Secrets of the FDA Revealed by Top Insider Doctor: Part 7

[Guest guest]

http://www.mercola.com/2005/sep/27/secrets_of_the_fda_revealed_by_top_insider_do\

ctor_part_7.htm

 

 

Secrets of the FDA Revealed by Top Insider Doctor: Part 7

 

 

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: How do you feel about taking the approval process out

of the hands of the FDA?

 

Dr. Graham: Well, where would you put it? If you put it somewhere

else, they're going to eventually become co-opted the way the FDA has

been co-opted. I think the most that we could probably hope for is to

try to disassociate the industry pressures from the approval decision.

 

You have to change the culture of the organization, and you have to

change the incentives in the organization. The culture and the

incentives that the FDA operates by would have to be changed, and

Congress can do that through legislation and by establishing different

standards for how a drug gets approved.

 

Not only do you have to show that the drug is effective, but you've

got to show that it works as well or better than other drugs that

treat that indication. You've got to prove to me that the drug is

safe, not that the drug is harmful because you're never going to prove

to me that the drug is harmful.

 

You set up stringent standards of evidence that might lead to the

approval of safe drugs that actually have benefits to the population.

Then, pair that up with an independent post marketing regulation.

Currently, the pre-market people who approve the drug decide what

happens after it's on the market. If the drug needs to come off the

market, they're the ones who have to say yes at the end of the day.

 

The people at the FDA who approved the drug, the Office of New Drugs,

they are the single greatest obstacle when it comes to removing unsafe

drugs from the market. I can vouch for that from personal experience.

What you have to do is you have to take that responsibility and power

away from them and put it with the group who sees their mission as

serving the public and protecting the public health from unsafe drugs.

I think if you do those two things you'd be a long way towards getting

the FDA on the right footing.

 

Also, it would probably be beneficial not to have the FDA's funding

come from industry. He who pays the piper calls the tune, and we now

have a captured agency. Industry underwrites more than 50 percent of

the Center for Drug Evaluation's budget. When industry yanks the chain

whose neck is going to get tugged? The Center for Drug Evaluation!

 

If industry isn't happy with them and the funding dries up what are we

going to do? We're going to have to let half our people go. The

program is going to shrink. Congress is going to be jumping up and

down on our back. So it's a captured agency and America is not well

served when industry is calling all the shots. Yes, industry has a

right to make a legitimate profit from marketing products that help

the American people. But you shouldn't have a situation that just

basically leaves the American public defenseless.

 

And, that's what we have right now. We're virtually defenseless.

 

Loudon: Are there other Vioxxs out there? Do you think this will

repeat itself at this high-profile level?

 

Dr. Graham: At this current moment, I don't think there are other

drugs out there that are as bad as Vioxx in terms of the enormous

numbers of people that were hurt.

 

During my Senate testimony, I did mention that there were five other

drugs that I thought the FDA really needed to reevaluate because, in

my estimation, the benefit to risk was misjudged. After I named those

five drugs, the FDA was in the media saying that I did junk science

and that these drugs were safe and effective and that I was a crackpot.

 

However, recently the FDA announced that they were going to take

Bextra off the market. Well, Bextra was one of the five I mentioned.

They announced that, with Accutane, they were going to impose a

restricted distribution system. Well, I had recommended a restricted

distribution system 15 years ago. The major problem with Accutane is

that it's just so widely overused that it causes an enormous amount of

potential harm to pregnancy exposure.

 

If we restricted the use of the drug to the small number of women who

really need it each year, the problem would be pretty much resolved.

But the FDA didn't want to do that because it would interfere with

company profits. If you restrict the distribution and only one-tenth

of the people who are getting it now are getting it tomorrow, profit

will drop 90 percent. Of course, companies aren't going to go along

with that and the FDA isn't going to do anything that's going to harm

corporate profit.

 

After my Senate testimony, the FDA announced that they can look at

other drugs – not only the other three of the five that I mentioned.

