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Embryonic Stem Cell Research: 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 Sherely of Watertown, Massachusetts, and Theresa Diesher of Seattle, who do research on adult stem cells and claim that allowing embryonic stem cell research wrecks their chances of getting federal grants; clients for adopted embryos; and the embryos frozen in IVF clinics.

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

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

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

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

Science Community Stunned

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

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

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

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

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

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

Should Scientists Have Been Surprised

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

It's sometimes easier for people (including scientists) to perfunctorily dismiss as terminally unenlightened or misguided, those who hold politically opposing views, for instance those who believe in Creation over evolution. Maybe it's not as head-splittingly frustrating as arguing or teaching. Perhaps a quick witted turn of phrase can morph anti-reason into fodder for jokes, yay! And why not deflect an ugly stand-off with some humor?

James Taranto, of the Wall Street Journal, for one, says that dismissive attitudes (here's one example I thought of: "Poll: So You Want to Build a Mosk?") harms liberal causes because 1) they tend to "mainstream those supposedly fringe notions" (ie: Pew Research Polls that constantly highlight subjects of "culture wars"), and 2) they "put the ugly attitudes of the liberal elite on display."

Scientists discuss these things frequently and blogging scientists have consumed years writing, discussing, comparing and vehemently arguing about various approaches -- hostility, framing, teaching, patience, humor, tolerance, diplomacy, "accomodationism", to deal with anti-reason. (Personally, I can't get attached to one approach or think another is "bad", I believe different writers and audiences will gravitate towards one communication method or another. They complement each other. )

But regardless of whether scientists are "civil", hostile, sarcastic, or choose to ignore what offends them, I wonder if all approaches are fatally flawed not only because of the reasons Taranto and scientists usually discuss, but because scientists are so up to their necks in scientific method. Do we then let ourselves believe that reason will prevail? And does that lead us to ignore what's at stake? The incredible belief everyone had in Obama that he could somehow transcend politics, indicates this may be so. Francis Collins "stunned" response indicates this may be so. Collins, if anyone, with his position and overt religiosity -- he's written books on this! -- should have had his ear to the ground.

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

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. Over countless news cycles Maher has infuriated doctors, public health officials, and responsible citizens with bizarre warnings about letting governments "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 panelists Alec Baldwin, Chris Matthews and Maryland Governor Martin O'Malley by rehashing his concerns with vaccines. Yesterday, Maher continued with a rambling column at The Huffington Post titled "A Conversation Worth Having", saying he aimed 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? "All vaccines"? Cagey creepy crapola -- bring it on, Maher.

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

Maher writes "I'm not a germ theory denier" and he claims "I do understand the theory of inoculation", exuding all the candor of a intelligent design proselytizer putting quotes around "the theory" of evolution. To the helpful 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." (Doesn't think the conversation is worth having?) Wikipedia-Polio_physical_therapy2.png

Cocksure and funny, Maher acts as though he's arguing about some scrutable line that any eight year old can see - you don't need to be a doctor or scientist. To the left 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 (yawwwwnn) 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 into 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".

Despite his unassailable 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 concurrently reduces the risks of morbidity and mortality associated with conditions like heart disease. This isn't just semantics. 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.

How is Maher's argument different than that of Tshabalala-Msimang's? Where does he draw his invisible line de-marking greedy Western medicine from essential life-saving medicine? How does this board member of the "Reason Project" (Wikipedia) 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", because

"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, eight or older. Based on her experience parenting and in public relations Fisher can certainly start a vaccination information center, appear on talk shows, testify at events like the "Vaccine Policy Analysis Collaborative: A U.S. Government Experiment in Public Engagement", and give lectures to naturopaths, chiropractors, and groups like "Body by God". Who's to say she can't?

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, would be medically unethical. You'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, more 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", 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".

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!

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Photo from Wikipedia under a 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.

Notes on Public Health - Live and Let Live

  • Progress on South Africa's New Stance on AIDS? Ten years ago, former South African president Thabo Mbeki told the National Council of Provinces that it would be "irresponsible" for the state to endorse antiretroviral drugs, noting a "large volume of scientific literature" attesting to the toxicity of ARV medicines. We've written about South Africa's HIV/AIDS denialism and obfuscation over years, when, despite international and national pressure on behalf of millions dying from AIDS, Mbeki's health policies never budged and the African National Congress (ANC) leadership failed.

    Now, President Jacob Zuma has eased concerns about his intentions for controlling the pandemic by articulating a new path for the country. He recently told the National Council of Provinces that he would fight the AIDS crisis, and warned that the "real danger that the number of deaths will soon overtake the number of births." Treatment Action Committee (TAC), hailed the new administration's stance.

