FDA INCAPABLE OF PROTECTING U.S., SCIENTIST ALLEGES

[Guest guest]

Issue September/October 2005

 

FDA Incapable of Protecting U.S., Scientist Alleges

An interview with Dr. David J. Graham, associate director of the FDA's

Office of Drug Safety

By Dick Carozza

 

From the September/October 2005 issue of

Fraud Magazine

 

Dr. David J. Graham, a scientist at the U.S. Food and Drug

Administration

for more than 20 years, says the agency could have prevented 60,000

deaths

from the arthritis drug Vioxx. But Graham, the recipient of the

ACFE's Cliff

Robertson Sentinel Award, says the problems at the FDA go beyond the

problems of one drug.

 

The long, sloping wall of the Vietnam Veterans' Memorial in

Washington,

D.C., contains the names of 58,000 men and women who died during that

war.

 

As Dr. David J. Graham, a scientist at the Food and Drug

Administration,

says, that's 2,000 less than the estimated U.S. citizens he believes

have

died from the effects of the arthritis drug Vioxx.

 

" Between 1999 and 2004, an estimated 20 million Americans took Vioxx,

80

million worldwide, " said Graham, the recipient of the 2005 Cliff

Robertson

Sentinel Award, at the recent 16th Annual ACFE Fraud Conference &

Exhibition. " We've estimated that up to 140,000 patients (who took

Vioxx)

suffered heart attacks. ... Of this number, 60,000 died, " said Graham,

associate director of the Food and Drug Administration's Office of

Drug

Safety and an employee of the agency for more than 20 years. " Vioxx

is a

poster child ... for what's wrong with the FDA and why I believe FDA

reform

is so urgently needed. "

 

In November of last year, Graham testified before the Senate Finance

Committee that the FDA had silenced him and his colleagues from

reporting on

the risks of Vioxx and other drugs. " The FDA has let the American

people

down and sadly betrayed a public trust, " Graham said during his

testimony.

He alleged that because the FDA is unduly influenced by the pharmacy

industry it is " incapable of protecting America against another

Vioxx. We

are virtually defenseless. " Merck & Co Inc., the maker of Vioxx, has

pulled

the drug from the marketplace. Meanwhile, Vioxx civil trials continue.

 

Graham remains at the FDA but says he has been " marginalized by FDA

management and not asked to participate in the evaluation of any new

drug

safety issues. It's a type of ostracism. "

 

In the following interview with Fraud Magazine, Graham says that " if I

failed to speak the truth, I would become part of the problem, and

all these

deaths would in part, be my responsibility, in the same way that FDA

was and

is, responsible for these deaths. The decision to speak the truth

wasn't

difficult. My conscience guided me in the way I should go. "

 

What does it mean for you to be awarded the Cliff Robertson ACFE

Sentinel

Award?

I was taken by surprise when Toby Bishop telephoned to tell me I'd

been

selected to receive the Cliff Robertson Sentinel Award, and I was

humbled by

the realization that my efforts were appreciated by an organization

dedicated to the pursuit of truth. I found it ironic that while FDA

condemned me for speaking truthfully before the Senate Finance

Committee,

that there were others outside of government who valued and respected

what I

had done.

 

In a nutshell, what has occurred in your professional and personal

life

since you testified before the U.S. Senate Nov. 18, 2004 about the

dangers

of Vioxx and the inadequacies of the Food and Drug Administration?

Professionally, I've been marginalized by FDA management and not

asked to

participate in the evaluation of any new drug safety issues. It's a

type of

ostracism. At the same time, however, I've been able to pursue some

research

interests of mine. Personally, family life has been extremely

stressful

since my testimony with isolation and hostility at work and constant

apprehension about possible retaliation by FDA management.

 

Your lawyer has described your position as " filling space under the

scrutinizing watch of a babysitter. " What are your FDA duties now?

Officially, my duties have not changed, but in reality, I've been

isolated.

.... I analogize it to Solzhenitsyn's gulag, or to the Soviet Union's

internal exile in the city of Gorky.

 

In your message at the 16th Annual ACFE Fraud Conference & Exhibition

you

said that between 1999 and 2004 an estimated 20 million Americans took

Vioxx. You've estimated that 140,000 of those Americans suffered heart

attacks and of that number up to 60,000 died of those heart attacks.

