New mothers, especially first-time mothers, tend to worry about whether they are doing what is best for their babies. A new service, Happy Vitals, will only add to those worries. We know that breast is best, but these folks make women question whether their breast milk is good enough. They say:
Happy Vitals provides families with the tools they need to monitor and improve the long-term health of their children. With our simple and easy-to-use tests, mothers can learn for the first time about the nutrient make-up of their breast milk, improve their diet and nutrition, and safeguard against exposure to heavy metals and other toxins that are harmful to a child’s growth and development.
After a crowdfunding/pre-sale campaign, they plan to start shipping kits this month. They offer various packages. For $149.95, they will analyze a sample of breast milk for four key nutrients: glucose, lactose, protein, and fat. For $559.95, they will also test for:
- Four “indicators of immunity”: cortisol, IgA antibodies, IgG antibodies, IgM antibodies.
- Eleven micronutrients: calcium, folate, iron, vitamin D, vitamin A, ferritin, magnesium, phosphorous, sodium, potassium, and vitamin B12.
- Four heavy metal toxins: arsenic, lead, mercury, and cadmium (based on samples of infant’s hair and nails.)
Delicious homemade Kimchi (fermented cabbage). It’s alive! Click for a closer look.
Fermented foods, such as sauerkraut and kombucha, have become popular for health reasons. I have made my own sauerkraut in the past and have recently made the tasty, fermented Korean side dish, kimchi. I did it not only for the taste but also for the hope that the bacteria responsible for the fermentation of the cabbage — lactic acid bacteria (LAB) — would contribute to the diversity of my gut microbiota.
As a research scientist in the field of bacterial pathogenesis, this made sense to me. Now that I have started blogging about health and fitness and have been writing more in depth articles about health related topics, I started wondering what research has been done on the health benefits of fermented foods. Can the bacteria in fermented foods even survive the harsh conditions of the human gastrointestinal (GI) tract, particularly the stomach?
I was amazed to learn that the fermentation of food has been used by humans for thousands of years as a way to preserve foods, and that the health benefits go beyond their microorganisms (don’t worry, citations are provided below). The fermentation process enhances the nutritional quality of food by contributing beneficial compounds such as vitamins, and by increasing the bioavailability of minerals. Probiotics, including those found in kimchi, have a range of positive effects on health, including the improvement of various intestinal inflammatory conditions, positive impacts on the immune system and even weight loss, and can alter the composition of the gut microbiome.
However, these effects mostly depend on whether the bacteria actually make it in sufficient numbers to the colon. And let me tell you, the journey to the colon is one harsh and dangerous ride!
A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.
For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.
Background: Initial approval of Vascepa and subsequent research
In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.
Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)
Weston A. Price Foundation: Not recommended
One of our readers requested a post about the Weston A. Price Foundation (WAPF). I knew it was not a trustworthy source of medical information, but I had not imagined just how atrocious it really was. After spending some time on the website, I realized that it is not just a cornucopia of false information about dentistry and nutrition, but is full of anti-vaccine propaganda and bizarre and dangerous health advice that could result in serious harm to patients.
The purpose of the Weston A. Price Foundation
It is a non-profit, tax-exempt charity founded in 1999 to disseminate the research of Weston A. Price, who “established the parameters of human health and determined the optimum characteristics of human diets.” (He did no such thing!) It publishes a journal “dedicated to exploring the scientific validation of dietary, agricultural and medical traditions through the world.” That statement reveals how poorly they understand science. The purpose of science is not to “validate” traditions and beliefs; it is to ask “if” those traditions offer any demonstrable benefits, and if the beliefs correspond to reality. (more…)
Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.
Over the years, mainly at my not-so-super-secret other blog, I’ve frequently made the points that the vast majority of physicians are not scientists and, in fact, that many of them suffer from a severe case of Dunning-Kruger when it comes to science outside of biomedical sciences—or even biomedical sciences outside of their medical field of expertise. The most common science I’ve seen physicians embarrass themselves attacking has generally been evolution, with a disturbingly high number of physicians denying evolution and embracing creationism. Of these, the doctor I wrote about most frequently back in the day was the creationist neurosurgeon Michael Egnor, but with the onset of the 2016 Presidential race there’s been a new creationist neurosurgeon in town with arguably even more ignorant attacks on evolution. I’m referring, of course, to noted neurosurgeon Ben Carson, whose creationist stylings have been so bad that I had to use him as a poster child to demonstrate how the vast majority of physicians are not scientists and all too many of us have an inordinate and unjustified confidence in medicine as a “check on BS.”
Over the last couple of weeks since my post on the second Republican debate, in which Donald Trump spewed antivaccine nonsense and Ben Carson pandered to antivaccine views, even though past statements by him demonstrate that he knows better, unfortunately Carson has continued to spew statements that are nothing but downright embarrassing, be they his statement in the wake of the Oregon mass shooting that it would be better to attack an armed gunman during a mass shooting “because he can’t get us all” (complete with a seeming attitude that those who died were cowardly), his doubling down on that by claiming that if the Jews had been armed maybe things would have turned out differently in the Holocaust (neglecting the fact that Jews did resist), or his many other statements that make me wonder how someone with so little critical thinking skills could get through medical school and a neurosurgery residency to become such a respected surgeon.
