whistleblower speaks out / must read the last paragraph

[Guest guest]

Corporate Crime Reporter

Devout Christian Graham Details Showdown with FDA

19 Corporate Crime Reporter 1(1), January 3, 2005

Graham said last week that his Catholic faith guided him in

blowing the whistle on his employer, the Food and Drug

Administration (FDA), for its failure to pull Merck's popular

painkiller Vioxx off the market.

Merck voluntarily pulled the drug off the market in September after

a study it conducted showed that Vioxx doubled the risk of heart

attacks.

" I'm a Catholic Christian, and though I continually fall short of

modeling the Gospel in my life, I have always tried to do so, "

Graham said in accepting the Joe. A. Callaway Award for Civic

Courage last week in downtown Washington, D.C. " In reflecting on

this award, I recall the verse from the New Testament scriptures

where Jesus spoke to his disciples about service and instructed them

to remember that we must remain humble, for there is no honor in

doing what we were told to do. "

" To paraphrase this verse, I have done nothing more than my duty, "

Graham said.

Graham is married had has six children. His wife is a lawyer who

home schools her children.

During his thirty-minute acceptance speech, and a short question-and-

answer period that followed, Graham portrayed his action in speaking

out publically against the FDA and the drug industry as a Christian

duty of conscience.

" For the past 20 years, I have worked at the FDA as a post-marketing

drug safety researcher, " Graham told a group of about 65, including

drug safety activists, some FDA colleagues, and members of his

family gathered to witness the awards ceremony. " Education I

received at the s Hopkins School of Medicine taught me to act in

the best interests of my patients, regardless of personal cost or

inconvenience. My religious faith taught me to preserve their lives

to the best of my ability and to do nothing to intentionally injure

or harm them. And when I became an epidemiologist at FDA, the entire

nation – all 290 million people – became my patients, a

responsibility I've taken to heart. "

Graham became something of a celebrity in Washington after going

before the Senate Finance Committee and caustically ripping apart

the FDA for failing to protect American consumers.

At that hearing, Graham estimated that between 88,000 and 139,000

people in the United States had suffered heart attacks or stroke as

result of taking Vioxx and that as many as 40 percent of those, or

about 55,000, died as a result.

But at the awards ceremony last week, he didn't use the 55,000

number, instead at one point referring to 40,000 dead, and at

another talking about 30,000 to 40,000 dead.

In any event, he stuck with his Senate testimony that the Vioxx dead

represented " what may be the single greatest drug safety catastrophe

in the history of this country or the history of the world. "

Graham said that had he known about " the cost and the extreme

difficulty of working in an environment that routinely dismisses or

twists the truth about drug safety and punishes you severely for

speaking the truth, I'm certain that I would have chosen a different

path. "

Graham quoted Frost famous poem, Road Not Taken – " Two roads

diverged in a wood, and I took the one less traveled by, And that

has made all the difference. "

" In many ways, this has been a description of my career, " Graham

said. " Please understand, I am not a hero and I'm not endowed with

extraordinary courage, despite the honor that has been bestowed on

my today. At each divergence of the roads where I faced an important

decision, I can honestly say that it was conscience not courage that

compelled me. "

" For me it was clear what I had to do and I set about to do that and

tried not to think about what would happen afterwards, " Graham

said. " Fear is the single greatest enemy of doing the right thing.

It is fear that works in all of our hearts to deter us from doing

what is right. To me, it is the compulsion of my conscience that

overcame my human fear, and this certitude that somehow or another,

things would work out for the good -- the Lord would provide for me. "

Graham said that earlier this year, he wanted to publish his study

of heart attack risks of Vioxx in the peer reviewed literature, but

that " the FDA reacted violently to that. "

While he was trying to convince his superiors to let him publish his

study, Merck was voluntarily pulling Vioxx off the market.

