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Archive for Politics and Regulation

An update on the case of Sarah Hershberger: Parental rights trump the right of a child with cancer to live

Five weeks ago, when last I touched on the case of Sarah Hershberger, the now 11-year-old Amish girl from Medina County, Ohio near Akron with lymphoblastic lymphoma whose parents had taken her off of chemotherapy after only two rounds, reports had been coming out of the cancer quackery underground that Sarah’s parents, Andy and Anna Hershberger, had fled to avoid a court order that appointed a medical guardian for her to make sure that she received appropriate science-based therapy. At the time I was unable to confirm these stories in the mainstream press. However, over the last month there have been significant developments in this case and even over the last week; so I thought that now would be a good time to update SBM readers on developments in the case.

The Thanksgiving confirmation

One thing that I didn’t mention a month ago is that David Michael and others have been actively raising money to support the Hershbergers’ legal battles. Then, over the long Thanksgiving Day weekend news reports began to trickle out confirming what the “alternative” health sites had been reporting, namely that the Hershbergers had fled. These reports started with story from a local Medina newspaper, then spread to a northeast Ohio television stations, and then to national news sources (like Good Morning America and CNN) and international news outlets. The Medina Gazette first reported:
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Posted in: Cancer, Medical Academia, Medical Ethics, Politics and Regulation

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The Skeptics for the Protection of Cancer Patients need your help

We at SBM don’t normally ask our readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it. However, given the story of Stanislaw Burzysnki, which I’ve been covering with frequent blog posts for over two years now, how could I not listen to the appeal of my friend and co-conspirator (note to Burzysnki fans: that “co-conspirator” bit was sarcasm) to take action in the wake of the USA TODAY story that ran two and a half weeks ago. Despite the disingenuousness of Burzynski’s response, unfortunately he’s still managing to find his way into legitimate scientific meetings.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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The new Surgeon General nominee and CAM: Is there a problem here?

Our fearless leader, Steve Novella, has informed me that he is traveling today. Unfortunately, I am preparing a talk for later today, and no one else seemed able to come up with a post; so I decided to adapt a recent post from my not-so-super-secret other blog and see what a different readership thought of it. I realize that I’m risking subjecting you all to Gorski overload, but, hey, if the world needs more Mark Crislip, why wouldn’t the world need more David Gorski too? Steve will return next Wednesday, as usual.

I don’t normally give a lot of thought to the Surgeon General because, quite frankly, in recent years it hasn’t been a position of much authority or influence. That’s why I didn’t noticed late last week that President Obama had nominated a new Surgeon General. Normally, my failure to notice isn’t such a big deal, because there really hasn’t been a Surgeon General who has really been particularly well-known or had much of an impact since Dr. C. Everett Koop, although back when President Obama first took office Dr. Sanjay Gupta’s name was floated as a possibility for the position. Obviously, he didn’t get it. (I’m guessing that being a neurosurgeon and CNN’s chief medical correspondent probably pays much better than being Surgeon General.) To be honest, I didn’t even know that the prior Surgeon General had stepped down, but apparently she did in July, leaving the position filled by an interim Surgeon General until a new one could be nominated.

The other day, I learned whom President Obama nominated to be her successor, Dr. Vivek Murthy, a faculty member at the Harvard Medical School:

President Obama will nominate Dr. Vivek Murthy of Harvard Medical School and Brigham and Women’s Hospital as surgeon general of the United States, the White House announced Thursday night.

Murthy is a hospitalist at the Brigham and is co-founder and president of Doctors for America, a Washington, D.C.-based group of 16,000 physicians and medical students that advocates for access to affordable, high quality health care and has been a strong supporter of the Affordable Care Act.

If he’s confirmed by the Senate, Murthy would replace acting surgeon general Boris Lushniak. The surgeon general serves a four-year term and the post is essentially a bully pulpit to speak out on public health issues.

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Posted in: Acupuncture, Politics and Regulation, Public Health, Science and the Media

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Faith Healing: Religious Freedom vs. Child Protection

We have written a lot about people who reject science-based medicine and turn to complementary/alternative medicine (CAM), but what about people who reject the very idea of medical treatment?

