There are two types of meningitis infection, viral and bacterial. The viral infection is not particularly serious and is usually self-limiting. The bacterial version is quite a different story. Although uncommon — due largely to the 1999 approval of a vaccine for children aged 11–18 years — bacterial meningitis is very dangerous: It has a 15 percent mortality rate, and approximately another 15 percent of those who contract it will suffer severe, long-term neurological damage, such as loss of hearing, seizures, and strokes.
Fortunately, recent research in this area has resulted in the approval of one vaccine for children as young as nine months of age — and another vaccine that could be used for children as young as two months is under FDA review. This is good news.
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Following approval by the FDA, vaccines are routinely placed on the Centers for Disease Control and Prevention’s (CDC) schedule of recommended vaccines. Once a vaccine is on this list, it is covered by virtually all insurance policies and the federal Vaccines for Children program. However, this summer, the CDC has taken the unprecedented step of scheduling four public hearings across the U.S. — “a listening tour” — ostensibly to determine whether the infant vaccines should be endorsed by the CDC for inclusion in the standard vaccination regimen of infants and young children.
Since when does the general public have the medical expertise required to evaluate the risks or benefits of a new vaccine? The mere fact that the CDC is delaying an addition to the children’s schedule of new vaccines, pending public input, has raised concerns within the medical community. And these concerns have nothing to do with medicine.
Rather, disturbing signs indicate that this is a new tactic designed to control health-care costs by suddenly adding a cost-effectiveness component to the normal decisionmaking procedure. Some medical professionals and health-care economists believe that we are seeing the early encroachments of the Patient Protection and Affordable Care Act (a.k.a. Obamacare) — the insertion of a government-based bureaucracy between the patient and physician.
If that scenario sounds far-fetched, just consider the evidence pointing to the path ahead. In addition to the unprecedented and puzzling public hearings, the summary of the CDC Vaccine Decision Making Stakeholder Meeting on May 25 contains the following questions: “How many people would it help; what are the costs (to society and to individuals); and what are the benefits (what do I get and what do we all get for the cost)?” Similarly, the agenda for the first regional meeting, in New Hampshire, on June 15 asks: “Does or would the cost of the vaccine matter? If so, how so? Does the cost of the immunization effort matter? If so, how so?”
There have been two regional meetings so far; neither was publicized, and attendance was low. So, what does the CDC get from this? Is it possible that these hearings are a sham, held merely to cover the CDC’s position in the event it decides not to add the vaccine to the recommended schedule? In that case, the CDC panel will be able to claim that the “public” was either indifferent to or against the vaccine — and point to the supposed “transparency” of the process. Based on these clues, we may be seeing how Obamacare will cut health-care costs — by deflecting responsibility to the few citizens who actually attend public meetings.
While the inoculation of older children has cut down on the incidence of meningitis, it has not been eradicated: Infants and toddlers remain vulnerable. According to the CDC, there are about 2,000 cases of bacterial meningitis each year in the U.S., and unvaccinated children bear the brunt of the infection. Vaccines typically cost about $100 apiece, but on average, treatment for a surviving child costs about $1 million. This means that vaccinations, in addition to saving lives and preventing severe illness, pay for themselves, at least in part.
There are other potential consequences of these public hearings. Inevitably, they will provide a forum for anti-vaccine zealots to continue to promote their irresponsible and thoroughly disproven claims that autism is connected to vaccination. And by adding an extra hurdle after FDA approval, which is already burdensome, hearings will also have a chilling effect on the companies currently conducting vaccine research.
It is clear that our government needs to find effective ways to cut spending — but this is not the way to do it. Saving money by denying life-saving vaccines to children is unconscionable.
— Josh Bloom is director of chemical and pharmaceutical sciences at the American Council on Science and Health.
We have to have public hearings to proceed to provide medications to children, but access to Viagra is treated as a right? Is Obamacare a vehicle to buy votes? Silly question.
I have a new and deeper appreciation of the danger to individuals and the country when government expands its power and influence. I don't have a solution, but I'm guessing that not allowing the problem to expand is part of it.
I love vaccines, but this article has so many incorrect and illogical assertions, possibly included out of a desire to oversimplify, that I fear it will be used by vaccine opponents. Please edit and rewrite.
It would be helpful if you listed the errors and inaccuracies, both for the benefit of the author from whom you are asking a rewrite as well as the rest of us that do not have your knowledge and insights on this topic.
