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Ebola, Global Health, In the News, Infectious Disease

Ebola: A look at what happened and what can be done

Ebola: A look at what happened and what can be done

As of September 28, the World Health Organization (WHO) estimates that, so far, more than 7,100 people have been infected with and more than 3,300 have died from the Ebola virus. These estimates of what has happened are almost certainly far too low; the estimates of what will happen are terrifyingly high. The current Ebola epidemic may well become the worst human disaster in this century. And we are not doing enough about it.

Ebola is unlikely to become a major problem in the developed world. But… it seems increasingly likely that hundreds of thousands, and quite possibly millions, of men, women, and children will be struck down by this ghastly plague

What happened?

Researchers will be trying to answer that question for years. This is the 24th known outbreak of Ebola virus disease since it was first recognized in 1976. All of the other outbreaks burned themselves out quickly, after between one and 425 people had been infected. Over nearly 40 years, fewer than 2,500 people are known to have become infected and fewer than 1,500 to have died. The outbreaks were all in Central Africa; they killed people in scattered villages, with few Western connections and fewer Western media on site.

However, the current outbreak started in West Africa, not Central Africa. I suspect this change in location will prove to be the key change, not so much in how it has affected human responses but how it has affected human susceptibility. Yes, the health infrastructures in Guinea, Liberia, and Sierra Leone were very poor (and are now far worse), but they were no worse than those in the Democratic Republic of Congo, South Sudan, or Uganda, the sites of most of the earlier outbreaks. But the lands where this outbreak start are more densely populated and better connected. Instead of burning out in one or two villages, hidden away in dense jungle, the virus spread from village to village, from village to town, and eventually from town to city. When it hit Monrovia, the slum-ridden, million-person capital of Liberia, an explosion was probably inevitable. (It has recently begun to expand in Freetown, the capital of Sierra Leone, as well as Conakry, the capital of Guinea.)

The growth of the epidemic has brought with it the growth of terror and the destruction of already tenuous trust, both in governments and in modern health care. It has also brought death from other, treatable conditions that cannot now be treated in health care systems that Ebola has collapsed. It has brought restricted transportation and supplies and, as a result, in some places, sharply higher food prices. It may eventually bring, in spots, starvation.

Recriminations have already started. Why didn’t the West provide powerful help in March 2014, when the epidemic (already about a year old) began to be noticed? Or why hasn’t Western science, expensively pursuing the latest “me too” drug for common Western conditions, produced a treatment, cure, or vaccine for Ebola? These critiques seem too harsh. No previous epidemic has ever ballooned like this one, even in Central Africa. And the chance of an epidemic outside those traditional regions, let alone in the West, appeared remote.

And while some have pointed fingers at the West, others have focused on the behavior of the affected West African populations. Much has been made of their reluctance to abandon traditional methods of burying their dead, their lack of trust in modern medicine, and even their physical attacks on health care workers. But before blaming the victims for their poor infection control measures, put yourself in their shoes. A five year old – perhaps your five year old – is feverish and vomiting. She is crying and holding her arms out to you for comfort, for help. In West Africa you would not have the chance to telephone for an ambulance, with well-protected professionals to treat the child. Touching her could kill you. But what would it do to you – what would it make of you – to ignore her? As Benjamin Hale wrote in Slate, Ebola is a fantastically cruel disease, turning against us our own compassion, care, and love.

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Health Policy, In the News, Stanford News

Analysis: The Supreme Court upholds the health reform act (really)

Analysis: The Supreme Court upholds the health reform act (really)

Well, that was interesting.

I’m in Berlin, on vacation, but at 4:00 PM [Thursday] turned on a television (to CNN International) to see what the Court would say. The word came down soon – the mandate is unconstitutional. Then, the mandate may be constitutional. Then, the mandate is constitutional. There followed some similar confusion about the Medicaid expansion – the Court held that it was constitutional but might be applied unconstitutionally, then that it was unconstitutional, and then that it was unconstitutional but the unconstitutionality was easily cured.

