by Justin Mckibben | Sep 6, 2018 | Drug Abuse, Fentanyl, Fentanyl, Marijuana, Medical Marijuana, Synthetic Drugs
Over a year ago, it was uncovered that a Big Pharma entity spent over $500,000 to oppose legalizing medical marijuana. This is just one example of how the pharmaceutical industry working over years to influence marijuana policy in America. What was so interesting about this company’s efforts is that their own product was a sublingual fentanyl spray.
That’s the same synthetic opioid that became a major factor in the ongoing opioid crisis in America as it was integrated into the illegal drug market.
Marijuana advocates see the move from drug makers to oppose legalization as an attempt to prevent competition. Studies show cannabis can be an effective substitute for pain treatment. Many states with medical marijuana laws acknowledge it as a means to help treat chronic pain patients.
So it became even more telling when it was revealed that the same fentanyl maker undermining medical marijuana was also developing their own synthetic THC.
Insys Therapeutics VS Cannabis
This isn’t the only time we have written about the shady dealings of Insys Therapeutics. Some may recall back in 2017 when the former CEO and founding father of the company had criminal charges brought against him, along with other company executives, for racketeering and corrupt marketing schemes.
For years, Insys has been trying to sway marijuana policy decisions. In 2011, the Big Pharma racket wrote to the DEA expressing opposition to loosening restrictions on naturally derived THC. In the letter Insys claims “the abuse potential in terms of the need to grow and cultivate substantial crops of marijuana in the United States.”
But later in 2016 the company petitioned the DEA to loosen restrictions on synthetic versions of CBD, which is another key component of the cannabis plant. Why? Because they were developing a CBD-based drug to treat pediatric epilepsy. At the time, Insys Therapeutics made a statement claiming their opposition to the marijuana legalization proposition was because, “it fails to protect the safety of Arizona’s citizens, and particularly its children.” However, the company did insist that is believed in the benefits of cannabinoids.
Now, the company accused of aggressively pushing an incredibly potent and potentially lethal opioid drug onto patients who did not need it is now working on another new racket- Syndros.
Syndros: Synthetic THC
As a chief financial backer of the opposition to medical marijuana in Arizona, Insys Therapeutics has worked hard to give itself a monopoly on the market.
Syndros is a synthetic version of the THC compound found in the cannabis plant. This is the main psychoactive component of the substance and is behind a lot of the controversy around marijuana legalization. However, Syndros was approved by the FDA to treat cancer and AIDS patients for symptoms including:
- Nausea
- Vomiting
- Weight loss
This drug is very similar to Marinol, another synthetic THC product that was already approved by the FDA to treat anorexia in cancer and AIDS patients.
Syndros and its generic variations are considered a Schedule II of the Controlled Substances Act. This acknowledges it for medical benefits, but indicates a “high potential for abuse.” So it is on the same level as prescription painkillers, morphine, and cocaine.
Meanwhile, marijuana is still a Schedule I drug, meaning the FDA still considers it more dangerous than morphine, Oxycontin and now synthetic THC.
Dronabinol Debate
Dronabinol is a synthetic THC nasal spray that was quietly granted a Schedule II classification about a year ago. The FDA allows it to be prescribed, sold and federally regulated. This is another product from Insys Therapeutics capitalizing on the components of cannabis while the company fought to smother any competition.
Ironically, in 2007 the company had admitted in a disclosure statement to the Securities and Exchange Commission (SEC) that if cannabis or synthetic cannabinoids were legal “the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.”
So in short- they adamantly opposed medical cannabis efforts for years in order to limit competition. Meanwhile, they were developing their own drugs derived from cannabis. But it was not enough for the company to oppose cannabis legalization efforts. Insys also worked to disrupt other Big Pharma companies from trying to create generic versions of its drug.
