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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

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

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.

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

The Map

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

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

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

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¹ Granted the UI's sometimes not entirely there

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

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.

A recent Financial Times article reported on a £1.6 million geoengineering trial launched by Spice (stratospheric particle injection for climate engineering) at a British Science Festival. In "Trial Seeks to Hose Down Warming Climate", Clive Cookson describes how the company aimed to test the feasibility of cooling the planet by creating atmospheric conditions simulating volcanic activity. Beyond the trial:

"A full-scale global cooling system would cost more than £5bn and take two decades to install, said Hugh Hunt of Cambridge university, another team member. It would require 10 to 20 gigantic balloons, each the size of Wembley stadium, attached to ships distributed in the world's oceans and pumping 10m tonnes a year of material into the stratosphere.""

Geoengineering - How Far Have We Really Come?

Interesting enough. We often hear of plans for geoengineering. Certainly weather modification has been around for so long that when a Texas licensing board approving projects convened recently, one member suggested that the technology was so routine the licensing board should disband. Although we know generally about cloud seeding and futuristic geoengineering, we don't often hear about experiments with some of the more sophisticated climate technologies, which makes the FT article somewhat interesting.

But even more interesting than the article itself was a letter to the editor in response to the article, published by the FT a couple of days later (Sept. 15). In it, the President of an American aerospace company wrote that the "trial" reported by FT was old news. He explained that injecting particulate matter into the atmosphere has "been in full swing at it for nearly a decade...", and continued "Dozens of aerospace, defence and technical companies like ours have been advising into the initiative for many years. He explained:

"...[a] series of tests to create a polymerised and ionised mixture of certain metals, including aluminium, barium, thorium and selenium, among other contents, was perfected and tested in US facilities. A joint public-private operation, initially called "Cloverleaf", was operationalised and subsequently supported by US state and federal weather modification legislature.

Throughout the continental US, dozens of tanker and other aircraft are daily applying thousands of gallons of aerosol nano-particulates that serve several objectives, including the purported ability to reflect UV radiation. Similar operations are being conducted in Canada and parts of Europe.[emphasis ours]

What the actual secondary effects of this operation are, including human health impacts, are currently unknown or undisclosed. The Bristol university team may be wise to "hose down" those facts as well. In the meantime, anthropogenic climate impact is in this regard, quite real indeed."

REALLY?

Before the Financial Times boldly printed this editorial, people firmly relegated "Cloverleaf Operations" to conspiracy theory territory. True, thousands of YouTube videos devote bazillions of hours to documenting "chemtrails" streaked across blue skies -- often accompanied by music of the producer's choosing, making them no less boring.

And true, hosts of crackling talk radio shows tell audiences that their guests "risk death" divulging whatever huge secret government chemical spraying operation they then divulge.

A search for "chemtrails" on YouTube actually turns up 29,200 results. But have you heard of this chemtrail thing? It's easy to ignore, unless, say, one or more of your formally rational friends goes through some weird mid-life crisis, and with testosterone flagging (my theory), veers off bizarrely denouncing the rational in favor of numerology, Mad Hatter utterings, and chemtrails. Else how would you know? Unless you read the Financial Times editorial section.

Fact or Fiction?

Of course some people -- the subset who espouse chemtrails and read the Financial Times editorials -- were elated: "PROOF!", they crowed on their blogs. But try to find one other mention of such a program in any other respected publication -- one who's mission isn't to divulge "scary secrets your government's hiding from you". Even if the chemtrail crowd isn't totally sniffing glue, the Financial Times editorial seems like a rather casual airing of the news -- and it is news.

It must be true, you say, it's the Financial Times! Many people attest that the FT and its sister publication The Economist do an above respectable job covering science. I really like both publications, but they both publish quite a few "science" articles that are more or less press releases for some company's pie in the sky technology that you've never heard of and will never hear of again. Yes, they have some in depth coverage of science, and sometimes feature British science establishment luminaries like Paul Nurse, but frankly I think their coverage of economics, yachts, and watches is better. The original article on the water aerosol trial was sort of in this in the sky technology vein. But the theme got way more interesting with the editorial.

Existent or Not Existent?

The editorial was written by Mr Matt Andersson, who signed as the CEO of a Chicago company called Indigo Aerospace. Indigo Aerospace is not listed in Hoover's, so it's hard to guess how much money he makes "advising into the initiative". Or maybe he didn't really mean in his letter that his company was running geoengineering programs but more literally that companies "like his" were. Or maybe his company does advise such initiatives.

Being curious, I easily learned that Indigo Aerospace used to be incorporated in Illinois, where they reportedly consulted to Booz Allen Hamilton, known for its military and government business. But as of May, 2011, Illinois lists the Indigo Aerospace Inc. as "involuntarily dissolved". So then is the corporate entity for which he signed as CEO not in existence anymore? This unfortunately throws doubt on his whole Cloverleaf assertion (at least to us). But why be judgmental? FT wasn't.

But we unfortunately don't know if the FT editorial is credible. If we were the FT editorial team we would do a bit more checking into this story -- really. Now we can only wonder: Do governments drastically change weather patterns, ruin sunsets, and subject us to chemical experimentation, and is this so ho-hum that we only read about it on conspiracy theorist sites, on Ron Paul 2012's blog, and in the editorial section of the Financial Times? It's potentially very interesting news people, more please. Or is it a conspiracy theory, as contended by every state agency, military organization, scientist, urban legend site, and news publication -- except for the FT? Mildly interesting but worthwhile noting. What do you wager?

Science Journalism Debauchery

Has anyone aside from science bloggers had so many rules imposed on them? OK, maybe science journalists. In the 1990's, when the debate over genetically modified (GM) seeds motivated the headline: "MUTANT CROPS COULD KILL YOU" (Express February 18, 1999), the British government attempted to correct the fear-mongering headlines. That didn't work, so to stem future journalistic liberties of that sort, the Parliament tried to subdue the culture that propagated such rumors.

They issued a a lengthy report warning of further journalistic depredation from "the approaching era of digital TV" and the "increasing ghettoisation". (No mention of the internet.) More journalists needed to be "scientists", they said, after surveying GM stories put out by all of eleven UK publications over two days. Only 17% of the stories were written by science journalists, they found, and not any of the commentary came from "science writers". The Science and Technology Committee of the House of Commons, the Royal Society, and SmithKline Beecham suggested punishing future misbehavior, especially for getting the facts wrong:

"media coverage of scientific matters should be governed by a Code of Practice which stipulates that scientific stories should be factually accurate. Breaches of the Code of Practice should be referred to the Press Complaints Commission."

Of course an editor at the Independent responded describing how writers could conquer the facts but still mislead the reader. Thankfully, there's often a compelling counterargument. So in the end, the report's authors settled for a rather bland collection of guidelines dealing with Balance; Uncertainty; and Legitimacy.

And of course while the Parliament fretted about the fate of genetically engineered crops, over at News of The World...

Digital Science Journalism - Publishing Freedom

When science blogging came along it seemed to offer an alternative to the maligned mainstream media science journalism. But despite its growing stature, it too has been besieged by criticism. Some of this came from mainstream media, especially in the beginning.

