SaneVax: April 2013, Lena Sundstrøm hosted a program questioning the use of Gardasil in Sweden with special guest appearances by Dr. Diane Harper, one of the lead researchers involved in HPV vaccine development; Dr. Chris Shaw, neuroscientist at the University of British Columbia; and Brittney Fiste, victim of adverse reaction after Gardasil. You can view the original broadcast here. Sandy Lunöe was kind enough to provide SaneVax with the following translation of the program:
TV host Lena Sundstrøm: I have 2 daughters and want them to get all the vaccines offered but the more I read the more confused I am regarding Gardasil. This evening we are looking at info which is given to girls and parents about Gardasil. What do we really know? Why is there such a hurry?
00.50. Linnea G, diagnosed with GBS after Gardasil is told by a doctor that she can die.
00.59. Dr Charlotta B (Swedish Medicines Agency) says that all vaccines can give side effects but the opinion is that the benefits of Gardasil outweigh the risks.
1.15. Linnea K (a girl also called Linnea who is considering whether to take Gardasil) reads on the back of an information brochure that she can ask for advice from a health care guide. She telephones them and asks about side effects.
Answer from health guide advice: The vaccine should prevent condylomas/genital warts. With condylomas/genital warts there is an increased risk of cervical cancer, therefore it is a good vaccine.
2.20. Is it true that condylomas/genital warts really cause cervical cancer?
Cervical cancer affects approx 450 women yearly in Sweden. About 125 of them die from cervical cancer yearly.
2.45. Anna N is interviewed. When she was diagnosed with cervical cancer she asked if she would die and received an answer from the doctor: I can’t say no.
She is well now but her mother died from cervical cancer. Anna fears for her daughter because her mother died so she advises her daughter to take Gardasil.
3.30. Ask your doctor about the only vaccine against cervical cancer – Gardasil. Gardasil protects against 4 different HPV infections.
3.40. Gardasil is developed by Merck. It protects against 4 different HPV infections. 2 of them can cause cell changes which can cause cervical cancer. But it is controversial how effective the vaccine really is against cervical cancer.
4.10. Diane Harper is one of the most significant HPV experts in the world. She is responsible for clinical studies of effect and safety prior to Gardasil approval.
Diane H: We have evidence that they prevent cervical pre-cancers. We don’t yet have any evidence that the vaccines last long enough to really prevent a cervical cancer. Merck has used fear tactics of making parents believe that their child would get cervical cancer if they did not get this vaccine and that is incorrect. Those inferences are incorrect.
5.00. Chris Shaw has studied Gardasil for 2 years.
Chris Shaw: There’s no such evidence that it will protect against cervical cancer. None. To date, we don’t know that the vaccine has prevented any case of cervical cancer, let alone 70% of them. We just don’t know. It could be true, but I don’t think that the evidence is yet there and we won’t know for years if it’s there.
6.00. Lena S: Swedish Council on Health Technology Assessment (SBU) which evaluates methods and risks in health and medical care pointed out as early as 2008 that the scientific basis for Gardasil is defective. Nobody knows how effective the vaccine is.
Måns Rosén: 12 year old girls are being vaccinated. The risk for them to develop cervical cancer will maybe increase first when they are 40-50 yrs old. One can prevent a great number of pre-cancerous conditions but not all because there are many HPV strains which also can cause cancer.
Lena S: So we don’t know if the vaccine protects against cervical cancer?
– No not definitely, but it probably protects against maybe 60 – 70%.
6.57. Lena S: The Stockholm County Council distributed this folder in 2012. Do you think that it holds what it promises?
Måns R: No, it exaggerates. One should have more information about what is most important to consider. Here it states that there is free vaccination against cervical cancer, that’s just what the industry has done and it gives the impression that it’s 100% which is not correct.
Lena S: Is there a risk that girls get exaggerated expectations regarding the vaccine and drop PAP screening?
– Yes that is a possibility.
7.39. Diane H: The most important message to women and parents making this decision is that the PAP screen system works and that the vaccination and the option of vaccination is kind of like icing on the top for a short defined period of time.
