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Primary Care Corner with Geoffrey Modest MD: Opioidsx3, and drug company shenanigans to boot

13 Jun, 17 | by gmodest

by Dr Geoffrey Modest

This is a triple blog on a few recent developments in the opioid world.

  1. The FDA just announced that they are seeking removal of Opana ER, long-acting oxymorphone hydrochloride, “based on its concern that the benefits of the drug may no longer outweigh its risks”. [And certainly many of us thought it was ridiculous to approve it from the start. We have all been through this scene before with oxycontin…].  The FDA found (not so surprisingly) that there was a shift in its route of abuse from nasal to injection after the product was reformulated (it had been reformulated “to make it more resistant to physical and chemical manipulation for abuse by snorting or injecting”….).   This increase in injection use has been associated with outbreaks of HIV, hepatitis C and some cases of thrombotic microangiopathy. And if the company refuses to remove the drug from the market voluntarily, the FDA will formally require its removal by withdrawing its approval. (see see https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm​  )

 

  1. the NY Times had an article on 6/10/17 highlighting the increasing role of the internet in buying opiates (they highlight fentanyl), using the “dark web sites” whereby the drugs can be bought anonymously using a special browser, buying the drugs with virtual (untrackable) currencies like bitcoin. A couple of 13-year olds were also highlighted, who had gotten the drugs this way. The reporter commented that “the leading dark net market, AlphaBay, had >21,000 listing for opioids and >4100 for fentanyl and similar drugs from dozens of dealers large and small”. see https://www.nytimes.com/2017/06/10/business/dealbook/opioid-dark-web-drug-overdose.html ​

 

  1. another NY Times article on vivitrol (extended-release injectable naltrexone), suggested lots of drug company shenanigans (see https://www.nytimes.com/2017/06/11/health/vivitrol-drug-opioid-addiction.html ). Basically,

–it is being marketed very aggressively (billboards, buses, subways)

–there are no head-to-head studies with buprenorphine to show its relative effectiveness (and the company seems to not have the least interest in doing those studies)

–it is more expensive than suboxone (eg, 3-fold) [though I should add that naltrexone is an old generic drug, used in the past with some limited success for alcohol dependence, reformulated as an extended release injection but with a dramatic increase in cost]

​–the studies supporting its use are weak: eg a Russian study of 250 patients, where 1/2 failed to stay abstinent for 6 months, though it was better than placebo. And this study and another had very high dropout rates (50% range)

–the new head of Health and Human services, tom price, “ignored widely accepted science” and is praising vivitrol as “the future of opioid treatment”, since the other meds (methadone and buprenorphine​, which work really well) simply “substitute for illicit drugs”

–not shockingly, the drug company Alkermes has been spending millions of dollars in contributions to officials involved in dealing with the opioid crisis (primarily spending money on them vs the usual: doctors and medical associations). it spend $19 million on federal lobbying since the drug was approved in 2010, and $222,521 in political contributions to congress last year

–the company even provides free shots to inmates, with the hope that they will continue to get them when out of jail (??getting people hooked on vivitrol??). And, this has worked pretty well: sales of $58.5M in first quarter in 2017, up 33%, 1/2 from Medicaid, and with huge expansion of Medicaid coverage for it (was 15 programs in 2012 in 9 states, now 450 programs in 39 states).

–and, this promotion of vivitrol may be very harmful: in the setting of the ongoing opioid crisis, and trump’s plan to spend $1 billion for new addiction and treatment programs over the next 2 years, trump and price could really undercut very effective treatments for a largely untested one that appeals more to them, perhaps both financially and ideologically (ie, a lock-step response of “just say no to opioids” without looking at the science or studies)….

 

so,

–it is consistently scary how our system works, in this case likely from greasing the palms of the officials. And it really could lead to vivitrol leapfrogging above buprenorphine or methadone in our political climate. i (and everyone else i know) are generally really impressed with the effectiveness of buprenorphine, including in its long-term use in patients. and it is so safe, as compared to other opiates (and most other meds….).

–getting rid of Opana ER, which many states in the US attempted initially but unsuccessfully​ to block, is a feather in the cap of FDA (it had seemed unlikely that the current FDA leadership would take such a strong position)

–the issue of the dark web is truly scary by making these drugs so much easier to access and so anonymously (eg by kids sitting at home but with internet access).

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