G. Caleb Alexander

Victoria Knight: The more opioid marketing, the more overdose deaths

Oxycodone, sold under brand name OxyContin among others, is an opioid medication used for treatment of moderate to severe pain. OxyContin was heavily marketed by the Sackler family’s Purdue Pharma, in the process leading to many overdose deaths.

Oxycodone, sold under brand name OxyContin among others, is an opioid medication used for treatment of moderate to severe pain. OxyContin was heavily marketed by the Sackler family’s Purdue Pharma, in the process leading to many overdose deaths.

By VICTORIA KNIGHT

For Kaiser Health News

Researchers sketched a vivid line on Jan. 18 linking the dollars spent by drugmakers to woo doctors around the country to a vast opioid epidemic that has led to tens of thousands of deaths.

The study, published in JAMA Network Open, looked at county-specific federal data and found that the more opioid-related marketing dollars were spent in a county, the higher the rates of doctors who prescribed those drugs and, ultimately, the more overdose deaths occurred in that county.

For each three additional payments made to physicians per 100,000 people in a county, opioid overdose deaths were up 18 percent, according to the study. The researchers said their findings suggest that “amid a national opioid overdose crisis, reexamining the influence of the pharmaceutical industry may be warranted.”

And the researchers noted that marketing could be subtle or low-key. The most common type: meals provided to doctors.

Dr. Scott Hadland, the study’s lead author and an addiction specialist at Boston Medical Center’s Grayken Center for Addiction, has conducted previous studies connecting opioid marketing and opioid prescribing habits.

“To our knowledge, this is the first study to link opioid marketing to a potential increase in prescription opioid overdose deaths, and how this looks different across counties and areas of the country,” said Hadland, who is also a pediatrician.

Nearly 48,000 people died of opioid overdoses in 2017, about 68 percent of the total overdose deaths, according to the Centers for Disease Control and Prevention. Since 2000, the rate of fatal overdoses involving opioids has increased 200 percent. The study notes that opioid prescribing has declined since 2010, but it is still three times higher than in 1999.

The researchers linked three data sets: the Centers for Medicare & Medicaid Services Open Payments database that shows drugmakers’ payments to doctors; a database from the CDC that shows opioid prescribing rates; and another CDC set that provides mortality numbers from opioid overdoses.

They found that drugmakers spent nearly $40 million from Aug. 1, 2013, until the end of 2015 on marketing to 67,500 doctors across the country.

Opioid marketing to doctors can take various forms, although the study found that the widespread practice of providing meals for physicians might have the greatest influence. According to Hadland, prior research shows that meals make up nine of the 10 opioid-related marketing payments to doctors in the study.

“When you have one extra meal here or there, it doesn’t seem like a lot,” he said. “But when you apply this to all the doctors in this country, that could add up to more people being prescribed opioids, and ultimately more people dying.”

Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University’s Heller School for Social Policy and Management, said these meals may happen at conferences or industry-sponsored symposiums.

“There are also doctors who take money to do little small-dinner talks, which are in theory, supposed to educate colleagues about medications over dinner,” said Kolodny, who was not involved in the study. “In reality this means doctors are getting paid to show up at a fancy dinner with their wives or husbands, and it’s a way to incentivize prescribing.”

And those meals may add up.

“Counties where doctors receive more low-value payments is where you see the greatest increases in overdose rates,” said Magdalena Cerdá, a study co-author and director of the Center for Opioid Epidemiology and Policy at the New York University School of Medicine. The amount of the payments “doesn’t seem to matter so much,” she said, “but rather the opioid manufacturer’s frequent interactions with physicians.”

Dr. , who is the co-director of the Johns Hopkins Center for Drug Safety and Effectiveness and was not affiliated with the study, said that the findings about the influence of meals aligns with social science research.

“Studies have found that it may not be the value of the promotional expenditures that matters, but rather that they took place at all,” he said. “Another way to put it, is giving someone a pen and pad of paper may be as effective as paying for dinner at a steakhouse.”

