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Create a blockbuster of prescription drugs and create an epidemic of prescription drugs start the same way: with a pill
It's only with the first pill that one can create the appetite for another. For one in 48 people prescribing a powerful opioid drug, one study concluded.
Prepare enough pills, give enough, persuade enough doctors to write enough prescriptions, and for some, brain chemistry diverted from desire
Doctors did not know for years that Purdue Pharma was lying about the risk of OxyContin addiction, let alone understood the role of OxyContin marketing in changing the way they treat the pain of their patients
. the nation's appetite for narcotics, the rewrite of the rules on the risk of drug addiction and the beginning of an era of drug addicts. More than just successful sales, it is this fundamental thinking change that is the legacy of OxyContin.
Purdue was not the only pharmaceutical company to conduct a campaign to ensure that doctors prescribe opioids.
The company announced last year that it would stop marketing OxyContin to doctors.
As for his early actions, "Purdue accepted responsibility for the actions of some of his employees more than 15 years ago, A spokesman told the Palm Beach Post
" Since then, we have led the industry to develop drugs with dissuasive properties, advocated the use of drug monitoring programs, and collaborated with law enforcement to expand the use of naloxone, "An antidote to overdose."
The company downplays the role of OxyContin in the prescription opioid crisis, saying that OxyContin has never had more than one However, as Purdue promoted the use of all opioids to make OxyContin widely acceptable, sales of all prescription opioid analgesics increased.
] Just as the appetite
.] The works Long Island construction urge Rory Singer received her first pill after an employment injury. Sam Deford, a student at the climbing school, was operated on the shoulder. Robbie Hrinuk was studying international trade and finance in Louisiana when he tried OxyContin.
They would not survive it.
They would break the law to get drugs. They risked losing the trust of their families.
When OxyContin and Oxycodone dried up, they turned to heroin.
The addiction is over for all in Palm Beach County, in different ways and in different places:, a sober house, alone in their bedroom
But for all, the addiction that has costed life had started in the same way – with a first pill.
'Exit from here & # 39;
Like most Doctors in the mid-1990s, Dr. Michael Kilkenny was not crazy about prescribing narcotics for something short of cancer and end-of-life pain.
Despite his reservations, perhaps it was inevitable that Purdue Pharma OxyContin
Kilkenny then practice Huntington, West Virginia, a city straddling two counties known for their steel mills and coal mines. Purdue marketed its new drug for people with common injuries related to work, logging and mining: chronic back pain, slow work-to-cure injuries.
Cities all along the Appalachian ridge sales force targeted.
Kilkenny did not buy. "I actually ran Purdue Pharma representatives from my office when they came to tell me," Oh, you should use OxyContin for osteoarthritis. "
" I (have been) trained (that) you do not use it for those
Kilkenny would change his prescribing practices, as well as hundreds of thousands of other doctors.
The oxycodone
the active ingredient of OxyContin, was available in Europe as early as 1917 – it was supposed to be a favorite of Hitler – and has been in the United States since the end of 1930s.
Mixed with aspirin or acetaminophen, it is sold as Percocet or Percodan, among other brands
. mind. OxyContin was not mixed with any other medicine. It was pure oxycodone.
When addicts oxycodone in Appalachia later dubbed OxyContin "hillbilly heroin", they were not far from the mark.
Oxycodone is derived from the same poppy plant that produces opium for morphine, the basis for
The 1996 release of OxyContin marked the first time that the FDA had approved a concentration so powerful of oxycodone.
A single 40 milligram OxyContin is the equivalent of 16 Percocet tablets. However, Purdue successfully argued that the 12-hour formula of OxyContin would not produce an euphoric "buzz".
Instead, the drug would be released gradually for half a day
. People who suffer would no longer have to watch the clock, counting every three or four hours before they can take another dose of a shorter acting pain reliever. For 12 hours at a time, they could return to their lives. They could sleep all night
It was the linchpin of the call of OxyContin
Roadmap for a rush
Purdue taught his sales force, and through them, the doctors, that there were fewer "peaks and valleys" in the oxycodone levels in patients taking OxyContin.
Fewer highs and lows mean less euphoria and less "comedowns".
This is a crucial point. The addictive potential of a drug is directly related to how fast it gets to your brain – the rush of euphoria.
