Recently in Business and Technology Category

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

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

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

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

Does International Public Health News Compel Us to Cheer Enthusiastically?

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

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

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

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

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

No one would 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? 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; listen to scientists around the web and in journals like The Lancet ⁴; or heed 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 the main question the trial seeks to answer.
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 after 12 months. 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 it 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, who was complementary of the RTS,S effort, if critical on some points.⁶

The history of the Sanaria vaccine is also an interesting, expensive, and laborious endeavor. The underlying idea seems promising, but for starters, technicians dissect out the salivary glands of mosquitoes to develop the vaccine.⁷

In the first trial, Sanaria injected 44 subjects. 42 people got malaria and 2 didn't, a 4.5% "success" rate. Although those subjects might have been better protected from malaria lounging in a malaria endemic region in mosquito-infested huts, Sanaria 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 the success of their trial and primed for the next controversial⁷ phase. At the moment, every possible vaccine holds promise, since we have none.

Their 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. Does that make this vaccine a beta version?

Is all the 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 the vaccine routes, 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 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). 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.

² The RTS,S Clinical Trials Partnership; First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children, October 18, 2011 10.1056/NEJMoa1102287

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.

Mundane Data Breaches

Mistakes usually occur after a conflagration of seemingly small, quotidian errors. Often no one seems to own the problem, it's simply a "glitch". In our technological world, we're quite accustomed to glitches and large data integrity losses. We stick the newly issued credit card into our wallet before even knowing (or caring) about the details of why it was replaced.

Technology "glitches" are not to be trifled with though, they shut down metropolitan train systems, admit ~32,000 students instead of ~16,000, and compromise the most private data of 31,000 people, 100,000 people, 4 million people...They're just boring news.

In medicine, repercussions from computer glitches make train outages seem trivial. From August 2008 through February 2009, a computer glitch in the Veteran's Affairs record system tied patients to the wrong medical records, leading to incorrect dosing, delays in treatment, and other errors. A computer glitch in another case incorrectly cleared women of breast cancer after mammogram screens showed they actually had tumors.

Bodily Injury and Death

Imagine the most unimaginable "glitch" and it's probably already happened. In one, famous 1980's case (PDF), cancer patients undergoing radiation treatments from the Therac 25, manufactured by Atomic Energy of Canada (AECL), intermittently received radiation doses 100X the prescribed dose. The resulting radiation could burn through the torso and leaving a burn marks on the victim's back. The trauma from radiation trauma killed some patients within weeks.

An investigation of the Therac 25 history showed how multiple errors begot fatal injuries. The high doses occurred when a technician first entered an "X" to incorrectly select a certain dose of high beam photon mode; then "cursor up"; then "E" to correctly select a certain dose in the electron mode; then "Enter", all within 8 seconds. This accidental series of keystrokes activated the high beam instead of the low-beam, but the high beam diffuser wasn't in place, so intense radiation burned ears, breasts, groins, clavicles.

When it happened to one patient, the sound system between the treatment room and the operator wasn't functioning. He had been treated multiple times in the past, so knew something was wrong when as he lay on the table for treatment he suddenly heard unusually loud noises, saw a flash of light, and felt a searing burn. Pause. Then it happened again. The technician only learned something was wrong when the patient pulled himself off the treatment table and began banging on the locked door.

Because the burns happened infrequently, because the error messages were imprecise or oblique, and because technicians, engineers and managers couldn't believe the Therac 25 was malfunctioning, operators continued to injure patients until 1987. In a letter to one hospital physicist AECL explained that their machines couldn't be malfunctioning because of modifications that improved the "hazard rate" by "at least five orders of magnitude! With such an improvement in safety (10,000,000%) we did not believe there could have been any accelerator malfunction."

A glitch -- an "accelerator malfunction"? Or errors attributable to peoples' actions?

Errors Upon Errors

The persistence of medical physicists at several hospitals quickened Therac-25 problem solving, but clumsy safety processes, a reluctant manufacturer, and slow FDA action impeded resolution. In the final analysis, a long list hardware, software, quality assurance and process issues such as these, contributed to the injuries and fatalities:

• The hardware and software were built by two different companies and only tested when the system was installed in the hospital.
• Code wasn't independently reviewed.
• Some engineering errors permitted overrides after malfunctions, other errors allowed for safety check bypasses.
• The FDA hadn't thoroughly tested the Therac 25 (a medical device) because previous models had a reasonable safety record. But the Therac 25 had undergone numerous changes, for instance manual control systems transitioned to software controlled systems.
• The company recalled the machines at one point, but because the first patients didn't die, the FDA under-classified the severity of the problem. But an intense radiation beam to the head could result in a more lethal dose than another body part, so later incidents were fatal.
• The medical physicists and the FDA made recommendations to AECL. The company complied with some safety directives, but ignored others.
• Technicians incorrectly diagnosed issues, for instance in one case a problem was wrongly attributed to a switch. The company replaced the switches. The problem recurred.
• AECL wrongly told some institutions who reported incidents that theirs was the first report. So each hospital thought their case[s] unique.

Elusive Intangible Injury

In the Therac-25 case, each contributor -- a software programer, an engineer, a technician, someone in quality assurance, a safety officer, staff at the FDA, a company executive -- made a small mistake. Lawsuits, FDA investigations, out of court settlements, and eventually national media exposure brought the case attention. The entire compendium of errors in the Therac-25 case is so classic and dramatic that it's used as a case study. But what about computer glitches where less harm is done to fewer patients over a shorter period of time? Or what if so many are hurt - millions, say - that the plight of any one individual gets diffused? What if the evidence is unclear - there there are no burn marks on the front and back of the body?

Can injured patients be made whole? In Therac-25 cases, the lawyers of families of patients with terminal cancer argued that patients died sooner and suffered more because of their Therac-25 injuries.

