Question, why an "international" study?

In Uncategorized on September 12, 2008 at 3:48 pm

American medicine is tightly controlled by the American government. American pharma testing is generally stricter than any European or International medical boards. I’m sure if there was an international study out there the rallying cry would be “we need an American study, strict American standards”

This language the “internationally controlled safety study” sounds so reasonable, but it is intentionally misleading. They ask for international studies because they know each vaccine is rigorously studied in the US before being added to the vaccine regime. And they ask for a controlled study, knowing that a full controlled study on the specific vaccine (where it is tested singly for safety) would never happen, because it is medically irresponsible to keep vaccines (that have already been proven safe) from children.

Right now parents who keep their children unvaccinated are freeloading off the vaccinations of other children. The unvaccinated face a much lower risk of getting LIFE THREATENING DISEASES (lest we forget that measles mumps and rubella are not just the common cold or chicken pox) because vaccination rates remain high enough. But as vaccination rates drop the penumbra of protection fades, this year has already seen more measles cases in the US than anytime in the past decade. Parents talk about not risking their child’s safety by getting them vaccinated, but even if for argument’s sake we posit that there may be some connection between vaccines and the very serious neurological disorders on the Autism spectrum, getting life-threatening measles is still a much more probable result of being unvaccinated than developing a Autism spectrum disorder.

And before you attack me (and anyone else who disagrees with you) as a tool of the pharma industry or someone bent on suppressing the “real” information because of this issue. You should remember that the lead doctor in the initial study that made the GI-MMR-Autism link (a study that was of the same size and scope of the test in this article, not the international controlled study you claim to want to disprove it) is currently facing an inquiry for serious ethical and medical misconduct charges and the results of the study have been retracted. When he did his research he had accepted a large sum of his funding from a group suing the British government over the MMR vaccine, and some of the children in the study were recruited from these (biased) parties. (Additionally he took a number of medical risks with some of these children, risks that caused damage and required additional medical care to fix.)The medical journal in which the study was printed and 10 of the 12 co-authors of the paper issued a retraction of the findings of the study saying:

“We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent”

Look Autism spectrum disorders are a serious issue, we need to stop chasing ghosts and bad science and start coming together to provide much needed funding for services that help the children (and the growing population of adults) affected.

Sorry for the long post.


  1. I am going to be just as long in my comments so I apologize in advance:

    Re: American medicine is tightly controlled by the American government. American pharma testing is generally stricter than any European or International medical boards

    Well, if that is the case maybe you should check out the number of lawsuits that are currently before the courts in the US versus the courts in the EU (individual member states or the EU collectively) pertaining to the numerous pharma products that resulted in death or serious injury to innocent patients because the pharma companies were in a rush to get those products to market, because to report various findings in the initial studies might have delayed their market launch and because the FDA/DDMAC (consumer pharmaceutical product division of the FDA) did not carry out the required proper due diligence pertaining to the approval of these products.

    Let me go back a few years and share some personal experience. I am the president/ceo of an advertising/pr agency in the city. One product that I actually worked on was being prescribed for ulcerative colitis. When my agency started working on this product, its market share was less than 0.43%, which in pharmaceutical terms is a disaster.

    Anybody that has ulcerative colitis will now what I am talking about, but the early symptoms of this disease include runny, painful diarrhea. A company that does not exist anymore, having merged with a larger company in the late 1990’s, developed this product and was in such a rush to get it to market that they covered up the side effects of the product by informing physicians that their patients were actually suffering the consequences of their disease. The major side effect of this product was runny, painful diarrhea, sounds familiar? Well, the FDA, which approved all the studies for this brand, slapped the pharma company with a massive fine and informed it that all its promotional materials had to reflect the fact that further testing had to be carried out to determine what brought on this side effect which was very difficult to determine from the actual disease symptoms. The pharma company refused to carry out the required testing and shelved the brand, allowing it to deteriorate to its ridiculously low market share.

    A new biotech company from the UK wanted to get into the gastroenterology market place because it had products in its pipeline for the treatment of Crohns Disease and so it bought this ulcerative colitis product. Hence I was brought into the fold to set up the market and prepare it for a relaunch to the gastroenterology profession. At first it appeared to be mission impossible, but armed with all the studies conducted on this product, both US and International, I spent one long weekend going through the data with a fine tooth comb.

    The burning question in my mind related to its 0.43% market share – why were physicians still prescribing this product and who were they prescribing it to – I found the answer at 7:00 a.m. on a Sunday morning, just as my mates were heading out to play golf and I was settling into my home office here in Ridgewood.

    Ulcerative colitis affects the colon and it is a chronic disease. People who have UC become depressed, it certainly ruins a lot of clothing and it makes long road trips to the country not possible, unless patients are on a treatment regime that works. Most UC patients suffer from what is known as pan-colitis which basically means that the whole colon is affected. Some patients suffer what is known as distal colitis which basically means that the left side of the colon is the only part of the organ that is affected.

    What I found in all the study data relating to this product highlighted that the highest efficacy levels, with the lowest side effect levels were experienced by those patients with distal colitis. I aligned the data, drew charts, made copies of everything and represented them to my UK biotech clients the following Wednesday morning, when I called a tactical meeting at my office in New York.

    From this meeting, we conducted physician-based focus groups and presented what we had found and asked them, based on what they now knew about this product, would they be willing to prescribe this product again, which they all had experience (very bad experience) with and the general answer was yes! My agency grew the brand from its miserable 0.43% to an approximate market share level of 37.6%.

    The point that I am making is the fact that pharmaceutical products have to be efficacious, but most of all they have to be safe and if there is data out there that show that safety is not an issue then physicians will prescribe it, patients or their caregivers will request it and everybody will reap the rewards, the pharma company included. But if there is not specific safety study available, because none was ever conducted or it was tarnished, well then their needs to be a joint effort to put patient/caregiver minds at ease and to make the physician’s job easier and in relation to the MMR vaccine this can only be achieved by conducting an internationally comprehensive safety study. At current rates, a large number of parents are not convinced that the MMR vaccine is 100% safe from autism, hence the rapid growth in the contracting of the measles virus, not only in the US but also in the EU, due to the non-vaccination of children.

    This study will cost money – are our children’s lives not worth it?

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