Even an hour after the case was announced, CNN’s Chief Legal Correspondent, Jeffrey Toobin, got the Medicaid part wrong, stating that the Court held Medicaid expansion unconstitutional without noting that it held the expansion could go ahead, albeit with a smaller stick. While he was talking, I kept waiting for him to apologize for announcing definitively, immediately after the oral argument, that “Obamacare is dead.” I’m still waiting. To see my own (partial) confession of error in a much less confident prediction (as well as a bit of crowing about something I got right), you’ll have to read to the end of this post.

So, first lesson from this decision: the press is really bad at reading Supreme Court decisions. We already knew that, but this was a particularly egregious example, at least on CNN. For future reference, if you are really interested in good and often fast legal analysis, check out SCOTUSblog. That’s where I got my first accurate take on the decision. It also gave me a link that allowed me to download the decision, complete with four separate opinions. You can get that, too, either directly from the Supreme Court’s webpage or, usually, from a link in a SCOTUSblog post on a decision.

But you don’t have to, if you don’t want to. I’ve now read – or at least skimmed – the 193 pages of syllabus plus opinion and am prepared to tell you what they mean, at least as a legal matter. I’m not prepared to guarantee I’m right, but I will promise to be better than CNN’s first hour of coverage – and a lot shorter than the Justices.

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Health Policy, In the News

The Supreme Court on health reform: Summing up

So, what does it all mean?

When?
First, set your alarm clocks for late June. The Court never lets its decisions be known before the official release of the opinions, but it always tries very hard to release opinions during the term they are argued; otherwise it re-argues them (not something it will want to do with this case!). The opinions can be released as soon as they are ready, but the more complex the case and the greater the number of separate opinions (dissents and concurrences), the longer the process takes. It would have hard to get a more complex case than this one and I suspect a lot of Justices will want to put in their own two cents.

There are now 93 days until June 30, which is a Saturday – so 92 days until the last business day in June. That’s not a lot of time for this complicated a case. My best guess is that the opinion comes out on June 29. Second best guess is Monday, July 2. (Sometimes they slip.) And third best is Thursday, June 28. Anytime before the last week of June seems like a real long shot.

How?
Second, now that the public oral arguments are over, the really important arguments in the case start: the arguments among and between Justices. Soon the nine Justices will meet in their conference room, attended by no one else. The most junior Justice, currently Justice Kagan, takes notes and answers the door. They will discuss the case and take a preliminary vote. The senior justice in the majority (the Chief Justice if he is in the majority, I suspect Justice Kennedy if Chief Justice Roberts is not in the majority) then assigns a Justice to try to write a majority opinion. The senior dissenting Justice (probably in this case Roberts, Scalia, or Ginsburg) next assigns a Justice to write a dissent.

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Ask Stanford Med, Health Policy, In the News

Ask Stanford Med: Answers to questions on Supreme Court review of health-care law

Ask Stanford Med: Answers to questions on Supreme Court review of health-care law

Thank you for taking the time to submit questions using the hashtag #AskSUMed or the comment section on Scope. Here are my answers.

Max asks: You mentioned your support of the individual mandate. Is this a legal or personal view – or both?

Both. As a legal matter, I think the Court’s precedents are most easily read as finding this within the Commerce Clause. After all, just a few years ago the Court, with the glowing agreement of Justice Scalia, held that growing marijuana in California, with California materials, for sale and use in California, involved interstate commerce. The idea that this is requiring people to participate in commerce is a little different, so there is no direct precedent, but I think the Court would have to make more new law to find it unconstitutional than to find it constitutional.