Shutting Out Competition
Now, according to publicly available documents, Insys has tried to extend its monopoly over its oral dronabinol product. In October 2017, Insys Therapeutics requested that the FDA decline applications from competitors seeking to produce generic versions of Syndros. They’ve already sued two such drug companies:
- Par Pharmaceuticals
- Alkem Laboratories
Each had submitted Abbreviated New Drug Applications (ANDA). And ANDA is the first step in the process of gaining approval for generic versions of existing drugs. The request from Insys consisted of two parts:
- It asked the FDA to decline to “receive or approve” any ANDA applications that didn’t establish “in vivo bioequivalence” to its drug.
- Asked that ANDA applications for its drug “include fed and fasted state bioequivalence studies.”
Essentially, Insys was claiming that Dronabinol was too complex to be replicated by generic competitors.
However, the FDA eventually denied the company’s petition.
Robin Feldman is a professor of law and director of the Institute for Innovation Law at UC Hastings College of the Law in San Francisco. She literally wrote the book on all the ways mainstream pharmaceutical companies try to subvert generic competition. When discussing the language used in Insys petition to the FDA, she states:
“Companies pile these exclusivities on one after another to keep generic competitors off the market as long as possible. So the reason I laughed is what you are seeing is a multipronged effort by the brand company to stave off generic entry as long as possible.”
Insys has been able to enjoy some time cornering the market on synthetic THC products. But apparently, it is very likely that more companies will be able to get in on the racket pretty soon.
The Other Synthetic Marijuana
Then there is the other synthetic marijuana sold on the streets, which is very different and extremely dangerous.
Meanwhile, we have seen countless stories in recent years of the synthetic THC products made on the streets for recreational use and how these chemical compounds have resulted in outbreaks of overdoses. Infamous brands like Spice and K2 are designed to mimic the properties of natural marijuana. However, these synthetic cannabinoids can cause a range of adverse side effects, including:
- Seizures
- Psychosis
- Cardiac arrest
These are the more dangerous synthetics made in unregulated labs with chemical cocktails that are unpredictable and frequently toxic. Thousands of people have been hospitalized over the years due to the synthetic THC on the street. There are even dozens of fatalities attributed to illicit synthetic THC products.
Again, these are two different variations of synthetic THC. Synthetics like Spice or K2 are not quite the same thing as medications produced by companies like Insys. However, it should at least give some pause to consider that they are being created with the same intention- to artificially manufacture the effects of cannabis.
Drug Makers Want Marijuana Monopoly
Officials all over America are calling out Big Pharma companies for pushing to stop cannabis legalization efforts. Some say many of these drug companies are just trying to sell more drugs that addict patients. Essentially, the argument is that pharmaceutical companies are actively making a profit from drugs containing marijuana constituents while lobbying to prevent medicinal cannabis growth and development.
So do companies like Insys have the best interest of the patient in mind? Can a company accused of questionable tactics and supposedly illegal kickbacks be trusted with a monopoly on synthetic THC? Or are they just want a monopoly on marijuana-derived substances?
And if opioid makers get to dominate the market on synthetic THC products, will they be willing to put more people at risk of drug abuse and addiction in order to maintain their dominance?
Whether it’s natural cannabis, illicit synthetic marijuana, or medical synthetic THC, the risk for substance abuse should be taken seriously. Marijuana use disorder is a real issue that affects a lot of people across the country every day. If medical marijuana products are going to continue to evolve, our treatment of marijuana use disorder has to evolve with it. Innovative and holistic treatment options can make all the difference.
Marijuana use disorder is a very real issue that people struggle with all over America. If you or someone you love is struggling with a substance use disorder, such as chemical dependency or addiction, please call toll-free now to speak with a specialist today. We want to help.
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by Justin Mckibben | May 9, 2018 | Big Pharma, Drug Abuse, Drug Trafficking, News, Opioids, Prescription Drugs
For the first time in six years, the DEA has ordered a suspension on a pharmaceutical wholesaler, and it’s a Big Pharma opioid distributor- Morris & Dickson.
We now know that officials all over the country, both at the state and federal levels, are joining forces to go after Big Pharma companies for pushing powerful opioid painkillers that contributed to one of the greatest addiction outbreaks in American history. While not everyone agrees on the role prescription drugs played in the opioid crisis, many believe the questionable marketing and distribution practices is reason enough for real intervention.
