November 06, 2017

Senator Harris Launches Investigation into Pharmaceutical Manufacturer Alkermes Regarding Opioid Addiction Treatment Manipulation

Harris Letter Requests Specific Documentation Surrounding Promotion and Distribution of Vivitrol

WASHINGTON, D.C. - Today, U.S. Senator Kamala D. Harris, a member of the Senate Homeland Security and Governmental Affairs Committee, launched an investigation into Alkermes, a pharmaceutical manufacturer, regarding its efforts to artificially boost sales of Vivitrol, a treatment drug for opioid addiction. Recent reports have revealed that Alkermes attempted to increase sales of its own product while contributing to misconceptions about other medications used in the fight to combat the opioid epidemic, and worked to limit their availability. Harris is requesting information from Alkermes including marketing materials, financial transactions, internal reports, and detailed records.

For the last several years, Alkermes aggressively marketed its drug to people in the criminal justice system, often convincing judges and corrections officials to offer Vivitrol to inmates and parolees rather than treatment drugs with more proven efficacy. Alkermes officials have also spent hundreds of thousands of dollars lobbying state and federal lawmakers and officials in order to receive favorable promotion of Vivtrol and federal funding.

“Drug addiction touches every community and family in America, and it’s clear that pharmaceutical companies like Alkermes have way too much influence and power and too little accountability,” said Senator Harris. “We are at the height of a crisis and companies are taking advantage of pain in order to profit. We must hold these companies accountable for their deliberate actions that magnify the opioid epidemic and drive up the cost of drugs for Americans.”

“Alkermes has taken unethical drug promotion to new depths by enlisting judges, law enforcement personnel, and legislators to favor Vivitrol over proven treatments,” said Dr. Adriane Fugh-Berman, Professor, Department of Pharmacology and Physiology, Georgetown University Medical Center. “Alkermes’ actions undermine public health.”

“Alkermes has engaged in massive lobbying efforts to obtain commercial advantage, including large contributions to federal and state legislators,” said Dr. Anna Lembke, Chief of Addiction Medicine at Stanford University School of Medicine. “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.”

In a letter to Alkermes Chairman Richard Pops, Harris requested:

  • Judicial officials and drug courts to which Alkermes has assigned sales representatives and the years in which the company has assigned these representatives;
  • Activities of Vivitrol sales representatives, including how Alkermes determines their assignments, their cultivation of participants in the “speaker’s bureau,” and their latitude to entertain or otherwise compensate participating physicians and other experts;
  • Jails or prisons at which Alkermes has provided free Vivitrol shots, including the location of the facilities, the years in which Alkermes provided shots, the costs associated with the shots the company provided, and any contracts between Alkermes and the facilities concerning the provision of shots;
  • Any slide decks, presentations, talking points, or other materials Alkermes has provided to participants or speakers in the “speaker’s bureau” for Vivitrol since 2010;
  • Amounts paid by Alkermes to the following entities since 2010 and the purpose of those payments:
  1. American Association for the Treatment of Opioid Dependence
  2. National Association of Addiction Treatment Providers
  3. American Society of Addiction Medicine
  4. National Institute on Drug Abuse
  5. National Association of Drug Court Professionals
  6. National Association for Alcoholism and Drug Abuse Counselors
  7. Treatment Research Institute
  8. National Center on Addiction and Substance Abuse
  9. Partnership for Drug-Free Kids
  • Copies of any presentations Alkermes has delivered to investors concerning its state and federal lobbying efforts;
  • Any studies or other data in the possession of Alkermes concerning the superiority of Vivitrol as an opioid addiction treatment as compared to buprenorphine or methadone;
  • Documents sufficient to show Alkermes funding of CME modules or other educational presentations for physicians, nurses, pharmacists, or other medical professionals concerning Vivitrol since 2010.

The full letter to Alkermes Chairman Pops can be found HERE.

This investigation builds off of Harris’ long record of taking on drug pricing, the pharmaceutical industry, and tackling drug addiction. As Attorney General, Harris launched CURES 2.0, a state-of-the-art overhaul of California’s prescription drug monitoring program that allows health providers and pharmacists to more effectively flag at-risk patients and curb prescription drug abuse. Harris also joined 34 other states and the District of Columbia in filling a lawsuit against pharmaceutical companies that allegedly engaged in a scheme to block competition for suboxone, an opioid addiction treatment.

During her time as Attorney General, Harris also obtained criminal penalties against an international prescription drug trafficking organization, and her department led a task force that investigated the medical director of a recovery center that had systemically over prescribed medication, leading to its operating license being revoked.

 

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