Five Takes On Vaccine Safety And Autism

On Thursday, the influential Institute of Medicine issued a report on vaccine safety. After analyzing more than 1,000 published studies that looked at vaccine-related adverse events, the IOM concluded that most vaccines are safe, serious side effects are rare and there's no link between vaccines and autism.

“We have a lot of evidence that vaccines save lives and avert a lot of suffering,” said Dr. Ellen Wright Clayton, a professor of pediatrics and law at Vanderbilt University in Nashville, Tenn. and chairwoman of the panel that wrote the report. She added: “The MMR vaccine does not cause autism...MMR and DTaP do not cause Type 1 diabetes. The flu shot does not cause Bell’s palsy and does not trigger episodes of asthma.”

But the report, by offering no new clinical data, did little to ease the concerns of those skeptical of vaccines. Here then, slightly edited, are five responses to the IOM report, four were solicited by CommonHealth and one came to us by email.

1. Alison MacNeil, a clinical social worker, lives with her husband and two children in Cambridge, Mass. Their six-year-old son Nick has autism and was the focus of the opening segment of the PBS Autism Now series that aired in April, anchored by Alison's father Robert MacNeil.

The most recent report from the IOM will provide cold comfort for families like mine who have witnessed their children’s regression into Autism and chronic illness following vaccination. Not to mention the families the VICP has awarded settlements finding a causal relationship between their child’s Autism and vaccination. No comfort at all for the 93 girls who have died following the Gardasil vaccine.
I take issue with the IOM’s stance that vaccine adverse events are rare. Since 1999 the VAER’s system has received 11,000 to 12,000 individual reports per year of vaccine adverse events. By 2010 VEARS had received 352,650 adverse reports. It is estimated that only 1-10% of adverse vaccine events are even reported. I also take issue with IOM’s denial of any causal relationship between vaccination and Autism. $2 billion dollars has been paid out for 2,541 vaccine injuries, 1,300 of those were for brain injuries. There are 5,800 cases remaining to be adjudicated.

It is not surprising that the IOM found a weak relationship between vaccination and adverse events in their review of the existing studies because the studies themselves are weak. The great majority of vaccine safety studies are poorly designed and produced by either the company that stands to profit from the vaccines use, or the agency charged with promoting vaccine compliance. Until we have properly designed vaccine safety studies, independently reviewed, with vested interests removed from the process, we are regurgitating stale and incomplete data.

This report offers no new information and will do little to soothe the nerves of anxious parents grappling with vaccine decisions. Daily these parents are made aware of the crisis in children’s health as they survey the damage at the playground, school bus stop and classroom. There is broad agreement that environmental factors are at least in part responsible for the stunning Autism statistic of one out of every 100 children. Our vaccine injured children are the data and they are everywhere. Surface reassurances like this report provide a weak argument against the backdrop of these visceral observations.

2. Sean Palfrey is a Professor of Clinical Pediatrics and Public Health, Boston Medical Center

This IOM report is extremely balanced, as would a meta analysis of probably millions of patients be expected to be. The sample size is immense and thus the power should be strong. It is reassuring to be told that such evidence shows that vaccines are very safe in the grand scheme of things, and, when compared to other studies of the effectiveness of vaccines to prevent disease, the safety and cost-benefit appear to be excellent.

Vaccines work by challenging the immune system to respond and thus ready itself to react in an overwhelmingly effective way when the body is subsequently exposed to the wild infectious agent. Fever, vomiting, diarrhea, cough are all means the body uses to fight off infections, and it is not surprising that some individuals receiving vaccines will react with these symptoms. It is a tribute to the extraordinary science of vaccine development that more people don't show these comparatively minor signs and symptoms.

Some small number of individuals, known or unknown to have immune deficiencies, vigorous immune reactions, and allergies of various sorts may have what we consider to be unwanted reactions when challenged with vaccines. As we learn more about who these people are and what their conditions entail, we will become better able to anticipate reactions and perhaps prevent them entirely.

This study is the most recent of a series of vast, authoritative studies demonstrating how safe vaccines are in comparison to many activities of daily living such as eating, driving, or walking in the street. Other studies have shown how serious the diseases are that these vaccines prevent and how dramatically these diseases have waned in the face of our effective vaccine campaigns. What it should also underscore is the need for parallel studies of other potential causes of those serious childhood illnesses that are actually increasing, such as asthma, autism, ADHD, diabetes, certain cancers, and obesity. It is to these we must turn our attention and invest our time, money and scientific expertise.