Lawsuits against opioid makers are taking place all over the US, and distribution companies are finding themselves in the hot seat.
DEA vs Opioid Distributor
This latest news comes following an investigation into Morris & Dickson. Allegedly, the investigation uncovered evidence that the Big Pharma opioid distributor neglected to inform the DEA about large quantities of addiction painkillers being bought up by independent pharmacies.
This is a problem because, according to The Hill, reporting such information to the DEA is a requirement.
Back in October of 2017 the investigation into the opioid distributor out of Shreveport, Louisiana got kicked off after reports came in that Morris & Dickson had sold narcotics to five of the state’s top 10 drug-purchasing pharmacies, but never filed any suspicious activity reports in any of these cases. In a statement Friday, the Justice Department revealed that according to the DEA investigation, independent pharmacies were allowed to purchase six times the amount they would normally order from the opioid distributor.
For the record- pharmaceutical distributors like Morris & Dickson are legally required to report unusually large shipments of narcotics to the government as a safeguard against prescription medications from making their way to the illicit drug market. DEA Acting Administrator Robert W. Patterson said in a statement:
“Distributors have an obligation to ensure that all pharmaceutical controlled substances their customer’s order are for legitimate use, and it is their duty to identify, recognize and report suspicious orders to DEA,”
“This is another reminder that DEA will hold accountable those companies who choose to operate outside the law.”
The Big Pharma opioid distributor will have the chance to appeal the suspension during an administrative hearing.
Morrison & Dickson Fight Back
Let the record show that Morrison & Dickson are definitely not taking these charges sitting down. The opioid distributor has struck back against the suspension with a federal lawsuit. They adamantly hold that they will fight the suspension. Company president Paul M. Dickson released his own statement, saying:
“Sadly, in this case, the DEA has gotten it wrong. We would’ve proved that to them had they given us the chance.”
They already asked a judge last Thursday to overturn the DEA suspension. In the legal claim against the DEA order the opioid distributor states:
“Make no mistake—this is a life and death situation. Morris & Dickson services 30-40% of the hospital drug market in Louisiana and Texas alone. If Morris & Dickson cannot ship needed medications to these hospitals, these hospitals may face immediate drug shortages.”
The company president also maintains that the opioid distributor has already greatly reduced its circulation of opioids. Dickson emphasizes that the company provides medications that many patients do desparately need. He also acknowledges the devastation caused by the opioid crisis, saying:
“Everyone in the Morris & Dickson family has been touched by the opioid crisis. That’s why we’ve taken aggressive and effective voluntary measures against any potential opioid diversion from medical use. We have reduced our opioid distribution dramatically. And it’s why we’re so proud of our history of 177 years with no outside enforcement actions against us.”
At this point, only time will tell if the company will have to adhere to the suspension for much longer.
Some people argue that moves like this from the DEA are too aggressive or an over-reach. However, given the circumstances, this seems like a logical response. Looking at the massive shipments of Oxycodone and Hydrocodone, it seems like it shouldn’t be too much to ask they notify the DEA.
What is Next?
Big Pharma executives testified for Congress yesterday, answering questions about their role in the prescription drug problem. The Washington Post reports that this could be a defining moment for the opioid industry. Witnesses for the hearing included high ranking executives from:
- Miami-Luken, INC
- McKesson Corporation
- Cardinal Health
- AmerisourceBergen Corporation
- HD Smith Wholesale Drug Company
During the hearing, Congressman Gregg Harper of Mississippi states:
“We have learned much from the investigation but still have many questions,”
“Why did the distributors repeatedly fail to report suspicious orders of opioids or exercise effective controls against diversion?”
He goes on to explain that the DEA identified opioid distributor companies as a key element to combating the diversion of drugs to the black market. He states that distributors have often claimed that they were too limited to properly address these issues, as they do not understand the whole scope as the DEA does. However, he argues that distributors do have a great deal of data collection, and should be aware of their impact.
