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Already 1977, inspectors from the Health Department have been inspecting NIPH.
They discovered alarmingly serious errors and failures at the NIPH's production facilities.
Nevertheless, NIPH was allowed to continue the production of the vaccine, though it was against the norms and regulations, like norms that regulate sterility, ingredients control, storage, knowledge about where vaccines were used and who got them.
In the report from 1977, Inspectors write:
"Conditions at the NIPH vaccine production facilities are very unsatisfactory and extensive measures are necessary to bring the production standard to an acceptable level."
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"Accidental errors could result in disproportional consequences, considering that some of the products are used on large groups of patients (Influenza vaccine, and even in higher degree DPT vaccine )."
1982 there was a similar inspection, and the conclusion was similar. Production was graded as unsatisfactory .
"In the same areas where vaccines were produced, animal experiments were carried." inspectors were reporting.
Several other problems were uncovered in the environment that was suppose to be sterile.
The the new report from the Inspectors from 1982 was ignored.
Reporter: Do you think that someone could have been injured by those vaccines produced by NIPH?
Hanne Nokleby: "I can't answer that question. I believe that direct causative relationship between vaccine and reported injuries is highly unlikely." (Hanne Nokleby, Director of the Vaccine Division at NIPH)
October 1983, minister Torbjørn Mork from the Social Department sent a letter requesting that NIPH must improve the production facilities and production and control process.
Minister Mork gave a 6 weeks deadline to NIPH to improve production facilities.
First after that letter, control leader at NIPH reports that the control function at NIPH is far below the danger level.
Conclusions of the Inspectors after official inspections of the vaccine department of The Norwegian Institute of Public Health in the year 1977 and 1982
Translated into English by Svein Erik Berner. August 20, 2006
Inspection report dated May 18, 1977
Conclusion on page 5:
The conditions for manufacturing vaccines at The Norwegian Institute of Public Health are very unsatisfactory, and extensive measures are needed to raise the standard to an acceptable level.
Inspection report dated January 12, 1983
Bases for the evaluation, page 2 and 3:
Although several improvements are made since the last inspection [in 1977], a lot still remains to be done in order to meet the demands set forth by the general GMP rules (i.e. demands in EU for Good Manufacturing Practice) and the guidelines for sterile production.
It is the opinion of the signing inspectors that it will not be possible to meet the GMP demands in premises available today for this production. Fully acceptable production conditions can only be reached if new, suitable premises are made available.
After having argued that Norway needs its own vaccine production, the inspectors set forth a number of recommendations (page 6 - 10). These conclusions, 15 all together, are considered minimum requirements for continued production in the present, provisory and provisionally accepted premises.
The Norwegian Department of Health decided to terminate the Norwegian production of DPT vaccine in 1983.
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EILERT FACT SHEET
Svein Erik Berner
Hogstadveien 91
N-1383 Asker.
Phone: + 47 66 98 83 24 cell phone: +47 413 14 915
Asker, July 2, 2005
Eilert Berner's DPT Vaccination, Summary of Facts.
- Name: Sten Eilert Skatvedt Berner.
Born on 7/26 -1981. (We refer to him as Eilert.)
- Eilert got his first vaccine 10/29/1981 some time after lunch, approximately at 1pm, at Asker Health Service Center (Asker Helsestasjon). It was a DPT vaccine with batch number 6280, produced in 1980. This DPT vaccine was produced by The Norwegian Institute of Public Health (Nasjonalt Folkehelseinstitutt).
- Eilert cried a lot more than usual in the hours and days following the vaccination. Usually he only cried before his meals, when he was hungry, or if he had air in his stomach after being fed. The area around the injection was also significantly swollen. However, based on the orientation we had been given at Asker Health Service Center, we regarded this as normal, and took no extraordinary precautions. We had been told that such swelling was normal, and that the child would likely get fever and cry more than usual. Consequently we did not take Eilert´s temperature, and thus we cannot document whether he had fever or not. Hanne Noekleby, director of the Norwegian Institute of Public Health, confirmed in an email to me, dated 05/29/2001, that the reactions mentioned above were quite common while the whooping cough component of the vaccine was of the old «whole cell» type.
