The CDC, FDA, Pharma companies, and Paul Offit really want to find a way to get everyone to trust vaccines. At least that is what they say. After saying this they usually throw out the same arguments:
- “young” parents don’t understand how horrible the diseases are
- autism isn’t caused by vaccinations
- parents are getting mis-information from quack websites
I’ve mentioned before that these arguments are simply not true for the vast majority of non-vaccinating parents. We aren’t too young (and thus as implied too stupid) to understand. We aren’t afraid of autism. We are in fact quite informed about vaccines from sites that are well respected and even vaccine-biased like the CDC’s Pink Book. Studies showthat vaccine refusers are educated people who have put much time into making this difficult decision for their families.
I’m left with the distinct feeling that these people don’t really want to restore trust. They are too busy denigrating those lacking trust as loons and blind celebrity sycophants. This got me thinking. What would make me vaccinate my kids? What would really restore MY trust in the program and the organizations/companies promoting it?
Here are my four steps for restoring faith in the US Vaccination program:
1. Conduct Placebo-controlled Longitudinal Studies
Placebo-controlled means that there is a control group that receives a placebo that is compared to the test group receiving the vaccine. Studies like this are never done. The “controls” in most vaccine trials also receive a vaccine albeit a different one than is being studied. This is like testing the efficacy of Aspirin and giving the control group Excedrin (which includes Aspirin). Any results would be impossible to interpret as deriving from Aspirin intake. Longitudinal is another important factor since it is false to assume that the effects of any drug are confined to the 7 days following exposure (as is done in most vaccine trials) especially in a drug that not only acts on the immune system but is intended to have long term effects (e.g. immunity).
The common complaint amongst vaccine evangelists regarding this request is that it would be unethical to withhold a vaccines from the control group because they are so clearly beneficial that to deny them would be a human rights violation. This is absurd. The Declaration of Helsinki, the World Medical Associations governing document on combining medical research with medical treatment, has clearly defined provisions for the use of placebo. When there is an existing “proven” therapy (as vaccine promoters would claim) then placebo-control is permissible under the following circumstances (according to the 2002 clarification of the Declaration of Helsinki);
- Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or
- Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.
So, for example, it would be unethical (and unconscionable) to give a placebo to a control group of women with stage IV breast cancer when there is treatment available. The thing with vaccines is that the person receiving the vaccine is healthy and not suffering from any disease. It would therefore not be an ethical conflict to offer a placebo since the recipient would not be subject to risk or harm. (note: “risk” is touchy since I’m sure someone would say the risk of the vaccine-available disease is increased. However between the unknown efficacy of vaccination – i.e. it doesn’t work for everyone and requires frequent boosters – and, more importantly there not being a current outbreak of said disease, the real risk is limited).
Don’t forget, of course, that patients in a study are also provided the right of informed consent prior to enrolling in the study. Thus if they personally felt the risk was too high they could decline participation.
The second complaint about conducting this type of study is that it would be impossible to find a group willing to enroll in a study that denied them vaccines. I beg to differ since the number of american’s completely refusing vaccines is on the rise, but the complaint then becomes that it would be “impossible to control confounding factors” like nutrition and environment. Um, yeah, you can never control everything that’s why you can use statistics to account for socio-economic status, diet, and a host of other things.
Lastly, I’ve heard that “we” don’t want to divert meager research dollars to vaccines which are “proven” safe and effective. Ok. Whatever. This is how you restore trust in vaccines. If the errosion of vaccine compliance is less important than the other research then that’s the decision you are making. If vaccines and vaccine compliance is as all-powerfully important (due to “herd” immunity) as you keep saying then put your money where your mouth is and prove it.
Seriously, it is totally doable and someone needs to do it. What are you afraid of?
2. Support Informed Consent
Informed consent has been a cornerstone of medicine since the Nuremburg Trials. Informed Consent is the policy that doctors disclose information about a treatment course in a thorough enough manner to allow the patient to make a decision to proceed or decline. According to the AMA, informed consent includes the doctor informing the patient of,
- The patient’s diagnosis, if known;
- The nature and purpose of a proposed treatment or procedure;
- The risks and benefits of a proposed treatment or procedure;
- Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);
- The risks and benefits of the alternative treatment or procedure; and
- The risks and benefits of not receiving or undergoing a treatment or procedure.
This is not only a crucial part of medicine but of a free society as well. Public health does not trump individual choice in a carte blanche manner. The state must have compelling cause to force medical treatment on an individual such as an epidemic.
