Tag Archives: Purdue Pharma

National Academies Panel Recommends Rethink on Opioids

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

A new report released by the National Academies of Science, Engineering, and Medicine (NASEM) makes several pointed recommendations about the way the United States Food and Drug Administration (FDA) approaches prescription opioid drugs, a class of pain relievers that are highly addictive and serve as a potential gateway to heroin, once supplies and sources of prescription drugs run dry (NASEM, 2017a). The panel, ordered under the Obama Administration’s FDA head in 2016, spent a year looking at the burgeoning opioid and heroin epidemics in the U.S. in an effort to better address these issues at every level of government (Diep, 2017). Among these recommendations are suggested guidelines for how the FDA considers the approval, regulation, and class scheduling of prescription opioid drugs.

National Academies of Science and Engineering Medicine

Photo Source: NASEM

Throughout the 1990s and early-2000s, pain advocates and pharmaceutical companies successfully lobbied the FDA to expand the indications (approved usage) for various high-powered opioid pain relievers that had previously been reserved for major surgeries, injuries, and palliative care. Purdue Pharma, in particular, scored a big win with its groundbreaking product, OxyContin, one of the first high-powered opioids to become commercially successful. What Purdue failed to mention while they were handing out free 30-day trial coupons for doctors to give to patients was that the drug was highly addictive. By the late-1990s, however, it became abundantly clear that these drugs had a high rate of addiction.

The recommendations put forth by NASEM as the FDA to adopt a position they term “opioid exceptionalism,” where “…the FDA thinks about opioid drugs differently from other products, …taking a public health approach to drug approvals and to other decisions about postmarket (sic) surveillance” (Servick, 2017). This would require the FDA to take into account the following:

  • benefits and risks to individual patients, including pain relief, functional improvement, the impact of off-label use, incident opioid use disorder (OUD), respiratory depression, and death;
  • benefits and risks to members of a patient’s household, as well as community health and welfare, such as effects on family well-being, crime, and unemployment;
  • effects on the overall market for legal opioids and, to the extent possible, impacts on illicit opioid markets;
  • risks associated with existing and potential levels of diversion of all prescription opioids;
  • risks associated with the transition to illicit opioids (e.g., heroin), including unsafe routes of administration, injection-related harms (e.g., HIV and hepatitis C virus), and Opioid Use Disorder (OUD); and
  • specific subpopulations or geographic areas that may present distinct benefit-risk profiles (NASEM, 2017b)

These recommendations come on the heels of a June recommendation by the FDA that pharmaceutical company, Endo, voluntarily remove its product, Opana ER, from the market in response to the public health crisis it says is in part because of illicit use of the drug by Injection Drug Users (IDUs) (Mandal, 2017). Endo recently complied with that request, despite insisting that it believes the drug to be safe when used properly (Ramsey, 2017).

Opana ER (Extended Release) is a reformulation of the drug in an effort to stem abuse by patients who were crushing the drug in order to snort it. This reformulation involved coating it with a plastic coating that Endo promised would make it “abuse deterrent/resistant.” Opana abusers, however, were quick to find a way around this by melting down the drug and its the plastic coating, filtering out the plastic through mesh, and injecting the drug directly into their bloodstream, resulting in a more intense effect (McEvers, 2016). Rather than alleviate abuse, Opana ER ended up creating a deadlier epidemic, as users were sharing needles to inject the drug, fostering the spread of both HIV and Hepatitis C (HCV). Once supplies of Opana ER dried up, those users often moved directly to heroin, as it is both cheaper and more readily available.

The NASEM recommendations will no doubt result in outcry from both pain advocates and pharmaceutical companies desperate to retain profits. Should they be adopted, the U.S. may finally be able to break its near-thirty-year abusive relationship with opioid pain killers.

