Recently in Biotechnology Category

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.

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.

Update 08/13: AB 70 was defeated. However, the Bring Your Genes to Cal program was altered because they planned to do the analysis in Berkeley labs, which are not certified medical labs. In accordance with state demands the students will not receive their own results.

Legislation usually moves along at a crawl, slowly, glacially -- except if you're the California State legislature trying to corral the University of California, Berkeley's personal genomics walkabout offered to incoming freshmen. The state bill AB 70 was introduced in December, 2008 to encourage transparency on how school districts classify "English learners" to "proficient".* Now, the text of AB 70 the "English learners" bill has been parasitically devoured and replaced with text to impede the University of California, Berkeley's program for incoming students, known as: "On the Same Page: Bring Your Genes to Cal".

How the State Tries to Come Between Cal...and Your Genes

Like many universities, freshmen are welcomed to UC Berkeley with some thematic program. Historically that's meant they all read a book, for instance last year they read Omnivore's Dilemma, by Michael Pollan. This year they decided on a more interactive learning experience, asking incoming Freshman to spit in a cup and submit that for analysis of lactose, alcohol metabolism, and folate gene variants. The idea seemed fresh and relevant, and Berkeley went forward with it apparently without much internal debate. Certainly getting students involved in their own health can't be bad can it?

Some people actually thought it was bad, however, and eventually the state legislature got involved -- very late to the game, of course. But as the university mailed out saliva spit kits to students, AB 70 suddenly gained what seemed like unprecedented speed and "urgency". If passed, it will be "enacted immediately."

The original AB 70 proposed adding a section to the education code requiring that school districts report their criteria for assessing English proficiency. The bill languished until being amended June 24, 2010. The amended title reflected not-too subtle changes. The old sponsor and bill purposes were simply crossed out, and the new sponsor and purpose inserted so it read:

"Duvall Norby English learners. Public postsecondary education: genetic testing."

That's how an English learners bill morphed into a bill to stop UC Berkeley from teaching about genetic testing.

Legislation 101

English learners text was crossed out:

....This bill would require the department, as part of its duties in administering the English language development test, to gather from each school district that has one or more English learners the criteria that the district uses for the reclassification of a pupil from English learner to proficient in English and to summarize and report the criteria it receives...

And in its place, text warning about allowing "On The Same Page: Bring Your Genes to Cal":

• Collecting, testing and storing genetic material presents "unique challenges to protecting individual privacy".
• Medical testing "subjects" should receive "substantial" written and verbal explanation before supplying consent
• Students "may feel coerced to participate in official activities involving widespread genetic testing"
• A 2006 GAO report showed that tests are "unproven, misleading, meaningless.."
• Students could "suffer consequences later in life" because of privacy breaches.

The June 24th version demanded that the school report quarterly, all the costs of the "solicitation" so that the state of California could recoup those expenses. The trouble with that legislation was that the solicitation already happened and was funded with a gift (probably, the funding is unclear). (The state only provides Berkeley with a small percentage of its funding.) So the August 02 amended version of AB 70 struck out "prohibits" and entered "requests" instead. The August version also struck out the demand for accounting of "unsolicited requests", and replaced that for a demand to account for "legal judgements or settlements resulting from violations of the informed consent requirements".

On Different Pages

The August amendments show the state adjusting to meet the realities of the program moving forward. It's a learning experience for all. Clearly the legislature is trying to wrap its head around the project, and adjusting as needed. As is Berkeley. As are organizations who oppose the program.

The text of the bill reflects very closely the rhetoric of the Massachusetts based Council on Responsible Genetics (CRG). Their primary concern seems to be privacy, and their multiple letters to California legislators practically dictate the content of AB 70. But as they gather more information about the project, they too change their rhetoric. In their most recent letter to California legislators, the Council For Responsible Genetics joined with the ACLU, Privacy Rights Clearinghouse, The Electronic Freedom Foundation and others, urging the legislators to "request a full accounting" of the "On the Same Page: Bring Your Genes to Call" program, specifically issues of conflict of interest, funding, privacy, and data confidentiality.

The Berkeley program certainly brings relevant topics to the fore, and who can challenge the importance of this? But Berkeley scientists and the Council on Responsible Genetics have stuck doggedly to their talking points. Scientists advocating the program stress the need for education about genomics, and accuse critics of being anachronistic and paternalistic. They stress individuals personal right learn genetic information. Therefore, they would argue, this is a relevant topic worthy of the attention of the program.

Certainly healthcare in America is at such a nadir that anyone with half a brain in their head who has visited a doctor lately would agree that giving individuals more information to take more ownership of their own healthcare would be great. Personal genomics could give such insight, democratize information, and benefit health consumers. But this is one (there are others) big hitch. Direct to consumer genetics testing (this is related) walks a fine line between being innocuous information and a "medical test". Bring Your Genes to Cal proponents simultaneously push the importance of the students learning about genomics - and by pushing this they get necessary support, while at the same time belittling the relevance of the tests and their results - so as not to attract unwanted attention.

Meanwhile, critics are focusing on the very issues that the University is trying to downplay. CRG insists on repeatedly labeling the Bring Your Genes to Cal tests "medical tests" in order to prompt alarm and greater scrutiny. The critics dwell on privacy, data confidentiality, and interpretation of data. To me, if genomics data is important enough that it's worth building this program around (as innocuous seeming as these variants may be), than it's important enough for the critics' issues to matter -- even if the involved scientists twist themselves into knots to avoid those discussions.

The state, for its part, is trying to respond, quickly at that, without having a clear handle on the issues. Perhaps they yearn for 2008, when AB 70 was stymied in controversy over adding a webpage to assure transparency in schools' English Learner programs.

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*AB 70 was also once a bill about state dams.

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.

Death Ascendency:

Scientists, pollsters and journalists like to complain that Americans can't be bothered to read or understand science. That distresses these pundits. I don't believe their contentions are altogether accurate or their hand-wringing justified, but true enough, Americans seem distracted or even obsessed with subjects other than science. Like what?

Death, for one. Remember, the hoopla over death panels, and fears about the death of a grandpa because of illegal immigrants? Maybe you've forgotten the multi-month media requiem for Michael Jackson, but can remember via Time Magazine's 100 page Special Commemorative Michael Jackson Issue, still on the news stands through October. And if you missed that, you can now watch the movie. If Jackson was reclusive in life, his death just won't die.

And it's not just Michael Jackson. This summer and fall, the string of newsworthy celebrity deaths led MSNBC, the New York Times and others to recount the "the endless funereal season". Trying to slip in a post on death over the last few months, if you didn't want to seem like you were milking the trend in an unseemly way, (because we're the unblog blog) was near impossible.

The preoccupation with death spanned news on politics, employment and entertainment. What did AP feature in a story on career advice? "Funeral science: One business that's still alive: Amid layoffs and a weak job market, interest in mortuary science surges." And after death it's not over, as the New York Times pointed out in: "After a Death, the Pain That Doesn't Go Away".

You can't escape death -- the theme I mean. It's what people are living, breathing and reading. Non-fiction? At least four new books focus on death. "Annililation: The Sense and Significance of Death", "The Philosophy of Death", "Our Stories: Essays on Life, Death and Free Will", and "Death". You get the gist, but for more, FT reviewed the books here. Not satisfied with new books? Someone along my route today poured over "Stiff: The Curious Life of Cadavers".

And in fiction? Mass-market fiction? Deaths by aliens, apparitions, and evil-doers, not to mention more than one bubble-gum romance featuring irresistible marble-chested vampires. In sunny, otherwise cheerful September, 12 of the 20 best selling titles from the NYT mass-market fiction list were: "Dead Until Dark", "Frankenstein: Dead or Alive", "From Dead To Worse", "Club Dead", "The Bodies Left Behind", "Dead To The World", "Living Dead In Dallas", "Dead As A Doornail", "Promises in Death" "Chosen To Die", "Definitely Dead", and "Altogether Dead".

