Tag Archives: thimerosal

President Trump’s Advocacy of the Debunked Link Between Vaccines and Autism

On March 28, 2014, more than a year before Donald Trump announced his candidacy for the Presidency of the United States, he tweeted: “Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!”

Although Trump’s anti-vaccine sentiment has not been a secret, he nonetheless took the medical community by surprise when, on January 10, 2017, just days before he was sworn in as the 45th President of the United States, he met with anti-vaccine activist, Robert Kennedy Jr., at Trump Tower in Manhattan, where, per Kennedy, Trump asked him to head a new government commission on vaccine safety (1).

Kennedy claimed that representatives of Trump’s transition team approached him before the meeting to ask whether he would be interested in participating in a vaccine inquiry. Moreover, he stated that Trump’s chief strategist, Stephen K. Bannon; Trump’s counselor, Kellyanne Conway; and then Vice President-elect Mike Pence also attended the meeting. A few hours later, a spokesperson for Trump confirmed that Trump was “exploring the possibility of forming a committee on autism,” but added that no final decisions had been made (1).

The “possibility” that Trump might form a committee on vaccines and autism (irrespective of who heads it) raises fears in the medical community that, by doing so, Trump would give a sense of legitimacy to the discredited anti-vaccine point of view, which, in turn, would give many parents misinformation regarding the crucial need to get their children vaccinated. Vaccines are safe and effective. What’s more, they have prevented more human (especially childhood) suffering and death than any other measure in history! If Kennedy’s panel (or any other action by Trump, which reflected his “alternative” view of vaccines) led to even a small decrease in vaccination rates, the result would be the otherwise preventable deaths of children, including infants too young to be vaccinated (2), as well as the elderly.

The idea that vaccines might cause autism first gained widespread attention in 1998 after the British medical journal, The Lancet, published a study involving only 12 children, by former British surgeon, Andrew Wakefield, which claimed to find a link between the measles vaccine and autism. However, an investigation by the British Medical Council later found that data in The Lancet paper was fraudulent. Moreover, Wakefield’s study received financial support from lawyers representing parents of autistic children; a conflict of interest that Wakefield did not disclose. The British Medical Journal took the extraordinary step of publishing a report in which it concluded that Wakefield’s study was not simply bad science, but a deliberate and elaborate fraud. The Lancet paper was retracted and Wakefield was stripped of his medical license. A subsequent large scale study by the U.S. Institute of Medicine, involving more than a half million children, found no evidence whatsoever of any connection between vaccines and autism (2).

Some individuals, including Kennedy, believe that thimerosal (a mercury compound once added to some vaccines as a preservative) is the link between vaccines and autism. However, thimerosal was added only to killed vaccines (e.g., the vaccines against diphtheria, whooping cough, and tetanus), whereas the MMR vaccine—the original source of the vaccine controversy—is a live vaccine. What’s more, all vaccinations in the United States have been thimerosal-free since 2001, while new cases of childhood autism have not abated since then. Furthermore, extensive studies by the US Centers for Disease Control (CDC), and by the US Institute of Medicine, could not find any connection between thimerosal and autism (2). At first, Kennedy completely ignored these studies, but later asserted that these government agencies were participating in a major cover-up (3).

Considering: 1) the overwhelming scientific evidence against the anti-vaccine point of view, 2) the extensive expert advice available to Trump from physicians and biomedical scientists both within and outside the government and, 3) the unceasing federal oversight of vaccine safety (by the both the CDC and the FDA), why would Trump reopen this issue at all, especially via a panel headed by a layperson, when doing so under any conditions will undermine public health? Is it to distract the public’s attention from more politically troubling issues, or is it merely a play to his base, or does Trump actually believe what he says?

Ben Carson, a physician and former presidential aspirant, and now Trump’s pick to head the Department of Housing and Urban Development, framed the vaccine issue as a matter of government infringement on the peoples’ liberties; a point of view that resonates with the political right (see Aside 1.), as does Trump’s bizarre view, as tweeted in 2012, that: “The concept of global warming was created by and for the Chinese in order to make U.S. manufacturing noncompetitive.”

[Aside 1: Carson, a physician by background, ignores the crucial concept of herd immunity. People who cannot get vaccinated (e.g., young infants, pregnant women, children suffering from leukemia or other immune deficiencies) are yet protected from measles by herd immunity; that is, the immunity in the entire population that results when a high enough percentage of individuals has been vaccinated. When that level of compliance is attained, there are not enough susceptible individuals in the population to sustain the chain of transmission. Thus, vulnerable individuals, who cannot be vaccinated, pay the price for vaccine noncompliance by those who opt out.]