3. Martha Constantine-Paton, a member of the panel that wrote the report, is a professor of biology at the Massachusetts Institute of Technology:

The committee reviewed clinical trial data, clinical case reports and any mechanistic data it could find in the literature on the risks of vaccines. They evaluated epidemiological data and mechanistic data from the primary literature for eight different vaccines and many different adverse effects. My role was as a neuroscientist with specific expertise in synaptic function and development.

Much of the public interest in the report will probably surround autism. We found that what little information surrounds the MMR vaccine as a potential cause of autism favors rejection or any cause and effect relationship. For most other vaccines there was no evidence available for any relationship. This is not surprising given that even though some autism syndrome disorders can be associated with several widely different single gene defects, the causes of the vast majority autism cases are of unknown and probably of varied etiology.

However I can't summarize in a few sentences the many other adverse effects we reviewed or the ones where we did find evidence that for some vaccines, for some people, the evidence did convincingly support a relationship between a vaccine and an adverse effect but many of these effect were not life threatening and transient. The committee was not asked and did not deal with assessing the benefits of vaccines or any policy issues related to vaccines.

4. Laura Sefcik lives in Columbus, Ohio with her husband, Sean, 4-year old daughter, Ava, and 2-year old son, Caleb:

I am always intrigued by new literature that reports there are minimal to no adverse health effects following vaccination. Vaccines are undeniably one of the greatest achievements of biomedical science and public health in the 20th century, ranking higher than seat belts, birth control and the fluoridation of drinking water.

As both a Masters-prepared social worker and public health practitioner, I fully support, and am thankful for, the use of vaccinations in the general population. And as a mother to a young daughter with autism, I fully trust and believe that vaccines did her no harm. In Ava’s case, her chromosomal disorder (Dup15q/Isodicentric(15)) is the leading contributor to her autism, which was evident soon after her October 2006 birth. We were not aware of her disorder until age 3, so she was fully vaccinated on the standard schedule, as her healthy younger brother has been. Had we known about her disorder earlier, we still would have continued to follow the standard schedule. I would much rather have a child with autism than watch my child die of any number of preventable infectious diseases.

I fear that this study will not do much to satisfy the anti-vaccine autism community, however. It is merely a literature review going over studies that did not convince people before. The committee’s claim that it has a “high degree of confidence” that there is no connection between the MMR vaccine and autism is not sufficient. For parents who lose a child to autism soon after an MMR injection, the evidence may be circumstantial, but it also very real.

I would like to see a new study done on this issue, and preferably by the private sector. Historically, it seems as though if any government agency conducts a study on vaccines and autism or other adverse health issues, the results are questioned.

While I am somewhat ambivalent about the study and its results, I am pleased that the issue continues to be monitored.

5. SafeMinds is a group that asserts a link between vaccines and autism. (Here's their statement via press release).

Due to a narrow set of objectives defined for the IOM by the government, the report only looked at a small set of published research studies linking just two vaccines to developmental disorders such as autism.

Only four epidemiological studies were considered of sufficient quality to evaluate the MMR vaccine in relation to autism and no studies were deemed of sufficient quality for the DtaP vaccine and autism analysis.

The committee did not attempt to evaluate six other vaccines for autism causation, the safety of the cumulative vaccine schedule and health outcomes like autism, or the safety of vaccine ingredients like mercury and aluminum in the context of chemical exposures from other sources like air pollution or consumer products.

The report considered 158 potential adverse outcomes from vaccines. Of these, 135 or 85% were found to have inadequate research to accept or reject a causal association. Of the 23 outcomes where the research was deemed adequate, 18 or 78% were found supportive of harm. Vaccines were cleared of safety concerns for just five of the outcomes considered.

"These statistics are hardly reassuring to parents who are now asked to give their young children over 32 vaccinations," noted Sallie Bernard, President of SafeMinds. The report found likely causality of immune dysfunction, seizures and encephalopathy from some vaccines. These conditions are often found in individuals with autism. "It is plausible that a subset of children became autistic because of these adverse events from their vaccines."