Fed­eral panel sug­gests lim­its on drug for di­a­betes

mem­bers split on whether to with­draw or re­strict sales of pill linked to heart attacks

Austin American-Statesman - - FRONT PAGE - By Gar­diner Har­ris

GAITHERS­BURG, Md. — A fed­eral med­i­cal ad­vi­sory panel rec­om­mended Wed­nes­day that the di­a­betes drug Avan­dia should ei­ther be with­drawn from the mar­ket or have sales se­verely re­stricted be­cause it in­creases the risks of heart attacks.

The panel’s votes, taken af­ter two days of in­ten­sive sci­en­tific dis­cus­sions, were a blow to Glax­oSmithK­line, which makes Avan­dia. The com­pany ar­gued that Avan­dia is a safe and needed op­tion in treat­ing di­a­betes.

But panel mem­bers voiced skep­ti­cism about the com­pany’s trust­wor­thi­ness af­ter ques­tions were raised about its clin­i­cal tri­als. And in­ter­nal com­pany doc­u­ments showed that the com­pany for years kept cru­cial safety in­for­ma­tion about Avan­dia from the pub­lic.

The panel took six votes on a va­ri­ety of is­sues, but its most im­por­tant came near the end of the meet­ing when asked what the Food and Drug Ad­min­is­tra­tion should do. Of the panel’s mem­bers, 12 voted that Avan­dia should be with­drawn; 10 voted that its sales should be re­stricted and the warn­ings on its la­bel en­hanced; seven voted only to sup­port en­hanced warn­ings on the drug’s la­bel; and three voted that the drug should con­tinue to be sold with its present warn­ings un­changed. No one voted for a fi­nal op­tion,

Con­tin­ued from A to weaken the la­bel’s present heart warn­ings.

Dr. Janet Wood­cock, di­rec­tor of the drug cen­ter at the FDA, said that the agency took the panel’s ad­vice se­ri­ously and that it would con­sider its reg­u­la­tory op­tions.

The FDA of­ten takes the ad­vice of its ad­vi­sory pan­els, but in this case, it was hard to pre­dict what the agency would do, given the split na­ture of the vote. The agency al­lowed com­pet­ing vi­sions to spill out in the ad­vi­sory hear­ing — some­thing un­heard of just a few years ago, when the FDA nearly al­ways spoke with a sin­gle voice.

“We will come to a de­ci­sion as soon as pos­si­ble, and we will an­nounce that pub­licly,” Wood­cock said.

Ap­proved in 1999, Avan­dia helps con­trol blood sugar lev­els in di­a­bet­ics by mak­ing pa­tients more sen­si­tive to their own in­sulin. It is one of a class of three drugs, the first of which, Rezulin, was with­drawn be­cause it caused liver dam­age. The sec­ond drug in the class, Ac­tos, made by Takeda, has ap­peared safe.

Avan­dia, which was once the biggest-sell­ing di­a­betes medicine in the world, saw its sales abruptly de­cline in 2007 af­ter a study by Dr. Steven Nis­sen, a Cleve­land Clinic car­di­ol­o­gist, found that it in­creased the risk of heart attacks. An ad­vi­sory com­mit­tee in 2007 de­cided that Avan­dia did in­crease heart risks but voted to keep it on the mar­ket.

Many of the same ex­perts who de­cided to keep the drug on the mar­ket in 2007 voted Wed­nes­day that it should be with­drawn or re­stricted. Those re­stric­tions could mean that pa­tients would have to ap­ply for spe­cial per­mis­sion to use the drug.

Re­ac­tions were as mixed as the vote.

In a state­ment shortly af­ter the com­mit­tee ad­journed, Glax­oSmithK­line noted that a ma­jor­ity of com­mit­tee mem­bers had voted to keep Avan­dia on the mar­ket.

Nis­sen said the com­mit­tee’s vote was the best he could hope for.

“Ef­fec­tively, this drug is gone,” he said.

Dr. San­jay Kaul, who voted to re­quire stronger warn­ings, said that the FDA must en­sure that Avan­dia is used far less reg­u­larly.

“Make sure this is avail­able as sec­ond-line and not as first­line,” Kaul urged.

The FDA gen­er­ally un­der­takes pro­grams to re­strict a drug’s sales only when a drug of­fers a spe­cific ben­e­fit, some­thing no study has shown about Avan­dia. Among the ex- amples of drugs the FDA has re­stricted are Ac­cu­tane, an acne drug that can cause birth de­fects, and Lotronex, a drug for ir­ri­ta­ble bowel dis­ease that in rare in­stances is fa­tal. A ma­jor­ity of the com­mit­tee found that Avan­dia in­creased the risk of heart attacks, but a ma­jor­ity also said that stud­ies had failed to prove it in­creased the risk of death. A ma­jor­ity also de­cided that if Avan­dia were to con­tinue to be sold, the com­pany should com­plete a clin­i­cal trial to prove it is safe. But sev­eral mem­bers said that the vote prob­a­bly made a trial im­pos­si­ble be­cause pa­tients would not want to risk tak­ing Avan­dia.

Glax­oSmithK­line said it was in the midst of a clin­i­cal trial that would test defini­tively if Avan­dia causes heart attacks. Sev­eral panel mem­bers said the trial came too late.

“The best time to do the trial would have been when the first sig­nal about lipids came up way back in the 1990s,” said Dr. Peter Sav­age, a mem­ber from the Na­tional In­sti­tute of Di­a­betes, Di­ges­tive and Kid­ney Dis­eases.

In the 1990s, Glax­oSmithK­line de­cided against just such a study be­cause it feared that the re­sults might hurt sales, ac­cord­ing to in­ter­nal com­pany doc­u­ments.

Paul Sakuma As­so­ci­Ated Press

Mem­bers of a fed­eral health ad­vi­sory panel voiced skep­ti­cism about the trust­wor­thi­ness of Glax­oSmithK­line, which makes di­a­betes drug Avan­dia, af­ter ques­tions were raised about its clin­i­cal tri­als.

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