Recently in Biotechnology Category

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

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

If Pigs Could Fly

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

Piglets
via Wikicommons.

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

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

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

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

They'd Fly Away?

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

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

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

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

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

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

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

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

Drawing of Man Using Compass via Wikimedia Commons

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

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

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

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

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

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

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

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

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

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

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

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

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

Or Not

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

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

That's all. Vote.

Does International Public Health News Compel Us to Cheer Enthusiastically?

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

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

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

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

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

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

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

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

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

Is Marginal Progress, "Success"?

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

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

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

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

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

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

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

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

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

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

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

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

Tough Economy for an IPO?

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

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

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

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

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

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

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

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

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

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

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

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

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

The Map

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

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

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

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

¹ Granted the UI's sometimes not entirely there

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

Challenging the Healthcare Bill

A judge recently ruled that 19 states challenging the federal healthcare bill had grounds to bring it to court. Of course not all of these states are totally behind the suit. The Washington State Attorney General Rob McKenna, for instance, is a Republican who enrolled his state in the lawsuit. However, Washington State Governor Christine Gregoire is a Democrat who strongly supports Obama's healthcare bill.

The judge, a Reagan appointee, suggested in his decision that the federal government may have overstepped its authority. But of course, shouldn't we expect this? If a group of religious zealots can halt potentially life-saving embryonic stem cell research funded by federal grants by successfully claiming their non-existent research will be infringed by competing research, then perhaps anything might fly up the flagpole in the courts. And will this challenge fair even worse in the courts than in Congress?

How Will Reform Fare? "Snip...Go Up...No More...Pink Ribbons"

Most policy debates play out on the national stage, with politicians vying for personal political points by soundbiting appealing messages for big funders. Knowledge of the issues? Intelligent discussion? It exists, but often gets swallowed up in banal point parrying. The following is an exchange between Harry Reid, a Democrat and Senate majority leader from Nevada, and Sharron Angle, his Tea Party challenger and a "mean-girl", according to Maureen Dowd. Dowd reported an exchange, precipitated by Angle, who asserted that health insurers should not have to cover anything. Reid responded that it was important that mammograms and colonoscopies be covered:

"If you do colonoscopies," he said, "colon cancer does not come 'cause you snip off the things they find when they go up and -- no more."

"Well," Angle replied tartly, "pink ribbons are not going to make people have a better insurance plan."

Anyone looking for intelligence at that Las Vegas debate would be hard pressed to sift out anything coherent there. Will the courts do any better?

Faustian Bargain: How The Federal Government Funds Anti-Science as Well as Science

In 2001, "pro-life" plaintiffs sued the federal government to stop the funding of human embryonic stem cell research. In response, the US government started the "Embryo Adoption Public Awareness Campaign" program, evidently to appease the pro-life evangelizers. Since 2002 then, HHS has granted $20 million to mostly fringe Christian "embryo adoption" programs that promote an extreme anti-science view of human development. In this way, the US government funnels tax-payer dollars to sell pro-life ideas that challenge and attempt to overwrite science.

In our last post, "Shock and Awe Strike Again, Embryonic Stem Cell Research Part I" we discussed the ongoing lawsuit by evangelical groups to stop stem cell research, specifically, Judge Royce Lamberth's preliminary injunction to stop Obama's reinstatement of some federal funding for human embryonic stem cell research (hESC). Lamberth used the Dickey-Wicker Amendment to stop any "piece of research" involving the destruction of human embryonic stem cells from getting federal funding. We asked whether scientists should have been "stunned" by the move, and pointed out that the same group of fringe plaintiffs filed a lawsuit against HHS in 2001. In this post we pick up where that post left off. We explore the concept of "embryo adoption" being advanced by agencies like Nightlight Christian Adoptions, which just sued HHS again.

Of the many Americans who self-identify as Christians (many don't), most recognize the value of science, the process of embryo development, the difference between a baby and a cell, the value of stem-cell research to saving lives, and finally the value of in-vitro fertilization (IVF) in helping couples have babies.¹ As we wrote in 2006, several highly respected theologians and scientists, including the head of NIH Francis Collins, have written books about how to be Christian while at the same time living in the modern science and technology world as a modern human being.²

On the contrary, the "pro-life", HHS funded "embryo adoption" agencies do the opposite. Although nothing but science has made their business possible, they try to pretend science is irrelevant. The agencies claim that they have the right and authority to decide who qualifies to try to bear an embryo/child. They make each childless couple who wants their services go through extended screening - as if the embryo were a child.

