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US

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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Business

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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US

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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