This week, the federal government is releasing the final version of long-awaited transparency rules to disclose the financial ties between medical researchers who receive billions of dollars in federal funding and the pharmaceutical industry. On Aug. 4, Sen. Chuck Grassley of Iowa urged the government not to dilute the rules. Grassley's prior oversight uncovered several instances of such financial relationships that were not public. Grassley's letter to the Office of Management and Budget came in response to a media report that the agency was removing the requirement in the proposed rule for a publicly available website that would publish the outside financial interests of researchers funded by taxpayers. The final rules include the diluted, weak requirement: Information about an individual with a significant financial interest in the subject of a federally funded research project must be disclosed via a publicly accessible website or via written response to any requestor within five business days. Grassley made the following comment on the final rules.
"Making the method of disclosure optional hurts public access. An institution that doesn't want to disclose information readily will be able to opt for the written request, knowing that requiring a request in writing is a barrier. It's easier to look up information online than have to find the right addressee, write the letter, and wait for a response. This is a missed opportunity to inject transparency where it's really needed. With less public scrutiny than we could have had, we'll lose a valuable layer of oversight. This is ironic, coming from an Administration that pledged more transparency in government. Transparency requires action, not just words."
The final rules are available here.
The text of Grassley's Aug. 4 letter is available here.
The text of Grassley's Aug. 4 news release follows below.For Immediate Release
Thursday, August 4, 2011
Grassley Urges Agency Not to Weaken Federal Health Research Transparency Rule
WASHINGTON - Sen. Chuck Grassley today urged a key federal agency not to dilute a long-awaited transparency rule that would help disclose financial ties between medical researchers who receive billions of dollars in federal funding and the pharmaceutical industry.
"The public's business ought to be public," Grassley said. "Transparency is a backstop against research that's compromised by doctors' self-interest, to the detriment of consumers. Backsliding on transparency would undermine the good work done in recent years to shine a light on these financial relationships."
Grassley wrote to the Office of Management and Budget in response to a media report that the agency is proposing to weaken transparency rules proposed in May 2010 by the Department of Health and Human Services. According to the article, the Office of Management and Budget is removing the requirement in the proposed rule for a publicly available website that would publish the outside financial interests of researchers funded by taxpayers.
The Department of Health and Human Services includes the National Institutes of Health (NIH), which is the primary means of federal funding of medical research at universities and large medical centers. The President's proposed budget for the National Institutes of Health for 2012 is $32 billion, with about 83 percent dedicated for research around the country.
In 2007, Grassley began looking into whether universities have disclosed their professors' outside financial interests and found several cases indicating that more transparency might be helpful, including:
--The chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company's drugs with an NIH grant. The Health and Human Services Office of the Inspector General is now investigating the matter.
--The chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking Food and Drug Administration approval of said drug. He was later removed from the grant.
--Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with Grassley's office.
Also, the Inspector General for the Department of Health and Human Services concluded that the NIH doesn't adequately monitor its outside grants for conflicts of interest.
A law enacted last year through Grassley and Sen. Herb Kohl will require public disclosure of drug company and medical device manufacturer payments to doctors, starting in March 2013.
The rule proposed for NIH grants would require the research institutions to determine potential conflicts of interest grant by grant, such as whether the doctor owns shares in a company that could cause bias in his or her federally funded research. The details would have to be posted online for public access. The Office of Management and Budget is proposing to eliminate the online requirement, according to a media article.
"If the online requirement is gone, it will be much harder for the public to see and use this information," Grassley said. "Without public scrutiny, we'd lose a valuable layer of oversight."
The text of Grassley's letter is available here.
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