But interestingly, while traditional science journalism often gets attacked from the outside, online science journalists indulge in lots and lots of self-flagellation. Perhaps this is to be expected from people who labor at the frontier of the often masochistic bench science, replete with high rates of experimental failure. Or perhaps self-criticism makes it easier for science bloggers to generate conversation? Work out their identities? Get traffic?

Of course there's much more to online science journalism then blogging, but I'm going to limit my comments to that. Acronym Required started about seven years ago, and from the rather echoey halls of 2004 science blogging, the medium exploded. Now it impressively fills some of the gaping holes in other science journalism.

We last commented on the state of "science" television programming in 2007 -- and why comment further? The science blogging world offers an amazingly vibrant alternative, filled with witty, reflective, analytical, smart, and generous writers -- especially considering the frequent debauchery of mainstream journalism. Which makes the persistent whine of self-criticism all the more puzzling. Is it some evolutionary thrust gripping science bloggers to impose governing rules on their peers?

This is especially amusing in the context of how blogs started, to augment search. Search itself started in a era that included the (albeit, totally unrealistic) perception of internet as free of boundaries, regulations, and governments. Consider this piece from early 1996:

"We are creating a world that all may enter without privilege or prejudice accorded by race, economic power, military force, or station of birth. We are creating a world where anyone, anywhere may express his or her beliefs, no matter how singular, without fear of being coerced into silence or conformity."

Radical, but the philosophy is actually alive and well among quite a few technologists today.

Search back then was pretty rudimentary, thus the role of blogs. To understand just how rudimentary, look at this old Yahoo page with its awesome user interface. (Accompanied by the great ad with a winking person who looks photoshopped from two different faces, asking awkwardly: "So, My Yahoo! or yours?".)

My point is, the world in which blogging started was simple. For one, an early blog was often not much more than some geek saying -- "hey I found this cool site": link -- so I'm cool too, right? These "trusted links" made a prehistoric stab at "community" and "personalization" -- because who could trust something called the "World Wide Web", with its random collection of and unknown "links"?

Secondly, through innovation if not mindset, the Internet and blogging celebrated independence from tradition. As the internet expanded, many bloggers took to the medium in defiance of the exclusive world and onerous rules of offline publishing. The audience for blogs in the beginning was a very small group of internet users, frontiersmen strongly connected by their independence, who were by default "the community".

Page Views

As the originators of the real commercial internet intended, soon people realized they could make advertising money on the internet, and "pageviews" became an all important metric. The number of people publishing on the internet grew and bloggers were then advised to "keep it short". This advice about post-length was couched as insight about readers short attention spans. But it was as much about drawing pageviews and revenue. "Keep it short" and the unspoken "make us money" became compulsory over 'make it interesting'.

When Tumblr and Twitter arrived on the scene with truly short-form platforms, some of the same organizations then suggested that blogs could actually be a venue for "long-form posts". Finally, just as the fashion industry moved away from dictating skirt lengths sometime in the 1980s, people eventually stopped dictating ideal post length. Of course they still told people what to do, they just moved on from making demands on post length.

To Join Or Not To Join

It's my impression that science bloggers find more rules to bandy about than others, but granted, I don't have enough data to swear that economists, say, are really more laissez-faire. I couldn't possibly document all the various rules that science bloggers have proposed for other science bloggers over the years, but to illustrate my point, I'll mention a few.

First there's the question of where to host your blog. Some insist that science bloggers should join a science blogging network. This came about when the number of online science bloggers reached a point where they could actually form a group. Those advocating joining offer compelling reasons -- traffic, exposure, "community". Now, the number of such science blogging "communities" has surpassed our ability to keep track of them. There are still pros and cons to joining of course, depending on your goals, technical abilities, impressions of the different online venues, how your schedule might accommodate blogging, etc. But your agreeable answer to join is existentially far more critical to a potential host than to you. After all, the hosts wouldn't exist without the bloggers.

Of course the notion of "online community" includes many possibilities. Communities can be collaborative, nurturing, educational - great; or, if you've observed them in action, joining such an online science community can be like joining the military, where participants -- "travel to exotic foreign lands, meet interesting and exciting people, then kill them."

Proving Your Worth

Once the blogger decides where to put their blog, a barrage of other considerations and demands will follow. For example, in 2007 bloggers for peer-reviewed research reporting (BPR3) emerged, proposing

"to identify serious academic blog posts about peer-reviewed research by offering an icon and an aggregation site where others can look to find the best academic blogging on the Net."

While interesting as a business aggregation proposal, the blog "Peer-To-Peer" diplomatically commented on the idea, saying it would be impossible for such an icon to assure the "quality of the blog post itself". Or, we might add, to insure the quality of the writer's analysis, the quality of the science journal, the quality of the science research, and so on.

Questions of ethics in science blogging are constant, carrying on from earlier discussions of ethics in blogging and science journalism. Way back in 2003, bloggers started wondering whether they should adopt journalists' standards. Perhaps journalism in 2003 was wrapped in mystique that shrouded realities like "MUTANT CROPS COULD KILL YOU", but the drumbeat of ethics has since trailed science bloggers. I can't see how this could be useful people have written strong arguments noting that blogging wouldn't exist if bloggers weren't ethical. Nor has the whole ethics thing really led to changed behavior as far as I can see, but those who push "ethics" will forever peer over our shoulders, stick in hand.

Still other people demand, as the Parliament did 1999, that science bloggers/journalists only blog about things they know. Quite a qualitative statement considering variations in breadth and depth of knowledge among both scientists and journalists. A comment here provides a good rebuttal to that idea. You could also reason that writing solely about what you know at any moment, like the biomechanics of kangaroo tendons, for instance, despite how interesting, might also be good way to become a lazy, narrow minded, outdated, and one bored stiff writer.

Recently the subjects of anonymity and pseudonymity re-emerged and preoccupied many science bloggers. I'm not going to weigh down this post talking about that, except to note 1) that the discussion has largely revolved around the value and necessity of a particular type of individual authentication, and 2) that the discussion has largely ignored the politics and economics driving such individual authentication.

Other people try mark out precise roles for science bloggers/journalists. Science writers should be "educators", they say, or "explainers", or priests of "how things work". Each such suggestion is an invitation for extensive discussion and cogitation, and naturally other people will vehemently disagree with every proposal. So then why don't bloggers just do what suits them best? Or does the constant criticism and re-definition create "community" (and pageviews)?

Getting The Details Right

We've touched on some general instructions to bloggers about how to blog about science. There are more detailed demands too, aimed at all of science blogging and journalism, as the divisions between online and offline media blur. For instance:

• 2005: Don't use the word "Global Warming": Thus implored some scientists reasoning that people would confuse climate change with their local weather.

• 2006: Don't use big words: So lectured the film "Flock of Dodos: The Evolution-Intelligent Design Circus". The version I saw at Tribeca 2006 highlighted words used by scientists in dialogue that were "too big", while characterizing Intelligent Design folks as small word people, i.e. comparatively approachable and understandable. It employed character assassination on all fronts by advising scientists to drop their testy, pompous attitudes, while it basically infantilized people who were religious. Some scientists took this whole thing to heart, overlooking how the movie slyly played to both audiences. People who knew the fairly simple polysyllabic words could be secretly smug that they knew the words when the definitions flashed on the screen like some weird spelling bee; and the other side of the audience could be smug about the portrayal of scientists as surly and smug.

