ReportWire

Tag: medical treatments

  • Legalization of ‘magic’ mushrooms back in the running

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    BOSTON — More than a year after voters rejected a plan to legalize “magic” mushrooms, advocates have renewed the push on Beacon Hill for the use of psychedelic drugs again.

    The Joint Committee on Public Health voted to advance bipartisan legislation that would decriminalize the drug for adults 21 and older for treatment of post-traumatic stress and other ailments for veterans, law enforcement officers or others who are “professionally diagnosed” with a “qualifying” condition.

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    By Christian M. Wade | Statehouse Reporter

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  • MBTA balks at expanding overdose prevention kiosks

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    BOSTON — MBTA officials are pouring cold water on a legislative push to make the opioid overdose reversing drug naloxone available at subway stations, citing a lack of proper staff and a shortage of funding.

    The T recently wrapped up a federally funded pilot project that installed 15 kiosks with doses of the medicine – also known by its brand name, Narcan – at several Red Line stations to help reduce fatal drug overdoses.


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    By Christian M. Wade | Statehouse Reporter

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  • Lawmaker hosts naloxone training at Statehouse

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    BOSTON — Rep. Kate Donaghue has a trick for always ensuring naloxone is on hand and ready to deploy if she encounters someone experiencing an opioid overdose: she keeps a dose tucked into the laminated pouch holding her Statehouse ID.

    Donaghue, whose son, Brian, died in 2018 to an overdose, on Tuesday hosted dozens of her colleagues, administration officials, public health workers and others for a training session about how and when to use naloxone.


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    By Chris Lisinski | State House News Service

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  • Data: Fewer opioids prescribed in Mass., NH

    Data: Fewer opioids prescribed in Mass., NH

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    BOSTON — While the scourge of opioid addiction continues to affect Massachusetts, the number of people getting legal prescriptions for heavily addictive medicines is falling, according to the latest federal data.

    Massachusetts had the second lowest opioid prescription rate in New England in 2022, following Vermont, the U.S. Centers for Disease Control and Prevention reported. Health care providers in the Bay State wrote 30.8 opioid prescriptions for every 100 residents, the federal agency reported.

    That’s a slight drop from the previous year but a substantial decline from the 66 per 100 prescription rate in 2006, when the CDC began tracking the data, which lags by two years.

    New Hampshire, which has also seen declining numbers of opioid prescriptions in recent years, had the third-lowest rate in New England in 2022, with 32 prescriptions for every 100 residents. Maine had the highest rate in the region, or 35.2 per 100 residents.

    Nationally, the overall prescription rate was 39.5 prescriptions per 100 people in 2022, according to the CDC data.

    Curbing opioid addiction has been a major focus on Beacon Hill for a number of years, with hundreds of millions of dollars being devoted to expanding treatment and prevention efforts.

    For many, opioid addiction has its roots in prescription painkillers such as Oxycontin and Percocet, which led them to street-bought heroin and fentanyl once those prescriptions ran out.

    In 2016, then-Gov. Charlie Baker and lawmakers pushed through a raft of rules to curb over-prescribing of opioids. Those included a cap on new prescriptions written in any seven-day period and a requirement that doctors consult a state prescription monitoring database before prescribing an additive opioid.

    Meanwhile opioid manufacturers have been hammered with hundreds of lawsuits from the states and local governments over their role in fueling a wave of opioid addiction. Attorney General Maura Healey’s office recently agreed to a multi-billion dollar settlement with OxyContin maker Purdue Pharma.

    Supporters of the tougher requirements say they have saved lives by dramatically reducing the number of heavily addictive opioids being prescribed.

    Pain management groups say the regulatory backlash has made some doctors worried about writing prescriptions for opioids, depriving patients of treatment.

    There were 2,125 confirmed or suspected opioid-related deaths in 2023 — which is 10%, or 232, fewer fatal overdoses than the same period in 2022, according to the latest data from the state Department of Public Health.

    Last year’s opioid-related overdose death rate also decreased by 10% to 30.2 per 100,000 people compared with 33.5 in 2022, DPH said.

    Health officials attributed the persistently high death rates to the effects of an “increasingly poisoned drug supply,” primarily with the powerful synthetic opioid fentanyl. Fentanyl was present in 90% of the overdose deaths where a toxicology report was available, state officials noted.

    Nationally, there were 107,543 overdose deaths reported in the U.S. in 2023, a 3% decrease from the estimated 111,029 in 2022, according to CDC data.

    On Beacon Hill, state lawmakers are being pressured to take more aggressive steps to expand treatment and prevention options for those struggling with opioid addiction.

