Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.

Naturopaths prescribing drugs?

I’ve never been able to figure out why naturopaths want to gain the power to be able to prescribe pharmaceutical drugs to patients. I really haven’t. After all, the entire philosophy of naturopathy as “finding and treating the cause of chronic problems, not just treating symptoms,” “letting nature heal,” and “treating the whole person,” whatever that means. Indeed, here’s what the American Association of Naturopathic Physicians says about naturopathic medicine:

First, do no harm. Naturopathic physicians follow three precepts to ensure their patients’ safety:

• Use low-risk procedures and healing compounds—such as dietary supplements, herbal extracts and homeopathy—with few or no side effects.
• When possible, do not suppress symptoms, which are the body’s efforts to self-heal. For example, the body may cook up a fever in reaction to a bacterial infection. Fever creates an inhospitable environment for the harmful bacteria, thereby destroying it. Of course, the naturopathic physician would not allow the fever to get dangerously high.
• Customize each diagnosis and treatment plan to fit each patient. We all heal in different ways and the naturopathic physician respects our differences.

Natural Standard defines a naturopath thusly:

Naturopathy is the practice of the use of natural substances to provide a healthier balance of internal chemistry.

A naturopath is a therapist who practices naturopathy. Naturopathic physicians (NDs) are primary healthcare practitioners. Naturopathic physicians are the highest trained practitioners in the broadest scope of naturopathic medical modalities. In addition to the basic medical sciences and conventional diagnostics, naturopathic education includes therapeutic nutrition, botanical medicine, homeopathy, natural childbirth, classical Chinese medicine, hydrotherapy, naturopathic manipulative therapy, pharmacology and minor surgery. Naturopathic practice excludes the use of most synthetic drugs and major surgery.

Naturopathic medicine is a natural and holistic approach to health and healing that recognizes the integrity of the whole person. Many treatment methods are used, including nutrition, herbs, manipulation of the body, exercise, stress reduction, and acupuncture.

It is not difficult to find naturopaths writing critical screeds against “big pharma” and the supposed evils of “allopathic medicine,” or the dismissal of “allopathic medicine” or “biomedicine” (one can almost see the sneer on the lips of the author writing that) as:

Human control over nature is characteristic of all Western Thought, including allopathic medicine. Since Descartes, matter has been considered separate from the spirit and the physical body, as part of matter, must be controlled for its own good. A physician is taught a “stewardship” view of the body that parallels society’s “stewardship” view of nature. It is well-intentioned, yet based on an attitude of control and domination. This is not to say that Biomedicine1 does not have its place. Rather, as we re-evaluate our relationship to the environment, we must necessarily re-evaluate our health care. “The ancient formula of one ill, one pill, one bill, which seems to have been the credo of physicians for many generations should be abandoned…Disease cannot be understood without an ecological study in depth [that includes] the environment, the host, and the culture”. Naturopathic medicine provides an alternative philosophy to Biomedicine that embodies environmental principles. These ecological tenets include finding deeper solutions than a technological fix, valuing diversity, accepting human limitations, trusting the Healing Power of Nature, and considering the ecosystem as a whole.

So why on earth would naturopaths want to prescribe pharmaceutical agents? It makes little sense, yet that is exactly what naturopaths are lobbying for in Ontario, as has been documented by Scott Gavura in the National Post and in the blog Skeptic North and Steve Thoms, as well as by our very own PalMD, Mark Crislip, and David Kroll. Worse, it appears that Ontario is poised to do just that and grant prescribing powers to naturopaths.

This would be a recipe for disaster. As we have discussed here many times, the key concept behind naturopathy is not scientific and the current movement for “naturopathic physicians” is in reality a resurrection of a 19th century health movement espousing the “healing power of nature.” Rather, at the heart of most naturopathic practices is primitive vitalism, a belief that has existed for hundreds, if not thousands, of years that there is a “life force” that can be manipulated for healing effect, an “energy” that modern medicines do not help. Many ancient health concepts derived from vitalism, such as the idea that disease is due to an imbalance of the “four humors.” It is the same concept behind reiki, acupuncture, and therapeutic touch, all of which are accepted and practiced by naturopaths. Another key belief behind naturopathy is that many diseases are due to “contamination” with “toxins,” which is why much of naturopathy concerns itself with “detoxification” regimens. Indeed, naturopathy is, more than anything else, a grab bag of virtually every implausible, unscientific, or even outright disproven “alternative” modality out there. It is not uncommon to see naturopaths offering colon cleanses, reiki, acupuncture, chelation therapy, and all manner of supplements. No woo is beyond the pale. Indeed, homeopathy is one major bit of quackery that is embraced by naturopaths.

