Вот официальное письмо о FDA расследовании Патрика Немечека.
http://www.circare.org/fdawls3/nemechek_fdawl_20100628.pdfВот еще официальный транскрипт судебного разбирательства где от квалификации и экспертизы Немечека не оставили камня на камне.
https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2014vv0878-58-0"In cross examination, Respondent raised threshold questions about whether Dr. Nemechek
possessed the expertise necessary to provide a reliable expert opinion in this case. Dr. Nemechek
is an osteopath (educated at the Kansas City University of Health Sciences in Kansas City,
Missouri), has never held board certification in immunology, neurology, or the sub-specialty of
the autonomic nervous system, and has no experience conducting research into some of the matters
his opinion touched upon, such as the function of cytokines in the immune system. See generally
Nemechek CV, filed as Ex. 15 (ECF No. 23-2); Tr. at 94-95, 154. He is in fact not board certified
in any particular specialty at all at the moment (although he was previously board certified in
internal medicine). Id. at 59. He also cited numerous publications in his CV, some of which he
represented dealt with immune system dysfunction. Id. at 61. In fact, close inspection of the listed
publications revealed them to largely consist of abstracts, articles he reviewed pre-publication but
for which he did not serve as a primary author, letters to the editor of journals, or items not actually
published in a peer-reviewed publication. Id. at 96-110. He maintained that he received specialized
training in the study and treatment of autonomic problems in Portugal in 2010, but could not
provide any details as to the course taken or individuals or institutions responsible for the course.
Id. at 110-12.
Instead, Dr. Nemechek relied almost wholly on his own experience in his present clinical
practice – and in particular on his efforts to treat problems attributed to autonomic dysfunction -
for his views on the neurologic and immunologic matters in contention. Tr. at 61-64, 110, 153-54.
Dr. Nemechek currently works in Arizona9
, where he operates “Nemechek Autonomic Medicine,”
a medical practice aimed at treating autonomic dysfunction, which (as its website indicates) is
purported to be “present in most all chronic diseases.”10 See Tr. at 62-64. As pointed out on cross
examination, Dr. Nemechek’s website asserts that he has developed a “protocol” for reversing
brain inflammation that, in turn, can successfully treat autonomic damage. Id. at 141. The protocol
9 Before relocating to Arizona, Dr. Nemechek had practiced medicine in Kansas, where for a time he focused on
assisting individuals with weight loss. Tr. at 115-17. At some point in that prior timeframe, Dr. Nemechek received a
warning from the Food and Drug Administration regarding the adequacy of certain of his study parameters. Id. at 113-
14.
10 See Autonomic Disorders, Nemechek Autonomic Medicine,
https://www nemechekconsultativemedicine.com/
disorders/ (last accessed on Feb. 2, 2018).
9
is claimed to have been effective in the treatment of Alzheimer’s disease11 and seizure thresholds,
and has also been deemed to be helpful in individuals with autism (Id. at 142) – although Dr.
Nemechek admitted that the protocol lacks reliable clinical support, and has never been the subject
of any peer-reviewed publications. Id. at 143.
Dr. Nemechek’s opinion began with an overview of the autonomic nervous system and its
relevance to Ms. Combs’s alleged vaccine injury. See generally First Nemechek Rep. at 3-4. As
Dr. Nemechek explained, the autonomic system is responsible for the “coordination and
regulation” of organ function, metabolism, and other “background” body functions that occur
without conscious intent. Id. at 3; Tr. at 66-67. One of its branches, the sympathetic nervous
system, functions as a “complete controlling mechanism” for immune system function and
inflammation. Tr. at 67. Autonomic dysfunction, or “dysautonomia,” includes orthostatic
intolerance, which he defined as the “inability to maintain proper blood pressure in your head when
you’re standing upright.” Id. at 68. Damage to the sympathetic nerve system, attributable to a lack
of “proper sympathetic inputs,” can result in this kind of dysautonomia as well as other symptoms.
Id. at 69. Dr. Nemechek made clear that his opinion is that Ms. Combs experienced autonomic
system damage as a result of the HPV vaccines, and not merely that the vaccines caused autonomic
dysfunction. Id. at 118.