• 2007: Don't publish on Fridays: The IPCC panel and hundreds of scientists took flack from the communication "framers" for publishing their 2007 report on a Friday (link accessed 04/11) because 'any veteran journalist would know better'. The same post chastised the report for lacking "drama" like portraying "polar bears on melting ice". The authors gave another paper kudos for "reframing the IPCC report" with a "corruption angle" that gave it "more legs". In other words, said the framers, don't be scientists or reporters be PR ringmasters.
• 2008 "Don't use the word "denial", "denialist", or "denier": Some scientists said that labeling climate change denialists as such was pejorative.

At the time, each of these instructions drew passionate discussions. But times change -- or don't change. Today it's fine to use "global warming" and "denialist". Science Friday still airs to large audiences on Fridays, and Science Magazine successfully publishes, Friday, after Friday, after Friday.

As charming as "Flock of Dodos" was, do big words really make science/scientists extinct? If we believe that message, should we then be discouraged that in 4 years, the Flock of Dodos trailer has 13,376 views on Youtube, while Hoax of Dodos, the Discovery Institutes pathetically best response, has almost as many -- 11,405 views? OK true, the "Pulled Punches" video (cut scenes from Flock of Dodos) has 18,605 views. But for perspective on what 18,605 views means on YouTube, the video "Emma Watson Punches Interviewer" (Jan 19, 2006), has 4,159,895 (all view numbers as of 05/11). Despite the fact that "Punch" is a catchy keyword to put in your comparatively boring science video, what does all this mean for science and science journalism?

"Blogging" is Worthy

What if none of these rules and instructions make science blogging "better", whatever better is? What if people still deny climate change for example, no matter what the facts and no matter what manner we convey them? While pursuing better communication is incredibly important, as is presenting ideas compellingly, how much of science knowledge lost by miscommunication is really any responsibility or fault of scientists and journalists (online or offline)? How much should be attributed to the political inclinations, personal distractions, and various passions of our audiences?

In reality most science journalists have zero time to write stories, whether or not they have generous deadlines. Those stories must always be very compelling just to get read. The extreme example of this fact, illustrated by a UK journalist, applies to most writing:

"You are writing to impress someone hanging from a strap in the tube between Parson's Green and Putney, who will stop reading in a fifth of a second.

We may not like this. We may wish readers didn't prefer reading science only when it's infused with sex or violence or something that 99% of the population have some opinion on. We may wish that journalists really comprised some "fourth estate", or could make a difference, or could educate readers. What if science writers could just all write about their own fascinating interest, rather than about something dictated by advertising? And what if the audience would just read, and not worry about about ethics, badges of legitimacy or whether education was happening as they read?

But until science journalists make a lot more money or have a lot more time, that won't happen on any large scale basis. But most science bloggers write for free or pittance. And if you write mostly for free on a blog, shouldn't you just write? Or does it have to be for some higher purpose (agreed upon by the consensus of one of many "communities")? Because wasn't that the whole purpose of blogging?

Science bloggers should keep in mind what their up against. The lifeblood of mainstream media consists of headlines the likes of this week's "GM Blunder Contaminates Britain With Mutant Crops", about "Frankenstein" crops.

So I'm sure whatever you write, dear blogger, will stand up just fine. And until "offline" journalism reaches different standards, can we stop insisting/demanding/pleading that bloggers "ARE journalists too"? Maybe science blogging could stand on its own apart from journalism if the community of science bloggers trusted themselves.

Why did so many journalists, columnists, editors, bloggers and commenters miss the most obvious clues to science misinformation in a recent bisphenol-A (BPA) story? Why didn't a Knight Journalism blogger call an ethics foul on the guy originating the gross error, as opposed to taking his side and accusing journalists of "ethics breaches?"

Where's The Shining Armored Knight?

A recent "Science Stories" piece at the Knight Science Journalism Tracker site funded by the MIT Knight Journalism Fellowship Program piqued my interest. KSJ tracker Charlie Petit wrote that a Huffington Post columnist was correct to reprimand a Milwaukee Journal Sentinel (MJS) managing editor for "breaching journalistic ethics".

According to Petit, the ethics violations occurred after Milwaukee Journal Sentinel's (MJS) opinion columnist Pat McIlheran wrote a short column on bisphenol A (BPA). McIlheran said he based his column on a science study. However, George Stanley, the managing editor for MJS, wrote in a comment to McIlheran's story that the author relied on a study by researchers who had conflicts of interest. Knight writer Petit weighed in after being alerted to the "breach" by a HuffPo columnist/American Enterprise Institute (AEI)/Stats.org writer. Petit wrote: "traditional lines of free speech protection have been crossed in a news room". (links to all articles below)

So the Knight Writer Criticized The MJS Manager of Journalistic Ethics --> Based on the Accusations of a BPA Shill writing for HuffPo --> Who Defended the Columnist Who Copied the Words --> of The Same BPA Shill Writing at AEI --> Shills Bent on Promoting Research Funded By the Plastics Industry -- Get It?

Petit stressed that columnists like McIlheran should have freedom to write "reasonably justified opinions" without "worry of public ripostes", especially "from senior members of the news team". As he put it:

"McIlheran was hired to write opinions based on reasonable grounds. The German study seems to provide them, even if it turns out to be wrong. The ME [managing editor] should have pushed "delete" before adding his thoughts to the public comment string...a misdemeanor violation of journalism's non-codified book of ethics, I'd say."

Petit compared the MJS's editor's ethical breach to the Washington Post's handling of a George Will column a couple of years ago. I assume Petit means Will's column "Deep Dark Doomsayers", which scientists, online journalists, writers and newseditors tore apart in February, 2009.

One Man's Hogwash is Another's Gold

The difference, Knight's Petit wrote, is that Will's article was "hogwash", whereas McIheran based his MJS column on real "science", specifically: "the German study". As well, said Petit, critics of the Post column called on op/ed editors to fact check their columnists, whereas the MJS editor breached ethics by commenting online.

I disagree. First, let's quickly consider Petit's comparison of Will's unreasonable "hogwash" to McIlheran's column based on "reasonable grounds" that "the German study seems to provide". Go back and read Will's column. He did reference research, including from the prestigious journal Science. He also cited respected newspapers and magazines, and "quoted" respected experts like Energy Secretary Steven Chu.

By Petit's criteria, if the the MJS column is based on "reasonable grounds", it follows that Will's column is too. Only when people pointed out en masse how false Will's column was did it become "hogwash". ¹ Similarly, McIlheran's column falls apart even faster with one close look. Therefore, the difference, I contend, is that 1) Will was a known climate denialist 2) who denied accepted science, AND most importantly 3) scientists and journalists were paying attention.

News Flash For Journalists and Journalism Ethics Scholars: Repeating a Shill's Words in Your Column Does Not Make them Your Defensible Words

This is a story about journalists, columnists, editors, commenters, and bloggers not paying attention, and by doing so misleading readers.

