How Far Will AbbVie's Humira Revenue Fall in 2023?

 Investors don't have much to complain about when it comes to Humira. The world's best-selling drug has earned AbbVie  (ABBV)  well over $100 billion in total revenue since earning its first marketing approval two decades ago.

Of course, all good things must come to an end.

Wall Street analysts expect AbbVie's revenue to decline nearly 10% from 2022 to 2023. The primary driver of the change in fortunes is the loss of patent protections for Humira. The blockbuster will be exposed to competition from nearly 10 biosimilar competitors by the end of next year. Biosimilars aren't exact copies of an innovator biologic drug product, but they can be thought of as generic versions of biologic drugs.

Things may get worse before they get better. Humira's revenue will tumble even further in 2023 and could decline by more than two-thirds by the time the dust settles. What does that mean for AbbVie's long-term trajectory?

Biosimilars Cometh for Humira

Humira is used to treat autoimmune diseases ranging from rheumatoid arthritis to plaque psoriasis. AbbVie has been able to squeeze increasing amounts of revenue from the product by increasing selling prices.

In the first six months of 2022, Humira generated $10.1 billion in global revenue including $8.6 billion in the United States. The country lacks price regulations that are common in other parts of the globe, while the product became exposed to biosimilar competition in Europe years ago.

AbbVie generated 37% of full-year 2021 revenue from global sales of Humira. That increased to 39% in the first six months of 2022. Among drug developers with a market cap of at least $100 billion, only Merck  (MRK)  leans on a single product to generate more than 30% of total revenue. It wields the immuno-oncology blockbuster Keytruda, which will dethrone Humira as the world's top seller in 2023.

Investors won't feel the full onslaught of lower-priced biosimilar competition immediately. Amjevita from Amgen  (AMGN)  will launch in January 2023, but most others won't hit the market until the summer. That provides AbbVie with another six months of healthy revenue generation from its golden goose. A swift decline will follow.

Biosimilars from at least six other companies will plow into the market by mid-2023. Another three could follow soon after, bringing the total number of competitors to 10. No other biologic drug has more than five biosimilars approved. That could bring Humira's total annual U.S. revenue run rate to $10 billion by the end of next year and to $5 billion or less within a few years.

AbbVie has already coughed up the majority of its European market share to biosimilars. The copycats collectively snagged 59% market share on a prescription volume basis two years after launching. Uptake in the United States is expected to be much faster due to structural differences in the market and higher prices.

As a result, Wall Street analysts expect the business to generate roughly $59 billion in full-year 2022 revenue and "only" $55.3 billion in full-year 2023 revenue.

A Possible Silver Lining

It's not as if AbbVie didn't have time to prepare a contingency plan. The pharma titan completed a gargantuan $63 billion merger with Allergan in spring 2020, which provided a blockbuster aesthetics and eye disease portfolio. That included the best-known product in the industry, Botox. Meanwhile, the company's internal pipeline has delivered multiple blockbusters of its own including Skyrizi and Rinvoq.

Organic and acquired growth will help to significantly blunt the impact of Humira's swiftly changing competitive landscape. There will still be some pain ahead considering the product generates nearly 40% of AbbVie's revenue, but it could've been a lot worse. At least it was a good run.

https://www.thestreet.com/investing/how-far-will-abbvies-humira-revenue-fall-in-2023

Despite Wind at Its Back, Dominant US Abortion Provider Struggles to Adapt

 Since the Supreme Court’s decision to overturn Roe v. Wade in June, Planned Parenthood CEO Alexis McGill Johnson has tried to present new state laws restricting abortion as an opportunity for the nation’s largest abortion provider. “Now that we are in a world where we are no longer defending Roe,” she told Time magazine, “we have actually an opportunity to reimagine and reconstruct something better.”

The sense that Planned Parenthood's fortunes are on the upswing is palpable, given the liberal backlash against the Roe ruling -- among women especially -- blowback evident in recent off-year voting and opinion polling. OpenSecrets says the organization reported a 4,000% increase in donations just after the decision, and half of the donations were from new donors. It is planning on spending $50 million on elections this fall, an unprecedented amount for a midterm cycle. 

