Perhaps one of the greatest threats to the enterprise of Science-Based Medicine is research fraud and misconduct. Rigorous research methods can be used to minimize the effects of bias, but when those methods themselves are the problem there is no easy fix. Related to this is the need for transparency. When fraud or misconduct is uncovered it erodes confidence in the system because it provokes speculation about how much fraud and misconduct has not been uncovered.
A recent study published in JAMA looks at one aspect of this issue – reporting of misconduct uncovered by the FDA. The good news here is that FDA trials, those that will be used to apply to the FDA for approval of a drug, are carefully monitored and inspected by the FDA. This is an important quality control measure. When the FDA uncovers misconduct it takes steps to correct it. If the misconduct is severe enough then any data that is associated with the poor research practices will be excluded from the trial so as not to taint the results. Even an entire study can be disqualified if necessary.
The problem highlighted by the study is that there is no systematic way for the FDA to communicate its findings through the peer-reviewed literature. Tainted studies, or ones that require a correction or retraction (because the violations were discovered after publication) may therefore persist in the peer-reviewed literature without any indication of the uncovered misconduct.
The subject of parental vaccine refusal and the impact that has on disease outbreaks has been covered many times on SBM and elsewhere. I apologize to our readers who are growing tired of the subject, but there is perhaps no subject more deserving of focus and repetition. There’s also an important angle to the discussion that I’ve written on previously and which deserves more attention, and that is the importance of the pro-vaccine parent voice, and the need for that voice to be heard.
It never ceases to amaze me how few of the parents I know think about the risk to their own children from vaccine-exempt children in their schools and communities. Even parents who do think about this rarely seem concerned enough to speak up or even discuss it with others, let alone become active in doing something about it. With the rise in vaccine-preventable disease outbreaks, including the current high-profile Disneyland measles outbreak, and the ongoing pertussis epidemic in California, the tide seems at least to be turning slightly. The dramatic impact that vaccine refusal and the resultant decline in herd-immunity can have on a community is now penetrating the public consciousness. My hope is that parental awareness and outrage grow regarding the flagrant disregard of science, common sense, and citizenship exhibited by those parents who refuse to properly vaccinate their children. My hope is that the culture of tolerance of this intolerable anti-science threat begins to turn, and that it is no longer seen as acceptable for some parents to put the safety of others at risk.
Which brings me to the focus of this post. (more…)
A Toronto naturopath’s advertisements were recently criticized on social media for insensitivity and racism:
Naturopath Jean-Jacqques Dugoua sells glutathione injections, claiming it will give “brighter, lighter and glowing skin”. His URL, lightnaturalskin.com seems to imply that lighter skin is more natural, and he claims the following:
After over 3 years of treating patients for skin concerns, Dr. JJ has developed the Skin Brightening IV, which includes glutathione, vitamin C and other vitamins/minerals. Not only is this treatment effective for most people, it is also safe. The Skin Brightening IV glutathione is a good alternative to skin bleaching creams, which can damage, scar, inflame, discolour or irritate the skin, or microderm abrasion, which is painful and may also irritate the skin and sometimes worsen hyper-pigmentation.
This safe and natural treatment involves principally the use of intravenous (IV) vitamins (excluding vitamin A), minerals and amino acids, including glutathione. All ingredients are regulated by Health Canada and obtained from pharmacies or pharmaceutical companies in Canada or the United States. The treatment is performed in compliance with licensure in Ontario.
Last week an article published by the New York Times entitled “Scrutiny for Laxatives as a Childhood Remedy” made the rounds. The article raised the question of a possible link between the use of a popular over-the-counter laxative, PEG (polyethylene glycol) 3350, and neurological or psychiatric problems in children. This wasn’t the first time this particular journalist wrote a piece on this topic, however. In 2012, she wrote about the popularity of the treatment among pediatricians despite a lack of FDA approval for use by children, a fact which applies to many if not most of the drugs commonly prescribed by pediatricians. (more…)
The New Year starts with telomeres as the trendiest of trendy biomarkers. As seen in Time, telomeres are the means to monitor our well-being so we can protect ourselves from all sorts from threats, including early death.
A skeptic needs to do considerable homework in order to muster the evidence needed to counter the latest exaggerated, premature, and outright pseudoscientific claims about telomere length being a measure of “cellular aging” and therefore how long we’re going to live.
What is a telomere and why does its length matter?
Harriet Hall recently described telomeres:
Every chromosome has a telomere, a repeated sequence of nucleotides at the end of the DNA strand. It is a disposable section that carries no genetic information. For vertebrates, the nucleotide sequence is TTAGGG; this repeats from 300 to several thousand times according to the species of animal. Telomeres are sort of like the aglet, that little hard piece on the end of a shoelace that keeps it from unraveling. They protect the end of the chromosome and keep it from losing important genes or sticking to other chromosomes.
Telomeres are sort of like aglets. Photo by Fieggen CC BY-SA 3.0 via Wikimedia Commons
Talk of telomeres isn’t just being used to sell dubious diagnostic tests and dietary supplements. There is a strong push to make telomere length the currency of how we think, measure, and do science about our health and well-being, and how we target our health interventions. Strong efforts are made to attach the science of telomeres to urgings that we take up yoga, meditation, and “being there” to save our lives.
A newly-published review of neuroscience research looking at the predictive value of functional and anatomical imaging raises interesting questions about the role of such studies in learning, psychiatric treatment, and even the treatment of criminals. “Prediction as a Humanitarian and Pragmatic Contribution from Human Cognitive Neuroscience” by Gabrieli, Ghosh, and Whitfield-Gabrieli and published in Neuron, does a thorough job of explaining the current state of the research and pointing to where future research is needed.
