Coincidences happen. Even when you get a flu shot.

The New York Times has an article about the CDC’s concern that people who get flu shots this year will blame anything that goes wrong with their health on shots. (i.e. Someone gets a flu shot, two days later he has a heart attack, so obviously flu shots cause heart attacks. RIGHT?)

So, those of us who remember our stats or are science-trained sometimes utter the phrase “correlation does not prove causation” in our sleep. But much of the rest of the country world isn’t so quick to remember this fact. The CDC is especially worried that the news media will seize on individuals’ claims that the vaccine made them sick, and publicize them, which will spread that misinformation to the general public who believe anything they hear on TV or read in USA Today.

Why do we care? If people want to make themselves crazy freaking out, why would nurse and lawyer want to get in the middle of that?

One big reason: we don’t want people who really need the protection to be afraid of getting it. Pregnant women are one such class — need the protection, but wanting to be extra careful. Senior citizens are another group who need the protection and may be more susceptible to scare tactics. It could really interfere with our public health goals of preventing this from becoming a pandemic if people are afraid to get the shot. Right, nurse?

So what can we do? We obviously can’t forbid “news” organizations from reporting these kinds of stories. (Hello, First Amendment.) What about some kind of voluntary agreement, where news organizations are made aware of the problem and its potential consequences, and agree not to report these kinds of stories without appropriate context describing the nature of the correlation? What if we set a threshold for how many incidents of the same sort must be observed before it becomes a “trend” that they could report? Admittedly this is more a question of journalistic ethics than of law, but… I want to be able to do something about it!

Other ideas? Anyone?

Swine flu again. . .

So there’s been more talk in the news about the impact of swine flu on the upcoming flu season– i’ve heard wild estimates that the incidence of flu could be double what we see in a normal flu season, with mostly mild to moderate disease. I’ve also heard estimates that ICU’s may be at 100% capacity entirely with flu patients. (heard mostly via NPR).

1. Not so much with the surge capacity?  We should get on that. Lawyer knows about this kind of thing from her days as a disaster preparedness VISTA.

2. Paying ICU nurses overtime = great for Nurse, expensive for hospital/medicare/whatever is paying. . .

3. Flu vaccines are coming to a hospital employee health deartment near you, but is there enough? And, speaking of, we generally vaccinate the most vulnerable– very young, very old, or compromised– in a situation like this, healthcare providers should perhaps be among the ones chosen. Those ventilators can’t work themselves. . .

And stay in!

Lawyer: This is my fourth and final post about legal issues surrounding public health emergencies. When can we isolate or quarantine people? How can we do it? What about can vs. must? This one is a real doozy — if we could count on people to do the socially responsible thing, we wouldn’t have to worry about this. But all kinds of reasons — from employers who won’t give paid leave or even guarantee you can keep your job, to lack of education about disease, to a general lack of community spirit, many people won’t voluntarily stay home or in a hospital if they are sick or have been exposed. Here are a few thoughts about the who/when/where/why of quarantine and isolation.

1. It really can prevent the spread of disease. In a real pandemic situation, if you keep the sick people away from everyone else (isolation) and those who have been exposed separate until an incubation period has passed (quarantine), the germs can’t get to the rest of the population anywhere near as fast.

2. We as a nation place strong value on individual liberty and have a real reluctance to confine people if we can help it at all. (Unlike, say, China.) And this is one of the great things about our country. But does this great value of ours override the government’s responsibility to keep its citizens safe? I’d say it does, until the danger is really imminent. (see China: overzealous.)

3. It’s not just in what you do — it’s in how you do it. New rules that are being hashed out and introduced require a mandated isolation to meet two tests: the isolation itself must be fair and warranted, and the means of conducting it must also be. There is a built-in due process mechanism that entitles an individual to an automatic medical review after a short period of isolation, and if the individual disagrees with the decision, he/she is entitled to make an appeal on medical grounds, and is entitled to a medical representative (sort of like a lawyer for them, except it’s a doctor.) If they go through this and still disagree and exhaust all the administrative channels, then they are entitled to a habeus hearing. Where they get an actual lawyer.

4. All these hearings and such introduce interesting questions — can an infected person appear in court? Can court personnel be excused if they aren’t comfortable? This has come up in the past in the case of TB, but it’s simpler there — often much more isolated, etc. Alternatives include telephonic hearings, which have been allowed in some contexts in the past. I’m starting to envision hearings via Skype or iChat. The times, they are a-changing.

Lots of sticky issues here. It’s the old safety vs. security debate that we are so fond of, in contexts ranging from forced searches at the airport to, well, pandemic preparedness. Tough stuff!

xposted Ready or Not

Don’t shoot yourself in the foot!

Lawyer:  Here is part three of my series on public health emergency law.