But close observers of the abortion debate say there’s limited potential for the organization to embrace a broader role – for example, in dispensing abortion drugs over providing surgical abortions. Its shift in that direction had been under way long before the Supreme Court ruling, but it faces competitive challenges, since abortion drugs are widely available over the Internet, and new risks, since the drugs more easily evade regulatory scrutiny.

Another controversial growth option in Planned Parenthood’s future is far afield from pregnancy: distributing hormones used by children and others to change their gender. CEO Johnson has said that providing “gender-affirming care” is one of the services that “is going to become even more important.” But that option carries big risks, complications, and uncertainties too.

Can Planned Parenthood evolve? For years, despite evidence to the contrary, it has emphasized its versatility, casting its operations as “community health clinics” that provide a variety of essential health care services, especially contraception and testing for sexually transmitted infections. In 2011, Cecile Richards, Planned Parenthood’s president at the time, suggested in a television interview that the organization provided mammograms, a point soon repeated by President Obama and others. In 2015, a Washington Post “fact checker” concluded, “The myth that Planned Parenthood actually offers mammogram X-rays to patients has been long debunked, and needs to stop being repeated.”

An oft-cited talking point from Planned Parenthood’s own fact sheet was that “3% of all Planned Parenthood health services are abortion services.” In this accounting, the cost of services wasn’t taken into account – prescribing oral contraceptives at a cost $20 and a second-trimester abortion that costs in excess of $2,000 are both counted as services Planned Parenthood provides, but they are obviously not comparable in terms of the organization’s income or incentives. Again, a Washington Post fact-checker declared the 3% figure “misleading,” dinged the organization for its lack of transparency about abortion services, and gave Planned Parenthood “three Pinocchios” for the claim.

So there’s little doubt that abortion is Planned Parenthood’s main business. Over the last three decades, its position as America’s leading abortion provider increased markedly, according to James Studnicki, a former professor of public health at the University of North Carolina and Johns Hopkins who is now vice president and director of data analytics for the pro-life Charlotte Lozier Institute. Between 1995 and 2014, abortions dropped 50% at non-Planned Parenthood abortion providers, “but Planned Parenthood abortions were up 142%,” says Studnicki, summarizing the results of a peer-reviewed paper he published in 2018.

By 2019, Planned Parenthood was responsible for about 40% of all  abortions in the U.S., compared to 10% of abortions in 1995, Studnicki said. In recent years, the total number of abortions in America has has been increasing, reversing a long trend of historical decline. There were 930,160 abortions in 2020, the Guttmacher Institute reports, an 8% increase from 862,320 abortions in 2017.

Nevertheless, Planned Parenthood's reach was diminishing even before the Supreme Court decision, as several states passed laws restricting abortion access -- restrictions the group now thinks it can capitalize upon. Tessa Longbons, a senior research associate at the Charlotte Lozier Institute, said that between June of 2021 and June of 2022, Planned Parenthood closed or merged 25 centers out of approximately 600 facilities the organization runs around the country. Danika Severino Wynn, vice president for abortion access at Planned Parenthood, told The New York Times that more closures are possible in response to the court’s June decision: “Affiliates in these states that are extremely hostile to abortion access are being forced to make the difficult decision whether or not to suspend providing abortion services following the court’s decision, due to their state’s legal landscape.”

Planned Parenthood did not respond to RealClearInvestigations’ request for comment, nor did the Guttmacher Institute, a pro-abortion research group historically affiliated with Planned Parenthood.

Regardless of whether Planned Parenthood closes additional clinics or pursues other sources of revenue, its core mission of providing abortions appears unlikely to change – although its proportions of chemical and surgical abortions likely will.

Chemical abortions accounted for the majority of all U.S. abortions in 2020.

Guttmacher Institute

Nationwide, chemical abortions made up over half of all abortions as of 2020. A number of individual Planned Parenthood affiliates have reported that more than 60% of the abortions they are doing are chemical abortions as opposed to surgical abortions.  

Chemical abortions typically involve a combination of two drugs – mifepristone (aka RU-486), which kills the fetus; and misoprostol, which causes the uterus to shrink, expelling the detached embryo through the vagina.

Because women can order these drugs online and self-administer them, it is not clear how Planned Parenthood will be able to dominate the market as it does with surgical abortions, which require doctors and expensive facilities. There are also unresolved legal questions, especially if some states outlaw the sale of these drugs, and liability questions regarding negative outcomes.