" The FDA would not have pulled Vioxx off the market, " Graham

said. " The FDA saw no problem with 100,000 people having heart

attacks because of Vioxx. "

" The week before Vioxx came off the market, I was in a meeting with

very senior people from the Office of New Drugs and my own Office of

Drug Safety, " Graham said. " And the things they were saying to me

was – why on earth were you studying Vioxx and heart attacks? We

have no regulatory problem with this drug. We in the Office of New

Drugs didn't approve your study. We don't want you studying that. "

" In a sense, Merck did a public service in pulling Vioxx from the

market, " Graham said. " I really can't comment on Merck's

motivations – how altruistic they were. But if you look at the

evidence and literature, it is clear that prior to the marketing of

these drugs – Vioxx and Celebrex – there were strong theoretical

reasons why one would expect that these drugs might increase the

risk of heart attack. And for that reason, FDA needs to be held

accountable. FDA was fully aware of these theoretical concerns and

knew also that these drugs, being in the class of drugs for pain

relief – that they would be used by tens of millions of people. "

Congress became interested in the drug safety problem only after

Merck pulled Vioxx off the market.

After all, Graham said – " this drug was given to 27 million people,

Merck is a big company, it's capitalization dropped 27 billion in

one day. "

The three big painkillers in this class – Vioxx, Celebrex and

Bextra – combined made over $4 billion in profits this year.

" And who knows how many people had heart attacks because of them? "

Graham asked.

Graham told the gathering that when Senator Grassley (R-

Iowa) began asking questions about Vioxx, " I knew my goose was

cooked. "

" They were going to have a hearing, and I would be asked to testify.

I was happy to tell the truth, " Graham said. " I wasn't so happy at

the prospect of being unemployed. "

" In any event, the time came to testify, " he said. " I suppose I

could have given a watered down version of the truth. But had I done

that, I wouldn't be able to live with myself, because I know that I

would have done wrong. And being a physician to 290 million

Americans, wouldn't know who it was who died because I failed to

speak the truth, or who ended up with a heart attack and didn't die

because I failed to speak the truth. But rest assured, there would

be many of those people and I would be complicit in the injury that

they suffered and the suffering that their families experienced when

a loved one dies suddenly from a heart attack. "

Graham said that " in Dante's inferno, there are levels of hell. "

" And there are levels of courage, too, " he said. " The disaster that

I face, losing my job, that's pretty terrible. I have six kids to

support. Some of them are of college age. Some of them are young.

And that is something to worry about. But it is not like losing your

life. Go back to the Holocaust. People who risked their lives hiding

Jews from the Nazis, recognizing that if they were betrayed or

caught, they would have lost their lives – they didn't have to do

that. But conscience drove them to do it. It was recognizing the

image of God, that we are all God's children, we are all his sons

and daughters. "

Graham said that on the weekend before his fateful testimony before

Grassley's Senate Committee, his bosses launched a three-pronged

attack against his credibility.

" They contacted Senator Grassley and tried to convince him that I

wasn't worth his support, that I was a liar, that I was a cheat,

that I was a bully, that I was a demagogue, that I was

untrustworthy, " Graham said. " At that same time, they contacted the

Government Accountability Project with the same line. They thought –

maybe we can get Senator Grassley to not support him, or maybe we

can get GAP not to defend him. And then let's go for the hat trick –

the editor of The Lancet. My center director contacted the editor of

The Lancet and accused me of scientific misconduct. "

" Scientific misconduct is the highest crime a scientist can commit, "

Graham said with a touch of bitterness. " Scientific misconduct is a

betrayal of all that science stands for. Scientific misconduct, if

you have committed it, is a career-ender. "

" Needless to say, it wasn't true, " he continued. " By the end of the

weekend, the editor of The Lancet had communicated to the center

director that I had handled myself in the finest tradition of

scientists, that there was no scientific misconduct, that there were

no scientific problems with the paper and that it should be

published. And the Center director agreed that it could be

published. "

" It was supposed to be published on-line the day before my Senate

hearing, so we would have the numbers in my testimony. The 100,000

heart attack number would be in The Lancet before the testimony – it

would have scientific credibility. But my managers set a trap – so

that if I allowed it to be published, they could fire me. So, I was

forced to withdraw the article from publication on the eve of its

publication. "