References:

__________

Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

Advertisements

Leave a comment

Filed under Uncategorized

West Virginia’s Rx Crisis

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Over the past two years, HEAL Blog has paid much attention to the prescription opioid and heroin epidemic sweeping America’s suburban and rural areas, particularly in the 13-state Appalachian Mountain region. Nowhere is this truer than in those counties and states where coal mining is the predominant industry. Mining coal can be brutal work, and miners have historically led the pack in terms of health issues. From Black Lung Disease to various types of cancer related to the inhalation of coal dust and exposure to chemicals used by the mining industry, it is a long-standing reality that the hard life coal miners face to make a living will likely result in long-term illness, pain, and/or disability.

Compounding the myriad health issues related to mining coal is how physicians, pain advocates, and pharmaceutical companies have capitalized upon these issues in the pursuit profits. In the late 1990s, prescription opioid painkillers that were once reserved for only the sickest, most desperately hurting patients gained acceptance as an acceptable treatment for even the most minor injuries, and Purdue Pharma, maker of OxyContin, one of the most widely abused prescription opioid drugs, was key in ensuring that their products were made available to as many people as possible, despite knowing (and withholding information about) the highly addictive nature of these pills. Purdue even went so far as to provide physicians with tens-of-thousands of coupons offering free 30-day trials of OxyContin to give their patients. And, with its work- and lifestyle-related injuries causing their patients pain, coal mining regions quickly became a pipeline for overprescribed opioid drugs.

Purdue Pharma logo

Photo Source: Purdue Pharma

Recent investigations and lawsuits in West Virginia have revealed astonishing levels of overprescribing, abuse, and overdoses in the state. Drug shipping sales records from drug companies (which those companies fought to keep confidential) indicate that, between 2007 and 2012, 780,069,272 prescription opioid drugs were shipped into state, amounting to 433 pills for every man, woman, and child in the state of West Virginia (Eyre, 2016a). A single pharmacy in the town of Kermit, WV (population 392) received nearly 9 million hydrocodone pills in a period of two years. In Wyoming County, a mom-and-pop pharmacy in Oceana, WV received 600 times as many oxycodone pills than the corporate Rite Aid pharmacy just eight blocks away. This essentially unfettered flooding of prescription opioids into the state has resulted West Virginia having the top four counties – Wyoming, McDowell, Boone, and Mingo – in the United States for fatal overdoses related to prescription opioid drugs, with two more – Mercer and Raleigh – also in the top ten. Logan, Lincoln, Fayette, and Monroe counties sit in the top twenty counties for opioid-related fatal overdoses.

West Virginia map of opioid overdoses, by county

Photo Source: Gazette-Mail

To make matters worse, state regulations have required wholesale distributors to set up systems to identify “suspicious” orders for highly addictive narcotics, and to report those questionable orders to the state’s pharmacy board, a regulation that drug companies ignored. Between 2001 and June 2012, the pharmacy board received just two reports – both from Cardinal Health; since June 2012, 7,200 reports about suspicious orders have been faxed in to the pharmacy board. This sudden flow of reports only came after former Attorney General Darrell McGraw filed lawsuits against fourteen drug wholesalers. Despite these reports, the pharmacy board did nothing with them, even failing to investigate or forward the reports on to law enforcement authorities (Eyre, 2016b). The state recently reached a $3.5M settlement with drug wholesaler, H.D. Smith Wholesale Drug Company over its role in the problem (Associated Press, 2017).

The state has since made receiving these drugs more difficult, which has led many patients addicted to them to turn to cheaper, more readily available heroin, and as such has resulted in a sharp increase in the number of heroin-related overdoses, deaths, and disease transmissions (primarily Hepatitis B and C). The state’s first syringe exchange programs opened in the Fall of 2015, which will hopefully stem the spread of disease, but they are located only in the state’s major cities. Additionally, treatment facilities for addition are vastly overcrowded, underfunded, and unaffordable for those whose meager resources are already stretched past the point of breaking.

West Virginia continues to be a state to monitor, along with Indiana, Kentucky, Ohio, and Pennsylvania, where opioid addiction can often lead to the rampant spread of blood borne diseases that were once rare in the region. It is difficult to overstate the severity of the epidemic, and HEAL Blog will do its best to report on the situation.

References:

 
__________

Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

1 Comment

Filed under Uncategorized