- Dr. Anthony Fauci reaffirmed the safety of AstraZeneca’s COVID-19 vaccine on Wednesday after U.S. health officials accused the company of providing “outdated and potentially misleading” data to make the shot appear more effective.
- On Monday, AstraZeneca said clinical trials found its vaccine to be 79% effective, but the group of independent experts overseeing the trial said that data did not include an additional month of testing that actually placed the efficacy rate at between 69% to 75%.
- The drugmaker issued another statement Tuesday claiming the 79% rate came from a partial report that was consistent with the full analysis and promised to publish that information within 48 hours.
- While Fauci criticized AstraZeneca for publishing a statement that “wasn’t completely accurate” and could contribute to vaccine hesitancy, he argued the data was still sound and the shot will prove very effective.
AstraZeneca Accused of Misrepresenting Data
Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, continued his efforts to dispel vaccine hesitancy and restore confidence in the AstraZeneca COVID-19 shot on Wednesday after U.S. health officials cast doubt on its most recent clinical trials.
In a press release Monday, AstraZeneca announced that the large U.S. clinical for its COVID vaccine found the shots to be 79% effective. However, just hours later, a group of medical experts overseeing the trial wrote a letter essentially accusing the company of cherry-picking its data.
According to outlets that saw the letter, the experts said they were concerned that the drugmaker had provided “outdated and potentially misleading” data on its inoculation to make it seem more effective than the full data showed.
Reportedly, the independent monitors pushed back on AstraZeneca’s claim that the jab was 79% effective because that figure did not include an additional month of testing, which, when taken into account, made the effectiveness range from 69% to 75%.
AstraZeneca responded in another statement Tuesday, claiming that the numbers published the day prior were indeed based on “an interim analysis with a data cut-off” of Feb. 17. That data, the company claimed, was still consistent with the full analysis of their vaccine trials. They promised to release the complete trial within 48 hours.
Public health experts reiterated their apprehension, with many also expressing concern that the situation will cause more scrutiny from regulators and erode public trust in the inoculation at a time when there is already doubt.
Last week, a European regulator reaffirmed the vaccine’s safety after over a dozen countries paused their rollout of the shot citing concerns it caused blood clots. The U.S. clinical trial, which is the largest trial to date, did not turn up any signs of this problem.
Experts Work to Instill Public Confidence
While speaking on Good Morning America Tuesday, Dr. Fauci criticized the drugmaker for issuing a press release that “wasn’t completely accurate,” but emphasized the solidity of the data and the need for experts to reify public trust in the jab.
“This is really what you call an unforced error because the fact is this is very likely a very good vaccine,” he said. “This kind of thing does really cast some doubt about the vaccines and maybe contribute to the hesitancy. It was not necessary.”
“If you look at it, the data really are quite good,” he added. “We have to keep essentially trying as hard as we can to get people to understand there are safeguards in place.”
As Dr. Fauci and other public health officials have also noted, the 69% to 75% efficacy rate widely believed to represent the actual effectiveness of the AstraZeneca vaccine is still quite good and similar to others on the market, like the one-shot Johnson & Johnson product.
Some experts have also said the AstraZeneca jab is arguably the world’s most important vaccine right now. The low cost and relatively easy storage compared to other COVID inoculations have made the AstraZeneca version especially accessible and thus absolutely critical in the global fight against the coronavirus. Currently, the COVID-19 shot is the most widely used globally, having been authorized in more than 70 countries.
While it has not yet been approved in the U.S., during a press conference Wednesday, Dr. Fauci assured Americans that the Food and Drug Administration’s review of the jab will be transparent.
“Hopefully, that will dispel any hesitancy associated with this little bump in the road we happened to have most recently with AstraZeneca,” he said.
“At the end of the day,” he added, the data shows that the AstraZeneca shot, “is going to turn out to be a good vaccine.”
See what others are saying: (The New York Times) (The Washington Post) (Business Insider)
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.”
See what others are saying: (The Washington Post) (The New York Times) (Axios)
Kathy Griffin, Ethan Klein, More Suspended From Twitter Over Elon Musk Impersonations
Many have pretended to be Musk in an attempt to highlight the potential issues paid-for verifications could cause on the platform.
Musk Takes on Impersonations
Comedian Kathy Griffin and internet personality Ethan Klein are among the many Twitter users that have been permanently suspended for impersonating the platform’s new CEO, Elon Musk.
Impersonation has long been against Twitter’s rules, but on Sunday, the billionaire took the policy a step further by announcing that “any Twitter handles engaging in impersonation without clearly specifying ‘parody’ will be permanently suspended.”
“Previously, we issued a warning before suspension, but now that we are rolling out widespread verification, there will be no warning,” Musk explained. “This will be clearly identified as a condition for signing up to Twitter Blue.”
Musk also said that any user who changes their name will temporarily lose their verification check mark.
The announcement came as many verified users began mocking Musk by changing their name and photo to match his, then tweeting jokes that were either absurd or out of character for the business mogul. Many did this to protest Musk’s plan to charge an $8 monthly subscription fee that would allow any Twitter user to become verified.
Klein was one of many who changed his name to “Elon Musk” and made a photo of the CEO his profile image. The podcast host sent out several jokes, including one referencing the increased use of the N-word on the platform since Musk’s takeover, and another referencing Jeffrey Epstein.
“Even though Jeffrey Epstein committed horrible crimes, I do still miss him on nights like this for his warmth and camaraderie. Rest In Peace old Friend,” he wrote.
His account was quickly banned, but Klein defended himself on TikTok, arguing that both his cover photo and bio labeled his account as “parody” and therefore should be acceptable under Musk’s guidelines.
“What more do you want from me?” he asked. “Comedy is dead. And Elon Musk dug the grave.”
Protests of Musk’s Twitter Control
For her part, Griffin likewise tweeted while masquerading as Musk, writing that after “spirited discussion with the females in my life, I’ve decided that voting blue for their choice is only right.”
Musk joked that she was actually “suspended for impersonating a comedian” and added that she can have her account back if she pays for the $8 subscription. Griffin, however, found another way around the ban.
The comedian logged into her late mother’s Twitter account and began using the hashtag #FreeKathy while calling out Musk.
“Mad Men” actor Rich Sommer and podcaster Griffin Newman have also had their accounts suspended for tweeting as Musk. Other celebrities, including TV producer Shonda Rhimes, musician Sara Bareilles, and model Gigi Hadid have protested Musk’s Twitter reign by leaving the platform altogether.
“For a long time, but especially with its new leadership, it’s becoming more and more of a cesspool of hate & bigotry, and it’s not a place I want to be a part of,” Hadid wrote on Instagram over the weekend.