Tag: chronic fatigue syndrome

Who Is Judy Mikovits?

Dr. Judy Mikovits has a PhD in Biochemistry and Molecular Biology, doing her thesis on Negative Regulation of HIV Expression in Monocytes.

She had several papers published with Dr. Frank Ruscetti, with whom she continues to work.

Instead of research, it seems that they now do:

  • Advocacy for vaccine injury legal cases worldwide. 
  • Research and documentation on medical exemptions for vaccinations.

What happened?

Who Is Judy Mikovits?

After working at the National Cancer Institute, it seems that Judy Mikovits became research director of the Whittemore Peterson Institute (WPI).

A paper by Mikovits and Ruscetti was retracted because no one else could replicate the work.

She was eventually fired after a paper she was lead author on, which found xenotropic murine leukemia virus-related virus (XMRV) in patients with CFS, was retracted and the institute accused her of stealing notebooks and manipulating data.

“But the leader of the team that authored the 2009 paper, researcher Judy Mikovits, apparently presented the same figure — carrying different labels and supporting a different point — in a talk given at a conference on Sept. 23 in Ottawa.”

Manipulation alleged in paper linking virus, chronic fatigue syndrome

An even larger study found no evidence of XMRV infections in patients with chronic fatigue syndrome, even as she had claimed the virus could cause CFS, Parkinson’s disease, autism and multiple sclerosis.

The source of XMRV in her patients?

“Well-controlled experiments showed that detection of XMRV was due to contaminated samples and was not a marker of or a causal factor in prostate cancer or CFS.”

Johnson et al on Xenotropic Murine Leukemia Virus-Related Virus (XMRV) and the Safety of the Blood Supply

The virus was in a contaminated cell line in which she and others were doing research. The virus wasn’t in the actual patients themselves.

Judy Mikovits on Vaccines

Before her paper was retracted and she was fired from her lab, Judy Mikovits did actually do research on viruses and she is a scientist. She didn’t do research on vaccines though.

Judy Mikovits is still finding retroviruses wherever she looks for them...
Judy Mikovits is still finding retroviruses wherever she looks for them…

That seems to be something she talks about a lot now though:

  • at anti-vaccine rallies
  • at anti-vaccine conferences
  • in anti-vaccine videos

Her claim to fame seems to be talking about contaminated vaccines and bashing Gardasil. And deep state conspiracy theories about why she was arrested and lost her job.

To be clear, a rotavirus vaccine was found to be contaminated with DNA of porcine circovirus type 1.  While that might sound a little scary, it is important to keep in mind that the PCV1 virus doesn’t actually cause disease in people and these weren’t even “biologically active virus particles.”

PCV1 isn’t a retrovirus though and Judy Mikovits wasn’t even the researcher who discovered the contamination, which has since been resolved. 

“These findings do not indicate the presence of either ALV or EAV infection in MMR vaccine recipients and provide support for current immunization policies.”

Hussain et al on Lack of Evidence of Endogenous Avian Leukosis Virus and Endogenous Avian Retrovirus Transmission to Measles Mumps Rubella Vaccine Recipients

Studies have looked at retrovirus contamination of vaccines, but they were  done over 17 years ago. And not by Mikovits. Studies that confirmed that vaccines are safe.

None of this has kept Judy Mikovits from scaring people about vaccines, especially the HPV vaccine.

“Cervical cancer is not a public health threat. It’s not an infectious disease. Why is it in the Department of Public Health? Why are we mandating every child over 9 years old, and I heard soon to be pregnant women, to get this vaccine? It makes no sense.”

Judy Mikovits

It is really hard to understand how someone who worked at the National Cancer Institute could make these statements. Cervical cancer is one of the most common cancers in women.

There is, of course, no mandate for 9-year-olds to get the HPV vaccine. In the United States, HPV vaccination is recommended, beginning at age 11 to 12 years. The HPV vaccine is not recommended for pregnant women and while several vaccines are recommended, no vaccines are actually mandated in pregnancy.

“It was never developed to prevent cancer. It was developed and approved to prevent warts. Warts are not a public health threat. It’s beyond… When scientists like myself, and I work in cancer and AIDS hear this, we are just…”

Judy Mikovits

Gardasil and Cervarix were developed to prevent HPV infections, which cause cervical cancer. HPV can also cause genital warts.

“I think we need to ban… Japan and India have, all HPV vaccinations now, until the appropriate studies are done, until the patients are tested…”

Judy Mikovits

Neither Japan nor India have banned HPV vaccinations.

Why should we? The HPV vaccines are safe, effective, and necessary.

And why would anyone listen to Judy Mikovits? 

More on Judy Mikovits

Et Tu, Slate? Flaws with Their Questions About Gardasil

Questioning vaccines doesn’t make someone anti-vaccine.

Something is missing in this article about Gardasil testing in Slate...
Something is missing in this article about Gardasil testing in Slate…

Doing a poor job of it and making folks scared to get vaccinated and protected?

I’ll let you decide what to call them…

Slate Investigates the Gardasil Clinical Trials

So after an eight-month long investigation, a journalist for Slate thinks he has evidence that the clinical trials that helped get Gardasil approved by the European Medical Agency were flawed.

What was the problem?

The way that they recorded possible side effects after folks were vaccinated.

“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials.”

What made the method convoluted?

“In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.

Merck, which is known as Merck Sharp & Dohme outside the U.S. and Canada, did not address the EMA’s safety concerns.”

When you read the internal 2014 EMA report about Gardasil 9, it is clear that Merck has a thorough response to each and every question that the EMA asked.

And those other quotes?

The EMA does state that:

  • “At all other time points in the study medical events were reported as “new medical history”. This is an unconventional and suboptimal study procedure.”
  • “While it is considered that the required safety data eventually has been made available for assessment, this feature of the study protocol brings some degree of uncertainty into safety assessment.”

So the EMA got the required safety data they were looking for, which is likely why Gardasil was approved in Europe.

They also said that “As the AE reporting procedure as seen at the inspection sites was in line with the approved protocol, the inspectors did not comment on it in the inspection reports. It was discussed with assessors during the course of the inspections, as in the inspectors’ opinion it is not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.”

This case of a subject with POTS was reported as being "well characterized" by the EMA, even though it likely wasn't caused by her Gardasil shots.
This case of a subject with POTS was reported as being “well characterized” by the EMA, even though it likely wasn’t caused by her Gardasil shots.

But if it was suboptimal, how come they were able to record someone getting diagnosed with POTS 1,389 days after their third dose of vaccine?

I’m starting to understand why Dr. Yehuda Shoenfeld wasn’t quoted in the piece. He likely knew how it was going to be perceived…

“Imagining a link between HPV vaccination and CFS is not all that far-fetched, according to Dr. Jose Montoya, a professor of medicine at Stanford University and a CFS expert.”

Not far-fetched at all, which is why studies are done to see if there really is a link.

So even if part of the study design was suboptimal, the Slate piece shouldn’t have cherry picked those quotes and should have included these other big pieces of information:

  • A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix (another HPV vaccine)
  • In 2015, the EMA confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
  • A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
  • A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
  • A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)
  • A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination

The Slate piece does mention two of these studies, but just barely. One gets a single sentence and the other, half a sentence.

We see page after page of anecdotes of folks with supposed vaccine injuries, but the evidence that shows the vaccine is safe is almost buried and easy to miss. Many of the other studies seem to be left out.

And just because these patients have agonistic auto-antibodies, it doesn’t mean that they are from a vaccine.

“Five of the 14 POTS subjects and 2 of the 10 “healthy controls” recalled a respiratory infection in the 6 months prior to onset of their symptoms or inclusion in the study for the healthy controls.”

Li et al on Autoimmune Basis for Postural Tachycardia Syndrome

Lastly, what’s with calling cervical cancer uncommon???

“Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early.”

European Medicines Agency

Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.

The HPV vaccines are safe. They work and they are necessary. Don’t skip them.

What to Know About the Slate Gardasil Investigation

Although the study design for Gardasil used for licensing in Europe might have been suboptimal, that doesn’t really come across in this Slate piece, as it seems clear that it didn’t result in safety data being missed, and as post-licensure tests have confirmed, Gardasil is safe.

More on the Slate Gardasil Investigation