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Minnesota governor signs bill codifying ‘fundamental right’ to abortion into law

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CNN
 — 

Minnesota’s Democratic Gov. Tim Walz signed a bill into law Tuesday that enshrines the “fundamental right” to access abortion in the state.

Abortion is already legal in Minnesota, but in the aftermath of the US Supreme Court overturning Roe v. Wade, the Protect Reproductive Options Act goes a step further by outlining that every person has the fundamental right to make “autonomous decisions” about their own reproductive health as well as the right to refuse reproductive health care.

“This is very simple, very right to the point,” Walz said Tuesday on “CNN Tonight.” “We trust women in Minnesota, and that’s not what came out of the [Supreme Court’s] decision, so I think it’s critically important that we build a fire wall.”

With the passage of the bill, Minnesota is now the first state to codify abortion via legislative action since Roe v. Wade was reversed, the office of the bill’s lead author in Minnesota’s state Senate, told CNN.

“Last November, Minnesotans spoke loud and clear: They want their reproductive rights protected – not stripped away,” Walz said in a news release. “Today, we are delivering on our promise to put up a firewall against efforts to reverse reproductive freedom. No matter who sits on the Minnesota Supreme Court, this legislation will ensure Minnesotans have access to reproductive health care for generations to come. Here in Minnesota, your access to reproductive health care and your freedom to make your own health care decisions are preserved and protected.”

The bill states that local government cannot restrict a person’s ability to exercise the “fundamental right” to reproductive freedom. It also clarifies that this right extends to accessing contraception, sterilization, family planning, fertility services and counseling regarding reproductive health care.

“The Pro Act also goes beyond just granting those rights to abortion, it really says all reproductive healthcare decisions aren’t our business, including access to contraception, including access to really anything that is related to personal and private decisions about your reproductive life,” Megan Peterson, the executive director of pro-abortion rights campaign UnRestrict Minnesota, told CNN following Walz’s signing of the bill.

In a letter to Walz ahead of the signing, Republican legislature leaders argued that the bill went too far and urged the governor to veto what they called “an extreme law.”

“As the PRO Act was being rushed through the legislature, Republicans offered reasonable amendments with guardrails to protect women and children,” state Senate Minority Leader Mark Johnson and House Minority Leader Lisa Demuth wrote, “Sadly, each of these amendments were struck down by a Democrat majority.”

In 1995, the Minnesota Supreme Court ruled in Doe v. Gomez that abortion was a fundamental right protected under the state’s constitution. The Protect Reproductive Options Act ensures that even in the event of a new state Supreme Court reversing the ruling, the right to abortion will be protected under state law.

“By passing this law, Minnesotans will have a second layer of protection for their existing reproductive rights. A future Minnesota Supreme Court could overturn Doe v. Gomez, but with the PRO Act now in State law, Minnesotans will still have a right to Reproductive healthcare,” Luke Bishop, a spokesperson for Democratic State Sen. Jennifer McEwen, the bill’s author in the Senate, told CNN over email.

Following the governor’s signature of the bill, the White House applauded Minnesota’s efforts, pointing to the popular support for women’s rights to make their own health care decisions.

“Americans overwhelmingly support a woman’s right to make her own health care decisions, as so clearly demonstrated last fall when voters turned out to defend access to abortion – including for ballot initiatives in California, Kansas, Kentucky, Michigan, Montana, and Vermont,” White House press secretary Karine Jean-Pierre said in a statement.

“While Congressional Republicans continue their support for extreme policies including a national abortion ban, the President and Vice President are calling on Congress to restore the protections of Roe in federal law,” she wrote. “Until then, the Biden-Harris Administration will continue its work to protect access to abortion and support state leaders in defending women’s reproductive rights.”

This story has been updated with additional information.

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Health

US cancer death rate drops 33% since 1991, partly due to advances in treatment, early detection and less smoking, new report says

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CNN
 — 

The rate of people dying from cancer in the United States has continuously declined over the past three decades, according to a new report from the American Cancer Society.

The US cancer death rate has fallen 33% since 1991, which corresponds to an estimated 3.8 million deaths averted, according to the report, published Thursday in CA: A Cancer Journal for Clinicians. The rate of lives lost to cancer continued to shrink in the most recent year for which data is available, between 2019 and 2020, by 1.5%.

The 33% decline in cancer mortality is “truly formidable,” said Karen Knudsen, chief executive officer of the American Cancer Society.

The report attributes this steady progress to improvements in cancer treatment, drops in smoking and increases in early detection.

“New revelations for prevention, for early detection and for treatment have resulted in true, meaningful gains in many of the 200 diseases that we call cancer,” Knudsen said.

In their report, researchers from the American Cancer Society also pointed to HPV vaccinations as connected to reductions in cancer deaths. HPV, or human papillomavirus, infections can cause cervical cancer and other cancer types, and vaccination has been linked with a decrease in new cervical cancer cases.

Among women in their early 20s, there was a 65% drop in cervical cancer rates from 2012 through 2019, “which totally follows the time when HPV vaccines were put into use,” said Dr. William Dahut, the society’s chief scientific officer.

“There are other cancers that are HPV-related – whether that’s head and neck cancers or anal cancers – so there’s optimism this will have importance beyond this,” he said.

The lifetime probability of being diagnosed with any invasive cancer is estimated to be 40.9% for men and 39.1% for women in the US, according to the new report.

