Cheri Pies, a public health professor who broke barriers with her seminal 1985 book, “Considering Parenthood: A Workbook for Lesbians,” a bible of the “gay boom” of the 1980s and beyond, died July 4 at her home in Berkeley, California. She was 73 years old.

The cause was cancer, said his wife, Melina Linder.

Later in life, Dr. Pies (her first name was pronounced “Sherry”) became a pioneering researcher and professor at the University of California, Berkeley School of Public Health, investigating the effects of economic and racial inequality in areas like infant mortality and health across generations.

But she made a name for herself decades before turning to academia with her groundbreaking book. This journey began in the 1970s, when Dr. Pies worked as a health educator for Planned Parenthood, counseling heterosexual women considering motherhood.

His focus began to shift in 1978, after his female partner adopted a daughter. At that time, the concept of openly gay parents was still mostly unknown in the mainstream culture.

That year, New York became the first state to say it wouldn’t reject adoption applications solely on the basis of homosexuality. A year later, a California gay couple broke barriers as the first known to jointly adopt a child.

Dr. Pies was struck by the lack of support available to same-sex parents, as well as the lack of background information on the unique challenges they face. She began holding workshops at her home in Oakland, California, advertising them with fliers at women’s bookstores and other places where lesbians congregated.

By the early 1980s, news of her work had spread beyond the Bay Area, and she was bombarded with letters and phone calls from lesbians across the country. In response, Dr. Pies compiled his teachings and experiences into a book. “Considering Parenthood: A Workbook for Lesbians,” published by lesbian feminist press Spinsters Ink, provided practical advice on a wide range of topics, including the use of sperm donors, legal issues around adoption, and ways to build a support network.

The book, released 30 years before same-sex marriage was legalized nationwide, opened the valves for countless other books on LGBTQ parenting.

“She was absolutely a pioneer, and those of us who came later built on his work,” said G. Dorsey Green, psychologist and author of “The Lesbian Parenting Book” (with D. Merilee Clunis, 2003), in an obituary for Dr. Pies on Mombian, a website for lesbian parents. “I would recommend his book to clients. This was when lesbian couples were just beginning to think about having children as lesbians. Cheri started this conversation.

Dr. Pies, who earned a master’s degree in social work from Boston University in 1976, eventually turned to academia, earning another master’s degree in maternal and child health from Berkeley in 1985 and a doctorate in health education in 1993.

She was director of family, maternal and child health programs for Contra Costa County, which borders Berkeley and Oakland, when she heard a lecture in 2003 by Dr. Michael C. Lu, who would become the dean of the Berkeley School of Public Health.

Dr. Lu spoke about a concept called life course theory, which is based on the idea that social and economic conditions at every stage of life, beginning with early childhood, can have powerful and lasting effects on generations. “What surrounds us shapes usexplained Dr. Pies during a 2014 lecture at the University of Alabama at Birmingham. “Some people would say your zip code is more important than your genetic code.”

At Berkeley, Dr. Pies would eventually collaborate with Dr. Lu and others to create the Best Babies Zone initiative, a groundbreaking program that would study — and, ideally, improve — health conditions in economically disadvantaged neighborhoods across the country.

In 2012, she became the program’s principal investigator, after Dr. Lu took up a post in the Obama administration. The initiative included home health visits and working with community leaders to create parent-child playgroups, improve park safety and improve job training. It started in Oakland, New Orleans and Cincinnati and expanded to six more cities in 2017, the year Dr. Pies retired from Berkeley. The program is still active today.

“There are people doing large-scale political work around structural racism, trying to change policy and practice,” Dr. Pies said in an interview posted on the Berkeley School of Public Health website in April. “Best Babies Zone is on the other end of the spectrum, going small to bring change to people who can’t wait for policy change to happen.”

The high incidence of low birth weight and sudden infant death syndrome in these communities was the focus of the program. “Babies are the canary in the mine,” Dr. Pies said in his speech at the University of Alabama. “If babies are not born healthy, you know something is wrong with the community.”

Cheramy Anne Pies was born on November 26, 1949 in Los Angeles, the second of three daughters of Morris Pies, a doctor, and Doris (Naboshek) Pies, a nurse. (She later changed her name to Cheri.)

Growing up in Encino, San Fernando Valley, the outgoing and exuberant Cheri was a fan of movies, especially musicals like “My Fair Lady,” and got a taste of the medical profession working as a receptionist in her father’s office.

After graduating from nearby Birmingham High School, she enrolled at Berkeley in 1967, where she earned a bachelor’s degree in social science in 1971.

Berkeley was then a cauldron of political passions during the Vietnam War era, following the Free Speech Movement protests that rocked the campus beginning in 1964. “Even though I wasn’t actively engaged in it, I was certainly exposed to politics,” she later said of the movement.

In addition to his wife, Dr. Pies is survived by his sisters, Lois Goldberg and Stacy Pies.

She would eventually channel Berkeley’s 1960s spirit of activism as an author and teacher, working to improve the lives of openly lesbian parents of the 1980s and beyond—whose numbers swelled so rapidly that in 1996 Newsweek magazine would report that an estimate six million to 14 million children in the United States had at least one homosexual parent.

“Adoption agencies are reporting increasing numbers of inquiries from potential parents — particularly men — who identify as gay,” the article reads, “and sperm banks say they are in the midst of what some call a lesbian-powered ‘gay boom’.”

Many of this generation would acknowledge their debt to Dr Pies for the rest of her life, Ms Linder said in a telephone interview: “Cheri and I could be anywhere in the world – hiking in New Zealand or just walking in the Berkeley Hills – and people would see her and stop to thank her, saying Ben or Alice or whoever it was wouldn’t be in their lives without Cheri.

During her annual visit, the patient’s doctor asks her if she plans to continue having regular mammograms to screen for breast cancer, then reminds her that it has been almost 10 years since her last colonoscopy.

She is 76 years old. Hmm.

The patient’s age alone can be an argument against further mammography appointments. The Independent and Influential American Task Force on Preventive Services, in its latest draft guidelinesrecommends screening mammograms for women aged 40 to 74, but states that “current evidence is insufficient to assess the balance between the benefits and harms of screening mammography in women aged 75 or older”.

Screening for colorectal cancer, through a colonoscopy or a less invasive test, also becomes questionable in old age. The working group gives him a C grade for 76 to 85 year olds, which means that there is “at least moderate certainty that the net benefit is low”. It should only be offered selectively, according to the guidelines.

But what else is true about this hypothetical woman? Does she play tennis twice a week? Does she have heart disease? Did his parents live well until they were 90? Does she smoke?

Any or all of these factors affect their life expectancy, which could make future cancer screenings helpful, unnecessary or even harmful. The same considerations apply to a range of health decisions at later ages, including those involving drug regimens, surgeries, other treatments, and screenings.

“It doesn’t make sense to draw these lines by age,” said Dr. Steven Woloshin, internist and director of the Center for Medicine and Media at the Dartmouth Institute. “It’s age and other factors that limit your life.”

Slowly, therefore, some medical associations and health advocacy groups have begun to change their approaches, basing their test and treatment recommendations on life expectancy rather than simply age.

“Life expectancy gives us more information than age alone,” said Dr. Sei Lee, a geriatrician at the University of California, San Francisco. “It leads to better decision making more often.”

Some recent task force recommendations already reflect this broader vision. For older people experiencing lung cancer testsfor example, the guidelines advise considering factors such as a history of smoking and “a health condition that significantly limits life expectancy” in deciding when to discontinue screening.

The Colorectal Screening Task Force guidelines call for consideration of “an elderly patient’s health status (eg, life expectancy, comorbid conditions), prior screening status, and individual preferences.”

Similarly, the American College of Physicians incorporates life expectancy into its prostate cancer screening guidelines; the same goes for the American Cancer Society, in its guidelines for breast cancer screening for women over 55.

But how does this 76-year-old woman know how long she will live? How does anyone know?

A 75 year old has an average life expectancy of 12 years. But when Dr. Eric Widera, a geriatrician at the University of California, San Francisco, analyzed the 2019 census data, he found huge variations.

The data shows that the least healthy 75-year-olds, those in the bottom 10%, would likely die in about three years. Those in the top 10% would probably live another 20% or so.

All of these predictions are based on averages and cannot determine the life expectancy of individuals. But just as doctors constantly use risk calculators to decide, for example, whether to prescribe drugs to prevent osteoporosis or heart disease, consumers can use online tools to get rough estimates.

For example, Dr. Woloshin and his late wife and research partner, Dr. Lisa Schwartz, helped the National Cancer Institute develop Calculator Know Your Oddswhich was posted online in 2015. Initially, it used age, sex and race (but only two, black or white, due to limited data) to predict the odds of dying from specific common diseases and the odds of overall mortality over a five to 20-year period.

The Institute recently overhauled the calculator to add smoking status, a critical factor in life expectancy and over which, unlike other criteria, users have some control.

“Personal choices are driven by priorities and fears, but objective information can help inform those decisions,” said Dr. Barnett Kramer, an oncologist who led the institute’s Division of Cancer Prevention when the calculator was released.

He called it “an antidote to some of the scare campaigns patients see on TV all the time,” courtesy of drugmakers, medical organizations, advocacy groups and scaremongering media reports. “The more information they can glean from these charts, the more they can guard against health care choices that don’t help them,” Dr. Kramer said. Unnecessary testing, he pointed out, can lead to overdiagnosis and overtreatment.

A number of health facilities and groups provide disease-specific online calculators. The American College of Cardiology offers a “risk estimator” for cardiovascular disease. A calculator from the National Cancer Institute assesses breast cancer riskand Memorial Sloan Kettering Cancer Center offers one for lung cancer.

However, calculators that look at single diseases generally do not compare the risks to those of mortality from other causes. “They don’t give you the context,” Dr. Woloshin said.

Probably the most comprehensive online tool for estimating the life expectancy of older people is ePrognosis, developed in 2011 by Dr. Widera, Dr. Lee and several other geriatricians and researchers. Intended for health professionals but also accessible to consumers, it offers around twenty validated geriatric scales for estimating mortality and disability.

The calculators, some for patients living alone and others for those living in nursing homes or hospitals, incorporate considerable information about medical history and current functional ability. Fortunately, there is a “time to benefit” instrument which illustrates which screenings and interventions may still be useful at specific life expectancies.

Consider our hypothetical 76-year-old man. If it’s a healthy person who never smokes, has no problems with daily activities, and is able to walk a quarter mile without difficulty, among other things, a mortality scale on ePrognosis shows that their extended life expectancy makes mammography a reasonable choice, regardless of what the age guidelines say.