How did

you calculate those last two figures? Can you talk more about the

Vioxx

problem?

The estimated number of fatal and non-fatal heart attacks was

obtained by

taking the results from two large clinical trials conducted by the

company,

that showed that high-dose Vioxx increased heart attack risk five-

fold and

lower dose, by two-fold. These risks were applied to the total number

of

people in the U.S. who took Vioxx, and the resulting numbers were

what you

mentioned in your question. I think it's important to recognize that

the

number of Americans who died from Vioxx-related heart attacks could

be very

similar to the number of American soldiers killed during the Vietnam

War.

This was an enormous public health disaster which FDA did nothing to

prevent. In fact, it is because of FDA's disregard for safety and

bias in

favor of industry, that the number who died from the drug became so

large.

 

You've worked for the FDA for more than 20 years. Had you come to

loggerheads with them in the past? Is this first time that you've

protested

against its actions in such a public fashion?

Over the course of my career, I have found myself in the minority on

many

drug safety issues. For most of these, history ultimately showed that

I was

correct, but because of FDA's reactive denial and delay, many

thousands were

needlessly injured or killed by the agency's inaction. FDA

consistently

overrated the benefits of the drugs it approved and rejected,

downplayed, or

ignored the safety problems that ultimately led to their withdrawal.

 

Internally, I wrote many reports and gave many presentations where I

recommended that serious regulatory action was needed, but this was

typically ignored. It was only with Vioxx and the Senate Finance

Committee

hearing, that I was put in a position where I either spoke truthfully

about

a system run amok, or betray that truth and join with FDA in covering

up the

problem. If I failed to speak the truth, I would become part of the

problem,

and all these deaths would, in part, be my responsibility, in the

same way

that FDA was and is, responsible for these deaths. The decision to

speak the

truth wasn't difficult. My conscience guided me in the way I should

go.

 

What specifically do you believe is broken in the FDA and what needs

to be

done to fix it? What must be done to improve the drug vetting system?

FDA is inherently biased in favor of the pharmaceutical industry. It

views

industry as its client, whose interests it must represent and

advance. It

views its primary mission as approving as many drugs as it can,

regardless

of whether the drugs are safe or needed. Structurally, the large

Office of

New Drugs with FDA's Center for Drug Evaluation, which is responsible

for

reviewing and approving drugs before they come to market, is the same

office

with the power and responsibility to regulate those drugs post-

marketing

when a safety issue emerges. This inherent conflict of interest

results in

unsafe drugs remaining on the market. The people who approved them

are very

reluctant to admit that a problem exists or that perhaps, a mistake

was made

by approving the drug in the first place. As a result, many thousands

of

Americans have died.

 

FDA's culture is also at fault. The pro-industry bias leads to an

environment where FDA tends to see things from industry's

perspective. Many

are the advisory committee meetings where the drug company

presentation and

the FDA presentation are virtually super-imposable. It makes you

wonder who

wrote the presentations. Also, the emphasis at FDA is on approval,

and the

focus in on efficacy - that is, does the drug have an effect. Safety

isn't

on the radar screen regardless of what FDA officialdom would have you

believe. Scientifically, FDA uses statistics in a biased manner that

favors

industry at the expense of patient safety. You see, when FDA reviews

a new

drug, it assumes that the drug is safe, and it facetiously asks the

company

to prove that it's not safe. Of course, there is no incentive for a

company

to prove that their drug is not safe because then FDA might not

approve it.

So, with a nod and a wink, drug companies jump through the very low

hoops

that FDA sets up for safety, and the public pays in two ways - with

its

money and its lives. Finally, FDA has a well-established history of

suppressing its scientists, of pressuring them to change their

recommendations and conclusions if they are unfavorable about a drug

and

retaliation against those scientists who don't buckle under FDA

pressure and

threats. FDA calls itself the world's leading consumer protection

agency. If

the public only knew the truth, they'd demand that Congress fix the

problem.

Of course, Congress has no intention of doing anything that would

upset

industry either. What has emerged is a lethal triangle involving FDA,

the

pharmaceutical industry and Congress. Pharmaceutical money funds FDA

and

exerts great influence with Congress. FDA allows deadly drugs onto the

market and Congress pretends that nothing is the matter.

 

You've said that the FDA officials view the pharmaceutical industry

as its

clients and not the American people. Why is this and how did it come

to be?

Beginning in 1992, with passage of the Prescription Drug User Fee Act

(PDUFA), where drug companies began paying substantial amounts of

money to

FDA so that FDA could review and approve their drugs more quickly,

there has

been a steady shift in FDA's cultural orientation. Currently, over 50

percent of the budget for FDA's Center for Drug Evaluation comes from

user-fees. If these dried up, it would be like a diver who has run

out of

air. You've heard the expression " he who eats the king's corn marches

to the

king's drummer, " and " he who pays the piper calls the tune. " Well,

FDA is

marching to the drum beat of industry as if its life depended on it.

 

This fatal development isn't entirely FDA's fault. When Congress

passed this

law, I suppose it's possible that it didn't realize that PDUFA would

lead to

FDA becoming a captive of the industry it's supposed to regulate.

However,

that is what has happened, and to a disastrous end. With Vioxx alone,

up to

60,000 Americans died, and for what? I'll let your readers answer that

question for themselves. Congress must admit that this unintended

consequence is real, and do something about it. Unfortunately,

Congress has

for the most part, denied that any problem exists. So, FDA has blood

on its

hands, and with the next drug safety disaster, that blood will be on

the

hands of Congress as well. And then maybe as in Shakespeare's

MacBeth, we'll

hear Congress say " out out damned spot. "

 

In previous interviews, you've said that the FDA places almost

complete

attention, focus, and value on what it perceives to be the benefit of

a

product and almost completely discounts the risk side. How does this

happen?

Can you elaborate?

FDA is evaluated by the pharmaceutical industry and by higher levels

of

government by the metric of how many drugs does it approve and how

quickly

does it approve them. Nothing else matters. The " complaint " one sees

most

often in print, from pro-industry and right-leaning think tanks is

that FDA

isn't approving drugs quickly enough and as a result, Americans are

being

denied " lifesaving " medicines. This is pure propaganda and deception.

The

truth is, most drugs submitted to FDA by the pharmaceutical industry

are

" me-too " drugs; that is, they're very similar to other drugs already

on the

market that treat the same ailments. These " me-too " s do not represent

a

medical advance and do not offer meaningful advantages over existing,

and

frequently much cheaper, drugs. The reason for the deception and

propaganda

is money. Industry and its supporters want to make as much money as

possible - money that comes out of the pockets of every American in

one way

or another.

 

Now, when reviewing a drug to decide if it should be marketed, the FDA

focuses on efficacy; that is, does the drug have a biologic or

pharmacologic

effect. For example, does the drug lower blood sugar or blood

pressure? Of

critical importance, the efficacy of a drug usually has little or

nothing to

do with its benefit. In fact, for only a handful of drugs, do we have

a

quantitative measure of benefit. Health benefits might include things

such

as prolonging life or delaying the onset of blindness or kidney

failure. But

this is something FDA doesn't measure and it's really what physicians

and

patients are looking for when they prescribe or take medicines. So,

when FDA

approves a drug, it usually has no evidence that the drug will

provide a

meaningful benefit to patients. The fact that FDA has never performed

a

formal benefit analysis does not stop it from proclaiming to the

world that

for a particular drug with a well-defined and serious side effect,

that the

benefits exceed the risks. This too is propaganda and deception.

 

Two recent examples illustrate this dishonesty. With Vioxx, we had

good

clinical trials data as well as a large body of epidemiologic data

showing

that the drug substantially increased the risk of heart attack and

sudden

death. FDA never performed a formal evaluation of the actual benefit

of

Vioxx in the population. By its inaction, FDA implicitly said that the

benefits of Vioxx continued to exceed its risks, and so it should

remain on

the market. When FDA did this, it was acting out of its bias in favor

of

drug companies. Many Americans died so that Vioxx could continue to be

marketed. Interestingly, two published studies looking at benefit

found that

Celebrex was much better at preventing stomach bleeding than Vioxx.

 

The second example involves Serevent, a drug used to treat asthma.

