Secrets of the FDA Revealed by Top Insider Doctor: Part 6

[Guest guest]

http://www.mercola.com/2005/sep/20/secrets_of_the_fda_revealed_by_top_insider_do\

ctor_part_6.htm

 

Secrets of the FDA Revealed by Top Insider Doctor: Part 6

 

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: Do you think Congress genuinely wants to fix the

problems at the FDA or are too many politicians influenced by the

pharmaceutical industry?

 

Dr. Graham: I don't know what Congress will do in the end. My hope is

that they will act decisively to reform the FDA and make the American

people safer by having strong post-marketing.

 

Will that happen or not? I don't know. I think there are many people

in Congress who see this as a serious problem and who very much want

to see a change. I think, at the same time, there are other people who

don't think it's such a bad problem, and many of those people honestly

believe that. For those people, I'd say they haven't seen the evidence

so they don't really understand how bad the problem is.

 

There are undoubtedly some people who are influenced by industry. Does

that influence their judgment in the end? I don't know. They'd

probably say no, it doesn't. Maybe at a conscious level it doesn't.

 

But we have the same phenomenon in the scientific world where we look

at research studies that are funded by industry and studies that are

funded by government, by National Institutes of Health or the Medical

Research Council in the United Kingdom. Multiple studies have been

done that have shown that if your study is funded by industry you are

much likelier – about five times more likely – to come up with the

result that's favorable to the drug company than if your study on the

same subject is funded by an independent body unrelated to the company.

 

Now, are the researchers who did this study biased? Are they

consciously cheating and manipulating the data and everything else?

No. I don't think that's happening at all, but the fact is if the

study is funded by industry, it's much more likely to be favorable to

industry. Without attributing bad motivations to the scientists doing

those studies, all I can do is point to a strong correlation.

 

With Congress I would be concerned that there could be a strong

correlation there because Pharma is very bright. They fund as many

politicians as they can. They get to the Republicans and the Democrats.

 

Look at the funding on the major committees: The Health, Education,

Labor and Pension Committee in the Senate or the Oversight and

Investigations Subcommittee in the House. The Wall Street Journal

reported recently that many people on these committees are funded by

industry to a substantial degree. Industry knows how to exercise

influence. What we have to do is overcome that influence with

evidence, and then rely on the fact that, at the end of the day, the

Congress will do what's best for the American people.

 

Will that happen? I don't know because then it gets embroiled in

politics. You know, Republicans versus Democrats, the left versus the

right, conservatives versus liberals. Yet, what we're talking about is

public health and public health is nonpartisan. I can say this with

certainty.

 

For every member of the House of Representatives, somebody in their

district died because of Vioxx. Somebody in their district had a heart

attack because of Vioxx. For every Senator in the Senate, many more

people in their state died because of Vioxx or had a heart attack

because of Vioxx. It doesn't matter whether it's a red state or a blue

state. Those are human beings and what we're talking about is public

health. What I'm hoping is that Congress will respond. There is a

problem and the evidence is overwhelming, but we'll just have to wait

and see.

 

Loudon: What are you thoughts on President Bush's attempt to pass tort

reform, which would protect most pharmaceutical companies from

lawsuits except in the most egregious cases?

 

Dr. Graham: I think it's dangerous and wrong for the following

reasons. We already have an FDA that's been neutralized by industry

and sees industry as its client. The Center for Drug Evaluation and

The Office of New Drugs dominates drug safety so that the drug safety

is not independent. Drug safety can't protect the American people. So

government now isn't going to protect the average citizen from the

consequences of unsafe drugs.

 

The only alternative they have left is the legal system – the tort

system. It's not a wonderful system. It would be much better if we had

effective post-marketing regulation so that we could get bad drugs off

the market before they hurt more people, but that's been neutralized.

All that's left to people now is the courts. That's the only way we

have of getting companies to change their behavior.

 

What tort reform will do is remove that threat as well. It's basically

giving companies immunity because now the people who are injured by

the drugs can't recover damages that might actually mean something to

industry. I mean $250,000 for damages... they blow that in one ad

campaign. To them that's nothing.

 

But a lawsuit for multiple millions of dollars has more of an impact.

Now, is that optimal? No. But the fact is that since we have a

regulatory agency that doesn't regulate and we have a public health

agency that doesn't protect the public, we have thousands of people

who are being injured by products that the FDA knows are unsafe. The

FDA knew there was a problem with Vioxx. They knew it was a big

problem back in mid-2000 yet did nothing about it.

 

There has to be a system in place that reins companies in. If the FDA

isn't going to exercise control over companies, then who will? How

will it happen?

 

I don't think that working through the courts and lawsuits is a

particularly effective way of doing it, but it's the only recourse we

have now, and that will be removed as well. You can demonize the trial

lawyers but I think that there are patients who are severely injured

by drugs. The defense is, " It's on the labels so we're protected. " The

problem is that nobody reads the labels so how do they protect anyone?

The FDA should be making those decisions.

 

Loudon: What can you tell us about all the antidepressants on the

market that millions of children are taking?

 

Dr. Graham: In early 2004, SSRI antidepressants and suicidal behavior

was a big safety issue. The FDA had suppressed a report written by a

colleague of mine in drug safety and had prevented him from presenting

this information in an advisory committee meeting. That information

leaked to the media, embarrassing the FDA because it had been caught

suppressing very important information – that most of the

antidepressants don't work for treating children.

 

Someone in my supervisory chain initiated a criminal investigation to

identify the person who had leaked this information to the media. It

turns out that the investigation ordered by these FDA officials was

illegal. They broke federal laws – at least two or three federal laws

– in ordering this investigation.

 

I think it's well established that depression is very common in

adolescence. With the antidepressants that we have on the market right

now only one of them has been shown to work in children and that's

Fluoxetine or Prozac. All the other SSRI antidepressants are no better

than sugar pills.

 

However, if you were to read the labeling for these drugs it doesn't

point that fact out, so patients think one SSRI is as good as another.

This is another way that the FDA has betrayed the American public and

has betrayed the public health. With the SSRI and antidepressants,

what the FDA should have insisted on was a signed informed consent at

the time a child was going to be treated. That informed consent would

say three things.

 

One, these are the antidepressants that are available. Only Fluoxetine

has been shown to work for depression in children. All the other drugs

are no better than placebo. That's point two. No better than placebos.

No better than sugar pills.

 

Third, all of these drugs appear to have the ability to increase the

risk of suicidal behavior. As a parent, if I see that in writing and

the psychiatrist or GP is going to write the prescription and put my

child on some drug other than Fluoxetine, I can say, " Doc, why are you

putting my child on a drug that doesn't work in kids. "

 

The FDA didn't want patients to have that information so they refused

to have signed informed consent. The companies didn't want the

patients to have that information because all of a sudden the

" off-label " use of these drugs would dry up. So whose interest was

being served there?

 

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.

 

<< Previous

 

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