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Embryonic Stem Cell Research: Shock and Awe Strike Again

Last week, U.S. District Judge Royce Lamberth issued a preliminary injunction to stop Obama's reinstatement of some of the federal funding for embryonic stem cell research.

The plaintiffs included Christian Medical Association; the Nightlight Christian Adoptions, an agency that sells the use of frozen embryos it calls "snowflakes" - from fertility clinics; two PH.D. scientists, James Sherely of Watertown, Massachusetts, and Theresa Diesher of Seattle, who do research on adult stem cells and claim that allowing embryonic stem cell research wrecks their chances of getting federal grants; clients for adopted embryos; and the embryos frozen in IVF clinics.

Lamberth previously ruled that none of these plaintiffs or cells had legal standing. However, the two Ph.Ds won standing when they appealed, on grounds that their adult stem cell research would be compromised if they had to compete for federal grants with embryonic stem cell research. Lamberth issued the preliminary injunction based on his judgement that the plaintiffs would prevail when the case went to trial, therefore they needed immediate relief because they're livelihoods were impacted by Obama's expanded hESC funding directive.

Judge Lamberth's decision was based on the Dickey-Wicker Amendment attached to every Department of Health and Human Services (HHS) bill since 1996. The rider was a pro-life fueled measure, intended to prevent cloning for research purposes. Since 1996, the Dickey-Wicker Amendment has ostensibly prohibited the use of federal funds for:

  • "the creation of a human embryo or embryos for research purposes;" or
  • "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under" certain existing laws."

Nevertheless, three administrations, the Clinton, Bush, and Obama, have allowed various levels of federal funding on research on embryonic stem cell lines. The judge's injunction goes so far as to roll back former President Bush's limited acceptance of federally funded stem cell research for certain stem-cell lines created by 2001. The Federal government has requested a stay (.pdf) of the injunction. Who will prevail? The government? Plaintiffs?

Science Community Stunned

The legal move was a blow to the science research community. Said NIH Director Francis Collins: "The NIH was frankly, I was stunned - as was virtually everyone here at NIH - by the judicial decision yesterday".

But remember, back in 2001, prior to the 2002 elections in which Republicans gained seats, and when President Bush was making decisions about stem cell research. A similar group of plaintiffs sued the government. The plaintiffs in Nightlight Christian Adoptions et al v. Thompson included Nightlight Christian Adoptions, the Christian Medical Association; two couples who wanted to adopt embryos and said that stem cell research reduced availability of embryos for adoption; and Dr. David Prentice, a former professor of life sciences at Indiana State University who said that there were better alternatives to hESC, who is now a fellow at the Family Research Council.

Now, nine years later, right before mid-term elections and after Obama plans to expand funding for stem cell research, we have basically the same lawsuit, from basically same plaintiffs.

People have various opinions about what the injunction means and how it will progress in the courts. A lawyer and commenters here at concurringopinions.com discuss why the government will prevail (or won't).

Some scientists speculate that the importance of federally funded embryonic stem cell research has faded, because so much work is done privately. Others, including the plaintiffs, argue that inducible pluripotent stem cells (iPSC) or adult stem cells are just as promising. But most people don't find these arguments too persuasive, and agree that embryonic research is at least a necessary prong to pursue potentially life-saving research. Of course "pro-life" and Christian groups argue that the blastocysts are people which shouldn't be used for research, even if it will save lives.

The plaintiffs' arguments do not persuade for many reasons. Their claim to economic injury is not only unconvincing on its face, considering the plaintiffs and NIH funding structure, it's dwarfed by the impact that stopping the research would have on the lives of sick people. As well, the livelihoods of the researchers are in jeopardy, as is the investment of millions of dollars of government funding that the judge's order seeks to abandon. 24 research projects in which the government has spent $64 million are currently threatened (.pdf) because they had been scheduled to receive $54 million in continuing NIH funding at the end of September.

Should Scientists Have Been Surprised

I was. But maybe I wasn't paying close enough attention. Or maybe I didn't want to believe that such anti-reason would even get a chance. But apparently, all it took was the "right" plaintiff and the "right" judge, at the "right" time.

It's sometimes easier for people (including scientists) to perfunctorily dismiss as terminally unenlightened or misguided, those who hold politically opposing views, for instance those who believe in Creation over evolution. Maybe it's not as head-splittingly frustrating as arguing or teaching. Perhaps a quick witted turn of phrase can morph anti-reason into fodder for jokes, yay! And why not deflect an ugly stand-off with some humor?

James Taranto, of the Wall Street Journal, for one, says that dismissive attitudes (here's one example I thought of: "Poll: So You Want to Build a Mosk?") harms liberal causes because 1) they tend to "mainstream those supposedly fringe notions" (ie: Pew Research Polls that constantly highlight subjects of "culture wars"), and 2) they "put the ugly attitudes of the liberal elite on display."

Scientists discuss these things frequently and blogging scientists have consumed years writing, discussing, comparing and vehemently arguing about various approaches -- hostility, framing, teaching, patience, humor, tolerance, diplomacy, "accomodationism", to deal with anti-reason. (Personally, I can't get attached to one approach or think another is "bad", I believe different writers and audiences will gravitate towards one communication method or another. They complement each other. )

But regardless of whether scientists are "civil", hostile, sarcastic, or choose to ignore what offends them, I wonder if all approaches are fatally flawed not only because of the reasons Taranto and scientists usually discuss, but because scientists are so up to their necks in scientific method. Do we then let ourselves believe that reason will prevail? And does that lead us to ignore what's at stake? The incredible belief everyone had in Obama that he could somehow transcend politics, indicates this may be so. Francis Collins "stunned" response indicates this may be so. Collins, if anyone, with his position and overt religiosity -- he's written books on this! -- should have had his ear to the ground.

Maybe it's a tempest in a teapot, as many seem to think. Maybe Lamberth had an off day and will change his mind, maybe the courts (moving right every day) will come to their senses. But at the moment, those who want to stop hESC seem to be determinately bulldozing things their way, decade after decade.

