Health Freedom

Freedom is a topic more complex than most realize; certainly more than I had realized.  In the sense of freedom of choice, more freedom does not necessarily mean one will be happier (see work by Barry Schwartz), nor does it mean that one will necessarily make the best decision (Bounded Rationality by Herbert Simon).  However that is the topic of another post.  Here I write my thoughts on the specific topic of health freedom.

On one extreme of health freedom is the days of the snake oil, where anything can be sold to anyone with any health claim, a full “buyer beware” system.  On the other extreme is an authoritative mandate that all must prescribe to an official course, scientific or otherwise, where one cannot decide on one’s own fate, even life or death.  Clearly neither are reasonable options.

In the US the situation is somewhere in between, with drugs and supplements regulated to a certain degree.  The National Center for Complementary and Alternative Medicine (NCCAM) is responsible for investigating complementary and alternative medicine scientifically, and this blog post shows how I feel about it.

Not too long ago, before widespread use of the internet, mainstream healthcare consisted of two words – “Doctor’s Orders”.  The MD was the expert, the professional, the authority.  Not many people were informed, and far fewer people misinformed.  A good old fashioned PDR was all that was needed.

The information revolution that came with the internet changed the entire landscape.  All of a sudden information is at your fingertips (whether one can properly make sense of it or not is a different story).  Unfortunately the driving force of the internet, the search engines, are designed such that search results are ranked based on popularity; accuracy plays no role in the ranking.  A vicious circle forms – medically accurate sites are unpopular because few understand the language, and the interfaces apparently have been designed by sadistic dysfunctional underpaid trolls on drugs, while quackery sites rise quickly by virtue of being written in plain English, sleek, well-designed, and have no shortage of salient material including false promises, unsupported claims, logical fallacies, plenty of anecdotes and “user testimonials”.

Suddenly to the physician, faced with a barrage of semi-informed inquiries, dubious questions, and the occasional legitimate inquiry of the latest e-pub clinical study that he didn’t even know about, that PDR seems about as useful as an outdated Yellow Pages, and the CME seems woefully inadequate.

Nowadays it is far more common for the physician to present options for treatment and defer the actual decision to the patient.  When done properly this is a reasonable approach, however it is time consuming and often impractical.  More often than not it is a way to shift the responsibility and provide an easy out for the physician.  Options are not equally valid simply because they are presented side-by-side, and although the physician is professionally obligated and morally bound to present the best objective expert opinion, sometimes it is not practical to present the options adequately for the often under-educated consumer to make an informed choice.

The bottom line is, although truly horrible decisions can be made with real harm and danger, I feel that a mentally competent adult should be able to make any choice regarding his/her own health, regardless of intent, up to extreme decisions such as suicide.  What I also feel is that one should NOT be free to impose his/her choice upon another person, regardless of intent, through action or inaction.

For example, one should be free to choose if, when, and how to die, be able to refuse treatment of any kind, and pursue whatever medical experiments on himself.  However one should not be free to impose this on anyone else, for example, people under his care, children, elderly, etc.  Parents should not be given free rein to decide whether their kid should get a qi manipulation instead of emergency surgery, or to replace life-saving medication with homeopathic concoctions; that is what I consider child endangerment.  It should be considered reckless endangerment when people with HIV knowingly have unprotected sex (inaction), even if one believes that he is cured of it through whatever modality.  Unless a subsequent test shows that one is HIV negative and no longer a risk.

This is my stance on health care, on religion, and on life.  One should be free to choose to believe in whatever they wish, be it scientific methodology, religion, magic, conspiracy, fairy tales, ideology, whatever.  One should be free to act upon those beliefs, as long as the effect is confined to himself or to consenting and informed participants.  One should be able to believe in any monotheistic or polytheistic god,  but should not be able to blow up those who do not subscribe to the same view.

It would be easy to make a straw man argument that I should, by extension, oppose all regulation and advocate an anything-goes, buyer-beware snake oil system, which is not the case.  I am simply stating that people should be free to do whatever they wish when it comes to their own body, informed or not.

