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Since March 4th, workers have fished 3,300 5,916 6,601 13,000 (03/18/13) dead, bloated pigs out of a river in Shanghai. Last week there was little information about where they were coming from, how they got there, or what they died from, only general agreement, as Bloomberg put it, that "nothing good comes from a dead-pig tide".

The Huangpu River feeds the drinking water supply for some of the city and although officials have so far assured citizens that the water is safe, and that they're taking water samples regularly, doubts persist.

If Pigs Could Fly

How the pigs got there is still a bit of a mystery. The carcasses are ear-tagged but officials can't decipher the tags, so they don't know the exact situation. Most likely, farmers dumped diseased pigs (some are infected with porcine circovirus) into the river at some upstream province. Despite the gruesome pig panorama, citizens are told not to fear the safety of pigs originating from the suspect provinces.

Piglets
via Wikicommons.

China produces half the world's pigs, five times what the U.S. produces. Pork is so central to the economy that pig price fluctuations effect the cost of living. This means that the large scale pig deaths over the past several months, albeit only tens of thousands in a pig population of millions, concern not only water drinkers and pork consumers but economists too.

When other food products befall catastrophe, the story may be different. When frosts freeze orange groves in Florida, for instance, producers warn consumers in the Northeast U.S. that orange juice prices might go up, that's it. Pig parts, however, are found in hundreds of products besides rinds and bellies and chops and loins. For instance, eighty percent of the U.S. heparin supply comes from pigs raised on farms in China, according to the director of Pharmacy at Boston Children's Hospital.

A few years ago, an epidemic of blue ear pig disease (porcine reproductive and respiratory syndrome virus (PRRSV)) ended up killing so many pigs that producers met the demand for heparin by adulterating the drug with a chemically similar substance. As the crisis unfolded, analysis detected oversulfated chondroitin sulfate that caused hundreds of severe allergic reactions and 175 deaths worldwide.

In the aftermath, journalists investigated the supply chain and found that the FDA had alarmingly little oversight into the production practices on pig farms in China. Since then, the FDA has increased its oversight. However, even last year, the Wall Street Journal reported that the FDA found contaminated heparin from fourteen more Chinese suppliers. The FDA put them on a watchlist with eight others.

They'd Fly Away?

In light of these investigations, consider that pigs provide material for many human life-saving technologies. A recent study describes the possibility of using porcine small intestine patches for pediatric patient cardiovascular reconstruction. Scientists are experimenting with porcine (and bovine) matrices for things like abdominal wall reconstruction.

Although some medicines, like insulin, are no longer made from pigs, the widespread use of pig parts in medicine often goes unacknowledged. Some religions forbid the use of pigs even for medical treatment, and some people get squeamish about pig body parts, according to designer Christien Meinderstsma in this Ted Talk. One Dutch heart valve company wouldn't send her their valve because they didn't want people associating their life-saving technology with pigs.

In her talk on the book, "Pig 05049", Meinderstsma highlights 185 products made with a pig she followed. A Greek cigarette uses pig parts to make a more "healthy", lung-like filter. Some frozen beef steak is made with beef bits glued together with pig fibrinogen or "meat glue". Some collagen injections for facial rejuvenation come from pigs. Pigs are also used to make soap, train brakes, fine bone china, and bullets (not silver, according to the picture...), and more than one hundred other things. They're amazingly ubiquitous, pigs, and floating in China's rivers too.

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Some related posts include Avian Flu In China (2005); Streptococcus suis in China (2005); a note on the heparin adulteration (2008) the H1N1 pandemic - (2009), and here.

U.S. Treasury Secretary Timothy Geithner mentioned on several Sunday morning shows last week, that one program targeted for spending cuts was direct payments to farmers, which would total about $46 billion over ten years and could contribute to the large cuts needed to negotiate away from the "fiscal cliff".

Alfalfa, Alicante, Spain (Wikimedia Commons)

The government initiated direct payments to farmers in the wake of the Great Depression, as a way of encouraging farmers not to abandon rural areas for the cities when the price of crops decreased because of surpluses. The practice quickly caught on, as Joseph Heller described in his 1955 book Catch-22:

"Major Major's father . . . was a . . . God-fearing, freedom-loving, law-abiding rugged individualist who held that federal aid to anyone but farmers was creeping socialism. . . .

His specialty was alfalfa, and he made a good thing out of not growing any. The government paid him well for every bushel of alfalfa he did not grow. The more alfalfa he did not grow, the more money the government gave him, and he spent every penny he didn't earn on new land to increase the amount of alfalfa he did not produce. Major Major's father worked without rest at not growing alfalfa. On long winter evenings he remained indoors and did not mend harness, and he sprang out of bed at the crack of noon every day just to make certain that the chores would not be done. He invested in land wisely and soon was not growing more alfalfa than any man in the county."

--Joseph Heller, Catch-22 (New York: Scribner Paperback Fiction, 1996), p. 93 (first published in 1955)

[From the back cover of Journal of Political Economy, Vol. 116, No. 3 (June 2008) Published by: The University of Chicago Press]

A malaria vaccine over two decades in the making given to infants in Africa was shown by preliminary data to be 30% effective. Good news or bad news?

It depends on who you talk to. Most scientists and public health workers described the partial phase III clinical trial result of RTS,S/AS01 as disappointing, frustrating, or underwhelming, while trial sponsors, a few scientists, the government of Ghana, and KTN streaming LIVE from Kenya 24/7, remained upbeat, stressing that given the millions of malaria infections, a 30% reduction in would give the vaccine a significant place in malaria prevention.

In 2010 there were an estimated 216 million cases of malaria and 655,000 deaths, 91% of which were in Africa. In the past decade years, the concerted effort to combat malaria has decreased deaths and infections significantly, by 25%. But without a doubt, an effective malaria vaccine would be, if not the end of a horrible scourge, at least be an excellent addition to the arsenal of indoor spraying, bednets, and available treatment options. The question is, given the costs of developing and deploying a vaccine and the current economic climate, what's considered effective?

Rough Waters
via Creative Commons License.

This month's 31% results are disappointing compared to last year's results from older kids, 5-17 months, that showed the vaccine to be 55% effective. As well, the newest results from the Phase III trial, show about half the efficacy of those from the previous Phase II trial for the same-aged infants, which seemed to show the vaccine as 62% protective.

Not 55% but 30% Effective

The RTS,S vaccine targets the Plasmodium falciparum and is made with proteins from both the parasite and Hepatitis B virus that serves to enhance the immune response. So why is the vaccine now apparently only 31% effective at preventing infection and 37% effective at preventing severe disease, almost half what it was? Scientists have several hypotheses. It might be the high levels of malaria around the test centers included in this data release, or that increased immunity from mothers in the younger infants blunts the response of the infants' immune systems against the vaccine, or perhaps since the vaccine for the infants was administered with other vaccines the infant immune systems responded less vigorously to the malaria shot. What there's no question about is how tricky it is to make a vaccine that successfully combats infection from an evolving and evasive parasite that moves through different stages of its lifecycle in different parts of the human (host) body.

With the efficacy data so low, scientists were left emphasizing how safe the vaccine is (important, of course, but not exactly the point at this stage). They stress how successful of the logistically complicated and ambitious trial (across 11 centers in 7 countries). Indeed the trial logistics are impressive, important, and a huge inroad to drug testing and public health, but the accomplishment doesn't address the high expectations and promises made during last year's data release.

Glass Now Less Than Half-Full

While the results were discouraging, some scientists weren't surprised. When researchers announced last year's interim results some scientists predicted based on the data that the younger 6-12 week cohort would be less protected by this vaccine. This was one of several caveats scientists pointed out. They also warned against early incomplete data releases, stressed that the older children weren't the target group, and questioned various aspects of the 55% number. We covered some of these questions in a post -- the same caveats and questions apply to this year's data release.

Vaccine development, especially against malaria, is incredibly difficult. Although there are about 30 vaccines in development now, according to the World Health Organization's Rainbow Tables, the closest candidates are 5-10 years behind this one. This fact of course influences the biggest unanswered question: How effective does a vaccine need to be in order to be put into production? There are limits to both attention and money available for urgent public health initiatives, so realistically, funding one initiative can potentially handicap others - but then the argument always swings back -- there is no malaria vaccine right now.

Vaccine Goals - Made To Be Eschewed?

To help guide answers to this question, the World Health Organization, in concert with invested organizations including the public and private sponsors of this vaccine, established in a roadmap(pdf) a "Strategic Goal" to "by 2025, develop and license a malaria vaccine that has a protective efficacy of more than 80% against clinical disease and lasts longer than four years." RTS,S/ASO1 is no where near this. But the WHO also established a "Landmark" Goal, to "by 2015, develop and license a first-generation malaria vaccine that has a protective efficacy of more than 50% against severe disease and death and lasts longer than one year." WHO is currently in the process of updating the roadmap, but warns that the Landmark goal is not being changed.

All scientists acknowledge that only more data analysis from this trial will provide clearer answers. The WHO provides information on vaccine development and its role in assessing the vaccine in 2014-2015. Some scientists predict that the trend of decreasing efficacy after 6 months shown in the data looks ominous: "The results look bad now, but they will probably be worse later", said vaccine expert, researcher for competing vaccines, and deliverer of not-very-upbeat messages Adrian Hill of Oxford University. (But if subsequent data looked somewhat better - the situation of this year's results compared to last year's - the reaction would probably be euphoric.)

Last year when we discussed the vaccine we commented on possible later outcomes that could stem from the incredible hype around interim results releases -

"...which leads us to wonder whether mid-trial fanfare primes us react to whatever future malaria vaccine news comes along with knee-jerk positive determinism? What if the younger data shows only (say, hypothetically) 30% efficacy? Would we ever abandon the effort...?"

Commenting on the latest results, Andrew Witty, GSK CEO told reporters in a conference call "We've been at this for 30 years, and we're certainly not going to give up now".

In other malaria vaccine news Sanaria, another malaria vaccine maker whose founders have been knee-deep in malaria vaccines for decades, recently hosted 7th graders in an event hosted by Montgomery County universities. The idea was to introduce kids to science and medicine so they don't think of people who work in biosciences as "crazy scientists", said Stephen L. Hoffman, founder and CEO of the company. Hoffman's latest malaria vaccine effort was profiled by Science in "New Hope for Crazy Vaccine", briefed by us last year. Sanaria received $3 million funding for Phase II trials last summer.

In still more malaria news, a program called the Affordable Medicines Facility - Malaria(AMFm) has been radically downsized, killed, and folded into obscurity within the Global Fund. The reasons remain a little mysterious. By all accounts, the program was successful, even "overwhelmingly successful", in lowering the pharmacy prices of drugs called Artemesin Combination Therapies (ACTs). If you contract malaria in Africa you often need to buy your own drugs. Patients will naturally buy the cheapest drugs, which happen to be those that are least effective or most susceptible to antibiotic resistance. The program made the ACTs competitively priced with monotherapies, therefore competitive in the marketplace and helpful to preventing artemisinin resistance and conquering malaria. The strategy was innovative and effective.

However, some critics claimed that this method wasn't getting the drugs to children, and that some people were buying up the drugs without a diagnosis. Defendants said these criticisms moved the goal posts, phase II could have solved some problems. But more scientists aren't at all sure why the program got cut, some suggesting that for some reason Oxfam and the President's Malaria Initiative lobbied hard against it. One contingent that is probably pleased with the outcome has been lobbying vigorously against AMF-m since its inception. The group's members are variously affiliated with pharmaceutical companies, 'free enterprise think-tanks', and target lobby efforts like "Africa Fighting Malaria", they selflessly devote their lives to promoting DDT spraying, and lobbying against generic drugs. One or more have written accounts claiming that the competitive pricing schemes employed by AMF-m used cheaper drug suppliers with inferior services -- a spurious, tedious and surprisingly effective go-to argument for decades by pharmaceutical companies lobbying against generics for the most deadly diseases AIDS, Malaria, etc.

The first time we commented on Mitt Romney was in April, 2005, when as governor of Massachusetts, he was changing his position on stem cells. The Massachusetts Senate and House of Representatives had passed a bill allowing human cells to be cultured for stem cell research. Romney hadn't succeeded in stopping the bill through lobbying, and the legislatures' overwhelming favor of the measure prevented him from vetoing it. Romney explained:

"I think you're going to see at the national level an interest in legislation which limits the creation of new embryos though cloning...So I think you're going to see a national effort to define the boundaries of ethics, and I hope that proceeds."

Seven and a half years ago Romney gave a clear indication about where he was aiming.

Drawing of Man Using Compass via Wikimedia Commons

He was crafting his positions for a run as president in 2008, as we wrote, and figuring out that stem cell research was a controversial "ethical" issue -- his statement signaled that he was in step with what he called a "national effort to define the boundaries". He woodenly hewed to the GOP message, the one that qualified him as A Contender. Only later, in 2006, did he start to make a more fluent story around his change of position, taking strident stands against abortion and embryonic stem cell research.

Romney's message massaging seems in retrospect indicative not only of his political ambitions, but of the man he is and maybe always was, a man whose convictions are politically defined not personally held. Although he once hailed the potential of embryonic stem cell research, he then showed the nation how easily he could adapt.

Did Romney's Position on the Stem Cell Issue Indicate His Positioning on All Other Issues?

Back when Bain needed capital in the early days and the only people willing to give him money ran shady Salvadoran shell companies, well, that's where he started. Decades later, when the people who had likely campaign donations questioned how he planned to win, he asserted that the only people who don't like him were the ones taking government hand-outs. The shifting hue and cry of Romney campaign has been constant, on stem cells, on immigration, on foreign policy, on climate, etc.

Although as Massachusetts governor he defied Norquistian demands for far-right economic positions, he now clambers out that pole, sleeves up to his elbows, ready to get to work dismantling whatever public institutions have profit making potential or regulatory aims on business. So of course he marched behind the religious right and their "sanctity of life" claims in 2005, because he's an adaptable guy. Which is exactly what concerns us most, that in his forever changing positions he seems totally unattached and untethered from any position or "truth" whatsoever.

What Sort of President Would Romney Be? (C'mon, Ot'll Be Fun)

Since he's so often equivocal, we're forced to make assumptions about the president he'd be. To do so, we'll look at the people he's campaigning to and for. For example, we've observed that people who scream about the "sanctity of life", often want to get rid of the life-saving government agencies like FEMA or the EPA. Strange. It's also worth noting that they're also keen to halt certain science and technology, the very science and technologies that we know are key to curing disease and enabling a decent quality of life for humans. In fact if you've ever read up on the positions of people like those who George W. Bush appointed to his President's Council on Bioethics, you'll know that their ideal world would abolish science altogether. Here's the view of Peter Lawler:

"In the Brave New World the tyrants will be the experts...We have a hard time seeing experts as tyrants, because they don't claim to rule through personal authority but on the basis of the impersonal results of scientific studies...most Americans have no idea of the extent to which they have already surrendered their sovereignty to such experts" (Lawler, Peter Augustine: Does Human Nature Have a Future? The end of history, Bobos, and Biotechnology)

Lawler's fear-mongering positions might seem far-fetched, but consider the larger agenda. A rational person would argue for, I'll say, the need for clean water and air, for technology investment, for women's rights to healthcare, for scientists, for expertise, and yes, for experts. But this bioethicist insists that the very scientists who are experts, who would show the health merits or clean air and water, are actually evil, co-opting You, and not to be trusted. (Forget that he says this as the author of a book claiming expertise in bioethics).

He labels biotechnology morally suspect along with numerous other things, sex except for procreation for example. In the same book, he notes on evolution:

"The interesting question today is whether Darwin will follow the other two great secularist system builders of the nineteenth century, Marx and Freud, onto the ash heap of history."

This religious play pulls in the most susceptible, those who believe that God reached down and molded everything from planet Earth to penises a couple thousand years ago. It bamboozles people into believing that empirical thinking can be supplanted with simplistic answers provided by politicians. Some of these people then line-up to dismantle the very systems that support a civil democracy, erecting flags and chanting U-S-A. Who can argue against U-S-A? No one.

For years, this has all seemed to me some bizarre far-off world of an unpleasant and distant past, best to be ignored. But it's not far-fetched as it seems if you listen to the current political debates fronted with "ethical" positions.

Or Not

For instance, the Indiana Senate contender said a few weeks ago that abortion should be banned ("sanctity of life") because God created the children of rape. Mourdock's comment was no less than sociopathic - violent not only to women but men, insulting to intelligent humans, sacrilegious and vile. Where was presidential candidate Mitt Romney? Silent and continuing to run TV ads supporting his Indiana GOP candidate...

Silent. A silence that assures supporters he'll toe whatever line is politically prudent. The calculated silence of a church going man who poses square-jawed and leader-like, yes, but whose compass now seems alarmingly stuck at a magnetic pole, needle wavering this way and that. So how would he be as president? Optimistically, people argue that Romney is a moderate, now just all revved up in campaign mode. I might agree. However when my thinking trends alarmist, I fear for the liberties we think are important, the right to clean air and water, progress in science that helps people live better lives, rights for women to control their bodies and work for fair salaries, rights for disabled people, immigrants, the poor, and on and on, all the things that democracy promises and a plutocracy wants to threaten...

That's all. Vote.

Romney Would Send FEMA Back To The States & Private Sector. Wait, Isn't That How FEMA Works Now?

Presidential candidate Mitt Romney famously said in 2011 that he'd take anything he could from the Federal Government and "send it back to the states, that's the right direction. And if you can go even further, and send it back to the private sector, that's even better." When the moderator asked if that included disaster management he said "we cannot afford to do those things without jeopardizing the future for our kids. It is simply immoral."

Context

People advised everyone to take Romney's comments in context, just as they advised when he told potential donors that he couldn't bothered with 47% of US citizens. So for context, a tornado had just ripped through Joplin, Missouri and Republicans in Congress were delaying federal funds, saying that FEMA didn't have the money. Perhaps, the analysts suggested, Romney was supporting his party's budget conscious ways but deep down inside he supported FEMA?

Congress finally came up with some FEMA money for Joplin, drawing up an aid package and offsetting the expenditures by cutting a $1.5 billion program to promote fuel-efficient vehicles. Now, asked frequently by reporters after Hurricane Sandy what his stance is, Romney doesn't answer, and his campaign confusingly assures people he wouldn't change FEMA.

Yet the numbers (such as they are, since Romney's campaign is elusive about it all) seem to belie his campaign's assurances. Obama would cut the FEMA budget by 3%, $453 million less in 2013 than 2012. Romney's FEMA, on the other hand, could be cut by as much as 40%. What would that mean for citizens?

Hurricane Isaac Photo by NASA

"Send it Back" -- FEMA, The States & Private Sector

Curiously, Romney says of FEMA he'll "send back to the states", and "send it back to the private sector"? Is FEMA a lost pet that long ago wandered away, a flea-bitten, scavenging nuisance? Send it back home to the states - shoo, shoo, go back. Was disaster recovery ever a state enterprise? Even a century ago, the federal government assisted - in a way - during the 1906 San Francisco earthquake that destroyed the city and killed thousands. Documents show that the mayor authorized "Federal Troops" to "KILL any and all persons engaged in Looting...."

More importantly, although Romney implies that FEMA doesn't currently involve states or the private sector, in fact, FEMA works directly with states and the private sector. Before disaster strikes, FEMA coordinates with states to identify businesses and organizations and to contract with those who work during disasters. During and after the disaster, FEMA remains according to the state's needs. In the Obama administration's FEMA, the states lead, and the private sector does the work - so what, exactly, does Romney want to change?

When a disaster can be predicted, like Hurricane Sandy, states request federal disaster aid ahead of time. These early requests avoid debacles like FEMA's Hurricane Andrew response in Florida in 1992. Under George H.W. Bush, Florida was so stranded that the Miami Herald's headline screamed: "WE NEED HELP!", and one official took to the airways demanding: "Where in the hell is the cavalry on this one...They keep saying we're going to get supplies. For God's sake, where are they?" So FEMA prepares ahead of time, coordinating with the states, the private sector, faith-groups and community organizations.

During the 2011 tornadoes in the south, FEMA awarded $13,358,680 to local businesses in Alabama, Mississippi, Tennessee, Kentucky, and Georgia. 90% of that money went to small businesses. Some of these states are the poorest in the nation. If the Romney/Ryan execution of "drown [the government] in the bathtub" works, how will these states, these small businesses, these people, survive disasters?

FEMA: Love It or Hate It, As Politics Demand

During Hurricane Sandy, Republican governor Chris Christy of New Jersey praised President Obama and FEMA mightily, saying: "The President has been outstanding in this", and "[Obama] and his administration have been coordinating with us. It's been wonderful." It wasn't the first time. In 2011 he also appreciated FEMA.

Christie's wasn't some weird fluke of Republican FEMA love. Missouri Representative Billy Long, "Ozark Billy", was voted the "Most Conservative Officeholder" in Missouri by the American Conservative Union. He loudly campaigns that he's "fed up with Obama" and the "liberal agenda". He asks people to help him defeat Obama, kill regulations regulations, 'big government', and the EPA. But when FEMA money came his way after the 2011 tornadoes, he said something different. Then, he raved about FEMA: "On a scale of one to 10, they are a 12...I think they are doing an excellent job."

Janus-faced congressional leaders cut taxes for the wealthy, shrink federal government, deregulate, and cut benefits and salary of firefighters and police. They lavish praise on Obama's FEMA when politically expedient, then run on flimsy one-issue platforms of defeating him. Do they just all go home and laugh big hearty laughs: "LOL...Pick..Mee...LOL...power$$$...LOL"?

Obama promised change once he got elected. Mitt Romney gives us change before the election. He says he's a job "creator" (which handily resonates with both religious people and Rand acolytes), but would slash FEMA's local jobs. He wants the states responsible for FEMA, but FEMA already works so well with the states that Obama's harshest GOP critics flop all over themselves doling out praise. He wants to send FEMA to the private sector, but FEMA already works closely with the private sector - is the private sector.

FEMA, An Agency At The Mercy of Politics

For further clues about a Romney FEMA, we could glance back to history. Thirty years ago, 1979 President Carter established FEMA to centralize the responsibilities of many federal agencies by rolling under one umbrella related disaster preparedness and response departments and functions. Since then, different administrations have used FEMA differently, and it pretty much follows party lines.

When led well, FEMA saves lives and hard hit communities. It's hardly noticed. When used as a political dumping ground by the GOP, citizens suffer. When it fails, the world notices.¹ When it fails FEMA gets picked up by politicians as the GOP poster child for "inefficient, wasteful government... justifying further cuts. Citizens suffer more.

For years, the US has been consolidating government functions, cutting costs, and eliminating redundancies. That's business and these actions reflect the core of all multi-million dollar consulting advice, long Romney's bread and butter. Would Romney, who campaigns that America wants a "grown-up" business leader, split FEMA up into 50 little pieces, all with their own redundant leadership, politics, heavy equipment, budgets and levels of experience?

Of course not, you might say, hopefully. Then what? The scope of FEMA's work is easy to underestimate. But FEMA was a bumbling disaster with Hurricanes Andrew and Hugo under George H.W. Bush, a "turkey farm" for political appointees who limo-ed and lunched their way around DC, whispering cold war themes of the pre-Reagan days.

President Clinton completely revamped FEMA by appointing James Lee Witt, the first person to lead the agency who actually had disaster management experience. Witt reorganized FEMA into a responsive, functioning organization, coordinating with states. As California Senator Feinstein remarked, the reorganized FEMA was "like night and day" compared to George H.W. Bush's agency.

But George W. Bush changed that. His appointee Michael Brown, known as "Brownie", headed FEMA during Hurricane Katrina and no reporter failed to point out his gaffes, miscalculations, and ineptitudes, noting his previous short-lived stint as commissioner of an Arabian horse association.²

Can Ozarkian Churches and Good Neighbors Replace FEMA?

FEMA has lots to recommend it. It can respond in a coordinated way to multi-state disasters. States like New York and California pay more taxes than states like Missouri and Alabama, but at least for now, that doesn't mean Missouri residents get the disaster assistance of Laos, whereas New York citizens get the disaster assistance of Monaco. But one could imagine this being different.

How would local politics affect the distribution of aid in a more decentralized FEMA? New Jersey Governor Christie apparently has been in a long standing feud with the Atlantic City mayor. The night of Hurricane Sandy he announced on TV that Atlantic City residents were on their own, because they hadn't evacuated like he told them to. How would this sort of hyper-local politics play out if states were the sole owners of disaster response?

The idea that faith-groups and neighbors can step in in lieu of governments is commonly promoted. This goes for international aid as well as national disaster relief. Despite media assertions, however, good neighbors cannot replace "big government". Indeed, FEMA has for years worked directly with faith-based and community organizations, coordinating disaster planning and reimbursing them for work they do. ³ Because even with faith, Missouri's Ozarkians cannot muster their own tornado recovery.

Shhh....Don't Say It

Like those old homilies about not talking politics at Thanksgiving, politicians like Obama and Romney don't dare talk about climate change. So amidst a chaotic swirl of tornadoes, hurricanes, deaths, and billions of dollars of damages, elected officials instead play Atlantic City games of trading FEMA aid for a fuel-efficient vehicles program.

And then in the midst of denying climate change, we hear from the Republican candidate that "it's immoral" to spend government money on "things" like hurricane disasters? Send it back to the private sector? Such as? There are some great carpenters in Breezy Point and a Comfort Inn a few towns over...good luck with that Mr. JoneSmith? Or...should FEMA activities be turned over to the military? Send it back to 1906?

Romney's comments and his failure to give detail on this issue deserves far more relentless attention. Our government may be in debt. But then maybe we should discuss more publicly the long term costs and benefits of oil-fueled military adventures that consume about a quarter of our national budget, versus, say, our investments into alternative energy? As we ignore climate change the disasters intensify. The longer we don't demand climate change action from our government, the more important FEMA becomes, the more critical government back-up is to our survival as individuals and communities -- therefore the more expensive FEMA becomes. WHY DON'T WE TALK ABOUT THAT?

Spooky times.

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¹ When the Acquila earthquake struck Italy in 2009, papers congratulated their countrymen for doing such an excellent clean-up job compared to the US during Hurricane Katrina (Italy is hardly the paragon of disaster-preparedness and Acquila still lies in ruins).

Acronym Required wrote about FEMA in posts during and after Hurricane Katrina.

If you look at the USGS earthquake map of the US, it all seems fairly predictable. The West Coast has earthquakes, - mostly in California. The rest of the country - not so much. Until recently. The 5.8 East Coast earthquake last August left people unharmed but "rattled". Last month, Oklahoma of all places, had a slew of earthquakes, including one that was 5.6.

Sparks, Oklahoma - Redefining Red State

That particular area of Oklahoma, around where the pipeline is slated to go through, has had over 1000 earthquakes in the past year, but historically had only 50 earthquakes a year. The biggest of the latest series of Oklahoma earthquakes measured 5.6 on the Richter scale. It was pretty scary, as the San Francisco Chronicle, reported: "'WHAM!', said Joe Reneau, 75, gesturing with swipes of his arms. 'I thought in my mind the house would stand, but then again, maybe not.'"

There's speculation that recent fracking activity is causing the spike in earthquakes. The way the media has it, fracking might precipitate earthquakes -- or it might not. IEEE Spectrum weighs in on the issue noting that yes, human activities like fracking and dam-building definitely cause seismic activity along established faultlines. Indeed, the USGS put out a report earlier this year linking fracking in Oklahoma to an increase in smaller temblors. Other experts say that fracking could only cause small earthquakes. A Stanford geologist characterized it: "as if you knocked a gallon of milk off the table".

The spate of activity had Oklahoma residents worried. If you've ever been through a series of earthquakes you understand the skittishness. Reeling from the earthquake and aftershocks, their unease became ripe breeding ground for rumors. One of the rumors said officials knew of another impending earthquake even larger than the 5.6 earthquake, but weren't telling residents. In response, officials held a meeting to quell both the rumors and the fears a couple of weeks ago.

Apparently 400 to 500 people attended the two hour meeting organized by the American Red Cross, and officials presented from the Oklahoma Geological Survey, state Emergency Management Department, Lincoln County emergency management office, state Insurance Department, Salvation Army and other groups. They moved the meeting to a bigger facility to accommodate the huge turnout. They wanted to dispel the rumors. As Newsok.com reported: "There should be no bigger quake coming, said G. Randy Keller, director of the OGS" Officials assured people they most likely wouldn't feel the aftershocks, and that governments were prepared for whatever happened. All things you would expect them to say.

Nothing's Too Different in Oklahoma

Officials thought the Oklahoma audience was perhaps frustrated by the experts inability to explain the spate of the earthquakes, though they were reassured. And that nervousness in Oklahoma is just the same as nervousness anywhere -- except Japan, I guess where they've had hundreds of aftershocks in the 5-7 range since Fukushima, including a 5.9 earthquake today, and they all just seem ho-hum about it.

In San Diego, California, the Juanita Faultline has recently caused a series of small earthquakes, leading SignsOnSanDiego to interview a local geologist about the likelihood of another earthquake. The article, "Should We Worry About Shaking on San Jacinto Fault?" illustrates the difficulty geologists have predicting the next earthquake. Foreshocks and tiny shocks called microseismicity sometimes precede earthquakes, but often they don't. The geologist spent most of the interview, citing the history of earthquakes along known faultlines to answer questions about the "next earthquake".

In Berkeley, California last month, a series of earthquakes along the Hayward fault led to similar nervousness in the Bay Area about the possibility of a larger temblor. Speculation abounded, and again geologists worked to get the facts out based on what they know about "hazard probabilities" along Califonia faults. Small earthquakes don't relieve stress they said. Mathematically, they noted, there's a very small chance that on any given day after a series of small earthquakes.

This all seems slightly analogous to a doctor predicting your likelihood of getting a particular disease by looking at your family's medical history. They can tell you that you too, are at risk of a heart attack. The insurance company might be more precise. And along some faultlines, geologists know the history and other details enough to say in the next 30 years, the probability of and earthquake larger then 6.5, say, is 65%.

And in L'Aquila?

Now a good part of the US knows what a temblor feels like, and many people have been told by experts to not worry. We can then imagine how the situation erupted after scientists reassured citizens of L'Aquila in March, 2009, that an earthquake was unlikely. In addition to the earthquakes, Italian citizens were subjected to the prognostications of a fellow citizen with no scientific knowledge who busied himself making dire predictions prior to the earthquake (similar to the earthquake soothsayer we recently blogged about, featured on FOX News.)

The next week, a 6.3 earthquake killed 309 people. A group calling themselves "309 martyrs" sued seven scientists. They accused the scientists of not providing enough evidence about both the hazardous buildings and risks of an earthquake. The town is also suing for about $68m in damages.

