Thursday, March 4, 2010

The Vaccine Debate

Jennifer Morganti, ND, Director of Education for NEEDS

The media had a field day in 2009 over flu vaccines, particularly vaccines for the H1N1/Swine Flu. Because there is so much information and misinformation in the media, it may be difficult to discern what is right for you and your family. I certainly don’t have all the answers, but I do have many questions and a little research has revealed some interesting facts. This topic will certainly remain one of the most controversial ones this year, but hopefully the facts and quotes below will shed some light on the topic.

When considering if you want to get a vaccine, drug, or anything, you should investigate its safety and its effectiveness.

This leads me to question how extensively the H1N1 vaccine has been tested. Unfortunately, it appears that safety testing has been limited. Generally, before a medication or vaccine is introduced to consumers, there are large, double-blind placebo controlled clinical studies to determine safety and efficacy. This was not the case with the H1N1 vaccine because the FDA wanted to introduce it to the market as quickly as possible, due to the perceived pandemic.

It may also be disconcerting to some that the CDC strongly recommended the vaccine to pregnant women (because they are at increased risk of dying from the swine flu), however, no studies have been completed to prove the vaccine is actually safe for pregnant women or their fetus. My question then becomes: “Does the fact that they have increased risk of catching the flu (and possibly dying from it) consequently prove that the vaccine is actually safe for pregnant women, when the safety hasn’t been properly evaluated?” Clearly, we are still lacking solid evidence. As of October 8th, 2009, the National Institute of Health was still in the process of recruiting volunteers to participate in a trial to test the safety of the H1N1 vaccine on pregnant women. “The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to determine vaccine safety in pregnant women and how the body reacts to different strengths of the H1N1 influenza vaccine.” They are only in the early stages of the study, yet the CDC has been strongly recommending that pregnant women get this vaccine without hesitation.

Lastly, when considering safety, we must decide how we feel about mercury (thimerosal) exposure. The FDA clearly states on their website: “As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.”

Regarding the efficacy of the vaccine, regulators assume that this vaccine will have similar efficacy as other flu vaccines, however, they say that this H1N1 virus is much different from previous seasonal viruses. Most concerning, the CDC tells the public to assume that one in every 100,000 vaccine recipients will suffer serious side effects, yet the FDA only requires the vaccine to be effective in three out of 10 recipients.

The CDC says that the majority of people over 65 already have natural immunity to the swine flu due to previous exposure in the 1970s. Unlike the standard seasonal flu, the CDC is not classifying this population as an “at risk” population for the swine flu.

The last big question in my mind is: “How big of a threat is the swine flu?” We tend to only hear about the severe cases of the swine flu. However, the CDC states that the severity of this swine flu is on par with other viral infections we have seen in the past decade. The World Health Organization (WHO) states, “the overwhelming majority of persons worldwide infected with the new H1N1 virus continue to experience uncomplicated influenzalike illness, with full recovery within a week, even without medical treatment.”

Are people more fearful of the swine flu than necessary? Perhaps. Recall the SARS virus. The British Medical Journal makes this sensible point: “The SARS outbreak showed that large numbers of infected people are not necessary to generate concern and fear over disease. The SARS virus is known to have affected only 8096 people globally, but the fear of infection, involuntary quarantine, travel restrictions and subsequent political antagonisms, and at least $18 billion in losses were felt by far more. It was not the virus but the response to it that caused these social and economic harms.”

Unfortunately, despite the lack of compelling evidence of vaccine safety and efficacy, the FDA and FTC are tightly restricting the dietary supplement industry from making any claims that natural products may help prevent the flu, and any mention of the swine flu has brought threats of severe penalties.

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