Wednesday, 12 July 2017

#MSPrevention & #NewsSpeak: will Pharma develop an EBV vaccine?

Why don't the Courts' consider the wider implications of their decisions? The anti-vaccine lobby is smiling. #MSPrevention #NewsSpeak

The story about hepatitis B vaccination causing MS seems to resurface every few years and the source is usually from France. The news piece below, in last week's Science, raises major concerns for the vaccine industry. The epidemiology is pretty clear; hepatitis B vaccination does not cause MS, so why did they rule to the contrary? 

Hepatitis B vaccination is common, MS is uncommon, and by pure chance a small number of  people will develop their first attack of MS soon after vaccination. The epidemiological studies have confirmed that the number of people developing MS in relation to hepatitis B vaccination is no higher than what you would expect by chance. It appears that the European court does not necessarily agree with the scientific data. The court's ruling potentially sets a dangerous precedent for vaccine manufacturers. 

Vaccines are amongst the most important and impactful innovations we have. Unfortunately, most of us have not lived, or experienced, what life was like before we had effective vaccines. In the pre-vaccine era life was a lottery.  At a personal level when I was training in South Africa I managed several patients with a terminal condition called SSPE (subacute sclerosing panencephalitis), that occurs as a result of wild-type measles infection. The sad thing is that SSPE is 100% preventable; all you need is to vaccinate people against measles to prevent SSPE. The anti-vaccine lobby has been so effective in sowing doubt in the mind of some people that there are now a large numbers of children getting wild-type measles infections. The latter means that we will begin to see SSPE re-emerging is few years time. Sad, very sad.   

Vaccine development is a very expensive and a very risky endeavour. Anything that acts as a disincentive to the Pharmaceutical industry, such as the court decision below, is bad news for the world. I have a vested interest in vaccinology; it is my ambition to be part of an EBV vaccination trial to see if we can prevent MS.  For the latter to happen we need Pharma, public health officials, politicians and society at large to be supportive of vaccination. The legal decision below, which is contrary to the science, just feeds the public's scepticism about the benefits of vaccination. Could you imagine if EBV vaccine development was stalled because Pharma thought it too risky to take forward?  


For those of you who are interested the following is a report of workshop that was recently hosted by the Wolfson Institute of Preventive Medicine on EBV and MS Prevention. It is clear to prove EBV is the cause of MS we need to do a vaccine trial and show that we can prevent MS. Simple? The Court's decision on hepatitis B has just made our job harder. 

   
Gretchen Vogel. Decision by Europe’s top court alarms vaccine expert. Science Jun. 27, 2017.

Excerpts:

..... Did the European Union’s highest court just deal a blow to science? "Vaccines can be blamed for illness without scientific proof," read many headlines about the European Court of Justice’s (ECJ’s) ruling on the case of a French man who claimed that a hepatitis B vaccine caused his multiple sclerosis (MS). Alarmed experts pointed out that no link between the vaccine and MS has ever been established and fretted that the Luxembourg-based court had opened the floodgates to large numbers of spurious lawsuits.

...... The case involves a French man, called “W” in court documents, who received the three recommended doses of a hepatitis B vaccine between December 1998 and July 1999. In August 1999, W developed symptoms of MS, an autoimmune attack on the protective sheath covering nerves. In 2006, he and his family sued Sanofi Pasteur, the vaccinemaker, claiming that the vaccine had caused the illness. (W died of MS-related complications in 2011.) Other people have made similar claims, but large epidemiological studies have found no connection between the vaccine and MS.

.... W initially won his case. In 2009, the regional court in Nanterre ruled that, because he had no obvious previous health issues and no family history of MS, the appearance of symptoms shortly after the third vaccine dose was sufficient to conclude that the vaccine was the likely cause. In 2011 the Court of Appeal of Versailles overturned that decision, ruling that although W had made a convincing case that the vaccine caused his MS, he hadn’t shown that the vaccine was "defective," as required by liability law because for the population as a whole the vaccine's benefits outweighed its risks.

...... W and his family appealed to the Court of Cassation, France’s highest court, which evaluates whether lower courts have properly applied the law. It ruled that the appeals court decision on whether the vaccine was defective should have weighed the specific facts of W’s case, not the general risks and benefits of the vaccine, and handed the case to the Court of Appeal in Paris. (The French legal system assigns cases to a new court when a decision has been overturned.) The Paris court reached a different verdict: It found that W had not proved the vaccine had caused his MS. The court cited the lack of scientific evidence for a connection between the vaccine and MS, and the fact that the disease process is thought to begin years before symptoms appear—in other words, before W was vaccinated.

...... If you start to have a significant number of court decisions in Europe that regard products as defective because of rare side effects, this could change things significantly.Jean-Sébastien Borghetti, Panthéon-Assas University

2 comments:

  1. Thankfully I took all the necessary doses for Yellow Fever, otherwise I would not be able to get vaccinated now after MS.

    The same thing happens with the attempt to link the vaccines and the growing number of autistic, which has been proven to be unrelated.

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