Recently in Pharmaceutical Interests, Public Interests Category

Films to See: "Escape Fire" and "The Waiting Room"

Many people muster strong opinions about Oscars - not I. Having enjoyed some of 2012's awarded movies, I watched the Oscars with appreciation, albeit distracted by the din of our crowd. The only thing that always disappoints me, every year, is how many important subjects and films get left out. The 2012 documentary movies "Escape Fire" and "The Waiting Room" focus on healthcare in the U.S.

"Escape Fire"

Escape Fire airs this weekend on CNN. The film isn't shy about its agenda, as one commentator puts it: "We don't have a healthcare system, we have a disease management system." The disease management system in the U.S. comprises many industries - pharmaceutical, insurance, hospital chains, and doctors' groups, so the film covers a lot of ground.


Escape Fire

Doctors and patients dependence on pharmaceutical drugs gets shown via an arresting story of a veteran being weaned off of painkillers. The pharmaceutical industry's economic calculations, deadly to patients, are recounted by Dr. Steven Nissen and the familiar story of Avandia. The insurance industry's stake in it all is discussed and memorably captured in a shot of all the insurance company representatives sitting around the table negotiating Obama's healthcare plan. The filmmakers somehow patch together an optimistic if controversial package of solutions for the impenetrable seeming morass they depict. A Safeway executive marshals employees to exercise and lose weight. Media-popular doctors hold forth with various remedies.

The story thread I appreciated most was that of a primary care doctor. To her dismay, time with patients kept being shortened to meet new economic demands. Supervisors told her to "get her productivity up", so she changed jobs more than once, hoping for a position that allowed her to adequately care for her patients.

Aside from patients, primary care physicians have taken the toughest hit in our *efficiency* driven system. There aren't enough of them, and the care in some parts of the country has become so slapdash it's dangerous. Yet at the bottom of every health article, at the end of every pharmaceutical ad, in every news piece about this or that medical research is a bright, incongruous little instruction: "Ask Your Doctor". As if. As if we had the same level of medical intimacy and trust, just technologically superior, as when my great grandfather worked through nights, house to house in his little town.

Interestingly, the system depicted by the riveting film "Escape Fire", however sickly, is what the healthiest patients get, those who have the very best insurance in a places chocked full of excellent hospitals. Fifty million uninsured patients in the U.S. don't get that.

"The Waiting Room"

Which brings us to the excellent film "The Waiting Room", by Steven Nicks, shortlisted in the top 15 Oscar picks. The movie's setting is Oakland, California's Highland Hospital waiting room, over 24 hours. It focuses on a different aspect of the problem than "Escape Fire" and takes a different tone. If on the continuum of polemic reporting, Michael Moore's "Sicko" scored a 9-10, "Escape Fire" might get a 6-7, and "The Waiting Room" would score a 0-1. Healthcare has been ruthlessly politicized in the U.S. and most people will bring some opinion to this film. In turn, the film strives to be empty of politics. It provides details for its characters, but doesn't do voice-overs, doesn't judge, and doesn't demand your defined conclusion.

Deplore the public cost of diverse homeless populations plagued by addictions, unemployment, poverty and in need of medical care? Those people end up at Highland Hospital. Disdain college grads who don't pay for health insurance? They too, sit in this waiting room. Despair a healthcare system that allows people to get sick and sicker until they end up in emergency rooms instead of getting primary care? Those sick people are here. Agonize how social services have been ruthlessly cut in poor cities? Highland Hospital helps these people also.

They sit shoulder to shoulder in our emergency rooms - our institutions of last resort. Every age, gender, and nationality, they're all here, men plagued with chronic labor-related injuries, primly dressed women abruptly out of work, twenty-year olds surprised by tumors, stroke victims who couldn't afford medicine, kidney dialysis patients from other states, and alcohol/drug addicts living on the streets.