    Acronym Required previously wrote about South Africa's new health minister and her stance on AIDS treatment in "New Minister of Health For South Africa. Change Afoot?"; and AIDS in South Africa in "Mbeki's AIDS Legacy and Ours", Public Health, AIDS, Mbeki, and the Media, "South Africa: Peddling Beetroot, Courting AIDS", ""Not in Paradise Anymore - AIDS in Africa - Reason for Optimism?", Zuma Dodges Corruption Charges", and others.

  • When Opposition is de Rigeur: In 2004, after the publication of "Mountains Upon Mountains", Partners in Health founder Jim Yong Kim moved to the World Health Organization to lead the HIV-AIDS program, where he initiated the 3 by 5 HIV/AIDS treatment plan with a goal to treat 3 million people by 2005.

    From the time that antiretrovirals became available in the 1990's, people in Western countries like the US and countries like Brazil, that endorsed universal public health, increasingly had access to retrovirals, which made an AIDS diagnosis for those people more manageable and less often lethal.

    But there was huge opposition to treating large scale AIDS pandemics in places like sub-Saharan Africa. The various reasons people gave for not treating ranged from logistical (transport over inhospitable terrain), to patient non-compliance, to high rates of fraud, to fear of Western drugs. South Africa's example was publicized and shocking but not isolated. However, by 2004 drug prices had dropped and the tone of objectors had softened, if only slightly. Here's Kim in 2004, urging the world respond to the AIDS epidemic quickly "at its own pace", that is, at a pace comparable to the rapidly advancing viral pandemic. The 3 by 5 plan allowed 1 million people to be on treatment by 2005, and today, more than 4 million are being treated.

    "For the activists, you must hold all of our collective feet to the hottest possible fire because large organizations and the powerful have a way of finding reasons to not take action. If you don't continue to push us, we will falter."

    A good message. Jim Yong Kim is now the president of Dartmouth College.

  • Problems in National Health: 17,000 kids in the U.S. Die each Year Because They Lack Insurance: John Hopkins Children's Center researchers studied data from more than 23 million children's hospitalizations in 37 states from 1988 to 2005. Compared with insured children, uninsured children faced a 60 percent increased risk of dying, the researchers found. The analysis attributed 16,787 of some 38,649 children's deaths nationwide during the period analyzed to lack of insurance.

  • Polls, Spin, Memos, and the Public Option: We previously wrote about Frank Luntz, whose healthcare memo urged defeat of the public option via specific spin doctoring and tested rhetoric last July. Well, of course with Congress chewing over healthcare, Luntz has been at it again. Luntz purports to have talked to some Americans who told him they want still worse healthcare with no public option -- the "massively expensive" option he opines with false, if resonant authority. The new memo reiterates much of the old one and it contains all the same language aimed at preserving the healthcare status quo. When invited to talk shows, he says that his polling shows that Americans are "mad as hell". And Luntz isn't the only one lobbying against healthcare reform.

  • Evidence Based Policy - Abstinence Funding Halted Decades After Proving Ineffective (Sometimes Time Wins): The Obama administration cut abstinence-only funding, after multiple studies showed that it doesn't work -- abstinence doesn't change sexual behavior, pregnancy, STD rates, or age of first sexual activity. Furthermore, studies showed that abstinence programs routinely dole out incorrect or incomplete information about condoms and contraception, causing confusion and misperceptions among the very vulnerable populations the programs claim to protect. (Abstinence-only doesn't work in HIV/AIDS programs either.)

    A recent Newsweek article focuses on the sudden funding decrease affecting those organizations which burgeoned during the last couple of decades because of the federal money. According to Newsweek's article, some U.S. programs like Kids Eagerly Endorsing Purity (K.E.E.P), in the South still manage to get lots of private funding, whereas other programs are at "in a race against time to keep these people in business."

Update January 24, 2010: In this post about the Tracy Kidder's book "Mountains Upon Mountains" and the MDR-TB story, we didn't talk about Haiti, where Paul Farmer began treating patients while in medical school at Harvard. There, Farmer met Ophelia Dahl, and together they started PIH with Jim Yong Kim. "Mountains Upon Mountains" tells the story of how they built the treatment facility in Haiti. The recent earthquake in Haiti is devastating and the work is not done for Haitians when the tragedy disappears from the headline news. There are many excellent agencies working in Haiti, but here's a link to the Partner's In Health page on Haiti. Remember Haiti -- even after the earthquake.

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I read Tracy Kidder's "Mountains Upon Mountains" last fall, as did many freshman college classes in the U.S. I'm not a college freshman, but I still found it a hopeful book, worth reading as antidote to ennui about the politics of healthcare or the environment, as a salve for cynicism about human nature or the media (perhaps by the end you won't need a goofy picture some fluffy, web-ubiquitous kitten), to remember where international public health was decades ago, or just because.

