8.06.2008

Vaccinations: Where I've Landed

This debate is really getting hot. The misinformation is flying all around, while critical information is either missing or being withheld. And more vaccinations are on the way, while the AAP is showing signs of taking a more aggressive stance against parents who wish to deviate from the CDC schedule.1 I've tried to distill down what I can from my own research. Yes, it's internet research, and my now ex-pedi would scoff at me for using the internet to research anything medical, but it's all I've got. I don't have a subscription to Lancet or the JAMA and there are plenty of abstracts of studies and government data available online. And with two graduate degrees, one of which included coursework in statistical analysis, experimental design, and regression analysis, I should be able to distinguish the hype from the actual information. I link to sources where possible.

1. If there were an award given out for the greatest invention of the twentieth century, I believe vaccinations would be on the short list for potential recipients.

2. Vaccinations save untold thousands of lives every year and prevent life-long injuries from disease including loss of cognitive function, deafness, blindness, and paralysis.

3. Vaccine manufacturers are not experiencing any sort of threat or burden from litigation or the threat of litigation for liability if their vaccines cause injury because they are IMMUNE from suit for injuries that their vaccines have directly caused. They have been ever since the Vaccine Injury Compensation Fund was created in 1986. The federal law that created the fund, which is paid into by the vaccine manufacturers, also made the vaccine manufacturers and every other party in the chain of supply down to the nurse who actually gives the shot immunity from suit for an injury caused by the vaccine. This immunity does not extend to negligence in the administration of the vaccine, but only covers injuries caused by the vaccines themselves. The immunity also does not extend to fraud or misrepresentation by the manufacturers, as well it shouldn't. I think it's enough that they are excused from liability for the injuries their products cause, don't you?

4. The studies to determine the safety of vaccines prior to their FDA approval generally observe the vaccine recipients only for about 3 - 6 weeks post-injection for any adverse reactions.

5. When adverse reactions do occur, they may or may not be reported to the Vaccine Adverse Event Recording System (although law requires the health care provider to report them, but how can this be enforced?), and there is little to no clinical follow-up of these cases to determine whether the vaccine caused the reaction, what were the short or longer-term outcomes, and whether any information can be obtained by studying these cases more quickly to determine whether there are additional contraindications for the vaccine for particular individuals. This alert from the National Vaccine Information Center regarding Gardasil's HPV vaccination gives a good example of the problem.

6. Scads and scads of studies have been run investigating the safety of vaccines, and time and again they are not able to turn up a statistically significant correlation between administration of the vaccines and adverse health responses. However, these studies (at least every one that I was able to review) were all epidemiological data reviews. Meaning, the study consists of gathering mountains of patient data from a bunch of clinics or hospitals or a specific region and slicing and dicing the data (yes, that's a technical term ;-p ) many ways to see if any relationship can be identified between the receipt of a particular vaccine and whatever health risk is being evaluated. The theory behind the value of epidemiological studies is that, if you have a large enough data sample, the size of the data alone should cancel out any oddities in the individual data so that you can have confidence that if any sort of relationship exists, it will show up in your analysis. Some of the studies rely on data that is from 20 or more years ago, some data pools are smaller than others, some are geographically limited, so these studies are only of limited value, and can't be pointed to, with scientific soundness, as evidence that vaccines are "safe." They can, however, be used to support the statement that so far, we have not been able to find a statistically significant relationship between vaccines and the occurence of asthma, irritable bowel disease, autism, encephalopathy, demyelinizing disorders (including multiple sclerosis), and a host of other diseases.

7. We still don't know what the causes are for a lot of these conditions that are on the rise or understand the processes in the body that are involved.

8. People point to the rise in childhood vaccines and the rise in autism as being parallel and therefore there must be some sort of relationship. Over the last forty years our living environment has changed radically, as have the diagnostic criteria for autism-spectrum disorders. The rise in vaccines alone is not sufficient evidence to link them to the rise in autism. The most recent research has suggested a genetic component to the onset of autism. Again, this does not prove or disprove that the now numerous vaccinations given to young children does not play any role in what must be a very complex etiology.

9. The body's first line of defense in most infectious diseases is the respiratory system. The most important part of our immune defense system, however, is our gut. This much we understand. Vaccines inject the material that triggers the immune response directly to the bloodstream, bypassing the respiratory system and the immune triggers that would have activated there. A few experts are concerned that this method of vaccine delivery could play a role in the increase of auto-immune diseases, particularly IBD. Although their concerns are only based on speculation, the idea that vaccine injections could be a contributing factor is not implausible. Meanwhile, there are very interesting developments in alternative methods of creating immunity other than injecting vaccines directly to the bloodstream, here and here.

10. Reading through some of the stories of cases that have been granted compensation through the Vaccine Injury Compensation Fund will curl your toes and make you go in and hold and kiss your sleeping children. Reading through some of the stories of how children used to suffer with polio and the iron lungs will do the same. This table shows the "adverse events" that are presumed, under the Vaccine Compensation Injury Program, to have been caused by the indicated vaccine. While actual causation is still not proven or, in many cases, attributable to any other cause, the legal presumption allows families to be compensated without having to prove causation.