Before it

was marketed in the U.S., FDA reviewed a clinical trial that

suggested that

Serevent might increase the risk of dying from asthma by three-fold.

Because

there was only 90 percent certainty that the risk was increased, and

not 95

percent certainty, FDA approved the drug, presuming it was safe. If

the

weather forecaster said there is a 90 percent chance of rain

tomorrow, would

anyone doubt that it's going to rain? Because of case reports of

patient

deaths on the drug, another clinical trial was performed. The results

of

this study were recently made public, showing that Serevent increased

the

risk of asthma death by four-fold. FDA held an advisory committee

meeting

where it failed to present data on the population impact of this four-

fold

increase in risk, and the committee voted unanimously that Serevent

remain

on the market. This level of risk translates to thousands of

unnecessary

excess deaths, and for what? FDA has never performed an analysis of

benefit,

to document the basis for its pronouncement that benefit exceeds

risk. If a

major point of asthma therapy is to prevent asthma death, what sense

does it

make to have an asthma drug on the market that has been shown to

increase

the risk of death from asthma 400 percent?

 

What's the status of five drugs you mentioned in your Congressional

testimony - Meridia, Crestor, Accutane, Serevent, and Bextra?

Ah, the " infamous five. " With Accutane, very little has changed and

what FDA

is planning to do is still far from adequate. Fifteen years ago, I

proposed

a means of reducing pregnancy exposure to this drug, but it was

ignored.

Curiously, after more than 45,000 pregnancy exposures to the drug,

FDA is

finally considering some of what I recommended, and even more

curiously,

this occurred after the patent on Accutane expired. Of note, the vast

majority of these pregnancies were aborted. Sadly, I think the

evidence

supports the conclusion that FDA and the company used induced

abortion as

their risk management plan for Accutane, rather than adopt an

effective

program of pregnancy prevention. Such a program would have seriously

cut

into profits generated by the drug. So, under FDA's watchful and

approving

eye, off-label use of Accutane increased nearly 300 percent, as did

the

number of exposed pregnancies. FDA is planning to announce a new

program

soon, but if past performance is any guide, this too will be woefully

inadequate.

 

Bextra has been removed from the market. It's interesting to note

that the

official reasons given by FDA for the withdrawal were all known and

apparent

either before approval or soon thereafter.

 

With Crestor, no additional regulatory action has been taken and the

same

holds for Meridia. As far as Serevent is concerned, FDA recently held

an

advisory meeting that concluded the drug should remain on the market.

However, important safety information from two large clinical trials,

both

of which showed that Serevent substantially increases asthma deaths,

was not

presented or discussed. Over the past 11 years, Serevent has probably

been a

major cause of asthma death in the U.S. There are no benefits that I

know of

that outweigh the large number of deaths caused by this drug.

Nonetheless,

FDA orchestrated the advisory meeting to get the pat on the back it

was

looking for, and still, neither Congress nor the public have ever

held FDA

accountable for its fatal decisions.

 

Can you give some examples in which you believe the FDA has pressured

you to

supply a good review of a drug that didn't deserve it?

With Arava, a drug for the treatment of rheumatoid arthritis, I did a

study

showing that Arava increased the risk of acute liver failure

substantially

without a correspondingly important benefit to offset this risk. I

and a

colleague recommended that Arava be withdrawn from the market. We were

severely pressured to change our review, even to the point of being

screamed

at by a senior FDA manager while his supervisor and my supervisor

looked on

and did nothing to stop the abuse. Another favorite ploy is for a

meeting to

be held where multiple FDA managers from the Office of New Drugs

criticize

what you've done and ridicule you for having done it, with the intent

that

you'll alter your report. This happened with Arava and with Vioxx.

 

Can you discuss what you believe to be the conflicts of interest on

FDA

advisory panels with specific examples?

FDA advisory panels are frequently heavily conflicted in several ways.

