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Archive for Politics and Regulation

When healing turns into killing: religious and philosophical exemptions from parental accountability

Parents have a fundamental right to guide the upbringing of their children protected under the Due Process Clause of the U.S. Constitution. This includes the choice of medical care for the child. They also have a First Amendment right to the free exercise of their religious beliefs, including the right to care for their children in accordance with the tenets of their religion. In a better world, these rights would be exercised in a manner that is consistent with a reasoned selection of medical care among choices supported by the best available scientific evidence. If, for example, deeply religious parents choose to forego a treatment that had only a minimal chance of extending their child’s life and terrible side effects in favor of palliative care because they believe that their child would be better off in heaven we could all agree that their choice is constitutionally protected.

Unfortunately, that is not the case. Religious believers and those whose “philosophy” favors pseudoscience in child medical care (surveys bloviating about the popularity of CAM to the contrary) are in fact a tiny minority of the American population who influence public policy in a manner that far exceeds their actual numbers. This influence allows these special interest groups to cause needless suffering and death among children and their families. As well, their actions siphon off medical and legal resources that could more properly be directed toward the common good when states and medical institutions are put in the position of having to go to court to protect children from their parents. And, by giving parents false choices between a belief in magic and standard medical care, unnecessary complications are introduced into what are already difficult and heart-wrenching decisions by parents who truly want to act in the best interests of their children. (more…)

Posted in: Cancer, Epidemiology, Legal, Medical Ethics, Politics and Regulation, Religion, Vaccines

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“Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy

One of my favorite shows right now is True Detective, an HBO show in which two cops pursue a serial killer over the course of over 17 years. Starring Woody Harrelson and Matthew McConaughey, it’s an amazingly creepy show, and McConaughey is amazing at playing his character, Rustin Cohle. I’m sad that the show will be ending tomorrow, but I really do want to see how it ends.

Unfortunately, as much as I like Matthew McConaughey as an actor, he is in part responsible for re-inspiring a movement that has the potential to do profound harm to patients and cancer research. That’s because his other big role over the last year has been in an Oscar-nominated movie, Dallas Buyers Club, where he plays Ron Woodroof, an early AIDS patient who in the 1980s smuggled unapproved pharmaceutical drugs into Texas when he thought he found them effective at alleviating his symptoms, distributing them to fellow sufferers by establishing the “Dallas Buyers Club” while battling the FDA. I haven’t seen the movie, and I really don’t want to, given that, from everything I’ve heard about it, it’s basically the story of a “brave maverick” who bucks the FDA, complete with all the tropes about indifferent bureaucrats who don’t care if these brave patients die. That might not be so bad if it weren’t also riddled with inaccuracies and misinterpretations of the AIDS crisis in the 1980s. Worse, the real Woodruff rejected the one truly promising drug at the time, AZT, as hopelessly toxic and instead smuggled drugs like Peptide T, which never panned out. Basically, what Woodruff appears to have smuggled as part of his activities for the “Dallas Buyers Club” was a mixture of useless supplements, experimental drugs that were never approved, and a handful of experimental drugs that showed promise. Meanwhile, the movie portrays the FDA as the implacable enemy of these sorts of activities, jackbooted thugs not unlike the stereotype promoted by “health freedom” quacks who don’t like the FDA preventing them from selling their quackery. As far as I can tell without actually seeing the movie, the overall message is a typical uplifting story of an underdog who fights the power and in doing so finds redemption. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation, Public Health

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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, Science and Medicine

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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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