The most recent information collected by the US National Poison Data System which is the annual report of the American Association of Poison Control Centers, showed there were 0 deaths caused by any dietary supplements in the United States in 2008 (the latest year with complete information available).  Various data suggests that half of Americans take dietary supplements, which amounts to somewhere around 56 billion doses of supplements in a year.  Of those 56 billion doses, there were NO (zip, zero, zilch, nada) deaths from the best available data we have.

Compare that to deaths from pharmaceutical drugs, which are well regulated and much safer than supplements, and then tell me how dangerous supplements are again.

You can download the Annual Report of the American Association of Poison Control Centers for free here.

What are your thoughts?  Share them with us in the comments below.

Part II here

In part I of this series we answered the basic question, what is evidence based medicine (EBM) with the definition:  EBM is the equal use of clinical experience and external evidence to make the best decisions about the care of patients.

In part II we saw how this definition is often discarded for the much more stringent and less useful definition of EBM as the selection of therapies according to the evidence presented in the scientific literature.  This evidence is ranked with double blind, placebo controlled studies at the top (considered most authoritative) and clinical experience at the bottom (considered least reliable).

In part III, my intention is to outline how I use EBM in my practice.  Alternative or natural practitioners are often dismissed by conventional practitioners with the refrain “not enough evidence” or “hasn’t been proven to work”.  This is true only under the strict definition of EBM we talked about in part II but as I will show I base my practice on a great deal of evidence, much of which is not given significant value by the conventional community.

In my practice of medicine, I break evidence down into four quadrants.

Quadrant I – Tradition

The use of food and plants as medicines dates back to the beginnings of humanity and is found in every culture around the globe.  The most widely known traditional medical systems are Chinese medicine and Indian (Ayurvedic) medicine which have experience spanning several thousand years, and many generations of healers.

There is a tendency in modern culture to view our predecessors as ignorant or at the very least to think, “they were doing the best they could, but we’re clearly so much smarter and better than they are, after all we have iPods and electricity…” and to discount their knowledge and wisdom.  I think this is an arrogant and prideful view.  Our ancestors faced many of the same health problems we face today and generations of experience helped them to accumulate a wealth of wisdom about what heals and what doesn’t.

This is not to say that tradition has all of the answers, it doesn’t.  Superstition pervades this quadrant, some of the therapies our ancestors used were ineffective and some were downright harmful, and the conditions of our modern lives are uniquely different from those of our ancestors.  But to throw out this quadrant of evidence because of these flaws is to “throw the baby out with the bathwater.”  We have much to learn from our ancestors, and in my opinion, evidence based medicine starts here.  I look at how my Naturopathic predecessors treated disease and restored health, and how traditional cultures around the world used food, plants and other medicines.  To this base I add…

Quadrant II – Scientific literature

Because I am a Naturopathic doctor (ND) and not a medical doctor (MD) I have been called anti-science.  Let me be clear, I am NOT anti-science.  I value and use science, but I also do not revere science.  For me it is one of four quadrants of evidence, not the only quadrant.

Science is incredibly valuable.  At its best it helps us to uncover mechanisms of action so we can more deeply understand how diseases and medicines work, and how to better use our medicines.  It also helps us strip superstition and bias out of tradition and our own personal experiences.  But science is also a human endeavor and not something passed on down from ‘on high’.  Recent exposés have shown the bad side of science, manipulated for monetary gain: some scientific studies are ghost written by marketing people looking to influence the prescribing habits of doctors, some pharmaceutical companies hold back scientific data that would make their drug look worse, and that studies are manipulated from the very beginning to give the results that are being looked for.

Scientific studies are not gospel, and in my opinion, need to be taken in the context of other quadrants of information.  So to them we add…

Quadrant III – Personal clinical experience

Nothing can replace a doctor’s experience with their patients and their medicine, which is why we all value a doctor with years of experience.  A doctor’s experience working with their therapies, seeing what works and what doesn’t on real people in front of them, gives personal knowledge of that therapy that cannot be learned from tradition or the scientific literature.

This is not to say we should rely only on clinical experience because we are all subject to our biases and the biases of our patients and the population that we serve.  But by placing it in the context of the other quadrants we gain irreplaceable knowledge.  The last quadrant is…

Quadrant IV – Non-rational or intuitive

This is the hardest category to explain, and as such is often just ignored and swept under the rug.  Medicine is not just a science, it is also an art.  Hunches, gut feelings and intuitive leaps of thought play a vital part in the practice of medicine, even for the staunchest scientific practitioners.  Sometimes we choose therapies because it simply feels right.

