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The PIED Piper of Nootropics

4016241122_a5b15e1356_z 75Nootropics are an emerging class of drugs that are designed to enhance cognitive function. They are part of a broader category of drugs known as performance and image enhancing drugs (PIED) which are used for enhancement of memory and cognition, sexual performance, athletic performance or musculature (also called “lifestyle” drugs).

It will probably come as no surprise to regular readers of SBM that nootropics and PIED are being abused and hyped without adequate evidence. One of the primary problems is that they are sold as supplements or as drugs, often over the internet without adequate regulation. One simple fix is to properly classify these drugs as drugs, and to properly regulate them as drugs.

Many of the cognition-enhancing “supplements” on the market make all the usual claims about “natural” enhancement – meanwhile they predictably contain just vitamins, herbs which have not been shown effective, perhaps nootropics (see below), and often a stimulant, like caffeine. The only drug in the mix which is likely to have a noticeable effect by the user is the stimulant.

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Posted in: Neuroscience/Mental Health

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Do Helmets Prevent Head Injuries?

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A cycling enthusiast asked me about helmets. It seems compellingly obvious to me that a head impacting the pavement without a helmet is likely to sustain more damage than a head protected by a helmet. He challenged that, citing a BMJ article by Ben Goldacre that questioned whether the evidence showed that helmets do any good. He said I was making a non-evidence-based assumption and challenged me to actually look at the evidence, so I did.

Goldacre says there is a:

complex contradictory mess of evidence on the impact of bicycle helmets. Like most places where there’s controversy and disagreement, this is a great opportunity to walk through the benefits and shortcomings of different epidemiological techniques, from case control studies to modeling.

He proceeds to give a lesson in epidemiology. He points out that there are a lot of emotion involved, and that epidemiologic studies, because of their inherent imperfections, are probably not capable of resolving the debate.

There are basically two questions:

  1. What is the effect of wearing a helmet for the individual?
  2. What is the effect of a public policy that promotes or requires helmet use?

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Posted in: Epidemiology, Politics and Regulation

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As in 2014, “right-to-try” laws continue to metastasize in 2015

As in 2014, “right-to-try” laws continue to metastasize in 2015

Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as “right-to-try.” Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures, which I likened to Dallas Buyers Club laws. Both Jann Bellamy and I wrote about how these laws are far more likely to do harm than good, and that is a position that I maintain today. The idea behind these laws is to give terminally ill patients access to experimental drugs—in some cases drugs that have only passed phase I testing—that might help them. It’s an understandable, albeit flawed argument. After all, it’s perfectly understandable why terminally ill patients would fight for drugs that give them hope, and it’s just as understandable why politicians and the public would see such a goal as a good thing. In practice, as I will explain again in the context of this update, such laws are far more likely to harm patients than help them. Indeed, as you will see, in the year since the first wave of right-to-try laws have passed, not a single patient that I can find has obtained access to experimental drugs under a right-to-try law, much less been helped by them.

Unfortunately, given how effectively “right to try” has been sold on grounds of providing terminally ill patients hope and as a matter of personal freedom, it’s clear that this wave is not going to abate. Since Colorado passed the very first right-to-try law almost exactly a year ago today, a total of 17 more states now have passed passed similar legislation, the most recent being Tennessee, and 22 others have introduced legislation. It’s a good bet that right-to-try will pass in all of those states, because, as I’ve explained many times before and in many interviews, if you don’t understand clinical trial ethics and science, opposing the concept of right-to-try comes across like opposing Mom, apple pie, and the American flag, and leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of enjoying drop kicking puppies through flaming goalposts.
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Lyme Testimony

The Lyme tick

The Lyme tick

As the saying goes, when you do not have the facts, argue the law. This tried and (?) true approach was successful in New York where a law was passed protecting those who are, shall we say, creative in treating patients with Lyme and ‘chronic’ Lyme.

The bill protects those from investigation of misconduct:

based solely on treatment that is not universally accepted by the medical profession.

The major bone of contention has been extended courses of IV antibiotics for ‘chronic’ Lyme, but there are a wide variety of treatments that may be used by so called “Lyme literate” doctors.