7.55. Lena S: How effective is the vaccine and may it cause serious side effects?
We ring to Merck who has developed Gardasil.
They refer us to Sanofi Pasteur MSD. They will not answer questions but refer us to the health authorities.
Sanofi Pasteur MSD (Tobias Cassel): Seeing that there is a decision that there will be a vaccination program, we supply the vaccine for the program which the authorities operate.
8.35. Charlotta Bergquist, (Swedish Medicines Agency): It has been shown by clinical studies that the vaccine protects against serious cell changes which are pre-cancerous conditions. If one removes pre-cancerous conditions effectively there is no possibility that one gets cancer in any other way. So one can say – yes, it protects against cancer.
Lena S: What information do young girls get about side effects?
Linnea K rings again to the health care guide and asks about side effects.
Answer from health care guide: “Let’s see. We started in 2012 and haven’t seen side effects up to now”.
Linnea F: “Can they come later?”.
Health guide: “No. They have tested it”.
Lena S: When we investigate more closely we find several reports about suspected serious adverse events.
9.49. We travel to USA and meet 26 year old Brittney Fiste in Dayton, Ohio.
10.00. Brittney: I no longer have feeling from my knees down in both of my legs and with physical therapy I was able to learn to walk on my own but I still have balance issues, I use a cane, crutches or a wheelchair.
10.22. Lena S: Brittney got the vaccine 6 years ago and became ill after the 2nd dose.
Brittney: I got the second shot and then I had a seizure and I lost the ability to see, speak and move. Then my hearing went and I got tunnel vision.
10.50. Lena S: Brittney cannot work. To get economic help her family reported her injuries to the social security administration system SSA.
11.09. SSA writes: The claimant has the following severe impairments from the Gardasil vaccine injury including muscle pain, impaired balance, migraines, photophobia and seizures.
Lena S: Brittney receives compensation payment monthly.
11.28 Diane H: Now we move to more serious side effects and those are things that really impair a girl or young woman from continuing to go to school or to work.
Lena S: Diane H has responsibility for the safety studies for Gardasil. She says that reports of suspected serious side effects should be taken seriously.
11.49 Diane H: Most of those have been a neurological interaction either with paralysis, with a feeling that they can’t think, that they can’t concentrate. There have been some serious studies that have shown some HPV associations. Those are really good scientific studies that need to continue to progress so that we understand more both of the science as well as the real risk of what is happening to these young girls.
12.14 Professor Chris Shaw: So usually you hope that the risks are very small and the benefits are very high. In the case of Gardasil I don’t think that you can make that claim. I don’t think that you can claim that the risks are small because the risks are actually significant, or that the benefits are high because we don’t know.
So right now you’ve got a very highly documented level of risk and an undocumented still to be determined level of benefit. And that makes it very difficult to claim that the risk-benefit analysis is going to give a positive outcome.
12.49. Charlotta B (Swedish Medicines Agency): Obviously things may occur after a vaccination but we have no signals that there is anything serious which would be a cause for alarm. There is good knowledge about Gardasil.
Lena S: It is not only in USA that a connection has been found between neurological injuries and Gardasil.
13.25. Lena S: If side effects only affect a few one should still be informed about the risk. 23 year old Linnea G from Stockholm got Gardasil when she was 17.
13.50. In her diary she writes: I only asked one question to the neurologist. I asked him to be completely honest. He answered that I can die.
Lena S: After the 2nd injection Linnea lost feeling in her legs and back. Her family took her to the emergency dept. Her condition got worse.
14.20. Linnea G: I only slept for 1-2 hours. They kept waking me up in case I stopped breathing.
14.35. Lena S: After some chaotic days Linnea and her mother were told that Linnea had GBS.
14.50. Linnea G: “The doctor said that I should be prepared that there is a risk that I might die. At best I will be paralyzed.
15.15. Lena S: But Linnea survives. After several weeks in hospital she moves to a rehab center.
The neurological condition means that she loses all muscle strength.
