGTON | June 09, 2005 7:11:28 PM IST

    A top U.S. Food and Drug Administration official says much still
    remains to be done by the government to uncover the dangers in drugs
    already on the market.

    The warning was issued to a medical advisory board in Washington by Dr.
    Janet Woodcock, FDA's deputy commissioner of operations, the New York
    Times reported Thursday.

    Woodcock, who has been asked to suggest safety improvements because of
    recent well-publicized drug industry troubles, said the government's
    safety system needs to be fixed, the report said.

    The keystone of the current system is the prescriber and that person is
    the one who decides if the benefits of a drug outweigh the risks for
    that patient, Woodcock said. This system has obviously broken down to
    some extent, as far as the fully informed provider and the fully
    informed patient.

    She said one way for the FDA to resolve problems with drugs on the
    market is to take advantage of electronic health records from
    managed-care organizations.

    She also said physician and hospital errors are major contributors to
    the current problem.

    -------

    TC

  2. Quoted message said:
    Quoted message said:

    The keystone of the current system is the prescriber and that person is


    the one who decides if the benefits of a drug outweigh the risks for
    that patient, Woodcock said.<<

    COMMENT:

    Woodcock is wrong. The FDA makes such a decission long before the drug
    even becomes available to provider and patient, and does it without
    knowing the patient, and without suffering the patient's problems. And
    that IS the problem.

    SBH

  3. "Sbharris[atsign]ix.netcom.com" <[email hidden]> wrote in message
    news:[email hidden]...

    Quoted message said:
    Quoted message said:
    Quoted message said:

    The keystone of the current system is the prescriber and that person is


    the one who decides if the benefits of a drug outweigh the risks for
    that patient, Woodcock said.<<

    COMMENT:

    Woodcock is wrong. The FDA makes such a decission long before the drug
    even becomes available to provider and patient, and does it without
    knowing the patient, and without suffering the patient's problems. And
    that IS the problem.

    SBH


    You are obviously correct Steve on the first part. Efficacy must be proven
    and safety must be proven for FDA approval before any doctor or patient sees
    it unless involved in a clinical trial.
    Insurance companies will not pay for the drug otherwise as far as I am aware
    of. If such approval did not exist then the patient would have to pay for it
    out of pocket and if that were to happen the price for the drug would
    actually go down I believe.
    The FDA and drug companies work together for obvious reasons. If the FDA
    weren't there the drug companies would invent their own so called
    independent body giving the blue seal of approval that they can market as
    "safe" and "effective".
    It provides relative safety for the patient and a marketing device for the
    drug manufacturers.

  4. Robert said:

    "Sbharris[atsign]ix.netcom.com" <[email hidden]> wrote in message
    news:[email hidden]...

    Quoted message said:
    Quoted message said:

    >The keystone of the current system is the prescriber and that person is


    the one who decides if the benefits of a drug outweigh the risks for
    that patient, Woodcock said.<<

    COMMENT:

    Woodcock is wrong. The FDA makes such a decission long before the drug
    even becomes available to provider and patient, and does it without
    knowing the patient, and without suffering the patient's problems. And
    that IS the problem.

    SBH


    You are obviously correct Steve on the first part. Efficacy must be proven
    and safety must be proven for FDA approval before any doctor or patient sees
    it unless involved in a clinical trial.
    Insurance companies will not pay for the drug otherwise as far as I am aware
    of. If such approval did not exist then the patient would have to pay for it
    out of pocket and if that were to happen the price for the drug would
    actually go down I believe.
    The FDA and drug companies work together for obvious reasons. If the FDA
    weren't there the drug companies would invent their own so called
    independent body giving the blue seal of approval that they can market as
    "safe" and "effective".
    It provides relative safety for the patient and a marketing device for the
    drug manufacturers.

    There's the rub: "relative safety".

    Your idea of relative safety is not the same as my idea of relative
    safety which is not the same as Pharma's idea of relative safety which
    is not the same as the FDA's idea of relative safety which is not the
    same as patients' idea of relative safety which is not the same as.....

    TC

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

    Quoted message said:


    "Sbharris[atsign]ix.netcom.com" <[email hidden]> wrote in message
    news:[email hidden]...

    Quoted message said:
    Quoted message said:

    >The keystone of the current system is the prescriber and that person is


    the one who decides if the benefits of a drug outweigh the risks for
    that patient, Woodcock said.<<

    COMMENT:

    Woodcock is wrong. The FDA makes such a decission long before the drug
    even becomes available to provider and patient, and does it without
    knowing the patient, and without suffering the patient's problems. And
    that IS the problem.