In MclIheran's 300 word column, fewer than 75 of those words were his. Most words were Jon Entine's, who first wrote about "the German study" for the American Enterprise Institute's (AEI) magazine "The American".² So while Petit declared that McIlheran's column was based on a scientific study "even if it turns out to be wrong" [clever, hedging like that], in fact McIlheran's MJS column was not based on a science study at all, it was based on someone else's interpretation of a study. The distinction is important. McIlheran linked to the study, but apparently didn't read it, because he repeated what he was told by Entine.

McIlheran/Entine's MJS column titled: "Bisphenol A? 'No Noteworthy Risk,' Says Big German Toxicology Panel", leverages the idea of a "big" panel and the large number of studies to substantiate claims of BPA's harmlessness. How large a number of studies? Wrote McIlheran:

"toxicologists reviewed about 5,000 studies and concluded that BPA, used in plastics lining the insides of metal cans and in some plastic bottles, is safe even in products used by young children and prenant women..."

Plus, he direct-quoted Entine's AEI article:

"some 200 studies--almost all small-scale 'explorative' studies on rats--have suggested that BPA might trigger biological activity, including possible neurological or endocrinological effects, and have called it an 'endocrine disruptor.' But after an extensive review of some 5,000 studies, the German toxicologists reaffirmed the scientific consensus that BPA is safe when used even by the most vulnerable populations--young children and pregnant women'"

The first time I read this I nearly spit my drink out of my mouth laughing at the rhetorical deceits, so clever, the: "small scale 'explorative' studies on rats"", "have suggested"", "have called it", and "reaffirmed the scientific consensus"; and not so funny: "even by the most vulnerable...". Together these words comprise two instances of "5,000 studies" and make up one-third of McIlheran's total word count. In short, he spares no space emphasizing the vast number of studies, in order to legitimize his claim that BPA is safe.

Fact-Checking

The gist, Entine/McIlheran wrote, is that scientists made an "extensive review of some 5,000 studies" and found "BPA is safe...even for the most vulnerable populations." The very people for which the FDA has the most concern.

So we glanced at the study abstract, as we're wont to do, and read the first two sentences, which say:

"Despite the fact that more than 5000 safety-related studies HAVE BEEN published on bisphenol A (BPA), there seems to be no resolution of the apparently deadlocked controversy as to whether exposure of the general population to BPA causes adverse effects due to its estrogenicity. Therefore, the Advisory Committee of the German Society of Toxicology reviewed the background and cutting-edge topics of this BPA controversy." (emphasis ours)

Does it say they reviewed 5,000 studies? No. No, they wrote: "more than 5,000 studies have been published". They repeated this line in the introduction of the paper for those who don't read abstracts. This of course makes more sense. I first clicked on the study because I wanted to see what the bibliography for a 5,000 study MEGA/METAreview would look like. 130-170 pages maybe? I wondered, did the journal publish a separate supplement to hold the bibliography?

No, the MJS columnist's source let's say, 'made a mistake'. But how did the mistake get propagated by so many journalists, editors, bloggers, and columnists, especially since this first clue that something was amiss was so easy to catch?

What the "big" panel of German scientists did, was claim "a controversy", then choose some "cutting-edge topics" to render opinions on, then when the press ignored the study (pretty difficult with BPA), AEI/Stats.org stepped in to publicize. (Reading the actual German study proved scintillating, but for now, we're focusing on the "ethics" of the whole thing.)

Define Free Speech

While Petit thinks the problem is the MJS editor, "ethics" and "free speech", I think the problem is that people at MJS, the Knight Science writer, and over one hundred commenters on all the various sites, plus many online sources, all repeated the false accounting. Repeated numbers put forward by industry without checking. Some of the writers even linked to the paper from their articles and/or directly quoted the study, but still said "5000 studies". To recap briefly:

• 1) In an AEI article Entine describes an "extensive review of some 5,000 studies" showing BPA is safe "even to young children and pregnant women".
• 2) Pat McIlheran, MJS columnist, repeats Entine's claim of an "extensive review of some 5,000 studies" finding BPA "harmless." He links to the study on PubMed. Why is the number of studies (albeit false) important? Ask McIlheran, who spent one-third of his post on it, or Entine, who emphasized the weight of "5,000" studies, versus the "200" studies.
• 3) George Stanley, managing editor of MJS criticizes McIlheran for quoting a study where "all" the authors have conflicts of interest, despite more obvious mistakes. ("5,000" is just one) MJS covered the BPA issue a few years ago, winning a George Polk Award, a John Oakes Award, a Grantham Prize Award, a Scripps Howard Award, a Pulitzer nomination, and spot on Bill Moyer's show. They were commended for reviewing over 200 scientific studies. The paper then basically stopped covering BPA.
• 4) Reporter Susanne Rust, award-winning former MJS writer (see above) and former Knight fellow, writes in a freelance MJS article that the "German study examined more than 5,000 scientific papers conducted on the health effects of BPA". Rust gathered comments from scientists for the article.
• 5) Jon Entine, writes a new article on HuffPo assailing both the MJS editor and reporter in a deceptively titled article: "Milwaukee Journal Sentinel Faces Ethics Questions Over Award-Winning BPA Reporting". It's altogether ham-handed. He criticizes Stanley for commenting that "all" of the authors had conflicts of interest, when only a few did. Rust, he says, "glowingly touts the Journal Sentinel for examining nearly 260 studies (as compared to the German group, which reviewed 5,000 studies)".
• 6) Charlie Petit, the Knight Journalism author, links to the HuffPo piece, urges people to read it to understand the issues, and criticizes the MJS managing editor Stanley for "ethics violations" and curtailing a columnist's rights to free speech.

The thrust and parry continued at MJS and elsewhere, but still no corrections. The end result was that columnists, writers, and editors at MJS and HuffPo let Entine, AEI, and Stats.org produce their reporting for them. But if journalists had simply done a 10 second fact-check of the "5,000 studies" claim or other assertions made by their sources or study, would their reporting have informed instead of misled the public?

Fabricating Everything

Of course where there's one mistake, there's more, as in the Will column. For example, in his HuffPo article, Entine re-characterizes the FDA's statement that they have "some concern" for bisphenol A, making the FDA sound off-hand and parochial. In fact, the FDA elevated their concerns for BPA in 2010, especially for infants, children, and fetuses.

"When asked if children faced health dangers", Entine wrote, "Joshua Sharfstein, M.D., the agency's principal deputy commissioner, minced no words: "The FDA is not saying that it's unsafe to use a baby bottle with BPA", since "if we thought it was unsafe, we would be taking strong regulatory action."

He ignores the realities of regulation ³, but more importantly, if you read FDA briefing transcript, you'll see that no one in the briefing said what Entine alleges -- "minced words" or not -- despite the HuffPo "quotes". In the Entine world quotes simply mean what you wish the FDA officials said.

Former FDA Deputy Commissioner Dr. Sharfstein said the safety assessment was "ongoing", and "we [the FDA] share the perspective of the national toxicology program of some concern for the health effects of BPA at low doses in the food supply." Marc Smolonsky, HHS Associate Deputy Secretary, also at the briefing, said:

"we are recommending families and parents to minimize exposure to BPA", and "thanks to new technology and advances in science we now have new research findings about BPA that shows subtle effects of low doses of BPA in laboratory animals, and this has raised new concerns."

