Research conflicts

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.

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.

Privacy protection

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, jwechsler@advanstar.com