What if doctors delay cancer treatment and the person dies an early death from breast cancer, as in the case we mentioned above? What can lawyers prove, how can victims be compensated? In the case where Veteran's Administration patients were matched with the wrong record, the VA denies that any negative outcomes. No harm reported, no harm done?

What about still "lesser" glitches, everyday database breaches?

Patients: Students of Misfortune?

The US HIPAA laws protect a person's medical data, file, or record from being accessed by an unauthorized person. Therefore someone couldn't enter your doctor's office, grab your paper record from the thousands stuffed floor to ceiling, and forward it on. Sometimes the law seemed overly strict. In the name of HIPAA, unmarried lifelong partners of hospitalized patients were forbidden from learning about their loved one's health.

Although HIPAA has provisions for electronic records, today's larger, more frequent mishaps leaves this regime seeming quaint. Consider the recent data breach at Stanford, where the emergency room records of 20,000 patients were posted on line. A New York Times article details how it happened. One billing contractor dealt with one marketing contractor, who interviewed one potential employee who leaked the data. The marketing contractor received got the data from Stanford Hospital, "converted it to a new spreadsheet and then forwarded it" to a job applicant, challenging them to

"convert the spreadsheet -- which included names, admission dates, diagnosis codes and billing charges -- into a bar graph and charts. Not knowing that she had been given real patient data, the applicant posted it as an attachment to a request for help on studentoffortune.com, which allows students to solicit paid assistance with their work. First posted on Sept. 9, 2010, the spreadsheet remained on the site until a patient discovered it on Aug. 22 and notified Stanford."

Would any of these patients know if they were harmed? What if they had some condition that an insurance company, employer, teacher or other would use to disqualify them as in this Stanford case? Will the class action lawsuit that's filed make them whole? What if someone recognized the value of such data and stole it, as in a recent Orlando, Florida case where hospital employees forwarded emergency room data for over 2,000 accident victims to lawyers? In the old days, hauling 20,000 patient files out of a doctor's office unobtrusively would be a challenge. Not so much with electronic data, all you need is a glitch.

HIPAA specifies that each responsible individual can be fined $250,000. Will the job applicant who outsourced her Excel Worksheet problem to StudentofFortune.com pay $250,000? The marketing contractor? The billing contractor? Stanford?

Often the public has no idea about medical injuries resulting from glitches, physical or otherwise, just as they didn't with the Therac-25. If someone dies, as in the Therac-25 case, perhaps the news will get out. But the more common the incidents, the more data is lost, the more are made to seem benign, the more harm is done, the less we learn about any particular incident.

You can read all this as a depressingly negative outlook on technology and health, but my view is different. Injuries and deaths due to vague "glitches" can be prevented by fixing small, but very tangible errors. The outsourcing of everything has increased the number of contractors, and with all these people, looser interpretations of rules and diffuse culpability. But it's not just contractors. Many employees are also very cavalier about data. Walk-in or call any major medical center and you will see glaring errors. Fixing such errors, attention to detail, and yes - support for regulatory oversight, can reduce harm.

Blue Screens

When I traveled to Italy a few years ago I found the blue screens on computers to be the most memorable travel experience, you know, aside from the terraces and olives and Caravaggios of travel lit - the "Blue Screens of Death". I hadn't seen so many blue screens since the 1990's. Fresh off the plane, the machine to purchase tickets took our money without producing train tickets. The station agent cocked his head and displayed doleful eyes at our request for a refund. Like it was the most absurd thing he'd ever heard! Then he walked around the room gesticulating at exhibits A, B, C, D...all blue screens on all computers, and he explained verbosely in Italian: That's why we wouldn't get a refund. He did finally produce our tickets, not because we explained how to fix the screen problem - which he dismissed with a flick of the hand; not because we subsequently insisted that he use a telephone work-around; but most likely because we threatened to sit there forever. We are usually in a big business hurry, but...

That was only the beginning of Blue Screens in Italy. Blue screens at the airport, blue screens at internet cafes, the hotels, the train stations, the offices, even at the empty museum exhibit -- how? This was a far cry from countries even a decade earlier where the remotest places, say in Asia, got on online and stayed up and doing business. That was my Italian experience.

Trials

Today, Italy is still looking a little medieval, isn't it? All that ancient stone architecture with the tiny little windows romantic in one view, lends a sinister backdrop to the bizarre Perugia murder trial, which Perugians complain sullied their town's reputation.

Then there's the other trial, that of the seismologists being tried for information they supposedly didn't provide to townspeople of L'Acquila before the earthquake. Thousands of scientists have written to protest the prosecution of scientists. Actually, the scientists did relay the risk of earthquake on that day, about 1:1000, but subsequently a government official garbled the message. At the same time, disturbingly, a non-scientist was claiming (falsely) to be able to predict earthquakes based on radon gas measurements. So that radon-guy jacked the townspeople up, then the official tried to reassure them, now the scientists are on trial.¹

Shutting Down Speech

This week, the computer screens went black in Italy. The government introduced a new wiretapping bill that imposed severe restrictions on online speech. The Italian bill declared that the online author of any 'alleged defamation' would need to correct the problem within 48 hours or be punished by a large fine. Guilt of defamation would be in the eyes of the "defamed". Wikipedia protested with a blackout.

Wikipedia's action got the bill partially changed to apply only to larger businesses, not blogs and Wikipedia. But as Nieman Lab explains, the bill stills stands. Furthermore, it's the overall state of press freedom in Italy that's "dismal". As Nieman Lab writes:

"Berlusconi owns the influential private media company Mediaset; he exercises direct control over state television. Italy's 100,000 professional journalists, to get work, must belong to the Ordine dei Giornalisti -- a group that is, in effect, a modern-day guild. This year's Freedom House survey of global press freedom, citing 'heavy media concentration and official interference in state-owned outlets,' ranked Italy as only 'partly free."

