Pharmaceutical companies have discovered an unexpected nemesis in their quest to bring new drugs to market: the placebo.
As Steve Silberman reports in a recent article in Wired magazine, the percentage of new pharmaceutical products being scrapped due to poor performances in clinical trials has been climbing steadily over the past decade.
Today, “[h]alf of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills,” he says. (For FDA approval, a new drug must beat a placebo in at least two trials.)
Furthermore — and this has drug companies equally worried — even some of its older products, like Prozac, are not faring well against the placebo in follow-up trials. Writes Silberman:
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. … It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger.
The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today’s economy, the fate of a long-established company can hang on the outcome of a handful of tests.
Silberman reports that Big Pharma, under the auspices of the National Institutes of Health, has launched a sort of hush-hush program (people would talk about it only anonymously) to figure out exactly why the placebo effect has been gaining strength.
I found a couple of the proposed explanations for this conundrum by the article’s experts particularly intriguing:
• Direct-to-consumer advertising of antidepressants, statins and other “blockbuster drugs” in the United States has been so successful that it’s difficult for Big Pharma to find potential volunteers here who aren’t already taking some kind of medication.
So drug companies are going overseas (Africa, India, China, and the former Soviet Union) to conduct their trials. But there they’re finding that “cultural dynamics can boost the placebo response in other ways,” says Silberman. “Doctors in these countries are paid to fill up trial rosters quickly, which may motivate them to recruit patients with milder forms of illness that yield more readily to placebo treatment.”
• When it comes to psychiatric drugs, one of Big Pharma’s problems with beating placebo may lie in its expansive definition of mental illnesses, including depression.
“Existing tests also may not be appropriate for diagnosing disorders like social anxiety and premenstrual dysphoria — the very types of chronic, fuzzily defined conditions that the drug industry started targeting in the ‘90s, when the placebo problem began escalating,” writes Silberman. “The neurological foundation of these illnesses is still being debated, making it even harder for drug companies to come up with effective treatments.”
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).
Now, if only that could be cured with a pill.
To learn more about the latest research on the placebo effect, I recommend Maj-Britt Niemi’s article in last February’s Scientific American Mind.