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.
When talking about the most effective treatment programs for addiction, we should also remember that maintenance drugs like Suboxone, Vivitrol and others are not exactly a solution. While they can be effective in keeping people alive and helping to overcome their sickness, the real healing does not come from magic pills or implants. The real transformation comes with developing the understand and the tools to take care of yourself. If you or someone you love is struggling, please call toll-free now.
CALL NOW 1-888-922-5398
While the nation is still struggling to find the right strategy to climb out of the opioid crisis in U.S. it seems many are holding onto the idea that Big Pharma is going to save us from the destruction they helped create. While we can agree that evidence-based medical assistance in recovery is a useful tool, some seem to think that the only fix for a pill problem is more pills, or in this case, more needles.
Just recently, after President Trump declared the opioid crisis a “National Health Emergency”, the advisory committee to the U.S. Food and Drug Administration (FDA) voted 18-1 that a new injectable drug called RBP-6000 could benefit addicts and the lower of two doses studied had an “acceptable” safety profile.
So what does this mean for the opioid epidemic efforts? Is Indivior a miracle injection that is going to make the epidemic more manageable, or is it another kind of Methadone or Suboxone that is just keeping people hooked?
What is RBP-6000?
For a little background, RBP-6000 is an experimental drug designed to help fight America’s growing opioid addiction crisis. It is described as a sustained-release buprenorphine. It is designed to be delivered once a month as a subcutaneous injection. The compound solidified once in contact with bodily fluids and releases buprenorphine over time.
If approved, it will be the first monthly injectable buprenorphine treatment. When creating the drug the manufacturers studied two dosing regimens.
In one, 300 milligrams were given once a month for six months.
In the other, two doses of 300 milligrams were followed by four doses of 100 milligrams.
According to reports, there was only a minute difference in effectiveness between the two doses, and they drug company acknowledge that the higher dose of RBP-6000 caused more side effects. Looking closely into some of the reports from the research, some side-effects include:
Injection site pruritus
Upper respiratory tract infection
While these side effects were not noted in an extremely high percentage of those tested, they are still relevant to consider until there is more extensive data available. So far, the report says the safety profile is consistent with that of Suboxone.
So RBP-6000 is like Suboxone using the delivery of Vivitrol; another injectable drug used to try and block the effects of opioids.
Big Pharma Making Big Moves
This is one sign of how Big Pharma is stepping in to make a buck off of the opioid epidemic yet again.
Indivior is the company behind RBP-6000. It was originally part of Reckitt Benckiser as the Buprenorphine division but has since split off to be a specialty pharmaceutical company. Indivior already sells Suboxone Film, a product which combines buprenorphine and naloxone. Suboxone is a maintenance drug widely used in America to try and curb the effects of opioid addiction and withdrawal, but Suboxone is known to have its own side-effects and withdrawals. Some even attest that Suboxone is itself addictive and very difficult to get off of.
Two months ago the share prices for Indivior took a deep hit after a U.S. court ruling clearing the way for a generic rival to Suboxone Film. So, with new competition on the way in the Suboxone market, Indivior put a renewed focus on another maintenance drug to bring to market.
Some analysts already expect that RBP-6000 could capture around 30% of the broader buprenorphine market. Some believe this new form of injectable buprenorphine could generate annual sales of around $700 million by 2021.
Jefferies sees potential sales of $1.3 billion by 2025.
So now the push for this new drug is boosting its sales prospects as competitors threaten revenues from Suboxone sales.
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Waiting for FDA Final Ruling
This endorsement on behalf of RBP-6000 comes less than a week after FDA Commissioner Scott Gottlieb announced the agency’s plans to promote extensive use among opioid addicts of less harmful opioids such as methadone and buprenorphine, the active ingredient in RBP-6000.
However, some of the FDA panelists still would like to see more data about which patients should be given the higher dose. Other panelists say they would like to have it available, even though they lack of data supporting any additional benefit of higher doses. So even though the drug is shown to have side-effects in higher doses, and there is limited information on how these side-effects impact the individual, the FDA is considering to let this drug pass the grade.
The FDA’s decision is set to be made by November 30th, although typically the agency follows the recommendations of its advisory panels. So it may very well already be a done deal.
Why It Matters
Again, with respect to the importance of offering alternatives to particularly dangerous opioids like heroin or fentanyl. It is important to have resources for the purpose of preserving of life. Keeping people alive long enough to get help is crucial. But we also have to see that this is not a miracle cure.
Methadone, Suboxone, and Vivitrol may serve a purpose for some in a certain capacity. However, these drugs are not an adequate substitute for comprehensive addiction treatment. Each one of these methods should be accompanied by a holistic treatment plan that addresses all aspect of addiction, including emotional and mental health.
Drugs like RBP-6000 may help subdue the more serious symptoms from the physical side of addiction, but they can also present their own risks.
It is important to offer safe medical assistance, but we have to remember that these Big Pharma companies are not selling us instant cures to opioid addiction. This isn’t even the first time we have seen a new drug come out to try and treat the opioid problem from companies that are closely related or directly responsible for narcotic medications that helped fuel the issue.
Remember, there is not a quick fix for this problem. We cannot prescribe our way out of the problem. It is going to take better treatment resources beyond more medications.
Drugs like RBP-6000 from Indivior are not necessarily a bad thing, but they also may not be the kind of treatment people should focus on. Instead, there are safe medical treatment options that offer holistic resources and mental health services. A lasting recovery begins with effective treatment. If you or someone you love is struggling, please call toll-free now.
CALL NOW 1-888-922-5398