For example, heroin is derived from morphine. Both can create a feeling of euphoria. Both are addictive. But heroin reaches the brain faster, producing a rush that morphine does not. This is why heroin, and not morphine, is most often trafficked by drug cartels.
Because OxyContin has been released gradually over time, patients would not want the drug for a euphoric run. They would not need more of the drugs to avoid the discomfort of physical withdrawal as the drug goes off – something that can happen in people who are not addicted to a drug.
A Purdue card seemed to prove the case. The graph showed the release of the drug over 12 hours as a smooth line, with some ups and downs.
However, the Purdue map used a method that tended to smooth out the ups and downs. Patients taking OxyContin had a potent shake, almost 40% of the drug in the space of an hour or two.
Just as critical, rather than gently eliminating, OxyContin dissipated rapidly in a few cases in less than eight hours
. The euphoric effect associated with unexpected relief of short-term pain – and the discomfort of physical withdrawal – could lead patients to ask, and doctors to prescribe, more and more of this highly addictive drug
. The marketing material dating back to the 1990s shows that the company knew that there could be a "revolutionary" pain and had a strategy to deal with it: More oxycodone.
19659002] In 2001, the company estimated that 20% of all OxyContin prescriptions – 351,000 – were written for doses to be taken every eight hours, not every 12 hours, at that time. – Richard Blumenthal, Attorney General of Connecticut
Purdue categorically denied that frequent dosing is related to addiction or death.
Yet Purdue understood the consequences, Blumenthal said in 2004, citing an internal presentation. He pointed out that a dose of OxyContin every eight hours was risking more euphoric highs.
That year, Blumenthal asked the FDA to warn the doctors of the problem and relabel OxyContin with a warning about the 12-hour problem. years later, the FDA responded: Patients have varied in their need to relieve pain. The agency was not convinced that the statistics compiled by Blumenthal showed a link between frequent dosing and death. Physicians, not the FDA, were in the best position to decide whether to prescribe OxyContin more often than every 12 hours would lead to addiction.
There would be no letter or warning.
FDA doctor oversees OxyContin approval, Dr. Curtis Wright would take a job at Purdue the year following his departure from the FDA, but not until the agency failed. approves the sale and marketing of OxyContin as a 12 hour narcotic.
Purdue could use his now controversial painting. marketed to doctors. The sales forces of the company would be encouraged to establish their own misleading charts.
Years later, the FDA will say that she had no idea that the label of OxyContin that she had left on would lead anyone to crush it. then sniff or inject the drug.
A nun in a small coal town in Virginia knew it almost immediately.
Pain in Pennington Gap
Now 80, Sister Beth Davis had moved to Pennington Gap to help coal miners. It took the deeply conservative community years to trust a New York nun, but decades of fighting on their behalf had made the mid-1990s one of the city's most recognized faces of lesser numbers. of 2,000 people. For drug addicts who were looking for help, she was also one of the most trustworthy.
A recovering alcoholic, Davis co-founded the city's Addiction Education Center. It was an ambitious name for any office furnished with chairs and a desk given.
But Davis was perfectly positioned to see the first effects of OxyContin training.
Pennington Gap is widely regarded as one of the first places Purdue
Like Huntington, there were many people who were suffering: loggers and coal miners injured at work
soon, there also had OxyContin addicts.
Months after the release of OxyContin in 1996, Davis remembers that people started coming to the treatment center hooked on a new drug
Perplexed, she called the local pharmacist.
"And he said to me, 'Mark my words. It will be the worst disaster ever to hit Lee County. He said, "They market this product as non-addictive, and it will be one of the most addictive drugs we have on the market.
"
Others shared the concerns of the pharmacist.
Long before OxyContin reached pharmacies, Purdue's focus groups revealed that family physicians, surgeons, and arthritis specialists were reluctant to go to pharmacies. idea. However, Purdue knew that if doctors focused on prescribing OxyContin to cancer patients or end-of-life pain – traditional uses of opioids – sales would suffer
. Arthur Sackler, whose brothers Mortimer and Raymond bought the drug company in 1952, was a pioneer in the art of pills marketing. It is valued at $ 100 million, earning him a place in the Medical Advertising Hall of Fame.
In 1996, Purdue launched what the DEA described as the most aggressive campaign for an opioid in the history of the United States. Patients could get their first pills for free: Purdue distributed approximately 34,000 "starter" coupons allowing patients to obtain a bottle without OxyContin.
