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Homeopathic industry and its acolytes make poor showing before FDA

Ask your pharmacist if nothing is right for you. (HT @leachkathleen)

Ask your pharmacist if nothing is right for you. (HT @leachkathleen)

On April 21 and 22, the FDA held a public hearing:

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. . . . FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

The FTC recently announced that it, too, is wading into the homeopathic waters. The FTC, which regulates advertising of homeopathic products, will hold a public workshop on September 21 in Washington, DC, “to examine advertising for over-the-counter (OTC) homeopathic products.” Like the FDA, it will also accept public comments online.

All of this regulatory buzz caused the FDA Law Blog to take notice. (The blog is hosted by a law firm specializing in food and drug regulation law.) A post titled “Will FTC Kill Homeopathic Products – or Will FDA?” gave this assessment:

Bottom line, if the FTC holds homeopathic products to the same scientific standards that are applied to claims for other OTC products like dietary supplements, as the FTC appears inclined to do . . . few if any homeopathic products will pass the test.

(more…)

Posted in: Clinical Trials, Health Fraud, Homeopathy, Legal, Naturopathy, Politics and Regulation

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David Tredinnick – Quack Candidate for Health Select Committee Chair

DAVID-TREDINICK-large570Today the UK Parliament will have a vote for the chair of the Health Select Committee. The two choices could not be more starkly different, so much so that this vote might be seen as a referendum on two world views, one that respects science and another that confuses pseudoscience and spirituality for medicine.

On one side we have Sarah Wollaston, the previous chair, who is a former general practitioner and has taken a solid stand against pseudoscience in medicine. She has previously tweeted, for example, “Homeopathy can also have serious harms when masquerading as a ‘vaccine’.”

Tredinnick, on the other hand, has previously argued that the NHS should incorporate astrology into the healthcare system. I have previously argued that homeopathy is the most absurd and easily debunked major form of alternative medicine. Astrology, however, is arguably more absurd, I had just never heard it offered as a basis for healthcare. Tredinnick has at least accomplished setting a new low bar for alternative medicine nonsense.

Tredinnick appears to be a true-believer, fully steeped in the propaganda that is CAM (so-called complementary and alternative medicine). He has said:

Ninety per cent of pregnant French women use homeopathy. Astrology is a useful diagnostic tool enabling us to see strengths and weaknesses via the birth chart.

And, yes, I have helped fellow MPs. I do foresee that one day astrology will have a role to play in healthcare.

(more…)

Posted in: Politics and Regulation, Science and Medicine

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Aging and Longevity: Science for Spring Chickens

Spring Chicken

We’re all going to die, but we don’t like to think about it. I’ll reach the proverbial threescore years and ten next month, so I’ve been thinking more about it, wishing I knew some reliable way to ensure that I would live many more years and remain fully functional until I suddenly collapsed like the Deacon’s wonderful one-hoss shay. There are myriad “longevity clinics” and “anti-aging” formulas, and every centenarian has an explanation that is the direct opposite of some other centenarian’s explanation. But what does the scientific evidence say? In his new book Spring Chicken: Stay Young Forever (Or Die Trying), Bill Gifford has done us a great service by investigating the latest scientific evidence about aging and presenting his findings in an engaging narrative form. He interviews some of the major players and introduces us to health fanatics who are convinced they can prolong their lives by doing things like monitoring their own blood cholesterol levels on a weekly basis, exercising obsessively, severely restricting their calorie intake, fasting intermittently, deliberately exposing themselves to stress like swimming in icy water, competing in extreme athletics, taking boatloads of hormones and supplements, experimenting on themselves with investigational drugs, and doing other questionable and sometimes bizarre things.

Are there limits to human life expectancy?

