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You Should Report Adverse Drug and Supplement Reactions

How do we know when a drug, supplement, or herbal remedy causes harm?  Most people assume that clinical trials provide the only mechanism for determining adverse outcomes but actually, consumers can report concerns directly to the FDA as well.

Did you know that the FDA accepts reports from consumers and healthcare professionals alike on their website, MedWatch Online Reporting?

Herbs, supplements, and “natural” medicines are bioactive substances that many people use to treat diseases and conditions.  They are not regulated for safety and efficacy, and are only now being scrutinized for accuracy of their contents.  Since we’re behind the ball on rigorously testing supplements (though it’s great that NCCAM is evaluating as many of them as their resources allow), it’s important for consumers of herbs and supplements to report adverse outcomes (like allergic reactions, harmful side effects, etc.) to the FDA.  How else will your fellow consumers find out about these unwanted side effects?

MedWatch also welcomes reports about adverse outcomes from prescription and OTC medications, medical devices, or cosmetic products.  I think this is an underutilized resource and could greatly improve public safety if we all pitched in and reported concerning events when they happen.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

The Power of Positive Thinking

Norman Vincent Peale wrote a bestselling book in the 1950’s,
“The Power of Positive Thinking.”  I read
it a few years ago and found it to be a tad simplistic but it had an undeniable point: a positive attitude is important in
life.

In my last post I described the dangers of magical thinking
– since it opens the door to pseudoscience-touting snake oil salesmen.  But now we will turn our attention to
positive thinking – a favorable psychological condition.

There is no doubt that there is a mind-body connection that
affects health.  “Type A personalities
are known to engage in behaviors that increase the risk for heart attack;
anxiety and perceived stress can cause higher output of adrenaline and
cortisol, and in turn contribute to inflammation, atherosclerosis, heart
disease, sleep disturbances, and weight gain.
Depressed individuals (for example) are more likely to suffer from pain
syndromes
, and may have impaired immune function.

Because our mind influences the health of our body, it is
physically therapeutic to focus attention on peace of mind as a preventive
health measure.  And in so far as
techniques are developed to reduce stress, decrease mental anguish, and improve
psychological wellbeing – they are helpful in keeping the body in a healthier
state.

Now, the temptation is to
exaggerate the benefits of peace of mind – that one might be able to avoid
cancer (for example) with the right attitude, which is blatantly false.  So this is where positive thinking and
magical thinking can be confused.
Magical thinking ascribes excessive value to a treatment, while positive
thinking understands the limitations of treatments and yet respects the reality
of the mind-body connection.

Let’s consider back pain, for example.  A magical thinker would look for the “secret
cure” for their back pain, and turn over every stone – fully anticipating that he would discover a miracle solution that others don’t know
about.  He would read books promising the
ultimate back treatment “that your doctor doesn’t want you to know about” and
would spend a great deal of money on treatments that have been
rumored to have some benefit in treating back pain (without any supporting evidence).  The magical thinker is vulnerable to snake
oil, and would rather risk thousands of dollars on experimental treatments than
consider traditional modalities first.

A positive thinker, on the other hand, will realize that
back pain is difficult to treat, has variable causes, and responds to different
therapies based on an individual’s unique circumstances.  A positive thinker would have a realistic
view of recovery, would accept the limitations of therapeutic options, but
would focus on his abilities rather than his disabilities and look for ways to
make the best of his current circumstances.
He would actively participate in physical activity, perhaps join a support
group, get good rest and engage in a healthy lifestyle while working towards a
brighter tomorrow one step at a time.

Definitions for clarity:

Snake oil is a treatment whose efficacy is knowingly exaggerated by those who wish to turn a profit on its sale.  E.g. diet pills that will “miraculously correct morbid obesity in a matter of weeks.”

A placebo is a treatment that has no known plausible mechanism for a physical effect – but may affect the individual through the mind-body connection.  E.g. a sugar pill that is substituted for a pain killer may cause a patient to experience his pain differently, though there is no active ingredient in the pill.

An untested treatment is neither snake oil nor a placebo but could be used as either under certain circumstances.  It is simply a proposed intervention of unclear clinical significance.  There are many of these currently undergoing scientific review, and it takes patience to analyze their potential efficacy and safety.