Sellers distribute swag for doctors: OxyContin fishing hats, plush stuffed toys, coffee mugs with heat-activated messages, compact discs, luggage tags and brand pencils "OxyContin – One step in the right direction. "
They were marketed to doctors but also to nurses, pharmacists, hospitals, hospitals and nursing homes.
The message: Opioids like OxyContin would allow older people with arthritis to dance again. The most important, says Purdue to doctors and nurses, is that OxyContin will almost never result in addiction.
Used by patients in real pain, the risks of addiction were ridiculously low, say the salespeople.
For the most part, only drug addicts have developed an addiction. Why does a doctor refuse to relieve a suffering patient?
Pseudo-addiction
The epidemiologist from South Florida, James Hall, recalls being surprised the first time that he heard the addiction of J. David Haddox [19659002drugaddictionincludespeoplewhoareclamoringformorepillswhoareindesperateneedofmedicationorwhoareusingadoctortogetmoredrugsthananydoctorwantstoprescribe
Haddox, doctor and dentist specialized in pain care, seen differently. People desperate for painkillers, patients willing to lie to doctors to get more addictive opioids, patients who hoard pills and who ask for more are just as likely to suffer from pseudo-addiction, says Haddox, who invented the term. for pseudo-dependence: give more drug to the addict patient.
Hall, a nationally recognized expert on drug abuse, had a devil's advocate question for Haddox: Was nicotine also a pseudo-addiction? Or was it real?
Haddox stuck to his weapons, Hall said, rejecting decades of science on the subject: Much of what was labeled cigarette addiction, Haddox said, was really a false addiction.
Haddox would continue to become vice president of Purdue's health policy, urging the "new science" of pseudo-addiction and admonishing health professionals who clung to the notion that opioids were really addictive.
The pseudo-addiction was then repudiated by former defenders. The CDC rejected the concept
But the pseudo-addiction continues to live, in 1800 Google Scholar quotes.
The Portenoy Crusade
Viewers of "Good Morning America" at the end of the summer of 2010 would see one of the best experts on pain: Dr. Russell Portenoy
That day, Portenoy assured both the host and the public that the addiction is "dramatically unusual" in people taking opioids for pain relief
. He added that "most doctors can rest assured that this person will not become addicted."
If the doctors felt certain, it was partly because Portenoy had led the charge for s & # 39; make sure they do it.
Portenoy is an international figure in pain medicine: founding president of the Department of Pain Medicine at Mount Sinai Beth Israel Medical Center and longtime advocate for pain relief outsourced
Portenoy n & # It was not only in favor of Purdue. OxyContin. He advocated a broader prescription of all opioids.
But he was the most prominent consultant of Purdue, the most prestigious and most frequent expert when reporters questioned the safety of OxyContin.
It Would Be Hard to Overdo the Influence of Purdue Medical Consultants
In a late evening ABC news segment in 1998, both Portenoy and Haddox were featured in an article about the how doctors did not do enough to treat pain. Haddox represented the American Academy of Pain Medicine. Portenoy represented the American Pain Society. The associations would receive hundreds of thousands of dollars from the company.
On a 2006 segment "CBS 60 Minutes", Portenoy told the host Morley Safer that some patients could take "In fact, Portenoy was advocating as early as 1996 the merits of opioids for people suffering from chronic pain on "Good Morning America".
Wrapping the coin, the popular medical expert of the television network, Dr. Tim Johnson, acknowledged a risk of addiction and advised caution. But, he told the millions of GMA viewers, the new sustained release opioids were particularly promising: "We believe that the new, extended-release forms of these pills prevent euphoria and hypersomnia . "
name the new pills. He did not have to do it. Just a new extended-release opioid for moderate pain came to the market this year: OxyContin.
And the study used to calm fears of addiction OxyContin did not exist.
Trickle-down science
In 1980, the New England Journal of Medicine issued a five-sentence letter, a paragraph to the editor
Known as the Porter-Jick letter, the Blurb has become the springboard for the upcoming wave of OxyContin marketing. Often cited as a comprehensive study by Purdue and others, the authors of the letter discovered that in a hospital, less than 1% of patients taking narcotics became addicted.
This paragraph was based on people sick enough to be hospitalized with opioids.
