Purdue Pharma

FDA regulators and Big Pharma executives had been quietly meeting for years regarding "enriched enrollment," a process by which adverse events occurring in clinical trials were expunged from the final published "evidence" of harm to patients before final drug approval.

Dr. Van Zee, Lee County, Virginia

Fentanyl is 25-50 times more potent than heroin.

The opioid "perfect storm"

Dopesick: Dealers, Doctors, and the Drug Company that Addicted America, by Beth Macy, Little, Brown and Company, 2018, 384 pages.In just over 300 pages, Beth Macy, author of Factory Man and Truevine, paints a searing and heartbreaking portrait of the Appalachian victims of the current opioid epidemic in the United States. The depth of the crisis was most recently revealed by the Centers for Disease Control and Prevention, which reported that it took the lives of at least 72,000 people in the US last year. Macy is a career journalist residing in Roanoke, Virginia.. Estimates are that another 300,000 will overdose and die in the next five years. Today in the US, it is vastly easier to become addicted than it is to obtain treatment.The ongoing murderous opioid plague began in rural America with the dispensing of "controlled" narcotic pharmaceuticals by physicians whose practice histories of prescribing excessive pain-relieving medicines were identified and made available via data mining by IMS Health and provided to Purdue Pharma of Delaware, makers of OxyContin and other narcotic analgesics.The author reviews the drug manufacturers' predatory practices in the rural communities of West Virginia, Virginia, Maine, and the rust-belt states of Ohio, Pennsylvania and Indiana, where shuttered factories, mines, and textile mills left a working-class citizenry desperate and vulnerable, with their resulting labor legacy of deep poverty and the physical pain of mine, factory and mill work.The Clinton administration sold NAFTA in 1994 as a "win-win" for US workers, including those employed at the Martinsville, Virginia textile and furniture factories, the pitch being that the capitalists' use of China's cheaper labor platform would result in the advance of US workers through retraining, leading to higher-paying jobs. The stock prices on Wall Street rose with every plant closure, cheered on by corporate CEOs and stockholders.Martinsville and Henry County subsequently saw unemployment rise past 20 percent, food stamp usage triple, and disability claims top 60 percent. The best-off wound up working for low wages at Walmart and eating what and when they could using food stamps and food pantries. By 2016, for every unemployed person in the US between the ages of 22 and 55, another three were not working or had ceased looking for work altogether.Princeton University researchers Ann Case and Angus Deaton told the Washington Post in 2015 that "diseases of despair," suicide and drug consumption, had taken the lives of 500,000 people between 1999 and 2013.Purdue Frederick, founded in 1952 by Mortimer, Raymond, and Arthur Sackler, brothers and psychiatric researchers, generated fortunes in non-prescription laxatives, skin antiseptics, and ear wax removal products in the 1950s and 1960s. After the acquisition of British and Scottish drug firms in the 1970s, the privately held company entered the pain relief sector in 1984 with the end-of-life-care analgesic, MS Contin (the longer-acting and continuous-release form of morphine sulfate). Before the patent expired for MS Contin in the mid-1990s, the product raked in $170 million annually.MS Contin's replacement was Oxycontin, a reformulation of the narcotic analgesic oxycodone, an ingredient extracted from thebaine, a byproduct of the Persian opium poppy. The company marketing arm was Purdue Pharma and resided in Delaware, a prominent corporate tax haven.In late 1995, the FDA approved Oxycontin, which dovetailed nicely with the emergence of the "fifth vital sign," the admonition by government certification boards that physicians, clinics, and hospitals perform pain scale assessments on patients being admitted to their facilities, in addition to the traditional pulse, blood pressure, temperature, and respiratory rate.A Purdue Pharma budget plan at the time stated: "This presents Purdue with the opportunity to provide true value-added services as the 'pain experts' in this key area."Macy writes:It was not until 2013 that a Milwaukee Journal Sentinel reporter discovered that the American Pain Society and the American Academy of Pain Medicine, while campaigning for expanded use of opioids for varied chronic pain conditions, had accepted millions from the narcotics manufacturers.After the Journal Sentinel exposures, Senators Chuck Grassley and Max Baucus