Report: GSK Knew Avandia's Risks for Years

Updated at 6:33 p.m. ET

A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

The report was released on the heels of an article in The New York Times saying that confidential government reports show diabetes patients would suffer 500 fewer heart attacks and 300 fewer cases of heart congestion each month if they took a similar pill named Actos instead of Avandia.

Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

Read the Finance Committee Report

CBS News Medical Correspondent Dr. Jennifer Ashton told CBS Radio News that the risks associated with the drug aren't exactly new.

"It should be re-emphasized that in 2007 the FDA issued a black-box warning against Avandia for an increased risk of heart attack and congestive heart failure," Ashton said, "so it's not new that patients who are on this drug or this class of drug should have very involved discussions with their health-care provider about their risks verses the benefits when it comes to taking those medications."

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

In 2007, the FDA ordered a warning to be included on Avandia's label warning that it might increase the risk of heart attacks. But the label also says data on the risks are inconclusive.

[antoniof123]

Well, I told you so is just a little too late that is the price of deregulation.

You voted for it over the last 40 years now you had the chance and want deregulation back.

Good luck America!

[Phxfire]

My dad was on Avandia. He had a massive heart attack without any previous heart condition, in fact he had received a physical and clean 'heart' bill of health just months before his attack. We were told to prepare for the worse, but thanks to so many, especially one nurse who wouldn't leave his side for days, he made it through. The doctors had no answer to why he could have been heart healthy only months before the attack. I want to know how long you have to be on Avandia to be at risk, how fast it causes damage; perhaps my dad would never have had the attack and not be on all kinds of drugs now that have serious, but unavoidable, side effects (i.e. bleeding). I am furious.

[starleo146]

y Fatesrider February 20, 2010 6:24 PM EST
My question: Why do we STILL allow drug companies to advertise prescription only drugs to the general public? At least half of these drugs that have been advertised have been recalled or found to be extremely hazardous one way or another.

I have questioned this so many times every time I see a commercial. I wonder how much it is costing us to buy that drug, you don't think the pharmaceuticals are paying for it, and after the commercial here comes all the side affects which take as long to recite as the add itself.

[alphaa10000]

CBS reports, "Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday..."
---

While lives are at stake, Sen. "Minimum Max" Baucus takes TWO years to raise a flag about Avandia?

Baucus is not out to lunch, merely corrupt-- his patrons in the pharmaceutical conspiracy asked him for as much time as possible to profit from Avandia before exposing the truth. Since Baucus is part of a gang operation, he bears direct responsibility for the damage he allowed by his retarded review and oversight.

Meanwhile, thanks to Baucus, patients who trusted their MD's advice and counsel unknowingly put their own lives at even greater risk. (Never, ever trust anybody who tells you "according to the FDA, this drug is OK".)

Such lack of oversight by federal officials at FDA, as well as corrupt senators like Baucus, has taken a heavy toll of patient health over the years.

As for Grassley, what can anyone say about his pretense to "oversight"? This is the GOP bozo who became concerned about "death panels" in health care reform legislation, when he knew there were none.

[th9876]

Another sad fact is that big pharma/politicians continue to stop us from traveling outside of the U.S. for more affordable medication using the excuse that drugs purchased elsewhere aren't safe - when FDA approved drugs appear to be the only drugs killing people.

[jasperlily]

How many of those 83,000 heart attacks were fatal? And why will these greed-ridden, corrupt people not be charged with premeditated murder? How long will it take for people to wise up to the fact that many governmental agencies are in bed with the corporations they are supposed to monitor, regulate and protect the people from?

[gmw7777]

Excellent insight! I couldn't have said it better myself.
START CARING ABOUT PEOPLE--NOT THE "BOTTOM LINE!"

[starleo146]

by gmw7777 February 20, 2010 10:34 PM EST
Excellent insight! I couldn't have said it better myself.
START CARING ABOUT PEOPLE--NOT THE "BOTTOM LINE!"

This is so true and I hope you vote your convictions when Nov. comes around. I was put on Avandia and had a heart attack and congested heart failure before they took me off of it. Just had open heart surgery, all because of a drug that was passed and doctors following pharmaceuticals advise. Years ago it took 10 years for a drug to pass FDA now it is everything passes till the public starts having problems, MONEY,MONEY

[baileyccc]

This is "Business as Usual" for Big Pharma. They do what they want they are sitting on hundreds of billions of dollars. Damn the health, profits is all that matters at anyone expense. Posted by baileyccc

[Fatesrider]

My question: Why do we STILL allow drug companies to advertise prescription only drugs to the general public? At least half of these drugs that have been advertised have been recalled or found to be extremely hazardous one way or another.

We don't allow cigarettes to be advertised on television or radio. Those can be legally bought over the counter by anyone over 18 at any time. Why the hell do we allow things that can't be legally bought over the counter by just anyone anytime, let alone things for which a doctor must evaluate before hand, to be advertised in prime time?

If we want health care reform, do the following:

1. A "bare bones" public option for the poor. People who can't afford insurance shouldn't have to die because of it.

2. Competition in the health care insurance industry. There are only regional oligarchies of health care insurers. There's very little actual competition between them. Competition will drive down health care costs.

3. Eliminate ads for prescription drugs. A Canadian or European can buy the same drugs at a tenth (in some cases) the cost of a US resident.

4. More emphasis on prevention.

5. Forced cap on specialist salaries. We have too many specialists and not enough general practitioners. A doctor should be paid not by how focused they are in one area, but by how many different fields they personally and directly address in their practice.

6. An independent (as in the special interests have no ability to influence the politicians who fund it) drug agency with real authority to do the testing and enforcement necessary to ensure the quality and claims of the drugs we use. All of the drug companies who want their drugs to be sold in the US must have this agency conduct their research for them. Choose those who will do the testing randomly from a pool of available researchers. Also, never let anyone do any research on a drug who has ANY ties (Family or financial) to the drug company whose drug is being tested.

[th9876]

They are still allowed to because they write the laws our politicians sign on to.

[alphaa10000]

An even more pressing question-- Why does the FDA not independently review and/or verify the claims of drug makers? We might suppose this is a life-and-death issue.

The only answer the FDA has managed to offer is a murky claim about "efficiency" in speeding drugs to market. This brand of FDA efficiency has killed a vastly inordinate number of patients.

Critics of drug company practices say the FDA ignores the blatant conflict of interest in pharmaceuticals approving their own test results.

[upursjakoff]

wel we all know that eventually we are going to be a victim of some drug interaction..and our money will pay for it too..!..we are nothing but poor/common americans..i mean...the water we have to pay for is poison...the food is poison..and the air we pay for is poison too..!..and then we to bail out the best bankers in the country,because they couldn't handle money..!..and we aren't even allowed to have 3 beers and drive without going to jail..this country blos..!

[gmw7777]

Thank you. And the banks said they had to pay bonuses to attract and keep "talented" bankers! Those people who lost all that money are TALENTED??!! The powers that be think the general public is stupid. The bankers should not be rewarded--they should be fired and prosecuted.
This country should be served by men and women who love their country better than their purses or wallets.

[elsiethecow]

Not to mention that many of "us" don't know how to spell! :)

[Rodeo_Joe]

83,000 !!! Is Bin Laden their CEO - what gives? Will there be a Military Response?