This story is a collaboration between STAT and ProPublica.

Purdue Pharma has tried to refute accusations that it fueled the opioid crisis by arguing it was a small player in the U.S. market for prescription pain relievers. But a new ProPublica analysis of government data shows that the company, the maker of OxyContin, had a far bigger impact than it portrays.

Purdue’s position rests on a Drug Enforcement Administration database, made public by a court order in July, which shows Purdue sold 3.3% of the prescription opioid pain pills in the U.S. from 2006 to 2012.

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Last month, when Purdue moved to dismiss a lawsuit by the Massachusetts attorney general alleging that it had downplayed the addiction risk of its potent drug, the company highlighted the DEA statistic in a slide presentation. One slide was headlined: “Purdue makes a very small fraction of opioids nationally.”

Company lawyer Timothy Blank told the judge, “The notion that Purdue has created this epidemic is a serious misconception.”

The number promoted by Purdue, however, is an inadequate measure of market share and understates the company’s role in the opioid epidemic, according to experts and the new ProPublica analysis. That’s because the percentage of sales doesn’t take the potency and dose of the pills into account. The analysis favored by Purdue treats every pain pill as the same, whether it is a 5 milligram Percocet or an 80 milligram OxyContin. It’s analogous to measuring alcohol sales by equating a 12-ounce glass of 100-proof whiskey with a similar-sized can of light beer.

ProPublica analyzed the same data set touted by Purdue but accounted for the wide variation in strengths of prescription painkillers. Besides counting the number of pills sold, the analysis measured the amount and potency of opioid that they contained. Higher doses of opioids are associated with a greater risk of overdose.

On that basis, the market share of Purdue is 16% — about five times higher than the number cited by the company. That makes Purdue the third-largest seller of opioids from 2006 to 2012, behind generic pain pill makers Actavis Pharma and SpecGx, a subsidiary of Mallinckrodt (MNK).

Market share of top prescription opioid manufacturers

ProPublica analyzed the Drug Enforcement Administration ARCOS database to calculate market share of oxycodone and hydrocodone shipments. The chart below shows market share percentage in two ways: using morphine milligram equivalents (MMEs) to take into account the potency of pills; and using pill number, with no adjustment for potency.

Alissa Ambrose/STAT Source: Drug Enforcement Administration ARCOS database

Note: Since 2012, Actavis Pharma has been acquired by Teva; Par has been acquired by Endo Pharmaceuticals; and SpecGX is a subsidiary of Mallinckrodt Pharmaceuticals.

“All opioids are not created equal,” said Len Paulozzi, a former medical epidemiologist at the Centers for Disease Control and Prevention who researched prescription opioid overdose risk. He said it is important to adjust for potency because “the risk of an overdose, whether fatal or nonfatal, is directly related to the dosage a person receives.”

Purdue’s contention that it was a minor participant in the opioid painkiller market is both a legal and a public relations strategy. The company has been working to settle more than 2,000 lawsuits blaming it for helping to create the public health disaster, and also to protect the reputation and legacy of the Sackler family, its owners. Once praised for their philanthropy, the Sacklers have more recently been condemned by politicians and advocates for their stewardship of Purdue.

Talks on a settlement, which included a provision that the Sacklers contribute at least $3 billion of their own money, recently reached an impasse and Purdue is considering filing for bankruptcy, the Associated Press reported Saturday. The Sacklers have been separately sued by more than a dozen states, including Massachusetts and Connecticut, for their role in overseeing the company’s allegedly illegal marketing of OxyContin.

Purdue has long experience at countering criticism of OxyContin. The first reports that people were abusing the drug surfaced two decades ago. Since then, Purdue has repeatedly argued that its flagship drug has done more good than harm. Even when Purdue pleaded guilty in 2007 in federal court to a criminal charge of illegally marketing OxyContin by downplaying addiction risks, it blamed misstatements by employees who didn’t follow company directives. More recently, the company and representatives of the Sackler family have said that the opioid crisis is now driven by “illegal street drugs” such as heroin and fentanyl.

Purdue declined to comment on the ProPublica analysis.

By minimizing OxyContin’s market share, the per-pill sales data that Purdue prefers also muffles the drug’s outsized impact in certain states, especially in the Northeast. For example, Purdue’s lawyer told the Massachusetts judge that the company sold just 4.6% of the prescription pain pills in the state from 2006 through 2012. But when the total amount of opioid ingredient in each pill is considered, Purdue’s market share in the state is actually more than four times higher at 20.5%.