The remaining 8 of the 20 best sellers didn't bother to include "Death" in the title, but don't despair, it's there. You could chose between "The Assassin" (subject obvious), a book on "scandalous deaths", or one each on death from lung cancer, a killer, a dead lover, a dead friend, the death of a child from acute promyelocytic leukemia, a string of dead medical tourists, and last but not least - a book that brings Elvis back from the dead to help investigate some mysterious deaths. Now at Halloween and moving into the darker, more appropriately morbid time of year, the media is naturally out of step so the mass market fiction list looks slightly more upbeat -- though Death still holds its own.

Until the Smell of Death Do Us Cart You Away

So what's a science writer do in The Demon Haunted World of deathly news and entertainment preoccupation? Science journalists struggling to work within this dreary paradigm last summer published versions of "The Smell of Death", a story about experiments on bugs by scientists at McMaster University.

Previous research had showed that noxious chemicals expelled by some animals upon death repel their live companions. It's true. Necrophoresis is the term for the behavior of ants and bees when they move their dead away from their nests. Scientists such as Henry Christopher McCook in 1879, E.O. Wilson, in 1958 first documented necrophoresis. Wilson showed that worker ants moved the dead bodies out of the living spaces, and the ants and were motivated by something other than the untidy look of their comrades carcasses strewn about the nest.

To investigate, Wilson's team sprayed what I'll call "eau de ground up dead ants" on live ants, and observed the ants move their perfumed but live fellow ants away from the nest as if they were dead. Following from that observation, researchers learned that the ants expelled a specific scent when they died that other ants of the same species could detect. Wilson determined that chemicals called oleic acids motivated movement of the dead bodies by their fellow worker ants. Scientists than discovered that while bees and ants remove their dead, termites merely avoid their dead -- they're necrophobic.

Building on a century of research on "necromones" then, the McMaster University scientists dispersed necromones among insects such as caterpillars, which aren't known to expel their own dispersants but do aggregate like social bees and ants as well as the semi-social termites. Their experiments showed that the fatty oleic acid compounds also repelled woodlice and pillbugs. Since necromones seem to effect multiple species, the scientists now suggest that the death chemical is common across many species.

Programmed Cell Death -- Upbeat, Hopeful, Vital

What else could scientists write about? Programmed Cell Death (PCD) springs to mind. Not only does it have "death" in the title, like all the best selling mass market titles, but it's actually vital to life and therefore a rather hopeful, non-dreary subject. PCD occurs in plants and animals, yeasts and bacteria. The human body creates more than a thousand billion of cells and just as many die through PCD, a carefully orchestrated event which allows some cells to be destroyed through a process that assures that healthy cells proliferate. PCD is different than necrosis, when cells die due to blood loss or insult. There's a bounty of research on PCD and it has it's own journals -- enough reading and writing that could see us well through the winter months and into spring.

Although the proliferation of cell death research and understanding is relatively recent, in the 19th century scientists noticed changes in the cells during insect metamorphosis and tadpole development which suggested cell death. Although early research focused on phagocytosis, in the mid-20th century evolving technology provided scientists with more sophisticated microscopes and histologic techniques which gave them a clearer view of cell processes. In their 2001 history of PCD in Nature Review Molecular Cell Biology¹, Richard A. Lockshin and Zahra Zakeri, describe how the 1960's at Harvard, afternoon teas attended by Carroll Williams' lab members served as humorous and informative exchanges for "ideas of the day", and in time coined the term "programmed cell death".

In 2002 the The Nobel Prize in Physiology or Medicine was awarded to Sydney Brenner, H. Robert Horvitz and John E. Sulston for their discoveries concerning "genetic regulation of organ development and programmed cell death." The researchers used the model organism nematode Caenorhabditis elegans to study cell death and established for the first time that certain genes control cell death. That there were genes controlling death showed that cell death is an integral part of development, not an accident.