    Last month, a coalition of more than 100 public health and community-based organizations wrote to House and Senate leaders urging them to pass substance abuse legislation before the Dec. 31 end of the two-year session.

    “There isn’t a day that goes by without several people in the Commonwealth dying from an overdose or losing loved ones to this disease,” they wrote. “As individuals and institutions working to combat the opioid epidemic, we know the Commonwealth must do more to prevent addiction, help people find pathways to treatment and recovery, and save lives.”

    Christian M. Wade covers the Massachusetts Statehouse for North of Boston Media Group’s newspapers and websites. Email him at cwade@cnhinews.com.

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    By Christian M. Wade | Statehouse Reporter

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  • Data: Fewer opioids prescribed in Massachusetts

    Data: Fewer opioids prescribed in Massachusetts

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    BOSTON — While the scourge of opioid addiction continues to affect Massachusetts, the number of people getting legal prescriptions for heavily addictive medicines is falling, according to the latest federal data.

    Massachusetts had the second lowest opioid prescription rate in New England in 2022, following Vermont, the U.S. Centers for Disease Control and Prevention reported. Health care providers in the Bay State wrote 30.8 opioid prescriptions for every 100 residents, the federal agency reported.

    That’s a slight drop from the previous year but a substantial decline from the 66 per 100 prescription rate in 2006, when the CDC began tracking the data, which lags by two years.

    New Hampshire, which has also seen declining numbers of opioid prescriptions in recent years, had the third-lowest rate in New England in 2022, with 32 prescriptions for every 100 residents. Maine had the highest rate in the region, or 35.2 per 100 residents.

    Nationally, the overall prescription rate was 39.5 prescriptions per 100 people in 2022, according to the CDC data.

    Curbing opioid addiction has been a major focus on Beacon Hill for a number of years, with hundreds of millions of dollars being devoted to expanding treatment and prevention efforts.

    For many, opioid addiction has its roots in prescription painkillers such as Oxycontin and Percocet, which led them to street-bought heroin and fentanyl once those prescriptions ran out.

    In 2016, then-Gov. Charlie Baker and lawmakers pushed through a raft of rules to curb over-prescribing of opioids. Those included a cap on new prescriptions written in any seven-day period and a requirement that doctors consult a state prescription monitoring database before prescribing an additive opioid.

    Meanwhile opioid manufacturers have been hammered with hundreds of lawsuits from the states and local governments over their role in fueling a wave of opioid addiction. Attorney General Maura Healey’s office recently agreed to a multi-billion dollar settlement with OxyContin maker Purdue Pharma.

    Supporters of the tougher requirements say they have saved lives by dramatically reducing the number of heavily addictive opioids being prescribed.

    Pain management groups say the regulatory backlash has made some doctors worried about writing prescriptions for opioids, depriving patients of treatment.

    There were 2,125 confirmed or suspected opioid-related deaths in 2023 — which is 10%, or 232, fewer fatal overdoses than the same period in 2022, according to the latest data from the state Department of Public Health.

    Last year’s opioid-related overdose death rate also decreased by 10% to 30.2 per 100,000 people compared with 33.5 in 2022, DPH said.

    Health officials attributed the persistently high death rates to the effects of an “increasingly poisoned drug supply,” primarily with the powerful synthetic opioid fentanyl. Fentanyl was present in 90% of the overdose deaths where a toxicology report was available, state officials noted.

    Nationally, there were 107,543 overdose deaths reported in the U.S. in 2023, a 3% decrease from the estimated 111,029 in 2022, according to CDC data.

    On Beacon Hill, state lawmakers are being pressured to take more aggressive steps to expand treatment and prevention options for those struggling with opioid addiction.

    Last month, a coalition of more than 100 public health and community-based organizations wrote to House and Senate leaders urging them to pass substance abuse legislation before the Dec. 31 end of the two-year session.

    ”There isn’t a day that goes by without several people in the Commonwealth dying from an overdose or losing loved ones to this disease,” they wrote. “As individuals and institutions working to combat the opioid epidemic, we know the Commonwealth must do more to prevent addiction, help people find pathways to treatment and recovery, and save lives.”

    Christian M. Wade covers the Massachusetts Statehouse for North of Boston Media Group’s newspapers and websites. Email him at cwade@cnhinews.com.

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    By Christian M. Wade | Statehouse Reporter

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  • Question 4: Should the state legalize psychedelic mushrooms?

    Question 4: Should the state legalize psychedelic mushrooms?

