Prominent ads at the Downtown Crossing train station ask “What Is Vivitrol?” An ad with fine print visible mainly from the opposite platform explain the drug’s benefits and risks. (Photo: Sue Reinert)

Advertisements showing a man or woman with an unfathomable expression and the printed question “What is Vivitrol?” have appeared in the past month or so to tease riders in red line trains and stations. The answer is not in the ad, but it’s no big mystery: Vivitrol is a relatively new and expensive treatment for drug addiction.

A bigger question is, why is this prescription medicine being advertised in the subway, a rare if not unique setting for drug ads? And are MBTA ads for Vivitrol a good way to give consumers a fair picture of the medicine’s benefits and risks?

Jennifer Snyder, a spokeswoman for Vivitrol’s maker, Alkermes (which began in Cambridge in 1987, but moved its offices to Waltham in 2009), said the company decided to launch the MBTA ad campaign because of the state’s spiraling opioid addiction epidemic. Since 2004, “more than 6,600 residents of Massachusetts have died as a result of opioid abuse,” Snyder said in an emailed statement that referred to state government statistics. “Along with those deaths are thousands of hospital stays, emergency department visits and enormous impact on people, families and communities.”

“This compelling public health issue in Massachusetts factored into Alkermes’ decision for the campaign,” Snyder said.

Fine print

She did not answer specific questions on how the advertising met requirements to present risks equally with benefits, whether the company has posted Vivitrol ads in other public transit systems, whether the Massachusetts Bay Transit Authority or company decided ad placement or whether the company sought review from federal Food and Drug Administration regulators – which is voluntary – before launching the campaign.

An FDA spokeswoman provided information on the requirements but declined to comment on the ads, saying the agency does not discuss specific advertisements.

As of this week, some had disappeared – ones that explicitly described the benefits and risks of Vivitrol. These advertisements had not been very prominent compared with those that simply asked what the drug is. They were posted high on the walls of red line and orange line stations at Downtown Crossing, disclosing the medication’s purpose as an addiction treatment and listing warnings and side effects in a box labeled “Important Facts.”

But these ads were difficult if not impossible to read because of their small type and placement far from the typical rider standing on the platform and facing the tracks. There was one readable benefit-and-risk ad for Vivitrol at Downtown Crossing, in a stairwell leading from the inbound red line platform to the station mezzanine.

Almost all the remaining Vivitrol ads on the MBTA simply ask what the drug is, and they may not be required to list risks, since they don’t proclaim any benefits, said Michael Carome, director of health research for Public Citizen, the advocacy group founded by Ralph Nader. “I’m uncertain whether an ad asking what a drug is with a link to a website telling detailed information violates FDA rules,” he said.

Virtues and risks

Vivitrol, whose chemical name is naltrexone, works differently from more well-known medications for drug addiction such as methadone and buprenorphine, which are narcotics themselves and operate by dampening the euphoria an addict gets from using opioids. Vivitrol instead blocks that high for an extended period, which may make it more effective but also carries risks of severe withdrawal symptoms and overdose if addicts relapse while on the drug or start taking it before they’re drug free.

Proponents of Vivitrol say addicts can abuse methadone and “bupe,” but not naltrexone. And patients treated with Vivitrol get an injection that lasts for a whole month, while those taking the other drugs must swallow a pill every day, making it easier for them to drop out of treatment, some addiction specialists say.

A recent study of male parolees that compared Vivitrol with the other addiction treatment drugs found that 43 percent of those treated with Vivitrol had relapsed by six months, while 64 percent of patients getting the other drugs had relapsed. After a year of no medication treatment, though, half of the men who successfully got clean had relapsed no matter which treatment they had been given.

Vivitrol presents different risks than methadone and buprenorphine. The medication carries a “black box warning,” the highest level, that it can cause liver damage or hepatitis. Other risks listed by Alkermes are overdose and death if a patient takes opioids after ending Vivitrol treatment, or tries to overcome the blocking effect of Vivitrol by taking a huge amount of opioids. Severe reactions at the injection site are also possible.

Addicts must have stopped taking opioids for seven to 10 days and be completely free of narcotics before starting Vivitrol. They could suffer severe withdrawal if they begin the injections while they still have opioids in their system. And a patient who needs opioids for legitimate pain treatment while he or she is on Vivitrol must find an alternative method, because Vivitrol may block the painkilling effect of opioids.

Available but expensive

Vivitrol was approved by the FDA in 2006 to treat alcohol addiction and in 2010 to treat opioid addiction. The Cambridge Health Alliance offers it in its addiction treatment program, and it can be prescribed by any doctor, but it is expensive; estimates range from $850 to $1,300 an injection. Private insurers generally cover it if patients meet requirements such as being opioid-free for at least seven days and being in a counseling and rehabilitation program.

MBTA riders curious about “What is Vivitrol?” might glean some or all of this information from going to the drug’s website, Vivitrol.com, and doing some Internet research, or even reading one of the drug’s benefit-and-risk ads when posted at Downtown Crossing – if they could make it out. Dr. Dennis Dimitri, president of the Massachusetts Medical Society, doubts this kind of direct-to-consumer drug advertising will help patients.

Speaking for the society, he said he’s sympathetic to informing people about opioid addiction treatment options, but “it’s difficult for the average patient to understand the significance of the information [in an advertisement], the real outcomes, risks and benefits … It’s best to talk to your personal physician.” Dimitri, who has not seen the subway ads for Vivitrol, added that he was grateful they probably reach a smaller proportion of the population than television ads for prescription drugs.