Showing posts with label Health Policy. Show all posts
Showing posts with label Health Policy. Show all posts

Monday, July 25, 2016

Bringing out the Dead: What We Know about Zika Virus Effect on Human Tissue

[(A) Control neurosphere (B) Zika-infected neurosphere Source: Science, 13MAY2016 http://ift.tt/2a4298S]

[(A) Control neurosphere
(B) Zika-infected neurosphere
Source: Science, 13MAY2016
http://ift.tt/2a4298S]

Because unproven claims persist that chemical exposure — specifically the pyridine-based pesticide pyriproxyfen — causes the birth defects seen in children born to women exposed to Zika virus, I am bringing out the dead, laying out the bodies.

By ‘bodies’ I mean sharing here pictures of cells you see in the embedded photos from a peer-reviewed study published this May.

In these images you’ll see the damage done to human tissue in lab conditions.

No pyriproxyfen was present.

How Researchers Studied Zika
This is the methodology researchers used:

1) The researchers used human stem cells to create neurospheres — the kind of cells which turns into nerve and brain tissue in an actual embryo.

2) They set aside control samples of neurospheres which were not infected.

3) They infected test samples neurospheres with Brazilian Zika virus.

4) They observed the changes in the infected neurospheres.

5) They compared them to the uninfected control samples.

6) They wrote and published a report on their findings.

The image above is the best example from their report of the difference between Zika-infected cells and the uninfected test samples.

What Researchers Found in this Study
In short, Zika inhibits, damages, and kills infected neurospheres.

This is what we can expect to happen to a fetus’ brain or nerve tissues when infected by Zika under the right conditions during early pregnancy.

[(A) Control mock-infected organoid (B) Zika-infected organoid (damage noted at arrows; growth was also inhibited)]

[(A) Control mock-infected organoid
(B) Zika-infected organoid (damage noted at arrows)]

What Else Researchers Found in this Study
The researchers also conducted a very similar test on human brain organoids. These are not single neurospheres but neuro-tissue grown from stem cells so that they form a model like a tiny brain. Not a brain, a tissue-based model of a brain.

They used the same six steps above using a mock-infected model, a Zika-infected model, and a dengue virus-infected model. (Dengue fever is caused by a flavivirus — the same family of viruses to which Zika and yellow fever belong.) Researchers found Zika virus caused similar destructive damage on these larger models while limiting their growth; they did not find the same damage or destruction in the dengue-infected models and none in the mock-infected control models. Zika alone damaged neurological tissue models.

Researchers also studied neural stem cells (NSCs) — the simplest neuro tissue model — and found similar results in which the Zika virus killed off NSCs. Studying NSCs, neurospheres, and organoids, the researchers observed Zika’s actions on different stages of neuro tissue maturity. In each of these models, from the simplest (NSCs) to the most complex (organoids), Zika was destructive.

[ZIKV (Zika virus) induces death in human neurospheres. These micrographs show the ultrastructure of mock- and ZIKV-infected neurospheres after 6 days in vitro. (A) Mock-infected neurosphere showing cell processes and organelles. (B) ZIKV-infected neurosphere showing a pyknotic nucleus, swollen mitochondria, smooth membrane structures, and viral envelopes (arrow). (C) Viral envelopes on the cell surface (arrows). (D) Swollen mitochondria. (E) Viral envelopes inside the endoplasmic reticulum (arrows). (F) Viral envelopes close to smooth membrane structures (arrows).]

[ZIKV (Zika virus) induces death in human neurospheres. These micrographs show the ultrastructure of mock- and ZIKV-infected neurospheres after 6 days in vitro.
(A) Mock-infected neurosphere showing cell processes and organelles.
(B) ZIKV-infected neurosphere showing a pyknotic nucleus, swollen mitochondria, smooth membrane structures, and viral envelopes (arrow).
(C) Viral envelopes on the cell surface (arrows).
(D) Swollen mitochondria.
(E) Viral envelopes inside the endoplasmic reticulum (arrows).
(F) Viral envelopes close to smooth membrane structures (arrows).]

Other Research on Zika Using Mouse Tissue
Three other studies published in May this year using mice or mouse tissues likewise showed evidences of neurological tissue and brain damage or growth suppression when infected by Zika virus. The studies came from research facilities in Brazil, China, and the U.S. — and in each study, pyriproxyfen was not included. The Zika-infected specimens showed damage and the control specimens did not.

The study from Brazil at the University of São Paulo also included research using human stem cells, comparing a Brazilian strain of Zika against an African strain:

Beltrão-Braga, Muotri, and their colleagues also grew brain organoids from human stem cells and infected these in vitro models with the Brazilian and African strains of the virus. In the human mini brains, both strains of the virus caused cell death, but the Brazilian strain appeared to also interfere with the formation of cortical layers. The virus didn’t replicate in the brain organoids grown from chimpanzee stem cells, suggesting it may have adapted to human tissue, the researchers noted in their paper.

Emphasis mine. Research published earlier showed Zika has already mutated rapidly after arriving in Brazil, with at least nine variants found inside the last two years.

What’s Next in Zika Research
What researchers don’t yet know, for starters: How Zika works — how does it damage or kill cells? When exactly does the virus do the most damage? What mechanisms interfere with Zika’s operations and can they be used in vaccines or drug therapy? What makes Zika different from dengue or other flavivirus? What does Zika do to adult neuro tissue to cause Guillain-Barre Syndrome? Which adults are most at risk? Will the different mutations in Brazil respond differently to vaccines? How long can humans carry live Zika virus? Has the virus mutated and become transmissible by bodily fluids or aerosol? These are just a few of the questions we still have about Zika.

There are some good guesses about Zika’s mechanisms — like this hypothesis focusing on vitamin A storage in the liver, which also suggests Zika may negatively affect liver cells (yet another avenue of research needed). But will a vaccine targeting this activity work for other flavivirus, too? What if this guess is wrong; are there other approaches we’ve yet to hear about?

We won’t have any of these answers in a reasonable period of time if we don’t have adequate funding.

It’s not just birth defects we are talking about here, either. Look at the damage in those images again; this virus not only damages fetal nerve and brain tissue, it kills fetuses. Infants born with Zika-related defects may be blind and may lead short, painful lives. And it may kill and maim adults, too, if they develop a serious case of Zika-related Guillain-Barre Syndrome.

Let’s not bring out any more Zika dead.

(Note: Forgive me for the simplistic terms used in this post if you have a background in science. I had to make this as brief and succinct as possible for those who don’t have that background.)
___________

Source:
Zika virus impairs growth in human neurospheres and brain organoids
BY PATRICIA P. GARCEZ, ERICK CORREIA LOIOLA, RODRIGO MADEIRO DA COSTA, LUIZA M. HIGA, PABLO TRINDADE, RODRIGO DELVECCHIO, JULIANA MINARDI NASCIMENTO, RODRIGO BRINDEIRO, AMILCAR TANURI, STEVENS K. REHEN
SCIENCE13 MAY 2016 : 816-818
Zika virus infection in cell culture models damages human neural stem cells to limit growth and cause cell death.
URL: http://ift.tt/2a4298S

Zika Studies Using Mice:
F. Cugola et al., “The Brazilian Zika virus strain causes birth defects in experimental models,” Nature, doi:10.1038/nature18296, 2016.

C. Li et al., “Zika virus disrupts neural progenitor development and leads to microcephaly in mice,” Cell Stem Cell, doi:10.1016/j.stem.2016.04.017, 2016.

J. Miner et al., “Zika virus infection during pregnancy in mice causes placental damage and fetal demise,” Cell, doi:10.1016/j.cell.2016.05.008, 2016.

Monday, April 18, 2016

Wonks and Activists

Marcy took on the excellent Jonathan Cohn’s piece on wonks vs. activists here, but I want to pile on. Wonks only get heard if politicians want to hear them, and even then, they aren’t always right.

Paul Krugman has written many laudatory pieces about Obamacare in both his blog and his column, but it is not working to the level the policy wonks promised. Enrollment levels are turning up lower than anticipated. Insurance company profits are up, leading to mergers and a loss of competition. And, of course, there are too many who have policies under Obamacare who can’t use them because of the costs.

In other posts I wrote about how Paul Krugman, a genuine expert, was completely wrong about the impact of trade treaties, especially NAFTA. Larry Summers, a genuine expert with a lot of real-world experience, has been disastrously wrong on a number of occasions, not least of which was his loud endorsement of financial deregulation, even after the Long Term Capital Management debacle. Summers was one of the people who quashed the efforts of Brooksley Born to regulate derivatives.

In each of these cases, there were plenty of people warning of disaster ahead. In each case, the liberal experts rejected the warnings. Krugman insulted the trade union leaders and the economists who supported them. Many people think the attacks on Brooksley Born were personal, or even sexist, but she had a proven track record of being right, while her opponents, who included Alan Greenspan and Robert Rubin along with Summers, don’t.

It’s important to note that unlike their conservative counterparts, who are always wrong, liberal experts are frequently right. For example, Krugman has been the loudest voice calling for use of fiscal policy to confront the current economic situation. From the outset of the crisis in 2008, he called for a bigger stimulus, and has done so steadily ever with increasing vigor and with some signs of anger. He is one of the few prominent economists to look at the failures of the discipline in the wake of the Great Crash.

Even so, the fact remains that wonks don’t have the greatest batting average. And there are several reasons for this.

1. Economists and most wonks use models for the bulk of their work, but the models are inherently limited. All models are based on data from the past, and operate on the principle that the past is reasonably predictive. The point of activism is to change the future so that it isn’t like the past. Activists can see the past clearly, and many leftish activists can see that the past was dominated by the rich who arranged things solely in their own interest. The work of the activist is directed at changing things so that the future doesn’t look like the past.

2. Models are inherently utopian. Krugman has written extensively about his views of the importance of models. there are inherent problems with models, as Krugman said himself:

Few economists saw our current crisis coming, but this predictive failure was the least of the field’s problems. More important was the profession’s blindness to the very possibility of catastrophic failures in a market economy. During the golden years, financial economists came to believe that markets were inherently stable — indeed, that stocks and other assets were always priced just right. There was nothing in the prevailing models suggesting the possibility of the kind of collapse that happened last year.

To make a model, you make assumptions about the economy, and what can safely be left out of the unending complexity of the real world so that the math and piles of data can be run through a computer. Most of the real world is left out of models and we can assume that important things are missing. For example, as Joseph Stiglitz says here, there are banks in the real world, but not in the models. The linked article gives a great example of the problems created by this choice.

But it’s actually worse. Markets are assumed to be stable, and people are assumed to be rational agents. That means that the models also do not incorporate fraud, which is a real problem in the US. They also don’t include corruption, in the form of legislative favors, regulatory capture, a politicized judiciary, and wimpy to non-existent criminal and civil law enforcement. It also means that markets are assumed to be competitive, which they aren’t. In other words, these models are utopian, and the people who rely on them to inform their punditry are bound to be wrong.

3. Obamacare rests on the idea that the solution had to be based on markets. Health insurance markets are primitive, so we have to make better ones. The competitors in these new markets are health insurance companies. But these new markets required insurance companies to compete, and that’s not the goal of insurance companies. Their sole interest is their profits. Competition drives down profits. They want to merge and eliminate competition so they can make all the profits possible market by market. How could the healthcare wonks fix that problem? They had to assume that other parts of government would enforce antitrust laws. That didn’t happen. So Aetna merged with Cigna and there will be more.

Here’s the ugly reality. If politicians like the liberal argument, the liberals get to be heard, to the exact extent the politicians like. The health policy wonks didn’t get to do anything beyond what Obama wanted. Krugman was heard on trade, because Bill Clinton wanted to hear NAFTA would be fine. If politicians don’t like the argument, they get new wonks who agree with them. Liberal wonks don’t get to argue for the public option or single payer because politicians don’t want to hear it. Krugman doesn’t get to be heard on fiscal stimulus, because politicians don’t want to hear it.

