Whistleblower speaks out - MerckVioxx & also bit on Wyeth Prevnar

"David 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."

"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. "


Corporate Crime Reporter


Devout Christian David Graham Details Showdown with FDA

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

David 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

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

"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 Johns 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

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 Robert 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

Graham told the gathering that when Senator Charles 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 Scottish 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

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.


Corporate Crime Reporter
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