Is Byetta the Next Rezulin or Avandia – Yet Another Promising Drug That Faces Demise Safety Issues
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Those of us who have personally seen the devastating impact of diabetes in our own lives and those of our loved ones are always looking for the next great drug that might provide hope to our diabetic family members. I remember so well following Rezulin through its development and pre-approval stages in the mid-1990s at a time when my father was facing his first amputations and a very sad future due to the ravages of diabetes. We sought out research centers conducting pre-clinical studies in hopes that Dad might qualify and be one of the “fortunate” who would be permitted to use this touted “wonder drug.”
Fortunately, Dad was never able to participate in one of those early studies, and his use of Rezulin once it was approved in 1997 was incredibly short-lived, as the drug’s great promise was quickly overshadowed by the rash of patients who died from drug-induced liver failure. Following the initial fanfare with the introduction of Rezulin, the drug was recalled in early 2000. Nearly 2,000 lawsuits were filed in coordinated federal proceedings in MDL 1348 in New York by a number of patients and their family members seeking redress for liver failure and other safety issues associated with the drug. Drug-induced liver failure is a condition that should have been detected in the pre-clinical studies (and there were red flags present long before Rezulin was fast-track approved by the FDA).
With Rezulin, as well as a number of other new drugs with safety issues, there were an insufficient number of patients studied prior to approval to detect small but serious health threats, such as liver failure. In addition, the participants in pre-approval studies tend to be healthier and often are not representative of the patients who actually will take the drug once it is approved. Also, participants in pre-clinical studies are very closely monitored for side effects, and often pulled from studies as soon as they show any signs of potential harm. All of this leads to the now-accepted (but certainly unacceptable) reality that pre-clinical studies are inadequate to truly safeguard patients from dangerous drugs and that those patients who ingest newly-approved drugs end up being essentially human guinea pigs.
Several years ago, Avandia provided similar promise like Rezulin, but has seen its use decline significantly over the past few years in light of safety concerns. Avandia has been implicated in causing both heart problems and liver damage, and consumer advocates are again urging the FDA to pull the drug from the market. Just as occurred with Rezulin a decade ago, Avandia users have suffered unnecessary harm and are seeking redress through litigation, with nearly 400 lawsuits currently pending in MDL No. 1871 in Pennsylvania federal court. This litigation is yet another example of the civil justice system serving as a safety net to protect patients from dangerous drugs and unnecessary harm where the FDA has been unable or unwilling to provide sufficient safeguards.
Byetta is yet another diabetes drug under attack. This particular drug is injected, which means that its cost to patients and our healthcare system are much greater – which also increases the incentive for aggressive marketing by the manufacturers, Eli Lilly and Amylin. Byetta was approved by the FDA in June of 2005. It is derived from the saliva of the gila monster. More than one million patients have received the injections since its approval. Recent studies have noted that patients using Byetta are at a greater risk of developing life-threatening pancreatitis. Recently, the FDA required the manufacturers to enhance the warnings after receiving more than 30 reports of patients developing acute pancreatitis. A few lawsuits have already been filed and seek information from Eli Lilly and Amylin regarding what the companies knew regarding the likelihood of development of pancreatitis and whether the knowledge of the manufacturers was appropriately reported to the FDA and included in the product’s labeling and marketing communications with physicians. Only time will tell whether Byetta will go the way of Rezulin and Avandia, or whether it will be permitted to remain on the market and continue cause harm to patients with essential immunity for its manufacturers under the latest Bush Doctrine – federal preemption which has been orchestrated to essentially provide immunity for drug and medical device manufacturers.