conducted investigative hearings targeting Purdue Pharma and the American Pain Foundation. Despite repeated calls for release, the findings remain locked away from the public view.Purdue Pharma sales representatives, with the lists in hand of the most frequent pain medicine prescribers in the devastated ex-mining and mill towns, called upon the doctors with all manner of freebies for the practitioner and even his family members, which included all-expenses-paid vacations to exotic destinations, free shrubbery for landscaping the home, and "Dine and Dash" meal tickets to the best available area eateries while lending an ear to an "Oxy" sales pitch.For gaining sales access to the doctors, attractive reps delivered flowers or holiday turkeys to clinic receptionists. On occasion, physicians even solicited bids from Big Pharma as to desired vacations or items,From 1996 to 2001, sales bonuses for Purdue Pharma reps ballooned from $1 million to $40 million. By 2001, Oxycontin sales hit $1 billion. Big Pharma advertising jumped from $360 million in 1995 to $1.3 billion in 1998.The flood of opioid pills by Big Pharma into Kermit, West Virginia, population 392, was discovered by Eric Eyre of the Charleston Gazette-Mail to have totaled almost 9 million hydrocodone tablets, shipped to a single pharmacy, delivering Mingo County the fourth highest overdose death rate of any county in the US.In 1995, Curtis Wright (who later went on to work for Purdue Pharma), the chief examiner for the Federal Drug Administration's New Drug Application (NDA) evaluating Oxycontin, pointed out that fully 68 percent of the pure narcotic in Oxycontin's 40 mg, 80 mg, and 160 mg tablets was recoverable from the core. When the drug was dissolved in water and injected, clinical trials showed withdrawal symptoms.Dr. Art Van Zee, practicing in St. Charles, in Lee County, Virginia, the second poorest town in the state in the state's poorest county, was one of the first in the US to alert county, state and federal authorities about the opioid invasion of rural America. One of his residency colleagues from a Philadelphia hospital told Macy that Van Zee, an advocate for socialized medicine, was the best doctor in the country. A clergyman's son from Nevada, he'd married a local Virginia woman, an aggressive lawyer and coal miner's daughter who helped him fight against the opioid makers.Van Zee noted that two years after OxyContin's release,, he'd been called out one night to attend an overdosing teenager he'd vaccinated as a baby.Meanwhile, the first 43 overdose victims had died in the region since OxyContin's release. Some people had become addicted quickly, not infrequently with a single two-week or one-month prescription, and had moved on to snorting the crushed tablets or liquifying the core and injecting it with livestock syringes and needles obtained from local feed stores. As the epidemic advanced, Dr. Van Zee and his wife attended more and more victims' funerals, townspeople that he'd known personally and considered friends.People began robbing one another in broad daylight-of lawnmowers, four-wheelers, and other items from the home-one man was even observed pushing a garden tiller down the sidewalk, all to sell for buying Oxys. A man was said to have traded the family mule for four of the tablets. Homes were broken into and medicine cabinets raided of the "leftover" opioids. Cemetery flower vases made of copper were stolen to sell and telephone poles with copper wiring were being chopped down for trade. An 80 mg OxyContin was going for $80. A Roanoke US attorney referred to Oxys as "the crack of Southwest Virginia."As law enforcement filled up the local jails, one of the family's attorneys pointed out, "The irony of it was, the victims were getting jail time instead of the people who caused it."Van Zee organized meetings to educate and alert his neighbors and the area to the developing catastrophe and initiated a petition drive to demand of the FDA they withdraw OxyContin from the market or mandate a modification of the compound to abolish its addictive attributes. In the summer of 2001, the FDA negotiated with Purdue to apply a black box warning, though a company rep contemptuously referred to it as "an exercise in graphic design."Meanwhile, the harder working Purdue field reps found it possible to obtain $100,000 bonuses in a quarter! That same summer, a company spokesman, after meeting with Virginia's state attorney general, said, "Let's be clear. The issue is drug abuse, not the drug."OxyContin was being prescribed widely across the US and had thus become a "staple of suburban teenage 'pharm parties,' or 'pharming,' as the practice of passing random pills around in hats was known."A Palm Coast, Florida woman lost her 18-year-old son to a single crushed 80 mg OxyContin, bought from a friend whose family was trying to earn rent money. An IT worker from Philadelphia received a frantic phone call from his 18-year-old daughter at their working-class neighborhood home, reporting that her brother had collapsed and died from an overdose of an OxyContin, which the father had not even heard of.A woman from Folsom, California managed to get in touch with Van Zee, and reported that her 24-year-old son had died from the ingestion of a single OxyContin at a Fourth of July party. She asked the Lee County, Virginia doctor, "How the hell had such a strong drug come on the market to begin with?" Back in the mining area of Grundy, Virginia, a dislocated miner told the author OxyContin "became my god."An ambitious federal prosecutor in Roanoke, Virginia hired a team of data-collecting attorneys, and having gathered a mountain of evidence against Purdue Pharma regarding the OxyContin crimes in Appalachia, sued the company for damages.A settlement was reached whereby Purdue Frederick, the holding company, would pay $600 million in damages while three Purdue Pharma executives would receive misdemeanor wrist slaps for mislabeling and misrepresenting OxyContin's addictive risks. The parents of dozens of dead children and families of overdosed workers pleaded with the judge that July day in 2007 for jail time for the company chiefs, to no avail. The executives were fined $34.5 million, which the company paid for them. The judge added on some community service time.The Sackler brothers were not present for the courthouse settlement.Contrary to Purdue Pharma's claims of the addiction rate of the opioid to be less than one half of 1 percent, rIt might be impossible to say exactly what date the high-grade heroin began arriving in Appalachia, and its relative, fentanyl. But when it did, it came cheaply and in another opiate flood. Fully four out of five people who abused these substances had been on an oral opioid, either prescribed, bought illegally, stolen or taken at a "pill bowl" party.Diacetylmorphine, or heroin, is two times more potent than morphine, and morphine is 10 times more potent than opium.As the author points out, once the heroin hook captures the brain, nothing else matters to the user but his or her continuing and frequent relationship to the molecule and, above all, to avert and avoid dopesickness, the horrific drug withdrawal symptoms.The profit margins for heroin are approximately 600 percent, and some of it sold in Virginia has been at 90 percent purity, quickly addicting its users and greatly adding to the risk of overdosing. A teenage boy who fatally overdosed on heroin had admitted to his mother that he had attended a high school party in 2006 and smoked marijuana laced with heroin. Users often as not become sellers to finance their continued use.In the olden days of heroin use, the drug potency was said to be 3 to 7 percent. Contemporary grade heroin is closer to 40-60 percent. In 2012, for every fatal overdose, there were another 130 opioid users.Macy describes "the real perfect storm fueling the opioid epidemic had been the collapse of work, followed by the rise in disability and its parallel, pernicious twin: the flood of painkillers pushed by rapacious pharma companies and regulators who approved one opioid after another."The injuries and tragedies to the families left behind of the destroyed opioid victims are almost unbearable to read about in this very important book. This reviewer wept in going through the volume twice in preparing this review, most especially in regard to the violence and deaths visited upon the young people.For every 10 addicted persons in the US, there is one bed available for admission to treatment and rehabilitation. It is unaffordable for all but the wealthiest members of this society. Only one-third of the available places use Maintenance Assistant Treatment, or MAT, the only method scientifically proven to dramatically reduce overdosing deaths and lessen the return to reusing heroin after treatment.As Nora Volkow, director of the National Institute on Drug Abuse (NIDA) of the NIH, told the author of Dopesick: "To be clear, the evidence supports long-term maintenance with these medicines in the context of behavioral treatment and recovery support, not short-term detoxification programs aimed at abstinence. All studies-every single one of them - show superior outcomes when patients are treated" with maintenance medications such as buprenorphine or methadone. "That is so much safer for them than going back to heroin."This very important book documenting the criminal and deadly practices of Big Pharma is highly recommended.