Currently, abortion drugs are approved by the Food and Drug Administration only through the first 10 weeks of pregnancy. Though even abortion-rights advocates concede that intense pain and bleeding for two weeks are normal outcomes, advocates are pushing for approval of mifepristone and misoprostol later in pregnancy when the potential for complications increases significantly as the fetus grows larger.

Just how common life-threatening side effects are in chemical abortions is disputed. An oft-cited 2009 study on women in Finland published in Obstetrics & Gynecology found one out of every five given abortion drugs in the first trimester experienced a complication, compared with one out of 20 women who underwent a surgical abortion. The most common adverse event was potentially life-threatening hemorrhaging, which represented 16% of the total complications.

In contrast, the Guttmacher Institute cites a study published in the pro-abortion journal Contraception showing “serious complications requiring hospitalization for infection treatment or [blood] transfusion occur in less than 0.4% of patients under the standard protocol.”

In 2013, a bulletin from the American College of Obstetricians and Gynecologists noted that researchers in North Carolina were unable to find American volunteers for a study on whether the drugs were effective in midterm abortions because of the trauma and risks involved. American women “strongly preferred” surgical abortion under anesthesia.

Abortion researchers have instead resorted to performing drug trials on women in developing countries. In 2017, Gynuity Health Projects, a New York-based group aligned with Planned Parenthood, began trials on second-term pharmaceutical abortions in Burkina Faso, despite concerns -- voiced even by the study's director in the country -- that critical health infrastructure was lacking to deal with the known potential life-threatening side-effects of chemical abortions, such as the ability to readily provide blood transfusions in the event of hemorrhaging.

In June, New York magazine published a series of explicitly pro-abortion features on “Life After Roe” with the aim of helping women obtain abortions. One of those features was a first-person account of a drug-induced abortion:

From the magazine's "Life After Roe" coverage.

thecut.com

My gynecologist told me to expect a “bad period.” … The actual problem was, as with so many experiences in women’s health care, my doctor didn’t adequately prepare me. She told me I’d have the cramping and bleeding of that “bad period” but didn’t describe the range and type of pain I might experience. Instead of offering sufficient pain medication or techniques to moderate pain, she prescribed six Tylenol with codeine, though she didn’t think I’d “need” them. I did, but who knows if it even helped? My pain came in waves; a grinding in my pelvis, like a mortar and pestle in the range of my pubic bone. (Years later, when I was in labor with my child, I realized I’d already experienced early contractions—during my abortion. Medication abortion can be a sort of in-between of the two experiences, a “bad period” and birth.)

And rather than explaining that I would bleed heavily for days — I spent at least 24 hours in a sort of towel cocoon until I felt as if I could bear to wear anything on my bottom half — she simply said I would “see some clots” but shouldn’t worry unless I soaked through two maxi-pads in an hour for two hours. After it was all over, I bled for two weeks with more mysterious contents in the pads: material that looked like coffee grounds (Google told me they were tiny clots), larger clots, dark blood, pink blood. Blood loss and the hormonal switching made me exhausted, weak, and bloated.

After my termination, physically, I felt off — mentally and emotionally, I felt even worse for being so ill-prepared and uninformed. As my husband put it, “We didn’t even get a f---ing pamphlet.” (I should say, my doctor wasn’t “bad” — and my experience wasn’t atypical.)

Last December, the FDA further loosened the safety regulations around mifepristone by removing the previous FDA requirement that the drug be administered in person by a doctor. Those seeking an abortion can consult with a doctor via telemedicine, receive the pills by mail, and go through the process of inducing an abortion without ever setting foot in a clinic. The FDA’s decision was announced just 15 days after the Supreme Court heard oral arguments in Dobbs v. Jackson, the case that would go on to overturn Roe v. Wade when the ruling was announced in June.

Pro-abortion rights groups don’t discount the risks of opting for an at-home abortion via telemedicine. A Gynuity “evaluation of a direct to patient telemedicine abortion service in the United States” found 8% of patients in the study given abortion pills via telemedicine ended up going to an ER or urgent care clinic.