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    BOSTON — Supporters of psychedelic mushrooms are urging voters to approve a referendum legalizing the hallucinogenic drug for “therapeutic” use, but critics argue the move would jeopardize public health and safety and fuel a gray market.

    Question 4 would, if approved, decriminalize psilocybin and other psychedelics and allow adults 21 and older to use the drugs under supervision at licensed centers. It would also allow people to grow their own mushrooms at home and give the drugs to others.

    Unlike the legalization of recreation cannabis in 2016, Question 4 if approved would not authorize retail sales of psychedelics. Psychedelics sold at therapeutic facilities would be subject to the state’s 6.25% sales tax and a new 15% excise tax.

    Adults 21 and older would be allowed to grow, possess and use psychedelics. A home-grow provision in the proposal would allow people to cultivate psychedelic mushrooms in their home in a 144-square-foot area, according to the referendum’s wording.

    The group Massachusetts for Mental Health Options, which has cleared several hurdles to put the question before voters, frames the effort as a way to help treat mental illness, citing studies showing the promise of psilocybin as a therapeutic drug.

    Backers of the referendum, which include military veterans and former police officers, argue there is growing body of evidence that psilocybin and other psychedelic substances can help in treating psychological disorders such as post-traumatic stress disorder and anxiety.

    “For years, I struggled with PTSD and depression … Psychedelic medicine was a breakthrough for me,” said Emily Oneschuk, a Navy veteran and outreach director for the group, said in recent TV ad urging voters to approve the measure. “It helped me embrace life again.”

    But opponents, including medical experts, argue that legalizing a drug that can lead to psychosis would jeopardize public health and safety.

    Chris Keohan, spokesman for the opposition group Coalition For Safe Communities, said major concern about question for Question 4 is that it wouldn’t allow cities and towns to opt out of hosting “therapy” centers. He said opponents are also alarmed about the “bedroom size” grow area that would be allowed for psychedelics under the home-grow provision.

    “We’re not challenging the medicinal benefits for the people that genuinely need the help,” he said. “But this was written to enable for-profit facilities to open up.”

    Another concern for opponents is the cost of psychedelic therapy, which would not be covered by insurance and would likely be beyond what most people in the state can afford to pay for out-of-pocket health care costs, he said. The ballot question does not set a cap on how much can be charged for the therapeutic treatment.

    “I’d like to know how many people in the state of Massachusetts are going through the painful issues that they talk about can afford $750 to $3,500 per visit,” Keohan said. “They are providing false hope to the people that need it the most.”

    He said another concern is that the referendum includes several kinds of psychedelic compounds, in addition to psilocybin, which create major health risks for patients. That includes mescaline, derived from the peyote cactus, and ibogaine, a drug that comes from the roots of the African shrub iboga, which is known to cause cardiac arrests and seizures.

    “Massachusetts voters aren’t stupid and they know when they’re being sold a bill of goods, and that’s what this is,” Keohan said.

    The ballot question is backed by the Washington, D.C.-based New Approach political action committee, which has supported similar initiatives in Oregon and Colorado, where psilocybin is legal. The group has raised and spent millions of dollars on advertising to sway voters on the referendum.

    The U.S. Food and Drug Administration has authorized “breakthrough therapy” status for the psychedelic drug for the purposes of clinical trials being conducted by private research companies.

    But psilocybin is still illegal under federal law, classified as a Schedule 1 drug under the U.S. Controlled Substances Act along with LSD, heroin and other drugs, with no accepted medical uses.

    A handful of Massachusetts communities, including Salem, Amherst and Cambridge, have approved plans to decriminalize small amounts of psilocybin and authorize its use for therapy.

    A legislative committee that reviewed the proposal concluded that the primary goals of the referendum — licensure and decriminalization — would likely “undercut each other by creating two separate systems for the use of psychedelic substances.” The lawmakers said that could fuel black market sales of the hallucinogenic drug.

    “The petition would both create a system of state-licensed and taxed therapeutic facilities on the one hand and, on the other, decriminalize the cultivation, possession, and distribution of a variety of hallucinogenic and psychoactive substances,” lawmakers wrote in a report on the proposal.

    A report by Tufts University’s Center for State Policy Analysis echoed those concerns.

    Christian M. Wade covers the Massachusetts Statehouse for North of Boston Media Group’s newspapers and websites. Email him at cwade@cnhinews.com.

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    By Christian M. Wade | Statehouse Reporter

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  • Walking for hospice care

    Walking for hospice care

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    DANVERS — Care Dimensions, the hospice and palliative care provider, stepped off for its 37th annual Walk for Hospice on Sunday morning on the campus of St. John’s Prep in Danvers.

