Susan
2009-01-22 22:16:34 UTC
x-no-archive: yes
Side Effects Are Doctors' Loyalties Divided? Critics Say Doctors'
Speeches Raise Costs, Influence Care Events Amount to Marketing for Drug
Companies, They Say Second of Two Parts
The Milwaukee Journal Sentinel
01-21-09
Madison -- Amid the evening din of customers ordering martinis and
carving up steaks, a few doctors seated themselves at a table in the
private dining room at Johnny Delmonico's restaurant.
Wine, steak and a white tablecloth helped set the atmosphere for the
guest speaker, Melissa Meredith, a physician and associate professor at
the University of Wisconsin-Madison School of Medicine and Public Health.
Moonlighting for the drug company Amylin, Meredith was there to give a
promotional talk about the diabetes drug Byetta.
Meredith was one of more than 40 UW physicians in 2007 who were paid to
work as speakers or authors by drug or medical device companies, records
show.
The doctors earned annual fees ranging from less than $5,000 to
undisclosed amounts exceeding $20,000, according to records. Even if
doctors earned hundreds of thousands on the side, they would have to
disclose only that they received "more than $20,000."
In most cases, they worked for at least two companies, and sometimes
three or four. Several doctors described their work as promotional. It
was not uncommon for them to earn at least $2,000 or $2,500 a day, and
possibly much more.
It's a practice that increasingly is drawing criticism because of
concerns that it can influence patient care and raise the cost of
treatment, in addition to blurring the line between research and marketing.
The deans of the state's two medical schools say they would like to ban
the practice or severely limit it.
"I am very bothered by our faculty using our school's name in giving
non-academic promotional, marketing talks," said Robert Golden, dean of
the UW medical school. "It's a major issue we are talking about now."
In October, the Wisconsin Medical Society, as part of its
recommendations for ethical behavior, said doctors should not serve as
speakers. The group has no authority to regulate or stop the practice.
Drug companies have another tool to promote their products: the use of
private firms that act as conduits between pharmaceutical companies and
university doctors. On numerous occasions, those firms have hired UW
doctors to give talks, and the university acknowledges that it does not
know how much they are paid or whether their talks are promotional or
educational.
These for-profit firms receive money from drug companies, which then can
be used to pay doctors to give talks at conferences and educational
events. While the doctors must disclose receiving money from the
intermediary company, they do not have to disclose that the money
ultimately might have come from a drug company.
Steve Nissen, a cardiologist with the Cleveland Clinic who no longer
accepts drug company money, said he is especially worried about
university physicians being hired as drug company speakers because of
their ability to influence others.
"We're teachers," he said. "It's critically important for academics to
be independent."
Company-sponsored lecturing by doctors who work for public universities
also raises questions about whether taxpayers are being well-served,
said Lisa Bero, a professor in the Department of Clinical Pharmacy at
the University of California, San Francisco.
"I (as a taxpayer) am paying them to teach students and see patients,"
Bero said. "I'm not paying them to be a jet-setter on behalf of a
multibillion-dollar drug company."
Pharmaceutical companies say university doctors can help educate other
doctors about the proper use of drugs.
But drug companies also seek out academic physicians because of their
influence. The companies refer to them as key opinion leaders or luminaries.
More prescriptions
Academic physicians can be especially influential on the prescribing
habits of other doctors when drug companies hire them to give lectures
or to write articles, critics say.
"If they can get one of them to favor their product, it will influence
others," Nissen said. "Why would they spend the money if it wasn't
effective?"
Often it works like this: A drug company pays a university doctor to
give a talk at a local restaurant, clinic or other location to a group
of private doctors who are invited by a drug company representative. The
doctors may get a nice free dinner. The speaker might get $2,500. The
drug company, if it is lucky, will get more doctors writing
prescriptions for its drugs.
"They love steakhouses," Nissen said. "I don't believe a talk put on at
a steakhouse with a biased speaker is the best way to educate colleagues."
Meredith wouldn't say exactly how much she was paid, but it was in the
range of $500 to $2,000, she said.
"In this part of Wisconsin, I am the diabetes doctor," she said.
