New Drugs Have Allure, Not Track Record
http://www.nytimes.com/2009/05/19/health/19mind.html?_r=1&ref=health
By RICHARD A. FRIEDMAN, M.D. May 19, 2009
Recently, one of my residents told me about a patient with bipolar disorder whose psychiatrist had prescribed an exotic cocktail of drugs — a sedative, a new mood stabilizer and the latest antipsychotic medication.
I was puzzled — not by her case, which the resident described as textbook manic depression, but by what was left out. This patient, it seems, was never offered lithium, the single most effective treatment for bipolar disorder.
When I met with my residents in their weekly seminar, I decided to make a big deal of this case. “What do you think about her treatment?” I asked them.
There was a long silence. “What’s wrong with it?” one resident replied. Finally, a resident offered that he knew the right answer was lithium, but that newer treatments were more popular.
Now I got it. Never mind that lithium has proved its safety and efficacy over decades of use; it’s passé — eclipsed by all the new and sexy blockbuster drugs.
Lithium salts have been used to counter bipolar disorder since the 1950s, when it was discovered that they greatly reduced the intensity and frequency of mood swings in about 70 percent of patients with the disorder. While lithium must be taken with care — it is therapeutic in a narrow range of blood levels, and overdoses can be toxic — it is also the only psychotropic drug that has ever been shown to have specific antisuicidal effects. That makes it especially valuable, given the high risk of suicide associated with mood disorders.
But lithium is cheap and unpatented, so drug companies have little interest in it. Instead, they have made a new generation of mood stabilizers, some more tolerable than lithium, but none more effective.
And lithium is hardly the only unsexy but effective drug to fall by the wayside. New medical treatments are a bit like the proverbial new kid on the block: they have an allure that is hard to resist.
Doctors and patients alike are inundated by drug company marketing. The companies like to say they are interested in educating the public and physicians about various illnesses, though I have yet to meet a single patient who learned anything informative about any disease from an advertisement.
Instead, I have seen scores of patients in my office, eager to get the latest antidepressant or mood stabilizer that promised them tranquility on their TV screens.
No wonder: drug company spending on consumer advertising skyrocketed 330 percent from 1996 to 2005, according to a 2007 study in The New England Journal of Medicine.
Unlike the public, physicians continue to believe that they are immune to the influence of drug companies, despite strong evidence to the contrary. Studies have shown that doctors with ties to industry are more likely to prescribe a brand-name drug over a cheaper generic version than doctors without such ties.
This is not to say that all influence is bad. If a new drug actually proves to be safer or more effective than its predecessors, then of course it should be prescribed for those whom it will benefit.
All too often, though, the new panacea is nothing more than a “me too” drug — a minor modification of an available drug, offering little or no advantage in safety or efficacy.
Not long ago I saw a patient who told me she had treatment-resistant depression. She had failed to respond to multiple trials of five new antidepressants, including two from the same class of drugs.
I called her psychiatrist, a smart young doctor whom I know, to ask if she had ever been given one of the older antidepressants, like a tricylic or a MAOI (for monoamine oxidase inhibitor). He had little experience with these highly effective older drugs, so he hadn’t thought to use them.
I suggested that she try an MAOI. After six weeks, she improved remarkably.
Now it’s true that the newer antidepressants are generally safer and more tolerable than older ones, which is an important advantage, but they are no more effective than older antidepressants.
My younger colleague had been trained recently and had tremendous knowledge about the latest research and drugs. But his training failed to provide him with the larger context in which to place all these exciting developments.
Specifically, how do all these new drugs stack up against older ones? That is not something that we know enough about. And it is not something drug companies have any interest in discovering. To earn approval from the Food and Drug Administration, a new drug just has to beat a placebo, not a standard drug, in two clinical trials.
But patients and doctors need to know not just whether a new drug outperforms a placebo, but whether it’s a real advance on what is already on the market. For that, we need head-to-head trials comparing new and standard treatments.
That is precisely the goal of comparative-effectiveness research, President Obama’s ambitious initiative to help determine which treatments really work. As you might expect, it has provoked strong resistance from the makers of drugs and devices who fear that their fancy new products may not be any better than current ones.
I don’t know about you, but I’d opt for an old drug with a known track record of efficacy and safety over an expensive newcomer with no added benefit — any day of the week.
Richard A. Friedman is a professor of psychiatry at Weill Cornell Medical College.
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