The Waiting Room

But the film doesn't run all their stories together like I just did, in a big forgettable jumble. It follows each person. How did a little girl with tonsillitis end up in the emergency room instead of in primary care? Her parents are separated, but both show up at the hospital. Her dad lost his job and missed his day with her yesterday on account of transportation. He anxiously hops around her during intake. His son died at two. The nurse, half his size, counsels him to settle down so he doesn't scare his daughter. The girl seems numb to it all.

Triage

Whatever you feel about their plight, whatever sentiment or opinion, the frenzied emergency room healthcare system doesn't have time for any of it. Sentimentality? No. Compassion? Yes. Medical technicians and intake nurses and doctors and interns triage when all beds are full and patient tempers are short. They treat patients as best they can, when specialists have months long waiting times, when "non-profit" hospitals turn away poor patients, and when community safety-nets like churches run out of giving.

The outcomes at Highland Hospital can stretch the boundaries of adequate medical care. Fresh gunshot wounds get run into a trauma room, a steady stream of community catastrophes delivered by ambulance, while men with not fresh but unhealed gunshot wounds groan for hours, days, in the waiting room. A homeless man occupies one bed for too long because he has no place to go. Someone who can't get surgery seems pleased with a pain med prescription. This is where the 50 million uninsured people who are not short-changed in the scenes of "Escape Fire" land sometimes enduring hours of wait before they see a doctor.

At discharge, patients summon fragments of pride. They negotiate payments and answering questions about unemployment checks and family resources awkwardly, over a small desk, everyone caught up in unfortunate circumstances. "The Waiting Room" captures the tension of these situations in a refreshingly empathetic way.

If the movie doesn't hammer home a message, it embraces realism. A new doctor, stunned, is told what to say to a family, told exactly which forms of the verb "to die" to use. After one trauma team struggles to save a gunshot wound victim, they attach a tag to a fifteen year old's toe and he gets wheeled into the morgue. We read a small sign next to the refrigerator door: "Put The Body in Any Available Space".

The film, being so good, won't say this, but economically, ethically, and psychically, everything that brought this Oakland boy to that place costs society. Whatever your politics - in every way, it costs you.

Escape Fire and The Waiting Room, two films highly worth seeing.

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

The Waiting Room played all over last fall, and aired on PBS. It is now playing a few other places around U.S., and is also available for purchase. The film team also produces an interactive multi-media site.

Malaria Vaccine - Rough Waters

A malaria vaccine over two decades in the making given to infants in Africa was shown by preliminary data to be 30% effective. Good news or bad news?

It depends on who you talk to. Most scientists and public health workers described the partial phase III clinical trial result of RTS,S/AS01 as disappointing, frustrating, or underwhelming, while trial sponsors, a few scientists, the government of Ghana, and KTN streaming LIVE from Kenya 24/7, remained upbeat, stressing that given the millions of malaria infections, a 30% reduction in would give the vaccine a significant place in malaria prevention.

In 2010 there were an estimated 216 million cases of malaria and 655,000 deaths, 91% of which were in Africa. In the past decade years, the concerted effort to combat malaria has decreased deaths and infections significantly, by 25%. But without a doubt, an effective malaria vaccine would be, if not the end of a horrible scourge, at least be an excellent addition to the arsenal of indoor spraying, bednets, and available treatment options. The question is, given the costs of developing and deploying a vaccine and the current economic climate, what's considered effective?

RowingUpstreamish2

Rough Waters
via Creative Commons License.

This month's 31% results are disappointing compared to last year's results from older kids, 5-17 months, that showed the vaccine to be 55% effective. As well, the newest results from the Phase III trial, show about half the efficacy of those from the previous Phase II trial for the same-aged infants, which seemed to show the vaccine as 62% protective.

