October 2011 Archives

Malaria Vaccine Data - Release then Patch?

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. MarianaRuiz Villarreal'sWikiMosquito.jpg Popular science journalists generally talk about cool, politically neutral science, or slick technology, or brilliant research successfully advanced to save lives; they write about winning clinical trials that will end scourges, any scourge - cancer, AIDS, Hepatitis, obesity... Good news!

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

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

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

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

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

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

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

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

Is Marginal Progress, "Success"?

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

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

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

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

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

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

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

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

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

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

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

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

Tough Economy for an IPO?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Vaccine Preventable Deaths

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. VaccineMap.jpg The US shockingly fanned the flames of the vaccine avoidance trend when it faked a vaccine campaign in Pakistan in order to to get access to Osama bin Laden. Meanwhile, tragically, people continue to die because there aren't enough vaccines to protect them.

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

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

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

1 Granted the UI's sometimes not entirely there

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

The Four Dog Defense

It's a well known strategy they say. But how well known is it if the world's biggest encyclopedia 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 (I'm ad-libbing here):

  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 some 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, the lawyers 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 toxicants 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 any of us.

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

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.

Technology Glitches and Patient Health

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.

Lest You Want to Do More Than Sit Under The Tuscan Sun

Blue Screens

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

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

Trials

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

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

Shutting Down Speech

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

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

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

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

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

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

Secret Geoengineering? Says Who?

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

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

Geoengineering - How Far Have We Really Come?

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

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

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

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

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

REALLY?

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

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

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

Fact or Fiction?

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

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

Existent or Not Existent?

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

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

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

follow us on twitter!

Archives