The report also includes projections for 2023, estimating that there could be nearly 2 million new cancer cases – the equivalent of about 5,000 cases a day – and more than 600,000 cancer deaths in the United States this year.

During the early days of the Covid-19 pandemic, many people skipped regular medical exams, and some doctors have seen a rise in advanced cancer cases in the wake of pandemic-delayed screenings and treatment.

The American Cancer Society researchers were not able to track “that reduction in screening that we know we all observed across the country during the pandemic,” Knudsen said. “This time next year, I believe our report will give some initial insight into what the impact was in the pandemic of cancer incidence and cancer mortality.”

The new report includes data from national programs and registries, including those at the National Cancer Institute, the US Centers for Disease Control and Prevention and the North American Association of Central Cancer Registries.

Data showed that the US cancer death rate rose during most of the 20th century, largely due to an increase in lung cancer deaths related to smoking. Then, as smoking rates fell and improvements in early detection and treatments for some cancers increased, there was a decline in the cancer death rate from its peak in 1991.

Since then, the pace of the decline has slowly accelerated.

The new report found that the five-year relative survival rate for all cancers combined has increased from 49% for diagnoses in the mid-1970s to 68% for diagnoses during 2012-18.

The cancer types that now have the highest survival rates are thyroid at 98%, prostate at 97%, testis at 95% and melanoma at 94%, according to the report.

Current survival rates are lowest for cancers of the pancreas, at 12%.

The finding about a decreasing cancer death rate shows “the continuation of good news,” said Dr. Otis Brawley, an oncology professor at Johns Hopkins University who was not involved in the research.

“The biggest reason for the decline that started in 1991 was the prevalence of smoking in the United States started going down in 1965,” said Brawley, a former chief medical officer of the American Cancer Society.

“That’s the reason why we started having a decline in 1991, and that decline has continued because the prevalence of people smoking in the United States has continued to go down,” he said. “Now, in certain diseases, our ability to treat has improved, and there are some people who are not dying because of treatment.”

Although the death rate for cancer has been on a steady decline, the new report also highlights that new cases of breast, uterine and prostate cancer have been “of concern” and rising in the United States.

Incidence rates of breast cancer in women have been increasing by about 0.5% per year since the mid-2000s, according to the report.

Uterine corpus cancer incidence has gone up about 1% per year since the mid-2000s among women 50 and older and nearly 2% per year since at least the mid-1990s in younger women.

The prostate cancer incidence rate rose 3% per year from 2014 through 2019, after two decades of decline.

Knudsen called prostate cancer “an outlier” since its previous decline in incidence has reversed, appearing to be driven by diagnoses of advanced disease.

On Thursday, the American Cancer Society announced the launch of the Impact initiative, geared toward improving prostate cancer incidence and death rates by funding new research programs and expanding support for patients, among other efforts.

“Unfortunately, prostate cancer remains the number one most frequently diagnosed malignancy amongst men in this country, with almost 290,000 men expected to be diagnosed with prostate cancer this year,” Knudsen said. Cancer diagnosed when it is confined to the prostate has a five-year survival rate of “upwards of 99%,” she said, but for metastatic prostate cancer, there is no durable cure.

“Prostate cancer is the second leading cause of cancer death for men in this country,” she said. “What we’re reporting is not only an increase in the incidence of prostate cancer across all demographics but a 5% year-over-year increase in diagnosis of men with more advanced disease. So we are not catching these cancers early when we have an opportunity to cure men of prostate cancer.”

Breast, uterine and prostate cancers also have a wide racial disparity, in which communities of color have higher death rates and lower survival rates.

In 2020, the risk of overall cancer death was 12% higher in Black people compared with White people, according to the new report.

“Not every individual or every family is affected equally,” Knudsen said.

For instance, “Black men unfortunately have a 70% increase in incidence of prostate cancer compared to White men and a two- to four-fold increase in prostate cancer mortality as related to any other ethnic and racial group in the United States,” she said.

The data in the new report demonstrates “important and consistent” advances against cancer, Dr. Ernest Hawk, vice president of cancer prevention and population sciences at the University of Texas MD Anderson Cancer Center, said in an email.

“Cancer is preventable in many instances and detectable at an early stage with better outcomes in many others. When necessary, treatments are improving in both their efficacy and safety. That’s all great news,” Hawk wrote.

“However, it’s well past time for us to take health inequities seriously and make them a much greater national priority. Inequities in cancer risks, cancer care and cancer outcomes are intolerable, and we should not be complacent with these regular reminders of avoidable inequities,” he said. “With deliberate and devoted effort, I believe we can eliminate these disparities and make even greater progress to end cancer.”

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Alzheimer’s drug lecanemab receives accelerated FDA approval amid safety concerns

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CNN
 — 

The US Food and Drug Administration granted accelerated approval Friday for the Alzheimer’s disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Lecanemab will be marketed as Leqembi, the FDA statement said. It has shown “potential” as an Alzheimer’s disease treatment by appearing to slow progression, according to Phase 3 trial results, but it has raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.

In July, the FDA accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway and granted the drug priority review, according to the company. The accelerated approval program allows for earlier approval of medications that treat serious conditions and “fill an unmet medical need” while the drugs continue to be studied in larger and longer trials.

If those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval. But if the confirmatory trial does not show benefit, the FDA has the regulatory procedures that could lead to taking the drug off the market.