Interestingly, while they self-servingly label embryos as children, they then seem to have no bioethical qualms about selling them. Of course embryos are not children, nor are they aborted fetuses, as some people mislabel them. They come from petri dish derived egg and sperm embryos donated by couples who couldn't conceive naturally. The couples choose to donate to research rather than discard the embryos. The embryos do not come from inside a human, and many of them, because of the health of the parents, or the process of laboratory in-vitro fertilization, are unhealthy, nonviable and will never develop. This is a point that many people on all sides miss, so I'm going to say it again. Most of these embryos are not viable. By signing up to their embryo adoption program, couples implicitly or explicitly accept the agencies' misleading anti-science marketing, but then paradoxically undergo cutting-edge scientific procedures to try to have a child.

These "embryo adoption" groups call this fringe thinking "Christian", and unfortunately, HHS funds them -- apparently they'd rather mainstream these anti-science beliefs then risk telling the truth in this heated political climate. Stunningly, while collecting their millions in grants, these same pro-life agencies then sue HHS to halt life-saving stem cell research.

No matter what religion you claim, whether you're atheist or agnostic, whether you know or care about IVF, fertility, or adoption, you should wonder why the federal government is giving millions of dollars to evangelical groups so that they can inculcate people with these medieval notions of science, human development, and family building. Furthermore, why is the HHS, dedicated to promoting science and the health of Americans, funding groups that turn around and sue them to stop that science?

Biting The Hand That Feeds

You may remember Nightlight Christian Adoptions from former President George W. Bush's Stem Cell Address to the nation in August, 2001. By then, the lawsuit against Health and Human Services (HHS) on which Nightlight was a plaintiff had been stayed, pending Bush's review of stem cell policy. In his address, Bush gave Nightlight special kudos and flanked himself with children born through frozen embryo transfer (FET). He called them "snowflakes", which coincidentally or not happened to be the name of Nightlight's "embryo adoption" program.

Shortly thereafter, Nightlight Christian Adoptions started receiving what now amounts to millions of dollars in grants from the very agency they had sued, HHS. Nightlight uses these funds to promote "embryo adoption", which is the explicit purpose of the "Embryo Adoption Public Awareness Campaign" run by HHS's Office of Population Affairs (OPA).³ Among other activities, Nightlight sponsors bioethics essay contests for law students, makes videos about embryo adoption, sends mass mailings to IVF clinics, holds skating parties for former "snowflakes", and advances notions about reproduction and development that fit its pro-life agenda. Nightlight has opened branches across the county and has raised their fees, thanks to HHS and >$2 million in funding. (Christian Newswire "Massive New Media Campaign Raises Public Awareness of Embryo Donation & Adoption to Remarkable Heights, May 28, 2008). So is this lawsuit all the thanks HHS gets?

Nightlight's Public Business Proposition: Failure is Success?

In their lawsuit, plaintiff Nightlight Christian Adoption said they oppose life-saving human embryonic stem cell research (hESC) because their business would suffer when frozen embryos are used for research.²This is misleading for several reasons. One, although Nightlight Christian Adoptions says 500,000 frozen embryos are available for adoption in clinics, their number is not accurate. Many of those several cell embryos aren't viable because they've been frozen too long. Many more aren't viable because most embryos that are only several days old won't develop because of genetic defects, implantation problems, or other issues.

Furthermore, multiple studies have shown the only between 2-3% of couples choose to give their embryos to other couples, as this 2007 Kaiser Network study shows. But despite this research showing couples' reservations about giving up their genetic material, Nightlight's (HHS funded) promotional materials advertise that in their poll, "they asked Americans" if they would give up their embryos and 70% said yes. And despite the high enthusiasm they polled, they receive HHS funding for "awareness" campaigns.

Even if hESC were a threat to their business, this shouldn't matter to Nightlight. Their awareness campaigns and expansion conflict with their website's FAQs. For instance, in one hypothetical question, the agency asks itself - then answers:

Question: "Does Nightlight encourage the creation and freezing of embryos?"

Answer: "No, we are trying to provide a loving option to the families of the 500,000 (estimated) embryos frozen in clinics throughout the United States...We would really prefer to work ourselves out of a job!"

So lets review. 1) They're spending money suing the government with claims that human embryonic stem cells are going to put them out of business; 2) They're suing to get more HHS funds for awareness campaigns and expanding their business with those funds; and 3) claiming on their website that they're trying to use all the embryos available to work themselves out of "a job". Head-spinning.