15.30. Linnea G: One has to build up all muscle strength. I could hardly hold a handle without losing it. I had to start all over again, it was like a newborn baby in an 18 year old body.
15.50. Linnea G’s mother Monica Geneborg: I started investigating about GBS. It was the neurologist who examined Linnea afterwards who said that vaccines are a probably cause of GBS.
Lena S: Linnea and her family reported the case to medicine insurance:
Medical insurance statement: There is considerable probability of a connection between the vaccine and reported injuries.
Lena S: They conclude that Linnea has an injury caused by the vaccine. She is granted compensation.
It is now 6 years after the vaccine. She is still not well and has constant pain.
16.44. Charlotta B (Swedish Medicines Agency): One can get side effects from all vaccines and medicines. But we have evaluated that the benefits outweigh the risks of the vaccine. Many side effects are reported but we do not have reason to believe that there is a connection.
17.06. Linnea G (recorded): There is a possibility that I will die, at least be paralysed.
17.10. Charlotta B: Vaccines can give serious side effects but the probable consequence is that one does not get a serious side effect but naturally that may occur. That’s what we can say.
17.30. Lena S: So one can get serious side effects from the vaccine?
Charlotta B: Yes one can and it has obviously happened.
17.45. Diane H: That’s the real question, right, is that public health experiment really worth doing. Some patients will say “I want protection and I want the vaccine and I am willing to put up with any kind of risk” and that’s great. Other patients are saying “I know the PAP screening system works and that puts me at zero risk for any possible side effects from Gardasil and I’m going to stay with the PAP screening system”. And both of those are perfectly appropriate responses.
18.14. Lena S: What does 17 year old Linnea Klippvik think? Should she get the vaccine or not?
Linnea K: Yes in principle. But I’ll think about it as it seems unclear.
Lena S: What is unclear?
Linnea K: It is not known if there will be side effects later.
18.40. Linnea G: I have it in writing that I have an injury caused by Gardasil. So it is very strange that we will now vaccinate a whole generation of healthy young girls. Why is there such a hurry? Why can’t we wait 10 years until we know more? Whichever way one looks at it we are lab guinea pigs. Those who get vaccinated today will definitely be that.
19.17. Lena S: What information can one listen to? Is it true that condylomas can cause cervical cancer? We’ll ask the Stockholm County Council (SCC) about the information which the young girls receive.
19.33. SCC: “Those who have condylomas/genital warts have an increased risk of cervical cancer”.
Lena S: Shouldn’t we listen to the information?
Henrik A: Yes one should listen to it.
Lena S: So you say that information about Gardasil is good?
Henrik A: Yes.
Lena S: Here’s an example of campaign material which you distribute. Will you please read aloud from “The vaccination”?
Henrik A reads: The vaccination protects against both cervical cancer and condylomas/genital warts.
Lena S: What is your opinion that it says that the vaccine protects against both cervical cancer and condylomas/genital warts?
Henrik A: That it is correct. It protects against cervical cancer approximately 70%, not 100%. It is therefore important that women continue going to gynaecological health control.
Lena S: But what you say now about 70% and that it is still important that women continue with the health controls, was that anywhere in the information?
Henrik A: In this little brochure the 70% is not mentioned.
Lena S: Why do you not inform anywhere that it only protects up to 60-70%?
Henrik A: This is only a brochure to draw attention.
Lena S plays recording.
20.50. Linnea G (recorded): I have written confirmation that I was injured by Gardasil.
Lena S: Do you understand Linnea who feels that she is a lab guinea pig?
21.00. Henrik A: They are not guinea pigs. It is a good vaccine.
Lena S: We shall continue next week when experts will answer questions about Gardasil.