Further, whether FDA approval of a drug would pre-empt a state ban remains a controversial legal question. “When [the FDA] approves an abortion drug for safety and efficacy, it's not talking about safety for the unborn human being obviously,” says Edward Whelan, a senior fellow at the conservative Ethics and Public Policy Center. “It's talking about safety for the mother and efficacy in killing the unborn human being. And when a state enacts a law barring that drug, it's not disagreeing with the FDA judgment on safety and efficacy.”

Abortion drugs could create other forms of legal jeopardy, according to Jonathan Mitchell, the former solicitor general of Texas. “It’s easy to just have a state pass a law that says if you manufacture this drug or distribute it in any way, you’re strictly liable for any personal injuries – not only to the mother, but also to the fetus,” he said. “You’ll be sued for wrongful death, put out of business, and all you need is one state to do this …  how many drugs have been taken off the market due to lawsuits over personal injuries that are far less dangerous than this?” 

For now, the regulatory uncertainty is causing some Planned Parenthood affiliates to act cautiously about offering chemical abortion for fear of running afoul of state laws. Montana, where chemical abortion is legal, and the four more restrictive states bordering it provide an illustration. Montana has seen an influx of out-of-state women seeking abortions. But Planned Parenthood of Montana, which runs three clinics in the state, has stopped offering abortion pills to anyone who doesn’t live in the state. According to NPR, the president of Planned Parenthood of Montana circulated an internal memo “citing concerns about the potential for civil and criminal action.”

Despite its initial caution, “I think Planned Parenthood will find ways to continue to provide chemical abortions even where they don't have facilities available,” says Studnicki.

As for “gender affirming care,” its growth has not gone unnoticed by Planned Parenthood.

Planned Parenthood’s annual report for 2018-2019 made no mention of hormone treatments for transgender patients, but its last two annual reports have touted it. According to its most recent annual report, Planned Parenthood has clinics in 33 states and the District of Columbia that provide cross-sex hormones to people who identify as transgender. In 2020, Planned Parenthood’s website claimed, “Nationally, Planned Parenthood is the second largest provider of Gender Affirming Hormone Care,” though that claim has since been scrubbed from its website.

About 1.6 million Americans identify as transgender and that number is growing quickly. A report released ethis year by the Williams Institute at the University of California, Los Angeles, shows that the number of young people identifying as transgender doubled between 2017 and 2020 and now represents between 1.3% and 1.4% of all Americans under the age of 24.

Given the growing market for transgender services, the financial incentives for Planned Parenthood are considerable. Last year, Abigail Shrier, author of “Irreversible Damage: The Transgender Craze Seducing Our Daughters,” published an interview with a Planned Parenthood employee who supports the organization’s core mission related to abortion, but had serious misgivings about how Planned Parenthood was doling out hormones.

According to the employee, “Trans-identifying kids are cash cows, and they are kept on the hook for the foreseeable future in terms of follow-up appointments, bloodwork, meetings, etc., whereas abortions are (hopefully) a one-and-done situation.”

The cost of prescription hormones alone can vary from around $400 to $1,500 a year, not including the cost of blood tests and other medical services necessary for transgender treatments.

The Planned Parenthood employee further told Shrier that one or two new biologically female teen patients were coming to the clinic she worked at every day. They were sent to a gender counselor at the clinic with “no actual professional credentials or formal training other than being [a male-to-female transgender person].” The gender counselor would send “notes to an actual licensed mental health professional somewhere off-site, and rubber stamp approve the patients to begin their transition. This is basically how they circumvented the requirement to speak to an actual counselor.”

Such apparent vulnerabilities in its operations suggest that Planned Parenthood’s effort to, in Johnson’s words, “reimagine and reconstruct something better” in a post-Roe environment remains unclear. 

“If they were a health care provider interested in women's issues such as prenatal care, if they were interested in essentially providing any other kinds of service, they might find different ways to continue to engage,” says Studnicki. “But my expectation is that over time, Planned Parenthood, at least as a clinic, will disappear in communities where abortion is restricted.”

https://www.realclearinvestigations.com/articles/2022/09/08/despite_wind_at_its_back_americas_dominant_abortion_provider_faces_a_struggle_to_adapt_851640.html

Mexico is losing the fight against drug violence

 Four years after being elected on a promise to fight organized crime with “hugs, not bullets,” Mexican President Andrés Manuel López Obrador is now taking steps to increase the military’s role in public security. In doing so, he hopes to contain a renewed surge in gang-related violence.

