I posted a note about the da Vinci surgical robot in 2009 in which I linked to an article suggesting that some of the surgeons using the devices were inadequately trained (see: Training and Credentialing Standards Proposed for Surgeons Offering Robotic Surgery). Here's a link to a more recent article about how the use of the device has drawn increased attention by the FDA (see: Surgical robot da Vinci scrutinized by FDA after deaths, other surgical nightmares; Study: Problems with Surgical Robots Going Unreported to the FDA). The manufacturer of this device, Intuitive Surgical, seems to be frequently navigating at the edge of the spectrum. Here's a very recent article about another misstep by the company involving some University of Illinois physician faculty (see: U. of I. doctors under scrutiny for surgical robot ad). Below is an excerpt from it:
When the makers of the da Vinci surgical robot asked University of Illinois doctors to appear in a national advertising campaign, their Chicago hospital saw an opportunity to promote its expertise with the device. But the plan backfired. Instead of gaining national publicity for being leaders in robotic surgery, the doctors and the University of Illinois Hospital and Health Sciences System are under scrutiny for endorsing a commercial product, a possible violation of U. of I. policy....[It has also been discovered that] some doctors pictured in the ad did not initially disclose their financial ties to the company that makes the robot, Intuitive Surgical..., as required by the university's policies on conflicts of interest. Intuitive selected the doctors to observe and monitor use of the device at other hospitals, work for which they were paid. The doctors disclosed that information only after the ad was published ....One surgeon received about $16,000 in the most recent one-year reporting period. For patients, the doctors' participation in the ad and the lack of transparency raise questions about whether their physicians can offer objective advice when discussing robotic surgery as compared with other options....The full-page ad, which ran in The New York Times Magazine on Jan. 19, shows a dozen U. of I. employees, dressed in white lab coats, with the caption: "We believe in da Vinci Surgery because our patients benefit." The names of the hospital and the doctors appear in smaller type above the employees. Intuitive Surgical paid for the advertisement, and U. of I. doctors and the hospital were not compensated for participating, according to the university. A disclaimer in the ad states that the company had paid some doctors for educational services. U. of I. officials have asked Intuitive Surgical to discontinue the advertisement, and two weeks ago the university launched an investigation into the "circumstances of participation" in the ad.
What could these U.I. surgeons have been thinking when they posed for this picture? I suppose that there is the possibility that they were duped and did not actually know that it would be used in a full-page advertisement in the New York Times. Even in the face of much tighter enforcement of physician relations with vendors in terms of "consulting" fees, I suppose there will be some of them who have failed to get the message. Perhaps the so-called Sunshine Act, a component of the ACA, will get their attention (see: Glaxo Stops Paying Doctors for Helping to Promote Their Drugs). Below is more information about the Sunshine Act courtesy of the AMA (see: Toolkit for Physician Financial Transparency Reports --Sunshine Act). The AMA also offers a toolkit that can be accessed via this link so that physicians can make sure that they are prepared when it’s time to review their 2013 financial data before it’s published.
The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. Manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013. Manufacturers will submit the reports to the Centers for Medicare & Medicaid Services (CMS) on an annual basis. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by physicians and their immediate family members. The majority of the information contained in the reports will be available on a public, searchable website. Physicians have the right to review their reports and challenge reports that are false, inaccurate or misleading.