The talk was one of the 20 or so she says she has given for drug
companies in each of the last two years.
"It's promotional," she said. "We all know why we are there and what we
are going to hear. You are going to hear about that drug."
Amylin declined to allow a Journal Sentinel reporter to attend the
meeting, so the reporter visited the restaurant unannounced and watched
the meeting from an adjacent room.
It was a low-key affair -- a handful of people sat at the table with
Meredith and the drug representative. Meredith said she talked to the
guests about when to use the drug and how to use it correctly. The group
drank wine and spent several hours at the restaurant.
Why would a drug company want to shell out thousands of dollars just to
get a few doctors to listen to a pitch about one of its drugs?
The answer may be in the math: Byetta, a daily injectable drug, costs
each patient about $250 a month, or $3,000 a year.
If just one doctor is swayed to begin prescribing the drug to one
patient, it could cover the cost of the talk. If five doctors show up at
a talk and begin prescribing the drug to five of their patients, it
could mean $75,000 in additional annual sales.
In an interview, Meredith acknowledged that she used slides approved by
the Food and Drug Administration, which were provided by the drug company.
"We're just talking heads," she said.
She said she does the talks to supplement her UW pay, which was $135,000
in 2007.
Unreported speeches
Meredith admitted that she did at least 40 such talks in the last two
years. But she didn't report a single speech to the university in her
conflict-of-interest statements.
She said she did not think work done for drug company speakers bureaus
had to be reported.
Golden, dean of the UW medical school, said an investigation into
Meredith's consulting work now is being conducted. He said he could not
comment beyond that because it was a personnel matter.
However, he said the policy is clear: Faculty members have to report all
outside income from organizations in their field, including any income
such as giving talks for drug companies.
"I like to think that people here pay attention to regulations," he
said. "I have no reason to believe there is any dishonesty among our
faculty."
In a statement, Amylin officials said doctors who prescribe the
company's medicines should be able to hear from and be trained by other
doctors who know the benefits and risks.
The company said it submits its presentation materials to the FDA before
they are used by speakers, and Amylin monitors its speaker programs to
make sure they comply with FDA regulations.
In August, the FDA said it had received six reports of life- threatening
inflammation of the pancreas in Byetta users. Two of the patients died,
and the other four were recovering after being hospitalized. The cases
involved either bleeding or tissue death in the pancreas.
That follows an FDA alert in October 2007 involving 30 reports of acute
inflammation of the pancreas in Byetta users.
Anne Erickson, an Amylin spokeswoman, said: "It has not been established
that Byetta causes pancreatitis; however, we cannot rule out that
possibility."
She said the company is monitoring the situation and working to "fully
understand this very rare occurrence."
Opposition from doctors
Physicians increasingly are speaking out against the practice of drug
companies hiring academic physicians to give dinner talks.
Many of the speaking fees are nothing more than de facto gifts, paid to
reward doctors for writing lots of prescriptions, said Brian Hurley, a
recent medical school graduate and president of the American Medical
Student Association.
"When you have them accepting money for speaking on these drugs,
essentially doing marketing, in our view, that's incompatible with their
role as a teacher," Hurley said. "They are paid for their reputation.
When people take their academic education and essentially sell it to
industry, their academic credibility goes out the window."
The same doctors who give drug company-paid talks also are teaching
impressionable medical students, said Arnold Relman, former editor of
the New England Journal of Medicine and a doctor since 1946.
"I think it is unethical, and it should be banned," he said.
In interviews and disclosure filings, UW doctors said their talks can
range from promotional to talking about a disease. In a few cases, they
say, they did not mention the name of a drug made by the company that
was paying them.
Golden said it is hard to distinguish marketing and education,
especially when the talks are done at restaurants and are not accredited
as official continuing medical education.
Golden said the medical school is in the process of bolstering its
conflict-of-interest policy; that might mean a ban on such talks, but
that might not be feasible because of faculty governance and free-speech
issues.
"I have no doubt it is going on," he said. "There is a reasonable chance
we may end up banning them."
