Healthy Skepticism Library item: 14958

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Publication type: news

Fauber J.
Doctors face pressure to disclose all side pay
Journal Sentinel 2009 Jan 11
http://www.jsonline.com/features/health/37397284.html

Full text:

First of two parts

Barry Fox is in big demand. The UW infectious disease specialist had lucrative side jobs working for seven different drug companies in just one year, including one that paid an undisclosed sum of $20,000 or more, records show.

Fox is one of dozens of University of Wisconsin-Madison physicians who also work for drug companies. Some sit on advisory boards; others do promotional or educational work. Fox, for example, did promotional work involving an antibiotic for one company in 2007, working five days for what appears to be at least $2,000 a day, his disclosure form says.

Doctors’ moonlighting for drug companies – though legal – is coming under increased scrutiny, both at UW and across the country. This month, the trade group Pharmaceutical Research and Manufacturers of America enacted a voluntary ban on company gifts of branded pens, sticky notes and other items and dinners for doctors. Also of special concern are university physicians who are sought by drug companies because of the influence and respect they wield with colleagues practicing in communities.

Most patients have no knowledge of the side work. Even the university is not aware of exactly how much its doctors earn from drug and medical device companies; they are required to disclose only ranges of income received, and no range beyond $20,000.

More than 30 UW physicians exceeded the $20,000 threshold in 2006 and 2007, records show. At least one of those doctors made at least 20 times that amount in previous years – more than $400,000, paid by a maker of orthopedic implants. But that became known in 2006 only because of records filed in a lawsuit.

Last week, for the first time, signs went up in a handful of UW Health clinics alerting patients about doctors’ drug company ties. In addition, the dean of the medical school said the university’s policies need to be shored up. Among other things, the medical school might begin requiring doctors to specify how much they are paid, said Robert Golden, head of the UW School of Medicine and Public Health.

Further, U.S. Sens. Herb Kohl (D-Wis.) and Chuck Grassley (R-Iowa) have introduced a bill that would require drug and medical device companies to disclose payments made to physicians. Kohl said it would be best to ban the practice, noting that the medical industry spends $20 billion a year in payments and gifts to doctors.

“The relationship between the doctor and patient is frayed,” Kohl said.

While Fox would not discuss his drug company work, many doctors who spoke to the Journal Sentinel acknowledged that they did not share information with patients about their drug company deals. Critics of these arrangements say they increase the cost of medicine, potentially compromise patient care and damage the integrity of medical research.

“It’s been going on for a long time, and it’s getting worse and worse,” said Marcia Angell, a former editor of the New England Journal of Medicine and a critic of drug company influence in academic medicine.

The deals also can lead to influential university physicians talking to local doctors about drugs that later are discovered to have dangerous side effects. UW doctors working for drug companies have given talks on an anti-smoking drug that has been linked to suicidal thoughts, blackouts and serious injuries, and an antibiotic that has been linked to tendon ruptures. Another doctor spoke on behalf of a company whose surgery drug later was taken off the market because of heart attacks, strokes and deaths.

Doctors who have financial ties to a drug company are more likely to prescribe that company’s drugs, critics say. And that can mean more use of costly brand-name drugs and less use of cheaper generic drugs.

It also can mean more prescriptions in which a drug is used for purposes for which it was not originally approved. So-called off-label prescribing accounts for 21% of all prescriptions, often without scientific evidence to support it, according to a 2006 study in the Archives of Internal Medicine. A study last year in the Journal of the American Medical Association found that 47% of drug-coated stent procedures were for off-label or untested uses.

While it is illegal for drug companies to promote off-label uses of their drugs, doctors who speak for companies can discuss off-label uses in their presentations.

UW is ranked as having one of the more stringent conflict-of-interest policies among major research institutions. Even so, large amounts of drug company money have seeped into the university.

Golden said consulting with the pharmaceutical industry can accelerate drug development and lead to job creation, but the school’s conflict-of-interest policy needs to change.

Medical schools such as UW’s try to manage conflicts of interest by requiring physicians to disclose financial relationships, but outright bans on the activities are needed, said Angell, now a senior lecturer at Harvard Medical School.

“They can wring their hands and issue some guidelines, but nobody really has to give up any money,” she said.

Medical schools have good reason not to prohibit such activities, she said. It allows them to pay their star faculty less because they can make substantial money working on the side for a drug or medical device company, she said.

But the practice comes with a price.

“We have enormous costs for medical care in America,” said Steve Nissen, a cardiologist with the Cleveland Clinic. “It has raised our health care costs beyond our ability to sustain them.”

Financial relationships also are common between drug companies and doctors at the state’s other medical school and research facility, the Medical College of Wisconsin in Wauwatosa. But unlike UW, the private medical school does not have to disclose any information.

Jonathan Ravdin, dean of the Medical College, would not allow the Journal Sentinel to look at disclosure forms filed by its doctors.

The college said 114 faculty members, most of whom were physicians, had outside financial relationships such as speaker fees and other consulting between July 1, 2007, and June 30, 2008.

The college is in the midst of bolstering its conflict-of-interest policy, including adding a ban on promotional dinner talks that are not part of an accredited continuing education event, Ravdin said.

Work with 7 companies

Reached by phone in March, Fox initially agreed to listen to questions.

“I have nothing to hide,” he said.

When asked what kind of work he did for a drug company, he said, “I’m not very comfortable with this conversation,” and hung up. Several attempts to reach him since have been unsuccessful.

In 2007, Fox, a family medicine and infectious disease doctor, had side jobs as a speaker or author with seven different drug companies, records show.

