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The steady decrease in pirates and the increase in global warming over the last few centuries are strongly correlated (i.e. they appear to change at related rates). However, does this imply that pirates were preventing global warming? What about foreign lemon imports and autism rates? Has the increase in US lemon imports contributed to the increase in autism rates? Undoubtedly, these examples seem silly and unlikely, but knowing why requires an understanding of the difference between correlation and causation. The following video (broken up in to two parts) summarizes these differences quite nicely.

Disclaimer: In no way do I mean to downplay the gravity of autism. With an incidence rate now estimated around 1 in 150, it inflicts a heavy burden on our families, friends, and communities. However, this makes it even more important to maintain a high degree of discretion when it comes to searching for a cause and a cure. Witch-burnings (e.g. the anti-vaccine movement) fueled by emotion and backed by poor evidence will only lead to dead ends and serve to slow down the progress of real scientific discovery.

Wouldn’t it be nice if our food didn’t impact the environment? Well, as The Onion points out, Taco Bell might have done it! Just in case you’re not familiar with The Onion, the following video entirely satirical.

Taco Bell’s New Green Menu Takes No Ingredients From Nature

They’re everywhere. They promise to give you a boost without bottoming you out. And, best of all, they come in an easily carried 2-oz plastic bottle. I’m sure you’ve seen them, they’re the 5-Hour Energy Shots. But are they really worth shelling out $1.50?

What ever happened to drinking plain old coffee or tea? After all, caffeine has been quarterbacking the energy supplement market for ages. With the way most energy drinks are advertised — touting guarana, taurine, ginseng, etc. — it may not be obvious, but caffeine is still running the game from the sidelines. It’s hidden in the ingredients of proprietary “energy blends”. Most energy supplements have them, 5-Hour Energy included, and they’re usually described at the very end of the nutrition facts.

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Monster, 5-Hour, and Red Bull all have similar blends: niacin (vitamin B3), ginseng (not in 5-Hour), taurine, and enough caffeine (either as an additive or from guarana) to match one cup of coffee (about 100mg of caffeine). 5-Hour also claims that their blend of B-vitamins goes above and beyond to prolong its energy boosting capabilities. However, Dr. Brent Bauer, Mayo Clinic director of complementary and integrative medicine, recently commented on the high levels of of B-vitamins in 5-Hour: “People need to know they are not some magic potion that’s going to immediately raise your energy level,” he said. “There is no data that show that.”

On top of that, I couldn’t find (using PubMed) a single acceptable study showing that taurine enhances the performance boosting effects of caffeine. I did, however, find a US Army nutritional review regarding the mental-energy boosting effects of caffeine and ginseng: it confirmed caffeine but doubted ginseng. An article from the New England Journal of Medicine also shed doubt on the efficacy of ginseng (as well as other herbal remedies). Producers in the supplement industry don’t have to prove the safety or efficacy of their products before marketing them, which could explain the absence of definitive information. So, really, it appears that caffeine is the only ingredient in energy drinks with proven effectiveness.

Back to the original question, is it worth it to buy those 5-Hour Energy Shots (or any energy drink, for that matter)? If you’re just looking for something tasty to sip on, then an energy drink might be your best bet. But, if getting a boost on the cheap sounds more appealing, 200 mg caffeine tablets cost about $0.10 per dose; B-vitamins are even less expensive. In the end, it’s really a matter of taste. Pick whatever caffeine source best fulfills your needs for frugality, flavor, and/or convenience.

I couldn’t help but post this entertaining clip from “That Mitchell and Webb Look” regarding Homeopathic Medicine:

Not long ago, US headlines were inundated with horror stories about the dangers of biphenol A (BPA), a chemical used to manufacture polycarbonate bottles. The articles invoked the words that would bring any American family to arms: “It could harm your children,” they read. BPA was effectively demonized. But what sources did the media use to justify the hype? Might BPA be no more a demon than a fluffy bunny?

As the saying goes, don’t believe everything you see on TV. At least, that is what is suggested by the non-profit, non-partisan investigation from STATS, Science Suppressed: How America became obsessed with BPA.

