February 19, 2019 / by 

 

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 where 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; of the flavivirus family, 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 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.


Pfizer’s Vision of R&D

Recently I saw Ian Read, the CEO of Pfizer, on CNBC explaining that the Pfizer/Allergan merger would enable the combined companies to spend more on research and development of new drugs. He also confirmed that Pfizer raised prices on at least 105 drugs for no apparent reason. You can watch a small part of the interview here.

Read tries to pass the price hikes off as some kind of market-driven thing, which is stupid because price hikes are mostly either for drugs protected by patents or for generics which have no competition. The increases averaged 9.4%, far in excess of inflation, and faster than the expected increase of 5.4% in total health care spending. It’s a money grab pure and simple. The CEO then explained that these prices are a drop in the bucket, since drugs account for only about 10% of total health care spending, which comes to a total of about $310 billion, or roughly $1000 per person in the US. Drug prices rose by an average of 10.4% in 2014, so a drop in the bucket is roughly $100 per US person. And anyway, Read says, they do negotiate prices with some providers and cut prices for some poor people; meaning that the rest is paid by drug insurance policy holders. All this public talk is just politics, says Read, who in 2014 received total compensation of $23.3 million. Surely for that kind of money he could do a better job of defending his company’s rapacious behavior.

Pfizer is planning to merge with Allergan and move to Ireland to cut taxes. Read claims he needs the money for research and development of wonderful new drugs. That suggests that Read thinks he doesn’t have enough money for R&D right now. Let’s see what the 2014 financial statements say about that. In 2014, Pfizer reported net income of $9.1 billion. P. 58. It paid dividends of $6.6 billion, and repurchased stock for $5.0 billion, a total return to shareholders of $11.1 billion. With that kind of management, no wonder there is no money for an increase in R&D.

Remember that R&D expenses are deductible in full in the year incurred, a temporary tax law now permanent thanks to Congress. So let’s see what we get for that tax cut. Pfizer reports that in 2012, it had an R&D expense of $250 million to “obtain the exclusive, global, OTC rights to Nexium”. P. 28. Pfizer get Uncle Sam to pay about $80 million of that price. In 2014, Pfizer counted as part of its increase in R&D this gem: “$309 million, reflecting the estimated fair value of certain co-promotion rights for Xalkori given to Merck KGaA”. That’s a non-cash transaction that cut Pfizer’s taxes.

And here’s a description of the R&D program at Pfizer:

We take a holistic approach to our R&D operations and manage the operations on a total-company basis through our matrix organizations described above. Specifically, a single committee, co-chaired by members of our R&D and commercial organizations, is accountable for aligning resources among all of our R&D projects and for seeking to ensure that our company is focusing its R&D resources in the areas where we believe that we can be most successful and maximize our return on investment. We believe that this approach also serves to maximize accountability and flexibility.

That’s management speak for “we make drugs that will maximize our income.”

Turning to the Allergan deal, CEO Read assures us that Pfizer will use the tax savings for R&D. Let’s first see what the savings might be. According to Americans for Tax Freedom, Pfizer paid effective world-wide tax rate of 7.5%. That compares with the 25.5% reported on its 10-K. P. 28. ATF offers a detailed explanation of the accounting, and explains that most US multinationals don’t use the same accounting treatment. ATF adds that Pfizer had as much as $148 billion parked overseas and untaxed in the US. At least that explains where they get the money to pay off their shareholders and keep Wall Street happy.

Let’s just ignore the claim of Frank D’Amelio, Pfizer’s CFO, that half the tax savings will go to shareholders as dividends. Pfizer has shut down a bunch of R&D facilities after each of its recent mergers.

Writing in Nature, former Pfizer R&D executive John LaMattina noted that the company’s three largest buyouts–Warner-Lambert, Pharmacia and Wyeth–resulted in sweeping research cuts and site closures, leaving more than 20,000 scientists out of work. And those who stick around were saddled with major R&D delays, LaMattina wrote, as integrating two large companies involves a painstaking review of assets that can slow development down to a crawl. Even more difficult to quantify is the effect on productivity, he wrote, as word of potential layoffs spreads fast throughout a large company and distracts workers from their projects.

After the merger the number two man, Brent Saunders of Allergan will oversee operations, including R&D. Here’s Saunders in August, 2015, discussing his vision of R&D with Randall Pierson of Reuters.

Saunders said discovery research, where researchers test ideas and compounds in test tubes and animals, typically eats up about 30 percent of pharmaceutical company research budgets, although only about one of every 20 such products that enters human trials succeeds and is approved.