There are other drugs on the market that I prefer not to talk about

that the FDA knows are killing people. Ten or 100 people a year are

dying because of the use of a particular drug or being hospitalized.

Hundreds or maybe thousands of people are being hospitalized each year.

 

For some of those drugs, the benefits do exceed the risks. For others,

it's clear that more could and should be done and maybe that means

restricting the distribution of the drug's use or maybe it means

banning an indication for the drug saying the drug should not be used

for particular indications. Maybe it would be something like with the

SSRIs where I believe there should be signed informed consent so that

parents will know that the drug the doctor is prescribing for their

son or daughter actually doesn't work in children.

 

I think that there are many things that can be done that haven't been

done. There are other unsafe drugs out there, and the nature of our

business is that a drug could be approved tomorrow that turns out to

be the next Vioxx and we won't know until it happens. Then the

question is, how quickly do we identify the problem and how quickly do

we take effective action against it?

 

We're pretty good at identifying these problems quickly. Where the FDA

falls flat on its face is that there is a long period of time in which

it does nothing. Then, what it normally does is woefully inadequate

and ineffective and as a result the body count mounts and that needs

to be changed. Maybe Congress will change that.

 

Loudon: Let's talk about incentives. When you say incentives what do

you mean? For example, working at the FDA, is their pay somehow based

on how many drugs they approve?

 

Dr. Graham: Currently, the performance evaluations for managers at the

FDA are built around the drug review. How many reviews did they get

done? Did they meet their Prescription Drug User Fee Act (PDUFA)

deadlines?

 

It looks bad if you miss your PDUFA deadlines. The unspoken mores –

what's the expected – is that you're going to approve as many of these

drugs as you can. There has to be an overwhelming reason for you not

to approve.

 

Frequently, what will happen is that these medical officers in their

review will recommend that a drug not be approved and they get

overruled by the higher-ups because the higher-ups are answering to a

different set of incentives. You have to change that. A lot of that

comes from the leaders. What I want to see is, does the drug really

make a difference? Is it beneficial?

 

There are many classes of drugs where we've got 10 or 15 members of

that class. They all lower your blood pressure. They all lower your

cholesterol. Another one comes along and the FDA feels its obligation

to approve it. Why?

 

Maybe the standard should be that for the drugs that come later in a

class, they've got to show that they're actually better than the drugs

on the market because we've already got these other drugs that work.

That would create incentives maybe within industry to develop drugs

that are better than the ones that are already there. Currently, the

way the incentives are for industry, it's safer to do a " me too " drug,

another drug in the same class.

 

Loudon: Do you think that the FDA should not be partially funded by

industry?

 

Dr. Graham: I think that PDUFA funding for the FDA is a mistake.

 

Loudon: Can you explain that a little more clearly because most people

don't know what PDUFA funding is?

 

Dr. Graham: The drug companies pay a substantial amount of money to

the FDA at the time that they bring a drug application for approval in

order for the FDA to review the drug. Basically, it's a tax. It's a

fee. Industry pays the fee, and the FDA will review the drug application.

 

But the real expectation is from the company: " We've paid our money,

now approve our drug. " That's basically how the FDA reacts as well. I

think that the funding for the FDA should be independent of the

industry that it's regulating and I think in the scientific field

there's good evidence to support this notion.

 

Industry money is influencing the decisions that get made, and it

creates this incentive structure. You have this culture, you have

these expectations, you have pressure from Congress. All of them come

to a head at the FDA and all of those incentives are in the direction

of " approve the drug. " That's what happens, so I believe that the FDA

is unduly influenced by industry and that undue influence is in part

the result of industry money funding the FDA operations.

 

Loudon: Dr. Graham, thank you for your commitment to your convictions

and for sharing insights that drove you to save many lives.

 

Dr. Graham: You're welcome. I hope I've helped.

 

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.

 

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