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:  “Remove the term H1N1 from the equation.” If your child had regular flu, would you take him to the hospital? If the answer is no, then don’t take him/her to the hospital now.

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People were scared [mainly due to the media’s hype and constant coverage of H1N1, along with declarations by governments and health organizations of pandemics and national emergencies].   Health care professionals were blaming the media — accusing them of being alarmist [most health care professionals working with patients, not those working in government or for the media, are not overly concerned about H1N1].  The doctor who met me [in a pediatric (kids) emergency room] started by saying he was giving the media a C+ in its overall coverage of H1N1, and blamed his busy ER, in part, on the media for stoking fears.

There is no question that pediatric emergency rooms are much busier than this time last year — about two to three times busier at the ER I visited, [but] many of the patients sitting in the waiting room were there with flu-like symptoms, worried about H1N1.  [In the media we hear that emergency rooms are slammed with patients and barely able to keep up, giving us the impression that most of these people are deathly ill, when in fact the vast majority are there with colds or flu-like symptoms that do not need medical attention.  Most are briefly examined and told to go home.]

[Dr. Gupta’s recommendations for parents:]

Point 1. As things stand now, the vast majority of children who develop flu-like symptoms this fall will have a few miserable days, and nothing more. And those days are best spent at home — not in the ER or a doctor’s office.

Point 2. If you are worried, you should call your pediatrician’s [or Naturopathic doctor’s] office first. Don’t take your child in without calling. Two reasons: Your child may not have H1N1, but could become exposed by being around sick children. And, after several hours of waiting, you are still likely to be told the basics — plenty of fluids, rest and dose-appropriate acetaminophen for a fever [I strongly disagree with the recommendation to bring down a mild-moderate fever with aspirin or acetaminophen as research has shown that doing so will INCREASE the length and severity of an illness.   A fever is part of the body's natural defenses against an illness.  In children if the temperature is less than 104 F and the child is tolerating it well there is no need to bring the fever down, simply make sure the child does not become dehydrated by supplying plenty of fluids.  If the fever needs to be brought down a short bath in tepid (luke warm) water is the best way to do so.]  After all, it is still the flu we are talking about.

Point 3. One doctor told me a way to think about things that was helpful. He said “remove the term H1N1 from the equation.” If your child had regular flu, would you take him to the hospital? If the answer is no, then don’t take him/her to the hospital now.

Point 4. Yes, hearing between 30,000 and 90,000 could die from H1N1 is scary, but keep in mind — around 40,000 people die from the regular or seasonal flu every year. The numbers may not be that much different, yet there is not panic about the regular flu. As things look now, H1N1 is causing only mild to moderate illness, not the widespread deaths people are worried about.

Point 5. There are some children who should be seen by their doctor. Call your doctor if:

• A baby younger than 12 weeks has a fever greater than 100.4 degrees Fahrenheit

• A child, older than 12 weeks has a fever for three days

• A child’s fever returns after a 12-24 hour time period

• A child is not passing urine or making tears for more than six hours

• A child does not smile or show interest in playing for several hours

Dial 911 if:

• A child cannot speak while trying to breathe

• Has a blue or dark purple color to the nail beds, lips or gums

• Is not responding to you because he is too tired or weak

One point that was reinforced to me over and over again by the pediatricians is the best place for a sick child is at home. And, with regard to school — after 24 fever-free hours without the aid of medications, he or she can go back.

This is the advice that my wife and I will be following this fall for our own children. Hope it is helpful to you, and the media can score an “A,” at least this time around.

[Full unedited, article here]

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Very reasonable advice.  If you or your child comes down with a flu-like illness, don’t panic.  As long as the sick person is handling the illness well, there is no need for further treatment or concern.  The most important therapies are to stay home, rest, and get plenty of fluids.  If things take a turn for the worse (high fevers, extreme lethargy or trouble responding, or any of the warning signs listed above) get a medical professional involved.  But remember, for the vast majority of people, H1N1 is a mild to moderate illness, not a life-threatening one.

What do you think?  Have you had swine flu this year?  How did you treat it?  We’d love to hear your thoughts.  Please post 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.

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.