It makes it seem like blue screens would be the least of their problems. I know, it's totally biased to judge Italy on these select things, just it would be to judge Americans on their predilection for their cowboy hats, guns and anti-science moves. Nieman Labs interviews several people (from Perugia) who understandably worry how severely the government threatens press freedom. And of course many other governments, not only Italy, seek to curtail internet expression. If governments continue to corral the "Internet" -- rather, the now familiar "internet" - will we have to start calling it the "Intranets"?

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

¹ In a recent post, we criticized Fox News for profiteering on the weird, absurd, and false earthquake predictions of Jim Berkland. This trial adds another dangerous twist to Berkland's odd-ball predictions. Confusing people about the real risks isn't just bad for science, it's an actual liability for governments.

Just Like 1908?

After Hurricane Irene, some people joked that the media sees hurricanes as a grand opportunity to dress up in the newest outdoor gear and brace against the howling wind, downed trees, and rain driving sideways (although sometimes pranksters steal the show.) Hurricanes have all the right elements for media profiteering too - drama, death, destruction and lots of "human interest". But to build drama, you need to build up the storm. On Friday night, August 25th, we linked to these four news stories in successive Tweets:

• Hurricane Irene could be the most destructive hurricane to strike New York City since: 1903 (Published August 26, 2011) 25 Aug tweet acronymrequired
• Hurricane Irene could be the most destructive hurricane to strike New York City since: 1908 (Published August 24, 2011) 25 Aug tweet acronymrequired
• Hurricane Irene could be the most destructive hurricane to strike New York City since: 1938 (Published August 26, 2011 10:28 p.m. EDT) 25 Aug tweet acronymrequired
• Hurricane Irene could be the most destructive hurricane to strike New York City since: 1985 (Published August 26, 2011 1:23AM) 25 Aug tweet acronymrequired

Not only can't forecasters predict with 100% accuracy the power or path of a storm, but certainly, as we showed, newspaper reporters can't. The media can't necessarily be faulted though, after all a hurricane is a moving target. In fact, as long as everyone tunes in, the media actually plays an helpful role public safety role, that is by creating more drama on television then any one person can witness outside, over-the-top media coverage can actually aid public safety officials.

The list of East Coast storms throughout history is extensive, but reporters plucked somewhat random mix of historical events out of the hundreds available: The so called Vagabond Hurricane of 1903, produced 65mph winds in Central Park; the deadly New England Hurricane of 1938, was a Category 3 at landfall; and Hurricane Gloria in 1985 struck as a Category 2 hurricane. It's unclear what storm in 1908 the Lehigh Valley Morning Call reporter was talking about, since none of the storms that year amounted to much, and on August 24th 2011, when the Morning Call published, most reporters were comparing Irene to Hurricane Katrina, not some random storm that blew out to sea in the Caribbean. Maybe the reporter hadn't had their morning coffee.

But there you have it, taken together, it's clear that storms can go many different ways and we don't have the technical or intuitive abilities to predict them exactly accurately, or at least to the degree that audiences seem to be demanding after the event.

That Healthy Cry, The Complainer - Alive and Well

When Irene actually hit, the hurricane created lots of flooding and destruction not to be trifled with. But as the New York Times reported after the storm, some New Yorkers were peeved at the pre-storm hype. New Yorkers expressed anger at the cops on bullhorns telling people to go inside, anger at the storm itself for not living up to its potential, and of course anger with Mayor Bloomberg. One person complained Bloomberg made people spend too much money: "The tuna fish and the other food, O.K., we're going to eat it. I don't need all this water and batteries, though."

But lets compare this outcome with the great bungling of Katrina in 2005, to see how things can easily go the other way. At least 1,836 people died in Katrina and property damage was estimated to be $81 billion 2005 USD.

FEMA took most of the fall for the Hurricane Katrina management disaster, along with FEMA administrator Michael Brown ,who appeared utterly useless despite fervent support from George W. Bush. As we wrote at the time in "FEMA- Turkey Farm Redux?", FEMA had failed US citizens in multiple hurricanes during the administration of George H.W. Bush in the 1980's, and had been expertly revived and made useful during the Bill Clinton administration under the leadership of James E. Witt. Then George W. Bush decimated the revived FEMA, using it as his father had. As the House Appropriations Committee reported in 1992, FEMA had been used as a "political dumping ground, 'a turkey farm', if you will, where large numbers of positions exist that can be conveniently and quietly filled by political appointment". (Washington Post July 31)

So given the recent history of Katrina, and the debacles of several state and city governments in last winter's multiple blizzards, it seems inane that so many people who lived through those disasters now fault Bloomberg as "the boy who cried wolf". But then people might complain no matter what, and given the somewhat unpredictable path of storms, I think everyone would agree that it's better to be alive complaining, than dead and swept out to sea because of lack of government warning.

Assuring Future Disasters are Worse

Of course we don't know how the government would have fared in a worse disaster. And while people complain about the lack of a bigger hurricane, FEMA is currently hindered from helping with Irene. Why? Apparently, a FEMA funding bill is being held up in the Senate while politicians with idiosyncratic proclivities indulge their hypocritical "family values" by meticulously delineating all the organizations that can't be paid with FEMA money.

To our detriment, we ignore larger issues while we complain. FEMA's role takes a role not only during and after a hurricane, but in adequately preparing people ahead of time, as we wrote in "FEMA and Disaster Preparedness". Neither FEMA nor state or local governments adequately helped prepare for Katrina, as we detailed in: "Disaster Preparedness - Can We?". Although states and cities didn't play as large a role in the the federal government failings as G.W. Bush would later say, rewriting of history, their role is important.