Politics & Rhetoric - Notes

Two quick notes, on how we participate in foiling political solutions:

Keith Humphreys on Politics and The Messenger is The Message

Keith Humphreys, who recently spent a year in the Obama Administration in the Office of National Drug Control Policy (ONDCP) as the Senior Policy Advisor to the Deputy Directory, talked to Stanford's 1:2:1 program about his experience and about the California Propositions to legalize marijuana. Humphreys talked about who really uses medical marijuana, dispelled the idea that taxes would benefit state programs, and explained who would most likely control the market (tobacco). You can listen here, all very interesting.

At the end of his interview, when asked if anything surprised him about Washington DC, he said that one thing that struck him was how impossible bi-partisanship had become (transcribed by me, not exactly, from his interview):

"...At the moment at least, it's the messenger is the message entirely. What I mean by that is, for example, on the health care reform bill, we have health exchanges, where you aggregate a bunch of small buyers up and you get a big risk pool and you get a better price. That had been a Republican mainstay for decades, that suggestion could have been an applause line for you if you were giving a talk on health care at the American Enterprise Institute. But now for some reason it's become "socialism", because the president was for it. But it's the same proposal."

[Another example] "...We had a proposal in the drug strategy to give vouchers to people who were in addiction treatment, so that they buy things like a pair of workboots to go back to their job, or a babysitting so they could go to their AA meeting...That had been something the Bush administration had proposed, and we gave it the largest budget increase it had had.

When Bush administration proposed it, it was derided by people on the left as this is voucherization, it's the end of the public sector, how typical of those awful Republicans. And then when we did it was wonderful, giving poor people a choice, it's about time someone stood up for the poor. And it wasn't a similar policy, it was the same policy. It almost doesn't matter what you're for, it's who you are that controls all the perception. And that's what makes it really hard to have a bi-partisan proposal. Because almost by definition, if the other guy is for it, it can't be any good..."

Stanley Fish on our Perceptions and Crime

We deceive ourselves about culpability. Stanley Fish describes how people shift their rhetoric seamlessly as the facts of a crime emerge:

"If the bad act is committed by a member of a group you wish to demonize, attribute it to a community or a religion and not to the individual. But if the bad act is committed by someone whose profile, interests and agendas are uncomfortably close to your own, detach the malefactor from everything that is going on or is in the air (he came from nowhere) and characterize him as a one-off, non-generalizable, sui generis phenomenon."

  • Ceiling of Plankton No More?

    Many kids learn the story of phytoplankton and the food chain as their first lesson in ecology. Now they'll learn what happens when the number of phytoplankton shrink. Between 1899 and 2008, phytoplankton declined by 1% per year, according to a recent study in Nature. More alarming, that includes a 40% drop between 1950 and 2008. In addition to fewer phytoplankton diminishing all ocean life and along with that fishing and human food sources, there are other implications to the decrease. Phytoplankton give the ocean a greenish color, and less phytoplankton will make the ocean color bluer. Scientists recently published a study showing that the change in color could change the intensity, number and possible paths of tropical storms.

  • DPRK's Ginseng Economy

    North Korea owes the Czech Republic about $10 million dollars, which the Czech authorities refuse to forgive. So a North Korean delegation recently asked to barter 5% of the debt away with some ginseng -- about 20 tons worth. The FT reports that ginseng is "an invigorating root used in dietary supplements and teas that are supposed to improve memory, stamina and libido". However, unfortunately, the "now-capitalist Czechs are unconvinced they need an injection of vigour". The Czech Republic only consumes 1.4 tons of ginseng a year. Czech officials said they'd prefer to receive some zinc ore. Aha...but when life gives you ginseng...

  • Goodbye to the Little Brown Bat?

    A few years ago, in caves of hibernating little brown bats Myotis lucifugus near Albany, scientists discovered a disease they called white nose syndrome, that could killed up to 90% of the bats in a cave. The scientists found the fungus, Geomyces destructans settled on hibernating bats' bodies and wake them up, apparently because the fungus "tickles" them. Then the bats burn energy searching for non-existent food.

    Now scientists have run computer simulations that predict the fatal consequence of the disease. According to this model, there's a 99% chance that the bat will become extinct within 16 years. Little brown bats are important to the Northeast ecology. A single bat can eat hundreds mosquitoes and insects and hour -- they're vital to the ecosystem and agriculture. The fungus infects many species of bats but not as drastically as this one. A few bats in the US also seem to survive(though not enough to save this species). Interestingly, scientists have found that members of five species of bats in Europe carry the fungus but don't seem die. They suggest that perhaps the bats evolved with the fungus in Europe. Humans transport the fungus from place to place.

  • Salmonella Poisoning for Good

    Bacteria often colonize in tumors, prompting scientists to study this phenomena for the benefit of cancer inflicted patients. Salmonella is most commonly known for prompting the immune system to react in food poisoning. For therapeutic use, the bacteria could potentially deliver drugs to tumors, or potentially activate the bodies own immune system against the tumors. For years, they have researched how to deliver altered Salmonella typhimurium to cancer cells. Early patient trials simply increased the dose of the altered Salmonella in patients to understand patients' tolerance. Last week, scientists published an article in Science Translational Medicine describing how weakened Salmonella trigger human immune cells to attack melanoma cells. The altered bacteria produce a protein involved in communicating the presence of cancer cells to the immune cells, which causes the immune cells to attack the cancer. Scientists intend to test their results in humans.

The University of California, Berkeley always amazes. It has an ultra-liberal reputation, yet it defies its label by harboring some of the most controversial figures, and protects them under the auspices of academic freedom -- an excellent institution -- strreetttched at Berkeley to fit many circumstances. The law school dean used it to protect John Yoo, the law professor who crafted the Bush administration's torture policy, for instance. Now the school has invoked the useful catch-all to clear scientist Peter Duesberg of wrong-doing over a paper he wrote denying the HIV viral link to AIDS. The University said there was "insufficient evidence" to do anything else.

Berkeley Did Not Judge the "Accuracy or Validity of the Article"

Although UC Berkeley didn't judge the "accuracy or validity of the article", those issues lie at the heart the ongoing Duesberg controversy. This was only Dueberg's latest foray, that he initiated last year by publishing a paper in a non-peer review journal called "Medical Hypotheses". He claimed in his paper that the HIV virus didn't cause AIDS, something he's been promoting for years. The paper did not undergo peer-review. Scientists refuted his false theories in a collective uproar, the journal retracted the paper, the journal editor was fired, and Elsevier, the publisher, promised to rethink the journal format.

