(http://www.who.int/csr/don/2009_10_09/en/index.html)
In the U.S. there have been approximately 147 pediatric confirmed deaths as of Oct 9 which is greater than the number in the last season.
http://www.cdc.gov/flu/weekly/index.htm#MS
For the current season, the proportion of deaths due to pneumonia and influenza is at the epidemic threshold as of the week ending October 3rd.
http://www.cdc.gov/flu/weekly/index.htm#EIPNVSN
Because the number of deaths according to CDC figures has reached epidemic threshold
and there is data that serious cases have a fatality rate above five percent, healthy adults who come into contact with children, those with families, pregnant patients, and healthcare providers should be vaccinated, given the safety and lack of known adverse effects of previous seasonal influenza vaccine campaigns, the preliminary safety data from the published trials (Clark/Stephenson in the U.K., Greenberg in Australia). Children who have never been to school or who are younger
and have no immunity to previously circulating strains, immunosuppressed patients, asthmatics, smokers, patients with lung or heart disease, cancer and diabetes SHOULD DEFINITELY be vaccinated.
2. CSL is the only vaccine I have seen published data on. Unfortunately, the CSL vaccine data showed 31.7 percent with antibody responses at baseline suggesting that either previously circulating viruses, previous seasonal vaccine, or concurrent infection stimulated immunity. Evidence of an antibody response is not the same as evidence that the vaccine is efficacious in protecting clinically against H1 N1.
Neuzil's Editorial: http://content.nejm.org/cgi/content/full/NEJMe0908224
Greenberg CSL data: http://content.nejm.org/cgi/content/full/NEJMoa0907413#F
3.There are still risks of unknown adverse effects, these vaccines have not been
tested in large numbers.
4.I don’t feel the formaldehyde risk is significant
Young patients ARE dying
The concern about this outbreak is that young patients are susceptible.
http://cdc.gov/h1n1flu/surveillanceqa.htm#12
In this analysis of patients confirmed to have H1 N1 by the CDC, most mortalities have occurred in younger healthier age groups.
During the current flu season as of Sept 26 2009, 128 pediatric deaths have been reported, although the percentage of deaths due to pneumonia and influenza is less than the epidemic threshold which is less than six point four percent.
The CDC reported on three pregnant women, one of whom, a 33 year old previously healthy woman, died.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5818a3.htm
A group in Mexico City led by Perez Padilla reported on 18 PCR confirmed cases of novel H1 N1, 12 requiring mechanical ventilation and seven deaths. Even though these were a small selected susbet of patients with influenza like illness, half of the patients were between the ages of 13 to 47. All deaths were in patients younger than fifty years old.There goes the argument that the Mexican patients simply die because of poor care there.
N Engl J Med 2009;361:680-9.
A recent Australian paper published Oct 9 which is significant since the Southern Hemisphere is at the end of their flu season found that there are 9 times as many pregnant women admitted to the ICU as would be expected from their proportion of the population, although it doesn't say how many actually required mechanical ventilation, it is obvious that pregnant women would reflect the most conservative management practices.
http://content.nejm.org/cgi/content/full/NEJMoa0908481#F4
A review published Oct 9 of 272 American patients patients admitted to the hospital with confirmed H1N1 by PCR found that 7 percent died. Of course, this is in the sickest population and doesn't reflect the majority of cases.
http://content.nejm.org/cgi/content/full/NEJMoa0906695
A mathematical model published in the Journal Science suggests that the best vaccination strategy would focus on children and their parents and that the strategy recommended by the CDC is suboptimal.
http://latimesblogs.latimes.com/booster_shots/2009/08/h1n1-flu-shot-vaccine.html
http://www.sciencemag.org/cgi/content/abstract/1175570
Vaccines
Vaccines for novel H1N1 have been developed and tested on limited numbers of patients. The vaccine used to make this strain is related to the more than 700 H1N1 strains. Only one circulating strain is unrelated. There is abundant safety data suggesting that if this H1N1 strain is like the other seasonal influenza vaccines there should be no serious adverse effects.