But degrading the power of Mexico’s drug cartels will require more than just sending the army onto the streets.

Last month, clashes between armed gangs left more than 200 people dead and dozens of businesses destroyed, underscoring the deterioration in security under López Obrador. Although homicide rates have dipped since the start of the pandemic, much of Mexico remains extraordinarily violent. The country is home to the world’s eight most dangerous cities, according to one research group. “Disappearances” have skyrocketed over the last decade. In 2021, close to 45,000 Mexicans fled their homes out of fear of violence, five times as many as in the previous year.

One U.S. military estimate says that up to a third of Mexico is “ungoverned space,” largely controlled by criminal organizations. López Obrador disputes that figure — and yet by most every measure, drug cartels have grown in number, potency and riches, buoyed by demand for illegal drugs in the U.S. Mexico is the dominant source of illegal fentanyl transported to the U.S., with cartels increasingly manufacturing and distributing their own versions of the drug.

Although López Obrador has long criticized the perceived excesses of Mexico’s drug war, his policies have proved no more effective. To fight corruption, in 2019 he replaced the federal police with a new, 115,000-person national guard, made up largely of former soldiers who lack experience in investigating crimes and enforcing the law. Even worse, he has scaled back counter-narcotics cooperation with the U.S., in retaliation for Washington’s efforts to prosecute high-ranking Mexican officials suspected of colluding with the cartels. Among other things, the government has placed limits on the operations of U.S. drug-enforcement agents and disbanded an elite intelligence unit that worked closely with the U.S. to apprehend prominent kingpins.

Mexico’s inability to quell surging drug violence threatens civilians on both sides of the border. In recent weeks, Mexican legislators have approved a request from López Obrador to put the army in charge of the national guard and authorized the military to handle public safety duties through 2028. While these moves aim to reassure the public, they won’t be enough to break the power of the cartels. The government needs to devote more intelligence resources and personnel to identifying and dismantling opioid-production labs and strengthen the ability of customs and port-security officials to interdict precursor materials used to make synthetic drugs. Mexico also should address the weakness of its criminal-justice system, which by some accounts lets more than 90 percent of crimes go unpunished. That will require funding to recruit and equip police, increased pay for prosecutors and judges, and building out the capacity of law-enforcement bodies to investigate and prosecute complex criminal cases.

Most important, Mexico should reinvigorate security cooperation with the U.S. and ease restrictions on American anti-drug operations. The two countries should work together to root out any current and former officials who’ve abetted the drug trade and hold them accountable. For its part, President Joe Biden’s administration should take more aggressive action to stop the flow of guns from the U.S. into Mexico — by intensifying anti-trafficking operations and requiring that law-enforcement agencies improve their collection of data on the sources of firearms seized in Mexico. It should work with Congress to increase funding for border security, essential to curbing the smuggling of fentanyl into the U.S. — much of which is carried by vehicles traveling through legal ports of entry. Curbing demand for drugs in the U.S. through education and addiction-treatment programs — an admittedly long and costly endeavor — is also essential to saving lives in both countries.

The U.S. and Mexico have a shared interest in combating drug trafficking and removing the impunity that criminal networks enjoy. A planned security dialogue in Washington next month would be a good place to start. Renewed commitment by both governments is a necessary step toward breaking the grip of drug cartels and the suffering they inflict on innocent people.

https://www.ncnewsonline.com/opinion/editorial-by-bloomberg-opinion-mexico-is-losing-the-fight-against-drug-violence/article_f536c342-3f4a-11ed-8c94-bfafc826f295.html

Structure of key part of chromosomes may up understanding of how humans age, develop cancer

 Scientists from Nanyang Technological University, Singapore (NTU Singapore) have mapped out the molecular structure of a key part of our chromosomes called telomeres, which play a pivotal part in ageing and cancer.

The NTU team discovered that the building blocks of telomeres are stacked in columns like a spring. They also found that the shape of telomeres leaves a part of the DNA exposed and unprotected, leaving it more susceptible to damage than previously thought.

The researchers said that their advance in genetic research would aid in explaining why humans age and develop cancer.

