Arizona Governor Doug Ducey mentioned the anti-opiate Vivitrol prominently in his state-of-the-state address this year, saying that some call it a "miracle drug."
But U.S. Senator Kamala Harris, a Democrat from California, says aggressive marketing by the pharmaceutical company pushing the drug is anything but miraculous. She's calling for an investigation.
Arizona began administering Vivitrol, which prevents users from feeling the high of opiates, to select state prisoners in August.
She pointed to recent media reports, including a June article in the New York Times, that showed Alkermes "has pursued an aggressive lobbying and marketing campaign" aimed at "law enforcement officials and lawmakers."
The company has boosted sales of the drug from $30 million in 2011 to $209 million last year, with the result being that "cheaper and more thoroughly studied treatments appear to have been stigmatized and marginalized," according to Harris.
Her letter contains an 11-point list of items she wants turned over, including:
• A list of jails and prisons that offered free Vivitrol shots to prisoners.
• How Alkermes handles its "speaker's bureau" for doctors.
• Materials provided to law-enforcement personnel or judges.
• Information the company gave to investors about its state and federal lobbying efforts.
As a junior member of the Senate Homeland and Governmental Affairs Committee, Harris can't subpoena the documents directly.
How Vivitrol ended up with such excellent product placement in Ducey's January address isn't known. One possible connection, however, could be the fact that Alkermes, headquartered in Dublin, Ireland, was until recently a client of Axiom Public Affairs, an Arizona public-relations company tied to Ducey.
One of Ducey's longtime friends, Jim Norton, was a managing partner of Axiom until he was indicted by a federal grand jury in May over an alleged bribery scheme along with developer George Johnson and former Arizona Corporation Commissioner Gary Pierce and Pierce's wife, Sherry.
Norton professed his innocence but distanced himself from the PR company following the indictments. Axiom removed "The Norton Companies" as a managing member in June, and changed the company name to Compass Rose Public Affairs. A month later it changed its name again, to Compass Strategies, LLC.
Sean Noble, a key Compass/Axiom partner who helped raise money for Ducey's 2014 election, did not return a call for this article.
Representatives from Ducey's office and Alkermes didn't call back, either.
The gist of Harris' complaint is that Alkermes figured out that the best way to make money was to schmooze non-medical clients like government officials, judges, and prison wardens. The company spent $19 million in federal lobbying alone, Harris told Alkermes chairman and CEO, Richard Pops, in her June letter, referring to the New York Times article. One Alkermes official told investors last year that the company hoped to "create a gentle federal breeze to kind of sweep behind us."
Vivitrol might serve a legitimate purpose, but its ever-increasing use has "stigmatized and marginalized" the use of opioid-treatment alternatives like methadone and buprenorphine. That's a problem, Harris' letter states, because the other two drugs are cheaper and possibly more effective.
Methadone and buprenorphine also block opiates from affecting users, but do it by replacing drug receptors in the body with similar, though less-debilitating opiates. Vivitrol, a brand name for an extended-release form of Naltrexone, is not an opiate, so users can't get addicted to it or overdose on the drug itself.
Harris also mentioned that Alkermes has promoted Vivtirol using a "'speaker's bureau' composed of doctors paid to promote the drug."
Treating America's opioid crisis should be carried out with "sound science" and "not the marketing and lobbying prowess of the pharmaceutical industry," she wrote.
The company "strongly disagreed" with Harris' comments, Alkermes officials said in a reaction to the senator's demands last week. In its statement, Alkermes disparaged the current system of using methadone and buprenorpine, asserting that it used a "disruptive approach" that better meets the needs of clients and society.
"The opioid addiction and treatment system must change if we are to implement and realize the promise of patient-centered care," the company stated, adding that its efforts have been "transparent."
Alkermes' marketing practices aren't illegal — but they are unethical, according to Dr. Anna Lembke, an addiction specialist and associate professor at Stanford University Medical Center.
Some politicians and bureaucrats, especially conservative ones, have strong biases against methadone and buprenorphine, she said. The message pushed by the Vivitrol salespeople "is playing on the biases and fears around using opioids to treat opioid addiction."
One example of that attitude came up in May, when former U.S. Health and Human Services Secretary Tom Price touted Vivitrol and told members of the press, "If we’re just substituting one opioid for another, we’re not moving the dial much."
Vivitrol may have its place in the "tool box" of addiction health care, Lembke said. The concern is that Alkermes' marketing campaign leads to better-funded Vivitrol programs — with the result that more addicts are failing to get treatment by the tried-and-true methods of taking methadone or buprenorphine.
