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Archive for Politics and Regulation

The illusions of “right to try” laws

[Ed. Note: For additional commentary on why "right-to-try" laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.]

There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside the FDA’s clinical trial process have touching anecdotes in spades. If I, or a loved one, had a terminal cancer, I’d probably be right there with them, telling my story and hoping to get my hands on an investigational drug, no matter how slim the chance for improvement it offered. But a less emotion-driven analysis of so-called “Right to Try” bills currently before several state legislatures reveals some sobering truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

“Right to Try” bills are pending before four state legislatures: Colorado, Louisiana, Arizona and Missouri. We’ll get to the details of these in a bit. Legislators in other states have expressed an interest in filing similar bills. On February 26th, a Missouri legislative committee “heard emotional debate from supporters of a bill that would allow makers of investigational drugs, biological products or devices to make them available to eligible terminal patients.” Among those testifying were the parents of a young girl with a brain tumor and the father, a physician, of a patient with metastatic colon cancer. These stories are hard to hear and make it hard to say no.

The Right to Try bill has been christened with another catchy name (Warning! Link to credulous media report!) – the Dallas Buyer’s Club bill after the terrific movie which just won Matthew McConaughey and Jared Leto Academy Awards for best actor and best supporting actor, and deservedly so. It depicts a macho, homophobic, HIV-infected cowboy (McConaughey) who saves the day battling the evil, bureaucratic FDA and the medical establishment. He skirts the law to bring life-saving drugs to AIDS patients at a time when AIDS was pretty much a death sentence. The plot even includes a delicensed American doctor who supplies the unapproved drugs from his Mexican clinic. And dietary supplements, of course. (You’d be tempted to suspect Stanislaw Burzynski, Hulda Clark and a naturopath co-authored the script.) But no matter its merits as a movie, it is just that, a movie. It is based on a true story but its interpretation of events has been called into question. (Orac also deconstructs the factual inaccuracies on Respectful Insolence today.) Nevertheless, it is a public relations boon to the Right to Try promoters, although, considering their decidedly right-leaning political inclinations, there has to be a certain amount of squeamishness in associating their cause with a movie featuring raunchy, sexually-explicit scenes, lots and lots of cussing, and a colorfully dressed trans-gender person (Leto) as its most sympathetic character. (more…)

Posted in: Cancer, Clinical Trials, Legal, Politics and Regulation

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Measles gets a helping hand

In a recent post I shared a bit of my personal, near-death experience with measles during the US epidemic of 1989-1991. As I describe in that post, I contracted a very serious measles infection at the end of medical school, and was highly infectious when I interviewed for a residency position at Seattle Children’s Hospital. Like others my age who received an ineffective, killed measles vaccine between 1963 and 1967, I had not been adequately protected. The MMR vaccine was not yet available, and no boosters were recommended at the time. Unfortunately, though my measles titers (a test of immunity to measles) were checked when I entered medical school, the school’s student health department failed to notice or respond to the results – I was not immune and did not receive a booster dose at that time, as I should have. That mistake was huge, and could have cost me my life. It also caused me to potentially sicken many vulnerable children during my tour of the hospital, as well as others I may have inadvertently exposed during the window of communicability as I walked the streets of Seattle. The Department of Health had to be called to trace all of my steps and attempt to track down and protect any potential contacts.
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Posted in: Epidemiology, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Vaccines

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Eric Merola and Ralph Moss try to exhume the rotting corpse of Laetrile in a new movie

Note: Some of you have probably seen a different version of this post fairly recently. I have a grant deadline this week and just didn’t have time to come up with fresh material up to the standards of SBM. This left me with two choices: Post a “rerun” of an old post, or recycle something. I decided to recycle something for reasons explained in the first paragraph of this post.

As I was deciding what to write about this week, I realized that, surprisingly, there is precious little on Science-Based Medicine about the granddaddy of modern cancer quackery, Laetrile. Given that the final nails were placed in the coffin of the quackery that was Laetrile more than 30 years ago in the form of a clinical trial that didn’t show a hint of a whiff of benefit in cancer patients, many of our younger readers might not even know what Laetrile is. But, as I explained when I wrote about Stanislaw Burzynski’s early years in the 1970s, which happened to be they heyday of Laetrile, in cancer quackery everything old is eventually new again, and Laetrile is apparently soon to be new again. True, it’s never really disappeared completely, because, again, no matter how discredited a cancer quackery is, someone somewhere will keep selling it and some poor cancer patient somewhere will be taken in. In any case, it occurred to me that we at SBM have discussed the politics of Laetrile. Indeed, Kimball Atwood once referred to it as the “the most lucrative health fraud ever perpetrated in the United States.” Moreover, Kimball makes a convincing case that the Laetrile controversy was an important precursor that laid the groundwork for advocates of “alternative medicine”—or, as it later became known, “complementary and alternative medicine” (CAM) or “integrative medicine—to successfully lobby for the founding at the National Institutes of Health of what later was named the National Center for Complementary and Alternative Medicine (NCCAM). However, there didn’t appear to be a post dedicated to discussing Laetrile itself, and something happened last week that allows me to rectify that situation.

