May 21 2007

The CAM Double Standard

The biggest problem with so-called complementary and alternative medicine – CAM (a misleading name for it is neither complementary nor a legitimate alternative) is that its proponents overtly seek to create a double standard in medicine. In an editorial published in the New England Journal of Medicine (NEJM Sept. 17, 1998 pg 839-841), then current editor in chief Marcia Angell and former editor in chief Jerome P. Kassirer wrote: “There cannot be two kinds of medicine – conventional and alternative. 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.” They got it exactly right.

The Standard of Care

Most people take for granted the notion that there are mechanisms of quality control in medicine. Doctors have to go through a rather long and expensive period of intensive training. They need to pass a series of exams to test their medical knowledge. Practicing medicine requires a license (in the US physicians are licensed by the state), and getting a license in turn requires that certain criteria are met. After licensure states hold physicians accountable to ethical and practice guidelines, and many now require proof of ongoing education. States can take action against a physician’s license for being unethical, or for practicing below the standard of care.

Quality is further regulated by the medical community itself. Hospitals and universities grant privileges based upon their own quality review, which may require being board certified in your specialty. At the very least hospital will not grant an operating room to a physician unless they are adequately trained as a surgeon (whereas licensure does not restrict this).

Drugs and devices also have a quality control standard. The Food and Drug Administration (FDA), or equivalent governmental body in other countries, requires evidence of safety and efficacy before a drug or medical device can make it into the marketplace.

Behind all of this quality control (apart from ethical considerations) is science. We rely upon the best scientific knowledge of the time to determine what works, what is safe, and what does not work or is unsafe. Intuition, revealed knowledge, wishful thinking, and even authority by itself is not enough – there needs to be evidence.

Because healthcare is such a vital public need it is justified to have such an elaborate system of quality control. In fact I would argue that our current institutions, while pretty good, can do better.

Healthcare Freedom

There are those with a libertarian political bent who argue that all this quality control is not necessary, that the free market can sort it all out, or that individual freedoms are more important than protecting the public from bad medicine. Although I strongly disagree with this position, I grant this is largely a political position – which means it is partly a personal choice. What do you value more – protection or freedom?

I bring this up because many in the CAM camp use the notion of healthcare freedom to promote their agenda. However, they are not honest in what they are truly advocating. At least the libertarians are upfront with their political views. CAM proponents, rather, use healthcare freedom not to argue that the standard of care should be reduced in favor of more freedom, but to create a double standard for CAM. I don’t know of anyone who is arguing for less education for doctors or eliminating licensure. Likewise, I have never heard a CAM proponent argue that pharmaceuticals should be freed from FDA regulation (while libertarians by contrast often do say this).

Healthcare Freedom Laws

Sixteen states in the US have so-called healthcare freedom laws. Essentially what these laws do is create a double standard for CAM. The wording in each state is different, but their effect is the same – a practitioner of CAM cannot have their license taken away or acted against because they are practicing substandard care as long as that care is deemed “alternative.” In other words, if an MD is practicing “conventional” medicine but what they are doing is significantly below the standard of care (it is demonstrably unsafe or ineffective), the state can act against their license. If, however, the same physician practices the same incompetent medicine, but labels it “alternative” they are immune from any action.

I have personally encountered exactly this situation. I was asked to give standard of care testimony against a Florida neurologist who was practicing, in my opinion, outright quackery. It was determined by the court, after hearing all the testimony, that indeed the physician was practicing substandard care. However, he appealed under Florida’s healthcare freedom law, claiming that what he was doing was alternative, and this appeal was successful. So now he is free to practice his unmitigated quackery, unhindered by any quality control.

Drug Regulation

The Dietary Supplement Health and Education Act of 1994 created a double standard for supplements by creating an absurd legal entity known as “structure and function” claims. Essentially this law, promoted by CAM enthusiasts under the justification of more freedom, removed supplements from FDA control. Now, herbs and supplements can be marketed without first having to prove safety. Further, manufacturers can make health claims for their products without having to do any research or provide any evidence. So this is an overt example of removing the standard of science, logic, and evidence as a mechanism of quality control in medicine.

What are structure and function claims? These are health claims that refer to body structure or function – and can use terms such as “support immune function,” or “promote heart health,” or “help the body fight cancer.” However, they cannot make direct claims to treat, prevent, or cure a specific disease. So they cannot claim that they cure cancer, but can claim that they support the body’s ability to fight cancer.

If this seems like a subtle, even pointless, distinction, that’s because it is. Supplement sellers have been able to easily get around the restrictions by cleverly crafting their statement. And make no mistake, that was the intent of the law – to subvert the quality control of scientific plausibility and evidence by making and end-run around FDA regulations.