The FDA referred parents to HHS for ways to minimize BPA. The FDA also stressed their efforts to change the regulatory paradigm so that the BPA was not classified as a "food additive", a change which would enable the FDA to regulate chemical more effectively. An important goal for the agency is to bring the Toxic Substances and Chemical Act (TSCA) up to date.

Plastic Bottles Out of Sight, BPA Out of Mind?

Public attention to BPA dwindled when people replaced their Nalgene bottles but more than polycarbonate bottles is at stake. Cash register receipts contain BPA - who knew? Soda cans, canned food, and baby formula contain BPA? What else? We'd like to trust that BPA is a non-issue, but then corporations wouldn't be working so hard at misinformation would they?

And while companies know the size of the market for BPA and the thousands of chemicals (toxic and not) being used, you and I and the government don't know which chemicals are in use in what products, which are dangerous, which contain BPA or other toxic chemicals, and how extensive health risks might be. Companies like to keep this knowledge out of the public eye, so they fend off regulators by any means. But regulators also respond to citizens too, which is why it's important for citizens to keep attention to the issue even after newspapers have won their accolades and moved on to the next thing.

Back to the ethics and freedom of speech charges made by our Knight columnist/ethist/arbiter. I've mentioned some ideas, but you decide the ethics. Some questions I find interesting are:

• In contentious issues, "ethics" are often manipulated, bandied about, and brandished at people for made-up reasons or because those people offended the accuser somehow - for instance if it's a news reporter whose investigative reporting threatens a company's profits. So then, if we trust Petit's claim that he's concerned with ethics, are his "non-codified rules" a good way to set ethical standards for the publishing industry?
• The real purpose of comment sections of on-line reporting is for 2-way conversation -- in internet time. The Knight columnist dredges up some ethics charge based on Entine's column, than tries to confine the disagreement to some hidden newsroom meeting place. Why? McIlheran wrote a patently false column on behalf of the chemical industry - basically. The editor, knowledgeable on the subject, wrote a short comment, pointing this out. Banning knowledgeable people turns comments sections into cages for the riffraff to slur one another. Why wouldn't the reader benefit from seeing discussion among the newspaper staff?

  If McIlheran, the column's author, as opposed to Entine, his AEI/Stats.org source, thinks the managing editor made a mistake, why doesn't he add a comment - participate - rather than, as he did, write a whole new column propagating the myths?

• Petit writes that the managing editor compromised McIlheran's freedom of speech. But this is patently false because McIlheran already exercised his freedom of speech, as did Entine, in publishing the MJS column with its claims about big new BPA studies. How could the managing editor's comment violate that? That freedom was not impinged.
• In fact, isn't it violating George Stanley's freedom of speech to curtail him from commenting? Should he write pseudonymously? After all, who essentially wrote McIlheran's column? No McIlheran but
• Given that there are no "codified rules", isn't it curtailing the free speech of the MJS editor to suggest he can't comment? What if the editor commented positively -- "this is a great summary"? Or neutrally - "this is a great summary of AEI's position!" Would that be ok?
• Has Knight's Petit in effect granted corporations/lobbyists freedom of speech over the press -- or individuals -- depending on how you see Stanley's position?

---------

¹ Coincidentally Stats.org asserts that they're not denialists because they believe in global warming.

² Milwaukee's Best No Longer. By Jon Entine Friday, April 29, 2011

³ We wish the FDA were that efficient, but they're not, they're the epitome of bureaucratic, and when their labyrinths falter there's always OIRA.

Acronym Required's authors have followed Bisphenol A science, regulation and lobbying since 2005. To be continued.

• 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

In our last post we riffed off column in the New York Times titled "Medicine of the Move" (earlier titled "The Body Politic"), where Gail Collins opened with the statement: "sometimes you just want to tell the medical profession to make up its mind". Granted, we conceded, medicine and science can seem confusing. We described in Part I how medical profession recommendations come from science research, which the press can make appear contradictory. As an example, we showed differences between caffeine/diabetes research as presented in the media, compared to the research presented in the original source. We walked through different experimental protocols that would appear to show different results to the unpracticed reader. Finally, we emphasized that although headlines make ordinary science progress into "news" every day, a small research step reported in the "news" should not be confused with a public health recommendation.

As for public health recommendations, yes, doctors change them. But is it that the medical profession that "can't make up it's mind"? After all, medical advice comes from science research studies. Maybe it's scientists who can't make up their minds? In this post I'll explain why people puzzle me when they often complain that doctors/scientists "can't make up their minds". Secondly, I'll explain why I believe this insidious popular notion is actually dangerous.

Would the World Be Better if The Medical Profession Didn't Evolve?

My first point I'll pose in the form of a question -- would the complainers rather that science and medicine be static than dynamic? Lets take the subject of Collins' NYT column that dealt with hormone therapy for female menopause.

First, lets look briefly to history. Hormone therapy came of age in the 1960's, a half a century ago. For perspective, let's look at an accelerated time frame. A century ago, doctors didn't understand that bacteria caused food poisoning. Doctors who admitted patients for so-called "ptomaine poisoning" could wash out patients' mouths, insert tubes in their stomachs, feed them milk, and wring their hands as they watched people stricken with food-borne bacterial infections die. Fifty years later, things had progressed. By mid-century, scientists understood bacterial infections and how they could be treated with antibiotics.

Medicine in the 1950's and 1960's saw the advent of the polio vaccine, the development of ultrasound to see babies inside the womb, and treatment of chronic kidney failure by hemodialysis. In 1960 and 1961 scientists along the East Coast of the US learned that the Hepatitis A virus was caused by shellfish contaminated with raw sewage. In the 1950's and 1960's doctors made major advances in cardiac surgery so they could repair congenital heart defects in babies. Such repairs became feasible when doctors realized that they could use a patient's relative as a live "heart and lung machine". From that, what I'll call a 'proof of concept', technology advanced to machines that could keep patients oxygenated during heart surgery. As you can imagine, the first "heart surgeries" were a messy business, and as in every field of medicine. The 1950's and 1960's brought major improvements to medicine, but in fits and starts. Mid-century, post WWII was the era when hormone therapy became popular.

Who To Blame?

Based on recent findings about the risks associated with hormone therapy, women and doctors now hesitate before turning to hormone therapy. Collins, who developed breast cancer that she attributes to hormone therapy, ended her NYT column with this: "Actually, I don't blame anyone. Except maybe the guy who wrote that "Feminine Forever" book." She's referring to an early hormone therapy proponent and author, gynecologist Dr. Robert Wilson. Today, the book's title sounds suspiciously pseudo-medicine but it probably sounded different to women in the 1960's, half a century ago. In that time of "women's liberation", Wilson chastised the predominantly male medical community for being callous to women. A 1966 Time Magazine article described Mr. Wilson's complaints about doctors:

"physicians generally dismiss post-menopausal changes as part of the 'natural' aging process. Their attitude, [Dr. Wilson] suggests tartly, stems from the fact that "most doctors, being male, are themselves immune to the disease." As he sees it, the menopause is "castration," and [Wilson] asks whether his colleagues would tolerate so casually a similar fate in themselves.

