The Big Pharma industry is still in the hot seat, and this week another lawmaker is adding a new name to the roster of drug makers to be investigated for shady marketing practices. Alkermes, the company behind the opioid treatment implant Vivitrol, is now being investigated for how they market their product.
Background on Vivitrol
Vivitrol is another name given to the generic drug Naltrexone. Originally approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence in 1994, Naltrexone eventually became approved for the treatment of opioid dependence. The medications primary use appears to be blocking the opiate receptors in the brain. It’s intended so that someone using heroin or other opiate-based drugs cannot experience the drugs high.
The Vivitrol shot is made by Boston-based biotech Alkermes. This medication stood out from other Naltrexone medications because Vivitrol is an injection given every 4 weeks with a monthly doctor visit. It is time released for longer lasting relief, instead of being a pill taken once a day.
Supposedly Vivitrol is intended to further help by reducing cravings for opioids. However, Naltrexone and Vivitrol have been refuted by many for having any notable effect on opioid cravings.
Enter Senator Harris
Kamala Harris is a Democratic California Senator who has announced she will be part of launching a new investigation into the sales and marketing practices of the makers of Vivitrol. According to the senator, Alkermes allegedly worked to increase sales of their opioid treatment medication through two questionable strategies:
“Aggressively” marketing Vivitrol to officials in the criminal justice system
Senator Harris says that Alkermes pushes for judges and lawmakers to use their product. The company even provided free samples, which resulted in Vivitrol being actively implemented in 450 treatment programs across 39 states.
Lobbying efforts by federal and state lawmakers
In her statement, Harris also alleges that the company has spent millions of dollars in direct appeals to government officials. Meanwhile, they were contributing to numerous congressional campaigns.
Due to the drug companies marketing, Vivitrol raked in well over $69 million dollars in the third quarter of 2017.
In her statement Senator Harris says,
“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.”
The senator even quoted the chief of addiction medicine at Stanford University School of Medicine, Dr. Anna Lembke, who said,
“Alkermes has taken unethical drug promotion to new depths by enlisting judges, law enforcement personnel, and legislators to favor Vivitrol over proven treatments. Alkermes’ actions undermine public health.”
Which seems like some pretty strong words. In the midst of the opioid crisis, it might be fair to say we should use every resource we can get. However, the Big Pharma enterprises still need to be put in check when it comes to overlooking more effective treatments.
In fact, a 2011 review of studies suggested that Naltrexone was not significantly superior to placebo, and the authors believed there was no sufficient evidence to support Naltrexone therapy for opioid dependence.
One reason Senator Harris seems to have Vivitrol in the crosshairs seems to be that the pharmaceutical company made a habit out of promoting Vivitrol as a more effective treatment than other maintenance drugs, such as Suboxone or Methadone, even though there is no substantive data to support this claim.
As part of the investigation, Harris contacted Richard Pops, the Alkermes Chairman, requesting the company provide data and communication. At the moment Alkermes is disputing the allegations. Senator Harris appears to be calling their bluff, as she was requested that Alkermes submit:
Alkermes has also been asked to turn over any materials provided to participants or speakers for Alkermes since 2010. They’re being asked to disclose amounts paid to the company by various associations, including:
American Society of Addiction Medicine
National Institute on Drug Abuse (NIDA)
Partnership for Drug-Free Kids
Any studies presented to these groups are also to be turned in.
In their own statement, Alkermes states they are “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.”
There is no telling whether or not this investigation is going to turn into a witch hunt or if it will blow the lid off of even more bad behavior from Big Pharma. While other drug companies that can be connected to the opioid crisis are already facing lawsuits and others even criminal cases for racketeering and fraud, the Vivitrol producers might find themselves on the chopping block sooner rather than later.
There is already much disagreement about whether or not the Vivitrol treatment is really effective in the first place. Some say the medication helped save their life. Many others have horror stories of uncomfortable side-effects made worse by cravings. Either way, pharmaceutical companies still need to be held accountable for their marketing methods, especially when they seem a little suspect.
For now, this is all a request. Only Republican Senator Ron Johnson has the power to issue subpoenas on behalf of the Homeland and Governmental Affairs Committee.