An Update on FDA Concerns Over Homeopathic Teething Products


Steven Novella recently wrote a post discussing an FDA warning against the use of homeopathic teething products over safety concerns related to the possibility of toxic amounts of belladonna. He goes into the hypocrisy of the FDA regulation of homeopathic products, a topic covered numerous times here on Science-Based Medicine, as well as the misleading initial response from Hyland’s, producers of the most popular homeopathic teething remedies in the United States and Canada. There have been some updates over the past two weeks that I’ll cover in this post. (more…)

Posted in: Science and Medicine

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Natural Health Products: Loosely regulated, little evidence of benefit, and an industry intent on preserving the status quo

Shouldn't you know that the pills you are paying for are safe, and actually do something?

Shouldn’t you know that the pills you are paying for are safe, and actually do something?

This week’s post will revisit a topic I recently covered, but it’s time-sensitive and needs your input. Health Canada, the Canadian equivalent to the US Food and Drugs Administration, is considering revisions to the way in which it regulates dietary supplements, which are called “natural health products” in Canada. It is rare that a regulator acknowledges that a regulatory system isn’t working, and publicly expresses a commitment to being more science-based. There is a time-limited opportunity for the public (including all of you non-Canadians!) to provide comment on how supplement regulation could be more closely aligned around scientific principles, rather than the supplement industry’s priorities. Whether you take dietary supplements or not, we can probably all agree that consumers should have access to safe products as well as credible, relevant information about these products, in order to make informed health decisions. It will likely not surprise you that these ideas are seen as threats to supplement manufacturers, who benefit from little regulatory oversight and few restrictions on what can currently be claimed about any product’s effectiveness. Since my last post, there have been some new reactions to the consultation that are worth discussing. (more…)

Posted in: Herbs & Supplements, Legal, Politics and Regulation

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Is Ageing a Disease That Can Be Cured?


There is an ongoing debate that has come to the fore recently about the ultimate limits of human longevity. The ultimate goal of medicine is to optimize health, with the result of maximizing the duration and quality of life. This is accomplished through health promotion, disease prevention, and disease treatment.

There is no question that this approach has increased life expectancy, which is the number of years one can statistically expect to live. The longevity debate is about life span – how long could a human theoretically live if they enjoyed optimal health? What is the ultimate limit of the human biological system?

A recent study by Dong, Milholland, and Vijg concludes that we are already reaching the maximal human lifespan, which they calculate at about 115 years. They looked at two statistical trends. First they looked at the age of the oldest person to die in each country, and found that this age increased from 1970 to 2000, reaching an average of about 115 years. From 2000 to present, however, this figure has peaked, and in fact trended down slightly.

They also looked at the age that had the greatest annual increase in survival. If both life expectancy and lifespan were increasing then this number should be increasing. They found that this number was also increasing from 1920 to about 1980, but then plateaued at around 100 years, and has only slightly crept up since then (101 for men, 102 for women).


Posted in: Epidemiology

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Dr. Richard Rawlins Reveals the Real Secrets of Alternative Medicine

Dr. Richard Rawlins reveals the secrets of alternative medicine in a new book

Dr. Richard Rawlins

Dr. Richard Rawlins, an orthopedic surgeon in the UK who is also a magician and member of the Magic Circle, has written an exhaustive review of alternative medicine, Real Secrets of Alternative Medicine: An Exposé.

“A conversation with Mrs. Smith”

A conversation with Mrs. Smith bookends the text. She comes to Dr. Rawlins for hip replacement surgery and asks if there is any alternative medicine she could try first. He tells her some patients say they have benefited, but personal experience is no substitute for critical analysis of evidence. He explains that there is no evidence to support those alternatives but that if she wants to try them, she can go ahead and try. Then she asks which one is most likely to help her. He tells her he can’t recommend one because he has not studied them in any detail. She says perhaps he should study them, and then write a book. So he does.

At the end of the book, he tells Mrs. Smith what he has learned: that complementary and alternative medicine (CAM) “works” but only as a placebo; it does not affect disease outcomes and can sometimes do harm. He quotes cancer researcher David Grimes:

By clinging to delusion, belief in alternative medicine denigrates the very wonder of science and medicine and the massive strides we as a species have made over the last century or so in understanding the world around us, and how our bodies work.