Telomeres are protective caps at the ends of the DNA molecules that make up our chromosomes. Like the plastic tips on the ends of shoelaces, the telomeres' function is to cap and protect the ends of the chromosome from damaging themselves by sticking to each other or fraying.

Previously, due to its chemical instability and complex repetitive nature, scientists have struggled to duplicate enough telomeric DNA in the laboratory to be able to use electron microscopes to observe how it is structured.

In their study published this month in the journal Nature, the researchers adapted existing processes to replicate DNA and saw that in telomeres, the nucleosomes, which contain tightly packed strands of DNA (deoxyribonucleic acid), are stacked in columns around chromosomal proteins called histones.

Professor Lars Nordenskiöld, Chair of NTU's School of Biological Sciences, who led the study, said: "Our study showed that telomeres are not structured in the zig-zag formation as depicted in textbooks, but rather in columns and a spring formation. This leaves the crucial part of the DNA -- its helix -- exposed. This helps us understand how telomeres, despite their essential role in preventing damage to DNA, are themselves hotspots for DNA damage. Our study will help researchers and doctors understand the reasons behind how telomeres are damaged at a molecular level, as detailed research on the structure of the DNA within telomeres and external factors, such as proteins and other cell processes, is limited."

The study, which represents an advance in understanding the underlying biology of how the human body ages and becomes susceptible to diseases, reflects NTU's commitment to responding to the needs and challenges of healthy living and ageing, which is one of four humanity's grand challenges that the University seeks to address through its NTU 2025 strategic plan.

To arrive at their results, the researchers used a state-of-the-art cryogenic electron microscope at the NTU Institute of Structural Biology to probe the structure of telomeres.

Besides growing knowledge of how telomeres are involved in processes such as ageing and DNA damage, the findings by the NTU research team may also be useful in developing potential treatments for diseases that are caused by dysfunctional telomeres.

These include aplastic anaemia when the human body stops producing enough new blood cells and dyskeratosis congenita, a rare genetic form of bone marrow failure, and the inability of the marrow to produce sufficient blood cells, which typically results in death by the age of 30.

Dr Aghil Soman, Research Fellow at NTU's School of Biological Sciences, who co-authored the study, said: "A specific future focus in our study of DNA will be how our structure interacts with previously discovered telomere-specific factors, with a keen focus on factors associated with cancer development and longevity. Our structure also provides an avenue to improve small molecule anticancer drugs. Armed with the structure of telomeric nucleosome assemblies, we can now potentially design anticancer drugs that solely target telomeres with high affinity. This would help overcome the limitation of drugs like cisplatin, which although it kills cancer cells in humans, also causes damage to the kidneys, liver, and brain."

Prof Nordenskiöld added: "The organisation of the proteins in telomeres, at the molecular level, revealed in this work, paves the way for further structural studies. This can shed light on the structure-function relationship of telomeres in the context of ageing and cancer. It can also provide a template to develop treatments for genetic diseases. From our study, we also discovered elegant grooves formed by DNA that suggest how remodelling might happen within telomeres. This could provide a future platform for studies on drugs to target damage at the telomeric level.

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Story Source:

Materials provided by Nanyang Technological University. Note: Content may be edited for style and length.

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Journal Reference:

1. Aghil Soman, Sook Yi Wong, Nikolay Korolev, Wahyu Surya, Simon Lattmann, Vinod K. Vogirala, Qinming Chen, Nikolay V. Berezhnoy, John van Noort, Daniela Rhodes, Lars Nordenskiöld. Columnar structure of human telomeric chromatin. Nature, 2022; 609 (7929): 1048 DOI: 10.1038/s41586-022-05236-5

https://www.sciencedaily.com/releases/2022/09/220929132638.htm

High blood pressure speeds up mental decline, but does not fully explain dementia disparities

 People with high blood pressure levels face a faster erosion of their ability to think, make decisions and remember information than those with normal blood pressure levels, a new study finds.

The researchers traced high blood pressure's association with declining brain function over years, in data from six large studies that they pooled and analyzed. They show that blood pressure-related cognitive decline happens at the same pace in people of Hispanic heritage as in non-Hispanic white people.

The team had set out to see if differences in long-term blood pressure control explained why Hispanic people face a 50% higher overall risk of dementia by the end of their life than non-Hispanic white people in the United States.