The second broadcast can be viewed here. Hosted by Lena Sundstrøm, participants included Linnea G., who has received compensation for Gardasil injury and her mother, Lena Tellefsen; Mons Rosen of the Swedish Council on Health Technology Assessment; Martin Rundquist from VOF, The Swedish Skeptics Association; Viveca Odlind, Professor of Gynecology, Swedish Medicines Agency; and Cecilia Young from Sanofli Pasteur MSD. Unfortunately, the National Board of Health and Welfare declined to participate. Translation provided by Sandy Lunöe.
Host Lena S: What do young girls know about Gardasil and what it protects against?
Young girls passing by were asked. Answered: Against cervical cancer, HPV virus.
Host: Viveca, do you think that information presented about Gardasil has been serious?
1.28 Viveca O: One may have reason to criticize the information which was given in the program. The information which the State Medicines Agency presents regarding our product resumé and monographs etc is very extensive and serious. But we have not been involved in campaigns and that which has been presented in campaigns is not completely correct.
Host: Do you no feel that it is necessary to be involved in campaigns?
Viveca: It is not me who can decide whether we should be involved. The most important thing is that there is adequate and correct information in campaigns.
If there is poor information it reflects on us too, for which we appologise. We wish that information which is given to parents, young people, to all shall be extensive and correct. There is full agreement about that.
Host: Mons, SBU, Swedish Council on Health Technology Assessment has pointed out that the scientific basis for Gardasil was weak.
Mons R: What we said was that it is a promising vaccine which can prevent pre-stages of cervical cancer but that we won’t know for decades if it can influence illness and deaths. It may prevent 60-70 % of cervical cancers but not all.
We think that the campaign information which the pharmaceutical company was responsible for with a whole page advert in a magazine was very poorly balanced. It did not mention that the vaccine does not protect for all. And we are concerned that women will have a false sense of security and believe that it is not necessary to go to gynecological health checks etc.
Martin R: Was a health check not recommended?
Mons: No, but if you get a vaccine which is claimed to prevent against cancer you can ask if you should have gynecological health checks.
4.15 Viveca: It illustrates clearly the necessity for balanced information. It must contain all the components, about that which is good and the conditions. And that it is effective is what we should be concerned about. It protects up to what we call cancer in situ which we regard as cancer risk, pre-stages for cervical cancer and there is a long development to invasive cancer.
Host: But can’t girls wait and see, they are very young…
5.00 Viveca: The whole idea is that they should get the vaccine and can react by developing antibodies …
Host: As a parent I have always been pro-vaccine. It seems that there are two camps, one is the skeptics and the other is the authorities who say that there are only advantages with Gardasil and that it is a myth that there are side effects.
Martin: All pharmaceutical products have potential to cause side effects and regarding poor Linnea here – there are tens of thousands who are not invited to the studio and who have not got GBS.
5.50 Host: But it Is very important that we concentrate on information which is given about Gardasil and when parents and young girls read the health guide it says that there are only advantages with Gardasil. What do you say as a serious scientist about the claim that there are only advantages? It states that claims about side effects are not correct.
Martin: Side effects should be considered in relation to risk. This is stated in package inserts for all medicines.
Host: So you don’t find it a problem that a scientist can claim that there are only advantages?
Martin: I vaccinate my children
Host: I do too but at least side effects can be mentioned
7.33 Host: Linnea, it has been confirmed that you have a neurological injury from Gardasil and you have also been granted compensation for this. What kind of information did you get when you took the vaccine?
Linnea G: Absolutely nothing. I did not receive any information and I read that it claimed that there were no serious side effects, but now this is stated. And I think that it is incredible that they could claim that there were no serious side effects because I am proof that there are. It is pure nonsense.
Viveca: It functions such that when Gardasil was approved , I don’t remember exactly but there were about fifteen thousand women who had got the vaccine and it was this which was the basis for approval. In that study I don’t think that type of side effect occurred. When a vaccine or medicine is marketed very many more people are vaccinated and then side effects are seen, it is quite usual, we have spontaneous reporting of side effects which come in all the time to the State Medicines Agency.
8.55 Host: The way you describe it, can you understand that young girls feel as though they are subjects for experimental studies?