One condition Dr. Nemechek deemed particularly relevant to his theory herein was
hypoglycemia, which he defined as a suboptimal blood sugar level. Tr. at 70. The autonomic
system helps regulate blood sugar levels, reacting with a variety of symptoms (e.g., sweating and
tachycardia) in the form of a “sympathetic discharge” if levels are driven too low. Id. at 71.
Accordingly, the sympathetic nervous system provides a “defense mechanism” to prevent
hypoglycemia. Id. at 71-72. Hypoglycemia can be dangerous – especially “neuroglycopenia,”
which Dr. Nemechek defined as lacking sufficient blood sugar levels in the brain to maintain
proper brain function, and which can result in a loss of consciousness. Id. at 77.
Dr. Nemechek then turned to the role a vaccine could play in causing dysautonomia. In his
view, vaccines have the capability of damaging the autonomic system, and can do so in different
ways. For example, a vaccine can induce an autoimmune reaction, by “triggering the production
of autoantibodies” that attack self structures. First Nemechek Rep. at 3; Tr. at 78. Alternatively,
cytokines (which Dr. Nemechek defined as chemicals produced by the immune system in response
to infection or injury that serve a “critical role in coordinating the body’s defensive [immune]
system”) can “surge” in production after stimulation by a vaccine, thereby causing injury. First
Nemechek Rep. at 7; Tr. at 78. Such an overproduction of cytokines could thereafter become
chronic, when microglia – non-neuronal glial cells in the brain that also play an immune defense
11 Alzheimer’s disease is categorized as a progressive central neurodegenerative disorder. Dorland’s at 528. The first
signs of Alzheimer’s disease include slight memory loss and personality changes, but these typically progress into
profound dementia in five to ten years. Id.
10
role – are primed to become an excess source of cytokine production, often as a result of some
prior insult (e.g., stress or a concussion). Tr. at 78, 140-41.
The receipt of multiple doses of HPV vaccines, Dr. Nemechek maintained, could amount
to an “immunological concussion” sufficient to prime such microglia. Once an individual had
microglia primed to produce cytokines, recovery from the initial insult would be thwarted,
resulting in “continual leakage of cytokines in the brain,” and a “growing level of . . . sympathetic
damage.” Tr. at 90-91. Thus, the ongoing primed microglia would encourage “persistent
inflammation” in the brain, worsening with each subsequent dose of HPV vaccine, until after the
third, when hypoglycemia could result from a person’s now-damaged autonomic nervous system,
resulting in syncope. Id. at 92-93. A “pattern of increasing symptomology” with each HPV dose
would, Dr. Nemechek opined, stand as strong evidence that microglial priming was in fact
occurring. Id. at 157.
To support his contention that “the development of cumulative brain injury from a vaccineinduced inflammatory insult is now a proven fact” (Second Nemechek Rep. at 2), Dr. Nemechek
cited a single article, C. Cunningham, Microglia and Neurodegeneration: The Role of Systemic
Inflammation, 61 Glia 71 (2013), filed as Ex. 74 (ECF No. 32-2) (“Cunningham”). Tr. at 84.
Cunningham is a review article that (through reference to other studies) considers how “systemic
inflammation negatively impacts on chronic neurodegenerative disease,” such as Alzheimer’s
disease, Parkinson’s disease, or amyotrophic lateral sclerosis. Cunningham at 72, 78. It does not
discuss how a vaccine might prime microglia, however, to produce cytokines in a chronic fashion.
Dr. Nemechek also referenced case reports involving the disease rheumatoid arthritis, and a drug
that helped patients improve their autonomic function by blocking a particular cytokine, in order
to corroborate the argument that cytokine overproduction could be pathologic. Tr. at 79.
Dr. Nemechek acknowledged that he could point to no literature that would establish how
a vaccine would initiate a chronic cytokine production process capable of causing injury akin to
what Petitioner has experienced. Tr. at 154. Nevertheless, he did attempt to offer some literature
involving the HPV vaccine that he maintained supported the conclusion that the HPV vaccine had
the potential to cause “changes reflective of abnormal function” in the autonomic nervous system.