Apoptosis (from the Greek word "falling off") is the most commonly studied form of cell death, although there are others. The most common example of cell death is the development of hands and feet, which start off as spade-like clumps of cells, then through apoptosis of the cells in-between, the fingers and toes emerge. In the developing brain millions of nerve cells get "pruned" through apoptosis to assure that proper connections are made. For instance in the development of the retina in the eye, 90% of certain types of cells die. Rather than being limited by cell biology techniques to observing cell death, scientists can now also use molecular biology techniques to understand specific proteins and genetic processes involved in regulating cell death.

When cell death goes awry, the repercussions are serious. In cancer, the cell death pathways malfunction and too many cells are allowed to proliferate. In Parkinson and Alzheimer diseases, cell death pathways allow the destruction of too many cells. Now scientists are zeroing in on specific proteins or pathways that could be altered to prevent aberrations in cell death that result in disease. From not knowing that cell death was an important part to living organisms, scientists are realizing how much it dominates life - sort of like the paperback mass-market fiction list.

¹"Programmed cell death and apoptosis: origins of the theory" 545-550 (July 2001) | doi:10.1038/35080097

The Politics of Problem Solving in the US. One: Know Your Audience

Michael Moore's 2007 film Sicko was familiar to me even before I watched it last night, because the media dissected all parts of the film with yeahs or boos when it opened two years ago. Moore's concise editorial on the US health care system didn't muddle his point about the superiority of nationalized health care by dwelling on gray areas or discussing exceptions or contradictions. It was a simple tale, US health care: bad; Canada, Cuba, Britain, France health care: good. Criticism about Moore's lack of journalistic rigor was fair, but I found the film surprisingly refreshing.

We've been living an unfolding disaster, whereby politicians meander down the middle of the road, hopping to one side or the other as dangerous objects from the other side veer too close. Always on the path to the next election, they can never stray too far from the middle. Progressive public relations 2009 dictates that you deliver uplifting rhetoric, then when your actions fail to bring the change you promise, you must call everything a giant success anyway. Journalist, activist or politician, you win support and earn money by appealing to all sides and botoxing a cheerful smile on your face.

The Democrats didn't bemoan the cuts after the House and Senate reached agreement on the stimulus package. The bill lost education and state aid, but the centrist crafters beamed on the podium. Susan Collins, Senator from Maine, toed her own Republican party line when announcing the final package of $789 TRILLION dollars. "It is a fiscally responsible number", she said brightly, without choking, sputtering, or falling backwards in a recoil effect from the force of the lie.

While politicians need to wag this way, there's none of this middle of the road stuff for Moore and his "Dog Eat Dog Films". US health care is rotten to the core, and Moore says so, pulling no stops and corralling the most unlikely players -- Cuba, Britain, and sick 9-11 workers -- to play their parts.

Moore focuses on the high profit US insurance industry and the managed care system. He tells real, scary accounts of insurance denials for services that led to the illnesses or deaths of patients. The story appealed to his select audience, but of course the problem is more complicated than greedy insurance companies. Moores' nationalization solution necessarily cuts out all the complications and idiosyncrasies implicit to delivering health care in a 21st centure US. So he was rightly criticized.

Two: Isolate the "Problem" and Develop a "Simple" Solution

But criticize away, every solution proposed for every complicated problem simplifies, whether Barack Obama proposes the solution, or Michael Moore does. When we look to solve complicated system failures, we tend to herd ourselves towards solutions that fall within the bounds of the current broken system. The solution of nationalized medicine for the healthcare problem isn't necessarily simple but Moore makes it look as simple and straightforward as an Old West movie gunfight.

Moore tried to sell a simple solution by making it look easy. Politicians, for lack of imagination, political will and guts, craft simplistic solutions. As it turns out, often the solutions involve technology, which has universal appeal and people don't know how hard it is.

What was the cause of the economic meltdown? It was people who bought mortgages that they didn't understand, like ARM's that ballooned. This caused massive foreclosures. I'll label this the "stupid homeowner" theory of economic meltdown. How do we dust our hands of this problem? Cass Sunstein and Richard Thaler come to the rescue in "Human Frailty Caused This Crisis", published by the Financial Times:

Regulators therefore need to help people manage complexity and resist temptation.... Regulators can reduce the chances of a future meltdown by making it easier to understand financial products....Fine-print disclosure should be supplemented by machine-readable files enabling third-party websites to translate hidden details of the terms.

