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.
This page requires Javascript.
Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
HAVERHILL — A petition with nearly 1,200 signatures from concerned residents and property owners is calling to stop a proposed 24-bed men’s substance use and mental health facility from moving into the neighborhood.
The petition, posted on Change.org and titled “Stop Riverbend House from coming into our neighborhood,” urges Haverhill residents to oppose Riverbend’s plan to open the “Bradford House” at 11 Kingsbury Ave.
This page requires Javascript.
Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
SALEM — A group of about 30 community members walked from the Salem Common to Riley Plaza on Thursday as a part of the annual Walk for Overdose Awareness.
The event included speakers stressing the importance of creating a larger support network for community members struggling with substance abuse and addiction.
This page requires Javascript.
Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
The Rockport School Committee, along with the town’s Public Health Department, is aiming to eliminate the effects of possible substance abuse in Rockport schools.
During the committee’s meeting on June 4, members heard from Dr. Ray Cahill, director of the Rockport Public Health Department, who updated those gathered about the “RIZE Mosaic Opioid Recovery Partnership Grant.” The grant aims to support children and families affected by the opioid crisis.
This page requires Javascript.
Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
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.
“Love On The Spectrum” is a reality television show centered on how people with autism view, seek, and find love. It’s a fun, inspiring, and heartwarming series that we can all draw many lessons from.
Related Articles
Enter your email to stay updated on new content on self improvement:
Apparently, you really can become a junk-food junkie.
That’s what a new study published by the British Medical Journal says, noting that ultra-processed foods — meaning food that contain “ingredients not available in home kitchens” and that typically have high levels of refined carbohydrates or added fats — are plenty addictive. And they’re on par with alcohol and tobacco, the study notes.
Specifically, the study says that food addiction — again, closely connected with the consumption of ultra-processed foods — is prevalent in 14% of the adult population. That matches the percentage for alcohol addiction and is just slightly below the percentage for tobacco addiction (18%).
The study warns that junk foods like sweets and snacks deliver those carbs and fats to the gut at a speedy rate, contributing to their addictive potential. It’s not unlike how cigarettes “rapidly deliver nicotine to the brain,” the study warns.
Additives also play a role in making these junk foods so appealing, the study says. That is, they increase sweet and savory tastes. Not surprisingly, the study notes that additives “that aim to improve [flavor] and mouthfeel are also common in cigarettes, including sugar, cocoa, menthol, and alkaline salt.”
If anything, the study points to issues with food addiction that don’t exist with other addictions since food is a critical part of our lives. “Addictive drugs are not necessary for survival; eating is,” the study says.
The study says understanding that ultra-processed foods are indeed addictive could “lead to novel approaches” in addressing the issue. It points to several policies that are already being taken across the world, such as levying taxes on sweetened beverages or posting nutritional information on the front of packages.
MarketWatch reached out to SNAC, a trade group representing snack-food manufacturers, about the study, but didn’t receive an immediate response.
Americans’ desire to snack doesn’t appear to be abating. In its most recent annual report, SNAC says the annual total sales for salty snacks grew by 15.6% in 2022 to $28.4 billion. Potato chips alone saw 14.5% growth to $7.8 billion in sales.
Their shared hippie spirit brought them together over a vegan potluck dinner, but the prospect of years in federal prison for allegedly stealing millions from a mentally-ill Malibu doctor, has driven a wedge between them.
A federal fraud prosecution against a pair of yoga gurus accused of siphoning cash from Dr. Mark Sawusch’s $60 million fortune took a significant turn at the end of August when one pleaded guilty and agreed to testify against the other, her ex-boyfriend, according to court documents and people familiar with the matter.
Anna Moore’s guilty plea before a federal judge in Los Angeles on Aug. 28 represents a serious legal challenge to her longtime partner, Anthony Flores, who faces decades behind bars if convicted in the case. Flores pleaded not guilty after his arrest in January.
Details of Moore’s agreement with federal prosecutors remain under seal, but people familiar with the matter say her ultimate sentence in the case will largely be determined after her level of cooperation is evaluated. A sentencing hearing for Moore was set for Nov. 6.