In Chapter 18, Kidder describes Partners in Health's (PIH) program in Peru to manage multi-drug resistance (MDR)tuberculosis (TB). By the late 1990's PIH's program, originally a trial, had decreased MDR-TB by 85%, curing the sickest patients.

The story is familiar now, perhaps legend, but still worth retelling. MDR-TB had been considered not worth treating in that patient population until PIH's persistence in Peru. Then (and now), the most successful treatment strategy was Directly Observed Treatment Short-Course (DOTS), which makes patients take first-line TB medicines under the eyes of doctor or healthcare worker, thus reducing non-compliance and risks of antibiotic resistance. While highly successful, DOTS didn't cure the MDR cases cropping up in Peru, where patients were dying regardless of medications they had or hadn't taken.

Paul Farmer and PIH's goal had always been to work towards health equity, to assure that people in poor parts of the world got comparable care to people in Boston. With MDR-TB, the PIH challenge became to convince global public health agencies, the TB community, and funders that these patients should be treated, at a time when the dominant public health paradigm dictated treating the greatest number of people with a limited pie of dollars. The PIH success in Peru helped their argument. But the expensive MDR program that PIH employed to cure patients still didn't make sense in public health circles because the cost of treating MDR-TB - to put it bluntly: didn't justify the lives saved.

PIH worked on the TB community, convincing them that the MDR protocol --"DOTS-plus"-- was technically feasible. Concurrently they worked on pharmaceutical companies and allied with NGOs to bring the drug prices down by as much as 90% on some drugs. They also worked with private funders to raise money, and by successfully coordinating these efforts, challenged the paradigm that precluded the poor from viable healthcare. As Jim Yong Kim put it, "The only time that I hear talk of shrinking resources among people like us, among academics, is when we talk about things that have to do with poor people."

It was a longer, tougher, more complicated and convoluted fight than my few sentences illustrate, or even that Kidder's skillful multi-chapter coverage details, but PIH's plan to treat MDR-TB patients more widely than in Peru worked. DOTS-plus was endorsed by public health, recognized as effective, and funded. Now people throughout the world increasingly get treated instead of being allowed to die. Their treatment decreases the spread of TB.

The challenges never end, of course, now there's the more lethal extensively drug resistant tuberculosis, XDR-TB. But, as the story shows, insistence and the persistence saves many lives.

Healthcare Spending - Everybody's Caper

Our Hypocritical Oaths:

When people complain about healthcare problems they tend to zero in on an isolated part of the system, like insurance. When they try to solve healthcare problems then focus on another part, like technology. They dredge up scapegoats to blame by accusing the poor or immigrants of driving up costs by depending on emergency rooms as primary care. The truth is, we all play a role in the gargantuan capitalist collective that is healthcare, and no matter how hard we try to be diligent consumers or responsible patients, we each enable a very unhealthy healthcare system.

On some level you may understand this. As you dangle your legs from the examining table clutching the corners of that little paper towel, you may recognize that you're sitting in a "care" facility that spends millions marketing to you about meeting your medical needs while unfailingly accommodating the needs of many other players -- the insurance company's stockholders, the investors in the shiny new medical complex, the medical fellow's future success, the administrators of various insurances, and the doctor's kids' educations.

Regardless of how smart and realistic and educated you may be, you aren't clever enough to avoid unnecessarily driving up health care costs, a fact you may well choose to ignore. Usually you can rationalize that the problems are not your fault. And since we all agree that it's not our fault, the dysfunctional system thrives and perpetuates itself.

But once and a while, a twinge of regret or guilt may creep over you. Perhaps it will happen after you wait five months to visit a certain specialist that everyone said is the best, only to realize that the ten words he deemed worthwhile his time to impart were less informative than what you read on Wikipedia -- except uttered by him they cost the insurance company and you $400 -- with the insurance discount. Maybe you should have known better.

Or perhaps someday you will look at what "you pay" on the bill compared to the five thousand dollars that insurance payed and momentarily feel as though you've scored a bargain at Ross Dress For Less -- even if you recognize that the insurance companies extraordinary profits came directly out of your pocket. Someday you'll be too busy to insist that the insurance company honor the preventative procedure contract; someday you'll acquiesce to doing some unnecessary high-cost procedure; someday you'll agree to do five more blood tests because you don't feel like getting your old records.

