On April 1, 2019, Chief Special Master Nora Beth Dorsey rejected a lawsuit from Dr. Theresa Deisher before the National Vaccine Injury Compensation Program for compensation for the loss of her young son (referred to as H.S.) who died on July 3, 2015, aged 14, from an aggressive cancer. It is horrible to lose a child at any age, and incredibly painful to lose a young child.
H.S.’s last year appeared to be difficult to all concerned, and I would like to offer Dr. Deisher my very sincere condolences. But there was no good basis to blame his cancer or death on vaccines, and the theories offered were very, very implausible.
Dr. Theresa Deisher case
H.S. (although the young boy’s name has been shared online, out of respect for his own and the family’s privacy I will use the initials used in the case) was born on March 28, 2001, and vaccinated on the existing schedule at the time – he received multiple doses of the DTaP, Hib, IPV, PCV and hepatitis B vaccines from about 6-7 weeks (May 9, 2001).
He received his MMR and varicella vaccines at a year old (April 5, 2002) and for some reason, a meningococcal vaccine at 18 months (it is usually given at 11-12 years old). He received his hepatitis A vaccine at two years, and influenza vaccines for several years starting at October 2003 (at two and a half), but not annually. He received his Tdap at 11½ – during October 2012, and his last vaccine was an influenza vaccine on December 2014, when he was aged 13½ after his cancer has developed. So until his early teens, at least, he appeared to have been vaccinated on schedule.
He appeared to have had very few medical problems during his younger years. Then, in July 2014, things went horribly wrong. He “presented to Dr. Michael S. Dudas, M.D., with a one-week history of fatigue, nausea, and bone pain. He also reported mild diarrhea and intermittent pain in a rib on his right side, and he was noted to be a ‘poor eater.’”
Testing led to a diagnosis of Burkitt’s lymphoma, an aggressive, fast-growing cancer that can be fatal if not treated quickly. H.S. was treated with chemotherapy and radiation. Treatment was hard, accompanied by “prolonged fevers.” He was discharged on April 8, 2015. But then things took a turn for the worse. From the decision:
…PET and CT scans conducted in May 2015 were “highly concerning for recurrent disease.” Id. at 103, 1441-42, 1485-86. On May 14, 2015, H.S.’s treating physician informed his family that this recurrence signaled that the Burkitt lymphoma was “aggressive and likely incurable.” Id. at 97. During the last few months of his life, H.S. underwent a wide variety of laboratory tests. Most significantly, a polymerase chain reaction (“PCR”) test for Epstein-Barr Virus (“EBV”)7 conducted in March 2015 was negative, as was a June 2015 blood test for HIV. [This will become important later. D.R.]
On June 25, 2015, H.S. presented to Seattle Children’s Hospital with complaints of “significant crampy abdominal pain and fullness in his upper abdomen,” which had developed during his recent Make-A-Wish trip in Alaska. Pet. Ex. 2 at 468. He was admitted and administered palliative measures. Id. H.S. passed away on July 3, 2015, due to “progressive respiratory failure secondary to his underlying cancer.”
Less than a year from diagnosis, after significant suffering, H.S. died, only 14. It was no doubt an incredibly painful time for the family.
At some point between July 2015 and March 2017, Dr. Theresa Deisher decided to blame vaccines for H.S.’s tragic death. On March 2, 2017, Dr. Deisher filed a claim for compensation against NVICP.
Dr. Deisher has claimed that fetal DNA in vaccines causes autism at least since 2009, testifying to the Minnesota legislature on the issue in 2012, publishing problematic studies on it in 2014, and again in 2015.
The use of cell lines in vaccines was a focus of hers long before H.S.’s cancer and appears to be religiously motivated, drawing on her opposition to abortion. It was also shown when she and other researchers brought a lawsuit against NIH’s rules on funding stem cell research. Dr. Deisher’s claims on a link between fetal DNA in vaccines and autism were rejected in a lengthy, thorough NVICP decision, but she clearly still believes in the basic ideas behind these theories, because to a large extent they were the basis of the claims connecting H.S.’s cancer and death to vaccines.
On a side note, most pro-life individuals and churches that have as their doctrine pro-life principles support vaccines that prevent deaths and harms to children and the unborn (or have no clear position on the issue), and do not see the use of decades-old cell lines as a good argument against it.
That apart, at the point of time that H.S.’s cancer was diagnosed Dr. Deisher had been claiming that fragments of fetal DNA in vaccines is harmful for several years. Not in the context of cancer, but it’s clear that Dr. Deisher saw vaccines using cell lines in a very negative manner, and it seems that in her pain she took to seeing these vaccines as the cause of H.S. death.
Epstein-Barr virus.
The claims
Three experts testified in favor of Dr. Deisher’s claims. Dr. Judy Mikovits and a frequent collaborator of her, Dr. Francis Ruscetti, and a plant biologist, Dr. Douglas Darnowski. Their claims all revolved about alleged contamination of vaccines. All of the experts pointed to the use of cell lines in some vaccines. Drs. Mikovits and Ruscetti also alleged harmful contamination by animal retroviruses, EBV (Epstein-Barr Virus) and SV40.