“We are aware of Ms. Moore’s decision to plead guilty. Obviously this changes Mr. Flores’ legal situation in the case, and we are currently reviewing our options,” Flores’ attorney Ambrosio Rodriguez said.
Messages left with Moore’s attorney weren’t immediately returned. A spokesman for the U.S attorney’s office for the central district of California declined to comment.
The tragic end to Sawusch’s life began on June 23, 2017, when the brilliant, but troubled, ophthalmologist met Flores and Moore in a chance encounter at a vegan ice cream parlor in Venice Beach, Calif.
Flores, who went by Anton David, was a guru-esque figure with long, flowing hair and a beard. He worked as a hair stylist on film shoots. Moore, a pixie-like blond, was an actress and singer. The couple had met years earlier at a vegan potluck dinner and had fallen in love over what they described as a shared hippie spirit. Together, they ran a yoga center in Fresno, Calif., while going back-and-forth to L.A.
Their spiritual vibe cast a spell on Sawusch, who had just days earlier been released from a mental health facility, where he had been committed after suffering a breakdown, court filings said. Within a week, Flores and Moore had moved into Sawusch’s multi-million dollar beachfront home in Malibu, Calif., federal prosecutors said.
Over the next year, the pair gained increasingly firm control over the doctor’s life and finances, with Flores establishing power of attorney over Sawusch’s vast fortune while plying him with a steady diet of marijuana and LSD as he also underwent experimental ketamine treatments for his bipolar disorder that left him addled, investigators said.
Sawusch later died in May 2018 of a lethal mixture of ketamine and alcohol, according to a coroner’s report. The Los Angeles County medical examiner’s office ruled the death an accident.
In her guilty plea, Moore said she was not immediately aware of the scope of Flores’ alleged efforts to steal the doctor’s money, but admitted that following Sawusch’s death she participated in a later effort in probate court to keep the stolen money. Prosecutors have alleged that this was a separate fraud.
When Sawusch’s family sought to take control of his estate, they discovered that almost $3 million had been transferred from his accounts to ones controlled by Flores in the days before and after the doctor’s death, federal prosecutors said.
Sawusch’s family launched a civil lawsuit against the yogi couple and convinced a California state judge to issue a restraining order freezing Flores’ and Moores’ accounts, and order they return the money. Instead, federal prosecutors say, the two engaged in a second fraud by making false claims in probate court that Sawusch had verbally told them he would give them a third of his fortune plus his Malibu beach house.
The couple claimed that the doctor had given them the money in return for them taking care of him and as part of an effort to protect his fortune from his family, from whom he was estranged. The family said those claims were untrue and that the pair had kept Sawusch isolated from his friends and family.
Eventually, the couple returned around $2 million of the doctor’s money, but around $1 million remained unaccounted for, according to federal prosecutors.
Flores and Moore broke up during the pandemic after nearly a decade together. Moore moved to Mexico while Flores remained in Fresno, where he was arrested in late January. Moore was arrested at George Bush Intercontinental Airport in Houston upon her return to the U.S. around the same time. Both have been held without bail since.
The Food and Drug Administration late Friday approved the first-ever pill that can be taken at home for postpartum depression.
The medication, called zuranolone, and jointly developed by pharmaceutical companies Biogen Inc. BIIB, +0.44%
and Sage Therapeutics SAGE, +0.25%,
is taken daily for two weeks, the FDA said in its release.
In a pair of clinical trials involving women who experienced severe depression after having a baby, the drug improved symptoms including anxiety, trouble sleeping, loss of pleasure, low energy, guilt or social withdrawal as soon as three days after the first pill.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
”And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” she said.
Women who are breastfeeding or had mild or moderate depression weren’t included in the trials.
Until now, the only available option for this condition has been an intravenous injection that the FDA approved in 2019. It requires patients to stay in a hospital for two-and-a-half days.
Postpartum depression affects one in eight new mothers in the U.S., according to the Centers for Disease Control and Prevention. Researchers suggest the actual rate may be higher and that half of such cases go undiagnosed.
Research finds that postpartum depression is more intense and lasts longer than the typical worries, sadness or tiredness that many women experience after giving birth. The condition can make it harder for mothers to bond with their babies and may increase the likelihood of developmental delays in infants.
Drug overdoses and suicides are leading causes of maternal death in the U.S., contributing to nearly one in four pregnancy-related deaths, according to the CDC.
Zuranolone stimulates a brain receptor called GABA that slows down the brain and helps control anxiety and stress. The drug, through trials, is thought to calm women suffering from postpartum depression enough to allow them to rest, which also improves symptoms.
Shares of Biogen are up 23% over the past year, and Sage has lost 14%, while the S&P 500 SPX
is up 8% over the same time.
The eastern and southeastern United States have the highest prevalences of Alzheimer’s dementia, according to new research released Monday at the Alzheimer’s Association International Conference in Amsterdam.
The study, by researchers at Rush Medical College in Chicago, includes county-level estimates of Alzheimer’s rates among adults age 65 and older in all 3,142 U.S. counties.
The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare reimbursement for the first drug shown to slow the progress of the disease, rather than just treating its symptoms.
Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease.
A nascent category of mental health treatments is getting a major cash infusion.
Blake Mycoskie, founder of the canvas-footwear phenomenon TOMS Shoes, has committed to giving $100 million to support psychedelic research and access, Mycoskie told MarketWatch in an exclusive interview. The money will help fund academic institutions investigating psychedelics’ potential to treat anxiety, depression, post-traumatic stress disorder and other mental-health issues, as well as nonprofits helping to connect patients in need with psychedelic treatments.
Traditional psychedelics include hallucinogens like LSD and psilocybin, or “magic” mushrooms–recently legalized in Oregon and Colorado. Other drugs that can alter mood and perception–such as ketamine and MDMA, also known as ecstasy–aren’t classical psychedelics but are broadly included in the research and policy discussions generating a surge of interest in this class of treatments. The U.S. Food and Drug Administration, for example, has granted psilocybin and MDMA “breakthrough therapy” status, a designation designed to expedite development and review of drugs for serious conditions, and could approve MDMA for treatment of PTSD as soon as next year.
Given the rapid developments in the field, ”we really need to get this right, and we really need to have these foundations and nonprofits funded properly,” therapists trained, and clinics open and running smoothly, Mycoskie said. “I felt a real sense of urgency,” he said, and asked his wealth manager, “what’s the most that I can give?”
The $100 million answer to that question amounts to about a quarter of Mycoskie’s net worth and marks a major milestone in psychedelics’ delicate image transformation. Shedding some of their dangerous-party-drug reputation, psychedelics are gaining attention from top pharmacologists, the scientific community, biotech companies and investors who see them as a critical part of the solution to America’s mental health crisis.
Cracked open
Mycoskie, 46, said his interest in psychedelics dates back to 2017, when a friend returning from a trip to Central America described his incredible experience with ayahuasca, a plant-based psychedelic brewed into a tea. As an entrepreneur under intense pressure to perform, Mycoskie said, he decided to try it for himself. The experience “cracked me open, and it connected me more to my faith in God, made me feel that we were all connected and everything was fine and perfect,” he said. “I came back just feeling like, wow, that was more powerful than any therapy I’d ever done.” He later tried MDMA-assisted therapy, he said, which also helped him process issues that traditional talk therapy had left unresolved.
Realizing how many people could benefit from similar treatments, Mycoskie started giving money to academic groups and the Multidisciplinary Association for Psychedelic Studies, or MAPS, a nonprofit organization. He also got involved in last year’s Colorado ballot initiative, which legalized psilocybin and several other psychedelic substances, including ibogaine, which has shown potential to treat substance-use disorders. Mycoskie has already given about $10 million to psychedelic research and access, he said, and plans to give about $5 million annually for 18 more years.