On a personal level, I think it is bizarre that more than 15 percent of our fellow Americans do not have health coverage; we are the only halfway rich country with such a record. I would rather try to fix that by a system that gives individuals some choices among privately competing sources of health coverage than by a fully federally controlled system. I think it is ironic that conservatives are arguing to block change that preserves some choice and some competition, when they know that there would be no strong constitutional arguments against a single payer system. The current health care financing system in this country is terrible and heading toward a catastrophic failure. At this point, I think something like the Obama system – or the Romney Massachusetts plan, or Alain Enthoven’s managed competition plan, or the Clinton health plan, or the early 1990s Heritage Foundation plan on which many of these are based – is a better way forward. But I would (reluctantly) take single payer over the present system, especially as that system will look in a few years.

Michelle asks: There has been much discussion about the three days of oral arguments. My question is what happens at the end of those three days? Will the fate of the health-care act be known on Wed., or are we in for weeks/months of uncertainty?

Set your alarm clock for the end of June. The Court tries very hard – and almost always successfully – to decide all the cases it hears arguments on in one term (October to the end of June) during that term. The more complicated the case and the more individual opinions (concurrences and dissents, along with majority opinions) are written, the longer the writing process takes. June 30 is 94 days away – which is quite soon for a case of this complexity and magnitude, let alone one where many justices are likely to want to write opinions, whatever the outcome. June 30 is a Saturday this year. I suspect they’ll shoot for Friday, June 29, but Monday, July 2 wouldn’t shock me.

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Health Policy, In the News

The Supreme Court on health reform: day three

Unlike each of the last two days, today’s argument covered two distinct issues. The morning was devoted to severability: if the Court finds that some of the Act is unconstitutional, what should it do with the rest of it? The Court devoted the afternoon to the Act’s Medicaid expansion, asking whether it was an unconstitutionally coercive use of Congress’s undoubted spending power. Both discussions were messy, but interesting.

Severability
Severability is like washing dishes. It’s boring, it doesn’t get a lot of attention, but from time to time it has to be done. And while there might be agreement on good ways to wash dishes, there is very little agreement on how to “do” severability. As today’s argument showed, there isn’t even much agreement on what would count as a “good” result, whereas dishes, at least, can usually be classed as clean or dirty.

There are two big problems with this area of law: One is that it has inherent difficulties. In many of the cases, the Court takes the view that its goal is to do what Congress would want done if Congress knew that some provisions of an Act were unconstitutional. Should the Court “save” the part that it doesn’t directly find unconstitutional or would Congress, in light of that new Court-made hole in the statute, prefer that none of the statute remain in effect? The problem, of course, is that there is absolutely no way to know what “Congress” would really want.

The second problem is that the Court’s reports contain cases going all different ways on severability issues and only rarely with any useful statements about the reasons for their decisions. Precedent just isn’t much help here – there are too many precedents and they are all over the map.

And, as if the Court didn’t have enough problems with the issue, its difficulties were compounded by some dumb arguments, from parties and judges.

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Health Policy, In the News

The Supreme Court on health reform: day two

Today saw 120 minutes of argument on the constitutionality of the individual mandate part of the Act. I should note that I have taken a public position on this issue and in favor of the individual mandate – I am a signer of the “Brief of 104 Health Law Professors as Amici Curiae in Support of Petitioners (Minimum Coverage Provisions).” That may color my view of today’s argument – or, perhaps more likely, as correlation does not imply causation, some underlying frame of my mind may color both my joining that brief and my view of today’s argument.

Before I talk about that argument, I need to point out the limits of argument. I had the pleasure and privilege of serving as a clerk to Justice Potter Stewart nearly 35 years ago (lower Pleistocene). I strongly suspect that what I observed then is still true today: oral argument is just one step, and not a very important one, in how cases are decided. That process starts with the papers seeking to convince the Court to hear, or not to hear, the case and is followed, more importantly, by the parties’ briefs (joined, in this case, by scores of amicus briefs). In my year at the Court, I would guess that the oral argument changed the result in only one case all term.

The oral argument is a window into a small part of the process, a window that is obscured by silence, by genuine uncertainty, by devil’s advocacy, and, mostly, by the fact that for many justices in many cases, the results are still uncertain.

Later in the week of the argument the Justices hold a conference on the cases they have heard and cast preliminary votes – and then, at least in close cases, the real persuasive work begins. Justices talk to each other, their clerks talk to other clerks, and, most importantly, draft opinions begin to circulate. Some arguments sound good but just don’t write up well. In others, new holes, and new possibilities, show up on paper. Justices bargain for changes in language in return for their concurrence in an opinion. Sometimes, they change sides. It is not unknown for the result to shift in the last couple of days before an opinion is issued and the majority opinion in a five to four case becomes, much to its author’s dismay, a four justice dissent. The oral argument is a window into a small part of the process, a window that is obscured by silence, by genuine uncertainty, by devil’s advocacy, and, mostly, by the fact that for many justices in many cases, the results are still uncertain.

I was asked to blog about the argument and so I have. Oral argument is a very uncertain clue to a case’s outcome, but is the only new clue we get between the briefing and the announcement. I suspect what follows is guilty of putting too much weight on what was said today. Don’t pay (too much) attention to me.

And now, the argument. I wasn’t in the building and didn’t even listen to the audio; I’ve just read the transcript. Based on that, and my previous expectations about the Justices’ positions, I’d say this had to be a disappointing day for the Administration (and other supports of the health reform bill), but not a terribly disappointing one. I came into this week thinking that the Court would probably vote to uphold the individual mandate by a vote of either five to four or seven to two, with a possible loss by a vote of four to five. After today, I have narrowed my expectations down a bit. I think the likeliest results are that the Court will uphold the individual mandate by a vote of six to three, followed by a vote of five to four, followed by a four to five loss.

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Health Policy, In the News

The Supreme Court on health reform: day one

This week the Supreme Court is devoting an impressive six hours of argument, over three days, to the Affordable Care Act. Four different federal Courts of Appeal had reached decisions about various provisions of the Act; the Court asked to hear arguments about four specific issues:

  1. Does the Anti-Injunction Act keep the Court from deciding the constitutionality of the individual mandate until the various penalties imposed by various parts the Act are actually imposed (probably in 2014)?
  2. Is the “individual mandate” within the powers the Constitution confers on the Congress?
  3. Does the Act’s required expansions of State Medicaid programs violate the Constitution? and
  4. If some provisions of the Act are unconstitutional, are those provisions “severable,” allowing the rest of the Act to go into effect, or “inseverable,” forcing the whole legislation to fall?

I will be commenting briefly on the arguments each day. I should note, though, that oral argument is a very uncertain guide to the how the Court, or even its members, will vote. Some justices never say anything at oral argument (Justice Thomas last asked a question more than six years ago), some like to play devil’s advocate, and (more fundamentally) Justices views can evolve as the arguments proceed and as the draft opinions are written, and re-written, and re-written. So, take all predictions of the Court’s ultimate conclusions that are based on oral argument with a teaspoon of salt. (Take all predictions based on other ground with at least as much salt.)

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Health Policy, In the News

Health reform opponents lose in another appellate court

But the government didn’t, exactly, win.

Today the Fourth Circuit Court of Appeals decided appeals of district court decisions from Virginia about the Affordable Care Act (the ACA). It dismissed the decision from the Eastern District of Virginia, Virginia v. Sebelius, that had held the Act unconstitutional. And then it dismissed the decision the from Western District of Virginia, Liberty University v. Geithner, that held the Act constitutional. In both cases, it decided that neither it nor the lower courts had jurisdiction to decide the cases. In the Virginia case, the Commonwealth was the only plaintiff and it challenged only one part of the Act – the individual mandate, which, as the court pointed out, couldn’t apply to it, as it is not an individual. It lacked “standing,” the court held. In the Liberty University case, the plaintiff challenged the penalties the IRS is supposed to use to enforce both the individual mandate and an employer mandate. This, the court held, ran afoul of an 1867 act that prevents courts for hearing cases brought to enjoin the assessment or collection of a tax, the idea being to force the taxpayer to pay the tax and then sue for a refund.

