Kamala Harris scrutinizes opioid treatment drug manufacturer

She may not have the same legal tools she had as California’s attorney general, but Democrat Kamala Harris is aiming to use her perch on the Senate’s chief oversight committee and her rising national profile to shine a light on the marketing practices of Big Pharma.

Specifically, Harris is demanding a ream of documents from drug manufacturer Alkermes about the way it has promoted Vivitrol, a drug used to treat opioid addiction.

The New York Times and NPR reported over the summer that Alkermes has seized on the country’s struggles to contain the opioid epidemic to aggressively market Vivitrol to an unusual set of customers: law enforcement officials and lawmakers. The tactic is “nearly unheard of for a pharmaceutical company,” the NPR story notes.

In the process, “cheaper and more thoroughly studied treatments appear to have been stigmatized and marginalized,” Harris wrote in a Nov. 6 letter to CEO Richard Pops, which was obtained by McClatchy.

Specifically, the reporting suggests Alkermes has sought to paint buprenorphine and methadone, two less expensive alternative treatments for opioid addiction known as “opioid agonists,” as risky in-and-of themselves.

“Alkermes’ current advertising campaign claims that Vivitrol is the only ‘non-addictive’ treatment for opioid addiction. This is a deliberate attempt to discourage use of opioid agonist therapy in favor of Vivitrol, despite the fact that the evidence for effectiveness of buprenorphine and methadone maintenance is robust,” Dr. Anna Lembke, chief of the Stanford Addiction Medicine Dual Diagnosis Clinic, said in an email. “Alkermes is playing on fears and biases against opioid agonist treatment, which are longstanding, despite the overwhelming evidence for their effectiveness,” Lembke added.

In her letter to Pops, Harris asks the company to provide a list of documents, including:

  • A list of judicial officials and drug courts to which Alkermes has assigned sales representatives.
  • A list all jails or prisons at which Alkermes has provided free Vivitrol shots.
  • Copies of any educational materials provided to law enforcement personnel or judges.
  • Research or data “concerning the superiority of Vivitrol as an opioid addiction treatment.”

In a corporate statement issued Monday afternoon, Alkermes said it “strongly disagrees with Senator Harris’ comments.” Vivitrol, the statement says, “is the only FDA-approved medication that completely blocks the effects of opioids. It does not produce physical dependence and thus is non-addictive.” And it says the company “believes that patients should have access to all medications.”

As California attorney general, Harris helped overhaul the state’s prescription drug monitoring system and joined a 2016 lawsuit with 34 other states against two pharmaceutical companies alleged to have tried to block competition to Suboxone, a widely used form of buprenorphine.

But Harris no longer has the threat of legal action she had as attorney general to force companies like Alkermes to cooperate with her demands. She is a junior member of the Homeland and Governmental Affairs Committee, which is the main investigative panel in the Senate. But only the chair of the committee, currently Republican Sen. Ron Johnson, can unilaterally issue subpoenas.

Individual senators do have some levers they can pull in investigations. Thanks to their national profiles, senators have the ability to draw attention to issues and apply public pressure. Most companies don’t want to appear as though they are being uncooperative or ducking a Senate investigation, even if their participation is voluntary.

The committee’s lead Democrat, Missouri Sen. Claire McCaskill, has instigated a broader probe of opioid manufacturers and how their marketing practices have contributed to the addiction epidemic. As part of their opioid investigation, McCaskill’s staff has compiled an in-depth report on how one company, InSys, developed strategies for ducking prescribing safeguards.

McCaskill’s committee staff worked with Harris’s staff as they drafted the letter to Pops. And McCaskill’s committee spokesman, Drew Pusateri, said the ranking member is “very supportive” of Harris’ efforts.

Harris’ reputation as an emerging Democratic leader gives her a bully pulpit that has the potential to make corporate CEOs squirm, even without the threat of legal action. But it’s no guarantee she’ll get the kind of detailed information she’s seeking from Alkermes. The company’s response to Harris’ letter will be a measure of just how much the company fears her wrath.

More than half million people have died between 2000 and 2015 from opioids. Today, opioid deaths are considered an epidemic. To understand the struggle individuals undergo once addicted to these drugs, we take a closer look at what happens to your

Emily Cadei: 202-383-6153, @emilycadei