The point of activism is to exchange one set of politicians for others who agree with the activists. Then liberal wonks can get to work and do something useful.

The Obamacare “Wonks” Are Awfully Selective about Which Taxes and Costs They See

Let me start this critique (what may be the first of two parts) of Jonathan Cohn’s scolding of Bernie Sanders on health insurance by looking at this passage, from the end of his piece:

[Bernie] might not get his plan through Congress, sure, but he could use his promise to extract other useful legislation from Congress. Maybe he could win approval for the “public option” insurance plan that was originally part of Obamacare, or for allowing the non-elderly to buy into Medicare.

These are legitimate arguments. But liberal policy wonks remember the struggle to enact and then implement Obamacare. They also also remember that universal health care was a progressive dream for nearly a century, one that proved impossible for presidents with names like Roosevelt and Truman (and Clinton!) to realize.

One reason reform took so long is that, for most of that period, activists and the wonks were pulling in different directions, with the activists pursuing single-payer and the wonks looking for compromises. The (mostly) unified front they showed in 2009 and 2010 was a big reason Obamacare became law. Now that unity is fading, creating a key divide in the Democratic campaign.

In this passage, Cohn talks about the things that Bernie Sanders might do as President that fall short of his goal of “single payer” health care (I put that in quotes because what we’re really talking about is government paid health insurance — as providers pull out of exchanges in Obamacare we’re actually moving closer to a much more alarming sort of single payer model).

He suggests that President Bernie, brought to earth by a reality of which, his critics suggest, he is woefully unaware of right now, might set up the government as a competitor to private insurers within the Obamacare structure. Cohn then moves from that possibility (which I would suggest would be remote except for some realities about Obamacare as enacted) to saying “liberal policy wonks” know that Obamacare was a struggle and they know how hard it was to get even what we got (Bernie, who was in the Senate fighting to make Obamacare better at the time, apparently is too senile to remember all this, I guess).

As a reminder, one reason both the public option and Medicare buy-in were opposed by some Democratic Senators (and especially insurance state Independent Joe Lieberman, whom Bill Clinton had a big hand in getting reelected in 2006), meaning we couldn’t even pass it with a supermajority, is because they would make it too easy to move towards single payer. The idea was private companies could not compete, and so would slowly lose most exchange business to the government.

Now, if I were someone pushing for the improvement of healthcare delivery in this country, I’d say, “wow, if Bernie could pull off Medicare buy-in, that’d get us closer to single payer! That’d be a huge win!” I also might consider ways that true Medicare buy-in (rather than just gradually lowering the age at which you could buy in) might address some of the problems with cost sustainability with Medicare. I’d further applaud that getting more people into Medicare would expose more people to the innovations in delivery tied to it (one of the two best things about Obamacare), and therefore would move delivery as a whole down that path.

In short, I’d be applauding.

But Cohn doesn’t do that.

Instead, he decries what we calls a split between “wonks” and “activists.”

Can someone please define what those words mean for me? Can you explain how a man who has spent a decade writing about ways to improve health insurance and even sometimes healthcare, as Cohn has, is not an activist of sorts? Has he just been writing for a paycheck all these years?

Don’t get me wrong. I consider Cohn an expert in the subject, unlike some other people who get included in Paul Krugman’s club of wonks. I respect much of what he writes. And I have no doubt that he has become an expert on this topic because he’d like to improve a shitty system.

But setting up a dichotomy between “wonks” (“yes, I am one of those wonks,” Cohn says elsewhere) and “activists” is an insidious way of saying “some of the people who work on this issue are not as smart as me.” Would anyone suggest such a thing about insurance company lobbyists, who are themselves “activists”? Nope. They’re just experts who use different methods to press for their desired outcome. But somehow people who lobby and organize on the other side are presumed to be unicorn sniffing half-wits.

