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Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates and these cures, long held back by the dam of the FDA, would flow to the people. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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The false hope of “right-to-try” metastasizes to Michigan

Nurse administers chemotherapy

Ed. note: Please read disclaimer in Dr. Gorski’s profile!

There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy and I have both written about them before, and with the passage of the first such bill into law in Colorado in May, I had been meaning to revisit the topic. Although “right-to-try” laws are a bad policy idea that’s not new, versions of such bills having been championed by, for example, the Abigail Alliance for at least a decade, the recent popularity of the movie Dallas Buyers Club appears to have given them a new boost, such that Colorado state Senator Irene Aguilar even frequently referred to her state’s right-to-try bill as the “Dallas Buyers Club” bill. It’s a topic I’ve been meaning to revisit since the news out of Colorado, but apparently I needed a nudge, given that it’s two months later now.

Unfortunately, that nudge came in the form of a right-to-try bill (Senate Bill 991) being introduced into the legislature in Michigan by Senator John Pappageorge and unanimously passing, almost without comment by the committee and certainly with minimal news coverage, through the first hurdle, the Michigan Senate Health Policy Committee. In parallel, the same legislation (House Bill 5651) has been introduced into the Michigan House of Representatives.
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Posted in: Cancer, Pharmaceuticals, Politics and Regulation

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Expanding the scope of practice of advanced practice nurses will not endanger patients

One of my New Year’s resolutions for 2014 for the blog, besides looking for talented bloggers to add to our pool of awesome bloggers, was to try to look at areas of science-based medicine that we don’t often cover (or haven’t covered before), such as the delivery of health care. Fear not, I’ll certainly do enough posts on the usual topics, but I am going to make a conscious effort to diversify a bit, if only for my own personal growth. Ironically enough, in the couple of months before the end of 2013, just such an issue came up in my state. Uncharacteristically (for SBM at least) the topic I’m going to take a look at has nothing to do with the infiltration of the pseudo-medicine known as “complementary and alternative medicine” (CAM) or “integrative medicine” into academia or CAM practitioners like naturopaths or chiropractors trying to lobby state legislatures for greater scope of practice to ply their pseudo-medicine on an unsuspecting public. It does, however, have to do with expanding the scope of practice of a group of medical professionals, and, unexpectedly and disappointingly, it’s a proposal that’s had considerable resistance from various physicians’ societies in the state. I’m referring to advanced practice nurses (APRNs), often referred to as nurse practitioners (NPs).

Before I go on, it’s necessary for me to point out my conflict of interest. No, I haven’t received funding from the all-powerful American Association of Nurse Practitioners (whose influence, actually, is dwarfed by state medical societies and various physician groups). I do, however, have a very personal relationship with a nurse practitioner, namely my wife. However, I would point out that she hasn’t been an NP that long, and I routinely worked with NPs collaboratively long before the idea of becoming a nurse or even an NP was even a germ of a thought in my wife’s brain. Make of that admission what you will as you read on.
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Posted in: Politics and Regulation, Public Health

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