Lecanemab, a monoclonal antibody, is not a cure but works by binding to amyloid beta, a hallmark of Alzheimer’s disease. In late November, results from an 18-month Phase 3 clinical trial published in The New England Journal of Medicine showed that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events.”

The results also showed that about 6.9% of the trial participants given lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared with 2.9% of those given a placebo. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group.

The most common adverse events in the lecanemab group were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening.

Some people who get ARIA may not have symptoms, but it can occasionally lead to hospitalization or lasting impairment. And the frequency of ARIA appeared to be higher in people who had a gene called APOE4, which can raise the risk of Alzheimer’s disease or other dementias. ARIA “were numerically less common” among APOE4 noncarriers, the study showed.

The drug’s prescribing information carries a warning about ARIA, the FDA says.

The trial results also showed that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group.

The Alzheimer’s Association welcomed Friday’s decision.

“By slowing progression of the disease when taken in the early stages of Alzheimer’s, individuals will have more time to participate in daily life and live independently,” President and CEO Joanne Pike said. “This could mean more months of recognizing their spouse, children and grandchildren. This could also mean more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”

More than 6.5 million people in the United States live with Alzheimer’s disease, according to the Alzheimer’s Association, and that number is expected to grow to 13.8 million by 2060.

Lecanemab will carry a wholesale price of $26,500 per patient per year, the drug’s manufacturers announced Friday.

Biogen and Eisai have listed the drug slightly below the reduced price of the Alzheimer’s medication Aduhelm, which now costs an average patient about $28,200. The companies had to lower the cost of Aduhelm – originally set at $56,000 per patient per year – after insurers balked at covering it.

In justifying the cost of Leqembi, the companies said in a news release that based on the estimated quality of life gained by people who take it, the value of the medication to society is around $37,000 a year, but they chose to go lower “aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability.”

The wholesale cost of a drug is akin to a car’s sticker price. It isn’t necessarily what patients will pay after insurance or other discounts are factored in.

Insurance coverage for this medication is not a given, however. Medicare restricted its coverage of lecanemab’s sister drug, Aduhelm, after clinical trials showed questionable benefits to patients. The agency agreed to cover the drug only for people enrolled in registered clinical trials, which limited access to the medication.

Center for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure said after the FDA’s decision Friday that her office would quickly review Leqembi, but for now, because of its accelerated approval, it will be covered the same way Aduhelm is covered.

“At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” Brooks-LaSure said in a statement.

Last month, the Alzheimer’s Association filed a formal request asking CMS to provide “full and unrestricted coverage” Alzheimer’s treatments approved by the FDA.

“What the FDA did today in granting accelerated approval to Leqembi was the right decision. But what CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong,” Pike said in a statement Friday.

“The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug’s evidence. CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer’s. Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months – memories, skills and independence. They’re losing time.”

CMS told CNN that it will review and respond to the association’s request. The agency also noted that it continues to stay informed about ongoing clinical trials, including the most recent lecanemab results published in the New England Journal of Medicine. Also, it has met with drugmakers to learn about their efforts since CMS’s coverage decision was announced.

The FDA approved Aduhelm for early phases of Alzheimer’s disease in 2021 – but that decision has been shrouded in controversy as a congressional investigation found last week that the FDA’s “atypical collaboration” to approve the high-priced drug was “rife with irregularities.”

Before Aduhelm, the FDA had not approved a novel therapy for the condition since 2003.

Aduhelm’s FDA approval and initial hefty price tag hit Medicare’s Part B premiums, driving up the 2022 standard monthly payments by 14.5% to $170.10.

About $10 of the premium spike – or just under half the amount – was due to Aduhelm, a CMS official told CNN in late 2021.

The premium increase was set before Medicare announced its limited coverage of the drug, but its actuaries had to make sure that the program had sufficient funding in case Aduhelm was covered.

Medicare’s decision, as well as Biogen’s slashing of the drug’s cost, prompted a decline in monthly premiums for 2023 to $164.90.

The FDA’s accelerated approval of lecanemab was expected, said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine.

Isaacson said lecanemab can be “another tool” in his toolbox to fight Alzheimer’s disease.

“I will prescribe this drug in the right person, at the right dose and in a very carefully monitored way, but this drug is not for everyone,” he said.

“I would do genetic testing for APOE4 first. I would have a frank discussion with my patients,” he said. “If someone is having side effects, if someone is on a blood-thinning medication, if someone has a problem, they need to discuss this with the treating physician, and they need to seek medical attention immediately.”

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After 25 years of wrongful imprisonment, 2 Georgia men set free after newly uncovered evidence exonerates them of murder charges

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CNN
 — 

After spending 25 years in prison on murder convictions related to the 1996 shooting death of their friend, two Georgia men were exonerated this week, after new evidence uncovered in a true-crime podcast last year proved their innocence, their lawyers said.

Darrell Lee Clark and his co-defendant Cain Joshua Storey were 17 years old when they were arrested for their alleged involvement in the death of 15-year-old Brian Bowling.

He died from a gunshot wound to the head in his family’s mobile home on October 18, 1996, according to Clark’s lawyers, Christina Cribbs and Meagan Hurley, with the nonprofit Georgia Innocence Project.

Moments before the gun was fired, Bowling was on the phone with his girlfriend and told her he was playing a game of Russian roulette with a gun, which was brought to his home by Storey, who was in the room at the time of the shooting, according to a news release from the Georgia Innocence Project.