The Special Master found that they provided no plausible theory of causation.
Fetal DNA
A major argument of the experts working for Dr. Deisher – an argument also raised by Dr. Deisher herself as an explanation of how vaccines cause autism – is “insertional mutagenesis.” This is the argument that the fetal DNA in vaccines can insert itself into human cells, alter their genes, and, in this case, cause enough damage to cause the cancer.
In the context of autism, Orac strongly criticized how implausible this theory is. Basically, it is extremely implausible the DNA would insert itself into the genome to an extent that would affect more than one or a few cells, far from what would be required to cause ASD. Similar criticisms – and others – were included in NVICP’s lengthy decision in the mini-omnibus cases, where Deisher’s theories were raised to support a claim that vaccines cause autism spectrum disorder (ASD).
As Chief Special Master Dorsey summarized, the government’s expert in this case – an actual cancer expert, Dr. Lewis Chodosh (who has published nearly 90 articles on cancer) – explained that similar problems face a claim that the DNA can cause cancer. Dr. Chodosh explained that there are multiple protective mechanisms to maintain “genome integrity”, and it’s rare for human cells to pick up “exogenous” DNA, and even more rare for it to cause cancer.
For that to happen, the entering gene would have to “activate an oncogene, or inactivate a tumor suppressor gene, to initiate the development of cancer” (see Note 1). While Dr. Deisher’s experts claimed B cells are more likely to take up DNA, with no citations, Dr. Chodosh explained that
[I]t is widely known in the immunology community that B cells are highly resistant to taking up exogenous DNA fragments in culture, even when using methods designed to stimulate DNA uptake – methods that obviously would not be operative in the skin or muscle of vaccine recipients.
And he provided citations supporting his comments.
In other words, it’s hard to insert genes into cells generally and more so for B cells, even when scientists are intentionally trying to do that. Even the studies cited by Dr. Deisher’s experts show that the risk of insertion is low and requires effort.
Other mechanisms through which the DNA could harm were also rejected – for example, their claim that “vaccine contaminants like human DNA could cause cancer through epigenetic mechanisms such as DNA methylation” was rejected, among other things, since young H.S.’s records did not suggest that “his DNA methylation machinery has been altered,” and the mechanism drew heavily on potential involvement of EBV or HIV – and H.S. had neither virus.
Retroviruses:
There was no evidence that the vaccines in question were contaminated by “replication-competent retroviruses.” Drs. Mikovits and Ruscetti suggested that the xenotropic murine leukemia virus-related virus (XMRV) “most likely entered the human population via contaminated vaccines.”
Dr. Mikovits last work as an active scientist was on XMRV, so she could claim some expertise on this, but the Chief Special Master rejected the claim because there is no evidence of XMRV contamination of vaccines, nor is there evidence that XMRV causes harm to humans – early studies suggesting links to prostate cancer or chronic fatigue syndrome have been countered by extensive data from multiple independent laboratories.
Chief Special Master Dorsey reminded us that the study linking XMRV to chronic fatigue syndrome was retracted, and added in footnote 20:
Dr. Mikovits and Dr. Ruscetti are two of the authors of the retracted study, published in Science in 2009, linking XMRV and chronic fatigue syndrome. Resp. Ex. B-42. Science retracted the study because (1) other laboratories were unable to replicate the results, (2) some of the experiments documented by the study showed poor quality control, and (3) the authors had omitted probative information from one of the figures in the study.
There was a theoretical possibility that the DNA derived from cell lines had some human endogenous retroviruses (HERVs) in it. These are retrovirus-like sequences that may be descended from retroviruses that integrated into our genome. But there is no evidence linking HERVs and Burkitt’s lymphoma – H.S.’s cancer – and even if there was, there would be no evidence that it was a HERV from vaccines that caused it, rather than the HERVs that are already part of H.S.’s genome (about 6-8% of the human genome are HERVs).
Science.
Epstein-Barr virus
A very large part of the report by Drs. Mikovits and Ruscetti focused on EBV and HIV. But H.S. tested negative for both, and the doctors offered no good reason to doubt the testing.
They claimed that H.S. “could have still had EBV in his immune cells but the DNA would have been hypermethylated and silenced and thus be invisible to the immune system and show no evidence of infection,” and that “while H.S. ‘did not encounter the [EBV] wild virus as that would have been detected in the clinical blood test that was administered [during his March 2015 hospital admission],’ such a test would not have detected EBV transmitted through vaccination.” But they provided no citations for the argument that PCR would not have detected EBV, and it’s not clear why the source – vaccines or wild – would make such a difference.
Dr. Chodosh provided references that PCR testing is very sensitive in catching EBV. If H.S. never had EBV, it couldn’t have caused his cancer. Vaccines do not contain EBV, so even if H.S. had EBV it would not be vaccine-related, but that’s a bit irrelevant since he did not have EBV.
