Associate Professor of History, University of Buffalo
Purdue Pharma, the company that makes OxyContin and other potentially addicting prescription opioids, has agreed to plead guilty to three counts and reached a settlement potentially worth at least $ 83 billion with the Ministry of Justice
The deal could pave the way for Purdue to move from a private for-profit corporation to a public trust serving the public good, as the company has proposed
But the settlement is up for approval by the federal judge handling Purdue’s bankruptcy case, and it may not resolve the thousands of lawsuits that Purdue faces for his role in creating the opioid crisis Notably, 25 state attorneys general called on the government a week before the Justice Department announced the deal to simply force the drugmaker to sell to a new owner instead.
I study the history of prescription drugs (and have served as a paid consultant and expert witness in opioid litigation) Although there have been recent efforts to create drug manufacturers nonprofit to help make certain pharmaceuticals more readily available, I know of no historical precedent for a large drugmaker like Purdue to become a nonprofit public health provider
But two equally ambitious efforts to create alternatives to the profit-driven pharmaceutical model during and immediately after World War II suggest the potential limits to the effectiveness of this arrangement.
Penicillin was discovered in 1928 but was only used during World War II It was the first antibiotic: a truly revolutionary class of drugs that defeated previously incurable infectious diseases
Because of the importance of penicillin to the war effort, the federal government played an active role in its development Federal scientists have devised ways to mass-produce it, federal agencies have persuaded pharmaceutical companies reluctant to manufacture it and the government’s ‘penicillin czar’ decided which patients would receive the precious drug
Despite the high stakes and faith in centralized planning, no one at that time seems to have even considered the possibility of developing antibiotics for non-commercial or non-profit purposes
As was the case with war goods such as rubber and tanks, private companies with federal contracts manufactured penicillin As was also the case with other war goods, the arrangement was unqualified success He dramatically increased production and allocated the antibiotic in such a way as to best serve the war effort
For penicillin, as with other products, federal economic controls quickly disappeared after the war As medical historian Scott Podolsky observed, drugmakers, freed from government restrictions, unleashed an avalanche brand-name antibiotics whose high-powered marketing campaigns have encouraged the overuse and misuse of new drugs
Interestingly, the Sackler brothers got their start selling antibiotics The Sacklers, future owners of Purdue Pharma, were medical advertising pioneers who ditched previous restrictions and advised their sales reps to consider doctors like « prey »
The Veterans Administration and Public Health Department have sought to keep their hands on the wheel by undertaking massive studies on the new, even more potent antibiotic streptomycin to determine how best to use the drug. drug against one of mankind’s deadliest microbial enemies, tuberculosis But their calls for precision and restraint stood little chance against drug marketers who skillfully exploited Americans’ desire for miracles.
The second precedent concerned the semi-synthetic opioid Metopon, discovered during World War II by pharmacologists working for the US National Research Council
Since the 1920s, opioids were much more regulated than other pharmaceuticals to protect consumers As I explain in my new book « White Market Drugs », they could only be sold by a licensed pharmacist on prescription from a doctor For decades, the Federal Bureau of Narcotic Drugs, together with pharmacologists from the National Research Council, has imposed strict restrictions on the development and marketing of new opioids
These government agencies have struggled daily to identify and thwart what they saw as dangerous hype from pharmaceutical companies pushing the latest miracle opioid
So, daringly, in 1946 the two agencies hatched a radical idea: they would patent Metopon and market it themselves Instead of trying to make maximum profit, they would only serve public health They Wouldn’t Advertise Metopon at All Instead, Doctors would Find Out from Sober, Informative Statements from Medical Journal Experts In addition, sales would initially be limited to patients with terminal cancer
The government believed that Metopon would win out over its competition not because of the hype but because it was actually superior But it didn’t work out that way
Sales were slow after the launch of Metopon in 1947 and remained low even after authorities cleared sales for more types of pain Even Harry Anslinger, head of the Federal Bureau of Narcotics and otherwise fierce critic of pharmaceutical opioid advertising, complained about lackluster marketing Although it remained technically available, Metopon has never gained more than a fraction of a minute from the US opioid market
Purdue’s proposed transformation differs from earlier attempts to find alternatives to the profit-driven drug distribution model
Rather than trying to get for-profit companies to do the right thing, or hope that a single ethically marketed drug could win, the Purdue regulation would legally oblige a major manufacturer pharmaceuticals to make public health a higher priority than shareholder profits
First, by legally defining the company’s obligations to public health rather than to shareholders, it would eliminate the types of abuse that can result from the pursuit of profit, such as marketing that encourages unnecessary or inappropriate use.
Second, by providing drug addiction treatment free of charge, it would increase access to health care for the types of patients – dependent, poor, and lacking adequate health insurance – generally underserved or even ignored in the system. current
In other respects, however, the Purdue settlement appears to deviate less from standard operating procedures than the 1940s attempts to reduce or eliminate the influence of profit in pharmaceuticals.
By all accounts, the new trust would be a for-profit entity.Indeed, profits from continued sales of pain medications like OxyContin and addiction treatment medications like buprenorphine and naloxone – estimated by Purdue at $ 8 billion per year – are crucial because the « payment » proposed by Purdue to offset the company’s share of the costs of the opioid crisis
In other words, to accomplish its mission, the new Purdue would have to pursue profits just like the old Purdue And since all pharmaceutical companies officially declare themselves to be in the service of the public good, how bad would that be? really different?
Then the new trust would still be Purdue Pharma, a company with a strong culture of maximizing sales and profits even as the opioid crisis escalated It could be credibly argued that Purdue’s innovation – the « value » she brought to the table – was not linked to any particular therapeutic advance in the drugs she developed, but rather resided in her genius for commercializing these products
I can see why it is tempting to be excited about the prospect of a new public trust devoted to tackling addiction
But for this proposed arrangement to make sense, Purdue would need the tools and expertise to pursue a mission radically different from what it was designed for. And history doesn’t offer much assurance that isolated public sector, not-for-profit drugmakers can make a big difference in a pharmaceutical system designed and fueled by profit.
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Purdue Pharma, Opioid, Oxycodone, US Department of Justice
World News – UA – OxyContin maker Purdue Pharma May Settle Legal Claims With a new « public trust » which would always be dedicated to profit
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