Because the court concluded it didn’t have jurisdiction over the cases, it couldn’t hold the ACA either constitutional or unconstitutional, although, in separate, individual opinions, two of the judges said (in a non-binding form we call “dicta”) that they would hold it constitutional, one as part of the taxing power and the other as part of Congress’s power over interstate commerce.

What does it mean? Same as before – the Supreme Court is going to decide the constitutionality of this health reform, though probably through the cases from other circuits (the 6th circuit upheld the law, the 11th circuit struck it down). Of the nine appellate judges, on three courts, who have reviewed these appeals, 5 (including one Republican appointee) have found the ACA constitutional, 3 (including one Democratic appointee) have found the ACA unconstitutional, and 1 hasn’t opined. But those aren’t the nine judges who count – the nine judges of the Supreme Court are likely to decide this issue sometime in 2012 or 2013.

For more details, see my blog post at the Center for Law and the Biosciences blog.

Hank Greely, JD, is a Stanford law professor and an expert on the legal, ethical, and social issues surrounding health law and the biosciences. He is director of the Center for Law and the Biosciences, and he chairs the steering committee of the Stanford Center for Biomedical Ethics.

Previously: Thoughts on the Eleventh Circuit health-care law ruling and U.S. Appeals Court rules against health-care law

Health Policy, In the News

Thoughts on the Eleventh Circuit health-care law ruling

The great “Constitutionality of the Health Reform Bill” contest is now tied, one to one. Earlier this summer, the Sixth Circuit, which hears appeals from federal courts in Michigan, Ohio, Kentucky, and Tennessee, ruled, in a two to one vote, that the bill is constitutional. Today, the Eleventh Circuit, which hears appeals from federal courts in Florida, Georgia, and Alabama, ruled, in another two to one vote, that it is unconstitutional.

The main message is that the Supreme Court is going to decide this issue. Before today, there was some chance that all the circuit courts would agree and the Supreme Court would not get involved; the circuit split created by the 11th Circuit decision makes that highly unlikely. It is not impossible – in either case the losing side can ask the entire court (not just the three judges on that particular panel) to rehear the appeal, taking it “en banc.” So the full Sixth or Eleventh Circuit (or both!) could overturn their panels. It seems more likely, though, that the full courts, expecting the Supreme Court ultimately to resolve the issue, will let these decisions speed up to the next level.

The two courts did disagree on the fundamental issue of the constitutionality of the individual mandate. There is nothing precisely like it in American history, which means that its constitutionality really is an open question – no earlier decision clearly answers this specific question. My own view is that the Administration’s legal arguments are better, but I do think reasonable people can disagree. (And, of course, unreasonable people can also disagree, or agree, on the legal issues and, even more, on the non-legal issues around the act.)

Several other appellate courts are also likely to weigh in on various aspects of the bill in the next few months. My guess is that the Supreme Court will agree to hear several of the appeals. One big question will be whether it ends up hearing them in the spring of 2012, in which case a decision would normally be expected by early July at the latest; or whether it hears arguments in the fall of 2012, in which case the decision will come after the next election.

Of course, the bigger question is how will the Supreme Court rule and on that I have little insight to offer. I think it should find the Act, and, in particular, the individual mandate, within Congress’s constitutional power, but I could easily see it going the other way. I would not be too surprised if it went in either direction – I will be surprised if the decision, either way, is unanimous.

By the way, those who think judges just follow politics should note that the Eleventh Circuit panel included one judge named by President George H.W. Bush and two named by President Clinton. The Clinton-appointed judges split. In the earlier Sixth Circuit decision, the majority, in favor of constitutionality, included one judge appointed by President George W. Bush and one by President Carter, with the dissent from a judge appointed by President Reagan. So the three judges on these appeals panels who were appointed by Democrats split two to one in favor of the Act; the three appointed by Republicans split two to one against the Act. Judicial decisions are not just politics – which we should all find somewhat comforting.