A preposterous solution to the financial crisis.

Here's a different example, this time the media comes up with the solution. Why is the US health care system flagging? According to USA Today and ABC News, it's because of illegal immigrants. The audience tested "solution" is so self-evident that it needs no explanation. Of course the "problem" is simply not true.

Three: Shut Down Any Solution that Disturbs the Current Paradigm.

Watch no less than five CNBC commentators taking on Nouriel Roubini and Tassim Taleb, trying to force them into making economic turnaround predictions. When Bill Gates comes to listen to you at Davos, chirps one commentator, isn't that "a data point" that indicates imminent economic recovery? Roubini and Taleb persevere through this ridiculousness, counseling how we must change the banks, the compensation, the culture, and everyone running it, "that class of people" who "failed and will fail again". The five person news team clamors noisily for investment advice. The five don't and won't get it, maybe since they're actually still all employed to prattle on like this. They tell the economists that they're there as a sideshow -- Roubini and Taleb have entered the mental ward that is this CNBC show.

The problems plaguing health care are as complex as fixing finance and the solutions offered are also simplistic. For health care, Obama drives towards electronic records. There's something to this, to having all the patients records in one place and accessible, no one can deny that, and we certainly support it. But technology is not the solution, it's another layer of abstraction on top of a broken system, a pay for service (not for health), for profit, high throughput scheme that focuses on "managing" patients, privatizing care, cutting costs, and improving efficiency. This focus on efficiency may work for churning out auto parts, but you can't care for humans via an assembly line.

When It's Not About Technology

Electronic records will help doctors and patients but most of all it will help the current winners, the insurance companies and for-profit entities that stand between to doctors and the patients. Doctors who currently have electronic record systems complain that they're not give time to respond to email, to enter records or to speak with patients, never mind diagnose them. Electronic records will certainly help "manage" costs. But "managing" costs and the endless drive to "efficiency" is what brought the system to its knees in the first place. The focus is wrong and the system is broken.

The New York Times had an interesting account this week by a patient who fared very differently than Michael Moore's sick, helpless lambs. Jay Neugeboren tells the story of how he was given a clean bill of health by his doctors and cardiologist. But shortness of breath and a burning pain in his back motivated him to call on some friends who were doctors. One of them recommended he go to the hospital, where he got an electrocardiogram which showed three arteries totally blocked, and one 90% blocked. Now, ten years after his quintuple bipass surgery, he's doing fine. Neugeboren emphasizes how lucky he was. His clinical profile -- lipid panel, blood pressure, weight, diet, exercise, lifestyle -- was excellent. Without his friends who took the time to listen to his problems, he said, no test or technology predicted how close to death he was. ¹

One caveat to the author's story is this: "I had no conventional risk factors or symptoms", he writes in the NYT. However in an excerpt listed on Amazon, he says: "My father, who died of emphysema at the age of seventy-two, had had a heart attack when he was fifty-nine, but he never exercised, had been overweight, and had smoked three packs of Chesterfields a day throughout his adult life." His father had a heart attack at the same age he did. Which suggests that he did have a conventional risk factor, genetic predisposition. But the author doesn't write that. Apparently he thought his lifestyle would trump genetics, and apparently his doctor thought so too. In his case it didn't. Disease is not necessarily predictable, for patients or doctors.

Because disease is not predictable, and because on so many levels we don't understand health, we need doctors to spend time with patients, to be detectives, first to sort through the patient history, then to decide what that history demands. Is the patient understating the problem or a hypochondriac. Technology shortens time with patients, but who does that benefit? Technology will give more information, but it will most reliably improve statistics with which insurance companies place bets about patient's health and improve their bottom line.