Golden said that if he can't ban such talks, he would like to change the
school's conflict-of-interest policy so faculty cannot mention their UW
affiliation or use the university's name or logo when giving the talks.
"It would be a huge change," he said.
Any change likely would take effect beginning July 1, he said.
Golden's counterpart at the state's other medical school, the Medical
College of Wisconsin in Wauwatosa, said he is planning this year to ban
dinner talks and speeches by its doctors that are not part of an
accredited continuing medical education event.
Jonathan Ravdin, dean of the Medical College, said he also plans to
prohibit the use of drug company-provided slides and scripts.
"This is not benign activity," Ravdin said. "A lot of these industry
relationships are marketing."
Ravdin declined to allow the Journal Sentinel to examine disclosure
documents filed by Medical College doctors, including money they were
paid to give talks for drug companies.
In recent years, the nature of the talks has changed, said UW
cardiologist Patrick McBride.
Training sessions
Drug companies started pushing doctors paid to give talks to attend
speaker training sessions. The companies also began requiring them to
use company-provided slides and scripts, he said.
In 2005 and 2006, McBride gave talks to other doctors that were paid
for, respectively, by Merck and Schering-Plough. The two companies
jointly market the cholesterol drug Vytorin.
McBride, now associate dean for students, said his talks were about
cholesterol, not about a specific drug. And the talks never were
promotional, he said.
He said the talks focused on meeting more stringent goals for lowering
LDL cholesterol, though Merck and Schering-Plough knew that to meet
those goals, their product might have to be used.
"They felt they had a good product, and if I talked about cholesterol,
it (Vytorin) would have to come up," he said.
In 2006, it was revealed that Merck had withheld crucial data about its
painkiller Vioxx, which was taken off the market in 2004 because it
increased the risk of heart attacks, strokes and death.
In December 2007, the House Committee on Energy and Commerce launched an
investigation looking into whether there was a delay in revealing the
results of a clinical trial of Vytorin until nearly a year and a half
after the trial ended. The trial showed that the heavily promoted
blockbuster drug did not reduce the buildup of plaque in arteries.
"I really felt like . . . they were acting unethically regarding the
reporting of data," McBride said. "I just felt like I didn't want to
work with them anymore."
On the disclosure form McBride filed with the university in April, he
reported doing no speaking work for drug companies, though he did
perform one day as a consultant for each of the two companies.
Firms act as conduits
The full extent of drug company money paid to university doctors for
speaking is obscured by the frequent use of for-profit entities known as
medical education and communication companies. They are funded by drug
companies and used to pay doctors to give speeches, usually as part of
continuing medical education programs.
At least a dozen UW doctors were paid to do consulting work by more than
20 such firms.
UW medical school officials acknowledged that they have no idea where
the money paid by the firms to UW doctors comes from.
And because of the potential for drug companies to use the go- between
firms to get favorable talks about their drugs, UW is considering
stricter rules regarding such talks, Golden said.
The university needs to be able to separate the legitimate talks from
"the slipperier ones that are just acting as a conduit for laundering
support from drug companies," he said.
The growing use of the companies has come under fire by those who say
they can be fronts for drug companies, allowing them to reward doctors
who give favorable speeches, but without any direct connection between
the drug company and the doctor.
One concern is that accredited medical programs are being used by drug
companies to market expensive, brand-name drugs, exposing patients to
greater risks than they would face with older drugs with more
established safety and efficacy. At the same time, those programs might
be used to skirt laws that prohibit drug company promotion of off-label
uses.
James Stein, a UW cardiologist, said the firms have become a cottage
industry over the last several years. While talks put on by the
companies often can be educational, oversight can be "pretty lax."
"It is not complete money laundering, but they are partial fronts," he
said. "I would say that more than half are bad. They are solely driven
by commercial interests. They are promotion-driven."
JSOnline.com
To read the first installment of this series, go to www.jsonline.com.
