Thursday, May 13, 2010

ALL IS NOT WELL

Early 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.

Despite lots of chatter in the media that the Rotavirus vaccines have been proven effective in preventing the disease, some studies presented to a recent WHO meeting, suggest that the reported efficacy rates in specific countries vary and depend in large extent to the overall development of the respective areas. In other words, it is difficult to determine whether it’s the vaccines that are preventing Rotavirus, or whether it’s improvements in sanitation, water supplies, and health care.

As to the risk of infection by humans, the FDA panel seems to take as gospel that there is little or no risk because there are no reported incidents of humans contracting PCV-1 or PCV-2 by ordinary contact with infected swine.

Apparently pigs are quite choosy about what infections they will transmit to humans.

Do the FDA panel members not appreciate that there might be a very real difference in transmission by external contact and by internal exposure to DNA? And even if the panel members base their lack of concern on the fact that no vaccinated children have been reported as having the same symptoms as pigs display, the assumption seems to be that clinical manifestations by one species, with no real means of communicating “where it hurts,” would be identical to the clinical picture in a very different species.

Autistic kids ⎯ at least those from families practicing biomedical interventions ⎯ tend to be exhaustively tested. Anecdotally, I am aware of numerous children on the spectrum who have been found to be carrying exotic diseases normally found only in primates, swine, and other non-human critters. I am certainly not proclaiming that those diseases, which are likely contracted through routine vaccines, contribute to the triggering of autistic symptoms. Nor do I know whether there is any harm at all. And that’s the point. We really don’t know. Nobody has been concerned enough to fund appropriate studies.

Maintaining a presumption of safety in the face of legitimate concerns does not serve our children’s interest. It serves only the profits of vaccine manufacturers and the eroding confidence in the sacred cow of public health: the vaccine schedule.

No, all is not well. But the response by the CDC, AAP, FDA, and the rest of the alphabet soup that delivers our health care, is that we should grit our teeth and say: “Thank you sir, may my child have another.”

5 Comments:

Anonymous Anonymous said...

"The benefits outweigh the risks." That translates several ways:
(1) The people charged with protecting the public have failed.
(2) An unknown percentage of people will be harmed.
(3) CDC and minions are comfortable with an unknown percentage of people getting harmed.

Lessons: Caveat emptor. And don't let those tax-funded public health administrators get to retirement before they provide honest answers.

5/13/10, 1:39 PM  
Blogger Ginger Taylor said...

You had me at "All is well!"

These people know that this is coming... when are they just going to issue some sort of lame mia culpa and trip the pressure valve before the pressure blows up the whole vaccine program?

I guess they have decided to die with their boots on.

5/16/10, 9:13 AM  
Anonymous Anonymous said...

Thanks for your post! Of course animal viruses don't usually infect humans...but hey, we all know that they CAN - given enough opportunity to swap genes and recombine with human DNA under the right circumstances (swine flu, avian flu, anyone?). I'd say direct injection into the body would provide these circumstances, wouldn't you? The 'experts' are worse than incredible, they are suspect.

5/16/10, 10:10 AM  
Anonymous Anonymous said...

A "risk-benefit analysis" is part of every medical ethics decision, from the intern on the ward to the IRB deciding on a research study. "Do the potential benefits to the patient outweigh the potential risks of the research?" is a standard, formal, "yes/no" part of every medical researcher's daily life. So maybe it's not surprising that two docs at this hearing used the same phrase. :-/

6/9/10, 6:37 PM  
Blogger Wade Rankin said...

In the case of these vaccines, however, the risk is unknown. How can there be any weighing?

6/9/10, 6:51 PM  

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