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The Compassionate Freedom of Choice Act: Ill-advised “right to try” goes federal

Not too long ago, I expressed alarm at a series of bills that were popping up like so much kudzu in various state legislatures, namely “right to try” bills. Both Jann Bellamy and I warned that these bills gave a false illusion of hope to patients with terminal illnesses. Basically, these laws claim to grant the “right” of patients with terminal illnesses to access promising experimental medicines that have not yet been approved by the FDA. Indeed, these investigational drugs need merely to have passed phase I trials, and these “right to try” laws would allow them to be used in pretty much any human with a terminal illness who can persuade a pharmaceutical company to let them have such drugs. Of course, as I pointed out, such laws are based on a false premise, namely that there are lots of promising drugs out there that could save lots of lives of terminally ill patients, if only the hidebound FDA would get out of the way and let the people try them. The problem (besides the false assumption behind such laws) is that they are all state laws, and the FDA and federal law still trump state laws with respect to drug approval.

Apparently, advocates of “right to try” laws have gotten around to trying to take care of that little obstacle, too. I’m referring to a federal law under consideration in the House of Representatives and championed by the usual suspects, including the Alliance for Natural Health USA, a “health freedom” group that has yet to see a pro-quackery bill it doesn’t like.

In any case, at the time I originally learned about this bill, HR 4475, which was introduced by Rep. Morgan Griffith (R-VA) and entitled “The Compassionate Freedom of Choice Act of 2014,” its text hadn’t yet been published to the Congressional website. I did learn that the bill has been floating around for a while in various forms (for instance, former Representative Ron Paul (R-TX) apparently introduced it.) Now its text has been published, as Guy Chapman has noted. He calls it a “quack’s charter,” and he’s only off by a bit. The bill doesn’t go quite as far as he believes, but the bill is still plenty bad, man. If enacted, HR 4475 would amend the Food, Drug, and Cosmetic Act by inserting after section 561 (21 U.S.C. 360bbb) the text of HR 4475. This section of the Food, Drug, and Cosmetic Act is entitled “Expanded Access to Unapproved Therapies and Diagnostics,” and it’s the section of the act that regulates exactly that. The interesting thing is that this particular section of existing law is the framework under which the whole system of single patient INDs (also known as “compassionate use exemptions”) is already based. As I’ve described before, single patients can receive promising unapproved drugs under what’s known as a single patient IND, which has to be approved by the Institutional Review Board and the FDA and allows single patients to receive unapproved drugs. You can (and many have) argued that the single patient IND process is too cumbersome and restrictive, but HR 4475 seeks to (mostly) nuke this requirement. You’ll see what I mean in a minute.
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Posted in: Clinical Trials, Politics and Regulation

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Traditional Chinese herbalism at the Cleveland Clinic? What happened to science-based medicine?

I don’t recall if I’ve ever mentioned my connection with the Cleveland Clinic Foundation (CCF). I probably have, but just don’t remember it. Long-time readers might recall that I did my general surgery training at Case Western Reserve University at University Hospitals of Cleveland. Indeed, I did my PhD there as well in the Department of Physiology and Biophysics. Up the road less than a mile from UH is the Cleveland Clinic. As it turns out, during my stint in Physiology and Biophysics at CWRU, I happened to do a research rotation in a lab at the CCF, which lasted a few months. OK, so it’s not much of a connection. It was over 20 years ago and only lasted a few months, but it’s something that gives me an obvious and blatant hook to start out this post, particularly given the number of cardiac patients I delivered to the CCF back in the early 1990s when I moonlighted as a flight physician for Metro LifeFlight.

Obvious and clunky introduction aside (hey, they can’t all be brilliant; so I’ll settle for nauseatingly self-deprecating), several of my readers have been sending me a link to a story that appeared in the Wall Street Journal the other day: A Top Hospital Opens Up to Chinese Herbs as Medicines: Evidence is lacking that herbs are effective. I also noticed that our fearless leader Steve Novella blogged about it and was tempted to let it pass, given that I had seemingly lost my window, but then I realized that there’s always something I can add to a post, even after the topic’s been blogged by Steve Novella. Whether that something is of value or not, I leave to the reader. So here we go. Besides, if this article truly indicates a new trend in academic medical centers, it’s—if you’ll excuse the term—quantum leap in the infiltration of quackademic medicine into formerly reputable medical centers. It’s a depressing thing, and it needs to be publicized.
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Posted in: Herbs & Supplements, Medical Academia

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The 2014 Ohio Mumps Outbreak

As I write this post, a large outbreak of mumps is ongoing in Columbus, Ohio. The city, which on average sees a single case each year, has seen over 250 since February. To put things in further perspective, only about 440 cases are normally diagnosed in the entire United States annually. The outbreak began on the campus of Ohio State University, where about 150 cases have been identified, but no information about the index case has been reported thus far.

Although the current outbreak will likely smolder for months, the total number of cases thus far is considerably fewer than the worst of the past decade. A 2009-2010 outbreak in New York and New Jersey ended up affecting about 3,000 people. In 2006, about 6,500 college students throughout the Midwest were infected. It is unlikely we will see these kinds of numbers in Ohio, but even our worst in recent years pale in comparison to those that have occurred in England over the past decade, where there was a peak of about 56,000 documented cases in 2005.

