A patient who is prescribed opioids for three to five months is 30 times more likely to die of overdose within five years compared to the general population, according to data compiled by the Massachusetts Department of Public Health.
A patient who takes prescription opioids for six to 11 months is 46 times more likely to suffer a fatal overdose.
And one who uses them for 12 months is 51 times more likely to die of overdose. (By comparison, people who smoke are 15-30 times more likely to develop lung cancer than nonsmokers, according to the CDC.)
These statistics were contained in the complaint that Massachusetts Attorney General Maura Healey filed two weeks ago against Purdue Pharma, the maker of OxyContin. Healey is seeking damages for the company’s alleged role in exacerbating the opioid crisis, which claimed the lives of more than 11,000 state residents over the past decade, including 671 who filled prescriptions for Purdue opioids.
Press coverage of the suit largely passed over these statistics, focusing instead on the fact that Healey also named as co-defendants in the suit 16 officers and directors of the private company, including eight members of the controlling Sackler family—an apparent first. Among them was Richard Sackler, who is the son of company cofounder Raymond Sackler; a former company chairman and president; and, according to the patent, a co-inventor of OxyContin.
Also overshadowed by the Sackler charges were disturbing allegations about marketing strategies allegedly pursued by the Purdue, which, if true, shed light on how the company itself believes its opioid products impact the human brain.
Attorney General Healey accuses the company, for instance, of consciously using discounts to entice patients to stay on opioids for at least 90 days, knowing that if they did so they were likely to keep taking the drugs for years.
Similarly, the complaint alleges that sales reps pushed doctors to increase dosages, knowing, again, that doing so increased the likelihood that patients would stay on the drugs much longer.
The statistics in the suit are based on an August 2017 report (see page 27) by the Massachusetts Department of Public Health, although some of the data was not as explicitly laid out there as in this month’s complaint. That report tracked 1.1 million Massachusetts residents who were prescribed opioids in 2011.
Purdue has generally declined to engage in any specific back-and-forth over the factual allegations leveled against it in the avalanche of lawsuits it faces. (At least 24 other states have sued the company, as have hundreds of municipalities.)
In an email to me about the Massachusetts complaint, its spokesperson wrote:
“We share the Attorney General’s concern about the opioid crisis. We are disappointed, however, that in the midst of good faith negotiations with many states, the Commonwealth has decided to pursue a costly and protracted litigation process. We will continue to work collaboratively with the states toward bringing meaningful solutions. We vigorously deny the Commonwealth’s allegations and look forward to presenting our substantial defenses to these claims.”
Because Massachusetts was one of 26 states that was involved in an earlier lawsuit against Purdue, which settled in 2007, its new complaint focuses only on how the company allegedly marketed its opioid products since then. The main products in question are OxyContin (oxycodone), Hysingla (hydrocodone), and Butrans (a patch that delivers buprenorphine as a painkiller, not as an anti-addiction medication). Filed in the Superior Court of Suffolk County in Boston, the suit alleges unfair and deceptive business practices and creation of a public nuisance.
One of Purdue’s beliefs about its opioid products, according to the complaint, is that the higher the dose a doctor prescribes the longer the patient will likely stay on the drug.
“Purdue trained its sales representatives that increasing a patient’s dose (‘titration’) was a key move when making sales. … Purdue monitored the pace at which doctors increased doses of its opioids and warned its sales staff when doses were not increasing fast enough. … Purdue required its sales representatives to ‘practice verbalizing the titration message’ to get patients on higher doses of opioids.”
The company allegedly performed a confidential study of 57,000 patients to determine how opioid dose “influences patient length of therapy,” according to an internal report shown to the board. It concluded that patients on the highest doses were “the most persistent” and that “83% of patients who discontinued were never titrated to higher doses.”
When public health authorities began warning about the dangers of high doses, company officials expressed concern in internal memos that dosage cutbacks would “negatively impact business,” according to complaint. “A small shift of roughly 15K prescriptions from 20mg or 15mg down to 10mg has a $2MM impact,” one document noted.
“In 2014,” the complaint continues, “when public health experts tried to save patients’ lives by warning against high doses of opioids, Purdue pursued a ‘stategic initiative’ to fight back and ‘maintain 2013 dose mix.’ …
“Purdue promoted the assertion that ‘opioid dose was not a risk factor for opioid overdose,’ even while it admitted in internal private documents that ‘it is very likely’ that there is a ‘dose-related overdose risk in [chronic non-cancer pain] patients on [chronic opioid therapy].’”
Another key objective for Purdue, according to the complaint, was keeping patients on opioids for at least 90 days. The company understood that a patient that took the drug for that long was likely to stay on it for years, the attorney general suggests. (A 2011 study in the Journal of General Internal Medicine found that “over half of persons receiving 90 days of continuous opioid therapy remain on opioids years later.” The complaint says that more than two-thirds of such patients will still be using the drug five years later.)
In an internal report, Purdue officials found that providing patients with savings cards, which entitled them to discounts for 90 days, led to a 39 percent increase in the number of patients that stayed on the drugs that long. Because the savings cards led patients to stay on the drug longer, the company calculated that they generated a “4.28 return on investment”—i.e., for every $1 million Purdue gave away in discounts, it recovered $4.28 million in added revenue due to patients staying on the drugs longer. The savings cards worked like “a teaser rate on a long-term mortgage,” the complaint alleges.
But patients who stayed on opioids 90 days also had a 30 times greater risk of overdose death than the general population, the Massachusetts Public Health Department later determined. Those who stayed on them for a year were at 51 times increased risk for fatal overdose. Purdue’s “directors and officers knew or should have known that putting patients on opioids at higher doses and for longer periods increased the risk of addiction, overdose, and death,” the attorney general asserts.
Of course, these are just allegations, and perhaps the company has a different perspective on what these documents mean, and whether they are being taken out of context. In the past I have also invited Purdue to let one of its lawyers do an in-depth Q&A with us. The offer stands.