HIGHLIGHTS

Open

REAL POSSIBILITIES

AARP Real Possibilities
Car buying made easy with the AARP Auto Buying Program

DRIVER SAFETY

Piggy bank on the road - AARP Driver Safety

Take the new AARP Smart Driver Course!

Contests and
Sweeps

Dream Vacation Sweepstakes

10 weeks. 10 amazing trips. Seize your chance to win!
See official rules. 

CHECK OUT OUR
NEW IPAD APP!

ATM Mobile App for iPhone and Ipad

Enjoy the best of AARP’s award-winning publications

on the go with the new

AARP ePubs iPad App

KEEP BRAIN ACTIVE!

AARP Games - Play Now!

AARP BOOKS

Planning for Long-Term Care for Dummies

Get expert advice on planning for your own or a relative’s future care needs.

Webinars

Learn From the Experts

Sign up now for an upcoming webinar or find materials from a past session.

Learning centers

Get smart strategies for managing health conditions.

 

Arthritis

Heart Disease

Diabetes

Most Popular

Viewed

Commented

share your thoughts

What does the health care law mean to you? Your story is important. We read and learn from every story and it helps us in our educational efforts. We may even use your comments (with permission) to brief legislators, inspire readers and more. Please share your story with us. Do

Drug Safety

Drug Tests Continue for Avandia Despite Safety Concerns

Some studies link the drug to heart attacks, but company hopes to test it on thousands of patients

An advisory panel to the U.S. Food and Drug Administration (FDA) voted on Wednesday not only to let the controversial diabetes drug Avandia remain on the market but also to continue a large clinical trial comparing the safety of Avandia with another, similar drug, Actos.

The vote to continue the drug trial came even though a majority of the 33 panelists said they believe current findings are sufficient to raise “significant safety concerns” about Avandia’s potential to cause heart attacks and other cardiovascular problems in comparison to Actos. Indeed, 12 of the committee members voted to recommend banning Avandia, also known as rosiglitazone.

The divided vote only seems to reinforce the question some researchers have been asking for months about the so-called TIDE trial comparing Avandia and Actos.

In an interview two weeks before the advisory panel met, David Graham, an FDA drug safety expert, said it’s unethical to do a trial to see how much harm a drug does to people.

Patients chosen to take Avandia as part of the trial “are not going to get any unique benefit, but they are guaranteed to get extra harm,” said Graham, who has advocated for Avandia’s withdrawal.

“They are being basically tricked into participating in a study that is unethical,” he added.

David Juurlink, M.D., a clinician and University of Toronto drug-safety researcher, has also called on regulators to halt TIDE. “Here are two drugs with identical clinical indications, and there’s a fairly strong signal that one of them is less safe than the other,” Juurlink, said. “So if you’re a patient,” he added, “why would you want to go on that drug? Would you really want to be randomized in a study to a drug that might kill you? That has no benefit?”

On the other hand, the committee’s votes also make clear that many of its experts consider the data on Avandia’s cardiovascular risk to be inconclusive.

“Having reviewed the data in great detail, I’m not sure if this is an unsafe drug,” says David Nathan, M.D., a Harvard professor and director of the Diabetes Center at Massachusetts General Hospital. “If we’re ever going to answer the question—and if this drug is still on the market I think we have to answer it—then you have to do the study.”

Nathan, who is not on the FDA panel, says he does not prescribe Avandia but can imagine instances where it might be appropriate, say for a patient who has done extremely well on it and is at relatively low risk for cardiovascular complications.

No research has suggested that Avandia carries any particular advantage over Actos. Both drugs are most often used as add-ons to other diabetes drugs to reduce blood sugar.

The TIDE trial was launched last year by Avandia’s maker, GlaxoSmithKline, at the request of the FDA. With hundreds of trial sites around the world, it is set to enroll more than 15,000 patients, with a completion date of 2015.

Katharine Greider lives in New York and writes about health and science.

Topic Alerts

You can get weekly email alerts on the topics below. Just click “Follow.”

Manage Alerts

Processing

Please wait...

progress bar, please wait

Tell Us WhatYou Think

Please leave your comment below.

Medical
Resources

Symptom Checker

Enter your medical symptoms to find out possible causes and treatments. Read

Health Encyclopedia

Find the information you need about health conditions, symptoms and medical procedures. Read

Health Screenings and Vaccines

What screenings and shots do you need? Read

Health blog

Discounts & Benefits

bring health To Life-Visual MD

AARP Bookstore

AARP Bookstore - woman reaches for book on bookshelf

VISIT THE HEALTH SECTION

Find titles on brain health, drug alternatives and losing weight. Do