What the Teabaggers Deny

There's the everyday differences of opinion about how to diagnose and treat certain diseases and other issues, these drive up healthcare costs. Then there are the recognizable and seemingly avoidable mistakes that you participate in and recognize. Regardless of, or because of your expertise in economics or medicine or finance or business, someday you'll be slapped by undeniable buyers' remorse or the chagrin of being duped or overtreated. Someday you'll sit down on the examining table fully aware of the trade-offs and controversies of health economics, of third-party payers, of diagnostic options, and treatment controversies, only to recognize sometime after your "care", in an exasperating burst of awareness, that your time or money (if not your health) got wasted.

Before then, you may choose to be too overwhelmed with life's business to consider your participation in the sorry healthcare system. Or you may hear other people talk about some useless procedures they endured and think 'poor sap - wouldn't be me'. Such was the case with Dr. Jack Coulehan, who relayed in last month's "Health Affairs, that he "lost the smugness and condescension I often felt when listening to others' stories about being trapped by the system and manipulated into excessively complex and specialized medical situations", and ended up as "a poster boy for excessive medicine."

Coulehan, a primary care doctor, professor emeritus and public health fellow at NYU, described his exasperating experience in the emergency room one Easter Sunday. The doctor knew he had shingles, having diagnosed at least one hundred patients with the disease:

"but I decided to visit our hospital emergency room to confirm the diagnosis and get my prescriptions. My wife drove. I sat in the car with my eyes closed, wondering how it was possible for me to have turned into one of those elderly people who suffer from shingles."

The attending physician confirmed his self-diagnosis, but Coulehan relented to see two more specialists. He relays his confused thinking during an exchange with the attending physician:

Attending: "Maybe we should have an ophthalmologist and a neurologist take a look at you. What about it, just in case?"

Coulehan: "I don't know...I don't think so...well, OK...maybe it's a good idea." A tiny doubt crept into my mind. Could we be missing something? Might it be a tumor behind my eye? Or a weird form of glaucoma? I wondered whether she was being extra careful because I was a fellow physician. But, if so, why?

After one MRI, Coulehan observes:

"When the attending neurologist returned from his lunch he seemed absolutely delighted that I might have a blood clot in the sinus -- a finding, he said, consistent with the redness around my eye. "Did you have any recent dental work?" he asked, searching for an infection as a possible cause of venous blockage. (I hadn't.) I was gripped by molasses-like passivity. The reasonable part of my mind cried, "This is crazy! Get me out of here!" But a twiggy little nugget deep in my brain asked, "What if there is something serious wrong?"

Coulehan went through hours and hours of waiting and testing, testing and waiting, into the evening, noting that "Easter Sunday appeared to be a dead day in the ER, except for me and my shingles". By the end of the day, Coulehan finally got the medical prescriptions he had decided he needed at six in the morning while sitting on the beach with his wife. After two MRIs, a CT scan, and a $9000 bill, the doctor concluded: "I understand now how all those people could have been so gullible, so easily manipulated by the system. Now that I'm one of them, that is."

If you've already been chagrined after relenting to some test or procedure that's totally useless if not harmful, Coulehan's article will assure you that you're in good company. Which of course is comforting but also ironic. Since we're all making the same choices, more than a few of which are undeniably bad or unnecessary, many people feel no particular personal responsibility. In fact some people, like the teabaggers lining up in Washington DC like it's 3AM the day after Thanksgiving at Best Buy, fear that any change in the system will deny them their rights to those bargains advertised on their insurance receipts.

Coulehan's whole article is available at Health Affairs September/October 2009; 28(5): 1509-1514 (subscription).

Notes: Another September Issue

  • In the Beginning...Mini-T: Before Homo sapiens, before meteors annihilated Tyrannosaurus rex, before that massive dinosaur bounded over the earth, a smaller, similar looking dinosaur existed. Raptorex kriegsteini had 1/90th the body mass of the ~2.5 ton T.rex and lived about 65 million years earlier. Palais_de_la_DecouverTrex.jpg A raptorex fossil found in China had the same body features as T. rex and scientists think that the specialized predatory morphology -- large jaw, small front legs, powerful back legs -- grew larger in future generations, evolving to become T. rex. The photo is of a T. rex is from Wikipedia Commons.

  • New Science Journalism: Futurity formally launched September 15. Futurity, not to be confused with "Singularity", is a collective on-line publication effort by leading research universities. The universities will promote their science accomplishments and fill the gaps of dwindling newspaper science coverage. Articles will be submitted by members of the Association of American Universities (AAU), with Stanford, University of Rochester, and Duke leading the effort. Critics point out that aggregating news generated by University PR departments (20% fact, 80% big story?) won't provide readers the same unbiased perspective as proper journalism coverage. True, but we can't ignore the fact that a significant amount of science coverage consists of press releases anyway.