Each of the four quadrants provides valuable evidence that I feel is, in and of itself, insufficient for the practice of EBM.   Conventional medicine, I believe, makes the mistake of discarding quadrant I (tradition) and IV (intuition), minimizing quadrant III (clinical experience), and attempting to rely almost exclusively on quadrant II (scientific literature).  Alternative medicine, I believe, also makes the same mistakes by rejecting quadrant II (scientific literature)  attempting to rely almost exclusively on quadrant I (tradition) and III (clinical experience), while some alternative practitioners think quadrant IV (intuition) by itself is enough.

I value each quadrant equally, and do not rely on any one to provide all the evidence for my treatments.  The strongest evidence is where each quadrant converges with the others; where a traditional use is verified by modern scientific studies, the clinical experience of the doctor and their peers, and by the practitioners and patients non-logical intuition.   This I believe is truly comprehensive, holistic EBM and best serves patients.

What are your thoughts?  We’d love to hear them, please post your comments below.

Part III of this series

In part I of this series, I explained what I believe evidence based medicine (EBM) should be:  the equal use of clinical experience and external evidence to make the best decisions about the care of patients.  In this interpretation of EBM both clinical experience and external evidence are important and necessary.

Clinical Experience <—-> External Evidence

Unfortunately this interpretation is rarely used in current discussions of EBM.  Instead we find this version of EBM widely promoted.

1.  Randomized, controlled studies

2.  Other studies

3.  Clinical experience & “consensus” opinion

Under this interpretation, the value of evidence is now ranked.   Double blind, placebo controlled studies are given the highest value, followed by a variety of other studies, and lastly clinical experience and consensus views from committees, associations, and experts.  Instead of external evidence and clinical experience being given equal weight we now find that clinical experience is considered the least valid (and valued) form of evidence.

This form of EBM is often used to disparage and discredit alternative or non-mainstream therapies with the refrain, “there’s no / not enough evidence” because the only evidence considered worthwhile is that produced from studies, and especially from double blind, placebo controlled studies.  The reports of hundreds or thousands of doctors and hundreds of thousands or millions of patients are brushed aside with the comment “anecdotal” as if that means they have no value.

To run a well conducted scientific studies, especially double blind placebo controlled studies, requires  scientists to be hired, the study designed, subjects recruited, screened, and selected, the trial run for weeks, months, or years (in some cases), the data collected, analyzed and then published.  All of this isn’t free and in fact costs a tremendous amount of money.

The government does sponsor some studies, but the current budget allocated for studying alternative therapies is pathetically small.  The majority of studies are funded by private companies, and in a capitalistic society the goal of business is to make money.  Studies funded by private companies are not done to prove whether a therapy is effective or not, but ultimately to prove that their therapy (being studied) is effective so that the results can be used to promote that therapy, and make money.

For example, a pharmaceutical company comes up with a drug they believe might have potential, they patent it which gives them exclusive rights to sell it for a period of time.  This ensures that if the drug is shown to be useful they will be the only ones who can sell it and therefore they will be able to make a lot of money with it.  The company will then fund scientific trials to prove that it is effective and bring it to market.

In contrast, something like vitamin C is cheap and widely available.  It is a natural substance and so cannot be patented.  If a company paid for a study on vitamin C and found it beneficial, anyone selling vitamin C could use the study to promote their brand of vitamin C.  The company that spent the money to have the study done would not have any advantage because they cannot patent and hold exclusive rights to vitamin C.  In fact the sponsoring company would be at a disadvantage because they spent the money to have the study done, while competitors could use the results of the study for free.

Pharmaceutical companies run the majority of trials on medical therapies, and because they cannot own natural therapies most natural therapies are not studied.  Further, as many natural substances may be replacements or alternatives for drugs, pharmaceutical companies have a further disincentive to conduct trials on natural substances.  The only studies they would have interest in running are those that prove that natural substances don’t work or are inferior to their products.

Therefore as alternative practitioners we find that the majority of our therapies are not studied in scientific trials, because there is no profit in doing so.  Most supplement companies, alternative medical societies, associations, and schools are small and don’t have the millions of dollars needed to run the studies to “prove” that the therapies work.  Evidence from practitioners and patients is discounted as anecdotal and therefore “worthless”.

