We Need to Know How Menopause Changes Women’s Brains

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During menopause, which marks the end of a woman’s menstrual cycles, her ovaries stop producing the hormones estrogen progesterone, bringing an end to her natural childbearing years. But those hormones also regulate how the brain functions, the brain governs their release — meaning that menopause is a neurological process as well. “Many of the symptoms of menopause cannot possibly be directly produced by the ovaries, if you think about the hot flashes, the night sweats, the anxiety, the depression, the insomnia, the brain fog,” says Lisa Mosconi, an associate professor of neurology at Weill Cornell Medicine director of its Women’s Brain Initiative. “Those are brain symptoms, we should look at the brain as something that is impacted by menopause at least as much as your ovaries are.”

In June, Mosconi her colleagues published in the journal Scientific Reports one of the few studies to observe in detail what happens to the brain throughout the menopause transition, not just before after. Using various neuroimaging techniques, they scanned the brains of more than 160 women between the ages of 40 65 who were in different stages of the transition to examine the organ’s structure, blood flow, metabolism function; they did many of the same scans two years later. They also imaged the brains of men in the same age range. “What we found in women not in men is that the brain changes quite a lot,” Mosconi says. “The transition of menopause really leads to a whole remodeling.”

On average, women in the United States enter the menopause transition — defined as the first 12 consecutive months without a period — at around 50; once diagnosed, they are in postmenopause. But they may begin to have hormonal fluctuations in their 40s. (For some women, this happens in their 30s, surgical removal of the ovaries causes immediate menopause, as do some cancer treatments.) Those fluctuations cause irregular periods potentially a wide variety of symptoms, including hot flashes, insomnia, mood swings, trouble concentrating changes in sexual arousal. During this phase, known as perimenopause, which averages four years in length (but can last from several months to a decade), Mosconi colleagues observed that their female subjects experienced a loss of both gray matter (the brain cells that process information) white matter (the fibers that connect those cells). Postmenopause, however, that loss stopped, in some cases brain volume increased, though not to its premenopausal size. The researchers also detected corresponding shifts in how the brain metabolized energy, but these did not affect performance on tests of memory, higher-order processing language. This suggests that the female brain “goes through this process, it recoups,” says Jill M. Goldstein, a professor of psychiatry medicine at Harvard Medical School founder executive director of the Innovation Center on Sex Differences in Medicine at Massachusetts General Hospital. “It adapts to a new normal.”

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The Delta Variant Thrives in a State of Political Public Health Discord

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ST. LOUIS — The day after Missouri Gov. Mike Parson finished his bicentennial bus tour to drum up tourism to the state in mid-July, Chicago issued a travel advisory warning about visiting Missouri.

Earlier this summer, as covid-19 case counts began to tick up when the highly transmissible delta variant took hold in the state, the Republican-majority legislature successfully enacted laws limiting public health powers absolving businesses from covid legal exposure.

The state health officer post has sat vacant since Dr. Randall Williams resigned suddenly in late April — leaving Missouri without a permanent leader as the covid numbers grew. And Brian Steele, mayor of Springfield, which is at the epicenter of swelling cases, faces a recall vote for his masking mandate that ended in April.

Hospitals in southwestern Missouri are overflowing. As of July 19, Centers for Disease Control Prevention data show Missouri is worst in the nation for covid case rates over the past week, in the bottom 15 states for vaccinations against the potentially deadly virus. Though cases are not even half of what they were during the winter spike, they continue to rise rapidly, sending a warning to other states with low vaccination rates about the havoc the coronavirus’s delta variant can bring.

Divisions abound in Missouri, where vaccines are widely available but only 40% of the state has been vaccinated. Public health mitigation measures to reel in the rising case counts would be wildly unpopular in a state that never had a statewide mask mandate. And the more the virus circulates, the higher the chance it could mutate further into something more transmissible or deadly, even for those already vaccinated.