Not 55% but 30% Effective

The RTS,S vaccine targets the Plasmodium falciparum and is made with proteins from both the parasite and Hepatitis B virus that serves to enhance the immune response. So why is the vaccine now apparently only 31% effective at preventing infection and 37% effective at preventing severe disease, almost half what it was? Scientists have several hypotheses. It might be the high levels of malaria around the test centers included in this data release, or that increased immunity from mothers in the younger infants blunts the response of the infants' immune systems against the vaccine, or perhaps since the vaccine for the infants was administered with other vaccines the infant immune systems responded less vigorously to the malaria shot. What there's no question about is how tricky it is to make a vaccine that successfully combats infection from an evolving and evasive parasite that moves through different stages of its lifecycle in different parts of the human (host) body.

With the efficacy data so low, scientists were left emphasizing how safe the vaccine is (important, of course, but not exactly the point at this stage). They stress how successful of the logistically complicated and ambitious trial (across 11 centers in 7 countries). Indeed the trial logistics are impressive, important, and a huge inroad to drug testing and public health, but the accomplishment doesn't address the high expectations and promises made during last year's data release.

Glass Now Less Than Half-Full

While the results were discouraging, some scientists weren't surprised. When researchers announced last year's interim results some scientists predicted based on the data that the younger 6-12 week cohort would be less protected by this vaccine. This was one of several caveats scientists pointed out. They also warned against early incomplete data releases, stressed that the older children weren't the target group, and questioned various aspects of the 55% number. We covered some of these questions in a post -- the same caveats and questions apply to this year's data release.

Vaccine development, especially against malaria, is incredibly difficult. Although there are about 30 vaccines in development now, according to the World Health Organization's Rainbow Tables, the closest candidates are 5-10 years behind this one. This fact of course influences the biggest unanswered question: How effective does a vaccine need to be in order to be put into production? There are limits to both attention and money available for urgent public health initiatives, so realistically, funding one initiative can potentially handicap others - but then the argument always swings back -- there is no malaria vaccine right now.

Vaccine Goals - Made To Be Eschewed?

To help guide answers to this question, the World Health Organization, in concert with invested organizations including the public and private sponsors of this vaccine, established in a roadmap(pdf) a "Strategic Goal" to "by 2025, develop and license a malaria vaccine that has a protective efficacy of more than 80% against clinical disease and lasts longer than four years." RTS,S/ASO1 is no where near this. But the WHO also established a "Landmark" Goal, to "by 2015, develop and license a first-generation malaria vaccine that has a protective efficacy of more than 50% against severe disease and death and lasts longer than one year." WHO is currently in the process of updating the roadmap, but warns that the Landmark goal is not being changed.

All scientists acknowledge that only more data analysis from this trial will provide clearer answers. The WHO provides information on vaccine development and its role in assessing the vaccine in 2014-2015. Some scientists predict that the trend of decreasing efficacy after 6 months shown in the data looks ominous: "The results look bad now, but they will probably be worse later", said vaccine expert, researcher for competing vaccines, and deliverer of not-very-upbeat messages Adrian Hill of Oxford University. (But if subsequent data looked somewhat better - the situation of this year's results compared to last year's - the reaction would probably be euphoric.)

Last year when we discussed the vaccine we commented on possible later outcomes that could stem from the incredible hype around interim results releases -

"...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...?"

Commenting on the latest results, Andrew Witty, GSK CEO told reporters in a conference call "We've been at this for 30 years, and we're certainly not going to give up now".

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

In other malaria vaccine news Sanaria, another malaria vaccine maker whose founders have been knee-deep in malaria vaccines for decades, recently hosted 7th graders in an event hosted by Montgomery County universities. The idea was to introduce kids to science and medicine so they don't think of people who work in biosciences as "crazy scientists", said Stephen L. Hoffman, founder and CEO of the company. Hoffman's latest malaria vaccine effort was profiled by Science in "New Hope for Crazy Vaccine", briefed by us last year. Sanaria received $3 million funding for Phase II trials last summer.

