Medical Research Fraud: U.S. Army Style

Study by Medtronic consultant comes under fire

A highly regarded surgeon and Medtronic consultant is under investigation for an allegedly fraudulent medical study involving an orthopedic product made by the med-tech giant.

By JANET MOORE, Star Tribune

Last update: July 12, 2009 - 10:09 PM

Featured comment:

Corporate Ethics-
I'm waiting for Bill George to share his thoughts about his former company since much of this nonsense happened under his watch while he was lecturing other companies about corporate ethics.

Article

Last August, when a British medical journal published a study by five current and former U.S. Army surgeons, the results seemed enormously promising for soldiers who had been maimed in Iraq and for Medtronic Inc.

Probing cases from Walter Reed Army Medical Center, one of the nation's top military hospitals, the article indicated that a Medtronic product that grows and repairs bone could offer a better chance of recovery for soldiers whose legs had been shattered in combat.

Since then, however, an Army investigation has found reason to think that the study overstated the effectiveness of the Medtronic product, inflated the number of patients who were treated and was published without the knowledge of four "co-authors,'' whose signatures were forged.

The case has turned into an embarrassment for Medtronic, which had paid more than $850,000 in fees and expenses to the lead author, Dr. Timothy Kuklo, between 2001 and 2009.

Medtronic says it had no role in the study or knowledge of its publication. But the case has prompted an inquiry by the U.S. Justice Department and Congress, intensifying the scrutiny that has come to bear in the last few years on medical device companies and their financial relationships with doctors.

The Army's wide-ranging investigation provides a rare window into a purported case of medical research fraud.

The article was published in The Journal of Bone and Joint Surgery and written by Kuklo, a highly regarded West Point graduate who retired from the Army in 2006 and is now on the medical faculty at Washington University in St. Louis.

Problems cropped up almost immediately, when a neighbor and fellow physician congratulated Dr. Romney Andersen, an orthopedic surgeon at Walter Reed who was listed as one of four co-authors. Andersen apparently was unaware of the article until that moment.

Yet Kuklo's name and work were certainly familiar to him. In documents from the Army investigation, Andersen describes Kuklo as a mentor, teacher and friend. When Andersen was contemplating a career as a general surgeon, it was Kuklo who encouraged him to pursue orthopedic surgery instead. While at Walter Reed, Andersen helped Kuklo drywall his basement, and the two (along with their wives) socialized as well.

When interviewed by the Army, the study's "co-authors" described Kuklo as a gifted physician and researcher, even a role model. But another of the four, Dr. Richard Islinger, told investigators that Kuklo's persona changed over the years -- he "became more overconfident and ambitious."

As a resident conducting research with Kuklo, Andersen said he noticed "an aberrancy in typical research" that involved "discarding inconsistent findings which did not fit his hypothesis." Andersen said he had misgivings, but added he was a young doctor inexperienced with the intricacies of research, according to Army documents.

Forgeries, misspelling

Kuklo has been heralded for his prolific research -- roughly 96 papers in nine years, according to Andersen, who fondly remembered calling his mentor the "nutty professor."

Troubled by his neighbor's comment, Andersen doggedly searched the Internet for a copy of the article. At first he came up empty because his name was misspelled on the study's copyright release forms. (His forged signature was also misspelled.)

Andersen subsequently contacted the three other "co-authors" and the editor of the journal, as well as officials at Walter Reed. None of the co-authors was aware of the study, according to Army documents.

"I heard about it when Dr. Andersen called me," Islinger said in an interview. "The bottom line is the signature was forged and the numbers were higher than what I remembered." Islinger, now in private practice in New Jersey, says he treated many of the patients involved while at Walter Reed.

The Army found that the 138 soldiers cited in the study differed from the number of cases contained in its wartime casualty database. The study also suggested the Infuse product had a much higher level of effectiveness than the co-authors' actual experience.

Islinger says the Medtronic product, Infuse, "is a very good product. But the results that were published? I don't see it as being that good."

Dr. J. Edwin Atwood, who led the Army's investigation, concluded in a report that the case "is the ultimate tragedy and catastrophe in academic medicine ... truly an academic institution's greatest nightmare."

Kuklo was not disciplined by the Army when the investigation ended, but a Walter Reed spokesman said last week that "additional matters have surfaced" that "warranted additional inquiry." He declined to comment further.

Kuklo has not commented publicly on the controversy and could not be reached for comment for this article.

The Medtronic connection

Following his discovery, Andersen discussed the article informally with Kuklo, Army records indicate, and asked if Kuklo's consulting for Medtronic posed a conflict of interest. Kuklo reportedly responded that during the course of the study, from March 2003 to March 2005, he was not a consultant for the company, and said he accepted only research and institutional support from the company while at Walter Reed.

Andersen said in a sworn statement that it was well-known at Walter Reed that Kuklo was "closely tied with Medtronic."

Physicians on active duty are permitted to engage in "off-duty employment," but only after approval from their commander. The Walter Reed spokesman said in an e-mail that "a search of our records has not revealed any request by Dr. Kuklo for off-duty employment with Medtronic."

No financial disclosures were provided for the journal article. The Army concluded it was likely written after Kuklo retired from Walter Reed.

Medtronic has not commented in detail on the Kuklo investigation, except to say that it didn't enter a general consulting agreement with him until 2006, after he had left Walter Reed and after the period of the study.

"The study in question was a Walter Reed Medical Center study, so their Institutional Review Board [an internal ethics body] was the approval and oversight authority,'' Medtronic said in an e-mail.

Medtronic did say it paid Kuklo $788,279 between 2001 and 2009 for travel expenses, consulting and honoraria for participation at company-sponsored events. In addition, Kuklo was paid $63,623 in indirect payments to third parties, such as hotels and airlines.

The med-tech industry argues that payments to doctors are legitimate compensation for advice on new products, training for doctors and conducting research on a company's behalf.

But some question whether the thousands of dollars spent on these relationships pose a conflict of interest and sway doctors' choice of products.

"The interest of a drug or device company is earning money for shareholders,'' said Steven Miles, a professor at the University of Minnesota's Center for Bioethics. "The interest of doctors is helping patients. If a doctor is a consultant and he's working for a drug or device company, he's working for the shareholders."

As the controversy unfolded, Kuklo went on voluntary leave from his position at Washington University, which would not confirm last week whether it was conducting its own investigation.

He is currently on "inactive status" as a Medtronic consultant.

Janet Moore • 612-673-7752

Bloggers Note:

This is not the first case of ethics violations for Medtronic.
In September 2003 the U.S. Department of Justice notified Medtronic that its Sofamor Danek spinal surgery unit was the subject of an investigation into allegations of illegal kickbacks to physicians.

For a comprehensive history on the MedTronics Company, click on title above;
http://www.fundinguniverse.com/company-histories/Medtronic-Inc-Company-History1.html

For Star Tribune article w/ place to comment, go to:

http://www.startribune.com/business/50493352.html?elr=KArksUUUU