Did The FDA Act Too Fast In Suspending Rotarix?
10 CommentsBy Ed Silverman // May 10th, 2010 // 8:14 am
Two months ago, extraneous DNA fragments of PCV1 virus were found in two lots of GlaxoSmithKline’s Rotarix vaccine, which is used to combat rotavirus. As the FDA acknowledged, porcine circovirus type 1, which is common among pigs, is not known to cause disease in animals or humans. Yet the FDA urged docs not to administer Rotarix until more research was completed.
The FDA stopped short of a product recall, since there was no new info to contradict earlier evidence that Rotarix is safe and effective. Instead, the FDA encouraged docs to administer Merck’s RotaTeq, which accounts for about three-quarters of rotavirus vaccines administered annually, while agency officials geared up for an advisory meeting that was held last Friday.
And so what happened? On the eve of the meeting, Merck found two types of pig viruses, PCV1 and PCV2 (which can cause illness in pigs), in its RotaTeq vaccine (see here). The upshot is that both vaccines pose the same puzzle. For its part, the FDA panel didn’t vote on whether the vaccines should remain on the market while additional studies are conducted, but did say the benefits outweigh the risks. Separately, Hong Kong suspended Merck’s RotaTeq (look).
Meanwhile, the FDA hasn’t updated its guidance to physicians about whether they should refrain from administering Rotateq as well. As a result, Glaxo continues to remain at a disadvantage, although the agency will issue advice “in the very near future,” Karen Midthun, acting head of the FDA unit that reviews vaccines told reporters. “We need to consider this very expeditiously.”
Erring on the side of caution is generally a good thing, especially given doubts about FDA commitment to safety in recent years. Vaccine makers can expect added delays and costs as the FDA requires new ways to detect unforeseen viruses. On the other hand, urging suspension was an unusual move and, one could argue, was hasty, since not all the evidence was in and the Merck vaccine may not be a better alternative after all. And so…
Was The FDA Correct To Urge Suspension Of Rotarix?
- No (57%, 53 Votes)
- Yes (43%, 41 Votes)
Total Voters: 93
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AnneS
Rotateq should be suspended too. Hong Kong suspended Rotateq – better to err on the side of caution.
patrons99
The graphic is priceless! Well done, Ed. Sometimes a picture is worth a thousand words.
clarkkent
So the FDA recommended using the American company’s vaccine over the British company’s vaccine; sounds like some home cooking to me.
Cindy
clarkkent, I agree, especially considering that Julie Gerberding, the former head of the CDC, is now the chief of Merck’s vaccine division.
vince
Did the FDA consult with noted vaccine expert Paul Offit on this decision.
likeitis
Clark and Cindy:
Most countries gov agencies act to protect their home-grown business interests, either covertly or overtly, depending on the suspect; I guess this is a given for basic human behaviour (not an expert!). US FDA is no different from any other national agency in this respect.
The important question is, was the US public denied access to a beneficial medicine on the basis of politics/prejudice rather than scientific grounds?
Its similar to the dismissal of an employee on trumped-up grounds of incompetence – very difficult to prove in practice, especially when everything is done verbally rather than written down.
Should GSK be calling in their human rights lawyers? Hmmmn…….
patrons99
likeitis -
your rhetoric is quite troubling:
“The important question is, was the US public denied access to a beneficial medicine on the basis of politics/prejudice rather than scientific grounds?”
“Should GSK be calling in their human rights lawyers?”
In response, and to avoid repetition, I’d simply like to provide this link to a very recent pharmalot thread on the same topic.
http://www.pharmalot.com/2010/05/now-a-pig-virus-dna-is-found-in-a-merck-vaccine/
patrons99
likeitis -
The relevant issue here is certainly not GSK’s right to sell their magical “potients” and preventive “remedies”. Nor is the relevant issue the “human rights” of patients who may OR MAY NOT have benefited. Condor identified the real issue in another recent thread:
“It is going to be a labeling and informed consent issue”.
likeitis
patrons:
Good points. I always appreciate the lucid comments from Condor and yourself.
I was referring to the human rights of GSK, not patients, who of course always come first in everyone’s rulebook. Nevertheless, FDA should probably reinstate Rotarix, when they are satisfied that the risks, if any, are basically the same as for the Merck rotavirus vaccine. Any other action would probably leave GSK’s reputation unfairly permanently tarnished….
BTW: I also think the ‘two little piggies’ graphic is spot on!
VINAY TRIPATHI
ITS REALLY SOCKING THAT WITHOUT ANY STRONG APPROPRIATE OBJECTION SUPPORTING DATA ROTARIX IS SUSPENDED.WHEREAS ALL OTHERS WHO EMA ETC ARE OUTWEGHYING BENEFITS AND ADVOCATING NOT TO SUSPEND.