Escalating political backlash to public health efforts has the state staring down the barrel of potential incoming disaster, said Kelley Vollmar, executive director of the Jefferson County Health Department.

“Missouri is the Show Me State,” Vollmar said, as the state has made headlines for its surging cases among its many unvaccinated residents. “I just wish we could do it for the right reasons.”

Kelli Jones, a spokesperson for the governor, said the national media spotlight on Missouri is misdirected. Flare-ups where vaccination rates are low are to be expected, she said, adding that hospitals in those areas may be strained, but that’s partly because a backlog of elective procedures are being performed during this iteration of the pandemic.

“When the national media catches on stuff, they don’t have all the full facts of all the details,” she said.

Jones Lisa Cox, spokesperson for the Missouri Department of Health Senior Services, both pointed to a $5 million multimedia campaign aimed at encouraging vaccinations. They have been heartened to see an increase in vaccine orders from vaccinators — this past week, it was more than triple the usual demand, Cox said.

Vaccines, however, take time to take effect.

Meanwhile, hot spot Springfield has requested state funding for an alternative covid care site to treat patients, saying health systems are at capacity. The Springfield-Greene County Health Department Facebook page shows the stark contrast between the vaccinated those resisting the call, as it’s littered with warring comments, some containing vaccine misinformation.

Will Marrs, a lobbyist for the Missouri Association of Local Public Health Agencies, was born raised in the heavily afflicted Springfield area. He’s been trying to persuade high school friends to get vaccinated but said it’s difficult to penetrate misinformation echo chambers.

Marrs blames national politics seeping into the Statehouse the political lifeblood of Missouri, arguing state legislators are following national Republican Party trends instead of shouting from the rooftops about the importance of vaccinations. Earlier this month at the Conservative Political Action Conference in Dallas, attendees cheered over the country not hitting vaccination rates.

And the state’s Senate delegation shows the trend: Sen. Josh Hawley, a Republican eyeing higher national office, has appeared on Fox News likening a vaccine misinformation initiative from President Joe Biden to a “surveillance state” that is “out of Beijing.” His counterpart, Republican Sen. Roy Blunt, who has frequently stressed the importance of getting vaccinated, is not seeking reelection.

“We’re in a crisis not only here in Missouri but around the country the world, we are acting like it’s just business as usual,” Democratic state Sen. Jill Schupp said of the Republican leadership in the state. “They have chosen to take the side that says, ‘I’m going to turn a blind eye to this, to this pandemic to this variant, I’m going to pretend like it doesn’t exist.’”

Parson has urged Missourians to get their vaccinations to prevent covid. But he also took a public shot at the federal government, tweeting: “I have directed our health department to let the federal government know that sending government employees or agents door-to-door to compel vaccination would NOT be an effective OR a welcome strategy in Missouri!”

Local public health workers, not federal agents, have been going door to door in Springfield elsewhere in the state to encourage vaccinations.

Jones said some of the critiques that Parson isn’t doing enough to promote vaccinations come from an ideological divide: The governor does not believe the government has the power to mandate such things, much as he doesn’t believe in mandating masks, she said.

“It comes down to some personal responsibility; the governor said that from the very beginning,” she said. “And people are just gonna have to decide to, you know, hopefully, to get vaccinated.”

Amid the uptick in cases, the White House announced it was sending a “surge response team” to help Missouri.

That “team” currently consists of one epidemiologist on the ground in southwestern Missouri a vaccination specialist offering virtual support, numbers based on what the state said it needed. Cox said the state is requesting more resources.

But two people — one remote — are hardly enough to combat decades of underfunding a year a half of political vitriol, said Brian Castrucci, CEO of the de Beaumont Foundation, which advocates for public health.

“We are being forced to apply band-aids where we don’t have the resources for stitches,” he said.

Back in eastern Missouri, Vollmar’s county is inching back up the covid case chart. She suspects everyone went to tourist (delta) hot spots in southwestern Missouri over the Fourth of July.