Not enough studies have been conducted on Vivitrol's safety, either, Lembke said.
Vivitrol treatments differ greatly from that of methadone, which has been used to wean people off morphine and heroin since the 1950s. While methadone must be taken every day, addicts get a Vivitrol shot just once a month. However, addicts must be clean for several days before taking Vivitrol. That can deter heavy users who can't handle the intense cravings, Lemke said.
Anecdotal reports have surfaced of addicts shooting up with too much heroin and overdosing in an attempt to overcome the anti-opiate effect of Vivitrol, she said.
Nick Stavros, CEO of Community Medical Services, also said he believes Vivitrol is appropriate for certain patients, but is not a fan of the way Alkermes' marketing downplays the effectiveness of methadone and buprenorphine. Community Medical Services is an opiate-addiction treatment center with 12 locations across the country, including four in Arizona.
Stavros recalled attending an industry dinner three years ago where a doctor brought in by Alkermes started the conversation by saying,"let's talk about all of the problems" with methadone and Suboxone, a brand name for burprenorphine.
"I’m not sure why Governor Ducey called it a 'miracle drug,'" Stavros said. "The governor's office has spearheaded a lot of positive initiatives, but there is very little research to qualify that description, and [there are] limited studies on the efficacy of Vivitrol."
Former Democratic state lawmaker Steve Farley, who's running for governor next year against Ducey, a Republican, claimed in a July press release that Ducey probably supports Alkermes because the company "is a partner at the American Legislative Exchange Council," also known as ALEC.
Citing the website Sourcewatch, Farley said that at an ALEC meeting in 2012, legislators and lobbyists passed a resolution presented by an Alkermes representative in support of Vivitrol.
Farley's spokesman, Joe Wolf, said Ducey's Vivitrol plug may have also been spurred by the governor's relationship with Norton.
"Either way, it was sketchy as hell," Wolf said of the pharmaceutical name-drop.
In the January address, Ducey noted that he had just signed an executive order authorizing use of Vivitrol so that "people leaving our prison system have the opportunity to be treated with this blocker, before they walk out the doors, to maximize their success of never ever going back."
The program began two months ago, with the goal of treating up to 100 prisoners over the next two years, said Bill Lamoreaux, Arizona Department of Corrections spokesman.
DOC helps locate the right candidates. Selected men and women get injected with their first dose of Vivitrol just before leaving the prison.
So far, six prisoners have received the dose before their release, Lamoreaux said.
The exact cost of the shots and how much the state pays has differed in news reports. A February article by Christianna Silva of Arizona Sonora News states that each shot costs $1,000. Christina Corieri, the health policy advisor for the state of Arizona, told Silva that the Arizona Healthcare Cost Containment System (AHCCCS) would likely pick up half of the cost, meaning the state would pay $3,000 for the six-month treatment, not including the cost of substance-abuse counselors.
In August, a prison official told KTAR news (92.3 FM) that Vivitrol costs $1,300 per shot.
“We pre-enroll them in AHCCCS prior to release, then the day that they’re released, their AHCCCS eligibility kicks in," Karen Hellman, the director of inmate programs and re-entry, told the radio station. "And then, as long as they remain on AHCCCS, AHCCCS will cover the cost of the shot for them, they may have a small co-pay, but it cover[s] the bulk of the cost as long as they’re on AHCCCS.”
As Channel 15, (KNXV-TV), reported in August, Violet Rose of Phoenix became the first prisoner to take Vivitrol under Ducey's program. The 27-year-old had battled drug addiction for years and turned to heroin last summer, just before landing in prison because of a probation violation for a drug offense.
"The low point was losing my kids, my children," she said of her experience, telling the TV station that she was determined to lead a sober lifestyle with the help of Vivitrol.
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Lamoreaux said that only one of the six prisoners on the drug have failed and "come back to us."
It was Rose.
She tested positive for methamphetamine, which Vivitrol doesn't affect, Lamoreaux said.
UPDATE: Daniel Scarpinato, Ducey's spokesman, got back to New Times two days after publication of this article. He denied that Ducey had been influenced by Norton in mentioning Vivitrol, and also downplayed the idea that the two men are good friends. As for Ducey's quote about a "miracle drug," Scarpinato said the reference in the state-of-the-state speech was to quotes by a nurse in a 2015 article in the Washington Post about Vivitrol.