Wednesday, December 21, 2011

IN MY VIEW: IOM Report Essentially Recommends that Tobacco Research Funds Be Laundered Through Corporate-Influenced Third Parties

In the last two days, I have commented on two aspects of the IOM report on modified risk tobacco products. First, I argued that the report recommends such stringent scientific standards for the approval of reduced risk products that it puts a nearly insurmountable obstacle in the path of these products and thus helps protect the most highly toxic existing tobacco products. Second, I argued that the report recommends another insurmountable obstacle in the path of reduced risk products: the need to conduct clinical trials with existing cigarettes as a control, which would be unethical.

Today, in the third in a three-part series on the IOM report, I address the IOM committee's suggestion that tobacco companies not be permitted to conduct their own studies in support of modified risk tobacco product applications, but that instead, they should provide funding to an "independent," "third-party" institution to conduct the research.

The reason for this requirement, according to the report, is that: "The history of public distrust and the absence of governance in the tobacco industry have created an isolated industry that lacks not only the expertise to produce the necessary range of credible and reliable data, but it also lacks the trustworthiness to acquire external expertise and avenues to disseminate acquired data."

The solution, according to the report, is: "To improve the credibility of the studies in support of an MRTP application under Section 911, tobacco product sponsors and the CTP should consider facilitating the creation of a third party or third parties for the conduct and oversight of these studies."

What might such a third party entity look like? The report suggests that a "possibility for an organizational model lies in the Reagan-Udall Foundation (RUF), which advises the FDA on modernizing regulatory science. It conducts and oversees studies on regulatory science, particularly in the emerging fields of pharmacogenomics and genomic-based prediction of drug response and adverse event risk."

The Rest of the Story

The IOM report is simplistic and naive in believing that by laundering money through a third-party, research funded by the tobacco industry magically becomes equivalent to research not funded by the industry or to research conducted independently of the industry. The research is still being funded by the tobacco companies and any influence of tobacco funding is not going to suddenly disappear. Instead, what the structure does is create the appearance that research is independent of the industry when in fact, that research is being funded directly by the industry.

In fact, what this could end up doing is reducing scrutiny of such research. Whereas work funded by the tobacco industry would undergo strict scrutiny, by laundering the money through an independent organization, the connection to the tobacco industry would no longer be apparent. The work would take on an automatic assumption of impartiality when such an assumption is not warranted.

An excellent example of this effect is a study conducted by Dr. Claudia Henschke of the use of CT scanning for the early detection of lung cancer.

In an October 26, 2006 article in the New England Journal of Medicine, Dr. Claudia Henschke of Weill Cornell Medical College and a group of other investigators reported the results of a study of the use of low-dose spiral CT scans as a screening tool to detect lung cancer among asymptomatic individuals. The article reported that 85% of patients with lung cancer detected had stage I cancer and the estimated 10-year survival among these patients was 88%. The study concluded that: "Annual spiral CT screening can detect lung cancer that is curable" and that "such screening could prevent some 80% of deaths from lung cancer."

The paper listed its funding sources at the end, one of which was the Foundation for Lung Cancer: Early Detection, Prevention & Treatment.

The New England Journal of Medicine has a policy of not publishing any paper supported with funds from the tobacco industry. Not seeing any disclosure of funding from the industry, the Journal published the paper.

The rest of the story is that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment was, according to a New York Times article, "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands. The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003."

According to the New York Times article and a concurrent article in The Cancer Letter, the Journal of the American Medical Association was also deceived by the absence of disclosure of Dr. Henschke's tobacco funding and would never have published her paper had they known that Henschke received tobacco industry money for her CT screening research.

Had the study been directly funded by Liggett, the article would have had to disclose this. Instead, the article was able to hide behind the Foundation sponsor's name, which sounded independent. Two major medical journals were deceived about the nature of the study's funding and the article did not receive the scrutiny that it would have if it were known that industry funding were behind the study.

The IOM report clearly views tobacco money as being tainted. But the committee is deceiving themselves if they believe that the money is magically cleansed just by passing hands from the tobacco industry to a third party.

Let's now look specifically at the entity which the IOM report puts forward as being an example of what an independent, third-party institution might look like: the Reagan-Udall Foundation.

Far from being an independent entity, the Reagan-Udall Foundation is heavily funded by and partly controlled by industry. On the Board of the Foundation are:
  • the President and CEO of the Grocery Manufacturers Association;
  • the President and CEO of GE Healthcare;
  • a senior adviser to the Genzyme Corporation; and
  • a group president of Johnson & Johnson.
Thus, the Reagan-Udall Foundation is partially controlled by Big Food, Big Pharma, and Big Biotechnology.

