Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts

8.19.2009

Vaccines: a product marketed for profit

I came across an article today regarding the HPV vaccine: "New study examines safety of HPV vaccine." One of many, I am sure, because of new information just released from the CDC regarding Gardasil.

I was interested to read the background and findings of this study as I am always in pursuit of new information regarding vaccines, their effectiveness, and their safety. I was shocked to discover that this study was not a careful examination and observation of the cause and effect on a controlled subject but rather a simple review of information reported to VAERS, the Vaccine Adverse Event Reporting System.

Regardless of the side of the controversy on which you stand, most agree that the accuracy of the information reported to the VAERS system is left wanting. In fact, the VAERS brochure as published by the CDC and the FDA, co-sponsors of VAERS reads:
VAERS is unable to determine that a vaccine caused or did not cause an adverse event.

Further, the Minnesota Department of Health, in an attempt to quell fears regarding reports to VAERS on Gardasil wrote in a Special Issue of Got Your Shots? News dated July 9, 2008:
VAERS data are updated continuously and the number of reports and the type of adverse events will vary depending on the date of analysis.

While the author of the article I read, Renee Tessman of KARE, was clearly trying to put a positive spin on the findings, it was also clear that members of the medical community were attempting to downplay the legitimacy of VAERS for fear the report may stir up concern regarding the vaccine. Kris Ehresmann of the Minnesota Department of Health is quoted in the article by Tessman saying: "I do think that the data is very useful but we do sort of have to keep it in context." The article goes on to say:
Ehresmann, who is division director for infectious disease, says that VAERS is set up so that anybody, a parent, a doctor, anyone, can call in to report a problem. Details of those reports are investigated later. So, she says, its possible problems and deaths reported may not always be a direct result of the vaccine. She says, "Is it really because the child was vaccinated or were they hit by a car?

And literally those kinds of things are in that system."


I won't get derailed on the foolishness of her comments. My question is: How can we, therefore, rely on such dynamic, uncontrolled data as a source for significant information regarding vaccines whether we are looking to the system in favor of vaccines or against them? And therein lies the crux of the issue.

There are two parties at play in this controversy - those that are in favor of vaccines and those that are against them. There is truly little room for a middle ground as I, and others, have discovered through this struggle.

So ask yourself this, what do those that are against vaccines have to gain by releasing information and studies regarding the concern of a vaccine? And what does the government or Merck, in the case of Gardasil, stand to gain when a study is released regarding the safety of a vaccine?

Just like every other product on the market, a company doesn't stay in business if their product doesn't sell. While the CDC, the FDA, and Merck would like to rely on data from VAERS as evidence of the safety, or lack of sufficient evidence regarding concern, of the HPV vaccine they are also quick to shirk off the information as insufficient when numbers and findings start pointing to concerns. But how many deaths is enough? And if the information is unreliable then why isn't the government looking to implement a more effective system? Why? Because when you start asking questions, you start getting answers, and you aren't always going to like what you hear.

11.08.2007

Even the drug companies give heed

From Merck's information about their Hepatitis B vaccine Recombivax HB:
CONTRAINDICATIONS
Hypersensitivity to yeast or any component of the vaccine.


From GlaxoSmithKline's information about their Hep B vaccine Engerix-B:
CONTRAINDICATIONS
Hypersensitivity to any component of the vaccine, including yeast, is a contraindication.


Recommended vaccination schedule for the Hepatitis B vaccine: birth, one-two months after birth, between six and 18 months later for a total of 3 shots by 18 months of age.

Note regarding food allergies from Dr. Alan Greene (www.drgreene.org), of which yeast/wheat is among the top 5 most commonly diagnosed food allergies: "Delaying the introduction of solid foods until the latter part of the acceptable window [12 months of age] may prevent some allergies. Delaying particularly allergic foods even long can further reduce the risk of allergies."

If both Merck and GSK indicate that a yeast allergy is a contraindication of their vaccines and if almost all pediatricians and sources on raising healthy babies indicate that certain foods such as cow's milk, eggs, peanuts, yeast, etc. should not be given to infants before one year of age, why do we administer the Hepatitis B vaccine two and likely three times before a child is one year old?

Furthermore, GSK fact sheet on Energix-B goes on to say:
Prior to immunization, the patient's medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions, and occurrence of any adverse event–related symptoms and/or signs in order to determine the existence of any contraindication to immunization with ENGERIX-B and to allow an assessment of benefits and risks.


How many day old infants do you know that have a revealing medical history, a record of vaccine sensitivity or signs that they might be allergic to yeast? When we routinely adminster the Hepatitis B vaccine to children on the day of their birth we are gambling with their health. If nothing else, delaying vaccination should be pursued to allow both parents and doctors to determine over time and with development if there are added risks to the child before they are vaccinated, not to mention the fact that their immune systems and brains will have time to do what they were designed to do rather than fight against foreign invaders (but that's another post in and of itself).

For more information about the controversy surrounding the Hepatitis B vaccine read the following articles:
-Mindless Vaccination Bureaucracy by Michael Belkin
-Michael Belkin: Testimony to Congress, Tuesday, May 18,1999
-Shots in the Dark: Who should decide which vaccinations children receive? by Sue A. Blevins