The diagnosis of only a few hundred cases per year is a clear victory of the mumps vaccination program, which started in 1967. Prior to the widespread adoption of the vaccine, 186,000 cases were seen in the United States annually. That works out to a decrease in cases of over 99%. This reduction didn’t occur because of improved sanitation, cleaner water, or even sunspots. It occurred because of the hard work and dedication of vaccine researchers, medical professionals and the widespread public acceptance of a safe and effective vaccine.

Mumps doesn’t get the kind of press that measles outbreaks do. There are a number of reasons why this is true and reasonable. I will get into more detail, but essentially mumps, although it can result in significant morbidity, just isn’t as sexy and it isn’t a good candidate for anti-anti-vaccine poster child. Measles wins in that regard, and let’s hope it stays that way. I am terrified at the thought of HiB meningitis returning. But that doesn’t mean that mumps outbreaks can’t serve as fodder for educating the public on vaccines. First though, a primer on mumps.
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Posted in: Epidemiology, Vaccines

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Naturopathy vs. Science: Vaccination Edition

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We saw it coming. The re-emergence of vaccine-preventable disease should surprise no-one that’s been following the anti-vaccine movement.

Rebutting anti-vaccine rhetoric feels like a Sisyphean struggle. Steven Novella likened it to a game of whack-a-mole, where the moles are the same old tropes that keep popping up, no matter how often they are refuted with facts. Vaccines are a remarkable success of modern medicine: They are health interventions that are both demonstrably effective and remarkably cost-effective. Vaccination has likely prevented more deaths in the past 50 years than any other health intervention. Smallpox was a ruthless killer that took 300 million lives, just in the 20th century alone. Today it’s gone – eliminated forever. And now there are now over two dozen diseases that are vaccine-preventable. They should be an easy sell, and to most people, they are. But the control of vaccine-preventable disease relies in part on herd immunity – sufficient immunization to stop the spread of infection (no vaccine offers 100% protection) and protect those that cannot be immunized. Even a modest number of unvaccinated individuals can lead to reemergence of disease. None of this matters to antivaccinationists, to whom vaccines are bad. Viewing anti-vaccine websites for only five to ten minutes can increase the perception of risk of vaccination, and decrease the perceived risk of omitting vaccines. It also lowers vaccination intentions. By changing perceptions of safety, the willingness to vaccinate decreases. Now imagine that someone you believe to be a health professional openly questioned the efficacy and safety of vaccines – would it reduce your willingness to vaccinate? The evidence says it does. And that’s why the modern practice of naturopathy or “naturopathic medicine” is so concerning. Naturopaths have opposed vaccinations since the invention of naturopathy – starting with smallpox: (more…)

Posted in: Naturopathy, Vaccines

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Herbal Center at Cleveland Clinic

The infiltration of pseudoscience and simply bad medicine into mainstream medicine continues. Hospitals are an easy breech point because they are run by administrators who may have more talent and interest in marketing than in science. Many hospitals in my area, for example, proudly display their “integrative” centers, offering nutrition advice and massage alongside more dubious offerings, such as reflexology and reiki.

So-called “alternative” treatments are tempting because they are often not covered by insurance, and so patients will have to pay cash for them, and they are often inexpensive to run – so they are a nice cash cow for hospitals.

The Wall Street Journal reports another, more serious, chapter in this infiltration – the opening of Chinese herbal clinics, specifically in the Cleveland Clinic. The article itself is reasonably balanced, and lacks the gushing anecdotes that most such pieces have, but could certainly have been more hard-hitting in terms of the serious problems with herbal medicine.

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Posted in: Herbs & Supplements

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Curing Hepatitis C: A Success Story and a Price Tag

Most people know about hepatitis B; babies get vaccinated for it at birth. But fewer people know about hepatitis C. C is actually more common than B, but most chronically infected people don’t know they have it. You might think ignorance is bliss, but patients who have no symptoms today may have liver cancer or a liver transplant in their future. Until recently, treatment for this stealth disease was disappointing, but according to three recent, large controlled studies published in The New England Journal of Medicine, the virus has been tamed. A short course of a new antiviral drug with few side effects was 99% effective in removing the virus from the blood.