From the author’s website: “Shameless use of cute baby to promote book”
When a baby is born, parents are often awed and alarmed to find themselves responsible for this tiny new person, and they desperately want to do their very best to keep their infant safe and healthy. New mothers worry about everything from SIDS to vaccines, from feeding practices to sleep hygiene, and they are bombarded with conflicting advice about caring for their babies. Myths and misinformation abound. Finally someone has written a truly science-based guide to the first year of life: The Science of Mom. The author, Alice Callahan, is a research scientist with a PhD in nutritional biology. When her first child was born, she had a lot of questions, and thanks to her background she knew how to look for reliable answers in the scientific literature. She started writing the Science of Mom blog and eventually turned her findings into a book.
Her first chapter covers the important concepts for understanding how to think about scientific studies:
- Good science is a process that takes lots of experiments, time, and people.
- Good science is peer-reviewed.
- One study on its own isn’t worth much, but scientific consensus is trustworthy.
- Some studies are more valuable than others (here she covers the various types of study from animal studies through observational studies in humans to RCTs and meta-analyses).
- Numbers matter (sample sizes).
- Don’t believe everything you read on the Internet (here she gives some practical tips for evaluating whether a website is reliable).
- Correlation is not causation (she uses my favorite example of the correlation between autism diagnoses and the sales of organic food).
- We can’t eliminate risks (but science can quantify the risks and benefits and families can use the information to decide what risks they are personally willing to take).
- Find smart allies (experts and providers you can trust).
- Forget about perfection and pay attention to your baby.
Ski faster with coconut water?
I don’t tend to worry too much about hydration, except when I exercise. I’ve been running regularly for over 15 years, and since I started I’ve usually carried water, or for longer runs, I drink old-school Gatorade. The formulation is basic: sugar, salt, and potassium. There are hundreds of electrolyte products marketed for athletics, but I’ve been faithful to the original: It’s cheap, I don’t mind the taste (even when it’s warm), you can buy it nearly anywhere, and it’s the usual liquid (besides water) offered at races. After exercise, I rehydrate with plain water, preferring to get my electrolytes and carbohydrates from food, rather than a specialty beverage, some of which are “designed” to support rehydration after exercise. The science of sports and hydration is constantly evolving, and so is the marketing. I’m apparently an outlier by still running with Gatorade. New hydration products criticize Gatorade for being artificial and inferior, arguing that natural sources of hydration are better. There’s been an explosion of rehydration beverages, marketed both for everyday hydration and sport purposes. Coconut water was the first natural product to find fairly wide popularity as a sports-oriented beverage. Now you can find maple water, cactus water, watermelon juice and even artichoke water. Is “natural” hydration better that substitutes, including plain old water? (more…)
The FDA recently announced it would send field staff out to collect samples of commercially-manufactured raw dog and cat food. The samples will be analyzed for Salmonella, Listeria monocytogenes and E. coli, all of which have been found in raw pet food, in the animals who eat it, in their feces, on their bodies after eating it, in the areas they inhabit, and on their owner’s bodies. Not surprisingly, this has led to both pet and human infection and illness. If the FDA finds pathogens, it could result in a recall, a press release and Reportable Food Registry Submission. The next day, the CDC joined the effort to curb illness caused by pathogens in raw pet food by posting information on safe handling.
Because of the risk to public health, and the lack of any proven benefit of raw pet food diets, the FDA does not recommend them.
However, we understand that some people prefer to feed these types of diets to their pets.
And why is that? For some of the same reasons humans follow absurd diet fads: the “lone genius” discovery, it’s “natural,” anecdotal evidence, appeal to antiquity, anti-corporate sentiment, and “holistic” practitioner recommendations.
Pictured: Something you might need if you actually had a leaky gut. Click to embiggen. Weirdo.
We are at a disadvantage. We have to rely on reality to validate the practice of medicine. Anatomy, physiology, pharmacology, chemistry, the basic sciences that made up the first two years of medical school education and a huge chunk of pre-med. And we have to rely on the truth, as slippery a concept as that can be. I can’t just make up a disease or a therapy.
It would be so much easier to not have to worry about reality in deciding on a disease and treatment for people with symptoms.
I came across “Healthy Life: Leaky Gut Syndrome” in my feeds. I am always attracted to exclamation marks! They must mean something important! Or surprising to the author!
It’s called “leaky gut syndrome” and patients say it can wreak havoc on everyday life, but some doctors say there’s no such thing!
Some doctors. Must be that pesky 10% percent or so of obstructionist doctors who don’t recommend Tylenol or Advil. (more…)