Tag Archives: EBM

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Breast Feeding: Froelich & CDC

This is another old post from The Physician Executive that I expect is still relevant because old habits like supplemental feeding in hospital nurseries die a hard death when they are the path of least resistance. It was originally published on June 16, 2018

Edwina Froelich, founder of La Leche League, passed away last week. La Leche League used to state that the three main obstacles to successful breast-feeding were doctors, hospitals and social pressure.

My experience has been one of utter frustration with maternity nurses, who should know better, but frequently feed their wards sugar water for no reason. Some kids can get hypoglycemic, but certainly not three quarters of the nursery. Some kids may lose weight, but that is a normal phenomenon, with the natural history of birth being a decline in weight and return to birth weight by day 10. It is not abnormal to lose weight, but it is abnormal to get formula or D5 on day 1.

These practices appear to me (on an anecdotal basis) to be widespread in places I have worked in the US, but they would be unacceptable in other places of which I have some knowledge: Montreal, England, or France. I understand from a cousin in Dubai that at least one hospital reflects the US’s breastfeeding dysfunctions, so I am sure there is tremendous variation from country to country, especially by socio-economic class.

The harm done is that by allowing alternatives to breast feeding, we don’t give a woman a reasonable chance of establishing her breast milk in the first place. To establish breast feeding, you need an infant sucking on a nipple, which provides the hormonal stimulus to produce milk in the first place. The more concerned you are that the breast milk may “not be enough”, the more you assure the fact.

The problem with personal observations is the tendency to generalize. Finally, the CDC surveyed hospital infant feeding practices, as reported in MMWR. American hospitals persist in providing alternatives to breast feeding to infants, such as sugar water and formula. I am sure that most well-meaning maternity ward nurses will explain that they are trying to make sure babies gain weight or not become hypoglycemic. Unfortunately, entire wards of infants are not likely to suffer from the risk factors for hypoglycemia and weight loss in the first three days is a natural phenomenon that does not get babies in trouble if skilled observation and timely intervention is available.

So breast feeding suffers for entire populations as we chase the shadows of unusual and uncommon poor outcomes that rattle us to the point that it is easier to just chuck formula into every crying newborn’s mouth.

Hopefully there will be more Edwinas around to take up the cause.

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Vaccine Objector Backlash


In March, a version of the following article appeared in Lacamas Magazine, a local lifestyle publication. It was very well received, and attracted an enormous number of hits. I need to rework something for the local daily paper, The Columbian. Until then, I offer you an opportunity to review and comment; it is a controversial topic but I believe science is the benchmark, not conspiracy theories. We are one epidemic away from the ostracization of people who object to vaccines. This is why my original title is somewhat inflammatory. It was softened for the actual publication.  



Many of the digital back-issues are online, but not the one containing this article. I will link to it if it comes back live.

Vaccines are the most effective tool of medical science to decreasing the burden of human disease since Edward Jenner in 1798 described a method of inoculating healthy people with cowpox to prevent smallpox. Countless lives have been saved worldwide with a record of remarkable safety and a miniscule degree of adverse reactions given the magnitude of the benefit. Despite the incontrovertible weight of the evidence, there remains an anti-vaccine movement and a persistent fear of immunizations of all sorts.[1]

Opposition to vaccines can be found as far back as 1905 when the case of Jacobson v Massachusets went to the Supreme Court. In that case, a father refused to be forced by the state to vaccinate his daughter in the midst of a smallpox epidemic. The Supreme Court found that despite a legitimate libertarian argument, there was a compelling reason to over-ride the rights of the individual when fighting an epidemic because there was direct link between the number of people who were immunized and the total spread of the epidemic. It turns out that interrupting transmission was a function of reducing the number of people who could transmit the virus. The benefit to the person was magnified when the effect on the community was examined.

More recently opposition started with Andrew Wakefield, an English surgeon, who became interested in vaccines and published a study that claimed to show a link between MMR (measles, mumps and rubella) and autism in 1996. Understandably, this captured the imagination of parents everywhere. Can anyone imagine causing brain damage to their children by accepting an injection which was supposed to protect them against a deadly disease? Emotions run high with autism; parents wonder if they did something wrong and grasp at any potential cause to explain he unexplainable.

There were problems with the hypothesis from the start. First, the assertion of a link between immunizations and autism rested on the observation that the increase in the occurrence of autism ran parallel to the increase in vaccinations. Of course many other things also increased in the same interval; there was also an increase in the number of doctors available who could diagnose autism and better diagnostic criteria to distinguish autism from other forms of developmental problems. One can make an argument that anything else that increased over the prior several decades was linked, but a link is not a cause. The number of cars on the road has also increased parallel to the increase in autism, and the lead in automobile emissions is actually biologically active when ingested in the form of dust by an infant. It is more plausible than mercury as a cause, but nobody would take the idea seriously.