A magical thinker is a person who is willing to accept snake oil as a valid treatment option for his condition despite a vast preponderance of evidence to the contrary.  Magical thinking is belief-based, rather than evidence-based.  Many very good and reasonable people are tempted to adopt magical thinking under duress.

A positive thinker is a person who choses to look for the positives in all circumstances, and approaches health with a can-do attitude.  Realistic and yet optimistic, the positive thinker will focus on abilities rather than disabilities – and reach out for support as needed to optimize his psychological well being.

All of this is simply to say that a positive attitude, peace of mind, stress reduction techniques and a healthy lifestyle are an important foundation for good health.  Placebos are most relevant for influencing psychological well being or pain perception (obviously they’re not appropriate for treating infections, type 1 diabetes, and the like), and magical thinking and snake oil are dangerous hindrances to wellbeing.  Stay positive and protect yourself from snake oil salesmen.  Knowledge is power. There are voices of reason to guide you here at Revolution Health.

This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

The Power of Magical Thinking

The most outrageous lies that can be invented will find believers if
a man only tells them with all his might.

–Mark Twain

I’ve always liked the term “magical thinking.”  I first discovered it in medical school when
we were learning about normal childhood development.  There is a period of time (about ages 3-6) in
which all children believe in magic – things that are not possible or rational
appear plausible to them.  I suppose that
Peter Pan is based on this psychological window – when children grow too old
they can’t go to Never Never Land anymore because they lose their ability to
fly (aka believe in magic).

As adults, we often remember our childhood fantasies with
fondness.  We relive the experience with
our kids, and enjoy the carefree wonder that comes along with fully believing
in implausible things.  In general,
magical thinking is an enjoyable part of childhood.

But there is a more sinister form of magical thinking – and
that develops when adults abandon reason for implausibility.  We see this in medicine quite a bit, as it is
the soil in which the proverbial snake oil salesman can grow his thorny weeds.  Preying on fears in a vulnerable victim, the
snake oil salesman leads the person down a common garden path of partial
truths, twisted facts and sheer lies.
Here are some of his favorite tactics:

  1. Trust
    erosion.
    “Your doctor is keeping
    important (if not life-saving) treatment options from you.”  Snake oil salesmen love to write books with the
    following titles “What your doctor won’t tell you about X.” or “New
    scientific break through X that your doctor doesn’t know about…”  This tactic is meant to break the trust
    between physicians and their patients, causing second guessing and
    unnecessary rifts.  More often than
    not, your doctor doesn’t know about treatment X because it’s so ridiculous
    that they wouldn’t give it a second thought or the medical community has
    already disproven it.
  2. Conspiracy
    theories.
    Snake oil hucksters love
    to tell you that the government (or your hospital, or your pharmacist, or
    your health plan, or your healthcare provider) is conspiring against you
    with the pharmaceutical companies (or your health insurance, or your
    doctor, etc.) to prevent you from getting the care you need or to coerce
    you into getting treatment that you don’t need.  Conspiracy theories are ubiquitous in
    the snake oil world and they are the most obvious red flag identifier in
    their arguments.  So if the next
    treatment option you’re considering is promoted with arguments that it’s
    best for you specifically because the evil government/pharmaceutical
    company/hospital/doctor is trying to prevent you from taking it  – be very wary indeed.
  3. Playing
    the victim.
    When rational
    scientists poke holes in the snake oil salesman’s pitch, his favorite
    argument is “I’m being attacked and suppressed by those who don’t want YOU
    to know the truth. This proves that what I’m saying is true – why else
    would they want to silence me!?”
  4. Making
    you feel inferior.
    The snake oil
    salesman loves to point to the “wild success” of treatment X in Europe, Asia, or any other country than your own.  He wants you to feel that you’re late to
    the party, and that everyone else is ahead of you and has already been
    enlightened.  You feel ashamed of
    your ignorance and want to get in on something that has thousands (perhaps
    millions) of foreign supporters – so it must be safe/true/right.
  5. Pseudoscience
    jargon.
    To give their snake oil an
    air of credibility, the salesman will use medical-sounding words to
    describe its purported mechanism of action. This is where the salesman can
    really work his art into the minds of magical thinkers.  The more convoluted and implausible the
    story, the more magical it is – and the better able to capture imaginations.
  6. A secret cure. Diseases can be crippling and devastating, leading people to despair.  The most serious and life threatening diseases (especially if there is no known cure) are the favorite target of snake oil salesmen.  Desperation breeds magical thinking, and opens the door to all kinds of false promises on the part of hucksters who have no qualms making money on fruitless “cures.”  They often pitch their snake oil as a secret cure that only a select few people know about (or have access to).  If a disease has no known cure, you can be 99.9% sure that a promise of a “secret cure” is an unconscionable ploy to gain financially from the suffering of others.