According to Congressman Harper, distributors also frequently argue that they are simply providing a service. They do not control the demand, but simply offer the supply based on the prescriptions from physicians. This argument seems a bit of a cop-out, and almost sounds like something a street-level drug dealer would say.
The committee also adds that over the course of 6 years, opioid distributor companies filled the state of West Virginia with over 780 million Hydrocodone and Oxycodone pills, while 1,728 people in West Virginia fatally overdosed on those two painkillers.
In their opening statements, each Big Pharma distributor representative acknowledged the devastation of the epidemic. However, when asked by Chairman Harper if they believed their companies contributed to the opioid epidemic, except for the chairman of the board for Miami-Luken Dr. Robert E. Mastandrea, they all said no.
In fact, Dr. Mastandrea seemed to be the only one consistently willing to admit that Miami-Luken had made mistakes that helped create the opioid crisis.
While it will take time to determine the impact of these testimonies, one thing we can say now is that drug distribution companies are quickly finding themselves on the chopping block when it comes down to the efforts to curb prescription opioids abuse.
For now, a crucial part of fighting the opioid epidemic is going to be providing safe and effective addiction treatment. It may not be easy to put a stop to the spread of addiction, but there are programs that can help you break out of the cycle of drug and alcohol abuse. If you or someone you love is struggling, please call toll-free now. We want to help.
CALL NOW 1-888-922-5398
by Justin Mckibben | Mar 20, 2018 | Donald Trump, Drug Dealers, Drug Policy, Drug Trafficking, Fentanyl, Heroin, News, Opioids, Prescription Drugs, Synthetic Drugs, War on Drugs
The fight against prescription opioid abuse, heroin, and fentanyl in America continues to intensify. Our political landscape may soon see even more drastic shifts because of it. Controversy and conjecture have surrounded many ideas brought to the table on both sides. Even the President himself has been behind some pretty divisive propositions. Then Monday, President Trump unveiled his plan for combatting the ongoing opioid crisis in America while in New Hampshire.
During his speech, the President talked up a few key elements of his plan; some we have heard of before, and others have only recently become a serious topic of conversation. As the administration puts the final touches on their proposals, we thought should take a look at some of the highlights and see which of his plans could actually work, and why experts and advocates believe others probably won’t.
Arguably, there are some pretty good ideas here… and some pretty bad ones, depending on who you ask.
An Opioid Vaccine
Let’s kick this off on a high note.
The Trump opioid plan includes supporting the search for a vaccine. This honestly seems like a good ambition to get behind, but will it work? Researchers at the Walter Reed Army Institute of Research and the National Institute on Drug Abuse developed an experimental heroin vaccine back in December. So far the compound has been tested with rats and mice. Their latest breakthrough found that antibodies in the vaccine bound to the heroin before crossing the blood-brain barrier. This reaction effectively prevents the euphoric effects of the drug.
While this is an exciting development, it is still a vast leap to go from treating mice to treating humans. We still have a long road ahead before this possible vaccine could be approved. However, more funding and resources from the federal government could make a big difference.
Even so, it is important to note that this vaccine will not be a cure-all answer that fixes everything. After all, we have seen opioid blocking methods before. Drugs like Vivitrol and other implants were also developed to hamper the effects of opioids, and they still haven’t stopped the crisis from growing. Experts are already saying this vaccine will only work in the short term and require repeated doses. It is expected to be an incredibly expensive treatment, and it may only be another variation of the Vivitrol shot. Still, some believe this vaccine, used alongside other treatment methods, could be a crucial tool in fighting opioids.
Big Pharma and Prescription Drugs
The Trump opioid plan also takes a look at prescription opioids. The President acknowledged the contribution of pharmaceutical companies and prescription drugs to the opioid crisis. In his statement, he indicated that this administration support research for opioid alternatives.
“That includes federal funding for the development of non-addictive painkillers.”
In talking about prescription drugs, President Trump said the administration also planned on addressing the issue of overprescribing addictive medications. He even touted the Justice Department’s new task force that may soon be fighting Big Pharma companies in court.