Hank Greely, JD, is a Stanford law professor and an expert on the legal, ethical, and social issues surrounding health law and the biosciences. He is director of the Center for Law and the Biosciences, and he chairs the steering committee of the Stanford Center for Biomedical Ethics.

Previously: U.S. Appeals Court rules against health-care law

Medicine and Society, NIH, Science Policy, Stem Cells

Judge Lamberth’s stem cell opinion is disappointingly bad

Judge Lamberth's stem cell opinion is disappointingly bad

I was shocked last week when I learned that Judge Royce Lamberth had enjoined federal support for human embryonic stem cell (hESC) research.

This case is about the so-called Dickey-Wicker Amendment. This amendment was first added to the HHS appropriations bill in 1996. Appropriations bills are good for only one year, so every year from 1996 to the present, Congress has added essentially the same language to the relevant appropriations bill. The current version states:

(a) None of the funds made available in this Act may be used for- . . . .

(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death . . . .

For 11 years, the Clinton, Bush, and Obama administrations have agreed that this language allows funding of research using hESC lines as long as that funded research project does not itself destroy embryos. Judge Lamberth held that this language clearly and unambiguously prohibits government funding of any hESC research:

This prohibition encompasses all “research in which” an embryo is destroyed, not just the “piece of research” in which the embryo is destroyed. Had Congress intended to limit the Dickey-Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of ESCs, or to research on the embryo itself, Congress could have written the statute that way.

In 1996, this interpretation might have been reasonable, though, I believe, still wrong. In 2010, the decision is clearly and unambiguously wrong, for at least three reasons.

First, the NIH does not say, “Here’s a pool of $100 million for hESC research; come and get it.” It says “Please write us a long and complicated application for a grant to do a specific piece of research and, if we accept your grant, we’ll give you some money to do the work you said you would do.” What the NIH funds are “pieces of research,” as defined by grant applications.

Second, HHS has maintained its interpretation of Dickey-Wicker for 11 years, through three very different administrations. If his reading of the language is unambiguously right, why did three very different administrations reject it? And if the language is, in fact, unclear, then under governing administrative law, the judge has to defer to HHS’s interpretation of the statute.

Third, the version of Dickey-Wicker that Judge Lamberth was supposed to apply was passed in 2009… by a Congress that had seen three administrations interpret the language permissively. If Congress had disagreed with that interpretation, it could have changed the wording of any year’s Dickey-Wicker Amendment to make that disagreement clear. It did not. In fact, twice Congress passed new legislation to overturn President Bush’s relatively restrictive policy on use of federal funding, only to see its bills vetoed. These facts make it very odd indeed to interpret the action of Congress in passing the 2009 version of this rider as clearly rejecting federal funding for any hESC research.

As a citizen, I support federal funding for hESC research as a matter of public policy. As a law professor, I teach and support sound, logical judicial decision-making. Judge Lamberth’s opinion is disappointingly bad. I do not know Judge Lamberth and I do not know whether this decision is the result of bias or is just an example of the occasional bad opinion one must expect from even a good judge. Either way, I hope – and expect – that the District of Columbia Circuit will quickly first stay the order and then reverse the decision.

A much more detailed version of this discussion can be found here.

Hank Greely, JD, is a Stanford law professor and an expert on the legal, ethical, and social issues surrounding health law and the biosciences. He is director of the Center for Law and the Biosciences, and he chairs the steering committee of the Stanford Center for Biomedical Ethics.

Previously: Stem cell ruling throws Stanford researcher’s project into limbo, A legal perspective on the human embryonic stem cell ruling, More concern over US judge’s stem cell ruling and Stanford stem cell expert weighs in on district court ruling

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