“Discovery is where the industry has its lowest return on investment,” he said, “and not a good (use) of Allergan’s research dollars.”

Instead, he said Allergan will acquire products from companies that have already done the research spadework, and then itself develop the medicines and submit them for regulatory approvals.

In other words, Saunders and Read like the business of buying other people’s research and then doing some tests and filling out the paperwork for drug approvals. This gets them a patent/monopoly, and a fat tax deduction for all the paperwork. Then they can sell the drugs for a profit that is taxed (if at all) at capital gain rates, and if a US company buys it, the US company gets to treat the price it paid as a fully deductible R&D expense. Sweet.

Remember that Read is magnificently compensated for running this business, but what does he bring to the table? It has nothing to do with drug creation and manufacture. His contribution is measured by how little Pfizer pays in taxes, and how well he engineers earnings, and certainly not by any contribution to the well-being of humans.

We don’t have to allow this business model to flourish with tax cuts and benefits. It’s corrupt to the bone.


Wednesday Morning: Adulting is Hard

While looking for Wednesday, I discovered there’s a video short series based on a grownup version of Wednesday Addams character. Cute, though from Wednesday’s POV becoming an adult isn’t all the fun one might expect.

So much for those carefree days when one could leave all the bad news and difficult choices to parental figures. It was all an illusion there were ever any grownups in charge.

Playstation moves to U.S. as Sony melds and migrates interactive entertainment divisions
What’s this really all about? Does this consolidation of Sony Computer Entertainment with Sony Network Entertainment and their move to California as Sony Interactive Entertainment allow better collaboration with Sony Pictures? Or does this allow for easy access by U.S. government entities suspicious of Playstation Network as a potential terrorist communications platform? Or is this a means to secure a leaky business by pulling more of Sony Group inside a single network? Sony explained SIE will “retain and expand PlayStation user engagement, increase Average Revenue Per Paying Users and drive ancillary revenue” — but that sounds like fuzzy vapor to me.

Bent spear? Oh, THAT bent spear…” Air Force review omits report of damage to nuke
I hope like hell President Obama has already called someone on the carpet and asked for heads to roll. Not reporting a “bent spear” event in a review of U.S. nuclear force isn’t exactly a little boo-boo. A “bent spear” in 2007 spawned a rigorous investigation resulting in a large number of disciplinary actions including resignations and removals from duty.

Zika virus: risk to U.S. mounting
There have been more non-locally transmitted cases of Zika virus here in the U.S. as another Latin American country warns women against pregnancy. Not to worry, it’s not like Ebola, relax, we’ve been told…except that we’ve seen this playbook before, where there were casualties as a pandemic began before either federal or state agencies took effective action. In the case of Zika, we may not see mortalities; casualties may be serious birth defects following a rapid spread with mosquito season. Fortunately President Obama has now asked for more accelerated research into Zika, though we may not see results before Aedes mosquito season hits its stride this year. For more information about this virus, see the CDC’s Zika website.

EU seeks hefty fines in draft law to overhaul auto industry regulations
At fines of €30,000 (£22,600) per vehicle found in violation, the EU might get some results out of proposed regulations governing automotive emissions standards. But the problem hasn’t been the lack of EU standards — it’s the inability to validate and extract compliance when so many member states are willing to turn a blind eye to their constituent manufacturers’ failings in order to preserve employment. Can the EU make these fines stick once new regulations are passed?

By the way, Consumer Reports published a really snappy overview of the VW emissions scandal. Worth a read.

Con Edison’s creaky website leaves online customers exposed
You’d think by now after all of the successful hacks on business and government websites that companies would catch a clue. But no, not in the case of Con Edison. Read the article here so you know what to watch for at other websites; all of ConEd’s site’s links do not open fully encrypted connections. This is a really easy thing to fix, should be the very first thing every single business allowing customers to log in or pay online should check.

Heading out to act like an adult for the next eight hours. Maybe less.


Harvey Hollins Is Supposed to Be Leading Flint Response but Snyder Sent Richard Baird Instead

In my posts on Flint, I’ve alluded to a guy named Rich Baird, whom Governor Rick Snyder calls his “Transformation Manager.”

This morning, the Detroit News reported Snyder is sending Baird to oversee his Flint response.

The governor is dispatching his fixer and confidant, Rich Baird, to Flint to help coordinate the state response and to reassure the city’s elected leaders of direct, daily contact with the governor’s office.

Eclectablog has written several important posts on who Baird is and, importantly, how he was originally funded.

