Safe and Effective?

It’s a marketing statement – safe and effective. Stop and think about it. What does that really mean? Is it a statement of absolute truth? Is it even marginally true? When medical professionals toss that statement out to their patients without context and objective information they’re violating patient trust and the obligation to provide informed consent. They are also exposing people to harm without offering a choice in whether to participate.

I’m writing this to my fellow medical professionals, asking you to take a few moments to peel away the layers of rhetoric, emotion, and paternalism. Let’s take an objective look at the issue of vaccinations. Regardless of the argumentative topics of herd immunity or the morbidity of disease, it is well accepted that we have an obligation to provide our patients with informed consent before we expose them to potential harm. It’s a term that is thrown around a lot. It rolls off the tongue easily enough – but do we put any meaning behind it?

The obligation to provide informed consent:

The preeminent medical society in our country, the AMA, lays this issue out clearly: Informed consent is a basic policy in both ethics and law that physicians must honor. So what does that look like? Well, the medical professional needs to “present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice”, and “the patient should make his or her own determination about treatment”. Now consider this: Federal Law requires vaccine providers to give specific vaccine information statements to patients for each vaccine administered prior to each dose. Of course, handing a parent a two page document with a bunch of complex terminology right before giving a shot is not an effective way to communicate important information – the right thing to do is to sit down with that person in a one-on-one setting and actually discuss the information.

So how good are we at giving patients the facts and discussing the risks versus benefits of vaccination? As a Public Health specialist, who has developed and run major vaccination programs for the Army I conclude – we are not doing very well, and we are not doing right by our patients.

 How safe are vaccines?

Vaccination against communicable disease is a priority for the Federal government. U.S. Code 42 § 300aa–1 states, “The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization”. OK, seems like a reasonable statement – I don’t have a problem with that. But now look at the very next part of that opening statement, “and to achieve optimal prevention against adverse reactions to vaccines”. Pay close attention here. That federal law does not say that vaccines will be made to have no adverse reactions. Optimal prevention: an interesting and slippery term. By whose definition? Since this is public health law the priorities and goals are formed around groups, not individuals. Optimal outcomes for the group may well cause harm to individuals. Federal law has absolved vaccine manufacturers of all liability, because the vaccine manufacturers and lawmakers knew that individuals were being done unavoidable harm. “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable”.

Part of formalizing the national vaccination strategy was a law passed in 1986. That law removed liability from both manufacturers and those who administer vaccines to patients. The law states, “There is established the National Vaccine Injury Compensation Program to be administered by the Secretary under which compensation may be paid for a vaccine-related injury or death.” Since 1988, over 15,000 claims for injury and death have been filed and 3981 were compensated.  Over $3 billion paid out in settlements.

So how safe are the vaccines that we administer? Health and Human Services is proud to tell us that in the time period for the statistics above 2,236,678,735 vaccines were administered. So less than 4000 proven cases of injury or death, that’s not too bad, huh? Well it’s only statistics until it happens to you. Do you tell your patients that they have a statute of limitations of 3 years to report injury and 2 years to report a death related to vaccination? Did you even know that? Likely not. If a vaccine injured person misses those filing deadlines with the Federal Vaccine Injury Court he has no recourse.

Then there is the HHS list of injuries (including death) that are legally presumed to be caused by vaccines. Oh, and how about the list of toxic ingredients in the vaccines? The most concerning to me are the DNA and diploid cells from human fetuses – no harm in introducing that kind of stuff into the blood stream right? (yeah I know that cannibals get kuru but they eat lots of human flesh – a few micrograms jabbed into a baby should be fine).

Then there’s the package insert that comes with each vaccine. How many have read it? Here’s the key part: “The health-care provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination”. So what are some of those things to inform our patients about? Here are some excerpts from the MMR package insert:

M-M-R II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.

mumps vaccine virus has been shown to infect the placenta and fetus,

There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy. However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse fetal effects.

Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established.

(but in another section we find)

Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations.

ADVERSE REACTIONS

Body as a Whole

Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Pancreatitis; diarrhea; vomiting; parotitis; nausea.

Endocrine System

Diabetes mellitus.

Hemic and Lymphatic System

Thrombocytopenia (see WARNINGS, Thrombocytopenia); purpura; regional lymphadenopathy; leukocytosis.

Immune System

Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history.

Musculoskeletal System

Only rarely have vaccine recipients developed chronic joint symptoms.

Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women.

Nervous System

Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) (see CONTRAINDICATIONS); subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia.

Experience from more than 80 million doses of all live measles vaccines given in the U.S. through 1975 indicates that significant central nervous system reactions such as encephalitis and encephalopathy, occurring within 30 days after vaccination, have been temporally associated with measles vaccine

the data suggest the possibility that some of these cases may have been caused by measles vaccines.

Post-marketing surveillance of the more than 200 million doses of M-M-R and M-M-R II that have been distributed worldwide over 25 years (1971 to 1996) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.{17}

the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. Cases of aseptic meningitis have been reported to VAERS following measles, mumps, and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.

Respiratory System

Pneumonia; pneumonitis (see CONTRAINDICATIONS); sore throat; cough; rhinitis.

Skin

Stevens-Johnson syndrome; erythema multiforme; urticaria; rash; measles-like rash; pruritis.

Special Senses — Ear

Nerve deafness; otitis media.

Special Senses — Eye

Retinitis; optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.

Urogenital System

Epididymitis; orchitis.

