Healthy Skepticism Library item: 17403

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Publication type: news

Fauber J
As universities tighten ethics policies, drug firms turn to private physicians to promote products
The Journal Sentinel 2010 Mar 14
http://www.jsonline.com/features/health/87601272.html

Full text:

This article is part of an ongoing series about how money and conflicts of interest affect medicine and patient care.

When looking for a doctor to travel the country and tout its costly prescription fish oil pill, GlaxoSmithKline didn’t select a heavyweight university researcher.

Instead, it wrote checks to Tara Dall, a Delafield primary-care doctor who entered private practice in 2001.

For just three months of speaking engagements last year, GlaxoSmithKline paid Dall $45,000, ranking her among the most highly paid of more than 3,600 doctors nationwide who spoke for the company, which released records for only one quarter of the year.

The practice of doing promotional speaking for drug companies has come under fire in recent years.

Critics say the talks can be biased and contribute to spiraling health care costs by promoting the use of expensive brand-name drugs over generics. The practice, according to critics, also leads to more non-approved and potentially harmful use of those drugs, so-called off-label prescribing.

For years, drug companies sought out influential university doctors with impressive credentials to bring their message to other doctors and persuade them to write prescriptions for their products.

But companies have been forced to back away from that approach as a growing number of medical schools, including the University of Wisconsin-Madison, have developed conflict-of-interest policies that ban such talks.

So much money is at stake that in January one academic doctor resigned his job at Harvard rather than give up his speaking income.

The problem: While medical schools can restrict biased speaking and require doctors to fully inform patients of their ties to drug companies, there are no such restrictions or requirements on private doctors.

“There are no skids on them,” said Jerome Kassirer, former editor of the New England Journal of Medicine and a critic of the practice. “There is no way to control their participation.”

Dall hedged when asked in an interview if she fully disclosed her financial relationship with GlaxoSmithKline to all the patients for whom she prescribes the company’s high-priced fish oil product, known as Lovaza.

“I think I would (disclose) if I was going to do anything off-label,” she said. “Whether I tell every single patient, I’m not sure.”

The next day she called back and made a short statement, but hung up without answering questions.

“It is absolutely disclosed to patients that I am a speaker and that I speak for pharmaceutical companies, and it is listed on my Web site,” she said.

Little revealed

Last year, the Journal Sentinel series “Side Effects” found that there was little disclosure to patients of drug-company moonlighting among dozens of doctors at the UW School of Medicine and Public Health.

That led to a ban on promotional drug speaking, although UW doctors still can make large sums of money from device companies or serving as consultants. And signs were posted at the UW medical facilities informing patients their doctor may have a financial relationship with a drug or medical device company and telling them the details will be provided if requested.

According to her résumé, Dall does talks for five other drug and medical companies in addition to GlaxoSmithKline as well as community talks, including an unpaid speech on heart disease she gave to General Electric Co. employees in Wisconsin last August.

There, she made an eyebrow-raising statement about heart disease.

“As soon as we identify what puts you at risk, we can absolutely fix it,” Dall assured them in the talk, a video of which is posted on her Web site. “We can totally prevent cardiovascular disease from happening. We can completely trump genetics.”

That’s wrong, according to Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, and Raymond Gibbons, a professor of medicine at the Mayo Clinic in Minnesota.

At best, cholesterol-controlling statin drugs reduce heart attacks and strokes by about one-third, Nissen said.

“We cannot trump genetics,” Nissen said. “If she was right, we could wipe this disease out just by giving drugs to people. Even if we put statins in the water supply, cardiovascular disease would still be the leading cause of death.”

Even with optimal drug therapy as well as proper diet, exercise and weight, one-third of cardiovascular disease still would occur, added Gibbons. “We would like for there to be something to prevent cardiovascular disease from happening,” he said. “There is not.”

Dall did not respond to several requests to explain the comment.