This did not have much to do with marketing that would determine the success or failure of OxyContin: prescriptions for people with moderate pain taking a dependence drug for long periods.
material. The paragraph took on an exaggerated and misleading importance, infiltrating into professional guidelines, regulatory oversight, the press and, most importantly, physician's offices
"I am basically mortified that this letter to the US is the only one of its kind. The publisher was used as an excuse to do what these pharmaceutical companies did, "said co-author Hershel Jick at the Associated Press in May 2017." They used this letter to spread the word that these drugs were not very addictive. "
Thirty-seven years later, the same medical journal published another letter, this one from Canadian researchers. They found that in more than 400 medical articles, Porter-Jick's letter had been "largely and uncritically cited as evidence that drug addiction was rare" in a long-term therapy, a model that had shaped the drug. opinion of doctors on the prescription. almost certainly benefited. The number of medical articles citing the letter and its "evidence" of low risk drug addiction spurred the year of the discovery of OxyContin,
Behind the "fifth vital sign"
In 1995, the year OxyContin was approved for sale, the American Pain Society Nonprofit has formally advocated that pain be treated as a fifth vital sign. Behind the scenes, Purdue had partnered with APS on the "5th Vital Sign" initiative, the company later wrote, noting that this had been a marketing success.
Doctors, nurses, hospitals and any other person treating patients for any illness, colds, heart disease, skin infections – should systematically assess the pain, as well as the other four vital signs: blood pressure, pulse, temperature and breathing.
Shortly after, the company and the American Academy of Pain Medicine issued a joint statement on doctors to aggressively treat pain.
Haddox, the doctor who defended the idea of pseudo-addiction, co-wrote the statement. He was a paid consultant to Purdue at the time, according to court records
Portenoy, Purdue's consultant, was on the guidelines committee for both medical associations. He was the only consultant listed in their joint statement
The statements described every argument that Purdue's sales force would make for years to come. The doctors misunderstood the pain. People were suffering unnecessarily. Opioids were safe and not addictive
In most cases, only addicts were at risk of drug abuse.
Doctors risked punishment
The joint statement echoed. His main points have been incorporated into the new prescription guidelines issued by the Federation of State Medical Councils.
Far from being punished for over-prescribing an addictive drug, the federation finally suggested that doctors who do not aggressively treat patients' pain could be punished
It was a serious threat. The federation represents state medical advice that has the power to investigate and discipline doctors.
The federation's educational material on the new guidelines for the treatment of pain was distributed to thousands of physicians
. powerful nonprofit organization that accredits hospitals, adopted its own standards of pain treatment in 2001.
Here too, Purdue played a role. During the year that preceded the new standards of the Joint Commission, Purdue stated that it had entered into an exclusive agreement with the commission to fund pain education, including a media program with a doctoral program. Money "without restriction". Purdue was the only company to distribute educational videos from the Joint Commission on Pain and a book on pain management. The video created by Purdue and the book were sold on the website of the Joint Commission
The standards of the Joint Commission never dictated that pain be treated as a fifth vital sign. They did not force doctors to prescribe opioids. And today, the Joint Commission categorically denies that its standards have contributed to excessive overprescription of opioids, writing on its website that "Everyone is looking for someone to blame." [19659002] However, the 2001 suggestions of the treaty appropriately were sweeping. Here are some examples of how standards might be implemented: One asks each patient when he felt pain, not just when he consulted a doctor, but to no matter what. what time in the last few months. The scales of pain assessment, such as the scale of 1 to 10 or the mood scale from merry to sad, are enlarged and displayed wherever a patient could be assessed.
"The medical mind has changed"
all reluctant doctors still hesitate to distribute OxyContin and other opioids. The concepts of opioid prescription, unthinkable a few years earlier, were now accepted medical practices: opioids were for everyone. They were safe. Only addicts became addicted.
Doctors who were reluctant to prescribe powerful opioids were not careful, they were "opioid".
Formerly reluctant doctors fell in line.
"They were crazy if you came in and said" I have pain, and they did not write opiates for pain, "said Jim Johnson, a veteran cop of the task force on the Huntington drug. "Medicare and Medicaid, they denigrated them for not taking care of the pain."
All companies selling opioids took advantage of Purdue's desire to radically change the doctors 'willingness to prescribe, and patients' willingness to take addictive painkillers.