Viveca: Yes, but for how long time and how big groups should we study for a vaccine like this before we feel that we have a dependable basis. It’s like that for all medicines. When they come out on the market you have a limited number of people who have taken them. Therefore it is very important that there is a continued follow up program because there are so many people, so you can quickly get information. Because there are so many people we see more side effects, as it is for all medicines. Our database is quite extensive.
9.58 Host: But it says that it has been well tested. Can you help me as a parent, I have one daughter who is vaccinated, the other is not. When for example Pandemrix vaccine for swine flu was concerned: When we look back for example regarding swine flu and and Pandemrix a professor at the Medicines Agency said that there have been influenza vaccines for many years so we know about long term effects. And after the narcolepsy cases occurred a leading representative of the health authorities said that the vaccine had a high safety profile when it was approved and that the cases of narcolepsy were absolutely unexpected. How can we tackle such situations as parents?
10.45 Martin: When clinical trials are done one cannot test 300000 patients and it would be necessary to have so many to see cases of narcolepsy, one does not do such big studies for medicines.
Host: Mons, regarding swine flu influenza the epidemic was milder than expected, but one can understand that there was concern that it would spread – but what do you think about this situation, I don’t think that there has been such a quick approval as that for Gardasil?
Mons: I’ll be careful the way I express this but it went very quickly and there was pressure that it should reach the whole population…. That is my personal opinion.
Host: Linnea, you said that you did not get information about side effects, did you get information about how long the vaccine would be effective?
Linnea: They did not know and they don’t know now either.
Viveca: There is a follow up for Gardasil, now we have data which shows that it has effect for 8-10 years. But it is correct that when it first was marketed it was known that it had effect for 5 years . The earlier the phase of the program the less knowledge we have about it.
12.25 Host: Martin, what is your opinion that it is very important that one maintains public confidence in vaccinations, and when there are weaknesses in vaccination programs that people can lose confidence in the authorities?
Martin: I think that it is the media which can make people lose confidence
Host: You don’t see any problem with this brochure? It says that Gardasil protects against cervical cancer. If you compare it with the authorities’ information here about gynecological health checks…
Martin: But this is not all the information they receive before they get the vaccine, this brochure is to attract them to going to the vaccination caravan.
Host: Do you not find it problematic that young girls are being lured into the vaccination caravan and getting the vaccine? It says that the vaccine protects against both cervical cancer and sexually transmitted disease…
Martin: 70% is a lot and in the other case 90 % ….
Host: But that is not what is in writing. It is written that it protects against cervical cancer, it gives the impression of being 100 %.
Martin: It does not state how high percent is on the paper…
Host: Mons, what is your opinion?
Mons: I think that the information from Stockholms ……. has more detailed information other places, but I think that if one tempts young girls to this it is clear that both parents and their children should get more information before….
14.0 Host: Do we know today about booster doses? There is conflicting information about this. The Medicines Agency believes that four years…
Viveca: We don’t know today,…
Host: Do you know if it will be free?
Viveca: That decision is not made by the Medicines Agency
Host: Would it have been better to have an aggressive campaign for gynecological screening?
Viveca: I will not say if it would be better or not but it would have been a possibility.
Martin: But then you will get to know if you are already ill instead of preventing illness.
Host: No, it shows pre-stages. Someone here can answer this but I’m quite certain that ..
Viveca: It has an incredibly high frequency for healing, very many are over treated. Our gynecologists treat many more than is really necessary. What could be done as an alternative to the vaccine program is that the whole system could be intensified
15.35 Host: We round off with this now, and we should be better to go for the health checks. After the break we will talk about how to report side effects and we will discuss this with Sanofi who is responsible for the vaccine, and Viveca. We shall also have a mother in the studio who has a thirteen year old daughter who is ill after Gardasil but who has not yet had a confirmation of a link between the illness and the vaccine. What does one do then?
16.18 Host: We are discussing the deficient information in relation to Gardasil. With us in the studio we have Viveca Odlind, professor in gynecology from the Medicines Agency, Cecilia Young, head of medical department for Sanofi Pasteur MSD and welcome also to Lena Tellefsen who is mother to thirteen year old Olivia.