11. Vaccine manufacturers are major donors to the American Academy of Pediatrics. One of the leading proponents of childhood vaccinations refuses to disclose how much money he has received from vaccine manufacturers. Doctors and non-profit research institutes are not required to disclose how much income they receive from vaccine manufacturers. Or from pharmaceutical companies, for that matter. One doctor from the retinal medicine field has remarked in Senate testimony that doctors ought to be required to don the logo's of their "sponsors" on their labcoats, much like NASCAR drivers, so their patients will be aware if the doctor might have a financial conflict of interest in recommending a particular treatment or procedure or test. Historically and today, the medical profession has held itself above the same conflict of interest ethical rules that apply to every other profession, successfully resisting any attempts to require them to disclose their financial interests in surgery centers, labs, pharceutical companies, or any other supplier of the care or treatment that they prescribe for their patients. Dr. J. Gregory Rosenthal put it very succinctly: "We are literally trading independent medical integrity for corporate profits." Feeding at the trough is fine, but don't be surprised when others notice the stink.

12. The CDC schedule only states the earliest date that vaccines can be "safely" (quote marks only to reflect the limits on available information) administered; it does not include information about the best time to vaccinate the child, or what the risks of contracting any disease might be if any vaccine were delayed by three months, six months, or a year. Infants have natural immunity to many diseases for their first 6 - 12 months that's maternally derived, but this immunity disappears by one year. Hence, the drive to vaccinate as early as possible. But there is not evidence weighing the risks of slightly delaying or spreading out the vaccinations for children living in the US. In fact, one study found that the immune response developed from the monovalent measles vaccine was slightly better than that developed in response to the combined MMR vaccine. As we learn more about the body's natural immune mechanisms and how to best support them, we may discover that there are certain "ideal" times for administering different vaccines, but this information is still a long way off.

13. There are other ingredients in the vaccines besides the vaccine material itself. The list of ingredients for vaccines posted on the CDC website does not match what is listed by the manufacturers on their websites.2 I'm a big fan of informed consent, but when parents and physicians aren't receiving good information about what's included in vaccines, they aren't able to guard against giving a vaccine to someone who may have a known allergic reaction to one of the ingredients.

Reviewing the information, it is obvious why parents are beginning to resist the large number of early childhood vaccinations for their children. The available information is good, but incomplete. There are clear risks and observed adverse reactions, even if the rate of incidence is very low - if you're a parent of a child who experiences one of them, the incidence rate might as well be 100%. There are many disorders on the rise that we don't understand. And our confidence in the impartiality of the medical profession is eroding. If the AAP wants to motivate parents to make what the AAP considers to be the best decision for their child's health - early and complete childhood vaccination - they need to first work to restore trust by requiring complete transparency from their members about their financial interests in the companies who supply the medicines and treatments that they are recommending.

At ten months old, Ada has received all of the CDC-recommended vaccinations to-date. But at her next appointment we will be putting off the MMR. I'm well aware that there is no evidence suggesting that it will be safer if I do it a little older, but there is evidence that her immune response will be slightly better if she receives the first immunization after she is 15 months old. I'm also aware that there isn't information for me to refer to that will help me understand what the chances of her contracting measles, mumps or rubella are in the 6 - 12 months before she gets the first vaccination of the series, but I have found some guidance from the CDC about when they consider giving the first MMR shot at or near the first birthday to be recommended.3 The MMR vaccine seems to be one of the ones that has a higher level of adverse reactions, and twelve months old just seems to be a little immature physically to process it all.

Given all of the data I have at hand, this is the best decision I can come to.

1. Prior to passing the law allowing Texans to file for conscientious objection to vaccinations, there were widespread allegations of doctors and nurses telling parents they were breaking the law by not getting their children vaccinated on the CDC schedule, reporting the parents to CPS for failure to vaccinate, and even forcibly administering a vaccination to a child with a known egg allergy.

2. Re the MMR vaccine:

From the CDC website: "Measles, rubella, and mumps vaccines are available in monovalent measles (Attenuvax , Merck & Co., Inc.), rubella (Meruvax , Merck & Co., Inc.), or mumps (Mumpsvax , Merck & Co., Inc.) form and in combinations: measles-mumps-rubella (MMR) (M-M-R II , Merck & Co., Inc.), measles-rubella (MR) (M-R-Vax , Merck & Co., Inc.), and rubella-mumps (Biavax II , Merck & Co., Inc.) vaccines. Each dose of the combined or monovalent vaccines contains approximately 0.3 milligrams of human albumin, 25 micrograms of neomycin, 14.5 milligrams of sorbitol, and 14.5 milligrams of hydrolyzed gelatin (Merck & Co., Inc., manufacturer's package insert). Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Live rubella vaccine is grown in human diploid cell culture."

From the Merck website (had to delve into the "medical providers" area of the website to find this): "Each 0.5 mL dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of measles virus; 12,500 TCID50 of mumps virus; and 1,000 TCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride [this is regular table salt, NaCl, but still omitted by the CDC], hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum, other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative." [emphasis added]

3. "Children should receive the first dose of MMR vaccine at age 12-15 months (i.e., on or after the first birthday). In areas where risk for measles is high, initial vaccination with MMR vaccine is recommended for all children as soon as possible upon reaching the first birthday (i.e., at age 12 months). An area where measles risk is high is defined as:
a county with a large inner city population,
a county where a recent measles outbreak has occurred among unvaccinated preschool-aged children, or
a county in which more than five cases of measles have occurred among preschool-aged children during each of the last 5 years.
These recommendations may be implemented for an entire county or only within defined areas of a county. This strategy assumes that the benefit of preventing measles cases among children aged 12-15 months outweighs the slightly reduced efficacy of the vaccine when administered to children aged less than 15 months." Found at the CDC website here.

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