    The event is designed to offer an opportunity to remember and honor loved ones who have died, while also raising funds for Care Dimensions, which is a nonprofit hospice provider serving more than 100 communities across Eastern Massachusetts.

    Funds from the walk support programs like grief support, music therapy, and other services that benefit hospice patients and their families.

    Before the walk got underway, there were activities and refreshments, as well as music and brief remarks. WCVB meteorologist A.J. Burnett again served as the emcee.

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  • Opioid deaths drop 10%, but remain high

    Opioid deaths drop 10%, but remain high

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    BOSTON — The scourge of opioid addiction continues to affect Massachusetts, but new data shows a double-digit decrease in the number of overdose deaths in the past year.

    There were 2,125 confirmed or suspected opioid-related deaths in 2023 — which is 10%, or 232, fewer fatal overdoses than during the same period in 2022, according to a report released this week by the state Department of Public Health.

    Last year’s opioid-related overdose death rate also decreased by 10% to 30.2 per 100,000 people compared to 33.5 in 2022, DPH said.

    Health officials attributed the persistently high death rates to the effects of an “increasingly poisoned drug supply,” primarily with the powerful synthetic opioid fentanyl.

    Fentanyl was present in 90% of the overdose deaths where a toxicology report was available, state officials noted.

    Preliminary data from the first three months of 2024 showed a continued decline in opioid-related overdose deaths, the agency said, with 507 confirmed and estimated deaths, a 9% drop from the same time period last year.

    Gov. Maura Healey said she is “encouraged” by the drop in fatal overdoses but the state needs to continue to focus on “prevention, treatment and recovery efforts to address the overdose crisis that continues to claim too many lives and devastate too many families in Massachusetts.”

    Substance abuse counselors welcomed the declining number of fatal opioid overdoses, but said the data shows that there is still more work to be done to help people struggling with substance use disorders.

    “While the number of opioid-related overdose deaths in the commonwealth remains unacceptably high, it is encouraging to see what we hope is a reversal of a long and painful trend,” Bridgewell President & CEO Chris Tuttle said in a statement. “The time is now to boost public investments and once and for all overcome the scourge of the opioid epidemic.”

    Nationally, there were 107,543 overdose deaths reported in the U.S. in 2023, a 3% decrease from the estimated 111,029 in 2022, according to recently released U.S. Centers for Disease Control and Prevention data.

    In New Hampshire, drug overdose deaths also declined by double digits in 2023, according to figures released in May by the state’s medical examiner and the National Centers for Disease Control.

    There were 430 deaths attributed to overdoses in 2023, an 11.7% decrease from 2022’s 487, according to the data.

    Curbing opioid addiction has been a major focus on Beacon Hill for a number of years with hundreds of millions of dollars being devoted to expanding treatment and prevention efforts.

    The state has set some of the strictest opioid-prescribing laws in the nation, including a cap on new prescriptions in a seven-day period and a requirement that doctors consult a state prescription monitoring database before prescribing an addictive opioid.

    Hundreds of millions of dollars are flowing into the state from multistate settlements with opioid makers and distributors, including $110 million from a $6 billion deal with OxyContin maker Purdue Pharma and the Sackler family.

    Under state law, about 60% of that money will be deposited in the state’s opioid recovery fund, while the remainder will be distributed to communities.

    Earlier this week, House lawmakers were expected to take up a package of bills aimed at improving treatment of substance abuse disorders and reducing opioid overdose deaths.

    The plan would require private insurers to cover emergency opioid overdose-reversing drugs such as naloxone and require drug treatment facilities to provide two doses of overdose-reversal drugs when discharging patients, among other changes.

    Another provision would require licenses for recovery coaches, who are increasingly sent to emergency rooms, drug treatment centers and courtrooms to help addicts get clean.

    Backers of the plan said the goal is to integrate peer recovery coaches more into the state’s health care system, helping addicts who have taken the first steps toward recovery.

    Long-term recovery remains one of the biggest hurdles to breaking the cycle of addiction, they say.

    Christian M. Wade covers the Massachusetts Statehouse for North of Boston Media Group’s newspapers and websites. Email him at cwade@cnhinews.com.

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    By Christian M. Wade | Statehouse Reporter

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  • Report: Injured workers at risk for opioid overdoses

    Report: Injured workers at risk for opioid overdoses

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    Workers who are injured on the job are at higher risk for fatal opioid-related overdoses, according to a new study, which calls for renewed efforts to reduce the stigma of drug addiction.

    The report, released Thursday by the state Department of Public Health, found that working-age Massachusetts residents who died between 2011 and 2020 were 35% more likely to have died of an opioid-related overdose if they had previously been injured at work.

    DPH researchers compiled information about individuals’ employment and work-related injury status from their workers’ compensation claims and linked it to data from their death certificates.

    Researchers reviewed the details of 4,304 working-age adults who died between 2011 and 2020 and found at least 17.2% had at least one workplace injury claim and died of an opioid-related overdose, according to the study.

    Public health officials say the study is the first linking the impact of work-related injuries to opioid-related overdose deaths.

    “Occupational injuries can take both a physical and mental toll, and those who suffer injuries at work may be discouraged from seeking help because of stigmatization and fear of losing their jobs,” Health and Human Services Secretary Kate Walsh said in a statement. “Avoiding or delaying care can lead to a preventable overdose death.”

    Walsh called for stepped-up efforts to “eliminate the stigma that accompanies substance use disorder in all sectors of society, including the workplace.”

    The release of the report comes as opioid overdose deaths remain devastatingly high in the Bay State, despite a slight decrease over the past year.

    There were 2,323 confirmed or suspected opioid-related deaths in Massachusetts from Oct. 1, 2022, to Sept. 30, 2023 — eight fewer than the same period in 2021, according to a report released in December by the health department.

    Health officials attributed the persistently high death rates to the effects of an “increasingly poisoned drug supply,” primarily with the powerful synthetic opioid fentanyl.

    Fentanyl was present in 93% of the overdose deaths where a toxicology report was available, state officials noted.

    Curbing opioid addiction has been a major focus on Beacon Hill for a number of years with hundreds of millions of dollars being devoted to expanding treatment and prevention efforts.

    The state has set some of the strictest opioid-prescribing laws in the nation, including a cap on new prescriptions in a seven-day period and a requirement that doctors consult a state prescription monitoring database before prescribing an addictive opioid.

    The Opioid Recovery and Remediation Fund, created by the state Legislature in 2020, has received more than $101 million from settlements with drug makers and distributors over their alleged role in the opioid crisis, according to the Executive Office of Health and Human Services.

    More than 25,000 people have died from opioid-related overdoses in Massachusetts since 2011, according to state records.

    Nationally, fatal drug overdoses fell by roughly 3% in 2023, according data from the U.S. Centers for Disease Control and Prevention.

    But the toll from fatal overdoses in 2023 remained high, claiming 107,543 lives, the federal agency said.

    Fentanyl and other synthetic opioids were responsible for approximately 70% of lives lost, while methamphetamine and other synthetic stimulants are responsible for approximately 30% of deaths, the CDC said.

    “The shift from plant-based drugs, like heroin and cocaine, to synthetic, chemical-based drugs, like fentanyl and methamphetamine, has resulted in the most dangerous and deadly drug crisis the United States has ever faced,” Anne Milgram, head of the Drug Enforcement Administration, said in a recent statement.

    The DEA points to Mexican drug cartels, who it says are smuggling large quantities of fentanyl and other synthetic drugs manufactured in China into the country along the southern border.

    “The suppliers, manufacturers, distributors, and money launderers all play a role in the web of deliberate and calculated treachery orchestrated by these cartels,” she said.

    Christian M. Wade covers the Massachusetts Statehouse for North of Boston Media Group’s newspapers and websites. Email him at cwade@cnhinews.com.

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    By Christian M. Wade | Statehouse Reporter

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  • Bluebird Bio Stock Is in Free Fall

    Bluebird Bio Stock Is in Free Fall

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    Two weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in the U.S. who suffer from the condition.

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  • SmileDirectClub winds down operations — but customers are told to keep paying

    SmileDirectClub winds down operations — but customers are told to keep paying

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    SmileDirectClub Inc. said late Friday it was winding down operations, effective immediately, seeming to cast its millions of customers adrift — except when it comes to their bills.

    SmileDirectClub
    SDCCQ,
    -45.32%

    said in a statement that its aligner treatment is not available to new customers. For existing customers, the company said, “we apologize for the inconvenience, but customer care support is no longer available” through its telehealth program, including periodic check-ins.

    The company did not immediately return a request for comment.

    People on the company’s SmilePay plan will need to make all payments until paid in full, the company said. SmileDirect also ended its lifetime guarantee.

    For those seeking refunds, the company said that “there will be more information to come once the bankruptcy process determines next steps and additional measures customers can take.”

    The company in late September filed for bankruptcy protection, saying it was seeking to find investors for a “comprehensive recapitalization.” In January, it laid off workers and ended a few international operations in a bid to become profitable.

    The company has long attracted criticism for its teledentistry model, which it has said aims to disrupt the orthodontics industry. There were allegations a few years ago that it had harmed customers by breaking teeth and causing nerve damage, which the company denied.

    Setbacks also include a scathing report from a short seller; regulatory action in California, Alabama and Georgia; and opposition to the company’s business practices from medical organizations including the American Dental Association and the American Association of Orthodontists.

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  • WHO’s new COVID guidelines see fewer patients requiring hospitalization

    WHO’s new COVID guidelines see fewer patients requiring hospitalization

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    Most patients are unlikely to develop severe disease or die if they get the current variants of COVID-19 as immunity levels have climbed given higher levels of vaccination.

    That’s according to the World Health Organization, which updated its COVID-19 guidelines on Friday for the 13th time.

    The guidelines highlight that fewer patients will require hospitalization as they are more likely to have non-severe COVID.

    “The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease,” the agency said in a statement.

    People who are immunosuppressed remain at higher risk, however, with an estimated hospitalization rate of 6%. But people who are older than 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.

    And patients who belong to neither of those groups are at low risk of hospitalization, at an estimated rate of just 0.5%. Most people are now considered low-risk, said the WHO.

    The agency continues to recommend the use of Paxlovid for anyone at high or moderate risk of hospitalization. The antiviral developed by Pfizer Inc.
    PFE,
    -1.20%

    is still the best choice for most eligible patients, given its therapeutic benefits, ease of use and fewer concerns about potential harms.

    In cases where Paxlovid is not available, the WHO recommends molnupiravir, an antiviral developed by Merck
    MRK,
    -1.11%
    ,
    or remdesivir, an antiviral developed by Gilead Sciences Inc.
    GILD,
    +0.92%

    Read now: Pfizer to more than double price of its COVID antiviral once drug moves to commercial market

    “For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol,” said the agency.

    The WHO said it recommends against the use of a new antiviral called VV116 for patients, apart from those who are enrolled in clinical trials.

    That oral antiviral is being developed by Junshi Biosciences and Vigonvita in China.

    It issued a warning against the use of ivermectin for people with non-severe COVID. The drug used to treat parasites in animals proved highly controversial during the pandemic when many people were persuaded by fraudulent research and online misinformation that it was an effective treatment.

    From the archive: ‘You will not believe what I’ve just found.’ Inside the ivermectin saga: a hacked password, mysterious websites and faulty data.

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  • Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

    Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

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    Pfizer Inc.
    PFE,
    -1.73%

    said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease. 

    The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers. 

    Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement. 

    The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions. 

    The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine. 

    The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine. 

    A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said. 

    The green light for Penbraya gives Pfizer the edge in its race with GSK
    GSK,
    +0.54%
    ,
    which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine. 

    The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.

    Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500
    SPX
    has gained 10%.

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  • Ardelyx wins long battle for FDA approval of kidney-disease treatment 

    Ardelyx wins long battle for FDA approval of kidney-disease treatment 

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    Ardelyx Inc.
    ARDX,
    -0.58%

    on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.

    The biopharma company said late Tuesday that the U.S. Food and Drug Administration approved tenapanor, marketed under the brand name Xphozah, for control of serum phosphorus in patients with chronic kidney disease on dialysis. A high level of phosphorus in the blood is often a sign of kidney damage and can lead to weak bones, joint pain, cardiovascular problems and other issues.    

    The approval concludes an extraordinary comeback for Xphozah. Ardelyx’s application for approval of the treatment was previously rejected by the FDA in July 2021, when the agency said the drug’s effect was “small and of unclear clinical significance.” To preserve cash, Ardelyx a few months later said it would cut its workforce by 65%, but it also pursued multiple appeals of the agency’s decision. An FDA advisory committee voted last November that the benefits of Xphozah outweigh its risks. The agency late last year ultimately granted Ardelyx’s appeal, and the company resubmitted its Xphozah application to the FDA in April. 

    More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx. 

    High phosphorus levels “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab told MarketWatch. 

    Chronic kidney disease patients with high phosphorus levels have traditionally been treated with phosphate binders that can soak up phosphorus from food during digestion, but that approach can require patients to swallow a large number of pills. The Xphozah treatment requires two pills a day, “each the size of a Tic Tac,” Raab said. 

    The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.

    Xphozah, which will be Ardelyx’s second U.S. product launch, should be available sometime in November, Raab said.

    Ardelyx will present updated data on Xphozah for hyperphosphatemia at an American Society of Nephrology meeting in early November, the company said in a release Monday. 

    Ardelyx shares jumped in late September after Japanese regulators approved tenapanor for hyperphosphatemia in adults with chronic kidney disease on dialysis. 

    Ardelyx shares fell 0.6% on Tuesday and have gained 21% in the year to date, while the S&P 500
    SPX
    has gained 13.9%. 

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  • Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

    Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

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    STOCKHOLM (AP) — Two scientists won the Nobel Prize in medicine on Monday for discoveries that enabled the development of effective mRNA vaccines against COVID-19.

    The award was given to Katalin Karikó, a professor at Sagan’s University in Hungary and an adjunct professor at the University of Pennsylvania, and Drew Weissman, who performed his prizewinning research together with Karikó at the University of Pennsylvania.

    “Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the panel that awarded the prize said.

    Thomas Perlmann, secretary of the Nobel Assembly, announced the award and said both scientists were “overwhelmed” by news of the prize when he contacted them shortly before the announcement.

    The Nobel Prize in physiology or medicine was won last year by Swedish scientist Svante Paabo for discoveries in human evolution that unlocked secrets of Neanderthal DNA which provided key insights into our immune system, including our vulnerability to severe COVID-19.

    The award was the second in the family. Paabo’s father, Sune Bergstrom, won the Nobel Prize in medicine in 1982.

    Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the economics award on Oct. 9.

    The prizes carry a cash award of 11 million Swedish kronor ($1 million). The money comes from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel, who died in 1896.

    The prize money was raised by 1 million kronor this year because of the plunging value of the Swedish currency.

    The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death. The prestigious peace prize is handed out in Oslo, according to his wishes, while the other award ceremony is held in Stockholm.

    Corder reported from The Hague, Netherlands.

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  • CBD 101: A doctor tells us how to use CBD for sleep, anxiety, and pain – Medical Marijuana Program Connection

    CBD 101: A doctor tells us how to use CBD for sleep, anxiety, and pain – Medical Marijuana Program Connection

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    Tinnakorn / Adobe Stock

    In recent years, CBD (cannabidiol, for those of you wondering what does CBD stand for) has emerged as a popular natural remedy for a range of health concerns, from sleep disturbances and anxiety to chronic pain. But how do you use CBD effectively to address these issues? 

    We spoke with Dr. Chris Adlakha of Elevated Wellness to get expert insights into the world of CBD. In this article, we’ll explore what CBD is used for and provide guidance on its usage. 

    Molecular structure of CBD
    kotoyamagami / Adobe Stock

    What is CBD used for?

    CBD, short for cannabidiol, is a non-psychoactive compound extracted from the cannabis plant. It has gained popularity for its potential therapeutic benefits. Dr. Adlakha, an expert in the field, emphasizes that CBD usage can vary widely among individuals due to differences in body composition and sensitivities to cannabinoids. 

    When asked about recommendations for determining the appropriate dosage of CBD, Dr. Adlakha explains: “There are no regulated guidelines for CBD dosing, although it is recommended to start at lower doses (i.e., 10-25mg) and then dose up slowly to find the ‘sweet spot.’ Everyone’s body composition and sensitivities to cannabinoids can be very different from one another.”

    USDA Certified Organic Tinctures and salves

    Everyone is different, so beginning slowly until achieving the desired effect is best. Without regulations in place to safeguard dosing guidelines, it’s best to start slow. Unlike prescription medications, where doctors prescribe…

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  • 5 things to know about the new COVID-19 vaccine

    5 things to know about the new COVID-19 vaccine

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    It may be time to get your COVID-19 vaccine again.

    There’s a new booster that’s coming out to guard against the virus. The Centers for Disease Control and Prevention said Tuesday that it was recommending the vaccine, which is being produced in versions by Moderna
    MRNA,
    +3.18%

    and Pfizer
    PFE,
    -0.20%

    -BioNTech
    BNTX,
    -2.06%
    ,
    for people 6 months of age and older.

    Here are answers to some common questions about the shot — and what you may need to know before you receive it.

    Why are we seeing another booster?

    Boosters are all about maintaining protection against the virus as new COVID-19 variants emerge. The CDC said: “The updated vaccines should work well against currently circulating variants of COVID-19, including BA.2.86, and continue to be the best way to protect yourself against severe disease.” The CDC also noted that “protection from COVID-19 vaccines and infection decline over time. An updated COVID-19 vaccine provides enhanced protection against the variants currently responsible for most hospitalizations in the United States.”

    So, everyone who is 6 months or older should receive it?

    That’s the CDC’s recommendation, but not everyone sees this booster as a firm requirement, depending on various medical and other factors.

    Dr. Paul A. Offit, a pediatrician with the Children’s Hospital of Philadelphia who specializes in infectious diseases, told MarketWatch that the new vaccine is a must for some who are at higher risk for developing serious illness, such as people who are over 75, people who have certain health problems (including diabetes, obesity or chronic lung or heart disease) and people who are immune compromised.

    And what about the others? Offit said it can be a case of “low risk, low reward.” Meaning there’s little harm in getting the booster and it may buy “a few months protection against mild disease,” Offit said. But he stops short of saying the booster is an absolute necessity for such people.

    Still, CDC director Dr. Mandy K. Cohen counters such an argument. In a column for the New York Times, Cohen noted that all the members of her family, including her 9- and 11-year-old daughters, would be getting the booster. “Some viruses…change over time. This coronavirus is one of them. It finds ways to evade our immune systems by constantly evolving. That’s why our vaccines need to be updated to match the changed virus,” Cohen explained.

    What if you recently had COVID? Or have just gotten the previous COVID booster?

    Offit said you should wait at least two months — and possibly as long as four months — before receiving the new vaccine.

    The CDC said, “You should get a COVID-19 vaccine even if you already had COVID-19,” adding “you may consider delaying your next vaccine by 3 months from when your [COVID] symptoms started or, if you had no symptoms, when you received a positive test.”

    When and where can you get the new booster?

    The CDC said the vaccine “will be available by the end of this week at most places you would normally go to get your vaccines.”

    How much will it cost?

    The new shots are expected to have list prices of $110 to $130, but the CDC said, “Most Americans can still get a COVID-19 vaccine for free.” That is, most health-insurance plans will cover the cost.

    As for those without insurance, the CDC said there are still plenty of free options, including programs run by local health centers and health departments as well as pharmacies participating in the CDC’s Bridge Access Program. For more information about where to get the booster, go to Vaccines.gov.

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  • CDC recommends updated COVID shots for people 6 months of age and older

    CDC recommends updated COVID shots for people 6 months of age and older

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    The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.

    Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc.
    MRNA,
    -0.53%

    and Pfizer Inc.
    PFE,
    +0.62%

    -BioNTech
    BNTX,
    -1.97%

    should become available later this week.

    “We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

    The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.

    The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.

    The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines. 

    The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.

    Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.

    Under the Bridge Access program, CVS Health Corp.
    CVS,
    +2.57%

    will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc.
    WBA,
    +1.35%

    will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.

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  • Appeals court rules to restrict abortion-pill access, but it will remain widely available for now

    Appeals court rules to restrict abortion-pill access, but it will remain widely available for now

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    A federal appeals court ruled Wednesday that access to the abortion pill mifepristone should be restricted, although the pill will remain widely available for now as the case moves through the appeals process.

    The opinion from a three-judge panel of the U.S. Fifth Circuit Court of Appeals said that mifepristone should remain available but with increased restrictions, effectively barring patients from accessing the pill by mail.

    In…

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  • These are the 8 best CBD gummies you can buy, period – Medical Marijuana Program Connection

    These are the 8 best CBD gummies you can buy, period – Medical Marijuana Program Connection

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    CBD’s hot streak shows no signs of cooling down any time soon, as shown by the eagerness with which consumers snap up products containing this cannabis compound. The benefits of cannabidiol create a high demand for CBD products. This results in a somewhat flooded market, which can seem like a good problem to have, that is, until you’re planning to buy a container of high-quality CBD gummies you can munch on, and you don’t know where to start. Having been in this challenging position a few times myself, I thought it prudent to seek advice from the experts, and ten cannabis industry pros came through with recommendations for the best CBD gummies that are currently available on the market.

    Looking for something else to consume? We’ve also rounded up the best CBD drinks and CBD snacks for you to consider.

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    Mendi CBD gummies 

    Many CBD users look to this substance for its pain-relieving properties, and account associate Kaulana Dilliner of Rebellious PR & Consulting in Portland, Oregon (a company that represents numerous CBD brands) considers Mendi CBD Gummies his go-to remedy for muscle aches. “I work out regularly, and I tend to get body pain often, so I use Mendi’s CBD Gummies to help recover. They immediately take away my pain overnight, and I feel fresh & new by the next morning. They’re also great for sleep, so if you have trouble sleeping, pop one into your mouth, and you’ll fall asleep instantly,” Dilliner tells us.

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