Dating back to the 1930′s, thousands of studies have heralded the safety of BPA. However, as the STATS investigation reports, the few recent dissenting studies regarding BPA failed to use sound scientific practice. Even the most prominent of them, headed by Frederick vom Saal, were rejected by foreign bodies, such as the European Union and the World Health Organization, as inherently flawed in their methods and conclusions.

However, despite their lack of recognition, those same studies were touted as evidence by the media. One newspaper, the Milwaukee Journal Sentinel, “explicitly warned by the head of the National Toxicology Program expert panel that it was relying too much on one scientist whose work and perspective had been repeatedly rejected by international risk assessments.”

Not only did small sample sizes taint the validity of the studies, but flawed methods in the administration of doses of BPA to study subjects (usually rats) further convoluted the results. In humans, 99% of BPA exposure occurs via ingestion. However, the studies that concluding BPA was harmful used primarily a subcutaneous (under the skin) injection to administer BPA. Why does this matter? Because BPA follows differing physiological pathways depending on the route of exposure:

When BPA is ingested, it is rapidly detoxified, first in the gastrointestinal tract (GI) and then in the liver by enzymes which add a sugar molecule to BPA, transforming it into a water soluble BPA-glucuronide. The sugar conjugate is easily and quickly excreted in urine. The half life of BPA-glucuronide is six hours. There is a minor metabolic pathway in which some BPA is converted to a sulfate, but this is also water soluble and quickly excreted from the body (Tsukioka et al.,2004; Völkel et al., 2002, 2005).

In both of these pathways, BPA is deactivated, meaning it loses its capacity to act like an estrogen (Matthews et al., 2001; Shimizu et al., 2002; Snyder et al., 2000). This is important to note as BPA is considered to have a weak estrogenic capacity (approximately 15,000 times weaker than the strongest naturally-occurring estrogen in humans) – one of the reasons it has been dubbed an “endocrine disruptor” by environmental activists. The way orally ingested BPA is metabolized removes that capacity.

When a rat or mouse is injected with BPA as opposed to being fed BPA different things happen. The chemical retains its estrogenic capacity as it circulates in the blood and enters cells.

Furthermore, the actual amount of BPA ingested by humans on a daily basis is 500,000 times lower than that needed to elicit adverse effects in rats: “We get vastly more estrogenic chemicals from eating nuts, cereals and bread,” says the report.

There is much more to the STATS report, but whether one is convinced of the safety of BPA or not is beside the point. The underlying point is that media outlets, as businesses, have the ultimate interest financially in selling more issues/gaining viewers. The best way to do so? Publish the most attention grabbing and emotionally driven stories possible (example: the initial hype about the killer swine flu). What’s the point in reacting to something based on anecdote or flawed data? As consumers of news media, it is important to stay skeptical.

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More than ever, American’s are purchasing over-the-counter (OTC) medications, supplements, and herbal remedies to self medicate and promote good health. But does the fact that these products can be purchased freely imply that they are absolutely safe for consumption? Do they go through the same FDA approval processes as other pharmaceutical products?

Generally speaking, for a new a new drug to sold in the US, its producer needs to submit a New Drug Application (NDA) to the FDA. Through the NDA, the producer presents studies that prove the safety and efficacy of the product. Once the FDA has approved the product, it can be sold to the general public, either as prescription-only or OTC, depending on the restrictions the FDA decides upon. The entire process is quite expensive for the drug producer. However, there are two ways in which a drug can enter the market without first acquiring FDA approval.

First, as a result of the Dietary Supplement Health and Education Act of 1994, manufacturers of supplements and botanical products are solely responsible for ensuring the safety of their products prior to market entry. There is no requirement for any studies on safety or efficacy to be conducted. And, should concerns regarding safety arise, the FDA is limited by the tremendous burden of proof required to regulate these products.