So that was it. In the era of women's liberation, Wilson accused men as standing-by while women became one day bra-less free spirits, the next "castrated" at the youthful age of 50. Which is why in 1966, as Time Magazine put it:

All over the U.S., women in their 40s and 50s are going to doctors and demanding "the pills that will keep me from growing old." Women in their 60s and over are asking for "pills to make me young again." In each case, what they are really asking for are doses of hormones to slow down or reduce the ravages of age.

Now, a half a century later, science studies are finally catching up with individual accounts and showing that some of the risks people had always worried about with hormone therapy could not be ignored. But for the last half a century some women got terrifying first hand knowledge of risks they probably had no had no idea they were assuming. Breast cancer is one of the most publicized concerns, with studies showing 8 in 10,000 women per year contract breast cancer who wouldn't have without hormone therapy. In addition, women who take estrogen and progestin risk more strokes, blood clots and urinary incontinence.

To be fair, there are associated decreases in the incidence of colorectal cancer and hip fractures with hormone therapy. Many women benefited and swore by hormone therapy. But the problem was, no woman nor her doctor, could predict which risk vs. benefits bucket she might fall into. That's always the hardest part, predicting risk given very few knowns and a vast number of unknowns. Today science continues to do research in order to try to find a way that women can glean the benefits of hormone therapy but not incur the risks.

As hormone therapy fades in popularity it may seem intuitive to damn whoever made it popular. Perhaps hormone therapy was in part a cultural movement that's gone the way of hippies? Not quite. Half a century later, women's liberation is less of a cultural driving force in the United States, but women of all ages take take other risks, for instance with plastic surgery. Decades from now, this too might look silly. But now, there's all sorts of rational urging that not only to stay young looking, but to keep a job, to stay in the job market, women must stay looking youthful.

Moving away from the NYT column, if you want to cast blame, there lots of targets. Profit making companies -- pharmaceutical, insurance and media -- all distort public health knowledge. Much has been said about each of these industries.

But people should just as well blame the human body for not making medical science easier and more predictable. Genetic variation assures that people can react differently to the same treatments. The same medication that cures one person, will do nothing for another, and rare cases will kill another. Many women never incurred any negative outcomes from hormone therapy. Scientists are still working to understand why. Doctor try to apply that knowledge for patients' health. Fortunately for all of us, scientists and doctors don't give up, therefore science and medicine continue to evolve. People who think change is a curse, who infer therefore that this progress is a curse should spend some time perusing old medical journals.

The Logic of Blaming Scientists

Medicine and science do change in half a century, true, and that's a good thing. But even if you're looking at science or medical progress over a short time span, does saying medicine/science can't make up its mind make sense?

Isn't it a little like saying "the press can't make up its mind"? After all, science research is almost always translated for the public by the press. What would Bill Keller say? Do "science columnists" like John Tierney at The New York Times behave in concert with journalists/data movers like Julian Assange at WikiLeaks? Can these journalists ("sources", to some) be lumped with journalists that come in the form of TV personalities blogging on the Huffington Post? Are they all part and parcel with twittering science journalism professors? Sure, you can clump together and label professionals if that feels convenient. But in an honest moment no one would compare the entire cohort of "scientists", "doctors", or even "journalists" to a school of sardines flitting hither and thither through the sea until they expire in Santa Barbara harbor from depleting all available oxygen.

Just as absurd, the statement that science or medicine "can't make up its mind" presses the illogical notion that scientists collude in order to present the disparate or outlying findings that you immediately find looking across any subject's vast body of research. I'm sure scientists would love to be gifted with such inordinate non-existent powers over research grants, graduate student experiments, science publishing, reviewers, etc. in order to collude, but the universe is not so magical.

Clearly, the fact that these statements about science agenda's, ignorance, or malevolence do not make sense, but that does not stop their spread. And while the NYT lede was perhaps tongue in cheek, the very common sentiment that scientists can't tell what's going on from all the conflicting research leads to more insidious behavior. This is our second point.

Fostering Dangerous Attitudes about Science and Medicine

Propagating the myth that scientists and doctors present "conflicting" results, and "can't make up their minds" leads citizens to exasperation with research. Few acknowledge how it's all filtered through the press. Fewer still peruse the even the summary, called an "abstract", of original studies, most of which are publicly available online (for instance health at Pubmed).

In this way, the commonly expressed sentiment that scientists change their minds can become in essence a self-serving excuse for apathy: 'How can I take care of my health when scientists and doctors can't even make up their minds?' As the subtitle of the NYT article puts it: "It's very difficult to be a civilian in the world of science." Oh, woe are we. But ironically, by blaming scientists/doctors, citizens resign themselves to fate and thus open themselves to manipulation.

So second to pointing out the fundamental essence of science and medicine that advances at a rapid pace, fortunately for us, I suggest that the myth that scientists can't make up their mind is insidiously destructive because it enables manipulation of the public in matters of science and medicine.

In personal health, if people believe they are helpless, they're less likely to try and understand the science that effects them, less likely to do research, and less likely ask questions of doctors. Distrust of allopathic medicine can also lead people to ignore doctors, to turn to "woo-woo" theories, or to become susceptible to relentless pharmaceutical advertising and absurd press headlines aimed at readers. It's fine to criticize woo-woo science, as many scientist do, taking on homeopathy, acupuncture, anti-vax, chiropractic, chrystals, etc.; but scientists and critics intellectually blinkered if they do that without acknowledging the anti-science industry that gives these sorts of "healers" their power.

Once people have fully accepted the premise that scientists and doctors "can't make up their minds" on personal health data, it's a small step to convince them that science can't make up "it's mind" on anything else either.

Are climate scientists predicting an Ice Age or Global Warming, cry shills for energy "business as usual" (BAU) such as fossil fuel lobbies? And now we have almost half of the US population not believing in climate change, a situation that doesn't bode well for any species. I simplify this of course, people also choose not to believe in climate change because they don't see anything they can do about it. But often that learned helplessness starts with a false indictment of scientists. As in personal health, the false indictment that scientists really don't know anyway is self-serving because it breeds fatalistic apathy.

The apathy leads to further victimization by those who work most effectively when citizens don't pay to close attention. Not only do people believe they can't do anything about global warming, they justify their stance by saying the scientists don't know what's happening either. This becomes the perfect atmosphere for severe policy moves like the destruction of the EPA. Polluted air and water disproportionately effect the elderly, poor, and very young who can't protest, but in the end it will effect everyone. Propagating distrust in science by claiming science can't make up it's mind creates the perfect apathetic breeding ground for such radical policies.

To conclude, I heartily disagree with the idea the medicine or science can't make up it's mind. First, too often people confuse press headlines with medical advice derived from many research studies, each of which is only a building block to public health recommendations. As medical history shows, it's these changes, commonly called progress, that has expanded our lifespan (albeit with risks). It defies logic to say that scientists collude to create conflicting results. Most importantly, the popular idea that science or health professionals "can't make up their minds" feeds a learned helplessness that in turn opens citizens to further manipulation.

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Whose responsibility is it to make sure that people understand science research? In the end, it's the people's, it's society's. Unlike many others, I don't agree that it's up to the scientists' to educate the general public. But that's the subject of another post.

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¹ Pointing out that the media can distort the actual results of studies for the sake of a headline, we asked why, for instance, the lead author would be quoted in this Science Daily study saying "We have known for many years that people with or at risk of Type 2 diabetes should limit their caffeine intake", when the author's actual science journal study (M.-S. Beaudoin, L. E. Robinson, T. E. Graham. An Oral Lipid Challenge and Acute Intake of Caffeinated Coffee Additively Decrease Glucose Tolerance in Healthy Men. Journal of Nutrition, 2011; 141 (4): 574 DOI: 10.3945/jn.110.132761) reported correctly that studies have found a "negative correlation between long- term coffee consumption and type 2 diabetes risks"? See? Study says one thing, news report on the study says another.

In "Medicine on the Move", Gail Collins opens her column with this: "sometimes you really do want to tell the medical profession to just make up its mind".

She writes: "estrogen therapy, which was bad, is good again. Possibly. In some cases." Not only that, she continues, current research shows that calcium pills are not "good" anymore and because of conflicting research women don't know whether or not to check for lumps or even get mammograms. The column seems sympathetic to women, who are presented as collectively confused by the scattershot findings of medical research: "'It's very difficult to be a woman,'" Collins quotes Dr. Leslie Ford of the National Cancer Institute.

You understand what she's saying. And not only is it tough to be a woman, it's tough to be a man. On prostate tests, should men screen? Operate? Oh, now don't operate. And the latest, don't even screen. What should men do?

And what about children? Treat their teeth with fluoride or not? Eat organic or not? Give them plastic bottles or not?

The bottom line is, we all care to some extent about personal health choices, and depend on the latest research to make our decisions. Doctors can help by passing on recommendations based on the research and their own filtering of the risks of one action or another. But the research can be confusing. One research study rarely drives a decision, rather, bodies of research sway medical recommendations like the one to recommend that women take hormones after menopause to preserve youth. And now, 50 years later, the recommendation that women not take hormone pills.

When hormones were first recommended for women a half a century ago, even then there were concerns about possible side effects. But doctors, women, and media surged ahead with treatment. Now, after many women have stopped hormone therapy recent studies are showing that some women benefit from hormones while for others there's limited risks. The science is slowly capable of a finer grain analysis of the issues.

The tricky part is translating the results of many research studies into public health recommendations. As this challenges doctors and those in public health, patients are also confused by what sometimes seems like an arbitrary process. The barrage of pharmaceutical ads on television is not helpful. And the barrage of "studies" reported in the press is mind-numbing. Based just on the media, it's too easy for the consumer to view each study as a separate public health recommendation, since the press presents studies not necessarily to educate but grab eyeballs and sell ads.

Is Coffee Bad For You?

Take for instance the press report last week on research that people who eat fatty meals then drink coffee can raise their blood sugar -- dangerously. Science Daily published an article titled: "Got a Craving for Fast Food? Skip the Coffee, Study Suggests". The title is not very intuitive, but hundreds of news outlets explained by quoting the author of the study, who stressed the importance of the study's findings for people with diabetes and metabolic disease: "We have known for many years that people with or at risk of Type 2 diabetes should limit their caffeine intake". She continued:

"Drinking decaffeinated coffee instead of caffeinated is one way to improve one's glucose tolerance. Limiting the intake of saturated fatty acids found in red meat, processed foods and fast food meals is also beneficial. This study has shown that the affects of these foods can be severe and long lasting."

"Severe and long lasting" -- wow, that's alarming. Let's check it out. What do other studies find? Indeed, previous research suggests there's a connection between caffeine and diabetes. For instance in the column to the right of the story on the Science Daily site, under "Related Stories", is a link to one story titled: "Cutting Caffeine May Help Control Diabetes (Jan. 28, 2008)". So two studies that say the same thing, that caffeine is linked to diabetes, and cutting it may control diabetes.

"New Evidence That Drinking Coffee May Reduce the Risk of Diabetes (June 10, 2010)" (my emphasis). Aha! That story conflicts with the other two in saying that caffeine may reduce diabetes.

What Happens to Mice who Drink Coffee Instead of Water?

I'm going to call this the "The Caffeine Controversy". The latest 2011 and 2008 stories appear to agree, so lets look at the 2010 story, published in "ACS' Journal of Agricultural and Food Chemistry". I'm not an expert in caffeine physiology or diabetes, so I'm going to do some basic stuff to try to learn more about whether I should believe the study.

First, who's the publisher? Different journals have different levels of clout or respect. ACS, the American Chemical Society is a professional organization for chemists, not to be confused with the lobby group the American Chemical Council (ACC). The researchers come from Nagoya and Kinki Universities, in Japan, as well as Pokka Corporation, a drink company. 4 out of 12 researchers come fom Pokka Corporation and the coffee used in the study was "a gift". So hmmm...It's not that coffee is that expensive or that great research isn't done by corporations, but just in general, how often does corporate sponsored research show that their product is dangerous to health? But lets keep looking at this study anyway.

The actual title of the paper is "Coffee and Caffeine Ameliorate Hyperglycemia, Fatty Liver, and Inflammatory Adipocytokine Expression in Spontaneously Diabetic KK-Ay Mice", which is way more nuanced than the press title "New Evidence That Drinking Coffee May Reduce the Risk of Diabetes". The study looks at physiological markers of lab mice genetically altered to become insulin resistant. The mice were given coffee instead of water in their diet, before being tested for biochemical markers hyperglycemia and diabetes.

We could look further at the specific tests they did, their statistics, the length of the study, the amount of caffeine used, or the effects of substituting coffee for water. We could examine their specific results, for instance fasting blood sugar was statistically insignificant between both groups, so they did an insulin tolerance test that showed the desired difference. But like most people, we don't have the immediate knowledge of the idiosyncrasies of these tests, so this would take a fair amount time. So instead let's look for studies that seem from the outset to be without conflicts of interest. Not that you should ever make assumptions.

What Happens to Humans who Drink Coffee?

So far we've looked a three studies and still don't have an answer, therefore the benefits or dangers of coffee remain "a controversy". And we don't even drink coffee, so do we care? But we're really curious about this statement from the researcher in the latest 2011 study, "We have known for many years that people with or at risk of Type 2 diabetes should limit their caffeine intake."

Why are we curious? This is a significant statement. According to NIH statistics from 2011, diabetes affects 25.8 million people. This amounts to 8.3 % of the US population according to the NIH, 11% of people over 20 years old, and 26.9% of people over 65 years old. About 30% of people over 65 years old have undiagnosed diabetes.

According the National Coffee Association daily coffee drinkers make up around 50% of the US population of about 300 billion people. Obviously, there's an overlap between these two huge groups. So it would be really relevant if the advice "avoid coffee consumption" were to be added to "exercise and lose weight" to prevent diabetes? And if this is the case, why then, do at least some hospitals treating patients who are diabetic allow them to drink coffee?

We'll turn to PubMed, where lots of published science research is collected. Fortunately, other researchers have also turned to Pubmed or MEDLINE to answer this very question. Two epidemiology studies have recently found that coffee actually lowers incidence of type II diabetes. These are fairly large studies that if true would dispute the current study. Lets look briefly at them.

