December, 2013

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~ Pennsylvania nurse, who was pregnant, loses her job after declining flu vaccine (read more)

~ Vermont Health Department prefers education rather than mandatory flu vaccination, acknowledges need for parental choice (watch video)

~ Vaccine Accountability and Injury Compensation: Why Not?  (read more)

~ Meningitis B investigational vaccine being pushed into US college students… (read more)

~ Annual Flu Vaccines Could Leave People Vulnerable to Novel Pandemics: Study – Int’l Business Times

 

Physician Cautions Against Flu Shot During Pregnancy

Updated July 1, 2013

Please note: The Department of Health and Human Services’ Healthy People 2020 target for flu vaccine injection into health-care personnel is 90%. Their 2020 target for flu vaccine and pneumo vaccine injection rates is 90% of all adults age >65 yrs. And they are targeting pregnant women. They want 80% to be injected with flu vaccine by 2020 (Sources: CMS, US Gov’t).

At the same time, the Department reports that between 2005 and 2012, flu vaccine injuries have caused a doubling in the number of vaccine injury claims. Flu vaccine injuries now represent 50% of all vaccine injury claims. The most common diagnosis? Demyelinating disorders (Source: DHHS).

This article was originally posted as, “Your Body. Your Baby. Their Flu” by Thinking Moms’ Revolution and has been reposted here with permission from the author, Dr. Kelly Brogan.

flu-shot-while-pregnant

As a conventionally trained, dyed-in-the-wool psychiatrist, I learned that mental illness is a manifestation of an imbalance of brain chemicals that can be largely reduced to too little serotonin and/or norepinephrine, too little dopamine, or messed up excitatory signals at the membrane level.  These deficits required pharmaceutical intervention for repair, just as one of my attendings once patronizingly said to an inpatient post-suicide attempt: if you had poor vision, you would need glasses.  There would just be no way for you to navigate the world without those glasses no matter how much you wanted to.

I don’t believe this anymore.  I’ve left the church and I’ve run into the woods where I’m listening to the sermons delivered by the natives there…those who believe in a natural order, in the body’s capacity to heal, in the sanctity of a clean environment, and in the interconnectedness of spirit, nourishment, and movement.  But this was a journey for me.  I started to open my eyes during my first pregnancy, when I began my fellowship in treating pregnant and postpartum women. I learned how to consent them, and what informed consent really looked like, around treatment with psychotropics in pregnancy and lactation. Many of these women had been on medication for the better part of their adult lives and either found themselves pregnant, were planning to become, or developed symptoms despite treatment.  I poured over the literature for hundreds of hours, memorizing authors and statistics, distilling complex analytic concepts, and building a rational path, with some forks in the road, for these women to travel.  I helped them to understand the known risks, the unknown risks, the alternatives, and allowed them to assess the perceived benefits.  This process would often culminate in a 90-120 minute session involving all and any interested family members and extensive communication with other providers – general psychiatrists, obstetricians, therapists, so that everyone was on the same page.

You can imagine that it began to rub me the wrong way when these very same patients would come in and casually mention that they had gotten a “flu shot”, often without a single medical provider involved (at CVS!), no consent, no discussion.  I didn’t know much about the flu vaccine other than that when I entered medical school, pregnant women and babies were in the “contraindicated” demographic.  I also knew that doctors, residents and med students almost never got the flu shot voluntarily.

I began to look into the literature through my lens of best quality pregnancy data: a prospective cohort study, well-controlled, looking at outcomes during pregnancy, at birth, and up to 5-7 years of childhood age or longer. I investigated the ingredients (egg proteins and associated unidentified viral DNA from this animal tissue, the allergen gelatin, polysorbate 80 which crosses the blood brain barrier, the carcinogen formaldehyde, the detergent triton x100, sucrose, resin, the antibiotic gentamycin, and thimerosol/mercury) and found that no study has looked at the effect of injecting any one of the ingredients, let alone the combination.  I was hoping to find large studies done annually for each preparation assuming that if there were 25,000 cases in the literature of SSRI exposure, there must be at least that for something formally recommended to pregnant women.  Hereinlies the important philosophical leap:  women are educated to avoid elective exposures to medication in pregnancy.  When there is an indicated intervention, medical, pharmaceutical, surgical, the personal risks and benefits are weighed of treatment vs no treatment vs alternatives.  But, here we have a one-size-fits-all recommendation with no risk-stratification according to immune status, personal medical history, genetic risk factors, or comorbidities.  A formal recommendation of a category C intervention whose package insert states:

“Animal reproduction studies have not been conducted with influenza virus vaccine. It is also not known whether influenza virus vaccine can cause fetal harm when administered to a pregnant woman. Although animal reproductive studies have not been conducted, the prescribing health care provider should be aware of the recommendations of the Advisory Committee on Immunization Practices. The ACIP states that if used during pregnancy, administration of influenza virus vaccine after 14 weeks of gestation may be preferable to avoid coincidental association of the vaccine with early pregnancy loss.”

Who is blowing air into this trumpet? I think we know.

To this day, I remain appalled at the double-speak on the part of the CDC around this intervention that has been conclusively found to be ineffective and dangerous in the general population and is grossly understudied in the pregnant population. Here are some tidbits about vaccinating for influenza:

• As Dr. Lawrence Palevsky, an enlightened pediatrician, discusses in his writings and patient education, we are awash in viruses and bacteria. Exposure does not equal infection. Presumption that 4 strains (the three chosen for the vaccine and the H1N1) are worthy of specific action is not based in evidence, nor common sense.

• Incidence of flu at the population level is grossly inflated as a fear-mongering tactic. When patients present with flu-like symptoms, they are rarely diagnostically confirmed as being Influenza type A or type B, and the vast majority of the time, may be neither. A brilliant 7 year old assessment by Ayoub and Yazbak states:  “In general, most symptoms of the “flu” are not caused by influenza virus but by a variety of noninfluenza viruses, bacteria, other infectious organisms, or even noninfectious conditions. According to the CDC, only about 20% of the cases of ILI are actually caused by the influenza virus. If this is true, then theoretically only 20% of all cases of ILI are preventable by influenza vaccination, and only when there is a perfect antigenic match between the vaccine strain and the circulating virus. Furthermore, even a perfect antigenic match does not guarantee an adequate antibody titer, nor does measurable antibody assure protection.”

• A Cochrane analysis of 50 studies (15 of which were industry funded) demonstrated that in the likely event that the included strains did not match circulating virus, there was a 2% incidence in the unvaccinated vs a 1% incidence in the vaccinated population of presumed influenza. There was no effect of vaccination on hospitalizations of complications. This review also discusses concerning signal for incidence of Guillain-Barre Syndrome (autoimmune paralysis).

• Pregnant patients are not at higher risk, do not die more frequently or suffer more complications from influenza. Ayoub and Yazbak dispute the two non-rigorous studies that are the basis for the claim that pregnant women suffer impaired immunity. Additionally, based on this study of 250,000 pregnant women in Australia and New Zealand, only 0.03% were admitted to the ICU for H1N1 complications and there is suspicion that obesity was the underlying driver of these complications.

• Analysis of CDC statistics reveals that there is 0-1 death per year of identified influenza in reproductive age women from 1997-2002. By comparison, vaccine-induced Guillain-Barre incidence is estimated at 20-40 annually.

• Documented risks of vaccination as sanctioned by a neat little government table include vasculitis, seizure, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia.

• Common side effects include symptoms like fatigue, fever, body and headaches (aka…the flu!) In the pregnant population, the largest conducted assessment of 49, 585 pregnant women in the Kaiser Permanente Healthcare System over 5 flu seasons demonstrated that no deaths occurred from influenza in the vaccinated or unvaccinated population, and that even in an “at risk” asthma subpopulation, vaccination did nothing to minimize hospitalizations, as the only admissions (0.018%) were for pneumonia. Two wonderful posts on this subject explore the applicability of this study to decision-making for the pregnant woman – Aviva Romm MD, holistic women’s health practitioner and Jennifer Margulis PhD, investigative journalist and women’s health advocate.

