Sunday, December 17, 2017

Opioids: How Many People Must a Pharmaceutical Company Kill Before It Becomes a Crime?

If an individual were to tell a lie and because of that act a person was to die, that individual would be considered to have committed a vile transgression and could be legally responsible for that death.  If a pharmaceutical company tells a lie to gain profit and tens of thousands of people die because of it, the drug company will likely be viewed as a successful business and stock prices will rise.  Any legal responsibility will merely consist of donating a few percent of its profits to the government as a fine.

The opioid epidemic that has engulfed the nation was the result of lies told by pharmaceutical companies.  Their behavior has been compared to that of the tobacco companies who misled the public for years about the known dangers associated with smoking.  The tobacco companies were eventually convinced to admit guilt and at least pay a severe financial penalty for their sins.  Mike Moore who was Mississippi’s attorney general at the time provides some insight into the process.  When the CEOs of the tobacco firms were asked what they wanted out of the settlement, they replied with this quote:

“We want to be able to go to cocktail parties and not have people come up and ask us why we are killing people.”

The producers of opioid drugs will not change their ways until the vilification of the companies and their executives reaches the level attained by the tobacco companies and their executives.

Let the vilification process begin.
The quote provided by Mike Moore was taken from an article in The New Yorker by Patrick Radden Keefe.  It was titled Empire of Pain in the paper version and re-titled online as The Family That Built an Empire of Pain.  The family in question is that of the Sacklers.  That name is better known for its public philanthropy than its family business, Purdue Pharma.

“The Brooklyn-born brothers Arthur, Mortimer, and Raymond Sackler, all physicians, donated lavishly during their lifetimes to an astounding range of institutions, many of which today bear the family name: the Sackler Gallery, in Washington; the Sackler Museum, at Harvard; the Sackler Center for Arts Education, at the Guggenheim; the Sackler Wing at the Louvre; and Sackler institutes and facilities at Columbia, Oxford, and a dozen other universities. The Sacklers have endowed professorships and underwritten medical research. The art scholar Thomas Lawton once likened the eldest brother, Arthur, to ‘a modern Medici’.”

What Keefe would prefer is that the Sacklers be remembered for their creation of the mass market for addictive opioids.

“The Sackler family’s ruthless promotion of opioids generated billions of dollars—and millions of addicts.”

There was a time not too long ago when doctors did not prescribe strong opioids except for painful terminal illnesses or for brief relief after an operation or other severe trauma.  It was believed that the danger of addiction was too high for regular use.  The opioid drugs had a definite medical value, but in such limited use the opportunity for profit was small.  Purdue developed a product called OxyContin which had oxycodone as the active ingredient.  Oxycodone is said to be twice as powerful as morphine.

“Oxycodone, which was inexpensive to produce, was already used in other drugs, such as Percodan (in which it is blended with aspirin) and Percocet (in which it is blended with Tylenol). Purdue developed a pill of pure oxycodone, with a time-release formula similar to that of MS Contin. The company decided to produce doses as low as ten milligrams, but also jumbo pills—eighty milligrams and a hundred and sixty milligrams—whose potency far exceeded that of any prescription opioid on the market. As Barry Meier writes, in ‘Pain Killer,’ ‘In terms of narcotic firepower, OxyContin was a nuclear weapon’.”

In order to make a lot of money from OxyContin Purdue had to counter the fear that opioids were highly addictive.  This they did by marketing their highly potent pills with the claim that the time release presentation virtually eliminated any concerns about addiction.  The claim was made that one pill every twelve hours would safely relieve pain, and therefore the pills could be used for almost any situation in which pain is an issue.  This would open up usage for relatively minor but chronic applications like arthritis, back pain and so on.

“The F.D.A. approved OxyContin in 1995, for use in treating moderate to severe pain. Purdue had conducted no clinical studies on how addictive or prone to abuse the drug might be. But the F.D.A., in an unusual step, approved a package insert for OxyContin which announced that the drug was safer than rival painkillers, because the patented delayed-absorption mechanism ‘is believed to reduce the abuse liability’.”

“The F.D.A. examiner who oversaw the process, Dr. Curtis Wright, left the agency shortly afterward. Within two years, he had taken a job at Purdue.”

Purdue’s first lie was to claim, without any evidence, that the addiction rate for OxyContin users was less than one percent.

“In 1999, a Purdue-funded study of patients who used OxyContin for headaches found that the addiction rate was thirteen per cent.”

The second lie was the claim that the time release format could provide 12 hours of pain relief, which if true would be a valuable marketing aid.

“But internal Purdue documents, which have emerged through litigation, show that even before the company received F.D.A. approval it was aware that not all patients who took OxyContin were achieving twelve-hour relief. A recent exposé by the Los Angeles Times revealed that the first patients to use OxyContin, in a study conducted by Purdue, were ninety women recovering from surgery in Puerto Rico. Roughly half the women required more medication before the twelve-hour mark. The study was never published. For Purdue, the business reason for obscuring such results was clear: the claim of twelve-hour relief was an invaluable marketing tool. But prescribing a pill on a twelve-hour schedule when, for many patients, it works for only eight is a recipe for withdrawal, addiction, and abuse. Notwithstanding Purdue’s claims, many people who were not drug abusers—and who took OxyContin exactly as their doctors instructed—began experiencing withdrawal symptoms between doses.”

When doctors began complaining that patients who took their medicine exactly as directed were coming in complaining of withdrawal symptoms (“itching, nausea, and the shakes”), Purdue came up with another lie.  They responded by utilizing a concept called “pseudo-addiction.”  The explanation for the patients’ response was not that the pills weren’t working as advertized, but that the dosage was not large enough.  The response to signs of addiction was to prescribe more OxyContin.

“As a pain-management pamphlet distributed by Purdue explained, pseudo-addiction ‘seems similar to addiction, but is due to unrelieved pain.’ The pamphlet continued, ‘Misunderstanding of this phenomenon may lead the clinician to inappropriately stigmatize the patient with the label “addict.”’ Pseudo-addiction generally stopped once the pain was relieved—‘often through an increase in opioid dose’.”

Long-term use of opioids such as OxyContin was a disaster in the making.  The very nature of opioids was such that the body would gradually develop a tolerance and more would be needed to produce the same effect.  That might be a negative in terms of health outcomes, but it is the ideal situation for a drug company: a pill for a chronic condition that provides no cure, and leads to a need for ever more pills as time goes on.

“David Juurlink, the Toronto doctor, told me that opioids are problematic even for users who don’t succumb to addiction. ‘Opioids really do afford pain relief—initially,’ he said. ‘But that relief tends to diminish over time. That’s, in part, why people increase the dose. They are chasing pain relief from a drug that has failed. I see all these people who are convinced they are one of the “legitimate” pain patients. They’re on a massive dose of opioids, and they’re telling me they need this medication, which is clearly doing them harm. For many of them, the primary benefit of therapy, at this point, is not going into withdrawal.”

Providing pills containing so much of an opioid was an open invitation for abuse.  Purdue even explained how the abuse might be accomplished in its packaging material.

“Almost immediately after OxyContin’s release, there were signs that people were abusing it in rural areas like Maine and Appalachia. If you ground the pills up and snorted them, or dissolved them in liquid and injected them, you could override the time-release mechanism and deliver a huge narcotic payload all at once. Perversely, users could learn about such methods by reading a warning label that came with each prescription, which said, ‘Taking broken, chewed or crushed OxyContin tablets could lead to the rapid release and absorption of a potentially toxic dose’.”

Purdue was aware that its pills were being used in ways that were illegal.

“For years, it had maintained a contract with I.M.S., a little-known company, co-founded by Arthur Sackler, that furnished its clients with fine-grained information about the prescribing habits of individual doctors. Purdue’s sales representatives used the data to figure out which doctors to target.”

“Purdue, using I.M.S. data….targeted populations that were susceptible to its product. Mitchel Denham, the Kentucky lawyer, told me that Purdue pinpointed ‘communities where there is a lot of poverty and a lack of education and opportunity,’ adding, ‘They were looking at numbers that showed these people have work-related injuries, they go to the doctor more often, they get treatment for pain’.”

Purdue had the information to identify where doctors were overprescribing opioids, but claimed it was not their job to assess “how well a physician practices medicine.” 

“But overprescribing generated tremendous revenue for the company. According to four people I spoke with, at Purdue such prescribers were given a name that Las Vegas casinos reserve for their most prized gamblers: whales.”

Purdue has continuously fought against any move to restrict access to its drug, using arguments lifted from the NRA on why guns are safe: it is people who are not safe.

“Confronted with the prospect of modest, commonsense measures that might in any way impinge on the prescribing of painkillers, Purdue and its various allies have responded with alarm, suggesting that such steps will deny law-abiding pain patients access to medicine they desperately need. Mark Sullivan, a psychiatrist at the University of Washington, distilled the argument of Purdue: ‘Our product isn’t dangerous—it’s people who are dangerous’.”

