A basketful of opioid makers have been drawn into federal and state investigations into their marketing practices, but now one U.S. senator is going after a company that says it’s just trying to help the country get control of the crisis of addiction to the powerful painkillers.
Yesterday, Sen. Kamala Harris, D-Calif., announced a new investigation into Ireland-based Alkermes focused on its marketing of Vivitrol to treat opioid addiction. Harris sent a letter to Alkermes CEO Richard Pops alleging that the company has spent millions on “an aggressive lobbying and marketing campaign to increase the use of Vivitrol instead of cheaper treatment alternatives, like methadone and buprenorphine, from other manufacturers.”
Harris pointed to media reports citing $19 million spent by the company on federal lobbying. She alleged that the company sent sales reps to judges who preside over drug courts and gave free shots of Vivitrol to prisoners as they left jail. “As a result,” Harris wrote,” cheaper and more thoroughly studied treatments appear to have been stigmatized and marginalized.” The Vivitrol marketing campaign pushed annual sales of the drug from $30 million to $209 million in the last five years, she contends.
Alkermes came under scrutiny for its marketing practices in May, after Health and Human Services Secretary Tom Price talked up Vivitrol and visited the company’s manufacturing plant in Ohio. Multiple media outlets cried foul, highlighting the company’s heavy lobbying efforts for a treatment that costs more than $1,000 per shot—far more than generic naltrexone and other choices.
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Harris is demanding that Pops cough up 11 sets of documents, including a list of the jails that allegedly got the free Vivitrol shots, copies of materials used by its sales reps, and donations paid to nine addiction-related nonprofits, including the Partnership for Drug-Free Kids and the American Society of Addiction Medicine. The company has until Dec. 2 to comply.
Alkermes barked back, releasing a statement pointing out that Vivitrol, which hit the market in 2006, is the only medication approved by the FDA to prevent relapse following opioid detoxification and that it is nonaddictive. The company also blasted the addiction treatment system, saying its fragmented nature means “too many providers do not offer treatment based on the patient’s physical needs, but instead provide a one-size-fits-all approach.”
In a statement provided to Fierce, Alkermes said it offers samples of Vivitrol upon written request from correctional institutions, but only if those institutions qualify for the program by providing "ongoing support services" to prisoners during re-entry. As for its lobbying expenditures, the company says it is "middle-of-the-road" compared other pharma companies and "we do not apologize for engaging in advocacy practices, and will continue to do so because these forms of communication and information exchange are vital to increasing awareness of Vivitrol and the need to improve the opioid treatment system."
The company says it will cooperate with Harris and that executives "look forward to telling our story."
Harris’ probe is one of many focusing on the behavior of pharma companies during the worsening of the opioid crisis. In September, Sen. Claire McCaskill, D-Mo., released a report alleging improper marketing practices by employees of Insys Therapeutics, maker of Subsys, including one instance of an employee posing as a doctor to request a prescription for a patient who later died of an overdose. Federal prosecutors last month charged now-former CEO John Kapoor with racketeering and fraud in connection with Insys' marketing, and several other executives also face charges.
McCaskill has requested information from several other opioid makers, including Purdue, Mylan and Johnson & Johnson. Drug distributors have also come under fire.
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Then there are the state investigations. In September, attorneys general in 41 states issued subpoenas to Endo, J&J, Teva Pharmaceutical and Allergan, along with requests for information from Purdue and three top distributors. Several state and local governments are also suing opioid makers, alleging they fueled the addiction epidemic using fraudulent marketing tactics.
For Alkermes, the Harris investigation is coming at a difficult time. The company’s shares are down 13% for the year to $48.76, as it struggles to collect enough positive data to persuade the FDA to approve its antidepressant ALKS 5461. The drug failed two key clinical trials because of a high placebo response, the company says. In August, the company kicked off a rolling submission for approval, but some analysts are not optimistic about the drug’s prospects.
In the wake of Harris’ demand for documentation on Vivitrol, Alkermes’ shares dropped another dime to $48.65 in premarket trading.
Editor's note: This story has been updated with responses provided by Alkermes.