The FDA, Vioxx, and crimes against humanity

[Guest guest]

http://www.newstarget.com/009693.html

 

Thursday, August 25, 2005

 

The FDA, Vioxx, and crimes against humanity

 

I am both shocked and appalled at the recent decision by the FDA

advisory panel to re-approve Vioxx and put the stamp of safety on all

Cox-2 inhibitors, including Bextra and Celebrex. This vote came

immediately after another vote in which the panel nearly unanimously

agreed that all of these Cox-2 inhibitors significantly increased the

risk of heart disease and heart attacks in patients. You may ask, " How

can a panel that just voted to recognize the greatly increased risk of

these drugs turn around and vote to have them classified as safe for

human consumption? " The answer is that they claim the benefits are

worth the risks.

 

Now, this is a fascinating bit of logic. Let's take a look at the

benefits outweighing the risks in dealing with Vioxx, Bextra, Celebrex

or other prescription drugs. What's the real reasoning behind this?

First, let's ask who this applies to. Who benefits from the drug, and

who takes the risk? It's very clear that patients don't benefit from

taking this drug, because patients are being killed in record numbers.

The current estimates of the number of people killed outright by Vioxx

alone are anywhere from 25,000 to 55,000. In my own estimate based on

Dr. David Graham's studies, more than 61,000 people have died -- and

that's from just one drug. So the patients aren't benefiting.

 

You might say, " Well, the patients, at least the ones who live, are

benefiting by having less pain. " The fact is, however, they can have

less pain in many other ways that don't require the use of dangerous

prescription drugs. There are a huge number of nutritional

supplements, vitamins, medicinal herbs and natural health therapies

that drastically reduce arthritis pain even better than Cox-2

inhibitors without all of these health risks.

 

Who benefits? Drug companies

Who, then, really benefits from keeping Vioxx and Cox-2 inhibitors on

the market? Well, the answer is clear: Drug companies. The stock

prices of Pfizer and Merck benefit; in fact, they shot up the moment

this decision was made by the FDA advisory panel. The real benefit of

these drugs is that they generate profits for the pharmaceutical

industry, which the FDA seems sworn to protect. The pharmaceutical

industry is the one reaping a benefit.

 

What about the risks of the drugs? Well, it's very clear that the FDA

takes no risk in allowing these drugs to be used. The pharmaceutical

companies take no risk in allowing them to be used. The only people

taking the risks are the patients themselves. The patients are the

ones suffering the heart attacks, strokes and the acceleration of

heart disease from consuming these drugs. It's the patients who have

to pay for all of the medical care associated with the detrimental

health effects of these drugs. It's the patients who lose quality of

life or have their lives prematurely ended because they've been taking

Cox-2 inhibitors. So all of the risks we're talking about fall on the

shoulders of the patients, while all of the benefits are enjoyed by

the pharmaceutical companies.

 

With that in mind, let's take another look at the quote from the FDA

advisory panel, which says that these drugs should stay on the market

because " the benefits outweigh the risks. " Translated correctly, what

this really says is: " The benefits to the pharmaceutical companies

outweigh the risks to the patients. " That is the statement that should

have been admitted by the FDA advisory panel, because this is all

about benefits for the drug companies while the risks are carried by

patients.

 

The FDA double standard

There's something else seriously wrong in this whole treatment of

benefits versus risks. You'll notice that the FDA only applies this

standard to prescription drugs; never to nutritional supplements,

herbal medicine, Chinese medicine or anything in the world of

alternative medicine. The FDA will argue that drugs that are killing

tens of thousands of Americans should be kept on the market because

they have some benefit, but when it comes to a natural remedy or a

medicinal herb, the FDA will bend over backwards to argue the exact

opposite.

 

It's never about the benefits versus the risks in the case of herbs.

The FDA will ban an herb nationwide and take it out of the reach of

consumers simply because a handful of consumers may have abused it and

suffered detrimental effects from it. There are a few dozen people who

have been killed by overdosing on ma huang or Ephedra. The FDA touted

that as evidence that the herb was dangerous to everyone, and they

decided to ban the herb nationwide, effectively turning vitamin shop

owners into criminals if they were to sell Ephedra.

 

Where was the whole argument of benefits outweighing the risks when

the FDA was taking a look at Ephedra? That argument was nowhere to be

seen. There are literally millions of people in this country who could

benefit from Ephedra as part of a Chinese medicine remedy. In Chinese

medicine, Ephedra is never taken alone, and never in high doses. It's

only taken as part of a medicinal recipe prescribed to patients on a

person-by-person basis, and it has been used for literally thousands

of years in China and Asia without harm. But here in the United

States, a few individuals took it to an extreme and managed to give

themselves a heart attack by overdosing on an isolated herb, so the

FDA said, " It's dangerous, and we have to take it out of everyone's

reach. "

 

If you were to apply the same argument to Vioxx, then the FDA should

say, " Vioxx has killed not just a dozen people, nor 100 people, nor

1,000 people, nor not even 10,000 people, but perhaps as many as

50,000 to 60,000 people. Maybe that should be a drug that we take off

the market because it's dangerous. " But no! The FDA says that " the

benefits outweigh the risks, " or, as I have translated here, " the

benefits to the pharmaceutical companies outweigh the risks to the

patients. "

 

You see, that's why the benefit versus risk argument is never applied

to herbal remedies. Herbal remedies don't benefit pharmaceutical

companies, so there's no reason for the FDA to go out of its way to

keep them on the market. In fact, the availability of herbal remedies

competes with prescription drugs. Consequently, the FDA, which is out

there to protect Big Pharma, has every reason to outlaw herbal

remedies. That alone will boost the sales of prescription drugs.

