If a drug is new does that make it better?

By Morton Mintz
mintzm@earthlink.net

President Obama and Vice President Biden said in an election campaign statement that they want to give "Americans and their doctors...accurate and objective information to make the best decisions for their health and well-being." They said they would seek, among other things, to “establish an independent institute to guide reviews and research on comparative effectiveness…”

A simple-as-all-get-out legislative fix, one requiring only a change of a few words in the prescription-drug law of 1962, is available, too. But it would be fiercely opposed by the pharmaceutical industry, Washington's largest lobby. Just in 2007, it had a $168 million lobbying effort, according to a Center for Public Integrity analysis.

Under the 1962 Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act, a manufacturer seeking approval of a new medicine need only demonstrate, with two clinical trials, its superiority to a dummy drug. "But patients and doctors need to know not just whether a new drug out-performs a placebo, but whether it's a real advance on what is already on the market," wrote Richard A. Friedman, a professor of psychiatry at Weill Cornell Medical College in a New York Times essay. "For that, we need head-to-head trials comparing new and standard treatments."

Lithium salts are an example. These "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," Friedman wrote.

“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 anti-suicidal 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," Friedman points out. "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....

"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."

At least implicitly, Friedman raises this question for the Obama administration, particularly for Kathleen Sebelius, Secretary of Health and Human Services, and Margaret A. Hamburg, the new Commissioner of the FDA:

Q. Will you press Congress to change the drug law to require that to win FDA approval, a new drug must be shown in clinical trials to be superior not just to a placebo, but to medicines already stocked by your local pharmacy?

Mintz began reporting on the FDA for the Washington Post in 1962.
   

Morton Mintz (Nieman '64) is a senior adviser to the Nieman Watchdog project. E-mail: mintzm@earthlink.net

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