Storey was charged with involuntary manslaughter, but months later, police began investigating the death as a homicide, and interviewed two witnesses whose statements led authorities to tie Clark to Bowling’s death, the Georgia Innocence Project said.

“Despite the circumstances, which strongly indicated that Bowling accidentally shot himself in the head, at the urging of Bowling’s family members, police later began investigating the death as a homicide,” according to a motion filed by Clark’s attorneys, requesting a new trial.

The two teenagers were sentenced to life in prison after being convicted of murder and conspiracy to commit murder, following a weeklong trial in 1998.

Clark’s exoneration came a year and a half after investigative podcasters Susan Simpson and Jacinda Davis began scrutinizing his case in their Proof true-crime podcast in 2021, and interviewed two of the state’s key witnesses.

Through their investigation, new evidence emerged which “shattered the state’s theory of Clark’s involvement” in Bowling’s death and the podcasters flagged his case to the Georgia Innocence Project, according to its news release.

The first witness, a woman who lived near Bowling’s home was interviewed by police, who claimed she alleged the teens confessed they had “planned the murder of Bowling because he knew too much about a prior theft Storey and Clark had committed,” according to the Georgia Innocence Project.

Based on her testimony, Storey was charged with murder and Clark was arrested as a co-conspirator despite having a corroborated alibi, stating he was home on the night of the shooting, which was supported by two witnesses, according to Clark’s motion for a new trial.

But the woman revealed in the podcast, police coerced her into giving false statements and threatened to take her children away from her if she failed to comply, according to the Georgia Innocence Project.

Police claimed the other witness, a man who was in a different room of the Bowlings’ home at the time of the shooting, identified Clark from a photo lineup as the person he saw running through the yard on the night Bowling was shot, the news release said.

It was uncovered in the podcast the man’s testimony was based on an “unrelated, factually similar shooting” which he witnessed in 1976, and he never identified Clark as the individual in the yard, nor did he ever witness anyone in the yard on the night of the shooting, according to the Georgia Innocence Project.

Davis told CNN in an interview when she and Simpson started their investigation, they weren’t expecting anything to come of it, but as they interviewed more people, it was “clear that it just wasn’t adding up.”

“It took us a long time to talk to both of those witnesses. The podcast was happening in almost real time as an investigation. When we finally found and were able to talk to those two witnesses, it really solidified that both of these guys had been wrongly convicted,” Davis said.

Clark’s attorneys filed pleadings in September to challenge a wrongful conviction and ask for a new trial, citing new information which proved his conviction was based on false evidence and coercion, Hurley told CNN.

Clark, now 43, was released from the Floyd County Jail Thursday after the Rome Judicial Circuit District Attorney’s Office and Floyd County Superior Court Judge John Neidrach agreed the conviction should be overturned and all underlying charges against him dismissed, after evidence in the case was reexamined.

Storey, who admitted to bringing the gun to Bowling’s home, was also released after accepting a plea deal for involuntary manslaughter, and a 10-year sentence with time served, after spending 25 years in prison. He was also exonerated of murder charges.

Storey told CNN in an interview he was afraid to go to sleep the first night after he was released in case he would wake up and “realize it was all a dream.”

“It’s been surreal to say the least,” he added. “I believe it’s going to be great. One step at a time. I never allowed my mind to get locked up all those years, anyhow.”

“You never think something like that is going to happen to you,” said Lee Clark in a statement released by the Georgia Innocence Project. “Never would I have thought I would spend more than half my life in prison, especially for something I didn’t do.”

Clark’s father, Glen Clark, told CNN in an interview, “I’ve been waiting for this day for a long, long time. 25 years. My son was wrongly accused, and I knew it all these years. It’s hard for me to live with that.”

“I watched my son go into prison as a kid, I watched him go through prison, I watched him come out as a man. He became a man in prison,” he added.

Clark is living with his family in their home in Floyd County for the foreseeable future as he focuses on readjusting to life outside prison and rebuilding his life, he told CNN. Storey said he also moved back to Floyd County, with plans to go back to school and get a job.

Clark said Judge Neidrach apologized on behalf of the state of Georgia and Floyd County this week during the court hearing this week, which was an important step toward healing.

“That really touched my heart, because I had been living in corruption for so long, and it meant a lot to have someone acknowledge that wrong,” he told CNN.

The Georgia Innocence Project will work to support Clark during his transition and connect him to resources, and a personal fundraiser has been organized on the MightyCause platform, open to the public for donations to Clark and his family, Hurley said.

“It’s probably going to take some time to like truly process that he is free and doesn’t have to go back behind prison walls, because he spent most of his life behind them,” Hurley said.

“More than anything, he’s looking forward to getting to spend time with his family and rebuilding some of those relationships that he was, frankly, ripped away from at the age of 17,” she added.

The exonerations of both men were the culmination of a collaboration between Clark, Storey and his defense team, as well as the Bowling family, which was willing to take an “objective look at this case and reevaluate some of the things they have been told in the past,” Hurley said.

Davis was in the courtroom during Clark and Storey’s hearing this week and said she’s still “in shock” and feels a huge amount of relief for both men.

“In the end, I also feel for Brian Bowling’s family who have been incredibly gracious and supportive as well. It’s really rare when you have the victim’s family support the convictions being overturned,” Davis said.

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Health

WHO renames monkeypox as ‘mpox’

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CNN
 — 

The World Health Organization announced Monday that “mpox” is now the preferred name for monkeypox.

