Arthritis - Documents Suggest Merck Tried to Censor Vioxx Critics

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Documents Suggest Merck Tried to Censor Vioxx Critics

Roman Bystrianyk

2005-06-09, 5:46 pm

http://www.healthsentinel.com/news....ist_item&id=913

Snigdha Prakash, "Documents Suggest Merck Tried to Censor Vioxx
Critics", NPR, June 9, 2005,
Link: http://www.npr.org/templates/story/...storyId=4696609

At least 38,000 Americans are believed to have died from taking the
pain pill Vioxx before it was withdrawn last year. Drug maker Merck is
now facing thousands of lawsuits.

Over the past few months, it has emerged that the company was aware for
years that Vioxx might be dangerous. Now, new documents obtained by NPR
suggest that even as Merck was making Vioxx into a bestseller, the
company was putting pressure on independent doctors. The company's
apparent aim: to keep them from discussing evidence of Vioxx's
potential safety problems. The documents show that Merck exerted
pressure not only on individual doctors, but also on several of the
nation's top medical schools.

Merck tells NPR it did nothing wrong.

NPR's Snigdha Prakash has the first story in a two-part report:

When a drug company wants to sell a pill to a doctor, its best
salesperson is usually another doctor.

Of course, drug companies don't call that selling. They call it
"medical education." Or even medical research.

Well before Merck launched Vioxx, the company was targeting influential
doctors who could help it build Vioxx's sales.

When they located a prospect, they entered the details about that
doctor into a spreadsheet at headquarters. Spreadsheet entries included
items such as:

"...treats all of the major sports teams, including the Lakers
basketball team and the Dodgers baseball team, as well as the
high-profile members of our society."

"... 2,4OO prescriptions per year... also known nationally... Writes
for a lot of rheumatology textbooks."

Merck's vast army of sales representatives gathered intelligence on
what it would take to win over individual doctors. Their notes included
the following strategic observations:

"Use in many speaking engagements... At least $20,000 for speaking
engagements for the remainder of the year."

"Will speak for us only at certain restaurants and high honorarium...
Likes to feel important... He needs the VIP treatment."

One of the physicians whom Merck recruited to promote Vioxx was
Gurkirpal Singh of Stanford University.

Merck wanted Singh on board because he was a senior researcher on a
seminal study of arthritis patients. The study showed that older
painkillers, such as Naproxen, commonly caused gastrointestinal
bleeding. It established the need for new painkillers, such as Vioxx
and its rival, Celebrex, that were gentler on the stomach.

NPR has examined Merck documents provided by sources working with
individuals and families who allege Vioxx harmed them. They're now
suing Merck.

Among those documents is a memo that shows Merck started to focus on
Singh in April or May of 1998 -- almost two years before Vioxx was
ready for market. The overture was successful. A year later, Merck was
launching Vioxx, and Singh was an important spokesman.

One document reads: "March-May 1999. Aggressively scheduled Dr. Singh
for talk in preparation for launch... Reviews and feedback of Dr.
Singh's presentations were generally positive." And it notes that "Dr.
Singh commanded relatively large honoraria."

Merck paid Singh fees of up to $2,500 for each talk. He gave 40 talks
over seven months.

Singh described the system in an interview with NPR:

"One setting which is where I was speaking predominantly was in the
grand round situation in hospitals, or in medical schools, or in the
universities, where like you're giving a formal lecture to the
physicians," Singh said. "It's always lectures to physicians. And then
the other set is usually these evening programs that drug companies
arrange, where you also present your research, and then there's often a
dinner with it."

Merck was pushing hard to catch up with rival drug maker Pfizer.
Pfizer's new painkiller, Celebrex, had beaten Vioxx to market by a few
months. It was gobbling up market share.

Then in early 2000, Merck got news of a potential problem. A large
study commissioned by the company showed that patients on Vioxx
suffered more heart attacks, strokes and deaths than those on the older
pain pill Naproxen.

For some researchers, the results were a red flag that Vioxx might be
dangerous. But according to the company, the new evidence was
outweighed by many previous studies that showed the drug was safe.

Merck scientists interpreted the study in a postive way. In a series of
press releases, Merck said the study showed that the older drug
protected against heart attacks -- not that Vioxx caused them. The
company confirmed that Vioxx was safe for the heart.

