On January 18, 2018, Dr. Melinda Wharton, Acting Director of the National Vaccine Program Office in the Department of Health and Human Services, sent Mr. Del Bigtree, an anti-vaccine activist, and producer of the anti-vaccine film Vaxxed, a response to questions he raised about vaccine safety.
The response is a very informative description of the substantial efforts regarding vaccine safety, and can and should reassure parents that there is abundant data – and many monitoring mechanisms in place – to examine and address vaccine safety, and that the expert consensus that vaccines are very safe is well-grounded.
This post will shortly describe the background to the letter from Dr. Wharton, then provide some of the highlights. I do, however, encourage people to read the full letter, available here (pdf), for themselves, to understand many vaccine safety issues.
- 1 Letter from Del Bigtree
- 2 HHS response to Del Bigtree
- 3 Update 2019 April 28
- 4 Notes
Letter from Del Bigtree
On October 12, 2017, Mr. Del Bigtree, an anti-vaccine activist and not a scientist, sent a letter on letterhead belonging to an organization calling itself ICAN to the Department of Health and Human Services [pdf]. The letter asked questions about vaccine safety, raising a number of talking points that those who engage regularly with anti-vaccine activists would recognize. The letter drew on 42 U.S.C. § 300aa-31(b), the citizen lawsuit provision of the National Childhood Vaccine Injury Compensation Act of 1986. In the relevant part, it says that:
…any person may commence in a district court of the United States a civil action on such person’s own behalf against the Secretary where there is alleged a failure of the Secretary to perform any act or duty under this part.
(b) Notice: No action may be commenced under subsection (a) before the date which is 60 days after the person bringing the action has given written notice of intent to commence such action to the Secretary.
Basically, Mr. Bigtree was asking his questions with a threat of litigation attached, as a prelude to a potential lawsuit. To my knowledge, such a lawsuit has not yet been filed. The Department’s thorough, detailed answer would make the chances of such a lawsuit – even if it passed the standing barrier – slim.
HHS response to Del Bigtree
On January 18, 2018, as mentioned, the Department of Health and Human Services responded. The reason we know of it is that a lawyer named T. Matthew Phillips – a lawyer litigating one of the less strong lawsuits against California’s SB277, the bill that removed the personal belief exemption to school immunization requirements – shared the letter (Mr. Bigtree did not).
Dr. Melinda Wharton, again, wrote the actual response to Mr. Bigtree. Her answers were detailed and helpful. Again, I will just touch on the highlight, and rearrange the order. Note that I am basically summarizing her points: this reflects her letter.
1. There are systems to monitor vaccine safety and many studies
Among the points Dr. Wharton highlighted were:
- A 2014 report reviewed all the risks of vaccines on the recommended schedule and concluded that the rare risk of serious adverse events must be weighed against the benefits of vaccines. This report is the latest word, updates previous Institute of Medicine (Now the National Academy of Medicine) reports, and provides a thorough review of vaccine risks (pdf).
- The CDC continues to study vaccine safety, and a list of their publications can be found here.
- The Department of Health and Human Services has a number of projects looking at precision vaccinology – tailored to the individual – and adversomics, the study of vaccine adverse reactions. Dr. Wharton added two examples, one of which is the Human Immunology Project Consortium. She mentioned that there are others – she may be thinking about the Clinical Immunization Safety Assessment (CISA) Project which looks, among other things, at vaccine adverse events.
- Hepatitis B vaccines were approved based not only on data summarized in the inserts, but on pediatric data from all around the world, and later studies confirmed the safety of these vaccines for infants.
2. Vaccines Don’t Cause Autism:
Dr. Wharton reminded Mr. Bigtree that many studies looked at the question of whether vaccines cause autism spectrum disorder (ASD), and found no link. In her words: “While there is still a lot to learn about ASD, research from public and private organizations indicate that environmental and genetic factors may increase the risk of autism, not vaccines or vaccine ingredients.”
Therefore, HHS will not accept his demand that they remove the claim that vaccines do not cause autism from the CDC website. After all, it’s what the evidence shows.
3. Research suggestions from Del Bigtree
Many of the research suggestions made by Del Bigtree in his letter to HHS have already been done, are not needed, or are not ethical. Dr. Wharton responded to his suggestions.
- Many vaccines are tested in clinical trials that include a placebo. An inert placebo control like saline is not required because it’s possible to understand the safety profile of a vaccine without it, as long as the control is well known. Note that with or without placebo controls, serious adverse events are examined by the FDA to assess whether there is an association with the vaccine.
