Norwegian Vaccine Stopped.
Oct 2006
Torbjorn Mørk, Minister of Department of Health, reacted
and stopped a Norwegian Vaccine production in October of 1983 because he feared
it was dangerous.
Read his letter here.
In Dokument 2 it is revealed that Health Authorities intervened and stopped the production of vaccines at The Governments Institute for People’s Health (SIFF) in October of 1983.
Article1 (image)
The Department understands the problems which the SIFF vaccine department is faced with when it comes to upholding a satisfactory production of vaccines and immunglobins under the current circumstances.
At the same time it is viewed with the greatest seriousness what has lately been revealed regarding side effects and specific production difficulties at the institute (SIFF).
The Department is therefore prepared to perform necessary action to improve the
situation and will ask the institute to put forward suggestions for a plan of
action that can lay the foundation for vaccine production in satisfactory and
safe forms a.s.a.p.
The following information is requested for the elaboration of a plan of action:
Production of vaccines which there has been problems with, are to be stopped (discontinued) until further notice and the products are to be replaced by import.
Production that can take place under justifiable conditions are to be preserved.
(End of first article)
In a letter signed by present Minister of Social affairs, Leif Arne Heløe and Minister of Health, Torbjørn Mork it is stated that “one views with grave seriousness at what has been revealed lately regarding the side effects and specific production difficulties at the Institute (SIFF)”.
“The Department is determined to put in place necessary efforts to improve the situation and will ask the institute, as soon as possible, to supply suggestions for a plan of action that may lay the foundation for a future vaccine production in safe ways.
Acknowledged problems with the vaccine.
(Article 2)
Staff that is unable to contribute to continued production, or who cannot be recruited to a program for competence structure, are to be regrouped for the sake of the employees and the institute (SIFF).
The Institute are advised to consider the change in situation while the elaboration of suggestions for a new plan of organization.
The Department requests that a plan of action as described above is presented before the 1st of December 1983 in consideration of budget calculations.
(Signed by Leif Arne Heløe and Torbjørn Mork)/
(End of second article)
Two inspection rapports from the Ministry of Health concludes that the authorities/government were familiar with that the self fabricated (?) vaccine from The Institute (SIFF) was insufficient.
“The conditions for pharmaceutical production at SIFF are VERY unsatisfactory and it is required elaborate measurements to raise the standard to an acceptable level” it is stated in a report from 1997.
And in a second report by two inspections/controls accomplished November 1983 the following is stated:
“Even though a definite improvement has been done in several fields since the last control, there are still many requirements to be met before the demands are met.
It cannot be accepted that the final mixture of various kinds of vaccines are not properly controlled because of the lack of resources at for instance the animals department.
The demand that the final product is to be analyzed is not to be avoided.
A log should be kept in conjunction with the export of vaccines from SIFF that denotes:
Product, amount and recipient.
The system should be constructed so that withdrawal can take place rapidly and effectively in case of side effects or production errors.
Formulations in the documentation in the line of:
Test not delivered to the control department we are all out, is Unacceptable (!)”
Were given a Six week dead line.
The Social Department gave The Peoples Health Department a six week dead line to present of plan of action and demanded that their self produced vaccine was to be replaced with an imported vaccine from a pharmaceutical company.
The letter from the Social Department also reveals that the authorities/government were familiar with the problems connected to the vaccines.
“The production of vaccines which there has been problems with, are to be stopped (discontinued) until further notice and the products are to be replaced by import.
Production that can take place under justifiable conditions is to be preserved”.
The 10th of January 1984 SIFF (The Institute for Peoples Health) bottled their last batch (vaccine which is manufactured in a single production) of self produced triple and whooping cough vaccine.
The countries Health personnel was in the mean time not informed that the fear of side effects was one of the reasons that the vaccine production was stopped.
Because when The Peoples Health Department in February 1984 announced that one has now started to import vaccines it was noted as a “temporary stop of production”:
“As of lately there has been some problems connected to the use of vaccines supplied by SIFF.
Because of the need to renovate the production facilities there is now a temporary stop of production of vaccines at SIFF.