  • Swine Flu Fallout: The H1N1 pandemic not only causes havoc for humans who fall ill, college campuses trying to manage the illnesses, and health workers. The pandemic effects society and economy in ways you don't necessarily think of. Consider, for instance:

      1.) Egypt can't keep up with its street garbage. As we wrote earlier this year, Egypt set out to kill all the pigs in the country, an unwarranted action. Many belonged to Christian herders whose pigs cleaned the streets of millions of tons of organic waste per year. Now parts of Cairo are knee deep in garbage.

      2.) Pork belly futures, which fell from 89 in April 2009 to 40 in August 2009, have now rebounded to their previous high.

  • A Chance To Recalculate the Bush Ozone Ruling?: The Environmental Protection Agency (EPA) announced last week that it would reexamine the standard set by the Bush administration for ozone which had motivated states to sue the EPA. Ozone is a health hazard at certain levels, and in 2008, the agency set a new standard at 75 parts per billion (ppb), down from 84 ppm. The EPA heralded this as a life-saving improvement, but according to science advisors of the Clean Air Scientific Advisory Committee (CASAC), only 60-70 ppm will prevent deaths.

    Susan Dudley headed the Office of Information and Regulatory Affairs (OIRA) in 2008 when the Bush administration decision was made. OIRA influenced the outcome of Bush's ozone ruling by sending a series of memos to the EPA impeding the ozone ruling and killing a secondary standard which would have triggered certain safety measures in some weather conditions. We wrote last year how Susan Dudley had argued on behalf of industry prior to her tenure at OIRA, that "smog was beneficial because it protected individuals from ultraviolet radiation, and that since asthma rates were associated with poverty, a smog ruling would have the 'perverse effect' of costing communities money, which would in turn increase poverty and asthma." Her's was a twisted cost-benefit analysis.

    Now Cass Sunstein heads OIRA. According to the Environmental Defense Fund (EDF), the EPA has calculated the benefits to society from the now thriving environmental industry and determined that those monetary benefits outweigh the costs of the standard. So is cost-benefit ok when the outcome favors the politics you prefer?

  • Team Players: Researchers at Oxford University published a paper in Biology Letters reporting that more elevated endorphin levels associated with team sports like rowing than single player activities.

  • Justice Department On Proposed Google Books Settlement The Justice Department said Friday that the settlement needed changes to address copyright, class-action and antitrust issues, and urged the Federal Court to reject the settlement. However, the government added that current discussions between the parties were productive and should continue.

  • EPA and NHTSA, Together At Last, Overlapping: The EPA also proposed new carbon dioxide emissions this week, in concert with the National Highway Traffic Safety Administration (NHTSA). The new rule would lower fleet standards to 35.5 mpg by 2016. As well, cars would be allowed to emit 250 grams of CO2/mile by 2012, as opposed to the current rule of 265 grams of CO2/mile. The Association of International Automobile Manufacturers, Inc. (AIAM), and Senator Markey praised the agencies for their collective effort.

    A coordinated effort from the two agencies that oversee automobile emissions and mileage efficiency has long been a goal of industry and policy makers, though a goal sometimes cynically pursued. We also wrote about EPA/NHTSA overlap here and here. The standards will cover model years 2012 through 2016, and as the Obama administration bills it: "the automobile manufacturers would be able to build a single, light-duty national fleet that satisfies all federal requirements as well as the standards of California and other states."

  • Migraines: McCain's Bane: Cindy McCain is heading to Congress, reports the New Yorker, to lobby for money to study migraine headaches. And you thought perhaps you'd heard the last of McCain science research jokes? She told the American Headache Society (AHS):

    "For the first time in my life, I'm going to go to Congress, and I'm going to be tenacious and be forceful and be honest and tell them that it's time. If you can give five million dollars to study flatulence in cows and its effects on the ozone layer, you can give me some money for migraine research."

    Migraines are, of course, a debilitating problem -- that's no joke. As McCain details in her talks, migraine headaches are sometimes set off by "triggers" -- foods like chocolate, or particular odors or chemicals. McCain reports that her company's beer, Stella Artois, contains sulfites "out the wazoo" that trigger her headaches. Travel is full of trouble. Sometimes a perfume bottle breaks and the debilitating noxious fumes cause her to repack her bags and fly home. Foreign food smells prove treacherous too, she says: "...like...forgive me, but the scent of cooking dog"

    She didn't say which countries serve the offensive "dog", often a subject of nasty rumors, or how one can tell that it's not chicken, water buffalo, or frog. But fortunate she is then, that her role is the ambassador of headaches not the ambassador of smoothing international relations with her would-have-been President husband.

