I meant to say they don't accept bullsh*t studies in which say there
are minimal side affects, but then hundreds of thousands of people die
when that drug the FDA lets them into the market because of the
studies scientists made and got paid by the pharmeceutical industries
to make trials look much better then they are. The FDA regulates the
trials. If hundreds of thousands of people are dieing from what the
FDA participated in (not made) then that is simply why DCA will never
be approved because the FDA has nobody to file lawsuits over to make
tons money just like they do on pharmaceutical companies.

On May 16, 3:21 am, aerope...@hotmail.com wrote:

The FDA has once again been caught red-handed ignoring the dangers of
a widely-prescribed drug and compromising the health of millions.
Internal email messages have now surfaced about how the FDA pushed the
antibiotic drug Ketek despite urgent warnings from its senior drug
safety scientists. The details of this scandal further highlight the
dubious operations of the Food and Drug Administration, which
consistently places the profits of drug companies as a higher priority
than public health.
Ketek was approved under suspicious circumstances in the first place.
A key clinical trial for the drug, involving 24,000 patients, was
repeatedly found to be fraudulent, according to FDA investigators. One
FDA document concluded that Sanofi-Aventis hid safety dangers from the
FDA -- dangers the FDA later discovered on its own.

One FDA safety scientist, Dr. Cooper, wrote, "I tried to argue that
given Aventis's track record in which they have proven themselves to
be nontrustworthy that we have to consider the possibility that they
are intentionally doing a poor job of collecting the postmarketing
data to protect their drug sales."

Dr. David Graham added, "For F.D.A. to refer to its being reassured by
postmarketing data from Latin America and Europe as a basis for
declaring 'Ketek is safe' is in my opinion a great abuse of such
surveillance data."

Yet the drug was approved anyway, and the FDA now cites a known
fraudulent study to defend the drug and argue against its withdrawal.

Four FDA safety officials (Dr. Charles Cooper, Dr. David Ross, Dr.
Rosemary Johann-Liang and Dr. David Graham) ultimately sounded the
alarm over Ketek's safety in internal emails. As now seems routine at
the FDA, they were ignored. (See The Rise and Fall of Rezulin to see
another such example.)

A drug that can kill
More than five million prescriptions have been written for Ketek since
its approval in the United States. Ketek can cause loss of
consciousness, blurred vision, and in rare circumstances, even death.
It has so far been linked to liver failure in fourteen adults, four of
which have died. Twenty-three more suffered serious liver injury.
Given that the reporting of drug side effects remains voluntary in the
United States, it is possible that the actual number of people harmed
by Ketek is ten to twenty times larger.
Senior FDA drug safety scientist Dr. David Graham -- best known for
blowing the whistle on Vioxx -- is now recommending that the agency
pull Ketek from shelves. The drug, Dr. Graham explains, is at least as
toxic to the liver as three other drugs that have been pulled by the
FDA. Furthermore, the FDA's original approval of the drug was based on
a safety study that FDA officials knew was fraudulent.

The FDA's approval of Ketek, Dr. Graham wrote in a June 16 email, was
a mistake. "It's as if every principle governing the review and
approval of new drugs was abandoned or suspended where telithromycin
[Ketek] is concerned," he wrote. "We don't really know if the drug
works; no one is claiming it works better than other, safer drugs; and
we're flying blind as far as safety goes, except for our own A.D.R.
data that suggests telithromycin is uniquely more toxic than most
other drugs." He concluded by recommending the drug be withdrawn.

In response, Aventis, the company that manufactures Ketek, announced
it was adding a warning to the drug's label. It's the standard
response of drug companies and FDA officials to any dangerous drug:
Slap a warning label on the drug and call it "safe enough." Warning
labels, however, don't make drugs any safer. They only provide a
justification for the continued promotion of drugs that even some of
the FDA's own scientists believe should be withdrawn from the
marketplace.

"It's no surprise to learn that the F.D.A. didn't listen to Dr. Graham
on the dangers of Ketek," said Sen. Charles Grassley. "The F.D.A. has
made it their business to discredit Dr. Graham and others who aren't
willing to cater to the drug companies."

Sen. Grassley is a frequent observer and critic of FDA activity, and
has worked on legislation to reform the agency.

How long will FDA fraud be allowed to continue?
While Ketek in no way appears to be more dangerous than drugs like
Rezulin or Vioxx, its approval and defense within the FDA serves as
yet another example of FDA officials covering their eyes and refusing
to see the dangers of the drug when there's so much money to be made
from selling it. Pleasing Big Pharma is unquestionably the FDA's top
priority these days, and any idea of actually protecting the public
remains a distant memory.
The FDA not only routinely approves and defends dangerous prescription
drugs (much to the delight of drug companies), it also goes out of its
way to discredit and outlaw nutritional supplements, herbal medicine
and anything tied to alternative medicine (also much to the delight of
drug companies). Rather than regulating Big Pharma, the FDA has now
become its greatest promoter.

The FDA's power is based on censorship and intimidation, not education
and empowerment. On numerous occasions, the agency has attempted to
censor and / or intimidate its own scientists, including Dr. David
Graham who was nearly silenced before he could testify to Congress
about the dangers of Vioxx.

The greatest threat to our safety isn't terrorism
As I have stated many times, I believe the Food and Drug
Administration is currently the greatest threat to the health and
safety of the American people, far outweighing the threat of terrorism
or violent crime. Over one hundred thousand Americans are killed each
year by FDA-approved prescription drugs, and well over two million are
harmed. Each year, FDA-approved drugs kill more Americans than died in
the Vietnam War plus the 9/11 terrorism events combined.
Yet astonishingly, the FDA believes that too much information about
the dangers of drugs is being communicated to the public by drug
safety officials like Dr. David Graham. If the FDA had its way, all
such information would be permanently censored, the public would never
be warned about drug dangers, and, in fact, the public would be denied
the right to sue drug companies for harm caused by FDA-approved
prescription drugs.

The Ketek fiasco is merely the latest in a long history of FDA
negligence and fraud that makes the agency a genuine threat to the
health and safety of the American people.