Brian Starkey didn't have insurance coverage when he was diagnosed with hepatitis C. So when a doctor pointed him to a study of Bristol-Myers Squibb's ($BMY) experimental BMS-094, he leaped at a chance to get free care. And as The Kansas City Star reports in an in-depth profile, that decision may have cost him his life.
Starkey's sudden death after taking the treatment--along with severe heart ailments suffered by a big group of the 113 enrollees in the drug study--scuttled a program that inspired Bristol's $2.5 billion acquisition of Inhibitex. And the attorney representing Starkey's family tells the Midwestern newspaper that the risks of toxicity were already apparent when Bristol rushed into clinical studies, anxious to grab a lead in the frenzied race to develop a new hep C treatment that would not require interferon.
"This was a poorly designed study that caused serious injury," attorney Robert Hilliard told the Star. "I'm convinced that they rushed it into trials in order to get FDA approval." Hilliard's firm represents a half dozen of the injured patients, several with severe heart damage. One of the patients requires a heart transplant. All are suing Bristol.
BMS' response: "Based on our due diligence, we believed that we could develop BMS-986094 at a dose that would provide sufficient viral suppression and resistance coverage while also having an acceptable safety and tolerability profile." Bristol has also promised to help officials and other companies like Idenix ($IDIX) to get to the bottom of the drug reactions as quickly as possible.
The patient reactions in the 094 study have also forced Idenix to slam the brakes on two of its experimental programs as the FDA carefully considers whether patients are being exposed to unnecessary risks.
For Starkey's family, including his 19-month-old son, the exercise in caution came too late.
- here's the story from The Kansas City Star