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Supreme Court Saves Nation’s Immunization Program

The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.

Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.

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Posted in: Legal, Science and Medicine, Vaccines

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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CAM and the Law Part 3: Malpractice

It is with some trepidation I venture into the next subject in this series — malpractice law. This is a touchy subject for healthcare providers, for obvious reasons. Regardless of the flaws in the system, however, malpractice law is one of the mechanisms put in place by government to regulate the practice of medicine. Like the other such mechanisms touched on so far, licensure and scope of practice law, malpractice laws apply to alternative medicine practices in ways that are broadly similar, but sometimes subtly and significantly different, from how they apply to scientific medicine. 

So far, alternative practitioners are sued for malpractice relatively infrequently compared with physicians, presumably because they represent a much smaller fraction of the care provided, they tend to be utilized by those with an ideological bias in favor of their approaches, and they are not viewed as nearly as rich a target for litigation. But this may change if the political and cultural winds blow in the direction of greater utilization of alternative medical approaches. 

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Posted in: Legal, Politics and Regulation

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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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Posted in: Homeopathy, Legal, Science and Medicine

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The DC as PCP?

Subluxation-free Chiropractic?

The long-simmering internecine wars among various factions of chiropractic recently reached a full boil when the Council on Chiropractic Education (CCE) had the audacity to eliminate the word “subluxation” from its draft 2012 “Standards for Doctor of Chiropractic Programs.” The CCE is the official U.S. Department of Education-approved accreditation agency for chiropractic colleges. It intends to adopt the revised Standards in January 2011and asked for comment from those affected.

“Totally unacceptable,” is the response of James Edwards, DC, in a recent article in Dynamic Chiropractic entitled “What Is the CCE Trying to Pull?

Perhaps taking up the spirit of this election season, Edwards defines the problem in terms of conservative vs. liberal ideologies: “After beating back and defeating the ridiculous ‘subluxation only, no diagnosis’ position of the extreme right-wing minority of the profession, we are now faced with the equally unacceptable ‘ivory tower’ position of the extreme left-wing minority of the profession.” Later in the article he refers to the proponents as the “left-wing fringe.”
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CAM and the Law Part 2: Licensure and Scope of Practice Laws

This post is intended to illustrate a bit about how medicine, including alternative medicine, is defined and limited legally by state licensure. This is, of course, an enormous topic, especially given the variety of laws and regulations among the 50 states and District of Columbia, and the many, often mutually inconsistent, court decisions interpreting them. A comprehensive survey would resemble Gibbon’s history of Rome and would likely be out-of-date the moment it was finished. My more modest goal here is to highlight a few of the ways in which licensure and scope of practice laws intersect the practice of CAM and give a few representative examples. 

The Rise of Medical Licensure

In the 19th century, a bewildering variety of different approaches to maintaining health and treating disease competed for the trust, and dollars, of prospective patients (or their owners, in the case of animal patients). Caveat emptor was the rule in an unregulated medical marketplace. Mainstream medicine was a competitor in this marketplace, though it was hardly science-based to any great extent compared to conventional medical practices today. Homeopathy was another pretty big player, along with osteopathy and numerous other more or less organized schools, as well as many individual snake oil salesmen, faith healers, local providers of folk remedies, and so on.1,2

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CAM and the Law, Part 1: Introduction to the issues

When I write or talk about the scientific evidence against particular alternative medical approaches, I am frequently asked the question, “So, if it doesn’t work, why is it legal?” Believers in CAM ask this to show that there must be something to what they are promoting or, presumably, the government wouldn’t let them sell it. And skeptics raise the question often out of sheer incredulity that anyone would be allowed to make money selling a medical therapy that doesn’t work. It turns out that the answer to this question is a complex, multilayered story involving science, history, politics, religion, and culture. 

While we science types tend to be primarily interested in what is true and what isn’t, that is a sometimes surprisingly minor factor in the process of constructing laws and regulations concerning medicine. What I hope to do in this series of essays is look at some of the major themes involved in the regulation of medical practice, particularly as they relate to alternative medicine. I will begin by touching on some of the general philosophical and legal issues that have defined the debate among the politicians and lawyers responsible for shaping the legal environment in which medicine is practiced. The I will review some of the specific domains within this environment, including: medical licensure and scope-of-practice laws; malpractice law; FDA regulation of drugs, homeopathic remedies, and dietary supplements; truth-in-advertising law; and anti-trust law.

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

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Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

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Posted in: Chiropractic, Health Fraud, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Public Health, Science and the Media

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A pox on your bank account: failure to vaccinate and its legal consequences

Here’s a question anti-vaxers may want to consider:

Can the parents of an unvaccinated child be held liable if their child becomes infected with a vaccine-preventable disease which then spreads from their child to another child or children?

Yes, they can.

In fact, for over 125 years, courts in this country have recognized a cause of action for negligent transmission of an infectious disease. In the first reported case (New York, 1884) the defendant infected the plaintiff with whooping cough. Cases since then have run the gamut: smallpox, tuberculosis, unspecified “venereal disease,” typhoid fever, scarlet fever, diphtheria, hepatitis, herpes, gonorrhea, HIV. If your favorite infectious disease is not on this list, don’t worry. The disease may vary, but the legal principles remain the same.
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Posted in: Legal, Medical Ethics, Public Health, Vaccines

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Naturopathic Prescribing: The Dark Side Beckons

I am a terrible Oregon chauvinist.  I think there is no better place to live on the planet. Period.  Great natural beauty, not a lot of people, best beer ever and no pro football team. Oregon is both casual and tolerant.  It is safe to say that dressing up in the Pacific NW means tucking your t shirt into your jeans.  And the citizens of the NW, especially in the Portland metro area, are tolerant of  a diverse number of alternative life styles. What more could you want?

No good deed goes unpunished. The downside of toleration is the proliferation of alternative medicine.  Portland has  a school of chiropractic, a college of oriental medicine and  the country’s oldest school of naturopathy, established in 1956.  It is a year older than me. There are about 850 ND’s in Oregon.  To judge from the number of alternative practitioner offices around my hospital,  most of the graduates stay in Portland.

There are five health care systems in Portland.   Three of the five have hired naturopaths as part of their complementary medicine programs.   My system, as of yet, does not have a scam practitioner on staff, a fact of which I am most proud.  Yet,  I suppose it will come some day. However, if you wonder if a hospital practices evidence and science based medicine, see if they have a naturopath, a chiropractor or an acupuncturist on staff.  If they do, they may be interested in issues other than providing quality health care.

Oregon has had a Board of Naturopathic physicians since 1929 to oversee naturopathic practice.  There has been a long tradition of legislative oversight of naturopathy in Oregon, but they have been able, until recently, to only prescribe medications that are naturally derived.  None of that synthetic nonsense for naturopaths. Natural products only.  Until this month.

In Oregon, naturopaths are no longer limited to natural, herbal and homeopathic concoctions, they can also prescribe substances that actually work.  Recently House Bill 327  was passed by the Oregon legislature to expand the prescriptive privileges of naturopaths.  Drugs can now be added to the naturopathic  formulary just by asking.  The bill was passed by the Senate 22-7 and the House unanimously.  Bummer. If you live in Oregon and want to pester your representative on their profound stupidity, a list is at  http://gov.oregonlive.com/bill/SB327/. Send them a link to this post.

As a shill for big pharma and a tool of the medical-industrial complex, I suggest this may not be such a  good idea.  Naturopaths do not have the training, experience  or understanding of medicine to safely prescribe medications. Their understanding of disease and the various therapies taught at naturopathic schools are antithetical to what is required to safely and knowledgeably  prescribe modern medications.
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