“The risk of just using age as a threshold means that we sometimes under-treat” very healthy older people, Dr. Widera said.

If she’s a former smoker with lung disease, diabetes and limited mobility, on the other hand, the calculator says that while she should probably continue taking a statin, she can end breast cancer screening.

“Concurrent mortality” – the possibility of another disease causing her death before the one she was screened for – means she is unlikely to live long enough to see a benefit.

Of course, patients will continue to make their own decisions. Life expectancy is a guide, not a limit to medical care. Some older people I don’t want to stop the screenings anymoreeven when the data shows that they are no longer useful.

And some have exactly no interest in discussing their life expectancy; just like some of their doctors. Either party can overestimate or underestimate the risks and benefits.

“Patients will simply say, ‘I had a great-uncle who lived to be 103,'” Dr. Kramer recalls. “Or if you say to someone, ‘Your long-term chance of survival is one in 1,000,’ a powerful psychological mechanism causes people to say, ‘Oh thank God, I thought that was hopeless.’ I saw it all the time.

But for those looking to make health decisions on evidence-based calculations, online tools provide valuable context beyond age alone. Given the projected life expectancy, “you’ll know what to focus on, instead of being scared off by whatever’s in the news that day,” Dr. Woloshin said. “It anchors you.”

However, the developers want patients to discuss these predictions with their medical providers and caution against making decisions without their involvement.

“This is meant to be a starting point” for conversations, Dr. Woloshin said. “It’s possible to make much more informed decisions, but you need help.”

The pharmaceutical industry, which suffered a crushing defeat last year when President Biden signed legislation allowing Medicare to negotiate the price of certain prescription drugs, is now waging an all-out assault on the measure — just as negotiations are about to begin.

the law, the Inflation Reduction Act, is an iconic legislative achievement for Mr. Biden, who boasted of taking on the pharmaceutical industry and winning. Medicare is the federal health insurance program for the elderly and disabled; provisions allowing it to negotiate prices should save the government estimated at $98.5 billion for a decade while reducing insurance premiums and out-of-pocket expenses for many older Americans.

Tuesday, Johnson & Johnson became the latest drugmaker to take the Biden administration to federal court in a bid to end the drug pricing program. Three other pharmaceutical companies — Merck, Bristol Myers Squibb And Astellas Pharmaceuticals – filed their own lawsuits, as did the leading industry trade group and the United States Chamber of Commerce.

The lawsuits make similar and overlapping claims that the drug pricing provisions are unconstitutional. They’re scattered in federal courts across the country — a tactic that experts say gives the industry a better chance of getting conflicting rulings that will speed up legal challenges to a pro-corporate Supreme Court.

The legal push comes just weeks before the Centers for Medicare & Medicaid Services releases a long-awaited list of the first 10 drugs to be negotiated. The list must be published by September 1; the manufacturers of the selected drugs have until October 1 to declare whether they will participate in the negotiations – or face heavy financial penalties if they do not. The lower prices will only come into effect in 2026.

Earlier this month, the chamber asked a federal judge in Ohio to issue an injunction that would block any negotiations while his case is heard.

Lawrence O. Gostin, a public health law expert at Georgetown University, said the Supreme Court may favor some of the industry’s arguments. In particular, he pointed to a claim by the drugmakers that by requiring them to bargain or pay a fine, the law violates the Fifth Amendment prohibition on taking private property for public purposes without just compensation.

“The Supreme Court is openly hostile to any perceived violation of the Fifth Amendment,” Gostin said, adding, “It wouldn’t surprise me at all to see these cases go all the way to the Supreme Court and have them overturned.”

For Mr. Biden and his fellow Democrats, that would be a painful blow. The president and Democrats have long campaigned to lower drug prices and plan to make it a central theme of their 2024 campaigns. White House press secretary Karine Jean-Pierre said in a statement that Biden was confident the administration would win in court.

“For decades, the pharmaceutical lobby has blocked efforts to let Medicare negotiate lower drug costs,” she said. “President Biden is proud to be the first president who beat them.”

Republicans have opposed the drug pricing provisions, which they see as a form of government price control. But the politics of the question is treacherous for them. Because so many Americans are concerned about high drug prices, it’s hard for Republicans to come to the defense of the industry, said Joel White, a Republican health policy strategist.

Instead, Republicans are focusing on another pharmaceutical industry priority: examining the practices of drug benefit managers, who negotiate prices with drug companies on behalf of health plans. Pharmaceutical companies claim that by accepting a middleman cut, pharmacy benefit managers are contributing to the high cost of prescription drugs.

For drugmakers, the stakes of legal challenges are higher than their dealings with Medicare, their biggest customer. The industry fears that Medicare is effectively setting the bar for all payers and that once lower government prices are made public, drug benefit managers negotiating on behalf of private policyholders will have more leverage to demand greater discounts.

Alongside its legal campaign, the pharmaceutical industry is waging a public relations offensive. The industry trade group that filed one of the lawsuits, Pharmaceutical Research and Manufacturers of America, known as PhRMA, is broadcast advertisements targeting drug benefit managers, and industry leaders publicly argue that drug pricing provisions will lead to fewer cures. The implication is clear: lower prices will mean lower revenues, which will discourage companies from developing certain drugs.