Copyright 2009, Journal Sentinel Inc. All rights reserved. (Note: This
notice does not apply to those news items already copyrighted and
received through wire services or other media.) The following fields
overflowed: BYLINE = {Second of two parts } {By JOHN FAUBER
***@journalsentinel.com }
Side Effects Are Doctors' Loyalties Divided? Critics Say Doctors'
Speeches Raise Costs, Influence Care Events Amount to Marketing for Drug
Companies, They Say Second of Two Parts
The Milwaukee Journal Sentinel
01-21-09
Madison -- Amid the evening din of customers ordering martinis and
carving up steaks, a few doctors seated themselves at a table in the
private dining room at Johnny Delmonico's restaurant.
Wine, steak and a white tablecloth helped set the atmosphere for the
guest speaker, Melissa Meredith, a physician and associate professor at
the University of Wisconsin-Madison School of Medicine and Public Health.
Moonlighting for the drug company Amylin, Meredith was there to give a
promotional talk about the diabetes drug Byetta.
Meredith was one of more than 40 UW physicians in 2007 who were paid to
work as speakers or authors by drug or medical device companies, records
show.
The doctors earned annual fees ranging from less than $5,000 to
undisclosed amounts exceeding $20,000, according to records. Even if
doctors earned hundreds of thousands on the side, they would have to
disclose only that they received "more than $20,000."
In most cases, they worked for at least two companies, and sometimes
three or four. Several doctors described their work as promotional. It
was not uncommon for them to earn at least $2,000 or $2,500 a day, and
possibly much more.
It's a practice that increasingly is drawing criticism because of
concerns that it can influence patient care and raise the cost of
treatment, in addition to blurring the line between research and marketing.
The deans of the state's two medical schools say they would like to ban
the practice or severely limit it.
"I am very bothered by our faculty using our school's name in giving
non-academic promotional, marketing talks," said Robert Golden, dean of
the UW medical school. "It's a major issue we are talking about now."
In October, the Wisconsin Medical Society, as part of its
recommendations for ethical behavior, said doctors should not serve as
speakers. The group has no authority to regulate or stop the practice.
Drug companies have another tool to promote their products: the use of
private firms that act as conduits between pharmaceutical companies and
university doctors. On numerous occasions, those firms have hired UW
doctors to give talks, and the university acknowledges that it does not
know how much they are paid or whether their talks are promotional or
educational.
These for-profit firms receive money from drug companies, which then can
be used to pay doctors to give talks at conferences and educational
events. While the doctors must disclose receiving money from the
intermediary company, they do not have to disclose that the money
ultimately might have come from a drug company.
Steve Nissen, a cardiologist with the Cleveland Clinic who no longer
accepts drug company money, said he is especially worried about
university physicians being hired as drug company speakers because of
their ability to influence others.
"We're teachers," he said. "It's critically important for academics to
be independent."
Company-sponsored lecturing by doctors who work for public universities
also raises questions about whether taxpayers are being well-served,
said Lisa Bero, a professor in the Department of Clinical Pharmacy at
the University of California, San Francisco.
"I (as a taxpayer) am paying them to teach students and see patients,"
Bero said. "I'm not paying them to be a jet-setter on behalf of a
multibillion-dollar drug company."
Pharmaceutical companies say university doctors can help educate other
doctors about the proper use of drugs.
But drug companies also seek out academic physicians because of their
influence. The companies refer to them as key opinion leaders or luminaries.
More prescriptions
Academic physicians can be especially influential on the prescribing
habits of other doctors when drug companies hire them to give lectures
or to write articles, critics say.
"If they can get one of them to favor their product, it will influence
others," Nissen said. "Why would they spend the money if it wasn't
effective?"
Often it works like this: A drug company pays a university doctor to
give a talk at a local restaurant, clinic or other location to a group
of private doctors who are invited by a drug company representative. The
doctors may get a nice free dinner. The speaker might get $2,500. The
drug company, if it is lucky, will get more doctors writing
prescriptions for its drugs.
"They love steakhouses," Nissen said. "I don't believe a talk put on at
a steakhouse with a biased speaker is the best way to educate colleagues."
Meredith wouldn't say exactly how much she was paid, but it was in the
range of $500 to $2,000, she said.
"In this part of Wisconsin, I am the diabetes doctor," she said.