From Australia, Greenberg et al report on a new H1N1 vaccine, which was tested on 240 healthy adults over the age of 18, almost half of whom had previously received a seasonal flu vaccine (not H1N1). The vaccine, produced in Australia, was effective in producing a brisk response in more than ninety five percent of subjects at titers of 1:40 in 21 days, although many subjects had baseline titers suggesting some cross reactivity between the current H1N1 type and previous vaccines or exposures to previously circulating flu viruses. This vaccine is the CSL Biotherapeutics vaccine and is approved for use in the USA for ages 18+.
http://content.nejm.org/cgi/content/full/NEJMoa0907413
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf
From the United Kingdom, Clark and Stephenson (with support by Novartis) report on a monovalent vaccine tested in one hundred and seventy five adults grown not in hens eggs but in cell culture which could be produced faster. It is delivered with an adjuvant (an oil in water emulsion) which has been reported in a few cases to cause vasculitis although more than 40 million doses have been given in Europe with no known adverse effects. It is not in current use.
http://content.nejm.org/cgi/content/short/NEJMoa0907650v1
The Novartis vaccine approved for use in the USA does not contain adjuvants, it is approved for children 4 years and older, and comes in either single dose vials which have less than 1 mcg of thimerosal or multidose vials which have twenty five micrograms.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf
Medimmune produces a FluMist vaccine used for children and adults above age 2 which can be given intranasally. It has no thimerosal or formaldehyde and is a live attentuated but genetically modified virus. Risk versus benefit should be considered before giving to patients with active asthma/wheezing or those who are immunosuppressed (which is silly since these are the at risk groups). Trials found an increase in wheezing and hospitalization in some groups.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf
The information on the Sanofi vaccine is here. According to the package insert the 2003 04 formulation (but not the current one) was tested on 19 children aged six months to 23 months of age. Only slightly more than half of children achieved immunogenicity after 21 days as reported by a response of titer greater than 1:40.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf
What Defines Responsible Professional Behavior and Advice?
Dr Tim O’Shea, a licensed chiropractor in California, has written about the H1N1
controversy. On his website, “The Doctor Within”, he states that With no swine flu and no epidemic, the solution is stop watching the nonsense coming out of your TV, stop reading internet stories and stop reading newspaper and magazine articles about swine flu. Be assured it will be over just as soon as all the money for the vaccine and the antiviral drugs gets spent. Live your life; with all the real problems we have today, we don't need any imaginary ones.
Swine flu or H1N1 or whatever they decide to call it next week will soon be fading off into the boneyard of plague hysteria memorabilia, along with smallpox, anthrax, SARS and Avian flu. The sales team did a phenomenal job, getting maximum mileage out of the ol' global pandemic spectre by applying the term to regular flu. We must applaud genius, and learn to recognize it. This certainly won't be the last faux pandemic - there's an inexhaustible supply.
We can learn from this experience how difficult it is to get verifiable information about important health issues. The irresponsible media has proven once again beyond a doubt whose agenda they represent. Vaccines are a serious decision for everyone. To get sound information from scientific sources not dependent on drug companies requires some amount of diligence. The new 13th ed. of the vaccine book [4] offers many such resources. This is the only way we can make a truly informed decision on such an important issue as what medicines and drugs we will allow into the bloodstream of our children.
http://www.thedoctorwithin.com/swine/swine-flu.php
I concur with Dr. O’Shea that it is difficult to get verifiable information about health issues. However, I disagree that there is no swine flu and I think it is irresponsible of Dr. O’Shea to tell readers to stop watching TV, reading internet and news sources and simply buy his Vaccine Book.
However, he makes some good points about misinformation in the media here...
http://www.thedoctorwithin.com/swine/swine-flu-vaccine.php
Is it Unethical to Treat Patients if You are Unvaccinated?
The responsibility for health decisions lies with the individual. A health care provider is only one of many people who will come into contact with patients. At the minimum I think it is ethical for healthcare providers to use respiratory precautions.
Goldfrank and Respiratory Isolation at NEJM
http://content.nejm.org/cgi/content/full/NEJMp0908437
If a patient wishes to be truly protected, they should seek vaccination, however there is no guarantee it will be effective and there is always a risk.
There is also nothing to stop patients from seeking healthcare providers who are vaccinated over those who are not.
Only you can decide for yourself if the benefits of vaccination outweigh the risk. In this case the principles of autonomy and non maleficience trump beneficience.
I can only describe as ridiculous the argument by Caplan at MSNBC that healthcare workers should "man up" to defeat H1N1. This assumes beneficence from the vaccine when it is unproven at the expense of provider autonomy and non maleficience.
Being an ethical provider and making responsible healthcare decisions demands that I counsel patients on their risks and what the benefits of a treatment would be so that they can decide, just as I would do for myself.
It would be unethical for me to just jump on the bandwagon without analyzing whether vaccination is necessary. It's a different story for each individual. Do I think young children should be vaccinated? yes. Do I think high risk immunosuppressed patients, pregnant patients and asthmatics should be vaccinated? yes.