Merck gave the study data to the Food and Drug Administration, and the
two began a protracted debate over what the study meant, and what to
tell doctors and patients about it.

Meanwhile, despite the positive spin of Merck's press releases, Singh
was uneasy about the new study.

"I was worried, because obviously this was something new," Singh said.
"This was something we had never seen before."

As an independent scientific expert, Gurkirpal Singh wanted to evaluate
the study for himself.

Singh asked Merck repeatedly for the data. "I wanted to know how many
heart attacks, how many strokes, how many deaths were occurring in each
one of the groups, and what were these actual number of patients at
risk, and how many ended up having an event," he said.

Singh says for months, Merck's scientific education department assured
him that the results would be available soon -- at one scientific
meeting, then another. They never were.

Singh got tired of waiting. He shared his concerns with at least one
prominent European scientist, and he began to allude to his concerns in
talks.

Inside Merck, Susan Baumgartner, a Vioxx marketing manager, wrote this
e-mail:

"June 19, 2000: Dr. Singh continues to play up the cardiovascular
adverse events associated with Vioxx... I think there are many other
speakers who deliver good messages, and we should not risk supporting
the negative messages that he continues to deliver."

The Merck sales machine, which included the departments of marketing,
scientific education and physician outreach, had begun to show its
other face. It had paid Singh fat speaking fees. Now it was canceling
many of his educational lectures.

The documents obtained by NPR show that for much of June 2000, Merck
executives conferred on how to rein in their skeptical consultant. At
least 23 local, regional and national executives took part in the
discussions. They feared that just as Singh's credibility had opened
doors for Merck, it could close them.

Singh was widely respected at the FDA. He also had connections with
large institutional buyers that were vital to Vioxx's sales.

Terry Strombom, who was senior business director for the San Francisco
region, sent an e-mail on June 5, 2000, that shows Merck was walking a
tight rope -- it wanted to censor Singh, but was afraid of alienating
him. The e-mail read:

"The one thing I am pretty sure of is that Dr. Singh could impact us
negatively if he chose to do so... I would recommend we handle this
very carefully... I just don't think canceling all the programs and
walking away completely will serve us well in the long term."

The e-mails show that at the same time that Merck was trying to censor
Singh, at least one Merck official acknowledged that Singh's concerns
about Vioxx were legitimate.

Heather Robertson, the coordinator of health education liaisons for the
San Francisco region, reported on a conversation with Singh's main
scientific contact at Merck, who has since left the company. Her e-mail
of June 5, 2000, read:

"I spoke to Kirsten directly for the first time this past week to learn
that Dr. Singh makes a balanced presentation (he must since he is an
FDA advisor) but reports product information that is not favorable to
Merck... Kirsten feels that no amount of work would change Dr. Singh's
position, and although we may not like to hear about it, his
information is scientifically accurate."

Later, Merck would advise its sales representatives not to discuss
Vioxx's risks to the heart, and to have doctors send their questions to
headquarters.

We showed the Merck documents to David Rothman, director of the Center
on Medicine as a Profession at the Columbia university college of
Physicians and Surgeons. He says the Merck documents consistently show
a disregard for the substance of the scientific arguments about Vioxx.

"The drug companies will use the language of objective neutral
science," Rothman says. "But what speaks much louder is 'You're for us,
or you're again' us. And if you're again' us, we're going to try to get
you.'"

Merck's surveillance system had many ways to pick up who was for them
or against them. Physicians, including advocates with financial ties to
Merck, contacted the company when they heard criticism.

A document from July 21, 2000, reads: "Communication from advocate
regarding a program given by Dr. Singh... It was hyper-inflammatory."

Singh's allegiance was shifting. He was now promoting Vioxx's rival,
Celebrex. He was being paid by Pfizer, and he was telling his audiences
that Merck had refused to answer his questions about Vioxx's safety. A
July 2000 document notes: "Received reports that Dr. Singh showed a
cartoon of a character hiding under a blanket and asked the audience to
speculate about what it is that Merck is trying to hide."

Merck's sales force was also keeping tabs on the buzz in doctors'
offices. As sales representatives gave out free Vioxx samples, they
asked doctors if they'd heard anything new about Vioxx. The sales reps
would transmit this intelligence via voicemail to the company's
National Service Center. Another Merck document, from July 26, 2000,
notes:

"NSC report that at nine meetings in the L.A. area over the last three
days, Singh presented sessions that were very unfavorable to Vioxx."