Ephedra, the Chinese herb containing the alkaloid stimulant ephedrine, exemplifies a botanical product that was able to circumvent the FDA’s NDA and approval process. Once sold in energy supplements and weight loss products, ephedrine was found by the FDA to “present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use” (FDA Ruling). The FDA could only attest to the lack of safety of ephedra after it had been on the market and caused many adverse reactions. And, even then, it took 10 years for the FDA to successfully remove it from the market.

Second, the FDA grants automatic approval to all of the substances contained in the Homeopathic Pharmacopoeia, which is authored by the non-governmental Homeopathic Pharmacopoeia Convention of the United States. Zinc gluconate, the primary ingredient of Zicam and a compound in the Homeopathic Pharmacopoeia, is marketed as a homeopathic cure for the common cold. And, since it is “offered for use in [a] self-limiting condition recognizable by consumers, [it] may be marketed OTC.” (FDA Compliance Policy Guide)

Literature suggests that zinc gluconate (at 33mM, the concentration used in Zicam) is ineffective at preventing the common cold (here is another study with similar results). And this is where complication begin to arise: if Zicam would have been required to submit an NDA, then its lack of efficacy alone would have kept Zicam off the market.

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But after 130 recent cases of anosmia, a temporary or permanent loss of smell, the FDA has issued a warning advising consumers to avoid using all three Zicam cold remedies. So, if Zicam poses even the slightest risk of anosmia and may elicit no more than a placebo effect, is it really worth using?

Botanical, supplement, and homeopathic products dodge the NDA requirement and are marketed under the guise of FDA approval. They imply to their consumers that the FDA acknowledges the safety and efficacy of their products. Automatic approval does not mean a product is safe and/or effective — it only means that congress created a loophole for manufacturers. Consumers need to realize this fact and exercise a greater degree of skepticism when dealing with these types of products.

Ben Cade brought up some strong points in response to the first post of Doctors, Off-Label Prescriptions, and A New Legal Precedent. In summary, he argued that the case of Dr. Ames v. Wash. State MQAC could not be used as legal precedent for considering off-label (non-FDA approved) prescribing of drugs and devices as malpractice. If some evidence of efficacy could be presented, then the burden of harm would not be reached, he suggested. Below is an excerpt of his aguemnts followed by my response:

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“The legal precedent set by this ruling means the MQAC could potentially charge doctors with malpractice merely for promoting off-label treatments regardless of their actual effectiveness.”

I think you overlook a vital clause of the court ruling and in so doing exaggerate the extent to which malpractice lawsuits will increase. The justices did not write that the usage of the device in question represented malpractice “simply” because it was not FDA approved, but additionally that Dr. Ames:

“Led patients to believe LISTEN could treat and diagnose allergies, when in fact it could do neither, placing these patients at risk of harm.”

This statement is crucial, because it implies that if LISTEN would have held some type of legitimacy or effectiveness towards treating allergies–whether FDA approved or not–then the burden of harm may not have been reached. The efficacy of many off-label drugs, treatments and devices while not possessing the FDA stamp of approval, has been noted in reputable medical journals, demonstrated through lab studies, or largely accepted within a specific field of medicine–i.e. amongst a majority of doctors and practitioners.

If an off-label treatment held wide spread support amongst a large portion of the medical community–for instance the use of aspirin you noted before it was sanctioned–then any harm the treatment may happen to cause would have to be weighed against its observed benefits. As a matter of public policy, this is true even if the drug in question was not designed for that specific purpose.

In future cases which argue malpractice turns merely on the presence of FDA approval, the judges will surely also look to the evidence concerning the drugs’ merits.

“Led patients to believe LISTEN could treat and diagnose allergies, when in fact it could do neither, placing these patients at risk of harm.”

This argument can be used in the case of just about any off-label pioneering. I recall a recent medical case in which physicians experimentally injected Botox into the larynx of a young girl with Tourette syndrome. Their theory was that it would calm her vocal cords and lessen her ticks. The treatment didn’t work. Also, there was no scientific evidence to back up this usage (other than the theory post by the physician). On top of that, the treatment had real potential to harm the patient (and much more than that presented by a diagnostic tool measuring electrical resistance at that).