What might Trump’s position on vaccines portend for those biomedical scientists and physicians who would publicly oppose his anti-vaccine sentiments? For a hint, this past December Trump’s transition team asked the DOE for a list of its employees who worked on climate change, or who had attended climate change meetings, thereby raising the specter of repercussions against those who do not adhere to Trump’s stance on the climate change issue. Would the prospect of such repercussions undermine the willingness of physicians and scientists to speak out against Trump’s stance on vaccines?

This past week, Tom Price, Trump’s pick to head the US Department of Health and Human Services (HHS), rejected the claim that vaccines are linked to autism. He did so during his confirmation hearing before the Senate Finance Committee, thus offering some hope that the Trump White House might not pursue its debunked stance on vaccines. Nonetheless, bearing in mind Trump’s unpredictability, and his alternative view of reality regarding other issues, scientific and otherwise, scientists must remain vigilant, and be willing to speak out against policy decisions based on ideological political agendas or “alternative” views of reality, rather than sound scientific evidence.

“Scientists, medics and commentators who have fought vaccine disinformation in the past must take a deep breath and return to the fray. There is no need to wait for this commission to be announced officially. There is no need to wait until it issues its findings. There is no cause to be surprised if it shows little regard for science — or even if it targets scientists who speak out in favor of vaccination… Lives are at stake (4).”

References:

  1. Shear MD, Haberman M, and Belluck P, Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety. NY Times January 11, 2017.
  2.  Andrew Wakefield and the Measles Vaccine Controversy, Posted on the blog February 9, 2015.
  3. Mnookin S, How Robert F. Kennedy, Jr. Distorted Vaccine Science, Scientific American, STAT on January 11, 2017, https://www.scientificamerican.com/.../how-robert-f-kennedy-jr-distorted-vaccine-scie…
  4. 4. Trump’s vaccine-commission idea is biased and dangerous.  Nature 541:259, 2017. doi:10.1038/541259a

Addendum: The following is from the January 11, 2017 NY Times report (1).

Both Mr. Trump and Mr. Kennedy have described themselves as “pro-vaccine.” But they have repeatedly expressed concerns about what they claim is a link between vaccines and the development of autism. At a Republican presidential debate in September 2015, Mr. Trump described knowing people personally who had seen a cause and effect.

“Autism has become an epidemic,” Mr. Trump said in the debate. “Twenty-five years ago, 35 years ago, you look at the statistics, not even close. It has gotten totally out of control.”

“I am totally in favor of vaccines,” he added. “But I want smaller doses over a longer period of time. Same exact amount, but you take this little beautiful baby, and you pump — I mean, it looks just like it’s meant for a horse, not for a child, and we’ve had so many instances, people that work for me.”

Mr. Trump has also repeatedly used Twitter to spread his concerns about the safety of vaccines. In particular, he has often raised doubts about giving children vaccines in a single large dose rather than several smaller ones… Mr. Kennedy said Mr. Trump “believes in those anecdotal stories” about the dangers of vaccines. He said the president-elect “says if you have enough anecdotal stories saying the exact same thing, that you can’t dismiss the validity.”

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Andrew Wakefield and the Measles Vaccine Controversy

Controversy over the measles vaccine, and the spate of vaccine noncompliance that underlies the current measles outbreak in the United States, stem mostly from a totally debunked 1998 study by former British surgeon, Andrew Wakefield. In Wakefield’s now infamous report, he and co-authors claimed to find a link between the measles vaccine and autism. Here are some essential facts concerning measles, the measles vaccine, and Wakefield’s paper.

We begin with the crucial concept of herd immunity. People who cannot get vaccinated (e.g., young infants, pregnant women, children suffering from leukemia or other immune deficiencies) are nonetheless protected from measles by herd immunity; the immunity in the whole population that results when a high enough percentage of individuals in the population has been vaccinated. When herd immunity is attained, there are not enough susceptible individuals in the population to sustain the chain of transmission.

But, if enough parents opt out of having their children vaccinated, then herd immunity is lost, and outbreaks might then occur, as is happening now. Herd immunity against measles requires vaccination rates as high as 95 percent. That is so because measles is one of the most contagious of all viruses. Yet, all too many parents are now opting out of vaccinating their children; in many cases for fear that the measles vaccine might cause autism.