- Eilert "collapsed" Sunday morning the 1st of November. He was outside in the garden, in his pram, while his parents were sleeping in their bedroom. Eilert was put into his pram at 7:30am after his diapers were routinely changed and he had got his bottle of milk by his father at 7:00am. That morning he whimpered, but took his meal without problems. His father did not discover anything alarming. When his mother took the pram inside at 10:30am, to clean him and feed him, he seemed limp and very pale. His breathing seemed to be weak and irregular. In addition, his eyes were «hanging» in opposite directions. His father came rushing when his mother screamed out that something was wrong. Not to waste time to determine whether the son was breathing or not, the father instinctively gave him 2-3 mouth-to-mouth breaths before realizing that Eilert was breathing on his own after all. His mother, in the meantime, tried numerous times to call an ambulance, but the phone did not give the normal ringing-signal as she waited for the emergency personnel to pick up. She then ran over to the neighbors and borrowed their phone, which fortunately worked. After she returned she said that she was certain that Eilert had been breathing when she picked him up from the pram. This we told the personnel at both Baerum Hospital (Baerum Sykehus) and The National Hospital (Rikshospitalet). This is confirmed in the medical record from The National Hospital, page number 1, which covers our statement upon arrival.
- The doctors at Rikshospitalet wrote in the medical record that Eilert most likely had experienced prolonged seizures before he was found in bad condition and very sick that morning. These reactions occurred between 66 and 69 hours after the vaccination.
- According to the log, the ambulance left Asker Fire Station (Asker Brannstasjon) at 11:15am and arrived at our house around 11:30am. We estimate that we arrived at Baerum Hospital shortly before noon. The consultation there took approximately one hour, after which we were sent by ambulance to Rikshospitalet, where we arrived around 1:30pm.
- Upon arrival at Rikshospitalet the doctors at the infant ward immediately did thorough tests and took samples. Eilert was given drugs to prevent seizures (Fenemal and Rivotril). He was still limp and pale, but frequently screamed fiercely for prolonged periods of time. This is documented in the medical record from Rikshospitalet.
- In the early hours of the 3rd of November Eilert had frequent seizures that lasted up to 30 minutes. In these 24 hours he had 19, almost continuous, seizures. At this point he had also been given Vival intravenously, in addition to the Fenemal and Rivotril, to reduce the seizures. We, as parents, experienced the first couple of days after Eilert was hospitalized as extremely critical.
- There were two doors that separated the garden from the bedroom. Eilert slept, based on advice from the nurse, in a separate room at night. It is therefore possible that he experienced intermittent seizures at night, without us knowing.
- Eilert was hospitalized at Rikshospitalet from the 1st of 1981 to the 19th of November 1981. The letter of discharge, dated 20th of December 1981, reads: "We have interpreted the condition to be encephalitis, highly likely caused by the triple-vaccination."
- Various tests were taken at the hospital, including Cerebral CT, EEG, samples of blood and spinal tap. There was revealed extremely high levels of protein in the spinal fluid. These tests, examinations and samples let the specialists at the infant ward determine that Eilert suffered by encephalitis.
- Eilert was hospitalized at the neurological section of Rikshospitalet from the 4th to the 6th of September 1984. The reason was that he started drooling, something he not usually did, after he fell 0.5 meters onto a playground rack in the kindergarten. The letter of discharge for this visit was written by specialist Karl H. Hovind and dated 7th of September 1984. Cerebral CT was done with and without contrast. The neurologist concluded that the observed changes in the brain were old and due to encephalitis. He also wrote that Eilert beyond any doubt must have very limited vision, something we, his parents and close family, experienced since the 1st of November 1981. Dr. Hovind concluded that the most recent symptoms were caused by a direct trauma against the facial nerve, and the symptoms quickly subsided.
- In a letter dated 26th of April 1988 Tryggve Lundar, doctor at the neurosurgical section at Rikshospitalet, writes: «All these changes are considered to be secondary to the encephalitis he contracted when he was a little boy». In the same letter he also writes: «Based on the observed changes in the X-ray pictures, the damage must be characterized as severe».