The number of therapies divorced from reality that are offered to Lyme patients is remarkable. I do not know if chronic Lyme patients have greater use of pseudo-medical therapies than other pseudo-diagnoses, but I am impressed by the offerings in a recent review:

Results. More than 30 alternative treatments were identified, which fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapy; chelation and heavy metal therapy; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. Review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

Conclusions. Providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.

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Posted in: Lyme, Politics and Regulation, Science and Medicine

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ACA: Six Key Elements of A Modern Chiropractic Practice Act

Screenshot 2015-05-13 22.46.07

In February, 2015, the American Chiropractic Association House of Delegates ratified “Six Key Elements of A Modern Chiropractic Practice Act.” For what it’s worth, this means that the “Six Elements” are part of the official “Public Policy” of the ACA.

1. “Chiropractic Physician” and “Chiropractic Medicine” as the Regulatory Terms of Licensure.

2. Scope of Practice Determined by Doctoral and Post-Doctoral Education, Training and Experience Obtained Through Appropriately Accredited Institutions.

3. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for Patient Examination, Diagnosis, Differential Diagnosis and Health Assessment.

4. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for the Care and Treatment of Neuromusculoskeletal and Other Health Conditions or Issues.

5. Full Authority for the Delivery of Information, Advice, Recommendations and Counseling Regarding General Health Matters, Wellness and Health Optimization.

6. Full Authority and Adaptable Requirements for the Management and Training of Health Care Teams and the Participation in Collaborative or Integrative Health Care Groups.

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Posted in: Chiropractic, Legal, Politics and Regulation

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HPV Vaccine Compliance

HPV vaccine small

There are few home-runs in medicine. Most of our choices have some sort of trade-off – drugs have side effects, interventions have risks, and many treatments have marginal benefits. Sometimes, however, medical science hits one out of the park and develops a treatment that is safe, effective, cost effective, and convenient. Any dispassionate view of the evidence can only lead to one conclusion, leading to the absence of any legitimate scientific or medical debate.

I think the human papilloma virus (HPV) vaccine falls into this category. We have learned that many oral and genital cancers are caused by a sexually transmitted virus, HPV. Getting vaccinated against several strains of this virus prior to becoming sexually active effectively protects against infection by the virus, and dramatically reduces the risk of these cancers. Think about it – we can prevent cancer with a vaccine. This is a no-brainer.

A recent study shows:

HPV DNA was detected in 90.6% of cervical, 91.1% of anal, 75.0% of vaginal, 70.1% of oropharyngeal, 68.8% of vulvar, 63.3% of penile, 32.0% of oral cavity, and 20.9% of laryngeal cancers, as well as in 98.8% of cervical cancer in situ (CCIS). A vaccine targeting HPV 16/18 potentially prevents the majority of invasive cervical (66.2%), anal (79.4%), oropharyngeal (60.2%), and vaginal (55.1%) cancers, as well as many penile (47.9%), vulvar (48.6%) cancers: 24 858 cases annually. The 9-valent vaccine also targeting HPV 31/33/45/52/58 may prevent an additional 4.2% to 18.3% of cancers: 3944 cases annually.

The new 9-valent vaccine covers more strains. The study suggests that there are over 28,000 cases of cancer each year in the US that could be prevented by this vaccine.

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Posted in: Vaccines

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Homeopathy and the UK’s National Health Service

Homeopathy in the UK, flag, small

Homeopathy is arguably the silliest form of alternative medicine: the published studies show no evidence of anything beyond nonspecific contextual effects, and the underlying premise is incompatible with the existing body of scientific knowledge. Homeopathy has increasingly been questioned or denounced by organizations in several countries, most recently in FDA hearings in the US.