The basic idea is to use noninvasive imaging to look at the structure or function of the brain as a way of predicting future behavior, and then using those predictions to help guide treatment and education interventions, and perhaps decisions regarding parole or further treatment of criminal behavior. This concept raises many issues, including the technology being used, the state of the research, the ultimate potential for this line of research, and ethical considerations.
The major question underlying this entire endeavor is, to what extent is brain anatomy and function destiny? (more…)
In a recent “Perspective” article in The New England Journal of Medicine, three physicians (Drs. Cox, Borio, and Temple) make a strong case for not letting the rush to save Ebola patients tempt us to deviate from good science and skip the randomized controlled trial (RCT). Their arguments cut to the essence of the scientific approach to medicine, and they deserve careful consideration.
Ebola is uniquely scary
Ebola is the kind of threat that really gets our attention. The virus was first identified in 1976, and prior to 2013 there were several small outbreaks in Africa with death rates as high as 90%. This time the death rates are lower, but the numbers are much greater. It has spread to several African countries, and a few cases have even reached the US and Europe due to infected travelers and health care workers. We face a risk that Ebola may become endemic, smoldering along as a constant presence in Africa.
There is no known effective treatment. Fear of Ebola has sparked bizarre conspiracy theories and claims of “natural” cures and prevention kits from homeopaths, alternative medicine advocates like Mercola, and purveyors of remedies like colloidal silver and essential oils. These have been covered on SBM here, here, and here. (more…)
In the fascinating, if not rational, world of so-called complementary and alternative medicine, the age of the patient rarely seems to matter. This stands in stark contrast to the practice of science-based medicine. Sure, there is some physiological overlap across the spectrum of age, but caring for children often requires a vastly-different approach and there are numerous conditions not seen or only seen in kids.
Alternative medicine is more about the underlying belief system rather than the actual physiology, however. Chiropractic is chiropractic whether the subluxation belongs to a neonate or a nonagenarian. In traditional Chinese medicine, the flow of chi is obstructed in youngsters and old fogeys alike. No matter the length of our telomeres in fact, every major form of alternative medicine appears to contain a subset of practitioners that claim unique expertise in maximizing health and wellbeing at any age. But for kids, they simply do the same thing they would do for an older patient.
Newborns appear to be an increasingly-popular target of irregular medical practitioners. Even the unborn baby still in their mother’s womb isn’t safe. A generous interpretation would be that these true believers simply wish to aid in establishing health early in a child’s life, while the cynic in me worries that establishing a lifetime of billing opportunities might be the primary motivating factor. (more…)
I have yet another grant deadline to deal with, this time for the Department of Defense Congressionally Directed Medical Research Programs, this time around its Breast Cancer Research Program. Unfortunately, that put a high degree of time pressure on me. Fortunately, there’s still stuff in the archives of my not-so-secret other blog that I deem quite appropriate for this blog and that can be updated with minimal effort. If you don’t know what I’m talking about when I refer to my not-so-secret other blog, then it’ll definitely be new to you. If you haven’t been reading that blog for at least four and a half years, it’ll be new to you as well. And even if you have seen it before, I think it’s worth revisiting.
Why? It came up because of an encounter I had on Twitter with Jane Orient, MD, who, as you might recall, is the executive director of the American Association of Physicians and Surgeons (AAPS). I’ve written about the AAPS before. You can get the details in the link, but if you don’t have time suffice to say that it is an entire organization of libertarian-leaning “brave maverick doctors” who think Medicare is unconstitutional, don’t believe that the government should have much, if anything, to do with regulating the practice of medicine, and reject evidence-based guidelines as an unholy affront to the independence of the physician. Along the way, the AAPS, through its journal, The Journal of American Association of Physicians and Surgeons (often abbreviated JPANDS), promoted antivaccine views, including the discredited concept that vaccines cause sudden infant death syndrome, HIV/AIDS denialism, and the scientifically unsupported idea that abortion causes breast cancer (a topic I might have to revisit, given the activity promoting it recently).
In any case, two or three weeks ago, I was having a bit of an exchange with Dr. Orient over anthropogenic global climate change (often abbreviated as AGW, for anthropogenic global warming, for short), the well-accepted science that concludes that CO2 generated by human activity is having a serious warming effect on the earth’s climate. As you might expect, she’s not big on this particular scientific consensus. I forgot about it, but then the other day saw this Tweet exchange between Dr. Orient and Ed Wiebe:
“What’s the harm?” is an insidious idea when used as a justification for unscientific medical treatments. The argument is typically put forward with the assumption that direct physical harm is the only type of harm that can result from such treatments, so as long as they aren’t toxic there is no downside to trying them. Harm comes in many forms, however: delayed effective treatment, wasted time and energy, financial harm, the psychological harm of false hope, and the downstream effects of instilling unscientific beliefs regarding health care.
One other form of harm is physical but is not due to direct physical damage or toxicity. Rather, it is caused by CAM treatments interacting with proven therapies. A recent survey, presented at the Clinical Oncology Society of Australia annual scientific meeting, explored the potential for such interactions among oncology patients. Lead researcher Sally Brooks found that, in addition to vitamins and minerals, cancer patients were most interested in fish oil, turmeric, coenzyme Q10, milk thistle, green tea, ginger, lactobacillus, licorice, Astragalus and reishi mushrooms.
As I have written many times before, herbs are drugs, but many patients do not treat them as such because they are regulated and marketed as “supplements,” more like food than drugs. There are concerns that many vitamin and herbal products may interact with chemotherapy or radiation therapy in order to reduce effectiveness or even increase side effects. (more…)