Doctors defend ties to drugs they endorse

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Conflicted medicine - Doctors defend ties to drugs they endorse

Sunday, October 24, 2004

By Marilynn Marchione

Associated Press

 

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They led influential medical groups, starred at prestigious meetings,

published in top journals and were undisputed giants in their field.

 

But when these famous doctors advised the government recently on new

cholesterol guidelines for the public, something else they had in common

wasn't revealed.

 

Eight of the nine were making money from the very companies whose

cholesterol-lowering drugs they were urging upon millions more

Americans. Two own stock in them. Two others went to work for drug

companies shortly after working on the guidelines. Another was a senior

government scientist who moonlights for 10 companies and even serves on

one of their boards.

 

Consumer groups and others now are questioning not only the advice these

doctors gave but also their fundamental ability to act in the public's

best interest.

 

The questions come as some of these companies lobby the government to

let drugs at the center of the cholesterol controversy -- statins such

as Lipitor, made by Pfizer, and Zocor, made by Merck -- be sold over the

counter. Prominent doctors with ties to statin makers are urging approval.

 

There's little doubt that statins save lives or that too few people take

them. But critics say the doctors' coziness with drug companies

compromises their credibility and undercuts their latest advice.

 

Conflict on the rise

 

Conflicts of interest are increasingly common now that two-thirds of

medical research at universities is funded by private industry. Twenty

years ago, only one-third was.

 

" The government is not producing drugs. All the big statin trials have

been paid for by the companies, " said Dr. Scott Grundy, a University of

Texas Southwestern Medical Center cardiologist who headed the

cholesterol panel.

 

Government has its own problems. A ban on private consulting was lifted

a decade ago, and recent years have seen one scandal after another

involving federal scientists taking money from companies directly

affected by their decisions.

 

Conflicts also have bedeviled trusted groups like the American Heart

Association, which rely on private cash for meetings and activities, and

the continuing-medical-education system, which often gives doctors

credits for attending drug-company-sponsored talks.

 

The drug industry spent $2 billion in 2001 on events for doctors --

double what it spent five years earlier, Dr. Jerome Kassirer, former

editor-in-chief of the New England Journal of Medicine, reports in his

new book, " On the Take. "

 

" The time has come to ask whether all of the money floating around

medicine has created a pattern of corruption, " he writes.

 

Experts have industry ties

 

Some say it's naive to think a panel of true experts with no industry

ties could be assembled today.

 

Christopher Seymour, executive director of the National Lipid

Association, a group that promotes cholesterol control and is largely

funded by drug companies, has six of the nine guideline doctors on his

board.

 

" Who in America is going to write these guidelines if you don't go to

the thought leaders? Should I call Dr. X in the middle of Peoria? What

gives them credentials to be on my board? " he asked.

 

But at the University of Illinois in Peoria, they think quite a lot of

Dr. Frank Gold, who in 30 years as a cardiologist has taken no

consulting or lecture fees from industry.

 

" I'm squeaky-clean, " he says, and " would jump at the opportunity " to

serve on a guidelines panel. " There are tons of people like me, and

they're even in places like Des Moines, Iowa. "

 

The statin flap involves drugs with so much science behind them and

proven benefits that doctors only partly joke about putting them in the

water supply.

 

More than half of American adults have high cholesterol, raising their

risk of heart attack. Doctors tell them to eat right and exercise, but

that usually produces only modest improvement. Statins drop cholesterol

dramatically and almost overnight.

 

New panel questioned

 

The government's National Cholesterol Education Program periodically

asks experts to help set cholesterol guidelines, and rules issued in

2001 advocate using statins to curb cholesterol problems.

 

New studies prompted a new panel to be convened to revise the

guidelines. Seven of its nine members had been on the previous panel.

The newcomers -- Dr. Sidney C. Smith, of the University of North

Carolina in Chapel Hill, and Dr. C. Noel Bairey Merz, of Cedars-Sinai

Medical Center in Los Angeles -- represented the American Heart

Association and the American College of Cardiology, respectively.