A week later, Singh would convey his concerns to one of the country's
largest and most influential drug purchasers, the Department of
Veterans Affairs. The VA started asking Merck if Vioxx was safe for the
heart. The company's most senior scientists were brought in to answer
the VA's questions. It was clearer than ever that Singh had become a
major liability for the company.

Dealing with Singh was now a job for Merck's senior vice president for
medical and scientific affairs -- Dr. Louis Sherwood. Sherwood was a
former academic and had been chief of medicine at a top medical school.

Merck documents obtained by NPR show that a detailed account of Singh's
activities was now prepared for Sherwood. Almost a dozen Merck
executives were involved. A senior regional executive who had
supervised Singh's scientific handlers sent this Oct. 4, 2000, e-mail:

"I have in excess of 80 e-mails pertaining to interactions with Dr.
Singh from March 1999 to present. The following is my best recollection
of what has happened. Because of the sensitive nature of the following,
I strongly encourage you not to share with anyone unless they clearly
have a need to know."

The profile of Dr. Singh is remarkably complete," says Columbia's David
Rothman, who reviewed the final document for NPR. "One can't help but
almost frame it in terms of an FBI dossier, except here Dr. Singh is
not cavorting with possible communists, or possible gangsters. Here the
dossier is filled with Dr. Singh's take on Vioxx, who is Dr. Singh
talking to. It's scrupulously watched and very, very carefully
recorded."

The profile was dispatched to Sherwood and six other executives. Around
the same time, Singh heard from a friend inside Merck: "I was told that
Dr. Lou Sherwood, who was then vice president at Merck, had become
'very interested,' in quotes, in what I was doing, and that Dr.
Sherwood is "very powerful, and he's going to crush you and he's going
to fix you.'"

Dr. Louis Sherwood's campaign to "fix" Vioxx critic Gurkirpal Singh
began with a series of phone calls to Singh's bosses at Stanford
University.

"I don't usually receive phone calls on a Saturday at home from
representatives of drug companies," says James Fries, a professor of
medicine at Stanford. "So it was definitely unusual."

The call came on Oct. 28, 2000. " I received a call from a medical
director at Merck, stating that someone on my staff had been making
wild and irresponsible public statements about the cardiovascular side
effects of Vioxx," Fries says. He says Sherwood hinted there would be
repercussions for Fries and Stanford if Singh's statements didn't stop.
He was left with the sense that Merck's financial support to Stanford
was at risk.

Fries started making calls of his own and learned that researchers at
seven other institutions, including the university of Minnesota, the
University of Texas Southwestern and a Harvard teaching hospital, had
also raised doubts about Vioxx's safety. Sherwood had placed calls to
those institutions as well.

"A number of investigators who had spoken publicly had been called or
the chairs of their departments had been called, "Fries says. "The
deans of their medical schools, and a variety of veiled and not so
veiled threats had been made -- that they were saying bad things about
the drug company, and that the people to whom they reported should take
steps to see that this stopped."

At Merck, Medical Director Sherwood wrote an e-mail to bring the
marketing department up to speed. NPR has obtained that e-mail. It
suggests that part of Merck's strategy to suppress criticism was
intimidation. The e-mail, dated Nov. 7, 2000, reads:

"Fries and I discussed getting Singh to stop making the outrageous
comments he has in the past few months... I will keep the pressure on
and get others at Stanford to help."

Sherwood advises one of the marketing executives how to pressure Singh
himself. He says: "Tell Singh that we've told his boss about his
Merck-bashing." And tell him, " should it continue, further actions
will be necessary (don't define it.) "

Lisa Bero is a professor of clinical pharmacy and health policy at the
University of California, San Francisco. She's done extensive research
showing how funding from drug companies influences academic science.
She reviewed Sherwood's email at NPR's request.

"I didn't realize how powerful the drug companies thought they were,"
Bero said. "For example, having enough influence over a department to
say 'change what your faculty member is saying.' I haven't ever seen
that documented before."

Another document written by Sherwood shows Merck tried to use that
influence on several occasions. After Stanford Professor James Fries
learned about Sherwood's calls to other medical institutions, he sent a
strongly worded letter to Merck's CEO. The letter questioned the
propriety of Sherwood's calls. Sherwood wrote an internal memo in
response. NPR has obtained that memo.