There is no documented case of anyone living longer than Jeanne Calment of France, who died at the age of 122. Jay Olshansky thinks biological forces limit how long we can live. Aubrey de Grey thinks some people alive today will live to be a thousand years old. Gifford explains the controversy and the reasoning behind both sides. Will we someday be able to re-engineer human biology to overcome the limits? The jury is still out. (more…)

Posted in: Basic Science, Book & movie reviews

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The war in California over nonmedical exemptions to school vaccine mandates

The war in California over nonmedical exemptions to school vaccine mandates

As I write this, I am currently at the Center for Inquiry (CFI) Reason for Change conference, where on Friday Steve, Harriet, and I did a panel on—what else?—alternative medicine and how it’s become “integrative medicine.” As a result, I’ve been very busy, which means that parts (but by no means all) of this post will look familiar to those of you who follow me at my not-so-super-secret other blog. However, it occurred to me after we did our panel discussion that there are important things happening in California that we’ve only barely touched on here on this blog. I’m referring, of course, to a bill (SB 277) that’s wending its way through the California legislature. SB 277, if passed, would eliminate nonmedical exemptions to school vaccine mandates. That’s not to say we haven’t discussed the issue of nonmedical exemptions, of which there are two types: religious and personal belief exemptions (PBEs), which can all be simply described as PBEs. Both Steve Novella and I have addressed them on SBM. For example, when an earlier bill (AB 2109) was passed that mandated that parents seeking PBEs consult with a physician or other listed health care professionals (which, unfortunately, included naturopaths) before a PBE would be granted, I documented how the antivaccine movement strenuously objected even to this minor tweak in the law that would make PBEs slightly more difficult to obtain. Unfortunately, even though, against all expectations, the bill passed, Governor Jerry Brown sabotaged it with a signing statement that betrayed California children by reinstating, in essence, religious exemptions. Specifically, Gov. Brown ordered the California Department of Public Health to include a check box on the form that parents could check to say they have religious objections to vaccines. Parents who checked that box could thus bypass even the anemic requirement to consult with a pediatrician before being granted a PBE.

The problem with nonmedical exemptions to school vaccine mandates is that vaccine-averse and antivaccine parents tend to cluster mostly in areas where white, affluent people live, as demonstrated in California and my own state of Michigan. So, even though antivaccinationists frequently tout high statewide vaccination rates as evidence that the process for obtaining PBEs does not need to be tightened up, they are disingenuously using a straw man argument against vaccine mandates, because it’s the pockets of low vaccine uptake that compromise local herd immunity that are the problem. We see these in Oregon, California, Michigan, and many other states with PBEs, and we also know that ease of obtaining PBEs is correlated with more PBEs and more outbreaks of vaccine-preventable diseases.

All of this came to a head earlier this year with what is now known as the Disneyland measles outbreak, a large multistate outbreak originating at Disneyland and traced to unvaccinated children. This outbreak so shocked California that the unthinkable happened. The possibility of passing a law eliminating nonmedical exemptions to vaccine mandates, something virtually everyone would have considered as much a fantasy as many of the characters played by the recently deceased great Christopher Lee played during his career, suddenly became an attainable goal. Senators Richard Pan and Ben Allen introduced SB 277, which would eliminate the personal belief exemption for children attending state licensed schools, daycares, and nurseries in California.
(more…)

Posted in: Politics and Regulation, Public Health, Vaccines

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Leaky Bowel

Pictured: Something you might need if you actually had a leaky gut.  Click to embiggen.  Weirdo.

Pictured: Something you might need if you actually had a leaky gut. Click to embiggen. Weirdo.

We are at a disadvantage. We have to rely on reality to validate the practice of medicine. Anatomy, physiology, pharmacology, chemistry, the basic sciences that made up the first two years of medical school education and a huge chunk of pre-med. And we have to rely on the truth, as slippery a concept as that can be. I can’t just make up a disease or a therapy.

It would be so much easier to not have to worry about reality in deciding on a disease and treatment for people with symptoms.

I came across “Healthy Life: Leaky Gut Syndrome” in my feeds. I am always attracted to exclamation marks! They must mean something important! Or surprising to the author!

It’s called “leaky gut syndrome” and patients say it can wreak havoc on everyday life, but some doctors say there’s no such thing!

Some doctors. Must be that pesky 10% percent or so of obstructionist doctors who don’t recommend Tylenol or Advil. (more…)

Posted in: Herbs & Supplements, Naturopathy, Nutrition, Science and Medicine

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Dubious MTHFR genetic mutation testing

Naturopathic catnip for patients.

