How the F.D.A. Determines The Safety of Drugs

[Guest guest]

JUST HOW SAFE IS " SAFE " ?

How the F.D.A. Determines The " Safety " of Drugs

http://www.aimsusa.org/howsafe.htm

FEW AMERICANS REALIZE THAT:

The approval of a drug by the U.S. Food and Drug Administration (FDA) does not

mean that the FDA has approved the drug for general use.

The FDA approves specific doses for the treatment of specific illnesses and

conditions.

Many health care providers, including doctors and nurses, have not been taught

how to distinguish between an FDA approved use of a drug, described in the

" Indications " section of the package insert, and a non-approved ( " off label " )

use of the drug.

There are no laws or regulations which prohibit a doctor, or any other health

care provider licensed to prescribe drugs, from prescribing or administering to

you a drug which has not been approved by the FDA for the treatment of your

illness or condition C and which may subject you to a risk that you may not be

willing to take.

A physician is not required to report an adverse drug reaction to the FDA, even

if the patient dies.

There is no prescription drug or over-the-counter remedy that is without risk,

even when taken according to directions.

Most prescription and over-the-counter drugs have never been tested for safety

in the elderly, infants, children, pregnant women and lactating mothers.

The FDA acknowledges that there is significant underreporting of adverse drug

reactions to the FDA. You owe it to yourself, and if pregnant you owe it to your

baby, to learn as much as possible about the drugs you take.

The information in this document may be disturbing, but it is information you

will need when making informed decisions regarding your health care.

Prepared by © Doris Haire, Chair

Committee on Maternal and Child Health

National Women's Health Alliance

[Guest guest]

The FDA does not actually test any drugs. Most of them do much more good than

harm. They save millions of people everyday, substantially improve quality of

life and help prolong life expectancy.

No drug is completely safe. All have potential side effects. Doctors prescribe

a medication when they ascertain that the benefits of its use will exceed the

potential risks. And doctors understand much less about the risks than people

tend to think -- their primary sources of information about drugs are the drug

companies themselves!

The FDA does not actually test any drugs. They only review the results of

clinical trials conducted and submitted by the pharmaceutical company seeking

approval for the drug.

The FDA's drug approval process is funded in large part by the drug companies

themselves. User fees were introduced in the early 1990s to help expedite the

drug approval process (reducing it from an average of 30 to 15 months). However

it raises the question of who the FDA is truly serving -- the people of the

United States or the pharmaceutical companies?

The long-term safety of drugs is not established before they are put on the

market. And this is true despite the fact that so many drugs are used daily to

treat chronic conditions such as high cholesterol, diabetes and Alzheimer's.

Drugs are frequently marketed and prescribed for medical problems they were not

approved for and have never been proven to be effective (or safe) in treating.

This practice is called " off-label " prescribing.

" Natural " products and herbal remedies are not always safe alternatives to

prescription drugs. This industry is not regulated by the FDA; therefore while

many of these products may be beneficial, few have been clinically tested for

efficacy or safety, and drug interactions are unknown. Reports of adverse events

from these products are now appearing regularly in the medical journals.

Only a small fraction of drugs represent any improvement over products already

on the market -- although they are marketed as " breakthrough " drugs. The

substantial premium being charged for these products is not a function of higher

quality, but represents an attempt to maximize profits while patents are still

in effect.

The pharmaceutical industry has the most powerful lobby in Washington. There are

more drug industry lobbyists in Washington than there are elected

representatives in Congress.

Although the pharmaceutical industry leads the public to believe that high

prices are necessary to support research and development efforts, they actually

spend more on marketing than on researching drugs. The truth is that the

pharmaceutical industry is more profitable than any other industry -- by a

considerable margin.

--- In , " healinghope " <mfrreman@...>

wrote:

>

> JUST HOW SAFE IS " SAFE " ?

> How the F.D.A. Determines The " Safety " of Drugs

> http://www.aimsusa.org/howsafe.htm

>

> FEW AMERICANS REALIZE THAT:

>

> The approval of a drug by the U.S. Food and Drug Administration (FDA) does not

mean that the FDA has approved the drug for general use.

>

> The FDA approves specific doses for the treatment of specific illnesses and

conditions.

>

> Many health care providers, including doctors and nurses, have not been taught

how to distinguish between an FDA approved use of a drug, described in the

" Indications " section of the package insert, and a non-approved ( " off label " )

use of the drug.

>

> There are no laws or regulations which prohibit a doctor, or any other health

care provider licensed to prescribe drugs, from prescribing or administering to

you a drug which has not been approved by the FDA for the treatment of your

illness or condition C and which may subject you to a risk that you may not be

willing to take.

>

> A physician is not required to report an adverse drug reaction to the FDA,

even if the patient dies.

>

> There is no prescription drug or over-the-counter remedy that is without risk,

even when taken according to directions.

>

> Most prescription and over-the-counter drugs have never been tested for safety

in the elderly, infants, children, pregnant women and lactating mothers.

>

> The FDA acknowledges that there is significant underreporting of adverse drug

reactions to the FDA. You owe it to yourself, and if pregnant you owe it to your

baby, to learn as much as possible about the drugs you take.

>

> The information in this document may be disturbing, but it is information you

will need when making informed decisions regarding your health care.

>

> Prepared by © Doris Haire, Chair

> Committee on Maternal and Child Health

> National Women's Health Alliance

>