Says pharmaceutical company’s ‘greed and recklessness’ spawned crisis
LATE LAST YEAR, an article in the Los Angeles Times caught the eye of US Rep. Katherine Clark of Melrose. The article alleged that Connecticut-based Purdue Pharma, the maker of Oxycontin, was moving aggressively to sell its signature drug abroad now that sales in the United States are on the decline.
The Times article said that Purdue’s network of foreign companies, known as Mundipharma, was running seminars in countries from Brazil to China urging doctors to fight “opiophobia” and prescribe painkillers. The Times found that the firms were advertising to encourage people to seek treatment for chronic pain and offering discounts for new opioid prescriptions.
Abroad, opioid abuse is not nearly the problem it is in the United States, but Clark thinks that’s because foreigners have not yet been hit with the full force of drug industry marketing. What she read in the Timessounded to her a lot like the game plan Purdue has followed in the United States. So Clark, whose district includes suburbs north and west of Boston that have been hard hit by opioid addiction, is taking the fight to Purdue and other pharmaceutical companies. She’s challenging their marketing practices and trying to shame them into doing more to warn doctors and patients of the risks.
In the United States, Purdue “created a huge problem for many people with devastating consequences. It led to addiction and, at the same time, the bottom line for Purdue Pharma continued to rise,” Clark says. “We are now watching as they pursue the very same marketing strategies in international markets.”
Clark took on Purdue and Mundipharma in a May letter to Margaret Chan, then the director-general of the United Nations’ World Health Organization, to make the case that opioid marketing qualifies as a global health emergency. “The greed and recklessness of one company and its partners helped spark a public health crisis in the United States that will take generations to fully repair,” Clark wrote.
The accusations of a junior House Democrat might not carry much weight but for Clark’s co-signatory, Hal Rogers, the Kentucky Republican who is the former chairman of the House Appropriations Committee and remains that panel’s most senior member. He represents an impoverished coal-country district on the West Virginia border where opioid abuse is epidemic.
Three of Clark’s Massachusetts colleagues in the House—James McGovern, William Keating, and Stephen Lynch—also signed.
Both Purdue and Mundipharma are taking it seriously. In a prepared statement offered in response to Clark’s letter, Purdue says it is an “industry leader in the development of abuse-deterrent technology and advocating for the use of prescription drug monitoring programs.” The company has redesigned its pills in an effort to prevent addicts from crushing and snorting them, subverting the pills’ slow-release mechanism, in order to get high.
Mundipharma’s statement says “the situation in Europe is very different to that in the US, with far fewer people misusing and abusing opioid medicines.” Nonetheless, the statement says, the company continues “to take active preventative measures, drawing on the experiences and insights of the US in tackling this issue.” Among those, it said, were “comprehensive monitoring programs, enabling a secure supply chain, and working with regulatory agencies to implement risk management plans.”
Clark’s attempt to shame Purdue comes at a crucial moment in the company’s campaign to protect its brand. The last several months have seen a spate of lawsuits targeting Purdue as well as distributors of prescription opioids, arguing that they misinformed doctors of the drugs’ addictive qualities which led to overprescribing and, ultimately, thousands of overdose deaths.
In the midst of litigation, brand reputation is crucial and it doesn’t help when members of Congress, from both parties, are tarring the company.
Opioid addiction in the United States has cost 200,000 lives since 1999, including more than 1,700 in Massachusetts just in 2015, the most recent year for which Centers for Disease Control and Prevention data are available. That’s more than in either Kentucky (1,273) or West Virginia (725).
In the last Congress, Clark worked with Rogers’ fellow Kentuckian, Senate Republican Leader Mitch McConnell, on legislation to task the Health and Human Services Department in Washington with developing treatment strategies for babies born with opioids in their systems, and to offer technical assistance to the states to help them respond. It was enacted in November 2015.
It was that bill that connected her with Rogers, who then invited Clark to the National Drug Abuse and Heroin Summit in Atlanta, an annual event that Rogers founded in 2012 in response to the scourge. Clark learned at that event about Rogers’ feelings about pharmaceutical company complicity and figured, rightly, that he would be an ally in going after their marketing strategies.
Clark’s efforts to cultivate Republicans on the issue are critical to her efforts to help addicts in the United States. That’s not only because Republicans control both the House and Senate, but also because President Trump has proposed big cuts to the budget of the Department of Health and Human Services, which not only leads the effort to treat addicted infants but also manages the government’s opioid grant money.
Trump would cut its discretionary budget $12.4 billion in fiscal 2018. The president also wants to cut by 5 percent the budget of the Office of National Drug Control Policy, which coordinates the fight against drug abuse. And his budget asks Congress to approve $800 billion in cuts over 10 years to Medicaid, the health care program for low-income households.
The opioid problem, which started with abuse of prescription painkillers, has led to increases in abuse of related street drugs, such as heroin and fentanyl. The Drug Enforcement Administration, the federal agency charged with policing illegal drugs, says 80 percent of newly addicted heroin users were once abusing prescription opioids.
Keeping the money flowing, both through Medicaid and grants specifically targeting opioid abuse, is crucial, says Clark. “We want to be able to address the need for more treatment beds for treating addiction and substance abuse as chronic disease that includes long term management, like with diabetes, and to be able to have prevention programs, school screenings, education programs,” she says.
In the meantime, she continues to seek out GOP allies. For example, she’s working with Evan Jenkins, who represents the West Virginia House district that borders Rogers’, on legislation that would provide grants to states to better train doctors on the risks of prescribing opioids.
Physicians exacerbated opioid abuse, many believe, by giving people with relatively minor pain problems highly addictive drugs. Clark is also looking to push legislation to increase the use of trackable, electronic prescriptions and is working with medical schools to ensure they stress the dangers of prescribing opioids. “We are hoping to see the end of the days where people went home after having a wisdom tooth removed with a 30- or 60-day supply” of a prescription opioid, Clark says.
The concerns of Clark and others are having an impact. In May, Scott Gottlieb, who heads the Food and Drug Administration for Trump, announced that he was considering new protocols whereby doctors would have to receive training on opioid prescribing as well as possible limits on dosing. State legislation signed by Gov. Charlie Baker last year made such training mandatory in Massachusetts.
Gottlieb also says he’s going to consider adding a cost-benefit analysis component to the opioid drug approval process, examining the painkilling benefits against the potential for addiction. For the drug companies, that’s a most unwelcome prospect.