An informed decision is only as good as the information it is based on, and the process to come to that decision.  The information is only as good as the trustworthiness of its source, since few of us are directly involved in raw data.  The human mind has evolved not to think scientifically, and that is why opinions, reviews, and anecdotes influence our decision-making process more than it should.  Emotions aside, the reality is that it is difficult if not impossible to make an optimal decision on complex matters anyway, since we are limited by the information available, the cognitive limitations of our minds, and the amount of time to make a decision considering the cost of gathering and processing information.

I personally subscribe to the cautionary principle of “do no harm”, keeping in mind that inaction may be a better option than action considering the potential harm.  I consider evidence based on scientific merit only, and whenever possible I read and try to evaluate the methodology and quality of the underlying studies.  I try not to be influenced by anecdotes, testimonials, and personal biases, however that is self-delusional to a degree.  I will get a typhoid fever shot to protect myself if I know I will be served by Typhoid Mary, since it is quite clear to me that typhoid fever is caused by bacteria rather than “excessive heat/wind” or “imbalanced energy”.  To those that do not, hey, it’s a free country.  I promise not to judge, unless it presents a clear and present danger to others.

Drugs and Supplements

Most countries have the equivalent of the FDA in the US, which regulates medicine and supplements to a certain degree. In 1994 the Dietary Supplement Health and Education Act(DSHEA) was passed, under which dietary supplements fall under. Of course having multiple industries and large amounts of money involved is not conducive to the best outcome for the consumer, but that is the reality. In colloquial and tribal terms, Big Pharma and Big Supplement got their territories carved out.

The main difference between drugs and supplements is that, for drugs, pharmaceutical companies are required to scientifically prove efficacy and safety, and claims can be made for the specific use approved. For supplements, unless it is a New Dietary Ingredient (NDI), manufacturers are practically free to do whatever they wish. Technically there are recent requirements to adhere to cGMP (2007, to ensure production quality), however in reality there is widespread non-compliance. It is up to the FDA to prove that a supplement is unsafe, and so far it has only done so on one occasion with ephedra, and nowadays does little more than posting warnings on its website and hoping people read them. Regardless of whom is to blame for the apparent lack of resources in the FDA, the fact remains that this part remains mostly unregulated.

One of the rationales behind supplements was that supplements were presumed to be safe because of long history of use. The huge cost of double blind, randomized controlled studies are prohibitively expensive and time consuming, and seemed like overkill for innocuous supplements. However, in reality, naturalistic fallacy aside, most supplements are far removed from their original states, with the active ingredient extracted and concentrated beyond what could have been reasonably consumed traditionally – much farther along the dose-response curve than its original form. In other words, an unregulated drug. There is no requirement for efficacy or safety studies. The reason you rarely if ever see a “Contraindications” section for supplements is not because it does not exist, but because it is not required and often unknown.

Of course, many of the supplements, especially traditionally known vitamins and minerals, have been well studied scientifically and the pharmacodynamic and pharmacokinetic properties are well known. Others have evidence ranging from peer-reviewed studies to fake anecdotes.  This graph beautifully shows some of the supplements, uses and current significant studies or lack thereof; the ranking is somewhat subjective but useful as reference.

My viewpoint is practical and some would say pessimistic or depressing.  I believe that regardless of multiple negative scientific findings, short of outlawing a product, actual behavior will not be significantly changed, due to confirmation bias, cognitive dissonance, distrust or just plain stubbornness.  It only takes one small scale, poor quality preliminary study with bad methodology, cherry picked data with dubious funding and strong researcher bias to be touted as the next miracle drug, I mean supplement.  The fact that journals rarely publish replication studies, especially when it contradicts prior claims, does not help instill trust either.  It is a sad but true reality.

Surprising Thoughts on NCCAM

According to their website, the mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care.

In my view, NCCAM is more of a politically driven organization than a serious scientific establishment. The fact is that it has spent more than $1 billion on research with limited results, with positive results being from rather poor quality studies (size, blinding, methodology, etc.) and mostly on subjective reported results (pain).  The most celebrated recent headline grabbing meta-analysis on acupuncture (Vickers et al.) did conclude a very modest advantage on certain types of pain.  However from my understanding, the treatment efficacy when compared to placebo is only about 30-40% better than what you would get by randomly poking yourself with a needle or toothpick.  Honestly it is not what I would write home about but hey, everybody has different standards.