“You can’t take hundreds of billions of dollars out of the pharmaceutical industry without expecting it to have a real impact on the industry’s ability to develop new treatments and cures for patients,” said Robert Zirkelbach, executive vice president of PhRMA. He quoted analysis funded by drugmaker Gilead Sciences which claimed the industry would lose $455 billion over seven years if companies negotiated with Medicare.

A study released last month which was funded by the Biotechnology Innovation Organization, another trade group, warned that pricing provisions would discourage innovation, resulting in up to 139 fewer drug approvals over the next 10 years.

But that assessment is at odds with an analysis by the Congressional Budget Office, which estimated the law would result in only one fewer drug approvals over a decade and about 13 fewer drugs over the next 30 years.

In addition, many new drugs “do not offer clinically meaningful advantages over existing drugs,” said Ameet Sarpatwari, a drug policy expert at Harvard Medical School. The Cut Inflation Act, he said, could spur companies to focus more on breakthrough therapies, rather than so-called me-too drugs, because the law requires the government to consider the clinical benefits of drugs when determining the price Medicare will pay for them.

Until now, Medicare has been explicitly prohibited from negotiating prices directly with drug manufacturers – an industry requirement in exchange for supporting the creation of Part D, the Medicare prescription drug program, which was signed into law 20 years ago by President George W. Bush.

Under the Reducing Inflation Act, the government will select an initial set of 10 drugs for price negotiations based on how much the Part D program spends on them. Other drugs will be added in the years to come.

Experts are waiting the initial medication list should include commonly prescribed medications such as the blood thinners Eliquis and Xarelto; cancer drugs like Imbruvica and Xtandi; Symbicort, which treats asthma and chronic obstructive disorders; and Enbrel, for rheumatoid arthritis and other autoimmune diseases.

Medicare already pays reduced prices for these drugs. In 2021, the most recent year for which data is available, Medicare spent about $4,000 per patient on Eliquis and Xarelto, which at the time had list prices of $6,000 per year. The lower price reflects discounts obtained from drugmakers by pharmacy benefit managers negotiating on behalf of private companies that contract with the government to manage Part D plans.

But these negotiations are opaque and only modestly reduce Medicare spending. The rationale for the drug pricing provisions of the Inflation Reduction Act is that since Medicare covers so many people, it can use its leverage to obtain even greater discounts.

The United States spends more per person on drugs than comparable countries, in part because other countries proactively control drug prices. Surveys show that many Americans forgo taking their medications because they cannot afford them.

Experts say Medicare’s negotiation program will likely result in direct savings for seniors, initially in the form of reduced premiums made possible by reduced drug spending. And when lower prices take effect in 2028 for drugs administered in clinics and hospitals under another Medicare program, known as Part B, it could mean lower payouts for seniors covered by traditional health insurance who don’t have supplemental insurance.

Proponents of the Cut Inflation Act say that in addition to saving money for the government and patients, the negotiations will inject much-needed transparency into the complicated drug pricing process. If a company refuses to negotiate, it must either pay a high excise tax or withdraw all of its drugs from Medicare and Medicaid.

“This is not a ‘negotiation,'” Merck said in its complaint. “That amounts to extortion.”

Taken together, the lawsuits make a variety of constitutional arguments. In addition to the claim that the government violates the Fifth Amendment by unfairly taking property, they include claims that the law violates the First Amendment by requiring drug companies to agree in writing that they negotiate a “fair price.” Another argument is that the excise tax amounts to an excessive fine which is prohibited by the Eighth Amendment.

“If the government can impose price controls in this way on pharmaceutical companies,” said Jennifer Dickey, deputy chief counsel for the chamber’s legal branch, “it could do the same thing in any sector of our economy.”

Biden administration officials say the law is not mandatory. They argue that companies are free not to negotiate and can issue press releases or make other public statements that disagree with the negotiated price. And they note that the government regularly negotiates the purchase of other products and that the Department of Veterans Affairs already negotiates drug prices with pharmaceutical companies.

“To me, Medicare is doing what it needs to do,” said Mr. Gostin, a professor at Georgetown. “He’s a huge buyer of a product, and he’s basically using that clout, that bargaining power, to get the best price.”

The pharmaceutical industry is “throwing the kitchen sink at the government”, he added. “They’re looking for what sticks, and their arguments are aimed directly at the Supreme Court.”

Washington state health officials said Friday that three people died and two were hospitalized in the Puget Sound area after contracting foodborne listeria infections in what appeared to be an outbreak.

Tests indicated the five patients, three men and two women, fell ill between February 27 and June 30 and likely had the same source of infection, officials said, although an investigation has yet to identify a common food source.

Each infected person was in their 60s or 60s and had weakened immune systems, officials said.

Four of the cases were in Pierce County and one in Thurston County.

THE Washington State Department of Health said it was working with “local health jurisdictions to gather information from interviews with patients and their families to help identify any common exposures.”

While the origin of the cases is still unclear, officials said the bacteria is commonly found in unheated cheeses and deli meats, unpasteurized dairy products and pre-made deli salads, such as potato or tuna salads.

Officials added that the microorganism will die at temperatures above 165 degrees Fahrenheit.

Last year, an outbreak of listeria in several states was linked to contaminated meats and cheeses. Other recent outbreaks have been caused by contaminated store-bought products ice And leafy greens.