In it, Sherwood writes there was no "orchestrated campaign or specific
program" to deal with what he calls '"problem individuals." Yet, he
lists groups of Merck executives who managed those critics. The memo,
dated Jan. 23, 2001, reads in part:

"I will only get involved when our representatives... regional medical
directors, Merck research lab physicians... or key individuals in the
therapeutic business group have felt frustrated by their inability to
reach out or to 'balance' selected individuals."

And Sherwood implies that when that happened, he did lean on Vioxx
critics -- and on their institutions: "Without trying to appear
immodest, I believe I am the most respected physician in the
pharmaceutical industry among academic chairs and deans... Therefore,
when I call them on a matter of urgent concern, they generally take it
seriously... This has been a source of strength for USHH, as I have
been able to exert balanced leverage in some difficult situations."
[USHH stands for the Merck division U.S. Human Health]

UCSF's Bero says, "Well, the first thing I thought is, 'What kind of
leverage are we talking about?' And the first thing I thought of was
money, in all the various ways that it can come to departments."

In 2004, Stanford's medical school got 9 percent of its research budget
-- $29 million -- from drug companies. NPR surveyed several medical
schools and found that's not unusual.

David Rothman is at the Columbia university college of Physicians and
Surgeons.

"Look, medical research is expensive," says David Rothman of the
Columbia university college of Physicians and Surgeons. "No one can
take a call from a drug company high official, critical of an
investigator, and not realize that behind that call is the implicit
reminder, implicit threat -- 'If you can't control your folks, how do
you expect us to continue to do business with you?''"

Merck and Sherwood deny the allegations in this story. Ted Mayer, a
lawyer representing Merck, says, "Merck was not trying to silence
critics. The scientific or the safety profile of this product was very
well known in data that was available to the public, and it was
vigorously debated in the public, and it's perfectly appropriate to
have that vigorous debate."

Mayer says Merck was concerned about Dr. Singh because many of his
talks went far beyond that vigorous debate: "The number of people who
heard those talks and who were physicians and understood the data well
believed that those talks contained unbalanced and inaccurate
information, and that the views weren't supported by the data and were
kind of at the extreme end among hundreds of scientists who were making
these kinds of presentations."

In an interview with NPR, Dr. Louis Sherwood says it was rare for him
to complain to department heads. He says he firmly believes in academic
freedom. He says he only made calls when faculty members were being
unfair to Merck and acting unprofessionally.

"I never, never made any threats to withdraw funding or hamper anyone's
faculty appointment," Sherwood said. "Under no circumstances did I ever
do that."

Then why did Stanford's James Fries feel threatened when Sherwood
called?

"No one likes to be criticized," Sherwood said. "Now sometimes, when an
academic physician is criticized for his or her actions, they may
interpret that as a threat. But under no circumstances did I threaten
Stanford or Dr. Fries or anyone with funding issues or anything else.
That would've been inappropriate."

FDA whistleblower Doctor David Graham estimates that at least 38,000
people died from taking Vioxx. Drummond Rennie, deputy editor of the
Journal of the American Medical Association, notes that "each one of
those is somebody, is a real person, with a real family, real people
who grieve for them."

"I think it's the job of a physician, physicians who're doing research,
physicians who work in drug companies -- all physicians -- to care
about that," Rennie said.

Merck says its physicians strongly believed in the safety and benefits
of Vioxx. The company says the risks of Vioxx weren't clear until just
last fall, when, it says, Merck acted promptly and voluntarily withdrew
Vioxx.

mlowry3@bellsouth.net

2005-06-09, 10:46 pm

Roman Bystrianyk wrote:
> http://www.healthsentinel.com/news....ist_item&id=913
>
> Snigdha Prakash, "Documents Suggest Merck Tried to Censor Vioxx
> Critics", NPR, June 9, 2005,
> Link: http://www.npr.org/templates/story/...storyId=4696609

<snip>

I listened to this report on NPR today.

If true, these executives at Merck should be taken out and shot. Well,
maybe not that blunt, but they should (if the allegations are true)
face the most severe criminal penalties allowed -- prison, forfieture
of money, etc.

I don't argue that "Big Pharma" exists...but when they get caught doing
things like those suggested in this story, and if these allegations are
proven true...these guys oughta fry.