    SBH


    You are obviously correct Steve on the first part. Efficacy must be proven
    and safety must be proven for FDA approval before any doctor or patient
    sees
    it unless involved in a clinical trial.
    Insurance companies will not pay for the drug otherwise as far as I am
    aware
    of.

    Many insurance companies pay for chiropractic, naturopathy and other
    conjecture-based mediciations. The also pay for medications that are
    technically not medically necessary, like Viagra and Levetra.

    Also, the insurance companies don't always pay for drugs that are FDA
    approved, especially if there is a similar one already on their formulary.

    Quoted message said:

    If such approval did not exist then the patient would have to pay for it
    out of pocket and if that were to happen the price for the drug would
    actually go down I believe.

    Actually, unless a drug is approved by the FDA, it cannot be sold as a drug
    for humans or other animals.

    Quoted message said:

    The FDA and drug companies work together for obvious reasons. If the FDA
    weren't there the drug companies would invent their own so called
    independent body giving the blue seal of approval that they can market as
    "safe" and "effective".

    Actually, food supplements (think conjecture-based medicine, aka alternative
    medicine) can be marketed as safe and effective if they have been proven to
    be safe and effective.

    Quoted message said:

    It provides relative safety for the patient and a marketing device for the
    drug manufacturers.

    Jeff

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

    Quoted message said:


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

    Quoted message said:


    "Sbharris[atsign]ix.netcom.com" <[email hidden]> wrote in


    message

    Quoted message said:
    Quoted message said:

    news:[email hidden]...

    Quoted message said:

    >>The keystone of the current system is the prescriber and that person


    is

    Quoted message said:
    Quoted message said:
    Quoted message said:

    the one who decides if the benefits of a drug outweigh the risks for
    that patient, Woodcock said.<<

    COMMENT:

    Woodcock is wrong. The FDA makes such a decission long before the drug
    even becomes available to provider and patient, and does it without
    knowing the patient, and without suffering the patient's problems. And
    that IS the problem.

    SBH


    You are obviously correct Steve on the first part. Efficacy must be


    proven

    Quoted message said:
    Quoted message said:

    and safety must be proven for FDA approval before any doctor or patient
    sees
    it unless involved in a clinical trial.
    Insurance companies will not pay for the drug otherwise as far as I am
    aware
    of.

    Many insurance companies pay for chiropractic, naturopathy and other
    conjecture-based mediciations.


    That's correct Jeff. The reason behind that is most back pain gets better on
    it's own and rather than seeing a medical specialist which costs much more
    they have found it cheaper to tell them to go to alternate care.

    The also pay for medications that are

    Quoted message said:

    technically not medically necessary, like Viagra and Levetra.


    That's correct but those are FDA approved and are very expensive.
    Naturopathy is much more cheaper including tiger penis soup or rhino
    testicles.

    Quoted message said:


    Also, the insurance companies don't always pay for drugs that are FDA
    approved, especially if there is a similar one already on their formulary.


    They certainly wouldn't pay for a non FDA aprroved drug including research
    drugs.
    There are many statins, blood pressure meds etc on the market that most of
    the time they will pay. Some insurance don't want to pay for newer drugs
    sometimes like Medicare.

    Quoted message said:


    Quoted message said:

    If such approval did not exist then the patient would have to pay for it
    out of pocket and if that were to happen the price for the drug would
    actually go down I believe.

    Actually, unless a drug is approved by the FDA, it cannot be sold as a


    drug

    Quoted message said:

    for humans or other animals.


    Drugs sold in Canada are cheaper. People are buying viagra from Pakistan.
    Just give them a credit card number.
    I was giving a scenario in which the FDA were to be abolished then the drug
    companies would set up their own organization because drugs would flood the
    market and prices would go down.

    Quoted message said:


    Quoted message said:

    The FDA and drug companies work together for obvious reasons. If the FDA
    weren't there the drug companies would invent their own so called
    independent body giving the blue seal of approval that they can market


    as

    Quoted message said:
    Quoted message said:

    "safe" and "effective".

    Actually, food supplements (think conjecture-based medicine, aka


    alternative

    Quoted message said:

    medicine) can be marketed as safe and effective if they have been proven


    to

    Quoted message said:

    be safe and effective.


    That's why they do it is to advertise that it is FDA approved.
    It is solely a marketing ploy as they don't need to do that.

    Quoted message said:


    Quoted message said:

    It provides relative safety for the patient and a marketing device for


    the

    Quoted message said:
    Quoted message said:

    drug manufacturers.

    Jeff

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