Baird, who had recently retired from PricewaterhouseCoopers, set up a consulting firm called MI Partners and took on one client: Governor Rick Snyder. He makes $100,000 year, paid for by unknown donors to the NERD fund, and sits at the right hand of the governor. His office is literally in the governor’s executive office suite. If you look at the Executive Office directory (pdf), there is Richard Baird’s name, listed along with the normal staffers paid like most other government officials with taxpayer money:

The important point though is that Baird, who has been a critical figure in Snyder’s emergency management schemes, started as a public/private fixer, working for private entities we can’t know about. In advance of the reelection campaign, at a time when people were demanding to know who had been paying Baird’s salary, Baird was brought onto state payroll. But he is a key figure in Snyder’s corporate driven effort to loot Michigan.

There are two reasons I’m interested in the report that Baird is overseeing Snyder’s response.

First, back in early December, Snyder’s hand-picked Task Force for responding to the Flint crisis met with him to tell him of their initial observations. One of their key recommendations, as made clear by a meeting summary they shared with him, was that he appoint one single person to handle the response. (See PDF 240ff)

We also believe it important that a single person or entity-potentially independent of any one particular state agency and mutually agreeable to this Task Force and you, Governor-be established to provide effective coordination of ongoing activities and reporting on the status of mitigation measures.

[snip]

Accordingly, in advance of our final report, we would like to ensure the independent coordinator suggest ed above engage trusted community groups to begin rebuildincommunity trust in state actions.

Snyder responded by “appointing” Harvey Hollins, his Director of Urban Initiatives, as that person “independent” of the “involved state agencies.”

You make a solid suggestion about establishing a person who is independent of any one of the involved state agencies to serve as the point person to coordinate t he ongoing work. I am recommending that Harvey Hollins, director of the Office of Urban Initiatives, carry out this effort. Harvey Is wellversed in the issues and the challenges faced by our cities and will be effective in this role. Senior members of our executive team will continue to engage with your task force and provide direction and support to Harvey to ensure you will have continued support and cooperation.

The thing is, Hollins was in no way “independent” of the decisions that poisoned Flint. He has been involved at every phase, down to coordinating Snyder’s hush-hush water filters when he was still trying to cover it up. So basically Snyder just “appointed” the guy he had “appointed” to oversee all the decisions that got Flint poisoned in the first place.

But now he’s putting (or the press is reporting that he already did put) someone else — Baird — in charge of his response.

Which brings us to what Snyder’s emails show about the involvement of Baird.

Now, I hope to get around to posting evidence from his released emails that Snyder has a second email account, and that much of what we see in the released emails are efforts to keep certain things off the books (not just in that second account but in phone or face-to-face conversations). So — as MotorCity Muckraker pointed out — it’s perhaps not surprising that Baird doesn’t appear to send Snyder many emails (on this account) but it is notable.

When he does appear in emails is interesting, however.

Baird appears in emails forwarded with public announcements relating to Flint in 2014.

  • PDF 5: January 15, 2014: Public announcement of federal funding
  • PDF 26: April 30, 2014: Flint EM’s budget talking points

Then Baird didn’t show up in emails again until the shit started hitting the fan in October 2015. It’s quite clear from these emails that Baird had a key role in responding to this crisis, including as the go-between with the Task Force Snyder set up to make the whole problem go away.

  • PDF 110: October 06, 2014: Public distribution of water filters
  • PDF 217: November 17, 2015: DEQ’s (significantly misleading) self-report to Snyder’s Task Force
  • PDF 240: December 7, 2015: Task Force (Ken Sikkema)’s formal conveyance of its report to Snyder
  • PDF 243: December 10, 2015: Response to Task Force, reflecting input from Baird
  • PDF 246: December 11, 2015: DHHS testing data
  • PDF 250: December 24, 2015: Office of Auditor General response to State Senator Jim Ananich
  • PDF 252: December 28, 2015: DEQ concurring in OAG’s analysis
  • PDF 269: December 28, 2015: Response to pre-shared copy of Task Force report, reflecting conference call involving Baird, noting a phone call to follow
  • PDF: December 29, 2015: Snyder’s statement about Task Force response, with note that Baird would meet face-to-face with Task Force on follow-up

By late December, it’s clear the governor’s staff was avoiding putting certain things in writing. In some key moments, in fact, Baird was involved in conversations about the response.

None of this is surprising. But it does make it clear that Snyder’s real response here is being led by his public-private fixer.


