- As part of a more than $8 billion settlement with the U.S. Department of Justice, Purdue Pharma will plead guilty to one count of conspiracy to defraud the U.S. government and two counts of violating anti-kickback, or bribery, laws.
- Because Purdue filed for bankruptcy last year, that full figure likely won’t be collected by the government.
- Under the settlement, which will need approval in bankruptcy court, Purdue would become a public benefit corporation that is controlled by the government, with revenue from opioid sales being used to fund treatment options and programs.
- A number of state attorneys generals and Democratic lawmakers have said the settlement does not hold Purdue or its owners fully accountable and could derail thousands of other cases against the company.
- They have also argued that the government should “avoid having special ties to an opioid company… that caused a national crisis.”
Purdue to Plead Guilty to 3 Criminal Charges
The Justice Department announced Wednesday that Purdue Pharma has agreed to plead guilty to three criminal charges related to fueling the country’s opioid epidemic.
Notably, those guilty pleas come as part of a massive settlement worth more than $8 billion, though Purdue will likely only pay a fraction of that amount to the government.
Purdue is the manufacturer of oxycontin, which is a powerful and addictive painkiller that’s believed to have driven the opioid crisis. Since 2000, opioid addiction and overdoses have been linked to more than 470,000 deaths.
As part of the settlement, Purdue will plead guilty to one count of conspiracy to defraud the United States. There, it will admit that it lied to the Drug Enforcement Administration by claiming that it had maintained an effective program to avoid opioid misuse. It will also admit to reporting misleading information to the DEA in order to increase its manufacturing quotas.
While Purdue originally told the DEA that it had “robust controls” to avoid opioid misuse, according to the Justice Department, it had “disregard[ed] red flags their own systems were sending up.”
Along with that guilty plea, Purdue will also plead guilty to two anti-kickback, or bribery, related charges. In one charge, it will admit to violating federal law by paying doctors to write more opioid prescriptions. In the other, it will admit to using electronic health records software to increase opioid prescriptions.
According to a copy of the plea deal obtained by the Associated Press, Purdue “knowingly and intentionally conspired and agreed with others to aid and abet” the distribution of opioids from doctors “without a legitimate medical purpose and outside the usual course of professional practice.”
The $8 billion in settlements will be split several different ways.
In one deal, the Sackler family — which owns Purdue — will pay $225 million to resolve civil fines.
As part of the main deal, another $225 million will go directly to the federal government in a larger $2 billion criminal forfeiture; however, the government is actually expected to forego the rest of that figure.
In addition to that, $2.8 billion will go to resolving Purdue’s civil liability. Another $3.54 billion will go to criminal fines, but because Purdue filed bankruptcy last year, these figures also likely won’t be fully collected — largely because the government will now have to compete with other claims against Purdue in bankruptcy court.”
Purdue Will Become a “Public Benefit Company”
Since Purdue is in the middle of bankruptcy proceedings, a bankruptcy court will also need to approve the settlement.
“The agreed resolution, if approved by the courts, will require that the company be dissolved and no longer exist in its present form,” Deputy Attorney General Jeffrey Rosen said.
However, that doesn’t mean that Purdue’s fully gone or that it will even stop making oxycontin. In fact, as part of this settlement, the Sacklers would relinquish ownership of Purdue, and it would then transform into what’s known as a public benefit company.
Essentially, that means it would be run by the government. Under that setup, money from limited oxycontin sales, as well as from sales of several overdose-reversing medications, would be pumped back into treatment initiatives and other drug programs aimed at combating the opioid crisis.
For its part, the Justice Department has endorsed this model.
Should Purdue Be Punished More?
There has been strong opposition to this deal, mainly from state attorneys general and Democratic members of Congress who say it doesn’t go far enough.
Those critics argue that the settlements don’t hold Purdue or the Sackler family fully accountable, especially the Sacklers since — unlike Purdue — they didn’t have to admit any wrongdoing.
“[W]hile our country continues to recover from the pain and destruction left by the Sacklers’ greed,” New York Attorney General Letitia James said, “this family has attempted to evade responsibility and lowball the millions of victims of the opioid crisis. Today’s deal doesn’t account for the hundreds of thousands of deaths or millions of addictions caused by Purdue Pharma and the Sackler family.”