First, the committee members are usually recruited by the FDA

reviewing

division directors, who are looking for people on the committee who

see the

world in a way similar to their own view. So, if you're favorably

predisposed to industry, you might look for committee members who are

similarly inclined. Frequently, committee members are researchers at

academic institutions who have performed studies for various drug

companies

in the past and may currently be conducting such research. This

results in a

situation where committee members may have a potential self-interest

in

adopting a pro-industry point of view. Most distressingly, however,

advisory

members frequently have active financial conflicts of interest that

could

influence decision making. This past February, FDA held an advisory

meeting

on the COX-2 pain relievers. The committee voted 17 to 15 in favor of

bringing Vioxx back on the market and 17 to 13 in favor of keeping

Bextra on

the market. Of note, 10 panel members had financial relationships

with drug

companies that made COX-2 pain relievers. I did a statistical

analysis of

the voting and amazingly, if you had a financial conflict of

interest, you

were 16 times more likely to vote to keep Bextra on the market than

if you

had no such conflict, and for Vioxx, you were even more likely. The

actual

number couldn't be calculated because everyone with a conflict voted

to

bring Vioxx back. Now, if you disqualified these panel members, Vioxx

and

Bextra were overwhelmingly rejected by the remaining committee

members. But

the real perpetrator here is FDA because FDA knew about these

conflicts and

" waived " them. The public needs to understand that FDA advisory

meetings are

carefully orchestrated, and the information that is presented is

scripted

and censored, so that a particular point of view is offered without

serious

challenge or examination. FDA uses its committees to provide it with

the

shield and support it needs to do what it wanted to do in the first

place.

 

On Nov. 9, 2004, you spoke with then-acting FDA commissioner Lester

Crawford. (Crawford is now the confirmed FDA commissioner.) What did

you

discuss and what was the outcome?

Dr. Crawford asked if I would come to the Commissioner's Office to

oversee

the revamping of drug safety at FDA. I explained that I was a

scientist, not

a manager or a bureaucrat, and I could think of 10 or 12 people

outside of

FDA who would be perfect for this job, especially if at the end of

it, this

person was told they could be the director of a new Center for Product

Safety.

 

You said that shortly before you appeared before the Senate to

testify,

senior FDA officials conspired in an organized, coordinated effort to

intimidate you. How did you know that the effort was planned and what

did

they specifically do?

The effort to intimidate me prior to my Senate testimony was

organized and

premeditated, and though I'm not a lawyer, I would say it amounted to

a

conspiracy. Why do I say this? Well first, the day before the Senate

announced there would be a hearing at which I would be testifying, I

was

invited to the FDA commissioner's office where I was asked to consider

leaving drug safety to move to the commissioner's office. This is very

strange because over the two previous months, I had been vilified by

FDA

management in the press and attacked and harassed by my own

management in an

attempt to get me to change my conclusions about Vioxx. Why would the

commissioner want a vilified and hated " junk scientist " to move to his

office to oversee the revamping of drug safety at FDA? It just didn't

make

sense. And how did he know that I would be testifying? I imagine he

was

tipped off by senators friendly with industry.

 

After I turned down this offer, a series of " anonymous " phone calls

were

made by senior FDA managers to Senator Grassley's office [sen. Chuck

Grassley (R-Iowa) is chair of the Senate Finance Committee. - ed.]

and to

Tom Devine, legal director of the Government Accountability Project

(GAP), a

non-profit organization that defends " whistleblowers. " These calls

amounted

to a smear campaign against me, maligning my character and integrity

and

accusing me of being a dishonest scientist and a liar. Some of these

phone

calls were made from government telephones (caller ID), which is a

federal

crime. Now the purpose of these calls was to discredit me as a

witness and

to possibly convince Senator Grassley that he should not have me

testify, or

if he did, then not to support or defend me afterwards. With GAP, the

purpose was to convince Tom that his group should not represent me.

If I

lost the support of GAP, maybe I'd back away from testifying, and if I

didn't, well, I'd have no legal counsel or defense. But here's the

core

evidence. There must be 10,000 lawyers in Washington, D.C. How on

earth did

these FDA managers know to call Tom Devine? The answer is simple. You

see,

in early 2004, FDA suppressed another FDA scientist who had concluded

that

SSRI antidepressants increased the risk of suicidality in children.