 

The only real regulatory action the FDA is taking on Vioxx, Bextra and

other Cox-2 inhibitor drugs is the requirement of a black box warning

on the drugs. This is supposed to be a big deal, but in fact it means

little to nothing. This is just a bigger print size of the same

warning that's been found in the small fine print of the drug for

years. Doctors routinely ignore this information. Patients almost

never see it. So a black box warning doesn't mean much anyway.

 

FDA speak: equally dangerous = perfectly safe

Even if it did mean something, there are some doctors who are trying

to argue that a black box warning isn't needed. Why? They're saying

that if Vioxx is shown to have no greater heart disease risk than

other Cox-2 inhibitors, the black box warning should be removed. This

is some really distorted, twisted logic here. They're saying that if

all Cox-2 inhibitor drugs are equally dangerous and are equally

responsible for killing tens of thousands of Americans, then none of

them should carry a black box warning, because none of them are more

dangerous than the other brand on the shelf next to them.

 

So even though the whole class of drugs is extremely dangerous

compared to herbal remedies or even relatively safe painkillers, some

doctors want these black box warnings removed on the basis that,

within this class of drugs, each one carries the same risk as the

next. This is the kind of huge distortion of logic that you see in

conventional medicine today. Obviously, these doctors are on the

payroll of the drug companies that stand to benefit from the removal

of these black box warnings. It doesn't take a genius to figure this out.

 

Just to give you an example of how silly this notion is, it would be

similar to discovering that a certain type of airplane was falling out

of the sky at a rate that was 1200 percent higher than other types of

airplanes and killing tens of thousands of Americans as a result. Then

you discover that there were two or three airplanes of a similar type

that also fell out of the sky at the same rate. You argue that nobody

should be warned about those planes because they all have pretty much

the same risk, even though there are completely different airplanes

available that have drastically reduced rates of danger. That's the

kind of logic that's being applied here. It is saying, essentially,

that these drugs are equally dangerous; therefore, they should all be

considered safe.

 

The FDA as drug racket mob boss

The only place you find that sort of distorted logic is, of course, at

the FDA. The bottom line with all of this is that the FDA has once

again proven itself to be a highly corrupt regulatory agency that will

go out of its way to protect the pharmaceutical industry at the risk

of public safety. For a while there, I thought that maybe this would

be a turning point where the FDA and the public would realize that

prescription drugs have been over-hyped and over-marketed, and that

maybe it would be time to rein these in and return to some common

sense in terms of treating symptoms of disease with synthetic

chemicals. But, no. With this decision, the FDA has proven that it is

willing to take this con even further.

 

The agency has proven that it is willing to put the lives of hundreds

of thousands of Americans at risk, and that it is willing to do

anything necessary to protect the profits of the pharmaceutical

industry. The FDA has demonstrated that there is no level of danger

that is unacceptable to the agency. A drug can kill tens of thousands

of Americans and yet earn the stamp of safety approval by the FDA.

 

(And, by the way, it's not all the people at the FDA I'm talking about

here, it's just the bureaucrats who are closely aligned with the drug

companies. The vast majority of FDA employees -- especially in the

drug safety office -- actually agree with most of this and they back

the idea of radical FDA reform that would take the bureaucrats out of

power.)

 

There is apparently no limit to the number of people that a drug can

kill in order for the FDA to consider it to be dangerous. You have to

wonder, with this class of drugs killing more Americans than were

killed in the Vietnam war and killing vastly more Americans than have

ever been killed by terrorists, at what point does the FDA become more

dangerous than terrorism? We're spending billions of dollars fighting

the so-called " War on Terror, " but what are we doing to fight the war

on Americans' health being waged by the FDA? The FDA has proven itself

to be dangerous to the health of the American people.

 

In my opinion, the FDA has proven itself to be the single largest

threat to the health of the American public that we've ever seen in

the history of this country. It is directly responsible for the deaths

of hundreds of thousands of Americans today. The agency has decided to

put its stamp of approval on a class of drugs that will undoubtedly

kill tens of thousands more people each and every year. This is not

just politics or a regulatory snafu. This is a crime against humanity.

The FDA is guilty of that crime, and its decision makers should be

punished as criminals.

 

Overview:

 

* The FDA, Vioxx, and crimes against humanity

 

Source: http://www.newstarget.com/009693.html