Speedy drug-review process 'broken'

WASHINGTON -- Almost 13 years after the Food and Drug Administration made it easier for companies to speed life-saving medicines to patients, US Representative Edward J. Markey says the system of accelerated drug review is ''broken" and fails to protect patients.

Markey, Democrat of Malden, said he came to that conclusion after reviewing documents he requested from the FDA and the Securities and Exchange Commission detailing whether drug companies conducted required clinical trials and reported that information to shareholders.

Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review. Some 42 of the promised studies remain unfinished, including those for such blockbuster drugs as the cancer treatment Gleevec, Markey alleged. Twenty-one of the studies have not been started, while 18 are on or ahead of schedule, according to Markey's research. His office relied on FDA data and did not contact drug companies directly.

Under legislation he expects to introduce next week, drug companies could face millions of dollars in fines if patients are harmed because tardy trials keep some health risks from being publicized. The proposed legislation would require drug companies to change the wording on labels to indicate that the safety and efficacy of conditionally approved products have not been proven.

''It was supposed to be a system of approve today and prove tomorrow. But it's become a system of approve today, but no further proof needed," Markey said.

Susan Cruzan, an FDA spokeswoman, said the agency has not reviewed the report. ''But accelerated approvals allow the agency to give earlier access to promising therapies for serious and life-threatening conditions," Cruzan said.

In addition, Markey found that 17 of 25 publicly traded companies failed to inform shareholders of the status of the clinical trials. Negative disclosures from such trials can affect earnings.

Iressa, the drug that piqued Markey's interest, received an accelerated review because it significantly shrank tumors in 10 percent of lung cancer patients. But last December its manufacturer, AstraZeneca, reported that a crucial clinical trial conducted after approval found Iressa patients did not live longer than those not taking the drug. Since AstraZeneca's disclosure, prescriptions and profits for Iressa have plummeted.

Markey's inquiry comes as Congress continues to examine the FDA's handling of drug-safety problems. Hearings have spotlighted such controversies as the withdrawal of Vioxx and risks from antidepressants taken by teens.

A spokeswoman for AstraZeneca, which was faulted by Markey for not beginning four promised studies on the cancer drug Arimidex, said the company is conducting post-approval trials. Arimidex sales reached $256 million in the first quarter of 2005.

''We take our post-marketing study commitments very seriously," said AstraZeneca's Mary Lynn Carver.

Markey said Novartis failed to begin three trials for Gleevec, which was originally approved by the FDA after a review that lasted less than three months. Gleevec generated $117 million in net sales during the first quarter of this year.

A Novartis spokesman, Geoffrey Cook, said the trio of trials includes two studies that the FDA decided needed to be redesigned -- after they had been completed. The third has been completed and the company is finishing its report. ''It's not as black and white," said Cook.

Eli Lilly and Co. was taken to task by Markey for not starting two trials for Alimta, a cancer drug that tallied $93.9 million in sales during the first quarter of this year. A Lilly spokesman, Gregory Clarke, said the international trials have begun and more than 2,000 patients will be enrolled. ''We live up to what we say we're going to do," Clarke said.

A Shire Pharmaceuticals spokesman, Matt Cabrey, said Markey's characterization of its study as being behind schedule was not ''technically accurate." The FDA in 1996 approved Proamatine to treat low blood pressure. Cabrey said Shire took over commitments for the drug after acquiring another company in 2000. Data collection was completed in May, he said, and a report to the FDA will be ready by year-end.

Diedtra Henderson can be reached at dhenderson@globe.com.