While she’s thrilled to have the game-changing vaccine, only roughly 30% of Jefferson County is vaccinated. Unlike last year during a similar rise in cases, she feels she doesn’t have the political buy-in from her area for mitigation measures like masking. Candidates for her local school board ran won on the idea of eliminating mask mandates in schools.

The state health department’s advisories to hot spots say “social distancing, masking, other precautions remain important” but do not mandate them.

Vollmar also warned about a lack of funding for contact tracers other public health measures needed for the wave she worries is coming. Funding has been slow to reach local health departments, much as it was last year when some county commissioners around the state withheld funding for local departments, angry about lockdowns other restrictions. Platte County in the Kansas City area paid roughly the same in pandemic relief funding to a local cruise ship company as it did to its health department, which served nearly 90,000 people.

“We all hoped that once the elections were over, that this would die down,” Vollmar said. “If you don’t have the support of your leaders, you don’t have the support of the community.”

Without a state health officer coordinating the response or getting the ear of the governor, Vollmar said, local officials like her have been interacting more with federal officials. The governor’s office said a new director will be announced Wednesday. Cox said the acting director, Robert Knodell — formerly Parson’s deputy chief of staff, who does not have a public health background — had been “very involved” in the response.

A 2020 KHN AP investigation found Missouri’s public health spending was one of the bottom 10 in the nation at $50 per Missourian per year before the pandemic. Missouri public health staffing had fallen 8% from 2010 to 2019 with the loss of 106 full-time employees.

Williams’ departure was one of at least 10 Missouri public health leadership departures this year, according to another piece of the KHN AP investigation. Nationally, that report found at least 248 state local public health leaders had departed since the beginning of the pandemic — leaving nearly 1 in 6 Americans without a local public health leader for some length of time.

But Schupp asked, considering the recent legislation political climate in Missouri, will any qualified state health officer want to come? “We’re not allowing anyone to do a good job,” she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Though Millions Are at Risk for Diabetes, Medicare Struggles to ExpPrevention Program

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Damon Diessner tried for years to slim down from his weight of more than 400 pounds, partly because his size embarrassed his wife but even more because his doctors told him he was at risk of developing Type 2 diabetes. His hemoglobin A1c level, a blood sugar marker, was 6.3%, just below the diabetes range of 6.5%.

Then, two years ago, one of his doctors helped get him into a YMCA-run Diabetes Prevention Program not far from his home in Redmond, Washington. The group classes, at first held in person then via Zoom during the covid-19 pandemic, were led by a lifestyle coach. He learned how to eat better, exercise more maintain a healthier lifestyle overall. He now weighs 205 pounds, with an A1c level of 4.8%, which is in the normal range.

“This has been a life-changing program,” said Diessner, 68, an environmental consultant. “My cardiologist said you have clearly beaten diabetes. I tell everyone who has blood sugar issues or just wants to lose weight that this is the thing to do.”

Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).

Researchers people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.

Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population potentially cut federal spending to treat diabetes-related conditions.

Before slimming down, Damon Diessner’s doctors told him he was at risk of developing Type 2 diabetes. (Laurie McKenzie)

On July 13, the agency proposed shortening the program to one year, starting in 2022, because providers complain that too few beneficiaries complete the second year. That other changes proposed by Medicare would modestly enhance reimbursement to providers. The government is also planning to waive a one-time $599 fee that groups offering the classes must pay Medicare to be part of its program. CMS said the rule changes would make it easier more attractive for MDPP providers, including YMCAs other local community organizations, to participate.

While providers have welcomed the proposed revisions as marginally helpful, they criticized CMS for not letting them provide classes counseling to Medicare beneficiaries through online methods including apps, videoconferencing texting. Many health insurers covering people under age 65 offer similar diabetes classes online, they claim success rates comparable to in-person classes.

