The husband of former Pacific Grove, Washington Mayor, Sandy Koffman just filed a wrongful death civil lawsuit against two drug companies following his wife’s death from pancreatic cancer last year. His wife had been taking Type 2 diabetes drug, Byetta.
Dan Koffman seeks damages and told The Herald Health (The Monterey Herald) that he hopes the lawsuit will increase consumer awareness concerning the Type 2 diabetes medication, Byetta. Koffman alleges Byetta led to his wife’s pancreatic cancer. Mayor Koffman was in office from 1994 until 2002; she died on August 3, 2012, at the age of 60 and had been taking Byetta to control her Type 2 diabetes, Koffman said.
According to lawsuit allegations, the drug companies were fully aware of Byetta’s dangers, but never warned doctors and patients. The drug is the result of a joint effort between Eli Lilly and Co. and Amylin Pharmaceuticals LLC, according to The Herald Health.
“I fell asleep … and got up about 3:30 a.m.,” said Koffman, “and as I was getting ready to turn the TV off I heard the word ‘Byetta’ and I heard the word ‘pancreatic cancer’ and that was enough to make my jaw hit the ground,” according to The Herald Health. Koffman said he is “certain” that Byetta caused his wife’s death. “I believe that is the reality,” according to The Herald Health, which noted that the Koffman’s were married for nearly 35 years. “We had a very long and incredible marriage and lots of adventures and lots of magic,” saying that their marriage was “97 percent magic and three percent cancer.”
Sandy Koffman took Byetta from about November 2007 until August 2011; she was diagnosed with pancreatic cancer around March 2012, the lawsuit states. She died that August and underwent “16 different procedures within a couple of weeks (of diagnosis) in an attempt to stabilize her and her digestive system,” the lawsuit says.” She was in excruciating pain all the time,” Koffman told The Herald Health.
Byetta is a drug in the class of incretin mimetics, which are sparking debate and renewing concerns about health risks, especially to the pancreas. In fact, a piece published in the journal BMJ, states that the drugs, which include Byetta, might be riskier than initially believed.
According to the journal, drug companies have withheld data on the potentially dangerous effects of incretin mimetics. BMJ analyzed thousands of pages of regulatory documents it obtained under Freedom of Information rules, locating unpublished data indicating, “unwanted proliferative or inflammatory pancreatic effects,” according to MedPage Today. “On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” Deborah Cohen, Investigative Editor for BMJ, wrote.
The drugs increase natural substances that lower raised blood sugar levels. Typically, patients with Type 2 diabetes are either diagnosed with abnormally low insulin levels or their bodies do not utilize insulin efficiently. The drugs imitate the body’s incretin hormones, which stimulate insulin release after consuming a meal.
In her report, Cohen indicated that drug makers have not conducted critical safety studies. What’s more, regulators have not requested such studies, according to MedPage Today. She also noted that access has been denied to the raw data that would have shed light on the safety of incretin mimetics.
The piece presents what MedPage Today describes as a “thorough timeline of incretin mimetic-related events,” that begins with the early signs of pancreatic risk seen in the drug class, which was the brought to the attention of United States and European regulators; boxed warnings discussing pancreatitis; and UCLA’s Peter Butler, MD’s work exposing risks associated with incretin mimetics; as well as data from other studies.
More than 100 lawsuits representing 575 plaintiffs nationwide allege injury due to Byetta, according Bristol-Myers’ latest quarterly regulatory filing.