In Oklahoma and L'Aquila, multiple officials met with hundreds of people and the press. The press later noted cheerfully that scientists "calmed" peoples fears and "reassured" them. Through all that communication, it's clear that there might be a possibility for misinterpretation?

The trial has been delayed multiple times and according to people who know the Italian court system, will most likely drag on for years. The episode chills earthquake scientists, who constantly grapple with how to relay risks in ways that people understand without freaking them out. It's a science in progress.

"God help us if this becomes like baby seals", said a University of Alberta energy economist after research about the extent of pollution downstream from the Athabasca Tar Sands became public a couple of years ago. Protests decrying the Keystone XL pipeline with its associated tar sands may not have reached "baby seals" fervor, but the plan to pump crude oil from Alberta to Texas certainly hasn't raised the popularity of Alberta and its oil extraction industry.

Baby-Sealing the Pipeline, If Not The Tar Sands

The extended pipeline would route through Nebraska's ecologically sensitive Sandhills and the Ogallala Aquifer that supplies millions of people drinking and agriculture water. Nebraskans are especially apoplectic about the prospect of the pipeline with all its hazards running through their lands. They worry about how 91 predicted leaks in the next 50 years will endanger drinking water.

Meanwhile, the company is urging the US to approve laxer standards to allow them to pump more oil at higher pressure through a thinner steel pipeline. TransCanada has promised the safety of the pipeline running over the aquifer and backed that up with bonds.

Of course people have challenged TransCanada's promises, but in corroboration, the US State Department reviews of the project had also been reassuring. That is, until this week, when the agency announced an independent investigation of the pipeline following revelations that the contractor hired by State to do environmental studies and public relations listed TransCanada as a client.

The Environmental Protection Agency (EPA), for its part, issued a scathing review of the pipeline project, criticizing projected greenhouse gas emissions, the history of Keystone pipeline spills, probable wetlands destruction, migratory bird disruption, and the impacts the pipeline could have on poor and indigenous populations.

Obama: Not In My Backyard (At Least Not Until After The Election)

Striking against the greenhouse gas emissions from the tar sands and the pipeline, the continued investment in oil energy technologies, and the related environmental affronts, protestors had noisily decamped to Washington DC over the last few months, letting their opinions be known as they marched around the White House and the EPA.

The total of all this -- the thousand turning up to hold hands in a giant circle round President Obama's home, the uncovering of conflicting interests, and the affected state governments discontents built to a grand crescendo until finally the White House announced it needed more time to study the situation.

The administration effectively put the decision off until after the election. (OK, I know, I Obama built my reputation on community organization, but enough for now...) The White House protestors went home to declare success.

Lobbying So Hard It's "Not Lobbying"

It's not for lack of lobbying that the pipeline was postponed. TransCanada and friends did just about all they could do. They spent millions, wrote editorials in places like the Wall Street Journal and USA Today, and got good support from entities like the American Petroleum Institute, not to mention economists, journalists and citizens on all sides of the political spectrum who impressed talking points like jobs, energy, international cooperation, and opportunity.

The Premier of Alberta, Alison Redford, so new to the job that an internet search results shows her predecessor as Premier, will visit Washington D.C. next week. "Not to lobby", she says, rather she'll explain the economic situation of her oil dependent province and try to improve Alberta's public image. The previous Premier was a big lobbyist for both the tar sands and the pipeline, as depicted in "Ed Stelmach's Clumsy American Romance". British Columbia's The Tyee scoffed at the duplicity of the full page "get out the facts" ad former Premier Stelmach posted in the Washington Post, and winced over the $55,800 of tax payers' dollars he spent on it after the Post rejected his editorial. Between this and visuals of the province as a giant tar sand pit, the new Premier is wasting no time trying to remake Alberta's image in order to sell some oil.

Who Will Love The Pipeline In Their Backyard?

In announcing the postponement, the State Department said it wanted to look at "alternate routes" for the pipeline. While protestors had been promising to stop the pipeline, the Governor of Nebraska was also busy taking his state's cause to Washington. He's not opposed to the pipeline, he said, explaining why he was pushing to get the pipeline rerouted, just didn't want it in that particular part of his state.

This delay that the Obama Administration just served to TransCanada is exactly what corporations do to everyone else when they're trying to keep business the same. One delay at a time, it is actually an end game, and the oil companies play it well. And it turns out they're not happy when someone else is doing the delaying. TransCanada has not been responsive to requests for it to voluntarily change its route. A company spokesperson had warned The Guardian: "You can't just erase a line on a map and draw one somewhere else", and said the move would put the whole project in doubt.

That's doubtful, given how much oil and money is on the table. As Nebraska and grassroots efforts claim a coup, TransCanada will accelerate its lobbying, of course. And where will the pipeline end up? If they keep the current siting, it runs not only through the Ogallala aquifer, the Sandhills and a Nebraska seismic zone, it also crosses through Oklahoma's seismic zone with its recent 5.6 earthquake (and 36 aftershocks in the past week). Would that be good? But what state wants the pipeline in their backyard?

Whatever the new plan, however positive the delay, I'm not sure the protestors can necessarily claim victory quite yet.

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Acronym Required wrote about the Alberta Tar Sands in Gas Pipeline: Open Season Coming to Alaska; Higher Pollution From Alberta Tar Sands, and others.

A US Court blocked the FDA from requiring cigarette warnings on boxes this week, calling the graphics "emotion-provoking images...". U.S. District Judge Richard Leon decided in a Washington court yesterday that tobacco companies shouldn't have to display images of diseased lungs or a cadaver bearing chest staples on an autopsy table, because this would "unconstitutionally compel speech." Nor should companies have to print 1-800-QUIT on cigarette boxes.

I guess what he's saying is that cigarette companies have the right to package fantasies up in the tobacco they manufacture, fantasies of how cool smokers are, that blithely omit the disease and death their product metes out. The FDA, on the other hand, has no right to present the more accurate side of the story.

You know that smoking causes cancer, heart disease, vascular problems. Did you know that smokers have 7 times the risk of abdominal aortic aneurism (AAA) than non-smokers? You probably know about second-hand smoke. Did you know about third hand smoke which stays in home and hotel walls and ceiling tiles for 30 or 40 years, affecting the health of not only present but future occupants?