“The proposed rule changes should have the intended effect on increasing access for Medicare members,” said Dr. Liz Joy, senior medical director for wellness nutrition at Intermountain Healthcare in Salt Lake City. It offered in-person classes at many of its hospitals but switched to online classes during the pandemic. “Virtual access would improve access reduce disparities for people who have barriers such as transportation distance,” Joy said.

A bipartisan bill in the House Senate, the Prevent Diabetes Act, would let virtual providers certified by the Centers for Disease Control Prevention participate in the Medicare Diabetes Prevention Program. The bill’s sponsors say virtual programs are needed to better serve lower-income, minority rural Americans.

The diabetes prevention initiative is just one of several programs that have been found effective in reducing or treating chronic medical conditions but have been underused due to the U.S. health care system’s lack of focus on disease prevention. For instance, Medicare’s coverage of personal nutrition counseling for people with diabetes or kidney disease is used by fewer than 1% of the 15 million beneficiaries with those conditions. Insurers, hospitals, doctors lack adequate financial incentives to offer preventive services.

“Patients might change providers next year, so why would a company invest in prevention if they don’t know that they’ll reap the benefits?” said Maria Alva, an assistant research professor at Georgetown University who has studied the MDPP. “And doctors are paid more for prescribing diabetes drugs than taking the time to recommend the diabetes prevention program.”

CMS started paying for the diabetes prevention program in 2018, following studies showing its effectiveness in helping overweight, prediabetic beneficiaries lose nearly 5% of their body weight, which can cut the risk of developing diabetes by 71%. The agency had estimated that the program would save Medicare $182 million over 10 years by reducing diabetes. CMS had projected that 110,000 beneficiaries would enroll.

An evaluation of the program by the research group RTI International published in March found there aren’t enough enrollees to determine whether participation improves health outcomes or lowers Medicare costs. With about 200 organizations providing MDPP classes at 762 sites around the country, CMS needs to prioritize signing up more providers, RTI said. Nationwide, about 1,900 organizations are certified by the CDC to offer diabetes prevention classes, but only a small percentage choose to participate in Medicare.

A key factor limiting providers’ participation up to now is that CMS has tied a bonus payment to beneficiaries’ losing at least 5% of their body weight, which only a minority of participants achieve. But studies show that weight loss of just 2% to 3% can significantly reduce A1c levels the associated risk of developing diabetes.

In contrast, the CDC recently updated its certification standards for Diabetes Prevention Programs to include two alternative measures for successful completion of the program — a 0.2% decrease in hemoglobin A1c levels, or a 4% weight loss combined with at least 150 minutes a week of physical activity.

But under Medicare’s new proposed rule, MDPP providers would receive up to $635 if a participant hit the 5% weight loss target attended 13 sessions over one year, or $661 if the person lost 9% of body weight. Providers’ payments would be capped at $338 if a participant fell short of the 5% weight loss goal.

Researchers providers say that payment model hurts organizations that serve low-income minority groups, whose members are less likely for a variety of reasons to attend all the sessions achieve 5% weight loss but who still can benefit from the program. Even without the penalty for not hitting the 5% target, Medicare’s payment rate doesn’t come close to covering the cost of running in-person classes, experts say.

“Five percent is a stretch goal, 9% is laughable,” said Dr. Amanda Parsons, who previously headed the MDPP program at Montefiore Health System in New York City, which serves mostly low-income Black Hispanic beneficiaries. “I want to know how many folks are coming anywhere close to achieving that.”

Asked to comment, CMS said CDC standards require providers to meet performance targets but did not explain why it didn’t adopt the CDC’s alternative success measures. On the issue of online classes, CMS said MDPP was originally intended to provide primarily in-person services.

Diessner, who far exceeded the 5% weight loss goal, said he was inspired to get into MDPP by watching his young grandson’s brave efforts to cope with Type 1 diabetes. Despite Diessner’s determination, his doctor had to lobby YMCA staff members over several months to get him a slot, because the few available classes were full. He was shocked when told the low number of participants nationally.