The talk was one of the 20 or so she says she has given for drug
companies in each of the last two years.
"It's promotional," she said. "We all know why we are there and what we
are going to hear. You are going to hear about that drug."
Amylin declined to allow a Journal Sentinel reporter to attend the
meeting, so the reporter visited the restaurant unannounced and watched
the meeting from an adjacent room.
It was a low-key affair -- a handful of people sat at the table with
Meredith and the drug representative. Meredith said she talked to the
guests about when to use the drug and how to use it correctly. The group
drank wine and spent several hours at the restaurant.
Why would a drug company want to shell out thousands of dollars just to
get a few doctors to listen to a pitch about one of its drugs?
The answer may be in the math: Byetta, a daily injectable drug, costs
each patient about $250 a month, or $3,000 a year.
If just one doctor is swayed to begin prescribing the drug to one
patient, it could cover the cost of the talk. If five doctors show up at
a talk and begin prescribing the drug to five of their patients, it
could mean $75,000 in additional annual sales.
In an interview, Meredith acknowledged that she used slides approved by
the Food and Drug Administration, which were provided by the drug company.
"We're just talking heads," she said.
She said she does the talks to supplement her UW pay, which was $135,000
in 2007.
Unreported speeches
Meredith admitted that she did at least 40 such talks in the last two
years. But she didn't report a single speech to the university in her
conflict-of-interest statements.
She said she did not think work done for drug company speakers bureaus
had to be reported.
Golden, dean of the UW medical school, said an investigation into
Meredith's consulting work now is being conducted. He said he could not
comment beyond that because it was a personnel matter.
However, he said the policy is clear: Faculty members have to report all
outside income from organizations in their field, including any income
such as giving talks for drug companies.
"I like to think that people here pay attention to regulations," he
said. "I have no reason to believe there is any dishonesty among our
faculty."
In a statement, Amylin officials said doctors who prescribe the
company's medicines should be able to hear from and be trained by other
doctors who know the benefits and risks.
The company said it submits its presentation materials to the FDA before
they are used by speakers, and Amylin monitors its speaker programs to
make sure they comply with FDA regulations.
In August, the FDA said it had received six reports of life- threatening
inflammation of the pancreas in Byetta users. Two of the patients died,
and the other four were recovering after being hospitalized. The cases
involved either bleeding or tissue death in the pancreas.
That follows an FDA alert in October 2007 involving 30 reports of acute
inflammation of the pancreas in Byetta users.
Anne Erickson, an Amylin spokeswoman, said: "It has not been established
that Byetta causes pancreatitis; however, we cannot rule out that
possibility."
She said the company is monitoring the situation and working to "fully
understand this very rare occurrence."
Opposition from doctors
Physicians increasingly are speaking out against the practice of drug
companies hiring academic physicians to give dinner talks.
Many of the speaking fees are nothing more than de facto gifts, paid to
reward doctors for writing lots of prescriptions, said Brian Hurley, a
recent medical school graduate and president of the American Medical
Student Association.
"When you have them accepting money for speaking on these drugs,
essentially doing marketing, in our view, that's incompatible with their
role as a teacher," Hurley said. "They are paid for their reputation.
When people take their academic education and essentially sell it to
industry, their academic credibility goes out the window."
The same doctors who give drug company-paid talks also are teaching
impressionable medical students, said Arnold Relman, former editor of
the New England Journal of Medicine and a doctor since 1946.
"I think it is unethical, and it should be banned," he said.
In interviews and disclosure filings, UW doctors said their talks can
range from promotional to talking about a disease. In a few cases, they
say, they did not mention the name of a drug made by the company that
was paying them.
Golden said it is hard to distinguish marketing and education,
especially when the talks are done at restaurants and are not accredited
as official continuing medical education.
Golden said the medical school is in the process of bolstering its
conflict-of-interest policy; that might mean a ban on such talks, but
that might not be feasible because of faculty governance and free-speech
issues.
"I have no doubt it is going on," he said. "There is a reasonable chance
we may end up banning them."