Bill Schuette’s Bogus Excuse for His Belated Investigation into Flint

This morning, Michigan’s Attorney General and aspiring gubernatorial candidate Bill Schuette appointed a lawyer who has donated $10,200 to his own state-wide elections and chunks more to other Republicans (as well as a smaller donation to Jennifer Granholm in 2005) to lead the “state” investigation into Flint (this is, of course, an investigation carried out by two private citizens granted the authority of the state, not the state itself — yet more private contractors who will make money off the screw-ups of Snyder’s emergency managers).

Just as interesting as the financial ties Todd Flood has with the Republican party is the excuse Schuette gave for all of a sudden deciding he needed to conduct an investigation just after the story leaked on January 5 that Detroit’s US Attorney, Barb McQuade, is investigating. Schuette said he decided to act in the wake of some resignations from staffers from the Department of Environmental Quality.

Initially Schuette had declined to investigate the Flint water crisis, but said that in early January new information including the resignation of Michigan Department of Environmental Quality officials had changed his mind.

This claim suggests some pretty whacky timing. The DEQ employees who had resigned by the time Schuette announced his investigation on January 15 were DEQ Director Dan Wyant and Spokesperson Brad Wurfel (Snyder subsequently announced the suspension of two unnamed DEQ employees on January 22).

But Schuette sure as hell didn’t sound like he thought Wyant’s resignation merited an investigation on December 29, when he released this statement.

I am saddened to hear of the resignation of Department of Environment Quality Director Dan Wyant. In my 20-plus years of knowing him, Dan has been a hardworking, dedicated public servant. I am committed to working with all parties, including the legislature and Governor, to ensure the public’s health and the well being of Michigan residents.

On the contrary, Schuette sounded like it was a terrible thing that those mean poisoned Flint kids brought about a career setback for his buddy.

Moreover, the emails Snyder released make it clear that the “resignations” and “suspensions” of these DEQ fall guys was very closely orchestrated.

The day before the governor’s Task Force on Water (directed by a GOP partisan but including the leader of an environmental group and some health academics) formally delivered an interim report to Snyder, December 28, someone sent an advance copy to the governor. (See PDF 269 for the advance copy and discussion that followed, and PDF 265 for the formal conveyance of the report to the governor.) Snyder’s Chief of Staff, Jarrod Agen, his legal counsel, James Redford, his Director of Urban Initiatives, Harvey Hollins (who was involved in the Flint issues throughout, and whom Snyder laughably appointed as the “independent” person to oversee the Flint response in December), his privately-paid bully “Transformation Manager” Richard Baird, and his Communications Director Meegan Holland had a conference call to figure out how to respond. Agen’s email to Snyder makes it clear that before that call, there had already been a plan to make “structural changes” at DEQ.

Attached is a letter from the Flint Water Task Force which will be formally sent to you tomorrow. The Task Force then plans to release this letter publicly on Wednesday morning.

You will see the letter is harsh against DEQ.

Rich, Redford, Harvey, Meegan, and myself all just gathered on a conference call to discuss our upcoming actions regarding Flint. While we don’t think this letter should change any of our actions, we agreed we may need to accelerate some of the structural changes at DEQ.

Our suggestions:

1) Make structural changes at DEQ as early as tomorrow: The recommendations in this letter suggest profound change at DEQ and openly criticize Director Wyant. If this is the path that the Task Force is on, it is best to make changes at DEQ sooner rather than later. That likely means accepting Dan’s resignation. It also means moving up the termination of the 3 DEQ personal previously planned for Jan 4 to tomorrow.

His notes also make it clear that there was already a plan to terminate 3 other DEQ personnel on January 4 (which presumably would be Wurfel and the two staffers who got suspended on January 22).

There’s no indication that Schuette was involved in these discussions (though given that he was already defending Snyder in multiple lawsuits, you would think he was in communication with Redford).

Still, it’s quite clear that the “resignation” of DEQ staffers was planned well in advance.

So why wasn’t Schuette’s investigation planned before it became clear that the US Attorney is also investigating?

At a time when MI is facing a $1.9 million bill for Schuette’s personal tirade against equality and can’t pay to fix its roads, Schuette has launched this private investigation that will need a separate appropriation to compete with the pre-existing federal one.

He did not put a timeline or cost estimate on the investigations, though he said he was in discussions with legislative leaders regarding a possible need for additional appropriation to fund the operation.

Schuette’s belated interest in seeing if any laws have been broken sure does stink.


Wednesday Morning: Otherwise Known as Mike-Mike-Mike Day

My condolences to the poor Mikes among us who have suffered every Hump Day since Geico’s TV commercial became so popular.