The judge says the images on cigarette boxes crossed the line between "factual information" and "government advocacy". The line is "frustratingly blurry", he says, but he sees it.

Does International Public Health News Compel Us to Cheer Enthusiastically?

Everyone wants drugs to cure diseases. Everyone wants vaccines to prevent them. And in a world of urgent international public health problems, what is more publicly urgent then developing solutions for AIDS or malaria? Positive news on this front is always welcome, and in line with that, you don't win popularity points by sticking pins in up-beat public health reports, results, or clinical trial data. Popular science journalists generally talk about cool, politically neutral science, or slick technology, or brilliant research successfully advanced to save lives; they write about winning clinical trials that will end scourges, any scourge - cancer, AIDS, Hepatitis, obesity... Good news!

Cheerful news, like recent headlines highlighting research showing a vaccine for malaria that may be 55.1% effective. NPR headlines enthused "Vaccine Slashes Infection Risk By Half", whereas a more cautions USA Today said: "Malaria Vaccine May Have Potential to Save Millions".

The RTS,S/AS01 vaccine is a decades long effort, now a collaboration between The Gates Foundation funded PATH Malaria Vaccine Inititive (MVI) and GlaxoSmithKline (GSK). The partners recently published interim results in the New England Journal of Medicine (NEJM)² and presented their results to the media. By all accounts, the Phase III trials delivered very good news.

The Mosquito Drawing by M. R. Villarreal can be found at Wikipedia ¹

But What Does "May" Mean, in "May Save Millions"?

No one could say that Bill and Melinda Gates haven't changed the face of international public health. Mr. Gates leads a relentless campaign pushing the power of vaccines; he berates governments that don't vaccinate enough people; and he effectively leverages the media to deliver his messages. Last year the Gates Foundation held a fund-raiser hoping to collect $3.7 billion from governments and instead received $4.3 billion. As Global Alliance for Vaccination & Immunization's (GAVI) chief executive put it, "Bill was a little like a poker player who put a lot of chips on the table and scared everyone else off." Perhaps Gates is more a bridge guy, but point taken.

Given this, who would write-up the newest Gates Foundation news as, "a vaccine shown to be at best 44.9% ineffective in a half-done clinical trial"? No one. With the intense drive for upbeat news, I credit USA Today for their cautious "may save millions". But if you look more closely, for instance read the editorial accompanying the NEJM report³, or listen to scientists around the web and in journals like The Lancet ⁴, or pay attention the malaria researchers interviewed by "Nature News⁵, the caveats of this recent malaria study grab your attention:

1. First, there's the announcement itself. The data released is interim data; the full results of the malaria trial will be released in three years. Interim data releases are not unprecedented but past experiences, for instance with an AIDS vaccine, caution us against overly enthusiastic receptions for incomplete trials.
2. The interim results were reported for children aged 5-17 months, but the target age group is infants aged 6-12 weeks. In other words, these results don't address efficacy of the vaccine for the target group.
3. NEJM reported that at 12 months, the vaccine reduced episodes of malaria by 55.1%. However a US military scientist working with Sanaria, a competing vaccine maker, told Nature News that RTS,S actually offered only 35-36% protection 12 months after the vaccine. It appears that the efficacy of the vaccine might wane over time.
4. Although the reports noted reduced mortality, another scientist emphasized to Nature News that the data didn't support that announcement. Scientists hypothesize that the vaccine may just delay infection.
5. Although the vaccine reportedly cut severe disease in older kids by 47%, combining that data with the available data of the younger kids gave only a 34.8% decrease. This suggests the data for the target group of younger kids might turn out lower than reported in these interim results.
6. In addition, incidents like convulsions and meningitis might be more frequent in the vaccinated group.

These might not be showstoppers. For instance researchers hope that booster shots will improve efficacy. But what if in the end the much touted vaccine turns out not to be a vaccine but just another shot? Scientists and public health workers concern themselves with such non-trivial caveats. What's behind the apparently waning efficacy? How is the adjuvant effecting immunity? Science is exacting even when media reports are not. People also have underlying concerns about what's driving policy, science or the press releases?

Is Marginal Progress, "Success"?

Two of the people interviewed by Nature News are affiliated with Sanaria, a company that is also developing a malaria vaccine. Sanaria just released their own news of a Phase I malaria vaccine study testing the safety of a live attenuated virus. Nature interviewed the first author on the Sanaria study published by Science, as well as the CEO and last author on the Science study. They were complementary of the RTS,S effort, if somewhat critical on some points.⁶

It's worth noting the history of the Sanaria vaccine, to give context to the executives' comments and perspective. Like the RTS,S vaccine, Sanaria's vaccine is an extremely expensive, tricky, and laborious endeavor. The underlying idea for seems promising, but for starters technicians must painstakingly dissect out the salivary glands of mosquitoes in order to develop the vaccine.⁷ It's unclear how this can scale.

On top of the laboriousness of vaccine development, once the vaccine was made it didn't seem to work. In their first clinical trial, Sanaria injected 44 subjects. 42 people got malaria and 2 didn't, a 4.5% "success" rate. These subjects might have been better protected from malaria lounging in a malaria endemic region in mosquito-infested huts, but the Sanaria execs quickly pointed out that it wasn't the stunning failure it looked like, rather, it was a trial that "yielded positive results" -- as their press release put it (without including relevant numbers). The company is buoyed by such "success" and primed for the next controversial⁷ phase.

Because vaccines promise a silver bullet solution to disease, at the moment, every possible vaccine holds promise, since we have no viable one.

Sanaria's position as competitors doesn't invalidate their commentary on RTS,S (complementary as well as critical), since Sanaria executives voiced reservations shared by many others. An editorial in last week's "The Lancet indicated that the release of unorthodox partial results seemed to be more politically than scientifically driven. Diplomatically, The Lancet editors wrote: "although the latest findings are encouraging, we look forward to the full results of the RTS,S/AS01 trial in 3 years time."⁵

When There is No Treatment, What Does A More Effective "Treatment" Look Like?

Will the upcoming younger cohort data meet World Health Organization (WHO) goals of 'Protective efficacy of more than 50% against severe disease and death lasting longer than one year'? ⁵ This is an important question. Vaccine experts usually aim for 80% or more efficacy, and representatives for PATH say they hope to get there eventually. So then, does that make this vaccine a beta version?

