Secrets of the FDA Revealed by Top Insider Doctor: Part 4

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Secrets of the FDA Revealed by Top Insider Doctor: Part 4

 

 

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According to the Journal of the American Medical Association (JAMA),

" Adverse drug reactions are the fourth leading cause of death in

America. Reactions to prescription and over-the-counter medications

kill far more people annually than all illegal drug use combined. "

 

Annually, drug companies spend billions on TV commercials and print

media. They spend over $12 billion a year handing out drug samples and

employing sales forces to influence doctors to promote specifically

branded drugs. The drug industry employs over 1,200 lobbyists,

including 40 former members of Congress. Drug companies have spent

close to a billion dollars since 1998 on lobbying. In 2004, drug

companies and their officials contributed at least $17 million to

federal election campaigns.

 

To get a full diagnosis of this provocative story, highly acclaimed

health guru Gary Null sent his lead investigator and director of

operations, Manette Loudon, to Washington, D.C. to interview FDA

employee and Vioxx whistleblower Dr. David Graham. What you are about

to read may leave you questioning the safety of all drugs, but it is a

story that must be told. Unless Congress steps up to the plate and

changes policy at the FDA, millions more will become unwitting victims

of adverse drug reactions from unsafe drugs.

 

Manette Loudon: Were there any warnings that Vioxx was a problem? Did

you see the disaster coming?

 

Dr. Graham: I think that I was afraid that there would be a disaster,

but I only became aware of this with the publication of the VIGOR

Study, which was this large clinical trial that was done that showed

that Vioxx increased the risk of heart attack five-fold. That study

was published in November of 2000. It was written, performed, and paid

for by industry.

 

What industry concluded was not that Vioxx increases the risks of

heart attack, but that the drug they were comparing it against --

Naproxen -- decreased the risk of heart attack. I knew that was not a

sustainable argument. There was no way that Naproxen was that

protective against heart attacks.

 

Clearly, Vioxx was the problem. I knew that Vioxx was on the road to

becoming a blockbuster drug (20 million users). All the ingredients

were there for a disaster.

 

The FDA is responsible in so far as it could have prevented much of

the damage, heart attacks and deaths simply by banning the high dose

Vioxx back in mid 2000 when they knew the results of the VIGOR Study.

But the FDA did nothing for almost two years. They were " negotiating "

with the company over a label. What did the label accomplish? Nothing!

 

Before the label, 17 or 18 percent of people who took Vioxx took the

high dose. After the label change 17 or 18 percent were still taking

the high dose. High dose use didn't change at all. People didn't read

the label, and if they read the label they wouldn't know what to do

anyway because it was very confusing.

 

The right thing to do would have been to pull the high dose off the

market because there is no benefit for short-term relief of acute pain

that exceeds this risk. The FDA made bad decisions based on its

culture and its institutionalized biases that favor industry and, as a

result, thousands of Americans died. Americans and Congress should be

screaming bloody murder. They should be beating on the doors of the

FDA demanding change.

 

Loudon: It's estimated that over 200,000 people a year die from

prescription drugs. Do you see this as a serious problem and do you

think many of these treatments are more dangerous than the disease itself?

 

Dr. Graham: Death from adverse drug reactions is one of the leading

causes of death in the United States. It turns out that most of these

adverse reactions are actually what are expected in the sense that

they are an extension of the drug's action. For example, we know that

drugs for diabetes can lower your blood sugar. If you're more

sensitive to the drug than the normal person and it lowers your blood

sugar too much, causing you to have a seizure while driving your car

and you get killed, well, you died from an adverse drug reaction, but

it wasn't something unexpected.

 

The blood thinner Coumadin is another example. That drug provides a

benefit, but it is also responsible for probably more deaths than any

single drug currently marketed. But it has a recognized benefit and

there aren't other drugs to do what it does or to do what it does

well. So physicians accept that there are patients who are in a

serious situation and who might die without the drug, so they take it.

 

Yes, drugs cause a lot of harm. Unfortunately, we haven't quantified

the benefits. For most of these drugs, it's more belief. It's faith.

We have faith that they'll confer a benefit, but the FDA hasn't

demonstrated that they confer a benefit.

 

We're getting much better at quantifying the risks. In the future,

what we need to do is just take the risks and look hard and

dispassionately at what the real benefits are. If the benefits aren't

there, we shouldn't be having discussions about labeling the drug. You

need to weed the garden patch of drugs that aren't doing what they're

supposed to do. The FDA has not been very good about that. It likes to

cultivate all these weeds.

 

Loudon: In a perfect world, what role do you see the FDA playing in

our nation's health?

 

Dr. Graham: In a perfect world, I think the FDA would need to be

restructured. If it were restructured properly, I think that it could

actually provide a great benefit to the public health. I would

recommend several changes.