Purdue has been taken to court over its methods many times and has admitted guilt.

“In 2006, Purdue settled with Hanly’s clients, for seventy-five million dollars. Shortly afterward, the company pleaded guilty, in a case brought by federal prosecutors in Virginia, to criminal charges of misbranding, and acknowledged that Purdue had marketed OxyContin ‘with the intent to defraud or mislead.’ (Rudolph Giuliani had tried, on Purdue’s behalf, to get the lead prosecutor to scuttle the case.) Michael Friedman, the executive vice-president, pleaded guilty to a criminal misdemeanor, as did Howard Udell and the company’s chief medical officer, Paul Goldenheim.”

“They all received probation, and were ordered, collectively, to pay nearly thirty-five million dollars in fines. Purdue agreed to pay an additional six hundred million. Given the billions of dollars that the Sacklers and Purdue had reaped from OxyContin, some observers felt that the company had got off easy. Arlen Specter, the Republican senator from Pennsylvania, remarked that such fines amounted to ‘expensive licenses for criminal misconduct’.”

Purdue has claimed all along that its only goal was to insure that the supply of opioids for people who were in pain not be restricted.  Its executives were the good guys.  But the increased awareness of its role in the opioid epidemic has not changed company policy for the better. 

In 2010, Purdue reformulated its pill so that when anyone tried to grind it up the result was not usable powder, but a “gummy substance.”  This was a move to limit abuse, but it was also a move to maintain a patent and to eliminate competition from generic drugs.  The new formulation was considered patentable and gained FDA approval, with the FDA lauding it for its “abuse deterrent” properties.

“Purdue had long denied that the original OxyContin was especially prone to abuse. But, upon receiving its patents for the reformulated drug, the company filed papers with the F.D.A., asking the agency to refuse to accept generic versions of the original formulation—because they were unsafe. The F.D.A., ever obliging, agreed, blocking any low-cost generic competition for Purdue. For more than a year, Purdue continued to sell the original formulation of OxyContin in Canada. According to a recent study, OxyContin sales in Windsor, Ontario—just across the border from Detroit—suddenly quadrupled, a clear indication that the pills were being purchased for the U.S. black market.”

The number of prescriptions for OxyContin diminished when the new formulation became available, but it can still be abused.  All one has to do is swallow the pills.  Ever looking for new customers, Purdue sought and received approval from the worthless FDA to market its pill to children as young as eleven years of age.  Continuing the analogy with the tobacco industry, as its domestic business slumped, it chose to spread the opioid epidemic worldwide.

“As OxyContin spread outside the U.S., the pattern of dysfunction repeated itself: to map the geographic distribution of the drug was also to map a rash of addiction, abuse, and death. But the Sackler family has only increased its efforts abroad, and is now pushing the drug, through a Purdue-related company called Mundipharma, into Asia, Latin America, and the Middle East.”

“In May, several members of Congress wrote to the World Health Organization, urging it to help stop the spread of OxyContin, and mentioning the Sackler family by name. “The international health community has a rare opportunity to see the future,” they wrote. “Do not allow Purdue to walk away from the tragedy they have inflicted on countless American families simply to find new markets and new victims elsewhere.” David Kessler, the former F.D.A. commissioner, believes that the destigmatization of opioids in the U.S. represents one of the ‘great mistakes’ of modern medicine.”

The nation seems completely incapable of putting corporate criminals in jail.  What then is our option?  Recall the comment from Mike Moore about tobacco executives tiring of being asked why they continue to kill people.  How often does the Sackler family get confronted with such a question?  How often do people assemble in front of a Sackler philanthropy and announce their displeasure that a family of mass murderers is being honored by its existence.  If the Sacklers can’t be imprisoned, their lives can at least be made uncomfortable.  Moore seems to believe this approach might work again.

“Moore feels that the Sackler family, as the initial author and a prime beneficiary of the epidemic, should be publicly shamed. “I don’t call it Purdue. I call it the Sackler Company,” he said. ‘They are the main culprit. They duped the F.D.A., saying it lasted twelve hours. They lied about the addictive properties. And they did all this to grow the opioid market, to make it O.K. to jump in the water. Then some of these other companies, they saw that the water was warm, and they said, “O.K., we can jump in, too.”  There may be significant legal distinctions between a tobacco company and an opioid producer, but to Moore the ethical parallel is unmistakable: ‘They’re both profiting by killing people’.”

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