Transparency in Medical Research: Does it hurt or help innovation?

Charles David Rosen, MD, President, Association for Medical Ethics.
Clinical Professor of Orthopaedic Surgery, UC Irvine

Dr Rosen, co-founder of Association of Medical Ethics (AME), spoke at the UCLA Health Business Association 2nd Annual Conference held today  and discusses ethics in medical device and inventions. Although the device industry is vehemently against transparency, he argues that transparency results in better products and devices for patients.

Sunshine Act

• Dr Rosen introduced the idea of transparency in medical device development to our law makers. Senator Grassley accepted his proposal and took it to Congress. Dr Rosen's and colleagues proposal became law: Sunshine Act 
• The Act requires payments made to MDs from Pharma and Device Companies to be published on the CMS website.

Physician-own Distributors (POD)

• Dr Rosen discusses the impact POD on patient care. He gives an example in spine surgery.
• MDs (spine surgeons) who are POD purchase devices from non-US countries
• He reports that there is a 20:1 mark up of the devices which are then implanted in patients in US
• In the spine surgery field, 30% of spine surgeons are involved in POD
• Impact of POD:
• OIG Draft report shows that POD surgeons saw more patients ("volume effect"). 
• Nearly 2x spines were fused with POD vs non-POD patients

Data

• Dr Rosen discusses his view on the impact of EHR on measuring transparency
• We know that data/information have predictive value
• The trend by Insurers is to measure Outcomes and tie it to reimbursement.
• Reimbursements will be dependent on outcomes
• Old /current system has been a Pay and Chase model: hospitals bill for whatever services are provided to patients and then, the hospitals chase down insurers for payment. This model will have to change. 
• One solution is to use data in the form of Registries, which are commonly practiced in European countries. These registries can show 1-2 years in advance when devices are problematic. 
• Another application of EHR for cost control will be to measure MDs against their respective cohorts. Any outliers will be "labeled" by payers.
• Innovation with Data and Transparency will result in better products and services
• Dr Rosen reports that a non-disclosure model permit big companies to squash innovation in small companies. Transparency will allow for a more equal-playing field for competition. "Great products will stand on their own". 
• Currently, big companies pay consultants to be part of the board
• So national guidelines which are written by prominent MDs are unduly biased
• Currently, 20-30% of procedures are unnecessary 
• Only by removing conflict of interest, devices can be independently tested and validated.

Not surprisingly, Dr Rosen reports that he faced threats to his career and reputation from the Industry for his efforts. He appears to be someone who has endured the harsh realities of advocating for more ethical behavior in MDs. He, at one point, wondered why he was undertaking this effort. After nearly two years of harassment, it took a letter from Senator Cole detailing these harassment from the industry towards Dr Rosen as a felony (i.e. threatening /intimating a Congressional Witness), which finally quieted the retributions from Industry. 

So, how do we resolve the need for physician expert consultants to facilitate technological innovations? Dr Rosen proposes that  financial conflict should be removed if we want independent validation of devices. It seems that we do not yet have a great solution to resolve these issues.