The latest drugmaker to feel the opioid-controversy heat is Alkermes, maker of Vivitrol, a branded, once-monthly version of a generic addiction treatment—specifically, the aggressive marketing and lobbying that have put its sales on a blockbuster trajectory.
Alkermes says the media criticism isn't a fair characterization of its efforts. In fact, the company characterized it as "dangerous in the midst of an unyielding epidemic." And it's not going to step away from spreading the word about its addiction remedy and advocating its use.
At issue is Alkermes’ marketing—and its even bolder lobbying efforts—aimed at building name recognition and driving sales of Vivitrol, first approved for alcohol addiction in 2006 and then for opioid addiction in 2010. The drugmaker's Vivitrol push has been so successful that the drug is headed for $1 billion in sales by 2021, analysts say, up from $200 million last year.
The flap is yet another instance of drugmakers attracting public and political scrutiny for their marketing efforts, with companies in the opioid and addiction field attracting more and more heat as lawmakers and the FDA take new steps to fight an epidemic of overdoses.
Vivitrol has enjoyed some high-profile shoutouts lately, following years of stepped-up lobbying spend. Alkermes' national political contributions, some made by staff, and lobbying outlays hit $4.5 million in 2016, according to data from OpenSecrets.org.
That surge of growth, revenue and lobbying-wise, has newsers gaping. The fact that Vivitrol is a pricey $1,000-plus per shot doesn’t help. Generic naltrexone is, of course, far cheaper.
The backlash began in May after Health and Human Services Secretary Tom Price mentioned Vivitrol by name as a potential treatment for opioid addiction. Naltrexone, which has been around for decades and now is most used in its daily pill form, works to block the effects of opioids on the brain. It's a different approach from the opioid-based addiction therapies such as methadone and buprenorphine, used as lower-level substitutes for powerful and dangerous meds.
Price had visited Alkermes’ Vivitrol plant in Wilmington, Ohio, in April to talk up the Trump administration’s commitment to fighting the opioid epidemic. A local judge pitched in to tout his use of Vivitrol in jail to prevent addicts from relapsing, according to a report from TV station WLWT.
Then came Price's second public backing for branded Vivitrol—and its implied superiority over the methadone approach—in May: “If we’re just substituting one opioid for another, we’re not moving the dial much,” Price said, as quoted by the Charleston Gazette-Mail. Hundreds of researchers and physicians cosigned a letter urging Price “to set the record straight.”
Headlines followed, beginning in The New York Times, but echoed in additional original reporting from NPR, ProPublica, Yahoo and smaller local newspapers and TV stations, Alkermes’ lobbying and marketing efforts—outdoor awareness ad campaigns have run from Ohio to Massachusetts—were detailed as “profit opportunities that drug companies and investors see in an opioid epidemic” by the NYT, and worse, as trying “to cash in on the opioid epidemic,” via NPR.
Alkermes disputes those claims. In a statement to FiercePharma, it said, in part, “Vivitrol is an important and distinctive medication that has been used by tens of thousands of patients. Unfortunately, recent statements in the press have criticized Vivitrol and our company. We believe that the opinions published in these articles are dangerous in the midst of an unyielding epidemic where very few patients are being treated to begin with.”
The company also added that it has no intention of halting its effort, saying, “Alkermes takes great pride in the work we do with physicians, public health officials and policy makers to expand their knowledge, understanding of clinical data, and access to Vivitrol. Our work is patient-focused, consistent and transparent, and we will continue it as we address this serious public health crisis.”
Meanwhile, Vivitrol sales are on an upward spike with even higher expectations. After taking in $209 million last year, Alkermes put up a 2017 sales forecast in the $280 million to $300 million range. In a corporate presentation posted in June, the company charted Vivitrol sales soaring to more than $1 billion by 2021.
By Alkermes' own account, Vivitrol is now used in 450 programs across 39 states which includes a “range from public health initiatives to criminal justice programs in drug courts, prisons and jails." Those stats represent "leading indicator[s] of the sustained growth of Vivitrol,” said CFO James Frates in its first quarter earnings call, via Seeking Alpha.
CEO Richard Pops added, “The trends underlying Vivitrol’s potential and growth are strong and supported by the activation of policymakers at the local, state and federal levels.”
By Alkermes’ own activation of policymakers, some have argued. National lobbying spending by Alkermes started climbing after 2012, from $164,000 that year up to $880,000 in 2013. Big jumps have come every year since, with totals of $2.6 million in 2014, $4 million in 2015 and $4.5 million in 2016, OpenSecrets.org reports.