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Author Topic: Placebo: How a sugar pill became a poison pill. Part 1 of a continuing saga...  (Read 1462 times)

ama

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Ein langer, lesenswerter Artikel von Steve Salerno.

[*QUOTE*]
------------------------------------------------------------------------
Sunday, March 27, 2011
Placebo: How a sugar pill became a poison pill. Part 1 of a continuing saga...

In the nearly six years I've been running SHAMblog, I've taken a fair amount of flak for my withering criticism of alternative medicine (and, for the record, I stand by that criticism). In the interest of honesty and fairness, however, this blog in the coming months will tell the story of placebo medicine: how during the past century, multiple precincts of traditional medical practice, from your local GP to the largest university hospitals, began trading in sugar pills: bogus drugs, bogus therapy, even bogus heart surgery. The dimensions of the problem are staggering and, as you will see, alarming. I will keep up with it as I'm able. I hope you get something out of it.

*********************************

[...]

And it gets worse. In 1920, the maternal death rate—representing women, like poor Mary Coswell, who died of pregnancy-related complications or during childbirth—was just under eight women for every 1000 births. By 2000 that grim statistic had been sliced to near-nonexistence: just one woman for every 100,000 births.

But again, let's assume 1920's death rate still applied in 2000, and that each of the 4 million births that year represented one mother (i.e. leaving out the nominal statistical impact of twins and other multiples). That simple exercise in “what if?” adds some 30,000 maternal deaths to our hypothetical mix. Inasmuch as the age of the typical American woman giving birth is 25, those 30,000 premature deaths lop another full year off overall longevity figures.

In 1912, President Taft signed a bill that ordered the creation of the Children's Bureau, which embraced as its charter mandate a full-out assault on the nation's alarming rate of infant mortality.
[...]
------------------------------------------------------------------------
[*QUOTE*]

much more in Steve Salerno's Blog:
http://shambook.blogspot.com/search?updated-max=2011-04-25T19%3A15%3A00-04%3A00&max-results=5


.
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Kinderklinik Gelsenkirchen verstößt gegen die Leitlinien

Der Skandal in Gelsenkirchen
Hamer-Anhänger in der Kinderklinik
http://www.klinikskandal.com

http://www.reimbibel.de/GBV-Kinderklinik-Gelsenkirchen.htm
http://www.kinderklinik-gelsenkirchen-kritik.de

Yulli

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In dem Blog hat eine Bombe eingeschlagen. Fast leer! Nur noch ein paar neue Posts, aber alles vorher, hunderte Posts, sind verschwunden. Ist Blogger.com eine Falle für Autoren?

According to fair use because of keeping the archive alive, this is what the web archive has spidered on 5th., January, 2012:

https://web.archive.org/web/20120105001317/http://shambook.blogspot.com/2011/03/placebo-how-sugar-pill-became-poison.html

[*quote*]
S H A M b l o g
Exposing the scams, shams, and shames of modern life.

Sunday, March 27, 2011
Placebo: How a sugar pill became a poison pill. Part 1 of a continuing saga...
In the nearly six years I've been running SHAMblog, I've taken a fair amount of flak for my withering criticism of alternative medicine (and, for the record, I stand by that criticism). In the interest of honesty and fairness, however, this blog in the coming months will tell the story of placebo medicine: how during the past century, multiple precincts of traditional medical practice, from your local GP to the largest university hospitals, began trading in sugar pills: bogus drugs, bogus therapy, even bogus heart surgery. The dimensions of the problem are staggering and, as you will see, alarming. I will keep up with it as I'm able. I hope you get something out of it.

*********************************

IN THE EARLY 1940s, two major wars were being fought in multiple theaters. One war—the more familiar of the two—took place entirely overseas, as Allied forces prepared for what they hoped would be a decisive sweep through Europe and the Pacific Islands, vanquishing Hitler, Mussolini and Tojo.

The other, less publicized war was occurring in laboratories in both Europe and the United States, as researchers sought to vanquish the unseen pathogens that made battlefield wounds so lethal (and, in civilian life, spawned terrifying epidemic scourges like tuberculosis and pneumonia). Although Scottish biologist Alexander Fleming had made his famously inadvertent discovery of penicillin in 1928, ongoing research into the substance's medicinal possibilities soon stalled. As Fleming saw it, the process of extracting the antibiotic agent from mold was so cumbersome and inefficient as to render its widespread use impractical. He also questioned whether penicillin—once isolated—would be the blanket cure that he heard some of his contemporaries describe in such extravagant terms. In Fleming's view, penicillin's efficacy depended on fairly precise, bacteria-specific dosing; absent that precision, he felt, the antibiotic might prove futile, or could even backfire. (His concerns were prescient, as it turned out.) For such reasons, surprisingly little had been done to commercialize the drug in the decade after its momentous discovery.

That changed after Hitler began crossing borders. British biochemists Ernest Chain and Howard Florey recognized the antibiotic's potential as a game-changer in this terrible new conflict. In 1940, with the backing of U.S. and British governments, Chain and Florey set about establishing a laboratory platform for mass-producing Fleming's so-called miracle mold. (In 1945, the three men would share the Nobel Prize in Medicine.) Leading U.S. pharmaceutical firms were conscripted into the endeavor. In much the same way that World War II transformed the face of Europe, this behind-the-scenes war on bacteria would have a transforming effect on the practice of medicine—if not necessarily the effect well-meaning researchers envisioned.

The two wars dovetailed on June 6, 1944, amid the blood-soaked sand of Omaha Beach. Late the previous year, after swiftly done clinical trials, penicillin production had been ramped up in order to be available to the large numbers of troops sure to be wounded in the looming invasion. The drug was a stunning success, saving countless lives at Normandy and in the bitter village-by-village firefights that ensued. Penicillin fast became a staple on all battle fronts.

From this point forward, the story unfolds against the backdrop of one of the most folkloric, heavily scrutinized and socially significant periods in American history: post-war Suburban Sprawl. Returning GIs quickly set about the business of finding wives, putting down roots and starting families. Domestic America shifted into high gear: Hospitals soon bulged with women who themselves bulged with child. Housing tracts sprouted on erstwhile cornfields faster than the corn once had. Fueled by the post-war ambitions of the incipient Baby Boom generation as well as a new revolution of rising expectations, the U.S. economy obligingly took off. Between 1940 and 1960, the GNP (precursor to the GDP) nearly tripled. Unemployment lolled at under 2 percent. Increasing numbers of women—when they weren't having babies—took their cue from Rosie the Riveter, opting to remain in the workforce or join it anew. The phrase “upward mobility,” coined in 1949, fast become a staple in the lexicon. Everyone was busy, busy, busy. Americans—husbands and wives alike—simply had no time to be sick; no time even for such mundane a malady as the common cold. Further, having set themselves on a flower-rimmed path to Happiness And Prosperity, these husbands and especially wives were bent on taking every possible step to protect their (demographically correct) two or three kids, fencing them off from loathsome microbial stalkers. They went to their family doctor and explained as much.

And all across the land, doctors nodded sympathetically and wrote prescriptions for this new miracle drug everyone was talking about: the one that had worked such wonders overseas, in the closing months of the Great War.

Between 1944 and 1947 mass production of penicillin dropped the unit price from $20 to less than a half-dollar per dose, thus making the drug universally affordable. In 1950 family doctors wrote some 48 million “scripts” for penicillin and the other antibiotics coming on-stream—representing an estimated 2.2 billion individual pills, or the rough equivalent of a two-week dosing regimen for each of the 157 million men, women and children then living in the United States. That does not include antibiotics given through injection. A 2008 World Health Organization (WHO) review of antibiotic abuse poses that most of those scripts were for illnesses that “were likely viral in origin [for example, the common cold] or where the prescribed antibiotic was not the antibiotic of choice for the agent responsible for the patient's illness.” (To this day, the CDC reports, “almost half of patients with upper-respiratory-tract infections in the U.S. receive antibiotics from their doctor,” even though “90 percent of upper- respiratory infections...are viral.”