Science Forgeries, Plagiarism and Mischief

  • HRT Therapy Evidence Ghostwritten: The New York Times reports on a joint effort by the Times, "PloS Medicine, and the Washington DC law firm Public Justice, to compel the Federal court to release documents showing that medical research papers bylined by respected researchers were actually written by a firm hired by the pharmaceutical giant Wyeth. The "ghostwritten" papers promoted the benefits of using the Wyeth estrogen product Prempro to prevent wrinkled skin, dementia and other effects of menopause. However the papers didn't give adequate attention to the risks of HRT treatment: stroke, heart attack, blood clots, cardiovascular disease, and cancer. Once these risks were revealed, doctors stopped recommending hormone replacement therapy (HRT) to menopausal women.

  • They Got The Same Results We Did!(?): In a recent editorial, Nature Medicine provides a warning about scientists who plagiarize previously published science articles. Nature refers to a recently published paper in a journal they magnanimously refer to as "Journal B", which had appeared in Nature six years earlier.

    Why would a research scientist so plagiarize? One reason, Nature suggests, is that plagiarism could boost a scientist or student's academic profile in a down economy. The journal provides a how-to:

    "use a solid paper as your base; carry out a parallel set of experiments in your favorite model; tweak the data so that the numbers are not identical but remain realistic; and, when you're ready to write it all up, paraphrase the original paper ad libitum. Last, submit your new manuscript to a modest journal in the hopes that the authors of the paper you used as 'inspiration' won't notice your 'tribute' to their work..."

    Nature also lists less obvious forms of plagiarism, such as lifting sections of text that adequately express ideas in a language that's not the scientist's primary one, lifting and rephrasing result sections, or scientists' misunderstandings about what is and isn't plagiarism.

  • When Bad Apples Fall Near The Tree: Talking Points Memo challenges lobbyist Jack Bonner's statement that some "bad employee" sent the forged letters to Congress opposing climate change legislation. The letters were supposedly sent from minority groups, but as it turns out, Bonner's firm was working on behalf of the coal industry. As TPM reports, this was not an isolated incident from a temporary employee but modus operandi for the firm where each employee works first as a temp.

  • Stem Cell Research Doesn't Always Get Retracted: Really. But lately the Stem Cell Institute at the University of Minnesota in Minneapolis isn't helping prove the point. New Scientist recently raised questions about research from several stem cell labs at the institute. One scientist reprimanded for academic misconduct had so many papers containing errors that three had to be corrected and one retracted.

    The journal then decided to look at all the papers coming out of the lab that that former student worked in and found possible duplications in seven papers from another researcher affiliated with the institute. Stem cell scientists made comments to New Scientist, expressing discouragement about the spate of problems at the one institute that happened to be under the spotlight. Given the pressure in the field, these scientists wondered how widespread the problems elsewhere could be.

Pharmaceutical Conflict of Interest Laws

Doctors Fret On Behalf Pharma: Pro Bono For What? No Free Lunch?

Vermont and Massachusetts recently passed strict conflict of interest laws that require certain drug and medical-device manufacturers to inform state health officials of gifts made to doctors. At least half a dozen states have similar laws. Pharmaceutical companies spent $2.93 million on marketing in Vermont in 12 months. Payments and gifts to some Vermont psychiatrists totaled more than $100 thousand dollars a year. Nationwide, pharmaceutical companies spend between $20 billion and "$57 billion per year" on marketing per year.

The majority of Americans approve of the measures. In a survey of the public opinion, 64% of Americans think it's important to know their physician's financial ties to pharmaceutical companies and 68% support legislation requiring pharmaceutical companies to disclose gifts to doctors according to the results of a Prescription Project survey.

The regulations aim to bar some gifts from industry to doctors and researchers and more closely monitor which doctors and researchers pharma pays. The Vermont Medical Society supported the new regulations, noting that trust is necessary to build doctor patient relationships. The president of the physicians group commented: "Gifts from the pharmaceutical industry can create at least the appearance of conflict of interest, so in our minds that has a negative impact on our relationship with patients."

Just Don't Say "Corrupt"

However, opposing the conflict of interest regulation is the Association of Clinical Researchers and Educators (ACRE), a group of 100 physicians led by Harvard hematologist Thomas Stossel.1 ACRE acknowledges that some physicians or researchers may take too much money from industry but argues that regulation of conflict of interest is not the answer. ACRE says that regulation will encroach on the free give and take between industry, physicians, and researchers that has yielded great research and medical progress. Nature reported frustration on the part of physicians who attended ACRE's July 23rd meeting:

"One attendee complained that he couldn't buy a $12 hamburger for a consultant who had agreed to speak for free. 'They're giving us a pro bono service and we're going to ask them to pay for their own lunch?' he lamented." 2

Really? Should free consulting from a pharma representative or consultant raise feelings of obligatory angst in attendees? If a pro-bono talk motivates such laments, what guilt do free samples provoke? What about a vacation trip? Will a $12 dollar hamburger fulfill the obligation? Or perhaps just a few prescriptions orders for patients?

