The following is a guest blog post by Dr. Susan Molchan, one of our independent expert editorial contributors.
On October 5 I attended an event entitled “How Fast to Cures?” hosted by Politico, a well-established media organization that publishes a magazine and other content on politics and policy in Washington, DC.
The topic of discussion by four professionals from various realms of the research and health care advocacy world was the increasingly contentious 21st Century Cures Act. The House of Representatives passed its version of the Act last summer, and the Senate is working on its complement. Its ostensible goals are to bring “health care innovation infrastructure into the 21st century,” thereby facilitating scientific discovery and delivery of cures for all matter of diseases. Many people think that many of the provisions of the Act as currently written will make newly approved drugs and medical devices less safe and effective, increase costs of these products, and actually discourage innovation in biomedical research, as colleagues and I outlined in a blog post published in Health Affairs last month. These may be anticipated “unintended consequences” as all-too-frequently happens with legislated “solutions,” or more likely, the legislation is truly intended primarily to benefit the pharmaceutical and medical device companies who fund many of the politicians and organizations advocating for it.
This latter impression carved itself into my mind when I walked into the room where the Politico discussion was to take place. I had a bit of a flashback. I immediately saw a pharmaceutical company logo—in this case that of Shire, which was sponsoring the forum. It was eerily like a medical conference, and I half-expected a smiling, impeccably dressed young drug rep to run up and offer me pens and pads and coupons for best sellers Adderall and Vyvanse. The company did serve lunch (which I skipped) and did have a number of (impeccably dressed) representatives present. I held back from asking any of them about the $56.5 million fine the Department of Justice (DOJ) had levied against the company last year for what the DOJ said was overstating effectiveness and down-playing hazards of Adderall, Vyvanse, and other drugs. The amount of the fine represented only about 1% profits. Such fines are considered by many pharma companies as a cost of doing business.
The Politico-Shire forum was held at the Newseum, a showcase for journalism, a profession with ideals that include fairness and an attempt to achieve balance versus bias in reporting (I think). While the questions and comments from moderator Arthur Allen from Politico seemed moderate enough, the panel was clearly stacked, in my estimation, favorably towards the 21st Cures Act, three to one. As I digested these panelists’ opinions, it was clear to me which ones had corporate partners that included pharmaceutical company interests.
But in contrast to medical conferences, no declaration of these conflicts of interests was made–something I thought a media-moderated discussion would have been especially attuned to. I looked at the Politico website to get a better idea of the sponsor-Politico relationship, and the first ad that popped up—right at the top of the page as well as additional ads at two other places–were from the Pharmaceutical Research and Manufacturers of America (PhRMA). Oh, no wonder no disclosures, I thought. PhRMA is the primary trade association for pharmaceutical companies in the U.S.
Clicking on the top ad, I found the featured content: “New poll finds majority of voters oppose government price-setting for prescription drugs” and “4 Facts on Why Importing Drugs is Bad for Patients.” These policies are also very bad for pharmaceutical companies.
So, for completeness, the participants of the forum were: Margaret Anderson, Executive Director of FasterCures, a Center of the Milken Institute, which receives plenty of pharmaceutical sponsorship for their conferences; Mary Woolley, President and CEO of Research!America, which, among its 350 member organizations lists over three dozen corporations including many pharmaceutical companies; Joel White, Executive Director of HealthITNow, which listed as partners FasterCures and Research!America, as well as a number of other organizations with corporate interests and/or heavy corporate sponsorship, e.g. the U.S. Chamber of Commerce, the National Alliance on Mental Illness; and finally Diana Zuckerman, President of the National Center for Health Research, a small research and advocacy organization that uses evidence-based information to encourage new, more effective treatments, programs, and policies. They do not benefit from financial relationships with pharmaceutical or medical device companies.
Everyone delivered their “lines” as expected, with the techie guy referring to “granular insights” more than once. The moderator referred to a commentary Diana had published together with Gregg Gonsalves, an AIDS activist from the ACT-UP era that opined that the 21st Century Cures Act would further erode progress in safety and effectiveness standards made at the FDA since that era. Diana gave a recent example of how her group looked at biomarkers (amyloid plaques in the brain) for Alzheimer’s disease in phase two studies of three drugs that appeared promising. The biomarkers responded to the drugs but the patients didn’t, and for one drug memory loss worsened. Under the standards of 21st Century Cures, she said, these drugs could well have been approved. Ms. Woolley disagreed, noting that the language in the bill doesn’t mandate approval based on such evidence. Moderator Allen brought the discussion back to the realities of Washington by saying, the bill may not mandate but “if I’m at the FDA . . . if I start getting calls from Congressman X, who’s got the Alzheimer’s Association and ten other groups all pressing ‘why aren’t you getting off your can on this drug?’” that’s where essentially what isn’t necessarily a legislative mandate in writing becomes one in reality. (Note: Like many advocacy organizations, the Alzheimer’s Association receives scads of money from the pharmaceutical industry.)
I could go on with examples, but this post is not a book. Let’s just say that this author — a physician who’s testified before Congress on conflicts of interest in medicine; is very well-informed about those conflicts; and has published on the issue before — was once again astounded by the reach of pharmaceutical companies, and sad to see what I thought was a fine media outlet let Pharma eat them for lunch.
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