In still more malaria news, a program called the Affordable Medicines Facility - Malaria(AMFm) has been radically downsized, killed, and folded into obscurity within the Global Fund. The reasons remain a little mysterious. By all accounts, the program was successful, even "overwhelmingly successful", in lowering the pharmacy prices of drugs called Artemesin Combination Therapies (ACTs). If you contract malaria in Africa you often need to buy your own drugs. Patients will naturally buy the cheapest drugs, which happen to be those that are least effective or most susceptible to antibiotic resistance. The program made the ACTs competitively priced with monotherapies, therefore competitive in the marketplace and helpful to preventing artemisinin resistance and conquering malaria. The strategy was innovative and effective.

However, some critics claimed that this method wasn't getting the drugs to children, and that some people were buying up the drugs without a diagnosis. Defendants said these criticisms moved the goal posts, phase II could have solved some problems. But more scientists aren't at all sure why the program got cut, some suggesting that for some reason Oxfam and the President's Malaria Initiative lobbied hard against it. One contingent that is probably pleased with the outcome has been lobbying vigorously against AMF-m since its inception. The group's members are variously affiliated with pharmaceutical companies, 'free enterprise think-tanks', and target lobby efforts like "Africa Fighting Malaria", they selflessly devote their lives to promoting DDT spraying, and lobbying against generic drugs. One or more have written accounts claiming that the competitive pricing schemes employed by AMF-m used cheaper drug suppliers with inferior services -- a spurious, tedious and surprisingly effective go-to argument for decades by pharmaceutical companies lobbying against generics for the most deadly diseases AIDS, Malaria, etc.

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.

Why Do Drugs Cost So Much?

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...

The Confusion of Science & Medical Research (Part II)

| Comments

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 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 at medical 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 'proof of concept' technology advanced to machines that could keep patients oxygenated during heart surgery. As you can imagine, the first "heart surgeries" were risky business, and are new procedures in every field of medicine, especially surgery. 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. At 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 in the era of women's liberation, Wilson accused men as standing-by while women were one day bra-less free spirits, and the next day "castrated" at the youthful age of 50. Which is why in 1966, as Time Magazine wrote:

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 scientists continue 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 in 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. So 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 TV personalities or "citizen journalists" at the Huffington Post? With twittering science journalism professors? Sure, you can clump together 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 ten thousand 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, these ideas about scientists' 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 really going on in 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.

Take 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 are 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 health, 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 half the US population doesn't believe in climate change, a situation that doesn't bode well for any species. I simplify 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.

(Whose responsibility is it to make sure that people understand science research? In the end, it's of our responsibility. 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.)

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

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.

Challenging Healthcare Reform - Hints of Outcomes from Campaign Snippets

Challenging the Healthcare Bill

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

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

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

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

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

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

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

Embryonic Stem Cells Part I: Shock and Awe Strike Again

Last week, U.S. District Judge Royce Lamberth issued a preliminary injunction to stop Obama's reinstatement of some of the federal funding for embryonic stem cell research.

The plaintiffs included Christian Medical Association, the Nightlight Christian Adoptions, an agency that sells the use of frozen embryos it calls "snowflakes" - from fertility clinics, two PH.D. scientists, James Sherley of Watertown, Massachusetts, and Theresa Deisher of Seattle, who do research on adult stem cells and claim that allowing embryonic stem cell research wrecks their chances of getting federal grants. Other plaintiffs in the suit were clients for adopted embryos, and the actual embryos frozen in IVF clinics.

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

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

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

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

Science Community Stunned

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

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

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

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

Some scientists speculate that the importance of federally funded embryonic stem cell research has faded, because so much work is done privately. Others, including the plaintiffs, argue that inducible pluripotent stem cells (iPSC) or adult stem cells are just as promising. "Pro-life" and Christian groups argue that the embryos are people which shouldn't be used for research, even if it will save lives. But scientists agree that embryonic research is at least a necessary prong to pursue potentially life-saving research, and many people, including Christians, agree.

