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No Compromise on Vaccine Refusal

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A few years ago some colleagues and I at the Institute for Science in Medicine were debating what our official position should be regarding non-medical vaccine exemptions. We all agreed that the ideal situation would be no non-medical exemptions. There is no legitimate reason for such exemptions and the evidence clearly shows that states who allow non-medical vaccine exemptions have lower vaccination rates.

The debate was about whether or not that should be our only position, to take a strong and uncompromising stance, or should we also advocate that states who do allow non-medical exemptions to make them as difficult as possible (which also is effective in reducing vaccine refusal). The concern was that the perfect solution was politically too difficult and the lesser solution was at least something (like a prosecutor including lesser charges in case they lose on the big charge).

I advocated for the latter position, which is what we ultimately decided. After the Disneyworld measles outbreak, however, I think the political calculus has changed. It is much more politically viable to simply advocate for the elimination of all non-medical exemptions. (more…)

Posted in: Vaccines

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Efforts to Encourage Breastfeeding Like the Baby-Friendly Hospital Initiative (BFHI) May Have Unintended Consequences

A brand-new newborn. According to BFHI rules, he must maintain continuous skin contact with Mom and start breastfeeding with in the first half hour.

A brand-new newborn. According to BFHI rules, he must maintain continuous skin contact with Mom and start breastfeeding within the first half hour.

“Breast is best,” but current efforts to increase the rate of breastfeeding may be misguided. A recent article in JAMA Pediatrics by pediatricians Joel Bass, Tina Gartley, and Ronald Kleinman is titled “Unintended Consequences of Current Breastfeeding Initiatives.” They criticize the Baby-Friendly Hospital Initiative (BFHI), saying “there is now emerging evidence that full compliance…may inadvertently be promoting potentially hazardous practices and/or having counterproductive outcomes.”

The BFHI

The Baby-Friendly Hospital Initiative was launched by WHO and UNICEF in 1991 and has been adopted in 152 countries. In the US it has been promoted as the standard of care by government agencies like the CDC and the Joint Commission, and has been implemented by a growing number of hospitals. The criteria for a hospital’s Baby Friendly accreditation include:

  1. Have a written breastfeeding policy that is routinely communicated to all health care staff.
  2. Train all health care staff in skills necessary to implement this policy.
  3. Inform all pregnant women about the benefits and management of breastfeeding.
  4. Help mothers initiate breastfeeding within one half-hour of birth.
  5. Show mothers how to breastfeed and maintain lactation, even if they should be separated from their infants.
  6. Give newborn infants no food or drink other than breastmilk, not even sips of water, unless medically indicated.
  7. Practice rooming in – that is, allow mothers and infants to remain together 24 hours a day.
  8. Encourage breastfeeding on demand.
  9. Give no artificial teats or pacifiers (also called dummies or soothers) to breastfeeding infants
  10. Foster the establishment of breastfeeding support groups and refer mothers to them on discharge from the hospital or clinic.

(more…)

Posted in: Obstetrics & gynecology

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The cruel sham that will not die: Right-to-try marches on in California and beyond

The cruel sham that will not die: Right-to-try marches on in California and beyond

We here at SBM, particularly Jann Bellamy and myself, frequently write about naturopathic licensing laws, noting that naturopaths are relentless. They keep trying and trying to get states to pass laws granting their specialty licensure, and, like the Terminator trying to kill Sarah Connor or her son, they absolutely will not stop, ever, until science-based medicine is dead there are naturopathic licensing laws in all 50 states by 2025. Part of their strategy is that they never give up. No matter how many times a given state legislature denies them what they want, they are soon back, and they keep coming back again and again and again and again until they get the law they want passed. It’s the problem with playing defense, naturopaths can fail as many times as they have resources for, defenders of science-based medicine can’t afford to fail once. Worse, once such laws are passed, naturopaths are back again and again and again and again to keep trying to expand their scope of practice. It never ceases to amaze me that physicians’ groups go ballistic protecting their turf when advance practice nurses lobby to expand their scope of practice to encompass what they are trained for but remain more or less silent when naturopathic quacks push to have the state place its imprimatur on their pseudoscience.

