FDA Officials, Researchers Say Avandia Panel Was Biased
Two FDA drug safety officials and some other medical experts are saying that the advisory panel that voted in July not to recommend an Avandia recall, despite acknowledging the increased risk of heart problems, was loaded with panelists who would be more sympathetic to the drug, skewing the vote.
Dr. David Graham and Dr. Kate Gelperin, of the FDA Office of Surveillance and Epidemiology, wrote a letter published on September 7 in the British Medical Journal saying that the advisory panel, which is supposed to consist of independent outside experts, included 16 people who were no longer active members of the normal advisory committees. All but one of those non-members who were invited to vote had already voted against removing Avandia from the market in 2007, when concerns about Avandia heart problems first became public. Editors at the journal have openly called for the FDA to recall Avandia.
The 16 members from the 2007 meeting made up half of the 32-member panel which voted 20 to 12 to keep Avandia on the market, despite acknowledging overwhelmingly that it probably increased the risk of heart attacks and other heart problems. The panel did recommend that Avandia carry stronger warnings and be more restricted in use. Although the FDA is not required to follow the guidance of their advisory committees, they often do.
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Graham, who has long called for an Avandia recall, and Gelperin called the way the advisory committee was structured “unprecedented.” Their analysis indicates that the current committee members who had not been a part of the 2007 meeting were 4.4 times more likely to vote for a recall of Avandia than the members that already decided in 2007 to let the diabetes drug remain on the market. If true, that means that had the committee just included its usual members, the vote would have resulted in a recommendation to recall Avandia.
Dr. Steven Nissen, whose 2007 study in the New England Medical Journal first suggested that Avandia increased the risk of heart attacks, also said that the panel was loaded in favor of GlaxoSmithKline in an interview with Heartwire.
“When I saw the roster, I knew it was going to be an uphill struggle,” Nissen told the publication. “I was very surprised that they had invited back people who had already voted to keep the drug on the market in 2007. Once you have opined publicly, it is very difficult to turn around and admit you made a mistake.”
The letter is not the first concern raised over the vote. The FDA has called in the U.S. Department of Health and Human Services’ Office of the Inspector General to investigate whether endocrinologist David Capuzzi, one of the committee members, failed to disclose conflicts of interest. It came to light only after the meeting and the vote that Capuzzi was paid to speak for GlaxoSmithKline from April 2009 to March 2010, and had been previously paid to sit on an Avandia advisory board for the company. The latter admission came from GlaxoSmithKline after Capuzzi claimed that the company had never paid him to talk about Avandia.
Capuzzi was one of only three committee members who voted that no further action needed to be taken to protect the public from Avandia side effects.
One panel member, Dr. Sanjay Kaul, said he did not believe there was evidence that the former members invited to vote were biased. Kaul has also questioned Nissen’s research and said it is still questionable whether Avandia causes heart problems. He also disagreed in August with critics who accused GlaxoSmithKline of misrepresenting the results of the committee hearing to doctors.
Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns grew about the increased risk of heart attacks and congestive heart failure from Avandia.
GlaxoSmithKline faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients that of Avandia heart attack risks. Last month the company announced it had reached Avandia settlements in about 10,000 of those suits.
