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Archive for Politics and Regulation

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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The Exciting Conclusion

On the slim chance that you’ve been perched on the edge of your seat wondering how the New Mexico appellate court ruled on chiropractic prescription privileges, whether the Council on Chiropractic Education got approved for another three years as an accrediting agency, if NCCAM ever came clean about spinal manipulation, and the fate of Brandon Babcock, DC, at the hands of the judicial system, here are your updates.

Prescription privileges for New Mexico chiropractors

A surprisingly titillating tidbit about New Mexico “advanced practice” chiropractors.

As discussed in previous posts, New Mexico “advanced practice” chiropractors succeeded in getting limited prescription rights. The statute specifically says they can:

prescribe, administer and dispense herbal medicines, homeopathic medicines, over-the-counter drugs, vitamins, minerals, enzymes, glandular products, protomorphogens, live cell products, gerovital, amino acids, dietary supplements, foods for special dietary use, bioidentical hormones, sterile water, sterile saline, sarapin or its generic, caffeine, procaine, oxygen, epinephrine and vapocoolants.

However,

Dangerous drugs or controlled substances, drugs for administration by injection and substances not listed [above] shall be submitted to the board of pharmacy and the New Mexico medical board for approval.

Apparently, the Chiropractic board couldn’t read the plain language of the statute and blew off this requirement, even though their own lawyer told them they couldn’t. This got them hauled into court by the medical and pharmacy boards. The International Chiropractors Association joined the fight. (more…)

Posted in: Chiropractic, Health Fraud, Legal, Politics and Regulation

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An experiment in paying through the nose for “unnecessary care”

Rats. Harriet stole what was going to be the title of this post! This is going to be something completely different than what I usually write about. Well, maybe not completely different, but different from the vast majority of my posts. As Dr. Snyder noted on Friday, it’s easy to find new woo-filled claims or dangerous, evidence-lacking trends to write about. Heck, I did it just last week, much to the continued consternation of one of our regular readers and commenters. Examining certain other health-related issues from a science-based perspective is more difficult, but I feel obligated to do it from time to time, not just for a change of pace but to stimulate the synapses and educate myself—and, I hope, you as well—about areas outside of my usual expertise.

We spend a lot of time writing about the scientific basis of medicine, clinical trials, what is and isn’t quackery, and how “complementary and alternative medicine” (CAM) subverts the scientific basis of medicine. However, SBM goes far beyond just that. At least I think of it this way. That’s why I’ve looked at issues that go more to the heart of health policy, which should be based on sound science and evidence. That evidence might take different forms than it does for determining, for example, whether Medicaid results in better health outcomes and by how much health insurance does the same. As is the case with policy issues and economics, conclusions are muddled and messy. The error bars are huge, and the number of potential confounders even huger. (more…)

Posted in: Clinical Trials, Diagnostic tests & procedures, Politics and Regulation, Public Health

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The Council on Chiropractic Education Straightens Up?

Three years ago, we reported that the Council on Chiropractic Education (CCE) was deeply embroiled in a heated dispute among various chiropractic factions over its new accreditation standards for chiropractic colleges. In a June, 2012 update of that post, we found the CCE still deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. Current events, however, require that we now report that the CCE remains deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. And it has come to this:

CCE does not represent me

Ostensibly, the debate is about whether chiropractic students should be taught to detect and correct the putative subluxation and CCE’s commitment to chiropractic’s remaining a drug and surgery-free practice. As we have discussed several times here at SBM, a faction of chiropractors fancy themselves as primary care physicians who are competent to diagnose and treat patients with a wide variety of diseases and conditions, such as diabetes and cardiovascular disease, with various methods, such as “Functional Endocrinology.” This is, in fact, the position of the largest and most mainstream of the chiropractic trade associations, the American Chiropractic Association (ACA). (The ACA is actively promoting reimbursement of chiropractors for required primary care benefits under the Affordable Care Act.)

At the other end of the spectrum, the chiropractic purists (or “straights”) believe chiropractors should limit themselves to the detection and correction of the (non-existent) chiropractic subluxation. And they are adamant about chiropractic remaining “without drugs or surgery.”

Protestations to the contrary notwithstanding, chiropractic belief in the subluxation is widespread among chiropractors in North America and in Australia. And as far as I can tell, chiropractors who eschew belief in the subluxation have merely renamed it and redefined it in terms so vague as to be meaningless. Those who want to expand chiropractic to include a broader range of treatments do not exclude the subluxation as a relevant clinical entity. They’ve simply tarted it up in an attempt to obscure its lack of scientific viability. (more…)

Posted in: Chiropractic, Legal, Politics and Regulation

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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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