More Shady Dealings in the FDA
The FDA has decided to back down from a recent planthat would
have required long-term studies of new psychiatric drugs before
allowing them on the market.
The reversal came after a panel of experts unanimously
recommended against requiring such studies. The panel's vote
came in the wake of complaints from industry executives,
academic researchers, and patient advocates.
Studies of Eight Weeks or Less
The new plan would have called for companies to conduct studies
for as long as six months before seeking approval. Currently,
psychiatric drugs are generally approved after only two
short-term studies, which may last only eight weeks. This is the
case for many forms of medication.
Physicians, however, usually prescribe psychiatric drugs for
much longer periods. Regulators in the European Union and other
countries require longer-term data.
Life-Saving Information Suppressed
Meanwhile, The Independent, a British newspaper, reports that
vital information about prescription medications has been
suppressed by the FDA. Even if the information can save lives,
the FDA, under pressure from the pharmaceutical industry,
routinely conceals information that could affect the commercial
value of the drugs, rendering physicians unable to assess the
real risks.
Where to Go for News?
Mike Adams, NewsTarget's Health Ranger, in his editorial on this
information, discusses the many problems with the FDA, and also
the disturbing implications of the fact that this report did not
appear in a domestic media outlet. It is, he points out,
difficult to find an outlet, other than sites such as
Mercola.com or NewsTarget itself, that accept no advertising
from drug companies. The inevitable result is that news that is
not acceptable to the advertisers is soft-pedaled or ignored,
lest they pull funding.
Washington Post October 26, 2005NewsTarget.com October 14, 2005
Dr. Mercola's Comment:Once again, the FDA reveals that it is
only beholden to its true constituents -- drug company
executives.
However, you might have been surprised to note that the safety
testing wasn't just protested by industry executives, but also
by academic researchers and patient advocates. Why would this
be? Why would patient advocates argue in favor of only
eight-week trials on drugs that patients may take for months or
years?
It might be interesting to find out who those 'patient
advocates' actually were. The FDA has a long history of using
'experts' who are little more than industry shills.
Federal law prevents the FDA from hiring experts with any
potential conflicts of interest. However, between 1998 and 2000,
the FDA waived this restriction more than 800 times. It has been
estimated that over half of all the members of their advisory
panels have financial ties to the pharmaceutical companies that
stand to gain or lose from their decision.
The New York Times investigated possible conflicts of interest
in the controversial 2005 panel that allowed the deadly COX-2
painkillers to remain on the market (Vioxx, Celebrex, Bextra).
They found that one-third of the panel had ties to the very drug
company they were seeking to regulate. If the votes of these
individuals were removed, then the COX-2 inhibitors would not
have been allowed to return to the market. The FDA has yet to
overturn their decision.
FDA senior associate commissioner Linda Suydam, who is
responsible for waiving conflict of interest restrictions,
states that often the best experts to hire are the same experts
that consult the industry. Unfortunately, this does not explain
how "consumer representatives" on advisory panels often also
have financial ties to the industry.
When it comes to consumer protection, the FDA is no great
savior. When it comes to protecting the interests of businesses,
however, the FDA will cheat, lie, ignore its own guidelines, and
do whatever it takes to get the job done.
News like this merely reinforces just how broken this
conventional health care model truly is, and why more people are
taking better responsibility for their health by seeking
alternative methods that treat their conditions more safely.
If for some reason this statement surprises you, I encourage you
to review the interview with one of my heroes, Dr. David Graham,
an FDA insider who helped expose the Vioxx scandal to Congress.
He reveals many of the secrets going on in the FDA in this
amazing interview.