Host: Lena, we understand that you have not yet received confirmation from medicine insurance that your daughter’s illness is linked to the vaccine but we would like you to be here so that we can discuss the situation about reporting side effects. I understand that there was a mistake …
Lena: Olivia became ill within an hour after the vaccine, she never got to the school nurse. She had flickering in her eyes, headache, cramps, rash,…
Host: When was this?
Lena: 3rd October.
Host: And who reported to whom about this?
Lena: The school nurse reported it directly to the medicines agency. Olivia was told to stay at home a few days and take headache tablets and then she would be better. They thought that she was allergic so she was given some antihistamines.
She had seven seizures within a month but the school nurse did not do anything. They said it was not caused by Gardasil in spite of there being a clear connection, we were not believed.
Host: You read information carefully before you made your decision about vaccinating. What information did you have?
Lena: I found information where it says that the vaccine can cause serious side effects but that which is in internet is lies, not true. And I went to the official site and it was stated there that Gardasil does not give more serious side effects than the placebo and I have medical education so I know that placebo is salt solution and one can’t get ill from that. So I felt safe.
Host: Cecilia Young from Sanofi, you have had contact with Lena regarding this case all the time.
Cecilia Y: Yes we have had contact since October last year and we have had a lot of contact. What we do when we receive a report about a side effect : we report it further and we have responsibility to follow it up.
It is the medical doctor who is treating the patient who has responsibility for the patient. What we have talked about with Lena is the information in our safety database about similar symptoms and how these symptoms have developed and how long they have lasted. That is the information I can give.
Host: We want to avoid that listeners will become scared. When do the side effects occur? Do they usually happen quickly like Lena describes ?
Cecilia: We must consider time and causal links. After a vaccination a lot may happen. The question is whether something which happens after vaccination is caused by the vaccine. We talked about side effects and products , but it was the observations which she made …
Host: But Linnea G here has confirmation that that there is a probable connection between her side effects and the vaccine.
Cecilia: Yes, we see a connection with time here, Linnea developed symptoms after the vaccine, so the question is whether there is a connection with time or with the vaccine. There are no studies which confirm a link between the vaccine and GBS. All studies point to the opposite.
21.12 Host: But that which is stated in FASS (The Swedish National Formulary of Drugs) …
Cecilia: That which is stated in FASS is not a causal link but observations made in the time after vaccinations. And all such information is included, reported from us and from the health authorities. It was Sanofi who asked that the observation about GBS be included.
Host: After the swine flu influenza and Pandemrix there was possibility to report side effects. Is there a similar system for Gardasil?
Viveca: We have a system for the possibility of reporting side effects both for health personnel and for patients directly to the Medicines Agency.
Host: Is it the same type of system?
Viveca: Yes it’s quite a simple system but it is spontaneous reports and we want this kind of reporting because the more reports we receive from various sources which are similar to each other the more probable it may be that there is a causal connection to the vaccine.
Host: Ceciliia, before the break we talked about deficient information and on your home page about Gardasil and there we can read myths and facts, that’s very good. But does it ask anywhere – it is true that one can get GBS from Gardasil or is it true that Gardasil protects against cancer or is it true that we don’t need to take health checks when we have taken Gardasil ….
Cecilia: To the first question if there is a connection between Gardasil and GBS. No. There is no confirmation of cause .
Cecilia: Next, Gardasil protects against cervical cancer
Host: It protects against HPV virus
Cecilia: No, no. It protects against cervical cancer, it protects against cancer in situ, the serious development before occurrence of invasive cancer and this must be reported to the health authorities, Gardasil protects against this. So it is a fact that Gardasil protects against cervical cancer.
Host: Up to 60 – 70 percent, it is believed…
Cecilia: No it is not just believed, it is known. At least 70 percent.
Host: But not 100 percent.
We have to round off the discussion now. Continue mailing in questions to us and we will try to answer them.