And Purdue took advantage. In the year when Joint Commission guidelines were published, doctors wrote 6.8 million prescriptions for OxyContin, the FDA reported. Sales climbed 36 percent to $ 1.5 billion
One foot in the door
Criticisms of OxyContin's over prescription were countered by arguments that reduce the availability of the drug. An analgesic would punish those who suffered from end-of-life pain, and in particular, cancer. The DEA has embraced the argument. As are members of Congress.
At a congressional hearing in 2002 on the drug, the United States. Senator Hillary Clinton said, "I'm worried about people who are suffering from cancer and other very painful diseases and conditions for which this drug is literally a lifesaver."
But the documents Purdue's internal experts point out that early marketing of OxyContin against cancer pain was also a way to prescribe OxyContin for much more common pain.
The treatment of cancer was in fact the "initial phase of penetration," wrote the company
. Purdue could go after the much wider group of patients with non-cancer pains, "by aggressive promotion and education."
Injection of celery into the veins
OxyContin has been prescribed for back pain, for arthritis, for migraines. The future of the drug, according to Purdue's marketing materials, concerned sports medicine, dentistry, obstetrics and pediatrics.
As rumors were circulating about people crushing OxyContin tablets and sniffing or snapping them, Purdue hammered the message, not average patients, who were at risk of abusing OxyContin.
Pills were not the problem. The people were.
"If I gave you a branch of celery and you ate it, that would be healthy for you," Purdue's Haddox told reporters. "But if you put it in a blender and you try to inject it into your veins, it will not be good."
The company asked for its opinion on the pharmacy study program. He proposed sending 100,000 senders to doctors nationwide to explain the pseudo-dependence.
Beyond the doctors, the company budgeted money for a computer algorithm survey to identify patients in distress. at a higher risk of fractures, respiratory problems and overdoses. Workers injured at work who receive two or more opioid prescriptions are twice as likely to be still disabled one year later
Purdue was targeting both.
Veterans taking opioids are twice as likely as civilians to commit suicide. But "Exit Wounds," a book funded in part by Purdue and published by the American Pain Foundation supported by Purdue, urged veterinarians in pain to consider opioids as "the gold standard" of care pain.
put more emphasis on pain management. Lobbied by the foundation of pain, the Congress in 2007 introduced two bills. The Veterans Health Care Policy Improvement Act required the Department of Defense to create a pain management program. An almost identical bill covered the soldiers on active service. Both have passed.
Between 2006, the year before Congress, and in 2011, 312 soldiers of the army overdosed and died. Presque sept sur dix avaient pris une pilule de prescription. Et la majorité de ces pilules étaient OxyContin.
Non 'zéro blessé'
Ce n'était pas seulement les adultes.
Le taux de substances contrôlées – drogues addictives – prescrit aux adolescents a doublé dans la décennie après qu'OxyContin a été apporté
Une étude réalisée en 2010 a révélé que près d'un adolescent sur quatre qui consultait un médecin pour un mal de dos était sorti avec une ordonnance pour un analgésique addictif
. Plus d'un adolescent sur 10 et environ un jeune adulte sur quatre se sont fait prescrire un analgésique addictif pour les maux de tête – une tendance qui a fortement augmenté après que la Commission mixte ait publié ses lignes directrices sur le traitement agressif de la douleur. Dans Pennington Gap, «nous avions une jeune fille, une jeune femme à Lee High School … et elle était assise à la bibliothèque, c'était à la fin de 1996 ou au début de 1997 et elle reniflait OxyContin dans la bibliothèque ", a déclaré Soeur Beth, la religieuse catholique. "Les gens ne savaient pas ce qui se passait."
"Ça a juste fait boule de neige."
Purdue commercialise de plus grandes doses
Quand Karen White s'est assise dans un Florida Denny's avec son superviseur, le représentant des ventes de Purdue Pharma
Elle soupçonnait certains médecins de la Floride de prescrire excessivement le médicament. Elle a demandé pourquoi elle avait demandé à d'autres représentants de rédiger leur propre évaluation de la gestion de la douleur à remettre aux médecins.
White avait été formée, elle a témoigné plus tard dans une déposition, pour éduquer les médecins. Purdue lui avait dit à elle et aux autr es qu'ils en savaient plus sur la gestion de la douleur que les médecins. Ce serait leur travail pour les médecins scolaires.
Ce jour-là, elle parlait d'un problème clé pour les médecins: la titration, la pratique consistant à augmenter ou à diminuer le dosage d'un médicament. En général, l'objectif est d'utiliser la dose la plus faible possible d'un opioïde qui procure un soulagement.
