According to a survey of public health experts from 10 universities, an estimated 500,000 Americans are likely to die of an opioid overdose within the next decade if something is not done to stem the fatal tides of the public health emergency that is the opioid crisis.
While drugs like methadone and buprenorphine have been what many call the gold standard for treating opioid dependence, there are still many critics that argue this form of medication-assisted treatment (MAT) is not effective enough.
In fact, this past May, United States Secretary of Health and Human Services Tom Price was quoted as saying that using methadone and buprenorphine to combat opioid addiction is only “substituting one opioid for another.”
In place of these two drugs, Price has been a vocal proponent of a drug called Vivitrol, the brand name of an injectable, extended-release form of Naltrexone, a pure opioid blocker in contrast to mild opioid methadone and partial opioid buprenorphine.
A recent study sponsored by the National Institute on Drug Abuse found that one monthly shot of Vivitrol was just as effective at staving off opioid use relapse as the daily pill dose of buprenorphine and naloxone, which is sold under the brand name Suboxone.
A once-a-month shot of a non-addictive opioid blocker seems like the clear choice over a daily administration of Suboxone, which can and has been abused on its own by people addicted to opioids trying to keep cravings at bay until they can find something stronger.
However, is Vivitrol really the miracle drug many believe it to be? A combination of cost, lack of research, some less than noble intentions, and a misunderstanding of the opioid epidemic itself casts a shadow on what should be an obvious victory.
THE COST OF CONVENIENCE
For many, Vivitrol provides a way around many stumbling blocks of lasting sobriety. It certainly makes sticking with a treatment plan easier, as it eliminates needing to remember to take a pill every day. And while that may not sound like a significant commitment, for those struggling with the difficulties of opioid withdrawal and the early stages of recovery, one less thing to keep track of can make a big difference.
The fact that it only requires a single administration a month also makes it a potentially more accessible option for those living in rural areas far from treatment clinics or who otherwise have difficulty in making frequent visits to one.
Vivitrol has also been found to be particularly effective on those whose opioid addictions are not as advanced as others, working to help treat the dependency before it gets worse and lead to an overdose.
Perhaps one of the most significant advantages of opting for treatment with Vivitrol rather than methadone or buprenorphine is that it removes the risk of potentially developing a secondary addiction to the medications being used to wean people off of drugs like heroin or hydrocodone.
However, these benefits come at a cost, literally.
Vivitrol currently costs a whopping $500 a shot under the Affordable Care Act and more than $1,000 under private insurance. In comparison, Suboxone costs a little over $50 for a month’s worth of tablets, and methadone is even less, with a month’s supply of pills commonly retailing for less than $15.
THE PUSH FOR VIVITROL: MONEY, MISINFORMATION, AND MAJOR DRAWBACKS
Alkermes, the biopharmaceutical company manufacturing Vivitrol, came under fire from many substance abuse experts due to its aggressive promotion of Vivitrol despite a lack of thorough research and studies on its effectiveness. In fact, prior to the previously mentioned study, Alkermes had managed to lobby for the U.S. Food and Drug Administration’s (FDA) approval despite only having conducted just one single clinical trial—held in Russia, during which almost half of the 250 participants relapsed over a six-month period.
Instead of promoting evidence of Vivitrol’s benefits, Alkermes has made a point to discredit the usefulness of long-studied, mainstay treatment drugs, calling them too dangerous and risky for regular use. And their campaign has proven to be very successful, with Vivitrol sales rising 600 percent in the last six years.
According to Dr. Joshua Sharfstein, a former Maryland health secretary, the problem of this form of marketing is more about making Alkermes money than trying to help fight against the opioid crisis, and said, “If you care about actually solving the problem, you cannot stigmatize the most effective treatments.”
In the meantime, the actual usefulness of Vivitrol as a practical opioid treatment medication faces several hurdles. The first and most significant is that, unlike Suboxone or other partial opioid agonists, which requires a partial detox period of around 12 hours to two days before it can be used, Vivitrol requires full detoxification to avoid acute opioid withdrawal. This process can take as long as 10 days, depending on the severity of abuse.
While the rates of relapse were lower among the patients in the NIDA study who received Vivitrol than those who had been given Suboxone, 28 percent of the participants who were supposed to take Vivitrol couldn’t make it through the necessary detox period to even use it. In comparison, only six percent of patients quit before being able to take Suboxone.
Of the results, Keith Humphreys, a professor at Stanford who was involved in the study said, “If you get on the medication, both are equally effective, but it’s harder to get on [Vivitrol] because you need the detoxification first.”
Another drawback of Vivitrol that is not being actively discussed is the danger it poses to those who take it and do relapse. Taking Vivitrol greatly reduces the user’s tolerance for opioids, meaning that if they stop using Vivitrol and relapse back to using the same amount of whichever opioid they were previously abusing, there is a much higher chance of a fatal overdose.
Vivitrol’s popularity is largely among law enforcement and the criminal justice system, with 15 states having written legislation requiring drug offenders to use Vivitrol before appearing in court. It has also supplanted methadone and buprenorphine as the treatment of choice for those suffering from opioid dependence in prison.
This is an issue because numerous studies have indicated that offenders with a history of drug use prior to being in prison and were released, with their tolerance to drugs such as heroin greatly reduced, were extremely vulnerable to relapse. Many of them died from an overdose in as little as two weeks after being released.
Unfortunately, since Alkermes failed to track any overdoses that might have occurred among participants in their Russian study who stopped taking Vivitrol, there is not enough data to make a solid link between stopping Vivitrol use and an increased risk of overdose death.
RETHINKING THE RESPONSE TO THE OPIOID CRISIS
Perhaps the most vocal critics of Vivitrol are the substance abuse researchers and experts who, while recognizing the benefits of the drug, argue that it is not, as many have called it, a cure for addiction.
Vivitrol does indeed block the body and brain from feeling the effects of opioids like heroin, which can help people remain abstinent, but it does not relieve the psychological suffering associated with withdrawal.
It makes the user drug-free in the literal sense that there are no opioids in their system, but that alone does nothing to guarantee that they will stay that way. Medications like methadone and buprenorphine have been proven to reduce the risk of overdose, but lack the appeal of “controlling and containing,” that fall in line with the unfortunately widespread views that those struggling with dependency on illicit substances such as heroin should simply be jailed rather than rehabilitated.
In response to Price’s praise of Vivitrol and criticism of methadone and buprenorphine, nearly 700 medical experts in the field of substance abuse wrote him an open letterdetailing more practical and effective measures to take in the fight against opioid overdoses:
- Investing in the treatment system by making it more accessible with more clinics and physicians to administer medication-assisted treatments.
- Ensuring that treatment remains affordable for those dependent on opioids. If medication treatment becomes a less cost-effective tool for managing opioid abuse, it will only serve to block people from receiving the care they need and contribute to more overdose deaths.
- Reduce the stigma surrounding opioid abuse and treatment, starting with viewing addiction as the chronic disorder it is rather than criminalizing it and those struggling with it.
- Recognize that treatment is only one piece of the puzzle when it comes to reducing the devastating effects of the opioid crisis and that other medical interventions are necessary to reduce the illnesses and disorders that frequently co-occur with substance abuse.
Vivitrol itself is not a harmful thing, in fact, it can be extremely helpful. What’s dangerous is the mindset that it has the power to fix the opioid epidemic on its own. In order for that to happen, much more change is still needed.
View the original article: