Placebos Get More Potent

You have to wonder about drug companies competing with placebos, and blaming the placebo effect when a sugar pill beats whatever they are peddling in clinical trials. You have to wonder about doctors who don’t question the validity of giving out pills that so often underperform the placebo.

The drug couldn’t be the problem. No, never. These drugs rake in far too much money for the companies that manufacture them. It’s got to be the placebo.

A recent article in WIRED Magazine, by Steven Silverman, was entitled Placebos Are Getting More Effective. Drugmakers Are Desparate To Know Why.

Of course this doesn’t mean placebos are getting more effective. How could a sugar pill get more effective? This is purportedly about the placebo effect. The psycho-somatic factors involved, where a person is given a sugar pill, can produce a healing effect as powerful, if not more powerful, than that produced by a drug.

Ultimately, Merck’s foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.

MK-869 wasn’t the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson’s disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn’s disease, an intestinal ailment, citing an “unusually high” response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It’s not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late ’90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger.

Blame the sugar pill. Apparently placebos are packing more punch. With 1 in 10 people on antidepressant drugs in America, the drug companies are scrambling to improve the results for the products they produce. Prescribe less? Heaven forbid! This is a multi-billion dollar industry. Who are you kidding? Unfortunately positive results from tests using placebos can be long lasting, too.

As one reader of the above article, Susan Perry, in a Second Opinion piece for the Minneapolis Post, entitled Drug companies desparate to figure out placebo effect, puts it:

After reading the article, I found myself wondering whether what’s running amok is not the placebo effect, but disease mongering (the invention of nonexistent medical conditions or the exaggeration of ordinary ailments in order to sell drugs or procedures).

When 10% of the US population are on antidepressant drugs, I’ve been thinking pretty much along the same lines. Rather than bitching about drug cartels, and the street people who keep them afloat, perhaps we should be doing a little bit more to counter our own prescription drug culture at home. Alas, there are problems in this world that no amount of chemical readjustment are going to fix.

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