Mycoskie was a bit squeamish at first, he acknowledges, about publicly backing research on drugs that are largely illegal. “Am I going to get held up at TSA every time I go through the airport?” he remembers thinking. The U.S. Drug Enforcement Administration categorizes LSD and MDMA alongside heroin as “schedule one” drugs, defined as “drugs with no currently accepted medical use and a high potential for abuse.” But with growing public awareness and acceptance of the drugs’ potential as mental-health treatments, he said, he felt emboldened to make a big public commitment, and “the research has caught up,” he said. “It’s important that people like myself put their name out there and their money out there to show that this really is a path forward,” he said.
Mycoskie’s $100 million commitment “is the biggest that we’ve ever seen in the psychedelics space,” said Joe Green, president of the Psychedelic Science Funders Collaborative, a nonprofit supporting philanthropy in the field, and a MAPS board member. Now that research has made great strides to support use of the medicines as mental-health treatments, that money can help ensure that “these actually come to the world in a safe and beneficial way,” Green said. With certain treatments legalized in Oregon and Colorado, for example, “the system requires licensed guides, facilitators, licensed service centers,” he said. “It’s not like cannabis medical–you won’t be able to take the mushrooms outside the service center.”
Psychedelic therapeutics market could be worth more than $8.3 billion by 2028
Mycoskie plans to publicize his pledge at the Multidisciplinary Association for Psychedelic Studies’ psychedelic science conference–billed as “the largest psychedelic conference in history”–this week in Denver. On the agenda: Sessions ranging from state policy and regulatory considerations to clinical trials of psilocybin- and MDMA-assisted therapy and “sex and psychedelics: weaving altered states for healing and pleasure.”
The news comes as lawmakers on both sides of the aisle are pushing for new funding for research into the use of psychedelics to treat PTSD in military service members as part of the fiscal year 2024 National Defense Authorization Act, which the House Armed Services Committee will consider Wednesday.
Already, public companies like Atai Life Sciences ATAI, -6.91%,
Compass Pathways CMPS, -3.37%
and Cybin CYBN, +6.81%
are developing therapies based on psychedelic substances. The psychedelic therapeutics market could be worth more than $8.3 billion by 2028, according to InsightAce Analytic. Even the federal government is throwing money at this niche, funding efforts to develop psychedelic mental-health treatments without the hallucinogenic side effects.
More than one in five U.S. adults live with a mental illness, according to the National Institute of Mental Health, and less than half of the roughly 58 million adults with any mental illness are receiving treatment. Suicide rates, which have been on a long upward trajectory, declined briefly between 2018 and 2020 before returning to peak levels in 2021, according to the Centers for Disease Control and Prevention. Nine out of 10 U.S. adults believe the country is suffering a mental health crisis, according to a survey last year by CNN and KFF, a health policy nonprofit. And commonly prescribed antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) don’t work well for many patients.
Nushama, a New York City wellness center offering ketamine-based therapy.
Courtesy of Nushama and Costas Picadas
Mental illness “is truly an epidemic, and we are losing the fight,” said Dylan Beynon, CEO and founder of Mindbloom, which offers a telehealth ketamine treatment program. While there are some existing solutions that are helping to bend the curve, he said, more research and educational support for providers and patients is needed, he said.
Indeed, some substantial hurdles still separate psychedelic mental-health treatments from many of the patients they might benefit, including a lack of insurance coverage for the currently legal treatments and debate over how to administer them safely. In the case of ketamine, for example, which is FDA-approved as an anesthetic and used off-label as a mental-health treatment, some providers favor in-person guided sessions while others, like Beynon, advocate for telehealth prescribing–a model that boomed during the pandemic.
Some experts have lately warned that the practice of psychedelic medicine may be getting ahead of the science. Given the growing public and commercial interest, “there is the risk that use of psychedelics for purported clinical goals may outpace evidence-based research and regulatory approval,” the American Psychiatric Association said last year in a position statement on psychedelic and “empathogenic” agents–a category that includes MDMA.
Mycoskie has also made some investments in the psychedelics space, although he said profits aren’t his motivation. He has invested in Mind Medicine Inc. MNMD, -0.50%,
which says it is developing “psychedelic inspired medicines” that aim to treat the underlying causes of distress in the brain. And Mycoskie helped fund a public benefit corporation linked with MAPS, which is taking MDMA through the FDA approval process–an investment that will pay dividends when the treatment is commercialized, he said.