But it's not the solution to the health care crisis, if the crisis is one about poor care -- which it is. Technology seems like a nuts and bolts solution to many people but is as ephemeral as the placebo offered to a villager who sees a doctor for the first time and wants a token to feel better.

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¹ Neugeboren wrote a book about his experience.

The New England Journal of Medicine reported yesterday in two on-line publications, that a malaria vaccine in clinical trials called RTS,S passed a round of tests. If further trials prove successful, the vaccine would help protect against Plasmodium falciparum

YAY!

It's a new day.

"...His triumph was decisive and sweeping, because he saw what is wrong with this country: the utter failure of government to protect its citizens. He offered a government that does not try to solve every problem but will do those things beyond the power of individual citizens: to regulate the economy fairly, keep the air clean and the food safe, ensure that the sick have access to health care, and educate children to compete in a globalized world..." (NYT)¹

Yes, there's work to do. Yes, it will be difficult. But today we recognize how much America's just accomplished.

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¹Obama won despite warnings about possible GOP ballot fraud stemming from information dribbling out of the Ohio trial concerning 2004 Ohio ballot fraud. In the latest episode, Michael Connell, a consultant whose firm has been accused of computer manipulation, denied knowing anything about GOP rigging the 2004 Ohio election results. Connell works for Randy Cole. Cole owns 15 companies that work simultaneously on GOP election campaigns (Bush/Cheney 2000/2004, McCain 2008, many others), anti-Abortion groups and churches, GOP mass mailings, government contracts, etc. Stephen Spoonamore, a key witness in the trial brings the allegations, explains in a multi-part series starting here.

The World of Silver Spoons and Golden Specks and All that Disinfects

Did you know that a Hong Kong company makes "Antibacterial Table Ware" that can "prevent people from the following diseases: duodenitis caused by spirillums, virosis hepatitis, dysentery caused by salmonella and food poisoning caused by golden staphylococcus"? Such wishful thinking is common in the product claims featured at the Project For Emerging Nanotechnologies' inventory of available nanotechnologies. (PEN is a collaboration of the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts.) "Antibacterial Table Ware's" antimicrobial power stems from the "nano silver coating" but the technology has some fine print limitations. During holiday dinner when you're sitting at the table laden with such utensils you would need to urge your mom to "please dawdle", as she ladles the gravy and potatoes onto your plate, so as to give the "Antimicrobial Table Ware" enough time to "kill the attached bacteria and microbial [sic] in ten minutes". (emphasis mine)

The company also makes hairdressing tools that "protect people" from diseases they would (never but for horrendous circumstances) pick up at the beauty parlor, "hairdressing-related infections such as trachoma, conjunctivitis, virosis hepatitis, dermatitis and AIDS." Nanotechnology claims by companies in the US tend to be slightly more responsible, but the precociously labeled products available as imports litter the internet, while regulation and oversight lags behind prolific headfirst investment in the new technologies.

In real life, nanotechnology is not as fantastical as some marketing boasts but is very impressive. Products incorporate elements that are 1-100 nanometers in length -- a nano being a billionth of a meter, and scientists can change the structure of an element in the lab to give it unique properties. So although Carbon nanotubules can be found in nature, in soot for example, one of the most common carbon nanotubules is produced when scientists vaporize carbon between two carbon electrodes. When you think of carbon you'd probably consider the soft form of it -- graphite, or the very hard form -- diamond; however, from carbon nanotubules, scientists now construct materials that are both very light and incredibly strong -- perhaps a hundred times stronger than steel. Carbon nanontubules are used to make electronic brushes used in engines and for future applications in optics, electronics and material science, .

Silver is a proven anti-microbial -- the FDA recently approved silver coated breathing tubes used in ventilators, that may help reduce the risk of pneumonia in hospital settings. Researchers use nanotechnology for drug development and are advancing sophisticated technology to accomplish feats such as delivering drugs to a specific location in the body or building scaffolding for the regeneration of bone, nerves and other body parts. Nanotechnology offers promising advances for almost every field, medicine is just one example. However before much of this promising research yields viable products, nanotechnology will also be relentlessly hyped for selling more mundane items with dubious benefits such as "antimicrobial" socks and refrigerators.