FDA held

an advisory committee meeting where it hid this information from the

public

and from its own advisory committee. This suppression of important

safety

information was leaked to the press by people within FDA and this

embarrassed the agency. My supervisor ordered an internal criminal

investigation to identify and imprison the perpetrators. Of course,

no one

from the Office of New Drugs was investigated. I contacted GAP and Tom

Devine at this time because I didn't want to have to hurt people I

knew by

testifying to these criminal investigators. Before they interviewed

you,

they made you sign a piece of paper saying that if you lied, and they

found

out about it, you could go to prison. Tom spoke with the

investigators, and

explained to them that their investigation was a crime because it

violated

three different federal laws and because it was simply a

whistleblower witch

hunt. Within days of this conversation, the investigation abruptly

ended but

not before the " official purpose " of the investigation was changed.

No one

knew that I had contacted Tom Devine except these criminal

investigators,

who put it in their report that was given to my supervisor. So, how

did

these other senior FDA managers know to call Tom Devine? I suppose it

could

be dumb luck, but I don't think so.

 

Why hasn't U.S. law enforcement listened to your complaints about the

intimidation by senior FDA officials even though it's a federal crime?

There is no law enforcement when it comes to the government

investigating

itself. In this regard, the government is above the law. And then

there is

the code of managerial and organizational loyalty. Basically, they

can hang

separately or together. By sticking together, FDA's senior management

create

a barrier that's difficult to penetrate. Finally, there is politics,

and the

investigations by the inspectors general are subject to the oversight

and

say-so of political appointees. This has been the case under

administrations

of both persuasions. So, despite federal laws being broken, none of

the FDA

managers responsible will ever answer for their offense. Indeed,

they'll

probably be promoted. Isn't that the American way?

 

In November of 2004, Sen. Grassley sent a letter to Daniel Levinson,

acting

inspector general of the Department of Health and Human Services,

asking for

an official investigation into whether the FDA has attempted to

discredit

you. What became of that investigation?

To my knowledge, the investigation by the IG has gone nowhere. I've

heard

rumors that it became biased and didn't gather the appropriate

evidence or

interview key witnesses. But by now, we should all realize that the

government does a really poor job of investigating itself. Talk about

conflict of interest and bias.

 

Is the inspector general of the Department of Health and Human

Services

investigating any of your allegations? How about the General

Accountability

Office?

I've been told that the GAO investigation is proceeding and that a

report

may be available by September. Again, I'm skeptical that the report

won't

get rewritten by higher-ups in government.

 

You've said that you have no viable legal rights under the

Whistleblower

Protection Act. Can you elaborate? Have you been placed under criminal

investigation? Can you discuss current introduced legislation that

might

protect federal workers' rights?

Currently, there is a federal Whistleblower Protection Act that was

enacted

into law a number of years ago, that was intended to give

whistleblower

protection to federal workers. Unfortunately, the First Amendment

free-speech rights intended by that law have been interpreted away by

the

administrative courts, resulting in a situation where federal workers

have

absolutely no protection. In fact, the current WPA has become

somewhat of a

trap for government employees who see waste, fraud or public

endangerment

within government and try to bring it to public attention. In the

private

sector, Congress recently passed the Sarbanes-Oxley Act giving

state-of-the-art free-speech rights to corporate truth-tellers (a.k.a.

whistleblowers). In light of financial disasters such as Enron and

WorldCom,

Congress saw that such protection was needed if the country's 401-K

and

pension plans were to be protected. We're faced with a similar crisis

within

government, and sometimes, what we're dealing with are the lives of

thousands, if not tens of thousands of people like you or me or any

of your

readers. So, in reality, the public needs to know that if government

scientists can't protect themselves, how will they be able to protect

them

from unsafe drugs?

 

In both houses of Congress, there is currently a reinvigorated

Whistleblower

Protection Act that would provide government truth-tellers with the

protections needed to ensure their First Amendment free-speech rights

to

bring into the sunshine waste, fraud, or public endangerment within

the

federal government. This bill would pass unanimously within both

houses if

it could come to a floor vote. However, I've been told that the

political

leadership in the House and the Senate will not allow the bill to

come to a

floor vote. Apparently, the Department of Justice is opposed to

federal

employees having the same free-speech rights as their counterparts in

the

private sector.