JamesSeptember 21, 2010 at 1:33 am
Due to the affects of Avandia my life has completely demolished. My heart would seem to be the age of an eighty year old man, yet I am only forty-five. I was told three in a half years ago that I have only five years to live if I kept a healthy life style. What is a healthy life style if a year in a half of that was in a shelter. Unlike most people I was not blessed with family members. I was adop[Show More]Due to the affects of Avandia my life has completely demolished. My heart would seem to be the age of an eighty year old man, yet I am only forty-five. I was told three in a half years ago that I have only five years to live if I kept a healthy life style. What is a healthy life style if a year in a half of that was in a shelter. Unlike most people I was not blessed with family members. I was adopted as an infant and my adopted mother died when I was only four years of age. My adopted father also passed away 10 years ago. I have no siblings. Around four years ago was a hard time in my life because of diabetes. I had not yet diagnosed with this disease so I had no idea what was wrong with me. The illness had started taking a toll on my life financially so my life had started to become a hardship. I ended up homeless for a time. While at work, as a brick layer, I was having a hard time climbing a ladder because of pain in my foot. I went to the hospital and at that time I was diagnosed with diabetes. Along with the treatment the doctor recommended he had also started me on Avandia. There are many people who live a normal life with diabetes everyday. I now knew what had taken over and even though my life had somewhat went down I could now take some control back and get back on track. Then a few months later I found myself in the hospital going through an emergency quadruple bypass to try to prevent a future heart attack. Feeling safe in the hands of the medical community, I continued to take the medication Avandia, having know idea of the true risk. In a short time my heart surgery had been a failure and the risk of a heart attack became present again. This time I had to have two stints placed in my heart. One month later I found myself having another stint put in. After overwhelming amount of emergency room visits and an overwhelming amount of heart catheterizations, the realization of a heart attack took place. After all of the surgeries and techniques the doctors tried to use the heart attack still happened. I was told I had to have a defibrillator to prevent once again more heart attacks. It was then that I saw a commercial advertising the effects of Avandia. I asked my doctor if this could be my problem and he then told me to not take the medication any more. To late, the drug that the doctors were giving me to help with one disease was a high risk for me. Avandia was killing me instead of helping me. The normal life with diabetes is no longer in the cards for me after all that I have been through. I had to spend a large amount of time continuing to live in a homeless shelter, and wandering if I would survive this life style let alone surviving the heart problems. The thought of becoming independent again was no longer a reality anymore. I filed for social security and received these benefit’s the very first try, this is way less than poverty amount of income but at least it was something. At least I wasn’t going to die of hunger. Medical insurance took forever to kick in, the stress of that alone can to a person to their knees, it took around a year to finally have insurance. When there isn’t much family to depend on things can get really hard in a situation like mine. Putting my hardship on a friend or a co-worker was not an option for me. I had became very depressed and just wanted to get things over with so I really just wanted to die. What kind of life am a going to live for in the condition I’m in? Is it worth it to caring on? The only people I was living my life with was doctors, nurses and hospital attendants. My quality of life had gone from brick layer to mostly just layer. I love the outdoors, I’ve always enjoyed working outside. Now the heat almost kills me let alone moving in it. Finally I had met a woman at the shelter, we became close and we even married. It was all so quick but when the reality set in that I was going to die we separated after only a month. Me I was just happy to have a companion and someone to care for. Since I have only a few years to live getting close with some is above and beyond impossible. I wouldn’t want to hurt some one in the way of loving and then dieing on them. Why would anyone want to go through that, it would be to much to ask. Avandia has effected my relationships with the very few people I have had and it will forever effect the relationships I will never get to build. The agonizing effects of Avandia on my life are way more superior then anything in my life. Sleeping is a chore every night because I’m afraid I will not wake up again. Avandia has made me age forty years that I will never see or live. I can’t do yard work or even imagine having my on yard again. Brick laying is over for me or any job for that matter. The thought of never being able to work for myself and generate in come over. Going old with some one is out of reach. The thoughts of grandkids are gone. The thoughts of riding a motorcycle are gone. Life has really changed for me. The effects of Avandia has permanently taken my independents away. Luckily, through my ex-wife, I found a few people with big hearts, they have taken me in and gave me a home so I’m am no longer in the shelter. They help with monitoring my medications and gave me a cell phone incase of an emergency. Was it hard for me to go to a stranger for help? Incredibly hard, I feel I have now created a hardship on them. There is also a family member of the couple that helps with doctor appointments and she helps with keeping my affairs in order. For them I am blessed, from Avandia I am dead. When you ask for permanent disabilities that have been caused by this drug, permanent is a large word. Permanent is forever and I don’t even have a couple of years let alone a small forever.
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