I recently spoke at the QED conference (Question, Explore, Discover) in Manchester, England. Another speaker, Michael Marshall, gave a talk on homeopathy and the National Health Service. He presented information that was new to me and that I thought was worthy of sharing with SBM readers. (more…)

Posted in: Science and Medicine

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The measles vaccine protects against more than just the measles

Vaccines Protect

One of the disadvantages of writing for this blog is that sometimes I feel as though I spend so much time deconstructing bad science and pseudoscience in medicine that I’m rarely left with the time or the opportunity to discuss some interesting science. Of course, even when I do that, usually it’s in the context of that very same bad science or pseudoscience, and this post won’t be different. Still, there was some interesting science with respect to vaccines published last week in Science, and I think it’s worth looking over. The only thing that surprises me is that the antivaccine movement hasn’t jumped all over it yet. On the other hand, its press coverage was relatively minimal, and I didn’t really notice it until an article appeared on (sadly, yes) The Huffington Post entitled “The Measles Vaccine Can Protect Against Much More Than Measles, According To New Study“:

A new study suggests the measles shot comes with a bonus: By preventing that disease, the vaccine may also help your body fight off other illnesses for years.

It’s long been known that contracting measles weakens the immune system for weeks or months, putting people, especially children, at increased risk for potentially fatal infection by a host of germs.

Now, scientists find that this vulnerable period goes on much longer than thought, up to three years. So the benefit of avoiding measles also extends longer than was appreciated. Researchers also found that measles vaccination campaigns were followed by a drop in deaths for other infectious diseases.

Experts said the work is a wake-up call to parents who don’t vaccinate their children out of unfounded fears about a link between vaccines and autism.

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Posted in: Basic Science, Vaccines

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“Science.” You keep using that word. I do not think it means what you think it means.

Science

I’ve discussed on many occasions over the years how antivaccine activists really, really don’t want to be known as “antivaccine.” However, if there’s one thing that rivals how much antivaccinationists detest being called “antivaccine,” it’s how much they detest being called antiscience. To try to deny that they are antiscience, they will frequently invoke ridiculous analogies such as claiming that being for better car safety does not make one “anti-car” and the like. It is here that the Dunning-Kruger effect comes to the fore, wherein antivaccine activists think that they understand as much or more than actual scientists because of their education and self-taught Google University courses on vaccines, that their pronouncements on vaccines should be taken seriously. If there are two antivaccine blogs that epitomize the Dunning-Kruger effect, they are Age of Autism and, of course, the most hilariously inappropriately named The Thinking Moms’ Revolution (TMR). It is the latter of these two that late last week produced a tour de force of Dunning-Kruger, coming, as the most hilariously off-base posts on TMR usually do, from the “Thinking Mom” known as “The Professor.” I shouldn’t be surprised, given her history, but nonetheless it’s worth taking a look at her latest post, Anti-science: “You Keep Using That Word. I Do Not Think It Means What You Think It Means.”

Actually, it does. And if The Professor is going to spend nearly 7,000 words riffing on a bit of dialogue from The Princess Bride, surpassing in verbiage all but a small minority of my posts, it almost makes me want to make this post 8,000 words.

Fortunately, for you, I resisted that temptation and instead merely retort: “Science. You keep using that word. I do not think it means what you think it means.” Then I demonstrate why.
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Posted in: Science and Medicine, Vaccines

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Separating Fact from Fiction: The “Magic” of Epigenetics?

Watch as I pull a rabbit out of my hat using the power of epigenetics!

Watch as I pull a rabbit out of my hat using the power of epigenetics!

Every few years, it seems, a new concept emerges as the favorite go-to means of marketing unproven and highly implausible approaches to health care. Explanations of the proposed healing properties of homeopathic remedies incorporating quantum mechanics immediately comes to mind as an example of this phenomenon. Or how proponents of the most absurd treatments will just add “Nano” to anything and claim scientific miracles of healing.

From the Nano SRT website:

Q: What Is Stress Reduction Therapy?
A: SRT is a remarkable new procedure that combines the disciplines of Acupuncture, Biofeedback and Homeopathy with Laser Light technology. A computerized scan or test is done to see what your body is sensitive to, and how it is out of balance, then help it learn not to be.

Q: What does the Nano SRT do?

A: Substance specific frequencies converted to a digital format, and presented in the form of sound and light, are what allow for patient assessment and therapy down to the molecular level. The frequencies are what make it possible to assess thousands of substance sensitivities in mere minutes, then allow the brain and nervous system to record a new association that is positive or neutral instead of the inappropriate ones that were previously stored in memory. This breaks the link between the stimulus and response, makes symptoms unnecessary, creates balance and harmony, from dis-ease and disharmony, and allows the body to function better.

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Posted in: Science and Medicine

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