Id. at 130. In particular, he relied on an article discussing 40 instances of reported neurologic
symptoms in Japanese girls who received the HPV vaccine between mid-2013 and the first quarter
of 2014. Tr. at 148; T. Kinoshita et al., Peripheral Sympathetic Nerve Dysfunction in Adolescent
Japanese Girls Following Immunization with the Human Papillomavirus Vaccine, 53 Intern. Med
2185 (2014), filed as Ex. 22 (ECF No. 24-7) (“Kinoshita”). Of the 40 subjects in Kinoshita, eight
met diagnostic criteria for orthostatic intolerance, while four met the clinical standard for postural
orthostatic tachycardia syndrome (“POTS”). Kinoshita at 2193, 2198. On cross examination,
however, Dr. Nemechek admitted that (in addition to involving disorders that Petitioner did not
have) the association Kinoshita proposed between the HPV vaccine and injuries involving the
11
sympathetic nerve system, like POTS, has been called into question. Tr. at 131-32.12
Dr. Nemechek similarly cited an article co-authored by Dr. Mark Geier (D. Geier and M.
Geier, A Case-Control Study of Quadrivalent Human Papillomavirus Vaccine-Associated
Autoimmune Adverse Events, 34 Clin. Rheumatology 1225 (2015), filed as Ex. 46 (ECF No. 27-
1)) – an individual whose qualifications to provide expert testimony in Vaccine Program cases
have been consistently rejected in numerous published decisions. Tr. at 134-36; see also King v.
Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 5470787, at *10 (Fed. Cl. Spec. Mstr.
Dec. 13, 2010) (“
n many cases, stretching over many years, special masters or judges of this
court have offered negative comments on the credibility, credentials, honesty, or other aspects of
the testimony or opinions of Dr. Mark Geier”).
Relying upon the above, Dr. Nemechek reviewed Ms. Combs’s record to illustrate how his
theory applied to her circumstances. He asserted that there was nothing in her record before the
first HPV vaccination to suggest she suffered from any form of orthostatic intolerance or syncope
(thereby allowing the inference that the vaccine was a factor in its subsequent development). Tr.
at 82. He deemed Mrs. Howard’s testimony of worsening after the second HPV dose significant,
since that evidenced recurrent microglial priming due to additional exposure to the vaccine,
producing injury that could not heal. Id. at 84. He also pointed to Petitioner’s June 2012 orthostatic
test results, which (among other things) revealed heart palpitations significant enough in rate
increase from sitting to standing to be considered abnormal – and even evidence of POTS. Id. at
87 (referencing Ex. 6 at 55). Tachycardia could, he proposed, establish that Ms. Combs had
experienced underlying autonomic harm. Tr. at 92. And he emphasized that Ms. Combs’s
purported “polycystic ovarian syndrome” (PCOS)13 was understood to precipitate insulin
regulation problems that could contribute to hypoglycemia. Id. at 76.
Dr. Nemechek’s theory did not embrace the diagnosis of vasovagal syncope that
Petitioner’s physicians reached after treating her, and he expressly denied it could explain her
symptoms. Tr. at 124. He agreed that an individual could experience vasovagal syncope without
12 Respondent’s expert, Dr. Low, specifically took issue with Kinoshita as supporting a connection between HPV and
autonomic conditions like POTS, stating that subsequent evaluation of its data by European medical institutions
revealed that the supposed correlation between vaccination and the onset of such injuries could be attributed more to
the age of onset of the subjects rather than time of vaccination, and that the incidence rates of such conditions were
no different than what would be expected for all girls in the relevant age groups – thereby suggesting that any increase
was merely a statistical artifact attributable to “overreporting” rather than establishing a significant and reliable
association. Tr. at 210-11.
