Archive for the ‘Pharma’ category

Placebos, Pharma and Government Drug Approvals

11-02-07

What does it mean for the FDA’s drug-approval process if, as this Economist article implies, the placebo effect is responsible for the apparent effectiveness of some of the drugs it approves?

The story triggering this thought is about sports medicine. It describes a study comparing painkilling effects of morphine with a placebo on athletes. The World Anti-Doping Agency bans the use of morphine during competition because “its painkilling properties would give users an unfair advantage.”

Killing pain, however, is one of the things that the placebo effect is best at. In 1999 Dr Benedetti himself showed that someone who is injected with morphine for two days in a row experiences a powerful analgesic response not only on those days but also on the next, if the morphine is replaced by a placebo without his knowledge. That led (University of Turin professor Dr. Fabrizio) Benedetti to wonder if the effect of legally administered pre-competition morphine might, perfectly legally, be carried over into a competition by giving a placebo.

In their new experiment, published this week in the Journal of Neuroscience, he and his colleagues simulated a sporting competition by pitting four teams of ten athletic young men against each other in a pain-endurance test. With a tourniquet strapped around one forearm, these men had to squeeze a hand-spring exerciser repeatedly until pain forced them to stop. Their scores, measured by the time they managed to keep going, were averaged over the whole team.

One of the teams received a morphine injection just before training sessions held two weeks and one week before the contest, and an injection of saline solution on the big day, along with the suggestion that it was morphine. Another received the same regime, but the saline was combined with naloxone, an opiate-blocking drug. The remaining teams received either no treatment at all, or the placebo on competition day alone.

Members of the team that received morphine followed by a placebo were able to endure significantly more pain during the competition than any of their rivals. In particular, those injected with naloxone did no better than the other two control groups. This finding supports the theory that placebos reduce pain by encouraging the brain to produce more natural opiates than usual.

The Economist thinks aloud about the implications. What if a doctor told an athlete he was being administered an illegal painkiller, and the athlete believed it. The placebo effect kicks in. Is that athlete cheating?

But the bigger picture is the power of the placebo effect. How much mainstream, FDA-approved medication was approved based on placebo-effect-fueled results from human tests? How many approved drugs are effective because of a feedback loop reinforced by doctors’ assurances, advertising and word-of-mouth? Is “the placebo effect” merely a pejorative term for the body’s ability to heal itself? Is healing-by-placebo any less valid than healing-by-drugs?  Do drugs interfere with self-healing/placebo effect, or are they enhanced by it?

Obviously, pharma companies need to have some level of testing and approval, if only to assure that their drugs don’t poison people. But when a drug seems to be effective but the placebo effect is suspected, the FDA considers that drug to have failed. Is that really the right way to look at it?

Taking it further, should the FDA be working with health practitioners on ways the government can help drug manufacturers create the basis of belief that would support the placebo benefits? And shouldn’t the government find a way to support homeopathic and other alternative medications, rather than — as they do now — trying to ruin users’ faith in them?

Placebo might be just another word for healing, in some instances. What are the implications of that?

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Big Pharma’s Profitable Buzz

10-17-07

Tim Wu argues this week in Slate that baby-boomers’ well-known appetite for getting high has, in fact, led to drug legalization. Or, to be more precise, buzz legalization.

Marijuana, cocaine and the kinds of recreational drugs you’d expect to find in the trunk of Hunter S. Thompson’s huge red Chevy convertible — you can still go to prison for those.  But, says Wu, the pharmaceutical industry has rendered those substances redundant:

(T)here’s been no significant change in federal drug laws, or in the political conversation surrounding them, in decades. A leading presidential candidate from either party endorsing a “free weed” movement seems unimaginable. And beyond marijuana, the drug legalization movement barely even makes an effort.

That’s why drug legalization is happening in a wholly different way. Over the last two decades, the FDA has become increasingly open to drugs designed for the treatment of depression, pain, and anxiety—drugs that are, by their nature, likely to mimic the banned Schedule I narcotics. Part of this is the product of a well-documented relaxation of FDA practice that began under Clinton and has increased under Bush. But another part is the widespread public acceptance of the idea that the effects drug users have always been seeking in their illicit drugs—calmness, lack of pain, and bliss—are now “treatments” as opposed to recreation. We have reached a point at which it’s commonly understood that when people snort cocaine because they’re depressed or want to function better at work, that’s drug trafficking; but taking antidepressants for similar purposes is practicing medicine.

This other drug legalization movement is an example of what theorists call legal avoision. As described by theorist Leon Katz, the idea is to reach “a forbidden outcome … as a by-product of a permitted act.” In a classic tax shelter, for instance, you do something perfectly legal (like investing in a business guaranteed to lose money) in order to reach a result that would otherwise be illegal (evading taxes). In the drug context, asking Congress to legalize cocaine or repeal the Controlled Substances Act of 1970 is a fool’s errand. But it’s far easier to invent a new drug, X, with similar effects to cocaine, and ask the FDA to approve it as a new antidepressant or anxiety treatment. That’s avoision in practice.

Given the high price of many of these drugs, Wu says it amounts to legalization “for better-off Americans.”  The symbol of the new drug legalization movement is Rush Limbaugh, says Wu:

He, like many celebrities, is a recovering addict. But with Limbaugh being somewhat outside of the 1960s drug culture, the medical marijuana movement was not for him. Instead, Limbaugh, the addicted culture warrior, has become the true poster child of the new drug legalization program.

The poor continue “to self-medicate with old-fashioned illegal drugs or just get drunk,” Wu adds. (And often go to prison.)

Wu’s essay is one of five written for a Slate series called American Lawbreaking.  His theme is that while we focus most of our attention on lawmaking as an expression of public policy, “tolerance of lawbreaking constitutes one of the nation’s other major—yet most poorly understood—ways of creating social and legal policy.”

Wu will chat online live about his series tomorrow (Oct. 18) on the Washington Post’s site at 11 a.m. eastern time.  WaPo chats are usually archived.