The investigations are centered around a campaign by the two companies to vaccinate children against Hepatitis B (HBV) between 1994 and 1998. There have been allegations that the companies did not fully disclose the side effects of the vaccine. During this period of time, nearly two thirds of the French public, and routinely all newborn babies, were given the HBV vaccine.  

What is particularly surprising is that while this action was reported on February 1st 2008 on Reuters, a search of both the BBC and the CNN websites did not show that it was being reported at all. Why is it that employees from two of the world's largest pharmaceutical companies are being investigated for manslaughter but there is no mention of it on these websites?

What do we know about HBV and the vaccination for this disease? First, we know that HBV is a blood borne virus. It can only be contracted through sexual intercourse and blood transmission. This means that a newborn baby or a child is at extremely low risk of contracting the disease unless they are having a blood transfusion in a country where blood is not routinely tested for viruses, or their mother is positive for Hepatitis B.

Secondly, we know that, for low risk groups, the vaccine does not appear to provide long term protection.  In one study it was found that only 1 in 10 children aged 5-7, who had been vaccinated at birth, still had antibodies against HBV².

Thirdly, we know that 90% of people exposed to HBV will develop an acute infection and then recover after a few months, while for the remaining 10% they will have chronic HBV and become carriers. 15-20% of those with chronic HBV will die of complications associated with the disease. This means that for every 100 people who are infected with HBV, 90 will recover, 10 will become chronic HBV carriers, and 1-3 people will die of HBV related complications.

Finally, we do not know what the true risk of contracting HBV is for any particular individual. Certain practices significantly increase the risk of acquiring the disease such as intravenous drug use, unprotected sex and blood transfusions if the blood is not tested for HBV. However, for a healthy, non-drug user, who is not having unprotected sex, we do not know the risk. The overall risk within the population of the USA is 5%. This is a skewed statistic though since it includes prostitutes and drug users who are at significantly increased risk, and infants who are at almost no risk.

It will be interesting to follow this case and see how it proceeds. Will pharmaceutical companies be held accountable for injury and death that the families involved believe were caused by the vaccine? Or will it be determined that there is no evidence that the vaccine is unsafe?

References

1. French judges probe firms over vaccinations, Reuters, Online: http://www.reuters.com/article/rbssHealthcareNews/
   idUSL0173467120080201, retrieved February 5th 2008.

2. Petersen, K.M. et al., 2004. Duration of Hepatitis B Immunity in Low Risk Children Receiving Hepatitis B Vaccinations from Birth. Journal of Pediatric Infectious Diseases, 23(7),650-655.

Childbirth International's take on research

It appears that journalists may report on the latest research using the abstract or the press release as the sole source of information. The problem with this is that the abstract is not always showing all the information that was gleaned from a study, or may be skewed towards what the authors were hoping to find.

News is often taken from organizations like Reuters. Again, this is a brief overview of the research, intended to highlight the most relevant points. Critical information about risks and complications may be left out.

Generally these news briefings do not provide any information on the number of people in a study and the methods used when the study was carried out. Nor do they usually mention any potential bias from the authors of the study, for example when a study author has financial interests that may be affected by the study results.

Childbirth International aims to highlight the issues related to some of the latest research and examine some of the relevant issues, enabling you to help your clients find their way through the maze of options available to them and understand evidence-based care.