Then the University received two letters, one from Treatment Action Coalition (TAC) in South Africa, criticizing Duesberg's paper for conflict of interest and for "making false claims". The letters asked the University to investigate. The school did so, however yesterday's action clearing Duesberg of wrongdoing indicates that the UC Berkeley mission, policy and conduct documents don't contain anything that's applicable to Duesberg's situation.

Duesberg's Legacy In South Africa

The main problem is not necessarily the statements Duesberg published last year, but the fact that for years he's been publishing them and they've significantly influenced policy and beliefs about AIDS and science in general. It's his actions outside the University, like Yoo's, that cause the most distress. Duesberg sat on former South African President Mbeki's advisory panel on AIDS back in 1999-2000, and the South African government frequently cited his AIDS ideas to support their policies. Mbeki didn't treat AIDS in his country, letting hundreds of thousands of people die.

Whether Duesberg was a handy foil for Mbeki's pre-determined policy -- whether Mbeki's countrymen died because the president was more driven to toe conservative economic and social policy the procure available AIDS drugs -- is unclear. What is clear is that the country had the highest death rate from AIDS in history, while wielding the most mendacious policies, which Mbeki backed-up with "science" created by Duesberg.

Yet there's nothing in Berkeley policy that specifically calls this a crime.

Peer-Review? Whatever. Duesberg = UC Berkeley= AIDS Denial = Mbeki's AIDS Policy = Death

A Berkeley spokesman told Nature: "The university relies on the scholarly peer-review process, rather than disciplinary procedures, for evaluating the value of scientific work." There. Very official. However AIDS denialists don't rely on peer-review. They revel in non-peer-review.

And unlike the University and scientists who care about peer-review, for Duesberg's purposes, getting a paper retracted by some flaky non-peer-reviewed tabloid called "Medical Hypotheses" doesn't matter. He has his audience. For years he's had a self-promoting website up, and his ideas have gained an audience. Next they'll go after "my parking permits" he says. His audience laps this stuff up -- the underdog, taking on the big evil science establishment.

UC Berkeley has their policies and official responses. Academic freedom, the concept, is inarguably beneficial, the heart of academia. But the fact remains, one of the most renowned research universities in the world supports a scientist largely responsible for some of the most deadly anti-science claims in history. If you search "Duesberg" in Google, his site is featured at the top. Here's how the Google results page text reads today:

"Peter Duesberg on AIDS - Duesberg.com - HIV / AIDS research ... Infectious AIDS - Have We Been Misled? This is the official HIV/AIDS research from the University of California Berkeley, Department of Molecular and Cell ... www.duesberg.com/ - Cached - Similar"

"Official" HIV/AIDS "research" from the University of California, Berkeley. The Wikipedia entry for Duesberg appears third today on the same Google search page. Here's how it reads:

"Duesberg hypothesis - Wikipedia, the free encyclopedia The Duesberg hypothesis is the claim, associated with University of California, Berkeley professor Peter Duesberg, that various non-infectious factors such ... en.wikipedia.org/wiki/Duesberg_hypothesis - Cached - Similar"

UC Berkeley policy has nothing to say. Peer-review? Here's what the world sees: Duesberg = UC Berkeley= AIDS Denial = Mbeki's AIDS Policy = Death. Somewhere deep in the heart of hearts of university bureaucracy, under all the official, vague missions, purposes, and policies, doesn't this cause angst?

Exonerated?

Interestingly, it's Duesberg himself whose been spear-heading the reporting on the investigation. Apparently Duesberg has enough confidence in the support of anti-science, AIDS denialist community, to know the outcome would work for his purposes. And since now Duesberg is claiming that he was "exonerated", it's like free marketing for his theories. How tragic.

---------------------------

1PLoS One, the audience reviewed journal, is also tangentially affiliated with UC Berkeley via PLoS co-founder and esteemed scientist Michael Eisen.

Acronym Required has written frequently on South Africa and AIDS, occasionally about HIV/AIDS deniers, and once in a while about UC Berkeley.

Segueing From The BP Oil Disaster to Cigarette Smoking

People commenting publicly about the BP spill need to choose their words carefully, as certain comments play badly on short-attention span TV. Parker Griffith (R-Alabama) recently refuted the oft-stated comment that the BP spill is one of the most impactful environmental disasters ever.

From Oncologist to Apologist

Griffith made a point to tell the congressional committee:

"...I'd like to remind the committee [that] the greatest environmental disaster in America has been cigarettes...let's be sure we don't leave that out...[T]he environment is an important concept. We regret the loss of life. But there's much that we can do, and we'll put this in perspective. This is not going to be the worst thing that's ever happened to America."

Master of relativist thinking, Griffith lets BP off because of tobacco and some ominous future disaster? And his idea of 'environment as concept' -- I like that. Maybe he was seeking to qualitatively bolster his disapproval of the moratorium on off-shore drilling that he called "a public relations stunt" earlier in the week.

We're used to oil spill gaffes, we chortle and put our hands to mouths in gestures of mock horror when hearing: "We care about the small people" (BP chairman Carl-Henric Svanberg), or "I'd like my life back"(from banished BP CEO Tony Hayward). But Griffith's comment wasn't a gaffe. He was serious.

From Republican To Democrat

Griffith is a lame duck representative who lost his primary after changing parties. He has campaigned to ban cigarettes in Alabama. He's a retired radiation oncologist, who says "I never fail to bring that up." He changed parties because he disapproved of the health care bill (interesting, since the bill purports to help lower income people, who are more likely to smoke).

So maybe after he exits Congress he can continue with his anti-smoking campaign, such as it is, since he's seems less effective, in terms of public interest, campaigning for sustainable energy and the environment.

Maybe there's a place for him (at BP), or getting more people to quit smoking. Now for the segue. Despite various government actions and the lack of recent press about cigarettes, tobacco remains profitable. Efforts continue to curb smoking through taxes and smoking bans, but cigarette consumption has leveled out after falling for decades, writes the Financial Times. Accordingly, future taxes will not impact tobacco profit, and tobacco is a good investment.

