Vaccines and autism: "Culture eats data for lunch"

A common saw in the business world is that “culture eats data for lunch every day”. The lesson is supposed to be that in trying to create organizational change, it is important not to assume that people do what they do simply because they are ignorant of the facts, and that these simply need to be presented to them and change will occur. This is also the case in many other areas, including public health, and it seems it is often easier to create change by presenting simple “facts” (even if they are wrong) that are easy to digest and concord with pre-existing belief systems than more complex or nuanced facts that are actually right.

Recently, in a Facebook “discussion”, I was informed of a couple of things by a friend-of-a-friend whom I do not know. One was that vaccines are bad because pharmaceutical manufacturers make lots of money on them, and they are evil. Indeed, I had acknowledged that I think that they are evil, and the “discussant” asked (rhetorically, I assume) how I could then trust them? I didn’t respond (who needs to waste time arguing with folks who will never be convinced) but it is a logical fallacy. Drug companies are evil, in that they systematically exploit every method they can to make money, and even more money, but this does not mean everything that they do or make is evil. They are happy to make lots of money selling drugs (or vaccines) that in fact work well; their evil is in hiding when they don’t work well, or have bad effects (think “Sackler” and oxycontin) and grossly overpricing them when they do. Vaccines do work, and incredibly well, some better even than others. There have been rather rare side effects (beyond local soreness or slight fever) associated with them, but the one getting the most play is their association with autism, especially measles (or measles/mumps/rubella, MMR) vaccine. They don’t cause autism as shown by many studies, some of which are cited below and all are available by searching PubMed (National Library of Medicine) or Google Scholar.

Or maybe not. The other thing that this discussant noted was that there are over 200 studies showing that it does cause autism, which was news to me. They didn’t provide the citations (it was, after all, just a Facebook post) but I presume they have them. The only other explanation I can think of is that it is a number that they heard of read somewhere and are repeating (something which most of us are, at least sometimes, guilty of). In any case, I haven’t been able to find them. I am not going to go into great detail here about the absence of a link between autism and measles vaccine, as there are already many good discussions available, two of which are a review of Vaccines and Autism by the Children’s Hospital of Philadelphia and Vaccines Don't Cause Autism. Why Do Some People Think They Do? From the Johns Hopkins Bloomberg School of Public Health. This article in StatNews also reviews the evidence. If you are interested in some of the studies done that showed no association between vaccine and autism, one big one was from Denmark that looked at over 650,000 children and was published in the Annals of Internal Medicine in 2019, Measles, Mumps, Rubella Vaccination and Autism: A Nationwide Cohort Study. There are dozens of others, which have looked at over 3 million children, and are easily found on searches on either NLM or Google.

If not 200, however, there are at least 2 studies, by the same author, Andrew Wakefield, that purport to show that measles vaccine causes autism. The first, published in the Lancet in 1998, Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, studied 12 children. It not only didn’t prove that the vaccine caused autism, but was so deeply flawed it could not have, and the Lancet retracted the paper (which you will see in a notification when you search it or follow the link above). Several of Wakefield’s co-authors removed their names from this paper. There was a second study published in 2002, using a different, but also flawed, methodology.

However, despite the vast preponderance of evidence, the Secretary of Health and Human Services, Robert F. Kennedy, Jr., is not convinced and is commissioning a new study of the link, to be done by David Geier, long associated with the movement to associate vaccines with autism, (who was not a doctor but practicing under the license of his father -- who had HIS revoked for experimenting on autistic children). I wonder what it will find?

In 2025, so far in the US, there have been almost 900 cases of measles, with 3 deaths, the most of both in many decades. Given that the mortality rate for measles is about 1/1000, it suggests an under-reporting of cases. 97% of those affected were unimmunized. This means that parents who choose to not immunize their children are risking disease and death from measles. And doing so for a “benefit” (not getting autism) that is unrelated. This is sad, but people believe what they believe for a variety of reasons, and act on those beliefs. There is also no shortage of papers studying and reporting on why this is so, e.g. Why Parents Say No to Having Their Children Vaccinated against Measles: A Systematic Review of the Social Determinants of Parental Perceptions on MMR Vaccine Hesitancy.