Faith healing is widely practiced by Christian Scientists, Pentecostalists, the Church of the First Born, the Followers of Christ, and myriad smaller sects. Many of these believers reject all medical treatment in favor of prayer, anointing with oils, and sometimes exorcisms. Some even deny the reality of illness. When they reject medical treatment for their children, they may be guilty of negligence and homicide. Until recently, religious shield laws have protected them from prosecution; but the laws are changing, as are public attitudes. Freedom of religion has come into conflict with the duty of society to protect children. The right to believe does not extend to the right to endanger the lives of children. A new book by Cameron Stauth, In the Name of God: The True Story of the Fight to Save Children from Faith-Healing Homicide, provides the chilling details of the struggle. He is a master storyteller; the book grabs the reader’s attention like a fictional thriller and is hard to put down. He is sympathetic to both the perpetrators and the prosecutors of religion-motivated child abuse, and he makes their personalities and their struggles come alive. (more…)

Posted in: Book & movie reviews, Faith Healing & Spirituality, Politics and Regulation

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Journal of the American Dental Association Falls for Tooth Fairy Science

The Tooth Fairy

The Tooth Fairy

Another venerable scientific journal has fallen prey to “alternative” medicine research. The Journal of the American Dental Association (JADA) has joined the New England Journal of Medicine and Annals of Internal Medicine, among others, with its publication of “A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder,” in the October, 2013, issue.

And what “chiropractic intervention” is this? The Activator Method Chiropractic Technique (AMCT) as taught by Activators Methods International (AMI), which also conveniently sells its own line of Activator Instruments. (Practice-building seminar DVDs sold separately.)

What is this Activator Method? In short, it is a method of detecting and correcting subluxations (the chiropractic version, not the medical one). Thus, the underlying premise of this study was that subluxations could cause myofascial temporomandibular disorder (TMD) pain and that finding and vanquishing these subluxations could bring about pain relief.

Now, as regular readers of this blog know, vertebral subluxations are a figment of the chiropractic imagination. They do not exist, as we have pointed out many, many, many times. And here is where alternative medicine has it all over conventional medicine and dentistry. In alternative medicine, once you invent a non-existent condition you can proceed to invent all sorts of diagnostic techniques and remedies to treat patients with this condition. The AMCT is a perfect example of this. Conventional medicine and dentistry, on the other hand, are saddled with the scientific method, biological plausibility, having to discard therapies when studies no longer support their use, and all sorts of other persnickety limitations.
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Posted in: Chiropractic, Clinical Trials, Dentistry, Legal, Politics and Regulation

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Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

So Burzynski operated from the late 1990s until summer 2012, charging exorbitant “case management” fees to enroll patients in his clinical trials, working with a credulous filmmaker who wanted to make a movie about him—twice—and flouting regulations designed to protect human subjects involved in clinical trials. Meanwhile, he branched out to “personalized gene-targeted cancer therapy,” which he promoted through Suzanne Somers; to AminoCare, which is basically antineoplastons sold as an antiaging nostrum (or, as Burzynski puts it, a “genetic solution to aging“); and to selling an orphan drug as a “prodrug” for antineoplastons.

So what happened in the summer of 2012? Apparently, there was a treatment-related death of a child, which led the FDA to issue a partial clinical hold on the Burzynski Clinic that prevented him from enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients. That partial clinical hold was extended to adults in January 2013, at which time the FDA arrived at the Burzynski Clinic to investigate. It was an event that was included at the tail end of Eric Merola’s second propaganda film about Stanislaw Burzynski and represented as, in essence, jackbooted fascists trying to keep the cure for cancer from The People. None of this stops credulous reporters from writing misleading articles with titles like Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US, which is a story about Laura Hymas, a woman whose good fortune is most likely not due to Burzynski. Not long before that, there was another credulous article featuring another Burzynski patient, Hannah Bradley, as one of four patients treated for cancer with alternative therapies who are allegedly doing well. Again, Hannah Bradley’s good fortune is highly unlikely to be due to Burzynski’s nostrums.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.
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Posted in: Cancer, Clinical Trials, Medical Ethics, Politics and Regulation

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Redefining cancer

Blogging is a rather immediate endeavor. Over the last nine years (nearly), I’ve lost track of how many times I saw something that I wanted to blog about but by the time I got around to it, it was no longer topical. Usually what happens is that my Dug the Dog tendencies take over, as I’m distracted by yet another squirrel, although sometimes there are just too many targets topics and too little time. Fortunately, however, sometimes the issue is resurrected, sometimes in a really dumb way, such that I have an excuse to correct my previous oversight. This is just such a time, and the manner in which the topic has been resurrected is every bit as dumb as the rant by the Food Babe that Mark Crislip so delightfully deconstructed last Friday. Unfortunately, for purposes of snark, I’m not Mark Crislip—but, then, who is?—but fortunately I am known elsewhere (and sometimes here) for being a bit “insolent.” So let’s dig in. We’ll start with the idiocy and then use that as a “teachable moment” about cancer biology. Funny how I manage to do that sort of thing so often.