Investors' Perennial "Love"

Investors will "come to love the sector", says FT, explaining how the price elasticity of demand for cigarettes has remained stable with price and volume for decades:

"...Last year's 25 per cent price increase per pack caused consumption to fall 8 per cent, an elasticity of -0.34, calculates UBS. By comparison, since 1969 prices have risen 87 per cent (adjusted for inflation), while consumption fell a third, giving a similar elasticity of -0.37. Based on this fairly steady relationship, UBS argues that tobacco manufacturers can sustain price increases of 4 to 5 per cent annually (8 to 9 per cent for retail prices) for the next decade, while absorbing consumption declines of 3 to 4 per cent..."

Very interesting, if discouraging because all told, FT concludes: "Not one for socially responsible investors but, for the rest, it may be time to light up".

From Politician to Lobbyist?

Which means that the recently proposed NY State cigarette tax increase may help state coffers, but it won't put cigarette makers out of business. At $5.85 $9 or $11 (in NYC) a pack, the American Cancer Society cheered the tax, because higher prices reduce the number of smokers. Of course the Seneca Nation doesn't like it, noting that they will fight for their ancestors treaties.

Lobbyists for cigarette retailers, also opposed, warn that black markets for tobacco will become more lucrative. Which is why multi-pronged regulation is best. The US Postal ban on mailing cigarettes goes into effect at the end of this month. But, cheers UBS, there will be enough smokers to keep the profit flowing.

Liberated from law-making, Griffith could put his crafty rhetoric skills to use for his favorite cause. And apparently he won't hurt the sector. And he could probably safely lobby for alternative energy too. What's the price elasticity of oil? Or will it just run out?

Healthcare Checklists

Checklists?

Atul Gawande's latest book, The Checklist Manifesto, advocates checklists to systemize the complexity of healthcare delivery and reduce medical mistakes. Making the media rounds, Gawande spoke for an hour recently on Democracy Now. He also testified before the President's Council on Science and Technology (PCAST).

Checklists, you ask? Certainly they're not new. Indeed, a few years ago, another physician, Dr. Peter Pronovost presented research showing the utility of checklists to tackle infectious disease in hospitals, and of course they've been used by airlines, oil change places, pizza delivery people, families going shopping, etc. Gawande's rendition appeared in this piece for The New Yorker in 2007. But his book is especially timely, given the current focus on healthcare reform.

The amount of information in medicine is vast -- 68,000 different patient diagnoses, 4,000 different surgeries, thousands of medicines. But despite our knowledge and exorbitant spending, healthcare outcomes in the US are lower than other industrialized countries -- 37th lowest, in fact, and sinking.

The fee for service incentives derail efficient healthcare, for instance by encouraging surgery. There are 230 million surgeries a year, 50 million in the US. Problematically, more surgeries means more surgical complications. The number of surgeries outstrips childbirths in the US, according to Gawande, but with 10-100 times the death rate. As he puts it, "150,000 people who die of complications of surgery, die within thirty days following surgery. And we know at least half are avoidable."

Gawande et al conclude that checklists help reduce mortality and morbidity from surgery and infections. Gawande also says they increase teamwork during procedures, for instance, by empowering nurses to point out missed checklist items. Better teamwork in turn increases success rates.

Checklists are not the complete solution to avoiding deaths, but when Gawande conducted research using checklists in eight hospital centers and 7,688 patients across the globe, the researchers found that deaths decreased by 46%, which, as a percentage looks quite dramatic, but according to their research surgical teams reduced deaths from surgery from 1.5% before the checklist to .8% afterwards. Serious complications fell from 11% to 7% according to the study, published in the New England Journal of Medicine (NEJM) last year.

Checklists as Partial Solution

But if the improvements observed by the research teams aren't artifacts, checklist implementation is still not without other issues. Harold Varmus pointed out in the PCAST panel that checklists could impede creative solutions, and noted that investigations into best practices inevitably unveil multiple equally effective ways of solving medical challenges.

As well, according to Gawande, sometimes checklists impede profit. There are strong financial incentives encouraging doctors to do procedures like surgeries. Gawande wrote last summer about the high cost of healthcare in McAllen Texas, where Medicare spends $15,000 per enrollee because entrepreneurial doctors have found ways to profit mightily within the fee for service system. In Boston, although the checklists reduced emergency asthma admissions at Boston Children's Hospital by 80%, asthma admissions were the number one revenue source for the hospital admissions. The surgeon stressed that payment systems need to be adjusted when necessary, checklists won't work on their own. The problem of keeping costs down he told Democracy Now, has not been accomplished by insurance companies.

Checklists: Simple and Cheap, Dumped into a Technology Centric World?

One of Gawande's chief points is that checklists are simple and cheap to implement compared to proposed solutions for healthcare which involve ever more complicated technology that doesn't necessarily scale. As Gawande says: "There are technologies that we've tried to introduce. We've pursued very expensive solutions. But what we've not recognized is that we can pursue an idea like checklists...".

When Gawande presented these views to the President's panel, he ran into some interesting opinions from some in the IT sector who sit on the panel. His low tech solution elicited questions like: "Will physicians accept technology?"

Gawande observed that there "can be a sense of seeing the technology almost as a panacea". Problematically he says, although technology can be beneficial, "we have not really gathered evidence on what the components are that make it a successful implementation versus unsuccessful". Two systems in two different organizations can save lives and money in one institution and be a total failure in another, as was the case with a physicians' order entry system that Brigham Women's successfully implemented, which then failed to deliver cost savings and life saving benefits when implemented at Cedar's Sinai.

No sooner had he said this, when Eric Schmidt, Google's CEO who sits on PCAST, asked him why doctors didn't use technology more. Schmidt tried to get some insight for "the model of healthcare that we'll have five or ten years from now."

"It's pretty clear that we'll have personal health records and you'll have the equivalent of a USB stick or cloud based medical history. You'll show up at the doctor with some set of symptoms. And in my ideal world what would happen is that the doctoor would type the set of symptoms that they see as a doctor and they would be matched against this data that is a repository. And then a knowledge engine would use best practices and all the knowledge of the world to then give the physician some standardized guidance. This is a generalized form of your checklist mechanism. As a computer scientist, this is a platform database problem...And it's also knowledge engineering problem.