But the new findings suggest that other factors may play a bigger role in that disparity.

Nevertheless, the new study in the Journal of Alzheimer's Disease serves as an important reminder of the key role that controlling blood pressure plays in long-term brain health, says Deborah Levine, M.D., M.P.H., lead author of the study and director of the University of Michigan's Cognitive Health Services Research Program.

"Our findings suggest that high blood pressure causes faster cognitive decline, and that taking hypertension medication slows the pace of that decline," says Levine, a professor of internal medicine at the U-M's academic medical center, Michigan Medicine.

"Since other studies have shown that people of Hispanic heritage in the United States tend to have higher rates of uncontrolled hypertension than non-Hispanic white people, due in part to worse access to care, it's vital that they get extra support to control their blood pressure even if blood pressure is only part of the picture when it comes to their higher dementia risk," she adds. "A risk factor like uncontrolled high blood pressure that is more prevalent in one group can still contribute to substantial health disparities."

Levine and her colleagues looked at changes in the thinking and memory abilities of adults over 18 who took part in six long-term studies conducted over the past five decades. On average, they had access to nearly eight years of data from each person, including systolic blood pressure, which is the top number in any blood pressure reading.

The size of the data set allowed them to trace blood pressure readings and changes on tests of cognitive performance, executive function and memory in Hispanic and non-Hispanic white adults more clearly than any one smaller data set could.

The data come from 22,095 non-Hispanic white adults and 2,475 Hispanic adults, none of whom had a history of stroke or dementia when they enrolled. At enrollment, the average systolic blood pressure was lower in Hispanic adults than non-Hispanic white adults (132.5 mmHg compared with 134 mmHg), despite Hispanic adults having older age than non-Hispanic adults (62 versus 54) and blood pressure tending to increase with age.

Overall, the downward trend in thinking and memory due to high blood pressure happened at the same pace in both groups.

When Levine and colleagues looked just at the two studies that had deliberately recruited people of Hispanic origin, they saw a faster decline in overall cognitive performance in the Hispanic group compared with the non-Hispanic white group.

But differences in blood pressure between the groups did not explain the differences in cognitive decline -- perhaps because Hispanic people had lower blood pressure than the non-Hispanic white people in these studies.

Levine notes that the studies included data on years of education. But they did not include full information about factors known as social determinants of health -- including income, education quality, early life experiences, family factors, living circumstances and more -- that might drive disparities in cognitive decline between Hispanic and non-Hispanic white people.

Two years ago, members of the study team reported on their findings from a similar analysis of data from Black and White people in some of the same studies. That study found that differences in blood pressure control over time helped explain the faster decline in cognitive performance in Black individuals.

Levine and colleagues at the U-M Frankel Cardiovascular Center are currently studying other aspects of cognitive decline disparities, including her own team's research on post-stroke cognitive declines, and Lewis Morgenstern, M.D., M.S.'s BASIC Cognition study. Having a stroke can increase the risk of dementia fifty-fold, but it is not known yet what impact controlling vascular risk factors such as blood pressure and blood sugar can have on dementia risk after stroke.

Funded by the National Institute of Neurological Disorders and Stroke (R01 NS102715; PI, Levine D)

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Story Source:

Materials provided by Michigan Medicine - University of Michigan. Original written by Kara Gavin. Note: Content may be edited for style and length.

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Journal Reference:

1. Deborah A. Levine, Alden L. Gross, Emily M. Briceño, Nicholas Tilton, Rachael Whitney, Dehua Han, Bruno J. Giordani, Jeremy B. Sussman, Rodney A. Hayward, James F. Burke, Mitchell S.V. Elkind, Andrew E. Moran, Sarah Tom, Rebecca F. Gottesman, Darrell J. Gaskin, Stephen Sidney, Kristine Yaffe, Ralph L. Sacco, Susan R. Heckbert, Timothy M. Hughes, Oscar L. Lopez, Norrina Bai Allen, Andrzej T. Galecki. Blood Pressure and Later-Life Cognition in Hispanic and White Adults (BP-COG): A Pooled Cohort Analysis of ARIC, CARDIA, CHS, FOS, MESA, and NOMAS. Journal of Alzheimer's Disease, 2022; 89 (3): 1103 DOI: 10.3233/JAD-220366

https://www.sciencedaily.com/releases/2022/09/220929133441.htm

FDA drops push for medical device cybersecurity requirement

 The FDA user-fee agreements bill was recently reauthorized, but without the previously introduced medical device cybersecurity rules, SC Magazine reported Sept. 29.