In some states, when sales are adjusted for potency, Purdue sold more painkiller medication than any other company: Purdue was the top seller in Rhode Island, with 31.2% of the opioid market, as well as in Connecticut, where it had 28.5%. In Ohio, which has consistently ranked among states with the highest rates of overdoses, Purdue had one-fifth of the market. In 13 states, Purdue was responsible for 20% or more of retail opioid painkiller sales.

Purdue’s market percentage by number of pills sold, by state

Alissa Ambrose/STAT Source: Drug Enforcement Administration ARCOS database

Purdue’s market percentage by strength of pill, by state

Alissa Ambrose/STAT Source: Drug Enforcement Administration ARCOS database

 

The market share nationally of some companies dropped when potency was considered. SpecGx, which has 37.7% of the market on a per pill basis, fell to 29%. Actavis declined from 34.6% of the total pill market to 30.4% in the ProPublica analysis.

The analysis of the DEA data cited by Purdue was first done by The Washington Post. It partnered with the publisher of the Charleston Gazette-Mail in West Virginia in a joint legal action that prompted the release of the DEA database. The database, called Automation of Reports and Consolidated Orders System, or ARCOS, tracks every opioid pill sold in the country from manufacturer to distributor to pharmacy.

The Post limited its analysis to shipments of oxycodone and hydrocodone, which accounted for three-fourths of all pill shipments to pharmacies. ProPublica also restricted its analysis to the same two drug classes sold by retail outlets and practitioners because the numbers cited by Purdue in court are based on that methodology.

The reason Purdue’s market share is significantly larger when measuring the amount of opioid ingredient sold is because OxyContin is formulated at strengths many times higher than most other pain pills.

When Oxycontin was unveiled in 1996, Purdue’s marketing campaign touted it as providing longer pain relief while allowing patients to take fewer pills each day. To accomplish that, Purdue packed into each pill a large amount of opioid that was slowly released over a 12-hour period. Its largest dose, until it was taken off the market in 2001 amid safety concerns, was a 160 milligram pill.

Abusers quickly figured out how to crush OxyContin tablets and remove the opioid inside. Some snorted it, while others reduced it to liquid form and injected it.

In determining the amounts of opioid painkillers sold by Purdue and other manufacturers, ProPublica calculated a rate called morphine milligram equivalent, or MME, which is commonly used by public health agencies, including the Food and Drug Administration and the CDC.

The calculation standardizes different types of opioids to the same morphine equivalent.  Hydrocodone, the opioid in Vicodin, has a potency that is equivalent to morphine. Oxycodone, the opioid in OxyContin, is one and a half times more potent than morphine. When converting to morphine equivalents, the amount of hydrocodone in a pill is multiplied by one, while oxycodone is multiplied by 1.5.

Using this formula, an 80 milligram pill of OxyContin has an MME of 120 while a 5 milligram Vicodin pill has an MME of 5.

The average total MME for a pill sold by Purdue in the DEA database was 61.5. By comparison, the average MME per pill sold by the largest manufacturer during this time frame, Actavis Pharma, was 11. For the second biggest manufacturer, SpecGx, it was even lower at 9.6 MME.

CDC guidelines advise against prescribing more than 90 MME per day. OxyContin users are typically directed by their doctors to take two pills per day. Based on the DEA database, the typical prescription from 2006 to 2012 would have totaled 123 MME a day — an amount 37% above the maximum recommended by the CDC.

A CDC review in 2016 concluded that higher opioid dosages are associated with increased overdose risk. One of the studies cited by the CDC found that patients taking between 50 and 100 MME of painkillers a day were up to 4.6 times more likely to overdose than those taking less than 20 MME. For patients receiving more than 100 MME a day, the risk was up to nine times higher than for the lower dose group.

“If Purdue sold a lot of 80 milligram pills, they are going to have proportionately more of the market on an MME basis,” said Gary Franklin, the medical director for the Washington State Department of Labor and Industries. “That is an important point to get out. People are dying from these higher doses.”

Franklin, who is an unpaid expert for the state of Washington in its lawsuit against Purdue, cautioned that other factors increase overdose risk as well. For instance, people who take benzodiazepines, such as Xanax, at the same time as opioids can fatally overdose on lower doses of painkillers.

The FDA, in a staff report this year, also found that a higher daily dose of opioid pain relievers “likely contributes causally to increased risk of intentional and unintentional opioid overdose.” The agency noted that other factors influence overdose risk and that a substantial portion of overdose victims either did not have a prescription for the pills they took or were prescribed a lower daily dose.

