By JOHN FAUBER

Earlier this year, Minesh Mehta, a cancer specialist at the University of Wisconsin School of Medicine and Public Health, co- authored a medical article on TomoTherapy, a radiation therapy system developed by researchers at the university.

Any doctor reading the article would have thought Mehta was an unbiased researcher with no conflict of interest or financial stake in TomoTherapy Inc.

After all, the journal article said Mehta reported no potential conflicts of interest.

But documents obtained from the university tell a different story.

Those records show Mehta had told the university he would make more than $20,000 in 2008 working as a TomoTherapy consultant. He also owned stock options in the company.

Mehta was one of at least nine UW physicians whose conflicts listed on financial disclosures to the university did not match what was revealed to the medical world in their published articles. The inconsistencies were found in a spot check conducted by the Journal Sentinel of about 40 UW physicians whose work has been published since 2005.

Disclosing conflicts of interest is a bedrock principle of modern medicine. It alerts doctors and others who read medical journals to potential bias and allows them to weigh the credibility and value of the articles.

In the last two years, a lack of disclosure in several high profile national cases has undermined the integrity of the medical field.

"There has been a consistent pattern of people not disclosing," said Merrill Goozner, editor of a health care newsletter and former director of the Integrity in Science Project of the Center for Science in the Public Interest.

The reason for the lack of disclosure can lie with either the researcher or the journal.

Just last month, a study in the New England Journal of Medicine showed orthopedic surgeons routinely failed to disclose financial ties to medical device makers in presentations at the 2008 annual meeting at the American Academy of Orthopedic Surgeons.

The issue is so important that editors of some of the world's leading medical journals last month banded together to demand stricter and more consistent disclosure of conflicts of interest.

However, even with more stringent disclosure demands, the system largely is voluntary and self-policing.

"The investigators are pretty much on the honor system," said Nora Disis, deputy editor of the Journal of Clinical Oncology.

She said disclosure is crucial to the integrity of the system.

"When you work in trying to improve human health, it's very important that you share knowledge," she said. "People need to know . . . that you are receiving compensation. That allows the reader to take a much more critical look at the conclusions that are being drawn from the data."

Disclosure is relevant

Mehta's piece on TomoTherapy, published in the International Journal of Radiation Oncology Biology Physics, involved an assessment of 3,800 treatments using TomoTherapy.

On July 3, 2008, the article was received by the journal. A revised form of the article was received Nov. 6 of that year, and it was accepted for publication a week later.

While two other co-authors from UW revealed their financial ties to the company, no such disclosure was made for Mehta, although his financial relationship with the company should have been fresh on his mind.

Less than two months earlier, on May 21, he told the university that he had begun working as a consultant to TomoTherapy in April and that he was reducing his university time by 10% to accommodate the lucrative new job.

At the time, he said his 2008 compensation from TomoTherapy Inc. would exceed $20,000. He also got stock options valued at the time at less than $10,000.

Ultimately, his consulting income with the company in 2008 would total $75,000, for 20 days' worth of work, according to records he filed with the university in April of this year. By then, the stock options were valued at $10,000 to $20,000.

The article was published in March of this year.

James Cox, editor of the journal, said Mehta's financial ties to TomoTherapy were Mehta's responsibility to disclose.

"Clearly it was very relevant," said Cox, head of radiation oncology at the University of Texas MD Anderson Cancer Center. "I have to ask myself how many authors out there have done the same thing. I can't go chase them down. There are too many authors."

In Mehta's case, he would not have to look too far. Mehta is a member of the journal's editorial board.

Cox said he likely will bring the matter up with the board of directors of the American Society for Radiation Oncology, which publishes the journal.

A variety of actions are possible, he said, ranging from publishing a notice about the failed disclosure to a censure. Mehta also could be dropped from the editorial board, Cox said.

"We take it very seriously," he said.

Mehta declined to discuss the issue with the Journal Sentinel.

Paid for talks

In 2008, UW doctor Barry Fox co-authored a medical journal article on treating antibiotic-resistant staph infections.

In the section of the article where doctors are supposed to list any potential conflicts of interest, it said "the authors have no financial disclosures to report."

However, documents Fox filed with the university show that he earned tens of thousands of dollars working for several drug companies giving talks to other doctors about antibiotics.

The article appeared in Plastic and Reconstructive Surgery, a journal published by the American Society of Plastic Surgeons. It could be used by doctors to earn required continuing medical education credit.

Such presentations and articles generally require the instructors to disclose their conflicts of interest.

Rod Rohrich, editor-in-chief of the journal, said Fox signed a form saying he had no disclosures to make.

If Fox had revealed his consulting work, the journal would have disclosed it in the article, Rohrich said.

"We are pretty rigid on that," Rohrich said. "The lack of disclosure was not the fault of the journal."

He said Fox may have made an honest mistake in signing the form. Rohrich said he re-read the article, and it did not appear to have commercial bias.

However, Goozner, the former head of the Integrity in Science Project, said every doctor who read that article for credit needs to be notified there was a failure to disclose conflicts of interest.

"It is just misleading the readers," he said.

Fox did not respond to attempts by the Journal Sentinel to reach him.

Narrow definitions

Sometimes the lack of disclosure is the fault of the medical journal.

In October 2008, Perry Pickhardt was among a group of UW researchers who co-authored a study in the journal Radiology on CT colonography, a non-invasive way to look for colon cancer.