 

A 2002 Health and Human Services survey of almost 400 FDA scientists -

almost 1/5 of the total number - found that a majority had significant

doubts about the adequacy of federal programs to monitor prescription

drugs

once they're on the market and that more than a third weren't

particularly

confident of the agency's ability to assess the safety of a drug.

More than

half of the respondents said they didn't think there was sufficient

time to

conduct an in-depth, science-based review in the six months required

for

drugs given priority status. Do you feel the results of the survey

(only

fully released after your 2004 Congressional testimony) vindicate your

concerns?

I think the results of this survey, and several others that have been

conducted (one by an outside FDA watch-dog group, Public Citizen, and

another by FDA's Center for Drug Evaluation) reveal that there is real

substance behind the remarks I made during my Senate testimony. FDA

professes to be a scientific and evidence-based organization that is

not

biased in favor of the industry that pays much of its operating

budget.

These surveys paint a very different picture. In a scientific

organization,

especially one dealing with patients' health and lives, there should

be no

(zero) examples of suppression or intimidation of its scientists. Yet

at

FDA, this is normative, routine and commonplace. And then FDA goes to

Congress and says no one is ever suppressed or pressured to change

recommendations. Anyone looking at the objective evidence, and

putting aside

whether they're a Democrat or Republican, conservative or liberal,

would

quickly see what the truth of the matter is. Regrettably, however,

drug

safety has become a political issue. Patient safety and public health

should

be bipartisan and above politics. But that is not what is happening

because

the pharmaceutical industry is extremely powerful and carries

unimaginable

influence within Congress and over the FDA

 

What are the personal costs from being a sentinel?

The personal costs have been high. From August of 2004, when I first

came

under fire by FDA management to change my conclusions and

recommendations to

a large study I had just completed, through this past February or

March,

life was hellish to say the least. Internal criticism, threats and

ostracism, coupled with an orchestrated campaign of slander and

innuendo,

initiated and carried out by FDA managers, took a great toll on my

family.

Apparently, pharmaceutical representatives and lobbyists also

participated

in this smear campaign on Capitol Hill. Why? Because the last thing

industry

wants to see is an FDA where post-marketing drug safety actually has

power

and authority to protect the consumer. An investigation of this

episode was

requested by Senator Grassley, but as I mentioned before, it appears

that

the Inspector General investigation will cover-up and gloss over what

occurred, only empowering FDA to do even worse things in the future.

 

What are your professional plans from here?

My passion is really with the field of drug safety, as a scientist and

researcher, not as a manager or bureaucrat. And FDA is potentially the

single best place to be to make a difference in the health and well-

being of

patients. So if I were able to, I'd like to continue my work at FDA.

From

time-to-time, I've looked at university jobs, but in this field, most

drug

safety research outside the government is funded by industry, which

can be

very constraining and, I believe, compromising. It's well-established

now

that research funded by industry is four to five times more likely to

reach

a conclusion favorable to industry than if the research was funded by

independent or neutral sources. The idea of working for industry also

holds

no appeal. Of course, I could always find plenty of work in the

litigation

field, but I'd much prefer to continue my work at FDA.

 

Have you received support (either private or public) from your

colleagues

and peers?

The support I have received from staff (but not management) within the

Office of Drug Safety has been overwhelming and positive. It has also

been

out in the open. I have also received many phone calls or personal

comments

in the cafeteria or elevator from FDA staff working in other areas of

the

Center for Drugs. And then there are the hundreds of e-mails,

letters, and

phone calls I've received from the public, expressing their thanks and

offering encouragement and prayers for me and my family.

 

After all that you've been through, would you do it again?

I have been asked this question several times and have thought about

it at

some length. I think the most honest answer I can give is that I

wouldn't

want to have to go through such anxiety and stress again, but faced

with the

same circumstances, I would have no choice, really, because the pain

of

knowing that I had contributed to the deaths of patients by my

silence would

be too much to bear. It gets back to this matter of conscience, and

acting

in accordance with it, and then trusting in God's providence. Human

life is

worth far more than a little difficulty at the office, and being able

to

look my children in the eye and for them to know that I have acted

with

integrity, is priceless. Plus, I'm able to sleep at night.

 

 

 

Dick Carozza is editor of Fraud Magazine. His e-mail address is:

dcarozza.