North Korean nuclear test detected by ‘earthquake’
About 10:00 a.m. North Korean local time Wednesday, an event measured at 5.1 on Richter scale occurred near the site of recent underground nuclear testing. South Korea described the “earthquake” as “man-made” shortly after. Interestingly, China called it a “suspected explosion” — blunt language for China so early after the event.

NK’s Kim Jong Un later confirmed a “miniaturized hydrogen nuclear device” had been successfully tested. Governments and NGOs are now studying the event to validate this announcement. The explosion’s size calls the type of bomb into question — was this a hydrogen or an atomic weapon?

I’m amused at the way the news dispersed. While validating the story, I searched for “North Korea earthquake”; the earliest site in the search was BNO News (a.k.a. @BreakingNews) approximately 45 minutes after the event, followed 17 minutes later by Thompson Reuters Foundation. Not Reuters News, but the Foundation, and only the briefest regurgitation of an early South Korean statement. Interesting.

Spies’ ugly deaths
Examining the deaths of spies from 250 AD to present, Lapham’s Quarterly shows us how very cruel humans remain toward each other over the last millennia. Clearly, vicious deaths have not foiled the use of spies.

Zika virus outbreak moves Brazil to caution women against pregnancy now
An outbreak of the mosquito-borne Zika virus in Brazil may be linked to a sizeable uptick in microcephalic births — 2782 this past year, compared to 150 the previous year. The Brazilian government is now cautioning women to defer pregnancy until the end of the rainy season when the virus’ spread has been slowed.

Compared to number of Ebola virus cases in 2014-2015, Zika poses a much greater risk in terms of spread and future affected population. The virus has not received much attention, in spite of more than a million cases in Brazil, as symptoms among children and adults are relatively mild.

BCP now available in Oregon over the counter
Thanks to recent state legislation, women in Oregon now have greater access to birth control pills over the counter. California will soon implement the same legislation.

That’s one way of reducing the future number of white male libertarian terrorists demanding unfettered use of public space and offerings of snacks.

Microsoft’s tracking users’ minutes in Windows 10
No longer content with tracking the number of devices using Windows operating system, Microsoft now measures how long each user spends in Windows 10. Why such granular measures? The company won’t say.

Worth remembering two things: 1) Users don’t *own* operating system software — they’re licensees; 2) Software and system holes open to licensors may be holes open to others.

New cross-platform ransomware relies on JavaScript*
Won’t matter whether users run Windows, Linux, Apple’s Mac OS: if a device runs JavaScript, it’s at risk for a new ransomware infection. Do read the article; this malware is particularly insidious because it hides in legitimate code, making it difficult to detect for elimination. And do make sure you keep backup copies of critical files off your devices in case you’re hit by this ransomware.

Buckle up tight in your bobsled. It’s all downhill after lunch, kids.

[* this word edited to JavaScript from Java./Rayne]


A Big Day at SCOTUS on Obamacare and Fair Housing

JusticeA little more than two hours ago, a fairly monumental day at the Supreme Court got underway. Two big boxes of opinion were brought out signaling at least two, and perhaps as many as four, new decisions were going to be announced. It was only two, but they are huge and critically important decisions King v. Burwell, better known as the “Obamacare case”, and Texas Dept of Housing v. Inclusive Communities Project, better known as the Fair Housing case.

Both King and Texas Housing are big, and both have been the cause of serious apoplexy and fear among liberals and progressives. And both were decided very much in the favor of the liberal position, so it was a very good day on both issues.

First off is King v. Burwell, and the full opinion is here. It is a 6-3 opinion written by Chief Justice Roberts. Many people seem shocked that the majority was 6-3. I am not. While I thought the challenger King plaintiffs had a cognizable legal argument, it always struck me as a losing one, and one the Chief Justice was unlikely to sign off on after his sleight of hand to keep the ACA alive in the earlier NFIB case.

Similarly, though Anthony Kennedy was a bigger concern because of his states rights history, he has a long history on protecting citizens on social justice issues (which is why we are about to get marriage equality, maybe as soon as tomorrow). And, once Obamacare was upheld in NFIB, and all the millions of additional Americans had been given health insurance access (which, let us keep in mind, is still different than actual healthcare), it really became a social justice issue, and thus one Kennedy would be very troubled to strip away.