Additionally, during the same speech, Dall referred to the advanced lipid test of another company that pays her to speak, but she did not disclose that financial relationship to those in attendance, said GE spokesman John Wheeler.

Paid the most

At $45,000, Dall received the most from GlaxoSmithKline among Wisconsin doctors during the three-month period for which records were released. That ranks her in the top 30 of about 3,600 doctors from around the country who were paid as speakers by GlaxoSmithKline.

She was paid up to $3,000 a talk and spoke 15 times in the three-month period, the company said. In the last year, Dall said, she has given at least 60 lectures, and probably more, about Lovaza.

U.S. Sen. Herb Kohl (D-Wis.) has co-introduced legislation requiring companies to release payments to doctors to highlight conflicts of interest for the public. With the bill pending, GlaxoSmithKline and at least three other companies have begun listing payments to doctors. These lists, which look only at 2009, provide the first glimpse at the extent of the massive marketing of drugs and financial ties between doctors and drug companies.

About 45 doctors from Wisconsin got payments from GlaxoSmithKline of at least $1,000 during the quarter for which the company released records. All but 10 of them were private-practice physicians.

Nationally, only eight doctors among the top 25 paid speakers had full-time university positions.

At least three other firms – Merck, Eli Lilly and Cephalon – also have listed payments to doctors for parts or all of 2009 activity.

Together, the lists show that more than 10,000 doctors and other health care professionals from around the country, including more than 125 from Wisconsin, were moonlighting for the four companies at some point in 2009, according to an analysis by the Journal Sentinel.

Near the top of Lilly’s list of Wisconsin doctors was Rod Halvorsen, a private practice obstetrician/gynecologist in Manitowoc who got $61,000 during the first nine months of 2009.

Halvorsen said he gives talks involving Lilly’s osteoporosis drugs, Evista and Forteo, as well as about osteoporosis in general.

He said he has a passion for the topic because his mother died as the result of osteoporosis.

“I don’t do this for the money,” he said.

When he prescribes Lilly-manufactured drugs for his patients, Halvorsen said, he does not tell all his patients he is a paid speaker and consultant for the firm.

Lilly’s disclosure of doctor payments is part of a 2009 settlement of a U.S. Department of Justice investigation of its marketing of its anti-psychotic drug, Zyprexa, which was being promoted for elderly dementia patients when it was approved only for schizophrenia and bipolar disorder.

“Obviously we are required to do it, but Lilly believes it is important to be transparent,” said Lilly spokeswoman Carole Puls.

The company also agreed to pay $1.4 billion to settle criminal and civil investigations.

Like Lilly, Cephalon’s agreement to list doctor payments stemmed from a federal government investigation of illegal, off-label marketing of drugs, including the use of medical professionals who spoke to other doctors. The company also had to pay $425 million to settle criminal and civil cases.

Unlike Lilly’s osteoporosis drugs, which are available only by prescription, doctors say there are plenty of over-the-counter supplements that are just as good as GlaxoSmithKline’s prescription fish oil, Lovaza.

Lovaza sales jumped from $140 million in 2006 to $679 million in 2009 (through November), according to data supplied by IMS Health, a drug market research firm.

William Davis, a Milwaukee cardiologist, said Lovaza is not worth the money.

Davis said at least six over-the-counter products have as much or more of the omega-3 fats EPA and DHA as Lovaza. All of them can be purchased for a fraction of the price, he said.

Lovaza, which has not been shown to reduce heart attacks or strokes, costs about $2,400 a year at Walgreens in its FDA-approved dose of 4 grams a day. Similar nonprescription products can be purchased for about $200 to $300.

But basic health care math is pushing some consumers to opt for Lovaza over the much cheaper nonprescription fish oil, Davis said.

That’s because, while insurance doesn’t cover the cost of supplements, it may cover all or the vast majority of a prescription, meaning Lovaza actually costs patients less out of pocket.

“Sadly, that’s the logic,” Davis said. “People are saying, ‘Screw it, I’ll just have my insurance pay for it.’ It’s a house of cards.”