Listeriosis, a disease caused by the bacterium listeria, is the greatest threat to the elderly, people with weakened immune systems and pregnant women.

Listeriosis usually manifests within two weeks of eating contaminated food and can cause flu-like symptoms, according to the Centers for Disease Control and Prevention. In pregnant women, severe cases can lead to miscarriage and other complications.

Washington state sees 10 to 25 cases of infection every year, according to the Tacoma-Pierce County Health Department.

From 2009 to 2021, the latest year for which data is available, the state recorded 18 listeria outbreaks which resulted in 238 hospitalizations and 47 deaths, according to the CDC

A tornado caused extensive damage to a Pfizer drug manufacturing site in Rocky Mount, North Carolina on Wednesday, threatening critical supplies to hospitals across the country.

The company estimated that a quarter of the injectable drugs it supplies to U.S. hospitals were made on Rocky Mount property, including drugs used in surgeries and other procedures to help block pain, keep patients sedated and fight infections.

Although the company has yet to reveal the extent of the storm’s impact, video footage from the site and interviews with the Nash County Sheriff and people briefed on the damage indicated that the tornado caused the worst damage to the company’s warehouse.

On Thursday, Pfizer declined to comment on the drugs affected or the proportion of its supply destroyed in the tornado, which could be significant given that many of these drugs required careful production and handling to ensure sterility.

It was also unclear to what extent the destruction would aggravate existing national drug shortages, which have reached a 10 year high These last months. Hospitals are on high alert as low-cost generic products made on the site are already among the most shortage-prone on the market.

“From a healthcare professional’s perspective, I’m just holding my breath,” said Michael Ganio, senior director of the American Society of Health-System Pharmacists.

The tornado moved through a 16-mile swath of the Rocky Mount area, about 50 miles east of Raleigh, around 12:30 p.m. Wednesday. It snapped trees at the base and threw houses 20 meters from their foundations, according to a summary of the National Weather Service. The tornado reached wind speeds of up to 150 miles per hour before ripping large chunks off the metal roof of a Pfizer building and overturning large trucks in the parking lot. Sixteen people were injured, but no fatalities were reported.

Several people said the tornado caused the most damage to a company warehouse; the impact on the manufacturing plant — and its ability to continue producing drugs — is not yet clear, according to Mittal Sutaria, senior vice president of pharmacy contracts at Vizient, which provides drug contracts to hospitals.

She said Pfizer had crews on site to assess the damage.

Dr Sutaria, who said Vizient had been in contact with Pfizer, added that the Rocky Mount site manufactures anesthesia products, as well as fentanyl and morphine, which are used in IVs for pain management. It also makes antibiotics given to fight against severe infections, and muscle blockers including succinylcholine, also used in surgery.

Keith Stone, the sheriff of Nash County, where Rocky Mount is located, told local reporters Wednesday that a large part of the Pfizer building was shattered, the roof was crushed and up to 50,000 pallets of medicine were destroyed.

About 100 vehicles were also damaged, including forklifts strewn across nearby train tracks, Sheriff Stone said in an interview Thursday. “It’s amazing what can happen so fast and take so much damage and go so fast,” he said.

Steve Danehy, a spokesman for Pfizer, said Thursday that the company’s Rocky Mount team was “working very hard to address and assess the situation,” but offered no details. The company said its staff survived the tornado without serious injuries.

Pfizer is expected to report its findings to the Food and Drug Administration, which tracks shortages.

“We are closely monitoring the evolving situation and working with the company to understand the extent of the damage and any potential impact on the country’s drug supply,” said Chanapa Tantibanchachai, spokesperson for the agency.

The Rocky Mount plant, established in 1968, employs 4,500 people and has 24 filling lines and 22 packaging lines. Although not as large as Pfizer’s manufacturing complex in Kalamazoo, Michigan, the North Carolina site spans 1.4 million square feet of manufacturing space. Drugs manufactured at the site are also shipped to Japan, Canada, Brazil and other countries.

The specific products manufactured at the Pfizer factory – and the market share they represent – ​​are generally not public information. However, the company sells dozens of injectable itemsincluding IV antibiotics, anti-epileptic drugs used in brain surgery, and even an antidote to coral snake venom.

Many Pfizer drugs were already in short supply before the tornado: About 130 products marketed to hospitals were listed as “sold out” and about 100 more were in “limited supply,” according to the company’s listing. of 660 products.

Pfizer has other manufacturing activities plants in Kansas, New York, Massachusetts and Wisconsin, where the company could potentially move some production to ease shortages resulting from the destruction of Rocky Mount.

Soumi Saha, senior vice president of Premier, a company that provides drug contracting services to hospitals, said Pfizer has a strong track record of building in some redundancy so that products are made at more than one site.

If the storm damage is limited to the warehouse and does not affect production schedules at manufacturing plants, it could alleviate potential shortages, she said.

Dr. Ganio recalled other drug shortages caused by disasters in production areas.

Hurricane Maria hit Puerto Rico in 2017, leaving hospitals scrambling for IV bags. Another happened last year when a region of China hard hit by Covid saw a disruption in produce a contrast dye for CT scans and other medical images. And in recent months, doctors have warned that the survival rates of some cancer patients are at risk due to production halting at a manufacturing plant in India after the FDA cited major quality flaws.

