Newly Discovered Documents Raise Questions About the MMR Vaccine’s Safety

It was in late April when then FDA head Scott Gottlieb warned that states might “force the hand of the federal health agencies” if they continue to allow vaccine exemptions. Gottlieb’s poorly-timed comments came on the heels of damning legal admissions from his agency. After failing to produce the clinical trials and safety studies relied upon to license both the flu and TdaP vaccines for use in pregnant women when presented with a FOIA request, the FDA was taken to court.

Gottlieb’s FDA conceded, “Clinical studies for TdaP and inactivated influenza vaccines did not specifically enroll pregnant women.” The FDA legal response went on to admit they “have no records responsive to your [plaintiff’s] request.” In short, the agency licensed the shots for use in pregnant women without the required scientific studies to ensure safety. In addition to the discovery that the FDA licensed the flu and TdaP vaccines outside of law and their own policy, the agency also actively promoted and marketed the flu shot to pregnant women. Shortly after Gottlieb’s authoritarian-like vaccine remarks he announced he was stepping down from his position at the agency.

Now, another set of problematic and scientifically concerning documents has just been released to the public from the FDA. This time the information centers around the pre-licensure studies the FDA relied upon to green-light Merck Sharp & Dohme’s MMR vaccine. According to the documents obtained, almost thirty percent of the children in all of the combined studies acquired “upper respiratory illnesses” and over twenty-one percent experienced “gastrointestinal illness.”

Questioning the MMR vaccine immediately conjures the specter of Andrew Wakefield who has been used for decades by much of the media to vilify anyone who questions any vaccine for whatever reason. Yet it is interesting to note that the ‘debunked’ work of Wakefield and his 12 co-authors the media slams was centered around normal children who all exhibited “gastrointestinal symptoms” and regressive developmental disorder shortly after their MMR vaccination. The now infamous study showed patchy chronic inflammation in the colon in 11 of the 12 children. The 1998 study is categorically ignored as continual ‘new’ discoveries over the past two decades make front page headlines showing links between the gut and brain function.

According to the now-public FDA FOIA documents, none of the pre-licensure trials appeared to look for or record MMR vaccine-associated injuries like pancreatitis, diabetes mellitus, encephalitis and encephalopathy, or Guillain-Barré Syndrome (GBS). GBS was first reported it in 1916 and considered a demyelinating disease until the 1980s when the acute axonal type of GBS was first reported. Since then, acute inflammatory demyelinating polyneuropathy and acute motor axonal neuropathy have been considered the two main subtypes of GBS. All of the FDA’s preclinical trial data in the FOIA documents took place in the late 1970s. Is there a link between the emergence of the two new variations of GBS first reported in the 1980s and rollout of Merck’s MMR vaccine around the same time frame?  

Another common issue seen in vaccine safety science is the incredibly short reporting windows for serve adverse reactions. For example, on the first day of life, most newborns receive a Hepatitis B vaccine. The two Hepatitis B vaccines licensed in the U.S. for newborns are Recombivax HB (Merck) and Engerix-B (GSK). Both were licensed based on clinical trials which reviewed so-called solicited and unsolicited reactions for no longer than five days after vaccination. When questioned about the Recombivax HB vaccine’s short detection window, Dr. Stanley Plotkin, whose 27/3 rubella virus is used in Merck’s MMR vaccine, had the following exchange:

Q: Is five days long enough to detect adverse
reactions that occur after five days?
Plotkin: No.

Q: Is five days long enough to detect
an autoimmune issue that arises after five days?
Plotkin: No.

Q: Is five days long enough to detect a
seizure that arises after five days?
Plotkin: It would be unlikely to have a seizure
occur after five days.

Q: Is five days long enough to detect any
neurological disorder that arose from the vaccine
after five days?
Plotkin: No.

The children comprising all the MMR studies in the now-public FDA FOIA documents were followed for 6 weeks for a limited, pre-determined set of “clinical complaints.”

In sharp contrast to the short safety testing periods for vaccines, most drugs have pre-licensure safety review periods which last years. For example, the drugs Enbrel, Lipitor, and Botox had safety review periods of 6.6 years, 4.8 years and 51 weeks, respectively, and each had an actual placebo control group. And these drugs are typically for adults, not infants and children.

As more information about the purported settled science and safety of vaccination come to light, it is apparent that the story isn’t complete and serious questions still remain. Yet in our current social media and political environment of overt censorship, open debate surrounding such topics must fight to be heard.

Until open debate is welcomed with transparency, citizen journalists, scientists, doctors, lawyers and researchers must continue to be vocal. In a timeless moment of perfectly aligned common ground, one willfully hidden and the other proudly proclaimed, Dr. Plotkin and Robert F. Kennedy Jr shared the same concern.

When Kennedy Jr. appeared for a Connecticut debate in which his Yale opposition bailed, he openly challenging the local media in attendance saying “All vaccines should undergo the same safety testing that we require for other drugs. That’s all I’m asking. Is this radical?…Is this something you’re not allowed to print?”

Similarly, in an internal email discovered through FOIA request, Dr. Plotkin also made the following statement regarding vaccine safety in a June 2018 correspondence to his colleagues:

“One point I do agree with [Robert F] Kennedy [Jr] about: there should be more safety studies…”

Imagine if Dr. Plotkin would agree to openly debate Kennedy Jr. regarding vaccine safety? Who knows what other common grounds they would find together.