The study says lawmakers should consider limits on drugmakers’ marketing “as part of a robust, evidence-based response to the opioid overdose epidemic.” But they also point out that efforts to put a high-dollar cap on marketing might not be effective since meals are relatively cheap.

In 2018, the New Jersey attorney general implemented a rule limiting contracts and payments between physicians and pharmaceutical companies to $10,000 per year.

The California Senate also passed similar legislation in 2017, but the bill was eventually stripped of the health care language.

The extent to which opioid marketing by pharmaceutical companies fueled the national opioid epidemic is at the center of more than 1,500 civil lawsuitsaround the country. The cases have mostly been brought by local and state governments. U.S. District Judge Dan Polster, who is overseeing hundreds of the cases, has scheduled the first trials for March.

In 2018, Kaiser Health News published a cache of Purdue Pharma’s marketing documents that displayed how the company marketed OxyContin to doctors beginning in 1995. Purdue Pharma announced it would stop marketing OxyContin last February.

Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, said that doctors treating patients with opioids need education about benefits and risks. She added that it is “critically important that health care providers have the appropriate training to offer safer and more effective pain management.”

Cerdá said it is also important to consider that the study is not saying doctors change their prescribing practices intentionally.

“Our results suggest that this finding is subtle, and might not be recognizable to doctors that they’re actually changing their behavior,” said Cerdá. “It could be more of a subconscious thing after increased exposure to opioid marketing.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Victoria Knight: vknight@kff.org, @victoriaregisk

Purdue Pharma played down OxyContin addiction danger

Side-effects of oxycodone,  the generic name for OxyContin, the brand name of a controversial Purdue Pharma product.

Side-effects of oxycodone,  the generic name for OxyContin, the brand name of a controversial Purdue Pharma product.

By FRED SCHULTE

For Kaiser Health News

Two decades ago, Purdue Pharma, based in Stamford, Conn. {see headquarters below}, produced thousands of brochures and videos that urged patients with chronic pain to ask their physicians for opioids such as OxyContin, arguing that concerns over addiction and other dangers from the drugs were overblown, company records reveal.

Kaiser Health News earlier this year posted a cache of Purdue marketing documents that show how the pharmaceutical company sought to boost sales of the prescription painkiller, starting in the mid-1990s.

Purdue turned the records over to the Florida attorney general’s office in 2002 during its investigation of the company. Additional Purdue documents from the Florida investigation detail how the company targeted patients and allayed addiction worries.

“Fear should not stand in the way of relief of your pain,” a pivotal marketing brochure said.

Purdue said it handed out thousands of copies of the brochure, which emphasized consumer power in treating pain, as well as a videotape. “The single most important thing for you to remember is that you are the authority on your pain. Nobody else feels it for you so nobody else can describe how much it hurts, or when it feels better,” the pamphlet states.

More than 1,500 pending civil lawsuits, filed mostly by state and local governments, allege that deceptive marketing claims helped fuel a national epidemic of opioid addiction and thousands of overdose deaths.

Last week, the New York attorney general’s office filed another suit that accuses Purdue of operating a “public nuisance” in it sales tactics and marketing of opioids. Like many others, the suit demands compensation for addiction treatment costs and other problems. Purdue and other drugmakers have denied all allegations.

President  Trump said last Thursday he wants the federal government to sue drugmakers in response to the addiction epidemic.

The Purdue brochure from the late 1990s spurred recent criticism from drug safety experts. Dr. G. Caleb Alexander, a physician at the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health, said the sales pitch was “simply not true” and called it “a smoking gun.”

“We have learned the hard way that many patients develop opioid [addiction] when using these medicines as prescribed,” he said.

Alexander said other drugmakers also appealed to patients hoping to influence their doctors — a tactic that was relatively new in the late 1990s. But Alexander said he was “shocked” to hear that Purdue did so with OxyContin, given the risks posed by long-term use of the morphine-like narcotic.

“These drugs [opioids] are in a class of their own when it comes to the harms that they have caused,” Alexander said.