Of course, family doctors knew from the outset that prescribing penicillin for colds made about as much sense as putting air in a car's tires when the radiator overheats. But they were developing a wider lens on “healing.” They were giving America peace of mind as it went about its proper business, the business of booming. So they kept right on writing prescriptions, and for almost every health complaint imaginable.

To be continued...

© Copyright by Steve Salerno at 7:40 AM 

Labels: medicine

7 comments:
a/good/lysstener said...
Steve, it's good to see you back. I hope you're able to keep up with this series on a regular basis. It sounds interesting. Like a book, which I have a feeling it was supposed to be. ;-)

We've missed you.

March 27, 2011 1:50 PM
Robert said...
Steve, are you about to suggest that a placebo, or fake penicillin, is better for a viral malady, particularly if it's the kind that usually clears itself up after a day or two? I think that would be better than actual, unnecessary antibiotics.

March 27, 2011 3:17 PM
Steve Salerno said...
I agree, Robert, but give this a chance to unfold, if you would. We've hardly scratched the surface.

March 27, 2011 4:20 PM
Dimension Skipper said...
Not sure how much it may tread on your future installments (which I'm looking forward to) if at all, but Discover Magazine seems to have a thing for outing bad medicine and bad medical practices, stuff most people don't even think to question...

The first artcle is a long 4-pager, the second a very short 1-pager, and the third is available in full only to subscribers (which I'm not), but just the teaser part is alarming enough.

Wonder Drugs That Can Kill
Modern pharmaceutical "breakthroughs" sometimes do more harm than good.
by Jeanne Lenzer (July 2008 issue)

Drug Companies Keep Quiet On Drugs That Don’t Work
by Nina Bai (November 25th, 2008)

The Problem With Medicine: We Don't Know If Most of It Works
Less than half the surgeries, drugs, and tests that doctors recommend have been proved effective.
by Jeanne Lenzer & Shannon Brownlee (November 2010 issue)

If there's any truth to those articles, it's no wonder that alt-med has found such a widely receptive customer base. It's hard to know who to believe.

March 27, 2011 10:17 PM
Dr Benway said...
“almost half of patients with upper-respiratory-tract infections in the U.S. receive antibiotics from their doctor,” even though “90 percent of upper- respiratory infections...are viral.”

The above does not *necessarily* mean that too many prescriptions are being written.

Given that untreated strep infections can lead autoimmune illness and other complications, if the risk to the patient from antibiotics were zero, one would *always* prescribe them, even if only one of a thousand patients had a true bacterial infection.

But the risk of antibiotic exposure is greater than zero and so doctors prescribe them a little less than always.

If doctors were to prescribe antibiotics to only 1/10 patients presenting with acute pharyngitis, many patients would suffer strep complications, as the doctors cannot know *which* one of the ten patients is truly in need of the medication.

Things are changing as the rapid strep tests improve. Or so I am told.

In short: reducing uncertainty regarding the diagnosis and uncertainty regarding risks/benefits of the intervention will decrease over-treatment. Other, more political efforts aimed at over-treatment (e.g., making doctors feel like bad people for prescribing something) can have unintended consequences that may take years to sort out.

March 28, 2011 1:23 AM
Dr Benway said...
"it's no wonder that alt-med has found such a widely receptive customer base"

Yes because alt med providers are so much more concerned with evidence than science based doctors.

/snark

Rabble rousing against "big pharma" may help to sell vitamins. But it does not bring clarity to medical decision making.

Of course the public are surprised by the level of uncertainty within medical research. But most doctors and scientists are quite used to it. I would point out that we continue to learn a great deal about physiology and pharmacology in spite of the fuzziness of our data sets.

On the other hand, NCCAM has resulted in a total of zero useful interventions for our patients.

Brownlee has no credibility in my book due to her unapologetic anti-vax article in the Atlantic a year or so ago.

Before writing any "what if everything we know about [insert disease] is wrong?" type article, know that I will never forgive a quote from the CCHR or any of its allies. Those guys sometimes have a point. Nonetheless, any fair point will have other voices to support it.

Research is expensive and resources are finite. It's foolish to demand blinded controlled trials of everything. Much that doctors do that has not been directly studied is at least highly plausible.

March 28, 2011 11:40 AM
Voltaire said...
Glad to see you're giving Big Pharma a well deserved scouring; they certainly have made mistakes like Vioxx.

What frustrates me is Alt Med points at problems with Big Pharma and use them to manipulate people into believing that Alt Med is as pure as wind driven snow. And of course we know that Alt Med is indeed as pure as wind driven snow... after it's fallen into a sewer.

March 30, 2011 12:12 AM
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Yulli

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Die Struktur des Blocks ist ein Müllhaufen. Mit Glück findet man aber doch noch die fehlenden Teile.

Dieses Stück ist vom Mai 2011:

https://web.archive.org/web/20111007123316/http://shambook.blogspot.com/2011_05_01_archive.html

[*quote*]
S H A M b l o g
Exposing the scams, shams, and shames of modern life.

Monday, May 30, 2011
You are free to read this. Or not.
I'm taking a break from my customary weekend habit of posting the latest installment of "Placebo" in order to post a link to this blog item by Sam Harris. It perfectly expresses my views on the subject of free will (although it does not express all of my views on the ramifications of a determinist system of thought; in fact, Harris makes what I regard as a naive assumption about the implications of deterministic thinking for the justice system, etc.).

Anyway, please read this.

(P.S. Thank you, Hilary.)

© Copyright by Steve Salerno at 5:21 PM 2 comments 

Labels: determinism, free will

Friday, May 27, 2011
Still at the Center of controversy.
A few days ago I received from reader Stuart Anderson* the following email about the Midwest Center for Stress & Anxiety:

Thanks for your blog. I just read it and had to add to the nonsense. My gullible wife ordered this program from a TV spot a week ago. She is now in the process of trying to obtain a return authorization from the company to send the stuff back to them. They are pulling out all sorts of tricks to avoid having to accept the return – past the trial period, etc., even though it is all bogus. My wife had to have her credit card company block all their charge attempts, even though they were not authorized to charge any more than the shipping charges. Sounds like a reputable company to me.
As the sarcasm of Anderson's parting shot makes clear, some corporate leopards may give their web site a major overhaul, but they seldom change their (ad) spots. More evidence: The comments continue to trickle in on my long-ago posts from April 3, 2007 and July 29, 2008.

Indeed, the gamesmanship is as constant as the twisted smirk that seems forever pasted on founder Cindy Bassett's face.

* Once again here, I cannot vouch for the accuracy of the statements made by Anderson. I publish his email because it seems contextually similar to many complaints that I have received, and read, with regard to the Center.
© Copyright by Steve Salerno at 7:15 AM 3 comments 

Labels: Lucinda Bassett, Midwest Center

Monday, May 23, 2011
Call it...a RoarShock test?
Last night as I was getting on a narrow entrance ramp after work, I was passed by a gargantuan, lifted, customized Hummer; the only things missing were the gun turrets. Actually, "passed" is far too mild a term for what transpired. The driver of the Hummer, concealed behind his not-street-legal blacked-out windows, clearly thought that I and my little Acura were trespassing in a sector of air and asphalt that properly belonged to him, so he asserted his claim. My sole option was to veer off to the right shoulder. ... OK, I suppose it's possible that I could've held my ground and just let him pass over me, but I didn't want to chance it.