Historically, and today, the prevalence of measles is higher in communities of lower socioeconomic status, for a variety of reasons discussed, for example, in Measles Outbreak in Socioeconomically Diverse Sections: A Review. Of course, many diseases are more common in communities of lower socioeconomic status, for the same reasons, prominently including lack of access to health care. What is concerning about the current measles outbreak is that it is so closely tracking, in the main outbreak in West Texas and adjacent New Mexico, low levels of immunization that result from belief that vaccines are bad, not because they are inaccessible.

Taking things on faith and not on evidence is a cornerstone of most religions, but belief in things like vaccines causing autism, and other evidence-free ideas, should not be on the same order as religious beliefs. However, it may be that being used to accepting some of the most important things on faith conditions one to being willing to accept others. Also, while the autism/vaccine question is pretty specific, it is easy to accept simplistic guidelines to guide a person as to what is “good” or “bad”, without the (unfortunately ubiquitous) subtleties. One example is “natural”; things that are “natural” are good, and things that are manufactured or modified are not. So, vaccines, being manufactured, could be bad. Of course, this idea is pretty dangerous; lots of natural things are poisons, and many beneficial natural things (like plants that help with certain conditions) are actually not as good as the standardized and purified forms made by those evil pharmaceutical companies. Aspirin is derived from willow back. But how much willow bark is good for my arthritic pain? In what season? What microclimate? How much will be too much and cause stomach ulcers? If something seems too good to be true it usually is; similarly using a single touchstone (e.g. “is it natural”) it is too simple and often wrong.

I used to be very concerned with people ignoring science and good research and believing, well, what they wanted to believe, for whatever reason. Now I am even more concerned about the seeming pride that they take in not believing science, as if that were a good thing, that in not believing what the evidence shows they are asserting their loyalty to a cause and victory over an enemy.

This is the much more important thing to believe in: US mortality is high, and strongly linked to wealth! Let us work on addressing that.

 

 

 

“It’s always worse than you think … even if what you were thinking is pretty bad”

On the heels of the Epi-Pen® scandal (well, at least I think it is scandalous, Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?, September 3, 2016) in which Mylan Pharmaceuticals and its CEO Heather Bresch raised the price of this life-saving medication 500% (and her salary by about the same degree), that itself followed last year’s Daraprim® scandal where Turing Pharmaceuticals and its CEO Martin Shkreli raised the price of this anti-parasitic drug over 5000% (Drug prices and corporate greed: there may be limits to our gullibility, September 27, 2015), we have some good news. Sort of. Brent Saunders, CEO of Valeant Pharmaceuticals, also identified last year for hefty price increases in two life-saving heart drugs,has now announced it will keep its price increases under 10%. Of course, it will raise the price 9.9%, which is certainly less than 10%, and even less than 9.99%, which they could have done and still been below 10%. There is speculation that this may have been in response to proposed federal legislation that would have increased the scrutiny on drug price increases of 10% or more, but of course we cannot know for sure.

The predatory greed of drug companies is becoming legendary, threatening to eclipse that of insurance companies as the leading bad guys in keeping Americans from being able to afford the medical care that they need. After all, insurance companies have increased every form of payment (premiums, co-insurance, co-payments and deductibles) that people, the insured, need to pay out of their own pockets in an effort to decrease the probability that they will be bankrupted when they need medical care. This is sometimes justified by the risks that they take; particularly by the “adverse selection” that occurs because it is the sick, rather than healthy, people who were most likely to sign up for insurance under the ACA’s insurance exchanges. The “individual mandate” of ACA was supposed to prevent this, but the penalties people have to pay are far less than the cost of buying insurance for many (if they are unsubsidized), and maybe they won’t even be caught. Or get sick.