Rawlins ends the book by telling Mrs. Smith “Conventional practitioners care more than you may think. That is the real secret.”

In between those conversations is a 370-page tour de force that covers the entire history of medicine and CAM, stresses the importance of scientific evidence, reviews how good the brain is at deluding itself, explains the placebo effect and the attractions of CAM, and argues that society should not pay for it. (more…)

Posted in: Book & movie reviews

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Mammography and overdiagnosis, revisited

Reading mammograms
[Editor Note: This is a greatly expanded version of my initial thoughts on a study about mammography published in the New England Journal of Medicine last week on my not-so-super-secret other blog. It’s such an important topic that I thought SBM should see my discussion too, and I couldn’t just cut and paste it. You deserve original material.]

I knew it. I just knew it. I knew I couldn’t get through October, a.k.a. Breast Cancer Awareness Month, without a controversial mammography study to sink my teeth into. And I didn’t. I suppose I should just be used to this now. I’m referring to the latest opus from H. Gilbert Welch and colleagues that appeared in the New England Journal of Medicine last week, “Breast-Cancer Tumor Size, Overdiagnosis, and Mammography Screening Effectiveness.” Yes, it’s about overdiagnosis, something I’ve blogged about more times than I can remember now, but it’s actually a rather interesting take on the issue.

Before 2008 or so, I never gave that much thought to the utility of mammographic screening as a means of early detection of breast cancer and—more or less—accepted the paradigm that early detection was always a good thing. Don’t get me wrong. I knew that the story was more complicated than that, but not so much more complicated that I had any significant doubts about the overall paradigm. Then, in 2009, the United States Preventative Services Task Force (USPSTF) dropped a bombshell with its recommendation that mammographic screening beginning at age 50 rather than age 40 for women at average risk of breast cancer. Ever since then, there have been a number of studies that have led to a major rethinking of screening, in particular screening mammography and PSA testing for prostate cancer. It’s a rethinking that affects discussions even up to today, with advocates of screening arguing that critics of screening are killing patients and skeptics of screening terming it useless. Depending on the disease being screened for, the answer usually lies somewhere in between. Basically, screening is not the panacea that we had once hoped for, and the main reason is the phenomenon of overdiagnosis. Before I go on, though, remember that we are talking about screening asymptomatic populations. If a woman has symptoms or a palpable lump, none of this discussion applies. That woman should undergo mammography.

Posted in: Cancer, Public Health

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Stem Cell Tourism for Eye Disease: No Passport Required


Stem cell clinics outside the United States, and outside the jurisdiction of the U.S. regulations, have flourished and the pursuit of treatment at these centers has been called “stem cell tourism.” Seekers of unproven stem cell therapies no longer need to look outside the U.S. Paul Knoepfler, a stem cell researcher and leading advocate for the responsible use of stem cell technology, wrote an SBM post on the regulatory aspects of stem cell treatment, a highly recommended read. He also coauthored an article highlighting the direct-to-consumer stem cell industry in the United States. For now, the article is behind a paywall. Fortunately, David Gorski summarized the article here. The authors found a shocking 351 businesses advertising stem cell treatment at 570 locations in the U.S. The problem is that the proliferation of for-profit facilities far outpaces the science on stem cell therapies. Most of these facilities are selling treatments without proven value and with mostly unknown safety.

Clearly, there is no shortage of “experts” prepared to sell you expensive, unproven stem cell treatments for a multitude of diseases. So who can you trust? If I wanted a source of reliable information about stem cell treatment, I might be tempted to seek out the world’s leading homeopathic ophthalmologist!

Introducing: the World’s Leading Homeopathic Ophthalmologist

How do I know Dr. Edward Kondrot is the world’s leading homeopathic ophthalmologist? It says so, right on his website. But it would be an injustice to simply characterize Dr. Kondrot as a homeopathic ophthalmologist. Dr. Kondrot is a Renaissance man of alternative medicine. He is a Board Certified Ophthalmologist, author, radio show host, Fellow of the College of Syntronics, Research Chairman for the College of Syntronics, Adjunct Professor Department of Research at Southwest College of Naturopathic Medicine, President of the Arizona Integrative and Homeopathic Medical Association and member American Academy of Ozonotherapy, just to name a few of the credentials listed on his bio. If you Google Dr. Kondrot’s name you will find he has quite a presence on the internet. I find this video to be particularly endearing. (more…)

Posted in: Basic Science, Science and Medicine

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R&D and the High Cost of Drugs

Would I lie to you?