As to the general overview, Rick Hasen at Election Law Blog has a great summary:

Before the case, so much ink was spilled (and more virtual ink virtually spilled) on the question of deference to the IRS’s interpretation of ambiguity under the statute (under the so-called “Chevron” doctrine) as well as principles of federalism, which were used to argue for results for and against the Administration in the case. There were also questions about the standing of various plaintiffs. There were arguments about the intent of the drafters, and what MIT economist Gruber said, or may have said, or may have misspoken about the way the law was supposed to work. In the end, the Court rejected application of Chevron deference to the IRS and federalism made no appearance. Nor did standing or Gubert get discussed. Instead the Court’s analysis went basically like this:

The question whether tax subsidies applied to poor people in states that did not set up their own health care exchange is important, so important that it is hard to believe that Congress would have delegated that question to an agency (and particularly to the IRS, whose job it is to collect revenue not design health care policy). So there is no “Chevron” deference on the question. The court has to use its tools of statutory interpretation to decide the case. The law, read as a whole, is ambiguous. It is certainly possible to read the challenged language as giving subsidies only to people in state exchanges and not in the federal exchange. But there are other parts of the law, read in context, that only make sense if subsidies apply to those in state or federal exchanges. In such an ambiguous case, it is the purpose of the law that should govern. “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”

Go read all of Rick’s post, it is also notable for its explanation as to why King is likely the last word on the ACA as a viable entity and Obamacare is here to stay. I concur.

I would like to point out one aspect of the King decision I find particularly rewarding – the lack of attention to all the extrinsic noise that has been generated over the many months the King case was pending by all the crazed pundits on both sides of the issue at heart. Absent was all the relentless sturm and drang about standing, loss of standing, federalism, what Hans, err Jon, Gruber said or didn’t say, post hoc interviews with Congress members, their staff and lobbyists and what it meant, and all other sundry sorts of faux legislative history by people that apparently would not recognize real “legislative history” if it hit them in the butt. That is very satisfying thing for somebody that thinks appellate decisions should, at their core, be based on the statutes, precedence and the record on appeal.

For this I am thankful for the clarity and cleanliness of Roberts opinion. As a side note, the majority’s scuppering of the Chevron basis has created a side issue among us in the legal chattering class as to whether it signals a weakening of the “Chevron Doctrine”. Rick seems to think there is a fundamental weakening here. I am not so sure of that at all, even though I have had sincere problems with Chevron pretty much as long as I have been practicing law, as it gives far too much deference to often out of control administrative agencies, and the appellate burden is very onerous to overcome bad administrative rulings.

We shall see how the components of today’s decision in King play out in the future, but it was a very good day for the law, and the ACA, today.

The second, and also huge, case handed down today is the Texas Fair Housing decision, and the full opinion is here. Although it will be overshadowed today by the more famous (infamous?) King Obamacare decision, the Texas case is absolutely critical to the ability to fight and control discrimination.

As the excellent Lawrence Hurley reports for Reuters:

On a 5-4 vote in a major civil rights case, the court decided that the law allows for discrimination claims based on seemingly neutral practices that may have a discriminatory effect. Justice Anthony Kennedy, a conservative who often casts the deciding vote in close cases, joined the court’s four liberals in the majority.

The ruling also was a triumph for President Barack Obama and his administration, which had backed Inclusive Communities Project Inc, a nonprofit group in Texas that claimed the state violated the law by disproportionately awarding low-income housing tax credits to developers who own properties in poor, minority-dominated neighborhoods.
…..
Although a broad win for civil rights advocates on the legal theory, Kennedy, writing for the court, indicated in the ruling that the Texas plaintiffs could ultimately lose when the case returns to lower courts.

The court was considering whether the 1968 law allows for so-called disparate impact claims in which plaintiffs only need to show the discriminatory effect of a particular practice and not evidence of discriminatory intent. There was no dispute over the law’s prohibition on openly discriminatory acts in the sale and rental of housing.

Kennedy wrote that Congress indicated in 1988 when it amended the law that it intended disparate impact claims to be available.

“It permits plaintiffs to counteract unconscious prejudices and disguised animus that escape easy classification,” Kennedy added.

Kennedy also made clear there are limits to the types of claims that can be brought, saying that “statistical disparity” alone is not enough. Plaintiffs must “point to a defendant’s policy or policies causing that disparity,” Kennedy added.

As Adam Serwer said on Twitter (here and here), “banks and insurance companies have been trying to tee up this case for years because they thought the Roberts court would rule in their favor” and “without this law, it’s unlikely any of the banks would have paid any price for trapping minorities in bad loans regardless of credit”. That is right. But it goes further than that, the “disparate impact” claim is one of the most important tools available to fight discrimination that may not be apparent on the face of a cagily crafted provision or business model policy, but which nevertheless is effected by it. Discriminatory animus has gotten very sophisticated, and this tool under the Fair Housing Act of 1968 is necessary to have to fight it.