History

In the beginning, there was jaundice. Patients turned yellow, developed flu-like symptoms, and sometimes died. Eventually doctors figured out that jaundice was a sign of liver disease and the condition was named hepatitis; and by the time I graduated from medical school in 1970, scientists had identified two viruses that caused infectious hepatitis: hepatitis A and B. Hepatitis A infection was transmitted by the fecal-oral route, usually by contamination of food; hepatitis B was transmitted by needles and blood products. Prevention was limited to good hygienic practices; treatment of acute hepatitis was limited to bed rest, supportive care, and IV fluids. Contacts could be given gamma globulin. In fulminant cases and chronic hepatitis, steroids were used. No treatment was very effective. Death and cirrhosis often ensued.
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Posted in: Clinical Trials, Pharmaceuticals

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Gluten-free skin and beauty products: Extracting cash from the gullible

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Even though yesterday was Easter, and, as unreligious as I am, I was still thinking of taking it easy, there was one target that popped up that I just couldn’t resist. My wife and I were sitting around yesterday reading the Sunday papers and perusing the Internet (as is frequently our wont on Sunday mornings), when I heard a contemptuous harrumph coming from her direction. She then pointed me to an article in our local newspaper entitled Gluten-free beauty products in demand among some customers. Now, I must admit that I haven’t been keeping up with the gluten-free trend, other than how easily it fits within the niche of “autism biomed” quackery, where, apparently, nearly every “biomed” protocol for autistic children demands that gluten be stripped completely from their diets, lest the evil molecule continue to infect them with the dreaded autism. I’ve kept an eye the literature, but haven’t really written about gluten. That’s why I could immediately tell why my wife had called my attention to the article:

Amy Soergel’s lip gloss was making her sick. The problem, she realized, was gluten — hydrologized wheat protein, to be exact. Then she went to the hairdresser who used a shampoo that made her neck burn. Again, it contained gluten.

“There’s hidden gluten in many places you may not consider,” including stamp and envelope glues, toothpaste and lip balms, said Soergel, who has a store, Naturally Soergel’s, near Pittsburgh that caters to people with allergies. Indeed, for people with celiac disease, a bit of gluten that might get swallowed from a lipstick or a stream of shampoo in the shower can be enough to cause illness.

A slew of gluten-free skin care products have come on the market, including items from well-known companies such as Murad, Dr. Hauschka, EO, MyChelle, Suntegrity, Acure and derma-e. Many are sold in Whole Foods and other health food stores. If they’ve been certified by a third-party agency, an icon usually appears on the packaging.

Whole Foods. Of course, it had to be Whole Foods (among others). Let’s take a look at the whole gluten-free movement and then at the end I’ll revisit the question of gluten-free cosmetics and skin products.
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Posted in: Basic Science, Clinical Trials, Nutrition

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Moxibustion

There are many forms of Traditional Chinese Medicine (TCM), and many have the same underlying theory: they stimulate non-existent acupuncture points to alter the flow of non-existent qi. For each form of TCM there are many variations on a theme. There are, for example, a half-dozen styles of acupuncture and multiple forms of cupping all trying to move the qi. That qi is an untameable beast, hard to corral into a proper gate even by the best acupoint wrangler.

There is, fortunately, yet another way, moxibustion, to alter that most intractable mysterious life energy.

Moxibustion is the burning of mugwort over acupoints.

What is mugwort? I resist the urge to make a Harry Potter pun about where Muggles go to school. No wait, I just did. Sorry. You know the old saying: yield to temptation, it may not pass you way again. Mugwort is a member of the daisy family, related to ragweed and, like ragweed, a common cause of hay fever. It is also used in food and was used in beer before hops was discovered.
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Posted in: Acupuncture, Traditional Chinese Medicine

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What Whole Foods Markets Doesn’t Tell You

Whole Foods Market is a relentlessly hip American supermarket chain which prides itself on organic fruits and vegetables, gluten-free just-about-everything, and high-end touches like wine bars and exotic take out items (roasted yucca, anyone?). The health products aisle is stocked with Bach Flower and homeopathic remedies. For example, in-house brand Flu Ease: “an established homeopathic formula that should be taken at the first sign of flu for temporary relief of symptoms including fever chills and body aches.”

Selling Flu Ease and like products certainly exhibits a lack of appreciation for scientific evidence, not to mention basic science. But I recently saw a product in the checkout line that was so filled with over-the-top quackery and so shocking in its disregard for the public’s health that I haven’t been back to Whole Foods since. And I won’t be going back.

The product? A glossy, slickly-produced magazine with the conspiracy-minded title What Doctors Don’t Tell You. The April 2014 issue promises, in banner-headline font size, a “New Light on Cancer.” It features the well-known symbol of fighting breast cancer, a loop of pink ribbon, but with a tear in the middle of the loop. We’ll look into this “new light” in a bit.

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Posted in: Cancer, Critical Thinking, Faith Healing & Spirituality, Health Fraud, Herbs & Supplements, Homeopathy, Nutrition, Science and the Media

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GSK Investigated for Bribing Doctors

The BBC reports that 11 doctors and a GlaxoSmithKline regional manager in Poland have been charged with alleged corruption. The apparent scheme was simple — GSK sales reps are given targets for new prescriptions for whatever drugs they are promoting. In order to meet those targets, it is alleged that one sales rep agreed to pay doctors £100 to give educational lectures to patients. The lectures never took place, and it was understood that in exchange for the payment the doctors would prescribe more of the rep’s drug.

The case is still under investigation but one doctor has already admitted guilt, stating that the £100 was simply too tempting.

Assuming the charges are upheld, such cases are very damaging to public confidence in the system. This is similar to cases of researchers faking their published research — I cringe every time I read about such cases.

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Posted in: Medical Ethics, Pharmaceuticals, Politics and Regulation

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