FRANKFORT, Ky. (WTVQ) – A Fayette circuit judge has agreed to unseal court documents that reveal data on how one opioid maker accounted for the majority of opioids in grams sold in Kentucky from 2006 to 2014.
Officials say the new information allows Kentuckians to see how Pennsylvania-based pharmaceutical manufacturer Teva persuaded physicians to prescribe its drugs, Actiq and Fentora, to treat chronic pain despite the drugs being approved by the Federal Drug Administration (FDA) only for breakthrough pain in cancer patients.
Previously redacted information in the complaint now available:
• Teva internally tracked its sales representatives to ensure that prescribers absorbed their messages.
• In 2004, the FDA met with Teva over concerns of promoting its drug Actiq for off-label use. According to records of the meeting, the FDA told Teva “off-label promotion is illegal, with a drug with a risk profile like Actiq, raises significant public health concerns.”
• Teva targeted non-oncologists in order to boost its sales of Actiq and Fentora. Teva developed a research and publication plan to target doctors outside of the cancer-treating population. “This included focused promotional and educational efforts directed toward pain specialists in order to increase their prescribing of Actiq and Fentora.”
The DEA database – Automation of Reports and Consolidated Orders System (ARCOS) – tracked about 380 million opioid pill transactions between 2006 and 2012 in the U.S.
According to the data, companies flooded Kentucky with more than 1.9 billion pills over a six-year period and Teva manufactured 690 million pills making it one of the top six manufacturers during that time.