- Also the center for vision in the brain was damaged. A comprehensive test, performed by eye doctor Sigmund Spetalen at Hovseter Center (Hovseter Kurssenter for blinde og svaksynte), on the 19th of May 1985, concluded that Eilert´s visual acuity was 1/60. The institution was run by the Blind Association and Eilert went to Doctor Sigmund Spetalen and Doctor Egil Ruud for several years for follow-ups.
- Eilert requires assistance at all hours, including help with basic functions. He does not say anything if he is cold, thirsty, needs to go to the bathroom or similar things. One has to observe his needs and ask. He does not take any initiative himself. Likewise, he cannot tell about something that has happened without being helped to start. He cannot eat with a knife and fork. He is able to feed himself, but the food must already have been cut into small pieces and put in front of him. Because of his poor vision, he is practically blind in a lot of situations. Eilert cannot write or read, but can verbally spell certain three-letter words. He is unable to recognize letters and Braille is useless, because his motor skills are comparable to those of a baby. He cannot do buttons, operate zippers or tie his laces. Therefore someone has to help him with clothes, personal hygiene, brush his teeth and so forth. He appears to have a concept of numbers and is able to count to two, sometimes three. He can actually count up to a hundred, but, in spite of daily practice, amounts larger than three appear to be meaningless. Consequently, he does not understand the difference between NOK 10 and NOK 100. Eilert has no concept of time, which makes it very difficult to express whether something happened yesterday or three years ago.
- Eilert is a happy boy that can walk and chat. He is unusually kind and patient; he has never hit anybody and never complains. His interests include police cars, fire engines, ambulances and septic tankers. Eilert has an acute sense of hearing; in particular he picks up and comments upon words when he hears something spoken with a dialect. We have fun speaking a bit of Spanish every now and then. He quickly picks up the vocabulary and often asks how to translate a word into Spanish. He is proud and happy when he masters something that sets him apart from other people. Certain parts of his brain have been spared, whereas other parts have been hit so hard that years of training have had no mention worthy effect. He is a sensitive boy, and gets very sad if he hears about other people, or animals, that suffer. He enjoys listening to music and recorded books. Occasionally he surprises those around him by making comments that are spot on, showing that inside he is a smart boy with social intelligence.
- Eilert was three months late when he was vaccinated. He was born 4 weeks prematurely, as far as I understand, and judged that his «maturity-level» was 36 weeks. His weight at the time of birth was normal, 3050 grams and 49 cm. On the day he received the vaccine, Eilert had a minor cold, was sneezing and a bit pale. Because of this, I requested that the doctor take a blood sample. Not because I feared the vaccine, but because I wanted to know whether he needed supplements of ferrum. The vaccine was administered first, after which a blood sample was drawn. Later I was told, by the doctor, that the sample showed 71.5% hemoglobin.
- Based on statistics and research one must assume that the DPT-vaccine is good for the population as a whole. But the government must take responsibility for those that are hurt by these vaccines, as a result of the public immunization program. In some sense, the kids that have reactions are sacrificed for the greater good of preventing epidemics. However, compensation to those that get sick should be included in the total cost of the immunization program.
- We were not told about possible serious complications in advance. Had we received such information, we would surely have postponed the vaccination a few months. Because Eilert was born prematurely, I would assume, as a layman, his immune system was less developed, and thus less capable of dealing with the vaccine.
- I, his father, have the main custody of Eilert after he was twelve years of age. But one week a month he lives with his mother and his aunt, and some days he lives in a relief home facility. It has not been possible to combine an ordinary job with having Eilert living at home. Over time I have had to cease my involvement as a business owner and executive officer in the companies I created. Instead I had to find work I could perform from my home office, which could be combined with the demanding task of seeing to Eilert. Only after Eilert grew up did I get sufficient support so that I could assume leadership responsibilities again. But Eilert is still my main occupation. I will gladly admit that I have been exhausted at times. On the other hand, Eilert gives back so much that cannot be compared to a career or money, so I do not regret assuming responsibility for him. Thanks to good help from my mother, sister, now deceased brother and Eilert´s mother, it has been possible for us to make a good private custody of Eilert. The parents of Eilert's mother also cared much about Eilert and were of great help in his first years before they died.
