Devout Christian David Graham Details Showdown with FDA
By 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 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 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 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 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 asked.
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
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.
Corporate Crime Reporter |
1209 National Press Bldg. |
Washington, D.C. 20045 |
202.737.1680 |