One group from Harvard's Departments of Nutrition and Epidemiology, Brigham and Woman's, Harvard Medical School, and Vrije Universiteit's Department of Nutrition and Health, searched MEDLINE through January 2005 and found nine cohort studies culminating 193,473 study participants. They results of all these studies show that habitual coffee consumption decreases risk of Type II diabetes (van Dam et al: "Coffee Consumption and Risk of Type 2 Diabetes A Systematic Review" JAMA. 2005;294(1):97-104. doi: 10.1001/jama.294.1.97). That's a pretty solid epidemiological finding. The group doesn't appear to have conflicts of interest.

A second group with researchers from the US, France, Australia, Netherlands and Scotland. Huxley, R. et al: "Coffee, Decaffeinated Coffee, and Tea Consumption in Relation to Incident Type 2 Diabetes Mellitus: A Systematic Review With Meta-analysis" looked at prospective studies between 1966 and 2009, 18 studies with 457,922 participants, also found an inverse relationship between diabetes and self-reported coffee, as well as tea and decaffeinated coffee drinking. This too is a solid finding. So these two studies differ from the one we're looking at, but it's fair to say that the results of epidemiological studies can differ from studies showing some metabolic influences of coffee.

Should Humans Forgo Coffee?

Of course there are more studies, in humans, in mice, epidemiological studies, and biochemical and physiological studies. For now, although it seems as though coffee may indeed alter glucose homeostasis, this may not add up to something that can be seen in epidemiological studies. It doesn't mean coffee doesn't have an effect, or isn't harmful. We could keep looking at studies if we drank coffee and wanted to make a decision about this. But circling back to the original study, we'd venture that the Ph.D student/researcher's statement, "we've known for years" that people at risk for diabetes (a third the population) shouldn't drink coffee (1/2 the population) is at best hyperbolic. More so considering that the paper's discussion section notes that one of their results may explain the "negative correlation between long- term coffee consumption and type 2 diabetes risks".

And since this was reported in hundreds of news reports, lets also look quickly at the methodology. The 2011 paper used 11 volunteers. Being that this was a controlled experiment, subjects fasted for 12 hours after going two days without coffee, exercise or alcohol. The researchers then had participants drink a "fat cocktail", which consisted of 1 gram of fat/1 kg of body weight. (I don't know what the exact fat composition of the drink was because I couldn't find the "Supplemental Table II".)

But if you were a 160 pound male (72 kg), your experimental "fat cocktail" would consist of 72 grams of fat, which amounts to 5.5 tablespoons of soybean oil (one of the ingredients used in the study); or more familiar to most people, 24 tablespoons of half & half cream; more than 3 McDonald's Double Cheeseburgers; (.pdf); or about 3 orders of large McDonald's French Fries. I don't know what you think, but this pile of food would be outside the range of and meal choice for me. The participants then waited five hours, before drinking the caffeine equivalent of 2-3 cups of coffee (5 mg/kg body weight). 1 hour later they were fed 75g of dextrose (like glucose) - about 75 grams of high-glycemic carbohydrates. By comparison, a large Coke from McDonalds has about 86g of carbohydrates and a package of sugar has about 4 grams of carbohydrates. This protocol, the fat then the sugar after a 12 hour fast, caused a physiological response in the participants. Suprise?

Crave Fast Food? Skip The Three McDonald's Cheeseburgers

"Craving Fast Food, Skip the Coffee", the title of the press report warns. But what if when "craving fast food" you just skipped the three cheeseburgers? What if you just had a small coffee in the morning, with your non-fat yogurt or your dry toast, ok maybe a pat of butter. What would that do? What if the press report for any study actually reported the real story about the research?

Or, what if the press report just included the actual title of the research? In this case the title of the research was: "An Oral Lipid Challenge and Acute Intake of Caffeinated Coffee Additively Decrease Glucose Tolerance in Healthy Men." This is a lot different than what the media reported. And while eating 6 tablespoons of soybean oil upon arising AM after a 12 hour fast might be something some people do, and indeed the results may be interesting, how does this translate to any sort of public health recommendation like the ones the authors and news is trying to make?

What if when interviewed, the lead author said, as she did in her paper ¹ that while a few studies have shown glucose responses to caffeine, there is actually a "negative correlation between long- term coffee consumption and type 2 diabetes risks?" What Science Daily published instead was basically a false statement "We have known for many years that people with or at risk of Type 2 diabetes should limit their caffeine intake", which the researcher qualified (above) by advising people not to eat a lot of red meat and to drink decaf. Isn't this last advice, just common sense? But then does it follow from their study? No. It's previous research.

As a consumer of health news, it's worth reading the actual studies, or even just looking at the title, because as we showed, they often contradict the headline in the press. Secondly studies differ. Epidemiological studies where people self report, differ from other literature reviews, differ from lab mice studies, and from studies where people are attached to an IV. Different methodologies between the same type of study can yield different results.

As consumers we could try to understand all the nuance differences, but like Gail Collins, I think it's impossible. It's enough just to know that different methodologies can produce different results but that doesn't necessarily mean anything. This may sound confusing, but it isn't any more confusing then talking to multiple people about anything, from fixing the squeak in your car to whether your tie looks good.

You may rightly point out that the caffeine controversy is different than the estrogen controversy that Collins refers to. But it's really not. You have scientific research presented by the media, which is a meld of companies with vested interests, scientists, reporters biases and limitations, and doctors and clinicians. Consumers (patients) need to make sense of it all.

Tragically, people got cancer from estrogen therapy. People will die from heart attacks, obesity, diabetes. Decisions they make about coffee may influence the rate of their demise, but we don't exactly know how. The indefiniteness of research today does not help us make today's decisions.

Or does it? Is it the science or medical professions who confuse us? Doctors? Or the press and pharmaceutical companies? Or do we confuse ourselves rather than trying to understand some basic stuff about scientific publishing, press releases, the news industry, doctors, and business? In the case of our 2011 science research study on caffeine, the actual peer-reviewed published study was fairly informative about the limitations of the research. Even the title was elucidating. I haven't yet seen widespread physician's recommendations regarding the dangers of coffee. The most hyperbolic accounts in this case occurred in the press (perhaps with the help of the Ph.D. student - and where was the adviser?)

Most professions are required to take continuing education credits. If we're in charge of our health except for periodic ten minute interactions with the doctor, maybe we should be trying to understand how science, medicine and news industries work in order to take care of ourselves? I'm not talking about diagnosing ourselves. In this case, most consumers know what a somewhat healthy diet looks like, and that it doesn't involve 3 orders of large fries at McDonalds for breakfast. People know they need to exercise. The consensus of scientists and doctors is not controversial, it's simple, we need not be confused. But fruits, vegetables and exercise don't sell newspapers and pharmaceutical drugs.

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¹ M.-S. Beaudoin, L. E. Robinson, T. E. Graham. An Oral Lipid Challenge and Acute Intake of Caffeinated Coffee Additively Decrease Glucose Tolerance in Healthy Men. Journal of Nutrition, 2011; 141 (4): 574 DOI: 10.3945/jn.110.132761

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.

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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).