By DAN OLMSTED
Back in 2005, when the FDA approved the four-in-one live-virus vaccine ProQuad as safe and effective, manufacturer Merck had high hopes. "Based on the public health benefits realized following the introduction of other combination vaccines, such as M-M-R II, we expect PROQUAD to become a primary option for prevention of measles, mumps, rubella and chickenpox," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccine Division.
That was then. Now, because of a twice-as-high risk of fever-related convulsions, the CDC's Advisory Committee on Immunization Practices has dropped its preferential recommendation for the four-in-one shot – measles, mumps, rubella (the MMR components) plus chickenpox. Read the story HERE.
As regular readers know, I first raised questions about ProQuad two years ago in a seven-part series titled Pox, focusing on two cases of autism in Olympia, Wash., following clinical trials leading up to the approval of ProQuad. Merck acknowledged they didn't report the cases to the FDA until after ProQuad was approved – just about the time I started asking, as it happened.
There's much more to say about ProQuad – including the fact that Merck last year "suspended" production citing shortages of the chickenpox vaccine, even as it keeps on cranking out the standalone chickenpox shot and the new shingles vaccine. Nobody I know in the environmental-biomedical community believes that after two decades and tens of millions in development costs, Merck ran out of just enough vaccine to fill ProQuad vials.
Then there's the media's stenographic approach to all this. Merck runs out of ProQuad vaccine? Gotcha. Seizures may scare parents but they don't really cause any problems? Ditto. The CDC committee tilts toward ProQuad while studies to determine seizure and fever risks are still under way, then backs away? No big deal.
I'm heading back to Olympia next week to speak at the state autism conference, and I'll do a follow-up story on the families I wrote about two years ago. But meanwhile the question I want to raise is this: What does the higher adverse event rate in ProQuad say about the MMR itself? I think it says that the more live viruses you brew in your cauldron, the greater the risk that once inside a baby's body they will interact in ways that cannot be predicted. ProQuad reflects on the MMR safety profile, in my view, and that should trigger a fresh look at concerns by so many parents that the MMR, as Jenny McCarthy puts it, is "the autism shot."
Andy Wakefield's comments two years ago after meeting with the Olympia parents seem ever more ominous: "It's actually heartbreaking, listening to these parents, for more than just the immediate reasons their child has met this fate. It's that you're staring into an abyss," Wakefield said. "You're listening to stories which reflect the fundamental misconception of vaccine manufacturers of what viruses are and what they do."
Dan Olmsted is Editor of Age of Autism.