Mistakes in the medical record from the National Hospital (Rikshospitalet)
Often things are busy in a hospital, it is a well known fact that mistakes occur in hospital journals. We, as parents, answered some questions between tests after our arrival at Rikshospitalet, but were never given a chance to make a comprehensive statement. Certain incorrect «assumptions» were made by the people appending to the medical record. These are minor mistakes that in no way threatened the well being of Eilert at the time being, but that are misleading when one tries to get a clear picture in retrospect.
While reading Eilert´s medical record from Rikshospitalet I found the following mistakes:
- 1. It says that Eilert was found in his bed, pale and with weak breath, some minutes before noon. The ambulance log shows that the car left Asker Fire Station at 11:15am on the 1st of November 1981. The wait for the ambulance was longer than expected. For us it seemed like an eternity. When it finally arrived it was with neither sirens nor flashing lights. At the time we estimated that we had been waiting for 45 minutes. The person who received the call may not have interpreted the situation as serious as we did. While waiting we got dressed, packed our toiletries and clothing, and waited for what seemed like a very long time. The point at which we discovered something was wrong with Eilert was 10:30am, not a few minutes before 12:00, as stated by the medical record. We arrived at Baerum Hospital shortly before 12:00, and it is probably this event that the journal refers to. Eilert could have had seizures before 8am without anybody noticing.
- The medical record states that Eilert was lying in bed when he was found. This must be an assumption the writer made, since Eilert´s parents were sleeping in their beds. Eilert was in a pram in the garden.
- The medical record by Rikshospitalet states that we, the parents, took Eilert to Baerum Hospital. In the letter of discharge sent to Asker Health Service Center it says that we drove him there ourselves. An ambulance was in fact used.
- Neurological test of infant by Doctor Ruth Bostad, 3rd of November 1981. Doctor Bostad writes that Eilert was found with some degree of cyanosis in bed and without respiration. We never met Doctor Bostad; hence we must assume she got the bed from the previous notes in the journal. She has probably also read about the two- three breaths that were administered, and assumed the child was not breathing. As I explained in detail in court, and which was also explained in writing to the court, it is incorrect that Eilert was not breathing. (See page 1, point 4 of this summary). Eilert was breathing by himself when he was found. Given that mouth-to-mouth was mentioned in the medical record, it is not surprising that doctor Bostad assumed Eilert had stopped breathing.
- The court's own specialists, MD Patric Olin and MD John Oestergaard, also write in their common report that Eilert was not breathing when he was found by his father. This is probably based on doctor Bostad's false assumption that the child was not breathing because the father administered mouth-to-mouth for a few seconds after the mother found the child and lifted it out of the pram.
- The medical record from Rikshospitalet states that we discovered Eilert´s serious symptoms 2 days after the vaccine was administered. The correct number is close to 3 days, between 66 and 69 hours. The «2 days» are repeated in notes made by several other doctors, most likely because they had access to the journal from Rikshospitalet and have used it for reference.
Why did the Norwegian Institute of Public Health not give me access to the data regarding the production and quality control of the vaccine?
Over a period of 20 years I have not myself been able to obtain data regarding the production of these vaccines or the quality assurance procedures that should have been followed. Several requests, by phone and in writing, to the National Health Institute and the National Drug Administration (Statens Legemiddelverk) did not produce any results. In the beginning I was told that I had no right to access these records. Later I was told the protocols could no longer be found.
Norway had, at the point of Eilert´s vaccination, committed itself to following international guidelines, known as Good Manufacturing Practice (GMP), for production and control of vaccines. Only very recently, in connection with the preparation for the second trial, we obtained some of those records from the National Health Institute.
We were particularly interested in one specific test: The Toxicity test, also known as "The Mouse Weight Gain Test", which could help to determine whether the vaccine was dangerous and could cause untoward reactions in man or not.
Unfortunately, the National Health Institute was however not able to give us any solid documentation or details about this test.
In the annual report of 1983 the National Health Institute writes that they have reduced the injection volume of the DPT vaccine to the half of what they earlier have practiced.
The importance of making all facts available
In this summary I have done my outmost to make all facts clear, so that medical and judicial considerations are not based on obvious misinterpretations.
This Fact Sheet has been reviewed and approved by Eilert´s mother, Gunn Karin Skatvedt.
Svein Erik Berner Father/caregiver
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