RESEARCH CONFLICTS
The transparency movement similarly seeks to expand disclosure of the financial interests of investigators involved in clinical
research on new drugs and biologics to minimize the role of money in shaping R&D and product use. The HHS Office of the Inspector
General (OIG) issued a report in January 2009 recommending that sponsors of clinical trials disclose investigator financial
information to the FDA before studies begin, instead of when the company files a market application, to improve investigator
compliance.1
Grassley is similarly pushing for stricter enforcement of financial disclosure requirements of researchers receiving NIH grants.
He has uncovered a number of prominent academics who failed to report millions in industry payments.
In anticipation of additional tracking and disclosure requirements, manufacturers are establishing their own transparency
programs. Pfizer (New York, NY) recently joined Eli Lilly, Merck, and GlaxoSmithKline (Middlesex, UK) in posting data on payments
to physicians. Academic research centers also are promoting transparency in researcher–industry relationships. Harvard Medical
School is reviewing its limits on staff income and stock holdings from drug and medical product companies. The Cleveland Clinic
is publicly reporting business relationships between staff and industry, and other prominent universities are adopting stricter
conflict-of-interest and disclosure policies.
To comply with multiple state and national reporting requirements, manufacturers are implementing data systems that are able
to track payments to health professionals. Information technology vendors have developed programs to compile a company's aggregate
spend that can collect all company payments to a physician, which may involve clinical research, consulting, and medical education
for different research programs and marketed products.
Meanwhile, physicians are leery of too much disclosure of individual practitioner quality and cost information and have gone
to court to prevent consumer groups from using claims data to compile doctor ratings. Such actions reflect the difficulties
in establishing disclosure and reporting requirements across the nation's healthcare system. Health reformers, however, regard
transparency in healthcare costs, prices, provider practices, and drug and medical product performance as critical to driving
down healthcare expenditures and expanding access to affordable care.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, jwechsler@advanstar.com
RESOURCES
1. Levinson DR. The Food and Drug Administration's oversight of clinical investigators' financial information. 2009 Jan [cited
2009 Feb 6]. Available from: http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf.
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