A thought occurred.

In this society we have evolved all sorts of complicated and elaborate psychological profiling designed to uncover mental pathology. I propose a much simpler test: Does the person drive a Hummer? Especially the big, tricked-out one? That's all the evidence I need.

Now, I'm not saying that only people who drive Hummers are unbalanced. We must be mindful here of the old logical fallacy: The fact that psychos drive Hummers doesn't mean that Hummer drivers are the only psychos. Some unbalanced people (notably the ones with limited funds or bad credit) drive other cars. But I think it's safe to regard Hummer ownership as confirming proof of mental/emotional dysfunction. Only a true asshole among assholes would accouter himself with as audacious, unapologetically grandiose a monstrosity.

After all, what does the Hummer do well besides offend sense and sensibility? For starters, it has always ranked among the most poorly made "luxury" vehicles in America, with an appalling number of initial-quality and reliability defects. Gas mileage? The most popular 8-cylinder version musters 14 mpg combined. Its handling characteristics are roughly equivalent to a Winnebago's, with skidpad marks ("lateral acceleration") in the laughable .60 range. (Come to think of it, maybe that's why the guy last night almost careened into me; he couldn't control the damn thing.) And for all its bulk and bravado, the Hummer isn't even that safe, at least not historically.

Oh, and guess who's widely "credited" with buying the very first one in the U.S.? Ah-nold. I rest my case.

In all seriousness, if you drive a Hummer, I'd like to hear from you. Tell me what motivated your purchase. I'd really like to know.

© Copyright by Steve Salerno at 10:02 PM 1 comments 

Labels: mores, role models

Sunday, May 22, 2011
Placebo: how a sugar pill became a poison pill. Part 9 of a contintuing saga...
Read Part 8.

In 1921, amid the early tumult of prohibition, a remarkable study took shape in Palo Alto, California. Stanford psychologist Lewis Madison Terman—as serious-looking a man as one is apt to find, with his specs, upright bearing and unsmiling mien—would one day be remembered mostly for designing and publishing the final accepted version of the Stanford-Binet IQ test.

In '21, however, Terman began work on another project that may have more lasting import for humankind, despite being known today to just a small circle of “longevity wonks.” Terman proposed to track the lives of 1528 American children from that point on. His subjects, encountered in the course of his study of intelligence, were all 10 years old. Terman himself was 44; he would follow them and their families for the rest of his life, and he obtained from his younger associates a pledge to do the same after he was gone. The goal was to note what kind of longevity the 10-year-olds achieved, and try to deduce the reasons why.

Terman recognized that scientists of that era—doctors in particular—associated longevity first with healthcare, then with nutrition and other environmental factors. Given his background, Terman understandably wondered how certain other factors might come into play: If a person is happy, does that bode for greater longevity? What about marriage? A stable circle of friends? Religious faith? Job satisfaction?

Although Terman died in 1956, his project went on to enjoy enviable longevity in its own right. Over the ensuing five decades, the Terman Life Cycle Study grew richer and more nuanced, piquing the interest of some of America's foremost psychologists, epidemiologists and gerontologists. Their conclusions about the so-called Terman Cohort challenge many popular beliefs about longevity. For intance, the workaholics in the sample often lived longer than the slackers; neurotic men in particular outlived their more laid-back counterparts. Unhappy individuals logged about as many years as the happy ones—and downright cheerful people could expect to end up on the wrong side of the longevity curve.

The notion that longevity has more to do with who we are than how we take care of ourselves is also legible in new research suggesting that lifespan may all be in the cards—or the genes. A controversial 2010 study reported in Science poses that in lesser species, genes determine variations in longevity both from species to species and within any given species. The study's authors inferred that by fully cracking the genetic code of a species or a representative individual, they could predict longevity with an accuracy of 77 percent.

Despite more objections from the AMA—rooted, one supposes, in the way the study implicitly marginalizes their members' efforts—the National Institute on Aging has agreed to fund this avenue of inquiry going forward. Wouldn't it be something if, among all factors that bode for long life, medicine turns out to be relatively unimportant....

In the meantime, and for all the progress since Hippocrates, human longevity remains a riddle, a moving target full of butterfly effects, unintended consequences and environmental variables that can't always be predicted, accounted for, or separated out. This much we do know: While people in 2011 may be dying of different things than people in 1911—whooping cough then, pancreatic cancer now—a lot of them are dying at the same approximate ages. “Over the past two thousand years there's been a lot of snake oil, a lot of claims made without any real impact on human lifespan,” says San Francisco biochemist Simon Melov, one of America's leading authorities on anti-aging. “Hygiene has changed tremendously, infant mortality has changed tremendously—but intervention in the basic aging process? It hasn't really changed all that much in two millennia.”

None of which stops the Franz Humers and Denton Cooleys (whom we met in earlier installments of this series) from selling their visions of perpetual life through chemistry or surgery. They realize that they make a mockery of the scientific method when they spin their syrupy vignettes about the nursing home Nana who's sitting in front of a cake with 100 candles on it thanks to some pill or procedure. They realize that a few cases here and there do not a trend-line or truism make; that there were plenty of instances of exceptional longevity centuries before CNN was on-hand to cover them. For if CNN had existed back in, say, 1635, surely some ancestral Anderson Cooper would've been camped out at Westminster Abbey to cover the big news that November: the demise of a man who'd attributed his stunning longevity not to regular visits with Elizabethan-era physicians, but to a regimen of “green cheese, onions, coarse bread, buttermilk or mild ale (cider on special occasions) and no smoking.” So said one Thomas Parr, buried at the Abbey by order of England's King Charles I upon Parr's death at age 152.*

To be continued...

* It must be said that some consider the story of "Old Tom Parr" as apocryphal: one of Mankind's earliest urban legends. Nonetheless, there are also respected sources who swear by it. In any case, it makes an anecdotal point that is increasingly borne out by more substantial data. And it was good enough for the whiskey manufacturers who decided to name their aged blend in tribute to him.

© Copyright by Steve Salerno at 6:06 AM 0 comments 

Labels: medicine

Thursday, May 19, 2011
Nightmare on I-476.
It's been a long time since I've blogged just to blog. (That doesn't count my ongoing series on the folly of modern medicine, which is really in a different category, at least to my eye.) And I'd be the first to admit, it's not like there's been this mass outcry for me to resume my regular SHAMblog activities. ("Oh Steve, oh Steve, please come back and enlighten us once more...!")

But this evening, as I was making the hour-plus commute home from where I'm working these days, something I heard on the radio so shook me that it almost sent me over the divider on the northbound turnpike extension and into oncoming traffic. Actually, it was a couple of somethings, which I heard in succession as my radio scanned from station to station. First I heard theater critic-cum-conservative talk-show host Michael Medved say of former president George W. Bush, without apparent irony, this:

"I think history will look back on Bush as a fine president...even near-great."

Not long thereafter I heard former Reagan political functionary-cum-blowhard Mark Levin (he pronounces it Lev-IN) describe Barack Obama as an "idiot."

Somehow I righted the car and made it home safely.

Dubya and "near-great" in the same sentence? Medved is saying this of the man whose greatest accomplishment while in office was managing not to get his tongue stuck in one of the White House drawers? The man who got pissed off over 9/11 and promptly invaded a country that had nothing to do with it, thereby incurring trillion-dollar costs that may haunt us for generations to come? The man who turned government into an oligarchical ATM for his country club pals? The man who ultimately sundered the U.S. economy? The man who wasn't even a conservative's conservative? NEAR-GREAT??

