Drug Review Process Doesn’t Protect Consumers
The federal government’s
drug review process does not ensure that consumers will be protected
from harmful prescription medications, according to a report
from the U.S. Department of Health and Human Services (HHS).
Since 1996, seven
drugs have been removed from the market for safety reasons.
Further, 40 percent
of U.S. Food and Drug Administration (FDA) long-term reviewers
believe the drug review process has worsened. Currently, the
review period for new drugs ranges from six to 12 months, however
the report recommends that the period be extended by one to two
months.
New drugs are
required to be reviewed for safety and efficacy before they reach
the market, and drug companies pay “user fees” that essentially
pay the salaries of drug reviewers.
The report includes
a survey of 401 new drug reviewers. In regard to the six-month
time period allotted for review of priority New Drug Applications
(a breakthrough drug or one that treats an unusual condition),
58 percent of reviewers said the time period was inadequate.
Additionally,
25 percent felt that the10 months provided for review of most
standard drug applications was also inadequate.
Some 18 percent
of the reviewers said that they felt pressured to approve drugs
for sale despite their uncertainties about the drugs’ safety
or efficacy.
What’s more is
that 21 percent of participants indicated that scientific disagreement
was only allowed to a small, or no, extend in the FDA work environment.
Previous research
has shown similar results. For instance, a 1998 study showed
that FDA medical officers found 27 new drugs that they had reviewed
and did not think should be approved but were approved by the
agency anyway.
Report authors
note that the FDA’s reliance on user fees from drug companies
skews the drug approval process toward the industry. They conclude
that their findings present a significant warning signal that
unsafe and ineffective drugs may not be kept off the market.
The Citizen March
31, 2003
--------------------------------------------------------------------------------
DR. MERCOLA'S
COMMENT:
The drug review
process cannot work when drug companies are paying the salaries
of the drug reviewers. As a consumer, it is your responsibility
to determine the safety of what you put in your body--drug, food
or otherwise.
Don’t be persuaded
into thinking a drug is safe simply because it has been FDA approved
and is featured in numerous advertisements. As this article shows,
even the people reviewing the drugs are doubting the effectiveness
of the review process.
The drug industry’s
grasp is far reaching and this area is no exception. As stated
above, 18 percent of drug reviewers felt pressured to approve
a drug even if they questioned its safety. This is not surprising
considering who is paying their salaries.
If you are considering
taking a drug, please look out for your own safety and do some
research of your own. You’ll likely be able to find information
about the drug’s trials, side effects and warnings.
Or, better yet,
give yourself the best chance of avoiding drugs altogether by
boosting your body’s natural defense--its immune system. You
can start the process by looking into the nutrition plan and
implementing an exercise program.
|