“Our Department of Justice is looking very seriously into bringing major litigation against some of these drug companies. We will bring it at a federal level.”
He acknowledges the recent work at the state level to hold Big Pharma accountable. President Trump said his administration will be working to reduce opioid prescriptions by 1/3 over the next three years. Hopefully, as time goes on there will not only be more accountability to those manufacturing these potent medications, but also more options for the thousands of people suffering from chronic pain who do need pain management.
Commercial Campaign
This show we have seen (fail) before. The crisis probably isn’t going to get fixed with re-runs and reboots.
For a long time, Trump has been talking about creating a media campaign to try and combat the opioid crisis. In his remarks on Monday, the president said,
“We are thinking about doing a really large-scale rollout of commercials that show how bad it is for the kids… Scare them from ending up like the people in the commercials.”
Trump said he would spend a lot of money and direct people to make the commercials depict “pretty unsavory situations” claiming that this strategy has worked before with cigarette smoking.
Sadly, the reality is that we have tried this before. Using anti-drug messaging that specifically targets kids and young adults is exactly what was done with the “Just Say No” ad campaign of the 1980s and early 1990s, and the DARE program of the same period. Neither program was proven to be particularly effective in reducing drug use. Some have even argued it did the opposite and actually intrigued young people into drug use.
This is just one part of the Trump opioid plan that reminds people of the ideas pushed in the failed War on Drugs that already destroyed countless lives and only ended up making the problem worse.
So how will this new campaign be different?
The Border
The President also mentioned the importance of combatting the flow of illicit drugs like fentanyl and heroin into the country. He became particularly energized of course when talking about his proposed border wall with Mexico, saying,
“90% of the heroin in America comes from the southern border, where eventually the Democrats will agree with us and we will build a wall to keep the damn drugs out.”
However, many are not so convinced that the wall will be especially effective in stopping drug traffickers. Support for the wall experiences ups and downs as negotiations over immigration continue. Then the President took the opportunity to scrutinize sanctuary cities, calling out California and claiming these places were harboring the most terrible kinds of criminals, including drug dealers.
If part of the Trump opioid plan is to apply even more pressure to sanctuary cities, we may see more back-and-forth when it comes to compromises on immigration policy reform. Recently the Republicans were using DACA as a bargaining chip with Democrats to get the infamous border wall built, but now Trump says Democrats are holding onto it so they can use the issue during the election cycle.
Death Penalty for Drug Dealers
Now, THIS proposal is the one part of the Trump opioid plan that is causing the most controversy, and understandably so.
UPDATE: Attorney General Jeff Sessions sent out a memo Wednesday officially asking federal prosecutors to pursue the death penalty in drug trafficking cases “dealing in extremely large quantities of drugs”. So the administration is now implementing President Donald Trump’s plan to ramp up “tough on crime” punishments in response to the opioid crisis.
In his speech, the President brought having the death penalty for drug traffickers to the forefront. This is an extreme even some of his supporters believed was more tongue-in-cheek than actual proposed policy. The details on this proposal were still pretty scarce at the time. Some support Trump pushing for the death penalty, saying this punishment would only apply to high volume, kingpin-level dealers. But what we should consider is this:
- The federal death penalty is available for a few drug offenses. This includes violations of the “drug kingpin” provisions in federal law.
- Reports indicate that Trump wants Congress to pass legislation that will reduce the amount of drugs needed to trigger mandatory minimum sentences for traffickers.
So should we assume that the President intends to expand what qualifies as “drug kingpin” activity to make the death penalty easier to enforce? If so, what does that mean exactly? And what does it mean for further enforcing other mandatory minimums?
The Justice Department has said it would seek the death penalty “when appropriate under current law.” While drug-related murder is already a capital offense, no one has ever been executed by those rules. However, President Trump says that he and the Justice Department are working very hard to change the laws. To do so would require an act of Congress, and many believe Congress is highly unlikely to expand the federal death penalty. So will any of this be changing soon?