Then we have Obama/"idiot." I realize that Levin was being figurative; he wasn't factually implying that Barack Obama's IQ is below the generally accepted "idiot threshold" of 30. He was using the term to derogate the policies espoused by the current occupant of the Oval Office. Still...these people lined up behind the aforementioned Dubya, then went that one better by getting all gooey over Sarah Palin (and later Christine O'Donnell, a candidate who launched her campaign by denying that she's a witch)...and Barack is an idiot?

This made me realize that there's no true hope for meaningful engagement or even mere dialogue anymore. Not when people who support a given ideology can become so myopic and rabid about The Cause that they say things like I heard on the way home tonight.

Maybe the world is indeed ending this Saturday. And you know, maybe I'm OK with that.


© Copyright by Steve Salerno at 7:36 PM 5 comments 

Labels: demagoguery, medicine, Obama, politics

Sunday, May 15, 2011
Placebo: How a sugar pill became a poison pill. Part 8 pf a continuing saga...
Read Part 7.

Healthcare apologists insist that medicine's true impact on longevity has been blurred by “lifestyle issues” that, in recent decades, worked to offset those gains. They note, for one thing, that up to a third of adults now meet the clinical definition for obesity. That line of argument slyly ignores the many positive ambient changes in the American way of life that should have produced even more robust longevity numbers than we now see. Among them:

► A cleaner environment. Amid the latter-day carping by environmentalists about vehicular emissions and greenhouse gases, it's easy to forget the challenge posed by mere breathing at the dawn of the Industrial Revolution. Pollution-control insiders divide the history of American environmental management into four periods, the first of which, 1900-1950, is tellingly labeled “the smoke era.” American city dwellers gazed up into a sky so clogged with soot that in theory a keen-eyed observer could count the particulate matter-per-cubic-foot as if in some bizarro variant of bird-watching:

“Soot-filled industrial cities of the East and Midwest blackened skies in the early part of the 20th century. Emissions were first detected, and regulated, by sight [emphasis added]... By 1950, visible emissions from many industrial sources were controlled...and the effects of different air pollutants on health were being discovered.”
—from “Will the Circle Be Broken? A History of the U.S. Ambient Air Quality Standards,” in a 2007 journal put out by the Air & Waste Management Association
Over the second half of the 20th Century, many erstwhile steel or coal towns, formerly blighted by industrial pollutants, made a spectacular resurgence and today uphold high standards for clean air and water.

► Ever-improving rules governing occupational health and safety. The 1970 advent of both OSHA (Occupational Safety and Health Administration) and MSHA (Mine Safety and Health Administration), plus independent rating services like the International Organization for Standardization, have wrought a wholesale rethinking of how factories and warehouses operate. The Economic History Association portrays the U.S. as an “unusually dangerous” place to work prior to the 1930s, describing early factories as “extraordinarily risky by modern standards”—though still safer than railroads or mines. On-the-job fatalities nowadays are a fraction of what they were as recently as the 1950s. Far fewer Americans work with the toxic substances—like benzene, asbestos, and trichlorethylene—that gave rise to so many “unexplained” cancers during the 1960s and 1970s.

► Better insights about proper nutrition. Americans may eat too often at McDonald's and KFC, but in general, many more of them than in days past make a good-faith effort to work fruits, vegetables, vitamins, fiber and other desirable nutrients into their family's diets. This trio of factors alone could be expected to help Americans live longer even if no one ever went to a doctor for anything.

And, of course—the elephant in the room—there's the significant decline in cigarette smoking since the days when Gerald Ford was clanking golf balls and banging his head on airplane doors. As the 1970s drew to a close, 40 percent of Americans regularly used tobacco products. The number had dropped to 24 percent by 2009. Cultural taboos and legislated constraints on where that remaining 24 percent lights up have materially reduced the exposure of the rest of us to second-hand smoke: Some parents may still smoke three packs a day, but they don't usually do it in their cars with their kids present. Coworkers, air travelers and diners can go about their business without having cigarette smoke waft over them from an adjacent cubicle, seat or booth.

Medicine's true impact on the battle against top killers like cancer and heart disease cannot be properly reckoned without taking such (literal) atmospherics into account. As was the case a century ago with TB, any ostensible successes may have less to do with medical intervention and more to do with the broader context in which those interventions are taking place.

But then, all of this sound and fury, all of this bickering over contextual variables and decimal places, may be just a diverting numbers game that misses the larger point by failing to address the real-world consequences of those few added years for the people who must live them. Over the objections of the AMA and other groups representing healthcare interests, the World Health Organization has begun publishing an alternate longevity statistic, Health-Adjusted Life Expectancy (HALE). The HALE index suggests that if medicine is adding years of life, it is also adding years of pain and disability—at a roughly one-to-one ratio. Today's “increased lifespan” too often becomes a nonstop dirge of repetitive surgeries, the suffering of chemotherapy and radiation, the embarrassment and despair of incontinence and/or impotence. In too many cases, death, when it comes, is merciful.

Deeply troubled by that prospect, Dr. William J. Hall of the esteemed Highland Hospital Center for Healthy Aging in Rochester, New York, observed in a 2008 issue of The Archives of Internal Medicine: “Longevity is a Pyrrhic victory if those additional years are characterized by inexorable morbidity from chronic illness, frailty-associated disability and increasingly lowered quality of life.”

To be continued...
© Copyright by Steve Salerno at 5:54 AM 5 comments 

Labels: medicine

Sunday, May 08, 2011
Placebo: How a sugar pill became a poison pill. Part 7 of a continuing saga...
Read Part 6.

Despite such subsequent advancements as the first influenza vaccine (1945), the first open heart surgery (1952), the first kidney transplant (1954), and the World Health Organization's official (if premature) declaration of the defeat of smallpox (1980), U.S. death rates remained remarkably level over the 60-year period between 1948 and 2007: 9.9-per-1000 in the earliest year, 8.0 in the final one. Adjusting for some of the plague-like factors that wiped out mass numbers of Americans in the bad old days, the longevity enhancements of the current era are shockingly modest.

Put simply, not that many adults are living that much longer than in years gone by. During the Civil War era, a 70-year-old man could expect to live to 80. In 1950, that same 70-year-old man could expect to live to—80. No measurable gain in a full century of medical progress!

Little has changed since, either, in spite of an endless array of pharmaceutical therapies, an aggressive, multifocal counterattack on cancer, and the myriad socially entrenched insights about proper health maintenance. Further, during the past half-century society has witnessed the proliferation of health-insurance plans that put these innovations within financial reach of most Americans. Nevertheless, the longevity of the average 70-year-old has increased by about 3.5 years over what it was when John F. Kennedy took office.

If this multigenerational parity still seems ludicrous on its face, consider the Founders. Washington died at 67, a bit young by present standards, but Franklin and Madison were 84 and 85 at their deaths. Jefferson died at 83, poetically on the same day, July 4, 1826, as his dear friend, John Adams, who was 90. Adams' son, John Quincy Adams, reached 80. Samuel Adams was 81. Andrew Jackson was 78. James Monroe attained 73. John Jay, 84. Hamilton died at 49—in the infamous duel with Aaron Burr, who lived to see 80. We can go even farther back. In her piece, “Dead at 40,” Carolyn Freeman Travers, research manager of the Plimoth* Plantation restoration, cites the supposition of modest life expectancy as one of “several common pieces of misinformation/mistaken beliefs about people in the past.” Of Massachusetts' Andover settlement she writes, “Circumstances evidently combined to encourage a high birth rate and an exceptionally low death rate, a combination which produced a population that grew at a rapid pace.” Citing the research of historian Philip Greven, Travers continues, “The average age of twenty-nine first-generation men at the time of their deaths was 71.8 years, and the average age at death of twenty first-generation wives was 70.8 years.”