How $20 Million Dollars From HHS Funds The Controversial "Embryo Adoption Awareness"

Nightlight's Snowflake embryo adoption program was pretty obscure until a few years ago. In August, 2002, the program had been in existence for 8 years, and only 18 children had been born, about 2 per year. Couples were obviously not convinced this was a good option. And thus it wasn't a good business model either. Nightlight was charging "$4,500 to broker an embryo transfer between couples. (Meckler, L., Aug 20, 2002, AP). That year Senator Arlen Specter inserted into a Health and Human Services spending bill a grant that distributed almost a million dollars Nightlight Christian Adoptions between 2002 and 2004. The agency received another $1.1 million dollars between 2007-2009 according to the US government tracking tool at transparency.gov (accessed 09/2010) (the tool is very disappointing on this matter because it has incomplete records for 2007-2009 and no records of previous years). In total, here's how much HHS's OPA publishes it has spent on the "Embryo Adoption Public Awareness Campaign" (accessed Sept. 2010):

FY 2002 $ 996,000
FY 2004 $ 994,100
FY 2005 $ 992,000
FY 2006 $ 1,979,000
FY 2007 $ 1,980,000
FY 2008 $ 3,930,000
FY 2009 $ 4,200,000
FY 2010 $ 4,200,000

In addition to Nightlight Christian Adoptions, HHS also funds Bethany Christian Services, Baptist Health System Foundation, and the National Embryo Donation Center -- all "embryo adoption" organizations that evangelize "pro-life" agendas. Recently, a far smaller number of grants have gone to secular organizations, but importantly, since the federal government initially funded exclusively religious organizations, HHS helped the pro-life agencies secure a foothold in the market. In fact, the US Department of Health and Human Services basically made the market for these pro-life agencies. (Note that although the HHS Embryo Adoption Public Awareness Campaign budget has increased, Transparency.gov only lists "New Grants" for 2007-2009. These amount to a fraction HHS's published budget, which makes it hard for us all to figure out where the money goes.)

Changing the Meaning of the Words "Person", "Embryo", "Adoption", "Donor"

In order for embryo adoption organizations to succeed they need embryos, which are in scarcer supply than they advertise, for reasons outlined above. The embryo adoption agencies also need to change perceptions, that is, change the meanings of words long defined by science and secular organizations. This is how the Department of Health and Human Services grants help.

These fringe groups start by using the phrase "embryo adoption", instead of "embryo donation". This is subtle, but important. The procedure of embryo donation has been around forever, offered sparingly by IVF clinics, available with a simple contract. Embryo "donation" as offered through fertility clinics meant: "you can donate these embryos to another couple". There was no religious intermediary collecting a fee and deciding who qualified.

The US government HHS funded campaign has served to advance the phrase embryo "adoption", instead of "donation". In their campaign, pro-life groups and "embryo adoption" agencies hijacked the term "donation" and now use it to refer to what IVF patients, who pay tens of thousands of dollars per IVF cycle, must donate (embryos) to the "embryo adoption" agencies -- ie: 'you donate your very expensive and dear embryos to us, and we put them up for (Christian) adoption" and profit from it.' That's an "awareness" campaign.

"Microscopic Americans"

The American Society For Reproductive Medicine (ASRM) writes here about the biologically and ethically deceptive practice of changing the labeling of embryo "donation" to "adoption". The phrase embryo "adoption" imposes the false notion that these few day old embryos are people. This mischaracterization is promoted by politicians, the media, and those receiving HHS funding. For example:

• "I believe every embryo is a child that deserves a chance to be born", the director for Nightlight Christian Adoptions embryo adoption program told the Associated Press. "This is more than mere tissue. They need an option they haven't had in the past." (Meckler, L., Aug 20, 2002 "Bush administration distributing nearly $1 million to promote embryo adoption", AP) [The "they" refers to the non-sentient embryos, many that have no chance of being viable]
• "Frozen embryo adoption offers hope to microscopic Americans". (Murdock, Deroy, August 27, 2001 The Adoption Option, National Journal ) (hat tip Salon)
• Senator Arlen Specter: "If any of those embryos could produce life, I think they ought to produce life." Calling his grant a "test", Spector said: "Let us try to find people who will adopt embryos and take the necessary steps on implanting them in a woman to produce life".

Like many other proponents of embryo "adoption", these people skip over, ignore or just don't know the actual viability of embryos, as I mentioned above. It's misleading to say that these are simply "unborn people", as the head of "Nightlife Christian Adoptions" called them, which need a warm cozy womb to be "implanted". It's misleading to say that a clump of nonviable cells are in need of "an option". Such rhetoric is a disservice to potential recipients, to science, and to the American public.