GlaxoSmithKline touts Lovaza as being free of mercury and other contaminants. But so are most over-the-counter fish oil products, according to an analysis by ConsumerLab.com.

“They are clean, and they deliver what they say they are going to deliver,” added Penny Kris-Etherton, a professor of nutrition at Pennsylvania State University.

Lovaza was approved to treat people with very high triglycerides. However, that’s a tiny portion of the population, 1.7% of Americans.

And GlaxoSmithKline acknowledged a lack of studies showing that treating high triglycerides reduces heart attacks and strokes.

GlaxoSmithKline said it does not seek private doctors over other health care professionals. But the company acknowledges its speaker program has been affected by new conflict-of-interest restrictions put in place by universities.

The company looks for respected, qualified experts who are good presenters, said spokeswoman Mary Anne Rhyne.

“Sharing information on complex disease states is important to advancing patient care, and health care professionals often learn best from their peers and colleagues,” she said in an e-mail.

Trend reversed

Years ago, drug companies often enlisted private doctors for speaking, but in recent years influential university doctors became the preferred promotional speakers, said Kassirer, the former New England Journal of Medicine editor.

“Now it looks like it’s going back,” Kassirer said.

There has been a clear trend to ban or restrict the practice at leading academic centers, including UW, Harvard, Stanford, Duke and the University of Pittsburgh, said Ann Bonham, chief scientific officer at the Association of American Medical Colleges.

Within five years, she predicted, most medical schools will take such action.

In 2008, the association issued a report strongly discouraging academic doctors from doing drug company speaking.

In January, the issue took an unusual twist when Boston doctor Lawrence DuBuske resigned his Harvard position rather than give up his speaking. DuBuske got $99,000 from GlaxoSmithKline in three months last year, more than any other doctor in the country.

In the past, drug companies had threatened to use more private doctors if medical schools restricted speaking, said Susan Chimonas, co-director of the Center on Medicine as a Profession at Columbia University.

Nissen, of the Cleveland Clinic, said he believes fewer university doctors are doing drug company speaking because he has been getting more and more fliers for dinner talks in which the speakers are private physicians.

Either way, such speaking is a problem because doctors are being used to boost sales, Nissen and Chimonas said.

Doctors can get dropped as speakers if they don’t properly promote a company’s drugs, Chimonas said.

Still, for a variety of reasons, large numbers of doctors continue to do the talks.

“I think it is money,” Chimonas said. “I think it is ego. Some of them think they are doing a good thing. They clearly are being used.”

More on Dall

Rhyne, GlaxoSmithKline’s U.S. director of media relations, described Dall as highly respected with significant experience in her field of clinical lipidology, which involves treating lipid abnormalities such as unhealthy cholesterol, triglycerides and related problems.

She said Dall brings a unique perspective as the medical director of one of the few lipid clinics in the country.

Dall sees patients at her office in Delafield, although in a brief interview she said she travels around the country and gives speeches two to three days a week.

While many doctors boast of articles in medical journals, Dall’s site notes she was featured in an ad in the Journal of Clinical Lipidology.

When it comes to published studies in peer-reviewed medical journals, there was little to be found for Dall.

She is listed as the lead author in a positive 2009 review article involving Lovaza. However, manuscript preparation for that study was supported by GlaxoSmithKline. And editorial assistance for the article, which was published in the peer-reviewed Southern Medical Journal, was provided by DesignWrite of Princeton, N.J.

DesignWrite is a medical communication company that previously had been linked to ghostwriting medical articles.

GlaxoSmithKline spokeswoman Rhyne said the article was initiated in 2007 when Lovaza was marketed as Omacor by Reliant Pharmaceuticals, which was bought by GlaxoSmithKline in December 2007. Rhyne said the article was reviewed only for accuracy.

Though GlaxoSmithKline and DesignWrite were involved, Dall said, she and her co-author put hundreds of hours of work into the article.