Until 2010, according to the DEA’s National Drug Threat Assessment Summary, OxyContin was “by far” the most commonly abused prescription painkiller in the country. In 2010, Purdue introduced a reformulated version of OxyContin that is harder to abuse. The new version can still be abused if crushed or taken orally, but it does not provide as potent a high as the older version, according to the agency.

In the Massachusetts hearing last month, Purdue relied on the lower per pill market share in oral arguments before the judge and in the accompanying slide presentation of data. One slide stated, “DEA Data Refute the Commonwealth’s Allegations.”

“What the commonwealth has done is create an extraordinary misperception in the community, and it is a dangerous misperception,” Purdue’s attorney Blank told the judge at the Aug. 2 hearing, according to a transcript of the proceeding. “The attorney general says it is all on Purdue. It is not all on Purdue.”

“All those prescriptions are not equal,” responded Assistant Attorney General Sandy Alexander. “Some of those prescriptions are for two pills of the lowest dose opioid. Purdue specialized in the most dangerous prescriptions because they were the most profitable.”

The Massachusetts lawsuit cites internal Purdue records in alleging the company pushed higher doses because they were the most profitable. Authorities also allege that the company knew patients taking more of the drug were more likely to overdose. One Massachusetts doctor, who was paid more than $80,000 by Purdue to give talks to other physicians, prescribed 24 of the highest dose OxyContin pills a day for a single patient, according to the state complaint.

“Purdue specialized in getting patients on the highest doses for the longest periods of time,” Alexander told the judge. “Those prescriptions, when you count them, they’re not all equally valuable to a drug company and they’re not all equally dangerous to the people of Massachusetts.”

Purdue’s market share from 2006 to 2012 would have likely been even higher save for an anomaly in the history of the drug. For a brief time, including the years 2006 and 2007, OxyContin had generic competition. Its sales slumped from $1.3 billion in 2005 to $752 million in 2006 and $1 billion in 2007, according to health care data firm IQVIA. Purdue sued the generic makers and gradually eliminated competition from them so that by 2008, OxyContin sales more than doubled from the prior year to $2.3 billion.

By that measure, dollar sales, Purdue has long been the market leader for prescription opioids. Internal Purdue records indicate OxyContin had more than 28% of the total market share in gross sales each year from 2008 through 2018. Since 1996, sales of OxyContin have totaled more than $35 billion. The Sackler family received at least $8 billion in company profits during that time, according to court records.

 

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  • This is all well & good, to hold those accountable for creating the onslaught of addicts that our country has seen. However, this whole ordeal has been nothing short of a catastrophe for the countless chronic & intractable pain patients who were forced to die by their own hand, after being ‘removed’ from the medications that they responsibly used to live their daily lives. Let’s factor in those very relevant numbers, as well.

  • Not comparing apples and apples. The WHO used to be very concerned about the suffering of people in developing countries who did not have access to pain relief. Mostly because they were too poor to access this. However the opioid zealots got to the UN and the World Health Organization and made them change their stance. As far as Europe and Australia a lot of these countries had over-the-counter codeine available so they wouldn’t have to write as many prescriptions. Plus we made the insane practice of having to write a prescription every single month instead of one prescription with three refills so that quadrupled the amount of prescriptions doctors after right here. You are not comparing similar things. All of these stats are put out to manipulate numbers to make us look bad. Figures Never Lie Liars always figure

  • I am many others are in pain continually. Not allowed to be like normal people. The lawsuit is about money and pain-I am tired of my pain- these silly groups and their so called do good lawsuit disgust me, Those that sell illegal medicine will benefit from this lawsuit.

    • Its shameful. Here’s an example:
      Dr. prescribes opioids to pain patient 4 pills per day 1 every 6 hours and patient takes exactly as directed.
      A drug abuser/ addict is given the same 4 pills and immediately crushes them up and snorts them within 1 minute…
      This is exactly the kind of thing that happens 99% of the time in this country everyday and yet, the government will continually group us pain patients with the abusers.
      Where is the sanity in this thinking?

  • Read online from THE NEW YORKER the thorough piece entitled EMPIRE OF PAIN; if you cannot figure out the Sackers and Purdue are guilty as hades after reading this article, well, stupid or dead cannot be fixed.

    • No….No they are not. Greedy, probably, but I hear there was some philanthropy. But guilty because alot of people were abusing there drug against all recommendations and doctors prescriptions? Hell no.