Under this version of EBM, the conventional community claims there is no evidence to support the use of alternative therapies.  However, if we turn this same standard upon the conventional community, we find they have little evidence to support many of the practices and therapies they use.  By some estimates, up to 80% of conventional practice do not have sufficient studies behind them to justify their use under this version of EBM.  Most MDs rely on evidence presented in scientific journals, what they are told by pharmaceutical representatives about medications, their own clinical experience and the consensus opinion of their colleagues and medical associations to provide evidence for the use of their practices and therapies.  The majority of this evidence is considered lowest tier evidence under this version of EBM.

It is my belief that this version of EBM sets unrealistic and non-usefully high standards for what can qualify as evidence to justify therapies and practice, and by doing so denies patients effective care.  In part III of this series I will lay out the form of EBM that I use in my practice and how I feel it best serves my patients.

What are your thoughts and opinions on EBM?  We’d love to hear them.  Feel free to share them below.

Part III here

Evidence based medicine (EBM) has emerged as one of the key concepts being debated in leading medical journals, doctors offices and conventions, insurance boardrooms, and government agencies  as a major piece of  the effort to reduce costs and improve outcomes in medicine.  In this series I’ll be explaining what evidence based medicine should be (part I), is (part II), and how I use it in my practice (part III).

The definition of evidence based medicine I believe makes the most sense comes from this paper.  BMJ 1996;312:71-72 (13 January) Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996). “Evidence based medicine: what it is and what it isn’t”. Excerpts from the paper will be in italics.

“Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”

The intention behind evidence based medicine is a good one.  As doctors we want to carefully and consciously use the best evidence to select therapies that are helpful to patients, and avoid those which are harmful or useless.  As the article says:

“[The purpose of evidence based medicine is to] invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious [effective], and safer.”

Whatever gives us the best results is what we want to use for the good of our patients.  But, how do we decide what is the best evidence?

“The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”

We combine our clinical experience as doctors (personal, subjective evidence) with the best evidence from external sources (impersonal, objective experience).   In contrast to what we will see in part II of this series, we see that evidence based medicine combines the clinical experience of the doctor with external sources, such as the scientific literature.

The article continues: “Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannised by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients.”

In this view of evidence based medicine, which I subscribe to, both clinical experience and the scientific literature are equally important.  One without the other is insufficient and leads to poor practice and outcomes.  Clinical experience without external evidence is narrowly focused and becomes quickly out of date, and the external evidence without clinical experience attempts to fit a “one size fits all” solution to individuals, which typically works very poorly.

In part II, we’ll move away from what EBM should be, to what it most often is.

What are your thoughts and opinions on EBM?  We’d love to hear them.  Feel free to share them below.

Bottom Line:  A combination of ignorance, arrogance, and greed often combine to keep effective therapies out of public awareness.

Sound too ridiculous to be true?  This interview with Dr. Burt Berskon, MD, PhD sadly illustrates this point all too well.

As a medical resident in a teaching hospital, Dr. Berkson was told to watch two patients die, take notes, and present on it.  Both had eaten poisonous mushrooms and were diagnosed with uncurable and fatal liver damage.  Despite being told there was nothing that could be done, and his orders to simply watch, Dr. Berkson felt compelled to try and help these two patients.  He had a PhD and had been a research scientist for 6 years before deciding to become a doctor, and he called his contacts at the NIH (National Institutes of Health) to find out if they had any ideas that might save these people.  They suggested alpha lipoic acid might work and rushed some to him.  Dr. Berkson gave it to both patients (by IV) and over two weeks both patients regenerated their livers and fully recovered.  He was thrilled, the patients were thrilled, and his bosses were angry.  He had disobeyed orders (they told him to watch, not treat) and he has used a non-approved drug.  Were they interested in what he did or further exploring the therapy?  No.

When more patients came in with fatal mushroom poisoning he was told not to use the alpha lipoic acid treatment that had saved the other two patients.  He did so anyway and these patients also recovered.  He was disciplined again and the only reason he kept his job was because of his contacts at the NIH.  He conducted a small trial with alpha lipoic acid showing 75 of 79 people with terminal (fatal) liver disease recovered.  Despite these stunningly spectacular results no one in the US was interested.  Journals had no interest in publishing his papers, companies had no interest in sponsoring further trials, and doctors had no interest in utilizing the therapy.  He traveled to Europe and was finally able to publish his research in Germany (where MDs DO use herbs, nutrients and other non-conventional therapies)

Later in the article Dr. Berkson talks about another non-standard remedy, low dose naltrexone (LDN).  A woman came to his clinic suffering from fatal pancreatic cancer that had spread to her liver.  She had been told that there was nothing more that could be done but had sought out Dr. Berkson for a second opinion .  He started her on a regimen of intravenous alpha lipoic acid and low dose naltrexone and five months later there was no sign of the cancer.  The woman wanted to return to her home state and when she returned home she found that there weren’t any doctors who would even consider continuing her treatment with alpha lipoic acid and LDN.  Dr. Berkson spoke with the woman’s primary doctor about the results they had seen and asked if she would continue the treatment.  Her response:

“You know, I really would not want to do anything different because the medical boards might look down on me. I’m not an oncologist, and if I treat the cancer, the oncology people might get angry about it. So I can’t do it.”