In his comments, President Trump stated,
“If we don’t get tough on the drug dealers, we are wasting our time. And that toughness includes the death penalty.”
President Trump’s call for the death penalty is being strongly met with condemnation. The proposal’s critics range from treatment advocates to law enforcement officials and civil liberty organizations.
Maria McFarland Sánchez-Moreno, executive director of Drug Policy Alliance, said in a statement,
“If this administration wants to save lives, it needs to drop its obsession with killing and locking people up, and instead focus resources on what works: harm reduction strategies and access to evidence-based treatment and prevention.”
Jesselyn McCurdy, deputy director of the American Civil Liberties Union’s Washington office, said,
“Drug trafficking is not an offense for which someone can receive the death penalty,”
McCurdy is referring to a Supreme Court precedent that puts constraints on using the death penalty for a convicted person who did not commit murder.
Furthermore, there are plenty of arguments that this kind of policy is not practical. Some say it would either be so broad it became unconstitutional, or so specific that it would be obsolete. This aspect of the plan has sparked nationwide debate. Americans everywhere are arguing whether or not a drug dealer should be responsible for the deaths of customers.
Sadly, this is so frustrating because past data does not hold with the idea that getting ‘tough’ on drugs is more effective than offering treatment opportunities. One of the best studies backing this is a 2014 study from Peter Reuter at the University of Maryland and Harold Pollack at the University of Chicago. Researchers determined that while simply prohibiting drugs to some extent does raise their prices, there’s no good evidence that tougher punishments or harsher supply elimination efforts do a better job of driving down access to drugs and substance misuse than lighter penalties.
In fact, many addiction advocates argue that harsher punishments can actually be counter-productive because they end up punishing people who need treatment, not incarceration. So the need for a more comprehensive approach to opioid addiction treatment is paramount. Hopefully, this administration will see the need to focus on support for treatment, instead of a primarily punitive focus.
Trump Opioid Plan on Treatment
This is a critical and commendable element of the Trump opioid plan, and I applaud some of its intentions. However, I wish we could talk a lot more about this and a lot less about captial punishment.
Still, I give them credit for saying they want to increase access to addiction treatment and adopting harm reduction. There isn’t much detail to go on though, as far as how this will happen. One aspect is to increase the use of medications such as methadone and buprenorphine.
As another highlight, Trump also asks Congress to repeal a rule blocking Medicaid payments to larger treatment facilities, which could provide a boost in the billions to inpatient clinics. Hopefully, this is one factor of the Trump opioid plan that will pan out, because one of the biggest issues the US faces with the opioid crisis is a limited access to adequate treatment options. If the White House allows Medicaid to reimburse larger treatment facilities, more people will be able to get effective care. Still, it is unclear how many resources the administration is willing to commit to treatment resources.
Hopefully, the Trump opioid plan will evolve and we will see a resurgence of resources going toward helping get people suffer the help they need. It is understandable to want to curb the rise of addiction through anti-trafficking measures and raising awareness, but we already have thousands and thousands of people struggling every day all over America who need help. Preventive steps are crucial, and the President is trying to push for them. But it is vital that we also give everyone already struggling more of a fighting chance. The possibility of more people having greater access could help create a huge shift.
Palm Healthcare Company believes in providing innovative and effective holistic treatment options for those who are battling with addiction. Our facilities believe in comprehensive and compassionate care, and our mission every day is to transform as many lives as possible. Together, we can make a difference. If you or someone you love is struggling with substance abuse or addiction, please call toll-free now. We want to help.
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by Justin Mckibben | Mar 1, 2018 | Big Pharma, Drug Trafficking, Law Enforcement, News, Opioids, Prescription Drugs
Attorney General Jeff Sessions made an announcement at a news conference Tuesday that the Justice Department will be creating a new task force to pursue the makers and distributors of prescription opioids. It seems that beyond pursuing new restrictions being put on prescriptions, there will be a more intentional focus on Big Pharma and those who many believe have made the opioid crisis possible.
