By Jonathan (Josh) Bloom, Ph.D.
Posted: Wednesday, March 28, 2012
Publication Date: March 28, 2012
As the Supreme Court hears arguments this week on whether the ObamaCare law is constitutional, here’s something to think about — a possible real-life example of what all that “death panel” talk really means.
The Advisory Committee on Immunization Practices — a division of the Centers for Disease Control — last month quietly refused to vote on whether to recommend Prevnar 13, a vaccine against streptococcal pneumonia, for adults 50 and older. That decision likely means tens of thousands of additional deaths.
ACIP review is another hurdle for vaccines (not required of traditional drugs) after Food and Drug Administration approval. The committee, 15 experts in immunization appointed by the secretary of Health and Human Services, develops recommendations for vaccination schedules and dosages for pediatric and adult use. Or not.
The vaccine is already recommended for children, mind you, and the Food and Drug Administration has approved it for older people. (Vaccines are unique in US medical regulation in needing ACIP as well as FDA approval; more on that below.)
The FDA OK’d Prevnar on the basis of data that show that it elicits a stronger immune response and is effective against a broader spectrum of bacterial infections than previous vaccines.
Since Streptococcal pneumonia is responsible for 300,000 hospitalizations and 25,000 deaths a year, ACIP recommendation ought to be a no-brainer.
Yet when the drug’s maker, Pfizer, sought ACIP’s endorsement, the committee for the first time ever refused to schedule a vote — despite three meetings over the course of a year during which the vaccine was discussed.
One of the experts present told me “there wasn’t a single member of the panel that wouldn’t take the new vaccine.” Yet they won’t recommend, even though it’s already used on adults in a number of European countries — including Greece, hardly the bastion of socio-economic acumen these days.
So what’s going on here?
I’m told that ACIP cited various reasons for waiting, including Pfizer’s supposed failure to meet new protocols and a desire to see the results of a European study. But neither excuse is persuasive. It looks a lot more like an improper focus on cost.
There’s nothing inherently wrong with determining whether a new therapy will be cost-effective — that is, would eventually save more money than it costs. But vaccines are extremely cost-effective, typically saving 10 times their expense per patient.
A recommendation from ACIP means that most insurance plans will cover a vaccine — and that Medicare must automatically pay for it.
At $97 per dose, the cost of vaccinating the 40 million adults 65 or older in the United States would be several billion dollars. Holding off would be a big short-term savings for Medicare.
The long-term expense would be far greater, but let someone else worry about that.
One quote from the last ACIP meeting is as revealing as it is chilling: “The working group plans to continue discussions regarding whether [Prevnar] should be recommended for adults 50 years of age and older as additional data on herd effects and efficacy against pneumonia become available.”
“Herd effect” refers to the fact that when enough of the population is vaccinated, the disease in question becomes less prevalent, thus protecting the rest of the herd — those who are unvaccinated.
So APIC is effectively pondering this experiment: We already vaccinate kids; let’s wait a few years and see how many seniors die.
If I were 65, I wouldn’t like this experiment one bit. It will take years to determine the full extent of the herd effect. Perhaps 100,000 unvaccinated seniors will die waiting for the answer.
The “death panel” discussions of 2009 were blatantly nonsensical. Anyone with half a brain knew that the government wouldn’t be hauling Granny off in a windowless van because she needed a hip replacement.
On the other hand, every year that this vaccine is unavailable to Medicare recipients, thousands of them will die unnecessarily.
If this is the way our government really intends to cut America’s medical costs, this story is not really about a vaccine at all.