So, if we do not know true incidence because we are lumping pneumonia with presumed influenza and typically confirming neither by standardized diagnosis, we have evidence of inefficacy through Cochrane, through Kaiser, and even here at the Lancet where they admit that efficacy was “moderate”, “variable”, “reduced”, or “absent” depending on the season, then at what cost are we administering this intervention? Well, I’m just going to go ahead and assume that if there were even a one in a billion chance of life long paralysis or death, most people would take their chances with a week of the flu instead. And these are obvious adverse events.

Perhaps the most concerning study I came across implicated the influenza vaccination in a strong inflammatory response in the pregnant woman. Here, the investigators identified significantly elevated CRP two days after vaccination and a similar (but non-significant) pattern for TNF-alpha. They address the notion of vulnerable subgroups as being more important than generalizable findings.  For example, the most depressed women at the time of vaccination exhibited an increased inflammatory response to vaccination – suggestive of inflammatory priming by the depressed state or an impairment of the inflammatory attenuation that is typical of a pregnant state. I study and lecture nationally about the inflammatory underpinnings of antepartum and postpartum mood and anxiety disorders. Inflammation in pregnancy is something I am not interested in actively promoting. If a woman’s real risk of developing severe flu is vanishingly remote, comparing that to active exposure to a CRP and IL6 elevating injection approximates malpractice.
This immune activation has been implicated, not only in development of postpartum depression, but in abnormal child behavioral development including autism and schizophrenia. IL6, the very cytokine that was specifically raised by the flu vaccine, is the one that has been implicated in rodents in abnormal behavior in offspring. In this study, the H1N1 vaccine (a popular version since 2009) was found to induce oxidative stress (the driving force behind every chronic disease we now struggle with as a population). In a study by Munoz et al intended to affirm the safety record of influenza vaccines in the pregnant population, careful review of the results indicates that infants who died after birth were not included in the statistical analysis that determined there was no risk to offspring, and vaccinated women suffered higher rates of preeclampsia, gestational diabetes, and hypertension (all inflammatory in nature).

Maternal infections may promote a similar (or worse depending on biochemical individuality) inflammatory response and have been associated with the development of schizophrenia and cerebral palsy in children exposed in utero, but if the vaccine is not only ineffective at preventing infection, but promotes its own inflammatory response, and potentially other acute and long-term adverse effects, what are we doing here?

As Ayoub and Yazbak conclude: “Because the benefits of influenza vaccination during pregnancy appear lacking, a safety-benefit analysis should not tolerate any risk to vaccine recipients or their offspring, even at a theoretical level.”

I couldn’t agree more.

A red flag was also raised for me, this past flu season when I received a Department of Health advisory in my inbox that stated that pregnant woman may be given thimerosol containing immunizations in the setting of a thimerosol-free vaccine shortage. Tough to make sense of the prohibition of tuna, but the injection of 25 mcg of ethylmercury (the EPA’s allowable limit is 0.1ug/kg/day which is far exceeded by this amount in an average weight female) into the tissue of a woman growing a fetus. Especially when the only primate study that has ever been done on vaccines demonstrates that injection of neonates with thimerosol resulted in definitive abnormal neurodevelopment in these animals.

Mercury has been dubbed the most toxic element on the face of the earth. Any agency that sanctions its active delivery to the most vulnerable in our race is not one I plan to follow blindly. I encourage my patients to do their own homework on all of the exposures that their bodies encounter. My homework on this one left me thrilled that I know of other ways to promote immunity and resilience, and have never had the flu in my life despite more than 13 years of hospital exposure and 4 years of parenting. Sleep, stress-management, whole, colorful, and fermented foods, garlic, ginger, vitamin C, sunshine (or NYer’s sunshine – vitamin D3), a high quality multivitamin/mineral to compensate for any nutrients lost in transit and used up in managing toxic exposures. There’s a better way.