We do these very, very well, as a general rule in computer science. And it befuddles me why medicine has not organized itself around this platform opportunity. Do you have an opinion as to why not? Do you have an opinion as to how such a system would evolve so that the doctors would use it, it would standardize practices in the way you described and ultimately lead to presumably debates over healthcare and what the right outcomes are and all the kinds of incentives. If you don't have such a platform you'll never measure it to scale...

There are a lot of assumptions implicit in Schmidt's statements, we won't go through them all here, although some physician/commentators on the internet have already had a field day. Gawande started out responding that the people who make those systems "don't know how the clinical encounter works" -- six problems in 15 minutes per patient, for starters. He ended up more conciliatory towards the idea of computerized checklists. But he emphasized that his checklists involve understanding systems engineering issues involved with ensuring well-functioning teams. That checklists were not simply a challenge of listing as Schmidt put it "all the knowledge in the world".

Gawande also proposed to the President's Council of Advisors on Science and Technology a new "science of health delivery" to study systems innovations, team organization and motivations, and coordinated deployment of healthcare. He even suggested a "National Institutes for Health Systems Innovation" to stand apart from the NIH (although such new agencies are fun to dream up but practically improbable).

Moving Forward on Platforms

For all the issues brought to the fore in "Checklist Manifesto", and for the all the issues at stake in healthcare, and to Gawande's warning about technology panacea's, it was interesting that the panel ended up quickly focusing on healthcare records. It's easy to imagine the temptation to look to health care records as that very panacea. A lot of the failures in medicine are also failures of communication, between the patient and doctor (15 minutes is often generous), between doctors, between facilities. Certainly technology already helps a lot of this, but for all the improvements in medical information technology to date, medical care is still fragmented, expensive, fraught with inconsistency and at times dangerous to the patient. Still, technology is necessarily part of the solution, and building the platform is critical.

So how would a new healthcare IT platform change the current medical system? There's a lot at stake for doctors and for patients. Any major change to the system could rearrange profits. Much of the routine patient care could be accomplished via a computer and a nurse or administrator. Why does a doctor need to charge $200 to tell you to take aspirin and drink fluids? Both Google and Microsoft are positioning themselves well -- it's hard to imagine either not grabbing the opportunity to root itself themselves into healthcare, they have a lot of mouths to feed back on their campuses.

It's troubling that the primary recipient, the patient, isn't very well represented in any of these discussions except by proxy of Google and various university doctors. 'We know what's good for you and we'll tell you what that is.' Everyone is advocating for "the patient", but Google is advocating for itself as well, as is Microsoft. And do university doctors in the upper echelons really experience the same problems with healthcare that your average patient does? That's what you get with 3rd party healthcare payers? The primary customer perhaps is not patients but insurance companies, who will no doubt benefit from the knowledge in more comprehensive databases of patient information.

The challenge perhaps is to improve healthcare (behind the patient's back), to not make it worse (no small feat), and to avoid simply adding another layer of expense and bureaucracy, to the gigantic Dagwood sandwich that is modern healthcare. It would be too easy to add more layers, to the layers and layers that comprise healthcare services, insurance, and companies that administer benefits, each one yielding profits from their slice, who in the end complicate healthcare and add costs for ambiguous ends.

Notes in a New Year, 2010

Haiti!

Help, donate: Partners in Health, or Medecins Sans Frontiers, or the Clinton Foundation, or the International Red Cross or text-to-give.

  • PLoS and Elsevier: On the Same Page?

    One of our favorite things, in the Obama era, is to see would be foes band together. So we look fondly upon the unlikely albeit fragile "alliance" that PLoS and Elsevier ended up in at a recent open access publishing roundtable. The occasion was a meeting around the report issued by the Scholarly Publishing Roundtable. The U.S. House Committee on Science and Technology and the White House Office of Science and Technology Policy (OSTP) convened the meeting of a group of fourteen publishers, university leaders, librarians, and other experts at the round table, who drafted basic agreements about how public access to journal publications. They emphasized:

    "the need to preserve peer review, the necessity of adaptable publishing business models, the benefits of broader public access, the importance of archiving, and the interoperability of online content"

    However, the Elsevier and PLoS representatives refused to join the other 12 members in signing the consensus agreement, although both agreed that points of the agreement were "positive". PLoS and Elsevier apparently both have a lot a stake, since they each sent extra representatives to the panel. Elsevier sent their General Counsel/Senior Vice President, and PLoS sent their Managing Editor as well as their CEO.

    Predictably, YS Chi, speaking for Elsevier, stated that he couldn't sign the agreement because it "supports an overly expansive role of government and advocates approaches to the business of scholarly publishing that I believe are overly prescriptive." No question about where giant, monopolistic, Elsevier ever stands.

    PLoS representative Mark Patterson's statement was a little more difficult to unpack. He said that the agreement "stops far short of recognizing and endorsing the opportunities to unleash the full potential of online communication to transform access to and use of scholarly literature." What did he mean? He didn't include "the need to preserve peer review" as one of his "positive" points of agreement....But does PLoS want more Federal support for PLoS? Explicit endorsement of pay to publish? A more "expansive role for government"? Who knows.

    For more information on open access and this agreement in general, there's a great public access policy forum here at the Office of Science and Technology Policy, and the "ever-enthusiastic public access policy team" at OSTP has extended the comment period. So you can comment, and there's lots to read.

  • H1N1

    The World Health Organization (WHO), has hit back at accusers who say that the organization, along with pharma companies, created a "fake epidemic" in H1N1. WHO reiterated its role to balance urgency and expediency with the uncertain nature of the epidemic. In an editorial generally praising the organization's response, Nature wrote this week:

    "The danger now is that last year's relatively mild pandemic will create a false sense of security and complacency. The reality is that next time we might not be so lucky -- especially given that this time most of the world's population, living as they do in developing countries, had no access to either vaccines or antiviral drugs."

    It's apparently easy for otherwise smart people to be cynical about the H1N1 pandemic. It is truly a challenge to explain risks and uncertainty of pandemics and the fact that the scientists and public health organizations are actually doing a great job.

  • Judge Overrules FDA on Electronic Cigarettes, Whatever They Are

    Some people believe that a president's most lasting legacy is in the judges he appoints; George W. Bush appointed judge Richard Leon of the Federal District Court in Washington. Leon recently moved to stop the FDA from regulating e-cigarettes, on grounds that they aren't tobacco. In fact, e-cigarettes are battery-powered tubes that vaporize nicotine with tobacco flavoring, that simulate cigarette smoking for the user. I can't make that sound good. Seems like the next best thing to sex robots. But anyway, these devices deliver addictive nicotine to the body, but the judge says the FDA can't regulate e-cigarettes as devices anymore.