“If the only practical consequence of your Department’s investigation is that a handful of billionaires are made slightly less rich, we fear that the American people will lose faith in the ability of the Department to provide accountability and equal justice under the law,” A coalition of 38 Democratic members of Congress said in a statement to Attorney General Bill Barr last week.
While this settlement doesn’t include any convictions against the Sacklers specifically, as the Justice Department noted, it also doesn’t release them from criminal liability and a separate criminal investigation is ongoing.
Still, last week, 25 state attorneys general asked Barr not to make a deal that includes converting Purdue into a public benefit company, urging the Justice Department to “avoid having special ties to an opioid company, conflicts of interest, or mixed motives in an industry that caused a national crisis.”
Part of their concern is that the government would essentially run this new company while also holding the original one accountable. Those attorneys general instead argued that Purdue should be run privately but with government oversight.
See what others are saying: (Associated Press) (The New York Times) (Fox Business)
North Carolina County May Be Without Power for Days After Substation Attacks
Tens of thousands have been left without power as temperatures drop.
Power Outage Prompts State of Emergency
Two power substations in Moore County, North Carolina were attacked on Saturday and sustained heavy damage from gunfire. The damage has left about 40,000 people without power as the temperatures fall.
Response to the crisis has been swift. A state of emergency was declared Sunday afternoon, an emergency shelter powered by a generator has been opened, and local schools have canceled classes for Monday.
Local authorities have partnered with state and federal agencies in an effort to find those responsible for the attack. The North Carolina State Bureau of Investigation as well as the FBI have joined the investigation
The Sheriff of Moore county, Ronnie Fields, said the attack was “targeted” while speaking at a news conference Sunday night.
“It wasn’t random,” he told reporters. “The person, or persons, who did this knew exactly what they were doing.”
A representative from Duke Energy, the owner of the substations, informed the public that the damages are significant and will require complete replacement of key parts. Unfortunately, the company will not be able to reroute power as they have during storms. The representative said that, because of this, people in Moore County may be without power until Thursday.
Investigation Into Perpetrators
As of now, authorities don’t know who is responsible. Sheriff Fields told the press that no group has taken credit for the attack. The investigation is ongoing.
“An attack like this on critical infrastructure is a serious, intentional crime and I expect state and federal authorities to thoroughly investigate and bring those responsible to justice,” Gov. Roy Cooper (D) said in a tweet Sunday night.
On social media, many have speculated that the attack was an effort to stop a local drag show from being performed. The show had reportedly garnered a significant number of protesters and a police presence. The power cut out Saturday evening shortly after the show had started.
Sheriff Fields reported Sunday night that, so far, no connection has been found between the attack and the drag show.
Adderall Shortage Sparks Fears of Opioid-Like Crisis
Experts specifically have expressed concerns that the lack of legal Adderall will force people to turn to black markets as they did when the supply of opioids was cut off.
Public health experts watching the ongoing Adderall shortage in the U.S. have raised concerns about the possibility that it could cause a major health crisis.
In mid-October, the Food and Drug Administration (FDA) announced that there was a nationwide shortage of immediate-release Adderall. The agency specifically noted that Teva Pharmaceuticals, which is the biggest manufacturer of the drug, was “experiencing ongoing intermittent manufacturing delays.”
Since then, the FDA has also reported that there are other manufacturers experiencing similar problems as well. In statements to the media, Teva has explained that the supply disruptions were triggered by a combination of a since-resolved labor shortage on its packing line this summer, as well as increased demand for the drug.
Adderall prescriptions have skyrocketed over the last two decades. From 2006 to 2016, the prescription of stimulants more than doubled in the U.S., and those numbers have grown since the pandemic. According to figures from the data analytics firm IQVIA, from 2019 to 2021, Adderall prescriptions alone rose by about 16%, surging from 35.5 million to 41.2 million.
Experts say the big spike over the last few years has been driven by the fact that more people are seeking these drugs to help cope with stress and distraction. Telehealth regulations that were relaxed during the pandemic also made it much easier for people to get diagnosed and prescribed in shorter periods of time.
