Source: Forbes.com
Author: Henry Miller

The agency has sown confusion by asking physicians to stop administering a vaccine that even they admit is safe.

By applying its now-customary excessive precaution, the FDA has painted itself into a most interesting corner. The result will likely be confusion among pediatricians and the public and parents reluctant to permit their children to get an important vaccination. And that in turn will cause unnecessary cases of rotavirus infection, debilitating diarrhea and, in a few children, death.

The FDA last March asked pediatricians to stop administering GlaxoSmithKline‘s ( GSK – news – people ) Rotarix, a vaccine that prevents rotavirus infection, a diarrheal illness that commonly affects infants and children and that can cause severe dehydration. Their rationale was self-contradictory and unpersuasive. On one hand, the FDA seemed still to be confident about the vaccine, explaining that, “Extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine.” And the positive experience of countless infants and children vaccinated since the licensing of the vaccine two years ago further confirms its safety.

So why do regulators want a “pause” in administration? Because using a new ultra-sensitive assay, small amounts of DNA from a pig virus were detected in the vaccine preparation. That might sound like a good reason for concern–except that the FDA itself confirms “that the material has been present since the early stages of product development, including during clinical studies.” In other words, all of the studies that confirmed the safety and efficacy of the vaccine were performed with the viral DNA present. Two additional critical facts: The virus is commonly consumed in pork products and is not known to cause illness in any host, including humans.

Dr. Margaret Hamburg, the head of the FDA, said at the time, “We’re not taking this action on the basis of a safety concern.” In regulatory parlance, there was no “safety signal”–that is to say, not even a hint of a problem from actual data.

What exactly was the problem the FDA was trying to fix by interrupting the use of this vaccine?

In addition to the apparent lack of logic on the part of regulators, there were procedural and legal concerns associated with the FDA’s action. The agency regulates pharmaceutical products but does not have a mandate to intervene in what is called “the practice of medicine”–that is, what doctors choose to do with approved products. Arguably, the FDA lacks the statutory authority to demand a “pause,” especially on such a flimsy rationale.

But that’s not all there is to the story. The FDA thought it could get away with its action because, well, it thinks it can get away with anything these days. (Its Obama-appointed General Counsel has as much as said so.) And regulators knew that there was an alternative vaccine available, Rotateq, produced by Merck ( MRK – news –people ). But using a new, high-sensitivity assay, Merck has now detected DNA fragments from two pig viruses in Rotateq, one of which is the same as the viruses detected in Rotarix. (The other does cause illness in pigs.)

So what are regulators to do? Having over-reached and over-reacted in the first instance, regulators’ risk aversion has put them in an awkward situation. Do they now rescind the Rotarix pause? Do they extend it to Rotateq? Do they flip a coin and ask for a pause on the one that’s designated “heads”?

What they opted to do was to bide their time until members of an external advisory committee, which met Friday, offered their (nonbinding) opinion. No vote was taken, but the committee concluded that the fragments of virus did not constitute a health risk.

Click here to read a statement GlaxoSmithKline issued following Friday’s FDA meeting.

There is a cautionary tale here. Instead of adopting the policy, “Don’t just sit there; do something” before you have all the relevant data, a more sensible approach is to gather the evidence necessary for a scientific decision. Lives were certainly not at stake; there was no evidence whatsoever that there was any actual problem with Rotarix. But now, given their action, the finding of virus DNA in Rotateq and the inevitable hysteria of the vaccine activists, some parents will be confused enough to delay vaccinating their children.

The FDA these days repeatedly and prematurely embraces Chicken Little’s conviction that the sky is falling. Whether or not that is true, what is falling is the public’s and the medical community’s confidence in the bureaucrats.

Henry I. Miller, a physician and former virus researcher, is a fellow at Stanford University’s Hoover Institution. He was an official at the NIH and FDA.