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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