“Both names will be used simultaneously for one year while ‘monkeypox’ is phased out,” the organization said.

Monkeypox was named in 1970, more than a decade after the virus that causes the disease was discovered in captive monkeys, the organization said. But monkeypox probably didn’t start in monkeys – its origin is still unknown – and the virus can be found in several other kinds of animals. The name was created before WHO published best practices for naming diseases in 2015.

Scientists and experts have pushed since the start of the recent outbreak to change the name to avoid discrimination and stigma that could steer people away from testing and vaccination. Stigma has been an ongoing concern as the outbreak has largely affected men who have sex with men. In the United States, Black and Hispanic people have been disproportionately affected, data from the US Centers for Disease Control and Prevention show.

This summer, New York City Health Commissioner Dr. Ashwin Vasan sent a letter to WHO to urge it to act quickly on a new name, saying there’s “growing concern for the potentially devastating and stigmatizing effects that the messaging around the ‘monkeypox’ virus can have on these already vulnerable communities.”

In August, WHO encouraged people to propose new names for monkeypox by submitting suggestions to it website. WHO said Monday that the consultation process included experts from medical, scientific, classification and statistics advisory committees “which constituted of representatives from government authorities of 45 different countries.”

“The issue of the use of the new name in different languages was extensively discussed. The preferred term mpox can be used in other languages,” WHO said in its statement.

WHO said Monday that “monkeypox” will remain searchable in the International Classification of Diseases in order to allow access to historic information, and the one-year period when both will be used allows time for publications and communications to be updated.

So far, more than 81,000 monkeypox cases in 110 cases have been reported to WHO in the recent outbreak. WHO says the global risk remains moderate, and outside of countries in West and Central Africa, the outbreak continues to primarily affect men who have sex with men.

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FDA approves first treatment to delay onset of type 1 diabetes

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CNN
 — 

A biologic therapy that delays the onset of type 1 diabetes received approval from the US Food and Drug Administration on Thursday.

It is the first therapy approved for prevention of type 1 diabetes.

The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield, from ProventionBio and Sanofi is given through intravenous infusion.

It is thought to work by turning down the body’s misdirected attack on its own insulin-producing cells. The idea is that protecting these cells buys people more time before they become dependent on insulin to manage their condition.

In clinical trials, Tzield delayed progression to full-blown diabetes by a little over two years. But the benefits have lasted much longer in some of the study participants.

One of them, Mikayla Olsten, was screened for diabetes after her 9-year old sister, Mia, suddenly developed a life-threatening episode of diabetic ketoacidosis and was diagnosed with diabetes. There was no history of diabetes in the family, and Mikayla wasn’t sick, but she had four of the five types of autoantibodies that doctors look for to assess a person’s risk.

“They told us when somebody has that many markers, it’s not if they’re going to develop diabetes, it’s when,” said her mom, Tracy.

Mikayla was 15 when she joined the study and received teplizumab. She’s now 21 and a senior in college. She gets an annual battery of tests to check her pancreas and blood markers, and Tracy Olsten says her condition hasn’t progressed in six years.

According to a scientific statement from the Juvenile Diabetes Research Foundation, the Endocrine Society and the American Diabetes Association, when a person has markers for autoimmune disease and episodes of uncontrolled blood sugar, the five-year risk for progression to insulin-dependent symptomatic disease is 75%. The lifetime risk of developing insulin-dependent diabetes is nearly 100%.

So far, Mikayla seems to be beating those odds.

Tracy said that for Mia, who is dependent on insulin, managing her diabetes is a constant chore.

“She has a tremendous amount of juggling that her peers don’t have to do. She has to plan ahead when she has a basketball game or practice on making sure she carbs up and decreases her insulin levels,” Tracy said. “She cannot go a minute or a day without thinking about it nonstop, and to be able to give Mikayla the opportunity where she doesn’t have to think about it 24/7 is amazing.”

Aaron Kowalski, CEO of the Juvenile Diabetes Research Foundation, says the main challenge in prescribing Tzield will be finding people who need it. The drug is approved for people who don’t have any symptoms of the disease and may not know they’re on the road to getting it.

“Screening becomes a really big issue, because what we know is, about 85% of type 1 diagnoses today are in families that don’t have a known family history,” Kowalski said. “Our goal is to do general population screening” with blood tests to look for markers of the disease.

Tzield is approved for use in people 8 and older who are in stage 2 of their type 1 diabetes. In that stage, doctors can measure antibodies that attack insulin-producing beta cells in the person’s blood, and they have abnormal blood sugar levels, but their body can still make insulin.

“The way in which not just industry but our medical system go about managing autoimmune diseases, and especial type 1 diabetes, is really suboptimal in today’s day and age,” ProventionBio co-founder and CEO Ashleigh Palmer said. “What we do is, we wait until the symptoms of the disease present to doctors, and then doctors treat the patient’s symptoms chronically for a lifetime. The trouble is that in type 1 diabetes, when the symptoms first present, it’s too late.”

The treatment comes in a single 14-day course of infusions that each last 30 to 60 minutes.

The most common side effects reported in the trial participants were low white blood cells and lymph cells, rash and headache.

With type 1 diabetes, a person’s immune system attacks cells called beta cells in the pancreas that produce insulin, a hormone that helps blood sugar enter cells, where it’s used for energy. The attack can happen for years before any symptoms of diabetes appear. Without insulin, blood sugar can build up in the bloodstream and break down the body’s own fat and muscle.