" I was still able to give my testimony. But that weekend, when I was

supposed to be writing my testimony, was shattered by having to deal

with this three-pronged attack. Fortunately, I was able to put

together the testimony. I had no idea that the testimony that I gave

would attract the attention that it did. I had no intention when I

testified to become a public figure, but your face is plastered in

the newspapers and this is what happens. "

Graham confided to the group that " my ish terrier bit part of

my nose off on the left side. "

" The nose that you see here is the result of reconstructive

surgery, " Graham said. " I need to let my plastic surgeon know that

most of the photographs have been coming from the left side and

nobody has commented on how bad a job he did. So, I think he must

have done a pretty good job. By the way, the dog is still a happy

member of the family. He is forgiven. But he is minus some androgen-

producing glands. "

It became clear from listening to Graham's talk that he blames the

FDA, not the drug companies, for the drug safety problems afflicting

the country.

" On 911, 3,000 people died, " Graham said. " With Vioxx, ten to

fifteen times that number died, but it didn't happen one at a time –

maybe on your street, maybe on my street, maybe lasitional 60,000

people had non-fatal heart attacks, one at a time. It happens below

the radar screen. But it is a national catastrophe nonetheless. The

FDA and FDA alone is responsible for it "

" It is not the fault of the drug companies, " he said. " We'll let the

courts decide what their liability is. For me, I can focus on FDA.

FDA had a sacred trust, it betrayed that trust, it betrayed the

American people. One hundred thousand people paid a high price for

that just with Vioxx. I don't know how many have paid that price

with Bextra, with Celebrex, with any of the other drugs that FDA

took too long to withdraw from the market. "

Graham said that the big drug companies " have been lobbying like

crazy " in recent weeks to prevent Congress from reorganizing the FDA.

" The last thing on earth drug companies want to see is strong post-

marketing drug safety because if there is strong post-marketing drug

safety, it is going to cost companies more money to research the

drugs before they get to market, and they are going to run the risks

of a drug being removed from the market, " he said.

Under current federal law, the FDA must guarantee that drugs are

safe and effective.

Graham said that the FDA requires that drug companies prove that

they are " at least 95 percent certain that this drug has an effect –

it lowers you blood pressure, it lowers your cholesterol, it lowers

your blood sugar – we are 95 percent confident it does that. "

But when it comes to safety, the FDA takes that statistical model

and turns it on its head, Graham said.

" Rather than saying – we are 95 percent certain that the drug is

safe to a given level, they say – we are not 95 percent certain that

it will kill, so I guess it doesn't. And the FDA gives that drug a

free pass. "

Graham also called for strong job protection for government workers

who, like himself " commit the truth. "

Graham said that a recent FDA Office of Inspector General survey

found that two-thirds of FDA medical officers are not confident that

the products that are approved are safe and that 18 percent felt

that they have been pressured to change their conclusions.

" I can guarantee you, there are other whistleblowers at FDA, " Graham

said. " There are many whistleblowers at FDA. Fear has them by the

throat. And they struggle with their conscience and they struggle

with the wrong that they see, and they are paralyzed by their fear.

And they are looking to see – can that Graham fellow get away with

committing the truth? "

" It remains to be seen whether I can get away with committing the

truth, " he said. " But it shouldn't be that way. "

The Joe A. Callaway award was established to recognize individuals

in any area of endeavor who, with integrity and at some personal

risk, take a public stand to advance truth and justice, and who

challenge unsatisfactory conditions in pursuit of the common good.

The award was also given this year to Mark Livingston, a

pharmaceutical quality control specialist who was involved in the

launching of Wyeth Pharmaceuticals' Prevnar pediatric vaccine.

In the fall of 2003, Livingston filed a lawsuit in federal court

alleging that Wyeth Pharmaceuticals compromised the manufacturing

process of bulk vaccine to meet demand.

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