Providers currently offering ketamine treatments say they’re eager to expand into MDMA and other therapies in the category as soon as they’re legal. Mindbloom, for example, currently offers a ketamine treatment program that’s available through telehealth in several dozen states and aims to start offering MDMA-assisted therapy late next year after FDA approval is finalized, Beynon said. Psilocybin-assisted therapy could come a couple of years after that, he said.
Nushama, a New York City psychedelic wellness center that offers ketamine-based therapy, delivered through in-person IV infusions, also hopes to expand into MDMA when it’s approved, said co-founder Jay Godfrey.
Treatment without the trip
Still on the horizon: New treatments that could produce psychedelic medicines’ mental-health benefits without the trip. University of North Carolina School of Medicine pharmacology professor Dr. Bryan Roth is leading an effort to create new medications for depression, anxiety and substance abuse that work similarly to psychedelics but without the hallucinogenic, disorienting side effects. His effort is backed by a $27-million grant from the Defense Advanced Research Projects Agency. Such treatments, Roth said, could help the many patients for whom such psychedelic effects are unappealing or ill-advised–such as military service members. “You would never want to give psilocybin or ketamine to somebody who has a gun,” Roth said.
Having worked with Vietnam veterans suffering from PTSD while training as a psychiatrist earlier in his career, Roth said, he’s keenly aware of the need for safe and effective treatments. “There was nothing we could give them for their symptoms,” he said. “The most we could do was give them medications to stop their ability to have dreams, so they wouldn’t have nightmares. That was basically it.”
“Undoing 52 years of propaganda is a heavy lift,” said Nushama co-founder Jay Godfrey.
Costas Picadas
Roth’s team has already developed compounds that have shown antidepressant effects without psychedelic side effects in mice, he said. The team is now working to find a clinical candidate suitable for testing in humans, he said.
Treatments that can help “break bad emotional or psychological patterns without scary, high-friction psychedelic experiences would be a great thing for patients, providers and the healthcare system,” said Mindbloom’s Beynon.
Much more remains to be done to reduce the stigma associated with psychedelics, experts say. It has been 52 years since President Richard Nixon declared drug abuse “public enemy number one,” and billions of dollars have been spent since then telling people that “these medicines are dangerous, that they’re addictive, and that they’ll fry your brains,” Godfrey said. “Undoing 52 years of propaganda is a heavy lift, but one thing I’m optimistic about is that the outcomes are starting to speak for themselves.”
A national obsession with a new class of weight-loss drugs is turning dangerous, doctors and researchers say, as many patients are inappropriately prescribed Wegovy, Ozempic and similar medications and supply shortages generate a market for unauthorized, potentially risky copycat versions of these drugs.
Social media buzz about the drugs has promoted the mistaken perception that the medications are appropriate for a broad swath of people who may want to shed a few pounds–with disastrous consequences for some patients, doctors say. Patients who previously recovered from eating disorders, for example, are coming in for treatment because they “have had their eating disorder reactivated by use of these medications,” said Dr. Elizabeth Wassenaar, a regional medical director at the Eating Recovery Center, which specializes in treating the disorders. Some patients have wound up in the hospital, she said, and in some cases the providers who prescribed the drugs were unaware of the patients’ eating-disorder history. “It’s a real warning to people who prescribe these medications that it’s not without risk,” she said.
Some doctors also question whether the safety of the drugs has been adequately studied in older adults, who may have an undesirable loss of lean muscle mass when taking the medications. That complicates an ongoing debate about whether Medicare should cover these drugs for weight loss.
And patients of all types are put at risk, experts say, by the illegal production of knock-off versions of the medications. The Food and Drug Administration and several state pharmacy boards in recent weeks have warned that some compounding pharmacies are producing unauthorized versions of the drugs–which poses particular safety concerns for injectable drugs such as Wegovy, said David Margraf, a pharmaceutical research scientist with the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy. “It’s not just a victimless crime,” he said. “People can be severely injured.”