Palmer says Tzield holds off the disease before symptoms appear by stopping the autoimmune disease process and the underlying destruction of beta cells. The treatment essentially reboots the immune system, preserving beta cell function.

“We really have no preventative measure for type 1 diabetes to date, and that is despite [the National Institutes of Health] funding hundreds of millions of dollars over the last 20-plus years of a program called TrialNet that has tested many, many different things, including this, and some of this came out of that work,” said Dr. Robert Gabbay, chief scientific and medical officer for the American Diabetes Association. “Finally, there is something that delays the onset of type 1 diabetes, and it’s so exciting.”

Unlike type 2 diabetes, which can be prevented with lifestyle changes like losing weight and exercising, type 1 is a genetic disease that has not had any prevention options until now.

“For some reason, we don’t screen for type 1 diabetes, even though there are biomarkers available to show that the autoimmune disease process is already underway,” Palmer said. He added that the hopes the drug will catalyze the medical system to start population-based screening during routine childhood well visits in order to intercept the disease and delay its onset.

With Tzield, doctors would screen individual family members of people with type 1 diabetes to see whether they have those specific antibodies. If antibody levels are high and it appears that the person is about to develop diabetes, the treatment will delay that process.

“If somebody has type 1, a common question that comes up is ‘well, what about my child? Are they going to develop type 1?’ It’s only about a 5% risk, so more often than not, they won’t, but if you could find the ones that would and treat them, that can make a big difference,” Gabbay said.

A delayed diagnosis of type 1 diabetes could have a significant impact.

“Obviously, the quality of life is substantially impacted, negatively impacted, if you are diagnosed with type 1 diabetes. It’s a disease that never goes away,” Palmer said.

People who are type 1 diabetics must monitor their blood glucose levels around the clock, affecting how they exercise and eat. High blood sugar can lead to diabetic ketoacidosis, in which the body starts to break down fat as its fuel, and can cause a buildup of acids called ketones in the bloodstream. That condition can lead to hospitalization, coma or death.

As of 2019, about 1.9 million people have type 1 diabetes in the United States, according to the American Diabetes Association, including 244,000 children and adolescents. Type 1 affects 8% of everyone with diabetes.

“The incidence of the type 1 is mainly in kids and teenagers, and when you are in the turmoil of adolescence, when you just want to forget that you have it,” said Olivier Bogillot, Sanofi’s head of US general medicines. “So when you have the ability with a treatment to just delay the onset of the disease, you can change the way the quality of life is impacted for families and for those kids.”

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World

Rishi Sunak is clear front-runner to be Britain’s new prime minister after Boris Johnson drops out

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London
CNN
 — 

Britain’s former Chancellor of the Exchequer Rishi Sunak emerged Sunday as the clear front-runner to be the country’s next prime minister, after Boris Johnson dramatically dropped out of the race to be Conservative Party leader.

The current PM Liz Truss resigned last week after just six disastrous weeks in office. Graham Brady, the Conservative official responsible for the leadership contest, said a new prime minister will be in place by Friday.

Candidates to replace Truss have until 2 p.m. (9 a.m. ET) on Monday to secure the support of 100 Conservative Party lawmakers to enter the race to become the party – and the country’s – new leader. Johnson’s decision to withdraw from the contest leaves Sunak competing against Leader of the House of Commons Penny Mordaunt.

If both candidates secure the backing of 100 MPs, it will then be up to the roughly 172,000 members of the Conservative Party to pick the new leader in online voting.

As of Sunday evening, Sunak was the only one of the pair to have met the necessary threshold of 100 nominations.

If he remains the only one to have reached this number of backers, he will automatically become the Conservative Party’s new leader. The party’s parliamentary majority ensures he will also become the country’s next prime minister.

After days of speculation, Sunak officially declared he’d be standing in the contest on Sunday, writing on Twitter: “The United Kingdom is a great country but we face a profound economic crisis. That’s why I am standing to be Leader of the Conservative Party and your next Prime Minister. I want to fix our economy, unite our Party and deliver for our country.

“There will be integrity, professionalism and accountability at every level of the government I lead and I will work day in and day out to get the job done.”

Many of Johnson’s supporters have blamed Sunak for helping to oust Johnson from power in July in the wake of a series of scandals, but on Sunday evening he paid tribute to the former PM after he pulled out of the race. “Boris Johnson delivered Brexit and the great vaccine roll-out. He led our country through some of the toughest challenges we have ever faced, and then took on Putin and his barbaric war in Ukraine. We will always be grateful to him for that,” Sunak tweeted.

“Although he has decided not to run for PM again, I truly hope he continues to contribute to public life at home and abroad.”

Keir Starmer, leader of the main opposition Labour Party, renewed calls for a general election on Sunday, after claiming people are “fed up to the back teeth” with the Conservative leadership and the consequences of their government’s decisions.

“There is a choice to be made. We need a general election! Let the public decide… Do they want to continue with this utter chaos, or do they want stability under a Labour government?” Starmer asked during a BBC interview.

Mordaunt was the first to declare her candidacy on Friday. She promised a “fresh start” for the UK, aiming “to unite our country, deliver our pledges and win the next general election.” She is also running under a catchy hashtag: “PM4PM.”

