Manipulating the medical financial disclosure process
Update: March 16, 2011
The New England Journal of Medicine investigated our report of Dr. Gillison failing to disclose her Merck funding when she published in the NEJM last year. They informed us, “The (Gillison) disclosure form was updated on March 10th to include the information. We did not consider this misconduct because it falls into a gray area. Thank you for bringing the matter to our attention.” The Merck database still does not disclose the funding to Dr. Gillison, exposing one of the many flaws in the current “voluntary” reporting systems in place prior to the Sunshine Act kicking in.
March 3, 2011
(From The Healthcare Channel)
The Physician Payment Sunshine Act was finally passed as part of the ACA healthcare law. By 2013, it will mandate that healthcare industry payments be reported in a public database. In an attempt to get ahead of that impending legislation, many of the major pharmaceutical companies implemented “voluntary” reporting of payments to doctors. ProPublica made a searchable website, Docs for Dollars, that is driven by the data from these voluntary efforts.
Are the current reporting efforts comprehensive or are many forms of payments still going undisclosed? If so, are doctors, the drug industry, or both part of the problem?
The mainstream press has featured numerous stories relating to the alleged problem of a “growing risk” to males from Human Papilloma Virus (HPV). Correlating with the timing of these seemingly new breakthroughs in medicine have been the FDA approvals of two vaccines to prevent some forms of HPV: Gardasil, made by Merck, and Cervarix, made by GlaxoSmithKline.
The initial “low hanging fruit” to which the pharmaceutical companies marketed these vaccines was to young females as a way to prevent cervical cancer. The other half of the human population, males, also acquire genital HPV, but it is less life threatening. A more urgent reason to drive vaccine adoption among males would be to prevent a form of cancer. Enter the oral cancer debate.
One of the leading researchers asserting that oral cancer is caused by HPV contracted during oral sex (as opposed to smoking and tobacco use) has been Maura Gillison, MD, PhD. For her influential 2010 New England Journal of Medicine publication, Dr. Gillison completed a lengthy financial disclosure form and checked “No” for all questions relating to possible industry payments. Docs for Dollars and the voluntary reporting website from Merck list no payments to Dr. Gillison, as of the time of this story. 
The Healthcare Channel has exclusively learned that Dr. Gillison was in fact receiving payments from Merck, going back to 2008, that benefited at the least her laboratory, while she was at Johns Hopkins. Her Merck funding related to the HPV-16 diagnostic test in the NEJM paper: a product with significant potential commercial value if her theory of HPV-associated-oral-cancer proves to be true. Dr. Gillison failed to report these payments to the NEJM.
Dr. Gillison does currently list Merck as a financial disclosure in her numerous speaking engagements. However, Merck still does not list her in the company database. A spokesperson for Merck explained that the Merck web site only lists “speaker fees” and that none of the other numerous forms of payments to doctors, such as travel fees, laboratory grants, payments to serve on mock FDA advisory committee panels, etc. are reported. When asked whether those data are comprehensive, the spokesperson replied, “No. They are not”.
Merck declined our numerous requests to list the details of the fees that Dr. Gillison now reports. The HCC has learned that Dr. Gillison was being funded to develop some form of diagnostic for HPV. Since this did not directly relate to oral cancer caused by HPV, in her opinion, Dr. Gillison did not report the payments to the NEJM.
The Ohio State University Medical Center, Dr. Gillison’s current place of employment, also declined our numerous request for details about her Merck funding, even though she currently is reporting Merck as a source of funds. The HCC learned that Dr. Gillison was interviewed for “several hours” by the senior in-house legal council of the medical center as a result of The HCC investigations.
A recent ProPublica investigative report found that academic medical doctors frequently ignore the new university polices that limit or forbid Pharma-paid-speaking-engagements. To address this, The Ohio State legislature has a bill under consideration that “would require pharmaceutical manufacturers to submit annual reports that list gifts given to physicians who are authorized to prescribe drugs”. At the federal level, The Inspector General of The DHHS, Daniel Levinson, commented in 2010 that there is a systemic problem of financial conflicts of interest within the FDA, NIH, CDC, CMS, and other divisions of The DHHS.
HHS, Infectious Disease, Late Breaking Data, NEJM, Ohio State University, Policy | apples49 | 
January 26, 2012 1:00 am
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By Matthew Herper, March 4, 2011 @ 8:16 pm
I talked to Gillison about this twice, in 2009 and 2010, for two profiles, and she was upfront about her work with Merck both times. See here, http://bit.ly/1dKT0hm and here http://bit.ly/e84zRd.
Moreover, I’d say Merck has been, if anything, reticent to actually test this. I think this is a case of the hysteria about pharmaceutical conflicts burying a real public health problem, not of disease mongering.
By The Healthcare Channel, March 4, 2011 @ 8:30 pm
From The Healthcare Channel http://thehcc.tv/
The story speaks for itself. The Merck funding was not mentioned in the NEJM lengthy disclosure and Merck to this day does not report it
By The Healthcare Channel, March 4, 2011 @ 8:35 pm
We are not suggesting whatsoever that the drug industry should not fund academic research. We are pointing out that the current system of financial disclosures is quite often manipulated or ignored. ProPublica reported that most medical centers with polices banning doctors from accepting speaker fees still do so. Merck only reports a small portion of funding to doctors, etc