Naturopathic catnip for patients.

Naturopaths, along with some chiropractors, acupuncturists and a few “integrative” physicians, are advising patients that they should be tested for MTHFR genetic mutations. Typically, the naturopath will start with the pitch that “conventional” medical doctors are ignoring your genes as a possible source of your health problems. (And it is mostly naturopaths who are doing this – just Google “naturopath MTHFR genetic mutation” and see what comes up.) NDs know better, of course – it could be a MTHFR genetic mutation causing your maladies.

Just what is the MTHFR gene? Allow me to introduce some actual scientific information here. According to Genetics Home Reference, a service of the National Library of Medicine,

the MTHFR gene provides instructions for making an enzyme that plays a role in processing amino acids, the building blocks of proteins. This particular enzyme is important for a chemical reaction involving forms of the vitamin folate (also called vitamin B9), a reaction required for the multistep process that converts the amino acid homocysteine to another amino acid, methionine. The body uses methionine to make proteins and other important compounds.

Back to pseudoscience. Next comes the scare tactic: telling you how a MTHFR mutation might affect your health: anxiousness, adrenal fatigue, brain fog, cervical dysplasia, increased risk of many cancers (including breast and prostate), low thyroid, leaky gut, high blood pressure, heart attacks, stroke, Alzheimer’s disease, diabetes, and miscarriages. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Health Fraud, Herbs & Supplements, Naturopathy, Nutrition, Obstetrics & gynecology, Vaccines

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Lawsuit Update

The First Amendment of the United States of America, guaranteeing freedom of speech

The First Amendment of the United States of America, guaranteeing freedom of speech

For those of you following the defamation lawsuit against me by Dr. Edward Tobinick, there has been a significant and positive update. For quick background, Dr. Tobinick filed a suit against me personally, the Society for Science-Based Medicine, Yale University and SGU Productions for an article I wrote here critical of his claims that perispinal etanercept can treat a variety of neurological conditions. All the defendants but me have since been removed from the case.

There are three plaintiffs in the case; Dr. Tobinick himself, his California corporation, and his Florida LLC. Last year I filed a motion to strike some of the claims as they apply to the California corporation under that state’s anti-SLAPP statute. The update is that last week the judge in the case ruled in my favor on this motion. These are public documents, so you can read the entire decision here. It concludes:

For the foregoing reasons, it is hereby ORDERED AND ADJUDGED that Steven Novella’s Special Motion to Strike (Anti-SLAPP Motion) [DE 93] is GRANTED. Tobinick M.D.’s claims for unfair competition under 28 U.S.C. § 1338(b) (Count II), trade libel (Count III), and libel per se (Count IV) are STRICKEN from the Amended Complaint.

(more…)

Posted in: Announcements, Legal

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Green Tea: Panacea or Poison?

320px-Genmaicha_tea_brewed_and_unbrewed

In the news: a woman in Fort Wayne, Indiana is suing the Arbonne International company in Allen Superior Court, claiming that its product contained toxic levels of green tea extracts, causing her to develop acute liver failure.

Green tea accounts for 20% of tea consumption worldwide. It has become more and more popular because of its many reported health benefits; the consumption of green tea in the US has risen by 40% just since 2000. A less-processed form of tea, green tea contains higher levels of antioxidants and polyphenols than other teas. It was traditionally used to control bleeding, heal wounds, aid digestion, improve heart and mental health and regulate body temperature. More recently, research has suggested that it has many health benefits.

