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Nov. 19, 2004, 7:50 p.m. EST

Experts see holes in FDA drug safety net

Agency can't follow up after initial OK, they say

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By Laura Gilcrest, CBS MarketWatch

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"We're using it, but only in combination with inhaled steroidal drugs," he said. But the studies haven't answered the question of whether Serevent, when used in that combination, carries a greater risk of severe asthma attack or death, Martinez said.

"The conclusion should be that if we could have the necessary studies after marketing, we would know further what is going on. But it's up to the companies whether to do them," Martinez said.

"Problematic' drugs

Arthur Levin, with the New York City-based Center for Medical Consumers, said that the five drugs fingered by FDA's Graham are "problematic" drugs, but added that "saying there's a problem is not the same as saying that they shouldn't be on the market."

However, Levin said that Graham was right on target regarding Roche's acne drug Accutane.

He noted that the acne treatment works exceptionally well in a small group of people. "It's a miracle drug for severe acne," Levin said.

But he added that the number of prescriptions written for Accutane "far exceed the number of people suffering from [severe acne]"

"What's disappointing to everybody is that physicians are prescribing Accutane for less severe forms of acne, when there are other therapies available," Levin said.

However, doctor's prescribing patterns are out of FDA's hands, he stressed.

Accutane also illustrates a key issue in the increasingly incendiary debate about whether FDA is adequately protecting the public from dangerous drugs, Levin added.

As FDA attempts to manage the risks of marketed drugs, there is "a lot of back and forth and repeated meetings" to set up a risk management strategy, Levin argued.

Graham told the senators that Accutane should be more tightly controlled, meaning that only certain, centralized pharmacies could distribute the drug. That suggestion came before an FDA advisory panel a few years ago, but a majority of the panel felt that procedures already in place, such as using patient informed-consent forms and rules requiring female patients to use birth control, were sufficient.

However, even with these safeguards in place, women taking Accutane were still getting pregnant, resulting in severe birth defects. Levin predicted that, in the current harsh spotlight being trained on FDA's drug safety system, the agency likely will move to a more controlled distribution of the drug.

Levin also applauded Graham's warnings about Crestor, noting that there are a number of other cholesterol therapies, called statins, on the market that don't carry the same risk of renal failure.

He also agreed with Graham's view that Meridia has limited value, because it is only effective for weight loss if patients use it on a regular basis. However, long-term use increases patients' risk of high blood pressure, he said.

One consumer group that issued a warning about Vioxx more than three years ago said Graham didn't name enough unsafe drugs.

Public Citizen has asked the FDA to remove two of the five drugs from the market, said Sidney Wolfe, head of Public Citizen's Health Research Group.

The group filed a petition with FDA about Meridia more than two years ago and urged the agency last March to pull Crestor, he said. Both drugs have done "enormous" damage to patients since their approvals, Wolfe said.

He also predicted that Pfizer's Bextra will also raise patients' cardiac risks once on the market and will eventually go the way of Merck's Vioxx.

Wolfe noted that Public Citizen will publish the latest version of its publication, "Worst Pills/Best Pills," due out in December, which he said contains a list of 181 drugs that the group advises patients not to use. Read more.

Laura Gilcrest is a reporter for CBS MarketWatch based in Washington.

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