The plaintiffs' arguments do not persuade scientists for many reasons. Their claim to economic injury is not only unconvincing on its face, considering that the plaintiffs don't do research and the NIH funding structure evaluates all promising technology, it's dwarfed by the impact that stopping the research would have on the lives of sick people. As well, the livelihoods of many science researchers are in jeopardy, as is the investment of millions of dollars of government funding that the judge's order seeks to abandon ~24 research projects in which the government has spent $64 million (.pdf), now threatened because they had been scheduled to receive $54 million in continuing NIH funding at the end of September.

Should Scientists Have Been Surprised?

I was. But maybe I wasn't paying close enough attention. Or maybe I didn't want to believe that such anti-reason would even get a chance. But apparently, all it took was the "right" plaintiff and the "right" judge, at the "right" time.

Maybe it's a tempest in a teapot, as many seem to think. Maybe Lamberth had an off day and will change his mind, maybe the courts (moving right every day) will come to their senses. But at the moment, those who want to stop hESC seem to be determinately bulldozing things their way, decade after decade.

Maher's Mainstream Media Anti-Vaccination Campaign

Maher Still Loco on Vaccinations:

As he has for years, Bill Maher continues to spread disinformation about vaccines. In countless news cycles Maher infuriates doctors, public health officials, and responsible citizens with his bizarre warnings about letting a government "stick a disease into your arm".

Challenged to get a word in edgewise between his fusillades about "mercury" and "diet" and natural "immunity", doctors and scientists nevertheless patiently correct his errors. They explain that a vaccine is not "a disease" but a disabled virus that looks to the immune system like a live virus or bacteria and therefore prevents infection by the actual deadly virus or bacteria1 like polio, measles, diphtheria, or influenza.

But the talk show host persists, as is his habit. Last month, Bill "I'm also not f-king my interns" Maher baffled amiable talk-show panelists Alec Baldwin, Chris Matthews and Maryland Governor Martin O'Malley by rehashing his concerns with vaccines. Wikipedia-Polio_physical_therapy2.png Yesterday, Maher continued his rant in a rambling column at The Huffington Post titled "A Conversation Worth Having". He noted he wanted to:

"clear up a few things about my beliefs concerning the flu shot, vaccines, and health in general...I will admit, I have gone off half cocked on this issue sometimes, and often only had time on my show to explain a fraction of what needed to be explained, and for that I am sorry...I agree with my critics who say there are far more qualified people than me"

Mea culpa? Unfortunately (and spoiler alert for the 2800 word article) no. I didn't say "anyone who gets a flu shot is an idiot", Maher said, "it was twittered...my bad". Then, "vaccination is a nuanced subject, and I've never said all vaccines in all situations are bad..." Nuanced?

Discerning Maher's Health Prescription -- "Sometimes It's OK to Fuck with Nature"

Maher writes "I'm not a germ theory denier" and claims "I do understand the theory of inoculation". With such pronouncements he exudes all the candor of an intelligent design proselytizer putting quotes around "the theory" of evolution. To a doctor who corrects him, Maher retorts snidely "Thanks, Doc, I thought there might be a little man inside the needle. Yes, I read Microbe Hunters when I was eight." Which is confusing since didn't he say: "the conversation is worth having?"

Cocksure and funny, Maher acts as though he's arguing the correct side of a clear line eight year old can see - you don't need to be a doctor or scientist. To one side of the line there are the OK vaccines, except, he hedges, vaccines are unproven. To the right, there are the not-OK vaccines that we should be debating, like flu vaccine. But actually, if you can't already tell, there is no line or margin, because Maher is arguing the same old run-of-the-mill anti-vaccine/medicine/science schtick you've already heard. He allows that "sometimes it's OK to fuck with nature" and prescribe medicine, but listen to enough Maher and you realize he maligns all medicine, all vaccines.

Casting Aside Science

Sure, at first you may be confused because he mixes recognizable words within gobbledygook. Do doctors ever ask patients what they eat, he asks rhetorically? No, he answers, "and a lot can be cured with diet and a healthier lifestyle" -- then Maher adds in parentheses -- "And a lot can't [be cured]. I also understand the role of genetics and generations of artificial selection". So mixing perhaps diet and exercise with pedigreed petunias and genetically altered crops?