Of course, disaster preparedness means not only motivating citizens to buy supplies and stay inside, not only mobilizing a deft response, but shoring up infrastructure ahead of time. In the wake of Katrina, we all heard about the failure of governments to build adequate New Orlean's levees, an issue Acronym Required wrote about in "Levees - Our Blunder". However before Katrina, few people realized just how flagrantly officials ignored warnings about the weak levees. When the hurricane breached the walls, politicians acted surprised, that surprise masking the blunt unwillingness of politicians and US citizens to support and fund infrastructure.

We wrote about more widespread infrastructure failings in 2007, in "Guano Takes the Bridge, Pigeons Take the Fall". But infrastructure is easy to ignore. Just as vociferously as citizens complain about the hype preceding Hurricane Irene¹, they remain stunningly silent on the lack of infrastructure preparedness. In fact there's loud clamoring to dismantle the very agencies that assure our safety. Obama has tried in some ways to address the infrastructure problem, not without criticism.

In the case of the New Orleans levees, the New Orlean's Times-Picayune reports that although $10 billion has been spent upgrading the levees, the Army Corps of Engineers is giving them a failing grade. The report says that the refurbished levees might stand a 100 year event, but a larger event will result in thousands of deaths and billions of dollars in property damage. This was exactly the criticism of the levees after Hurricane Katrina in 2005.

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

¹ Here's an interesting analysis of the hype-factor of news relating to Hurricane Irene. The author uses a quantity of publications analysis to argue is that the storm was not hyped.

New Scientists Who Don't Do Science

Every so often, actually with disturbing frequency, claims about the underlying cause of autism spring up like fungii in manure after a rain. It's practically required that claims of this genre be built on false premises or make invalid conclusions, like this week's link between internet use and autism. Oxford personality Baroness Susan Greenfield breathed life into this rumor in an interview with New Scientist, then defended herself by saying provocatively: "I point to an increase in the internet and I point to autism, that's all." But where's the evidence, and why is this stuff being published?

Greenfield's been at this for a while, "popularizing science" for decades, and recently "popularizing science" at the cost of science itself. In 2008 she warned the children's brains were being destroyed by technology in a book reviewed in the Times:

"As it happens, her new book, ID: The Quest for Identity in the 21st Century, digresses all over the place in little flash floods of maddening provisos and second thoughts. It's as if she dictated it while bouncing on a trampoline, fixing an errant eyelash and sorting her fraught schedule on a BlackBerry."

Back in 2009, before the UK's Royal Institution fired Lady Greenfield, she argued that the total immersion in "screen technologies" was linked to a "three-fold increase in prescriptions for methylphenidate" (prescribed for attention deficit disorder). She told the paper that people were losing empathy and becoming dependent on "sanitized" screen dialogues, just like packages of meat in supermarkets had replaced "killing, skinning and butchering an animal to eat".

Had you ever thought of the internet like that? No? Science popularizing has that power. I'm not deriding science popularizers, I'm criticizing the practice of distorting science. Greenfield's analogies opened up new worlds of understanding for Guardian readers too. 254 people commented, some sarcastically:

• "That's exactly what my mum said about reading The Beano."

• "I hear it gives you cancer as well""

Guardian readers know how to take a piss. But Oxford's Greenfield knows how to get publicity. So her 2009 headline followed and preceded myriad other claims, all to scare people about technology. To her latest, scientists online responded briskly, with vitriol, meaning that in terms of popularity, Greenfield had a field day. We've been following false arguments about autism for a few years, so we wanted to look more closely at how Greenfield's latest claim about the internet causing autism differs from the claim that television caused autism that we covered back in 2006. For one, back in 2006 they actual did research -- well, economics research.

But Who Needs To Do Research When They'll Print the Stuff You Make Up?

Maturing her arguments of 2008-2009, Greenfield now adds autism to the mix, upping the ante by playing not just to fuddy-duddy technophobes but to all parents and their worst nightmares. One day the child seems fine, then something mysterious happens and the child is no longer themselves. What happened? Doctors and scientists have no clinically actionable idea. Greenfield knows.

Perhaps it makes life easier for some autism suffering families to attribute changes in their child to some outside agent. It's also common to say that a crime has been perpetrated by people from another state or town or country. We've seen autism blamed on vaccines, television, rain...Uncomplicated agents that can be controlled by parents are especially attractive - TV. But where's the evidence? When the New Scientist asked that, Greenfield replied:

"There's lots of evidence, for example, the recent paper "Microstructure abnormalities in adolescents with internet addiction disorder" in the journal PLoS One...There is an increase in people with autistic spectrum disorders. There are issues with happy-slapping, the rise in the appeal of Twitter - I think these show that people's attitude to each other and themselves is changing."

How nimbly she links computer use, with "internet addiction disorder" (IAD) -- not recognized by US psychiatrists; with brain change; with behaviors; and even with attitudes - facile. But the paper didn't say anything about attitudes; didn't prove "addiction", didn't prove detrimental brain changes, didn't prove behavior changes.

Can You Compare the Cognition of Chinese 19 Year Olds Playing Games 12 Hours A Day To 1 Year Old Cooing Babies?

The PLoS One paper deserves more comment than I'm going to devote here. To note, though PLoS One depends on the community for peer review, and although this paper has over 11,000 views (14/08/11), not one person has peer-reviewed - "rated" - the paper. Nevertheless, it's cited all over the internet as proof that "internet use" does bad stuff to the brain, take your pick - "shrinks it", "wrinkles it", "damages", "contracts", "re-wires" it... But the paper is not about "internet use". It's about on-line gaming.

The PLoS One authors write that the research is particularly important to China because unlike in the US, in China, IAD is recognized, and is cited as a big problem. The Chinese vigorously treat the "disorder" with strict treatment regimens including until 2009 shock therapy.