These two incidents are only a piece of the article, which is found here.  It is well worth reading and will sadly open your eyes to the fact that there’s far too much too much ignorance, arrogance, and greed in medicine.  I’m grateful to practice Naturopathic medicine where I have the freedom to explore non-conventional therapies.  Where the priority is still caring for the patient, and big money and big politics haven’t corrupted that.  Most MDs and other conventional practitioners (nurses, etc) are truly caring, dedicated people (I know quite a few), but unfortunately the system has become more about making money than healing.  I’ll be exploring both alpha lipoic acid and LDN as potential options for my patients and I hope by spreading the word it’ll encourage other doctors to take a look at these non-conventional but effective therapies.  A world of healing DOES exist outside of the conventional system, and if we set aside our ignorance, arrogance and greed we can be free to use whatever therapies help patients heal.

What are your thoughts?  We’d love to hear from you.  Please feel free to post below.

1. I recently posted about a report from the Food Standards Agency of England which reported that there were no differences in nutritional content between conventionally grown and organic food. This article from the Life Extension Foundation argues that that claim is wrong and that: ‘”The science has consistently shown that organic food provides higher levels of Vitamin C and total antioxidants, two nutrients that the American public needs more of,” said Richard Wiles, Senior Vice President for Policy and Communications with the Environmental Working Group. “The London study is not supported by the majority of the science. We should not attach too much significance to its findings until it can be replicated,” Wiles added.’

2. Are proponents of organic food naïve? I found the following article by a conventional farmer fascinating and thought-provoking. While I believe that a number of his logical arguments are flawed, he raises some points I think we need to consider.  As a fan of organic food, this article made me wonder, are all the chemicals a “necessary evil”?  Would the “best” farming system include the many insights of organic and permaculture farming and combine it with the targeted and minimal use of chemicals (herbicides, insecticides, etc.)?

3. In another post I spoke about some of the less-than-ethical tactics that the pharmaceutical companies use to increase their sales and bottom line. Ghost writing, where a scientific article is written by a media agency and signed off by a prominent doctor that had little or nothing to do with it, is one of those things. The following article talks about some examples of this practice.

4. This three part blog post (Part 1. Part 2. Part 3) is one woman’s birth story. Originally a die-hard fan of medicalized childbirth, to her own surprise she finds herself deciding to opt for a natural birth. Compelling, raw, and very, very honest.  WARNING: Not kid friendly. These posts contain quite a bit of profanity.

What are your thoughts?  We’d love to hear them, please share them in the comments below.

I recently watched two Bill Moyers webisodes, one on the insurance companies, and one on the pharmaceutical companies.  They’re around 20-30 minutes each and well worth watching.

Bottom line: Insurance and pharmaceutical companies are businesses just like any other American capitalistic business.  That means their first, most important, and only goal is maximizing their bottom line.  If they don’t, Wall Street punishes them and their stocks plummet in value.  In that regard they are no different from Wal-Mart or Apple computers.  The difference is  that when other companies maximize their profits, they lay off people, or deliver a cheaper, inferior product.  When the insurance and pharmaceutical companies cut costs and increase profits they drop coverage, raise policy rates, deny care, and increase the cost of medications.  This, indirectly, results in the suffering and death or real, live people.  Should these industries play by the same rules as other non-healthcare businesses?