Calling oneself a wonk is also an easy way absolve oneself of examining what function wonk-scolding plays — a way to pretend one is delivering just unmediated rationality and not an argument designed to bring about some outcome. Here, the desired outcome seems to be the restoration of unity between those deemed “activists” and those deemed “wonks.” But not just to restore unity, mind you, but to restore unity by getting “activists” to be satisfied with what “wonks” tell them is realistic.

In other words, it’s a plea from one kind of activist for another kind of activist to fall back in line behind the policies the first kind of activist espouses, and, especially, to stop suggesting Obamacare (and, frankly, a whole bunch of other policies enacted by Obama and defended by Hillary Clinton, as well as some foreign policy ones that go beyond what Obama has done) isn’t an adequate solution.

So let’s go back to what else Cohn says. First, he explains why (unnamed) “liberals sympathetic” to government insurance consider it unrealistic by warning that even trying to move towards government insurance will “produce a major public backlash.”

Even many liberals sympathetic to the idea have said that Sanders’ scheme is simply not realistic. They worry that trying to push through another comprehensive health care package so soon after the Affordable Care Act’s tumultuous enactment would produce a major public backlash.

Note what Cohn has done here (besides putting his own argument in the mouths of unnamed anonymous liberals). In the rest of his piece, Cohn suggests that achieving government insurance is unrealistic. Fair enough — in a four year term it may well be. But here, he somehow ties what might fairly be considered the impossibility of actually achieving it with the specter of “major public backlash” if someone even tries.

I’m not sure if Cohn has noticed, but there is an ongoing major public backlash already. It was so bad in 2010 that it made predictable off year congressional losses far worse than they might have been. Much of that backlash is just Republican posturing. But not all of it. Some of the backlash comes from legitimate complaints about Obamacare: the government botched the original sign up, people actually weren’t able to keep their insurance plans, their selection of doctors has gone down, people are being forced to buy shitty insurance they can’t afford that won’t even make care affordable. Some of the backlash is unjustified, but some of it actually is justified.

But Cohn says we can’t talk about moving to government insurance because if so it will … cause what is already happening to continue happening? Or perhaps because it will legitimize some of the legitimate critiques of the Obamacare that activists like Cohn pushed back in 2009? Is that it? We can’t even talk about government insurance because doing so would bring people like Cohn in for some criticism?

Finally, here’s the line from the debate that Cohn frames this entire discussion around, where Hillary attacked Bernie’s plan because it would impose a $2,300 tax on the working poor.

But during the debate she also made another claim: That under the Sanders plan, some low-income people now on Medicaid would be much worse off. “A working woman on Medicaid who already has health insurance would be expected to pay about $2,300,” Clinton said.

[snip]

Here’s why. If the federal government is going to provide everybody with health insurance, then it must raise enough money to pay for those benefits. To do this, Sanders has said, he’d create a new payroll tax, equal to 8.9 percent of wages. In theory, employees would pay only a portion of that, with employers covering the majority. In reality, economists say, the employer share also comes out of workers’ paychecks, if not right away then over time.

[snip]

An 8.9 percent payroll tax would work out to a new payroll tax burden of $2,314 — just as Clinton said.

Today, by contrast, you’d be getting Medicaid without having to pay any new taxes. The money for the program comes out of general revenue and if you’re one of the newly eligible folks, then the money is coming almost entirely from taxes that fall on the wealthy and on corporations in the health care industry.

Now, “wonks” love to criticize Bernie for promising things he can’t deliver. But note what Cohn has done in this last paragraph: under Obamacare this working poor mother of two gets health insurance “without having to pay any new taxes.” Her health insurance “comes out of general revenue” which comes from “taxes that fall on the wealthy and on corporations in the health care industry.”

I think Cohn means to suggest that the revenue passed under Obamacare fall on the wealthy and corporations. He surely doesn’t mean that general revenue funds generally come from taxes that fall on the wealthy and corporations, because many rich people and corporations actually don’t pay income taxes. Indeed, it’s all that we can manage to keep corporations — some of them the health care ones Cohn says pay for all this, paying any taxes at all. What he really means is the taxes that pay for Medicaid come largely from the affluent and middle class taxes and even borrowing. That single mom likely still isn’t paying for her own Medicaid, but it’s not actually rich corporations that are doing so.

