Doctor Payoff Scandal Over Medtronic Device
December 16, 2009
Natural News
By David Gutierrez
A Senate investigation has revealed that medical technology company Medtronic paid almost $800,000 in consulting fees over the course of three years to a researcher who falsified scientific data in a study on one of the company’s products.
The Army has accused orthopedic surgeon Timothy R. Kuklo of doctoring the results of a study on a Medtronic bone-growth product known as Infuse. The study was carried out on U.S. soldiers with severe leg injuries while Kuklo worked at Walter Reed Army Medical Center.
The study was published in the British Journal of Bone and Joint Surgery, but the journal withdrew the study after an Army investigation concluded that Kuklo had falsified data and forged the names of four other military doctors as co-authors.
By the time the scandal broke, Kuklo was working at Washington University. He had joined the faculty there in 2006 and began work on a followup to the original study, this one funded directly by Medtronic. Not until mid-2007, however, did he reveal to the University that he was receiving more than $50,000 per year from Medtronic in consulting fees. Because receiving such a high level of compensation placed him in breach of university conflict-of-interest rules, Kuklo was told either to cut his compensation to $10,000 per year or to abandon the study. He abandoned the study.
A university investigation later revealed that three days after Kuklo turned in a September 2006 conflict-of-interest form affirming that he had no relationships with any companies related to his research and anticipated no such ties, he signed a consulting agreement with Medtronic that was retroactive to August.
The Senate launched its own investigation of Kuklo in February 2009, leading Medtronic to reveal that it had paid Kuklo almost $800,000 in consulting fees since mid-2006, $132,000 of that in 2009 alone. The company ended its relationship with Kuklo in May, and Washington University has placed him on paid leave pending the resolution of the various investigations that the affair has sparked.
What Would You Choose? Viagra or Implant Surgery?
October 15, 2009
Abc News
By Joseph Brownstein
People may be used to getting spam e-mails offering discounts on Cialis, Levitra or Viagra, but if a new clinical trial is successful, men with erectile dysfunction may someday be flooded with e-mails for another option: a stent.
Medtronic has begun testing on a new pelvic stent for men who have not been helped by drugs. Investigators will begin with 50 patients at 10 different medical centers.
“This is a common problem. Men many times do not have satisfactory results from first-line medical therapies,” said Dr. Krishna Rocha-Singh, director of the Prairie Vascular Institute in Springfield, Ill., who installed the first of the stents in a patient last week.
Singh said erectile dysfunction can also be a sign of larger problems, with potential blockages of major blood vessels.
“Erectile dysfunction could be a symptom of a vascular source,” he said, noting that it could be an early sign of what could lead to heart attacks or strokes. “The patients we’re treating in our practice [with erectile dysfunction] had the same problem elsewhere in other parts of the body.”
By opening up blood flow, Singh explained, stenting might solve some of those problems. However, he pointed out, it remains to be seen which patients would be helped by the stent, a question he hopes the clinical trial will answer.
Other doctors in the field said the device may prove beneficial, but only to a small subset of men.
Best for Younger Men?
Dr. Jerome Richie, the chief of urology at Brigham and Women’s Hospital in Boston, said, “I would foresee this stent as an application for younger individuals who have had traumatic injuries that decrease arterial inflow. Other than that selected group, I do not foresee widespread applicability.”
Dr. Ajay Nehra, a professor of urology at the Mayo Clinic, agreed that young men whose erectile dysfunction stemmed from traumatic injury would be the most likely to be helped, and said they may prefer a stenting operation to a pill, since an erection would not feel as medically induced later on.
“Men would ideally like to have natural, spontaneous erection, and that’s why the medical device is trying to look at alternative options than pills, per se,” said Nehra.
Will There Be Demand?
For many men with erectile dysfunction, the available pills do not help. For that reason, a number of doctors thought the stent could become a commercial success.
Medtronic paid $850,000 to author of bogus bone growth implant studies
June 18, 2009
AP
by Matthew Perrone
Medical device maker Medtronic paid about $850,000 over nearly 10 years to a former Army surgeon accused of forging signatures and falsifying data for a study touting the benefits of one of the company’s implants.
Medtronic, the world’s largest device firm, previously declined to release details of its financial arrangements with Dr. Timothy Kuklo, who authored a paper on Medtronic’s Infuse implant that later had to be retracted from publication.
The Army found that Kuklo, now a university professor, forged the signatures of four colleagues and made up data overstating the benefits of Medtronic’s implant on leg injuries of soldiers at Walter Reed Medical Center.
Medtronic reiterated on Thursday that it had no involvement with Kuklo’s discredited medical journal article.
The Minneapolis-based company said it paid Kuklo $850,000 in direct and indirect payments between 2001 and May 2009, when it placed the surgeon’s consulting arrangements on hold. Most of that amount was for training activities or consulting, though he was also reimbursed for airfare and other travel expenses.
The company’s disclosure comes after a series of probing letters from Sen. Charles Grassley, R-Iowa, a longtime critic of the drug and device industry’s influence over physicians.
“We are making Dr. Kuklo’s compensation information public on a one-time basis in the interest of transparency in this unique case,” said Marybeth Thorsgard, a company spokeswoman.
The company said Kuklo worked for the company training other physicians to use Medtronic’s products between 2000 and 2006. In August 2006 he became a consultant for the company on product development issues.
The Department of Defense permits military physicians to receive payments for training and consulting, provided they disclose the information on conflict of interest forms.
Kuklo retired from the Army in 2007 and is now a professor of orthopedic surgery at Washington University in St. Louis. He is currently on a leave of absence, according to university officials.
Last November the Department of Justice subpoenaed documents from Medtronic as part of a probe into whether the company encouraged doctors to use the Infuse spinal graft for unapproved purposes. Grassley is conducting a similar inquiry.
While doctors are allowed to use drugs and devices for nonapproved uses, companies are not allowed to market the techniques.
Infuse is a man-made version of a human protein that spurs bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.
However, serious complications have been reported when doctors use the graft for alternate uses, such as neck surgeries. The FDA has said that use can lead to problems swallowing, breathing and speaking, which in some cases required additional surgeries.
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