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

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

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

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

Does International Public Health News Compel Us to Cheer Enthusiastically?

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

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

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

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

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

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

Given this, who would write-up the newest Gates Foundation news as, a vaccine shown to be at best 44.9% ineffective in a half-done clinical trial? With the intense drive for upbeat news, I credit USA Today for their cautious "may save millions". But if you look more closely, for instance read the editorial accompanying the NEJM report³; listen to scientists around the web and in journals like The Lancet ⁴; or heed the malaria researchers interviewed by "Nature News⁵, the caveats of this recent malaria study grab your attention:

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

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

Is Marginal Progress, "Success"?

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

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

In the first trial, Sanaria injected 44 subjects. 42 people got malaria and 2 didn't, a 4.5% "success" rate. Although those subjects might have been better protected from malaria lounging in a malaria endemic region in mosquito-infested huts, Sanaria quickly pointed out that it wasn't the stunning failure it looked like. Rather, it was a trial that "yielded positive results" -- as their press release put it (without including relevant numbers). The company is buoyed by the success of their trial and primed for the next controversial⁷ phase. At the moment, every possible vaccine holds promise, since we have none.

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

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

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

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

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

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

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

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

Tough Economy for an IPO?

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

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

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

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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.

It's a well known strategy they say. But how well known is it if Wikipedia doesn't even have an entry? It goes like this. Say you're the owner of a dog who's just bitten someone. If you're a chuff, churl or cretin -- or you may say, your average defensive citizen -- you deny it via the so called "Four Dog Defense". Here's how one lawyer explained it to the St. Petersburg Times in 1997 ¹:

1. First of all, I don't have a dog.
2. And if I had a dog, it doesn't bite.
3. And if I had a dog and it did bite, then it didn't bite you.
4. And if I had a dog and it did bite, and it bit you, then you provoked the dog."

The St. Petersburg Times article wasn't actually about a dog, but about the landmark tobacco cases. And the tobacco industry played it something like this, as you may know:

1. Smoking definitely doesn't cause cancer, there's no evidence it causes cancer.
2. There's no consensus on the evidence; smoking may cause cancer but second hand smoke definitely doesn't.
3. Mice may get cancer but mice are not humans, cigarettes are not additive.
4. People choose to smoke -- and who are we to impose on people's constitutional rights? - etc.

Four Dogs Launched a Thousand Ways

"Four Dogs Defense" might to you sound more like a Kung Fu movie, but once introduced, you'll recognize it more often then you'd like. Some people describe the Four Dog Defense as a trial lawyer's adage, but the tobacco industry used it for decades to successfully deflect charges that cigarettes cause cancer. Despite volumes of documents proving of their deception in the form of the tobacco papers, the same companies today mount the same defense, albeit with diminishing success.

You might also be familiar with this strategy not only because of tobacco, but asbestos, lead, bisphenol A or any number of chemicals or "benign" products (sugar, alcohol, etc.) currently on the market.

The Natural Resources Defense Council (NRDC) used the "Four Dog Defense" to frame their recent investigation: "The Delay Game: How the Chemical Industry Ducks Regulation of the Most Toxic Substances". The report compellingly describes tactics the industries used to stall regulation. It focuses on three chemicals, trichloroethylene (TCE), formaldehyde, and styrene, which have been on the market for decades despite proof they cause morbidity and mortality.

NRDC describes how vested industries spend millions of dollars demanding the EPA conduct new science reviews, how the industries demand "independent" assessments and hire "independent" scientists to do favorable studies; and how they dispatch lobbyists to "influence" politicians and the EPA. Thus, toxic chemicals like formaldehyde, lead, atrazine, TCE stay on the market thanks to a collection of vested interests preventing the EPA from acting on well established science.

