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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Researching the Magic of Homeopathy

A Canadian academic, Dr. Mark Loeb, who is a respected infectious disease researcher who knows how to conduct high quality research, wants to study homeopathic nosodes. Nosodes are essentially homeopathic vaccines.

Tim Caulfield, a Canadian professor of health law and policy, thinks the study is misguided and unethical. The two are having a respectful public debate about the risks and merits of doing such a study.

David Gorski and I have actually published in the peer-reviewed literature on the broader question of studying alternative medicine: “Clinical trials of integrative medicine: testing whether magic works?” So we have both weighed in already on this debate, but since this is a major theme of science-based medicine I thought it was important to bring the discussion here as well. It is an interesting dilemma worth discussing, and we are seeing that exact dilemma play out on the question of this specific proposed study.

Homeopathy is pseudoscience

For quick background, both sides in this debate agree that homeopathy is 100% pseudoscientific nonsense. Homeopathy was invented by one person, Samuel Hahnemann, about 200 years ago. It was not based on any scientific research or knowledge base, it did not develop out of emerging knowledge of biology or physiology. It was simply invented out of whole cloth based loosely on the superstitious belief in sympathetic magic – the notion that substances contain a mysterious “essence” that can be transferred to the body and stimulate the life force. (more…)

Posted in: Ethics, Homeopathy

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A Credible Placebo Control for Chiropractic Research

D.D. Palmer, the father of chiropractic, died in 1913. Over a century later, his ideas have never been properly tested with placebo controls - until now.

D.D. Palmer, the father of chiropractic, died in 1913. Over a century later, his ideas have never been properly tested with placebo controls – until now.

The research on chiropractic has been far from rigorous. One of the problems is that studies of spinal manipulation therapy (SMT) can’t be double blinded, and it is very difficult to even do single blinding. So most studies resort to non-manipulation control groups like “usual care” or “wait list” or “pain medication.” Those studies are practically guaranteed to lead to false positive conclusions: they make SMT look more effective than it would look if you could provide a control that patients couldn’t distinguish from real SMT.

In a study just published in the European Journal of Neurology, Chaibi et al. successfully used a credible placebo manipulation on patients with migraine. It showed that SMT doesn’t work for migraine, but that’s not news. The news is that it showed how to improve the methodology of SMT studies to get more reliable results. (more…)

Posted in: Chiropractic, Clinical Trials

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In which we are accused of “polarization-based medicine”


A little over a month ago, I wrote about how proponents of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine,” go to great lengths to claim nonpharmacological treatments for, well, just about anything as somehow being CAM or “integrative.” The example I used was a systematic review article published by several of the bigwigs at that government font of pseudoscience, the National Center for Complementary and Integrative Health (NCCIH) about CAM approaches for the management of chronic pain. You can read my whole post for yourself if you want the details (and read Edzard Ernst and Steve Novella for more), but the CliffsNotes version consists of two main points. First, the review didn’t really show that any CAM approach worked, given how the authors included so many studies with no placebo or sham control and didn’t systematically assess the quality of the studies. Second, this study is the best publicized example of how NCCIH, looking for a reason to justify itself, has latched on to the opioid addiction crisis in this country and gone “all in” with CAM for chronic pain. Of course, the problem is that none of the real “alternative” treatments show any convincing evidence of efficacy; so NCCIH has to claim exercise (in the form of yoga and Tai Chi, for instance) and various other modalities that aren’t really “alternative” as being part of CAM. True, the authors did try to claim that acupuncture works for back pain and osteoarthritis of the knee, but the flaw of including mostly studies with no placebo/sham control completely undermined that claim. Basically, taken in its entirety, the NCCIH’s systematic review failed to find convincing evidence that any CAM therapy really works for chronic pain.

So I wrote my post, noting also how this review article and its framing of CAM as equivalent to any nonpharmacologic treatment were clearly in line with the last two NCCIH strategic plans, perused the comments our readers left, and pretty much forgot about the study, because fortunately, it didn’t seem to get much traction. (Releasing it right before the Labor Day weekend probably didn’t help NCCIH much.) However, there is one person who did not forget, and that person is John Weeks. Last week, he published a response to the criticisms of the NCCIH review in the Journal of Alternative and Complementary Medicine (JACM) entitled “Polarization-Based Medicine: Protests Against the Mayo-NCCIH Pain Guidance Evoke the Bigotry of the Political Season.”

