Shortages and Sunshine - Pharmaceutical Executive


Shortages and Sunshine

Pharmaceutical Executive

Seeking results

Demands for transparency also apply increasingly to clinical trial activities and results, thanks to new laws and regulations that expand trial registration requirements and the disclosure of research findings. However, evidence that much research information remains unknown raises questions about how well sponsors comply with research disclosure policies.

The good news is that sponsors of FDA-regulated clinical studies are doing a better job in registering trials on the website, as required by the FDA Amendments Act of 2007 (FDAAA). This has created a massive database at the National Institutes of Health (NIH), with information on some 100,000 studies.

What seem to be missing are required reports summarizing the results of registered trials. FDAAA gives sponsors 12 months following study completion to provide results, and preapproval studies don't have to be posted for up to three years to protect proprietary information. However, an analysis published last December (2011) in the journal Health Affairs by researchers at the University of British Columbia found that only 12 percent of completed trials issue results within a year. And just 14 percent of post-marketing studies meet the one-year submission timeframe, despite the importance of timely information on drugs already used by patients.

A similar report published in the British Medical Journal (BMJ) in January (2012) found that only 22 percent of registered trials subject to mandatory reporting in 2009 made results available within a year of study completion. Interestingly enough, pharma companies do better in posting study results than investigators funded by NIH, but no one gets high marks. The analysts urge stricter enforcement of reporting requirements to improve research transparency: NIH should withhold grants to slow responders, and FDA should levy $10,000-a-day fines. House Democrats agree and sought explanations for disclosure delays from commissioner Hamburg and NIH director Francis Collins.

Despite these problems, transparency advocates want to extend disclosure to include data from clinical trials for products that FDA fails to approve. While all investigational studies have to register on, summary results are required only for research that supports medical products that eventually reach the market. But many scientists believe that much useful information can be obtained from failed studies, and it could help sponsors and investigators avoid repeating unsuccessful research.

Too much sunshine?

Fake Drug Fools Oncologists
On another front, pharmaceutical, biotech, and medical device companies soon will have to report all payments to doctors for inclusion in a new public database. The main thrust of this "Sunshine" policy, which was included in the Affordable Care Act of 2010, is to disclose all industry "transfers of value"—fees, grants, free meals—that could influence medical practice and prescribing. Fees to physicians and teaching hospitals for research activities also are included, a requirement that medical societies fear will make payments for bona fide research activities look like big handouts from pharma.

Because the Centers for Medicare and Medicaid Services (CMS) issued its proposed rule for implementing Sunshine in December 2011—months past the original due date—the agency is postponing initial data collection from pharma until after it finalizes the policy. No one knows, though, when that will occur or how the data filing process will be carried out.

Meanwhile, industry and provider groups met the mid-February deadline for filing comments, which reflect concerns about how payment data will be posted and reviewed. Many commenters seek broader contextual information on the CMS website describing the nature of relationships and interactions between manufacturers, physicians, and teaching hospitals. There's also interest in dropping reports for accredited and certified continuing medical education, which often is funded by grants from marketers that have no say on physicians serving on the programs.

The research-related reporting provisions came under fire from medical societies and research organizations, many asking CMS to drop this provision altogether. The American Thoracic Society, for example, said that public reporting of research payments implies that "research is somehow an inappropriate activity for physicians." Congress included reporting on research, the pulmonologists note, to prevent industry from "hiding" payments under the guise of research, but not to taint investigators. The Association of Clinical Research Organizations (ACRO) similarly proposed cancelling reports on payments from manufacturers for legitimate research activities "as there is no evidence that such payments bias prescribing or other practice behavior."

A specific problem is that the proposed reporting system will lead to double counting of payments for R&D services. This will occur, as Pfizer explains in its comments, because a $10,000 payment to a teaching hospital serving as a clinical study site also would be reported as a $10,000 "indirect research payment" to the associated principal investigator. To prevent such errors, the Association of American Medical Colleges (AAMC) suggests that industry should report research-related payments only to the institution involved, and not to individual physicians connected to a hospital.

ACRO predicts that public reporting of legitimate research activities could cut the number of physicians participating in trials by one-fourth. Without many of the proposed changes, says ACRO, data related to research will be "incomplete at best, terribly inaccurate at worst."

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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