Monday, December 31, 2007

More Questions about Industry Influence on the Reagan Udall Foundation

According to the FDA News, an appropriations bill just passed denied funding to the new Reagan Udall Foundation. According to an FDA press release, "the private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety."

Questions have been previously raised about the influence industry would have on this foundation. The FDA News previously reported

Rep. Rosa DeLauro (D-Conn.), chairwoman of the subcommittee that funds the FDA, has warned that there is no framework to minimize the industry’s influence on the foundation.

Earlier this year, DeLauro sent a letter to FDA Commissioner Andrew von Eschenbach expressing concerns with pharmaceutical industry funding of the foundation, saying it could endorse the approval of drugs based on lower standards. The FDA should postpone activities related to the foundation until it can assure the pharmaceutical and device industries will not have undue influence, DeLauro said.

Not only would the foundation get money from industry, the leadership of the foundation would have direct and indirect industry ties. The legislation setting up the foundation authorized some seats on the board of directors for people representing industry. Thus the new board includes the President and CEO of GE Healthcare, a Senior Health Policy Advisory [sic] from Genzyme Corporation, and the Group President of Johnson and Johnson Pharmaceutical Research and Development (per the press release).

Other board members appear to have conflicts of interest, however. We previously posted to note that Dr Tadataka Yamada was formerly an executive of GlaxoSmithKline, and was alleged by a report by the US Senate Finance Committee to have been involved in the intimidation of an early critic of rosiglitazone (Avandia) (see post here). Also, Dr William Brody just retired as a board member of Medtronic Inc, and as of the July, 2007 proxy statement, held over 76,000 Medtronic stock shares or options.

Some quick work with Google reveals that two other board members also have industry ties. Phillip A Sharpe, according to his CV, is:

He also was "Co-founder of Biogen, Inc., 1978 (now Biogen Idec), Chairman of the Scientific Board (to 2002) and member of the Board of Directors."

Also, the not-for-profit chaired by Ellen V Sigal, Friends of Cancer Research, gets extensive funding from the pharmaceutical industry. Its largest donors include Amgen, AstraZeneca, Bayer HealthCare, Bristol-Myers Squibb Oncology, Genentech Inc, GlaxoSmithKline, Johnson and Johnson, Novartis Oncology, Pfizer Inc, and the Pharmaceutical Research and Manufacturers of America, according to its most recent report.

That adds up to a majority (seven of 13) of the Reagan Udall Foundation board with ties to the pharmaceutical, biotechnology, and medical device industries. There is reason for concern that this foundation, despite its relationship to the FDA, is likely to put the interests of these industries ahead of those of the general public.

Yet, the FDA News quoted Peter Pitts, described as "Center for Medicine in the Public Interest President," on Rep DeLauro's concerns, "These sorts of fear tactics are extraordinarily contrary to public health. It just shows how low a point we have reached when a member of Congress can accuse the FDA and the pharmaceutical industry of actually striving to lower standards. It’s just absurd." Pitts, of course, neglected to mention that (as we have discussed most recently here) he holds down the day-job of Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the site. As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view, which the quote above seemed to do.

The pharmaceutical, biotechnology, and medical device industries already have extraordinary resources to market their wares and shape public opinion. They do not need a government sponsored foundation to help them innovate or develop products. The public does deserve a government agency that protect its health and safety by making sure that drugs and devices are safe and effective, and that operates free of the influence of those with vested interests, especially in the drugs and devices the agency is supposed to evaluate.

ADDENDUM (4 January, 2008) - See follow-up on this by Ed Silverman on the PharmaLot blog.

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