The vaccine link was supposed to be thimerosal, a mercury-containing preservative in the MMR vaccine. Mercury is indeed neurotoxic, but not all forms of mercury are active when absorbed into the body. For example, it is the fumes that are the best absorbed and the most active. Inorganic mercury is found almost universally in the soil and water in nature and poses no hazard. Theoretically, someone could swallow elemental mercury and not suffer any effects, because it cannot be absorbed that way (of course fumes may be released before, during or after digestion, so no one will say swallowing mercury is safe.) The mercury in thimerosal is very tightly bound and probably inert. The same way, mercury in the soil behind dams cannot be released into the food chain until bacteria convert it into a form that can be absorbed by eating fish. But mercury in fish is a well-recognized problem and there is no connection between autism and ingesting mercury-containing fish. It is difficult to think about how a relatively inert form of mercury can have any biological activity when injected. In fact, it was found that babies excrete thimerosal much faster than would be expected from our knowledge of how the body handles the toxic forms of mercury. This is one more small piece of evidence suggesting that mercury in thimerosal does not have time to interact with tissue. Nonetheless fear and controversy won out and vaccine manufacturers responded to the concerns. Thimerosal was never universally present in all vaccines and has since been removed in most every vaccine available today, except where it is impossible to use something else for technical reasons. Rates of autism continue to increase.

Then Wakefield’s study blew up! The co-authors smelled something fishy in the results especially when information emerged that proper methods in conducting the study were not followed. Eventually, it became clear that the data had been falsified, Wakefield was accused of fraud and he lost his license to practice medicine. It is believed that he falsified data so that he could profit from being a consultant on all the lawsuits that would follow. He currently lives in Texas.

The damage he caused was in stirring up a controversy that was not based in any sort of fact, in spreading false information and fear leading people to refuse vaccination and suffer the burden of increased vaccine-preventable disease making a come-back, in intense efforts to remediate a problem that did not exist and untold research dollars that would have been better spent seeking the real cause of autism. We can see the traces of his misinformation when someone like Congresswoman Michelle Bachman says that she knows people who got autism from the HPV vaccine. The statement is appallingly ignorant, brutally stupid and horribly violent for the children who would benefit from the vaccine.

Some people seem to feel that the number of vaccines is an overwhelming assault on the immune system. The problem with this notion is that in each vaccine there are a handful of highly purified proteins designed to arouse a strong immune response. Purification may always introduce trace chemicals, but at levels less than the neighborhood pool. A bowl of chicken soup probably contains an order of magnitude greater number of proteins that the entire set of childhood vaccines from birth to the teen years. It seems much more likely that prematurely feeding an infant adult food would be more harmful.

The number of needles required frequently comes up with parents. It is easy to understand how five injections at one time can be heartbreaking, especially as the child begins to wail. Older doctors however remember the days that circumcisions were done on infants without anesthesia. Without condoning what seems like a barbaric procedure to some, there is some dissonance between insisting on a circumcision on one hand and worrying about an extra needle on the other. The pain is limited. The benefit is huge.

The immunization regimens are constantly being revised and changed as circumstances permit, including the increasing availability of combination vaccines to reduce the number of individual injections. We must also remember that vaccines have become victims of their own success. When polio is fresh in people’s memory — the paralysis, death and suffering wrought by a horrible disease — it is easy to convince parents that the vaccine is necessary. When the disease has become rare because of the widespread use of a vaccine, the benefit does not seem as significant. Until the disease starts coming back, that is.

Other accusations thrown around about vaccines are that they represent a conspiracy on the part of pharmaceutical companies. This is laughable to people who have been interested in vaccines since the decades that research had stalled. In the 80’s, fear of litigation led most manufacturers to withdraw from vaccine research and development and shortages were looming. In 1986 Congress created the National Vaccine Injury Compensation Fund so that people who were injured by vaccines could be compensated publicly  After all, there is a societal good to vaccination that makes even the rarest adverse reaction doubly tragic. Two things happened after establishing the fund; first vaccine manufacturers reinvested in developing vaccines and lawsuits plummeted. It seems the new fund was more rigorous in making awards, not subject to the vagaries of the “jury lottery” of super-sized awards and nuisance claims. In other words, vaccines do not have a history of being particularly profitable, at least until the past couple of years when prices have started to sky-rocket. In the mean-time the compensation fund is one government program that is significantly over-funded because there have been so few claims made.

Incidentally, the body that makes vaccine recommendations is the American Committee on Immunization Practices, set up by the CDC at arm’s length. It has representation from numerous medical, public health and consumer groups and has remained stubbornly independent. It accepts no money from industry, works only peripherally with the FDA, limiting its recommendations to FDA approved parameters and constantly weighs the risks and benefits of any immunization. All their deliberations are public, transparent and available online. With the National Science Foundation and The Institute of Medicine, the ACIP is one organization that is least likely to be swayed by the big pharma’s financial interests.