And so, dear readers, one must never underestimate the power
of magical thinking.  It is the bedrock
of bad medicine, can lead people away from life-saving therapies, and will
continue to exist for as long as people are willing to entertain the arguments
of the snake oil huckster.  Sadly, I
predict that snake oil will be around for as long as human suffering exists –
and it will inflict its venom most effectively on the ignorant, desperate, and
vulnerable.  It can be vanquished,
however, on a case-by-case basis by its only natural foe: the scientific
method.  Hold fast to evidence based
medicine, and you will avoid much of the pain of pseudoscience, thorny lies,
and snake oil.  I will be there with you,
fighting the good fight.

In my next post I will describe the power of positive
thinking – which has value in medicine, as do placebos.  I will explain the difference between the
placebo effect and snake oil, an often confused but important distinction.

This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

Yogurt Can Prevent Hospital-Acquired Diarrhea?

Well, having grown up on a yogurt farm – nothing delights me more than scientific evidence that this fine dairy treat is good for your health.  Hats off to my friends at the Imperial College, London who just published a study showing that elderly, hospitalized individuals may use yogurt  to avert nasty bacterial infections that cause explosive diarrhea.

Yes, it’s the battle of the bugs at its best – the most common yogurt bacteria: Lactobacillus casei, L. bulgaricus, and Streptococcus thermophilus work together as pretty effective colonic bouncers for enemy bug C. difficile.  In this study, elderly patients (n=57) at risk for hospital acquired diarrhea (due to antibiotic use) were given 2 small active culture yogurt drinks/day during the time they received antibiotics and for one week afterwards.  Another group (n=56) was given similar drinks, but the yogurt cultures had been sterilized with heat (so there were no actual live bacteria in the yogurt).

And guess what?  None of the patients who drank the live yogurt got C. difficile infections, while 9 in the other group did!  That means that for every 5 elderly people in the hospital (and taking antibiotics) you could potentially save one from getting a painful gut infection.

So if grandma’s in the hospital on antibiotics, you might want to ask her doctor if she can eat yogurt. It may make the difference between a short stay and a long and unpleasant healthcare experience.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

New FDA Rule Raises Bar for Supplement Industry

Well, hooray for the FDA.  On August 24th a new rule will be phased in, requiring all supplement manufacturers to demonstrate that their products contain the ingredients listed on their labels (nothing more, nothing less).  This rule will help to reduce contamination issues (some supplements have been found to contain dangerous levels of lead, bacteria, and other contaminants) and false advertising (some supplements don’t contain as much of an ingredient as the label claims).

This is really good news, and better late than never.  Although some manufacturers were already conforming to this rule (kudos to them), this will require compliance for the rest of the companies out there who have been misleading the public about the contents of their supplements.

Some say that this rule doesn’t go far enough to ensure the safety and efficacy of the contents of the supplements, and that these bio-active ingredients should undergo the same degree of testing as pharmaceutical products.  Unfortunately, studying all the supplements for efficacy would be an enormous and extremely expensive task that is totally cost-prohibitive.  At this point, the best we’ve got is NCCAM, and they are slowly grinding their way through a long list of supplements that are purported to be useful for the treatment of various conditions.  They are systematically reviewing them to see if indeed they produce the desired effect, without any undesired effects.

And so at this point, let the buyer beware – supplements may or may not be as helpful as the manufacturer claims, and they may not be as side-effect free as they suggest either.  But soon you’ll at least be able to know that they don’t contain toxic chemicals, heavy metals, or dangerous bacteria – and that’s a giant step in the right direction for public safety.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

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