It is actually required by law that physicians provide patients with a Vaccine Information Sheet (VIS) prior to each vaccination. Raise your hand if you’ve gotten one! That’s what I thought. Most parents aren’t even informed what shots the child is getting. It is just routine “shots” that are not explained or questioned. Even if your doctor is one of the ones that hand out the VIS – the VIS is very misleading and has only a smidge of actual information. For example, the Hep B VIS has the following statistics to inform parents;
- In 2005, about 51,000 people became infected with hepatitis B.
- About 1.25 million people in the United States have chronic HBV infection.
- Each year about 3,000 to 5,000 people die from cirrhosis or liver cancer caused by HBV.
ZOMG! Gimme that shot! Well, actually that doesn’t give me much information that I can use.
How suceptible is my child?
- 2007 Hep B Incidence by Age and Sex (source: http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5803a1.htm )
Hep B infection is almost non-existent in children under 15. The VIS information is so grossly misleading as to be useless.
Also, the Hepatitis B Foundation talks about risk factors for HepB transmission:
[box]HBV is spread by blood or sexual contact.
To protect sexual partners, members of the household, or colleagues at work, the following measures to prevent transmission of HBV are recommended:
- Using latex condoms when having sex; sexual contacts should be vaccinated
- Never sharing personal grooming items that may be contaminated with blood such as razors, toothbrushes, or nail clippers
- Cover open sores, cuts or scratches
- Clean any blood-contaminated surfaces with bleach
The following activities are NOT associated with spread of HBV:
- Sharing of food and utensils
- Kissing, hugging
- Handshakes or casual contact
- Coughing or sneezing
[/box]And that is if you are a known carrier of HepB – something you usually know when you are pregnant. I would be in favor for HepB vaccination of infants of mothers with known HepB or with unknown HepB status.
Anyways, I could go on and on for each vaccine. My point is the VIS is clearly vague at best and misleading more likely. This is not informed consent because it is not informed. I’m going to write this because it will make me do it: I want to make my versions of the VIS – not biased, just with real numbers and what I think a mom should know before she jabs her 12 hour old infant.
3. Support Universal and Unfettered Vaccine Choice
Vaccine choice has three arms;
1. National Standardization of Legal Exemptions
Every state allows exemptions to mandatory vaccination laws. There are four kinds of exemptions:[box]
- Natural Immunity - proving you have natural immunity from contracting the disease. For example Ohio’s law states, “A pupil who has had natural chicken pox, and presents a signed statement from the pupil’s parent, guardian, or physician to that effect, is not required to be immunized against chicken pox.“
- Medical Contraindication - for medical reasons you are unable to be vaccinated e.g. being allergic to a vaccine ingredient, immunodeficient, etc. Ohio’s law states, “A child whose physician certifies in writing that such immunization against any disease is medically contraindicated is not required to be immunized against that disease.“
- Religious Objection - In Ohio this reads as “religious convictions” but it differs state to state. All states, except Mississippi and West Virginia, allow religious exemptions. The problem is some states put a huge burden of proof on the parent to “prove” their reason is religious or to be part of an “bona fide” church that opposes vaccination. For example, in Ohio I must only submit a letter signed by me that I oppose vaccination for religious reasons. Period. In New York, on the other hand, I would have to “apply” for religious exemption and prove that my reasons were purely religious and sincerely held. The idea of a school district deciding my sincerity in any objective manner gives me chills. (From what I understand NY also does not have a natural immunity exemption.) Some states require specific forms, in person counseling, and notarization - which disadvantage the poor. The AMA is actually actively promoting the abolishment of religious exemptions (section H-440.970 on page 406) and this whole organization exists to end religious exemption on numerous issues.
- Philosophical Objection - In Ohio this is stated as “reasons of conscious”. Only 20 states allow this type of exemption and it is even more controversial. It seems we as a culture believe that a religious conviction is an order of magnitude more “real” than other types of convictions? I have both religious and philosophical objections to vaccines and I honestly don’t know how to separate the two. Paul Offit and the AAP are vociferous about eliminating philosophical exemptions.
2. Information Dissemination on Exemptions - If you have the legal right to exemption it does little if there is a systemic approach of concealment and coercion. In Ohio, for example, I challenge you to find information about legal exemptions on the Department of Health website. It would be exceedingly rare to find a school that has a simple exemption check box on the “MANDATORY” vaccine sheets or staff that will let you know about them. In my 3 weeks in perinatal and 5 weeks in the NICU I talked to many nurses and doctors about vaccination (offering flu shot for me and HepB for the boys) and without question they all said “well you’ll need it before they get to school.” They were truly astonished when I told them that Ohio has exemptions and the vaccines are not really mandatory. I don’t think this is collusion on the medical personnel’s part, simply a complete and utter lack of education on the topic. Clearly, however, at some level of government it has been decided that parents shouldn’t be openly offered their legal rights.
