The transparency movement similarly seeks to expand the disclosure of financial interests by investigators involved in clinical
research on new drugs and medical products to minimize the role of money in shaping drug development and use and to ensure
that potential financial rewards will not lead to fudged data or skewed results. FDA and the National Institutes of Health
(NIH) have broadened financial-disclosure requirements for clinical investigators, but these bodies face pressure to expand
disclosure and to enforce reporting requirements vigorously.
The Office of the Inspector General (OIG) issued a report in January 2009 recommending that sponsors of clinical trials disclose
investigator financial information to FDA before studies begin, instead of when the company files a new drug application (NDA).
FDA now advises manufacturers to collect financial information whenever they engage an investigator during the research process
to be sure that no serious conflicts of interest could compromise study outcomes. But the OIG says that too few clinical investigators
submit the requested financial information and that many NDAs lack required reports. Companies object that earlier filing
would require reports about many investigators who are involved in studies that are never used to support efficacy.
Sen. Grassley and others also seek greater disclosure of manufacturer payments to scientists receiving NIH grants. NIH requires
researchers to report payments from drug companies that exceed $10,000 to detect conflicts of interest, but Grassley has uncovered
various prominent academics, particularly several leading psychiatrists involved in testing and making presentations about
widely used antidepressants, who failed to report millions in industry payments. NIH officials agree that more must be done
to police such activity, but are reluctant to examine the tax returns or income reports from thousands of researchers.
In anticipation of diverse and detailed tracking and disclosure requirements, manufacturers are establishing their own transparency
policies and programs. An updated marketing code from the Pharmaceutical Research and Manufacturers of America (PhRMA) advises
companies to disclose consulting arrangements with physicians who also serve on formulary committees. Pfizer (New York) recently
joined Eli Lilly, Merck (Whitehouse Station, NJ) and GlaxoSmithKline (London) in announcing plans to post data about financial
relationships with health professionals, and some companies are setting total annual caps on payments to individual physicians
to reduce possibilities for excessive influence.
Healthcare systems and academic research centers also are promoting transparency in researcher–industry relationships. Harvard
Medical School recently said it was reviewing its financial relations policy, and the Cleveland Clinic plans to publicly report
the business relationships of its staff with pharmaceutical makers. Stanford University, the University of Pennsylvania, and
branches of the University of California in Los Angeles and San Francisco have adopted strict conflict-of-interest policies.
Compliance with all the reporting requirements on the state and national levels is prompting manufacturers to implement data
systems that track payments to health professionals. IT vendors have developed programs to compile a company's "aggregate
spend" on research and marketing activities across corporate divisions and product lines. The aim is to collect in one place
all company payments to a physician, which may involve clinical research, consulting, and medical education for different
research programs and marketed products.
The move to make public data about physician prescribing information, as well as payments from manufacturers, raises concerns
among practitioners that broad public disclosure of prescribing records and practice patterns can be misinterpreted by the
public and generate inappropriate criticism. The American Medical Association has taken the issue to court to block the release
of physician-level Medicare claims data to a consumer organization seeking to compile physician report cards in local areas.
A Federal Appeals court recently supported the doctors' position that such disclosure violated their right to privacy. Employers
and insurers sided with the consumer group in arguing that transparency in healthcare quality and cost information can help
identify high-quality and efficient care.
In a related area, though, consumer advocates agree with physicians that pharmaceutical companies should not gain access to
physician prescribing information for marketing purposes. New Hampshire, Vermont, and Maine have enacted curbs to prevent
pharmaceutical sales representatives from targeting marketing efforts to high prescribers. And a federal Appeals Court ruled
in November 2008 that patient and prescriber privacy override the commercial speech rights of data-mining companies such as
IMS Health, which collect and sell prescribing data. The issue may end up before the Supreme Court.
Such legal conflicts reflect the difficulties in establishing disclosure and reporting requirements across the nation's healthcare
system. Physicians may be justified in fearing that superficial analysis of claims data might not recognize that a skilled
doctor gets a low-quality rating because he cares for more high-risk patients. But health reformers 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 Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, email@example.com