The cybersecurity rules would have required developers to create processes for identifying and addressing security vulnerabilities and threats for products brought to market.

Greg Murphy, CEO and president of computer security service Ordr, told SC Magazine the removal of the cybersecurity provisions "illustrates why healthcare organizations can't wait for government regulations before acting." 

The bill passed in the House in June. It aimed to reauthorize user-fee agreements, target lower costs, support innovation and improve generic drug competition.

https://www.beckershospitalreview.com/supply-chain/fda-drops-push-for-medical-device-cybersecurity-requirement.html

Next On Europe's Doomsday List: Collapse Of Cell Phone Networks

 It's not just heating that could be missing across Europe this winter: cell phones may be the next to go. That's because if power cuts or energy rationing knocks out parts of the mobile networks across the region, mobile phones could go dark around Europe this winter according to the latest doomsday reporting from Reuters.

While everyone knows by now that Europe's chances of rationing and power shortages have exploded ever since Moscow suspended gas supplies, in France, the situation is even worse as several nuclear power plants are shutting down for maintenance. And the cherry on top: telecom industry officials told Reuters they fear a severe winter will put Europe's telecoms infrastructure to the test, forcing companies and governments to try to mitigate the impact (i.e., more bailout demands).

The problem, as four telecoms executives put it, is that currently there are not enough back-up systems in many European countries to handle widespread power cuts, raising the prospect of mobile phone outages. Realizing that in just weeks Europe could be cell phone free, countries including France, Sweden and Germany, are scarmbling to ensure communications can continue even if power cuts end up exhausting back-up batteries installed on the thousands of cellular antennas spread across their territory.

Alas, like with everything else in Europe, it's too little, too late and Europe is facing a truly historic cell phone black out because while Europe has nearly half a million telecom towers, most of them have battery backups that last around 30 minutes to run the mobile antennas. After that they go dark.

One of the alternatives being discussed is pushing Europe back to communist era blackout regimes: In France, a plan put forward by electricity distributor Enedis, includes potential power cuts of up to two hours in a worst case scenario, two sources familiar with the matter said.

The general black-outs would affect only parts of the country on a rotating basis. Essential services such as hospitals, police and government will not be impacted, the sources said. And now, it appears that cell phones are considered essential too: the French Federation of Telecoms (FFT), a lobby group representing Orange, Bouygues Telecomand Altice's SFR, put the spotlight on Enedis for being unable to exempt antennas from the power cuts.

Enedis said it was able to isolate sections of the network to supply priority customers, such as hospitals, key industrial installations and the military and that it was up to local authorities to add telecoms operators infrastructure to the list of priority customers.

"Maybe we'll improve our knowledge on the matter by this winter, but it's not easy to isolate a mobile antenna (from the rest of the network)," said a French finance ministry official with knowledge of the talks.

Telcos in Sweden and Germany have also raised concerns over potential electricity shortages with their governments, several sources familiar with the matter said. Swedish telecom regulator PTS is working with telecom operators and other government agencies to find solutions, it said. That includes talks about what will happen if electricity is rationed. PTS is financing the purchase of transportable fuel stations and mobile base stations that connect to mobile phones to handle longer power outages, a PTS spokesperson said.

The Italian telecoms lobby was even more forceful, and told Reuters it wants the mobile network to be excluded from any power cut or energy saving stoppage and will raise this with Italy's new government. The power outages increase the probability of electronic components failing if subjected to abrupt interruptions, telecoms lobby chief Massimo Sarmi said in an interview.

Until a solution is reached, to save power, telecom companies are using software to optimise traffic flow, make towers "sleep" when not in use and switch off different spectrum bands, Reuters sources said. The telecom operators are also working with national governments to check if plans are in place to maintain critical services. In Germany, Deutsche Telekom has 33,000 mobile radio towers and its mobile emergency power systems can only support a small number of them at the same time, a company spokesperson said.

https://www.zerohedge.com/technology/gone-30-minutes-next-europes-doomsday-list-collapse-cell-phone-networks