In May 2010, the Department of Health and Human Services (DHHS), proposed a new rule to amend its regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. This was to update to the National Institutes of Health (NIH) 1995 rules.
A major portion of the proposed rule required that reporting of financial conflicts be posted on the institutions website and the creation of financial conflict of interest websites.
However, earlier this month, NIH decided to drop the plan requiring universities to publicly disclose online what drug companies pay their faculty members, according to a report in Nature.
Background
The proposed new rule came about after congressional and media investigations revealed that prominent NIH grant recipients had failed to tell their universities or medical schools about lucrative payments from companies that may have influenced their government-funded research.
The DHHS called the proposed websites “an important and significant new requirement to … underscore our commitment to fostering transparency, accountability, and public trust.”
Under the proposal, institutions with NIH-funded researchers would determine, grant by grant, if any financial conflicts existed for senior scientists on the grant. For example, these would include receiving consultancy fees, or holding shares in a company, “that could directly and significantly affect the design, conduct, or reporting” of the research. The institutions would post the details online, where they would stay for at least five years.
According to NIH Director Francis Collins, MD, partnerships with industry and non-profits are essential in developing new therapies. But he made clear that to keep the public trust that research should be conducted without bias.
Francis Collins hailed it as a “new era of clarity and transparency in the management of financial conflicts of interest.” But the director of NIH “may have spoken too soon when he described a new rule.”
NIH Drops Disclosure Requirement
According to Nature, the cornerstone of Collins transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped. “They have pulled the rug out from under this,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a Ralph Nader guided “consumer-protection” organization based in Washington DC.
A government official with knowledge of the ongoing negotiations on the rule told Nature that the institutions will now be allowed to choose how to disclose this information, and will not be obliged to post it online.
Part of the reason for dropping the websites stems from the White House Office of Management and Budget (OMB). The OMB must sign off on the finalized form of the rule before it is published.
Consequently, the OMB is also charged with enforcing an executive order issued by President Barack Obama in January. It requires government agencies to consider the costs of new regulations, and to tailor them to minimize cost and bureaucratic burden.
“The websites don’t appear out of nowhere,” says Heather Pierce, senior director of science policy at the Association of American Medical Colleges (AAMC) in Washington DC. They would “require employees to not only create the website but to pull the information, review it, and make sure it is up to date and accurate.” This kind of work would have significant costs and require a tremendous amount of resources, training, oversight, and monitoring.
That is not the only objection from the powerful academic lobbies. During the public comment period last summer, the Association of American Universities and the AAMC submitted a joint statement saying: “There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed.”
The two groups note that the Physician Payment Sunshine Provisions of the affordable care act, a new law requiring drug firms to disclose their payments to physicians, requires the DHHS secretary to create a publicly available online database listing these payments. The groups suggest that the same model could work to publicize the financial conflicts of NIH-funded researchers.
NIH’s press office did not confirm the report on the status of the NIH’s long-delayed revised conflicts-of-interest rules and would say only that, “the current rule is under consideration by OMB.” But if the report is correct, the change would address the complaints from academic organizations.
Ultimately, it is important for the public to realize the implications of what is happening at NIH and within HHS. Publicly posting payment information and disclosure data has significant costs and to date, no direct benefits to patients or the public. While many proponents believe such information will help reveal bias and potential for conflicts of interest, there is no evidence to show that the benefits from publishing such information will outweigh the significant costs associated with developing this kind of system.
The goal of NIH funding is to provide research monies for basic research, and startup pharmaceuticals and devices mostly early phase research. It is hard to understand how scientists working at this level will be “overtly” influenced by industry funding.
Those who support the disclosure of such information are self-proclaimed “conflict-of-interest” experts, who receive funding and research grants to study “potential” bias. Instead of discovering ways to improve patient care and outcomes, these so-called “experts” want these payment databases so they can have an endless flow of data and information to keep them busy writing papers on “potential” instead of treating patients. Such “experts” are themselves conflicted for wanting this information only to fuel their own work because they have yet to tell us how such data will improve any part of our health care system.
NIH’s decision, if true, should be welcomed, and a sign for federal regulators at the Centers for Medicare and Medicaid (CMS) that the implementation of the Physician Payment Sunshine Act will also have similar issues and consequences.
While transparency is certainly a noble and important aspect of health care and medicine, and is necessary to ensure trust and integrity in our medical system, America and patients have priorities that are more important. We need cures for diseases, treatments for millions of Americans, and ways to reduce costs and hospital admissions. America needs more doctors and health care practitioners and we need more effective ways at preventing medical problems.
The Obama administration should be applauded for considering the effects that “rules” have on the progress of science.
Resolving these issues demands more money, education, training and staff, and the more time we spend counting the pennies and nickels doctors get for collaborating with industry, the less time patients will have to spend with their families. As the AAMC correctly recognized, the posting of this information will have little value to the public. Accordingly, Americans and federal agencies must focus on providing patients value, not in counting dollars, but by lives saved.