“I see lots of people out in the street who could use help with this,” he said. “The idea that so few people are taking advantage of it is a travesty.”

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Analysis: Necessary or Not, Covid Booster Shots Are Probably on the Horizon

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The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 that the company would apply for Food Drug Administration emergency use authorization for the shot. Top government health officials immediately emphatically announced that the booster isn’t needed right now — held firm to that position even after Pfizer’s top scientist made his case shared preliminary data with them last week.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe effective”?

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior covid shot. The booster is likely to be safe — hundreds of millions have taken the earlier shots — Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe effective in one sense but simply not needed — at least for now?

Reliance on the simple “safe effective” standard — which certainly sounds reasonable — is a relic of a time when there were far fewer simpler medicines available to treat diseases before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe effective” determination is not always an adequate bar, it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in covid revenue this year.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis Type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness — the health value of a product relative to its price — a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker — like an antibody level — a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug development, marketing law recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the price being offered. But there’s no such automatic process in the U.S.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, the company will gain some revenue even if only the worried well, who can pay out-of-pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Dr. Anthony Fauci has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe effective” standard or adds a second layer of vetting, when new products hit the market manufacturers promote them, Americans will be left to decipher whose version of effective necessary matters to them.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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China reports first human case of Monkey B virus after veterinarian’s death

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A veterinarian in China has become the first person in the country to contract die of the extremely rare Monkey B virus, Chinese officials said last weekend, according to reports. 

The veterinarian, 53, suffered severe nausea a fever two months after dissecting two monkeys at a breeding research institute in Beijing died on May 27, according to the Washington Post. 

The Monkey B virus, also known as the Herpes B virus, usually comes from contact with a macaque monkey can cause severe brain damage or death, according to the U.S. Centers for Disease Control Prevention.

The virus attacks the central nervous system has about an 80% fatality rate if untreated, the Post reported, citing infectious disease expert Kentaro Iwata of Japan’s Kobe University. 

The CDC says there is only one documented case of the virus spreading from person to person. 

A U.S. resident who had visited Nigeria was diagnosed with monkeypox last week after returning to Texas, according to the CDC.

LINGSHUI, April 4, 2021 — Macaques rest at Nanwan Monkey Islet in Lingshui County, south China’s Hainan Province, April 4, 2021. (Photo by Guo Cheng/Xinhua via Getty) (Xinhua/Guo Cheng via Getty Images)

MONKEYPOX DETECTED IN HOSPITALIZED US RESIDENT WHO VISITED NIGERIA, CDC AND TEXAS OFFICIALS CONFIRM 

Monkeypox is a completely different virus – it causes flu-like symptoms a rash is linked to smallpox – but both viruses can be contracted through contact with animals. 

Herpesvirus Herpesvirus Simiae Or Monkey B Virus Leads To A Lethal Encephalomyelitis. Image Made According To A View Under Transmission Electron Microscope, Viral Diameter 180 Nm. (Photo By BSIP/UIG Via Getty Images)

Herpesvirus Herpesvirus Simiae Or Monkey B Virus Leads To A Lethal Encephalomyelitis. Image Made According To A View Under Transmission Electron Microscope, Viral Diameter 180 Nm. (Photo By BSIP/UIG Via Getty Images)

After the Chinese veterinarian’s blood saliva samples tested positive for Monkey B virus, two of his colleagues tested negative, according to the Post. 

The virus was first detected in 1932 since there have been fewer than 100 diagnosed human cases, the newspaper reported. 

American primate researcher Elizabeth R. Griffin died in 1997 at 22 years old six weeks after a macaque monkey threw infected liquid into her eye. Griffin’s infection was preventable her diagnosis treatment were delayed, her biography on the Elizabeth R. Griffin Research Foundation’s website says. 

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Her family later founded the organization in her honor, which focuses on prevention through biosafety training. 

Chinese health authorities said it’s necessary to “strengthen surveillance in laboratory macaques occupational workers,” the Post reported. 

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