As the COVID-19 pandemic subsides, it is time to focus attention on the slow-moving, devastating epidemic that America's opioid crisis has created. Overdoses of prescription opioids have been responsible for approximately 15,000 deaths per year over the past 10 years. Add all opioids, prescription and black market, to the number of deaths, which is close to 50,000. Fentanyl from the black market, and OxyContin, a well-known pharmaceutical manufactured by Purdue Pharma, played a significant role. This perfect storm was caused by the company's dysfunctional culture and complacent oversight from the US Food and Drug Administration, the research community and the medical community. We must learn from this experience so we can prevent another tragedy.There has been a lot of outstanding reporting about the OxyContin story and the role played by Purdue Pharma as well as the Sackler family who owns the company. In Empire of Pain, Patrick Radden Keefe recently wrote a compelling account of the story. Although the book is primarily about the terrible business actions of Sacklers I was intrigued by Keefe’s detailed reporting and asked him to explain why scientists and doctors in the company could not stop the crisis sooner. He said that one of the most surprising aspects of this story is the lack of whistleblowers. It would be normal to expect exactly what you describe: people to come forward and protest to alert authorities. Keefe also said that Purdue was not an open-source company and that loyalty to the Sackler clan was important. He also mentioned a dream among scientists at Purdue that they had solved the problem of managing pain with OxyContin. These drugs have been known for many years to have significant therapeutic benefits, but also serious downsides. Keefe said that Purdue believed they had cracked the code on managing pain with OxyContin.A 1995 chemical explosion at Purdue's New Jersey manufacturing plant killed five people and injures dozens more, is one of the most memorable episodes in the company’s history. Profits were the only motivation, so many corners were cut to create a danger that should have been obvious. Keefe stated that the family that controls the company and was driving that drive for profits does not accept any responsibility. They do not attend any funerals. They never express any regret to me.The FDA failed to correct the problem. The FDA warned about the addictive nature of the drug in 2009, even though it was approved for use in 1995. David Kessler was the FDA commissioner at the time OxyContin was approved. He was later quoted saying that the FDA took Purdue's word on both the science and marketing aspects of the drug. After the drug had been approved 14 years ago, FDA Commissioner Margaret Hamburg began holding hearings and issuing warnings about the potential dangers of the drug. Joshua Sharfstein was FDA's deputy Commissioner at the time. He told me that FDA must remember that it is the last line defense against something terrible happening. For a variety reasons, FDA didn't fulfill that role.The OxyContin story is a tale of greed and hubris. Science is partly responsible for not being able to make the case for OxyContin, but also for believing that science can solve all problems. Keefe argued that the original Sackler brothers, who were born in 1950, had a very American belief that science can solve any problem.