In his disclosure form, he said he worked 10 days for Wyeth Pharmaceuticals and was paid an undisclosed sum of at least $20,000 for educating other health care providers about the company’s antibiotics.

Fox said he did promotional talks and medical education for AstraZeneca and its antibiotic meropenem, working five days and getting paid $10,000 to $20,000.

The report said he spent five days working for Schering-Plough and was paid between $10,000 and $20,000.

Some of that work involved the drug Avelox. In July, the Food and Drug Administration issued a warning for the drug and other antibiotics in the fluoroquinolone class because of an increased risk of tendon ruptures and tendinitis.

From November 1997 to December 2005, there were nearly 800 reports of tendon ruptures and other tendon problems in people using fluoroquinolone drugs, according to a legal action brought against the FDA last year by the group Public Citizen. The Illinois attorney general also had asked the FDA to issue the warning.

Fox also worked two days as a speaker/author for Schering-Plough in 2006 and was paid $5,000 to $10,000.

Fox was paid $173,441 in 2007 by UW.

Influencing prescriptions?

More and more, critics say, deals like the kind Fox benefited from are meant to influence doctors’ prescription habits.

“The people in the drug industry will tell you that their job is to be friends with the doctor,” said Eric Campbell, associate professor of medicine at Harvard Medical School, who has studied drug industry ties to university doctors.

Over time, however, financial ties between university doctors and drug companies can lead to a “subtle and insidious change in perception” in which the doctors develop a sense of entitlement that can affect their professionalism, according to a June report by the Association of American Medical Colleges.

The deals can harm the objectivity and integrity of academic teaching, learning and practice, the report said.

What’s more, many UW doctors said they did not tell their patients that the drugs they prescribed were made by companies that paid them on the side. Of 20 doctors who were interviewed, 14 said they did not tell patients about their financial relationships with drug companies when they prescribed drugs made by those companies.

“I don’t see the relevance,” said UW pediatrician Theresa Guilbert. “I work for many different companies that make many different drugs. I don’t perceive it as a conflict for the patient.”

Guilbert, an assistant professor and asthma specialist, reported payments from five companies, including money for speaking that she described as promotional.

Guilbert said she gets about $1,500 to $2,500 per talk, though about 80% of the drug company work she does involves other consulting.

“I can live with myself,” said Guilbert, who received $152,000 in compensation from UW in 2007.

Advocates for full disclosure say doctors need to tell patients about ties to medical companies to dispel any concern about their motives for prescribing the drug or implanting a device.

Whistleblower lawsuit

Thomas Zdeblick, a UW orthopedic surgeon, took a second job in 1998 working as a consultant to Medtronic, a large medical device company.

Although Zdeblick was paid $400,000 a year by Medtronic for just eight days of work, the school did not learn how much he was paid until years later because he was required only to list income of “>=$20,000” in his disclosure forms.

Details of the contract became public in 2006 as the result of a whistleblower lawsuit filed against Medtronic and 16 surgeons in federal court. A former employee of Medtronic claimed that Zdeblick and other doctors were given lucrative consulting contracts in exchange for using and promoting Medtronic products.

At the time, Zdeblick’s patients at the UW Hospital and Clinics weren’t told of his consulting job with the company that made many products he used in back surgery.

Zdeblick said that he did nothing wrong and that he worked more than the eight days required in his contract.

Again in 2008, Zdeblick, who did not return phone calls, listed Medtronic on his university disclosure form, saying he worked eight days and was paid an undisclosed amount of $20,000 or more.

The university said Zdeblick also received $890,000 in UW salary and income from the UW Medical Foundation.

Indeed, other fees of $20,000 or more were paid to orthopedic surgeons who also had some of the highest six-figure university salaries.

Orthopedic surgeon Paul Anderson owned stock, stock options or received compensation of at least $20,000 from six different medical firms.

In addition to his outside income, Anderson received $755,000 from UW in fiscal year 2007.

Several attempts to reach Anderson were unsuccessful.

Informing patients

Some doctors have kept their patients at least partially informed.

In 2006, a group of doctors in the UW Preventive Cardiology Clinic began sending patients a statement informing them that several physicians had financial relationships with drug companies.

“We are sensitive to the possibility that these relationships could be considered conflicts of interest,” the form says. “We believe in full disclosure.”

Patients are told that doctors are willing to discuss their relationships with drug companies.

Since 2001, James Stein, a UW cardiologist, said he has been urging the university to disclose all such relationships between doctors and drug companies.

“It didn’t get a whole lot of traction,” he said.

After Stein’s clinic began using the form in 2006, he said, he recommended it for all UW doctors, but it was not adopted.

Stein said he also changed his own behavior, either turning down consulting offers from drug companies or turning over any money he receives to charity. Last week, he said he had stopped working as a speaker for drug companies altogether.

“I think we have a very deep responsibility to our patients,” he said. “They have to be confident that when we take care of them, we only have their interests in mind.”

Beginning this month, if patients at a handful of UW clinics want to know more about consulting deals their doctors might have, they may request the details anonymously, Golden said.

Eventually, all UW Health clinics and check-in points for patients will have the signs, he said.

Golden acknowledged that by not requiring doctors to specify how much they receive, the university is not getting full disclosure. He said an overhaul of the conflict-of-interest policy is being considered, including disclosing the actual amount paid by a drug or device company.

“We want to know if someone is getting $20,000 rather than $200,000,” he said.

He said the change could be in place by April, when the disclosure forms must be filed.