Is all this media hoopla deserved for a beta version vaccine? A physician working in Africa distributing bed-nets warned against statements that might mislead people "to overestimate the impact of any single new intervention", in a comment at NEJM. Acknowledging this commenter also has vested interests doesn't detract from his message. 75% of the MVI/GSK study participants used bed-nets. But would people in real-life discontinue the more cumbersome bed-net efforts with a vaccine on the horizon? Will bed-nets still be funded with a 50% effective vaccine? A 30% effective vaccine? If you're a mom and your kid gets a vaccine that is 50% effective, what precautions do you then take to prevent infection? Does a 50-50 vaccine make your life better?

The tremendous investment in vaccines, both in terms of money and expectations, shouldn't slow other prevention and treatment efforts. But realistically, we don't have unlimited resources. It would be naive to think that the prolonged difficulty of vaccine development, the immense investment, and lack of a viable alternative don't influence funding and policy decisions.

Some of the problems scientists identified with this vaccine trial have persisted for years. In this 2006 book chapter recently released online, an economist analyzes RTS,S vaccine data of previous trials (PDF) (HT Nature News⁵). He reports on waning efficacy; and questions how the public health community decides which vaccine candidates merit further investment. 5 years later, as the latest trial barely noses over the 50% bar, we grapple with the same issues and questions he raised back then, but billions more dollars have been invested.

Which leads us to wonder whether mid-trial fanfare primes us react to whatever future malaria vaccine news comes along with knee-jerk positive determinism? What if the younger data shows only (say, hypothetically) 30% efficacy? Would we ever abandon the effort? As more and more money gets invested, do decision makers begin to act less rationally?

Media reports may boost stocks, may raise money and may discourage competitors, but in the end, the science behind the vaccine, the science that's supposed to underpin public health decisions, is fussy and complicated -- caveats matter. After all, you're asking people and governments to donate tens of billions of dollars, and you're promising 7 billion people that your vaccine will keep millions safe.

Tough Economy for an IPO?

Can we push for an end to malaria as if we were trying to put a computer on every desktop? Does this big money, big marketing, big media approach to public health that some find so jarring actually work? I'm not saying it doesn't. Perhaps it will become a more accepted way of developing medicines and vaccines. Maybe public health needs exactly this kind of paradigm shift.

But even if a 40% or 50% effective vaccine is acceptable from a public health perspective, once this vaccine is developed, governments will still need to consider costs. In this economy, some ask, how much will governments shell out for a vaccine with a 50% efficacy rate? Can you and should we market vaccine with lots of pre-release fanfare to push governments towards buying the vaccine?

Asked about cost per vaccine, GSK wouldn't answer directly, but stressed how the company will reinvest all the proceeds to improve the vaccine. Shares of GSK rose slightly on the RTS,S vaccine news, and shares of biotech company Agenus which makes the RTS,S vaccine adjuvant rose from $.48 prior to the announcement, to $2.80 (which got Agenus re-listed by the SEC). All things that may influence decisions. However when questioned about the unconventional data release, PATH's MVI director didn't mention politics, billions of invested dollars, stakeholder expectations, or the saved Massachusetts biotech companies. He said: "we felt it was our scientific and ethical duty to make the results public when they become available."⁵

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¹ The mosquito drawing is by Mariana Ruiz Villarreal. It is the anatomy of a Culex pipiens, a vector for malaria. This image was selected as Wikipedia's Picture of The Day for 10 September 2010.

³White, N. F.R.S.; A Vaccine for Malaria October 18, 2011 10.1056/NEJMe1111777

⁴Editorial: The Lancet, Volume 378, Issue 9802, Page 1528, 29 October 2011, doi:10.1016/S0140-6736(11)61659-0

⁵Butler, D.; Malaria Vaccine Results Face Scrutiny: Published online 26 October 2011, Nature 478, 439-440 2011, doi:10.1038/478439a

⁶Epstein et al: "Live Attenuated Malaria Vaccine Designed to Protect Through Hepatic CD8+ T Cell Immunity": September 8 2011 Science 28 October 2011: Vol. 334 no. 6055 pp. 475-480 DOI: 10.1126/science.1211548

⁷ Kappe1, S., and Mikolajczak1, S.; "Another Shot at a Malaria Vaccine". Science 28 October 2011: Vol. 334 no. 6055 pp. 460-461 DOI: 10.1126/science.1213934

⁸ Farlow, Andrew.; "A Review of Malaria Vaccine Candidate RTS,S/AS02A", Chapter Three of The Science, Economics, and Politics of Malaria Vaccine Policy, a report written in 2005 and 2006 and published 14 April 2006 and January 2010. Department of Economics, and Oriel College, University of Oxford.

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We previously wrote about Phase II Clinical Trials of the RTS,S vaccine here. We wrote about US funding for malaria here and here; vaccine strategy here; malaria prevention here and here. We've also written frequently on international public health, including the development of a AIDS vaccine, here and here.

The Map

Acronym Required previously wrote about parents who self-vaccinate in lieu of getting vaccinations, a sort of barbaric hazing for this era's unlucky children. And while some people in the West shun vaccines because they think they're dangerous, people in Africa shun them because they suspect shots are a Western plot to kill them. The US shockingly fanned the flames of the vaccine avoidance trend when it faked a vaccine campaign in Pakistan in order to to get access to Osama bin Laden. Meanwhile, tragically, people continue to die because there aren't enough vaccines to protect them.

When people refuse vaccinations, we lose herd immunity; microbes have get a chance to mutate; and of course people get sick and die. The trend has contributed to large outbreaks of whooping cough, mumps, chicken pox, and measles world-wide, as well as polio, typhoid fever, meningitis and hepatitis A. Now there's a great map Vaccine-Preventable Outbreaks, put out by the Council on Foreign Affairs, so you can see the impact of this all.

(The vaccination map ranks as one of my favorite maps, as does Newspaper Map.¹)

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¹ Granted the UI's sometimes not entirely there

We previously discussed vaccinations in Maher's Mainstream Media Anti-Vaccination Campaign; The Wild Wooly Internet; Polio Vaccines, The End of a Scourge?; Vaccine Development For Developing Countries and others.