It's just too cheap

A RESEARCH GROUP at Seattle's Veterans Hospital announced last week that it had identified a drug to treat a medical condition that makes life hell for millions of Americans. Until now, there's been no satisfactory treatment for their condition, but this drug, simple to administer and without noticeable side effects, has brought about the remission of all symptoms in four out of five cases and gives relief indefinitely. It would be just about perfect, if it didn't have one fatal defect: It doesn't cost enough.

The drug in question is prazosin (PRAISE-uh-sin), and it's not new. It was introduced over 30 years ago as a treatment for high blood pressure, but it wasn't very effective and was soon displaced by more potent anti-hypertensives. Now it's mostly prescribed to treat minor ailments, like the difficulty some men experience urinating due to age- related enlargement of the prostate.

As director of mental health services for the Veterans Administration Puget Sound Health Care System on Beacon Hill, psychiatrist Murray Raskind is not primarily concerned with the prostates of his patients, though a lot of them, combat veterans of Vietnam and Korea and even World War II, are old enough to need attention in that area.

Raskind came to the VA as an expert in geriatrics, and his first work here concentrated on the ravages of Alzheimer's disease. "But it quickly became clear that post-traumatic stress disorder (PTSD) was a tremendous problem and that treatments for it were inadequate. In particular, some of my patients had been suffering for decades from persistent, severe, and sleep- disrupting combat-related nightmares. Among one group of African-American vets, many had had psychotherapy of one sort or another and had also taken multiple medications of all descriptions without success. One, who felt responsible for the death in combat of his best friend, had nightly nightmares so intense and guilt-evoking that he was considering ending his own life."

Raskind reviewed the little that's known about the biology and the origin of PTSD. He began to suspect that adrenaline—the hormone the body produces to put all systems in a high-response mode—might be involved. For soldiers in the field, nighttime, when an enemy can approach invisibly, can be the most stressful period of the day. Raskind wondered if his patients' adrenaline response might have become conditioned to snap on too easily, so that any disturbance, however innocent, could trigger terrible memories, panic, and nightmares.

Drugs have been available for decades capable of muting the adrenaline response by blocking adrenaline receptors in the brain. "I found a recent article saying that one particular old adrenaline blocker, propranolol, had been effective in suppressing another PTSD symptom, irritability and excessive anger. We tried that. Three days later, the patient came back and said his nightmares were worse, not better.

"But there's more than one kind of adrenaline receptor, and different drugs affect different receptors differently, so next I tried prazosin, which Pfizer had introduced about the same time as propranolol. We raised the dosage little by little, and a couple of weeks later, he came up to me after a group session, shook my hand, and said that for the first time in 30 years he was getting a good night's sleep."

That was five years ago. Since then, Raskind's group has tried the prazosin treatment with larger and larger ensembles of patients under more and more rigorous test conditions. The result has been the same. In more than four out of five patients, prazosin not only eliminates sleep-disrupting nightmares but allows normal healthy dream function to resume. It seems to work as well for women who've experienced traumatic stress.

The number of people whose suffering could be alleviated by the drug is huge: Raskind estimates that among the more than 10 million Americans diagnosed with PTSD, 20 percent to 30 percent suffer severe nightmares; a similar percentage of the tens of thousands of New Yorkers being treated for the disorder post-Sept. 11 report sleep-disrupting dreams.

Unfortunately, the only medications approved for use in PTSD are Prozac-like antidepressants such as Pfizer's Zoloft and GlaxoSmithKline's Paxil, and though they seem to have a positive effect on some of the symptoms making up the syndrome (recurrent memories, avoidance behavior, passivity, irritability) even their makers don't claim they're effective against recurrent nightmares.

Even more unfortunately, from Raskind's point of view: Prazosin costs less than a penny a day, so none of the half-dozen or more drug companies that make it has the slightest financial incentive to invest millions of dollars in the clinical trials required to get FDA approval for his anti-nightmare treatment, not to mention more millions to market the drug to physicians or advertise it to the public. "We approached one big company to see if they'd take it on," he says. "They said they couldn't afford to."

Raskind's group has already published some of its results, and the American Journal of Psychiatry is considering a paper containing the group's most recent research. But that won't be published for at least a year, and the professional literature is a slow and inefficient way to get the word out to the trade. It's a painful irony that millions of people may not learn for years about a medicine that could knock out the condition that's tormenting them, merely because they can afford it.

Roger Downey's science column appears every other week.

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