This better way embraces periodic sickness as part of comprehensive wellness. The only way to truly protect ourselves and our infants is through natural immunity bolstered by wild-type exposure in the community. Once you have a particular flu strain, when it comes around again, you will be uniquely protected, and you will pass on this protection to your newborn. There is no replacement for this. We cannot outsource our health to pharmaceutical companies. They just don’t know what health is.

~Kelly Brogan, MD

(Sign up for Doctor Brogan’s Newsletter, HERE).

As an undergraduate at M.I.T, Dr. Brogan studied Cognitive Neuroscience and worked with Harvard undergraduates to create a public forum for the discussion of alternative medicine, directing conferences for the Hippocratic Society. She attended Cornell Medical School where she was awarded the Rudin Scholarship for Psychiatric Oncology and began her work in Reproductive Psychiatry, which she went on to train in during her residency at NYU/Bellevue. A strong interest in the interface of medicine and psychiatry led her to pursue a fellowship in Consultation Liaison/Psychosomatic Medicine at NYU/Bellevue/VA Hospital. Since that time, she remains on faculty and has focused her efforts on her private practice where she cares for patients with medical illnesses, as well as women at all stages of their reproductive life cycle. A passion for holistic living, environmental medicine, and nutrition are the bedrock of her functional medicine practice. She has published in the field of Psycho-Oncology, Women’s Health, Perinatal Mental Health, Alternative  Medicine, and Infectious Disease. She is Board Certified in Psychiatry, Psychosomatic Medicine, as well as Board Certified in Integrative and Holistic Medicine.

***

See also:

Influenza Vaccination During Pregnancy: A Critical Assessment of the Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Natural-Pregnant-Belly

New Flu Vaccine: What is in it?

Mercury content (μg Hg/0.5 mL): http://www.cdc.gov/flu/protect/vaccine/vaccines.htm

Other ingredients in the flu shot: http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf

Vaccine-Associated Enhanced Respiratory Disease: Vaccination may make flu worse if exposed to a second strain; http://medicalxpress.com/news/2013-08-vaccination-flu-worse-exposed-strain.html

Study: seasonal flu vaccination increases risk of other lab-conf respiratory infections; http://cid.oxfordjournals.org/content/early/2012/03/13/cid.cis307.full.pdf+html

Annual Flu Vaccines Could Leave People Vulnerable to Novel Pandemics; Article about Study – http://www.ibtimes.com/annual-flu-vaccines-could-leave-people-vulnerable-novel-pandemics-study-371160

One must visit the publicly shared FDA documents on vaccine approvals where you will find, inside the “Summary Basis of Regulatory Action letter, and inside the following information about the vaccine ingredients:

Like the licensed trivalent influenza vaccines, Fluzone Quadrivalent is a sterile suspension prepared from influenza viruses propagated in embryonated chicken eggs. The virus is harvested from the allantoic fluid, inactivated with formaldehyde, concentrated, purified in a linear sucrose density gradient solution using a continuous flow centrifuge, and finally chemically disrupted using a non-ionic surfactant, Octylphenol Ethoxylate (Triton® X-100) to produce a “split virus”. This split virus is then further purified and suspended in sodium phosphate-buffered isotonic sodium chloride solution. The upstream manufacturing processing of Fluzone Quadrivalent is identical to that for Fluzone High-Dose, and differs only in the formulation of the final bulk to a lower concentration per mL in order to achieve a 15 μg HA per strain/dose at a volume of 0.5 mL. Data derived from 3 consecutive batches of final bulk product demonstrated validation of the Fluzone Quadrivalent formulation process.

 

 

From FiercePharma:

 

According to the U.K. research firm, Sanofi’s Fluzone QIV, and other quadrivalents, should eclipse sales of three-strain vaccines over the next few years. It forecasts sales of Sanofi’s product should bring in $384 million in 2022 and predicts compound annual growth of nearly 14%. It said Sanofi’s Fluzone franchise of influenza vaccine products “is expected to help position the multinational vaccine manufacturer as a formidable player in the U.S. market.”Of course, it already is a formidable player. According to EvaluatePharma data, it is the top vaccine seller globally, with 2012 vaccine revenues topping $5.5 billion. Sanofi’s Fluzone/Vaxigrip flu shot is already one of the two top-selling vaccines along with PENT Act-HIB, a DTPq, Hib and polio vaccine. EvaluatePharma says those two should remain among the top 3 best sellers for another 5 years.