Purdue ne voulait pas seulement vendre des médecins en prescrivant davantage d'OxyContin, dit-elle.
Elle voulait vendre des médecins en prescrivant de plus fortes doses White se sentait contraint de se concentrer sur la commercialisation des comprimés OxyContin de 80 milligrammes, au lieu des comprimés à faible dose, montrent les documents de la cour.
Un opioïde qui crée rapidement l'euphorie est plus addictif que celui qui ne le fait pas. OxyContin libère rapidement de l'oxycodone. Plus de la drogue pourrait déclencher plus d'euphorie, et plus de risque de toxicomanie.
Purdue, a déclaré White, voulait augmenter le dosage. Les remises ont été offertes aux pharmacies pour leur première commande de 80 milligrammes d'OxyContin. Un document de marketing de Purdue demandé par l'avocat de White s'appelait «Étapes pour augmenter la titration». Un autre document pour les médecins demandait: «Actuellement, quelle est votre plus forte dose d'OxyContin?»
White a refusé de commercialiser des doses de plus en plus importantes. drogue aux médecins.
Elle a été renvoyée. Elle a déposé une plainte contre Purdue, citant des représailles pour avoir soulevé des inquiétudes au sujet des tactiques de vente d'OxyContin. Purdue a répliqué que cette mauvaise performance coûtait cher à son travail. Elle a perdu.
Avant cela, cependant, White a nommé des noms, identifiant 13 médecins et pharmaciens de Floride qu'elle soupçonnait de prescrire OxyContin de façon excessive. On est mort depuis. Sur les 12 restants, 11 ont été arrêtés ou ont perdu leur licence en raison de sur-prescription. Et au moins une douzaine de leurs patients ont fait une overdose fatale après avoir pris OxyContin.
'Une sorte de peste acridienne'
En 2001, OxyContin était un blockbuster milliardaire.
Il était également sous le feu; le sujet d'une prochaine audience du Congrès, des rapports de presse sur les surdoses dans le Maine et un examen approfondi de la FDA sur l'étiquetage.
Purdue n'a pas renoncé à son affirmation que les patients souffrant de douleur deviennent rarement dépendants à son médicament. Mais l'entreprise a offert d'aider à payer pour des bases de données de surveillance des ordonnances, y compris une base de données en Floride, qui pourrait suivre les modèles de prescription abusive.
Elle a envoyé des lettres et des dépliants aux médecins des toxicomanes qui pourraient chercher des opioïdes. dépensé des millions sur la recherche de pilules résistant à l'abus, la société a déclaré à un sous-comité du Congrès. Il a promis qu'une version reformulée d'OxyContin qui serait plus difficile à dissoudre et injecter était proche de la libération commerciale.
Et Purdue a convenu avec la FDA d'un changement d'étiquette avertissant clairement qu'OxyContin pourrait causer l'addiction et la mort.
publicly described the cooperation with the FDA as one of many efforts to curb abuse.
Internal documents described it as a marketing bonanza.
“In effect, the FDA has expanded the indication for OxyContin” to include patients with moderate pain , expanding the potential market, the company concluded. “This broad labeling is likely to never again be available for an opioid seeking FDA approval.”
The next year, 2002, Purdue ads in the Journal of the American Medical Association drew the FDA’s ire for misleadingly broad marketing.
In one, a smiling, healthy older man was shown fishing with a young boy, an image suggesting OxyContin could boost opportunities for healthy exercise and outdoor activities. Warnings about the risk, the FDA said, were limited to the left-hand corner in smaller white type on a background of green trees and blue sky.
“It is particularly disturbing that your ad would tout ‘Life with Relief’ yet fail to warn that patients can die from taking OxyContin,” the FDA wrote in a rare formal written warning.
Purdue issued a corrected ad, which described the FDA warning, the violations cited by the agency and provided prominently displayed information on both risks and approved uses for OxyContin.
Eastern Kentucky’s U.S. attorney had equally harsh criticism. OxyContin abuse was “like some sort of locust plague rolling through southeastern Kentucky,” Joseph Famularo told reporters.
Five months after stepping down from his job, Famularo was advocating on Purdue’s behalf.
Addicts, not the drug, were the problem, he said.