Novo Nordisk NVO, +0.33%,
the maker of Wegovy and Ozempic, itself sought to tap the brakes on the craze around these drugs in a statement posted on its website this month, saying it’s concerned about reports of the drugs being used “for purely cosmetic or aesthetic weight loss,” unauthorized versions of the drugs hitting the market, and “insufficient clinical evaluations by some telehealth providers” promoting the drugs.
Drugs such as Novo Nordisk’s Wegovy, Ozempic and Rybelsus and Eli Lilly’s LLY, -0.36%
Mounjaro mimic the effects of a gut hormone known as GLP-1, which can help control blood-sugar levels and reduce appetite. (Mounjaro also affects another hormone called GIP.) Ozempic, Rybelsus and Mounjaro are FDA-approved for treatment of type 2 diabetes, while Wegovy is approved for people with obesity and certain people with excess weight combined with weight-related medical problems.
Billions of dollars in drug sales hinge on the breadth of the patient population prescribed these medications. Last year, more than 5 million prescriptions for Ozempic, Mounjaro, Rybelsus or Wegovy were written for weight management, up from just 230,000 in 2019, according to data and analytics firm Komodo Health. Obesity drugs could be a $54 billion market by 2030, up from $2.4 billion in 2022, Morgan Stanley said in a report last year. Reports of GLP-1 drug users seeing improvements in addictive behaviors such as smoking and drinking have lately amplified interest in the medications.
The drugs have become such a cultural phenomenon that Walmart during its quarterly earnings call last week blamed the medications for a shift in consumer-spending patterns that pressured its margins. In the first quarter, the company saw “a shift to health and wellness,” John Rainey, Walmart Inc.’s WMT, +0.18%
executive vice president and chief financial officer, said on the call with analysts. “And part of that is related to these GLP-1 drugs that are to treat diabetes,” he said, adding that the shift “comes at a lower margin, and so that has some impact on our business as well.”
Noom, a digital health company that for years has emphasized a behavioral approach to weight management, this week announced a new program that will make Ozempic, Wegovy, Mounjaro and other medications available to eligible patients. “Prescriptions are not the goal of our program. They’re very much an adjunct,” Dr. Linda Anegawa, Noom’s chief of medicine, told MarketWatch. Medical professionals will review patients’ entire health history, order labs to assess their metabolic health, and engage in video visits with patients as they determine what treatments might be appropriate, she said.
Telling your brain you’re not hungry
The reason GLP-1 drugs help control weight is pretty straightforward, said Dr. Daniel Drucker, who helped discover GLP-1 and is senior scientist at Lunenfeld-Tanenbaum Research Institute in Toronto. When people take these drugs, he said, they simply eat less because they feel more full. “GLP-1 will tell your brain that you’re not hungry,” he said, and people taking these medications may feel less stressed about food or find themselves thinking less about food. And the effects may go beyond eating, he said, as some people also see improvements in smoking, drinking, and other addictive or compulsive behaviors. “These are really interesting areas for further investigation,” he said. Drucker has been a consultant or speaker for Novo Nordisk, Pfizer PFE, -0.61%
and other pharmaceutical companies.
Novo Nordisk said in a statement to MarketWatch that it is not conducting any dedicated clinical studies to evaluate Ozempic, Rybelsus or Wegovy in patients with substance-use disorders or addiction-related illnesses, and Eli Lilly said it does not have any studies planned for investigating tirzepatide–the active ingredient in Mounjaro–for treatment of addiction.
Adolescents’ use of the drugs for weight loss is a particular concern for some doctors. Wegovy is approved for treatment of obesity in children 12 and older. “The adolescent mental health crisis is unprecedented,” said Wassenaar, with many teens suffering severe mood disorders, eating disorders, and suicidality, and teens struggling with depression may think, “if I lose weight, I’ll feel better and people will like me. There’s this magic drug, and all I have to do is inject it.” And if patients can start taking these drugs as early as 12 years of age, “we just don’t know what that’s going to do to them in 10 or 20 years,” she said, because there’s not enough long-term data.