The authors used addiction criteria (i.e. "do you feel satisfied with Internet use if you increase your amount of online time?"), and asked the subjects to estimate how long they had had the addiction. They then used brain imaging to show that brain changes correlated with self-reported duration of online game playing. There were 18 subjects, 12 males average age 19.5 years, and presumably 6 others (females?) who the authors do not characterize.

The subjects played online games 8-13 hours a day. I can't evaluate the data, I don't know enough about voxel based morphology. But I'm not surprised someone "playing online games" 8-13 hours a day, 6.5 days a week for 3 years is different than the controls, who were "on the internet" less than 2 hours a day. Likewise, I would expect a soldier engaged in street patrol in Afghanistan 10 hours a day, 6 days a week for three years to be different than someone who walked their dog around the block in sunny suburbia 3 days a week for the last month. (If I were in a joking mood I'd say that kids playing online games 13 hours a day 6 days a week must have extraordinary abilities to actually still be in college.)

Even if you believe in IAD, the authors acknowledge the study's limitations. They say they don't prove IAD caused changes; don't prove that the subjects brains weren't different to begin with; acknowledge the "IAD duration" measurements (self-assessment) are crude; and the data aren't rigorous to conclude negative changes.

None of these caveats slowed Greenfield, who cited this paper and linked it to all sorts of unrelated things. But autism is NOT related. Wikipedia describes what she calls "Happy-slapping" as an outdated British fad", evidently more a media fad than a scary phenomenon - it's not related to autism. There's nothing inherently sinister about using Twitter - it's not related to autism.

Greenfield trained as a neuroscientist. Does she not know this stuff? In 2003, she mocked people who attributed anything to "scary technology." So why is she now popularizing the opposite message? Her PLoS One example is nothing more than pulling some study out of thin air and linking it to her own machinations about technology. Claims such as hers provide ripe fodder for quacks, crazies and zealotry.

How Does Technology Change Us? Research Shows Beneficial Effects in Online Gamers

Here's the second instance of "proof" Greenfield gives in the New Scientist interview, and note that again cites an academic paper and links it incongruously to her own made up stuff. She says:

"...A recent review by the cognitive scientist Daphne Bavelier in the high-impact journal Neuron¹, in which she says that this is a given, the brain will change. She also reviews evidence showing there's a change in violence, distraction and addiction in children."

But the Bavelier et al review says something different. The scientists specifically warn that no research predictably links brain changes to behavior like violence, distraction or "internet addiction" to technology - TV, video games. The authors cite studies showing the research remains too confounding, as they say in their conclusions:

• "the interpretation of these studies is not as straightforward as it appears at first glance"

• most reports tabulate total hours rather than the more important content type, therefore are "inherently noisy and thus provide unreliable data."

• technology use is "highly correlated with other factors that are strong predictors of poor behavioral outcomes, making it difficult to disentangle the true causes of the observations"

• Perhaps "children who have attentional problems may very well be attracted to technology because of the constant variety of activities."

Bavelier et al stress that the effects are unpredictable, for instance "good technology" like the once ballyhooed Baby Einstein videos can turn out to have zero or negative effects. Conversely assumed "bad technology" can be good. They write:

"action video games, where avatars run about elaborate landscapes while eliminating enemies with well-placed shots, are often thought of as rather mindless by parents. However, a burgeoning literature indicates that playing action video games is associated with a number of enhancements in vision, attention, cognition, and motor control."

This point from Bavelier et al is quite interesting because it appears to contradict the general conclusions of the PLoS One authors we cited above concerning online gamers -- assuming the study subjects played comparable games. Exploring these different results is potentially more interesting than a rhetorical sleight of hand tossing a science study citation in to falsely bolster gobbledygook.

To wit, the studies Greenfield uses don't support her points. That technology's effects are still unpredictable is widely acknowledged. Greenfield herself used to promote a computer program called MindFit which claimed to improve mental ability. The game didn't work. But it also didn't make kids pick up knives and murder each other. It's hard to understand Greenfield's motivation for denouncing technology as anything other than provocation.

Greenfield says: "It is hard to see how living this way on a daily basis will not result in brains, or rather minds, different from those of previous generations." But "hard to see" isn't science. A "brain", is not a "mind", nor is it "behavior", nor an "attitude". That's not to say brains don't change, or that technology couldn't affect us. Brains show changes during many activities, often temporarily. It's just to say that technology is not inherently, as she called it, "chilling".

I Point to Television and I Point to Picnics, To Family Dinners, To Teens Doing Charity, To Children Building Sand Castles on Sunny Days

As she is now vilifying the internet as a physiological change agent, Greenfield previously claimed that television changes the brain deleteriously. Now she dismisses the notion. When New Scientist asked her: "What makes social networks and computer games any different from previous technologies and the fears they aroused?" she responded:

"The fact that people are spending most of their waking hours using them. When I was a kid, television was the centre of the home, rather like the Victorian piano was. It's a very different use of a television, when you're sitting around and enjoying it with others..."

Nice image, the innocent television, like the innocent Victorian piano. Happy family times of the Victorian Era, singing around the piano, food aplenty, spirits flowing, enlightened, goal oriented well adjusted children unhindered by repressive social situations. Oh wait, it wasn't always like that? We learn more about the good 'ole days by venturing dangerously out on the internet where you can find the following first hand accounts:

Isabella Read, 12 years old, coal-bearer, as told to Ashley's Mines Commission, 1842: "Works on mother's account, as father has been dead two years. Mother bides at home, she is troubled with bad breath, and is sair weak in her body from early labour. "I am wrought with sister and brother, it is very sore work; cannot say how many rakes or journeys I make from pit's bottom to wall face and back, thinks about 30 or 25 on the average; the distance varies from 100 to 250 fathom. I carry about 1 cwt. and a quarter on my back; have to stoop much and creep through water, which is frequently up to the calves of my legs."