Mark, MD

P.S. Good Science Rules!!! (And that goes for you, too, Hulda!)

cathyb

2005-06-09, 10:46 pm

mlowry3@bellsouth.net wrote:
> Roman Bystrianyk wrote:
>
> <snip>
>
> I listened to this report on NPR today.
>
> If true, these executives at Merck should be taken out and shot. Well,
> maybe not that blunt, but they should (if the allegations are true)
> face the most severe criminal penalties allowed -- prison, forfieture
> of money, etc.
>
> I don't argue that "Big Pharma" exists...but when they get caught doing
> things like those suggested in this story, and if these allegations are
> proven true...these guys oughta fry.
>
> Mark, MD
>
> P.S. Good Science Rules!!! (And that goes for you, too, Hulda!)

I remember being mildly chuffed that one of the big firms had
voluntarily withdrawn a possibly dangerous drug.

>From the BBC website:

"Merck's chairman Raymond Gilmartin said: "Although we believe it would
have been possible to continue to market Vioxx with labelling that
would incorporate these new data, given the availability of alternative
therapies, and the questions raised by the data, we concluded that a
voluntary withdrawal is the responsible course to take."

If these new allegations are true, and prima facie, the evidence as
reported in the media looks fairly convincing, let's wait for the
trial. Hopefully they'll throw away the key.

Please note, however, that the scandal was exposed by doctors and
professionals who are themselves, part of mainstream medecine. Just not
soon enough.

Cathy

zee

2005-06-10, 8:46 am

zee

2005-06-10, 8:46 am

cathyb wrote:
> mlowry3@bellsouth.net wrote:
>
> I remember being mildly chuffed that one of the big firms had
> voluntarily withdrawn a possibly dangerous drug.
>
>
> "Merck's chairman Raymond Gilmartin said: "Although we believe it would
> have been possible to continue to market Vioxx with labelling that
> would incorporate these new data, given the availability of alternative
> therapies, and the questions raised by the data, we concluded that a
> voluntary withdrawal is the responsible course to take."
>
>
> If these new allegations are true, and prima facie, the evidence as
> reported in the media looks fairly convincing, let's wait for the
> trial. Hopefully they'll throw away the key.
>
> Please note, however, that the scandal was exposed by doctors and
> professionals who are themselves, part of mainstream medecine. Just not
> soon enough.
>
> Cathy

Well, Graham, yes. But Graham alone. He was threatened and censured by
his superiors. Graham went to the media.

Zee

cathyb

2005-06-10, 8:46 am

zee wrote:
> cathyb wrote:
>
>
> Well, Graham, yes. But Graham alone. He was threatened and censured by
> his superiors. Graham went to the media.
>
>
> Zee

That's true, but it seems to me that Singh was also doing his best--he
was actually criticising a drug publicly that was made by a company
from which he earned substantial amounts of money.

Cathy

Sharon Hope

2005-06-11, 5:46 pm

Did you notice that Merck was trying to compete with a like Pfizer drug that
hit the market just ahead of them? Is this a problem with that class of
drugs? If so, why leave Pfizer out of the mix of dirty tricks? At least
Merck pulled the drug from the market.

Yes, 38,000 people's lives were lost first, and yes, they had engaged in
unethical practices, but what about Pfizer going on marketing their version?

But, then again, when Bayer pulled Baycol voluntarily after all those rhabdo
deaths, Pfizer kept on marketing Lipitor, which also had a sizeable number
of rhabdo deaths.

"cathyb" <cathybeesley@optusnet.com.au> wrote in message
news:1118374759.570467.128170@f14g2000cwb.googlegroups.com...
>
>
> mlowry3@bellsouth.net wrote:
>
> I remember being mildly chuffed that one of the big firms had
> voluntarily withdrawn a possibly dangerous drug.
>
>
> "Merck's chairman Raymond Gilmartin said: "Although we believe it would
> have been possible to continue to market Vioxx with labelling that
> would incorporate these new data, given the availability of alternative
> therapies, and the questions raised by the data, we concluded that a
> voluntary withdrawal is the responsible course to take."
>
>
> If these new allegations are true, and prima facie, the evidence as
> reported in the media looks fairly convincing, let's wait for the
> trial. Hopefully they'll throw away the key.
>
> Please note, however, that the scandal was exposed by doctors and
> professionals who are themselves, part of mainstream medecine. Just not
> soon enough.
>
> Cathy
>