Despite his clear understanding, lets review. The risk of some diseases, like diabetes Type II, can be reduced with healthier lifestyle. Some conditions, like obesity can be prevented with diet, and losing weight reduces the risks of morbidity and mortality associated with conditions like heart disease. True. But diet won't prevent crippling polio, or a flu pandemic or death of a pregnant woman, or stop a kid from succumbing to weeks of illness and a 105 degree influenza fever. And typical of Maher's machinations on science, medicine and disease, he jumps down the rabbit hole with "genetics and "generations of artificial selection". Scientists use artificial selection to breed products like corn by selecting for certain traits. Humans are not hothouse flowers, subjected to "generations of artificial selection".

How Does Maher Distinguish Himself From Dr. Beetroot?

In cajoling his audience to exercise skepticism and caution and arguing for "debate", a word that should tip anyone off to incoming falsehoods; Maher says:

"Someone needs to be representing the point of view that says the preferred way to handle flus is to have a strong immune system to begin with..."

Actually, we can think we recognize this "point of view". Take, for instance South Africa's former health minister, Dr. Manto Tshabalala-Msimang, (known derisively as Dr. Beetroot), who spent years telling South Africans to boost their immune systems against the AIDS virus with diet, beetroot and lemon.

In a familiar refrain, the South African Mbeki government insisted that Western drugs were too profit oriented and dangerous. As a result of this decision, hundreds of thousands of South Africans died from AIDS, and the dying isn't over, since infectious disease pandemics gather momentum over time. Newly elected President Zuma recently warned that the death rate from AIDS may overtake the birthrate in that country.

Is Maher's argument any different than that of Tshabalala-Msimang's? What de-marks greedy Western medicine from essential life-saving medicine? How does Maher, a board member of the "Reason Project", which is dedicated to scientific and secular knowledge, identify good medicine?

How is Maher's Position Different Than A Mennonite's?

Instead of agreeing with scientists and doctors, Maher chooses to listen to Barbara Loe Fisher who he finds "extremely credible":

"after devoting her life to studying this, she says that flu vaccines aren't proven and...points out that what we need, but do not yet have, are studies of vaccinated vs unvaccinated children."

Fisher is not a scientist or a doctor, and that's ok, anyone can educate themselves about vaccinations. Based on her experience parenting and in public relations, Fisher started a vaccination information center, appears on talk shows, testifies at events like the "Vaccine Policy Analysis Collaborative: A U.S. Government Experiment in Public Engagement", and gives lectures to naturopaths, chiropractors, and groups like "Body by God". Who's to say she can't do all that?

But given that Maher says she's devoted her life to studying vaccinations, you'd think she'd understand that vaccinating some children against polio, but not others, as she proposes in her hypothetical "study" would be medically unethical. It's medical ethics 101, a doctor would know this, as would most cogent adults. I'd think that Maher would also see the moral quagmire.

Furthermore, unfortunately, there's lots of evidence to prove that what Fisher and Maher say is the untested theory of vaccination is flat out false. As the NYT reported in 2003:

"The last two American polio outbreaks were in Amish and Mennonite communities in 1979 and in a Christian Science school in Connecticut in 1972. Measles killed 3 students of 125 infected in a Christian Science school in 1985, and a similar-size outbreak among the Amish in 1987 and 1988 killed 2 people. In 1991, 890 cases of rubella, leading to more than a dozen deformed children, hit Amish areas."

Since then, Africans who believed rumors that vaccinations are an attempt by Westerners to spread the HIV virus or sterilize Nigerians, started a polio epidemic. The Amish also suffered polio outbreaks. Mennonites, who don't believe in vaccination but do believe in travel caused outbreaks of measles in Minnesota, then South America. Like the Amish, Mennonites don't believe in vaccinations or insurance, but do believe that hospitals should cure them for a discount, once they get sick.