Worse, as Scott Gavura and PalMD have argued, naturopaths do not have the knowledge base to be able to prescribe drugs safely. Indeed, Peter Lipson showed that quite conclusively when he issued a “primary care challenge” and quite correctly likened naturopathy for hypertension to “modern shamanism.” Their claims of treating the “whole patient,” notwithstanding, they do not have an adequate knowledge of how drugs work, what the potential side effects might be, or how various drugs might interact with each other or with the various supplements that naturopaths are fond of using. However, as we have seen in the past, pseudoscientific movements are nothing if not persistent and patient. After the Ontario government repudiated recommendations to allow naturopaths to prescribe drugs, the naturopaths are back and on the verge of persuading the Ontario legislature to give them what they want, as puzzling as it may be why they want it, given how much in conflict naturopathic philosophy seemingly is with “allopathic medicine.”

Maybe naturopaths have figured out that they can only go so far prescribing placebo medicine and ineffective modalities that can be outright dangerous, like chelation therapy and colon cleanses.

The anti-vaccine movement and “greening” Oregon’s vaccines

A less well-known but even more potentially dangerous example of purveyors of pseudoscience trying to influence government laws and policy is the anti-vaccine movement. It’s had some success and caused a great deal of mischief by successfully planting two of its own (Lynn Redwood, President of SafeMinds, and Lee Grossman, president and CEO of the Autism Society of America, both of whose organizations buy into the scientifically discredited notion that vaccines cause autism) on the Interagency Autism Coordinating Committee (IACC), where they have caused great mischief by constantly lobbying for a study of “vaccinated versus unvaccinated” children and in general trying to push the idea that vaccines cause autism, all helped by another anti-vaccine zealot, Mark “I’m a serious scientist, really” Blaxill, MBA, who blogs for Age of Autism. It’s also possible that anti-vaccine zealots had some role in the victory of “vaccine choice” supporter Chris Christie over Jon Corzine for governor of New Jersey, although, having recently lived in New Jersey, I’d say that it was far more Corzine’s incompetence than his stand on vaccines that led to his defeat earlier this month.

Other political and legal initiatives of the anti-vaccine movement have been much less successful. For example, for all the momentary attention it brought the movement, Jenny McCarthy’s and Jim Carrey’s “Green Our Vaccines” rally in Washington, DC last year resulted in no real concrete gains for the anti-vaccine agenda, try as various anti-vaccine activists might to point to use it for “momentum.” Later last year, after the election of Barack Obama, the efforts of Robert F. Kennedy, Jr. (whose masterpiece of cherry picking, Deadly Immunity, had stoked the flames of the anti-vaccine movement back in the summer of 2005) failed to persuade President Obama to give him a cabinet post in his administration. More recently, the Autism Omnibus, a huge class action legal appeal to the Vaccine Court, flamed out spectacularly, as the best “science” the movement could put forward was not enough to convince a special court that is plaintiff-friendly by design that “vaccine injury” can cause autism. Worse, this ruling came down in close temporal proximity to the revelation that a hero of the anti-vaccine movement, Andrew Wakefield, upon whom Age of Autism had bestowed its 2008 Galileo Award, had almost certainly–shall we say?–applied a bit too vigorous a “massage” to the “data” (if you can call it that) that he had used in his now infamous 1998 Lancet article allegedly linking the MMR vaccine to “autistic enterocolitis.”

Now, failing to convince using science, Generation Rescue, through its propaganda blog Age of Autism, is announcing a new initiative whose explicit intent is to try to enact an anti-vaccine agenda into law. This time, though, GR is much more clever about it than it may have been in the past. Gone are all those nasty and “inconvenient” signs among marchers at the “Green Our Vaccine” rally equating vaccines to toxic waste or even “weapons of mass destruction” and proclaiming that vaccines had “poisoned our son.” In its place are appeals to “informed consent” (the same ploy that the granddaddy of anti-vaccine groups, the NVIC, has used), for more “testing” of vaccines, and–of course–for the “vaxed versus unvaxed” study. GR’s plans are, in fact, laid out in detail for anyone to read in three posts by Kent Heckenlively:

• The “Green Our Vaccines” Initiative for Autism
• The “Green Vaccines” Initiative
• A Quick Guide to the “Green Vaccines” Initiative

Here is how Heckenlively describes the reason for this initiative:

I’d hoped the Special Masters of the Vaccine Court would put an end to the vaccine/autism catastrophe.  Nobody was more surprised than me by the decisions earlier this year in the cases of Cedillo, Hazlehurst, and Snyder.   
As an attorney I have great respect for the judicial system but the decisions struck me as terribly flawed.  Maybe I shouldn’t have been surprised.  The Vaccine Court isn’t really part of the traditional legal system.  It was a creation of the pharmaceutical companies to shield themselves from liability.  Why else would a plaintiff be unable to force a defendant to produce a single document or witness without the permission of the Special Master? These companies and the U. S. government know they have something to hide.

He’s even more explicit in the latest post:

We’re not going to get anywhere with our current legal system because everything gets funneled into Vaccine Court.  We’re not going to get far with the current media because they’re so heavily funded by pharmaceutical drug ads.  We’re not going to get far with the medical community because they’re part of the machinery.

And don’t even get me started on the politicians.  On one hand you have pharma handing out millions of dollars to politicians, and on the other you have parents of children with autism who are slowly bankrupted by this disease.  Who do you think is going to have more money to “support” the politician of their choice?

So what is this “initiative”? It’s an attempt to build a grassroots movement to persuade legislatures to pass legislation that ties in to the anti-vaccine agenda of Generation Rescue and similar groups. The proposals that this movement seeks to promote fall into five categories that GR wants to hire political consultants to “poll test” while at the same time wording them so that the pseudoscientific anti-vaccine agenda behind them is not obvious:

1. Research/Testing – Oregon requests the federal government to return the records of the Vaccine Safety Data-Link from private industry and make them available to independent researchers, conduct a study of vaccinated and unvaccinated children, study the health effects of aluminum adjuvants, and other substances used in vaccines like hydrolyzed gelatin and sorbitol.
2. Disclosure/Informed Consent – Comparison of Oregon schedules with that of the CDC and other first world countries and full disclosure of vaccine ingredients, as well as the level of safety testing on them.
3. Banning – Thimerosal ban across the board, as well as the flu shot for pregnant women, multiple vaccinations at a single visit, a six month ban on vaccines for premature births, and three months for any infant.
4. Changes to Existing Law – Adding a philosophical exemption for Oregon, reducing required vaccines, restriction of the Vaccine Act of 1986 to unavoidably unsafe components of vaccines, and additional rights of military personnel to choose alternative vaccination schedules.
5. Consumer/Parental Choice – Giving parents the freedom to choose aluminum and formaldehyde free vaccines, a different vaccination schedule, a titer check before vaccination, as well as one for mitochondrial disorders which might be exacerbated by a vaccine, and the right to have multiple vaccines such as MMR split up into individual doses.

How did Oregon get so lucky to be the “test state” for this initiative? Well, that’s where J.B. Handley lives. Sorry, Dr. Crislip.

That aside, it all sounds reasonable on the surface, doesn’t it? It’s particularly true if you don’t know the science behind vaccines, the anti-vaccine canards behind each of these five areas, and what these initiatives really mean. For example, it sounds so reasonable to open VSD data to “independent” researchers, doesn’t it? In fact, what GR really wants is for their pseudoscientists to be able to pick over the data and try to find spurious correlations. In fact, that’s just what happened when Mark and David Geier gained access to the VSD database in 2003, as Kathleen Seidel recounts. They went beyond what their IRB-approved research protocol allowed, tried to remove data, and as a result Kaiser Permanente’s IRB Administrator received a warning letter from the CDC about the Geiers’ attempts to merge datasets in a way that could compromise patient confidentiality. In reality, what GR wants is the opportunity for more anti-vaccine “researchers” to abuse the VSD as they have abused the VAERS database in order to produce dubious studies that claim to show a link between vaccines and autism. As for the call for a “vaccinated versus unvaccinated” study, I discussed that issue in detail a while back, and it’s worth reading again to see what the real agenda is behind calls for such a study, as well as to understand why such a study is not only impractical but superfluous.

