In a move that defies all logic, the FDA advisory panel investigating the contamination of Rotavirus vaccine with pig virus has recommended that vaccine use be continued because “The vaccines offer a clear public health benefit that far outweighs a “theoretical” risk from PCV (Porcine Circo-virus)”. How very reassuring. Not.
PCV type 1 was found as a contaminant in the Rotarix vaccine in March and a temporary halt was placed on its use. Last week PCV type 1 and 2 were found in the rival vaccine RotaTeq. Clearly this is a manufacturing process problem. We have absolutely no idea whether these viruses could be harmful, although we do know that they do not appear to cause any immediate diseases. In the face of large numbers of unknowns, it is usually clinically prudent to stop the use of the vaccines altogether until the manufacturing problem can be solved or the PCV virus proved definitively harmless.
Apparently not for the FDA. Such a decision only calls into question the known incestuous links between the FDA and the pharmaceutical manufacturers. In case you think I am being a bit harsh in my judgement, take a look at the decision process of the advisory committee. they base their judgement on:
It seems unlikely that the FDA’s warning to avoid Rotarix will stand given that no data indicate the virus is harmful to people and that Merck’s vaccine also contains the virus.
GlaxoSmithKline scientists presented data to the panel indicating the PCV1 virus is not harmful to humans, at least in the short term.
“PCV1 infection is widespread but does not cause any disease in pigs or other animal species including humans,” X.J. Meng, MD, PhD, of GlaxoSmithKline, told the committee.
There was less information on PCV2, but an FDA official said it has been known to cause illness in pigs, although not in humans.
The argument runs that the other vaccine is contaminated, so lets un-ban the first one. Logically, we should be stopping use of both vaccines. The statement “PCV1 virus is not harmful to humans, at least in the short term” means only that it does not cause immediate disease. But what about recombinant effects? We spent weeks worrying about Swine flu mutating into a more deadly strain and seem completely unconcerned about injecting our children with a xeno-virus. How about long term slow-virus effects? I do not know enough virology to know if that is a concern, but it seems that the GSK virologist seems a little blase about the whole deal. The very fact that this is a virologist from the actual drug company is a concern. Is this not a little like taking assurances from the tobacco company researchers that smoking does not cause lung cancer? Why is there not an independent risk assessment from a virologist with no Big Pharma interests?
But this is not the only dangerous part of their logic. Recall that this is the FDA. They are only setting approval for drug use in the US. That makes the statement below a particularly stupid argument:
RotaTeq and Rotarix are administered orally to millions of infants worldwide to prevent rotavirus, which can cause severe diarrhea and dehydration and is deemed responsible for the deaths of more than 500,000 infants each year, primarily in low- and middle-income countries. [emphasis mine]
It seems to have escaped the attention of the advisory committee that the US is a first world country. Deaths from Rotavirus infection are relatively rare. It is therefore by no means certain that use of this vaccine outweighs the risk.
I might be excessively paranoid here, but it seems to me that the interests of the pharmaceutical companies are being considered ahead of medically prudent safety measures. That is unconscionable from a government organisation that is supposed to ensure the safety of medicines for public use.