    In other tobacco regulation news, an article in the New England Journal of Medicine (NEJM) discusses opposition to the Family Smoking Prevention and Tobacco Control Act on First Amendment grounds. Even the ACLU objects to the Act, which prohibits the use of certain words by cigarette advertisers, saying that

    "regulating commercial speech for lawful products only because those products are widely disliked -- even for cause -- sets us on the path of regulating such speech for other products that may only be disfavored by a select few in a position to impose their personal preferences."

    Instead advised the ACLU, "the antidote to harmful speech can be found in the wisdom of countervailing speech -- not in the outright ban of the speech perceived as harmful." But as the NEJM authors wrote:

    "How did we come to believe that the exchange of commercial appeals in the marketplace of goods and services should be equated with free exchange in the marketplace of ideas? Are our freedoms really secured by a constitutional doctrine that would limit our capacity to inhibit the promotion of toxic goods? This is an opportune moment to reflect on these questions and their implications for the relationship between public health goals and the rules that should be foundational in a democracy."
  • EPA's Updated Smog, Ozone Standard

    The EPA proposed new standards for smog last week, which would update the Bush Administration standards. The agency will set the "primary" standard, which protects public health, at a level between 0.060 and 0.070 parts per million (ppm), measured over eight hours, and will also propose a new secondary standard. These standards were recommended by scientists years ago to decrease deaths and smog levels dangerous to children, the elderly, and those with asthma and respiratory disease. As we wrote earlier, the Bush's EPA pushed the weaker standard of .075 ppm. We also wrote about the Obama EPA's stated intention to change the standard last fall.

  • Airport Screening to Double as Healthcare?

    "We are headed toward the moment when screeners will watch watch-listers sashay through while we have to come to the airport in hospital gowns, flapping open in the back", wrote Maureen Dowd recently, commenting on holes in airport security processes. But I think she's seeing a cup half empty. We may well be headed for a moment when airport screening, reviled as a breach of privacy to some, is the closest thing to healthcare people can get.

    The public option has fallen "off the table" again, by now "fallen off the table" so many times that even when it intermittently appears back "on the table", it's obviously shopworn, if not smashed to bits.

    But the glass could still be half full. Think of the savings, if airport screening could double as healthcare screening : "You're cleared for flight sir, and don't worry about that lump..."

  • What to Call It? Science Terminology

    For various reasons, political, scientific, logical (or not) or historical, people refer to the same thing using different terms. Here are two examples.

    Canada does not call the tar sands "tar sands", anymore, they're "oil sands". Of course "tar sands" is more descriptive of the energy-intensive process, of extracting oil, but "oil sands" sounds like something that you would naturally siphon some oil out of, it sounds better.

    In 2005, physicist Lisa Randall urged that "global climate change" was the appropriate phrase to use, because "global warming" would lead people to argue that their winter was actually very cold. Others argued that "climate change" sounded less dangerous, so therefore would be used to manipulate people who would be fearful enough about "global warming" to urge policy changes, whereas "climate change" seemed benign. But it gets even more complicated for some agencies. NASA differentiates between "global warming", which is surface climate change, and "climate change", and "global change", and "global climate change", which deems the most accurate term. I think everyone pretty much knows what everyone's talking about now, though I dare not make conclusions about that.

  • Oh, and Happy Not-So-New Year

    Did you travel over your break? Have fun?

    In the US, marketing aimed at tourists is off the rails. Perhaps marketers have learned that people who travel in a heightened state of orange level stress will sooth themselves by buying absurd products. You may argue that it's a global trend, and indeed, the badminton set peddled to me by a man on the muddy backroad of a major city in Asia seemed ridiculous, until I flipped through Sky Mall Magazine and spied the "King Tut Life Sized Sarcophagus Cabinet" that can be "delivered curbside" (to impress your neighbors). Personally, I would rather pay to bat around a little white badminton birdie in a mud puddle, while talking baksheesh with kids who speak, at will, touristica French, German, English or Japanese. By comparison, traveler oriented products in the US seem conceived by desperate marketing departments who've lost their wits. Case in point -- the sarcophagus cabinet. Or:

    • If you were assigned to seating group 2 or above recently, on my least favorite airline I still fly on, you heard this announcement: "Board now. Enter via aisle closest to the wall, NOT THE RED CARPET." Because "the red carpet", actually a two foot doormat, is reserved for first class customers.

      Some people bemoan the lot of the economy passenger, the so-called "poverty parade", and the herd animal like treatment. But as a first class customer you pay an extra few thousand dollars to traipse across a red mat with bars on each side to keep you in bounds. Sure the legroom's nice, I won't argue, but you have to walk "the red carpet" to get there, and once there in that bigger, comfier seat, you're subjected to complimentary cheesefood snacks. Supposedly smart people actually buy this privilege.

    • At your hotel, you will be sold the usual-- rooms, room service, laundry services, shoe shines and upgrades, not to mention the mini-bar. But what if the five dollar peanuts in the mini-bar are too devilish a temptation for you and your New Year's resolutions? No worries, there's a market-based solution. Pay $50 to have the mini-bar hauled away at one hotel I was recently at.

    • Want to use the hotel refrigerator for your water? $50 fine at another hotel. And the same people who stay at these hotels complain that the EPA's bureaucracy confines their business style.

    • Maybe you actually love business travel and want to bring home a bit of the experience, like the "pulsating" showerhead that your can actually buy from one hotel's glossy catalogue. The catalogue carried other mundane household hardware and dog cushions stamped with the hotel's logo. Pretty special.

    Couldn't we just travel unsolicited sometimes? Definitely not in 2010. Happy New Year.