But it goes beyond that.  Removing people from policies or increasing rates are legal and legitimate (at least sometimes).  But as this story illustrates, insurance companies are more than willing to use quasi-legal and ethically scum-bag behavior to further their bottom lines.  And recission, where the insurance companies look for any excuse (no matter how trivial) they can find to deny care, is equally vile behavior.  And it gets worse.  Both industries routinely buy off politicians (the pharmaceutical industry has two lobbyists for every member of Congress) to prevent legislation that would bring these practices under control… and reduce their profits.  And more…

The pharmaceutical companies:

1. Engage in deceptive direct to consumer advertising that down plays side effects and shows images of people frolicking through fields and beaches and other idyllic scenes (if you take their drug).  These ads also serve to medicalize normal life events.  Where before it was a result of aging or other normal circumstances, it’s now an actual disease, which of course requires treatment with a drug.
2. Turn the scientific literature into little more than propaganda.  Perhaps their worst offense.  Many of us believe in scientific studies, that it helps us understand the truth.  Sadly this is not the case.  It’s been clearly shown that they…
   1. Rig scientific trials.  Design the studies for scientists so the outcome they desire is guaranteed.
   2. Ghost write trials (this is most often done by an ad agency, not a scientist) so that the studies say what they want them to say.  This has gone as far as completely making up the data used in studies.
   3. Repress studies that disagree with the point that they are trying to make.  Studies are rejected by journals (can’t get published).  Studies fail to get any attention in the media.  Scientists are told they won’t receive any funding for future studies, or that they will lose their jobs, if they study the “wrong” thing or have “wrong” conclusions.
   4. Create inaccurate media frenzy.  Which studies make the headlines?  Most often, those with pharmaceutical sponsors.  Pharmaceutical companies buy a lot of advertising in media.  Publishing an article with the “wrong” conclusion can cost TV stations, radio, and newspapers major advertising revenue, so it often doesn’t get published.   What does get published is too often ghost-written by ad agencies, not reporters.
   5. Buy experts.  Try to find an expert in a field and chances are almost certain they have been “bought” by a pharmaceutical company.  Whether it’s research money, gifts, vacations, or just plain money, many “experts” make a great deal of their livelihood by sticking to the corporate line and being generously rewarded.
3. Buy doctors.  Like the experts most doctors are relentlessly chased by drug reps who are beautiful (many come from the ranks of cheerleaders and models), young, and friendly, who flatter and pay attention.  Who provide gifts (from pens and notepads, to free dinners, free events, free vacations), and samples.  The reps use computer programs to monitor the prescribing habits of doctors.  Doctors who prescribe more of their drugs receive greater rewards, doctors who prescribe less get more pressure.  Most doctors genuinely believe that their decisions are their own, but studies have shown this is far from the truth.  These salesmen and women profoundly impact the medical decisions that doctors are making.

Both industries have taken strong notice of the tactics used by the tobacco companies, and use them to aggressively maximize their bottom lines, even as they cause death and suffering.

If we’re honest, we have to say that these two industries are probably no worse than others.  We’ve seen the lows that the financial industry went to, in terms of short-term profit, creating trillions in debt and plunging the world into a recession.  The capitalist system, as it applies to health, is filled with incentives to make money and disincentives to provide good care.  Should we expect any better from the pharmaceutical or insurance companies?

Watch Bill Moyers interview with Wendell Potter on insurance companies here.

Watch Bill Moyers interview with Melody Petersen on pharmaceutical companies here.

What are your thoughts?  We’d love to hear them.  Please post your comments below.

I recently saw a PBS special called Sick around the World.  The basic idea of the show was to look around the world at other modern democracies and see how they have implemented universal coverage.  By learning from them perhaps we can find solutions to our own problems.  Reporter T.R. Reid traveled to five countries: Great Britain, Japan, Germany, Taiwan, and Switzerland to understand their universal health coverage.

Bottom line: If we want to provide universal coverage to our population here in the US, there are the lessons taught to us by other modern democracies doing it.

1. It is possible to create universal coverage using private insurance companies, private doctors, and private hospitals.  However, health care cannot be left entirely to the free market and must be regulated.
2. Insurance companies must be forced to accept everyone; no exclusions, no pre-existing conditions, no dropping coverage, etc.
3. Insurance companies should not be able to make a profit on basic care.  Insurance companies in countries like Germany and Switzerland are non-profits.
4. Everyone must be forced to buy health insurance; the government pays for policies for the poor
5. Doctors, hospitals, pharmaceutical companies and equipment manufacturers must accept fixed prices for their goods and services.  In all 5 countries visited doctors earned less than they do in the United States.  This was offset by the fact that they graduated without medical school debt (often around $200,000 in the US) and their malpractice insurance was 1/10^th of what it is in the United States.

The special is a little less than an hour, available free on the Internet and well worth your time.  While the issue is massive and complicated, if we believe health care is a right and we see that other modern democracies are providing it, aren’t we obligated to as well?

Watch the show here.

What are your thoughts?  Is health care a right or a privilege?  We’d love to hear from you, please post your comments below.