Although I do see your argument, and if a doctor actually made it past the first one or two cases and was able to justify some clinical effectiveness, then I can see where a judge might rule in favor of the physician. However, the true barrier to innovation lies in the impedance inherent in taking the risky step of pioneering a new method of treatment on that first patient. In such a case, where neither FDA approval nor anecdotal evidence of efficacy would be present, a physician would be hard pressed to provide evidence that his treatment was both effective and did not present a potential for harming the patient.

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However, this all still presumes that the physician (or his attorney) could argue past the other clauses stating “that medical review boards are able to rely on their own expertise in evaluating medical practices” and that no other evidence was necessary to convince “a layperson that he was using a machine for purposes for which it was not designed and for which he was not specifically trained.” The evidence consisted of a lack of FDA approval and one contradictory expert opinion.

Furthermore, the ruling states that “Generally, Washington law does not require that expert testimony be provided to MQAC” and that the MQAC can “draw inferences from the evidence presented to them.” Furthermore,  “it is not inappropriate for MQAC to draw its own conclusions as to the acceptable standard of care.” So, the expert testimony regarding efficacy would not have been necessary for MQAC to make their decision anyway.

I would hope that this case isn’t used as precedent for claims of malpractice. However, the wording of the affirmation still appears to loosen the reigns on what type of behavior actually constitutes malpractice. In my opinion, the Supreme Court would have been better off leaving out “the lack of FDA approval” as proof of ineffectiveness. In the case of Dr. Ames, it would have been simple enough (and less consequential) to affirm the ruling on the basis of supplemental expert testimony affirming the lack of clinical efficacy of LISTEN in treating allergies.

The ability to prescribe medications for off-label uses (those not explicitly approved by the FDA) provides physicians with the freedom to innovate — a freedom that has enabled the discovery of many new uses for old drugs. For example, physicians prescribed aspirin for the prevention of heart attacks long before the FDA approved its use in that context. Although it lacked FDA approval, the drug was obviously clinically effective.

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However, the Washington State Supreme Court recently affirmed a ruling by the Medical Quality Assurance Commission (MQAC) that expands what is considered medical malpractice in Washington State. As a result of loose wording in the conclusion, the ruling sets a new precedent for malpractice and threatens doctors who promote off-label use of drugs and medical devices. (Links to original documents: Supreme Court Ruling, Amicus Brief, and MQAC Ruling).

In 2004, the MQAC found that Dr. Ames committed malpractice (defined by RCW 18.130.180 (4) and 18.130.180 (16)) for using the Life Information System Tens (LISTEN), a diagnostic tool that measures electrical resistance in the skin, for the treatment of allergies.  On June 4, the Washington State Supreme Court affirmed the MQAC ruling and concluded that “…no additional expert testimony regarding LISTEN, or Ames’s use of it, was necessary. The evidence presented demonstrated by clear and convincing evidence to a layperson that he was using a machine for purposes for which it was not designed and for which he was not specifically trained. Substantial evidence exists that he led patients to believe that LISTEN could diagnose and treat allergies, when in fact it could do neither, placing these patients at risk of harm” on the grounds that “LISTEN has not been approved by the Food and Drug Administration (FDA) for use in detecting and/or treating allergies, although biofeedback machines have been approved for other uses.”

One-fifth of all prescriptions in the United States are for off-label uses. Of those, 73% had little scientific evidence supporting their efficacy. Also, due to the limited number of studies done on children, up to 62% prescriptions given to children are considered off-label. Cardiac, psychiatric, and allergy drugs have the highest rates of off-label usage, but the practice of prescribing drugs for non-FDA approved uses is also important in the treatment of rare conditions for which no standard treatment or drug therapy exists. If FDA approval required in proving efficacy prior to prescribing medications, then doctors would be unable to pursue the aforementioned methods of treatment.