There are a number of measures written into various laws that allow government agencies more flexibility during public health emergencies. We have a lot of regulations surrounding health care, including privacy rules, procedures for various state-fudned health care programs, and regulations about the use of drugs and medical equipment, and when we need to act fast, these rules, which are important protections most of the time, can really get in the way of a quick and coordinated response. Here are a few interesting possibilities:

Emergency Use Authorizations: The Health and Human Services Secretary can ask the FDA commissioner to issue an authorization to use a drug or device that has not yet been approved if there is reason to believe that its risks are minimal and it will help with the health emergency. Likewise, they can authorize the use of an approved drug in a new population or for a new use. These have been used in the past, and there is one in place now allowing the use of flu drugs in children.

Certain laws relating to Medicare/Medicaid — specifally, some of the requirements of health care professionals (i.e. specific timetables for certain kinds of paperwork, requirement that the license be in the specific state where they are providiing services, etc.)

These kinds of built-in flexibilities are important to a functioning system! We wouldn’t want to operate this way all the time, but we also wouldn’t want to be bound by regulations that don’t make sense in a context that requires rapid action. The potential concern — that flexibility opens up the possibility for abuse — is mild in this context, and the alternative is far worse. (As I write this, Arizona has moved up in the list of states with the most cases, but the flu also continues to look mild, and the hot weather may slow its spread — here’s hoping!

(xposted on Ready or Not.)

Liability Issues

Part 2 of my series on legal issues surrounding public health emergencies: Liability.

Federal laws protect federal workers responding in an emergency, even temporary hires, and that’s great — but there are all kinds of other liability issues to take into account.

One that’s important to us: what about volunteers? Volunteers usually work with a local organization or a local government, not directly with the federal government, so it’s their rules that cover you. Pima County will cover registered volunteers of the county, even if they are temporarily registered in an emergency situation — but only if you are acting in a role assigned to you by the county after you register with them. States and counties have their own rules and plans, and it’s really a patchwork system.

It’s important for the government to provide good liability coverage for volunteers, because their services are likely to be needed — especially medical volunteers — but who wants to volunteer if they think they’re going to get sued? Take-home message: if you want to volunteer, make sure you find out what kind of liability coverage will be provided to you by the organization or government for which you are volunteering, because there is no federal law that automatically covers you.

Another interesting issue: use of experimental treatments. Since the PREP act was passed in 2005, the HHS secretary (btw: congrats, Ms. Sebelius!) can authorize emergency use (more about that in a later post in this series) of a not-yet-approved drug or use of approved drug for treating a potential health emergency. If this happens, broad protections are extended to everyone from the drug’s manufacturer to the nurse who gives the injection and everyone in between. They are basically immune from tort liability! (This applies to FDA-approved drugs, too, but the emergency use struck me as the most interesting application.) There’s plenty more to say, but for non-law geeks, this is probably enough for one sitting. Stay tuned for future posts on flexibility, availability of resources, and civil liberties!


Thoughts on Swine Flu from lawyer, wearing her disaster preparedness hat

Seen the stories recently about the swine flu that’s killed up to 61 people in Mexico? And has also been found in California and Texas? Especially scary because its victims are not the very old and very young, who are typical flu victims — it’s killing young, healthy adults. The article linked above gives details.

Mexico City has closed schools and museums to work on containing it, and though we don’t have a serious outbreak here, it remains possible. It raises some really tough questions. One topic is non-pharmaceutical interventions (NPI) — the most common of which are social distancing measures. (Maybe we’ll talk about drugs and vaccines and who should get them in another post.)

At what point does it become necessary or wise to close schools? Museums and movie theaters? Workplaces? My take is that closing museums and movie theaters and the like can help prevent the spread of disease and kind of sucks, but doesn’t create any huge social problems. Closing schools leaves many families up a creek — but is one of the most effective ways to prevent the spread of illness among  children. I’m in favor of it — and also in favor of requiring employers to allow employees to take leave if a school closure is enacted. It’s still a tough situation for a lot of people, but better a tough situation than dying of swine flu. And that’s really the bottom line here.

What about imposing requirements that people wear masks in public? What about curfews and quarantines?  It’s tricky — we don’t want to make overly restrictive laws (and even if we do, people may not obey them) but we do want to keep the public safe, and there will always be those who act irresponsibly. Even with the force of law, there’s not a lot that can be done to keep a few irresponsible people from spreading infection and posing a great risk to public health. When greatly restrictive laws have been imposed to combat previous outbreaks, governments have been unable to enforce them. Distribute masks with instructions on how to use them and why it’s important. Give people the tools to protect themselves. Success through education, not force.

Recently, we discussed what health care workers should be required to do in a public health emergency.  This discussion could become a lot less abstract in the coming months. If you work in healthcare, check into your institution’s policies.

Containment doesn’t seem to be an option here — it isn’t confined to a small geographical area — but in other pandemic situations, that’s another tough choice we’d face.

Here is my hope: that if US city and state governments end up facing this choice, they are as transparent as possible. Communicate clearly with the citizens. Let us know what’s going on. Make recommendations. Give us options. Help us understand why you’re asking us to do certain things rather than just telling us we have to.

Stay tuned for more thoughts as the situation unfolds!