1 Boring Old Man

Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off
Healthcare Renewal
by Roy Poses
August 8, 2011

^{After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs.}

^{Weakening FDA Conflict of Interest Rules}

^…

^{Weakening NIH Conflict of Interest}

^{As discussed in Nature,}

^{Francis Collins hailed it as a ‘new era of clarity and transparency in the management of financial conflicts of interest’ (S. J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400–2402; 2010). But the director of the US National Institutes of Health (NIH) may have spoken too soon when he described a new rule, proposed last year, that would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers. Nature has learned that a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped.}

^{In more detail,}

^{The NIH’s parent agency, the Department of Health and Human Services (DHHS), proposed the new rule in May 2010, 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.}

^{But of course the medical schools decided that it would just be too much trouble to do all this:}

^{‘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’. 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.’}

^{Given how academic medical institutions have expanded their administrations and bureaucracy, the enormous amounts they spend on management, and the huge compensation they give their executives, and further given how much of their revenues come from government sources (Medicare, Medicaid money for patient care, Veterans Administration money supporting many faculty members, Medicare money funding graduate medical education, and NIH and other government research grants), the notion that getting a few staffers to process disclosures would be administratively or financially burdensome is just laughable.}

^{At least Iowa’s Republican Senator Charles Grassley, seemingly one of the last politicians in Washington who cares about the integrity of government programs and spending, is upset. As reported again by Nature,}

^{The US Senate’s leading advocate for government transparency wrote today to the White House’s budget office, demanding that it protect a proposed rule that would obligate universities to post their publicly-funded biomedical researchers’ financial conflicts on a publicly accessible website. The public’s business should be public… I urge OMB to follow through and approve a rule that includes a publicly available website,’ Senator Charles Grassley, Republican of Iowa …, wrote in in this letter to Jacob Lew, the director of the White House’s Office of Management and Budget (OMB).}

^{Furthermore, he wrote:}

^{I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government.}

^{We will see if his protest does any good, but again it appears that government officials are more worried about the revenues of big health care organizations than the needs of the public.}

^{Retreating from Threats to Disbar Forest Laboratories CEO}

^…

^{Summary After a bit of blustering by the current US administration about transparency and integrity it appears to be back to business as usual in the US capital. Over the last 20 years, government has increasingly answered to corporate CEOs instead of "we, the people." Protecting patients’ and the public’s health has given way to protecting the financial health of large health care organizations, and the compensation of rich CEOs. Federalism is giving way to corporatism. As long as this continues, expect our health care system to continue its slow collapse. Eventually, expect the CEOs to get in their private jets and escape while the rest of us picks up the pieces. Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients’ and the public’s health first, way ahead of the financial comfort of corporate CEOs.}

The two recent surveys showing the increase in prescriptions of psychoactive drugs by Primary Care Physicians posted below [medicine at its worst…] highlight the stakes involved in reform, and the Hospital Corporations and PHARMA lobbies will not go down easily. In spite of all the punitive settlements against PHARMA, they’ve still made a killing, and they are obviously fighting tooth and toenail to block the needed reforms and transparency. It would be naive to assume that reform would be easy. Senator Grassley is a Saint, maybe the first Republican Saint since Lincoln, but he can’t do it by himself. But the part that gets to me is that the Academic Institutions are on the wrong side of this battle. "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.’" There’s something terribly wrong about that alignment. That’s something that I just don’t understand. My notion of academia must be even more naive than I know. I guess it’s time for some [potentially disillusioning] research…