Sadly, I’ve come to the conclusion that “right to try” laws are a lot like naturopathic licensing laws in that respect, only worse. Why worse? Unlike naturopathic licensing bills, right-to-try bills rarely die; most of them pass. In fact, only one right-to-try bill that I’m aware of has ever been successfully resisted and blocked from becoming law, and that required a veto by the governor. I’m referring, of course, to the California right-to-try bill vetoed last fall by Governor Jerry Brown. Amazingly, Brown’s veto held. Well, a new right-to-try bill is back in California, less than a year after the old right-to-try law had been vetoed. Passed in the legislature by overwhelming margins, it’s now back on Gov. Brown’s desk, and he has to decide what to do with it.

Its supporters hope that this time will be different, that this time Gov. Brown will sign the bill. They might be right. The rationale Gov. Brown used when vetoing the bill was that he wanted to wait to see what happened with reform of the FDA Expanded Access (sometimes called “Compassionate Use”) program. It’s quite possible that, despite the FDA moving forward with such reform, right-to-try advocates might persuade the governor that it isn’t enough. They’re wrong. In any case, given the resurrection of the California right-to-try law, now seemed like a good time to review what’s been happening with these laws since last year and discuss the situation in California and at the federal level. It isn’t good for patients or drug development. On the other hand, now that it’s been nearly two and a half years since the first right-to-try law was passed in Colorado, we have time to see just what a sham these laws are.

But first, since it’s been nearly a year since I last discussed right-to-try, let’s review why these laws are so pernicious.
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Posted in: Clinical Trials, Ethics, Politics and Regulation

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Good Thinking Society’s successful challenge to NHS homeopathy

[Editor’s note: For no reason whatsoever other than to share great news, we bring you this contribution from Michael Marshall, project director of the Good Thinking Society and vice president of the Merseyside Skeptics Society.]
Homeopathy in the UK, flag, smallAs regular readers of this blog may know, skeptics here in the UK have been campaigning for some time to end the funding of homeopathic remedies by the National Health Service. This is a campaign that we at the Good Thinking Society – the charity I work for full-time, led by science writer Simon Singh (yes, that Simon Singh) – have been at the forefront of over the last couple of years, and we recently secured a significant victory as NHS Liverpool brought their homeopathy service to a close, as a direct result of the legal challenge we brought in 2014.

While the background to our project was ably and generously described by Harriet Hall here at Science Based Medicine following her appearance at the QED conference last year, it is perhaps worth detailing the progress we’ve made in the last year, and how this success came about. After a series of Freedom of Information requests allowed us to determine where in the country homeopathy is funded by public funds, we were able to monitor for new funding decisions being made – knowing that any decision to spend public funds can be subjected to scrutiny and to legal challenges if not carried out correctly. (more…)

Posted in: Announcements, Homeopathy, Politics and Regulation

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An Unexpected Miscellany of Medical Malarkey

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I had originally intended a focused discussion of a single topic, but life circumstances have conspired to prevent me from doing so.  In the place of my intended post, please enjoy the following collection of hastily assembled pseudomedical odds and ends brought to my attention over the past few weeks. (more…)

Posted in: Acupuncture, Science and Medicine

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Do pill organizers help or hurt?

"Blister packs" help people take their medication on the correct schedule.

“Blister packs” help people take their medication on the correct schedule.