Given the worrisome shortages affecting so many lives — and which have led to hoarding of some drugs and barter between advocates who trade and find rare drugs for the most desperate — policy experts, lawmakers and federal officials have been discussing solutions in recent weeks.

On Thursday, Senate lawmakers passed a pandemic preparedness bill by a key health committee. It included provisions to stem shortages and increase drugmaker reporting to alert the FDA to circumstances that could lead to shortages so the agency can help avoid them.

The bill would also require a report from the FDA within 90 days of the legislation passing on the agency’s ability to deal with shortages and whether it needs more help from lawmakers.

However, the natural occurrence of a tornado was a stark reminder of the need to better manage shortages.

“This reinforces the need for resilience in our supply chain and a real focus on preparedness, not just for the next pandemic,” Dr. Saha said, “but for any unforeseen circumstances that create shocks in our supply chain.”

In 2004, Gilead Sciences decided to stop looking for a new HIV drug. THE public explanation was that it was not sufficiently different from an existing treatment to warrant further development.

Privately, however, something else was at stake. Gilead had devised a plan to delay the release of the new drug to maximize profits, even though executives had reason to believe it might prove safer for patients, according to a trove of internal documents made public in litigation against the company.

Gilead, one of the world’s largest drugmakers, appears to be adopting a well-known industry tactic: playing on the US patent system to protect lucrative monopolies on top-selling drugs.

At the time, Gilead already had a pair of successful HIV treatments, both backed by a version of a drug called tenofovir. The first of these treatments was due to lose patent protection in 2017, when competitors would be free to introduce cheaper alternatives.

The promising drug, then in the early stages of testing, was an updated version of tenofovir. Gilead leaders knew he had the potential to be less toxic to patients’ kidneys and bones than the previous version, according to internal memos uncovered by attorneys who are suing Gilead on behalf of patients.

Despite these possible benefits, executives concluded that the new version risked competing with the company’s existing, patent-protected formulation. If they delayed the release of the new product until shortly before the existing patents expired, the company could significantly increase the period that at least one of its HIV treatments would remain under patent protection.

The “patent extension strategy,” as Gilead documents repeatedly called it, would allow the company to keep prices high for its tenofovir drugs. Gilead could switch patients to its new drug just before cheap generics hit the market. Putting tenofovir on a path to remain a lucrative juggernaut for decades, the strategy was potentially worth billions of dollars.

Gilead ended up introducing a version of the new treatment in 2015, nearly a decade after it might have been available had the company not halted development in 2004. Its patents now extend until at least 2031.

The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s old HIV drugs say the company unnecessarily exposed them to kidney and bone problems.

In court filings, Gilead’s attorneys said the allegations were baseless. They denied that the company halted development of the drug to boost profits. They cited a 2004 internal memo that estimated Gilead could increase revenue by $1 billion over six years if it released the new version in 2008.

“If Gilead had been driven solely by profit, as plaintiffs claim, the logical decision would have been to accelerate” development of the new version, the lawyers wrote.

Gilead’s lead attorney, Deborah Telman, said in a statement that “the company’s research and development decisions have always been, and continue to be, guided by our goal to provide safe and effective medicines to the people who prescribe and use them.”

Today, a generation of expensive Gilead drugs containing the new iteration of tenofovir accounts for half of the HIV treatment and prevention market, according to IQVIA, an industry data provider. A widely used product, Descovy, has a sticker price of $26,000 per year. Generic versions of its predecessor Truvada, whose patents have expired, now cost less than $400 a year.

If Gilead had moved forward with development of the updated iteration of the drug in 2004, its patents would have already expired or would soon.

“We should all take a step back and ask ourselves: how did we allow this to happen? said James Krellenstein, a longtime AIDS activist who has advised attorneys suing Gilead. He added: “This is what happens when a company intentionally delays the development of an HIV drug for monopoly gain.”

Gilead’s apparent tenofovir maneuver is so common in the pharmaceutical industry that it has a name: product skipping. Companies get rid of their monopoly on a drug and then, shortly before generic competition arrives, they switch – or “jump” – patients to a more recently patented version of the drug to extend the monopoly.

Drugmaker Merck, for example, is developing a version of its flagship cancer drug Keytruda that can be injected under the skin and is likely to expand the company’s revenue streams for years after the infused version of the drug faced its first competition from other companies in 2028.

Christopher Morten, an expert in pharmaceutical patent law at Columbia University, said the Gilead case shows how the US patent system incentivizes companies to slow down innovation.

“There is something profoundly wrong that happened here,” said Mr Morten, who provides pro bono legal services to an HIV advocacy group which in 2019 without success challenged Gilead’s efforts to extend the life of its patents. “The patent system actually encouraged Gilead to delay the development and launch of a new product.”

David Swisher, who lives in central Florida, is one of the plaintiffs suing Gilead in federal court. He took Truvada for 12 years, starting in 2004, and developed kidney disease and osteoporosis. Four years ago, when he was 62, he says, his doctor told him he had “the bones of a 90-year-old woman.”

It wasn’t until 2016, when Descovy finally hit the market, that Swisher turned off Truvada, which he said was hurting him. By then, he said, he had become too ill to work and had retired from his position as director of flight operations.

“I feel like all that time has been taken away from me,” he said.

First synthesized in the 1980s by researchers in what was then Czechoslovakia, tenofovir was the springboard for Gilead’s dominance in the HIV treatment and prevention market.