But even if Cohn meant only to refer to the planned funding method for Obamacare, his claim is problematic. That’s because one of the taxes targeting the industry, on medical devices, has already been suspended. Another tax that Obamacare boosters liked to pretend will only affect the wealthy, the Cadillac tax, will actually affect more people than that, including unions (which is why Hillary has promised to scrap it, as has Bernie). Plus, the Cadillac tax boosters sold it with a claim that workers wages would go up after their companies cut their health insurance. Those claims always seemed like fantasy — at least to me and actual experts like Larry Mishel, the latter of whom was pretty much ignored by the “wonks” during the debate. In the last six years that has become even more clear.

This is important: In a key fight about funding during Obamacare, the “wonks” promised workers (especially union workers) a wage increase, but evidence now strongly suggests it would lead instead to a wage cut. Yet those same “wonks” (though Cohn wasn’t one of the more obnoxious Cadillac tax defenders) are now scolding Bernie about the realism of his claims. Why should we listen to the “wonks” when they too promised illusory unicorns?

Finally, though, I want to look at the premise of Hillary’s attack, that Bernie’s plan would be bad because it would impose an 8.9% tax on a working poor woman. Cohn admits that’s surely something Bernie would fix before implementation, but he apparently finds the criticism legitimate because “doing so would require new trade-offs.” Trade-offs like those that continue to need to be made on Obamacare to make up for the Medical device and Cadillac tax, I’d respond.

But here’s the other thing about that 8.9% tax. I absolutely agree that an 8.9% tax on the working poor in exchange for health insurance would be steep. But let’s consider what Obamacare is for a segment of the middle class that are forced to buy insurance — spending up to 13% of their income — that they can’t use. Sure, it will minimize but by no means eliminate the problem of medically related financial crisis in the case of a catastrophe. But the rest of the time, it functions as a tax, a payment necessitated under this scheme to make care accessible for others. One that — unlike that poor woman who’d pay $2,300 if Bernie’s implementation of single payer somehow didn’t fix things along the way — wouldn’t necessarily provide care in response. (Note, in reality, 22% of Medicaid recipients also can’t afford to use their insurance, though unlike the general number of underinsured, that’s a number that Obamacare has improved.)

Now, we knew this was going to be a problem, though the “wonks” generally didn’t like to talk about it during the debate (though Cohn is actually one who did admit it at least once in response to me raising it), because somewhere between 16 and 21% of people in Massachusetts couldn’t afford to use their RomneyCare. Hillary has suggested she’d throw more money at the problem (and, ultimately, insurers) to address the problem, but she hasn’t actually explained what trade-offs she’d make to achieve that. Again, it seems okay for Hillary to remain silent about the trade-offs she’d have to make whereas when Bernie does he’s a fantasist.

Partly, though, Obamacare is designed to underinsure people, because there’s a belief that unless people feel the sting of obtaining care, they’ll get too much of it. “Bending the cost curve” under Obamacare is largely driven by increasing the costs of actually using insurance to the end user as opposed to, say, eliminating the many layers of private profit that doesn’t actually improve health care but makes it expensive.

In truth, the people the “wonks” deem “activists” aren’t actually stupid, or naive, or unicorn herders. Some of them are actually experts of longer standing than those writing in favor of Obamacare. Rather, they disagree about what acceptable costs are, as well as about whether it makes sense to continue pointing out that the US has an unbelievably ineffective healthcare delivery system with terrible outcomes that not only is immoral, but saddles our economy with a burden that other developed countries don’t have, making us less competitive in any industry not driven by this exorbitant spending. Yes, there is also a difference of opinion about whether it is more effective “activism” to set the goal where everyone agrees it should be — providing actual health care — or to instead set more moderate goals that also have the effect of naturalizing a particular ideology. But ultimately there is a real debate about policy here, and rather than use “activists” to continue to set the bar on the most efficient way to provide the best health care, a lot of those close to Hillary would prefer they just shut up.

