If you take a look at the people who testified for and against the drug and the panelists, you will find that there are huge conflicts of interests. For example Dr. Brian Strom was an opponent of the drug and a panelists. He is the editor of "Pharmacoepidemiology and Drug Safety". He also receives considerable compensation from the Japanese drug company that makes Avandia's alternative (Takeda Pharmaceutical - Actos) and has been instrumental in protecting Actos from investigations into Avandia. Here is a link to a news story about it ---

http://blogs.wsj.com/health/2007/07/30/another-avandia-mystery-actos-data/

Dr. Strom has previously been censored for misuse of NIH funds and was demoted from Department Chair as a result of inquiries at the University of Pennsylvania into his conflicts of interests.

And this is just one person and one drug and one corruption of the process. This will not stop until we start sending people like Dr. Strom to jail!

This pill was never in danger of being pullled IT IS A SCAM.

The FDA is a dangerous agency that sellout the people for kickbacks and are in the pockets of the billion dollar drug makers.

This drug has caused thousands of heart attacks but gives the drug maker 4.4 billion a year!! so it stays

A filmmaker has been reversing diabetes WITHOUT MEDICATIONS in now 10 countries but the FDA does not promote this
just google SPIRIT HAPPY DIET or click here http://spirithappy.wordpress.com

A lot of ppl don't realize this, but the FDA doesn't test a single drug on the market, nor do they insist on any independent testing. All testing is done by the manufacturer - meaning they, in essence, are frisking themselves. Why are we supposed to trust their "findings" when the manufacturer has a clear interest in getting this drug approved for the market?

The FDA never saw a hazardous drug they couldn't keep on the market. They are a joke. If anyone think these jokers are making sure the food and drugs American consumers purchase are safe they are sadly mistaken.

My mom had diabetes for 10 years before she died in 2008. She was on avandia for more than half of those ten years and according to her autopsy she died from cardiac arrest. Now I don't know how big a contributor Avandia was in my moms death but just the fact that there "may" be a link between heart attacks and Avandia it makes me want to investigate more into it.

Hi to whom it may concern,

My friend I live with is on this drug . Her doctor has not pull her off it and see's

no problems so far with her on it.

i am alleging very sure that avandia is responsible for the strokes that i had starting in 2003 and resulting in my having to retire early. ended up in hospital in 2007 with stroke and took till 2009 to doctor to take me off avand/ment. am now walking again without cane; health has improved tremendously.

diabetes control is a never ending work in progress.

for some this may be a great drug; but it needs super watching.

All drugs have problem. It reacts different to everyone. You are the one to take it or not.

I started out on drugs to control my diabetes. Those drugs stimulated my pancreas to secrete more insulin. That made my pancreas become almost useless quiker. I now Insulin dependent. Both my father and grandfather had daibetes, so I come by it honestly.

I have been on Avandia for a number of years and have had no problem with it. I would rather risk a heart attack than have uncontrollable blood sugars spikes. You have to weigh the risks. All drugs have some sort of risk. Look at tylenol, how many problems have they had with that?

I have to agree with those posters that don't trust the fda. I personally don't trust any government agency. Look at medicare. They a shoving a mandated health care program down our throats, and stealing from medicare to do it.

Avandia is a insulin sensitizer for PAT84. I personally did not see any adverse out comes with my patients on avandia my first one to two years out of residency. Now, I did not see much benefit in it either. It's performance was poor, and I took most people off of it that has been started by my predecessor.

Dr. Mike

Internal Med

My father died unexpectedly of a heart attack a few days before Thanksgiving last year. It was quite a shock because he had not been having any symptoms leading up to it. He was on Avandia. Coincidence? Maybe. But he's been added to the list of cases they have on file.

If you need a TZD, Actos is the way to go. I haven't rx'ed Avandia for 4 years.

Better yet, healthy diet and exercise throughout life (since childhood) and avoid getting obese and diabetic in the first place (apologies to those with certain medical conditions). Those with bad genetics (e.g. obese parents) have a much harder task and have to put in far more effort than others, but ya gotta take personal responsibility before permanent damage is done.

1 pound of fat = 3500 Calories. You only gain weight if you eat more than you burn-off, regardless of your medical conditions or genetics. You can lose half a pound per week if you average a 250 Calorie deficit per day.

About the only drug that has worked for my mother-in-law, and her insurance won't permit her to have it - - - I should say they won't authorize it. And, she is not at risk like others for the side effects.

What a system. Glad we have health care reform.

Spend

Spend!

SPEND!!!

THIS DRUG KILLED MY FATHER IN-LAW. It should be removed from the market. He never smoked or drank a day in his live. He was Air-force and took very good care of his health. He exercised regularly never skipping a week.

Anyone that has diabeties already has heart health risks and they are saying this drug can cause heart problems then NO ONE with diabetes would be a good canidate for it.

My father in law had a double bypass in April. July 5th had a stroke. While recovering in the hospital had cardiac arrest. He died August 15th.

His death was a shock, even to his PCP. He took Avandia for 5 years.

I find the FDA's approval of Avandia and leaving this drug on the market disturbing. Trust in the government isn't at an all time high and this isn't helping. I have read that taking Avandia has shown to cause a 43% chance in heart problems, this number ridiculous. Just 20 or 30 years ago when drug companies started charging exorbitant prices for their pharmaceuticals the public was outraged with the blatant exploitation of peoples vulnerability and fears when falling ill, especially life threatening illness. The drug companies argument that they needed to charge this amount to make up for research and development costs fell on deaf ears back then, but not today. The fact that once the pharmaceutical companies get FDA approval they can market their drug when a drup flop, or a drug that ends up not working can make billions world wide, doesn't promote transparency and incentive to produce a viable product. Trying to get the FDA in their pockets doesn't promote the government workers employed by the FDA to maintain an uncorrupted unbiased stance in the big business and big bucks involved in the drug company world. In fact, name brand drug companies have actually paid generic companies to not market their products, and many complied, the financial rewards and the politics that good. So an attitude of trust, especially when lives are at stake, isn't forthcoming with me with many products produced by big drug companies and those approved by the FDA.

