Medical device firm flies in controversial surgeon

-TheAge

09/22/2009 - A CONTROVERSIAL American surgeon being investigated by the US Senate over his financial ties with medical device giant Medtronic was flown by the company to Australia to lecture doctors at a medical conference last month.

Medtronic consultant Dr David Polly lectured doctors at a weekend conference arranged by Medtronic in the NSW wine region the Hunter Valley, just weeks after he was attacked in a US Senate inquiry.

In July, US senator Charles Grassley described as alarming Dr Polly's failure to disclose that he was being paid by Medtronic in 2006 when he lobbied the US Government to fund medical research, which later included the use of Medtronic product Infuse.

Dr Polly resigned from the board of the American Academy of Orthopedic Surgeons just a day before he flew to Australia.

Dr Polly was paid $US1.14 million by Medtronic in fees and expenses between 2003 and 2007, according to a Senate inquiry into the marketing of Infuse, a bone-growth product used to repair bones in many Australian patients.

Medtronic was forced to cancel the appearance of a second US surgeon, Tim Kuklo, at the Hunter Valley conference in response to revelations that Dr Kuklo, who is also a paid Medtronic consultant, had falsified results in a study that praised the benefits of Infuse.

Dr Kuklo, who is being investigated by the US Department of Justice, is listed on Medtronic documents as a member of the international faculty at its meeting in the Hunter Valley.

Another conference attendee, prominent Queensland surgeon Paul Licina, has raised concerns about the safety of Infuse in two papers, but was not invited to speak by Medtronic.

Dr Licina, who declined to be interviewed, concluded in one of his papers that ''the incidence of an exaggerated inflammatory response with [Infuse] in the lumbar spine may be under-recognised''.

In his second paper, Dr Licina warned that the use of Infuse in some operations might not lead to clinical success and ''was associated with increased cost and complications''.

Medtronic Australia told The Age that the safety and efficacy of Infuse had been established via peer-reviewed trials.

Last week, The Age revealed concerns from federal Health Department officials and the Australian Orthopedic Association that the regulation of medical devices in Australia was inadequate. The concern is heightened by the poor or non-existent disclosure of financial ties between Australian doctors and medical device companies.

In contrast, a series of government investigations and scandals in the US has forced some companies to disclose their financial ties with American doctors.

The Age can reveal that earlier this month, thousands of dollars given by medical device companies to the Asia Pacific Arthroplasty Society - an organisation started by local surgeons who specialise in joint replacement - were used to fly seven NSW doctors to the society's conference in Xian, China, where the doctors stayed for nothing at the Sheraton Hotel.

The doctors are NSW orthopedic surgeons Richard Verheul, Simon Coffey, Michael Neil, Craig Waller, Rami Sorial, James Sullivan and Wui K. Chung. Dr Chung founded the arthroplasty society and is believed to have been a long-time paid consultant to medical device company De Puy, although he could not be reached for comment.

Dr Neil, who delivered several papers at the China conference, said the trip was not a junket. ''This was a pretty gruelling week,'' he said.

Dr Sullivan said the conference was ''certainly no holiday'' and that the companies had sponsored it because ''they want to develop the market in China''.

A spokeswoman for De Puy, owned by Johnson and Johnson, denied the company contributed to any surgeon's travel or hospitality, but said it did give ''an educational grant'' to the conference organisers ''for the development of educational content''.

De Puy did not disclose the size of the grant or how much it pays Australian surgeons in consulting fees, but said all such payments were related to genuine training and educational purposes.

Medtronic heavily subsidised expenses for doctors who attended its Hunter Valley conference.

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