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 sw
eep 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...

Read Part 2


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.

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.

Steve Salerno said...

I agree, Robert, but give this a chance to unfold, if you would. We've hardly scratched the surface.

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.

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.

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.


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.

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.