This story was updated at 11 a.m. to include a comment from Senate President Stan Rosenberg's office.
A common way to promote a drug goes something like this: a well-dressed sales representative walks into a doctor’s office and pitches the medication.
When Alkermes got FDA approval to market Vivitrol, for treating opioid addiction, the company took a different approach: targeting lawmakers and law enforcement officials.
Alkermes, a Waltham-based drug company, has come under fire this month. Both the New York Timesand NPRhave raised questions about their drug, Vivitrol. The investigative reports challenge the drug’s efficacy and detail Alkermes’ lobbying strategy, suggesting the company sought to profit off the opioid epidemic.
Here’s a look at what has happened in Massachusetts.
The Lawmakers
The New York Times reports that Alkermes hired lobbyist and former Lieutenant Governor Tom O’Neill. Alkermes went on to spend tens of millions of dollars on lobbying, including tens of thousands here in Massachusetts.
“It is striking as you look across the country to see how much traction they have gotten since they started this campaign,” said Pam Wilmot, the executive director of Common Cause Massachusetts, an advocacy group for government accountability.
Wilmot says this kind of lobbying is a tried and true strategy – but it’s a problem.
“We don’t want decisions being made on money and politics,” she said. “We want decisions being made on the merits of what kind of treatment is best for people who use drugs, or for the general public in terms of public safety and public health.”
A review of state campaign contributions by WGBH News found that Alkermes has donated to dozens of Massachusetts political campaigns – including that of Governor Charlie Baker, House Speaker Bob DeLeo and Senate President Stan Rosenberg.
Baker’s office did not comment specifically on the donations but released a statement saying his administration “is committed to increasing the tools available to combat this epidemic,” and that they are working to ensure access to all medication-assisted treatments.
A spokesperson for Rosenberg said it is not the job a legislator to evaluate the effectiveness of drug treatment. DeLeo’s office did not responded to requests for comment.
While it is nearly impossible to document a direct link between campaign donations and legislation or policy that favors a company’s interests, there are examples where Alkermes’ donations raise questions.
For example, State Senator Jennifer Flanagan and State Representative Elizabeth Malia both have pending bills directing the state’s Department of Public Health to provide physician training to administer the drug. Both politicians received campaign donations from Alkermes.
Malia did not respond to requests for comment and Flanagan said the donations didn't influence her.
"I think that people's lives are at stake, and I don't equate that with campaign donations,” Flanagan said.
The Law Enforcement Officials
The New York Times reports the drug company has worked hard to get their product into jails and prisons.
The strategy? Offer a free dose of Vivitrol for inmates with opioid addiction who are nearing release. Once they are out of prison, patients keep getting monthly injections of the drug.
The only difference is that Medicaid usually picks up the tab. According to the Times, it costs about $500 per shot for Medicaid and $1,000 per dose for private insurers. That’s far more than alternative medications.
Middlesex County Sheriff Peter Koutoujian developed a program called Medically Assisted Treatment and Directed Opioid Rehabilitation (MATADOR), which does just what Alkermes had envisioned.
Launched in 2015, MATADOR offers a Vivitrol dose – donated by Alkermes – to inmates, enrolls those eligible in Medicaid, provides a recovery coach and encourages counselling.
Koutoujian has presented to Alkermes’ investors and received several thousand dollars in campaign donations from the company, its employees and its senior executives. A spokesperson says Koutoujian recently returned those donations largely because he didn’t want them to be a distraction.
“I am incredibly proud of this program and the significant recidivism reduction results we have seen since its inception,” Koutoujian said in a statement.
Of all the participants, 80 percent had no recidivism event, including no re-arrests or re-convicts. That’s compared to 72 percent for the general inmate population after one year of release.
Plus, among the 75 participants who successfully completed the 6-month program, 94 percent had no recidivism event.
However, the medical community is still skeptical of Vivitrol’s efficacy.
“It just simply doesn’t seem to be as successful as the other options that we have,” said Sarah Wakeman, the medical director of the Mass General Hospital’s Substance Use Disorder Initiative.
“We have well over 50 years of research looking at the treatment of opioid use disorder with medications like methadone and, then subsequently, buprenorphine.” Wakeman said. “The results are overwhelmingly favorable for those medications.”
Wakeman said there’s far less research on Vivitrol and, so far, no studies comparing it to the proven alternatives. She said the research that has been done suggests – for carefully selected patients – Vivitrol may be better than no treatment at all.
But, she said, one big risk of the drug is that when a patient stops taking it, “their tolerance has been completely removed, and so their risk of dying from an overdose increases dramatically.”
This means Vivitrol is often best used for people with less severe opioid addiction. So, Wakeman worries when she sees Vivitrol used in prisons and jails because people there often have a severe history of opioid use.
So, why don’t inmates get those better-researched and less expensive alternatives? Wakeman says there’s one answer: “We don’t use those medications in large part due to stigma and misperceptions.”
The Times and NPR investigations found that Vivitrol’s manufacturer Alkermes used those misperceptions to its advantage – for example, suggesting that buprenorphine is too similar to street drugs.
“It’s quite concerning that literally people’s lives are at stake and we’re letting our treatment decisions be guided by this persistent stigma instead of by science,” said Wakeman.
In a statement to WGBH News, Alkermes said they are surprised at the New York Times and NPR investigations, saying the reports are an attack on the company’s integrity. Alkermes maintains their work has been transparent and that patients should have access to all FDA-approved medications for opioid addiction.