So how is Laetrile about to become new again? Remember our old buddy Eric Merola? He’s the guy who made two—count ‘em—two conspiracy-laden, misinformation-ridden, astonishingly bad bits of “great man” propaganda disguised as documentaries about a Houston cancer doctor peddling unproven cancer treatments and charging his patients tens and even hundreds of thousands of dollars for the privilege of being under his care while receiving this magic elixir, known as antineoplastons. Over the last several months, ever since he unleashed Burzynski: The Sequel on an unprepared and uninterested world, Merola has been hinting about his next project. Given Merola’s involvement in Zeitgeist: The Movie and his primary role in throwing together two hack propaganda pieces that were so blatantly worshipful of Burzynski that Leni Riefenstahl, were she still alive and able to see them, would have told Merola to cool it with the overheated hero worship and portrayal of his movie’s subject as a god-man a bit, I knew his next movie would be more of the same. I also knew it would not be about Burzynski.
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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A cure for chiropractic

Almost 10 years ago, a thoughtful article, entitled “Chiropractic as spine care: a model for the profession”, appeared in the journal Chiropractic & Osteopathy. The authors were a group of both academic and practicing chiropractors, as well as representatives from a health insurer specializing in coverage of CAM provider services. Another article, under different authorship, appeared the same year deploring some aspects of chiropractic education. In 2008, a third article came out with a similar theme, “How can chiropractic become a respected mainstream profession? The example of podiatry.” All three are open access and worth reading. The authors are to be commended for taking on an extremely contentious subject in their own profession.

The first article is a refreshingly honest look at the current state of chiropractic. The authors note the inability of chiropractors to consistently define who they are and what they do, which results in public confusion (including among those in the healthcare industry) about just what role chiropractors should play in the healthcare system. The authors deplore the continued existence of the “subluxation” in chiropractic and it’s accommodation by no less than the Association of Chiropractic Colleges. And they thoroughly deconstruct any notion that such a thing exists. The idea that chiropractors are capable of acting as primary care physicians is given equally short shrift and debunked as well.

The article points out that, whatever the confusion among chiropractors about who they are and what they do, the public has decided on its own: the public perception of chiropractors is that of back pain specialists. Back-related problems account for over 90% of the reason patients see chiropractors. They also argue that chiropractic must embrace evidence-based healthcare and stop relying on their clinical experience, noting the many reasons (e.g., regression to the mean) that a chiropractor’s observations may be explained by something other than treatment effectiveness. They admit that the chiropractor’s stock-in-trade, spinal manipulation, might not hold up under an evidence-based standard. (A possibility that is becoming a reality.) They even quote Marcia Angel’s observation on “alternative” medicine:

There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Twenty days in primary care practice, or “naturopathic residency”

The metastasis of alternative medicine throughout the health care system comes, in no small part, at the hands of the federal and state governments, mostly the latter and most particularly the state legislatures. Under their jurisdiction rests the decision of who can, and cannot, become a licensed health care practitioner, and what they can, and cannot, do. This is the gateway through which much of pseudo-medicine flows.

I’ve read many CAM practitioner licensing statutes (all of the chiropractic practice acts, in fact) and many legislative proposals to license or to expand the scope of practice. Typical of the boilerplate recited in support of this legislation is the education and training of these practitioners, which is touted as a means of protecting the public from charlatans and quacks out there selling snake oil to the credulous. Naturopathic licensing bills routinely require graduation from a naturopathic “medical” school accredited by the Council on Naturopathic Medical Education. (See, for example, Michigan House Bill 4152, which both David Gorski and I have discussed on SBM.) Unfortunately, what CAM provider legislation often does is simply provide legal cover for selling that very same snake oil.

Naturopaths are licensed in 17 states so far, although what they can and can’t do varies considerably. In some states, they have a scope of practice similar to that of an M.D. or D.O. primary care physician. At the most liberal end of this spectrum, N.D.s can prescribe drugs (as Michigan’s bill would allow), although this, too, varies depending on what’s listed on the state’s naturopathic formulary.

All of this has led me to conclude that the state legislatures do not have internet connections. Because, if they did, it would be pretty easy to Google around and figure out just what this naturopathic “medical” education entails and how practicing naturopaths apply their education and training in actual practice. In fact, I’ve done this myself and reported the results here on SBM. In the last day or so, I found out even more by looking around the websites of the Council on Naturopathic Medical Education, the American Association of Accredited Naturopathic Medical Schools, and its member institutions. We’ll get to the fruits of that research in a minute. (more…)

Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Pharmaceuticals, Politics and Regulation

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Washington State’s Unconscionable, Unconstitutional Child Protection Law

I recently wrote about the conflict between child protection and the religious freedom of believers in faith healing. That issue has reared its ugly head again in the state of Washington.