  • If you have real pain ,you have to stop it or the trauma will kill you, people have to have the right to choose what helps them function and survive that pain or your not alive, should not judge this because people will do whatever they can to live without pain ,dont keep pushing legal tracked meds away or illegal drugs will keep killing ,there’s no end to this issue never will be just fight heroin on the streets

  • This pain medication is a miracle medicine for millions who are suffering in triple zero chronic pain. Patients taking OxyContin are given their life back and can function as a human being and not one that stays in their bed in a fetal position barely able to breathe because of their triple zero pain level that’s chronic controlling every aspect of their life. If you’re are fortunate not to have pain then you will NOT be able to grasp the magnitude of how pain takes your life away in it’s entirety. Simple things become a challenge ie brushing your teeth, taking a shower, having to get yourself to the bathroom can seem as though electrical strikes, sledgehammer, getting hit by a train in the same moment magnified by 10 x’s. Truthfully no words can begin to tell a pain patient’s level of pain in many cases so that the average doctor or person may understand. Until one feels the relentless pain they will not understand the critical nature of taking pain medications 24/7 in order for some quality of life. It’s a travesty that our government has put their regulations on Pain Medications that they’re NOT educated. How & why is this happening to good people who DO NOT choose their life in pain it happens because they were once living their life as a person should & health issues or accident happened out of their control! Don’t penalize legitimate pain people it’s not their fault! However, those that choose to abuse or illegally take pain medications this IS THEIR fault because they choose to take that pill or shoot pain medications! Don’t blame innocent pain patients because someone CHOOSE to take medication illegally and then overdosed. It was their choice. People must be accountable for what they do and stop blaming others and corporate America! Take ownership for your actions, it’s so simple but appears impossible nowadays. Stop hiding behind your mothers skirts and grow up!

    • Your comments are valid that these drugs are life saving and revolutionary. Your comment that the evil people who abuse and overdose is there fault is a shallow conclusion. The start of addiction for many begins when people that are injured or in need of these drugs stop using them. Purdue and other pharmaceutical companies pushed these drugs on doctors to push them onto patients, especially the high dose ones(the most profitable). It’s like a legal drug ring.
      So when hospitals and drug stores stop giving you this highly addictive drug you turn to the streets. This is when things get even messier, with cheaper forms of the drug.
      We have to understand that many of these people don’t want to be addicted. Its not by choice.

    • Jimmy G. addicts DO have a real problem and no they did not wish to have this problem. However the advocate that started by a prescription is a rare person and most of the time I have other co-existing conditions that make them susceptible to addiction. But these people would just as easily become addicted to cocaine or alcohol or meth and often take all of these at the same time is illegally obtained opioids. To say it is Purdue fault is falling for the simplistic narrative that the parents of the deceased kids would like to believe that if it was not for this evil doctor and evil pill Little Johnny would never have become an addict. Not only is it not true that’s the addicts off the hook when facing up to their own actions would go a long way towards healing blaming somebody else is just like the alcoholic that blames the wife for his drinking. It’s not healthy and it’s not realistic and it’s hurting people who actually need these medications

    • Tammy Malik

      So I guess this thorough article is wrong according to your beliefs. I don’t think you understand that Purdue definitely is a large player in the distribution and start of this epidemic. They paid doctors to push these drugs to people that didn’t even need it. They handed it out like candy. And they urged doctors to push the stronger/higher dose pills. Why would the government be trying to charge them billions for wrongdoing? Because there are very legitimate facts and reasons of their wrongful power hungry, profit hungry motives.

  • This is another powerful . constructive . informative profound report and or health news by STAT , a very wonderful . legitimate and most prudent Institution that i am able to cite .,recommend along with the highest reward for the refreshing .yet critical situation and status .that the health care industry in this nation .The United States Of America first and foremost and globally within the secondary aspect . As i have continuously and frequently wrote that due to the fact that The .U..S.A with only about three hundred fifty seven million people compare to China and India for which in the order of one point four billion humans in China and one point two billion humans in India . The United States Of America uses about thirty percent more of all the pain killers globally . Yes =the epidemic is here , and the Pharmaceutical Empires are all aware of this and they continue to exploit . abuse and destroy humans all for the Power and Love of Money . Purdue is only one more . i thank you . Trevor Merchant . today .Monday , September. 09. 2019 at 4. 23 p.m . daylight savings time New York City .

    • Why would the govt be going after Purdue? Hmmm, could it be money? Or to make the DEA and the war on drugs seem relevant again? So much easier to go after Drs, pharmacies, and manufacturers than drug cartels. Much easier than the current fake fentanyl dealers that were CREATED by #opiodhysteria by creating a demand for easy to make, hide, and smuggle opiod. Unlike the safe medications that they have strangled.

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