Setting the stage for increased transparency in the New Year, heart valve maker Edwards Lifesciences (Irvine California) said it will voluntarily disclose its financial relationships with U.S. physicians, a move the company's CEO and chairman said should have no significant downside on the way devices are developed and commercialized.

Michael Mussallem, who also serves as chairman for the Advanced Medical Technology Association's (AdvaMed; Washington) board, told Medical Device Daily that the company is providing the disclosure "because of public interest in this subject and our concern that a trust issue is developing" – one of the negative sort.

But he also admitted that device makers who follow suit may encounter a few hurdles in disclosing financial relationships with doctors.

"Most companies would be challenged to very accurately report physician payments because they are occurring in various parts of the company and systems have not been created to promptly and accurately report the data," Mussallem said. "Some companies might also be concerned that certain physician collaborations are confidential and should not be disclosed for competitive reasons.

"Lastly, it would be a concern if hospitals or doctors became worried about the perception of a relationship and declined to work with industry in the future, which would harm device development and, ultimately, patients."

Opting for transparency as the better path, however, Edwards will post on its web site its financial relationships with physicians who receive $5,000 or more a year in consulting fees, royalties or honoraria from Edwards. The company intends to start tracking the data on Jan. 1 and will publish it annually beginning in the second half of 2009.

The company's efforts are voluntary, but they come on the heels of AdvaMed's recent revision of its code of ethics for device firms (Medical Device Daily, Dec. 22, 2008) and the fact that U.S. lawmakers have introduced a bill that would require medical manufacturers to disclose the physician payments.

Staying ahead of the rule-makers, Mussallem said the company hopes that the early experience will prevent any future laws from being too onerous or implemented in onerous fashion.

When asked what impact the transparency will ultimately have on consumers, he said the effort is one that would hopefully provide some enlightenment about the "innovation process."

"Patients want to trust that physicians have their best interests in mind and that they're not driven by some hidden agenda," Mussallem said. "Transparency in financial relationships provides clarity about any potential concern related to the relationship between the doctor and a company. One of the disappointing things is that while the public can see the potential downsides of these relationships, they are often not aware of the absolute necessity for these collaborations."

"Medical devices need a clinical champion. However, doctors do not have the resources to do the development. Similarly, industry has the resources, but not the clinical expertise. Lifesaving devices can only be developed with both parties working together," he told MDD.

He said this is key to helping the public better understand the vital role that physician partnerships play in medical innovation.

So, inquiring minds will ask: How much is too much compensation for physician input, consulting and work when device are developed?

"[W]hat's key," he said, "is that the compensation is fair, based on the contribution of the physician. For example, if it's a big idea that impacts many, many lives, or there is a tremendous amount of time dedicated by the physician in developing a technology, payments would be higher."

Just how high remains to be seen in mid-2009.

Mussallem also pointed out that physicians should begin to take proactive steps to be open and honest with their patients.

"We encourage physicians to disclose their meaningful conflicts with patients," he said. "Patients should be pleased to know that their doctor has distinguished him[self] or herself by being asked to participate in the innovation process."

The shift in disclosures is not expected to have an effect on how clinical trials are performed or how the data are perceived by FDA, according to Mussallem.

"We believe that clinical trials and the data that they generate are not today influenced by physician payments," he said. "The heavy burden of cost that hospitals bear to collect clinical data is appropriately supported by the companies requesting the clinical research. Further, there are already disclosure requirements at the time of an FDA submission, as well as within the institutions."