And here we go again with more anti-vaccine nonsense from Del Bigtree‘s Informed Consent Action Network (ICAN) – this time it’s about Merck’s VARIVAX chickenpox vaccine. And, of course, there’s nothing that they present that is accurate or worrisome.
VARIVAX is a well-studied vaccine that is both demonstrably safe and demonstrably effective. However, Bigtree and ICAN always think they have some amazing catch that shows that vaccines are bad. And they are never right, so that’s why we have to spend time taking it down.
Let’s see what they have to say, but first a little bit about chickenpox.
Chickenpox and VARIVAX
Despite the claims of the anti-vaccine crowd, chickenpox is a serious disease with some dangerous complications.
Chickenpox is an infection caused by the Varicella zoster virus (VZV). Although most cases are in children under age 15, it can attack older children and adults can get it. The virus spreads easily from person-to-person.
The classic symptom of chickenpox is an uncomfortable, itchy rash. The rash turns into fluid-filled blisters and eventually into scabs. It usually shows up on the face, chest, and back and then spreads to the rest of the body.
Other symptoms include:
- Loss of appetite
The disease usually lasts from 5-10 days.
Before the launch of the vaccine, according to the CDC, “an average of 4 million people got chickenpox, 10,500 to 13,000 were hospitalized, and 100 to 150 died each year.” And untold numbers who eventually developed shingles decades later.
VARIVAX was first licensed in Japan and the USA in 1995. In the USA, the CDC recommends the first dose at age 12 through 15 months and the second dose at age 4 through 6 years.
What Del Bigtree say about VARIVAX
Bigtree and ICAN used their well-worn and laughably overstated Freedom of Information Act (FOIA) requests that are never “gotchas” against vaccines. This time, of course, they want you to believe that the FDA was “hiding” information about the VARIVAX chickenpox vaccine based on some ridiculous claims.
Because I don’t want to let ICAN get clicks from real science people, here are screenshots of their press release:
Before I head down the path of debunking some of the junk science presented in these ridiculous claims, let me remind the reader of one important point – there are 18 peer-reviewed studies that were eventually published to support the New Drug Application are included in the VARIVAX package insert. In other words, this comical lawsuit wasted the time of the FDA while enriching ICAN’s attorneys.
Seriously, you and I could have looked up those 18 peer-reviewed articles, gotten pdf versions, and sent them to Del Bigtree after about 47 minutes of work. Just remember that when you think Bigtree has done anything amazing, he hasn’t.
But, here we go with the “placebo control” trope that ICAN and many anti-vaxxers use. Before I get into the clinical research of VARIVAX, let me be clear about something – placebo-controlled trials are unethical if there is an antecedent vaccine. Of course, in the early 1990s, there was no previous chickenpox vaccine, so this point is not germane, though I just wanted to make it clear for the casual reader.
That being said, there are 234 clinical trials with the VARIVAX vaccine (as of 30 September 2020). I’m going to bet that Del Bigtree has NOT reviewed all 234 clinical trials. Moreover, Bigtree does not understand that every drug on the market is constantly monitored by post-marketing studies that provide the FDA and scientists with constant data about the safety and effectiveness of any drug, including vaccines.
But let’s get back to some of Bigtree’s wild claims about the studies that were included in the clinical trial data. There are four clinical trials that were most pivotal:
- BJ Kuter et al. and RE Weibel et al. examined 956 individuals 1 to 14 years of age (n=491 vaccine, n=465 placebo) for up to two years. They found no serious adverse events related to the vaccine, and only observed fevers, a typical immune response to vaccines. Bigtree tries to claim that they were related to the vaccine, but they are non-specific events that may be observed in the general population. Furthermore, the numbers are so low, there is no statistical difference between the control and vaccinated group. Finally, Bigtree’s claim that this is an “underpowered” study is not fact-based. What Bigtree ignores is that this study is part of a larger clinical trial – we will get to that.
- ICAN tries to claim that the placebo was illegitimate. Just to be clear, a placebo is described as:
Placebos are inactive substances or interventions, most often used in controlled studies for comparison with potentially active drugs.
It does not mean that the placebo has to be saline, it can also include other inert substances to make sure the saline is safe (for example, it needs to have products to make sure it doesn’t become contaminated). A placebo is just something that is not expected to cause the effect expected from the real vaccine.