World AIDS Day 2009

Progress and Promises on AIDS:

Today, on World AIDS Day 2009, while looking for a statistic, I entered into Google the search: "HIV infections decrease". The sometimes precocious search engine offered an instantaneous correction: "did you mean HIV infections increase" [sic] No, I silently answered, frowning, before I caught myself attempting communication with a search engine. Then I flipped the search to Google News. Google insisted I must mean "increase". So I got the statistic I was looking for and relented to Google's know-it-all suggestion. Indeed although Google was wrong, I understand the reasoning, even if only algorithmic: The first search phrase, "decrease", yielded only 1,940,000 results in .22 seconds, whereas the second, "increase", gave 3,550,000 results in .18 seconds.

Just like the search engine, we brace ourselves for the worst with HIV/AIDS, we're habituated to hearing bad news. As the pandemic continues and effective methods for decreasing HIV infections, increasing treatment, and procuring funding seem at times as elusive as ten years ago, sometimes we need to look up once a year on AIDS day with some real intention just to see the inches gained in the sand we've been trying to get traction in.

Otherwise, even though the number of number of infections has decreased by 17% since 2001, all the World AIDS Days blur together and we're tempted to ask questions. Questions like -- has anything actually changed since the 20th World AIDS Day of 2007, when 61% of HIV infected population were women? Or from 2008 World AIDS Day? Or the first World AIDS Day 22 years ago?

Last year, on the the 21st World AIDS Day, we noted milestones like Bush's PEPFAR funding effort, and Barbara Hogan's appointment as South Africa's Health Minister. However, things change quickly in this area of public health, and this year brought both positive and negative news for PEPFAR and South Africa, two of our areas of interest.

The year started out promisingly, with Obama's inauguration and his pledge to pay even more attention to AIDS, especially for the recently increased national infections. He noted that his strategy would-

"...be based on the best available science and built on the foundation of a strong health care system"....however, he warned, "in the end, this epidemic can't be stopped by government alone, and money alone is not the answer either."

After being sworn in, Obama immediately got rid of the ban on international funding for groups that provided counseling on abortion. Condoms, an essential part of prevention, lost the evil connotation they had during the Bush administration. (The church took up the campaign when Pope Benedict XVI announced falsely in March that condoms would worsen the AIDS crisis). Obama was true to his campaigning words here. Science studies show that condoms are effective, and abstinence programs are not. Studies also show that attention to public health is central to preventing and treating infectious disease. Indeed, healthcare has been a theme of Obama's administration -- albeit to what end, we don't know. The president also recently lifted the HIV/AIDS travel ban, which has ostracized AIDS patients, something that's also been proven to undermine prevention and treatment programs.

Unfortunately, but again true to his word, Obama hasn't provided the leadership people hoped he would, even though government leadership has proven central to any successful HIV prevention and AIDS treatment program. Worse, although Obama the president-elect promised $1 billion per year in PEPFAR funding, the 2010 budget proposal contains only $366 million. The funding shortfalls have effected HIV and AIDS treatment programs, for instance eligible patients in Uganda are being turned away for lack of funds. The president's funding choices earned Obama a scathing D+ from AIDS NGOs.

Change in South Africa

In good news, South Africa's President Zuma has made several promises that show he's wised up from the time in court not long ago, when he defended himself on rape charges and said that a shower would prevent infection by HIV. Last month, Zuma promised that South Africa would vigorously address the national AIDS crisis.

Last May, when Zuma announced the reassignment of Barbara Hogan, whom he replaced with Dr. Aaron Motsoaledi, there was some concern from South Africa's public health community about the assignment, concern the Dr. Motsoaledi was inexperienced, while Hogan's work was widely praised. However public health groups have since welcomed the new minister's straightforward acknowledgments of past mistakes.

We hope South Africa's new realizations -- like that the nation's deaths from AIDS increased more than 100 percent in 11 years -- are not just a rhetorical distancing of the ANC party from former President Thabo Mbeki's and his denialism, but a real commitment to an AIDS program. Optimistically, today Zuma announced the government's intention to treat all babies and pregnant women infected with AIDS.

In other major HIV/AIDS news this year, initial reports of a successful vaccine clinical trial in Thailand brought increased public attention and then consternation to later news of the same trial. The second news release informed the world that when researchers did further analysis of the results they doubted that the benefit was statistically significant. That's the way it goes though, steps forward, and steps back. The work continues tomorrow, and for the next 364 days we'll all work towards a more upbeat World AIDS Day 2010.

Healthcare Spending - Everybody's Caper

Our Hypocritical Oaths:

When people complain about healthcare problems they tend to zero in on an isolated part of the system, like insurance. When they try to solve healthcare problems then focus on another part, like technology. They dredge up scapegoats to blame by accusing the poor or immigrants of driving up costs by depending on emergency rooms as primary care. The truth is, we all play a role in the gargantuan capitalist collective that is healthcare, and no matter how hard we try to be diligent consumers or responsible patients, we each enable a very unhealthy healthcare system.

On some level you may understand this. As you dangle your legs from the examining table clutching the corners of that little paper towel, you may recognize that you're sitting in a "care" facility that spends millions marketing to you about meeting your medical needs while unfailingly accommodating the needs of many other players -- the insurance company's stockholders, the investors in the shiny new medical complex, the medical fellow's future success, the administrators of various insurances, and the doctor's kids' educations.

Regardless of how smart and realistic and educated you may be, you aren't clever enough to avoid unnecessarily driving up health care costs, a fact you may well choose to ignore. Usually you can rationalize that the problems are not your fault. And since we all agree that it's not our fault, the dysfunctional system thrives and perpetuates itself.

But once and a while, a twinge of regret or guilt may creep over you. Perhaps it will happen after you wait five months to visit a certain specialist that everyone said is the best, only to realize that the ten words he deemed worthwhile his time to impart were less informative than what you read on Wikipedia -- except uttered by him they cost the insurance company and you $400 -- with the insurance discount. Maybe you should have known better.

Or perhaps someday you will look at what "you pay" on the bill compared to the five thousand dollars that insurance payed and momentarily feel as though you've scored a bargain at Ross Dress For Less -- even if you recognize that the insurance companies extraordinary profits came directly out of your pocket. Someday you'll be too busy to insist that the insurance company honor the preventative procedure contract; someday you'll acquiesce to doing some unnecessary high-cost procedure; someday you'll agree to do five more blood tests because you don't feel like getting your old records.