- Therefore, the claim that vaccines’ licensing is not well-founded because it’s not based on long-term clinical trials with controls receiving an inert placebo is based on a misunderstanding of which controls are proper controls.
In 2013 the Institute of Medicine – now the National Academy of Medicine – conducted a comprehensive review of the immunization schedule. It found no safety concerns related to it.
- The review also pointed out the ethical concerns about conducting a prospective study comparing vaccinated and unvaccinated children, because that would mean intentionally leaving children unvaccinated, at risk of illness and death – which is unethical. Therefore, Mr. Bigtree’s demand for a prospective study of that kind is based on a misunderstanding (or worse, lack of care) for the ethical problems in the demand.
- While this wasn’t mentioned in the letter, a retrospective study has its own issues. Basically, it is hard to do because unvaccinated people are a tiny minority which is not random – getting a group large enough for meaningful comparison will be hard, expensive, and it would still be probably tricky to control for the differences (for example, non-vaccinating parents may have different patterns of healthcare usage, affecting the completeness and validity of medical records). Note that one such study – the KIGGS study – ended with only 94 completely unvaccinated kids out of a random sample of over 17,000 (and the only statistically significant difference it found was that unvaccinated children had higher rates of preventable diseases).
- Dr. Wharton mentions that the CDC is leaving on the table the possibility of more studies if safety signals come up, prepared a plan for doing such studies, and in fact, is already doing some of these studies – again, safety is taken very seriously.
- HHS conducts research to discover if vaccines have longterm adverse events and funds external studies – for example, it participated in a retrospective study in seven countries that looked at the incidence of narcolepsy during 2003-2013, after there were concerns about an increased risk of narcolepsy from 2009 H1N1 vaccines.
4. Regulatory changes Del Bigtree desires are ill-founded, impractical or already exist
To be fair, one of two of these was simply a request for information – for example, Del Bigtree asked for details on how HHS assures healthcare providers record manufacturers and lots for each vaccine they administer, and Dr. Wharton explained that. Other questions were more proactive.
HHS is already working to improve the Vaccine Adverse Events Reporting System (VAERS).
- HHS already has a process in place to identify conflicts of interest in members of advisory committees and avoid them, though there is a waiver process if certain criteria are met.
- There are no current rules that allow HHS to restrict the future employment of federal employees. There are limits on appearing or communicating with the government on matters they handled during their careers. I would add that maybe it’s advisable to add some chilling requirements, but that’s not specific to this issue. There are limits on participating in areas in which a federal employee or a member of an advisory committee, or their close family members, have a financial interest.
- Committee membership in federal committees is set in a variety of legal sources and reflects a need for expertise and a broad perspective. My reading of her more detailed answer is that Mr. Bigtree’s demand that “vaccine safety advocates” behalf of these committees was answered twice. First, the existing process already assures that those qualified and committed to improving vaccine safety be more than half of the committees. Second, if the term refers to members of the anti-vaccine organization, that’s not likely to happen. Reminder: many people care about vaccine safety. Parents who vaccinate certainly do, as do doctors. The people who overstate vaccines risks and describe vaccines as “child sacrifice”, as Mr. Bigtree did in the past, are not vaccine safety advocates. They are anti-vaccine.
- The demand that HHS allocates to vaccine safety 50% of its budget was also rejected, given the strong monitoring system already in place.
- The demand that HHS support creating a vaccine safety department outside it is rejected because there is already a division of labor and various actors monitoring vaccine safety. HHS helps coordinate collaboration among many organizations within and without it to monitor safety.
- HHS does not see a reason to repeal the National Vaccine Injury Compensation Program because it works well to “ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines.” Congress is also unlikely to pass such a law – it just expanded the program in the 21st Century Cures Act.
In short, Mr. Bigtree’s concerns were answered, while the vaccine safety apparatus and data explained.
Update 2019 April 28
In an investigative article, journalist Jackie Kucinich found out what happened to the reports HHS did not provide.
At a March 2019 hearing of the Senate Committee on Health, Education, Labor and Pensions, Chairman Lamar Alexander (R-TN) said the reports were actually required within two years of the law’s implementation, not every two years. And, Alexander said, “the HELP Committee has two reports from the Department submitted to Congress dated May 4, 1988, and July 21, 1989.’
- This article was originally published in March 2018. It’s been updated with more recent news about some investigative reporting about the actual requirements of reporting of vaccine issues to Congress. Also, some light copyediting was performed to clean up dead links and a few grammar and spelling errors. Typical housecleaning.
- This article was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
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