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for a drug that doesn't work as advertised. Tales from the healthcare for profit world.
May 13, 2009
Doctor Falsified Study on Injured G.I.’s, Army Says
By DUFF WILSON and BARRY MEIER
A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday.
An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.
“It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,” Colonel Coots said in a telephone interview on Tuesday. “So this really was all falsified information.”
The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.
Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation.
A West Point graduate who also has a law degree from Georgetown University, Dr. Kuklo worked at Walter Reed from early 2003 until he retired from the Army in March 2007.
While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents.
During the six-month period ending last October, sales of Medtronic’s bioengineered products, principally Infuse, reached $419 million, according to a company filing.
Back in 2005, while still at Walter Reed, Dr. Kuklo listed Medtronic as a financial supporter “in excess of $500” in a disclosure statement accompanying a preliminary report about the use of Infuse on American soldiers injured in Iraq. The Army is not disputing those early results.
Infuse was approved by the F.D.A. in 2002 for use in the lower spine and in 2004 for fractures of the shinbone. The studies on which the F.D.A. approved shin-bone treatment involved patients injured in accidents like car crashes and falls.
But because doctors are free to use any product approved by the F.D.A. for whatever purposes they see fit, surgeons at Walter Reed used the product to see if it could help soldiers with far more severe, combat-related injuries.
During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report.
The results reported by Dr. Kuklo in his Infuse study “suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors,” according to the Army’s investigation.
Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period — 138 soldiers — was greater than the number for which the hospital could find records.
“It is a significant breach of academic protocol,” Colonel Coots said. “It’s a breach of trust.”
http://www.nytimes.com/2009/05/13/bu...ef=todayspaper
A West Point graduate physician. Why would he do it, except for the $$$.
May 13, 2009
An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.
“It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,” Colonel Coots said in a telephone interview on Tuesday. “So this really was all falsified information.”
The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.
Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation.
A West Point graduate who also has a law degree from Georgetown University, Dr. Kuklo worked at Walter Reed from early 2003 until he retired from the Army in March 2007.
While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents.
During the six-month period ending last October, sales of Medtronic’s bioengineered products, principally Infuse, reached $419 million, according to a company filing.
Back in 2005, while still at Walter Reed, Dr. Kuklo listed Medtronic as a financial supporter “in excess of $500” in a disclosure statement accompanying a preliminary report about the use of Infuse on American soldiers injured in Iraq. The Army is not disputing those early results.
Infuse was approved by the F.D.A. in 2002 for use in the lower spine and in 2004 for fractures of the shinbone. The studies on which the F.D.A. approved shin-bone treatment involved patients injured in accidents like car crashes and falls.
But because doctors are free to use any product approved by the F.D.A. for whatever purposes they see fit, surgeons at Walter Reed used the product to see if it could help soldiers with far more severe, combat-related injuries.
During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report.
The results reported by Dr. Kuklo in his Infuse study “suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors,” according to the Army’s investigation.
Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period — 138 soldiers — was greater than the number for which the hospital could find records.
“It is a significant breach of academic protocol,” Colonel Coots said. “It’s a breach of trust.”
http://www.nytimes.com/2009/05/13/bu...ef=todayspaper
A West Point graduate physician. Why would he do it, except for the $$$.
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