Se­nate re­port says Avan­dia maker Glax­oSmithK­line knew of heart at­tack risks

Re­port sug­gests sharp dis­agree­ments re­main at the FDA over how to han­dle Avan­dia’s risks


came within one vote of rec­om­mend­ing a with­drawal of Avan­dia.

The Se­nate re­port sug­gests sharp dis­agree­ments re­main at the FDA over how to han­dle Avan­dia’s risks. in­ter­viewed Glax­oSmithK­line and agency em­ploy­ees as well as what it called anony­mous whistle­blow­ers.

Based on its knowl­edge of the heart at­tack risks, Glax­oSmithK­line “ had a duty to suf­fi­ciently warn pa­tients and the FDA of its con­cerns in a timely man­ner,” the re­port said.

In­stead, the com­pany tried to down­play find­ings that the drug could in­crease car­dio­vas­cu­lar risks while also work­ing to down­play find­ings that a ri­val med­i­ca­tion might re­duce such risks, it said.

Glax­oSmithK­line said in a state­ment the drug is safe. It said the com­mit­tee re­port took data out of con­text from analy­ses of Avan­dia.

In May 2007, the New Eng­land Jour­nal of Medicine pub­lished an anal­y­sis of dozens of stud­ies on nearly 28,000 peo­ple who had taken Avan­dia. The jour­nal said there was a 43 per cent higher risk of heart at­tack for those tak­ing Avan­dia com­pared to peo­ple tak­ing other di­a­betes drugs or no di­a­betes med­i­ca­tion. The find­ings raised con­cerns be­cause twothirds of the peo­ple with Type 2 di­a­betes, the most com­mon form, die of heart prob­lems.

“Con­trary to the as­ser­tions in the re­port, and con­sis­tent with the FDA-ap­proved la­bel­ing, the sci­en­tific ev­i­dence sim­ply does not es­tab­lish that Avan­dia in­creases car­dio­vas­cu­lar is­chemic risk or causes my­ocar­dial is­chemic events,” Glax­oSmithK­line said.

In their let­ter to Ham­burg, the se­na­tors said the doc­u­ments the com­mit­tee re­viewed in­cluded an anal­y­sis con­ducted by two safety of­fi­cials at the agency. The anal­y­sis com­pared Avan­dia to Takeda Phar­ma­ceu­ti­cal’s di­a­betes drug Ac­tos, and found that Avan­dia has an in­creased risk of heart at­tack and heart fail­ure. Ac­tos is co-pro­moted by Pfizer Inc.

At FDA’s re­quest, Glaxo agreed in 2007 to con­duct a six-year study be­tween its drug and Ac­tos, to give a de­fin­i­tive pic­ture of Avan­dia’s safety. The study, which will in­volve 16,000 par­tic­i­pants, is still en­rolling pa­tients.

But FDA re­searchers quoted in the re­port called the study “un­eth­i­cal and ex­ploita­tive,” since pa­tients will con­tinue tak­ing Avan­dia, a drug with known risks, over Ac­tos, which has not shown any links to heart prblems.

FDA spokesman Ge­orge Strait said the FDA is re­view­ing new data on Avan­dia and will present those find­ings to an ad­vi­sory com­mit­tee this sum­mer.

“Mean­while, com­mis­sioner Ham­burg is reach­ing out to en­sure that she has a com­plete un­der­stand­ing and aware­ness of all of the data and is­sues con­cern­ing this drug,” Strait said.

Avan­dia was Glaxo’s third best­selling drug in 2006 with rev­enue of $2.2 bil­lion. But the safety con­cerns dis­closed the fol­low­ing year slashed rev­enue to $1.2 bil­lion by the end of 2008.

Avan­dia is in­tended to con­trol blood su­gar by in­creas­ing the body’s sen­si­tiv­ity to in­sulin, a pro­tein crit­i­cal to di­gest­ing sug­ars.

In­sulin-reg­u­lat­ing treat­ments have long been pre­sumed to lessen the heart risks al­ready as­so­ci­ated with di­a­betes, which is linked to obe­sity.

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