As a public health physician and a former employee of a vaccine manufacturer who attended this meeting (and one who has many problems with the Affordable Care Act), I have serious objections to this article. First of all, the author is misinformed about the purposes of both the stakeholder meeting and the public meetings. The purpose of the stakeholder meeting (invitee-only) was to solicit expert input on the issues related to the Advisory Committee on Immunization Practices (the Federal advisory committee that provides guidance to CDC and HHS on vaccines) process and whether that process should be revised to include factors that have been absent in the past. In an era where healthcare costs are increasing at alarming rates, cost is one of many factors that should be included (and more than that, the concept of value should be considered in ALL healthcare decisions). But again this was one of many factors we discussed. The regional meetings provide additional input and are part of CDC’s effort to be more transparent and allow the public to provide comments. It’s hypocritical to call for more transparency from our government and then criticize it for being transparent. All of the meetings are focused on vaccines and the vaccine decision process in general, with the meningococcal vaccine as an example. Again, the meetings were NOT specifically about this vaccine, but rather the entire process with this vaccine as a test case. And stating that the purpose of the public meetings is “ostensibly to determine whether the infant vaccines should be endorsed by the CDC for inclusion in the standard vaccination regimen of infants and young children” couldn’t be further from the truth. The experts on the ACIP will still make the determination as they’ve always done.
Second, the author cherry-picks questions from the stakeholder meeting. While I would argue that those questions in and of themselves are important to answer, there were many other questions regarding FDA and ACIP processes and the actual science behind the meningococcal vaccine, as well as several presentations of case studies about the devastating effects of meningococcal infection. I actually thought the meeting was tilted too much to the side of recommending the vaccine be part of the schedule for all eligible children.
Finally, I question the logic of the author’s argument regarding “the insertion of a government-based bureaucracy between the patient and physician.” The ACIP (and CDC where it is housed) are already involved in this process and will continue to be in the same role. Is he arguing against any government involvement at all, which would include FDA , or is he arguing against government getting public input as part of its decision making process (or both)? I doubt the author would eliminate the FDA approval process or the ACIP recommendation process, both of which are unchanged by these meetings. I also doubt the author would be against public input, particularly when: 1) it could be informative; 2) increases transparency; and 3) doesn’t change that fact that those with the medical, scientific, and public health expertise will still be making the vaccine recommendations.
Or is he just upset at “Obamacare” and using this flimsy example to rail against it. There are many problems with the health reform law. Not only is this not one of them, but also it actually has nothing to do with the legislation.
Vaccines are wonderful. They are truly one of the great public health miracles. They have saved millions of lives and even saved millions of dollars at the same time. However, like all medical interventions, there are risks and benefits, and questions that should be asked related to them. Getting evidence-based answers and expert opinions when the evidence is unclear, which is what the CDC is doing here and always attempts to do, is how the best medical and public health decisions are made.
There are more than 2 types of infectious meningitis. (Viral meningitis, bacterial meningitis, tuberculous, parasitic) Viral meningitis is usually self-limiting, but a subset (viral meningoencephalitis) can be devastating or deadly. I am not sure which 1999 vaccine approval the author is talking about. I am guessing he means Prevnar or pneumococcal conjugate vaccine, which has indeed reduced bacterial meningitis rates, but that vaccine is part of the early childhood schedule and is not usually given to 11 to 18 year olds. The meningitis vaccine given to 11 to 18 year olds is Menactra or meningococcal conjugate vaccine, and I believe it was approved in 2005, not 1999. (An earlier introduced vaccine, against Haemophilus influenzae, has also been extremely successful in lowering meningitis rates among young children, beginning in the late 1980s.)
This reads just like the press release from one of the nationwide "Tell CDC to allow vaccine for the children!" gigs hosted by the local children's hospital.
Note the total lack of numbers about deaths by age and residence as well as any cost estimates. In fact, the vaccine schedule being proposed makes little economic sense. Most of the people likely to get the disease, college dorm residents and military recruits, are already required to get the vaccination.
The nationwide campaign feels like a vaccine manufacturer has dropped a lot of money into the think tanks pushing it.
I'm faintly puzzled by the odd idea that a taxpayer supported public health program should NOT consider costs versus benefits.
If the vaccine costs $100 per dose and is given to approximately 4 million infants per year, we are looking at 400 million dollars. Meningitis caused by this particular bug (the vaccine is not effective against all the bugs which can cause bacterial meningitis) is rare.
There are probably other, more effective ways to deploy $400 million dollars if we want to say infant lives. Why not make a list of the major causes of death among babies, pick the top cause off the list and see what can be done?
This is a press release and should be labeled as such. I suspect funding for the American Council on Science and Health comes from the pharmaceutical industry. This doesn't make the substance correct or incorrect, but NRO should offer more information than the innocuous-sounding name of this group so readers can make a more informed judgment about the article.
