Secrets of the FDA Revealed by Top Insider Doctor: Part 3

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Secrets of the FDA Revealed by Top Insider Doctor: Part 3

 

 

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: All of these attacks backfired on them. Tell us a

little bit about that.

 

Dr. Graham: Well, Sen. (Charles) Grassley (R-Iowa) and his staff

quickly realized that what they were saying about me was fabricated.

The editor of The Lancet also realized that what the high level FDA

officials were saying to him was a pack of lies. He sent e-mails to

them saying it looked to him as if they were trying to interfere with

his editorial process. He was very savvy to what these people were doing.

 

Tom Devine, as he said publicly, was very interested in doing the

right thing. He said, " We don't want to protect somebody who's a

lawbreaker and who really isn't representing the truth so produce your

evidence. " They had no evidence because there is no evidence. But I

produced my evidence. I showed him all the documentation, all the

emails, and the reports that I've written. They flunked every test and

I passed every test.

 

In all of the criticism I have received relating to Vioxx and drug

safety, they've never attacked the work or the science that I've done

or the results that I've come to. What they've done is call me names.

The ad hominem attack is the last refuge of the indefensible. They

don't have an argument that's substantial.

 

They know that they're vulnerable. They know that they've disserved

the American people. The FDA is responsible for 140,000 heart attacks

and 60,000 dead Americans. That's as many people as were killed in the

Vietnam War.

 

Yet the FDA points the finger at me and says, " Well, this guy's a rat,

you can't trust him, " but nobody is calling them to account. Congress

isn't calling them to account. For the American people, it's dropped

off the radar screen. They should be screaming because this can happen

again.

 

Loudon: On CNN with Lou Dobbs you said that there was a certain

" culture " that exists at the FDA. Can you explain what you meant by that?

 

Dr. Graham: The FDA has a very peculiar culture. It runs like the army

so it's very hierarchal. You have to go through the chain of command

and if somebody up above you says that they want things done in a

particular way well, they want it done in a particular way. The

culture also views industry as the client.

 

They're serving industry rather than the public. In fact, when a

former office director for the Office of Drug Safety criticized me and

tried to get me to change a report I'd written on another drug --

Arava -- he said to me and to a colleague who was a coauthor on this

report that " industry is our client. "

 

I begged to differ with him. I said, " No, industry is not the client,

it's the American people, the people who pay our taxes. That's who

we're here to serve. " He said, " No! Industry is our client. " I ended

the conversation by saying, " Well, industry may be your client, but it

will never be my client. "

 

Another aspect to the culture at the FDA is that it overvalues the

benefits of drugs and undervalues the risks of drugs. And so the FDA

will always say to you, " Well, we're leaving this drug on the market

because the benefits exceed the risks. " Well, the FDA has never

assessed the benefit of any drug that it's ever approved.

 

It works on what's called efficacy. Does the drug work or not? Does it

lower your blood pressure or does it lower your blood sugar? Not, does

it prolong your life? Does it prevent you from having a heart attack?

 

Those are benefits. All they focus on is efficacy.

 

For example, ask the FDA why on earth they didn't ban high dose Vioxx

after the VIGOR Study showed in early 2000 that it increased the risk

of heart attack by 500 percent? High-dose Vioxx was approved for the

short-term treatment of acute pain. What earthly benefit was there

that exceeds a 500 percent increase in heart attack risk? Ask the FDA

to produce its benefit analysis that shows that the benefits exceed

the risks. It doesn't exist.

 

The FDA has never looked at benefit. The FDA just says to the American

people, " The benefits exceed the risks. Trust me. Believe me. " If you

held the FDA to its proof the American people would see how badly

served they've been by the FDA and its culture that belittles safety

in the drug companies' interest.

 

If the FDA were to pull a drug due to safety issues, it would hurt the

marketing of the drug. It might also call into question why they

approved the drug in the first place. Therefore, you get this culture

of cover-up, this culture of suppression, this culture of denial and

this culture that demonstrates above all else that industry is the

client and not the American people.

 

Loudon: Have your peers turned against you?

 

Dr. Graham: No. I've been very fortunate. Tom Devine at GAP has told

me that the experience of a typical whistleblower is that they'll have

the support of their peers but the peers will be so afraid of

retaliation that they won't express that support in public.

 

I've had a very different experience. I've been basically embraced by

my peers as someone who has said what they want to say and what they

wished they had been able to say and that they recognize as the truth.

They're really proud of the fact that I've said it and they're not

afraid to be seen with me. They're not afraid to work with me. I've

been pretty fortunate in that way.

 

Now with management it's been another story. Upper management avoids

me and doesn't talk to me. I could be walking down the hall and I'll

say hello, and they'll act like I'm not there. They don't give me

interesting work assignments. They don't call me in to consult on

things that I should be consulted on even though I am the senior

epidemiologist in the Office of Drug Safety with more experience than

any of the other people there. I'm looked up to by the scientific

staff because of that expertise.

 

Basically, I feel like I'm in the Gulag.

 

Loudon: How do you cope with that going to work each day?

 

Dr. Graham: It's difficult. It's a mind game. They're hoping that I'll

just become very frustrated and disillusioned and leave or that I'll

slip up in some way so that they can take some sort of action against

me. As Tom Devine at GAP has said, I have to be " Saint David. " I can't

afford to make any mistakes.

 

That's very difficult and it is a little bit discouraging. But I've

been a target of retaliation in the past. You take 10 drugs off the

market well, no good deed goes unpunished at the FDA. I've experienced

retaliation with many of those other episodes but not as severe as

what I've experienced with Vioxx.

 

This is the first time that my job was actually in jeopardy and where

the FDA actually intended to fire me. That was stopped only because

Sen. Grassley intervened. He put the heat on the FDA and told them,

" Lay off. This guy has told the truth. He's helped America. Whose side

are you on? "

 

 

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 FDA back to its roots and

really protect the public safety. It would set up a new independent

Center inside the Food and Drug Administration (FDA) to review drugs

and biological products once they are on the market.

 

The bill addresses the fact that 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