Gilded Age

Nanotechnology products tout anti-bacterial, anti-reflective or stain resistance properties, many of which are not yet proven. Just as flatware marketing preposterously proposes to protect you from infections like Hepatitis A, hundreds of other products collectively promise to erect a magical nanotechnology barrier, a personal missile shield between you and the millions of germs that threaten you.

When you're done sipping your silver nanoparticle preserved soup from your special silver spoon you might want to brush your teeth with "cutting edge toothpaste which innovative nanotechnology is applied", made from "pure nano-sized gold that is highly effective in disinfecting the bacteria in your mouth". And if that company went out of business (likely), you can find some Korean made silver nanotechnology toothpaste that will serve the purpose. The PEN inventory lists hundreds of products with these sorts of thrilling if unsettling properties.

More concerning than blatant labeling for the benefits of nanotechnology however, is the empty labeling from companies which choose not to advertise their nanotechnology because of federal regulations. For instance, the "FresherLonger Miracle Food Storage" containers used to be marketed as "infused with silver nanoparticles that will keep soups, sauces, meats and vegetables "fresher three or even four times longer". Now the same product doesn't mention the silver nanotechnology, only the "airtight silicone-gasket locking system" which helps "retard spoilage". The change in product literature was made to avoid the EPA's regulation of products claiming to be pesticides -- antimicrobials are considered by the EPA to be pesticides.

$50 billion dollars worth of goods incorporating nanotechnology were sold last year, and nanotechnology is entering the consumer marketplace at the rate of 3-4 products a week according to the Project on Emerging Technologies (PEN). There are over 600 consumer products currently on the market, everything from utensils to washing machines to teddy bears, camera lenses, make-up, hearing aids, suntan lotion,clothing, and waterless car washes.

NanoNannies?

Beyond the veracity of labeling, is consuming particles that can't even be seen under a microscope floating around in your body safe? One skin care product called "DNA Skin Optimizer" notes that "Nano technology was chosen because it makes it possible to place the sensitive ingredients in the form of tiny crystals directly into the cell nucleus" -- which, were it true, is certainly not a comforting prospect. Scientists don't know if how nanoparticles accumulate in the body and what interactions and effects they might have, since there are very few studies on the safety of these products.

Last week, however, Nature Nanotechnology published a pilot study suggesting that the safety of carbon nanotubes warrants further investigation. (Poland et al. "Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study"; doi:10.1038/nnano.2008.111) The researchers subjected the meseothelial lining of the body cavity of mice to carbon nanotubules of varying lengths. Like asbestos, the long fiber carbon nanotubules created an inflammatory response in the mesothelium and scarring, while shorter fibers did not, which indicates (at least) that people who work with carbon nanotubules in manufacturing might be at risk for the same types of problems seen with asbestos exposure.

The environmental risks of this new technology explosion are also unknown but disconcerting. Last month researchers from Arizona State University did some experiments on silver ion containing socks that were marketed for their ability to cut down on foot odor. The researchers washed several brands of socks, and the silver washed out of the socks at various rates. The study motivated concern that the inevitable increase and indiscriminate use of nanotechnology would cast silver into streams and run-off causing environmental damage and endangering the health of species that live in and depend on streams and rivers. Products like Samsung's EPA approved washing machine releases silver ions into every load of wash, a gimmick Samsung calls: "Silver Wash that sterilizes your clothes".

Nanotechnology has broad funding support from Congress and research in this area is flourishing. However scientists and some consumer groups are worried that there are too many unknowns about nanotechnology's safety and that more research should be aimed at investigating the potential hazards. Scientists from industry, environmental groups and academia acknowledge that not only are we producing products with unknown risks without regulation, but that the lack of regulation may cause consumers to become skittish about nanotechnology.

Earlier this month a group of consumer groups recently petitioned the EPA to take a stronger stance on nanotechnology, specifically on products that market silver as a pesticide (antimicrobial). Congress is currently considering legislation on nanotechnology but legislators pared funding for studies on the health and environmental risks of the technology.