Bigtree is trying to make a big deal that there are limited placebo-controlled studies that support the use of Varivax. But that’s not as important as he claims, because there is more than just one placebo-controlled study, AND the one he references is a powerful study. Bigtree is trying to find a placebo bogeyman but there isn’t one.
Here’s the thing – the actual underlying article from Kuter et al., which followed the patients for two years, did not support any of the claims from Bigtree. Not a single one, period, full stop.
If we avoid cherry-picking 25-year-old clinical trials that were used in the original New Drug Application, we will find more robust data that show that the vaccine is very safe and very effective:
- A 10-year follow-up study of the VARIVAX clinical research group found nothing.
- Researchers examined 6,574 VAERS case reports for VARIVAX, and they found mostly minor issues, many of which are common to all vaccines like higher temperatures. The researchers could not find any vaccine etiology for the more serious adverse events – they did not appear to be related to the vaccine.
- As I have said many times, the pinnacle, the meta-reviews (or systematic reviews) are the absolute platinum standard of clinical research. In an issue of Pediatrics, a meta-review found that serious vaccine-related complications are extremely rare. In a huge study of >1.8 million vaccine recipients, purpura was observed at a rate of around 1-2 per 100,000, an extremely rare adverse event. Otherwise, there is no evidence that there are other serious adverse events related to VARIVAX.
And once again, ICAN/Del Bigtree think they’ve won something. But they haven’t.
- No FOIA lawsuit was required to get this information. It was publicly available in a boatload of easily-accessible public documents PLUS in an easy-to-read section of the package insert.
- And Bigtree’s interpretation of one of the main studies that supported the New Drug Application for VARIVAX was misinterpreted and misused by him.
- Finally, there are massive amounts of post-marketing studies that support the safety profile of VARIVAX.
ICAN and Del Bigtree have told us nothing, absolutely nothing, about the safety and effectiveness of the chickenpox vaccine. But I’ve told you of several clinical trials that show that the vaccine is safe and effective.
So, I guess it’s the choice between the babbling of a non-scientist making false claims from a nonsensical lawsuit or the evidence-based writings of an ancient feathered dinosaur.
- Di Pietrantonj C, Rivetti A, Marchione P, Debalini MG, Demicheli V. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev. 2020 Apr 20;4(4):CD004407. doi: 10.1002/14651858.CD004407.pub4. PMID: 32309885; PMCID: PMC7169657.
- Kuter BJ, Weibel RE, Guess HA, Matthews H, Morton DH, Neff BJ, Provost PJ, Watson BA, Starr SE, Plotkin SA. Oka/Merck varicella vaccine in healthy children: final report of a 2-year efficacy study and 7-year follow-up studies. Vaccine. 1991 Sep;9(9):643-7. doi: 10.1016/0264-410x(91)90189-d. PMID: 1659052.
- Kuter B, Matthews H, Shinefield H, Black S, Dennehy P, Watson B, Reisinger K, Kim LL, Lupinacci L, Hartzel J, Chan I; Study Group for Varivax. Ten year follow-up of healthy children who received one or two injections of varicella vaccine. Pediatr Infect Dis J. 2004 Feb;23(2):132-7. doi: 10.1097/01.inf.0000109287.97518.67. PMID: 14872179.
- Maglione MA, Das L, Raaen L, Smith A, Chari R, Newberry S, Shanman R, Perry T, Goetz MB, Gidengil C. Safety of vaccines used for routine immunization of U.S. children: a systematic review. Pediatrics. 2014 Aug;134(2):325-37. doi: 10.1542/peds.2014-1079. Epub 2014 Jul 1. PMID: 25086160.
- Weibel RE, Neff BJ, Kuter BJ, Guess HA, Rothenberger CA, Fitzgerald AJ, Connor KA, McLean AA, Hilleman MR, Buynak EB, et al. Live attenuated varicella virus vaccine. Efficacy trial in healthy children. N Engl J Med. 1984 May 31;310(22):1409-15. doi: 10.1056/NEJM198405313102201. PMID: 6325909.
- Wise RP, Salive ME, Braun MM, Mootrey GT, Seward JF, Rider LG, Krause PR. Postlicensure safety surveillance for varicella vaccine. JAMA. 2000 Sep 13;284(10):1271-9. doi: 10.1001/jama.284.10.1271. Erratum in: JAMA 2000 Dec 27;284(24):3129. PMID: 10979114.