The FDA has sunk to a new low with approval of a dangerous vaccine for infants

Gonna Raise a Holler

A recent New Yorker magazine cartoon nailed it.

Under a caption that read, “Inside the F.D.A.” two men in lab coats stand in front of a table covered with mounds of pills. One of the men says, “These medicines all taste pretty good – let’s approve them.”

Funny. And when it comes to safety, flavor would seem to be just as good as whatever the current standard is that’s used to give new drugs the green light.

What’s not funny at all is that the newest FDA drug approval travesty may put infant children at grave risk.

The fix is in

Would you enjoy letting loose a good scream over the FDA’s lax safety standards? Well, loosen up your vocal cords and get ready.

We’ll start with rotavirus – a condition that almost every child picks up before the age of five. And it’s not pretty. Fever, nausea, vomiting, and stomach cramps precede diarrhea. In fact, rotavirus is one of the most common causes of diarrhea in children. If diarrhea isn’t controlled, the resulting dehydration may require hospitalization. Deaths caused by complications related to the virus are generally uncommon outside of developing countries with inadequate healthcare.

So GlaxoSmithKline scientists developed Rotarix – a rotavirus vaccine to be given to infants six to 24 weeks old. A large study showed that Rotarix successfully prevented severe and mild cases of gastroenteritis caused by rotavirus. But after that, things started to go south.

A previous rotavirus vaccine had been shown to cause intussusception – a condition that causes intestinal blockage. So GSK mounted another trial to assess this danger. No cases of intussusception occurred, but as the FDA reported: “Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients.”

Unfortunately that report came in an April 2008 FDA news release announcing that the agency had given GSK approval to market Rotarix.

Yes, you read that correctly – Rotarix appeared to cause convulsions and pneumonia- related deaths, and the FDA gave it the stamp of approval.

Wait – hold that scream. This oversight farce has a Part 2.

Years and years and years

There was one little catch to the FDA’s approval of Rotarix: Due to those pneumonia- related deaths, GSK executives had to agree to mount a post-marketing safety trial that will involve about 40,000 infants.

You’ve got to wonder, who in the world would agree to play Russian Roulette with their newborn children and enroll them in a study in which everyone is aware that some subjects may die. (The probable answer: The desperate and poverty stricken.) And this is for a vaccine that prevents a condition that’s rarely life threatening when a child is properly treated.

Meanwhile, the trial is set to begin about a year from now, with a final report scheduled for March 2012. Which means, of course, that this vaccine will have been on the market FOUR FULL YEARS before researchers are able to confirm if it’s actually safe.

Okay – all together now – let’s shake the rafters at FDA headquarters with a scream that will hopefully wake up all those citizens who still believe the FDA has ANYthing to do with ensuring drug safety.


New Yorker cartoon by Farley Katz, 5/12/08,
“FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus” FDA News, 4/3/08,