Clark County’s Public Health Officer Alan Melnick is fond of saying that “vaccines prevent diseases that kill kids.” This is also true for adults. The ACIP makes recommendations based on the best science and evidence available with the aim of saving as many lives as possible with the lowest risk of any adverse events. The science and the evidence demonstrate that there is a community benefit that exceeds just the individual protection. Diseases like whooping cough and measles can still occur in an immunized population if enough people remain uncovered. It is not enough to immunize your own kids if neighbors and schoolmates refuse their immunizations; your kids can still get sick. The risk is small but probably greater than the risk of a serious reaction to a vaccine. It is an inflammatory statement that may yet prove true; that not immunizing your own kids can allow diseases to spread that potentially can kill other kids as well as your own. Vaccine objectors have not yet faced this backlash, but it remains that human beings living in communities have a responsibility first to themselves and their families, but then also to the communities which sustain them.

[1] An immunization is an intervention designed to increase an immune response to a specific agent. Vaccines have come mean the same thing although historically the word vaccine refers to vaccinia, the cowpox virus used to prevent smallpox.

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EBM Assesment in the Real World; or Critical Assessment on the Internet

A little discussion on Twitter led me to elaborate on red flags. Back in the days when I taught at a residency program, the Internet was exploding and it was important to apply the principles of critical assessment in order to evaluate the credibility of such vast access to new information. These are the same skills and principles we use in evidence-based medicine (EBM). The whole thing begins by not believing what you hear or read and being systematic and rigorously in analyzing the reasons not.

This Twitter interchange pretty much followed the same pattern. Shelley Petersen is a London based journalist and social networking marketer who focuses on innovative medical technologies and maintains an active twitter feed chock full of medical science articles. One of her articles raised a lot of red flags for me and when she asked me what those flags were I thought it was too much for 140 characters. It was time to tramp back over the article and provide a detailed analysis of what struck me as improbable and unreliable about the information.
The article was from a Pittsburgh paper and was fairly balanced, presenting some contrary perspectives, so the red flags were about what the principal was saying. In brief, the CEO of a private company was discussing how a long recognized function of telomere shortening and how it explained aging and all the diseases associated with aging.
1. Everyone has an inherent bias, mine is to be skeptical. The CEO of a company is to sell something. In this case, I suspect it is to sell a narrative to investors. I am dubious at the get-go, so red flag number 1.
2. Most research happens at universities. Scientists know that some of the best research happens at smaller universities, but when the only experts cited in any article are from Harvard and MD Anderson, I begin to suspect spin. Certainly I would expect some degree of balance between “name” institutions and other excellent university departments which are less of household names. Over-citing can raise flags.
3. Telomeres are not new. Telomere shortening is not new. When one individual claims he has insights that nobody else has been smart enough to figure out over decades, it is wise to be suspicious. Moreover telomere shortening is an epigenetic phenomenon. Nobody believes that epigenetic phenomena occur at the same pace everywhere in all tissues at the same time. Telomere shortening in fibroblasts does not predict telomere shortening in ovaries, or any other tissue. So wildly expansive claims should leave the reader incredulous that decoding this one phenomenon will end aging, cure all cancer (where telomere shortening may eventually pan out to a mechanism in one or another subtype of cancer), get rid of heart disease, cure wrinkles and fix your stiff knees..
4. Activating the immune system is a phrase that is a throw-away for naturopaths and quacks. Ask anyone with allergies or rheumatoid arthritis. An active immune system is not a good thing and depending on your definition, may well lead to a cancer, like say… lymphoma, a cancer of the immune system. Let’s face it, we all need a well-regulated immune system, but “activation” is meaningless in any scientific context.
5. Anyone who tries to market an innovative pharmaceutical product as a supplement is selling snake oil, plain and simple. The FDA evaluates specific therapeutic claims for specific pathological entities. They do not even evaluate absolute efficacy, drugs only need to demonstrate superiority over placebo. No such regulation exists for supplements, so many companies that do not have the ability to go through a rigorous review and demonstrate scientific merit will circumvent the process and come to market as a supplement. With the notable exception of nutritional deficiencies, there is usually no merit to claims that vitamins, supplements or minerals cure cancer, heart disease or any other disease, except maybe obesity and weight loss issues supplemented by means of ECA stack, etc. The idea that taking something as simple as a supplement may be appealing but has no basis in fact, since it is still an exogenous product, natural or otherwise. 
The principles of critical assessment are to assess date, author, quality of the publication and citations. Biological plausibility is important in assessing a scientific article, along with the link between the data and the claims made. This can be applied to journalistic information as well and when claims are expansive or vague, skepticism should take over. Any attempt to circumvent well-established processes to verify and certify scientific findings completely invalidates the speaker’s credibility in my mind. Being skeptical means you will believe only a small fraction of what you read, but this is not necessarily a bad thing. There is very little truth in much of what you come across on a daily basis, but there is plenty of hype and plenty of reasons for people to try and attract your attention.
Shelley’s work exposes me to a wide variety of information, which I find useful. The article itself was well-balanced and prudently presented, but the company and the spokesman were presenting snake oil under the guise of science.