ACRE's Stossel objects to the gift ban because it suggests that physicians have "'have a corruption problem'". In Marcia Angell's January, 2009 NY Review of Books article, "Drug Companies & Doctors: A Story of Corruption", the author reviewed three books on pharmaceutical corruption.3,4 The books were published after the congressional inquiry into drug company payments that uncovered quantities of drug money flowing into psychiatry doctors' pockets.

A Senate investigation led by Chuck Grassley (R-IA) (pdf!), uncovered payments to three Harvard psychiatrists who received over a million dollars each over a several year period. One psychiatrist at Stanford and one at Emory also received payments of over a million dollars.

A study in 2007 by Columbia University researchers showed that doctors don't feel that their personal integrity is compromised by taking gifts or money from pharmaceutical companies. But they do feel that other doctors would be compromised by such gifts. Chimonas et al concluded: "Our findings suggest that voluntary guidelines, like those proposed by most major medical societies, are inadequate. It may be that only the prohibition of physician-detailer interactions will be effective."

Marcia Angell points out that although the cases highlighted by the media tend to be more extreme, most physicians (94%) do have some relationship with drug companies. And certainly many of these payments are inconsequential and/or don't sway research or influence prescribing patterns. But clearly many do, or else pharmaceutical companies wouldn't be spending tens of billions of dollars on doctors and research.

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

1 The group is now supported by membership fees, according to Nature and the organization website. However in 2008, according to a note accompanying a British Medical Journal article, Stossel was on the boards of several pharmaceuticals, and received fees for speaking to corporations and other organizations about conflict of interest.

2 Willard, Cassandra, "Physicians fight back against disclosure rules" Nature 460, 556-557 (2009) | doi:10.1038/460556b. Also published in Nature Medicine.

3 The NY Review of Books received a letter from the legal representative of one of the doctors covered in her article, complaining about the use of the word "corruption" in the headline and text of Angell's review, because it inferred the doctor had been engaged in "bribery" or "similar dishonest dealings". The weekly disagreed.

4 The three books are: Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial by Alison Bass (Algonquin Books of Chapel Hill); Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs by Melody Petersen (Sarah Crichton/Farrar, Straus and Giroux); and Shyness: How Normal Behavior Became a Sickness by Christopher Lane, (Yale University Press).

Healthcare Reform Progress

Your Healthcare Dollars At Work Lobbying Congress to Defeat the Public Option?

Bill Moyers focused on health care last week, interviewing Wendell Potter, who worked as a corporate public relations executive at Humana and Cigna for the last 20 years, then recently retired from what he describes as a lucrative and posh executive position. Potter's one of those clever people who after they retire their position of import and influence, find a way to remain in the spotlight by suddenly seeing all the inequities they helped propagate before retirement.

Potter delivers some timely reminders though, with bonafide authority. For instance, in the 1990'a, the for-profit insurance industry's "medical loss ratio", that is the amount that insurance companies spent on patients, was about 95% of each premium dollar, whereas now it's only 80%. The insurance companies need to keep this percentage shrinking in order to meet investor demands. An efficient way to accomplish this is to kick people of the insurance rolls, and deny claims. What does insurance spend the extra money on? Acquisitions to increase market share? Executive compensation? Perhaps lobbying Congress for more market share?

The Language of Luntz

Moyers shared a healthcare reform communication memo, "The Language of Healthcare" by Frank I. Luntz. Luntz's name may be familiar to anyone who follows the climate change denial business guided by his public relations blueprints, the pro Israel settlements language, or many other GOP policy positions and "science based" rhetoric.

Luntz's healthcare memo presents "poll-based" advice on how to spin a healthcare solution which favors existing stakeholders like insurance while keeping the government out of healthcare. Luntz highlights "words that work" and "words that don't work".

For example, he writes:

"If the dynamic becomes "President Obama is on the side of reform and Republicans are against it," then the battle is lost and every word in this document is useless."
Or:
"One-size-does-NOT-fit-all." The idea that a "committee of Washington bureaucrats" will establish a single standard of care for all Americans and decide who gets what treatment based on how much it costs is an anathema to Americans. According to him, there are a number of ways to attack this:
  • Demand the 'protection of the personal doctor-patient relationship';
  • Compare the personalized relationship with their doctor to the distant, cold, calculations of a federal medical panel;
  • Utilize examples of medical breakthroughs that would be undermined or jeopardized. .."

