Nootropics 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.
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.
One of the greatest triumphs of marketing over evidence was the incredible rise of vitamin supplement use in the 20th century. Supplement makers successfully created a “health halo” around vitamins, and taking your vitamins became a virtue, something mothers told their children to do. The evidence, however, does not tell such a simple story.
In recent years it has become increasingly apparent that there are unintended consequences to taking vitamin supplements, and in fact there may be a net negative health effect. This is especially true for those who are healthy and don’t need vitamins, and for those who exceed the recommend dosages.
A recent review of the last 20 years of literature on the subject, presented at the American Association for Cancer Research 2015 meeting, found an overall increased risk of cancer among vitamin users. Dr. Tim Byers presented the study, which echoes the result of a 2012 review that he and others published. He specifically refers to two famous studies showing an increased risk of cancer from vitamins.
The 2011 SELECT trial found an overall increased risk of prostate cancer among men taking vitamin E. (more…)
Pepsi has announced that it will remove aspartame from its formulation of diet Pepsi products in the US this year. Apparently this is a reaction to a 5% drop in the sales of Pepsi. Seth Kaufman, vice-president of Pepsi, said “Aspartame is the number one reason consumers are dropping diet soda.”
This move comes in the same week that Chipotle announced it is removing GMO food from its food chain. Unlike Pepsi, who cited only public opinion, Chipotle went one step further and directly cited pseudoscientific fears of GMOs as their justification. (But that’s another story.)
Like GMOs, aspartame has been widely studied and found to be safe, but remains the target of fear-mongering and conspiracy theories. It is not clear why this one food additive has continued to be the target of a fake controversy, other than that fears and conspiracies can take on a life of their own. The best example of anti-aspartame conspiracy theories comes from Janet Starr Hull, who wrote:
I will never accept the news of aspartame safety. I think it is a “business” decision to discredit/discount the research results that aspartame DOES cause cancer, major nerve disorders, birth defects, and brain imbalances. Think about it – can you imagine the chaos that will occur when the truth of aspartame dangers is accredited. The FDA has known about the dangers, the corporations have known about the dangers, and the medical community (if it is really worth anything) has known about the dangers.
That is a common claim of conspiracy theorists – the truth is being suppressed out of fears that it will bring chaos if revealed. I think our society will survive Pepsi moving over to a different sweetener. (more…)
Pictured: not a risk of autism
A new study published this week in JAMA, “Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism”, puts one more nail in the claim that the MMR is associated with autism.
You may wonder why, after years and multiple studies showing no association between the measles-mumps-rubella vaccine (MMR) and autism spectrum disorder (ASD) there would even be a need for such a study. The authors explain:
Despite research showing no link between the measles-mumps-rubella (MMR) vaccine and autism spectrum disorders (ASD), beliefs that the vaccine causes autism persist, leading to lower vaccination levels. Parents who already have a child with ASD may be especially wary of vaccinations.
The study is a retrospective cohort study involving 95,727 children with older siblings. They looked at whether or not the older sibling had a diagnosis of ASD, whether or not they were vaccinated with MMR, and whether or not they themselves developed ASD. They found:
MMR vaccination rates (≥1 dose) were 84% (n = 78 564) at age 2 years and 92% (n = 86 063) at age 5 years for children with unaffected older siblings, vs 73% (n = 1409) at age 2 years and 86% (n = 1660) at age 5 years for children with affected siblings. MMR vaccine receipt was not associated with an increased risk of ASD at any age. For children with older siblings with ASD, at age 2, the adjusted relative risk (RR) of ASD for 1 dose of MMR vaccine vs no vaccine was 0.76 (95% CI, 0.49-1.18;P = .22), and at age 5, the RR of ASD for 2 doses compared with no vaccine was 0.56 (95% CI, 0.31-1.01; P = .052). For children whose older siblings did not have ASD, at age 2, the adjusted RR of ASD for 1 dose was 0.91 (95% CI, 0.67-1.20; P = .50) and at age 5, the RR of ASD for 2 doses was 1.12 (95% CI, 0.78-1.59; P = .55).
Flag of the World Health Organization (WHO)
The World Health Organization (WHO) has recently released a new position statement on mandatory reporting of all interventional clinical trials. This is a positive step in the trend towards higher quality and greater transparency in clinical trials.
The underlying ethical concept here is that the public has a right to data that results from experimentation on humans. The researchers do not ethically own that data. They have been granted the privilege of performing research on humans as part of a social contract that includes the timely public reporting of the data.
