March 20, 2017
New research suggests the majority of patients have seen a physician in the last year who received an industry payment, and many patients are not aware of that fact, nor that information on those payments is available to the public. Among the companies who reportedly made industry payments to physicians in 2015, the orthopedic-focused Stryker Corporation, which is currently embroiled in legal battles regarding their Stryker LFIT V40, paid more than $60 million.
Many Americans Unaware Their Doctors Have Received Payouts
The study, published in the Journal of General Internal Medicine, found that of the nearly 2,000 participants (adult Americans who filled out a survey), 65 percent saw a physician who had received an industry payout in the 12 months prior. It also concluded that few of those patients—only five percent—had any idea their doctors had received a payment or were currently receiving payments.
“These findings suggest that although physicians who accept industry payments are in the minority, they are caring for a very substantial portion of America’s adult patient population,” researchers wrote.
Industry payments can be made for a range of reasons, including royalties and licensing, for which Stryker made the bulk of its payments. Royalty and license payments are made to physicians who invent or help develop devices or medications. This includes physicians who helped develop new joint replacements, such as the oft-challenged Stryker LFIT V40. But Stryker also paid more than $17 million in 2015 (the most recent year of data available) to physicians for consulting fees, a category whose boundaries are not as clear cut.
Perhaps most concerning, however, was the more than $3.5 million the company spent on physicians’ food and beverage. While the much lower amount and the relatively minimal cost of most individual food and beverage payouts can seem harmless, a 2016 study in JAMA Internal Medicine determined that physicians who had received a single meal from a company promoting its drug of interest were significantly more likely to prescribe that drug , and that physicians who were bought multiple meals or more expensive meals were even more likely to prescribe the drug in question.
Orthopedic Device Reps Add Influence
Some researchers point to conflicts of interest stemming from these industry payouts, and concerns run especially high with devices like the LFIT V40, which has been criticized for frequent taper lock failure and potential health problems, like metallosis (commonly known as metal poisoning). In cases where payments they’ve received may make doctors biased to a less-effective device, the issues are obvious.
Another complicating factor is the medical device representatives (essentially salespeople for the devices) who may assist surgeons in the operating room. A 2016 study in PLOS one highlighted this concern, noting that while the device reps can offer expertise on the device and help surgeries run more smoothly, creating that reliance between surgeons and device reps could lead to pressure to purchase.
In that study, certain device reps even expressed their own discomfort at being asked by their employers to promote newer, more expensive devices instead of recommending existing devices that have more data to back up their effectiveness.
Promoted Product Isn’t Always the Safest
Newer products with less-proven safety records are nothing new in the industry. Stryker has been critiqued for hurrying their products to market, possibly leading to hip implant recalls. The company has used the 510(K) pre-approval process to avoid the longer FDA safety review process, but the number of hip implant recalls they issue has put the method into question.
Most recently, Stryker is facing problems with the LFIT V40 (a component in hip implants), for which they issued an “Urgent Medical Device Recall Notification” to surgeons in August of 2016. The notice cited a “higher than expected” number of complaints regarding taper lock failure with the devices, which can lead to, among other things, hip implant complications that ultimately need revision surgery. Many people have also filed a Stryker hip lawsuit.
Patients wishing to see a breakdown of the payments Stryker made in 2015 or to check whether their doctor (or a doctor they’re considering) has received payments from the company, can visit the Open Payments website.