And by statute, the Foundation's Board must include "four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries."

Far from being an independent third-party scientific foundation, the Reagan-Udall Foundation serves as an institutionalized strategy to ensure that industry has a continuing influence on health policy, in spite of the science.

Moreover, it ensures that conflicts of interest abound and that scientific decisions are not made independently from corporate interests.

The Reagan-Udall Foundation has been criticized because it goes a long way toward turning the FDA into a drug company. It has been further criticized because of undue influence by corporate interests. As a Health Care Renewal article by Dr. Roy Poses pointed out, several of the Foundation's Board members who do not directly represent Big Food, Big Pharma, or Big Biotechnology have previously worked for those industries and/or have financial conflicts of interest with those industries. In fact, Dr. Poses notes that a majority (7 of 13) of the original Reagan-Udall Foundation Board members had "ties to the pharmaceutical, biotechnology, and medical device industries." The Health Care Renewal article concludes that: "There is reason for concern that this foundation, despite its relationship to the FDA, is apt to put the interests of these industries ahead of those of the general public."

The article concludes: "The pharmaceutical, biotechnology, and medical device industries already have astounding resources to market their wares and shape public opinion. They don’t 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 bureau is supposed to evaluate."

An article at 24-7 News summarizes the problem:

"Drug company executives are allowed to serve on a new Food and Drug Administration (FDA)-related board called the Reagan-Udall Foundation. ... The foundation is supposed to help improve the drug approval process, but with so many scandals involving defective drugs in recent years, is it wise to give the pharmaceutical industry so much say on the Reagan-Udall board? Does this just shriek conflict of interest? Well, this new food and drug research foundation, which is affiliated with FDA, brings private companies into a curiously close relationship with regulators like the FDA. Serving as chairman of the Reagan-Udall board is former FDA Commissioner Mark McClellan; executives from drug makers Johnson & Johnson and Genzyme, medical device maker General Electric Company, and the Grocery Manufacturers Association, which includes Hormel Food Corporation and Kellogg Company, were among those picked to lead the Foundation. ... consumer advocates and some lawmakers have criticized the relaxed partnership, stating that allowing companies to fund government-sanctioned research could increase the FDA’s vulnerability to industry clout. They also question how the FDA will be able to objectively review products that incorporate its own research and if this new collaboration will open potential for pressure on the FDA."

Byron Richards describes the Reagan-Udall Foundation in even more alarming terms: "Kennedy and Enzi are claiming that the Reagan-Udall Foundation for the FDA is nothing but a friendly non-governmental research foundation. I will fully document in a subsequent article that this is not the case. It is actually the tool by which Big Pharma and Big Biotech will lock in their profits for the next 50 years, as FDA joins them in the drug development and marketing business. This is one of the greatest safety threats in the history of America."

Representative Rose DeLauro (D-CT) criticized the legislation that created the Reagan-Udall Foundation, calling on the FDA "to cease all activities related to its creation." DeLauro argued that: "the Reagan-Udall Foundation will compromise FDA’s independence and favor the drug industry that will be funding it. Even FDA officials have acknowledged that the donors to the Foundation will have the primary say over how the funds are used."

The IOM committee is deceiving themselves if they think that a so-called "independent" third-party like the Reagan-Udall Foundation is going to use tobacco industry funding to produce unbiased scientific research.

The IOM report wants to have it both ways. It wants to view tobacco industry money as tainted and any tobacco-funded research as non-credible. But then it wants to make tobacco industry funding of research the basis for modified risk product applications. The only difference is that rather than conducting the research itself, the tobacco funding will be laundered through a third party. It just doesn't work. A horse of a different color is still a horse.

The bottom line is that if you are going to regulate the tobacco industry and require the industry to submit scientific research to support its applications for certain classifications of products, you cannot then tell the industry that it cannot conduct research and use that research in its applications.

The rest of the story is that the IOM report play along with the continuing hoax that is the Family Smoking Prevention and Tobacco Control Act. The Act was designed to protect today's highly toxic, existing cigarettes by putting huge obstacles in the way of the introduction of potentially safer products. The anti-smoking groups and politicians who supported the legislation want it to look like they are reforming the tobacco space and forever changing the landscape to favor the protection of the public's health. But the opposite is true. The Act institutionalizes the existing tobacco market and makes true reform almost impossible.

The IOM committee can hide behind the charade of having us believe that research funded by industry automatically becomes objective and unbiased when the money changes hands to a third-party. But the truth isn't all that difficult to see. It's not only the tobacco companies that have been deceptive. It's the anti-smoking movement as well.

No comments: