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Saturday, January 1, 2022

NYC will consider race when distributing life-saving COVID treatments

 New York City will take a patient’s race into account when distributing potentially life-saving COVID treatments, the Department of Health and Mental Hygiene revealed on their website.

The city will “consider race and ethnicity when assessing individual risk,” reads the agency’s official guidance from Dec. 20, which adds that “longstanding systemic health and social inequities” can contribute to an increased risk of dying from COVID-19.

The guidance applies to both the distribution of monoclonal antibodies and oral antivirals like Paxlovid and Molnupiravir.

“Monoclonal antibody treatments have averted at least 1,100 hospitalizations and at least 500 deaths among people treated in New York City,” the city said in October.

The race-based approach in treatment has already begun to have real-world consequences. One Staten Island doctor said he filled two prescriptions for Paxlovid this week and was asked by the pharmacist to disclose the race of his patients before the treatment was authorized.

The Department of Health and Mental Hygiene's guidance applies to both the distribution of monoclonal antibodies and oral antivirals like Paxlovid and Molnupiravir.
The Department of Health and Mental Hygiene’s guidance applies to both the distribution of monoclonal antibodies and oral antivirals like Paxlovid and Molnupiravir.
via REUTERS

“In my 30 years of being a physician I have never been asked that question when I have prescribed any treatment,” said the doctor, who requested anonymity. “The mere fact of having to ask this question is a slippery slope.”

Both patients, who are white, were ultimately granted their prescriptions.

A recent “Request for Proposals,” form on behalf of the city Department of Health and Mental Hygiene stressed the agency’s commitment to “racial equity.”

“The … DOHMH is committed to improving health outcomes for all New Yorkers by explicitly advancing racial equity and social justice. Racial equity does not mean simply treating everyone equally, but rather, allocating resources and services in such a way that explicitly addresses barriers imposed by structural racism (i.e. policies and institutional practices that perpetuate racial inequity) and White privilege,” it read.

It is unclear if the new “race” guidance has yet to exclude whites from getting treatment, but observers and doctors fear that a system is being created that could lead to racial exclusions in the future during a drug shortage or case surge.

“We are collecting demographic data on COVID antivirals at the request of the city for anonymized data reporting purposes only, as is commonly done with COVID tests and vaccines,” Michael Krueger, a pharmacy rep said. For now, the city is participating exclusively with Alto Pharmacy to distribute the new drugs.

Medical experts said it is correct for COVID treatment to be allocated based who is at the highest risk, but stressed that race was not a biological risk factor.

“I have not seen [race] as one of the risk factors for severe disease and death,” Martin Kulldorff, a Harvard epidemiologist and professor, told The Post. “The reason that a lot of African Americans have died in New York — which is true — is because the rich people and more affluent were working from home while the working class were exposed.”

Some observers and doctors fear that a system is being created that could lead to racial exclusions in the future during a drug shortage or case surge.
Some observers and doctors fear that a system is being created that could lead to racial exclusions in the future during a drug shortage or case surge.
Getty Images

“The lockdowns have discriminated against minorities. Basically they have discriminated against the working class, and minorities are a bigger proportion of the working class.” Kulldorff added.

In a public notice, the state Department of Health said last week that “Non-white race or Hispanic/Latino ethnicity should be considered a risk factor” — putting it in a class with other COVID risk factors like age and obesity.

“There are severe supply shortages for all COVID-19 outpatient therapeutics,” warns city health officials, who urge providers to follow the state guidelines.

Some observers and doctors fear that a system is being created that could lead to racial exclusions in the future during a drug shortage or case surge.
The DOHMH said it is “committed to improving health outcomes for all New Yorkers by explicitly advancing racial equity and social justice.”
Getty Images

The directives follow a slew of new laws signed by Gov. Hochul aimed at “address[ing] discrimination and racial injustice.” One of the new edicts formally declares racism to be a public health crisis.

“It’s just absurd and it shows this is not about public health. This has not been about the health of New Yorkers from the get-go,” Andrew Giuliani, a GOP candidate for governor. told The Post. “Politics before the health and safety of New Yorkers. It continues from the Cuomo administration to the Hochul administration with these new laws.”

“New Yorkers of color have borne the brunt of this pandemic due to structural racism and the legacy of disinvestment in many minority communities,” Michael Lanza, a city Health Department spokesman, told The Post. “Doctors are advised to consider the disproportionate impact felt by these communities in addition to systemic health disparities when prescribing treatments for people who are at highest risk for severe COVID-19 outcomes.”

Lanza added the data was only being collected “to assess equitable distribution” and that race would never be used as a reason to deny treatment.

Antiviral treatment for coronavirus infection represents the cutting edge of treatment for the virus. Interest in the therapeutics has peaked with the arrival of the new Omicron variant and its widespread ability to evade the vaccine.

On Dec. 22, the federal Food and Drug Administration approved an emergency use authorization for Paxlovid “for the treatment of mild-to-moderate coronavirus disease” for anyone 12 and older. Molnupiravir received its emergency use authorization a week later.

https://nypost.com/2022/01/01/nyc-considering-race-in-distributing-life-saving-covid-treatment/

Fitbit patent targets depression and bipolar detection

 Google unit Fitbit has been increasingly focused on mental health, and it seems it’s investigating further ways to track your psychological wellbeing.

The company has filed a new patent for technology that can study mental wellbeing from physiological data. And it seems that Fitbit is targeting those with clinical mental health issues

The patent is vague about the mental health issue it’s targeting, but mentions depression and bipolar specifically.And it has outlined a device that can “screen for and predict mental health issues and cognitive states.”

Fitbit talks about using resting heart rate and sleep data, and how that can be interpreted by Fitbit to assess mental health. This is already part of its Stress Management feature, but the patent augments this with some pretty future-looking metrics.

And curiously, gamification plays a large part in the patent.

fitbit game mental health

The patent outlines how games are currently used to assess mental health, and there seems to be an element of this in technology. Fig 1A and 1D show games on the Fitbit wearable itself, which presumably would used in conjunction with sensor data to assess cognitive states.

And there seems to be other ideas about how data could be captured, which could be more controversial.

The patent abstract also talks about using the microphone to examine user’s voice – which could reveal signals about mental health. Fitbit notes this would require users to opt in.

Fitbit also notes that vocal data has already been studied as part of bipolar diagnosis, but this would require an “extended analytical period" on the device.

fitbit range

Fitbit devices already track stress

Fitbit says this technology would feed into "predicting, modelling and correlating with mental health episodes and disorders." The patent talks about "machine learning trained algorithms and individual event predictions", which we assume means correlating with existing known mental health disorders.

The patent names Conor Heneghan, who is Fitbit’s (and Google’s) Senior Staff Research Scientist – and has been at the forefront of developing many of its sleep-related features.

It seems Fitbit wants to move beyond the stress and EDA-based data and start to look at more serious, clinical mental health issues.

https://www.wareable.com/fitbit/new-fitbit-patent-targets-depression-and-bipolar-detection-8666



Sandoz launches generic Narcan Nasal Spray in US to help reverse opioid overdose

 

  • Opioid overdoses accounted for more than 73,000 deaths in US in one year (through April 2021) based on Center for Disease Control and Prevention’s latest provisional data1
  • Opioid overdose deaths increased almost 40 percent during COVID-19 pandemic (June 2019 vs May 2020),2 highlighting need for more people to have access to overdose-reversing medicine during evolving national crisis

TikTok trend can have teens believing they have serious mental disorders

 A new trend on TikTok could lead some teens to believe they have a serious mental disorder, according to some experts.

The app, which has become a community for users to connect and for teens to show off dance moves and share other fun videos, has recently had some trending videos of young people claiming to have a borderline personality, bipolar or dissociative identity disorder, which is spreading like wildfire on the platform.

Posts with the hashtags, "dissociative identity disorder" and "borderline personality disorder" have been viewed hundreds of millions of times. And some of those videos list possible signs to look out for and encourage viewers to self-evaluate.

Samantha Fridley, 18, said these videos influenced her to believe that she was suffering from a mental disorder.

"I remember seeing these videos on my 'For You' page of people saying, like, 'These are signs that you have this disorder,' bipolar or borderline and all these other weird disorders that I've never even heard of before," Fridley told "GMA." "My mind would be like, 'Maybe I don't have just depression and anxiety, maybe I have something else.'"

"After working with a therapist for a long time, I started realizing that I don't have borderline personality, I don't have disassociated identity, I don't have bipolar. I just have what I've always had, which is depression and anxiety," she added.

According to the National Alliance on Mental Illness, borderline personality disorder is extremely rare -- only 1.4% of the U.S. adult population is estimated to have this condition and it is rarely diagnosed in adolescents.

Mental health professionals say these videos may pose an alarming risk to a potentially vulnerable population.

"If you spend 15 minutes, 30 minutes, 60 minutes viewing people talk about these disorders over and over again, that can make it seem like these conditions are a lot more prevalent than they actually are in the world," said psychologist Ethan Kross, the author of "Chatter: The Voice in Our Head, Why It Matters, and How to Harness It."

To help teens on TikTok, experts are urging parents to maintain an open line of communication with their kids about mental health.

"Take the time to empathetically hear them out," Kross said. "How intense are these symptoms? How long are they lasting? Does it seem like they're interfering with your child's ability to live the life that they want to live? Again, if the answer to those questions is yes, that's a cue to then take the next steps to get a formal diagnosis."

In a statement to ABC News, a TikTok spokesperson said, "We care deeply about the well-being of our community, which is why we continue to invest in digital literacy education aimed at helping people evaluate and understand content they engage with online. We strongly encourage individuals to seek professional medical advice if they are in need of support."

https://www.goodmorningamerica.com/wellness/story/experts-troubled-tiktok-trend-teens-believing-mental-disorders-81964649

AAN Updates Painful Diabetic Neuropathy Guidance

 Gabapentinoids, serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and sodium channel blockers were more likely than placebo to improve diabetic neuropathy pain, according to a new practice guideline from the American Academy of Neurology (AAN).

Those classes typically had comparable effect sizes around the 0.5 standardized mean difference (SMD) cutoff for a medium effect size, reported Brian Callaghan, MD, MS, of University of Michigan in Ann Arbor, and co-authors:

  • Gabapentinoids (SMD 0.44, 95% CI 0.21–0.67)
  • SNRIs (SMD 0.47, 95% CI 0.34–0.60)
  • Sodium channel blockers (SMD 0.56, 95% CI 0.25–0.87)
  • SNRI/opioid dual mechanism agents (SMD 0.62, 95% CI 0.38–0.86)
The exception was tricyclic antidepressants, which showed a large effect size with a low confidence in the estimate (SMD 0.95, 95% CI 0.15–1.8), they wrote in Neurology.

The new guideline updated the AAN's 2011 guidance on treating painful diabetic neuropathy and focused on oral and topical drugs.

"New studies on sodium channel blockers published since the last guideline have resulted in these drugs now being recommended and considered as effective at providing pain relief as the other drug classes recommended in this guideline," Callaghan said in a statement.

Peripheral neuropathy is a common complication of diabetes. It occurs more frequently in patients with longer duration of diabetes or poor glycemic control. Diabetic neuropathy often goes untreated.

In clinical trials, about 30% pain reduction is considered a success, the AAN guideline authors observed. Patients should be made aware of the expected efficacy of neuropathy interventions, because some may expect complete pain relief, they added.

The guidance also recommended that clinicians should:

  • Assess patients with diabetes for peripheral neuropathic pain
  • Evaluate neuropathy patients for concurrent mood disorders, especially depression, and sleep disorders, including obstructive sleep apnea
  • Offer tricyclic antidepressants, SNRIs, gabapentinoids, or sodium channel blockers to reduce pain, and consider other factors besides efficacy such as potential adverse effects, patient comorbidities, and cost
  • Not prescribe valproic acid (Depakene) for patients with childbearing potential, and not prescribe it for other patients unless multiple other drugs have failed
  • Try medications from another effective class if patients don't experience meaningful improvement or have significant adverse effects with their first treatment
  • Consider other ways to reduce pain including topical treatments like capsaicin, glyceryl trinitrate spray, or Citrullus colocynthis; nontraditional treatments like Ginkgo biloba; or interventions like cognitive behavioral therapy, exercise, tai chi, or mindfulness, depending on patient preferences

The guidelines also recommended against use of opioids to treat neuropathy, including SNRI/opioid dual mechanism agents like tramadol (Ultram) and tapentadol (Nucynta), and to consider offering patients currently using these drugs a safe taper and non-opioid treatment options.

The risk profile of tramadol is poor, with respiratory depression, addiction, and overdose reflected in a black box warning, though the drug originally was marketed as less opioid-like and less risky, the guideline authors noted. Tapentadol, a Schedule II opioid, also is associated with severe adverse events, including life threatening respiratory depression, addiction, overdose, and death.

Opioids are often prescribed for peripheral neuropathy, but no clinical trials show that they work in the long term. "Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed," Callaghan said.

The AAN also published a quality measurement set to accompany the guidance to help improve care for all polyneuropathy patients, not just those with painful diabetic neuropathy.


Disclosures

The guideline was developed with financial support from the American Academy of Neurology (AAN).

Callaghan reported relationships with Ann Arbor Veterans Affairs, DynaMed, AAN, the Vaccine Injury Compensation Program, and NIH. Co-authors reported relationships with academic centers, nonprofit groups, publishing companies, government agencies, and pharmaceutical firms.

What Happened to the Novavax Vaccine?

 In JuneMedPage Today wrote about whether Novavax and its "tried-and-true" subunit protein approach to a COVID-19 vaccine could potentially ease vaccine hesitancy. In this story, we explore what's known about the vaccine and why it still isn't on the market.

Pfizer, Moderna, and Johnson & Johnson: Ask any American, and they'll likely be able to rattle off the trio of COVID-19 vaccines available in the U.S.

But what about Novavax's "tried and true" protein subunit vaccine?

Early this year, public health experts told MedPage Today that Novavax -- whose vaccine strategy is used in other vaccines on the market today -- could provide another option to reach the vaccine hesitant.

The recombinant nanoparticle technology used in Novavax's protein subunit vaccine candidate (known as NVX-CoV2373) generates full spike protein, and the vaccine is formulated with an adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies, according to the company.

The technology is the same as that used in the Flublok influenza vaccine, and is similar to other vaccines that have been around for a long time, like the hepatitis B vaccine.

However, nearly a year later, the Novavax vaccine still isn't available in the U.S. In August, Novavax announced that it was delaying submission of an emergency use authorization (EUA) to the FDA until the fourth quarter.

On December 15, full results from PREVENT-19, Novavax's pivotal phase III trial of its vaccine, were published in the New England Journal of Medicine.

The company said in an announcement that the trial achieved its primary endpoint of preventing infection at least 7 days after the second dose. Overall efficacy was 90.4% and efficacy against moderate-to-severe disease was 100%. Adverse events were mostly mild to moderate and transient. Severe reactions were infrequent, and there were no safety concerns related to vaccination.

Novavax did not immediately make a member of leadership available for an interview following the publication of the study. However, a spokesperson told MedPage Today in an email that it expects to submit its complete chemistry, manufacturing, and controls data package to the FDA by the end of 2021.

"We still anticipate a significant market need in the U.S. and globally," the spokesperson said.

At the same time, with the mRNA vaccines already saturating the market, it's not entirely clear how the Novavax vaccine will be rolled out or how it will resonate with consumers in the U.S., should it be granted an EUA from the FDA.

Mayank Mamtani, MSc, a senior biotech analyst and head of healthcare research at B. Riley Securities, told MedPage Today that the way to think about the vaccine is as an alternative to the mRNA vaccines. It is a "very strong vaccine," and while it may come late in the game, it has been differentiated, he noted.

"This is a very attractive option to have," he added.

In a December 16 research note, Mamtani wrote that NVX-CoV2373 is "well-suited for COVID's likely evolution into a relatively benign flu-like paradigm," adding that prior NEJM publications included datasets clinically validating that the Novavax platform "maintain[ed] high efficacy despite antigenic drifts, including via the adjuvant-specific effect."

"We view tolerability profile of a vaccine candidate to be a key consideration for use in a post-pandemic environment, where [Novavax] continues to stand out as the least reactogenic vaccine," he wrote.

The Novavax vaccine has made significant strides in other countries.

On December 20, the company announced that the European Commission had granted the vaccine conditional marketing authorization in people 18 and older. They noted that it had recently received an EUA in Indonesia and the Philippines, where it will be commercialized under the trade name Covovax. Covovax also received an emergency use listing from the WHO.

One day later, Novavax said it had initiated a booster study.

The vaccine's extended stability and simple storage requirements of up to 6 months at refrigerator temperatures make it "well suited for global deployment," according to the authors of the NEJM study.

"The efficacy of NVX-CoV2373 in preventing moderate-to-severe COVID-19 as well as any symptomatic COVID-19 in people at high risk for acquisition and complications of COVID-19 will make this vaccine a valuable tool in controlling the pandemic and its most serious health and economic consequences," they wrote.

Even with the trial's promising results, the question remains as to whether the Novavax vaccine will reach more of the vaccine hesitant in the U.S.

https://www.medpagetoday.com/special-reports/exclusives/96461

Future of 'Overdose Prevention Centers'

 On July 14, 2021, MedPage Today reported on how Rhode Island became the first state to authorize a safe injection facility -- a site which allows people to inject or consume their own illegal substances under supervision. As part of our review of top stories in 2021, we follow up on what has happened since this authorization, with the launching of a pilot program for the same type of overdose prevention centers in New York City.

On November 30, 2021, New York City opened the first official overdose prevention centers in the country. Users bring their own drugs into the sites, where they are monitored by staff who provide clean needles and give overdose reversal drug naloxone when needed.

One underground, unsanctioned site has been active in the U.S. since 2014, but New York is the first city to open such a facility publicly with the support of local officials. Over 100 safe injection sites are currently operating in at least 10 other countries.

"With more than 100,000 people across the country dying unnecessarily" from drug overdoses, it was the right time to act, said Melissa Moore, director of civil systems reform for the Drug Policy Alliance, a non-profit that supports harm reduction and drug decriminalization.

In just those 3 weeks up until December 21, the New York City sites have been used more than 2,000 times and their staff helped to avert 59 overdoses, Moore told MedPage Today.

"We are meeting people who use drugs where they are in their life journey to support them in building their self-worth," said Sam Rivera, executive director of OnPoint NYC, in a press release from the New York City Department of Health celebrating the latest data.

James Baker, MD, MPH, past chair of the Massachusetts Medical Society's Committee on Mental Health and Substance Use, whose son died of a heroin overdose at the age of 23, said he was pleased to see the city putting the health of its people "ahead of outdated laws." And, he added: "That's very hopeful for places like Boston."

Advocates in Boston, Seattle, San Francisco, Philadelphia, and several other cities are battling to open their own sites, and often face serious opposition from community leaders, local officials, and sometimes the federal government. The sites are still, in fact, illegal.

Some critics argue that sites like New York's will simply enable users who will go on to die in other settings.

David Murray, PhD, co-director for the Center for Substance Abuse Policy Research at the Hudson Institute in Washington, D.C., said claims that the sites work are "really pretty dubious" given what he views as weak and biased studies.

The fact that there are overdose reversals on site at a facility "may be very misleading," he said. People who use drugs often do so multiple times in a day and may continue to inject in settings where they aren't protected, Murray said.

"We see evidence that people continue to die, to overdose -- but just not on the facility itself," he noted.

Others say the centers will have minimal impact.

Keith Humphreys, PhD, a professor of psychiatry and behavioral sciences at California's Stanford University, said the sites are "just not that consequential," nor are they "scaleable."

"The first of these sites was 30 years ago, there's not even 150 of them on the entire planet," he said.

Humphreys said that while he wouldn't stop anyone from opening a site, there's a key question he wants answered: "What else could your public health department have done with that same amount of money?"

Humphreys, a former Obama administration senior drug control policy advisor, stressed that the question isn't only whether a public health tool "works" but how well it works relative to other investments, such as methadone and other forms of medication assisted treatment with stronger evidence behind them. He also compares the sites to more scalable tools like needle exchange programs and naloxone -- "things that could take care of a whole population rather than a very, very small number of people who happen to live in a very small area around a supervised injection room."

Alex Kral, an epidemiologist from the nonprofit health research institute RTI International, argued that there's never as much debate around how to save a person who's had a heart attack from dying, for example. "If the goal is to make sure that we improve these people's lives as much as possible, the first thing we have to do is save them; because if we don't save them, we're not going to improve their lives."

Baker agreed. "Right now ... there are so few options available to help people who are out on the street and using every day. Any option that helps bring them back to their families and to society and health is a good option."

New York City's Program

The site in Washington Heights follows a peer model, meaning staff supervising users have their own lived experience with addiction, explained Kral, who visited both sites a week before they opened.

In contrast, the East Harlem site, which is modeled off of Insite, a well-known safe injection site in Vancouver, has medical staff and a health clinic on site. Both sites have booths for injecting or consuming drugs and ventilated smoking vestibules, Kral explained.

For users, it's about more than having a safe place to inject, Moore said. "It's actually about the relationships that staff within the harm-reduction agencies are able to build with people, and then be able to connect them with other care, other forms of public health support," she said.

Sites also provide users with fentanyl test strips, which given the increased danger of fentanyl contamination and poisoning is "really crucial," Moore said.

Neither site has had to call for an ambulance, which is another benefit -- reducing the strain on an overburdened hospital system, particularly during COVID, according to Moore.

More sites are expected to open in 2022. One in the Bronx, one in Manhattan, and a third in an undetermined location, she added.

Will the Feds Intervene?

In opening these overdose prevention centers, New York ignored federal law. A section of the Controlled Substances Act, dubbed the "crack house statute," makes it illegal to operate, own, or rent a site with the intention of using, selling, storing, or manufacturing drugs.

In Kral's view, Mayor Bill de Blasio (D) simply ignored that law. Incoming Mayor Eric Adams has said he supports the sites, as do four out of five district attorneys, who penned an op-ed asking President Biden to endorse them, Moore said.

So, there's little concern for interference from local government but still a chance the federal government could shutter the sites, Kral said.

Moore, however, is hopeful. She quoted HHS Secretary Xavier Becerra who, in a recent interview with NPR on drug policy in October, spoke of being "willing to go places where our opinions and our tendencies have not allowed us to go [before]."

While that statement wasn't an explicit endorsement, Moore characterized it as "a fair amount of dancing around it, but some signaling there."

Kral pointed out that, in spite of Becerra's known support for overdose prevention centers as Attorney General of California, the HHS Overdose Prevention Strategy released last month made no mention of the sites.

As for the other important federal player, Kral noted, "we've heard absolutely nothing ... from the Department of Justice."

Over the last 50 years of drug policy, Kral said a pattern has emerged, which starts with an act of civil disobedience, (the opening of an unsanctioned overdose prevention center) and continues with a city or two adopting a controversial measure, and after some time, a state or two.

Both needle exchange and naloxone programs followed this pattern, he noted.

The federal government did nothing to stop those programs, nor did they help them, he said, for as long as 20 years.

Given that context, "I wouldn't expect to hear from the federal government on this issue for ... maybe another decade or so," Kral said.

How to Open a Safe Injection Site

There are two routes to opening safe injection sites or overdose prevention centers: one is the legal route, and the other is the political route, Kral said.

New York took the political route, as de Blasio essentially thumbed his nose at federal officials and said, "We're just gonna do it." Philadelphia and several other cities and states appear to be taking the legal route.

Ronda Goldfein, Esq., vice president of Safehouse, the Philadelphia nonprofit working to establish an overdose prevention center there, despite praising New York's "wonderful, brave move," said her group has "consistently said that it wouldn't open without legal authority to do so."

The nonprofit is also not in the position to ignore a court order, said Goldfein, who is also executive director of the AIDS Law Project of Pennsylvania.

Under the Trump administration, the Department of Justice sued Safehouse in 2019 and is still in active litigation. Ignoring the order would only create a "distraction" for the movement, over whether the group would be in contempt or not. Instead, Goldfein said, Safehouse wants to "keep our eye on the prize, which is to save lives and do it in the safest way, for all concerned."

Rhode Island Gov. Daniel McKee (D) signed a law in July authorizing safe injecting sites there. In California, a bill known as SB-57 that would allow California to open safe injection programs in San Francisco, Oakland, and Los Angeles, passed the state Senate in April 2021. Kral noted it is expected to head to the state assembly early next year.

However, Philadelphia, oddly, is in the best position to negotiate its case.

In October, the Supreme Court chose not to review the case against Safehouse, Goldfein said during a panel discussion in November. But by petitioning the Supreme Court, Safehouse forced the Biden Administration to weigh in on its plans.

"In many ways, we don't regret being sued," Goldfein said, because the lawsuit has allowed the group to have conversations with the Biden administration on the issue that, to her knowledge, no other advocates are having.

The nonprofit initially expected a response from the DOJ -- the "first tell" from the Biden administration regarding where they stand on these sites -- in November, but this was postponed to early January.

And now, Goldfein told MedPage Today, the DOJ and Safehouse agreed to another extension to the government's response, this time to March 7, 2022.

With that extension, Goldfein wrote in an email, "Safehouse is optimistic that, with continued conversations, a mutually satisfactory resolution will be reached."

As for New York's influence, Goldfein said, "I think that every day that a site stays open, that lives are saved and that ... there's no residual fallout ... I think that all strengthens our position."

https://www.medpagetoday.com/psychiatry/addictions/96468