Do I think otherwise healthy adults and teens like those at St Francis Prep should be vaccinated? no do I think healthcare workers should be vaccinated? no. while I agree we are at HIGH risk (not trivial) I believe we (like most healthy adults and teens)most likely already have substantial immunity based on our previous exposure to the flu every season and vaccination every year to whatever circulating virus is around. I don't think there is data proving that provider vaccination compared to non vaccinated providers reduces risk of pneumonia and influenza deaths in patients.
in Greenberg's NEJM study, there was an antibody response in thirty one percent of patients at baseline (BEFORE vaccination). where did that come from?
http://content.nejm.org/cgi/
Right now H1N1 is so widespread that it is equally likely that a patient could get the disease in the playground, on the bus, at school, or elsewhere. The horse has already left the barn..
Donald Rumsfeld
Something that greatly disturbed me when I was doing research was that Donald
Rumsfeld was on the Board of Directors and owns stock in Gilead Biosciences,
which is the maker of Tamiflu (Oseltamivir). Draw your own conclusions. http://www.gilead.com/wt/sec/pr_933190157/http://www.snopes.com/politics/medical/tamiflu.asp H1N1 history
H1N1 has been around since 1918 in one strain or another, and there are many
different “strains”, since H1N1 simply identifies the hemaglutinin and
neuraminidase proteins in the virion, which have varying sequences. The virus
jumps back and forth between birds, pigs and humans, and the different genomes
in the virus mix and match to create different strains. The World Health
Organization selected a strain to use as a reference virus for the vaccine,
(A/California/07/2009 (H1N1). There are no less than seven hundred and ninety four 2009 influenza A H1N1
related viruses. Only one out of seven hundred and ninety five H1N1 viruses
has reduced titers against the vacine reference strain. http://www.sciencemag.org/cgi/content/full/325/5937/197?ijkey=a4bfd8fc46c55cb106e27bf83a98de4edcee3346 http://www.cdc.gov/flu/weekly/index.htm#MS http://virus.stanford.edu/uda/ TestsNot all patients need to be tested for H1N1, if a patient is positive for
influenza A in a rapid antibody based test and the patient has no risk factors
and is otherwise healthy and will not be admitted to the hospital, testing will
not likely alter treatment decisions. If a patient is to be admitted to the hospital and has risk factors such as young
age, pregnancy, is immunocompromised, diabetic or has lung disease, viral testing
should be considered. The diagnostic test of choice for HIN1 is PCR, which stands for polymerase chain
reaction, which differentiates between different subtypes of H1N1. Kary Mullis
invented PCR. http://www.karymullis.com/pcr.shtml Kary Mullis states on his website for his company Altermune that he is planning on
attaching one of his epitope molecules to the influenza virion to allow it to be
phagocytosed. He is not a vaccine manufacturer but he has an eonomic interest and
stands to gain from this. There is no thimerosal. No formaldehyde. Not a vaccine in the traditional sense.
What’s the catch? http://www.karymullis.com/altermune.shtml Proof that H1N1 is real?Given that Rumsfeld has stock in Tamiflu and only hundreds have died is it fair to
ask if the H1N1 thing is simply an orchestrated stunt of the government to stoke
fear and sell tamiflu and vaccines? If so, how do we explain the origin in Mexico and the initial infections in American
high school students?
You may recall that Kary Mullis supported Duesberg’s theory in the 90’s that AIDS
was not caused by HIV, rather it was due to toxic drugs. Now why hasn’t Duesberg
or Mullis had anything public to say about H1N1 being a hoax? http://www.duesberg.com/ There is no doubt that HIV medicines are toxic. It makes sense that a prominent
scientist who at one time supported the idea that HIV doesn’t cause AIDS does not
have more to say about the current H1N1 controversy, particularly since he has a
vested interest in the game. But there are enough reputable scientists in the United States and around the
world doing PCR that we know that H1 N1 exists. To state it doesn’t ignores a
LOT of scientific evidence. It would be easy to assume the CDC primers and PCR technique are suspect,
especially since H1N1 was originally isolated as an unsubtypable strain in
reports by laboratories performing PCR on samples prior to being sent to the CDC.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5818a3.htm
Independent labs outside the US in Canada and Ireland have independently confirmed
H1N1 exists. J Clin Virol. 2009 Jul;45(3):196-9. Epub 2009 Jun 10.Development of a real-time RT-PCR for the detection of swine-lineage influenza A
(H1N1) virus infections. Carr MJ, Gunson R, Maclean A, Coughlan S, Fitzgerald M,
Scully M, O'Herlihy B, Ryan J, O'Flanagan D, Connell J, Carman WF, Hall WW.National Virus Reference Laboratory, University College Dublin, Dublin, Ireland. J Clin Microbiol. 2009 Sep 30. [Epub ahead of print]Switching gears for an influenza pandemic: validation of a duplex RT-PCR for
simultaneous detection and confirmation of pandemic (H1N1) 2009. Leblanc JJ,
Li Y, Bastien N, Forward KR, Davidson RJ, Hatchette TF.