Sarah Gooder, 8 years old, trapper, as told to Ashley's Mines Commission, 1842: "I'm a trapper in the Gawber pit. It does not tire me, but I have to trap without a light and I'm scared. I go at four and sometimes half past three in the morning, and come out at five and half past. I never go to sleep. Sometimes I sing when I've light, but not in the dark; I dare not sing then. I don't like being in the pit. I am very sleepy when I go sometimes in the morning."

Greenfield's current glorification of TV defies the fact that TV has been roundly implicated for causing all sorts of unsocial behavior and not only by Greenfield before she changed her mind.

The Autism TV Link: "Why Not Tie it To Carrying Umbrellas?"

In 2006 Acronym Required used a study by economists linking autism and television to write a satirical ten step tutorial on how to publish bad science and get lots of media attention for it. The authors proved that a theories popularity, if brought to the attention of a non-critical media was independent of clearly stating no link between autism and television in your study. You didn't even need to be a scientist.

After reviewing those economists' work, Joseph Piven, director of the Neurodevelopmental Disorders Research Center at the University of North Carolina, weighed in on the autism television-watching idea, asking the Wall Street Journal "[W]hy not tie it to carrying umbrellas?" And so the researchers did! And in 2009, in "It's Back! The Rain Theory of Autism", we described how the same researcher group that blamed autism on televisions decided that it wasn't television causing autism, but rain.

The nice thing about making up "science" or just leveraging your status for narcissistic purposes, is that you can change, chameleon-like, at will. If your aim is to generate a headline in mainstream media rather than research, it doesn't matter what the science says. Most people don't remember headlines from one day to the next and they aren't that curious to dig further.

I believe a natural response to Greenfield's wild claims is humor and sarcasm, the same response the Guardian readers had. To Greenfield's latest foray, Carl Zimmer started an amusing twitter exchange with this: "I point to the increase in esophageal cancer and I point to The Brady Bunch. That's all. #greenfieldism".

A string of #greenfieldisms followed, like "@carlzimmer I point to Alzheimer's and I point to cheese doodles. That's all. #greenfieldism". (Of course this territory is risk ridden, because of the prevalence of actual real random "studies" like the one about mice who eat fast food and get Alzheimer's.)

When challenged, Greenfield didn't back down, instead she spewed forth with more analogies, like a clogged toilet if test-flushed. Asked for a response to the fact that there's not evidence claiming detrimental effects of technologies, she scoffed that you wouldn't see effects for 20 years. With just as absurd a distracting non-sequiter she once asked someone who challenged her on the technology-is-bad assertions if they denied smoking causes cancer.

Flexible "Theories" Make For Good Publicity for Scientists, For Newspapers...

I think it's cathartic, funny and educational to diffuse Greenfield's claims with humor. Wicked-fast coordinated Twitter de-bunking of such people is of course useful and could be made even more useful. Unfortunately the issues aren't always as simple as a Greenfieldism. And debunking the rhetoric of individuals seeking publicity on the backs of science is only one angle.

I think it's important to note that it wouldn't be news if there weren't ready and willing news outlets. The New Scientist printed all her assertions about links between technology, brain structure, autism, and behavior. They didn't ask questions. They didn't challenge. They didn't say: wait, isn't autism diagnosed at ages 2-4? Who's propping their 6 month old up in from on the computer to play war games? Why?

The Guardian, like most papers, publishes articles that range in quality. A Guardian comment on the 2009 article about Greenfield's theories, that called the article "absolute nonsense", and wrote I am surprised that the Guardian has published this..."sloppy journalism"..."absolute drivel", pulled in 160 "approve" votes, far more than any other comments. So even if readers hate the article, they'll still read it. Media succeeds because of advertising and hundreds of comments translates to how many hundreds of thousand of hits?

The media is quite capable of selective coverage. They ignore important scientific, political, and economic stories that they consider politically sensitive. But is anti-science coverage ever "censored"? Not if it can drive traffic, and sell ads - provide economic benefit to media outlets.

But to what extent can we accept this concession to the market if it gives us in return uncritical readers, uncritical patients, and uncritical citizens? Does it create an atmosphere amenable to medical quacks? Might it prime a population to be more receptive to political efforts to curb real free speech via social media technologies? Too bad so many potential critics (even bloggers) are involved with or depend on mainstream news outlets, which makes them understandably hesitant to bite the hand that feeds (or might feed) them.

---------

¹ Bavelier, D., Green, C.S., & Dye, M. (2010). Children, wired - for better and for worse. Neuron. 67, 692-701, Volume 67, Issue 5, 692-701, 9 September 2010 Copyright © 2010 Elsevier Inc. All rights reserved. 10.1016/j.neuron.2010.08.035

Acronym Required writes frequently on the diffusion and distortion of science in politics. We've written about individuals mixing religion with science, art with science, for instance here

Gus Speth, NRDC founder, book author, law professor, and former academic dean, discusses the root causes of the collective lack of action on climate change and the environment in an interview with Bulletin of Atomic Scientists¹. He starts by pointing out that the United States, one of the world's wealthiest countries, has lost ground not only GDP but on on other quality of life indicators -- economic equality, life expectancy, and the environment. If the world continues its current path, climate change will inevitably get worse. The impact of continued environmental degradation is entwined with economic decline -- but not in the way that prominent messengers would have you believe.

True, climate change is difficult for individuals to come to terms with, especially if it's not directly impacting them. But understanding of the problem is amplified by what he calls "manufactured reaction". It's politics and lack of leadership that's paving the path to continued calamity, Speth says:

"Anxiety about acting on climate change was successfully injected into the Tea Party movement; and, as a result, a large percentage of the Republicans who came into office after the 2010 election were people who were on the record as climate deniers, and now the Congress is full of these people..."

Speth notes how the difference between politics now and the 1970's hampers action.

"American politics since, say, 1980, has gone seriously downhill. The level of public discourse on issues has deteriorated; the willingness of politicians to take up tough issues has deteriorated; and it's just a very different scene today in our country....

In the 1970s we passed a host of environmental measures, almost always with serious bipartisan support. There wasn't really a polarization on environmental issues between the two parties, certainly not like what we have today. Politics was far more civil, and it was far more bipartisan. For example, Senator Edmund Muskie, a Democrat, was a champion of the Clean Air and Clean Water Acts, but that legislation was also made possible by people like John Sherman Cooper, a Republican, and Howard Baker, also a Republican, and others. I think we've lost a lot of ground politically since that time."

He notes that the Tea Party is a force because of their ability to communicate ideas to the public. On the other hand, effective to communication about climate change and the environment has suffered because no one is communicating the most important ideas to the public, not the media; not the president, not environmental groups. On the media, he says:

"...the news media, when they report these events, aren't taking the time to talk to climate scientists about what's going on. The most they do is ask a meteorologist to comment, rather than digging in to get the real story...The coverage of these issues in Europe and Japan is much better, but the US mainstream media won't get into it. I think they're scared of losing viewers, frankly."

On what Obama needs to do:

"I think that he has got to find a way of using the scientific community, and the extraordinary strength of American and international science on climate change, to go to the public and talk about it. He's got to bring out what has happened in terms of this denial syndrome and expose it."

On policy, he says:

"We should establish a declining cap on the carbon entering the economy, sell the allowances for the carbon that does enter, and rebate the proceeds to the American public on a per capita basis."

Speth notes that major environmental groups have become close to Washington, so they now take an incremental approach constrained by what they think politicians can bear. So much of the action and most of the money today focuses on not losing too much ground from previous actions, rather than defining future goals based on what really needs to be done, for instance, on climate change action. Additionally, Speth notes that environmental law in its current form exists in a silo. Instead, it needs to become incorporated with tax law, corporate law, and laws that impact consumers.

Speth also discusses the "growth imperative" - the fact that politicians and corporations focus on growth, but what they're really talking about is profits. Talk about "the economy" is usually based on the crude GDP measure. However it's a myth that profit creates jobs. In fact our current cycle is one of skyrocketing profits while swaths of workers are laid off. By muddling growth and profits with individual well-being, politicians and corporations can continue to reject investments in clean energy and regulatory attempts to force cleaner manufacturing and production.

There's much more to the interview. Some points are quite obvious to you or me perhaps, but what I like is how the Bulletin of Atomic Scientists and Speth cut through the morass of excuses, hand-wringing, and finger-pointing that clutter discussions of climate change and the environment. They clearly focus on the underlying problems with law, economics and politics that smother critical change -- change not as a promise but as action.

¹ Gus Speth: Communicating Environmental Risks in an Age of Disinformation" doi: 10.1177/0096340211413559 Bulletin of the Atomic Scientists July/August 2011 vol. 67 no. 4 1-7 Article highlights here; full article (subscription) here

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

On Communicating Climate Change: "Communicating Climate Change"

On Climate Change denial: Sea Change or Littoral Disaster

Business and Climate Change: "Carbon Emissions Disclosure Project"

Ice core research to study atmospheric conditions 650,000 years ago: "Holocene Days"

Politics and climate change: "Will Loose Lips - Or Global Warming - Sink Ships?".

Carbon emissions regulation after Katrina: "The Environment & Katrina-Slick Oil Fallout"

Drought in the "Amazon", and in "Australia".

Science research communication and climate change: "Research, Politics and Working Less", and "Science Communication".

• Cell Phone Warnings

  Recently, the World Health Organization's (WHO) International Agency for Research on Cancer (IARC) put the risks of cancer associated with cell phones in a 2B group: Possibly carcinogenic to humans, based on their analysis of available studies. From greatest to lowest risk the classifications are Group 1: Carcinogenic to humans, Group 2A: Probably carcinogenic; Group 2B Possibly carcinogenic; Group 3: not classifiable as to carcinogenicity; Group 4: Probably not carcinogenic.

  Scientists and journalists responded to this with their own interesting and sometimes quirky analyses. Many said the new information made them feel safe about cell phones and pointed out that the 2B group included the coffee. Others said they were concerned about the new classification, and focused on the fact that the 2B group includes DTT. And others argued in more complicated ways, things like - since DTT only affects eagles' eggs, they felt ok about cell phones. Some people reason that they know with certainty that tobacco is carcinogenic, and cell phones aren't in that category. Do people merely construct rationales to coincide with the intensity of their cell phone use?

  Because logically, of course, some of this reasoning breaks down. It's not clear what people mean when they announce they'll take a risk with cell phones *because coffee is a possible carcinogen too*. Most likely they haven't read the research on the possible/maybe/sometimes connection between coffee and bladder cancer (the deciding factor for IARC on coffee). No, they're not thinking *bladder cancer*, they're thinking they'll take their chances with cellphones since they drink coffee all the time. But possible/maybe/sometimes isn't really reassurance.

  Some people say that since cell phones have been in use for 15 years or so, we would know if they caused cancer. But the use patterns were different, as were the strength of signal. And recall that cigarettes were only widely acknowledged to be carcinogenic in the 1950's and 1960's, when people had been smoking for hundreds of years. Then it took decades for that research to be acted upon. And people still smoke, no matter how clear it is that smoking causes cancer. At the present stage of cell phone research, we might not even know enough about physics and individua physiologies to understand how cell phones cause or don't cause cancer. There's lots of unknowns.

