- 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)
Texas Doctor Says He Violated Abortion Law, Opening Matter Up for Litigation
Under the state’s new law, any citizen could sue the doctor, which would make the matter the first known test case of the restrictive policy.
Dr. Braid’s Op-Ed
A Texas doctor revealed in an op-ed published in The Washington Post Saturday that he performed an abortion in violation of the state’s law that bans the procedure after six weeks, before most people know they are pregnant.
The law, which is the most restrictive in the country and does not have exceptions for rape and incest, also allows civilians to sue anyone who helps someone receive an abortion after six weeks.
In the op-ed, Dr. Alan Braid, who has been practicing as an OB/GYN in Texas for 45 years, said that just days after the law took effect, he gave an abortion to a woman who was still in her first trimester but already beyond the state’s new limit.
“I acted because I had a duty of care to this patient, as I do for all patients, and because she has a fundamental right to receive this care,” he wrote. “I fully understood that there could be legal consequences — but I wanted to make sure that Texas didn’t get away with its bid to prevent this blatantly unconstitutional law from being tested.”
Braid went on to say that he understands he is taking a personal risk but that he believes it is worth it.
“I have daughters, granddaughters and nieces,” he concluded. “I believe abortion is an essential part of health care. I have spent the past 50 years treating and helping patients. I can’t just sit back and watch us return to 1972.”
If someone does opt to sue Braid over this matter, he could potentially be the state’s first test case in playing out the legal process. However, it is unclear if anti-abortion groups will follow through, despite their threats to enforce the law.
A spokesperson for Texas Right to Life, which set up a website to report people suspected of violating the ban, told reporters this weekend that it is looking into Braid’s claims but added, “It definitely seems like a legal stunt and we are looking into whether it is more than that.”
Even if abortion opponents hold off on Braid’s case, there are other legal challenges to the Texas law.
Shortly after the policy took effect, the Department of Justice filed a lawsuit attempting to stop it. Last week, the department filed an emergency motion asking a federal judge in the state to temporarily block the ban while that legal battle plays out, with a hearing for that motion set for Oct. 1.
Regardless of what side the federal judge rules for, the other is all but ensured to sue, and that fight could take the question to the Supreme Court in a matter of months.
See what others are saying: (NPR) (The Texas Tribune) (The Wall Street Journal)
Pfizer Says Low Dose of COVID-19 Vaccine Is Safe and Effective in Kids 5 to 11
Pfizer Says Kids’ Vaccine Works
Pfizer announced Monday morning that its joint COVID-19 vaccine with BioNTech is safe and effective in kids ages 5 to 11.
While Pfizer’s vaccine candidate for younger children is the same version the FDA has already approved for people 12 and older, the children’s dose is only one-third of the amount given to adults and teens. Still, Pfizer said the antibody response they’ve seen in kids has been comparable to the response seen in older participants.
Similarly, the company said side effects in children have been similar to those witnessed in adults.
Pfizer said it expects to finish submitting data, which still needs to be peer-reviewed and then published, to the FDA by the end of the month. From there, the agency will ensure that Pfizer’s findings are accurate and that the vaccine will be able to elicit a strong immune response in kids at its current one-third dosage.
That process could take weeks or even all of October, but it does open the possibility that the vaccine candidate could be approved around Halloween.
While experts like Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have called Pfizer’s announcement largely predictable, they’ve also urged people to let the research run its course.
With cases among children skyrocketing in recent months, some parents have begun urging pediatricians to give their children the jab early. Those kinds of requests are likely to increase with Pfizer’s announcement; however, officials have warned parents about acting too quickly.
“No one should really be freelancing — they should wait for the appropriate approval and recommendations to decide how best to manage their own children’s circumstances,” Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, said according to The Washington Post.
See what others are saying: (The Washington Post) (The New York Times) (Axios)
Contradicting Studies Leave Biden’s COVID-19 Booster Plan Up in the Air
While some studies show that the effectiveness of Pfizer and Moderna’s COVID vaccines decrease over time, other publications argue the decline is not substantial and a full-flung booster campaign is premature.