Thursday, April 14, 2016

CDC: Zika Virus Confirmed as a Cause of Microcephaly

CDC director Dr. Tom Frieden confirmed Wednesday that the flavivirus known as Zika is a cause of microcephaly and other severe fetal brain defects.

The confirmation is based on an evaluation of available data for potential teratogenic effects. Using both Shepard criteria and Bradford Hill criteria, researchers proved prenatal Zika virus infection has a causal relationship with microcephaly and other serious brain anomalies.

The first set of seven criteria used in the assessment were developed by Dr. Thomas Shepard to assess an agent’s teratogenicity — the ability to cause birth defects. The criteria of proof are:

1. Proven exposure to agent at critical time(s) in prenatal development

2. Consistent findings by two or more epidemiologic studies of high quality

a. control of confounding factors
b. sufficient numbers
c. exclusion of positive and negative bias factors
d. prospective studies, if possible, and
e. relative risk of six or more

3. Careful delineation of the clinical cases. A specific defect or syndrome, if present, is very helpful.

4. Rare environmental exposure associated with rare defect. Probably three or more cases.

5. Teratogenicity in experimental animals important but not essential.

6. The association should make biological sense.

7. Proof in an experimental system that the agent acts in an unaltered state. Important for prevention.

______
Note:
Items 1~3 or 1, 3, and 4 are essential criteria.
Items 5~7 are helpful but not essential.

Shepard criteria summary:

1. The microcephaly and other brain defects observed in infants and fetuses were consistent with maternal Zika infection during first and second trimester of pregnancy. Mothers exhibited symptoms, and/or had infections confirmed by labs, and/or had traveled to areas where Zika was endemic. This criterion was met.

2. Data documenting the location of Zika virus infections and the subsequent incidence of microcephaly in those areas was supported by two epidemiologic studies. But as sample sizes were too small and controls were lacking, this criterion has not yet been met.

3. Cases manifesting with a very specific defect (an atypical microcephaly) or syndrome (a narrow range of neurological defects in tandem with microcephaly) satisfied this third criterion. With Zika infection, microcephalic cases displayed adequate bone tissue and scalp skin production, but ‘collapsed’ due to the disrupted development of fetal brain tissue. This is not common in other microcephalies.

4. An adequate number of cases fulfilled the criteria of rare exposure and rare defect — one example cited was that of a pregnant woman who traveled for a week to areas with Zika were Zika was not endemic. She tested positive for Zika during her second trimester, and the fetus displayed brain defects associated with Zika after the infection.

5. Studies for this criteria — teratogenicity in animal models — are still under way. This criterion is not yet satisfied.

6. This criterion is met as the causal relationship makes biologic sense.

7. This criterion does not apply to infectious agents.

The essential Shepard criteria have been met for proof of teratogenicity.

Bradford Hill criteria summary

Of the nine criterion — the strength of association, consistency, specificity, temporality, biologic gradient, plausibility, coherence, experiment (on animal models), and analogy — only two criterion are not applicable or not available. The remaining seven criterion were met in much the same manner as the Shepard criteria 1, 3, 4 were met.

What’s next

A spectrum of additional fetal abnormalities has not yet been fully identified in association with Zika infection. This will become clear once some pregnancies being monitored reach term.

We don’t yet know if Zika virus affects adult neurological tissues; some cases of Guillain-Barre Syndrome (GBS) have been reported in areas where Zika is endemic. GBS has occurred in patients after viral infections where neurological tissues have been affected; it would make biologic sense for there to be a causal relationship between Zika and GBS. However, GBS has occurred in patients long after an initial infection, making it difficult to see obvious relationships without further screening and testing.

A Zika vaccine may be some time off; only yellow fever and a couple of encephalitis viruses have vaccines while others like West Nile and dengue do not.

Mosquito control varies widely from state to state, let alone by county or municipality. We do not know if it is adequate to ensure Zika’s spread via Aedes aegypti and Aedes albopictus mosquito species is limited. U.S. experience with the spread of West Nile Virus may be informative.