The embryos in question are the product of IVF. About 1 in 10 people seek fertility medical intervention, often in-vitro fertilization (IVF), because some part of their reproductive anatomy or physiology isn't working. The IVF embryos produced are therefore often flawed and don't develop. The recipients also have fertility problems, and a portion of these issues involve receptivity of the womb to embryo implantation. Doctors don't simply thaw an embryo out and plunk "microscopic Americans" into a uterus 'to let them thrive'.

Unlike the perception given by Senator Spector, Nightlight, and the conservative columnist, the doctors don't "implant" the embryos. After thawing, they're "transferred" into the woman in a process called "Frozen Embryo Transfer" (FET). They'd like to make you think it's like thawing a pie and popping it into the oven. It's not. Implantation is a sensitive physiological process, dependent on different factors and a different process then thawing. 50% of the embryos will not survive thawing, and most of the remaining 50% won't implant in the uterus, won't develop, and won't be born.

What Happens To All Those Other Homunculi?

Nightlight's "Snowflake" program "matches" frozen embryos of IVF patients with recipient parents, and requires a homestudy and counseling to assure that the parents are fit to purchase the embryos, Nightlight also promotes the idea that frozen embryos (most ~2-9 cells) the majority of which are not viable, are children.

The program fee is currently $8000, which doesn't include things like the homestudy -- $1,500-$3,000, medical costs (hormones, FET cycle and doctor's fees), etc. The $8000 fee will buy one batch of embryos, unless those cells do not result in a birth, in which case the couple gets another batch, and if those don't result in a birth then the couple will get a third. If none of those work the couple can pay another $2,500 for some more frozen embryos. You may be asking yourself, why would they need so many batches of embryos if each frozen embryo is a "microscopic American"? You would be asking an excellent question.

The actual FET success rate is difficult to discern from Nightlight's FAQs, but here's what they say (August, 2010):

• "To date Nightlight has matched 454 genetic families (with approx. 3314 embryos) with 312 adopting families."
• "2474 embryos have been thawed for transfer of which 54% (1328) were viable."
• "There are 225 Snowflakes children and 25 adopting families are currently expecting 32 babies"
• "About 1/4 of the Snowflakes moms who have achieved a pregnancy have carried multiples."

We could add 225 Snowflake children +32 expecting babies and get 257 births of 2474 embryos thawed, which would make the birthrate about 10% (lower than I would expect). That number is surprisingly low. But also note that apparently 2/3 of the genetic families had embryos, and about 1.4 of the 3314 embryos only gave 2474 thawed. This looks like many that somehow didn't even get to the thaw point. At any rate there's a reason why the company offers multiple batches for one price. But the agency fee is only one a portion of the price. Each time a couple goes to the fertility clinic for a transfer, they pay another fee. Each time a couple needs to do another cycle, the women subjects herself to powerful hormones. So sub-par embryos and inaccurate marketing, costs these childless couples money and create an extra health risks for women.

Although many Americans are being taught (because of HHS) that these embryos are "unborn children", the fact is, embryos are not children, just several day old cells with a small probability of being able to develop into children with the help of decades of experiments in IVF science.

It's Not Only About Semantic Changes, IVF and Embryo "Adoption"

"Embryo adoption" is a pretty middle of the road concept when you look at the what some pro-life people and groups lobby for. Christian Brugger Ph.D, wrote at the site culture-of-life.org, (Village Voice) about a 2008, HHS funded conference on embryo adoption attended largely by "devout Protestants" and Christian embryo adoption "facilitators". He reported that these two camps agreed that the embryos "stranded in U.S. concentration cans" were a problem. But some Catholics and "committed Christians" also spoke about the "intrinsically evil" problem of heterologous embryo transfer (HET), stressing that women should only get pregnant through marital intercourse. That is, as Brugger reports, many people say that this whole "embryo adoption" campaign is an attempt to give embryos legal rights by granting them legal "personhood", which would then bring into question fertility treatments, abortion, and certainly embryonic stem-cell research.

Fundamentalist Christian intervention into fertility and family building may seem patronizing, but it could be worse, as this exchange reported in the Village Voice shows:

'In July 2001, JoAnn Eiman, then-director of the Snowflakes program, traveled to Washington, D.C. to address Congress. At one point in the panel discussion, Congresswoman Carolyn Maloney, (D-New York) asked Eiman if she was in favor of actually forcing people to place their excess embryos up for adoption. Eiman said no. But later, in California, after the Congressional office sent her a transcript of her testimony and asked her to make appropriate corrections, Eiman changed her mind.

