Effect Measure

A good story by the AP’s Lauran Neergaard yesterday highlighted the need for better public health surveillance and the efforts being made to improve it so as to keep track of possible rare side effects from the swine flu vaccine. This is an issue we’ve talked about a lot here, most recently in the context of not being able to fully test any vaccine for rare adverse outcomes prior to deployment. There’s more involved than that, but first here’s Neergaard’s lede:

The U.S. government is starting an unprecedented system to track possible side effects as mass swine flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services. (Lauran Neergaard, AP)

No pre-deployment clinical trial could hope to pick up a risk of 1 in 100,000 but even risks that small will occur when you are vaccinating more than 100,000,000 people. But we’ve discussed this quite a it, most recently here. So here’s another part of the article, one that might surprise you:

Then there’s the glare of the Internet ? where someone merely declaring on Facebook that he’s sure the shot did harm could cause a wave of similar reports. Health authorities will have to tell quickly if there really do seem to be more cases of a particular health problem than usual.

So the CDC is racing to compile a list of what’s normal: 25,000 heart attacks every week; 14,000 to 19,000 miscarriages every week; 300 severe allergic reactions called anaphylaxis every week.

Any spike would mean fast checking to see if the vaccine really seems to increase risk and by how much, so health officials could issue appropriate warnings.

The implication here — and it is a correct — is that we don’t have these elementary facts instantly available, facts like how many heart attacks occurred last week (or even last month), where did they occur and to whom. Consider what CDC is trying to jury rig for the vaccine issue:

  • Harvard Medical School scientists are linking large insurance databases that cover up to 50 million people with vaccination registries around the country for real-time checks of whether people see a doctor in the weeks after a flu shot and why. The huge numbers make it possible to quickly compare rates of complaints among the vaccinated and unvaccinated, said the project leader, Dr. Richard Platt, Harvard’s population medicine chief.
  • Johns Hopkins University will direct emails to at least 100,000 vaccine recipients to track how they’re feeling, including the smaller complaints that wouldn’t prompt a doctor visit. If anything seems connected, researchers can call to follow up with detailed questions.
  • The Centers for Disease Control and Prevention is preparing take-home cards that tell vaccine recipients how to report any suspected side effects to the nation’s Vaccine Adverse Event Reporting system. (from the same AP article)

Every other industrialized country has a national health care system that makes keeping track of these elementary facts possible. The US doesn’t. We have a lot of electronic medical records, all right, but they are mostly devoted to billing and insurance. And there are a lot of different proprietary software systems that can’t be easily adapted, altered or modified and can’t talk to each other. One of Obama’s initiatives to control costs is Electronic Medical Records (EMR), but the economic benefits he touts are almost certainly being oversold. It won’t save us that much money.

But what a decent system could do — and the system that we might get might be very, very far from a decent one from the provider and patient perspective — is provide the kind of surveillance information that would make assuring the safety and efficacy of vaccine programs and a myriad of other things possible.

As we’ve noted too many times to count, nobody cares about public health surveillance until they suddenly need the information it produces and then it’s too late. Surveillance is essential public health infrastructure but frequently is a casualty when budgets get cut. Surveillance systems are invisible to the public and politicians, unless they serve some kind of economic benefit for a powerful industry and then you can be sure some CongressThing or Senator will have gotten a federal agency to foot the bill. We spent a long post yesterday giving the details of one part of CDC’s cobbled together patchwork flu surveillance system, but there are many more systems out there, hanging by slender threads, that alert us to problems with consumer products, violent deaths, unintentional injuries and much more.

Surveillance systems not only alert us to problems, they allow us to know something isn’t a problem. That can save a vaccination program and thereby save lives. One of the many benefits of a national health system would be the required EMR that would go with it. And that would make possible the kind of continuing surveillance and special disease tracking that CDC is desperately scrambling to set-up on an ad hoc basis even as it launches an ambitious vaccination program for the first influenza pandemic of the 21st century.

The anti universal health care talking point that this country has the best health care system in the world is a joke. A sick joke. Sick, like our health care system. We can’t even count up how many people are sick and from what on a timely basis. America the backward.


  1. #1 PalMD
    September 28, 2009

    As usual, a fantastic, important post. In Michigan, anyone administering swine flu shots must register with the state and record them in the state’s tracking system. I believe that they are planning something similar for oseltamivir rx’s but the fact that i’m not sure says something about our system.

    I have an EHR at my practice. My hospital has a different EHR as does the major university downtown and the one in Ann Arbor.

    I’m jealous when I read scandanavian or other european studies which have the use of huge databases. Here we are in a fabulously rich country, and the best public health system is a sparsely populated state in the upper midwest (MN). C’mon, what the hell is wrong with us?