I surprise myself as I write the following, but this is how I currently feel:

Although it has been so far unproductive and arguably wasteful, contrary to what one might think, I actually have very little problem with the NCCAM’s existence, as long as it adheres to scientific methods. From a business point of view, this is simply a pet project, the cost of doing business. Their annual budget is less than $150 million, which is about what the US pays on interest alone on its national debt every 3 hours, in other words, petty cash. It is a relatively small price to pay to give a punching bag to a senator who has the view that “It is not necessary for the scientific community to understand the process before the American public can benefit from these therapies”. This statement makes the assumption that the therapy (bee pollen for allergy) is beneficial (not supported), is safe (not true, a 10 second search yielded this and this, ironically allergy-related), and needs no scientific evidence for the general public to use. Strangely enough, under DSHEA, bee pollen is a supplement and can already be used by the general public; you can take all you want, but simply cannot make claims that it can treat allergies. I find it sad and disturbing that someone with this thinking methodology is the chairman of the Senate Committee on Health, Education, Labor and Pensions.

Of course, there are moral implications. The layperson could take an investigation of a treatment (however implausible), hell, even the organization’s existence, and mistake it for an illusional, official endorsement. For example, if there were an official “National Center for Bigfoot Affairs” under the US Fish and Wildlife Service, it would not be unreasonable for the layperson to presume that Bigfoot existed.

I see it as part of the inefficiencies of the system.  For example, in a corporation, there are internal and external inefficiencies, key personnel get certain perks and privileges, pet projects, reciprocal back-scratching, you name it.  Yet often nothing is done about it, because the hidden cost of eliminating some of the inefficiencies far exceed the savings.  The savings realized by nickel and diming your employees to death are far exceeded by the price paid in lost productivity and loyalty.

Even though I have no problem with the NCCAM budget, it pales in comparison with the true cost, which is the enormous amount on money spent on CAM by the public under the misguided implicit endorsement of NCCAM.  I argue that the money would be spent anyway, with or without NCCAM.  I believe that most money spent on CAM is spent to feel good, to feel empowered, to feel that they are taking charge of their health, to feel liberated against Big Pharma, Big Government, Big Food, and Big Whatever.  The therapeutic value lies more in the patient/care provider interaction, a healthy dose of blissful ignorance, and reinforced by the act of spending itself (based on cognitive dissonance theory), rather than a measurable physiological effect.  Evidence-Based Medicine and Science-Based Medicine would likely disagree, but from a business, utilitarian, moral-free viewpoint, an immeasurable but nevertheless real benefit (unit of happiness, perception of pain relief) being traded for money voluntarily seems like a fair trade to me.

The real moral quandary is when people delay or forgo proven treatments due to their belief in CAM and cause real harm.  Too many of these happen unfortunately.  Although many can be considered Darwin Awards winners, many happen to babies, children, and those relying on help.  Those unable to care for themselves and most in need of help, through no fault of their own, are put in harm’s way by well-intentioned but ill-informed caregivers.  As tragic as the situation is, I callously argue that the existence, or lack thereof, of NCCAM would not likely significantly alter the situation.  The majority of decision-makers who chose the path to CAM-related serious harm and deaths likely possess a pathological mindset far too extreme to have their behavior influenced by the mere existence of a government organization.  A Taliban suicide bomber is unlikely to take off his bomb suit just because the Pakistani government opened up a National Center for Religious Tolerance.

In an ideal world, complementary and alternative medicine would be proven or rejected solely based on merit and high scientific standards.  In reality, CAM relies on a sympathetic governmental agency in which many would like to discount and discard the careful, rigorous examination process (not conducive to positive results) and treat opinions and anecdotes as data.  This is not an ideal world, and I settle for this.  I say let those that want to explore mysterious, unproven, implausible modalities do so.  If an effective therapy or modality emerges, great.  I await that day.