Or, says Luntz:

"The Democrats plan will deny people treatments they need and make them wait to get the treatments they can actually receive. This is more than just rationing. To most Americans, rationing suggests limits or shortages - for others. But personalizing it - "delaying your tests and denying your treatment" -- is the concept most likely to change the most minds in your favor."

The Luntz document contains 28 pages of explicit wording suggestions that he suggests people should use to persuade people to choose the "right option".

The insurance industry and other health care interests are lobbying hard against a government-sponsored, nonprofit, public health insurance option, and are spending, according to The Washington Post , up to $1.4 million per day to sway Congress in this direction.

President Obama remains upbeat, saying that the administration has made "unprecented progress", and telling Congress, "don't lose heart".

Healthcare Notes

  • GE Healthcare Marketing Push

    GE and Siemens, which has also made significant investments in healthcare, are currently lobbying Congress against the Obama administration efforts to reduce medical scanning costs in Medicare. Bloomberg News reported that Medicare imaging costs more than doubled to $14.1 billion from 2000 to 2006, according to a June 13 congressional report.

    GE plans to rollout a new healthcare products marketing campaign based on its "Eco-magination" project, which GE told the Financial Times brought in $17bn in revenue last year from the sale of products ranging from jet engines to wind turbines. The new healthcare marketing initiative will "involve numerous parts of the sprawling conglomerate, ranging from its industrial divisions to the media unit, NBC Universal", according to FT. ("GE to pitch its vision on need for healthcare", Apr. 1, 2009) Watch for it on your local TV station.

  • Electronic Records

    A study in the New England Journal of Medicine recently showed that few hospitals have electronic records systems in place. Only 1.5% of hospitals who responded to the authors' survey had electronic systems in all units, while 7.6% had electronic records in some units. Another article in the same journal noted that the current records' systems are proprietary software where the lack of a single standard makes integration with other software systems infeasible.

    The Obama administration plans to infuse $19 billion into an effort to get electronic records in place, but the effort could cost up to $100 billion dollars over the next ten years. Which makes it an attractive business to enter. Wal-Mart is now joining Microsoft and Google and GE in offering digital records options. According to PC World, the retailer:

    "plans to bring its low-cost, high-volume mentality to the healthcare industry by offering a deal that includes hardware, software, installation, maintenance and training to convert a doctor's office from using paper to digital medical records."

    Walmart will coordinate the vendors to offer the $25,000 system. Doctors may get $40,000 - $65,000 federal tax write-off to install and use medical records systems.

  • Cancer Screening

    A couple of weeks ago two studies came out showing that the prostate specific antigen (PSA) blood test for prostate cancer, which allowed all men to be easily screened for the disease, may or may not be helpful. Screening may result in overdiagnosis and overtreatment in some men for whom the disease would never progress.

    In a similar situation, last week, a kerfuffle in Britain motivated British health officials to promise to rewrite patient information that gave misleading information about the benefits of mammograms. A recent study also suggested that breast cancer screening also led to over-diagnosis. Part of the problem is that doctors have limited knowledge about which cancers will progress rapidly, and which won't progress.

    Such uncertainty is common in medicine. Even if doctors can access all the technology in the world, should they run another test or save the money? How do they assess a patient's most simple claims -- "it hurts?" Is the cancer aggressive? Will the patient follow the treatment protocol?

  • "Real Age" Antics

    According to a recent New York Times story, RealAge, an on-line health survey that people voluntarily sign-up for and receive health tips from, is actually a marketing tool for pharmaceutical companies:

    "While few people would fill out a detailed questionnaire about their health and hand it over to a drug company looking for suggestions for new medications, that is essentially what RealAge is doing"

    Apparently the company would email people pharmaceutical suggestions based on symptoms they listed. I had other qualms with the service, like that it rated people's health based on questions about lifestyle choices which were backed up with incomplete or controversial evidence, like -- how many servings of soy do you eat a day? Clearly the privacy issues put a whole new spin on the company's service.

  • Antidote

    Should you need one. The New Yorker runs a Cartoon Caption contest every week, where readers (and potential subscribers) submit captions for a cartoon. The staff picks three of the best captions, then on-line readers vote on which of the three they like best. Sort of the New Yorker's "American Idol". This week's cartoon might be science related, a rare event.

    The cartoon depicts a big hefty naked man striding out of the ocean onto the beach. He appears to be saying something and he looks excited. He's following a fish, which has leapt out of the water and is airbound, glancing behind, fish-eyes wide. Here are the three caption choices:

    • "Now that I've met your family, I want you to meet mine"
    • "Your in trouble when we get to the bicycles"
    • "Hi there! Can I interest you in some promotional material about intelligent design?"

    Vote here.

September 2010

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