Healthy Skepticism Library item: 17479

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Publication type: news

Meier B, Wilson D
Senator Seeks Data on Doctor Accused by Army of Falsifying a Product Study
The New York Times 2009 May 18
http://www.nytimes.com/2009/05/19/business/19surgeon.html?_r=2&scp=1&sq=Senator Seeks Data on Doctor Accused by Army of Falsifying a Product Study&st=cse

Full text:

A top Republican lawmaker has opened an inquiry into a former Walter Reed Army Medical Center doctor whom the Army has accused of falsifying a medical study involving a product made by Medtronic, a company for whom he works as a paid consultant.

Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, released letters Monday seeking information about the physician, Dr. Timothy R. Kuklo. The letters were sent late Friday to Walter Reed officials, two medical journals and the head of Washington University in St. Louis, where Dr. Kuklo works as an associate professor in the medical school.

The New York Times reported last week that a British medical journal had retracted an article by Dr. Kuklo earlier this year after learning from Army officials that he had, among other things, forged the names of four other doctors he cited as the study’s co-authors.

Army investigators determined that Dr. Kuklo’s article had overstated the benefits of a Medtronic bone-growth product, called Infuse, that was used at Walter Reed to treat American soldiers who had suffered severe lower leg injuries in Iraq.

Army officials also cited discrepancies in the data cited by Dr. Kuklo, saying he had described more injuries than Walter Reed records showed.

Dr. Kuklo, who worked at Walter Reed from 2003 to 2007, has declined to respond to numerous telephone calls and e-mail messages seeking comment. Officials of Washington University have also declined to say whether they are investigating Dr. Kuklo, although Army officials and others say that the school is conducting such an inquiry.

Medtronic may also face repercussions from the case. Since last year Senator Grassley and, separately, the Justice Department have been investigating whether the company illegally promoted uses of Infuse that were not approved by the Food and Drug Administration – by paying doctors, among other alleged measures. The company has denied doing so.

Medtronic, while acknowledging that Dr. Kuklo is a company consultant, has repeatedly declined to say when it hired him as a consultant or how much it has paid him over the years, either directly or to support his research.

But the company’s and doctor’s financial relationship goes back to at least 2001. From 2001 to 2006, Medtronic spent more than $13,000 to pay Dr. Kuklo’s travel expenses to numerous medical conferences and other professional meetings, according to Defense Department records reviewed by the Center for Public Integrity and Northwestern University’s Medill Journalism School.

In a response to an inquiry last September from Senator Grassley, Medtronic provided the lawmaker with a list of outside doctors who were paid consultants for Infuse. Dr. Kuklo, who has made about 15 paid presentations for Medtronic about the bone-growth product, was not on that list, a spokeswoman for Senator Grassley said last week.

Asked last week by a reporter about that issue, a Medtronic spokeswoman, Marybeth Thorsgaard, said in a written statement that the doctor was not included because “some consultants, like Dr. Kuklo, have general agreements that are not specific to a single therapy or subject matter.”

In the Friday letter to Walter Reed officials, Senator Grassley asked for information about, among other things, direct or indirect payments by Medtronic to Dr. Kuklo and other Army doctors involved with Infuse or other company products. He is also seeking the full report of the Army’s investigation as well as relevant conflict-of-interest policies.

Col. Norvell V. Coots, commander of the Walter Reed Health Care System, said Monday that he welcomed the review.

“My guess is we will probably find something more here,” the colonel said in a telephone interview.

A spokesman for Washington University said it would cooperate with Senator Grassley’s request.

One of the medical journals that received the lawmaker’s inquiry was the British periodical The Journal of Bone and Joint Surgery, which published and later retracted Dr. Kuklo’s Infuse study.

The other was an American journal that has the same name but operates separately from the British publication. It had read but rejected Dr. Kuklo’s article before he submitted it to the British publication.

Senator Grassley asked the journals to provide him with any information relevant to the submitted article, including whether Dr. Kuklo disclosed receiving funding from Medtronic. The published article did not contain such a disclosure.

A spokesman for the British publication said it would provide whatever information it was able to Mr. Grassley’s committee. The American publication did not respond to a request for comment on Monday.