In 2001, the Food and Drug Administration first approved a product containing Gilead’s first iteration of tenofovir. Four more would follow. The drugs prevent the replication of HIV, the virus that causes AIDS.

They have become decisive players in the fight against AIDS, credited with having saved millions of lives around the world. The drugs came to be used not only as a treatment but also as a prophylactic for those at risk of becoming infected.

But a small percentage of patients who took the drug to treat HIV developed kidney and bone problems. It has proven to be particularly risky when combined with booster medications to improve its effectiveness – a practice that was once common but has since fallen out of favor. THE World Health Organization and the United States National Institutes of Health discourage the use of the original version of tenofovir in people with weak bones or kidney disease.

The newer version does not cause these problems, but it can cause weight gain and elevated cholesterol levels. For most people, experts say, the two tenofovir drugs – the first known as TDFthe second called job — offer roughly equal risks and benefits.

Internal company records from the early 2000s show that Gilead executives sometimes debated whether to rush the new formulation to market. At times, the documents present the two iterations of tenofovir as similar from a safety standpoint.

But other memos say the company believed the updated formula was less toxic, based on lab and animal studies. These studies showed that the new formulation had two advantages that could reduce side effects. It was much better than the original at delivering tenofovir to its target cells, which meant that much less tenofovir leaked into the bloodstream, where it could get to the kidneys and bones. And it could be given at a lower dose.

The new version “could result in a better side effect profile and less drug-related toxicity,” read an internal memo in 2002.

That same year, the first human clinical trial of the new version began. A Gilead employee mapped out a development timeline that would have brought the new formulation to market in 2006.

But in 2003, Gilead executives began to downgrade by rushing it. They feared it would ‘end up cannibalizing’ the growing market for the older version of tenofovir, according to minutes of an internal meeting. Gilead’s head of research at the time, Norbert Bischofberger, asked the company’s analysts to explore the new formulation’s potential as an intellectual property “extension strategy,” according to a colleague’s email.

This analysis resulted in a note from september 2003 which described how Gilead would develop the new formulation to “replace” the original, with development “timed to launch in 2015”. In the best-case scenario, the company’s analysts calculated, their strategy would generate more than $1 billion in annual profits between 2018 and 2020.

Gilead decided to resurrect the new formulation in 2010, putting it on track for release in 2015. John Milligan, president and future chief executive of Gilead, told investors it would be a “milder, milder version” of tenofovir.

After securing regulatory approvals, the company embarked on a successful marketing campaign aimed at physicians that promoted its new iteration safer for kidneys and bones than the original.

In 2021, according to Ipsos, a market research company, nearly half a million HIV patients in the United States were taking Gilead products containing the new version of tenofovir.

Susan C. Beachy contributed to the research.

The patient was a 39-year-old woman who visited the emergency room at Beth Israel Deaconess Medical Center in Boston. His left knee had been hurting him for several days. The day before, she had had a fever of 102 degrees. It was gone now, but she still had chills. And her knee was red and swollen.

What was the diagnosis?

On a recent steamy Friday, medical resident Dr. Megan Landon presented this real-life case to a room full of medical students and residents. They’ve been brought together to learn a skill that can be devilishly difficult to teach: how to think like a doctor.

“Doctors are terrible at teaching other doctors how we think,” said Dr. Adam Rodman, internist, medical historian and event organizer at Beth Israel Deaconess.

But this time, they could call on an expert to help them make a diagnosis: GPT-4, the latest version of a chatbot published by the OpenAI company.

Artificial intelligence is transforming many aspects of the practice of medicine, and some healthcare professionals are using these tools to aid in diagnosis. Doctors at Beth Israel Deaconess, a teaching hospital affiliated with Harvard Medical School, decided to explore how chatbots could be used — and misused — in training future doctors.

Instructors like Dr. Rodman hope medical students can turn to GPT-4 and other chatbots for something akin to what doctors call a curbside consultation — when they brush off a colleague and ask for their opinion on a difficult case. The idea is to use a chatbot in the same way doctors look to others for suggestions and ideas.

For more than a century, doctors have been portrayed as detectives who piece together clues and use them to find the culprit. But experienced doctors actually use a different method – pattern recognition – to figure out what’s wrong. In medicine, it’s called a disease storyline: signs, symptoms, and test results that doctors piece together to tell a cohesive story based on similar cases they know or have seen themselves.

If the disease scenario doesn’t help, Dr. Rodman said, doctors turn to other strategies, such as assigning probabilities to various diagnoses that might fit.

Researchers have tried for more than half a century to design computer programs to make medical diagnoses, but nothing has really succeeded.

Doctors say GPT-4 is different. “It will create something that is remarkably similar to an illness scenario,” Dr. Rodman said. In that way, he added, “it’s fundamentally different from a search engine.”

Dr. Rodman and other physicians at Beth Israel Deaconess asked GPT-4 for possible diagnoses in difficult cases. In a study published last month in the medical journal JAMA, they found he performed better than most doctors in the weekly diagnostic challenges published in the New England Journal of Medicine.

But, they learned, there is an art to using the program, and there are pitfalls.

Dr. Christopher Smith, director of the medical center’s internal medicine residency program, said medical students and residents are “definitely using it.” But, he added, “whether they learn something is an open question.”