  2. #2 floormaster squeeze
    September 28, 2009

    I think there will be an overcount of the number of people getting the Swine Flu vaccine from insurance records because some people will get the shot twice and both will be counted (summing the single procedure code). This could have been much worse if the general recommendation had been for people to get two shots but it will probably be a bit of overcount if they add those numbers to the numbers done in general “walk-up”/site administration.

    Also, and excuse my clinical ignorance, are there any effects from the quality of administering the vaccine? Does it matter who gives the shot (even a little)? I ask because I really want to understand the real effectiveness of the vaccine and often there are differences in administrating things in the trial from the real world. It is clear that many people with a variety of skills and backgrounds are going to deputized to give the shot.

  3. #3 Graeme
    September 28, 2009

    We DONT need a government run universal health system to get this data. All that is needed are proper incentives within the prevailing framework. Let’s not over complicate this . Lawyers and privacy advocates are major stumbling blocks to progress here, but actions of individuals show repeatedly that they are willing to share information when it’s easy and they see a benefit

  4. #4 Gaythia
    September 28, 2009

    I think that the key quote in this article is the quote from Dr. Daniel Salmon about coincidences.

    This is a very important message for the general public to absorb. It is also important that the public understands the issue you raise above, that other countries are doing this sort of medical data analysis continuously.

    I hope that the Center for Disease Control, John Hopkins and other medical institutions that may try to do follow up with vaccine recipients give some serious thought as to how their requests are presented. In the past, I think that the medical community relied on a form of secrecy which kept many concerns out of the eye of the public. In the much more open age of the internet, communication is key.

    I would imagine that being asked to itemize all of the symptoms one has experienced since receiving a vaccine could put one in a worried mindset. Since many people have not experienced similar follow up after other forms of medical treatment, this may make vaccines seem especially dangerous. This could leave people quite susceptible to appeals from anti-vaccination activists.

  5. #5 Poppie
    September 29, 2009

    The thought occurred to me that perhaps there has been an actual movement to prevent the consolidation of national medical information in order to obscure the facts of death in various locations and occupations in the U.S.
    If people had solid scientific information on deaths related to exposure to certain chemicals in their towns and workplaces, or if they had cancer clusters showing up near manufacturing dumps, or as a result of exposure to radiation, or tobacco usage, or even excessive sunlight, they would be too likely to draw conclusions about the value of their properties, the need to sue their employers, or go after their governments for allowing exposures.
    It would make it all to easy to point fingers and find the causes of what ails so many.
    Interesting useful news always has a way of making itself known, and humans have a natural inclination to itemize, catagorize, and explain it, EXCEPT when people are actively and vigourously supressing it for some reason ……

  6. #6 Phila
    September 30, 2009

    they are willing to share information when it’s easy and they see a benefit

    Posted by: Graeme | September 28, 2009 10:43 AM[kill]‚Äč[hide comment]

    “When they see a benefit” being the operative phrase. There are many possible pitfalls there, from being ignorant to being actively misled (cf. the people who think that census workers are using GPS as part of some plot to herd Christian patriots into internment camps).

    What Revere’s describing is a national security issue. That’s supposed to be the government’s job.

  7. #7 Nomen Nescio
    September 30, 2009

    I’m jealous when I read scandanavian or other european studies which have the use of huge databases. Here we are in a fabulously rich country, and the best public health system is a sparsely populated state in the upper midwest (MN). C’mon, what the hell is wrong with us?

    having immigrated from Scandinavia to the USA, i’d say there seems to be a much greater likelihood of the U.S. government (on most, maybe all, levels) to abuse powers and information granted it. in Scandinavia, there seems to be a stronger ethos of community service among government employees and bureaucrats, resulting in less corruption, nepotism, and abuse of power. there’s also a strong culture of privacy, backed up with thoroughly enforced legal limits on information use; that makes a huge difference to how things work in the USA.

    here in the USA, i find myself having to stop and think about whether it’s wise or safe for me to divulge too much to random government employee X — whether X be a paper pusher, or a police officer, or whatever. handing out my personal information for collection in the sort of databases you so envy? in Scandinavia, i could do that and feel sure my private data would not fall into the wrong hands, or be misused to harm me — here in the states i’d reflexively refuse, feeling sure it’d be sold to the highest bidder and used without the least concern for how its use would impact me. it’s all a lingering and ongoing part of the culture shock i went through on immigrating.

    and i live in Michigan, which still has a fair bit of the “Minnesota nice” in its local culture. i understand government overreach is more pronounced still in other regions.

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