The internal Purdue documents, dating from 1996 to 2002, show that the company began marketing OxyContin to doctors in late 1995 for treating moderate to severe cancer pain. With modest sales of $49.4 million in 1996, Purdue posted a loss of $452,000 on the drug. In 1997, sales reached $146.5 million for a pretax profit of $16.5 million, the company records show.

In 1998, as Purdue hawked OxyContin for conditions such as arthritis and back pain, it decided to “increase communications” with patients, company records show.

The goal: “convince patients and their families to actively pursue effective pain treatment. The importance of the patient assessing their own pain and communicating the status to the health care giver will be stressed.”

Purdue’s six-page pamphlet for patients, provided to the Florida attorney general, was titled “OxyContin: A Guide to Your New Pain Medicine.” “Your health care team is there to help, but they need your help, too,” the pamphlet says. It says OxyContin is for treating “pain like yours that is moderate to severe and lasting for more than a few days.”

To patients or family members worried about addiction, Purdue’s pamphlet said: “Drug addiction means using a drug to get ‘high’ rather than to relieve pain. You are taking opioid pain medication for medical purposes. The medical purposes are clear and the effects are beneficial, not harmful.”

Asked to comment this week, Purdue spokesman Robert Josephson said the company “discontinued the use of this piece many years ago.”

Dr. Michael Barnett, a physician and assistant professor at the Harvard T.H. Chan School of Public Health, said that some of Purdue’s early marketing claims may have seemed reasonable to many doctors 20 years ago.

But he faulted the medical profession for not demanding scientific evidence that opioids were in fact safe and prudent for widespread use.

“I think a lot of physicians are coming to the realization that a lot of what we were taught about pain management was pure conjecture,” he said. “I feel foolish for believing it.”

In hindsight, he said, Purdue’s sales tactics seem “almost a satire of an unscrupulous corporation that really has no interest in understanding the implications and complications of people using their drugs.”

Dr. Art Van Zee, a physician in southwestern Virginia who was among the first to recognize the ravages of OxyContin misuse, said that some people who became addicted were already drug abusers.

But he added: “There clearly are people that I’ve taken care of who took it as directed orally and became opioid-addicted.”

Purdue also paid a New York City production company to shoot a videotape called “From One Pain Patient to Another,” featuring testimonials by seven patients from the Raleigh, N.C., area under the care of pain doctor Alan Spanos. Filming took place at the patients’ homes, places of work and other area locations on July 17, 1997, according to the documents.

Purdue did not pay the patients, though Spanos received $3,400 as a “physician spokesman” on that video and another, the company records state. Contacted recently by phone, Spanos would not comment. In the documents, Purdue said that the patients “participated willingly, wishing to speak out regarding the importance to them of being able to receive effective therapy for their chronic pain.”

Between January 1998 and June 2001, Purdue distributed 16,000 copies of the video to doctors, who showed them to selected patients.

The video did not mention OxyContin directly, but the Food and Drug Administration did balk at a claim in the video that fewer than 1 percent of people taking opioids became addicted. The FDA said that claim was not substantiated, according to a December 2003 General Accountability Office audit.

Purdue destroyed remaining copies of the video in July 2001, including 4,434 Spanish-language versions, according to the company records.

By then, annual OxyContin sales had topped $1 billion as Purdue pushed to “attach an emotional aspect to non-cancer pain so physicians treat it more seriously and aggressively,” according to the company’s marketing reports.

Asked about the video, Purdue spokesman Josephson said the drugmaker has not made that claim — regarding 1 percent addiction — “in more than 15 years.”

Purdue submitted the marketing records to the Florida attorney general’s office during its investigation of the company. The state settled the case in 2002 when Purdue agreed to pay $2 million to help set up an electronic prescription-tracking program.

Florida officials released the records to two Florida newspapers in 2003 after Purdue lost a court battle to keep them confidential. KHN posted some of those documents earlier this year for readers to review on its website.

 

Purdue's headquarters is in this building in downtown Stamford.

Purdue's headquarters is in this building in downtown Stamford.