Attention Ambulance Chasers (AKA Person injury lawyers) Make sure you are the first in line to start a class action lawsuit against the makers of Avandia. And don't forget to advertise on TV so people will know who to call thinking this will be a bonanza for them. Then after legal fees they get next to nothing and you get rich.

The lawyer always wins.

All of these products should be tested first on the children of the people that make and market them.

Once again the FDA caves to the almighty power of big pharma by continuing to allow a dangerous drug that, by all rights and common sense, should be banned. Don't blame the Obama administration though. If the President were Republican, the drug wouldn't even get restrictions. In the meantime, drugs that are approved and in use around the world aren't allowed here based on questionable science and more likely to protect pharma profits that would fall if competing drugs were allowed on the market. I'm disappointed and disgusted, but hardly surprised.

should I stop taking this drug? I am very concern about the finding!!

Yes Avandia must be removed and the company pay for such a drug to be on the market. I know first hand what Avandia did to my heart. At 38 I almost had heart surgery due to narrowed arteries from this medication. I stopped taking the pill because I knew something was hapening to me from the medication. I was taking it for 4 years. I flushed the pills down the toilet and decided to live whatever life God has given me without the medication.

After 5.5 years I can say, thank God, I'm 10x healtier and my heart problems seem almost over. I recommend to anyone who's on ANY type of medication to get off of it UNLESS you have not other choice,

I'm a bit concerned. My doctor had me on Avandia for 4 years when I wasn't diabetic. Turns out that every single one of his patients were diagnosed with Diabetes. He was scamming the insurance companies - he was getting paid for all these people who would come into the office every 3 months for blood tests (I was one of them). When he wouldn't see me for an issue unrelated to diabetes (couldn't even get an appointment and he was my primary care doctor) I found a new doctor. This new doctor did blood work (numerous time to be sure of the findings) and discovered that not only was I NOT diabetic - I never was. So now what's going to happen to me having been on Avandia and Fortamet for 4 years?

It's interesting to see all the comments and viewpoints from the physicians and the general public and how much they seem to differ. I am a cardiologist and deal with MI's and DM on a regular basis. Based on personal experience, I would say that about 70% of my patients who have suffered recurrent MI's are diabetics. Nearly all the diabetics who present to me with "chest pain syndrome" and those I have cath'd, I would say over 90-95% have some degree of atherosclerosis. And remember, all a "normal cath" means is that you have normal intraluminal vessel diameter. You cannot visualize on a regular coronary angiogram if there is "positive remodelling" of the vessel or not, unless an IVUS/ICUS is performed. Plus, you cannot visualize the microvasculature, which is what typically DM affects. DM is a well proven cardiac risk factor and in many cases we consider it a coronary disease equivalent (diabetics are at about 3-5 times increased risk of having an MI/stroke compared to the normal population, depending on which study is referenced). For those of you wondering if Avandia had caused your (or loved ones) MI, it would be extremely difficult to discern if it was secondary to DM or to the drug itself causing the plaque rupture. I have seen young people in their 20's who are vegetarians, marathon runners, non-smokers come in to the CCU with massive MI's....there are lots of things we can control (ie. smoking, drugs, diet, etc) and there are a lot of things we cannot (ie. genetics, plain 'ol bad luck). Yes, the FDA does have an obligation to the consumer to help discern the safe drugs from harmful ones, but it is a difficult task as they need to balance "letting a drug out fast as it may cure cancer", vs "withholding it for a few more years even though ppl may be dying from a disease so we can run more trials". I've seen enough death that I tell all my patients to just live life and take care of yourself. There are things beyond anyones control. Nonetheless, I'm sure lawyers will be all over this...what a sad place we live in sometimes.

"

THIS DRUG KILLED MY FATHER IN-LAW. It should be removed from the market. He never smoked or drank a day in his live. He was Air-force and took very good care of his health. He exercised regularly never skipping a week.

Anyone that has diabeties already has heart health risks and they are saying this drug can cause heart problems then NO ONE with diabetes would be a good canidate for it.

My father in law had a double bypass in April. July 5th had a stroke. While recovering in the hospital had cardiac arrest. He died August 15th.

His death was a shock, even to his PCP. He took Avandia for 5 years."

All those blaming this drug for absolutely causing the death of a loved one, prove it. You can't. I understand the need to look for a cause when a loved one dies unexpectedly. But in the statement above, you state there were no health problems with your father. OK, then why was he on Avandia.

Research on cholesterol is showing that the raw numbers we pay so much attention to may be meaningless, and far less important that lipid particulate size, as well as other factors that are genetically-mediated. Marathon runners sometimes die of heart attacks.

I always have to wonder how anyone can point to a single factor, that being a drug, in a population of patients often with multiple risk factors, and the undeniable culprit in causing an adverse event. It seems to me that as a society, we often turn to the entity with the deepest pockets to lay blame. On the other hand, with the massive liability and the specter of class action lawsuits based on sometimes questionable or nebulous data, it's no wonder why drugs are so expensive in this country.

We want our drugs 100% safe, 100% effective and cheap, and I believe these goals are at odds with each other.

Or maybe being diabetic increases your risk of heart attacks and strokes and cancer and alzheimers. Perhaps if you considered decreasing your carb intake and exercising your risk of a heart attack would decrease. Just saying.