Would I lie to you?

Until a year ago very few people had ever heard of Martin Shkreli. In 2015 the then-32-year-old CEO of Turing Pharmaceuticals LLC became the poster boy for Big Pharma eXXXcesses when Turing acquired rights to Daraprim, an antiparasitic drug used widely to treat toxoplasmosis. The acquisition itself wasn’t particularly controversial. Raising the price of Daraprim from $13.50 per pill to $750 per pill was.

And so another round of hand-wringing and teeth-gnashing over health care costs began. There was a Congressional hearing where Shkreli preened and smirked and refused to answer questions, later asserting that he had been subpoenaed “unethically” and that it is, “hard to accept that these imbeciles represent the people in our government.” Benjamin Brafman, Shkreli’s attorney, clarified afterward that, “he meant no disrespect…” He wouldn’t want to leave the wrong impression. (more…)

Posted in: Ethics, Pharmaceuticals, Science and Medicine

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When should I get the influenza vaccine?

The worst flu season ever. And it started early.

The worst flu season ever. And it peaked early.

I was asked this question by one of my infection control practitioners. We started offering the flu vaccine the first week of October and some have delayed getting the shot for fear that immunity will not last the season. She pointed me to this NPR article, “Yes, It Is Possible To Get Your Flu Shot Too Soon,” as driving the fear of too little too soon.

So when should you get the flu shot?

Short answer – I don’t know.

There are multiple variables that make it a difficult question to answer. When does flu season start? When does it end? Influenza has immunologic variation from year to year and different strains circulate each year. How good is the match between the circulating strains of influenza and the vaccine? How good is the immunologic response of the host?

So many questions. By answering these question maybe we can come up with an estimated optimal time to receive the flu vaccine. (more…)

Posted in: Vaccines

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Is there a distinct standard of care for “integrative” physicians? The Woliner case

Board certification in family medicine and "integrative" medicine: different standards of care?

Board certification in family medicine and “integrative” medicine: different standards of care?

Florida Atlantic University student Stephanie Sofronsky was diagnosed with Hodgkin’s lymphoma in 2011, after review of her case by oncologists and pathologists at Moffitt Cancer Center in Tampa, the NIH/National Cancer Institute, and the Mayo Clinic in Jacksonville. By June of that year, a PET scan showed the cancer had progressed to her pelvic region. She decided to be treated locally by oncologist Neal Rothschild, MD, and met with him to discuss chemotherapy and ongoing management of her cancer. At this point, with Stage III Hodgkin’s lymphoma, she had an 80-85% chance of being in complete remission with appropriate treatment.

Unfortunately, at the same time, Sofronsky was also seeing Kenneth Woliner, MD, a family medicine practitioner. Despite the fact that world-renowned cancer specialists agreed that Sofronsky had Hodgkin’s lymphoma, and knowing that she was about to start chemotherapy, Dr. Woliner told Sofronsky that cancer was “low on his list” of possible medical concerns and that increased lymphoctyes shown in her tests were not indicative of cancer, insinuating that oncologists “often overreact” to the presence of lymphocytes and recommend chemotherapy before making an actual diagnosis. Dr. Woliner suggested instead that Sofronsky have her house tested for mold, which could be causing allergies, and therefore her symptoms. Convinced, Sofronsky pursued treatment for her allergies and cancelled her follow-up appointment with Dr. Rothschild.

Sofronsky complained repeatedly to Dr. Woliner of symptoms that were, as our good friend Orac points out, consistent with progressing lymphoma – back pain and pain and swelling in her lymph nodes, abdomen and legs, to the point of having to use a cane. Yet, Dr. Woliner, over the next couple of years, continued to attribute her symptoms mostly to her allergies and also thyroid issues and some other minor illnesses. On February 7, 2013, at her last visit to his office and in significant distress from pain and severe leg swelling, he ordered a 100 mg shot of iron, despite the fact that her blood tests showed she was not iron deficient. She rapidly decompensated and died in the hospital three days later of from complications of untreated Hodgkin’s lymphoma. (more…)

Posted in: Cancer, Ethics, Health Fraud, Herbs & Supplements, Legal, Politics and Regulation

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