The spectacularity of these trends was not lost on contemporaries. In 1644, William Bradford, long-time governor of the Plymouth Colony, wrote, “I cannot but here take occasion not only to mention but greatly to admire the marvelous providence of God! That notwithstanding the many changes and hardships that these people went through, and the many enemies they had and difficulties they met withal, that so many of them should live to a very old age!”

BY FAR THE most important variable in the science of longevity is the reckoning of individuals who become a death statistic at birth or soon after. No single factor has more decisively swayed the pendulum, for better or worse, than infant mortality.

Turn-of-the-Century America was an inhospitable place for newborns. In several American cities up to 30 percent of babies died before taking their first steps, and as you might imagine, some of the individual stories from this era are grievously tragic. One such story concerns the Coswells of Illinois. Between 1894 and 1907, Mary Coswell delivered no fewer than five stillborn children. With the fifth birth, Mary herself died. Another contemporaneous account mentions (but does not name) a husband and wife who, after the woman's second stillbirth, went to a nearby overlook and in front of horrified bystanders, joined hands and leaped to their death.

It's hard to overstate infant mortality's impact on longevity numbers from the early 20th Century. In 1900, a male child at birth had a life expectancy of about 48 years—but if he survived to age 1, his remaining life expectancy jumped instantly to 54 years. That gain represents the “write-off” of first-year mortality: With the appalling toll in infant deaths now shunted back to an earlier data set, the rest of the cohort “gains” an instant six-year longevity benefit (in much the same way that grading on a curve lops off the lowest marks and allows the arithmetic mean to rise commensurately). Over the ensuing decades the first-year gap narrowed, then disappeared. By 1980, that first completed year subtracted from remaining life expectancy, just as all subsequent years do.

Here's another way of looking at it. In 1920, when life expectancy at birth was a shade above 56 years, the infant-mortality rate stood at 85.8 deaths per 1000 live births, or 171,000 infant deaths in total; few of those aforementioned tenements remained untouched. By 2000, life expectancy at birth had risen to an even 77, and the infant-mortality rate had dropped to 6.9 per 1000 live births, or 28,000 infant deaths nationwide. Had 1920's rate of infant mortality still applied in 2000, the total number of infant deaths that year would've skyrocketed to well over 300,000. Those additional deaths at “age zero” would've chopped seven full years off 2000's overall life expectancy of 77.

And it gets worse. In 1920, the maternal death rate—representing women, like poor Mary Coswell, who died of pregnancy-related complications or during childbirth—was just under eight women for every 1000 births. By 2000 that grim statistic had been sliced to near-nonexistence: just one woman for every 100,000 births.

But again, let's assume 1920's death rate still applied in 2000, and that each of the 4 million births that year represented one mother (i.e. leaving out the nominal statistical impact of twins and other multiples). That simple exercise in “what if?” adds some 30,000 maternal deaths to our hypothetical mix. Inasmuch as the age of the typical American woman giving birth is 25, those 30,000 premature deaths lop another full year off overall longevity figures.

In 1912, President Taft signed a bill that ordered the creation of the Children's Bureau, which embraced as its charter mandate a full-out assault on the nation's alarming rate of infant mortality. Over the next decade that goal drew on the wisdom of the finest minds in public health, clinical medicine and social welfare. This tandem effort at first centered on the sanitary processing and handling of milk, then shifted its emphasis to other areas of hygiene and education, then took up the matter of promoting comprehensive infant- and maternal-welfare services. These initiatives wrought a sea change in the medical and cultural view of childbirth: from a historical model of care that kicked in only after delivery, to a comprehensive program of prenatal mentoring and monitoring.

The dividends began to show themselves almost immediately. Although healthcare indisputably played a supporting role in extending the lives of countless infants from that period, the bulk of the care was preventive, not interventional. It was seldom a case of “treating” newborns who fell ill. Rather, the goal was to prevent newborns from falling ill to begin with.

In any case, by the time World War II GIs returned home and put down roots, the major victories in this omnibus war on infant mortality had been won. Thus America's all-important triumph over infant death was achieved in large part without today's costly “miracles of modern medicine.” Sonograms and fetal heart monitors—now deemed obligatory elements of a proper prenatal regimen—weren't invented till the late 1950s, and wouldn't come into general usage for two decades more. It's fair to say that their impact on infant mortality has been negligible. Indeed, if one wanted to be a curmudgeon, one might point out that in recent years, America's infant-mortality rate has crept back up slightly—this, in an era when expectant mothers can avail themselves of a panoply of health services that their forebears from Model T America could not have imagined.

* She uses the Colonial spelling.

© Copyright by Steve Salerno at 7:04 AM 1 comments 

Labels: medicine

Monday, May 02, 2011
Placebo: How a sugar pill became a poison pill. Part 6 of a continuing saga...
Read Part 5.

This is where you might expect journalists to “fact check” the self-serving fluff and, as necessary, set the record straight. Regrettably, the climate of arm's-length detachment that should separate reporters from their sources does not apply in medical journalism. Health reporters tend to be in the thrall of celebrity doctors and research scientists to begin with, and undertake little true investigative journalism that isn't spoon-fed to them by the rare healthcare dissident or some crusading personal-injury lawyer. News reports on major healthcare scandals—drugs that kill people, doctors whose supbar skills have invited scads of malpractice lawsuits—are framed as aberrations, departures from the norm. “NEW MEDICAL BREAKTHROUGH!” constitutes one of the timeless feel-good themes that the media rely on to leaven the otherwise-relentless onslaught of bad news. And an improvement in longevity is the supreme feel-good story.

No less a media heavyweight than Time, commenting on life-expectancy figures released by the CDC in December 2009, uncritically repeated researchers' contentions that “improvements in life expectancy are largely due to improvements in reducing and treating heart disease, stroke, cancer, and chronic lower respiratory diseases.” The merest peek behind the curtains would've resulted in a very different headline.

On paper, the upswing in American longevity since 1900 is difficult to ignore: about 49 for both genders then versus about 78 for both genders now, an apparent gain of nearly three full decades. But this striking then-and-now statistical juxtaposition has been framed in the public dialogue as if mass numbers of Will Rogers' contemporaries suddenly keeled over on their 49th birthdays. Nothing could be farther from the truth. Seldom has a data set been more deceiving or a statistical “fact” more spurious. The credulous reporting of those “facts” bespeaks a woeful misunderstanding of the concept of life expectancy.

Most laypeople (and too many journalists with a rudimentary knowledge of the health beat) unthinkingly use the terms longevity and life expectancy interchangeably. They regard the entire subject as a one-dimensional computation that yields a single fixed number—that number being the age at which an adult can expect to die: “Well, I'm a 74-year-old man, and male life expectancy is 75, so if there's anybody I've always wanted to tell off, I've got one year to do it!” Not so. Life expectancy—as the term is used by scientists, demographers, actuaries and allied professionals—is a sliding scale. Somewhat like a GPS navigational system that recalculates your route if you miss a turn, life-expectancy tables recompute your odds of dying at each new age plateau you attain. That new calculation is made based on the average number of additional years of life logged by others who have reached the same plateau. In scientific and actuarial circles, this is known more specifically as “life expectancy by age.” Among other things, it's the primary basis for life-insurance underwriting.

When the media and general public make casual reference to longevity, they actually mean “life expectancy at birth”: the average final age attained by all members of a given universe born in a given year, encompassing everyone from that rare centenarian in the nursing home down the street to babies who barely managed to take their first breaths before dying. Projections of future life expectancy are based on observed experience as that entire data universe inches forward a year at a time. The current figure for life expectancy at birth is 75.3 years for men and 80.4 years for women, which resolves to 77.9 years. In no way, however, does this imply that a man who actually reaches age 75 should spend his birthday shopping for caskets and lining up a favored eulogist. In actuarial terms, a male who attains that milestone today has a life expectancy of an additional 10.8 years.