Washington law currently denies the children of Christian Scientists equal protection under the law governing child abuse and neglect, and it grants a special exemption from criminal prosecution for abuse and neglect to that one specific religion and not to any others. Even if you supported religious exemptions in principle, there would be no excuse for the preferential treatment of one single religion. This law is clearly unconstitutional. (more…)

Posted in: Faith Healing & Spirituality, Politics and Regulation, Religion

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pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

Being a cancer surgeon and researcher, naturally I tend to write about cancer a lot more than other areas of medicine and science. It’s what I know best. Also, cancer is a very common area for unscientific practices to insinuate themselves, something that’s been true for a very long time. The ideas don’t change very rapidly, either. Drop a cancer quack from 2014 into 1979, and he would probably be right at home. Of course, part of the reason is because the “elder statesmen” of cancer quackery today were getting their starts in 1979. Still, the same ideas keep recurring even as far back as a century ago and even older, and if you broaden your criteria, these ideas exist on a continuum, either having descended directly from various ancient ideas such as vitalism, miasmas, or humoral theory or branched off somewhere along the way. Others branch off from the progress of science, taking a germ of a seemingly reasonable idea and turning it into quackery. It is the latter with which I plan on concerning myself today, the reason being that over the weekend I heard some truly awesome news. One of the most egregiously practicing non-physicians who claim to be able to cure cancer that I’ve ever encountered was arrested—yes, arrested!—and arraigned on criminal charges. I’m referring to “Dr. Alkaline” himself, he of the pH Miracle Living program and his Articles of Health blog, “Dr.” Robert O. Young. Behold:
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Posted in: Cancer, Naturopathy, Politics and Regulation

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Stanislaw Burzynski: Using 1990s techniques to battle the FDA today

It figures that I couldn’t go three weeks into 2014 without the topic of Stanislaw Burzynski rearing its ugly head. I had hoped to make it to February or even beyond before feeling the gravitational tug of the wretched hive of ignominious and unethical behavior, but here we are, only 20 days into the new year. So be it.

2013 finished with serious setbacks for Stanislaw Burzynski and his unproven cancer treatment that he dubbed “antineoplastons” (ANPs) way back in the early 1970s. As you might recall, in November, two things happened. First, the FDA released its initial reports on its inspection of the Burzynski Clinic and Burzynski Research Institute (BRI) carried out from January to March 2013. They were damning in the extreme, pointing out the shoddy operating methods of the institutional review board (IRB) used by the BRI to approve and oversee Burzynski’s “clinical trials” (and I use the term loosely) of ANPs. Violations included using expedited approvals to review single patient protocols, something so far outside the purview of what the expedited approval process was intended for, namely approving minor tweaks to human subjects research protocols without requiring a full meeting of the IRB, that the FDA called Burzynski out for it. Other violations included failure to report serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or the IRB, failure to follow proper informed consent procedures, failure to determine that risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, and a lot of other violations, which are listed in my previous post on the subject. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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2013 Legislative Review: placenta take out

It’s official in Oregon now. You can take your placenta, along with your new baby, home from the hospital. This was already a practice among the CAM set but apparently new mothers were running afoul of laws designed to protect us from bio-hazards. New legislation exempts “the removal from a health care facility . . . of a placenta by a postpartum mother.”

Now, why would anyone want a placenta? Well, SBM is nothing if not your complete source of all things CAM and Harriet Hall has already covered the subject. The short answer is that in Traditional Chinese Medicine placenta-eating is thought to confer all sorts of health benefits on the new mother. I learned of this new law from USA Today, which explains that “some experts say” it has positive health benefits. Well, thank goodness for that. Wouldn’t want a new law passed without “experts” weighing in.

But if handling a placenta makes you squeamish, not to worry. The Placenta Power Wellness Service in Portland (among others) will steam, dehydrate and encapsulate it into a handy pill form for about $150-$250. (Each placenta will make 80-120 capsules, according to the website). If you wish, you can get raw placenta encapsulation instead. Placenta tincture, placenta salve and a print of your placenta (sort of like those newborn footprints) are available for extra. That would be a real conversation starter, sitting there on the mantel.

According to Placenta Power Wellness Service, anecdotal evidence shows women experience an increase in energy, mood enhancement, milk supply and feelings of elation. Plus, it’s been used in Traditional Chinese Medicine “for centuries.”

And folks, that is all you need to get a statute passed adding practices or products to the legally-available health care armamentarium: anecdotes, sometimes relayed by “experts.” Traditional use is icing on the cake. (Or maybe the placenta.) It’s the reason for the DSHEA, the chiropractic, acupuncture and naturopathic practice acts, “health freedom” laws, and getting the Homeopathic Pharmacopoeia dumped in toto into federal law, with updates courtesy of the homeopathic industry. “I’ve seen it work!” “It worked for me!” Depending on the method, the evidence for the astounding variety of practices and products legally permitted by these laws generally ranges between none and some, with, I’d wager, most hovering in the “it can’t work” to the “we don’t know if it works” range. Not to mention the evidence of safety, or lack thereof. (more…)

Posted in: Acupuncture, Chiropractic, Homeopathy, Legal, Naturopathy, Obstetrics & gynecology, 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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