Novo Nordisk said in a statement to MarketWatch that “teenage obesity is linked to weight-related health problems such as high blood pressure, high cholesterol and type 2 diabetes,” and that cutting calories and increasing physical activity may not be enough for some patients. “The decision to prescribe an anti-obesity medication is at the discretion of the physician and the patient/parents,” the company said.
Eli Lilly said that tirzepatide is not currently being studied for chronic weight management in children or adolescents.
Many patients may have trouble filling lower-dose Wegovy prescriptions through September, according to drugmaker Novo Nordisk.
Novo Nordisk via AP
Some doctors are also concerned about broad use of the drugs among older adults. Many older adults have sarcopenia, an age-related loss of muscle mass and strength that can contribute to frailty and fall risk later in life–and losing weight can mean an additional loss of muscle mass that may not be advisable for some patients, doctors and researchers say.
While “there’s a huge push to get Medicare to cover these drugs, it’s not really certain whether they would be helpful in this population or actually more harmful,” said Judy Butler, a research fellow at PharmedOut, a research and education project at Georgetown University Medical Center. Noom is not enrolling patients over age 60 in its new program, Anegawa said, partly because “we really don’t have enough data yet with many of these drugs in the geriatric population.”
In the pivotal clinical trials for Wegovy, 9% of the Wegovy-treated patients were between 65 and 75 years of age, and 1% were 75 and older, Novo Nordisk said in a statement. “No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients,” the company said. In an ongoing cardiovascular outcomes trial, about 38% of patients are 65 or older, the company said.
By law, Medicare generally does not cover drugs prescribed for weight loss–although some drugmakers and industry groups are pushing to change that. Some of the drugs now generating intense demand also come with a hefty sticker price: Wegovy, for example, has an estimated annual net cost of about $13,600, according to the Institute for Clinical and Economic Review. If Medicare coverage rules changed and 10% of beneficiaries with obesity used Wegovy, total annual Medicare Part D spending on the drug could be as much as $26.8 billion, according to a recent study published in the New England Journal of Medicine. That’s more than 18% of the net total Part D spending by beneficiaries and the Medicare program in 2019.
Dangerous copycats
There are potential physical as well as financial costs. Side effects of the drugs can range from nausea and vomiting to gallbladder problems, inflammation of the pancreas, and thyroid cancer.
More broadly, some doctors question the prescribing of drugs solely based on obesity, absent other risk factors. “If somebody is obese and has diabetes, high blood pressure, and high cholesterol, losing weight may improve those parameters, but obesity on its own does not need to be treated,” said Dr. Adriane Fugh-Berman, a professor at Georgetown University Medical Center and director of PharmedOut. “It’s cardiovascular fitness that is important, no matter what weight you are,” she said. “We should stop focusing on the weight itself as a risk factor.”
Dr. Robert Gabbay, chief science and medical officer at the American Diabetes Association, counters that “obesity is a disease, and therefore needs to be treated as such.” Although there are people with obesity who don’t have other serious conditions, he said, “that’s relatively uncommon.”
Despite the concerns, shortages of the drugs persist. Novo Nordisk says it anticipates that many patients will have trouble filling lower-dose Wegovy prescriptions through September.
For patients who are relying on GLP-1 drugs for treatment of diabetes, even a short-term interruption in access to the drugs can cause blood-glucose levels to rise and result in serious complications, Gabbay said. Patients also tend to gradually ramp up dosage of these drugs to get to the effective dose, he said, and if they lose access to the medication “they might have to start back at the beginning again,” putting them several months behind on their treatment.
The shortages can also create risks for a broader set of patients, experts say, as they spur demand for copycat versions of the drugs. The approved active ingredient in Wegovy and Ozempic is semaglutide in its base form, but some compounding pharmacies may be using salt forms of semaglutide, the FDA said in a late April letter to the National Association of Boards of Pharmacy. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements” restricting the types of active ingredients used in compounding, the FDA said in the letter. Boards of pharmacy in several states, including West Virginia, North Carolina and Mississippi, have also recently issued warnings about compounded semaglutide.