To no small degree, as the 19th Century gave way to the 20th, life expectancy was tied to one's luck at avoiding a trio of infectious diseases that stalked and killed with impunity. In 1900, the combined U.S. death rate from tuberculosis, flu and pneumonia was 396.6 per 100,000 population. (To put that in context, the current death rate from all cancers combined is 200 per 100,000 population.) TB alone claimed 194 lives per 100,000. The disease was commonly called “consumption” for its profoundly debilitating effect on late-stage victims, who appeared to waste away as if being consumed from the inside out. So severe was the panic surrounding TB that dedicated sanatoriums sprang up on the outskirts of dozens of cities for the express purpose of “treating”—that is, quarantining and warehousing—victims of the highly contagious killer.

So final a death sentence was a diagnosis of tuberculosis thought to be that doctors at these sanatoriums felt they had little to lose by attempting surgical interventions which, for sheer barbarism, rivaled anything thought up a few decades later by Josef Mengele. In the most gruesome of these, doctors would remove a patient's rib cage and encircling musculature in the theory that excising these “obstructions” might literally give a patient more breathing room. Such measures only inflicted horrific pain and in most cases hastened death.

Life in turn-of-the-century America was also marred by “slate-wiper” pandemics such as the Great Flu of 1918-1919, and random but regular outbreaks of polio and diphtheria, the latter disease one of the most feared blights among children prior to the 1930s. Terrified mothers kept their kids indoors after school, or kept them home from school altogether. The mere rumor of a child up the street who'd fallen ill was enough to drop attendance in city schools to levels that render modern America's worst truancy problems hardly worth discussing. Birthday parties ended the moment a child coughed or complained of feeling unwell. And yet here's the thing: The most dramatic breakthrough in the bedrock measure of U.S. mortality, deaths per 1000 population, happened between 1900 and 1930—when nothing dramatic at all was happening in medicine to account for it. In the earlier of the two years the Grim Reaper was frightfully busy, targeting 17.2 of every 1000 Americans; in a typical tenement of the sort that had begun to crowd the skies of lower Manhattan by 1900 (as depicted in films like Hester Street and Godfather II), residents attended five or six funerals. By the latter year the Reaper's day was far less busy at 11.3 deaths per 1000, largely because the cumulative toll from the aforementioned “big three” of TB, flu and pneumonia had plummeted by more than half, from 396 to 173 deaths per 100,000. That precipitous drop, it's clear, had little to do with medicine and everything to do with a massive public-awareness campaign emphasizing nutrition, sanitation and personal hygiene. After all, the gold standard TB-zapper streptomycin was still years removed from being isolated (1943), doctors treating pneumonia would not have penicillin in their arsenals till after World War II, and human trials of Salk's polio vaccine would not commence until 1954. So it's not that the lifespan of homo sapiens Americanus was magically extended by onrushing healthcare know-how. It's more that the unfortunate background circumstances that skewed the stats, leading to preposterously conservative assumptions about the limits of longevity, began to remit on their own.

If fewer people died, it was mostly because fewer people got sick to begin with.

To be continued...

© Copyright by Steve Salerno at 6:28 AM 0 comments 

Labels: medicine

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Monday, April 25, 2011
Placebo: How a sugar pill became a poison pill. Part 5 of a continuing saga...
Read Part 4.

“Looking back over the past century, it is clear that medical science has made breathtaking advances,” said Roche CEO Franz Humer after a few opening pleasantries. “This is shown, for instance, by the fact that life expectancy has risen enormously to around 80 years, compared with 55 in the late 19th/early 20th century when Roche was established.” He continued in that vein for a while, touting the links between Big Pharma and enhanced lifespan, underscoring his industry's instrumental role in the progress of Mankind, subtly highlighting the Roche brand throughout. “While it may be unwarranted at this point to expect the same historic increases in longevity looking forward,” he conceded toward the end, “there is little doubt that whatever gains we realize will be directly related to what we in our industry do.”

To humanize his point, he shared a few choice stories of striking longevity from the corporate archives, culled from a Roche outreach to doctors prescribing the company's products. When audience members applauded, they were applauding themselves as well.

Today's medicine is full of Franz Humers: men and women who say all the right things because it's in their interest to do so. Nowhere is this ethic stronger or more visible than in the area of life extension. Enhanced longevity via cutting-edge medicine is how the healthcare monolith puts a statistical face on its promises (though on close inspection that face turns out to be more of a carnival mask). From their perspective—and the perspective of most consumers—longevity is the ultimate metric of medical worth. It is how the Franz Humers of the world tangibilize the value of what they do. Longevity is also the quintessential debate-stopper, the trump card that makes all other points sound trifling, all skepticism sound contrary and quarrelsome. If doctors can show (or appear to show) that they deliver added life, then the patient (a) is predisposed to use more medicine and pay more for it and (b) will spend less time questioning what he pays now. In the same way, outsiders will spend less time scrutinizing what the healthcare industry does. Both literally and figuratively, the industry's stock goes up.

When it comes to taking credit for the march toward immortality, the hubris of the medical establishment is boundless and nonsectarian. Some insiders unabashedly project forward, reasoning from the purported gains in longevity over the past quarter-century that humans in the next century can routinely expect to live well past 100. Dr. Donald B. Louria of the Healthful Life Project—subsidized by Roche—writes, “I believe the question increasingly is not whether life expectancy in the United States at birth will increase from the current 77 years to 100 or even 120 years, but when.” Such musings are a way of setting a tone, establishing a warm buying (and investing) climate, without the point-by-point specificity that could come back to haunt someone later if construed by the SEC as an improper type of forward-looking statement.

It's an artful balancing act, and one that industry insiders have honed and perfected, such that no matter who's speaking, there's a decided sound-bite sameness to the words. Another pharmaceutical titan, Merck & Co., manufacturers the anti-cholesterol compound, Zocor. Here's Merck CEO Richard Clark (total 2009 compensation: $19.9 million) expounding on anti-aging: “At the start of the previous century, humans barely made it into their 50s. Today they routinely survive well into their 80s or more. The average lifespan is close to 78. How much clearer could the benefits of medicine be?” Hmm. Now where have we heard that before? Pioneering Texas Heart Institute surgeon Dr. Denton Cooley, who in 1969 performed America's first heart transplant, sounded as if he and his colleagues deserved personal thanks for improving longevity when he told a 1991 interviewer, “It's simple math: A half-million times each year surgeons do the [coronary bypasses] that we perfected here at the Institute... Those are a half-million men and women each year who have lived on and helped create this century's 25-year improvement in lifespan.” And in a keynote speech to another major symposium, Australian Health 2000, Michael Wooldridge, the nation's former Minister for Health, had this to say of Australia's track record in the area of life extension: “There has been a 20-year gain in life expectancy, for men from 55 years in 1900 to 76 years today and for women from 59 years to 82 years. Millions owe their very lives to the pills they take each morning with their juice and toast.”

It's not surprising that Wooldridge would credit much of that progress to pharmaceuticals, since he came from that sector of healthcare, and hoped to return there after his stint in government. This revolving door between politics and industry is another factor that raises questions about the credibility of the “official” information the public gets on longevity. During his tenure as Health Minister, Wooldridge was accused of having too-cozy ties with Big Pharma; critics alleged a serious conflict of interest that compromised government oversight of the drug industry. Unfazed, Wooldridge promptly appointed to a major healthcare regulatory agency a former executive of GlaxoWellcome-Australia who had just retired as head of the Australian Pharmaceutical Manufacturers' Association. (GlaxoWellcome is now part of the $28 billion GlaxoSmithKline empire. CEO Andrew Witty's total 2009 compensation including bonuses: $12 million.) A few years after Wooldridge left government, the Pharmaceutical Manufacturers—perhaps grateful for his advocacy and friendship?—appointed him head of their association.

