Secrets of the FDA Revealed by Top Insider Doctor

[Guest guest]

http://www.mercola.com/2005/aug/13/fda_david_graham.htm

 

Secrets of the FDA Revealed by Top Insider Doctor

 

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 Food and

Drug Administration (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.

 

Loudon: Dr. Graham, it's truly a pleasure to have the opportunity to

interview you. Let me begin by asking you how long you've been with

the FDA and what your current position is?

 

Dr. David Graham: I've been with the FDA for 20 years. I'm currently

the Associate Director for Science and Medicine in the Office of Drug

Safety. That's my official job. But when I'm here today I'm speaking

in my private capacity on my own time, and I do not represent the FDA.

 

We can be pretty certain that the FDA would not agree with most of

what I have to say. So with those disclaimers, you know everything is OK.

 

Loudon: On November 23, 2004 (during the) PBS Online News Hour

Program, you were quoted as making the following statement: " I would

argue that the FDA as currently configured is incapable of protecting

America against another Vioxx. Simply put, FDA and the Center for Drug

Evaluation Research (CDER) are broken. " Since you've made that

statement, has anything changed within the FDA to fix what's broken

and, if not, how serious is the problem that we're dealing with here?

 

Dr. Graham: Since November, when I appeared before the Senate Finance

Committee and announced to the world that the FDA was incapable of

protecting America from unsafe drugs or from another Vioxx, very

little has changed on the surface and substantively nothing has changed.

 

The structural problems that exist within the FDA, where the people

who approve the drugs are also the ones who oversee the post marketing

regulation of the drug, remain unchanged. The people who approve a

drug when they see that there is a safety problem with it are very

reluctant to do anything about it because it will reflect badly on

them. They continue to let the damage occur. America is just as at

risk now as it was in November, as it was two years ago, and as it was

five years ago.

 

Loudon: In that same PBS program, you were also quoted saying, " The

organizational structure within the CDER is currently geared towards

the review and approval of new drugs. When a serious safety issue

arises at post marketing, the immediate reaction is almost always one

of denial, rejection and heat. They approved the drugs, so there can't

possibly be anything wrong with it. This is an inherent conflict of

interest. "

 

Based on what you're saying it appears that the FDA is responsible for

protecting the interests of pharmaceutical companies and not the

American people. Do you believe the FDA can protect the public from

dangerous drugs?

 

Dr. Graham: As currently configured, the FDA is not able to adequately

protect the American public. It's more interested in protecting the

interests of industry. It views industry as its client, and the client

is someone whose interest you represent. Unfortunately, that is the

way the FDA is currently structured.

 

Within the Center for Drug Evaluation and Research, about 80 percent

of the resources are geared towards the approval of new drugs and 20

percent is for everything else. Drug safety is about 5 percent. The

" gorilla in the living room " is new drugs and approval. Congress has

not only created that structure, they have also worsened that

structure through the PDUFA, the Prescription Drug User Fee Act, by

which drug companies pay money to the FDA so they will review and

approve its drug. So you have that conflict as well.

 

Loudon: When did that go into effect?

 

Dr. Graham: The Prescription Drug User Fee Act came into play in 1992.

It was passed by Congress as a way of providing the FDA with more

funds so that it could hire more physicians and other scientists to

review drug applications so that drugs would be approved more quickly.

 

For industry, every day a drug is held up from being marketed,

represents a loss of 1 million to 2 million dollars of profit. The

incentive is to review and approve the drugs as quickly as possible,

and not stand in the way of profit-making. The FDA cooperates with

that mandate.

 

Loudon: And what about those new drugs? Are they any better than what

already exists on the market?

 

Dr. Graham: It's a myth that is promulgated not only by industry but

also by the FDA itself. It's a misperception that our lawmakers in

Congress have as well and they've been fed this line by industry.

 

Industry is saying there are all these lifesaving drugs that the FDA

is slow to approve and people are dying in the streets because of it.

The fact is that probably about two-thirds to three-quarters of the

drugs that the FDA reviews are already on the market and are being

reviewed for another indication.

 

So, for example, if I've got a drug that can treat bronchitis and now

it's going to be used to treat a urinary tract infection, well, that's

a new indication. But it's the same drug and we already know about the

safety of the drug. There is nothing life-saving there. There is

nothing new. There is nothing innovative.

 

A very small proportion of drugs represent a new drug that hasn't been

marketed before. Most of those drugs are no better than the ones that

exist. If you want to talk about breakthrough drugs -- the ones that

really make a difference in patients' lives and represent a revolution

in pharmacology -- we're talking about maybe one or two drugs a year.

Most of them aren't breakthroughs and most of them aren't life-saving,

but they get treated as if they were.

 

Loudon: Are you at liberty to discuss some of the problems your

colleagues are finding with other drugs and if so, how widespread is

the problem?

 

Dr. Graham: I'm really not at liberty to talk about things that

pertain to my official duties at the FDA. I can talk in my private

capacity, but I can't talk about material that would be confidential.

 

What I can say is that there are a number of other scientists within

the FDA who have also worked with drugs that they know are not safe,

even though the FDA has approved or allowed them to remain on the

market. They face some of the same difficulties that I do. The

difference is that either the problem isn't as serious in terms of the

numbers of people that were injured or that it's a fatal reaction --

they're not willing to expose themselves to retaliation by the FDA --

and retaliation would surely follow.

 

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

in putting this interview with Dr. David Graham together.

 

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

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

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

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

 

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,

 

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 I put it up on my 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

 

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