Issue 183: Exported Controversial Vaccine

Issue 183:

Exported Controversial Vaccine

In the newsletter sent 7 days ago I informed you about a documentary airing on Norwegian TV2 channel. The documentary ( streaming video) is now available on the web.  http://webtv.tv2.no/webtv/?treeId=33

Unfortunately, it is in Norwegian language and it is not free.  In order to gain access to TV2 web-TV, you have to sign and pay a subscription. Subscription costs $5/week or $10/month and is renewed automatically.  If the only reason for subscribing is access to a few documentaries, you are advised to unsubscribe after viewing it, or you will be charged automatically for as long as you are subscribed.

There is one more interesting documentary in Norwegian airing tonight at 22:30 local time:
http://pub.tv2.no/TV2/magasiner/dokument2/article771764.ece

English version:

Exported Controversial Vaccine

By Connie Barr, Karen Aarre and  Kjell Persen

At the same time while Norwegian authorities were paying compensation to vaccine victims, the same vaccine was exported to New Zealand and used on small kids.  To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment, says Jan Helge Solbakk, professor in medical ethics.

1988 started the largest experiment ever conducted on Norwegian population. 180,000 school teenagers were used as test subjects in the largest Norwegian vaccine trial ever. It lasted from 1988 to 1991.

Norwegian Institute for Public Health was testing it's new  vaccine against meningococcus b, dangerous bacteria that kills 30 people every year in Norway.

The information brochure given to teenagers states: "it is unlikely to expect serious complications", while the information submitted to the Norwegian Parliament states: "serious side effects can not be excluded" during the experiment.

Jan Helge Solbakk, professor of  medical ethics

Foto: TV 2

Jan Helge Solbakk, professor of medical ethics, was working on the ethical sides of the trial.  He claims: "project leaders new that trial  subjects may suffer serious complications during the trial, statistically speaking."

"Trial subjects were not properly informed about the possibility of serious side effects during the trial. We encouraged the project leaders, during an open meeting, to do it in a better way, informative way" says Solbakk to Dokument 2.

512 side effects were reported during the vaccine trial.
14 were considered serious.
5 school kids developed serious neurological diseases.

During the second trial, involving 53,000 kids, 10 serious side effects were reported, while 1 child developed serious neurological disease.

Worried about the side effects

Hans Cato Guldberg, professor of medicine, was a member of a committee that was to evaluate side effects during the experiment.  He was worried.

"Some time after the experiment was over, I came to a conclusion that there were serious side effects to this vaccine. And, the number was relatively high.  I was worried. At the same time, I felt that project leaders were trying to tone down the danger of vaccine, said Guldberg.

Results of the vaccine trial were compiled 1991. Vaccine was providing protection in 57% of cases.  That was not enough to add it to the Norwegian vaccination program.  As meningococcus b epidemic was dying out, vaccine was never used in Norway the way it was meant.

Foto: TV 2

After the request from the World Health Organization (WHO), vaccine was exported to New Zealand, during 2001. Using the same technology and the same methodology from 1980s, researchers from the Norwegian Institute of Public Health tailored a new vaccine for New Zealand.  The multinational pharmaceutical company Chiron was awarded rights to mass produce the vaccine.

Usually, vaccine is suppose to pass different tests before it is approved for mass use on population. But, this vaccine was tested in a record short time.  Phase III trials were totally dropped.  Rare side effects are often not discovered before the phase III trials.  Phase III trials are  randomized, placebo controlled  trials.  Instead of testing this new vaccine through a new phase III trial, safety data and affectivity data were just taken from the Norwegian vaccine and assumed valid for the New Zealand vaccine.  Because safety data of this vaccine were incomplete, the vaccine was not officially approved on  New Zealand. Instead, mass vaccination of 1.1 million New Zealand kids started with a temporary approval.

Breach of the international research ethics

On New Zealand, the Norwegian vaccine was used as guaranty that the New Zealand vaccine is safe and effective.  It was the Norwegian Institute of Public Health that was the guarantor.

"First: Norwegian vaccine was not safe! Second, it is a serious overstatement to say that vaccine is effective. Third: it is against international regulations and against research ethics to start to vaccinate small children on New Zealand with a vaccine that was tested on a different group of people, Norwegian school kids. To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment, says Jan Helge Solbakk, professor in medical ethics."

Watch the documentary on TV2 tonight at 22:30 local time:
http://pub.tv2.no/TV2/magasiner/dokument2/article771764.ece

In case you have no possibility to watch or to understand this documentary, read the next newsletter. We will bring you the most important data from the documentary.

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