A growing number of new start-ups have been taking advantage of lax rules, flooding social media — and specifically TikTok — with advertisements telling people to get ADHD meds if they feel distracted or tired. Many professionals say these apps pose issues because they are designed for such quick diagnosis so it can be hard to tell if ADHD is actually the problem people who present those symptoms are dealing with.
The resulting effect has been renewed speculation that stimulants are being overprescribed — a factor some believe could also be driving this shortage.
Additionally, Adderall is a Schedule II controlled substance, so it is highly regulated by the Drug Enforcement Administration (DEA), meaning there are caps on how much each company can produce so they can’t just ramp up production to make up for the backlog. It is also difficult for pharmacies to just pivot and start carrying new brands because of the regulations on this drug.
Leo Beletsky, a professor of law and health sciences at Northeastern University and faculty director of the Health in Justice Action Lab, worries all these elements could create the perfect storm for a full-blown crisis.
In an interview with Rogue Rocket, he outlined two overarching concerns.
“One is that you have lots of people who had access, sort of regular access to medication that they may not now have access to, and there are individual-level risks that sort of cascade from that,” he said. “Insomnia, depression, in some instances, you could even see suicidal ideation. So all of these are kind of, you know, health risks that result from rapid tapering or discontinuation, discontinuation of taking Adderall.”
“What is an even bigger concern or, an equally important concern, is that lots of people without access to the pharmaceutical supply will turn to the illicit market and counterfeit Adderall is readily available on the illicit market and other forms of unfettered means. Specifically, methamphetamine is available, widely available on the illicit market 24/7. You know, there’s no shortage in that market,” he continued.
Beletsky explained that there are a number of harms that can come as a result of people turning to the black market — and there is first-hand evidence of this from the opioid crisis. As he noted, opioids were also widely criticized as being overprescribed, and so when access was cut for prescription opioids, people turned to illegal markets and there was a massive spike in the use of heroin, counterfeit opioids, and fentanyl contamination.
“The public health, sort of population-level concern is that we might see similar patterns here where lots of folks are being pushed into the market and they’re, you know, it’s the Wild West. Counterfeit Adderall oftentimes does have methamphetamine,” he stated. Counterfeit Adderall can also be cross-contaminated with other dangerous drugs like fentanyl.
“Methamphetamine is even cheaper than counterfeit Adderall pills, and so the concern is that folks might start smoking meth and even injecting meth, which is, you know, increasingly common,” Beletsky continued. “It would be a huge public health disaster if thousands or even millions of people started taking methamphetamine in or trying to replace this pharmaceutical supply.”
Beletsky pointed out a number of tools the FDA has at its disposal to address the possible crisis and clear up the shortage, including encouraging other competitors to create new sources of production, as well as encouraging the importation of Adderall from abroad.
However, while the agency would have the power to fast-track these actions to skirt regulatory hurdles, so far, they have not taken any of these steps. In response to questions as to whether the FDA will intervene and speed up the process, a spokesperson told Rogue Rocket that the agency “evaluates all its tools and determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.”
When asked when the FDA thinks the shortage will be resolved, the spokesperson said it is “expecting the supply issues to resolve in the next 30-60 days.”
But Beletsky said he does not buy that timeline.
“I’m afraid that they may be over overly optimistic given the scale of the problem,” he told Rogue Rocket. “My guess is it’s going to take months to resolve. And I hope that, you know, most folks are able to kind of make do and not start kind of purchasing alternatives from the illicit market.”
The professor emphasized that the current shortage is a symptom of broader problems with America’s overall system for drug regulation that goes beyond the FDA and centers on the powers granted to the DEA.
Unlike the FDA, the DEA is a law enforcement agency, and Beletsky notes it has a long history of focusing on controlling the supply of these kinds of drugs rather than ensuring there is adequate access for the people who need them.
As a result, the DEA has very little control over both the legal and illegal markets for controlled substances. Because of this, people lack proper access to the prescriptions they need while the massive, unregulated black market is thriving.
Beletsky argued it is imperative that we use this latest shortage as yet another wake-up call to highlight the need for rethinking how drug access is structured in America.
“I think that it’s really important to highlight the failures of the DEA in this context, because the DEA, much more than the FDA, is responsible for finding that balance between access and control,” he said. “I think that we really need to reevaluate the role of the DEA in our drug regulatory system. And the FDA, on the other hand, probably could use additional authority.”