What the Teabaggers Deny

There's the everyday differences of opinion about how to diagnose and treat certain diseases and other issues, these drive up healthcare costs. Then there are the recognizable and seemingly avoidable mistakes that you participate in and recognize. Regardless of, or because of your expertise in economics or medicine or finance or business, someday you'll be slapped by undeniable buyers' remorse or the chagrin of being duped or overtreated. Someday you'll sit down on the examining table fully aware of the trade-offs and controversies of health economics, of third-party payers, of diagnostic options, and treatment controversies, only to recognize sometime after your "care", in an exasperating burst of awareness, that your time or money (if not your health) got wasted.

Before then, you may choose to be too overwhelmed with life's business to consider your participation in the sorry healthcare system. Or you may hear other people talk about some useless procedures they endured and think 'poor sap - wouldn't be me'. Such was the case with Dr. Jack Coulehan, who relayed in last month's "Health Affairs, that he "lost the smugness and condescension I often felt when listening to others' stories about being trapped by the system and manipulated into excessively complex and specialized medical situations", and ended up as "a poster boy for excessive medicine."

Coulehan, a primary care doctor, professor emeritus and public health fellow at NYU, described his exasperating experience in the emergency room one Easter Sunday. The doctor knew he had shingles, having diagnosed at least one hundred patients with the disease:

"but I decided to visit our hospital emergency room to confirm the diagnosis and get my prescriptions. My wife drove. I sat in the car with my eyes closed, wondering how it was possible for me to have turned into one of those elderly people who suffer from shingles."

The attending physician confirmed his self-diagnosis, but Coulehan relented to see two more specialists. He relays his confused thinking during an exchange with the attending physician:

Attending: "Maybe we should have an ophthalmologist and a neurologist take a look at you. What about it, just in case?"

Coulehan: "I don't know...I don't think so...well, OK...maybe it's a good idea." A tiny doubt crept into my mind. Could we be missing something? Might it be a tumor behind my eye? Or a weird form of glaucoma? I wondered whether she was being extra careful because I was a fellow physician. But, if so, why?

After one MRI, Coulehan observes:

"When the attending neurologist returned from his lunch he seemed absolutely delighted that I might have a blood clot in the sinus -- a finding, he said, consistent with the redness around my eye. "Did you have any recent dental work?" he asked, searching for an infection as a possible cause of venous blockage. (I hadn't.) I was gripped by molasses-like passivity. The reasonable part of my mind cried, "This is crazy! Get me out of here!" But a twiggy little nugget deep in my brain asked, "What if there is something serious wrong?"

Coulehan went through hours and hours of waiting and testing, testing and waiting, into the evening, noting that "Easter Sunday appeared to be a dead day in the ER, except for me and my shingles". By the end of the day, Coulehan finally got the medical prescriptions he had decided he needed at six in the morning while sitting on the beach with his wife. After two MRIs, a CT scan, and a $9000 bill, the doctor concluded: "I understand now how all those people could have been so gullible, so easily manipulated by the system. Now that I'm one of them, that is."

If you've already been chagrined after relenting to some test or procedure that's totally useless if not harmful, Coulehan's article will assure you that you're in good company. Which of course is comforting but also ironic. Since we're all making the same choices, more than a few of which are undeniably bad or unnecessary, many people feel no particular personal responsibility. In fact some people, like the teabaggers lining up in Washington DC like it's 3AM the day after Thanksgiving at Best Buy, fear that any change in the system will deny them their rights to those bargains advertised on their insurance receipts.

Coulehan's whole article is available at Health Affairs September/October 2009; 28(5): 1509-1514 (subscription).

Healthcare Reform Progress

Your Healthcare Dollars At Work Lobbying Congress to Defeat the Public Option?

Bill Moyers focused on health care last week, interviewing Wendell Potter, who worked as a corporate public relations executive at Humana and Cigna for the last 20 years, then recently retired from what he describes as a lucrative and posh executive position. Potter's one of those clever people who after they retire their position of import and influence, find a way to remain in the spotlight by suddenly seeing all the inequities they helped propagate before retirement.

Potter delivers some timely reminders though, with bonafide authority. For instance, in the 1990'a, the for-profit insurance industry's "medical loss ratio", that is the amount that insurance companies spent on patients, was about 95% of each premium dollar, whereas now it's only 80%. The insurance companies need to keep this percentage shrinking in order to meet investor demands. An efficient way to accomplish this is to kick people of the insurance rolls, and deny claims. What does insurance spend the extra money on? Acquisitions to increase market share? Executive compensation? Perhaps lobbying Congress for more market share?

The Language of Luntz

Moyers shared a healthcare reform communication memo, "The Language of Healthcare" by Frank I. Luntz. Luntz's name may be familiar to anyone who follows the climate change denial business guided by his public relations blueprints, the pro Israel settlements language, or many other GOP policy positions and "science based" rhetoric.

Luntz's healthcare memo presents "poll-based" advice on how to spin a healthcare solution which favors existing stakeholders like insurance while keeping the government out of healthcare. Luntz highlights "words that work" and "words that don't work".

For example, he writes:

"If the dynamic becomes "President Obama is on the side of reform and Republicans are against it," then the battle is lost and every word in this document is useless."
Or:
"One-size-does-NOT-fit-all." The idea that a "committee of Washington bureaucrats" will establish a single standard of care for all Americans and decide who gets what treatment based on how much it costs is an anathema to Americans. According to him, there are a number of ways to attack this:
  • Demand the 'protection of the personal doctor-patient relationship';
  • Compare the personalized relationship with their doctor to the distant, cold, calculations of a federal medical panel;
  • Utilize examples of medical breakthroughs that would be undermined or jeopardized. .."

Or, says Luntz:

"The Democrats plan will deny people treatments they need and make them wait to get the treatments they can actually receive. This is more than just rationing. To most Americans, rationing suggests limits or shortages - for others. But personalizing it - "delaying your tests and denying your treatment" -- is the concept most likely to change the most minds in your favor."

The Luntz document contains 28 pages of explicit wording suggestions that he suggests people should use to persuade people to choose the "right option".

The insurance industry and other health care interests are lobbying hard against a government-sponsored, nonprofit, public health insurance option, and are spending, according to The Washington Post , up to $1.4 million per day to sway Congress in this direction.

President Obama remains upbeat, saying that the administration has made "unprecented progress", and telling Congress, "don't lose heart".

September 2010

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