The evidence for health benefits

The University of Maryland Medical Center has a helpful webpage that summarizes all the relevant research and provides a long list of references. Green tea may reduce the risk of heart disease (but the FDA prohibits that claim on labels; they concluded there was no credible evidence to support it). Green tea lowers total cholesterol and raises HDL. Population studies suggest that it may help protect against several kinds of cancer, but the evidence is mixed: other studies suggest that it may actually increase the risk of some cancers, and it may interfere with cancer chemotherapy. It may help in inflammatory bowel disease, diabetes, liver disease, and weight loss. There is even preliminary evidence that it might prevent dental cavities, might be useful in arthritis, might help treat genital warts, and might even prevent symptoms of colds and flu. Studies show that drinking green tea is associated with reduced risk of dying from any cause. At first glance, it might sound like a panacea, but the evidence is still questionable. Much of it is from small, preliminary studies that have not been replicated or that contradict each other. (more…)

Posted in: Herbs & Supplements

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Mandatory breast density reporting legislation: The law outpaces science, and not in a good way

Over the years, our bloggers here at Science-Based Medicine have written time and time again about the intersection of law and science in medicine. Sometimes, we support a particular bill or law, such as laws to protect children against religion-inspired medical neglect; laws making it harder for manufacturers of homeopathic “medicines” to deceive the public; or California Bill AB 2109, a bill whose intent was to make it more difficult for parents to obtain nonmedical exemptions to vaccine mandates but whose implementation after being passed into law was profoundly sabotaged by Governor Jerry Brown. or, more recently, California SB 277, a bill currently wending its way through the California legislature that would eliminate nonmedical exemptions to school vaccine mandates and has, not surprisingly, engendered extreme resistance from the antivaccine crowd, including by Robert F. Kennedy, Jr. In the vast majority of cases we explain how the law lets us down when it comes to science in medicine, and, unfortunately, examples are many: Naturopathic licensing laws; supplement regulation (or, more appropriately, lack of regulation); misguided, deceptive, and patient-hostile “right-to-try” laws; state laws regulating medical practice that allow quackery to flourish unchecked; laws regulating pharmaceutical cost transparency that ask the wrong question.

The case I will discuss here is unusual in that it is a case of the law getting ahead of what the science says in a manner that will likely do little, if any, good for patients, cause a lot of confusion until the science is worked out better, and end up costing patients money for little or no benefit. I am referring to laws mandating the reporting of high-breast-density to women with dense breasts undergoing mammography. These laws are sweeping the country (albeit not as rapidly as “right-to-try” laws), with a total of 22 states having passed them as of today since Connecticut became the first to do so in 2009. The most recent of these laws went into effect in my own state of Michigan exactly one week ago:

Women with dense breast tissue — the sort that can hide potentially deadly tumors from routine mammograms — must be notified in writing and encouraged to consider additional tests under a new state law that is effective Monday.

While mammograms remain the gold standard for detecting breast tumors, they’re less reliable in almost half of women with dense breast tissue. Dense or fibrous tissue shows up as splotches of white on a mammogram — so do tumors.

That will likely surprise many of the millions of women who rely on mammography for catching the earliest signs of cancer, said Nancy Cappello. The Connecticut woman was shocked in 2004, when her gynecologist found a lump — advanced cancer that had already spread to her lymph nodes — just months after a mammogram deemed her cancer-free.

(more…)

Posted in: Cancer, Politics and Regulation, Public Health

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Chiropractic Manipulation of the Neck Linked to Stroke in a 6-Year-Old Child…

neckjer

The risk of suffering a stroke when undergoing aggressive chiropractic manipulation of the neck is not a new concern. We’ve discussed it several times on the pages of Science-Based Medicine over the years, most recently in November of 2014 when Steven Novella covered the death by chiropractor of 30-year-old Jeremy Youngblood, whose fatal brain injury occurred while seeking treatment for a sore neck. For a nice review of cervical manipulation in general, the evidence against its inappropriate use, and an assessment of the literature on this subject, check out prior posts by Dr. Hall and chiropractor Samuel Homola.

I believe that my take on the issue is in line with my fellow SBM authors. There is no role for high velocity, low amplitude (HVLA) thrust-type maneuvers that cause sudden and intense rotation of the neck in any patient, for any reason. It is not effective for neck pain, headache or any other complaint, and it is a proven risk factor for injury to the vertebral arteries and subsequent stroke. Some patients are at higher risk, such as the elderly or those with atherosclerosis or connective tissue disorders, but this type of injury can occur at any age and even in a perfectly healthy individual. (more…)

Posted in: Chiropractic, Science and Medicine

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