A Medical Device Daily

A ranking member of the U.S. Senate Finance Committee has asked the FDA and the maker of an artificial spinal disk about potential financial conflicts of many of the doctors involved in the research that led to agency approval of the device.

Doctors at about half the research centers involved in the study of the Prodisc had a direct financial interest in the device’s success, according to an article in the New York Times.

Prodisc is manufactured by Synthes (Solothum, Switzerland), whose U.S. headquarters received a letter of inquiry from Charles Grassley (R-Iowa), of the Senate Finance Committee this week. The FDA also received a letter from Grassley.

Grassley’s letters ask the agency and Synthes to provide accounts of what the company disclosed to regulators about the researchers before the disk’s approval in 2006. Grassley also asked how the agency and company handle potential conflicts among clinical investigators.

The company indicated it would cooperate while the FDA did not comment, according to The Times.

The inquiry is part of a broad look by Grassley and others in Congress into close financial ties between physicians and the manufacturers of drugs and devices. Grassley has introduced legislation that would require corporations to publicly disclose any money they give to doctors (Medical Device Daily, Feb. 21, 2008).

In related news, Senate lawmakers this week questioned executives from Stryker Instruments (Kalamazoo, Michigan) and Zimmer Holdings (Warsaw, Indiana) on gifts and consulting fees paid to surgeons who use their implants, according to an Associated Press report.

Sen. Herbert Kohl (D-Wisconsin), who called the hearing, accused both companies and physicians of putting their financial interests ahead of patients.

Device makers have said surgeons are paid fairly to provide important feedback on new devices. But an inspector from the Department of Health and Human Services (HHS) told lawmakers that many consulting arrangements involve no work at all and are instead aimed at buying loyalty from surgeons who implant hundreds of devices each year.

HHS inspector Greg Demske said it is difficult to prosecute companies for illegal kickbacks because they are often disguised as educational grants or royalty fees.

The Advanced Medical Technology Association (AdvaMed; Washington) has expressed support for the appropriate disclosure of financial relationships with physicians by putting forth key changes to proposed legislation that would help ensure patients receive useful, meaningful information that puts such payments in full context.

“Continued innovation in medical technology relies on direct interaction with physicians who have first-hand clinical experience with advanced medical treatments in their practice of patient care. Our industry works closely with physicians to invent new medical devices, improve existing technologies and provide training to physicians to ensure they can use devices safely and effectively,” said Stephen Ubl, president/CEO of AdvaMed.

“The importance of the relationship between physicians and medical technology innovators cannot be understated – it is a critical component of the engine that drives the next wave of medical advancements,” Ubl said. In an effort to underscore the importance of physician/medical innovator collaboration, and to ensure openness with those relationships, AdvaMed would support S. 2029 (the Physician Payment Sunshine Act), provided that key changes are made to the bill.”

Medtronic (Minneapolis) issued a statement suggesting that the Sunshine Act can and should go even further by requiring the same level of disclosure by all companies in the industry, regardless of size and including those companies owned in whole or in part by physicians. Companies with yearly revenues less than $100 million and physician-owned companies are currently excluded from the bill, and they account for more than 75% of the companies in the industry.

“We have been pleased to work with the members of the Senate Special Committee on Aging, the Senate Finance Committee, and members of the House of Representatives and Senate on this legislation,” said Bill Hawkins, Medtronic president/CEO. “We will continue to work with the sponsors of this legislation to incorporate all companies in the industry into the bill and bring greater transparency to these important relationships.”

In other Washington news:

• Thousands of uninsured children in Louisiana will now have access to regular medical care through the State Children’s Health Insurance Program, Center for Medicare & Medicaid Services Acting Administrator Kerry Weems said.

Weems reported CMS approval of a request by Gov. Bobby Jindal to expand the state’s current SCHIP, called LaCHIP, at an event hosted by the governor at the state capitol.

Under this LaCHIP expansion, enrollment will be extended to children in families that have incomes up to 250% of the 2008 federal poverty level ($53,000 for a family of four). The benefit package is modeled on the state’s employee benefit plan.

In 2006, the state’s program served 142,389 children in families with incomes up to 200% of FPL.