Funding for additional research, education, training, vaccine development and mosquito control, as well as funding increases for birth control are much needed, But the GOP-led Congress will likely avoid this issue during the remaining days it is in session this election year.

In the meantime, if you’re around mosquitoes in warmer areas of the U.S., are pregnant, plan to be pregnant, or might get someone pregnant, check the CDC’s guidelines on Zika.

Thursday, March 31, 2016

Thursday Morning: Taboo You

Still on spring break around here. If I was legit on a road trip some place warm right now, you’d find me lounging in the sun, sipping fruity cocktails at all hours, listening to some cheesy exotica like this Arthur Lyman piece I’ve shared here.

Though horribly appropriative and colonialist, it’s hard not to like exotica for its in-your-face corniness. I think my favorite remains Martin Denny’s Quiet Village. It brings back memories from the early 1960s, when life was pretty simple.

Let’s have a mai tai for breakfast and get on with our day.

Urgent: Increasing number of hospitals held ransom
Last month it was just one hospital — Hollywood Presbyterian Medical Center paid out bitcoin ransom.

Last week it was three — two Prime Healthcare Management hospitals in California and a Methodist Hospital in Kentucky held hostage.

Now, an entire chain of hospitals has been attacked by ransomware, this time affecting the servers of 10 related facilities in Maryland and Washington DC. The FBI is involved in the case. Is this simple extortion or terrorism? The patients diverted from the facilities to other hospitals’ emergency rooms probably don’t care which it is — this latest attack interfered with getting care as quickly as possible. Let’s hope none of the diverted patients, or those already admitted into the MedStar Union Memorial Hospital chain, have been directly injured by ransomware’s impact on the system.

The MedStar cases spawns many questions:

  • Was any patient’s physical health care negatively affected by the ransomware attack?
  • Given the risks to human health, why aren’t hospitals better prepared against ransomware?
  • Have hospitals across the country treated ransomware as a potential HIPAA violation?
  • Was MedStar targeted because of its proximity to Washington DC?
  • Was Hollywood Presbyterian Medical Center targeted because its owner, CHA Medical Center, is South Korean?
  • Were any patients being treated at MedStar also affected by the OPM data breach, or other health insurance data breaches?
  • How much will ransomware affect U.S. healthcare costs this year and next?

Bet you can think of a couple more questions, too, maybe more than a couple after reading this:

Hospitals are considered critical infrastructure, but unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted.

Computer security of the hospital industry is generally regarded as poor, and the federal Health and Human Services Department regularly publishes a list of health care providers that have been hacked with patient information stolen. The agency said Monday it was aware of the MedStar incident.

Apple iPhone cases emerge
After the San Bernardino #AppleVsFBI case, more law enforcement investigations relying on iPhones are surfacing in the media.

  • L.A. police crack open iPhone with fingerprints obtained under warrant (Forbes);
  • FBI will assist county prosecutor in Arkansas with iPhone belonging to alleged teen killer (Los Angeles Times); the method may be the same hack used on the San Bernardino phone, which was supposed to be a one-off (Network World);
  • ACLU found 63 other cases in which FBI used All Writs Act to obtain iPhone/Android smartphone data from Apple and Google (The Register).

Stupid stuff

  • In spite of screwing up not once but twice by releasing its racist, obnoxious Tay AI chatbot, Microsoft tripled down on a future full of chatbots you can build yourself with their tools. (Ars Technica) — Ugh. The stupid…
  • UK’s Ministry of Defense awarded funding to Massive Analytics for work on “Artificial precognition and decision-making support for persistent surveillance-based tactical support” (Gov.UK) — OMG Precog in warfare. Human-free drone attacks. What could go wrong?
  • Rich white guys queue up outside Tesla dealerships for days waiting to pre-order the new Tesla 3 (Vancity Buzz) — Vancouver, Sydney, probably other places I’m too arsed to bother with, because rich white guys.

That’s quite enough. Back to pretending I’m lying under a cerulean sky, baking my tuchis, cold drink in hand.