In the interest of protecting the public from ineffective treatments, the MQAC and Supreme Court ruled fairly in the case of Dr. Ames. However, the Supreme Court went too far in presuming that a lack of FDA approval suggests clinical ineffectiveness. The Supreme Court, in effect, has redefined what comprises malpractice. The legal precedent set by this ruling means the MQAC could potentially charge doctors with malpractice merely for promoting off-label treatments regardless of their actual effectiveness. As a result, the Supreme Court’s decision could greatly discourage medical innovation by Washington’s doctors and limit the number of treatment options available to patients with rare conditions.

In its June 8 issue, AMNews released an article pointing out that “Unpaid care hikes private insurance premiums by billions”. Sweet and straightforward, the title hits the nail right on the head — cost-shifting, spreading out the cost of charity care for the numerous uninsured Americans, puts the financial burden of caring for the uninsured on the shoulders of insured Americans.

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“Hidden Health Tax: Americans Pay a Premium”, a report compiled by the independent actuarial group Milliman, Inc., concluded that of the $116 billion dollars in health care costs attributable to America’s uninsured in 2008, $42.7 billion dollars worth went unpaid for by governmental assistance or patients themselves. To recoup a $42.7 billion annual loss, hospitals have to negotiate higher payments from insurance companies. And higher payments make for inflated premiums.

A 2008 report from Kaiser Permanente pegged the average national insurance premiums for employer-provided family coverage at $12,680. $1,017 of the yearly cost is attributable to cost-shifting, as estimated by Milliman, Inc. And cost-shifting accounts for $368 per year of the $4,704 price tag for employer-provided individual coverage.

The burden of cost-shifting is exacerbated by the fact that uninsured individuals are more expensive to care for. Without the benefit of health insurance, preventative and continued care are effectively out of reach. Uninsured individuals end up neglecting their chronic and acute health conditions until they reach critical mass — they seek treatment when their condition is at its worst — and they usually end up in hospital emergency rooms.

Not only is emergency room care the most expensive care delivery outlet, but relying on emergency care creates a revolving door phenomenon. Without continued care to monitor their condition, uninsured individuals, many of whom have completely manageable conditions, end up back in the emergency room after their condition worsens again. Avoidable costs keep adding up, and cost-shifting ensures that insured health care consumers end up with the bill.

Extending coverage to the 45 million uninsured Americans has reached the point of necessity. No matter the mechanism — whether through mandated insurance with subsidies or an expanded public plan — covering the uninsured will result in a real cost savings. Reform will benefit every health care consumer financially while promoting better health for millions of Americans.

America’s per capita health care spending dwarfs that of other industrialized nations. But for what benefits? Americans don’t live as long as citizens of other industrialized nations; many American’s face bankruptcy by health care spending, a phenomena unique to the US; and, with the current growth rate of Medicare and Medicaid, the federal budget will have to take away funding from other social programs just to keep up with health care spending over the next few decades. America obviously needs reform.

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But what isn’t obvious is how reform should manifest. Should we push for a single-payer system similar to those in Japan, the UK, and Taiwan, or should the new system be more like Switzerland’s and utilize private insurers? However, with an issue as delicate and important as health care reform, any proposal will need solidarity in the American public. At the very least, the American legislative system demands it — reform that lacks solidarity is bound to fail.

Single-payer proposals promise intricacies that affect too many stakeholders — throw out the private insurers, scrap the system, we’re starting over. Since when has any mammoth proposal come close to making it through congress? There will be too many details in a single-payer plan for lawmakers to bicker about.

The Clinton health reform plan of the early 1990′s was born into a climate similar to the one the Obama plan will inevitably meet. But the Clinton plan failed to pass. Why? Even though it didn’t propose anything as radical as single-payer health care, it tried to overstretch the piecemeal limits of American legislative progress.

Health care needs reform, but reform needs united support to ensure success. While single-payer systems have an excellent track record in other nations for lowering health care costs and maintaining admirable health outcomes (high life expectancy, low infant mortality, etc.), a single-payer proposal just won’t pass in the United States. Even if a single-payer system is the best option, proponents of reform need to be realistic. Piecemeal change is the name of the game, and we need a plan that will actually make it through congress.