FDA and Medicare Records reveal Sackler-Associated Drug Companies as Leaders in Controlled Substance Markets.
In the Pre-Covid Era, almost every day’s newspaper would contain at least one article about our last-worst epidemic of opioid abuse. Since Covid-19 justifiably soaks up much of our attention, the infrequent article about opioids now takes me by surprise. The odd article that leaks through reminds us that the opioid tragedy has not gone away. Indeed, as the desperation attendant to Coronavirus spreads, there is every reason to believe that the fellow-traveler of opioid abuse is blossoming also. The current news environment has allowed the progress of previously reported high-profile litigation against an assortment of opioid manufactures, marketers, and sellers to proceed in the relative background.
Last week, the United States Department of Justice announced that one arm of litigation came to a head when Purdue Pharma LP pled guilty to three felony charges related to its marketing and distributing of OxyContin. The settlement agreement (subject to bankruptcy court approval) includes a payment of $8.34 Billion, but to whom or what is not clear to me. Since Purdue declared bankruptcy, it seems unlikely that anywhere near that amount will ever be paid. Companies don’t go to jail. Even billions of dollars can be an tolerable cost of doing business in Big Pharma. As part of a broader overall settlement, the Sackler family owners of Purdue resolved a number of additional civil charges for $225 Million. Some commenters have expressed opinions that the Sacklers and Purdue are getting off easy. That may well be so, but the Justice Department’s announcement notes that “the resolutions do not include the criminal release of any individuals, including members of the Sackler family, nor are any of the company’s executives or employees receiving civil releases.” In my opinion that is eminently proper.
Continue reading “Proposed Purdue Pharma DOJ Settlement Emphasizes Role in Opioid Epidemic.”
Opana ER is the brand name of the specific extended release preparation of oxymorphone HCL marketed by Endo Pharmaceuticals, Inc. This was the drug of choice that underlay the explosion of opioid addiction and of HIV/AIDS and hepatitis infections in intravenous users in nearby Scott County, Indiana. Opana is back in the news, but not in a good way for Endo. The FDA assembled an expert review panel last week to opine on whether the benefits of Opana ER outweighed its risk to its users. The short summary of its findings and recommendations is that the benefits do not outweigh the risks, and that the drug’s continued marketing should be controlled in a variety of possible ways including removal from the market, or restrictions on who can prescribe it and under what conditions.
To summarize the findings of the article below, Opana ER is not a big player in the prescription opioid market in any event. Its active ingredient, oxymorphone, is manufactured or distributed in the US by at least 19 different companies but fills less than 1% of opioid prescriptions. (I must admit up front that have no idea who actually makes what pills or where the active ingredient in the various preparations comes from.) A detailed list of individual versions of oxymorphone by NDC from the labelers below is available here. (or here as Excel file.) It occurs to me as I see such long lists of labeler names, that with so many ways for a drug to enter the community, opportunities for diversion from supervised distribution become correspondingly more numerous. Given all the apparent distributors, is it even possible for an Endo or a Mallinckrodt to know where the drugs they might manufacture end up? Mallinckrodt in particular has been accused of not keeping very good track at all, at least in Florida. Continue reading “FDA Panel Finds Opana-ER Not Worth The Risk!”
Kentucky’s high rates of opioid prescription must be reduced before even more prescribers are added. National data suggest that adding Physician Assistants to the prescribing mix is unlikely to reduce the number of opioid prescriptions written.
Louisville’s Courier-Journal this week featured an opinion piece by Andrew Rutherford, President of the Kentucky Academy of Physician Assistants, advocating for the passage of Kentucky Senate Bill 55 which would authorize physician assistants in Kentucky to prescribe controlled substances. Emphasizing the stakes involved in the proposal, articles later in the week reported on the latest rash of opioid overdoses in our region– presumably due to the inevitable fentanyl-enhanced “bad batch” of heroin. Several on-line commenters to the second articles suggested that since those who overdosed had made their own risky-decisions, that they should be permitted to suffer the consequences without an intervention of attempted resuscitation. It is suggested that this Darwinian mechanism would ease the opioid abuse problem. Unfortunately however, among the personal choices leading to opioid addiction is the choice to visit a licensed healthcare professional who, with good intentions or not, prescribes opioids. Once an individual becomes addicted, the concept of “choice” become irrelevant. A reasonable question to be asked is, “Do we really need to put more opioids in the hands of Kentuckians? My answer would be an emphatic no. Continue reading “Should Kentucky Physician Assistants Prescribe Controlled Substances?”
Bad heroin is an oxymoron, but over the past week, several dozen opioid overdoses appeared in local emergency rooms or were rescued by emergency medical technicians. At least one died. It is being reported that some 300 overdose cases were reported in our region. Since these patients responded to the opioid-specific rescue drug, naloxone, it is assumed they overdosed on one opioid or another. Toxicology studies are pending, and public health authorities are not overstating what they know, but we can reasonably assume the substances injected or otherwise consumed contained an unexpectedly high amount of heroin; the powerful synthetic opioid fentanyl; or carfentanil, the new-to-the-scene, elephant-strength, fentanyl look-alike. For decades, heroin available to end-users has been cut, or diluted with a variety of non-opioid substances – some more benign than others. In recent years, the availability of higher quality heroin from Mexico has both driven down the price and increased the potency of street heroin. Presumably both sellers and users have been adjusting their practices to account for the greater potency. Uncertainty about the purity or safety of available heroine products is said to be the reason that addicts in southern Indiana chose the prescription drug Opana as their opioid of choice. This of course did not protect them from an accompanying epidemic of HIV infection and viral hepatitis.
For reasons not fully known to me, for the past year or more, heroin preparations used by addicted individuals have been shown to contain fentanyl. It is apparent that these augmented preparations can catch whole communities of users by surprise. The arrival of heroin with augmented lethality is signaled by an increase in overdoses and deaths within a confined geographic area. While I was there in the summer of 2015, such an outbreak of heroin-associated deaths occurred in Washington County, Pennsylvania.
Whether the offending additive was fentanyl or its cousin carfentanil is relevant not just to law enforcement, but for the rescue community. Unexpectedly high doses of naloxone are required to wake up individuals who have ingested these super-opioids. The appearance of such overdose outbreaks caused by more highly purified heroin or other opioids announces to a community that their problem with drug addiction is worse than they thought. I take that to be the message for us in Louisville. Continue reading “A Batch of Bad Heroin Arrives in Louisville.”