The WHO statement calls for all registered clinical trial results to be made public in an open-access public forum in a searchable format within 12 months, and publication in the peer-reviewed literature within 24 months. They urge more rapid dissemination, but state that the 12/24 month time frame is the upper limit of when results should be reported.
The WHO statement is part of a larger trend toward greater transparency but also quality in scientific research. It is part of a recognition that we cannot understand how to best practice medicine and allocate resources based upon individual studies. We need to look at the entire scientific literature as a whole. Even when individual studies may be of high quality, there are many potential factors that can distort the scientific literature and therefore misinform doctors, scientists, and regulatory agencies. (more…)
Wikipedia’s front page
Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.
Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.
Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.
This is all meant to ensure that individual patients receive the highest quality of care.
Last year Edward Tobinick sued the Society for Science-Based Medicine, SGU Productions (the producers of the Skeptics’ Guide to the Universe podcast), Yale University, and me personally for libel and (of all things) false advertising. I am frequently asked how the suit is going so here is an update.
The lawsuit involved an article I wrote on Science-Based Medicine on May 8, 2013. Dr. Tobinick’s practice involves giving perispinal etanercept to treat sciatica, Alzheimer’s disease, traumatic brain injury (TBI), and chronic deficits following stroke. He claims that he can reverse the symptoms of these various conditions within minutes. He uses highly emotional videos and anecdotal evidence to promote his treatments.
Further, he has medical use patents on these and other treatments and charges other physicians a substantial fee for training and a royalty simply for treating patients with his methods. Medical use patents are considered by the AMA and other medical organizations to be unethical and are banned in 80 countries (but not the US).
My original article was highly critical of Tobinick’s practice. I emphasized the fact that he is making dramatic clinical claims, which he himself characterizes as revolutionary, without ever having conducted a single double-blind placebo controlled trial. In my opinion none of these uses of etanercept are supported by adequate clinical evidence. In fact, there are no published double-blind placebo-controlled trials of etanercept for post-stroke symptoms or TBI. There are some studies for sciatica, but a 2013 systematic review concluded:
There was insufficient evidence to recommend these agents when treating sciatica, but sufficient evidence to suggest that larger RCTs are needed.
There is a single pilot study of etanercept for Alzheimer’s – a phase II trial with 41 subjects total. That’s it – this is hardly sufficient evidence on which to revolutionize the treatment of multiple complex neurological disorders. In fact, during the hearing, his own expert testified that we are “not there yet.”
Of course, any story illustrating the issues surrounding brain death is going to be a sad and tragic tale. In December of 2013, Jahi McMath suffered bleeding complications following a tonsillectomy and tissue removal for sleep apnea. This resulted in a cardiac arrest with an apparent prolonged period of lack of blood flow to the brain. While her heart function was brought back, Jahi suffered severe brain anoxia (damage due to lack of oxygen) and was declared brain dead on December 12, 2013.
Jahi’s tragic story is not over, however, because her family refused to accept the diagnosis of brain death. They took legal action to keep the hospital from pulling life support, and eventually worked out a compromise where the family was able to remove Jahi to their own care. At present Jahi is apparently being cared for in an apartment in New Jersey, on a ventilator and fed through a feeding tube.
There is often some confusion as to what brain death actually is. The term is unfortunately often used to refer to a persistent vegetative state or other severe impairment of consciousness, but this is not accurate. Brain death refers to a complete lack of function of the brain, including basic reflexes in the brain stem. There is a specific protocol for declaring a person brain dead, requiring detailed examination by at least two attending physicians to document the complete absence of any brain function. If the slightest pupillary reflex is present, then the patient cannot be declared brain dead. The criteria also include provisions that there are no medications in the person’s system that can suppress neurological function and their core body temperature is sufficiently high (being too cold can also suppress neurological function).
Vani Hari, the “Food Babe”.
The default mode of human activity is to construct our own internal model of reality based upon our desires, biases, flawed perceptions, memories, and reasoning, and received narratives from the culture in which we live. That model of reality is then reinforced by confirmation bias and jealously defended.
But we also have the capacity to transcend this pathway of least resistance. Philosophy is the discipline of thinking carefully and systematically about ideas to see if they at least are internally consistent. Science is the discipline of systematically and carefully comparing our internal models of reality against objective reality, and then changing those models to suit the evidence.
Everyone engages in a combination of bias, superstition, logic, and evidence-based reason to varying degrees – the question is, to what degree? The goal of science-based medicine is to increase the proportion of science and reason in the mix with respect to the practice of medicine and public health.
There are many forces at work in society, however, that explicitly oppose the role of science because, in my opinion, they find it inconvenient to their internal model of reality or whatever narrative they are selling.