  But still, everybody wants an answer. So do journalists and bloggers feel compelled to try to give one? This is sort of funny since no one really knows yet. But science journalists and bloggers should especially understand a bit about how research works and the inherent uncertainty and risks and the unpredictability of evolving health research. So why feel compelled to provide an answer? Personally, (see, because we can't help ourselves) I think there's enough research that I won't walk around with my cell phone in my front pocket or stick a little mini cell phone inside my ear all day and night. And I hate to say this but I really do want to see more non-industry research.

• Our Ancestors Social Groups...Two Million Years Ago

  Scientists looked at the teeth of two million year old fossils and found that female hominids were more likely to leave the area they were born in, whereas males were more likely to stay closer to the cave they were born to...Oh wait, that's not catchy. We should say something like this: "Ancient male hominids had 'foreign brides'", or, hominid men "like[d] their man caves", they were "mama's boys" or were "homebodies"? See, all the good ones are taken. But by all means, lead anachronistically to catch the reader's attention.

  "Foreign Brides"? Really? It's not cool enough that scientists figured out how to analyze the teeth of our human ancestors from 2 million years ago in order to determine their possible social group structure? ¹

  Using newly evolved laser technology, Copland et al profiled the strontium mineral levels in the teeth from Australopithecus africanus and Paranthropus robustus, and from modern plant and animals around two caves in South Africa. Strontium moves up the food chain from plants to animals, and accumulates in developing teeth until about the age of eight. Scientists can analyze radioactive strontium levels in teeth for instance, and compare them to surroundings bedrock to determine birthplace. In this study, the two caves were within a band of dolomite bedrock in South Africa and non-dolomite geology surrounds this band. Researchers designated the dolomite band as local, and the non-dolomite regions further afield (~3 - 30km), as non-local.

  The teeth from both species were previously found to be similar in size, but importantly, females typically have smaller teeth than males. So the investigators found that females of the Australopithecine more likely had teeth with non-local strontium profiles, and the males teeth more likely to have a strontium profile reflecting their dolomite home turf. A probable explanation is that the females left the social structure they were born in to. This conclusion is supported by the pattern of female dispersal in our nearest ancestors, chimpanzees and bonobos. By comparison, in gorillas and other primates to whom we're not related, males tend to leave their natal group.

  ¹ Copland et al; Nature 474, 76-78 (02 June 2011) doi:10.1038/nature10149

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

After being sued to stop the funding of human embryonic stem cell research by evangelizing "pro-life" plaintiffs in 2001, the US government started the "Embryo Adoption Public Awareness Campaign" program. Since 2002, the US Department of Health and Human Services (HHS) has granted $20 million through this program, mostly to fringe Christian "embryo adoption" programs. People who run these programs promote an extreme anti-science view of development and use the HHS funds for marketing "embryo adoption", selling pro-life ideas that challenge and attempt to overwrite science.

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 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

These "pro-life", HHS funded "embryo adoption" agencies do the opposite. They want to hijack the nation back to some medieval time. Although nothing but science has made their business possible, they try to pretend science is irrelevant. They make a each childless couple who wants their services go through extended screening as if the embryo were a child. They claim that they, the agency, has the right to decide who qualifies to try to bear a child (from mostly unhealthy, unviable embryos). By signing up to their program, a couple implicitly or explicitly accepts 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 -- at the risk of mainstreaming these anti-science beliefs.

Stunningly, while collecting their millions in grants, these same pro-life agencies sue HHS to halt life-saving stem cell research.

No matter what religion you claim or 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

In our last post, "Shock and Awe Strike Again, Embryonic Stem Cell Research Part I, " we discussed 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. In our post, we asked whether scientists should have been "stunned" by the move, and pointed out that the same group of fringe plaintiffs had 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.

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 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, this 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 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. Despite real research on 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. But if this were true, they wouldn't need HHS funding for an "awareness" campaign, right? Despite their optimistic figure, there's tremendous hesitancy around giving embryos, which is why in real polls, only 2-3% of actual IVF couples consider this option -- thus the HHS funding to "promote awareness".

Even if hESC was a threat to their business, this shouldn't matter to Nightlight, because according to their FAQ:

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 maybe Nightlight Christian Adoptions is not really trying to "work" themselves "out of a job"?

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, thus it wasn't a good business model either. At that time, Nightlight charged "$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 transparency.org (which 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 the 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 advanced 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 give up (embryos) to the "embryo adoption" agencies, ie: "you donate your embryos to us, we put them up for (Christian) adoption". The American Society For Reproductive Medicine (ASRM)"Adoption" writes here about the biologically and ethically deceptive practice of changing the labeling of embryo "donation" to "adoption".

"Microscopic Americans"

The phrase embryo "adoption" imposes the false notion that these few day old embryos are people, and the mischaracterization is promoted by politicians, the media, and those receiving HHS funding. Here are some of the milder examples:

• "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)
• "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 or ignore the actual viability of embryos. 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 several day old 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 also flawed and often 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 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). Implantation is a sensitive physiological process, dependent on different factors then thawing. 50% of the embryos will not survive thawing, and most of the remaining 50% won't implant, 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 -- $1,5000-$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 might be asking yourself, why would they need so many batches of embryos if each frozen embryo is a "microscopic American"?

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+32 for 257 births of 2474 embryos thawed, which would make the birthrate about 10% (lower than I would expect). That number is surprisingly low, but note that more than 1/4 of the genetic families have embryos that (presumably) don't take at all, which is 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 risk for the woman.

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 a 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, for starters, 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?'"

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 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 and difficult and experimental procedures. This, so that these groups can make money off the embryos while claiming to be saving 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 Sherely of Watertown, Massachusetts, and Theresa Diesher of Seattle, who do research on adult stem cells and claim that allowing embryonic stem cell research wrecks their chances of getting federal grants; clients for adopted embryos; and the embryos frozen in IVF clinics.

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

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

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

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

Science Community Stunned

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

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

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

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

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