The measles incubation period is another important issue. The elapsed time, between initial infection and onset of illness, averages 10–12 days (rash may not appear until 18 days). Moreover, infected individuals can transmit the virus for several days before becoming ill. These points, together with the exceptionally high rate of measles transmission, mean that keeping sick children home from school or play group, is not an effective means for containing spread of the disease.

Next, consider the severity of measles, which all too many people, including some medical professionals, do not appreciate. [I heard one medical doctor on TV say measles is like the common cold.] Before the introduction of the first measles vaccine in 1963, and the WHO-sponsored global eradication program, death rates from measles ran as high as 7 to 8 million children, worldwide, annually. And, despite the current availability of effective measles vaccines, there still are more than 30 million measles cases per year worldwide, of which more than 1 million are fatal. As you might expect, the vast majority of fatal measles cases occur in unvaccinated populations in the developing world. In fact, in some unprotected groups, measles is the major cause of death in children less than five-years-old. [Reliable information on all aspects of measles can be found on line at “Measles – Centers for Disease Control and Prevention,” http://www.cdc.gov/…/meas.]

The above data unmistakably support the case for vaccination against measles. Ever since the first measles vaccine was introduced in 1963, the incidence of measles has been dramatically reduced in all regions of the world where vaccination programs were put in place. In the United States, the number of measles cases declined from about 500,000 per year before 1963, to no endemic cases whatsoever in 2000!

But, since measles persisted elsewhere in the world, and, since the measles virus is so highly contagious, it returned to the United States in the years between 1989 and 1991, when vaccination rates fell below the critical level needed to maintain herd immunity. In that earlier 1989 outbreak, poor compliance with vaccine programs was, ironically, due to the success of the vaccine program. Because measles was no longer existent in the United States, it was not in the public’s consciousness, resulting in public complacency towards vaccination.

At present, segments of the public are opting out of vaccinating their children largely because of Wakefield’s discredited 1998 paper in The Lancet, which asserted that the trivalent measles, mumps, and rubella (MMR) vaccine might cause autism. Here is the story of how and why Wakefield’s 1998 paper fell into disrepute.

The validity of Wakefield’s 1998 findings first came under question in 2004 when an article in the Sunday Times of London reported that Wakefield had not disclosed a conflict of interest that might have compromised his objectivity. The newspaper revealed that Wakefield accepted £55,000 ($103,000) to support his study, from lawyers representing parents of autistic children. The purpose of the financial support was to validate the parents’ legal claims against the vaccine manufacturer. Astonishingly, some of the families in Wakefield’s study actually were selected by these lawyers. Next, in 2006, the Sunday Times reported that the lawyers had paid Wakefield personally more than £400,000, none of which was ever reported.

The Sunday Times report that exposed Andrew Wakefield
The Sunday Times report that exposed Andrew Wakefield

Irrespective of Wakefield’s conflict of interest, the 1998 study was exceptionally weak on several counts. First, its conclusions were based on a sample size of only twelve children. What’s more (and virtually unbelievably), the association between the vaccine and autism was concluded merely from interviewing the children’s parents; people who were not likely to be the most objective of observers, since at least some were looking for someone or something to blame for their children’s condition.

The credibility of Wakefield’s already weak paper took a major hit when it was revealed in 2009 that he had manipulated patients’ data. Wakefield’s paper claimed that the families of eight of the twelve children attributed their children’s autism to the MMR vaccine and that the children’s problems emerged within days after their vaccinations. The Wakefield paper also reported the discovery of a new inflammatory bowel disease it associated with the vaccine, and it proposed that the new disease also might be connected to autism. However, an investigation by the British Medical Council (BMC) found that in most cases the data in The Lancet was not in accord with the children’s medical records. In only one case was there any suggestion that there was any problem within days of the vaccination. In fact, in many of the cases, the parents expressed concerns about autism before their children’s’ vaccinations. And, a November 2011 paper in the British Medical Journal reported that an investigation of Wakefield’s raw data revealed that none of the twelve children in his study had signs of inflammatory bowel disease.

The BMC’s investigating panel ruled that Wakefield had “failed in his duties as a responsible consultant”, acted both against the interests of his patients, and “dishonestly and irresponsibly” in his published research. What’s more, the British Medical Journal took the extraordinary step of publishing a report in which it concluded that Wakefield’s study was not simply bad science, but a deliberate and elaborate fraud. Shortly afterwards, Wakefield was removed from the United Kingdom’s Medical Register and barred from practicing medicine in the UK.

In a large scale study, involving more than a half million children, the U.S. Institute of Medicine (IOM), a respected independent arbiter, found no evidence whatsoever of any connection between vaccines and autism. Other large and well designed studies likewise found no such connection.