Novo Nordisk said in the statement posted on its website this month that it is “actively monitoring and taking action against” entities unlawfully selling compounded semaglutide, adding that no FDA-approved generic versions of semaglutide currently exist.
Unauthorized compounded versions of the drugs could raise serious concerns about sterility and other quality-control issues, the Resilient Drug Supply Project’s Margraf said. “If this drug is in high demand and there isn’t enough supply, people will find a way to get it from a gray-market source,” he said. “People are going to find ways around the laws and potentially harm patients.”
Eli Lilly & Co.’s market cap neared Johnson & Johnson’s market cap on Friday, as the stock has benefited from a slew of positive data in trials for key treatments.
Earlier Friday, Lilly stock LLY, +0.00%
was on track to close with a greater market capitalization than J&J JNJ, -0.13%,
which would have marked the first time since 1997. Lilly stock ended flat, however, for the session at $434.43.
The stock has been steadily rising since the release of positive data from a trial of a treatment for Alzheimer’s disease in early May, showing significant slowing of cognitive and function decline in patients with early symptomatic Alzheimer’s disease.
Nearly half, or 7% of participants, had no clinical progression at one year, compared to 29% on placebo. The drug, called donanemab slowed clinical decline by 35% compared to a placebo and resulted in 40% less decline in the ability to perform activities of daily living, including managing finances, driving, engaging in hobbies and conversing about current events, the company said.
The company is planning to proceed with global regulatory submissions as quickly as possible and expects to make a submission to the U.S. Food and Drug Administration this quarter.
That’s not all. In April, Eli Lilly released data on its new obesity drug tirzepatide that showed patients in a trial losing up to 15.7% of their body weight, or about 34.4 pounds.
More than 80% of people taking tirzepatide lost at least 5% of their body weight, the company said, compared with about 30% of those taking a placebo.
The degree of average weight reduction seen in the trial “has not been previously achieved” in similar Phase 3 trials, Dr. Jeff Emmick, senior vice president for product development at Lilly, said in a statement.
Source: FactSet, Dow Jones Market Data
The company is planning regulatory submissions for that drug later this year. Tirzepatide was approved by the FDA last year as Mounjaro, a treatment for Type 2 diabetes.
Lilly has several other pipeline prospects, including lebrikizumab, a treatment for atopic dermatitis; mirikizumab for ulcerative colitis; empagliflozin, a treatment for chronic kidney disease; and pirtobrutinib for relapsed/refractory mantle cell lymphoma.
Lilly’s stock is up about 20% in the year to date and up 50% in the past 12 months.
Johnson & Johnson’s stock, meanwhile, has fallen 9% in the year to date and is down roughly the same over the past 12 months.
The company swung to a first-quarter loss as it booked a multibillion-dollar charge to settle lawsuits stemming from its talc-containing powders.
J&J booked a $6.9 billion one-time litigation charge relating to lawsuits filed by people alleging the company’s talc-containing powders caused cancers, asbestos poisoning and other illnesses. The company has offered to pay at least $8.9 billion to settle the suits, and remove an overhang on the stock.
Shares of BioVie Inc. rose sharply in premarket trading Tuesday after the clinical-stage biopharmaceutical company reported positive results from a pair of Phase 2 studies assessing the potential of its NE3107 drug candidate in Parkinson’s disease and Alzheimer’s disease.
The Carson City, Nev., company said the study of NE3107 in Parkinson’s met both main objectives, with patients treated with a combination of the drug and levodopa seeing meaningful improvements in their motor score and an absence of adverse interactions of NE3107 with levodopa.
BioVie said that based on the study findings, it will proceed with planning the Phase 3 program for discussion with the U.S. Food and Drug Administration.
Meanwhile, BioVie said patients treated with NE3107 in the Alzheimer’s study experienced improved cognition and biomarker levels, with no drug-related adverse events observed.
BioVie shares, which closed Monday at $5.21, were recently up 15% to $5.98 in premarket trading.