Mordaunt came third in the last leadership election, narrowly missing out on being put before the members. With 105 votes from MPs in the last election, she too is expected to clear the new threshold, and to perform well among the party membership, in part due to her military credentials. Mordaunt is a reservist of the Royal Navy and served a short spell as Secretary of State for Defense.

The last time the Conservatives held a leadership race – following the demise of Johnson’s government – Truss came first, Sunak second and Mordaunt third. Johnson did not run.

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Business

Girl Scouts of the USA receive largest ever donation from single donor

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CNN
 — 

Girl Scouts of the USA received its largest ever donation from a single individual, a gift of $84.5 million from MacKenzie Scott, the ex-wife of Amazon

(AMZN) founder Jeff Bezos, the group said in a release.

The donation will be awarded to 29 local councils selected by Scott, along with the national chapter.

Scott, one of the wealthiest women in the world, divorced Bezos in 2019. Last year, Scott announced donations of $2.7 billion to nearly 300 organizations, following donations of $1.7 billion and $4 billion to various causes in 2020. One of the largest was a $436 million gift to Habitat for Humanity International and its affiliates, to be used to promote home ownership in Black and minority communities.

Since mid 2020, Scott has donated $12.8 billion to more than 1,200 organizations, according to Forbes.

The grants to the Girl Scouts will be used, in part, to “create more equitable membership opportunities in communities that have been under engaged” and “foster meaningful program innovation informed by the current interests and needs of girls to prepare them for leadership, including an expanded focus on career readiness and mental wellness,” the release said.

“This is a great accelerator for our ongoing efforts to help girls cultivate the skills and connections needed to lead in their own communities and globally,” Girl Scouts CEO Sofia Chang said in a release.

Girl Scouts of the USA says it’s the largest leadership organization for girls in the world, with 2.5 million members worldwide.

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World

Maiden Pharma: Gambia child deaths linked to cough syrups made in India, says WHO

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The deaths of dozens of young children in Gambia from acute kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, the World Health Organization said on Wednesday.

The findings, announced by WHO Director-General Tedros Adhanom Ghebreyesus, followed tests on several medicinal syrups that were suspected of causing 66 child deaths in the tiny West African country.

Tedros told reporters that the UN agency was conducting an investigation with Indian regulators and the company that made the syrups, New Delhi-based Maiden Pharmaceuticals Ltd.

Maiden Pharma declined to comment, while calls and messages to the Drugs Controller General of India went unanswered.

The WHO issued a medical product alert on Wednesday asking regulators to remove Maiden Pharma goods from the market.

The products may have been distributed elsewhere through informal markets, but had so far been identified only in Gambia, the WHO said in its alert.

The alert covers four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

Lab analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, the WHO said.

Medical officers in Gambia raised the alarm in July, after dozens of children began falling ill with kidney problems. The deaths confounded medics before a pattern emerged: dozens of patients younger than five were falling ill three to five days after taking a locally sold paracetamol syrup.

Gambia’s director of health services, Mustapha Bittaye, said similar problems have been detected in other syrups but that the ministry is awaiting confirmation of the results.

He said the number of deaths has tapered off in recent weeks and that the sale of products made by Maiden Pharmaceuticals was banned. However, until recently, some of the syrups were still being sold in private clinics and in hospitals, he said.

Gambia’s Medicines Control Agency sent a letter on Tuesday to health professionals ordering them to stop selling any of the products listed by WHO.

Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically as well as exporting them to countries in Asia, Africa and Latin America, according to its website.

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Health

Worries over stigma are driving a push to rename monkeypox, but the process is slow

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CNN
 — 

Since the beginning of the monkeypox outbreak, scientists and activists have pushed for the name of the virus and the disease to be changed to something “non-discriminatory” and “non-stigmatizing.”

Public health experts have worried that stigma could steer people away from getting tested and vaccinated. A new name can help slow the spread of the disease, they say, but it needs to come quickly.

Globally, nearly 60,000 cases have been identified, placing the name “monkeypox” in individuals’ medical files. The World Health Organization’s director-general promised in June that a change in the name was coming “as soon as possible,” and WHO said it was working with experts to change the name of the virus, its variants and the disease it causes.

But that was months ago.

Typically, the scientist who isolates a virus gets to suggest a name. The naming of the species is the responsibility of WHO’s International Committee on Taxonomy of Viruses.

Scientists have been calling this virus “monkeypox” for 64 years.

In 1958, researcher Preben von Magnus and his team in Copenhagen, Denmark, discovered two outbreaks of a “pox-like disease” in a colony of crab-eating macaque monkeys that their lab used for polio vaccine production and research.

The first human case of monkeypox wasn’t documented until 1970. Scientists discovered a case in a 9-month-old boy in the Democratic Republic of Congo. The child recovered from the monkeypox infection but died six days later from measles. After that, cases of the painful disease were documented in West and Central Africa.

Cases in other places were almost all linked to travel, according to the CDC. But in 2018, the agency noted that over the previous decade, more human cases had been reported in countries that had not seen the disease in several decades. This emergence, it said, was a “global health security concern.”

The global push for the name change started this year, when an outbreak took off in countries where monkeypox was not commonly found.

The naming process had already been underway to reconsider the names of all orthopoxvirus species, WHO said in an email to CNN, including cowpox, horsepox, camelpox, raccoonpox and skunkpox, as well as monkeypox.

According to WHO taxonomy committee member Colin McInnes, the panel has a mandate to bring “virus species nomenclature into line with the way that most other forms of life are named.”