Other

Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals (see CONTRAINDICATIONS

How about effectiveness?

The recent whooping cough epidemics in the U.S. have occurred in highly vaccinated populations. In the 2012 outbreak in Washington 758 of 1,000 (75.8%) patients aged 3 months–10 years were up to date with the Pertussis vaccine (that’s a vaccine effectiveness of 25%). In the 2014 epidemic in California 98% of ill teenagers had received at least one vaccine and 87% had received a booster (vaccine effectiveness of 23%). A study of pertussis in the Netherlands in 1996 revealed that “The increase in pertussis incidence was higher among vaccinated than among unvaccinated persons of all ages”. Not only that – viral shedding and disease transmission are shown to occur through vaccinated children.

Since 1979 the only cases of polio reported in the United States were caused by the vaccine strains of the virus. There are now new strains of polio virus around the world that have mutated and are resistant to antibodies produced from vaccination. While we may have altered the ecology of polio viruses in our environment, we have not gotten rid of them – they will always be around us and they will mutate.

How about flu? Well, we know that this season (2014-15) the flu vaccine is reported to be 18% effective (but get that shot anyway). In the 2013-14 season a Navy ship with a crew of 101 fully vaccinated members 25 became ill with a strain of flu that matched the vaccine strain. That’s an attack rate of 25% in a fully vaccinated population in a year that we were told the vaccine was highly effective. Attack rates in the 5-10% range are usually seen in the adult population. This is evidence of reduced immunity in populations that receive repeated flu vaccination.

Now for the Measles hype: how good is the vaccine at protecting children? Illinois outbreak 1984, 25 came down with measles – 21 were vaccinated. In an Iranian outbreak 20% of cases were vaccinated. In a Chinese outbreak 39% of cases were vaccinated. In another outbreak in the U.S. 29% of cases had documented vaccination. Then consider that otherwise healthy children can get sick and shed and transmit virus after being vaccinated. OK, so walk into that encounter with your patient and tell the parents about how the CDC guarantees them that the MMR series is 97% effective at protecting their child.

 So where do we go with all of this?

Medical practice is evolving. We make mistakes along the way, and we need to own up to them. The push to mandate vaccinations is one of those mistakes for several reasons.

• Vaccines do not offer complete protection – to the individual or the group.
• Manufacturers and those who administer vaccines are exempt from all liability – that is at odds with common law and common sense.
• Medical professionals are ethically, legally, and morally obligated to provide informed consent – if a patient cannot decline to take a treatment then there is no informed consent and we violate our obligations and trust.

We have committed to uphold an ethical principle of providing informed consent. That requires telling patients the truth. Then having a discussion about risks, benefits, and options. Finally, that informed individual makes a choice, and we respect the decision.

Closing Thoughts

Vaccines are big business – over $40 billion dollars in revenue per year. On top of that hundreds of new vaccines are in the development pipeline. Put on your businessman hat and consider: in the United States there is only one way to sell a vaccine that is exempt from all product liability – get it put on the childhood vaccination schedule. So Mr. Businessman, how do you protect your product and bottom line? Ensure that every one of your new vaccines be considered for inclusion in the CDC childhood vaccination schedule.

Health is not the absence of disease. Childhood diseases can be both mitigated and prevented through means other than the imperfect science of vaccination. In the current framework of law and policy the individual is sacrificed for the sake of the group. That is not a position to be supported by those who take care of real, individual people. That is not what someone committed to promoting health does.

Troy Ross, MD, MPH

Reno, NV

March 30, 2015

If you’re curious to learn more about the “safety” of vaccines:

http://www.sv40foundation.org/cpv-link.html

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6333a1.htm

http://www.immunopaedia.org.za/index.php?id=881

http://www.who.int/ith/vaccines/polio/en/

http://ije.oxfordjournals.org/content/29/4/757.full

http://cid.oxfordjournals.org/content/29/4/855.full.pdf

Supporting Hyperlinks:

http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion808.page

http://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html

https://www.law.cornell.edu/uscode/text/42/300aa-1

http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf

http://www.hrsa.gov/vaccinecompensation/statisticsreport.pdf

http://www.hrsa.gov/vaccinecompensation/fileclaim.html

http://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.pdf

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123789.pdf

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6128a1.htm

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6348a2.htm

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640897/

http://wwwnc.cdc.gov/eid/article/6/5/00-0512_article

http://www.cdc.gov/vaccines/pubs/pinkbook/polio.html#secular

http://www.sciencedaily.com/releases/2014/11/141104111408.htm

http://www.cdc.gov/flu/news/updated-vaccine-effectiveness-2014-15.htm

http://198.246.124.29/mmwr/pdf/wk/mm6342.pdf#page=7

http://www.who.int/biologicals/vaccines/influenza/en/

http://www.cdc.gov/mmwr/preview/mmwrhtml/00000359.htm

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0094846

http://www.ncbi.nlm.nih.gov/pubmed/18396664

http://journals.lww.com/pidj/Fulltext/2010/09000/Measles_Outbreak_Associated_With_an_International.3.aspx

http://www.ncbi.nlm.nih.gov/pubmed/15804301

http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20649

http://www.sciencedirect.com/science/article/pii/S0264410X01004959

http://www.ncbi.nlm.nih.gov/pubmed/2563426

http://www.cdc.gov/measles/vaccination.html

http://www.phrma.org/sites/default/files/pdf/Vaccines_2013.pdf

http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf