With Tysabri decision, FDA declares no drug is too dangerous to be FDA approved

March 28 2006

http://www.newstarget.com/019331.html

The U.S. Food and Drug Administration, the agency that claims to be
responsible for protecting consumers from dangerous food and drug
products, has just surrendered its primary responsibility. Recently,
an FDA advisory panel voted to recommend that a dangerous
prescription drug Tysabri, which was withdrawn from the market a year
ago due to its promoting of a deadly brain disease, should now be put
back on the market.

But here’s the really shocking part: The justification for this
decision to reinstate a drug with known deadly side effects is based
on the idea that patients should now weigh the risks of dangerous
drugs and decide for themselves whether the risks outweigh the
benefits, if any.

Stop the music for a minute. Do you realize that with this decision,
the FDA has just rendered itself irrelevant? If patients are going to
be held responsible for making risk vs. benefits decisions on
prescription drugs, then why do we need the FDA at all?

As you may have guessed, there are enormous problems with this new
stance by the FDA. The first is that patients do not have the medical
knowledge to understand and interpret the significance of these side
effects that will no doubt only be mentioned in small print somewhere
on a piece of paper that most patients will probably ignore. How can
the FDA justifiably turn over safety decisions on deadly drugs to
patients?

The second problem with this new stance by the FDA is that it exposes
a wicked double standard: With prescription drugs, patients should be
able to weight benefits vs. risks, even for drugs that may kill you.
But with herbs and nutritional supplements, no such decision is
extended to patients. The FDA merely bans whatever natural substances
it wishes, usually based on reports of very small numbers of people
being harmed be extremely rare overdoses (such as with ephedra). In
those cases, the FDA proudly proclaims it is, “Protecting everyone
from a dangerous herb!”

In other words, the FDA now sees its job as protecting the public
from “dangerous” herbs while shirking safety responsibilities on
truly dangerous prescription drugs. It’s up to the public to decide
whether deadly drugs are worth the risk, according to the FDA. But
when one herb which has been safely used for 5,000 years in Chinese
medicine happens to harm 20 people who overdosed in a mad weight loss
frenzy, the FDA bans it “to protect everyone!”

The FDA’s position now comes down to simply this: Everyone needs to
be protected from herbs and nutritional supplements, but no one needs
to be protected from prescription drugs.

And this now completes the full reversal of the FDA. The agency now
has both feet squarely in Bizarro world.

In doing this, I wonder if the FDA realizes it has made itself
irrelevant. If the agency is now merely going to pass through drug
safety decisions to doctors and patients, then why do we need the FDA
at all? The agency is no longer a gatekeeper. It is a toll booth,
where drug companies pay a toll on their way to customers. And
apparently, the toll fee is happily accepted regardless of whether
the drug in question helps people or kills them.

I’ve often said that no drug is too dangerous to meet FDA safety
requirements, and now the FDA has proven it. Even a drug that
outright kills patients with a painful, horrifying death will now be
FDA approved. There is no longer even the concept of safety standards
at the FDA. Now, there is merely avoidance of assessing safety.

The agency that was once tasked with actually regulating the drug
industry has now become its largest marketing department. The concept
of drug “safety” is now history. Any drug, no matter how dangerous,
is now qualified for FDA approval. If thalidomide were a new drug
today, the FDA would no doubt happily approve it for any use as long
as it carried a small-print warning about its side effects.

In fact, we may soon see the FDA (arm-in-arm with Big Pharma
marketing reps) bringing back all sorts of deadly, dangerous drugs
over the next few years. Drugs that were once withdrawn from the
market due to outrageous side effects (such as Vioxx, which
reportedly caused the death of tens of thousands of Americans) will
now be re-approved and dumped onto patients who must now make their
own safety assessments of patented, synthetic chemicals.