Worse yet is the harrassment, lies, and coercion that go on in some pediatricians offices. Threats of calling Child Protective Services for medical neglect, horror stories about how your baby will die, and refusal to see a patient that doesn’t toe the line. We interviewed 4 pediatricians before we found one that was respectful or our legal right not to vaccinate.
3. Separate vaccines - We can not have vaccine choice without separate vaccines. Companies are deliberately reducing single-vax manufacturing in order to stop deviation from the standard CDC schedule. What they are doing is reducing choice. Can you imagine if your zoloft were ONLY available in a combo with Xanax? Or how about if Lipitor came ONLY with Metaformin.
The fact is that each vaccine carries its own benefit and risk. Look at DTaP – there couldn’t be three more different diseases. One is non-communicable (T), another for a disease that nearly every child gets anyways (P), and the other for a horribly virulent disease. Someone, like me, who might consider Diptheria vaccination is cut short because it is not offered alone.
Merck stopped production of the separate measles, mumps, and rubella vaccine in order to outsmart Dr. Sears’ alternate vaccine schedule. Now women who need the rubella vaccine after pregnancy must get the MMR even though they have immunity to M and M. They are forcing unneeded medication in an attempt at coerce vaccine compliance.
This is what I mean when I say unfettered vaccine choice. The exemptions laws should be uniform in every state and plainly available to parents. Notification of the option of exemption should be a required part of the informed consent discussion with a pediatrician prior to vaccination. I have no problem with a doctor letting his opinion be told (wouldn’t a cardiologist do the same?) but it should not be disrespectful or coercive or full of lies.
In echo of “get your rosaries off my ovaries” I have to say “get your vaccine law out of my bloodstream!”
4. Restructure the Advisory Committee on Immunization Practice and the Vaccines and Related Biological Products Advisory Committee
There are two government advisory committees involved heavily in the vaccines our children are given. One is the Vaccines and Related Biological Products Advisory Committee (VRBPAC) which advises the Food and Drug Administration (FDA) on the licensure of new vaccines and the Advisory Committee on Immunization Practice (ACIP) advises the Center for Disease Control and Prevention (CDC) on recommending vaccines to doctors and state health departments. The problem is both are plagued by serious conflicts of interest. To see the extent of these conflicts check out the US House of Representatives Committee on Government Reform’s report on Conflicts of Interest in Vaccine Policy Making.
5. Stop Shielding Pharma from Justice
The fact that injuries and death result from some vaccines is not in dispute. It should not take decades and thousands in legal fees for these parents to be compensated for their loss or medical burden. The argument is that pharmaceutical companies won’t make vaccines if they have to be liable for harm. I understand that drugs can have unavoidable risks and in an ideal world pharma could be trusted to provide the safest drugs possible through responsible development, trials, and post-market surveillance. However, Pharma has proven time and again that they can not be given our trust in this manner. Their devotion to their investors and the bottom line have made their decisions questionable at best. See Vioxx as an example. It wasn’t just that Vioxx was dangerous but they knew and did nothing.
Because the government line is that vaccines are a miracle, I understand the need for a “special” court for vaccine litigation. However, special can not mean a black box that is designed to shield Pharma and place the burden unduly on the injured. This court needs an overhaul in the worst way. In the 2011 Supreme Court decision that upheld the law stating that parents can not sue in state court, dissenting Justices Sotomayor and Ginsburg (the ruling was 6-2 in favor of Pharma shielding), stated that by shielding drugmakers from lawsuits, what the government is actually doing is removing the pressure to create better and safer vaccines. I agree.
I think these steps would go a long way to having a vaccine system that has integrity. I’m certain that most of the vaccine pushers would say all these things are pointless. That’s fine but please stop pretending you “have no idea” why people don’t trust the system or that you are truly trying to ensure a fair and safe vaccine program.
I am not a loon or too young or a hyper-protective mother. I am not “anti-vax” a term that just inflames and misses the point. I do not get all my information from “some random webiste”. I am an intelligent woman who cares about my child’s health and that of my community. I am not a conspiracy theorist nor do I wear a tinfoil hat. I have sincere doubts about vaccines being a positive thing for our individual and communal health. My doubts are enough to stop me from vaccinating my children. Other mothers make different decisions. None of us make them lightly. Stop patronizing us. It is misogynistic (those silly mothers!) and counterproductive to your mission.
note: my numbering was off due to multiple drafts of this post and there are actually FIVE listed! I sold myself short on the post title. I have fixed the numbering and the title but kept the permalink the same so any incoming links would still work! Sorry! Can I blame mommy brain?