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Monkeys, Myths, and Molecules: A Chemist Separates Fact from Fiction

9781770411913_0

“Dr. Joe” (from the title of his radio show) has done it again. He keeps putting out books faster than I can take them in; this one is titled Monkeys, Myths, and Molecules. It is packed with pithy analyses of health-related subjects that should be of particular interest to SBM readers.

Dr. Joe is Joseph Schwarcz, a chemistry professor and science popularizer based at McGill University. I’ve reviewed two of his many previous books before, Is that a Fact? here on SBM and The Right Chemistry over at Skeptic.com, as well as his free online chemistry lectures, “Food for Thought“, over at edX.org. As usual, this new book is a compendium of short (four-page) articles on a variety of subjects, written in a humorous, accessible style, and larded with intriguing trivia like where to see the largest illuminated advertising sign in the world.

If you read this book, you will:

  • Learn that Mozart only had seven teeth when he died.
  • Learn what was the first synthetic drug ever given to a human, and who administered it.
  • Learn that Popeye really ate spinach for the vitamin A, not for the iron, and how myths about myths about spinach (no, that’s not a typo) led to ever-increasing misinformation.
  • Hear the story of American military experts in WWII who had the bright idea of turning bats into weapons by attaching small incendiary devices to them. In an experiment hilariously gone wrong, the flaming bats set fire to a general’s car. (Remember that saying about military intelligence?)
  • Learn the role of coprolites (fossilized animal poop) in the development of modern agriculture.
  • Learn why Greek yogurt is not friendly to the environment.

Dr. Joe is a packrat for tidbits like these. I wonder where he finds them all. He seems to have a bottomless supply. (more…)

Posted in: Book & movie reviews

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The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly

The 21st Century Cures Act: Unnecessary and misguided.

The 21st Century Cures Act: Unnecessary and misguided.

The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform, as evidenced by HIV/AIDS activism in the 1980s and 1990s that led to the development of fast-track approval mechanisms for drugs for life-threatening conditions, a change whose effects have been mixed. It’s also a powerful force potentially for ill, as I’ve documented in my posts about the understandable but misguided “right-to-try” movement. After all, what politician can say no to a constituency representing desperately ill people who only want a shot at survival? It’s not all desperate patients, however. Also wanting more rapid drug approval are powerful business interests in the form of the pharmaceutical and medical device industries, for whom the time and expense of prolonged clinical trials eat into profits and make some drugs not worth developing from a business standpoint.

In 1962, after Frances O. Kelsey, MD, PhD (who died on Friday at the age of 101) successfully prevented the approval of the drug thalidomide in the US, a drug found to cause serious birth defects, Congress passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments required that drug companies not just show safety before their drugs could be FDA-approved, as had been the case prior to the amendments, but also to provide substantial evidence of effectiveness for the product’s intended use. That evidence had to be in the form of adequate and well-controlled clinical trials, which at the time was considered a revolutionary requirement. (Believe it or not, no requirement for high quality clinical trials existed before 1962.) This led to the current system of phase I, II, III, and IV clinical trials in force in the United States today. The amendments also included a requirement for informed consent of study subjects and codified good manufacturing processes, as well as the requirement that adverse events be reported. This has been, with some tweaking over the years, the law of the land regarding how the FDA approves drugs for specific indications

Medicine is a lot more complex now than it was in the 1960s however, and there has been a growing sentiment that the system is, if not broken, at least functioning in a way that is behind the times, a manner that was acceptable and appropriate 40 years ago but is no longer so in this era of genomics, precision medicine (formerly known as “personalized medicine”), and targeted therapies. The new drug approval process, which can take up to a decade and cost a billion dollars, it is argued, is too rigid, cumbersome, and slow for the 21st century. (Why it wasn’t too rigid, cumbersome, and slow in the 20th century, no one seems to say. I guess that “21st century” sounds way cooler.)

Into this ongoing controversy have marched Rep. Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), who have sponsored a bill passed by the House of Representatives in a rare display of bipartisanship in July. The bill, H.R.6, is entitled the “21st Century Cures Act“. Given how it passed the House by a vote of 344-77, one would think that it should glide through the Senate easily. Certainly, its sponsors and supporters have mounted a mighty PR effort. That might not be the case, given that in the Senate a single senator can hold up or even kill a bill through a filibuster, and to shut down a filibuster or prevent a threatened filibuster requires 60 votes. Be that as it may, I’m not so much interested in the politics of this bill, which, if it survives the Senate, will almost certainly be significantly amended, but rather what the bill does.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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Do You Believe in Magic? Oregon Does.

Pictured: OHP and HERB picking "evidence-based treatment options"

Pictured: OHP and HERB picking “evidence-based treatment options”

Do You Believe in Magic?

Do you believe in magic for a back pains fix

How the needles can free her, where ever it pricks

And it’s magic, if the chi is groovy

It makes you feel happy like an old-time movie

I’ll tell you about the magic, and it’ll free your soul

But it’s like trying to tell a CAM ’bout randomized control

If you believe in magic don’t bother to choose

Although subluxation is simply a ruse

Just go and get adjusted on the table

It won’t wipe off the pain no matter how hard you try

Your wallet is empty and you can’t seem to find

How you got there, so just blow your mind

If you believe in magic, come along with me

We’ll CAM until morning paid for by the OHP

And maybe, if the CAM is right

I’ll meet you tomorrow, sort of late at night

And we’ll go dancing, baby, then you’ll see

How the magic’s in the CAM and the CAM’s in me

Yeah, do you believe in magic

Yeah, believe in the magic of a back pains fix

Believe in the magic of CAM

Believe in the magic that can set you free

Oh, talking ’bout magic

Do you believe like I believe… Do you believe in magic

Do you believe like I believe… Do you believe, believer

Do you believe like I believe… Do you believe in magic

The Lovin’ Spoonful. Sort-of.

Maybe not my best lyrics.

More Oregon magic

It continues.

Oregon has a problem with prescription pain pills. Oregon leads the nation in the abuse of such drugs, federal statistics show, with Oregon’s rate of prescription drug abuse 39 percent higher than the national average. Go us.

Why that is, I do not know. As an Infectious Disease doctor I prescribe a narcotic about once a year. There are real problems with the treatment of chronic pain and while I am aware of the issues and the changes over the last 25 years, it does not impact my practice, so my knowledge of the issues is basic.

I am also well aware of the Oregon Health Plan (OHP). The OHP was intended to make health care more available to the working poor, while rationing benefits. They were fairly transparent that resources were fixed and not everything would be covered.

Given limited resources, part of the plan has always included a prioritization of treatments and diagnostics, paying for care that give the most bang for the buck. Not a perfect way to ration care and as is always the case, no good deed goes unpunished. (more…)

Posted in: Acupuncture, Chiropractic, Legal, Medical Academia, Naturopathy

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Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation

Sisyphus

Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.

Society for Science-Based Medicine

Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century

All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)

Posted in: Announcements, Health Fraud, Homeopathy, Legal, Politics and Regulation

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About that Cell Phone and Cancer Study

Which poses a greater risk - the cell phone or the lack of a helmet?

Which poses a greater risk – the cell phone or the lack of a helmet?

Recently there was another round of scaremongering headlines and articles claiming that cell phones can cause brain cancer. The Daily News wrote: “The scientists were right — your cell phone can give you cancer.” Many online news sites declared: “SHOCK STUDY: CELLPHONES CAN CAUSE CANCER,” in all caps to make sure you understand that you should be alarmed. None of the mainstream reporting I saw looked past the press release.

The study

Let’s take a look at the actual study: “Oxidative mechanisms of biological activity of low-intensity radiofrequency radiation” published in Electromagnetic Biology and Medicine.

The first thing to note as that this is a review article. It does not present any new data. It is not an experiment or observational study. It’s not even a meta-analysis. It is just a group of researchers looking at the literature and proclaiming that it confirms what they already believed.

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Posted in: Science and Medicine

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Is Homeopathy Unethical?

Homeopathy is full of crap!  Click to embiggen.

Homeopathy is full of crap! Click to embiggen.
Borrowed with loving attribution from Hell’s News Stand. Go to He…go there!

“A gentle ethical defence of homeopathy” by Levy et al. was recently published in an ethics journal. A full-text preprint is available online. They say:

Utilitarian critiques of homeopathy that are founded on unsophisticated notions of evidence, that adopt narrow perspectives on healthcare assessment, and that overstate the personal, social and ontological harms of homeopathy, add little to our understanding of the epistemology of medicine. But when they are used to denounce the ethics of homeopathy – they are not only ill-considered and counterproductive, but philosophically and socially perverse.

I found their arguments unconvincing. (more…)

Posted in: Homeopathy, Medical Ethics

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Medical marijuana as the new herbalism, part 4: Cannabis for autism

Medical marijuana as the new herbalism, part 4: Cannabis for autism

When I first started writing about the claims made for medical marijuana and the cannabis oil derived from it, it didn’t take long for me to characterize medical claims for cannabis as the “new herbalism,” as opposed to pharmacognosy, the branch of pharmacology devoted to the study of natural products. The reason is simple. Although I support legalization of marijuana for recreational use, when I look at how medical marijuana has been promoted as a “foot-in-the-door” prelude to legalization, I see testimonials and flimsy evidence ruling over all. I see all the hallmarks of alternative medicine herbalism and none of the hallmarks of pharmacology. Here’s what I mean. Pharmacognosy examines an herb, plant, or other natural product and seeks to identify the chemicals within it that have pharmacological activity against a condition or a disease, the better to purify and isolate those chemicals and turn them into drugs. Herbalism, on the other hand, emphasizes the use of whole plants or extracts from plants, rather than the isolation of the most active compounds. Thus, herbal remedies often contain hundreds, or even thousands, of different compounds, of which only one or a few are active. Even extracts, such as cannabis oil, contain many compounds.

In contrast to pharmacognosy, herbalists make the claim that whole herbs and plant components possess a synergy that is missing from the purified active constituents and/or that the mixture is safer than the pure components because one compound can reduce the side effects of another without reducing therapeutic efficacy. When looked at closely neither claim stands up to scrutiny. Synergism between plant constituents is rare and very difficult to demonstrate, for example. In essence, herbalism turns back the clock 200 years to a time before scientists had developed the techniques and abilities to isolate active ingredients with pharmaceutical activity. Moreover, herbalism, in contrast to pharmacognosy, emphasizes anecdotes over scientific evidence.

Indeed, in my previous posts in this series on medical marijuana, one theme has emerged, which is that cannabis—specifically, a class of active chemicals in marijuana known as cannabinoids—has potential for some diseases but is not the panacea claimed by its proponents. It does not cure cancer, for instance, contrary to glowing testimonials promoted by people like Rick Simpson. For other conditions, the evidence is either not particularly compelling or only mildly promising.

So I reacted with considerable dismay on Friday night when I saw this news report on the 11 o’clock news, “Michigan panel recommends allowing marijuana for autism“:
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Posted in: Herbs & Supplements, Politics and Regulation

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Neck Adjustment for Newborn Supraventricular Tachycardia: More Chiropractic Manipulation of Reality…..

[Editor’s note: Not enough Clay for one day? Check out this post on homeopathy over at The Scientific Parent!]

SVT

It was recently brought to my attention that a chiropractor was promoting his profession on Facebook by claiming to have treated and cured a potentially life-threatening cardiac arrhythmia. The condition in question, supraventricular tachycardia (SVT), can be very serious and even deadly in patients of all ages. Needless to say, the thought of anyone but a well-trained medical professional with access to appropriate medication and equipment to control the heart rate if necessary was unsettling to say the least.

After a deep breath, I followed the link and was sadly not surprised to find that it was true. In fact, after taking a minute for the rage to subside, and a few more to delve deeper into the case, I found that it was in reality much worse that I had initially imagined. The intervention, a stealthy adjustment of the child’s first cervical vertebrae, was performed by her father while she was being treated in a neonatal intensive care unit just hours after being born.

The events in question were posted by the chiropractor on a public account for his practice. Still, I feel hesitant to link to them directly as they reveal not only the name of the child but the identity of the cardiologist and intensive care doctor involved in her care (who naturally cannot respond because of privacy laws). If readers want to go to the trouble of locating the source of my outrage, they certainly can.

I will provide details of the child’s care as described by her father, but first a brief primer on SVT to set the stage a bit.
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Posted in: Chiropractic, Science and Medicine

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Rehydrating with an appeal to nature

Ski faster with coconut water?

Ski faster with coconut water?

I don’t tend to worry too much about hydration, except when I exercise. I’ve been running regularly for over 15 years, and since I started I’ve usually carried water, or for longer runs, I drink old-school Gatorade. The formulation is basic: sugar, salt, and potassium. There are hundreds of electrolyte products marketed for athletics, but I’ve been faithful to the original: It’s cheap, I don’t mind the taste (even when it’s warm), you can buy it nearly anywhere, and it’s the usual liquid (besides water) offered at races. After exercise, I rehydrate with plain water, preferring to get my electrolytes and carbohydrates from food, rather than a specialty beverage, some of which are “designed” to support rehydration after exercise. The science of sports and hydration is constantly evolving, and so is the marketing. I’m apparently an outlier by still running with Gatorade. New hydration products criticize Gatorade for being artificial and inferior, arguing that natural sources of hydration are better. There’s been an explosion of rehydration beverages, marketed both for everyday hydration and sport purposes. Coconut water was the first natural product to find fairly wide popularity as a sports-oriented beverage. Now you can find maple water, cactus water, watermelon juice and even artichoke water. Is “natural” hydration better that substitutes, including plain old water? (more…)

Posted in: Nutrition, Science and Medicine

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Placebo by Conditioning

power-of-placebo-effectTruly understanding placebo effects (note the plural) is critical to science-based medicine. Misconceptions about placebo effects are perhaps the common problem I encounter among otherwise-scientific professionals and science communicators.

The persistence of these misconceptions is due partly to the fact that false beliefs about placebos, namely that “the” placebo effect is mainly an expectation mind-over-matter effect, is deeply embedded in the culture. It is further exacerbated by recent attempts by CAM proponents to promote placebo-medicine, as their preferred treatments are increasingly being demonstrated to be nothing but placebos.

One idea that proponents of placebo medicine have tried to put forth is that you can have a placebo effect without deception. The study most often pointed to in order to support this claim is Ted Kaptchuk’s irritable bowel syndrome study. However, this study was flawed in that it told participants that placebos can heal, so it wasn’t exactly without deception. (more…)

Posted in: Medical Ethics, Science and Medicine

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