Senator Harris Scrutinizes How Alkermes Pushed Its Opioid Addiction Drug

Drug Product

After U.S. Sen. Kamala Harris publicly decried Alkermes and its marketing of opioid addiction treatment Vivitrol, the Waltham, Mass.-based company fired back and defended its product and criticized the treatment system for the national opioid epidemic.

Harris fired the first shots on Monday. She announced an investigation into Alkermes regarding its efforts to “artificially boost sales” of Vivitrol. Harris said reports have surfaced that suggest Alkermes attempted to increase sales of Vivitrol while “contributing to misconceptions about other medications” used to treat opioid addiction. Additionally she said Alkermes worked to limit the availability of those other drugs through lobbying efforts. Through those lobbying efforts of state and federal officials, Harris said Alkermes “aggressively marketed” its drug to people in the criminal justice system – arguments first reported by ProPublica in June. She said the company convinced judges and corrections officials to “offer Vivitrol to inmates and parolees rather than treatment drugs with more proven efficacy.” Harris also alleged that the lobbying efforts by Alkermes resulted in favorable promotion of Vivitrol and federal funding.

Harris wasn’t alone in her condemnation of Alkermes. Joining her was Dr. Anna Lembke the chief of addiction medicine at Stanford University School of Medicine. Lembke said Alkermes lobbying efforts and large financial contributions to state and federal lawmakers have allowed it to gain commercial advantage. Additionally, she suggested that Alkermes’ marketing efforts about the efficacy of Vivitrol is misleading.

“Alkermes’ current advertising campaign makes the misleading claim that Vivitrol is the only “non-addictive” treatment for opioid addiction, contributing to existing stigma on the use of opioid agonist therapy in the treatment of opioid addiction, despite a large and robust evidence base showing the effectiveness of opioid agonist therapy for opioid addiction,” Lembke said in a statement.

Her accusations lead to shares of Alkermes falling from $51.17 to $48.89 on Monday. Shares are still down this morning, trading at $48.61 as of 9:38 a.m.

This morning, Alkermes said it strongly disagreed with Harris’ accusations. The company said Vivitrol is one of three opioid addiction drugs approved by the U.S. Food and Drug Administration, but it’s the only one “approved for the prevention of relapse to opioid dependence following detoxification.” Methadone and buprenorphine are also commonly used to combat opioid addiction, but both are opioid-based treatments. The company said Vivitrol is the only treatment that completely blocks the effects of opioids. The drug is non-addictive and “represents a disruptive approach that challenges the treatment status quo.”

Not only did the company defend the efficacy of Vivitrol, but it also challenged what it called the status quo of the current treatment system. In its defense, the company said the system is “fragmented” and has relied on a “one-size-fits-all approach.”

“The opioid addiction treatment system must change if we are to implement and realize the promise of patient-centered care: care customized to the clinical needs of the patient, regardless of the treatment setting in which the patient is seen. Alkermes has been transparent in its efforts to support patient-centered care. Alkermes is focused on ensuring that patients, healthcare professionals and criminal justice officials are educated on Vivitrol and believes that patients should have access to all medications,” Alkermes said in a statement.

Harris’ probe of Alkermes is the latest in a line of actions taken by lawmakers against drug companies that manufacture opioid-based treatments. Charges were recently filed against a number of former Insys executives, including its founder John Kapoor. In July, the FDA told Endo Pharmaceuticals to remove its opioid pain medication, reformulated Opana ER, from the market.

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