There is persistent tension over the issue of drug regulations. On one side are those who think that before we sell drugs to the public with health claims, we should ensure there is a reasonable amount of objective quality scientific evidence to demonstrate that the drugs are safe and effective. I admit this is the side of the discussion on which I fall, and it is clear that most of the public assumes this is the case.
The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme version, held by some Libertarians, there should be no regulation (or perhaps minimal regulation for safety) and the free market should sort out what works and what doesn’t.
The Food and Drug Administration (FDA) is the regulatory agency in the US responsible for ensuring the safety of drugs and that efficacy claims are backed by adequate evidence. The FDA, however, is a creature of congress, from which it derives its authority. It can only do what the law says it can do. Within that law the FDA also has a certain amount of discretion. How much evidence is enough is a judgment call. Therefore who heads the FDA can have a significant impact on how tightly or loosely regulated the pharmaceutical industry is at any given time.
The FDA’s mandate is now being threatened from both ends, congressional law and possible picks by Trump to head the FDA.
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Stories take on a life of their own. That is the origin of urban legends, myths, and even religion. A good narrative feeds on itself and can be self-sustaining. It evolves and adapts and finds fertile ground in most human hosts (unless they have been inoculated with a sufficient dedication to facts and logic).
Aspartame, an artificial sweetener that was approved by the FDA in 1981, has been the focus of conspiracy theories ever since. The “holistic medicine” and “natural health” subcultures have largely been responsible for spreading misinformed hysteria about aspartame, first through chain letters and newsletters, and now through the internet.
Ever adapting, they have added some new wrinkles to the legend of aspartame, making sure that their baseless fearmongering is making use of the latest buzzwords.
Aspartame is Safe
First for some background, the anti-aspartame brigade claims that this food additive has been linked to cancer, neurological disorders, and a long list of complaints and diseases. They are simply lying, or the equivalent of lying by cherry picking data, dismissing evidence out-of-hand, and making up whatever claims they need to support their position. Continue Reading »
In February Playboy model and instagram star Katie May died suddenly of a stroke at age 34. Recently TMZ obtained a copy of the coroner’s report from her autopsy which concludes that the stroke was due to a tear in one vertebral artery, which in turn was caused by neck manipulation by a chiropractor.
This is a good time to review the evidence surrounding the issue of chiropractic manipulation and strokes, which is a concern expressed by many experts but largely denied by the chiropractic profession.
Strokes in young people (<50) are extremely rare. A stroke is caused by blockage of an artery feeding the brain leading to lack of oxygen causing injury and even death to brain cells. Arteries can be blocked if a blood clot lodges in the artery (an embolus), or if a clot forms in the artery (a thrombus).
One major cause of young strokes is trauma to one of the four arteries that feed the brain: two carotid arteries in front and two vertebral arteries in back. The trauma can cause a tear in the inner lining of the artery, which is called a dissection. That tear causes turbulence in blood flow, which in turn can result in a blood clot (when blood isn’t flowing it tends to clot). That blood clot or thrombus can block the artery if it gets big enough, or a piece can break off and lodge down stream, either way causing a stroke.
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A Canadian academic, Dr. Mark Loeb, who is a respected infectious disease researcher who knows how to conduct high quality research, wants to study homeopathic nosodes. Nosodes are essentially homeopathic vaccines.
Tim Caulfield, a Canadian professor of health law and policy, thinks the study is misguided and unethical. The two are having a respectful public debate about the risks and merits of doing such a study.
David Gorski and I have actually published in the peer-reviewed literature on the broader question of studying alternative medicine: Clinical trials of integrative medicine: testing whether magic works? It is a bit of a dilemma, and we are seeing that exact dilemma play out on the question of this specific proposed study.
Homeopathy is Pseudoscience
For quick background, both sides in this debate agree that homeopathy is 100% pseudoscientific nonsense. Homeopathy was invented by one person, Samuel Hahnemann, about 200 years ago. It was not based on any scientific research or knowledge base, it did not develop out of emerging knowledge of biology or physiology. It was simply invented out of whole cloth based loosely on the superstitious belief in sympathetic magic – the notion that substances contain a mysterious “essence” that can be transferred to the body and stimulate the life force.
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Children with autism are an especially vulnerable population. Just being a child makes you vulnerable, especially when you have any medical condition. You are in the hands of your parents, the health care system, and the state to best look after your needs.
Unfortunately, we frequently see stories in which all three have failed to look after the needs of children (sick or not).