In 2010, The Lancet responded to the above revelations by retracting Wakefield’s 1998 paper. Moreover, ten of Wakefield’s twelve co-authors issued a retraction, which included the following: “We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper…”

The Lancet retracts Wakefield’s paper
The Lancet retracts Wakefield’s paper

Despite these developments, Wakefield has stood by his claims, and many still regard him as a hero. What’s more, Wakefield’s claims continue to influence many parents, and they are a major reason for the sharp decline in vaccination rates in the United Kingdom and in the United States.

Why might The Lancet have published Wakefield’s 1998 paper in the first place? As explained by Richard Horton, Editor-in-Chief of The Lancet, the journal was interested in the new gastrointestinal disorder described in the paper, rather than in the parents’ testimony regarding a possible link between the MMR vaccine and autism. Horton states: “The central thrust of the paper was this new syndrome. This is not an uncommon kind of report. If you read any text book of epidemiology, the very first description of any new syndrome often comes with either a case report or a case series.” [Note the rather inconspicuous title of Wakefield’s highly flawed but influential paper: “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”]

Horton also noted that the journal was well aware that the Wakefield paper might have an adverse public health impact, which it sought to avoid by including in the paper the disclaimer that there was no proof of causation or association between the MMR vaccine and autism, and also by identifying the paper as an “early” report. But the media and the public could hardly be expected to disregard the sensational story behind the disclaimers.

We conclude with a few related items.

Doubts about Wakefield’s scientific credibility might have been raised before he ever turned his attention to the measles vaccine and autism. In 1993 he published reports concluding that the measles virus might cause Crohn’s disease, and two years after that he published a paper (in The Lancet) suggesting a link between the measles vaccine and Crohn’s disease. Neither of these claims could be verified by a number of subsequent peer-reviewed studies.

Some individuals believe that thimerosal (a mercury compound once added to some vaccines as a preservative) is the link between vaccines and autism. Regarding the possibility that thimerosal in the MMR vaccine might be responsible for autism, the MMR vaccine is a live vaccine, and thimerosol was added only to killed vaccines (e.g., the vaccines against diphtheria, whooping cough, and tetanus). What’s more, all routine vaccinations in the United States have been thimerosol-free since 2001.

One might presume that the way to convince vaccine skeptics of the safety of vaccines, and of their importance for the good of all, is for public health experts and medical practitioners to confront the deniers with the data and the facts. Yet the result of those efforts is usually quite the opposite of what is intended. When confronted with the facts, the deniers dig their heels in even deeper to hold on to their anti-vaccine position. And, we scientists don’t reassure the public by always qualifying our pronouncements with statements such as “to the best of our knowledge” or “as far as we know.” [I am by no means suggesting that we ought to abandon our inclination to not speak in absolutes.]

The state of affairs was not helped when some 2016 presidential aspirants (one of whom is a medical doctor) not only equivocated over the pubic health aspects of the vaccine controversy, but also framed it as an issue of government infringement on the peoples’ liberties. As expected, the latter position has more political potency among conservative voters. However, the debate does not break cleanly between liberals and conservatives, or along income or education demographics. In fact, the movement to forgo vaccinations has become popular in some more liberal and affluent communities; the organic grocery demographic. [Somehow it is better to expose a child to a dangerous disease, so that the child might have “natural” immunity to the disease, rather than have the child receive a safe vaccine that prevents the dangerous disease in the first place.] Even veterinarians are running up against the anti-vaccine movement, as more and more pet owners are foregoing vaccines against distemper and other pet ailments.

Because government enforcement of vaccine regimens might be viewed by many as an intrusion on individual liberty, all but two states (Mississippi and West Virginia) allow exemptions based on religious beliefs. In addition, nineteen states allow exemptions based on personal (whatever that may mean) beliefs. All states do allow medical exemptions, since some children (e.g. those receiving chemotherapy or who have certain immune disorders) cannot receive vaccines. Nevertheless, despite the fact that states in which it is easier to obtain non-medical exemptions have higher rates of vaccine-preventable disease, moves are afoot in several states (including Mississippi and West Virginia) to make it easier still to obtain personal belief exemptions.

Reference: Wakefield, A. J., S. H. Murch, A. Anthony, J. Linnell, D. M. Casson, M. Malik, M. Berelowitz, A. P. Dhillon, M. A. Thomson, P. Harvey, A. Valentine, S. E. Davies, and J. A. Walker-Smith. 1998. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. The Lancet 351:637–641.