 

 

]);"  href="https://www.vaccineshoppe.com/image.cfm?doc_id=12799&image_type=product_pdf"><img alt="A new influenza vaccine has been FDA approved, expecting to rake in the cash for Sanofi. Are you allowed to know what is in it?</p><br /><br /><br />
<p>http://www.fiercepharma.com/story/sales-upside-sanofis-fluzone-quadrivalent-looks-strong/2013-06-12</p><br /><br /><br />
<p>Note page 1: CONTENTS*...*"Sections or subsections omitted from the full prescribing information are not listed."</p><br /><br /><br />
<p>https://www.vaccineshoppe.com/image.cfm?doc_id=12799&image_type=product_pdf</p><br /><br /><br />
<p>"According to the U.K. research firm, Sanofi

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How Effective is the Flu Vaccine?

The best and most comprehensive review on flu vaccine was released just recently. This study seems to have been originally designed to secure more government funding for influenza vaccines. But the results are chilling. The Center for Infectious Disease Research and Policy (CIDRAP) spent several years studying available flu vaccines, and concluded in their official press release that, “policy shifts toward a universal recommendation for influenza vaccination often were based on professional judgment and not on sound data.”

View the report as a powerpoint presentation, here.

Read the full report from CIDRAP at the University of Minnesota here.

The lead author of this important, (government-funded??) study, Dr. Osterholm, is director of the Center for Infectious Disease Research and Policy (CIDRAP), director of the NIH-supported Center of Excellence for Influenza Research and Surveillance within CIDRAP, a professor in the Division of Environmental Health Sciences, School of Public Health, and an adjunct professor in the Medical School, University of Minnesota. He is also a member of the Institute of Medicine (IOM) of the National Academy of Sciences and the Council of Foreign Relations. In June 2005 Dr. Osterholm was appointed by Michael Leavitt, Secretary of the Department of Health and Human Services (HHS), to the newly established National Science Advisory Board on Biosecurity. In July 2008, he was named to the University of Minnesota Academic Health Center’s Academy of Excellence in Health Research. In October 2008, he was appointed to the World Economic Forum Working Group on Pandemics.

Also, more information on how well the flu vaccines work can be found in the Cochrane Collaboration studies. This from coalition member Dorian Yates:

In terms of the effectiveness of the flu vaccine, the international Cochrane Collaborative, which reviews scientific data for accuracy and lack of bias, has conducted numerous scientific reviews on the efficacy of flu vaccines. Its studies have found that there is no compelling data to demonstrate the efficacy of the vaccine in preventing flu nor its ability to affect lost working days.

In its review of health care workers and the elderly:
“We conclude that there is no evidence that only vaccinating healthcare workers prevents laboratory-proven influenza, pneumonia, and death from pneumonia in elderly residents in long-term care facilities.—
“http://onlinelibrary.wiley.com/doi10.1002/14651858.CD005187.pub3/abstract

Its review of 75 studies on the efficacy of the flu vaccine to prevent flu in the elderly, the Collaborative found, “Due to the poor quality of the available evidence, any conclusions regarding the effects of influenza vaccines for people aged 65 years or older cannot be drawn.”
—http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004876.pub3/abstract

Cochrane also reviewed studies on the effectiveness of the vaccine in preventing flu in healthy adults. The review found that, “Vaccine use did not affect the number of people hospitalised or working days lost but caused one case of Guillian-Barré syndrome (a major neurological condition leading to paralysis) for every one million vaccinations. —”http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001269.pub4/abstract

While assessing the ability of flu vaccine to prevent flu in healthy children, the review concluded that, “In children under the age of two, the efficacy of inactivated vaccine was similar to placebo.”—http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004879.pub4/abstract