When Merck's AIDS vaccine candidate failed in clinical trials, the National Institute of Allergy and Infectious Diseases (NIAID), in the National Institutes of Health (NIH) called a summit. The drug candidate did not reduce HIV infections, in fact the adenovirus based vaccine seemed to increase the risk of infections.

The meeting of scientists on March 25th in Washington focussed on the future of HIV/AIDS research in light of the fallout of Merck vaccine trials. Scientists including Anthony Fauci, who heads the NIAID, agree that funding needs to be redirected towards a broader research agenda and ideas beyond drug development and vaccines. Science last week noted that the decision about whether to proceed with the large NIH clinical trial planned for its HIV vaccine is still pending. ("Review of Vaccine Failure Prompts a Return to Basics" DOI: 10.1126/science.320.5872.30)

Nature also reported on the summit last week, pointing out that these clinical AIDS trials went forward not necessarily based on the strength of the science -- one of the vaccine candidates had a unimpressive track record -- but because programs needed to "show the public that progress is being made, thereby justifying the millions of dollars from philanthropists and taxpayers". ("Broken Promises" doi:10.1038/452503a).

The Nature editorial offers analysis of this HIV-AIDS vaccine experience, noting that ambitious commitments made in a flush funding environment in the early part of this decade short-changed basic research. These choices to heavily fund drug development are regarded less forgivingly in light of the trial failures and the budget shortfalls of recent years, according to the journal. Nature warns other fields, for instance stem-cell research, autism, and Parkinson's disease, are repeating these same mistakes.

The business approach comes with a high stakes mentality and ample, vigorous marketing that can ratchet up expectations both within the organization, the field and the public arena. The business-oriented nature of many philanthropic organizations influences the focus on development and can distort public expectations. But investors can and do influence the direction of an entire field. When a field becomes dominated by a few foundations it can gather tremendous productive momentum, but it can also stampede so hard down a particular path with such strong momentum in a particular direction. If that direction proves to be less fruitful than hoped research cannot turn around on a dime.

Each high-funded disease has its own idiosyncratic pitfalls, but behind the good works and fine intentions of charities, but the science research rarely responds to pressure, unlike many entrepreneurial ventures. When scientists request research funding, the results don't always yield answers as quickly as businesses might hope -- research is the mythical man myth on steroids. Some people investing in biotech and international public health come from businesses very unlike public health with its vagaries of not only politics and human behavior, but biology.

In today's fast paced communications and computing climate, intense focus on "results" is inherent to our culture. Expectations carry over from the successful and extraordinarily speedy progress of the genome sequencing. Scientists and politicians built hopes during that time that drug development and an accelerated understanding of human disease would follow. It has, but did we expect more? TV drug advertising gives the impression that scientists are developing a pill for every insignificant hangnail, when many of these drugs aren't new, just the subjects of new marketing campaigns. Meanwhile tougher diseases and conditions remain elusive.

High profile funding can influence the research environment and lead to a very public dead end. In the larger picture, despite the wisdom that should be accruing from these experiences, politicians, technology leaders, and pundits sometimes wax-on about technology's potential to produce solutions not only for specific diseases but for extremely complicated social problems such as global warming and healthcare. But while science research may yield pharmaceuticals and oil extraction techniques but one cannot look to science or technology to solve the healthcare crisis in the United States. Science and technology contextualize these problems and are integral in our lives but despite heady declarations, they are not central to the solutions.

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Acronym Required has written previously about these subjects, AIDS and research directions, and vaccines. Here are a couple of our vaccine articles:

Vaccinations -- Why Worry?
Polio Vaccinations - The end of a scourge?
Group B Strep Vaccine Development
Vaccine Development For Infectious Diseases

A recent report by Marks & Clerk, "Biotechnology 2007" found that from 2002-2006, academia led corporations in the number of patents filed. Japan, the University of California, and the U.S. government were the top assignees.