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."

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