The issue of disclosure and informed consent is also deceptive in that risks of vaccination are already disclosed and parents already have to give informed consent. The purpose of this item is to be able to play the “toxin” gambit by listing all sorts of scary-sounding ingredients in vaccines whose identity is already listed on the CDC website and to play up theoretical “risks” of autism that have not been scientifically validated, particularly the claim that the U.S. is “overvaccinated.”

The third item is particularly despicable, in my opinion. For one thing, the idea that thimerosal causes autism is a scientifically discredited hypothesis. For another thing, most childhood vaccines are already thimerosal-free, other than trace amounts, the exception being the flu vaccine. Finally, it’s the height of irresponsibility to call for banning the flu shot for pregnant women during the H1N1 pandemic. After all, they are one of the groups who are at increased risk for complications and can thus use the protection. Even worse is the call for a six month ban on vaccinating premature babies; premature babies arguably need protection even more than babies born after the normal period of gestation. There is no valid scientific justification for any of these proposals; more than anything else, they are born of the anti-vaccine movement’s fear and loathing of vaccines, and the proposal to ban multiple vaccines at a single visit is clearly custom-made to reduce the number of babies receiving all the currently recommended vaccines.

The last two proposals, I will admit, are clever. As I pointed out before, it’s far more attractive to frame one’s argument as being for something like “parental choice” than against something like life-saving vaccines. However, what these two proposals represent is an attempt by the anti-vaccine movement to legislate the standard of care to its wishes. Aluminum is safe and effective, with over an 80 year history of safe use, while removing formaldehyde from vaccines is totally unnecessary given that it’s a chemical that our own bodies make in quantities far greater than is in any vaccine. I once pointed out to Dr. Jay Gordon that he and his children are probably exposed to far more formaldehyde from auto exhaust when he sits in Los Angeles traffic than any vaccine contains. Moreover, formaldehyde is used for a specific purpose, namely to inactivate the virus being used for the vaccine. If formaldehyde weren’t used for that purpose, some other chemical, perhaps one not nearly as well-studied, would have to be used. Basically, what these last two proposals would do is to allow anti-vaccine activists to dictate the standard of care to physicians and to use basically any ingredient that they don’t like in vaccines as an excuse to refuse vaccines. It would also allow them to force doctors to order tests that aren’t routinely indicated, such as measuring antibody titers, or that are only very rarely indicated, such as tests for mitochondrial disorders because they mistakenly think mitochondrial diseases render children more likely to become autistic after vaccination. Apparently, such parents don’t mind subjecting their children to muscle biopsies for no good reason, because that’s what it sometimes takes to nail down a diagnosis of mitochondrial disorder. At the very least it takes a battery of other tests. It’s not a trivial matter and, because mitochondrial diseases are so uncommon, routine screening is far more likely to cause false positives than it is to be reliable.

Like naturopaths seeking prescribing privileges, the anti-vaccine movement has lost on the science. It can’t support its claims that vaccines cause autism or other neurolodevelopmental disorders, and it can’t validate the various “biomed” treatments that it promotes to “reverse vaccine injury” any more than naturopaths can show that their methods work reliably or that they have sufficient knowledge to be able to prescribe drugs safely. It’s all of a piece with many forms of pseudoscience, such as how it took a powerful Senator to ram NCCAM down the throats of NIH scientists, not based on any scientific merit or clamoring by the medical community for such a center but rather based on the raw political power of a woo-friendly politician.

Pseudoscientific movements are persistent and patient, too. If the naturopaths and Generation Rescue don’t get their wishes this time, they’ll be back again and again and again. Count on it. I liken them to casino interests in my city. Casino operators first started trying to get casinos into the city of Detroit at least three decades ago. Every time a measure was put on the ballot to allow them it was voted down. Casino owners just kept trying again and again and again, until several years ago they got what they wanted, probably thanks to the opening of casinos across the river in Windsor. A similar story played out in Ohio, where casino interests tried four times and failed four times to get the voters to allow casino gambling in Ohio before finally getting the votes they needed earlier this month. The analogy to casino gambling is an apt one, too. If states allow pseudoscience like that anti-vaccine movement or naturopaths to dictate medical policy and the standard of care, we will be indeed gambling with public health in a way as risky to medicine and health policy as walking into the MotorCity Casino is to $500 in a gambler’s pocket. The difference, of course, is that in the case of letting people like J.B. Handley there’s virtually no chance that we could win big–not even the same chance a one-armed bandit provides.