Booster Rollout in Flux
President Joe Biden’s plan to offer COVID-19 booster shots is facing serious hurdles just a week before it is set to roll out. Issues with the plan stem from growing divisions among the scientific community over the necessity of a third jab.
The timing of booster shots administration has been a point of contention for months, but the debate intensified in August when Biden announced that, pending regulatory approval, the government would start offering boosters on Sept. 20 to adults eight months after they received their second dose of Pfizer or Moderna.
The announcement was backed by the director of the Centers for Disease Control and Prevention (CDC), the acting commissioner of the Food and Drug Administration (FDA), and White House chief medical advisor Dr. Anthony Fauci, among others.
However, many scientists and other health experts both inside and outside of the government have continually criticized the plan. They have claimed the data supporting boosters was not compelling and argued that, while the FDA approved third doses for immunocompromised Americans, the push to give them to the general public was premature.
The plan also drew international backlash from those who argued the U.S. should not launch a booster campaign when billions of people around the world have not gotten their first dose yet. Earlier this month, the World Health Organization (WHO) extended its request that wealthy countries hold off on giving boosters until at least the end of the year.
Those arguments appeared to be bolstered when federal health regulators said earlier this month that they needed more time to review Moderna’s application for booster shots, forcing the Biden Administration to delay offering third shots to those who received that vaccine.
Now, Pfizer recipients will be the only people who may be eligible for boosters by the initial deadline, though that depends on a forthcoming decision from an FDA expert advisory committee that is set to vote Friday on whether or not to recommend approval.
Debate Continues in Crucial Week
More contradictory information has been coming out in the days leading up to the highly anticipated decision.
On Monday, an international group of 18 scientists, including some at the FDA and the WHO, published a review in The Lancet arguing that there is no credible data to show the vaccines’ ability to prevent severe disease declined substantially over time, so boosters are not yet needed for the general, non-immunocompromised public.
The experts claimed that any advantage boosters may provide does not outweigh the benefit of giving the extra doses to all those who are unvaccinated worldwide.
On the other side, a study released Wednesday in The New England Journal of Medicine found that people who received a third shot of Pfizer in Israel were much less likely to develop severe COVID than those who just had the first two jabs.
The same day, both Pfizer and Moderna published data backing that up as well. Pfizer released an analysis that said data on boosters and the Delta variant from both Israel and the U.S. suggested “that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.”
Moderna also published data, that has not yet been peer-reviewed, which also found its jab provided less immunity and protection against severe disease as time went on.
Further complicating matters was the fact that the FDA additionally released its report on Pfizer’s analysis of the need for a booster shortly after Pfizer’s publication. Normally, those findings would shine a light on the agency’s stance on the issue, but the regulator did not take a clear stand.
“Some observational studies have suggested declining efficacy of [Pfizer] over time […] while others have not,” the agency wrote. “Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death.”
It remains unclear what the FDA panel will determine when they meet Friday, or what a similar CDC expert panel that is expected to meet next week will decide regarding vaccination policies.
Notably, officials at the two agencies are not required to follow the recommendations of their expert panels, though they usually do.
Even if the FDA approves Pfizer’s application as it stands to give boosters to those 16 and older, people familiar with the matter said the CDC might recommend the third jabs only for people 65 and older or those who are especially at risk.
Regardless of what is decided, experts have said that it is absolutely essential for the agency to stand firm in its decision and clearly explain its reasoning to the public in order to combat further confusion and misinformation.
“F.D.A. does the best in situations when there are strongly held but conflicting views, when they’re forthcoming with the data and really explain decisions,” Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health told The New York Times. “It’s important for the F.D.A. not to say, ‘Here’s our decision, mic drop. It’s much better for them to say, ‘Here’s how we looked at the data, here are the conclusions we made from the data, and here’s why we’re making the conclusions.’”