Of course for every move that industry makes to stall the EPA - demanding studies, suing, producing biased studies, and publicizing contrarian views aimed to confuse and stall regulation - the EPA and tax payers pay mightily to defend science. Circularly and ironically, taxpayers who already paid for the research to make their living environment healthy, then pay for defense when industry and lobbyists to attack that very science. The taxpayer pay for these attacks on science and the EPA (that the Tea Party and GOP so dearly want to abolish), both with our money and our health.

The TCE Story

This four dog defense strategy has kept trichloroethylene (TCE) on the market for decades. TCE is a solvent used for metal degreasing, commonly for cleaning airplane parts. It's also used in household items such as paint removers, glues, correction fluid, electronic equipment cleaners, rug cleaners, and adhesives. TCE is linked with leukemia, cancers, developmental defects, and problems with the male reproductive system, the immune system, liver, kidney and nervous systems.

TCE is found in hundreds of Super Fund sites, places like like Lawrence Livermore National Laboratory, and military bases. Many of these sites are not giant dumps somep other place in America but right in our communities. When a new housing development gets built in the vicinity of some high stature physics lab in an expensive suburb, for instance, the EPA describes how TCE can contaminate air that gets into homes and water. TCE leaches from the soil into water supplies, evaporates into the air, and poisons humans by any means of ingestion.

And what happens when homeowner's get sick? The four dog defense continues. The effects of TCE on human health were detailed in Jonathan Harr's 1996 non-fiction book A Civil Action.

A Civil Action

As Harr recounts, a large number of people began to die in Woburn, Massachusetts, in what public health officials identified as a leukemia cluster. Three companies, including W.R. Grace and a tannery owned by Beatrice Foods, dumped TCE onto land and it leached into the water supply. During discovery before the trial, companies' defense lawyers deposed the plaintiffs, grilling them on the details of their daily lives. As Harr describes in his book, they produced exhaustive inventories of products used in each plaintiff's house, what they ate, drank, cleaned with...

"five hundred brand-name household products -- cleaning agents and detergents, rug shampoos, cosmetics, nail-polish removers, insect repellents, paints, lawn fertilizers, cold remedies, cough syrups, herbal teas, coffee, even peanut butter."

The goal-oriented lawyers are relentless:

"Do you eat peanut butter?" one of Facher's young associates asked Anne Anderson.
"No," said Anne.
"Did you ever eat peanut butter?"
"I guess everybody living has probably tried it," replied Anne.
"Do your kids eat peanut butter?"
"Well, the same jar has been sitting there an awfully long time, so I guess we don't eat much"
"What kind is it, plain or chunky?"
"Plain, smooth," said Anne."
"You made your children peanut butter sandwiches?"
"They ate some, when they were small"
"When you say, 'some,' could you quantify that?" One or two sandwiches a week for the children?"

Peanut butter can contain aflatoxin, a carcinogen.

As Harr writes, Jan Schlichtmann, lawyer for the plaintiffs, knows that the defendant's lawyers are trying to dilute the evidence in order to develop uncertainty about the origin of the cancers. When at 5:00PM, he requests that the defense lawyers to end their deposition, they ignore him and continue their questioning.

"Do you eat bacon?...(Bacon contains dimethylnitrosamine, a carcinogen.) How often? How many slices? Do you fry it or bake it? Do you have Teflon pans (Teflon is made of a resin containing acrylonitrile, a carcinogen.) How often do you use them? Do you chew sugarless gum? (Saccharin, a carcinogen in mice.) How often? Do you pump your own gas?..."

It continues with each plaintiff, over the next three weeks -- do you bathe, shower, wear deodorant, own a cats, have plastic shower curtains, drink beer, smoke? Each activity or product contains certain carcinogens, passes on certain risks...

While the pre-trial "discovery" of "A Civil Action" drags on, people continue drinking TCE polluted water and breath TCE polluted air.

"Roland Gamache was dying of leukemia by the time his second deposition began. Neither he nor his wife could admit this to each other. But the lawyers all knew. In early October, Gamache did not have strength enough to get out of bed...."