SV40
This is a very bizarre claim. In the 1950s-1960s, some polio vaccines were contaminated with SV40. While there are good reasons to doubt the claim that that contamination caused cancer, it was real contamination. But H.S. was born in 2001, and never received the vaccines in question. It is even less convincing than other claims.
Animal Retroviruses
The petitioners provide evidence that some live vaccines were contaminated with animal retroviruses, but none that were infectious to humans (and one study addressed a vaccine – Rotarix – that H.S. didn’t get, which was contaminated with a pig virus that’s neither infectious to humans nor dangerous to them).
Summary of the Dr. Theresa Deisher case
The Chief Special Master concludes,
In short, petitioner’s experts have piled speculation atop speculation in an effort to connect H.S.’s childhood vaccinations to his Burkitt lymphoma. Speculation as to possible causes, however, is not sufficient to support a finding that a vaccine caused an injury.
For many of the claims, she could have added the term “implausible” before “speculation”.
Additional points
The special master pointed to several other problems in the claims from Dr. Theresa Deisher:
- The main risk factors alleged by Dr. Deisher’s experts were that H.S. received vaccines at a “young age” and that the cancer, according to Drs. Mikovits and Ruscetti, was activated by “puberty”. But neither of these things set H.S. apart from the vast majority of babies. That makes them not very good risk factors – how do they show causation? Most babies get vaccines very young. If they live long enough, all or most children will reach puberty. How is this case different from other cases of Burkitt’s lymphoma that are not linked to vaccines? What makes these risk factors?
- Over ten years passed between the vaccine and the onset of cancer. The explanations Dr. Deisher’s experts gave for that gap were not convincing – Drs. Mikovits and Ruscetti blamed puberty which, according to them, hyper-activated the immune system – not only did they not provide any citations for the role of puberty in cancer, but also they did not explain the fact that many cases of Burkitt’s lymphoma happen long before puberty. Dr. Darnowski blamed immune activation that can happen at any time, but that’s too undetermined to assess if there’s a link to vaccines.
- Dr. Darnowski tried to rely on a graph which, allegedly, showed changes in sporadic-type Burkitt’s lymphoma after MMR II (there are three types of Burkitt’s lymphoma). The endemic variant is most common in malaria – suffering areas and very linked to EBV. The sporadic type is the common one in areas where malaria is not endemic and is only rarely associated with EBV. The immune-deficiency associated type is usually in people with HIV infection or people taking immunosuppressive drugs). Chief Special Master Dorsey did not give the graph much weight, for three reasons. There was no information about the methods used to create it, making it impossible to assess how reliable the graph was. The graph was created by a researcher in Dr. Deisher’s organization, Sound Choice Pharmaceutical Institute, raising questions about conflicts of interest. And the graph’s premise – that there was a pattern of change after introducing the vaccine – is in tension with Dr. Darnowski’s own theory of how the vaccines caused Burkitt’s lymphoma, which is that a random later immune activation led to the cancer – random occurrences are in tension with a temporal pattern.
- Chief Special Master Dorsey also raised concerns about the reliability of the experts. For Drs. Mikovits and Ruscetti, the problems were in their report: first, it focused on EBV and HIV, which H.S. tested negative for, and it was unclear how their theories applied to a child who was negative for their viruses. Further, they either did not cite medical literature or misrepresent literature they did cite. For example:
…the experts display a table in their report entitled “Relations between coinfecting viruses and HIV-1,” which they describe as follows: “The table below shows co-expression of retroviruses and herpes viruses including EBV critical pathways necessary to stop the progression of the cancer. Immune deficiency and HIV infection are risk factors for the development of aggressive Burkitt’s lymphoma and support our plausible theory of causation.” Pet. Ex. 12 at 10 (internal citation omitted). This table does not mention cancer. Furthermore, the undersigned struggles to comprehend how a table documenting “coinfecting viruses and HIV-1” is applicable to an HIV-negative patient like H.S.
For Dr. Darnowski, the problems were different: he was simply speaking outside his field. His expertise is in areas of plant biology, not cancer or vaccines.
Finally, the Chief Special Master expressed concerns about Dr. Deisher’s involvement in presenting the theories in the case – theories very similar to those rejected in a detailed opinion in the autism mini-omnibus cases. https://www.skepticalraptor.com/skepticalraptorblog.php/nvicp-mini-omnibus-autism-decision-vaccines/#Related
Conclusion
Dr. Theresa Deisher suffered a tragic, painful, horrible loss. She lost her young teenaged son in less than a year of intense suffering from aggressive cancer. I am sorry for her.
But it’s hard to avoid the impression that in her pain, she made an unconvincing link between her tragedy and a cause she was already passionate about, her hostility to vaccines using fetal cell lines. The arguments built to connect the loss and vaccines were speculative, against the literature, and extremely implausible. The Chief Special Master handled the claims with care and did a thorough job showing the holes, and her decision to reject compensation was extremely well supported.
Notes
- This reflects language cited from the opinion of the Special Master.
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
