On 19 July 2016, New York Attorney Patricia Finn filed a complaint in a federal district court against the pharmaceutical firm Merck, officials in the Department of Health and Human Services, and Julie Gerberding (formerly director of the CDC, and currently Merck’s Executive Vice President for Strategic Communications, Global Public Policy and Population Health). This Merck vaccine lawsuit, called Doe v Merck, is an amended complaint that was filed on 20 July, and will be the one examined in this article.
While the complaint was filed in the name of a Jane Doe and Baby Doe, the text of the complaint made it very clear that Jane Doe is in fact Maria Dwyer, and Baby Doe is her son Colin Dwyer. Colin Dwyer’s case was one of the test cases in the Omnibus Autism Proceedings (OAP) for the National Vaccine Injury Compensation Program (NVICP). The Dwyer case, like the other five test cases in the OAP, was rejected.
There are a lot of anti-vaccine tropes about the CDC (Centers for Disease Control and Prevention), none of which make a lot of sense. There’s the conspiracy theories that the CDC is bought off by Big Pharma. Or the CDC whistleblower meme that they hid evidence that vaccines cause autism. However, the CDC usually gets the science right, like they did with the recent FluMist vaccine recommendation.
The CDC, a federal government agency made up of scientists, physicians, and public health officers, who come from civilian and military backgrounds, are the first responders to almost any infectious disease outbreak across the world. They are the front line of science against disease.
They use scientific data, gathered through clinical trials or lab experiments, to make public recommendations about diagnosing, treating and preventing diseases. They’re impartial about their recommendations – they go where the data leads them.
Because vaccine deniers lack any scientific evidence supporting their unfounded belief system about immunizations, they tend to rely upon unscientific information like anecdotes, logical fallacies, misinterpretation of data, or Italian provincial courts to make their case about the lack of safety of vaccines.
It’s rather easy to debunk these claims, but because of the nature of the internet, old news is recycled as “brand new,” requiring a whole new round of blog posts to discredit the misinformation. It’s impossible to recall one single instance where a vaccine refuser made a statement about vaccines that was not, in fact, rather quickly debunked. Not one.
One of the latest ones involves a so-called lead Gardasil researcher, Dr. Diane Harper, a former “consultant” to Merck (and GSK, who manufacturers Cervarix, a bivalent HPV vaccine), who apparently had some research role in the clinical trials of the HPV vaccines. But what are the facts?
There antivaccination crowd runs the gamut from truly scary deniers who invent all sorts of lies to try to stop vaccines to people who seem to think that the risk of vaccine adverse events somehow surpasses the risk of the disease itself, mostly because they lack the cultural memory of what it was like in the world pre-vaccines. Vaccines are a critical part of the drop in the infant mortality rate by over 90% since the 1930’s, so we have just forgotten.
A recent study found that delaying the MMR vaccine (for measles, mumps and rubella), in the second year of life, doubled the risk of a seizure occurring after the vaccination. Now seizures are not unusual with vaccination, and are a result of the high fever that some children get after vaccination. But seizures are fairly common in children who haven’t been vaccinated recently. It’s always scary to parents, but they are minor, usually cause no long-term damage, including epilepsy.
The researchers, led by Simon Hambidge, MD PhD, of the Institute for Health Research at Kaiser Permanente Colorado, analyzed data from 323,247 children, born between 2004 and 2008, whose records are in the Vaccine Safety Datalink system, a collaborative effort between CDC’s Immunization Safety Office and 9 managed care organizations (MCOs), that monitors immunization safety and address the gaps in scientific knowledge about rare and serious events following immunization
The researchers located records 5,667 children who had experienced a seizure in their first two years of life and did not have a seizure disorder. The researchers then compared the timing of these children’s seizures to the dates they had received various vaccinations and considered whether the vaccines had been received on time or not, per the CDC’s and ACIP’s recommendations
The analysis revealed that there was no correlation between receiving any vaccine and experiencing seizures for children during their first year of life. However, those children who received the MMR vaccine between 12 and 15 months old, when it’s recommended, were at about 2.6X higher risk of a seizure than an unvaccinated child. That translates to about one seizure for every 4000 children receiving the vaccine. If parents delayed the MMR vaccine until any time between 16 and 23 months, the risk of a seizure was 6.5X greater than when not being vaccinated. In other words, delaying the vaccine 4-8 months more than doubles the risk of seizures.
Thus, if you’re coming up with your own vaccine schedule, you’re increasing the risk of a minor, but kind of scary, adverse event–a febrile seizure. Why would one do that to gain no other benefit? That’s not clear to me.
Hambidge SJ, Newcomer SR, Narwaney KJ, Glanz JM, Daley MF, Xu S, Shoup JA, Rowhani-Rahbar A, Klein NP, Lee GM, Nelson JC, Lugg M, Naleway AL, Nordin JD, Weintraub E, DeStefano F. Timely Versus Delayed Early Childhood Vaccination and Seizures.Pediatrics. 2014 May 19. pii: peds.2013-3429. [Epub ahead of print] PubMed PMID: 24843064.
1 or 2 in 100 (1.6%) will have convulsions (violent, uncontrolled shaking)
Two thirds (67%) will have apnea (slowed or stopped breathing)
1 in 300 (0.4%) will have encephalopathy (disease of the brain)
1 or 2 in 100 (1.6%) will die
Even in adults, there are substantial complications, such as broken ribs from coughing, that can have a significant impact on the overall health of the individual.
One of larger concerns with recent outbreaks of pertussis has been that adults with lapsed immunity or unvaccinated older children may pick up the infection, then pass it to these unvaccinated or partially vaccinated infants (usually less than 1 year old).
As the report states, a child cannot be vaccinated with DTaP (the vaccine for diphtheria, tetanus and pertussis) until they are about 2 months old. However, because infants are susceptible to whooping cough, all adults, children, friends, relatives, everyone, who is in contact with that child should be vaccinated against pertussis, a process called cocooning.
When an antivaccination militant says “my unvaccinated child won’t hurt your child”, this is where their lies are uncovered. For example, an unvaccinated older child may have whooping cough, and the parent take him or her to a pediatrician for the horrible cough, and that infected child passes it to other children.
On October 24, 2012, the Centers for Disease Control and Prevention recommended that “providers of prenatal care implement a Tdap immunization (Tdap or DTaP vaccine) program for all pregnant women. Health-care personnel should administer a dose of Tdap during each pregnancy irrespective of the patient’s prior history of receiving Tdap. If not administered during pregnancy, Tdap should be administered immediately postpartum.” This recommendation is based upon the Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States, guidelines, published Fall 2011, for whooping cough(Bordetella pertussis).
ACIP reviewed published and unpublished data from VAERS, Sanofi Pasteur (Adacel) and GlaxoSmithKline (Boostrix) pregnancy registries, and two small studies here and here. ACIP concluded “that available data from these studies did not suggest any elevated frequency or unusual patterns of adverse events in pregnant women who received Tdap and that the few serious adverse events reported were unlikely to have been caused by the vaccine.” In addition, both tetanus and diphtheria toxoids (together) and tetanus toxoid (alone) vaccines have been used worldwide in pregnant women to prevent neonatal tetanus without negative effects. The ACIP concluded that administration of the pertussis vaccine after 20 weeks of pregnancy was preferred to minimize any risk of a low percentage adverse event.
According to the CDC, only about 3% of pregnant women receive the vaccination. However, the CDC believes if the new recommendations are implemented, there would be a 33 percent reduction in cases, a 38 percent reduction in hospitalizations and a 49 percent reduction in deaths from whooping cough.