Jeff Sessions said the task force will “examine existing state and local government lawsuits against opioid manufacturers to determine if we can be of assistance.”
Meanwhile, Sessions also included the Justice Department is going to be backing a lawsuit in Ohio against major prescription opioid makers.
Ohio VS Opioid Makers Lawsuit
In truth, this lawsuit isn’t just about the state of Ohio. It consolidates more than 400 complaints by cities, counties and Native American tribes nationwide. Buckeye Nation has definitely been hit hard by the opioid crisis, but for now, the stage is set here for a massive effort against questionable practices from opioid makers.
The lawsuit that solicits the Justice Departments attention is pending in Federal District Court in Cleveland. It goes after various companies for using misleading marketing to promote prescription opioids, including:
- Manufacturers
- Distributors
- Dispensers
The lawsuit also accuses the defendants of:
- Downplaying the risk of addiction to these drugs
- Failing to report suspicious orders by consumers, which would indicate the drugs were being abused
Furthermore, there are some big names in Big Pharma being listed as defendants, including:
- Johnson & Johnson
- Purdue Pharma
- Teva Pharmaceuticals
The suit is also going after large distributors, such as:
Not to mention pharmacy chains like:
So how will the Justice Department be engaging in the current lawsuit? How will this new development impact the outcome of the case?
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Statement of Interest Against Opioid Makers
During the press briefing, Sessions explained that the Justice Department plans to file what is called a “statement of interest” in the Ohio lawsuit. This is a technique that past administrations typically would only resort to in cases that directly affect the federal government’s interests, such as diplomacy and national security.
However, with the intensity of the opioid crisis being what it is, it is perfectly understandable to make it such a high priority for the current administration to get involved with. So far, recovery advocates have been largely unimpressed with the half-measures that have been presented thus far with the Trump administration to address the issue.
By invoking the statement of interest, the attorney general is legally able to argue on behalf of the government’s interest in any court in the country. However, it does not make the government a plaintiff. All things considered, Sessions said his department will use criminal and civil penalties. He states,
“We will use whatever tools we have to hold people accountable for breaking our laws.”
Which is quite a statement, considering it isn’t at all common for criminal charges to be brought against Big Pharma.
The Devil Is in the Data
What brought the Justice Department into this began with a discussion on access to certain data. This past Monday, lawyers for the Drug Enforcement Administration (DEA) came to the Ohio courtroom to discuss how much data they would share about the national distribution of painkillers.
The DEA said it would only provide two years of information in the case, asserting that the agency did not want to compromise ongoing criminal investigations. However, Judge Dan Aaron Polster’s request is to provide the sides with nine years of data. He said the agency has until next Monday to decide whether it will comply. This data can assist in determining:
- The number of pills distributed
- The locations
- The distributors
This information could be crucial in allocating liability.
Richard Fields, a lawyer who represents state attorneys general and sovereign Native American nations in opioid litigation, predicts that the statement of interest from the Justice Department “will help unlock this data so that we can hold manufacturers, distributors and pharmacies accountable for flooding communities with pills.”
Therefore, it appears Sessions is going to be taking some big steps toward calling out Big Pharma for their involvement in the opioid crisis. Sessions says the government will be taking a hard look at doctors who overprescribe prescription painkillers. Even legal drugs like these too often lead to addiction and abuse of illegal drugs like heroin.
Ohio Attorney General Mike DeWine says he believes this is a game changer. With all the suffering communities in Ohio have seen over the past several years, we can only hope.
Holding Big Pharma accountable is a huge step. Nevertheless, we should also highlight the need for state and community officials to promote safe and effective addiction treatment. Innovative and holistic recovery programs can make a dramatic difference in helping heal communities. If you or someone you love is struggling, please call toll-free now.
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by staff | Nov 9, 2017 | Fentanyl, Heroin, Law Enforcement, Maintenance Drugs, News, Opioids, Vivitrol
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.
Investigating Vivitrol
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:
-
Marketing records
-
Financial records
-
Internal reports
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
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National Institute on Drug Abuse (NIDA)
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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