Texas Fair Housing was a 5-4 decision authored, somewhat surprisingly, by Anthony Kennedy where he joined the four justices of the “liberal bloc”. It is yet another indication of where Tony Kennedy is on “social justice” issues, again a trend that augurs well for marriage equality. We shall know soon enough!


As Disneyland Measles Outbreak Rages in California, Pakistani Father Arrested After Unvaccinated Son Contracts Polio

There is very interesting news out of Pakistan today that the father of a child who has developed polio has been arrested because he refused to allow his son to be vaccinated:

After a polio case was detected here on Thur­sday, the Kohat administration arrested the father of the affected child because he had refused to get his child vaccinated against polio when vaccinators visited his home. Two health supervisors and a patwari have also been taken into custody for showing negligence in performing their duty.

Three-year-old Moham­mad is the second victim of polio in Dhodha area of Kohat district this year.

Deputy Commissioner of Kohat Riaz Khan Mehsud told Dawn on telephone that he issued orders for arrest after an inquiry revealed that the father of the affected child, Mullah Mohammad Yousuf, had not allowed vaccinators to give polio drops to his son.

But Yousuf is not the only parent who has been arrested:

He said 56 people had so far been arrested this year for refusing to get their children vaccinated against polio.

Also on Thursday, two men were arrested in Kohat for not allowing vaccinators to give polio drops to their children. They were identified as Amir Khan and Hassan Khan.

Islamic extremist groups in Pakistan agitate against polio vaccines, spreading conspiracy theories that the vaccines are Western attempts to kill or dominate Muslims. They even attack health workers and in 2014, those attacks killed more people administering vaccines than the disease itself killed.

But of course, in a civilized country like the United States, there couldn’t be misguided attempts to prevent vaccination despite the solid scientific basis of the public health benefits of vaccines, could there? Sadly, the mass delusion that has led far too many parents to leave their children unvaccinated due to unfounded fears of autism is having the very predictable result of outbreaks of viral diseases previously under control. Here’s the latest on the current outbreak of measles that epidemiologists have traced to Disneyland. Unfortunately, we are learning that because of the reckless behavior of not vaccinating children, even those who have been vaccinated are now developing the disease because of the increased exposure from the outbreak:

As the measles outbreak that started at Disneyland grew to at least 70 cases Wednesday, much of the attention has focused on how the vast majority of patients were not vaccinated for the highly contagious disease.

But some medical experts also have expressed concern about the five patients who contracted measles despite being fully vaccinated.

Their cases point to a lesser-known aspect of the measles vaccine: That even those who get the shots have a small risk of getting sick, especially older people who were immunized in the 1960s, ’70s and ’80s.

In 1989, the vaccination program for measles was changed from one dose to two, and that had an effect on how frequently vaccinated patients got the disease:

There’s a 5% chance of vaccine failure in people who have had only one dose of measles vaccine, and a less than 1% chance in people with both doses, experts said.

But the expanding pool of unvaccinated people means much more exposure for those who have been vaccinated. Here are the numbers from the current outbreak:

The measles cases spread at Disneyland a week before Christmas. Experts have said the theme park was a perfect incubator because it attracts visitors from all over the world, such as places in Europe and Asia where measles is still a large problem.

Since then, the disease has continued to spread, mostly through people who were not vaccinated. Health officials have immunization records of 43 measles patients; 37 were unimmunized, one had only one shot, and five were fully immunized.

In the US, those who choose to leave their children unvaccinated are acting out of a misinformed belief that vaccines lead to autism. Sadly, science has clearly debunked that idea, so the parents making that choice are just as illogical as the ones in Pakistan giving in to Islamic extremists.

A good layperson discussion of the science of autism and vaccines can be found here. Perhaps the most authoritative study on vaccines and autism was this one by the Institute of Medicine, published in 2004, which stated clearly:

This eighth and final report of the Immunization Safety Review Committee examines the hypothesis that vaccines, specifically the measles-mumps-rubella (MMR) vaccine and thimerosal-containing vaccines, are causally associated with autism. The committee reviewed the extant published and unpublished epidemiological studies regarding causality and studies of potential biologic mechanisms by which these immunizations might cause autism. The committee concludes that the body of epidemiological evidence favors rejection of a causal relationship between the MMR vaccine and autism. The committee also concludes that the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism. The committee further finds that potential biological mechanisms for vaccine-induced autism that have been generated to date are theoretical only.

A strong reason that the data don’t support a causal relationship between vaccines and autism is that there is instead a strong genetic component related to developing autism:

Scientists have discovered that one of the most common genetic alterations in autism — deletion of a 27-gene cluster on chromosome 16 — causes autism-like features. By generating mouse models of autism using a technique known as chromosome engineering, researchers provide the first functional evidence that inheriting fewer copies of these genes leads to features resembling those used to diagnose children with autism.

In that study, scientists found that by reproducing the chromosomal change that is found most commonly in autism patients (autism spectrum should be considered a group of related diseases which can have differing causes) in mice, behavior very similar to autism was seen:

“Mice with the deletion acted completely different from normal mice,” explains Guy Horev, a Postdoctoral Fellow in the Mills laboratory and first author of the study. These mice had a number of behaviors characteristic of autism: hyperactivity, difficulty adapting to a new environment, sleeping deficits, and restricted, repetitive behaviors.

As if that’s not enough, consider this study from Japan, where it was found that in an area where the MMR vaccine was discontinued, autism rates did not go down:

The MMR vaccination rate in the city of Yokohama declined significantly in the birth cohorts of years 1988 through 1992, and not a single vaccination was administered in 1993 or thereafter. In contrast, cumulative incidence of ASD up to age seven increased significantly in the birth cohorts of years 1988 through 1996 and most notably rose dramatically beginning with the birth cohort of 1993.

The significance of this finding is that MMR vaccination is most unlikely to be a main cause of ASD, that it cannot explain the rise over time in the incidence of ASD, and that withdrawal of MMR in countries where it is still being used cannot be expected to lead to a reduction in the incidence of ASD.

So, as global autism (ASD = autism spectrum disease) rates were increasing in the late 1980’s through mid 1990’s, that increase was not affected in Yokohama by the termination of the measles vaccine.

Finally, a more detailed study published in August 2013 (pdf) found that there was no correlation between autism and the number of vaccines administered or the total number of antigens in vaccines that a child received.

Perhaps the Pakistani practice of arresting parents who refuse to vaccinate their children is something to be considered here in the US. The decision to leave a child unvaccinated creates an unacceptable risk for that child. And as we are seeing in the current outbreak, the growing pool of unvaccinated people means that individual cases of the disease are capable of growing into an outbreak large enough to infect even properly vaccinated patients. The LA Times article linked above notes that about one fourth of the infected California patients required hospitalization, so their disease was relatively severe. Irresponsible parents who choose not to vaccinate endanger their children and all of those with whom they interact. If reason won’t work with them, it’s time to determine what will bring them to their senses.


Why the 2016 Senate Election Is Sure to Be About ObamaCare, Again

Mitch McConnell already announced how the GOP plans to retain the Senate in 2016: ObamaCare.

Again.

In his press conference today, he said that one tweak they’ll make to ObamaCare will be to eliminate the individual mandate, which is one of the least popular parts of the law. That will pass immediately, probably before the first January snowfall. It’ll probably, on that first go-around, even get a few Democratic votes.

Obama will then veto the bill.

Then the GOP will take it up — probably in the Senate — for an override vote.

Democrats will be faced with the choice of voting to uphold Obama’s veto. Or making the politically far more popular vote, helping the GOP to override Obama’s veto.

One way or another it’s a huge win for the GOP. If they override the veto, the Executive will have to jump through major hoops to make insurance attractive and affordable enough (ha) to keep enrollment high enough it works for insurers. If they don’t override the veto — meaning fewer than 12 Democrats vote to override it — then retention of the very unpopular mandate will be the issue the GOP runs on in every Senate race next cycle.

There are currently expected to be 10 Democratic seats up for reelection in 2016, so technically the Dems could free those 10 to vote with the GOP to help them avoid a very unpopular vote. But that doesn’t include several of the Democrats who are most likely to vote with the GOP on the mandate in any case (people like Jon Tester, for example).

In any case, it’s an obvious play for Mitch to do, and one with huge upsides for the GOP whichever way it turns out.

Mind you, by 2016, the benefits of ObamaCare will also finally be more evident (and if the GOP overturns Medicaid in states where it has vastly expanded coverage, especially KY and AR, that’ll be a huge issue for Republicans to defend against). But the GOP clearly intends to continue to make it an electoral problem for the Democrats.

Copyright © 2018 emptywheel. All rights reserved.
Originally Posted @ https://www.emptywheel.net/health-policy/page/3/