Scientific Research

There is now also a double standard for scientific research, embodied in the National Center for Complementary and Alternative Medicine (NCCAM) – a center with the National Institutes of Health (NIH). The NCCAM ostensible was to provide scientific research into CAM claims, but it has not accomplished this, or really anything. The real purpose was to promote CAM and to give it a patina of scientific legitimacy, and in this, its real mission, it has succeeded.

NIH and other medical research funding organizations have standards by which they decide who to give money for research. The standards (although always evolving) are mostly common sense – is the research plausible, is it practical, is the question important to the practice of medicine, do the researchers have the experience and resources to actually carry out the research, etc. NCCAM serve the function of bypassing this quality control in how the public’s limited health research dollars are spent by awarding grants to research that would not pass the usual standards – research into highly implausible notions, into questions that have already been adequately answered in the negative (like the current research into chelation therapy for vascular disease), with poor study design, or not designed to even address safety and effectiveness.

Further, there is a double standard in terms of how the results of scientific research are used. In medicine, if one or more studies show that a treatment does not work, is not safe, or is inferior to another treatment, and this represents the best scientific evidence we currently have, then it is generally considered unethical and bad medicine to continue to use the treatment. In other words, if the evidence shows a treatment does not work, physicians stop using the treatment – at least until better evidence comes along.

CAM proponents, however, have never ever stopped using or promoting a modality because of evidence of lack of efficacy (let along absence of evidence of efficacy). A study showing a complete lack of effect for chiropractic manipulation and childhood asthma did not stop straight chiropractors from treating asthma with manipulation. (Here is a Cochrane review of manual therapy for asthma concluding there is no evidence of benefit. The recent negative study of Echinacea and colds has not slowed the sale of Echinacea.

In short CAM practitioners do not use scientific research the same way that mainstream practitioners do. They use it to promote their services and products, that is all. They do not base their practice on the evidence. Whenever a study seems to support a CAM modality, they will site it as scientific validation for what they have already known. When a study seems to show that a CAM modality does not work, they simply dismiss the study because CAM cannot be subjected to scientific protocols.

The double standard also extends to research journals. The National Library of Medicine (NLM) registers many pro-CAM journals that have a clear editorial bias. Meanwhile they have rejected journals that seek to provide a scientific treatment of CAM modalities as “biased.”

Medical Education

CAM has also made an unfortunate penetration into medical schools. I have no problem with teaching about healthcare beliefs and practices – in fact I encourage it. But CAM modalities are being taught in many medical schools uncritically as if they were legitimate scientific treatments. The purpose of many of these courses is not to teach students but to indoctrinate them. These efforts have been supported by the American Medical Student Association. If the courses were not taught as “alternative” the quality of the information they contain would never pass the rigorous standards of a medical school curriculum.

The reason for this is that it is easy for ideologues to infiltrate such institutions. There is a culture of political correctness within academia that makes fertile ground for those who say they just want to “provide another point of view.” Meanwhile those who would stand up for scientific medicine are criticized as “having an axe to grind.” Everywhere you turn, there is a double standard biased against scientific medicine.

Conclusion

The standard of care, based on good science, intellectual integrity, ethical conduct, and high standards of education – has been subverted by an ideology, the ideology of CAM. It has subverted the standard in practice, research, education, and publishing. The damage is significant and likely to be long term.

I also see this as part of the larger cultural conflict between science and anti-science. Culture matters, and ideas can become embedded in a culture and then persist for centuries. We are currently engaged in a conflict between those who think that our society and culture should be dominated by science and reason, and those who think it should be dominated by superstition, spirituality, and a philosophy of post-modernism misapplied to science – in effect denigrating science as just another philosophy deserving of no special status

It appears to be an unfortunate human characteristic that we are motivated more by irrational emotions or extremism than by calm intellectualism. In the context of CAM, I see a very activist and vocal minority have influence far greater than their numbers or the value of their ideas merit. Meanwhile the “scientific majority” are largely standing on the sidelines, either not perceiving the threat, or not wanting to risk political incorrectness in order to defend science from nonsense. Or, most often, they see is as just not worth their time and effort.

The result, I fear, will be a permanent culture change within medicine. I do not think that scientific medicine will ever go away – it is just too valuable and effective. Rather our healthcare system will be increasingly burdened by a resource-sapping parasite of CAM, draining away healthcare and research dollars while confusing the public and distracting them away from the most effective treatments.

I think the worst can be avoided, however, if the public is made acutely aware of the true nature of CAM promotion – that it entails the creation of a double standard where the public’s safety and provisions for quality control are being sacrificed so that CAM practitioners can have the freedom to do whatever they want without the burden of meeting the standard of care that has evolved over the last 100 years.

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