Novel Influenza A (H1N1) Virus Infections in Three Pregnant Women --- United States, April--May 2009
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5818a3.htm
The source of the virus is uncertain.
The virus became a concern in the United States only after American high school students at St Francis Preparatory School in Queens returned to the US from a spring break trip to Mexico. They sought medical attention at their school and specimens were sent to the CDC after the New York City Department of Health sent investigators to their school. All of the American children had mild illness and none died. The CDC and other investigators have performed PCR on 42 of the 44 specimens confirming that the novel H1N1 virus was present in swabs taken from the nasopharynx.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5817a6.htm
An analysis of airline travel patterns from Mexico in 2008 (the year before the outbreak) found a correlation between the leading destinations from Mexico and the importation of H1N1. The point made by Laurie Garrett in “A Coming Plague” is that international airline travel is a root cause which creates mixing of viral genomes that would not otherwise be “stirred up”.
Bacterial coinfection is a factor
Strep pneumoniae is identified in approximately a third of cases, and vaccination for pneumococcus (the most common bacteria causing pneumonia) is reasonable.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5838a4.htm
Toxic ingredients.
The only vaccine without formaldehyde AND thimerosal is the live attenuated MedImmune vaccine.
However, the amount of formaldehyde you pick up from the vaccines is less than the amount you get painting your nails or bringing home new clothes from the store. Single dose vials are available without thimerosal.
Thimerosal is a mercury containing preservative in vaccines.
Although there is about twenty five micrograms of thimerosal in those vaccines which use it as a preservative, the metabolite of thimerosal is ethylmercury. There is no evidence that ethylmercury has the same neurotoxic effects as methylmercury.
The FDA standards for safe levels of methylmercury are 0.1 micrograms per kilogram per day which for a 100 kilogram adult would be 10 micrograms per day. There are no FDA standards for ethylmercury.
Old studies from the 1930’s show that ethylmercury can be quite toxic, although some studies in children show that ethylmercury is rapidly cleared.
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
Formaldehyde
Vaccines contain formaldehyde, approximately 100 micrograms per dose. Formaldehyde is a toxic fixative, a product of combustion and a major component of smog, it can also be formed from the oxidation of methane. It is found in pressed wood such as plywood, resins, latex paints in cosmetics and fingernail polish, and in permanent press fabrics, paper towels and paper bags. It is a flammable gas at room temperature. It is metabolized to formate by formaldehyde dehydrogenase, this happens quickly and it has a short half life when injected intravenously. Every student who has every performed an anatomy dissection can testify to the pungency of formaldehyde when inhaled but there is no available data on the pharmacokinetics of formaldehyde injected into a muscle.
Elaborate and seemingly cruel studies performed in 1983 by Jeffcoat studied the effects of radio labelled formaldehyde applied to the skin of monkeys. The formaldehdye was not well absorbed into the blood.
To get a sense of perspective on how much 100 micrograms of formaldehyde is, levels of formaldehyde given off by household products can be assessed. Nail polish gives off approximately 21,000 micrograms of formaldehyde per square meter per hour. New unwashed clothing gives off between fifteen to five hundred and fifty micrograms per square meter per day. Paper grocery bags give off 0.4 micrograms per square meter per hour.
http://www.atsdr.cdc.gov/toxprofiles/tp111.pdf
Formaldehyde is approved by the FDA for use as a food additive at 2 and a half kilograms per ton of poultry feed to combat salmonella.
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm127665.htm
The FDA reports that some aquaculture producers (fish farms) have (illegally) been using chemical grade formaldehyde as an antiparasitic.
http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm110108.htm
What DO the Pediatricians Say?
The American Academy of Pediatrics advises against using thimerosal containing vaccines in pregnant women, particularly since mercury may have unknown effects on brain development in utero. However they hedge their bets and say that the risks should be balanced against the benefits of vaccination.
http://pediatrics.aappublications.org/cgi/reprint/104/3/570
Interestingly, the American Academy of Pediatrics states that the amount of formaldehyde in vaccines is safe, although no references are provided.