The problem is that they could rely on AI for diagnostics the same way they would rely on a calculator on their phone to solve a math problem. This, Dr. Smith said, is dangerous.

Learning, he says, involves trying to understand things: “That’s how we remember things. Part of learning is the struggle. If you outsource learning to GPT, this struggle is over.

At the meeting, the students and residents broke into groups and tried to figure out what was wrong with the swollen knee patient. They then turned to GPT-4.

The groups tried different approaches.

One of them used GPT-4 to search the internet, the same way one would use Google. The chatbot spat out a list of possible diagnoses, including trauma. But when asked by band members to explain his reasoning, the bot was disappointing, explaining his choice by saying, “Trauma is a common cause of knee injury.”

Another group brainstormed possible hypotheses and asked GPT-4 to check them. The chatbot’s list aligns with that of the group: infections, including Lyme disease; arthritis, including gout, a type of arthritis that involves crystals in the joints; and trauma.

GPT-4 added rheumatoid arthritis to the top possibilities, although it was not high on the group’s list. Gout, the instructors later told the group, was unlikely for this patient because she was young and female. And rheumatoid arthritis could probably be ruled out because only one joint was inflamed, and for only a few days.

As a curbside consultation, GPT-4 seemed to pass the test, or at least agree with students and residents. But in this exercise, he didn’t offer any ideas or disease scenarios.

One reason could be that students and residents were using the bot more as a search engine than a curbside lookup.

To use the bot correctly, the instructors said, they should start by telling the GPT-4 something like, “You’re a doctor and you see a 39-year-old woman with knee pain.” Then they should list its symptoms before asking for a diagnosis and asking about the bot’s reasoning, as they would with a medical colleague.

This, the instructors said, is a way to harness the power of the GPT-4. But it’s also crucial to recognize that chatbots can make mistakes and “hallucinate” – provide answers that have no basis in fact. Its use requires knowing when it is incorrect.

“It’s not wrong to use these tools,” said Dr. Byron Crowe, an internal medicine physician at the hospital. “You just have to use them the right way.”

He gave the group an analogy.

“Pilots use GPS,” Dr Crowe said. But, he added, the airlines “have a very high level of reliability”. In medicine, he said, the use of chatbots “is very tempting,” but the same high standards should apply.

“He’s a great thinking partner, but that’s no substitute for deep mental expertise,” he said.

At the end of the session, the instructors revealed the real reason for the patient’s swollen knee.

It turned out to be a possibility that each group had considered and that GPT-4 had proposed.

She had Lyme disease.

Olivia Allison contributed reporting.

The news

President Biden has chosen Dr. Paul Friedrichs, a military combat surgeon and retired Air Force major general who helped lead the Covid-19 response at the Pentagon, to lead a new White House office created by Congress to prepare for and manage future biological threats.

The White House announced the appointment on Friday and said it would take effect Aug. 7. It will then fall to Dr. Friedrichs to set up the new office, the Office of Pandemic Preparedness and Response Policy, though the administration has christened it with a shorter Washington acronym: OPPR.

The appointment comes after a long search for a director that ended where it began — at the White House, where Dr. Friedrichs recently joined the staff of the National Security Council as senior director for global health security and biodefense. Prior to that, he served as the Joint Chiefs of Staff Surgeon at the Pentagon, providing medical advice to the Chairman of the Joint Chiefs of Staff. His intended selection was reported last week by the Washington Post.

Why it matters: Future health threats loom.

The coronavirus pandemic has often been described as the worst public health crisis in a century. But experts agree that given current migration patterns and the way humans intersect with animal life, it won’t be a century — and possibly not even a decade — before the next pandemic arrives.

The era of the Covid “tsars” is over. Mr. Biden’s first White House coronavirus response coordinator, Jeffrey D. Zients, is now the White House Chief of Staff. The second coordinator, Dr. Ashish K. Jha, resumed his post as dean of the Brown University School of Public Health.

Covid-19 has made it clear that a biological health threat does not respect borders – including the borders that divide federal agencies. Dr. Friedrichs’ appointment signals a more permanent and coordinated effort to prepare for and respond to pandemics — an effort that will last beyond the Biden administration and be centralized within the White House.

Background: Dr. Friedrichs served decades in the Air Force.

In a February speech, Dr. Friedrichs, who retired from the military in June, reflected on his 37-year career in the Air Force and shared a bit about himself. Her father served in the navy at the end of World War II and her mother was a Hungarian freedom fighter whose parents were killed by the Russians. His wife was a military doctor when they met.

He also reflected on the military’s role in the fight against Covid-19, an effort that included helping to develop and distribute vaccines and providing medical support to struggling hospitals. “The military health system has become the punchline that has stepped in to help our civilian partners as we collectively struggled through this pandemic,” he said.

And after: The work will focus on preparation.

Dr. Friedrich’s new position gives him the authority to oversee national biosecurity preparedness. He will have to work on the development of new generation vaccines, ensure an adequate supply in the national strategic stock and intensify surveillance to monitor new biological threats.

He will also need to work with Congress to secure funding for preparedness efforts. Lawmakers created the new White House office as part of a government spending package passed late last year.

“When President Biden took office, we inherited a once-in-a-generation public health and economic crisis, but no plan to get out of it,” Zients said in a statement. “This office – under the strong and capable leadership of Major General Friedrichs – will lead the charge to ensure this never happens again.”