In order for medication to work, getting a prescription filled isn’t enough. You have to actually take the medication. And that’s where you (the patient) come in. Estimates vary based on the population and the medication, but a reasonable assumption is that 50% of people given a prescription don’t take their medication as prescribed. In pharmacy terminology we usually call this medication compliance, but because that sounds a bit paternalistic, the term medication adherence is also used. People forget doses, deliberately skip doses, and sometimes even take more than directed. Often, the prescription isn’t finished completely. Perhaps not surprisingly, people are less likely to adhere to their prescribed medication schedule when the condition they are treating has no symptoms. All things being equal, you’re more likely to take your pain control medicine than your hypertensive medications: Pain medications have side effects, but should help you feel better right now. Hypertension medications can only make you feel worse. Statins (as a group of medications) are another good example. We treat high cholesterol to lower the risk of heart disease: heart attacks, strokes, and death. It has no obvious benefit now, nor will we ever be able to point to the benefit we received. We’re taking the medication to reduce the risk of something happening in the future. If the drug isn’t taken regularly (or at all) then you’re not going to get the expected benefits of statin therapy. The “value” that treatment delivers is reduced (or eliminated). And if you stop a medication periodically, then restart it, you might get more side effects than you would have if you just took it regularly. (more…)

Posted in: Medical devices, Pharmaceuticals, Quality Improvement, Science and Medicine

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Patient Groups and Pseudoscience

Patients should get health information from doctors, not quacks.

Patients should get health information from doctors, not quacks.

The biggest challenge we face promoting high standards of science in medicine is not making our case to the community. Our case is rock solid, in my opinion, and backed by evidence and logic. There is no question, for example, that homeopathy is 100% bogus and should not be part of modern medicine.

Our challenge is that there are literally billions of dollars to be made selling fake medicine and dubious treatments. This means that unscientific practitioners have an immediate financial incentive to promote themselves and their treatments, and they will tirelessly do so, on any front they can find. Further, the stars of unscientific medicine have the resources to do so – to intimidate critics, cozy up to politicians, open centers in respected hospitals, and market their brand.

We simply don’t have the manpower to confront them on every front, and the mainstream scientific and medical communities are frankly just not paying enough attention. They are largely unaware that pseudoscience is infiltrating their profession right under their noses, or they have been lulled into thinking this is a small and benign phenomenon.

Patient groups

These many fronts in which science confronts pseudoscience include the media, hospitals, continuing education, journals, the marketplace, politics and regulation, and research funding.

(more…)

Posted in: Health Fraud, Naturopathy, Science and Medicine

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Genetic Testing: Does Knowing Risk of Disease Make a Difference?

Genetic variants may provide information you'd rather ignore

Genetic variants may provide information you’d rather ignore

The complete sequencing of the human genome by the Human Genome Project was a remarkable accomplishment and a cause for celebration. Several companies including 23andMe, Navigenics, and deCODE have capitalized on that scientific achievement by offering genomic testing directly to the public. They promise more than they can deliver, and consumers don’t understand the limitations of the test results. The subject has been covered in several SBM articles.

One of the expected benefits of genomic testing is that if people knew they were at high risk of a disease, they would take preventive steps to reduce their risk. That seems plausible; but a recent study, a systematic review in the BMJ (formerly the British Medical Journal) calls that assumption into question. It found that communicating DNA-based disease risk estimates did not increase risk-reducing health behaviors or motivation to engage in such behaviors.

(more…)

Posted in: Diagnostic tests & procedures

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The stem cell hard sell

It's generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

It’s generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

Stem cells are magical. Stem cells are all-powerful. Stem cells cure everything. Stroke? No problem! Paralysis? Stem cells’ll fix it. Autism? Yes, even autism.

That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which stem cells are used in these clinics, they are still at best experimental and at worst completely unproven. In fact, at their worst, they can do great harm.

I learned about the unrelentingly positive spin the media tend to place on stem cell treatments when I first started blogging about Gordie Howe’s stroke and Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies reached out to the Howe family to see if it could help him with its products. When Howe and McGuigan discovered that Howe was not eligible for any of their US clinical trials, they facilitated Howe’s receiving an unproven stem cell therapy through one of its partners in Mexico, Novastem, which uses Stemedica stem cell products to treat patients in its clinic, Clínica Santa Clarita. In the ultimate bit of privilege for a sports hero (or, as I saw it at the time and as it ultimately turned out, an excellent investment for marketing and advertising of Stemedica products) Gordie Howe even received the treatment for free, even though Clínica Santa Clarita charges everyone else around $30,000. Let’s just say that I didn’t find the explanations for waiving this rather massive fee in Gordie Howe’s case to be persuasive, and I was rather disturbed at the entitlement expressed by Howe’s son over it, who didn’t see the ethical problem at all. Nor did I find the excuses given by Stemedica and Novastem for why their clinical trial protocol in Mexico was so substandard.