Another such story has surfaced: the BBC reports about a four-year old boy, recently diagnosed with autism, whose parents sought help from a naturopath. This fake doctor prescribed a dozen supplements to the boy (because that’s what they do), apparently telling the parents this would help with their son’s autism. Instead, the boy became extremely ill and would likely have died without critical intervention.
Specifically, he was given a toxic dose of vitamin D (yes, there are toxic doses of vitamins), which caused him to have dangerously high calcium levels. He developed vomiting, extreme thirst, and lost 6.5 pounds in 3 weeks. Fortunately he was treated and has recovered.
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A recent study that concludes human lifespan is approaching its maximum (around 115 years) has created some interesting debate. It’s the good kind of scientific debate that focuses on how to interpret data and infer the implications of limited data.
The authors, Dong, Milholland and Vijg, examined the mortality database, which includes death statistics from 38 countries. They looked at the age of the oldest person to die in each country by year. They also looked at the change in life-expectancy by age group.
To clarify one point of terminology that is often confused: life expectancy refers specifically to the number of years a person is statistically likely to live from their current age. Usually when you see life expectancy figures quoted, those are life expectancy from birth.
For example, a person born in 2012 in the US has a life expectancy of 78.8 years. If you were 65 in 2012 in the US your life expectancy was 84.5 (both are slightly higher for women and slightly lower for men).
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If you have a child in school then you have probably already noticed how common perceived food allergies are. Every year we get a list of foods that are banned from the school because of reported allergies. Peanuts are the most common. This is a reasonable policy for the school as genuine food allergies can cause life-threatening anaphylactic reactions.
It has also been known for a long time that the number of people who perceive that they or their children have a food allergy (35%) is far greater than the number of people who have proven allergies (2-5%).
A recent review of the literature, published in the Canadian Medical Association Journal, takes aim at one factor contributing to this gap between public perception and medical reality – IgG antibody testing. Continue Reading »
Mark Zuckerberg, the founder of Facebook, and his wife, Priscilla Chan, recently announced their initiative to “cure, prevent or manage all diseases by the end of the century.”
That is a fairly ambitious goal, to say the least, but coming from someone with the resources of Zuckerberg it’s worth exploring what he actually intends to do. To start, he plans on investing $3 billion in medical research. That is a serious investment.
To put that in perspective, however, the NIH 2017 budget is $34.1 billion, an increase of $2 billion over 2016. That includes $1.39 billion for Alzheimer’s research alone. The NIH spent over $500 billion dollars since 2000.
So, while the Chan Zuckerberg Initiative is generous and is likely to have a positive impact, it is hard to imagine how $3 billion will accomplish what $500 billion has not. It’s not as if there aren’t thousands of medical researchers around the world already trying to prevent, cure, and manage disease.
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Gatorade, which is basically sugar water with a little salt and potassium added, is extending their strategy of making sugar water sound healthful by marketing a prominently labeled “Organic” version of their product: G Organic.
What makes the product organic is that the sugar is sourced from organic sugar cane. This is an excellent example of how marketing creates then exploits a health halo around products even when it makes absolutely no sense.
The sugar industry, and producers of high sugar products, have been engaged in a campaign over decades to market sugary products to the public while somehow convincing them that the products are not bad for them, and in fact may be good for them.
The science is pretty clear. Having a diet high in refined sugar is a major health risk factor. It increases triglycerides, which increases risk of heart disease, it causes tooth decay and obesity, which leads to diabetes and other health issues.
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Dr. Bob Sears is a Capistrano Beach pediatrician who is famous for opposing mandatory vaccinations and the current CDC vaccine schedule. He has promoted his alternate vaccine schedule, which spreads out the vaccines much greater than the standard schedule. This has made him a darling of the anti-vaccine movement, an expert who supports part of their narrative (specifically, “Too many too soon” and parental choice).
Recently the Medical Board of California filed a complaint against Sears for “gross negligence.” There are three counts, the first for recommending a 2 year old patient not receive any further vaccines because of apparent reactions to previous vaccines. The complaint alleges:
Respondent was grossly negligent and departed from the standard of care in that he did not obtain the basic information necessary for decision making prior to determining to exclude the possibility of future vaccines, leaving both patient J.G, the patient’s mother, and his future contacts at risk for preventable and communicable diseases.
The complaint also alleges that Sears failed to adequately assess the patient after a head injury with complaint of headache, and also that he failed to keep adequate records by not filing the letter excusing the patient from vaccines in the chart.
The Standard of Care Continue Reading »