“When it comes to essential medicines, we really need much more authority for governmental regulation to step in and sort of help to stabilize access to these particular medications, as well as many others.”
How to Seek Help
Beletsky noted that there are several steps people who need Adderall can take until the shortage clears up.
“I think it’s important to note that there are other alternatives in the pharmaceutical supply that are not in shortage,” he explained. “And so talk to your provider about what additional tools may be available, you know, other stimulants that you can […] try to kind of bridge the gap.”
“I think it’s also important to note that if you do turn to, you know, folks are turning to buying Adderall or other alternatives on the illicit market, it’s really important to test that supply, especially for fentanyl.”
For more information on obtaining test strips and other harm reduction tools, Beletsky recommended visiting Next Distro or finding your local harm reduction agency, which can be done on the National Harm Reduction Coalition website.
For those suffering the impact of the Adderall shortage, The Washington Post has a guide with helpful tips and ideas from professionals.
See what others are saying: (WIRED) (The New York Times) (Axios)
Senate Approves Respect for Marriage Act, Clearing Path for Finalization
The bill was passed 61-36 with bipartisan support from 12 Republicans and is expected to be approved by the House next week.
Respect for Marriage Act
The Senate passed a landmark bill Tuesday that will codify the right to same-sex and interracial marriage into federal law.
The legislation, called the Respect for Marriage Act, was passed in a bipartisan vote of 61-36 with 12 Republicans bucking pressure from many of their colleagues and powerful conservative groups.
The bill would repeal the 1996 Defense of Marriage Act (DOMA), which defined marriage as a union between one man and one woman. While it will not require all states to allow for same-sex marriage, it does mandate that they recognize out-of-state same-sex marriages performed legally in states that do allow them.
Furthermore, the proposal contains a provision that Republican supporters insisted on, which clarifies that religious nonprofit organizations do not have to provide goods or services for same-sex marriages and that the federal government is not authorized to recognize polygamous marriages, among other measures.
Lawmakers introduced the bill after the Supreme Court reversed Roe v. Wade, stirring concerns that the high court could come after other basic rights. In his decision to overturn Roe, Justice Clarence Thomas said he believes the court should reconsider Obergefell v. Hodges, the 2015 case that established gay marriage.
Many Republicans initially opposed the Respect for Marriage Act, claiming it was not necessary because Obergefell was still in place, and accused Democrats of trying to pull off a political stunt ahead of the midterms.
The accusations prompted the bipartisan group of Senators driving the push to postpone a vote on the matter until after the elections.
“I feel like we were told in pretty clear terms that we would have some people support only if the vote came after the midterms,” Sen. Tammy Baldwin (D-Wi.), who led the effort, told Rogue Rocket after the decision in October.
An earlier version of the bill passed the House this summer, though the changes to the language of the policy require the lower chamber to vote on it again.
That passage is all but assured as Democrats still hold the House and the last version was approved with a broad bipartisan majority that included 47 Republicans. President Joe Biden, for his part, applauded the Senate vote and said he looks forward to signing the bill.
Shift in Opinion
Other proponents of the bill also cheered its passage in the Senate, which just two decades ago would have been unimaginable, and not just because of Republican opposition.
Democrats, too, have only more recently shifted to support same-sex marriage and LGBTQ+ rights more broadly. President Bill Clinton, a Democrat, signed DOMA into law, and President Barack Obama first voiced his support for same-sex marriage while running for his second term in 2012.
The transformation in public opinion has happened relatively fast, especially when compared to other civil rights movements. When Clinton signed DOMA in 1996, gay marriage had the support of just 27% of the public. Now, polling shows seven in ten Americans support legal recognition.
Still, the Republican party appears to lag behind the times, with 70% of senate Republicans having opposed the Respect for Marriage Act.
“This is a great example of politicians following public opinion rather than leading it,” Sasha Issenberg, author of “The Engagement: America’s Quarter-Century Struggle over Same-Sex Marriage,” told Axios.
“Now it’s Republicans who are torn between placating some of their loudest activists and taking a position that aligns with where general-election voters are.”