And while these leukemia victims answer inquiries by lawyers working on behalf of TCE dumpers, somewhere else in the world, in another room, at another polished bird's eye maple conference table, lawyers for a different chemical or product question different plaintiffs about their possible exposure to solvents -- have you ever glued anything (glues contain can TCE)? Walked by the old Naval base in the next block?

In the end the Woburn case didn't repair the TCE victims, nor did it motivate universal action on TCE. But law schools use the book as a case study to instruct future lawyers prosecuting (as well as defending) the makers of toxic chemicals. As you can imagine then, with this sort of defense fully proven to work, people injured from environmental toxins have a difficult time getting remedy from the courts.

The Doggy-Dog World of Politicians

Given the tenacity and success of the four dog defense, it was against great odds that after decades years of stalling, not only by industry and lawyers, but by politicians, White House administrations, and the Department of Defense and Department of Energy, the EPA released its final IRIS assessment of TCE last week.

The EPA's last assessment of TCE came in 1987, almost a quarter of a century ago. In 2001 the EPA calculated that based on research to that date, TCE was 5-65 times as toxic as previously thought, especially to children. It can be found in 761 Superfund sites. Since the Department of Defense and Department of Energy would be responsible for cleaning up many of the sites, the agencies fought vigorously to prevent EPA action. OMB reports that DOD action against the rule cost taxpayers a million dollars.

The EPA's path to updating the Toxic Substance Control Act (TSCA) was tortuous, likewise for the the EPA's completion of the IRIS assessments for the backlog of chemicals with suspected or proven health affects. The EPA is struggling to overcome a failed strategy of depending on industry to produce safety profiles of chemicals, which hasn't adequately safeguarded our health. (Acronym Required started reporting this here in 2005, decades into the battle ²). But progress is hindered - as you can see, industry mounts gargantuan hurdles against the EPA.

Even once people are somewhat convinced that a chemical such as bisphenol A is toxic, lobbyists for industry deploy the four dog defense. This is long after the media loses interest, long after the public tires of hearing about it, long after the environmental groups start in on their next agenda, and long after most politicians drop the issue (now that they're not getting calls from their constituents).

As we speak, politicians that we (you) voted for, "working in our interest" actively fight against the EPA's IRIS assessments and against EPA moves to strengthen TSCA. Their most successful claim against regulating chemicals that cause the loss of life and impede people's ability to work? That the "stringent" rules will "cost jobs". Politicians are lawyers after all, so they know the four dog defense perhaps better than we or Wikipedia.

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¹ "Can This Man Tame Tobacco?" David Barstow St. Petersburg Times April 7, 1997

² Acronym Required wrote about TSCA in of posts a couple of posts about Teflon in 2005; in a few posts on Europe's REACH, for instance The EU on Chemicals: More Strife Across the Pond?; a here and in many posts about bisphenol-A.

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.

New Scientists Who Don't Do Science

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Pharmaceutical Research and Manufacturers of America (PhRMA) says it costs $1.3 billion to bring a new drug to market, and researchers dispute the lobby's claim. Could the ponderous costs of clinical trials, increasing regulation, a burgeoning FDA, and a litigious society keep driving drug prices up?

Perhaps we should we go back to simpler times, like 1895:

"The Cost of Making Antitoxin In the District:

Health Officer Woodward appeared before the Commissioners on the 10th inst., and submitted the following estimate for the suppression of contagious diseases: For the production of antitoxin for the treatment of diphtheria:

• twelve horses at $40 each, $480;
• maintenance of twelve horses at $10 each per month, $1200;
• bacteriologist, $1,800;
• materials and apparatus, $320;

Total: $3,800."

-The Journal of the American Medical Association Vol. XXIV, January 19th 1895: Miscellany.

It was the horses, obviously, driving costs up. Or perhaps they overestimated the cost of horses to support resistance to cheaper imports and generics, and to justify raising drug prices...

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?

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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.

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