Traditionally, poxviruses were named after the animal in which the disease was first spotted, but that created some inconsistencies, he said.

Monkeypox probably didn’t start in monkeys. Its origin is still unknown. The virus can be found in several other kinds of animals like Gambian giant rats, dormice and a couple of species of squirrels.

McInnes, who is deputy director and principal scientist with the Moredun Group, which develops vaccines and tests for livestock and other animals, studies squirrelpox – which also may be in line for a name change. He has been looking into the feasibility of producing a vaccine against the virus, which can be fatal for red squirrels in the UK.

The current species known as “monkeypox virus” and the others would then be renamed to “orthopoxvirus ‘something,’ ” he said in an email to CNN.

“It is the ‘something’ that is currently being debated,” McInnes wrote.

He said some scientists would prefer that the monkeypox name be kept in order to retain the link to 50 years of published research. Others would like a totally different name.

The WHO committee has until June 2023 to suggest changes.

In August, WHO announced that a group of experts had come up with new names for the clades, or variants, of monkeypox. Prior to more modern conventions about names, scientists would name a variant for the region where it emerged and was circulating.

Now, to remove any stigma that comes with naming a disease for a region or country, the Congo Basin clade will be called clade I. The former West African clade is clade II. A subvariant, clade IIb, is what is primarily in circulation in the current outbreak.

Many scientists say WHO needs to work with more urgency.

In July, after weeks had gone by no action, the New York City health commissioner sent a letter to WHO, urging it to “act in this moment before it is too late.” It cited “growing concern for the potentially devastating and stigmatizing effects that the messaging around the ‘monkeypox’ virus can have on these already vulnerable communities.”

Since the outbreak has largely affected gay and bisexual men and other men who have sex with men, stigma has been an ongoing concern for WHO Director-General Tedros Adhanom Ghebreyesus.

“Stigma and discrimination can be as dangerous as any virus,” Tedros said when he declared monkeypox a global health emergency in July.

In the US, the virus is disproportionately affecting Black and Hispanic people, according to the CDC. Local public health data also shows that fewer members of either community are getting the monkeypox vaccine.

Experts are concerned that in addition to the barriers that make access to any kind of health care difficult, some people may not get the vaccine or get tested because of the stigma associated with the disease.

In the WHO 2015 naming conventions, the organization encouraged those who name diseases to avoid places, names, occupations and animals due to stigmatization.

In August, WHO encouraged people who want to propose new names for monkeypox to submit suggestions to its website. More than 180 ideas have been suggested, some with a wide mix of creative explanations.

Some – like lopox, ovidpox, mixypox and roxypox – had no explanation.

A handful – like rodentpox, bonopox and alaskapox – may have been facetious.

Johanna Vogl, who submitted “greypox,” wrote that the name “refers to a phenotypic mark of the disease, greyish blisters and is not associated with human skin color nor a location, group or animal.”

Other suggestions come with more robust scientific explanations. Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston and an instructor in emergency medicine at Harvard, suggested changing the name to opoxid-22.

“While the monkeypox virus causing the current outbreak is not a novel pathogen, I propose that due to its designation as a public health emergency of international concern, renaming it is warranted,” Faust wrote in his proposal. He added that although this particular lineage of the virus seems to have originated before 2022, using this year may “limit confusion.”

Opoxid-22 reflects what’s known about the virus while removing “monkey” from the name.

Faust said he was bothered by the inaccuracy of the monkeypox name and the stigma it conveyed. But he said he submitted the name when he was waiting for some other work to finish.

“Honestly, I was just procrastinating,” Faust said.

He said that if WHO picked his name, it could help more people seek treatment, testing and care.

“This is important,” Faust said. “The right name should sound dry, technical, boring, so people aren’t afraid to say that they have that problem, right?”

Rossi Hassad, a professor of research and statistics at Mercy College and a fellow of the American College of Epidemiology, submitted a few names including zpox-22, zopox-22, zovid-22, hpox22 and hpi-22.

His proposal argues that given the uncertainty over where the virus originated, a more general name derived from a zoonosis – meaning a disease that can be transmitted from animals to humans – would eliminate the word “monkey” and be more inclusive.

Adding “22” would reflect the year in which scientists learned about this “outbreak with unusual and worrisome human-to-human transmission,” the proposal says.

Hassad said he was motivated to submit names because the word “monkey” can carry a lot of negative connotations.

“It has been used in racial and racist slurs against certain groups. I think it will be disingenuous not to recognize the damage that that word has done,” he said. “It is also scientifically incorrect. It’s a misnomer. If we want to be scientific, we have to be correct.”

Some US health departments aren’t waiting for WHO, but the change is inconsistent.

San Francisco’s Department of Health calls it MPX. Chicago’s calls it MPV. Other cities hit hard by the outbreak, including Houston, New York City and Philadelphia, have stuck with the traditional name, as has the CDC.

Daniel Driffin, an HIV patient advocate and a consultant with NMAC, a national organization that works for health equity and racial justice to end the HIV epidemic, said he hopes the name will change. At the same time, he is disappointed that it wasn’t until this outbreak, when people outside of Africa were widely affected, that the pushing for the change started.

“It’s a name steeped in racism. It’s a day late and a dollar short. But I support the change and think it will help,” Driffin said. “Think about the populations who will continue to be impacted disproportionately with this disease. It’s been Black and brown folks, so if we can strip racist oppressive tendencies from the nomenclature, I think we have to do that.”



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