Ask Your Doctor About 'Soma'

"By this time the soma had begun to work. Eyes shone, cheeks were flushed, the inner light of universal benevolence broke out on every face in happy, friendly smiles. Even Bernard felt himself a little melted."

-- Brave New World, ch. 5

A Food and Drug Administration panel surprised Washington GovCorp yesterday by voting 8 to 7 to require a "black box warning" on "several drugs widely used to treat attention-deficit hyperactivity disorder." Potential cardiovascular complications was one reason. What's catching the attention of Big Pharma, though, is that the panel majority also acted because it suspects doctors are over-medicating children with alleged behavior disorders.

The recommendation is advisory, only. Approval by the FDA itself is far from certain, although usually the FDA follows recommendations of its expert medical panels. Reports the Washington Post:

Members of the board said the recommendation was driven as much by worries that the drugs are being overused in the United States as by the possible side effects: About 10 percent of 10-year-old American boys are taking such medications, and there have been recent sharp increases in the number of adults taking them.

"On the surface, it is hard to believe," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."

Brand names Ritalin, Concerta, Methylin and Metadate -- which last year generated $3.1 billion in sales -- were singled out by the board. But the panel might just as easily have targeted the disconnect between drug company promotions for adult anti-depressants and scientific reality, as Florida State University doctors Jeffrey R. Lacasse and Jonathan Leo did recently in a medical journal.

No doubt some children with serious hyperactive disorders benefit from the ADD and ADHD drugs, as a superb Frontline investigative report, "Medicating Kids," convincingly shows. But 10 perent of all 10 year-old-boys in America? Or, 9.3 percent of all 12-year-olds, as the New York Times reports?

Professor Ken Livingston, M.D. has written, "There is something odd, if not downright ironic, about the picture of millions of American school children filing out of "drug-awareness" classes to line up in the school nurse's office for their midday dose of amphetamine."

The pharmaeutical industry isn't happy with the FDA panel's recommendation. FDA bureaucrats are downright shocked.

Robert Temple, director of the FDA's Office of Medical Policy. Asked whether the panel's action surprised him, he said, "I don't know if taken aback is quite the word... it does not astonish me, but it wasn't the primary matter for what we went to them for."

It wasn't 'what we went to them for' because, as the Post report notes, the FDA medical panel "is not supposed to get into the practice of medicine."

Maybe not. But the FDA is supposed to regulate prescription drug marketing. The trouble is, the agency's marketing enforcement arm has been grossly underfunded and highly politicized over the past five years. Regulation of pharmaceutical marketing abuse has nearly disappeared, as USA Today reported last summer:

The FDA's drug-marketing enforcement office has only 40 employees to review more than 30,000 pieces of promotional material a year. Those include TV and print ads, sales brochures for doctors and company postings on Internet sites.

By contrast, Public Citizen reported, drug companies deployed "an army" of K-Street lobbyists with bags full of potential campaign donations. Many of these are former members of Congress themselves, like Florida's own Connie Mack. Another Public Citizen report titled The Medicare Drug War has the details. Congressman Henry Waxman is asking the GAO to investigate.

The latest action by the FDA advisory panel shines a tiny pinpoint of light into the darkness where the pharmaceutical industry, K Street lobbyists, and the Republican-dominated Congress recently engineered a trillion-dollar Medicare prescription drug fiasco that raises concern among both liberals and the few remaining traditional conservatives. It's also causing conflicts of interest for physicians.

As one University of Virginia newspaper columnist suggests, next time you're in your doctor's office, don't ask for the latest mood altering drug. Ask what your congressman has done to help rein in Big Pharma before it ruins the health of the nation -- financial and otherwise.