 

Those groups in July endorsed and published the new guidelines. A day

later, the Center for Science in the Public Interest said the advice was

tainted by panelists' industry ties, which weren't disclosed. They

ranged from long-ago research grants to stock ownership and deals

providing thousands of dollars in income from statin makers.

 

The most complicated situation is that of Dr. H. Bryan Brewer, chief of

the molecular-disease branch of the National Heart, Lung and Blood

Institute, which houses the federal cholesterol program.

 

He is on the scientific-advisory board of Lipid Sciences Inc., a private

biotechnology firm developing cholesterol treatments, and Seymour's

National Lipid Association. He also is a consultant or speaker for 10

companies and even attended a meeting in July 2003 of a federal Food and

Drug Administration advisory committee debating whether to recommend

approval of Crestor, a statin made by one of them -- AstraZeneca.

 

The meeting was on a Thursday, and it couldn't be determined whether

Brewer was there on government time. He refused requests for an

interview. In a memo to National Institutes of Health director Dr. Elias

Zerhouni, Brewer wrote that he was " only an observer and did not

participate " in the meeting, which led to the drug's approval a month later.

 

Doctors defend ties

 

Some guideline panel members talk candidly about their industry ties.

Grundy said he makes less than $10,000 a year in speaker fees and

refuses to promote any particular drug in a talk.

 

Dr. Neil J. Stone, of Northwestern University Medical School in Chicago,

said he takes speaker fees when a talk forces him to miss work and then

often donates them to universities.

 

Smith said he owns about $10,000 worth of stock in Johnson & Johnson,

which has partnered with Merck & Co. to sell a statin over the counter

in England.

 

" I didn't even know I had it till I called the fellow that handles the

accounts, " Smith said. " Nobody volunteers time for one of these

committees because they think a small amount of stock they may have in a

retirement plan is going to benefit. "

 

Bairey Merz listed stock in Johnson & Johnson plus consulting, lecture

or research money from nine firms, including several statin-makers. She

declined to be interviewed but said in a brief statement that she had

not breached any ethics rules.

 

Efforts to interview three other panel members -- Dr. Luther T. Clark of

State University of New York Downstate Medical Center in Brooklyn, Dr.

Donald B. Hunninghake of the University of Minnesota in Minneapolis, and

Dr. Richard C. Pasternak of Massachusetts General and Harvard Medical

School in Boston -- were unsuccessful. Multiple requests to interview

Clark and Pasternak were not answered by spokesmen; Hunninghake could

not be located through the university.

 

Hunninghake quit before the guidelines were released to become a

full-time industry consultant, according to the cholesterol program.

Pasternak joined Merck soon after the guidelines came out.

 

Financial conflicts aren't the only danger. " Group think " can set in

when a panel doesn't include people who can look at the science with

different views than cardiologists do.

 

" These folks made their careers on being aggressive on treating risk

factors, " but internal-medicine doctors might feel differently, said Dr.

Harlan Krumholz, who runs a center for medical outcomes research at Yale

University.

 

Statin pioneers

 

Indeed, many doctors making the case for statins helped establish their

effectiveness.

 

" Most of us did all the original trials of the statins, " said Stone, who

was motivated by family members dying of heart disease, including his

father in 1985.

 

" He never got a chance to get a statin, " Stone said. " I'm actually

stunned that people who know the evidence don't see the enormous value

of this class of drugs. "

 

The only panel member with no financial conflicts -- the federal

program's coordinator, Dr. James Cleeman -- is upset by attacks on the

guidelines, such as the letter signed by 35 scientists and doctors

asking NIH to launch an independent review.

 

" They are science-based, " Cleeman said. " The public should have

confidence in them. I'm an unconflicted person, and I read the science

the same way. "

 

 

 

© 2004 Kalamazoo. Used with permission