'We force people to put their kids into foster care if they're not good parents,' she says. 'If parents aren't parenting their children, aren't we responsible for making sure they do? Do we leave them frozen forever?'"

Thus, the Snowflakes director goes one step further in characterizing unviable clumps of cells as frozen children, she claims they're actually victims of negligent parents. If you scan through the evangelical Christian media on this, and public comment forums like this, where 50,000 people left comments about stem cell research for the NIH, it's easy to see that many people don't have the faintest idea about human development, about what a "stem cell" is, about what an embryo is, or about the potential of embryonic stem cell research. These people are obviously swayed quite easily, and they are being sold a false vision of an embryo not as a few cells in a petri dish with a small and precarious chance of healthy development with the help of science, but as a "unborn baby". Because of various pro-life campaigns, these people actually visualize an embryo as a "microscopic American", a preformed human, a homunculus. The "Embryo Adoption Public Awareness Campaign" of the US Department of Health and Human Services promotes this deception.

To summarize, scientists have developed fairly effective IVF through the rigorous application of the scientific method over many decades. Many embryos are not viable and do not survive. The procedures are still evolving, that is, they're still experimental. But in hopes of having kids, families spend tens of thousands of dollars on IVF -- they re-mortgage their houses to pay for these very expensive procedures. Then some fringe "embryo adoption" evangelists get these same couples to "donate" their embryos, obtained through these expensive, difficult and experimental scientific procedures. This, so that these groups can make money off the embryos while claiming to be "saving little human lives". Then these same "embryo adoption" groups sue the government, the very same Department of Health and Human Services which is supposed to be assuring the science and health of Americans, the very same HHS that has largely enabled their "embryo adoption" businesses. Millions of dollars in federal grant funding is being used to basically defile science and control how people build families, by promoting a view of human development that happens to be dead wrong.

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

¹ It's true, as the NIH wrote recently, that halting hESC research funding as the judge ordered on as a result of Nightlight Christian Adoptions et al, will stop critical research on diseases like cancer and Parkison's, which the NIH has invested millions of dollars pursuing. But although Nightlight sues to halt lifesaving research, paradoxically Nightlight is all about leveraging some of the very same research, IVF research, that their business depends on.

²We don't often talk about religiously contentious issues, in fact perhaps the last time we did was in 2006, in "Science, Faith, and Books", where we wrote: "Acronym Required generally veers away from discussing of religion and science, except when religious fundamentalists tromp into science territory and we feel compelled to join the crowd and give them a bit of a swat."

³ This is housed in what was until 3 days ago the "Office of Public Health and Science (OPHS)" -- it's now the "Office of the Assistant Secretary for Health" (OASH).

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 Sherley of Watertown, Massachusetts, and Theresa Deisher of Seattle, who do research on adult stem cells and claim that allowing embryonic stem cell research wrecks their chances of getting federal grants. Other plaintiffs in the suit were clients for adopted embryos, and the actual 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?

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 back in 2001, prior to the 2002 elections in which Republicans gained seats, a similar group of plaintiffs also sued the government. The plaintiffs in that suit, Nightlight Christian Adoptions et al v. Thompson, included Nightlight Christian Adoptions, the Christian Medical Association, and two couples who wanted to adopt embryos. The suit 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 asserted that there were better alternatives to human embryonic stem cells (hESC). Prentice 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 commenter here at concurringopinions.com discussed 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. "Pro-life" and Christian groups argue that the embryos are people which shouldn't be used for research, even if it will save lives. But scientists agree that embryonic research is at least a necessary prong to pursue potentially life-saving research, and many people, including Christians, agree.

The plaintiffs' arguments do not persuade scientists for many reasons. Their claim to economic injury is not only unconvincing on its face, considering that the plaintiffs don't do research and the NIH funding structure evaluates all promising technology, it's dwarfed by the impact that stopping the research would have on the lives of sick people. As well, the livelihoods of many science 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 (.pdf), now threatened 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.

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.

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

*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 to communicate with a search engine. Then I flipped the search to Google News. Google News search also insisted I must mean "increase". So I finally got the statistic I was looking for, and then relented to Google's know-it-all suggestion and looked at "HIV infections increase". Google was wrong, as I already knew, HIV infections were actually decreasing. But I understand the reasoning, even if it's only algorithmic: The first search phrase, ending with "decrease", yielded only 1,940,000 results in .22 seconds, whereas the second, ending with "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 (C. 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