Wade Rankin of Injecting Sense wrote about the Rotavirus vaccine review by FDA earlier this month.
in his movie career, Kevin Bacon played a character named Chip Diller, in the seventies classic, Animal House. His role was small, but he contributed two scenes that were oh-so-memorable.
During a pledging ceremony at the evil and exclusive Omega house, young Chip is repeatedly paddled on his posterior. With each new helping of pain and potential harm, the new pledge is made to exclaim, “Thank you sir, may I have another.” Later in the movie, we see Chip, dressed in his ROTC uniform, acting as a parade marshal for the homecoming festivities. In response to the mayhem created by those bad boys from Delta house, Chip screams out that everyone should “remain calm; all is well.” Of course, all is not well.
I’ve been thinking of Chip lately while observing the coverage ⎯ or to be more precise, the lack of coverage ⎯ of the disclosures that extraneous DNA from pig viruses (and other foreign bodies) was found in both of the Rotavirus vaccines.
For a good discussion of the problem, see these posts (here, here, here, here, here, and especially here) in Age of Autism.
Here’s the basic background. First, in March GSK’s Rotarix vaccine was found to contain DNA from PCV-1, a pig virus. The FDA suspended its use, pending review. Of course, in the meantime, that left the market clear for the sole competitor, Merck’s RotaTeq (developed by our old pal, Paul Offitt).
Then shortly before the FDA hearings on the Rotarix tainting, it was discovered that the RotaTeq vaccine, in fact, contained DNA from two pig viruses, PCV-1 and PCV-2.
The FDA meeting on the Rotarix fiasco occurred, predictably on a Friday. Traditionally, Friday afternoon tends to be when one releases news that one hopes will never be heard. The FDA’s (in)action was all too predictable. No vote on further suspension of the vaccines was taken. Although the panel did say that further long-range studies were advisable, and that parents should be informed that the errant viruses were found in the vaccines (and, of course, Friday afternoon is the ideal time to disseminate that thought, isn’t it?), the overall impression is that nobody on the panel thought there was any immediate concern.
One of the FDA panel members, Dr. Harry Greenburg, was quoted as saying: “The benefits (of the vaccine) far outweighs the risk.” Apparently there was a script floating around the meeting room, because another panelist, Dr. Melinda Wharton, was quoted as saying, “Based on where we are with current knowledge, to me the known benefits clearly outweigh the risks.”
And that was the theme of the scant attention paid by the media. The benefits outweigh the risks. Remain calm; all is well. That theme was based on two elements: the vaccines are effective, and there is a low risk of infection. Read the full post at Injecting Sense