Although it is not known whether Michael Wooldridge's audience applauded at the end of his speech that day, many in attendance were the same types who gave such a warm reception to Humer: numbers types, bottom-line types. Albeit a particular kind of numbers and bottom lines: the kind that appear in prospectuses and annual reports to shareholders. For the folks in Healthcare Central, those numbers have been quite good for quite some time.

And because they want things to stay that way, they're coy about another set of numbers—the ones that would reveal the grievously disappointing truth about supposed advances in human longevity.

To be continued...

© Copyright by Steve Salerno at 7:15 PM 3 comments 

Labels: medicine

Sunday, April 17, 2011
Placebo: How a sugar pill became a poison pill. Part 4 of a continuing saga...
Read part 3.

On a fine spring afternoon in March 2005, pharmaceutical executive Dr. Franz Humer, a man who'd grown accustomed to the applause of his peers, rose at a major Zurich symposium to deliver a speech guaranteed to generate more of the same.

Humer had a knack for painting colorful frescoes of the oft-hazy Big Pharma landscape. Despite fierce competition for market share in their respective niches—e.g. Viagra vs. Cialis vs. Levitra for erectile supremacy—the industry's major players periodically would call a truce long enough to attend conferences that celebrated their collective genius. In that respect they were like Hollywood on Oscar Night: Whatever jealousies exist over box-office receipts, whatever backstage machinations are in play over plum roles, they fade away as one and all bask for a few hours in the magic of make-believe. As it happens, that's an analogy with more than passing relevance here.

Humer was then CEO and board chairman of F. Hoffman-La Roche, nowadays simply “Roche.” Also known for his nonpareil efficiency, Humer that morning had made the 85-km commute from his company's Basel headquarters ensconced in the buttery luxury of a stretch Mercedes limo from Roche's corporate fleet. Had the trip been much longer, he would've flown, not driven, likely on Roche's corporate jet, which was similar to the jet Humer kept for his personal use, though admittedly a tad larger.

From Humer's point of view, the timing of the speech could hardly be better. With the first fiscal quarter not yet complete, Roche was well on its way to posting record sales of $35 billion and returning to investors an incremental yield of 50 percent over 2004. Part of this success could be traced to the company's established positions in the perennially hot mental-health segment, where Roche boasts a track record that few can match. In the 1950s the company pioneered the game-changing class of anti-anxiety drugs known as benzodiazepines. The hit parade began in 1957 with Librium, which became an instant (and over-prescribed) darling of psychiatrists everywhere. Three years later Roche topped even that by launching one of the most commercially successful drugs ever, Valium. To this day the drug remains a staple not just for treatment of anxiety but for surgical sedation as well. But Roche's soaring good fortunes in the spring of 2005 had more to do with its distribution of the first oral drug approved for use against the two primary types of influenza—Tamiflu—which Roche had licensed a decade earlier from a U.S. biotechnology firm, Gilead Sciences. In truth, the Roche/Gilead relationship was a stormy one. Tamiflu had been subject to a series of formal warnings and recalls that led to messy litigation in which the biotech David accused the pharmaceutical Goliath of uninspired marketing, poor quality control, and miscalculating Gilead's royalty payment on sales of the drug. Still, with fears of avian flu then sweeping the globe faster than the malady itself, and with other flu strains suddenly glowing on parents' radar screens, Tamiflu was the right drug at the right time. The two companies called off their legal teams and patched things up, and Roche was now raking in profits hand over fist.

All of which delighted Franz Humer, who was, first and foremost, a money man. The “Dr.” before his name misleads. Humer's doctorate is in law, not medicine. Also, like many of those at today's upper echelons of medical administration, Humer holds an MBA. At the time of his speech, he had occupied his lofty position at Roche since 1998, and in the intervening years had seen the right side of the corporate sales chart climb ever higher. (Such achievements helped soften the sting of Roche's being named, by one leading consumer watchdog group, “top corporate criminal of the 1990s” for its “anti-consumer, anti-competitive practices.”) In 2005, Humer himself would receive a base salary of 8.4 million Swiss francs, which sounds like a lot of money until you realize that it's barely $8.3 million U.S. Fortunately for Humer, his contract included substantial bonuses and equity participation, both of which were about to kick in with a vengeance. The total compensation package made him the third-best-paid CEO among Europe's publicly traded companies.

As an administrative hired gun, Franz Humer was an elite member of a managerial species that in recent decades has taken over from the doctors and scientists who once ran organized medicine. (After leaving Roche in '08, Humer became a board member at Diageo, whose only connection to healthcare is that its customers sometimes need it: Diageo's top brands include Smirnoff, Jose Cuervo and Captain Morgan.) These new-breed healthcare honchos recognize that Job 1 is to hit quarterly earnings targets, to deliver a healthy bottom line. An increasingly healthy bottom line. Further, they must deliver it again and again, thus meeting Wall Street's ever-rising expectations, feeding its insatiable hunger for More.

Self-aggrandizement—of their companies, their products, their managerial acumen—is a key part of the business plan. In pharmaceuticals especially, perception is reality. If the consuming public thinks that certain pills will melt its fat or mute its migraines, then the manufacturer of those pills makes money and The Street is happy, regardless of whether the pills' effects can be documented in a scientific way. It is therefore essential that top brass miss no opportunity to reinforce these perceptions by accentuating the positive. On that day in March of 2005, Franz Humer was accentuating big-time.

To be continued...

© Copyright by Steve Salerno at 7:36 PM 5 comments 

Labels: medicine

Sunday, April 03, 2011
Placebo: How a sugar pill beame a poison pill. Part 3 of a continuing saga...
Read part 2.

To be sure, the early warning signs were there for the seeing. Sulfa drugs actually predated penicillin, but within two years of their debut became problematic for general usage because so many of the target bacteria had mutated into resistant strains. This omen would be ignored, as would a gloomy caution from the father of penicillin himself.

“The greatest possibility of evil in self-medication is the use of too-small doses so that instead of clearing up infection the microbes are educated to resist penicillin,” Alexander Fleming lamented to The New York Times in 1945. Fleming foresaw the debut of types of “septicaemia or pneumonia which penicillin cannot save.”

Similar clarion calls were issued, but not heeded, from time to time in the decades that followed. “Little by little,” wrote Harvard infectious disease expert Dr. Maxwell Finland in a 1978 editorial for the New England Journal of Medicine, “we are experiencing the erosion of the strongest bulwarks against serious bacterial infection.” No matter. Two additional decades would pass before a meaningful concerted effort was undertaken to stem the ever-rising tide of antibiotic proliferation. That top-down effort commenced in 1999, a year after doctors and hospitals achieved a dubious milestone: They wrote an unprecedented 80 million prescriptions for penicillin, streptomycin and other antibiotics. That encompassed some 25 million pounds of pills flying out of American pharmacies and hospital dispensaries.

By that time an irreparable amount of damage had been done. In the years between 1945 and 1998, almost every known bacterial pathogen developed resistance to one or more commonly used antibiotics. By 1984, half of all Americans who contracted tuberculosis had a strain that resisted at least one antibiotic. In a recent WHO study, 25 percent of cases of bacterial pneumonia involved microbes that were resistant to penicillin, and an additional 25 percent were complicated by resistance to multiple antibiotics. Each year Americans contract 150,000 cases of pneumonia and 15,000 cases of bacterial meningitis for which effective antibiotics cannot be found. A sobering percentage will die, especially if the patients are elderly and/or infirm.