Abuse of cancer science for political purposes

I realize that we at SBM are supposed to stay, for the most part, apolitical, but the idiocy that’s leading me to revisit a topic is unavoidably political because it involves using a profound misunderstanding of science for political ends. Specifically, I’m referring to the misuse of a legitimate scientific debate about cancer screening and diagnosis for purely political ends. First, however, for those not living in the US or my fellow citizens who might be blissfully unaware (in this case) of recent events, during the first half of October, our nation underwent what can only be described as a self-inflicted crisis that could have caused worldwide economic turmoil if it hadn’t been (sort of) resolved at the last minute. The reason for the crisis boiled down to the extreme resistance of some of our more radically conservative Representatives to the Patient Protection and Affordable Care Act, usually referred to as just the Affordable Care Act (ACA) or, colloquially, Obamacare. Normally when we write about Obamacare here on SBM, it’s to complain about how advocates of unscientific medicine and outright quackery have tried to piggyback their advocacy on the ACA in order to have health insurance plans sold through government exchanges cover modalities like naturopathy, chiropractic, and other so-called “complementary and alternative medicine” (CAM) or “integrative medicine.” In related posts, I’ve examined the evidence with respect to the relationship between health insurance and mortality and whether attacks on Medicaid as not improving the health of patients insured by it have any validity. (Let’s just say they are oversimplifications and distortions.)
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Posted in: Cancer, Politics and Regulation, Science and the Media, Surgical Procedures

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Acetaminophen: Still the pain reliever you should trust?

Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.

The investigation summarizes the key “Takeaways” as follows:

  • 150 Americans die per year from accidental acetaminophen overdoses
  • The safety margin (safe dose vs. toxic dose) with acetaminophen is small
  • Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
  • For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
  • The manufacturer has taken steps to protect consumers but has also opposed other safety measures

While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)

Posted in: Pharmaceuticals, Politics and Regulation, Science and Medicine

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Licensing Naturopaths: the triumph of politics over science

Naturopaths shouldn’t get too excited about having a special week in their honor. The U.S. House of Representatives gave watermelons a whole month. As between naturopathy and watermelons for my good health, I’ll go with the watermelons any day. You’ll soon understand why.

Today is not my usual blogging day. But when David Gorksi announced SBM’s celebration of Naturopathic Medicine Week, I volunteered an extra post to answer the question I am sure is on everyone’s mind: How in the heck do they get away with this stuff?

The answer lies in the creation of Naturopathic Medicine Week itself: politics. Just as Sen. Barbara Mikulski turned her credulous acceptance of naturopathy into a Senate Resolution and slipped it by her Senate colleagues, clueless legislators around the country are sponsoring bills to license naturopaths, in some cases as primary care physicians. And it’s not as if these legislators don’t know they are incorporating quackery into primary care. Practices such as naturopathic “organ repositioning” (an anatomical impossibility) and Mark Crislip noted, what little data there is suggests that naturopathic primary care is associated with worse outcomes. But evidence is not necessary in the political realm. And now the political process has given naturopaths an additional incentive for licensure. They argue that the Affordable Care Act mandates reimbursement for their services. (more…)

Posted in: Cancer, Energy Medicine, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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Dietary supplement industry says “no” to more information for consumers (again)

Once again, the dietary supplement industry is fighting efforts to give consumers more information about the safety and effectiveness of dietary supplements.

Big Supp is very clever. It sells consumers on the phony idea that they need dietary supplements for good health. Even as the evidence continues to mount that consumers don’t need supplements and shouldn’t take them, the industry continues to convince the public otherwise. And in 2011 they raked in $30 billion.

The state and federal governments have served as handmaidens to the industry in this clever marketing strategy. Congress’s gift to the supplement industry, the Orwellian-named Dietary Supplement Health and Education Act (DSHEA) “effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective,” as SBM’s Scott Gavura pointed out. DSHEA allows supplements to make “structure and function” claims, although no one seems to know what that means, including the FDA.

States have done their part in granting chiropractors and naturopaths the authority to give “nutritional” advice and recommend dietary supplements, sometimes on the basis of dubious diagnostic testing purporting to reveal imagined nutritional deficiencies. This gives them carte blanche to sell supplements to their patients, a clear conflict of interest.

And when proposed regulation threatens their profits, the dietary supplement industry and its surrogates enlist the very public it duped to join the battle. The industry convinces the public that someone is trying to take away their access to supplements they never needed in the first place. This threat is dressed up in terms designed to push all the buttons of a public already primed to be leery of “the government” – their “health freedom” may be taken away. Actually, freedom to choose among health care practices is most threatened by withholding readily-available information which would adequately inform health care decisions. (more…)

Posted in: Herbs & Supplements, Legal, Politics and Regulation, Public Health

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