 

First, I would separate safety and post-marketing from the

pre-marketing. I would create a separate center for product safety.

Actually, Sens. (Charles) Grassley (R-Iowa) and Chris Dodd (D-Conn.)

have recently introduced legislation to create an independent center

for post-marketing safety that would serve to protect the American

people from unsafe drugs. This isn't happening now.

 

On the pre-marketing side, the FDA needs to pay greater attention to

safety. They need to have larger clinical trials. They need to compare

drug products against other drugs that treat the same indication

rather than comparing a drug against a sugar pill. What we want in the

end are drugs that actually have better benefit.

 

The FDA also needs to determine the post-marketing benefits of a drug.

I've done that for several drugs. How many people are actually

benefiting? How many people are living longer versus those who are

having their lives shortened? Only when you have that kind of

information can you make rational decisions about a medication. The

times when I've done the benefit analysis, I've been chastised,

criticized and suppressed by the FDA. These benefit analyses should be

done as a matter of routine.

 

There is a lot that the FDA could do to improve, but the changes

aren't going to happen on their own. Congress is going to have to make

them happen. There's an expression, " The zebra doesn't change its

stripes nor the leopard its spots. " The FDA isn't going to change the

way it does business. Changes will have to be imposed from outside.

 

Loudon: How you do feel about direct-to-consumer advertising?

 

Dr. Graham: Direct-to-consumer advertising in general is a great

disservice to the American people. We see wonderful ads of people

demonstrating their health, whether they're skating across the ice or

doing their Tai Chi. Madison Avenue knows that a picture is worth a

thousand words, so they convey an image and a message, and it makes an

impression on patients and on physicians. It creates needs or desires

where there really isn't a need or a desire.

 

There was a recent study in The Journal of The American Medical

Association that showed that if patients mentioned a drug that they've

seen on television to their physician they were much more likely to be

prescribed that drug by the doctor. Drug companies know this. That's

why they do it. Would the Vioxx disaster have been as great and as

large in the absence of direct-to-consumer advertising? I submit that

the numbers would have been far lower than what they were.

Direct-to-consumer advertising is part of what made Vioxx a

blockbuster drug. It helped to rev the market up to get people to want

to use the drug.

 

Clearly, direct-to-consumer advertising does not serve the American

people well. Madison Avenue is smarter than the most intelligent

American. That's why they make so much money and that's why the drug

companies go to them to sell their products.

 

We're not living in a neutral world where the information we're

getting is objective and unbiased. It might be that the average

American, given all the data, all the facts, and all the information

in an objective way could make an intelligent, rational decision. But

we don't live in that kind of world.

 

We live in a world where what we're seeing is a visual image of these

people being vital and healthy and cured of their illnesses. And it's

all because of this little pill that they're taking. A patient with

that condition says, " I want to be just like that person. " So they go

to the doctor and say, " I want that pill. "

 

Are their lives changed? Maybe some people's lives are changed, but I

think most aren't.

 

Crusador would like to thank Manette Loudon and Pam Klebs for their

help in putting this interview with Dr. David Graham together.

 

Crusador is a hard-hitting, in-depth health publication that cuts

through the health lies that are so prevalent in our world today.

Crusador is published every two months. To obtain a free sample or to

to this one-of-a-kind publication visit their Web site.

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Dr. Mercola's Comment:

 

Dr. David Graham has also helped write new legislation called the

Grassley Dodd Bill that is currently held up in committee. It is a

radical bill that should help transform the Food and Drug

Administration (FDA) back to its roots and really protect the public

safety. It would set up a new independent Center inside the FDA to

review drugs and biological products once they are on the market.

 

The bill addresses the fact that the Office of New Drugs carries too

much sway over the FDA's drug-safety apparatus. Today, drug makers

have the ability to negotiate with the FDA officials who approved

their drugs to begin with when the FDA considers corrective action. By

creating a Center for post-market review, this legislation puts you,

the American consumers, where you belong at the FDA, and that's front

and center.

 

I don't ask you to write your congressman frequently, but this one is

worth it. You can help save some lives by helping to increase pressure

to change the way the FDA is run. The drug companies do NOT want this

bill passed and they have the largest lobby in Congress so we really

need all the help we can get.

 

You can find out how to contact your Congressman by going to the

following URL:

 

* http://www.house.gov/writerep/

 

All you need to do is write a simple short note telling them how you

feel the FDA is critically broken and you believe that the new

proposed legislation would really help improve that.

 

If you want to review the entire bill, it is up on the site.

 

Related Articles:

 

The FDA " Foxes " Keep Guarding the Drug Safety " Henhouse "

 

Testimony of David J. Graham, MD, MPH

 

Vioxx Reapproved by FDA Panel Members With Ties to Drug Companies