Bacteria have proved to be authentically diabolical foes of Mankind, displaying a Darwinistic genius that is unmatched in Nature. It appears that one strain can even share key parts of its genetic coding with another strain, thereby “teaching” a wholly different class of bacteria how to defeat a given drug. So it is that nearly all strains of Staphylococcus aureus—which, in the 1950s, could be treated successfully with a single penicillin regimen—today are resistant not just to penicillin but to many other antibiotics as well. Collectively these super-strains are lumped under the familiar umbrella term Methicillin-resistant Staphylococcus aureus, or “MRSA.” MRSA is deemed responsible for 14,000 annual hospital deaths that would not (and should not) have occurred, based on the ailments for which those victims initially were admitted. For surviving patients, MRSA vastly complicates their recoveries and extends their average hospital stay threefold. To such grim figures one must add the 140,000 annual emergency-room visits caused directly by adverse antibiotic reactions, as per a CDC study reported in September 2008. Estimates of the incremental cost antibiotic resistance inflicts on society range as high as $35 billion.

In some hospitals and childcare settings, antibiotic resistance is so entrenched that any attempt at treatment with low-cost, garden-variety antibiotics is pointless. Practitioners must turn instead to more costly, exotic compounds—a tactic that inevitably nurtures resistance to those drugs, too, thus calling for even newer and costlier compounds. “Treatment” becomes a maddening catch-22, a frantic race to stay a step ahead of the ever-evolving infectious agents. It's not only alarmists who think this is a race that bacteria just might win: that the bugs will develop immunity to all existing pharmaceutical countermeasures before we get enough new drugs into the pipeline to combat them. (Strangely enough, it may be the lowly but nearly indestructible cockroach that provides an answer to this riddle. New research shows that chemicals in a roach's brain provide the creature with superior resistance to the bacteria that have themselves become resistant to antibiotic measures. Scientists are exploring ways of harnessing this substance and applying it in human settings.)

The dire predicament has even taken as its casualty many of the antibiotics manufacturers themselves. With the cost of developing and commercializing a new drug now approaching $2 billion, antibiotics manufacturers and their investors have come to see their marketplace niche as unsustainable—a case of throwing good money after bad. Why invest such colossal sums in a new drug that may be obsolete within a year or two? For such reasons, as well as the byzantine vagaries of the drug-approval process, manufacturers are exiting the sector in droves. Thirty-six companies made assorted antibiotics in 1980. At this writing, fewer than a half-dozen remain. Though some of that attrition is a natural byproduct of industry consolidations, there's no question that the sector attracts far less interest these days from biotech firms and the venture capitalists who fund them.

And that is how a sugar pill becomes a poison pill.

To be continued...

© Copyright by Steve Salerno at 9:53 AM 1 comments 

Labels: medicine

Placebo: How a sugar pill became a poison pill. Part 2 of a continuing saga...
Read part 1.

In this mad rush to fill the collective national bloodstream with bug-killing fluids, doctors paid little attention to “subtleties” like proper dosing. An antibiotic regimen marred by ill-conceived dosing—too-small concentrations that end too soon—decimates bacteria but does not kill them off entirely. Although the penicillin-aided body may rise up and overwhelm the microbes in the present instance of infection, the few surviving bacteria—as if bent on proving the wisdom of the famous Nietzsche quote about “what doesn't kill us”—form the prospective beginnings of a stronger super-strain. The hardy stragglers find a new host and breed wildly, now immune to the original, haphazardly administered antibiotic.

Here our narrative takes a brief but important detour to Mexico. As the Ozzie & Harriett era hit its stride, a new wave of Mexican immigrants streamed across the border, excited by this revivified American Dream exploding just to the north. Sensitive to the needs of these new arrivals—most of whom were separated from formal healthcare by barriers linguistic and financial—pharmacias in fast-growing Hispanic neighborhoods quietly began selling antibiotics over-the-counter. In turn, their customers began self-dosing indiscriminately (and, when feasible, sending mercy shipments of some portion of their pharmaceutical “score” back across the border to relatives who'd stayed behind). The renegade druggists, too, knew that their compassion was apt to have little or no bearing on a patient's actual health, but by this time they were part of an inexorable zeitgeist, an authentic cultural revolution. They had gotten swept up in a current that washed away reason.

What the various component parts of this vast antibiotic-dispensing machinery could not have known or even imagined at the time was that they were also incubating an accidental business model. And much like a highly contagious cold itself, that business model one day would infect every precinct of healthcare, from the neighborhood Marcus Welby to the Mayo Clinic, with devastating implications for the practice of medicine. The business model was premised on a deceptively simple idea: that you had to treat something, even if you realistically had nothing to treat it with. Indoctrinated in this thinking from the very beginning of their academic careers—and bearing complete faith in the new technologies forever being supplied to them by a burgeoning medical-equipment industry—future generations of doctors would come to conceive cancer, heart disease and other major ailments in the same way their predecessors once conceived the common cold.

If this mentality were reduced to a bumper sticker, it would be an updated twist on the old Cartesian principle of existence: I'M A DOCTOR, ERGO I TREAT.

At the same time, a complementary phenomenon was taking shape in the form of a psychological pas-de-deux danced by doctors and their patients. The doctors, for their part, were cultivating what might be called a placebo affect: a bedside manner and reassuring patois designed to inspire a level of faith in their healing arts that was seldom vindicated by the underlying science. Meanwhile, large numbers of Americans fulfilled their part of their bargain by going to the doctor for the sheer peace of mind of, well, going to the doctor. “I think the family physician became a kind of security blanket for suburban America,” says Penn State's Arthur Caplan, one of the nation's best-known bioethicists and a keen-eyed chronicler of medical trends. “It's as if the medical outcome was almost secondary.” Healthcare thus became a misguided alliance between physician and patient in which the latter came to rely on the former for a psychosomatic cure-all: The visit was itself the treatment, allowing the patient to believe that something was being done, whether or not such was legitimately the case. “Most people who go to the doctor are going to get better anyway,” explains Dr. Sally Satel, co-author of One Nation Under Therapy: How the Helping Culture is Eroding Self-Reliance. “That's because most illnesses are self-limiting. They won't kill you, and sooner or later they just go away. But that's not how the average person looks at it. People feel they're supposed to go to the doctor when they're sick, and then when they get better, they credit the doctor and his treatment.”

In the 1950s, Americans dragged themselves and their families to the doctor in droves. During the so-called “Golden Age of Antibiotics,” between the post-war period and the early 1980s, human life expectancy jumped by an ostensible eight years, an increase then attributed to the wide availability of antibiotic compounds. (This too would prove fallacious.) So encouraging was the trend-line that in 1969, U.S. Surgeon General William Stewart smugly announced the end of pathogen-borne illness: In a brash and boastful speech to Congress, he told legislators it was “time to close the books on infectious diseases.” For sheer naivete, the remark rivaled the line attributed to Charles Duell, commissioner of the U.S. Patent Office at the dawn of the 20th Century. Duell is said to have lamented that there was little future in his line of work, since “everything that can be invented has already been invented.”*

We now know better. We know because the world is living with the fallout from indiscriminate use of antibiotics and the haughtiness that occasioned it. And we're feeling the effects of that fallout not just in terms of pharmaceuticals, but in every single area of medical practice.

To be continued...

* In the interest of journalistic accuracy, whether Duell actually made the remark in exactly those words remains controversial.

© Copyright by Steve Salerno at 9:51 AM 1 comments 

Labels: medicine

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