How is Maher's position different then that of a Mennonite? Can we have this conversation? How does Maher square his position on vaccines with his libertarian views, when people end up demanding hospital bailouts because they didn't take it upon themselves to prevent illness?

The Dredged Up "Under-reported Point of View" is Often Wrong, Concludes A Bright Person

The consequences of not vaccinating become graver and more frequent as more people refuse vaccinations. The value of vaccinations is not "debatable". Vaccinations have saved millions of lives, saved millions of dollars by keeping people out of hospitals, and boosted productivity of nations. But Maher ignores all this and calls for some cost benefit analysis, which is familiar anti-science denialism.

Maher appeals to all of those who eschew facts and take solace in unpopular views.

"I'm just trying to represent an under-reported medical point of view in this country, I'm not telling a specific pregnant lady what to do...[I]t's just that mainstream media rarely interviews doctors and scientists who present an alternative point of view..."

Pregnant women and kids are most susceptible to dying from H1N1 virus. Pregnant women have decreased lung capacity that increases the threat of pneumonia, and they have decreased immunity due to their pregnancy. The reason the media doesn't interview doctors and scientists with "alternative points of view" on the subject, is because doctors and scientists agree that vaccines save lives, and that pregnant woman and parents of children shouldn't die because they've been convinced by talk show hosts to doubt the CDC, the doctors, and the scientists.

Maher's is not selling an "under-reported medical point of view", as he claims, rather he's latched onto a non-medical, non-science point of view. Hmmm....why does he persist?

Bill Maher's Mainstream Media Profit Motives

Unbelievably, after flogging his point of view for years, Maher says he has no motive and expects no outcome: "[M]y audience is bright, they wouldn't refuse a flu shot because they heard me talk about it...." But his audience claps when he talks non-scientific hokum -- perhaps only because they're prompted? Either they're not thinking at all, or they're confused about science, or they're easily swayed by paranoid views, or they think they're at a gladiator show - in which case they will eventually be disappointed by the "debate." Can such folks be considered "bright" in the 21st century?

To the point, though, if Maher's especially non-bright, non-medical, non-scientific point of view weren't selling, weren't rewarded with clapping and viewers and advertising dollars, would he still be ranting on? Maher's anti-vaccination position has populist appeal that draws viewers and boosts ratings. His refutation of "mainstream media's profit motives" sells well. But lets be clear. HBO's Real Time, with millions of viewers each night, is mainstream media. What's not? Acronym Required, for instance, is not "mainstream media". So by his reasoning, you should listen up here. (No, actually I advocate you to do your own research and consult your own MD.)

And why pick on science? Scientists are a remarkably easy target, as we noted before when John McCain chronically made fun of science research. When Maher chose to accost religion, at least 50% of Americans are quite religious, and that's a lot of potential audience members to insult. Plus, religious people can get dangerous. Other Maher campaigns have also backfired, like when Maher's remarks about military recruiting spurred one Congressman to demand that Real Time be canceled.

Considering his options then, and the groups he's already alienated, scientists make a good target. They're pretty tame, therefore easy to pick on safely, and a select target for a large potential audience, since everyone's thinking of getting the flu vaccine. Maher can perhaps equivocate about good vs. bad vaccines and fool a lot of people. So Bill Maher and his mainstream media show try to expand his audience by maligning science to become more mainstream? So they forsake scientists, but also pregnant moms and kids in the process? Is this the conversation? More or less? Bravo, talk show host!

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

Photo used via Creative Commons license.

1 11/19 Added "bacteria"

Acronym Required wrote on vaccinations previously, for instance in Vaccinations, Why the Worry? we wrote about the long history of rebellion against vaccinations. We also wrote about vaccinations here and in various posts and vaccines for specific illnesses.

Bill Maher's shenanigans have been will covered by scientists like Respectful Insolence here and here, by Pharyngula; by Aetiology here and here here and by many others.

follow us on twitter!

Archives