Trump Officially Declares Opioid Crisis, page-3

Opioid manufacturers seem to me to have become the whipping boys for rising opioid deaths in the United States. It's easy to see their status as well-earned – after all, a number did engage in highly unethical tactics and all could be said to have profited from the sale of opioids. However, I think one of the main reasons for the focus on demonizing pharma is that, with their deeply lined pockets, they make great suing targets.

There has been widespread coverage in the US media of the fact that death from opioid overdose continues to rise. The main solution to date has been to restrict access to prescription opioids even further. Doctors are feeling highly pressured by regulators not to prescribe opioids, leaving some genuine pain sufferers without access to these medications.

What has received less coverage in the media is the fact that opioid deaths are rising despite opioid prescriptions falling. Perhaps it doesn’t fit with the dominant narrative, but in 2016, 3 in 4 fatal opioid toxicities involved illegal, non-prescribed fentanyl. In addition, approximately three in five opioid deaths involved benzos (eg. Valium, Xanax) – concurrent use of opioids and benzodiazepine increases the risk of respiratory depression and hence, death. The illegal fentanyl that is swamping the United States and killing its citizens is manufactured in Chinese labs and entering courtesy of dark web ordering/payment and US postal service delivery or coming through the border, mainly from Mexico. This is difficult and extremely costly to address; hence, focusing on suing pharma is a more attractive option for government.




Anyway, now that I’ve had my little rant, I want to focus on that push to further reduce opioid prescriptions in the United States. The Department of Justice and the Drug Enforcement Agency recently released their proposal for opioid manufacturing quotas for 2019. This is something that is done on an annual basis. The proposal would make 2019 the third consecutive year with reduced quotas. For example, as shown in the table below, the quota for oxymorphone for 2019 is proposed to be 2,880,000 g, down 54% from 6,250,000 g in 2016.




As is highlighted in the latest POH presentation (slide shown below) that Ross Murdoch is currently using in the United States, the TPM/oxymorphone patch potentially uses just 25% of the equivalent oral dosage and reduces the need for supplemental medication (which is often further (IR) opioid medication). Surely that feature has to attract the interest of both the FDA and opioid manufacturing pharmas?