As they say, it’s on.

Posted in: Clinical Trials, Critical Thinking, Medical Academia, Politics and Regulation

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Pulp Fiction

I'm sorry, did I break your concentration?

I’m sorry, did I break your concentration?

As so often happens at Science Based Medicine, the inspiration for today’s post comes from a reader of the blog, seeking evidence-based advice and references after receiving conflicting (and perhaps even contradictory) information from other sources. On one hand, it saddens me when people get bad advice from health care professionals or elsewhere, whether it’s from their “regular” doctor, an “alternative” practitioner, or from Dr. Google; on the other hand, the fact that well-meaning patients are seeking out science-based recommendations through Science Based Medicine is encouraging and emphasizes the important role this blog serves.

The email that was referred my way was written by a man who is considering having a tooth extracted in the hopes that it will alleviate some general health issues he is having. He writes:

May I request that you write an article refuting the claims made in the book “Toxic Tooth — How a Root Canal Could Be Making You Sick”?

The purpose of my request is that I am considering getting a root canal pulled out.

After an initial back and forth where I told him that I’d look into it and to meanwhile not do anything hasty, he related his general symptoms (all correspondence reprinted with permission):

My personal information is I am a ** year old male, and I have a lot of fatigue. MDs are not able to tell me why. I have a TSH of 12. MDs are not able to tell me the root cause. I have Monocytes of 13, normal range is 4-13, this means I have an infection. This makes me wonder if maybe that root canal is the cause of that infection.

To translate (very superficially and simplistically): His TSH (Thyroid Stimulating Hormone) level is elevated. TSH is a hormone released from the pituitary gland and helps regulate the thyroid hormones which are involved in the body’s cellular metabolism. Normal values are in the 0.3–3.0 µIU/mL in an adult, and an elevated TSH usually means that the patient has an underactive thyroid (hypothyroidism). On rare occasions, it can indicate the presence of a thyroid tumor or other uncommon issues. His monocyte level is a bit elevated as well, which could mean the presence of a chronic infection or perhaps an auto-immune disease, but that lab value alone is not enough to make that call. But I’m just a dentist; what do I know? (more…)

Posted in: Science and Medicine

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Another way ibuprofen can kill us?

Does ibuprofen really raise your risk of heart failure by 83%? No.

Does ibuprofen really raise your risk of heart failure by 83%? No.

Do you ever take ibuprofen? Naproxen? Cold medication with an anti-inflammatory ingredient? The non-steroidal anti-inflammatory drugs (NSAIDs) are among our most well-loved medications. We start giving them in infancy, for fever, and continue use through to adulthood for everyday aches and pains. But it’s our later stages of life when we really ramp up the use, and daily consumption becomes common for conditions like arthritis. While they may be easily accessible and included as ingredients in thousands of consumer products, NSAIDs have a long list of potentially serious side effects. Not only can they cause stomach ulcers and bleeding by damaging the lining of the gastrointestinal tract, they can also increase the risk of fatal cardiovascular disease. Now there’s new research that looks at the relationship between NSAIDs and heart failure, a condition where the heart cannot pump adequately and appropriately. The study, “Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study” resulted in some fairly dramatic, alarming headlines:
daily mirror headline NSAIDS ibuprofen heart failure

Headlines like this suggest that NSAIDs are killing us indiscriminately, which may make you wonder how so many of us manage to have lived this long. And while The Daily Mirror got the facts wrong, they quoted from a well-conducted study. There is a real risk of heart failure from NSAIDs. But context is everything. (more…)

Posted in: Science and Medicine

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FDA Warns About Homeopathic Teething Products

homeopathic-teething-croppedThe FDA recently put out a consumer warning about homeopathic teething gels and pills. The warning states:

The FDA recommends that consumers stop using these products and dispose of any in their possession.

The warning is not because all homeopathic products are inherently useless. As we have discussed here often, the basic principles of homeopathy are pure pseudoscience. The practice of diluting substances so that almost no or no active ingredient remains means that most homeopathic products are just sugar pills. Further, clinical studies show that homeopathic products don’t work. There isn’t a single homeopathic product that has been shown to be effective for a single condition with rigorous clinical trials.

The FDA acknowledges this, writing in their warning:

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.


Posted in: Homeopathy

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