Dispatches from the road, part II: The Danish autism studies
I'm going to post something written by a guest blogger, Kristjan Wager. The reasons I'm posting are twofold. First, Kristjan, a fairly regular commenter on this blog who also happens to live in Denmark, has something interesting and informative to say about the Danish institute that did the widely-cited studies that failed to find a link between the thimerosal in childhood vaccines and autism. Second, I'm on vacation, and it's great to be able to put up at least one substantive post while I'm gone, with my only effort being to type a pithy introduction of a paragraph or two and do a little minor editing of the text for grammar and style. (English isn't Kristjan's first language, but minimal editing was required; I wish I could write so well in another language.)
One of the tactics used by those advocating a thimerosal-autism link is to attack the Danish study, since it is so widely quoted. Sometimes they try to attack the methodology, but, because the methodology was generally sound, such attacks usually don't get much traction. So, the next attack is to do a variant of the "pharma shill" attack, but this time on the scientists who did the studies, because they work for a government institute that manufactures vaccines. Indeed, RFK Jr. himself has said:
The Institute of Medicine as well as the Centers for Disease Control and the Food and Drug Administration base their defense of Thimerosal on four flimsy studies ginned up by the pharmaceutical industry and federal regulators who green-lighted the use of Thimerosal in the first place. Those fraudulent studies deliberately targeted European populations which were exposed to a fraction of the Thimerosal given to American children.
When debating autism and a possible link to childhood vaccinations and/or thimerosal, the Danish studies of a possible link are often brought up. There are several such studies, looking at different aspects of possible problems with childhood vaccinations, and so far they have all reached the conclusion that there is no link between neither childhood vaccinations nor thimerosal and autism.
When the studies are brought up, the proponents of a link often attack them based on their methodology and the authors of the studies. I haven’t analysed the studies well enough to be able to speak with any authority on the subject of the methodologies, however I can comment on the validity of the attacks on the authors. A good example of such an attack can be found on the blog adventures in autism, in which the author, ginger, writes:
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the government owned vaccine manufacturer who would be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
First a little background on the Danish health system and Statens Serums Institut.
Denmark has universal health care, which means that everything except medicine
is free, and you will get financial aid for most medicine. In some countries with universal health care, there is a two-tiered system, in which most people have health insurance, ensuring that they get treated in a private hospital if they get sick. In Denmark that is not the case. Private hospitals exist, but were only allowed within the last two decades, and are not used much. The Danish health system also covers the cost for people with special needs, such as some people with autism. Vaccinations are considered normal health care, and as such they are given with no charge to the public.
Statens Serums Institut is a public enterprise that operates as a "market-oriented production and service enterprise". It operates under the Ministry of Health, and is covered by the Danish Health Law (Sundhedsloven) § 222 which, among other things, states that the institute secures the delivery of vaccinations, including the vaccinations to the childhood vaccinations program. According to § 222 2) the Ministry of Health and the Ministry of the Interior decides the rules regarding payment of the institute. A description of the Danish Childhood Vaccination Program can be found here.
If you look at Statens Serums Instituts annual report (pdf), you can see that the institute had a net revenue of 979.9 million kroner in 2004, and had a operational profit margin of 1.9%. All in all, the institute had a net income of just over 11 million kroner in 2004. That is approximately $2 million. In other words, Statens Serums Institut is by the standards of medical companies a non-profit business, and the institute has a very small profit in making the vaccinations.
One of the reasons why Statens Serums Institute has such as small net income is that it puts a lot of money into research and development, not only of new products, but also of existing products. Since the Institute, by law, has to ensure the delivery of childhood vaccinations, a lot of research goes into this aspect, which is why studies authored or co-authored by employees of the Institute are often cited when debating links between childhood vaccinations and other diseases/ailments. If you look at the annual report, you can see that they have the following comment:
On the research front, the Institute has documented that childhood vaccines do not cause other diseases such as autism and diabetes. This is of great importance to childhood vaccination programs world-wide.
The liability of Statens Serums Institut
First of all, if a link between childhood vaccinations, or any components in them, and autism was found, this would not make Statens Serums Institut liable. Since the childhood vaccination program is a state run program, it would be the State of Denmark that would be liable. Of course, since Statens Serums Institut is owned by the state, it doesn’t mean that employees there wouldn’t want to try to cover up a connection, so the state wouldn’t be held liable. However, there are some other things to take into consideration before reaching such a conclusion.
The Danish law system is different from the American law system, and it’s not possible to sue the state as it would in the US. Instead the liability is covered by "Lov om klage- og erstatningsadgang inden for sundhedsvæsenet", which deals with such issues within the Danish health care system. In chapter 3 of that law, the rules governing compensation for ailments gotten as a result of treatment are defined, while chapter 4 deals with compensation following ailments as a result of medicine. I haven’t been able find out if vaccinations would be considered treatment or medicine, but most people I’ve spoken to tend to believe it would be covered under medicine.
The law makes it clear that liability is not dependent upon the knowledge of harmful effects at the time of the administration of the medicine, nor even upon the fact that such effects should be plausible at the time. However there are some strict time frames for how long after a medicine (or treatment) was administered that it is possible to try to obtain compensation. In the case of treatment, it can happen up to five years after the patient or a relative discovered that there was a connection between the ailment and the treatment. In the case of medicine, it can happen up to three years after. In both cases it can’t be more than ten years after it happened. So, in the case of childhood vaccinations, it would mean that even if a link was found between the childhood vaccinations, or a component in them, and autism, any person who had the vaccination administered more than 10 years ago, would not be able to get any compensation under Danish law.
Now let’s go back to the original quote:
The study is further compromised by the fact that several of the coauthors were employed by the Statens Serums Institut, the government-owned vaccine manufacturer who would be held liable if it was indeed found that the use of thimerosal in vaccines contributed to autism.
All in all, I think it's reasonable to conclude that it is extremely unlikely that researchers at Statens Serums Institut would choose to risk their careers to cover up a thimerosal-autism link. And I haven't even gotten into all the legal aspects of what would happen to that person if they did in fact cover up so a link. This might be something I can cover in a future post, if Orac will let me post again.