Of course, the degree to which insurance companies are actually losing money rather than simply making less profit than they would like is uncertain, but it is clear that, at least in some markets, it is close. The transfer of many patient-borne costs from premiums to co-insurance, co-payments, and deductibles is designed to keep premiums from going even higher, but of course impacts the sick more. In (at least slight) contrast, the price increases of pharmaceuticals can only be justified by an ethos of “charge what the market will bear”, and make as much as possible before regulators come down on them. In a really ‘cool’ effort reported by the New York Times on September 16, 2016, Mylan is trying to get the federal government to add Epi-Pen to its list of life-saving preventive medications. This would mean direct users would not have to pay so much, but Mylan would continue receive its outrageous price – supported by all of us, as federal taxpayers. Now, there’s a really terrible solution! (Good solution: lower the price. A lot.)

And they have been doing it for a long time. Pharmaceutical companies bought dinners, bought presents, and bought trips for doctors who prescribed their drugs. There has been some clamping down on the most egregious excesses in recent years, but they have not been eliminated. Especially concerning are the revelations (no news to physicians) of the aggressive promotion of opiod pain relievers to doctors, and their contribution to the incredible epidemic of prescription opioid addiction in the US today (48,000 women died of prescription drug overdose between 1999 and 2010, a period during which prescription drug addiction increased over 400% among women and 237% among men, according to the American Society for Addiction Medicine. The Centers for Disease Control and Prevention (CDC) reported:

We now know that overdoses from prescription opioid pain relievers are a driving factor in the 15-year increase in opioid overdose deaths. Since 1999, the amount of prescription opioids sold in the U.S. nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have also quadrupled since 1999.

The entire campaign to “eliminate pain” was largely supported by opioid manufacturers, such as Purdue and Abbott through their creative marketing to physicians. The most “funny”, reported by STAT, was the use by a drug rep of creatively-arranged donuts to catch the attention of an orthopedist who would not otherwise meet with him, by appealing to his sweet tooth. It is not, of course, really funny, and it is almost worse that physicians could (and maybe still can) be bought not by trips to the Bahamas but by a box of donuts!

Speaking of donuts, we have the even more incredible exposé in the Times that for decades, beginning in the 1950s, the sugar industry worked assiduously to fund and support researchers whose work blamed dietary fat, rather than refined carbohydrates (sugar) for the prevalence of heart disease, (“How the sugar industry shifted blame to fat”, September 12, 2016). This was not a one or two time payoff to a couple of researchers, but a continued campaign over more than a generation to have the scientific community, and thus the rest of us, minimize the impact of sugar on heart disease. This work forestalled the more recent campaigns to limit sugar-containing foods, especially soft drinks, and was a major contributor to an epidemic even greater than opioid addiction, obesity and its related health effects. Sugar is not a prescription drug, but it probably has had more negative health consequences than all prescription drugs together.

So who can we trust? I have often argued for the scientific community, but such reports of corruption of scientific research are sobering; at least, we can say that today there are increased safeguards in place. Clearly we cannot trust politicians; while they will respond to the crises in the news (like drug price increases and such) they are dependent on contributions from large corporations, and those large corporations are pursuing their financial interests. Whether directly involved in our medical care, like insurance companies and drug companies and hospital chains, or dramatically affecting our health like the high-calories food industry (including sugar), or polluting and destroying our environment like many energy companies, our interests (at least as far as our health is concerned) are not their interests, and there is often (or usually) little overlap between the two. As a physician colleague put it, “It’s always worse than you think … even if what you were thinking is pretty bad.”

Pursuit of financial gain by such companies is not in the interest of our public, or private individual, health. The most vulnerable of us – the poorest, sickest, youngest and oldest and least empowered – suffer first and most, but all of us suffer. Drug prices should be regulated tightly, and competition (including pricing as in other countries or import of drugs) should be encouraged; insurance should be single-payer, and the impact on the public’s health the main criterion in deciding on environmental pollution.

Profit should have no place in determining our health or health care.