Pickhardt has done extensive research in the field. He also has pulled in tens of thousands of dollars from several companies that make products used in CT colonography and owns stock options in one such firm.

However, the article said Pickhardt and the authors had no financial relationships to disclose.

In fact, Pickhardt had revealed many potential conflicts to the journal, which decided not to list them, said Herbert Kressel, editor of the journal and an emeritus professor of radiology at Harvard Medical School.

Kressel said the journal had a narrow definition of what constituted a conflict. He said that definition entailed writing about a specific product rather than a topic that might involve companies that make products in that field.

The journal now is considering a stricter policy, in part because readers are entitled to know about such conflicts, he said.

"Our journal would be better off being more transparent in publishing all of the stated conflicts," he said.

Pickhardt could not be reached for comment. He has disclosed conflicts in articles he co-authored in other journals.

Vague disclosures

The disclosures made in orthopedic surgery journals tend to be vague and incomplete. Often they don't say what the financial relationship is or spell out how much money has been paid. Sometimes the disclosures don't even say which company is paying the author.

There is a reason for that, says Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics, an organization concerned with the pervasive influence of drug and device companies.

"People are worried no one will listen to them anymore if they know how much they are being paid by a company," he said. "They are going to discount it."

In 2007, UW orthopedic surgeon Paul Anderson co-authored an article in the journal Spine on the Bryan cervical disc prosthesis made by Medtronic, one of several device-makers for which he has moonlighted.

For years, UW doctors did not have to tell the university how much money they actually made working for drug and device companies. Rather, they merely had to state whether it was in excess of $20,000, the top range, or some other lower range.

From 2003 through 2007, Anderson pulled in undisclosed sums of more than $20,000 a year from Medtronic. In 2008, the first year that UW doctors had to specify their outside income, his Medtronic income was $150,000.

However, based on his article in Spine, it is hard to tell if he received anything from Medtronic.

In part, the disclosure reads:

"One or more of the author(s) has/have received or will receive, benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g. honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position."

Rosen said the statement doesn't say anything about Anderson's financial relationship with Medtronic.

"It's gibberish," he said. "It's covering your legal butt."

Anderson, who also serves as an associate on the journal's editorial board, did not respond to the Journal Sentinel's attempts to reach him for comment.

Loretta Pickett, managing editor of Spine, said authors are not asked to disclose details of financial conflicts such as whether it is from speaking or royalties, or how much money they receive. Instead, they are allowed to pick a statement such as the one used in the article.

"We've always gone on the honor system," she said.

The journal now is considering requiring authors to disclose more detailed conflict information, she said.

In 2009, UW orthopedic surgeon Thomas Zdeblick co-authored an article in the Journal of Bone & Joint Surgery that involved two other Medtronic products, the LT-Cage, a device used in spinal fusion surgery; and BMP-2 a bioengineered protein that promotes bone growth.

The study concluded that the two products had long-term effectiveness, reduced pain and improved other clinical outcomes.

Zdeblick has a long and lucrative relationship with Medtronic, both as a consultant and as someone who has received at least $19 million in royalties for a variety of devices that he invented and patented with the company.

One of the devices is the Novus LT Cage, for which he received $1.4 million in royalties in 2007, according to a January 2009 letter to UW from U.S. Sen. Charles Grassely (R-Iowa), who has been investigating payments to doctors by medical firms.

However, the journal article does not mention that Zdeblick receives royalty payments from Medtronic, which funded the study.

Instead it states that he and the other authors are consultants to Medtronic and that one or more of them or a family member got payments or other benefits of more than $10,000 from Medtronic in any one year.

Zdeblick, chairman of the department of orthopedics and rehabilitation, had no comment other than to say he followed all appropriate procedures that were in place at the time.

Rosen, a clinical professor of orthopedic surgery at the University of California-Irvine School of Medicine, said there is a huge difference between $10,000 and $19 million.

"I have no objection to people making as much money as they can or inventing something and making a fortune off it," he said.

But the amount of money they make and how they make it should be fully disclosed when they present research, he said.

That is especially true with royalties, he said, because they are closely tied to financial success of the doctor and the company that makes the device that is the subject of the article.

Differing policies

In contrast to the cryptic, legalistic disclosures of Anderson and Zdeblick are the uncommonly detailed disclosures of Robert Lemanske, a UW pediatrician.

In a 2009 article on asthma therapies, he not only spelled out the type of compensation, but how much.

For instance, the disclosure section of the article said he had been paid $29,000 in 2005; $31,000 in 2006 and $15,000 in 2007 for speaking by Merck.

Robert Golden, dean of the UW School of Medicine, said journals have differing policies about what is disclosed.

"We do not control what the journals require, nor how they present disclosures or lack thereof," he said in an e-mail.

Golden said he could not comment on any investigations into a lack of disclosure.

Undetailed conflicts

Minesh Mehta: Didn't disclose his stock options or that he got the equivalent of $3,750 a day to consult for a radiation therapy company.

Barry Fox: Co-authored an article on staph infections that did not disclose his ties to several companies that make antibiotics.

Paul Anderson: Was paid large sums working for the device company Medtronic, which were not detailed in a study.

Thomas Zdeblick: Paid millions of dollars in royalties from Medtronic, but did not disclose the extent of them in a study.

More coverage online To read past stories in the "Side Effects" series, which looks at the conflicts of medical doctors, go to www.jsonline.com/sideeffects

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