13 Polycystic Ovarian Syndrome is a hormonal disorder common in young women of reproductive age, causing the
ovaries to develop small fluid-filled follicles. Symptoms include irregular periods, excess androgen (male hormone),
and polycystic ovaries. The cause is unknown, but long-term complications can include type 2 diabetes and heart
disease. Polycystic Ovary Syndrome (PCOS), Mayo Clinic, https://www.mayoclinic.org/diseasesconditions/pcos/symptoms-causes/syc-20353439 (last accessed on Feb. 2, 2018). Ms. Combs’s medical records
suggest that she was diagnosed with PCOS in early September 2012. Ex. 2 at 7-8.
12
also suffering from autonomic damage, although he also maintained that such damage could cause
it as well. Tr. at 125-26 (citing E. Lambert et al., Sympathetic Dysfunction in Vasovagal Syncope
and the Postural Orthostatic Tachycardia Syndrome, 5 Frontier in Physiology 1 (2014), filed as
Ex 75 (ECF No. 32-3)). Indeed, Dr. Nemechek acknowledged that there were many possible
causes for vasovagal syncope apart from damage to the autonomic system. Tr. at 127-29.
Dr. Nemechek also opined that the timeframe in which Ms. Combs developed syncope was
medically acceptable. He attributed some of her overall course (in which she allegedly began
exhibiting pre-syncope symptoms in March 2012, a month after the second HPV dose, but then
experienced them in an up-down pattern over the next several months) to the “unique feature of
this microglia priming phenomenon,” which became self-perpetuating as chronic cytokine
production began. Tr. at 81-82. But Ms. Combs may reasonably have not realized at first that her
earliest symptoms (for example, the purported dizziness that resulted in her March 2012 fall) were
serious. Id. at 144. Ultimately, he generally referenced Cunningham as supporting the
reasonableness of the timeframe, stating it could possibly support the initiation of neurologic
damage beginning as soon as a week after vaccination. Id. at 145-47.
On cross-examination, Dr. Nemechek acknowledged reliability problems with the part of
his theory that identified microglial activation as a source of Petitioner’s alleged autonomic
damage. He agreed that there was no test that existed to establish microglial activation was
occurring at all, and that Petitioner’s treaters had never performed any testing that might indirectly
or directly confirm this. Tr. at 137-38, 156. He also admitted to holding the belief that a wide
variety of instigating factors that individuals regularly encounter could just as likely cause
microglial activation as a vaccine. For example, a diet deficient in omega-3 fatty acids14 could
result in such activation, and could also be treated with a diet including a different kind of oil that,
while not capable of reversing activation, could at least be “protective” against the purported
inflammation that the activation purportedly encourages. Tr. at 139.
Dr. Nemechek was also unable to deny that his theory had larger deficiencies. Thus, he
could not specifically identify where in Petitioner’s body the alleged sympathetic damage being
caused as a result of the HPV vaccine was occurring (although a charitable reading of his theory
would place it as initiating in the brain). Tr. at 126-27. He could point to no independent,
corroborative evidence that Ms. Combs’s symptoms were the product of cytokine overproduction,
such as inflammation. Id. at 158. He also noted the circularity of his theory, which relied on
objective evidence of orthostatic intolerance (for example, the blood pressure and pulse readings
taken for Ms. Combs in June 2012) to establish the autonomic damage he was alleging to have
14 Omega-3 fatty acids are a category of fats necessary for body cells to properly function. The most common (and
crucial) omega-3 fatty acids are eicosapentaenoic (EPA) and docosahexaenoic (DHA). Omega-3 fatty acids are
typically found in oily fish, such as salmon, tuna, and trout. What Are Omega-3 Fatty Acids From Fish Oil?, Mayo
Clinic, https://www.mayoclinic.org/what-are-omega-3-fatty-acids-from-fish-oil/art-20232583 (last accessed Feb. 2,
2018).
13
occurred – even though he simultaneously admitted that such orthostatic results could be obtained
for a person with a functioning, undamaged autonomic nervous system. Tr. at 119-20, 122. And
he allowed that, although his theory seemed to propose that hypoglycemia in the brain explained
most of Ms. Combs’s syncopal events, she had not been consistently shown to be hypoglycemic
in each episode. Tr. at 123. "