Insys responds to report of misconduct
Insys Therapeutics has issued the following response to a recent report containing accusations centered on adverse events and diversion related to the company’s breakthrough cancer pain drug, Subsys:
“Insys takes patient safety very seriously and is committed to working with the healthcare community, including healthcare providers (HCP), payors, pharmacies, and most importantly, patients, to help ensure the proper prescribing and use of the company’s products. As a manufacturer of a breakthrough cancer pain drug, Insys also is committed to complying with corresponding laws and regulations, including those related to adverse event reporting.
“Subsys is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who already are receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients must remain on around-the-clock opioids when taking Subsys. In light of the approved indication of Subsys, it is not unexpected that a percentage of patients, many of whom are gravely ill with cancer, pass away while on Subsys; it does not establish that the patients’ deaths were caused by their use of Subsys.
“Adverse events included in the FDA Adverse Event Reporting System include events that occur while a patient is using a pharmaceutical product regardless of whether they are related to, let alone caused by, the pharmaceutical product in question. Since the launch of Subsys, the FDA’s Adverse Events Reporting System lists 244 deaths. Of those 244 cases, three were definitively due to Subsys overdoses (one accidental, one intentional and one unknown).
“Additional data shows that of the 244 cases, 134 cases were reported by the HCP as due to the cancer for which they were prescribed Subsys. Eight of the 244 cases were reported by the HCP as not due to cancer but definitely were not due to Subsys. Eighty-three of the 244 cases as reported were due to unknown causes as Insys was unable to obtain the information from the HCP after multiple requests. In six of the 244 cases, the HCP was uncertain whether or not the patient was actually using Subsys at the time of death due to the timing associated with the patient receiving the prescription and the actual time of death.
“Insys voluntarily delayed the launch of Subsys until after the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program was implemented due to the company’s commitment to ensuring the product would be used and prescribed appropriately.
“The FDA has not requested that Insys make any changes to the Subsys label since launch due to safety concerns, nor has the FDA raised any concerns to Insys regarding the safety profile of Subsys.
“Insys is committed to patient safety and strives to ensure patient access to Subsys. While Insys does not generally comment on inaccurate and false statements made regarding the company and its products, Insys finds the recent false accusations and complete misrepresentations of publicly available data concerning the number of deaths associated with the use of Subsys, a product that is helping many patients suffering from breakthrough cancer pain, both shameful and disingenuous, particularly in light of the biased agenda held by the individuals who made those misrepresentations.”