Similarly, Maine U.S. Attorney Jay McCloskey, who had once called the drug the biggest criminal and social threat in that state, took on Purdue as a client after going into private practice.
Purdue cops to a crime
John Brownlee had barely moved into his office as U.S. attorney for the Western District of Virginia when the Republican appointee started digging into whether Purdue’s aggressive OxyContin marketing had crossed the line into criminal behavior.
Brownlee’s first subpoena for Purdue corporate records went out a year later, in 2002.
It would be followed by nearly 600 more, an extended tug of war between federal prosecutors seeking information and Purdue, which balked at its release.
By 2006, Brownlee had made his case against Purdue. The company had buried science on the true addictive nature of OxyContin. It misled doctors. It distorted the “peaks and valleys” graph to pump sales.
It wasn’t just addicts who could become addicted.
Purdue as a corporation pleaded guilty to a felony charge of misbranding OxyContin. It agreed to pay $600 million in fines and fees.
Purdue’s president, its top attorney and former chief medical officer each pleaded guilty to a misdemeanor charge of misbranding. They agreed to fork over another $34.5 million in fines and were placed on three years’ probation.
Not everyone at the Department of Justice was ready for the deal to go through.
Powerful warning
In late October 2006, Brownlee got a green light to criminally charge Purdue if the company balked at a plea deal. He also got a phone call at home.
Mike Elston, chief of staff for then-U.S. Deputy Attorney General Paul McNulty, was on the line.
“He (Elston) told me he had received a phone call from one of the (Purdue) lawyers about the case,” Brownlee later testified in a congressional hearing. Purdue’s attorneys “had once again said that we were moving too quickly,” Brownlee said.
Purdue wanted more time.
Brownlee had known Elston barely 90 days, had spoken to him just once and never about the case.
“I sensed that he was inquiring almost on (Purdue’s) behalf,” Brownlee testified.
If so, it would not be the first time Purdue had gone to Brownlee’s superiors seeking help. The year before, a Purdue lawyer had directly approached James Comey, then a deputy U.S. attorney general, to try to convince Comey that Brownlee was misinterpreting DOJ policy.
“I actually grabbed one of my — not grabbed — but one of my prosecutors and I drove up to Washington from Roanoke and sat down with Mr. Comey and laid out for him exactly what we had done,” Brownlee testified.
Comey gave him the green light.
On the night of the phone call from Elston, Brownlee testified that he told the chief of staff that DOJ had given him permission to move forward, “and we were going to do just that, and he needed to back out of the way of the case.”
Eight days later, Elston put Brownlee’s name on a list of federal prosecutors to be fired.
The list became public and triggered charges that Alberto Gonzalez, U.S. attorney general under President George W. Bush, was cleaning house based on political considerations. Elston resigned. Brownlee would keep his job for another year before he resigned.
‘The wrong thing to do’
As it turned out, almost no one liked the deal.
Doctors warned of dire fallout for patients if doctors were afraid to prescribe painkillers.
Families of those who overdosed on OxyContin wanted prison terms for the executives. And not just families. U.S. Sen. Arlen Specter, then a Pennsylvania Republican, was not pleased.
In the congressional hearing where Brownlee detailed Elston’s unusual phone call, Specter said, “Where someone places a dangerous instrumentality in commerce with reason to believe that a death may occur and a death does occur, that constitutes malice and supports prosecution for murder in the second degree.”
The deal stayed in place.
In the wake of the 2007 criminal case, Purdue had been chastised, its key science claims discredited and its premier drug made the increasing focus of national criticism.
The Joint Commission released new pain management guidelines. Purdue-supported associations such as the American Pain Foundation are under congressional scrutiny for their ties to drug companies. The CDC has issued pain management guidelines urging doctors to use opioids sparingly, citing the risks of addiction and death. Purdue has financially backed states’ prescription-drug monitoring programs and partnered with the National Sheriff’s Association to provide overdose antidotes.
It no longer markets directly to doctors.
Portenoy has all but apologized for his role. “If I had an inkling of what I know now, I would not have spoken in the way that I spoke,” he said in a 2011 interview.
“It was clearly the wrong thing to do.”
The pills flowed anyway. The year following the plea deal with Brownlee, OxyContin prescriptions rose by 185 percent.
Increasingly, Florida was the source.
Palm Beach Post Reporter Lawrence Mower and staff researcher Melanie Mena contributed to this story.
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