It turns out that this new, poorly regulated industry operates a lot like the many quack cancer clinics that I’ve blogged about over the years and like a lot of other dubious businesses, such as multilevel marketing scams. This comes in the form of a recent paper in Stem Cells Translational Research by Paul Knoepfler, who describes attending a marketing seminar.
(more…)

Posted in: Health Fraud, Science and the Media

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Building a Case for CAM

[Editor’s note: Mark Crislip is taking a well deserved vacation from blogging, and James Thomas has kindly agreed to provide another guest post to fill the gaping need left in all of your lives. Enjoy!]

Building a case for complementary and alternative medicine. This shouldn't be hard!

Building a case for complementary and alternative medicine. This shouldn’t be hard!

According to the Orwellian-named National Center for Complementary and Integrative Health, roughly 33% of adults aged 18-44 and about 37% aged 45-64 use some form of CAM. More disturbing is that 12% of children aged 4-17 used some form of CAM in the last 12 months. If there is good news, it is that the NCCIH takes a broad view of “complementary health approaches” including acupuncture, Ayurveda, biofeedback, chelation therapy, chiropractic care, energy healing therapy, special diets (including vegetarian and vegan, macrobiotic, Atkins, Pritikin, and Ornish), folk medicine or traditional healers, guided imagery, homeopathic treatment, hypnosis, naturopathy, non-vitamin, non-mineral dietary supplements, massage, meditation, progressive relaxation, qi gong, tai chi, and yoga. In fact these approaches range from the wacky (energy healing therapy, homeopathy) to the mainstream (massage, yoga) with nothing alternative about them. With more than 60 million Americans using some form of CAM, it is fair to ask if we can build a case for truly integrating CAM into mainstream medical practice.

So who are these people using CAM and just what are they using it for? CAM users can be found in almost every demographic but the largest cohort is white, female, and fairly well educated. A good deal of CAM is used for common and often vague conditions with back pain being the most commonly cited. But it is also used by cancer patients, for cardiovascular disease, and even for Alzheimer’s disease. The problem is that none of the CAM approaches are useful for any of these conditions; strike that, none of the CAM approaches are useful for anything at all much beyond placebo.

I’m going to keep this essay down to a more reasonable length than my earlier offerings (pauses here for the applause to fade) so I’m not going to talk much about most CAM “modalities.” Reiki is deconstructed here and here, or for those who just want a Crislipian good time, here. Homeopathy is eviscerated here. For the deeper dive go here, or for the full monte, here. If after that you still have questions about homeopathy you should probably get a hobby.

But wait, there’s more!

Chiropractic, and acupuncture, and hypnosis, and chelation, and, and…go to the masthead and enter the CAM of your choice in the box with the little magnifying glass. If some charlatan has offered it as a medical treatment, this is your gateway to good information about it. But (and that ‘but’ was your spoiler alert), none of it has much impact on any measurable medical condition. CAM does not shrink tumors, CAM does not dilate bronchi, CAM does not strip pounds of icky toxins out of your colon. Those claims and most others are easily dismissed by anyone with basic reasoning skills and the URL for Pubmed (here it is: http://www.ncbi.nlm.nih.gov/pubmed).

There are however, two arguments in favor of CAM that deserve a bit more careful consideration: electro-acupuncture for pain relief through the mechanism of stimulating endorphin release, and the more general argument that many patients have needs unmet by the medical mainstream, often psycho-social needs that do not have an ICD-10 (a type of diagnostic code) and for which no treatment infrastructure exists within the mainstream health care delivery system. These are the cases I’ll try to build today. (more…)

Posted in: Critical Thinking, Science and Medicine

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