Until the production can be continued a certain amount of vaccines formerly produced at SIFF will be imported”, writes The Peoples Health Department in an MSIS report for week 6 of October 1984.
Watch Dokument 2 at TV2, Monday the 9th of October, 22.30/
http://pub.tv2.no/TV2/magasiner/dokument2/article764204.ece
Av Olav Njaastad og Kjell Persen
09.10.06 10:51
Helsedirektør Torbjørn Mork grep inn og stanset norsk vaksineproduksjon i oktober 1983 fordi han fryktet den var farlig. Les brevet her.
I Dokument 2 kommer det frem at helsemyndighetene grep inn og stanset produksjonen av vaksiner ved Statens instititutt for Folkehelse (SIFF) i oktober 1983.
I et brev undertegnet daværende sosialminister Leif Arne Heløe og helsedirektør Torbjørn Mork heter det at "en ser med stort alvor på det som i den senere tid er fremkommet om bivirkninger og spesielle produksjonsvansker ved instituttet."
"Departementet er derfor innstilt på å få gjennomført nødvendige tiltak for å bedre situasjonen og vil be instituttet om snarest å fremlegge forslag til et handlingsprogram som kan legge grunnen for en fremtidig vaksineproduksjon i betryggende former."
Erkjente problemer med vaksinen
To inspeksjonsrapporter fra Helsedirektoratet slår fast at myndighetene kjente til at den egenproduserte vaksinen ved Folkehelsa ikke holdt mål.
"Produksjonsforholdene for legemiddeltilvirkning ved SIFF er meget utilfredsstillende, og det kreves svært omfattende tiltak for å bringe standarden opp på et akseptabelt nivå", heter det i en rapport fra 1977.
Og i en annen rapport fra to inspeksjoner utført november 1982 heter det følgende:
"Selv om det er gjennomført klare forbedringer på flere områder siden forrige ettersyn, mangler det fortsatt mye før kravene er oppfylt … Det kan ikke aksepteres at sluttblandingen av ulike typer vaksine ikke blir skikkelig kontrollert pga manglende ressurser bl a i dyreavdelingen. Kravet om at sluttproduktet skal analyseres kan ikke fravikes … Det bør føres kartotek i forbindelse med utsendelse av vaksiner mv fra SIFF som angir produkt, mengde og mottaker. Systemet bør videre legges opp slik at tilbakekalling kan skje raskt og effektivt i tilfelle kvalitetsfeil eller bivirkninger … Formuleringer i dokumentasjonen av typen ”Prøve ikke levert kontrollseksjonen, har ikke mer igjen”, kan ikke godtas.”
Fikk seks ukers frist
Sosialdepartementet ga Folkehelsa en frist på seks uker på å komme frem med en handlingsplan, og forlangte at Folkehelsas egenproduserte vaksine måtte byttes ut med en importert vaksine fra en legemiddelprodusent. Brevet fra Sosialdepartementet avslører også at myndighetene erkjente at det var problemer knyttet til vaksinene:
"Produksjon av vaksiner som det har vært problemer med, stoppes inntil videre og produktene søkes erstattet ved import. Produksjonen som kan foregå under forsvarlige forhold, søkes opprettholdt."
10. januar 1984 tappet Statens institutt for Folkehelse sin siste batch (vaksine som er fremstilt i en enkelt produksjon, red. anm.) med egenprodusert trippel- og kikhostevaksine.
Landets helsepersonell ble imidlertid ikke informert om at frykten for bivirkninger var en av grunnene til at vaksineproduksjonen ble stanset. For da Folkehelsa i februar 1984 meddelte at man nå hadde begynt å importere vaksiner, ble det hele omtalt som en "midlertidig stans i produksjonen":
"Den senere tid har det vært en del problemer problemer knyttet til bruk av vaksiner levert fra SIFF. På grunn av behov for å ruste opp produksjonslokalene, er det nå blitt midlertidig stans i produksjonen av vaksiner ved SIFF. Inntil produksjonen igjen kan komme i gang, vil en del vaksiner tidligere produsert ved SIFF, måtte importeres", skriver Folkehelsa i en MSIS-rapport for uke 6 i 1984.
Se Dokument 2 på TV 2 mandag 9. oktober kl. 22.30