Golden said that if he can't ban such talks, he would like to change the
school's conflict-of-interest policy so faculty cannot mention their UW
affiliation or use the university's name or logo when giving the talks.
"It would be a huge change," he said.
Any change likely would take effect beginning July 1, he said.
Golden's counterpart at the state's other medical school, the Medical
College of Wisconsin in Wauwatosa, said he is planning this year to ban
dinner talks and speeches by its doctors that are not part of an
accredited continuing medical education event.
Jonathan Ravdin, dean of the Medical College, said he also plans to
prohibit the use of drug company-provided slides and scripts.
"This is not benign activity," Ravdin said. "A lot of these industry
relationships are marketing."
Ravdin declined to allow the Journal Sentinel to examine disclosure
documents filed by Medical College doctors, including money they were
paid to give talks for drug companies.
In recent years, the nature of the talks has changed, said UW
cardiologist Patrick McBride.
Training sessions
Drug companies started pushing doctors paid to give talks to attend
speaker training sessions. The companies also began requiring them to
use company-provided slides and scripts, he said.
In 2005 and 2006, McBride gave talks to other doctors that were paid
for, respectively, by Merck and Schering-Plough. The two companies
jointly market the cholesterol drug Vytorin.
McBride, now associate dean for students, said his talks were about
cholesterol, not about a specific drug. And the talks never were
promotional, he said.
He said the talks focused on meeting more stringent goals for lowering
LDL cholesterol, though Merck and Schering-Plough knew that to meet
those goals, their product might have to be used.
"They felt they had a good product, and if I talked about cholesterol,
it (Vytorin) would have to come up," he said.
In 2006, it was revealed that Merck had withheld crucial data about its
painkiller Vioxx, which was taken off the market in 2004 because it
increased the risk of heart attacks, strokes and death.
In December 2007, the House Committee on Energy and Commerce launched an
investigation looking into whether there was a delay in revealing the
results of a clinical trial of Vytorin until nearly a year and a half
after the trial ended. The trial showed that the heavily promoted
blockbuster drug did not reduce the buildup of plaque in arteries.
"I really felt like . . . they were acting unethically regarding the
reporting of data," McBride said. "I just felt like I didn't want to
work with them anymore."
On the disclosure form McBride filed with the university in April, he
reported doing no speaking work for drug companies, though he did
perform one day as a consultant for each of the two companies.
Firms act as conduits
The full extent of drug company money paid to university doctors for
speaking is obscured by the frequent use of for-profit entities known as
medical education and communication companies. They are funded by drug
companies and used to pay doctors to give speeches, usually as part of
continuing medical education programs.
At least a dozen UW doctors were paid to do consulting work by more than
20 such firms.
UW medical school officials acknowledged that they have no idea where
the money paid by the firms to UW doctors comes from.
And because of the potential for drug companies to use the go- between
firms to get favorable talks about their drugs, UW is considering
stricter rules regarding such talks, Golden said.
The university needs to be able to separate the legitimate talks from
"the slipperier ones that are just acting as a conduit for laundering
support from drug companies," he said.
The growing use of the companies has come under fire by those who say
they can be fronts for drug companies, allowing them to reward doctors
who give favorable speeches, but without any direct connection between
the drug company and the doctor.
One concern is that accredited medical programs are being used by drug
companies to market expensive, brand-name drugs, exposing patients to
greater risks than they would face with older drugs with more
established safety and efficacy. At the same time, those programs might
be used to skirt laws that prohibit drug company promotion of off-label
uses.
James Stein, a UW cardiologist, said the firms have become a cottage
industry over the last several years. While talks put on by the
companies often can be educational, oversight can be "pretty lax."
"It is not complete money laundering, but they are partial fronts," he
said. "I would say that more than half are bad. They are solely driven
by commercial interests. They are promotion-driven."
JSOnline.com
To read the first installment of this series, go to www.jsonline.com.
Copyright 2009, Journal Sentinel Inc. All rights reserved. (Note: This
notice does not apply to those news items already copyrighted and
received through wire services or other media.) The following fields
overflowed: BYLINE = {Second of two parts } {By JOHN FAUBER
***@journalsentinel.com }