From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

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In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

Oz did not respond to a request for comment on that statement.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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  • Bribing kids to eat vegetables might backfire. Here’s what to do instead

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    It’s a tactic many parents know well: “eat two bites of broccoli, and then you can have dessert”.

    It seems like a practical solution for encouraging kids – especially picky eaters – to eat healthy foods. And in the short term, it often works.

    But using food as a bargaining chip can do more harm than good.

    s0ulsurfing – Jason Swain/Getty Images

    Why food bribes backfire

    Although well-intentioned, bribing children with treats to eat healthy foods can:

    Create unhealthy associations

    Studies show using discretionary foods such as sweets as rewards increases children’s preference for those foods.

    Over time, children start to see dessert as the “prize” and vegetables as the “chore”. This skews their perception of food value and can lead to an unhealthy relationship with eating.

    Bribes also link food with achievement or behaviour, which can foster emotional eating patterns later in life.

    Disrupt appetite regulation

    Children are born with the ability to self-regulate how much they eat, based on internal signals between the gut, brain, and hormones. It’s common for appetite to fluctuate – ravenous one day, uninterested the next – depending on activity, growth and development.

    However, food rewards can override these natural cues. When children learn to eat to earn a reward rather than to satisfy hunger, research suggests it can increase the risk of overeating.

    Increase fussy eating

    Fussy eating is a normal phase in early childhood and typically improves once children start school.

    But pressuring children to eat, especially with the promise of a reward, can make them even more resistant to trying new foods. Several studies show food rewards are linked to greater food fussiness over time.

    What to do instead: evidence-backed strategies

    Instead of resorting to bribes, here are research-informed ways to support healthy eating habits in children:

    1. Focus on effort, not outcomes

    It can take eight to ten exposures before a child accepts a new food. So keep offering it without pressure.

    Praise your child for trying something new, rather than for finishing their plate.

    Let them decide whether to eat it – and how much. The goal is to build positive experiences around food.

    2. Pair new foods with familiar favourites

    Children are more likely to try unfamiliar foods when served alongside ones they already enjoy.

    So if your child loves potato chips, try introducing roast carrot “orange chippies” as a variation.

    Offering the same food in different formats (such as avocado in sushi one day, on crackers another) also increases acceptance.

    3. Make healthy food visually appealing

    Studies show kids respond better to food presented in fun and colourful ways. Use different shapes, textures, and colours to make meals more inviting – think fruit skewers, rainbow veggie plates, or “build-your-own” meals.

    4. Involve children in the kitchen

    Children are more likely to eat food they’ve helped prepare. Even young children can assist with age-appropriate tasks like mixing, measuring, or choosing recipes. Cooking together is not just a learning opportunity, it also builds a sense of ownership and pride.

    5. Model the behaviours you want to see

    Children learn by watching. Research shows that when parents regularly eat and enjoy healthy foods in front of their kids, these children have better diets than their peers who don’t see their parents enjoy healthy foods.

    Try to share meals as a family when possible and model the enjoyment of nutritious foods.

    The bottom line

    While bribing children to eat healthy food may offer short-term success, it can undermine their ability to self-regulate, distort their relationship with food, and increase fussiness in the long run.

    But with patience, consistency and positive role modelling, children learn to enjoy a variety of healthy foods – no bribes required.

    Nick Fuller is the author of Healthy Parents, Healthy Kids – Six Steps to Total Family Wellness. His free, practical recipe ideas can be found at feedingfussykids.com.

    Nick Fuller, Clinical Trials Director, Department of Endocrinology, RPA Hospital, University of Sydney

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Syphilis Is Killing Babies. The U.S. Government Is Failing to Stop the Disease From Spreading.

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

    Karmin Strohfus, the lead nurse at a South Dakota jail, punched numbers into a phone like lives depended on it. She had in her care a pregnant woman with syphilis, a highly contagious, potentially fatal infection that can pass into the womb. A treatment could cure the woman and protect her fetus, but she couldn’t find it in stock at any pharmacy she called — not in Hughes County, not even anywhere within an hour’s drive.

    Most people held at the jail where Strohfus works are released within a few days. “What happens if she gets out before I’m able to treat her?” she worried. Exasperated, Strohfus reached out to the state health department, which came through with one dose. The treatment required three. Officials told Strohfus to contact the federal Centers for Disease Control and Prevention for help, she said. The risks of harm to a developing baby from syphilis are so high that experts urge not to delay treatment, even by a day.

    Nearly three weeks passed from when Strohfus started calling pharmacies to when she had the full treatment in hand, she said, and it barely arrived in time. The woman was released just days after she got her last shot.

    Last June, Pfizer, the lone U.S. manufacturer of the injections, notified the Food and Drug Administration of an “impending stock out” that it anticipated would last a year. The company blamed “an increase in syphilis infection rates as well as competitive shortages.”

    Across the country, physicians, clinic staff and public health experts say that the shortage is preventing them from reining in a surge of syphilis and that the federal government is downplaying the crisis. State and local public health authorities, which by law are responsible for controlling the spread of infectious diseases, report delays getting medicine to pregnant people with syphilis. This emergency was predictable: There have been shortages of this drug in eight of the last 20 years.

    Yet federal health authorities have not prevented the drug shortages in the past and aren’t doing much to prevent them in the future.

    Syphilis, which is typically spread during sex, can be devastating if it goes untreated in pregnancy: About 40% of babies born to women with untreated syphilis can be stillborn or die as newborns, according to the CDC. Infants that survive can suffer from deformed bones, excruciating pain or brain damage, and some struggle to hear, see or breathe. Since this is entirely preventable, a baby born with syphilis is a shameful sign of a failing public health system.

    In 2022, the most recent year for which the CDC has data available, more than 3,700 babies were infected with syphilis, including nearly 300 who were stillborn or died as infants. More than 50% of these cases occurred because, even though the pregnant parent was diagnosed with syphilis, they were never properly treated.

    That year, there were 200,000 cases identified in the U.S., a 79% increase from five years before. Infection rates among pregnant people and babies increased by more than 250% in that time; South Dakota, where Strohfus works, had the highest rates — including a more than 400% increase among pregnant women. Statewide, the rate of babies born with the disease, a condition known as congenital syphilis, jumped more than 40-fold in just five years.

    And that was before the current shortage of shots.

    In Mississippi, the state with the second highest rate of syphilis in pregnant women, Dr. Caroline Weinberg started having trouble this summer finding treatments for her clinic’s patients, most of whom are uninsured, live in poverty or lack transportation. She began spending hours each month scouring medicine suppliers’ websites for available doses of the shots, a form of penicillin sold under the brand name Bicillin L-A.

    “The way people do it for Taylor Swift, that’s how I’ve been with the Bicillin shortage,” Weinberg said. “Desperately checking the websites to see what I can snag.”

    The shortage is driving up infection rates even further.

    In a November survey by the National Coalition of STD Directors, 68% of health departments that responded said the drug shortage will cause syphilis rates in their area to increase, further crushing the nation’s most disadvantaged populations.

    “This is the most basic medicine,” said Meghan O’Connell, chief public health officer for the Great Plains Tribal Leaders’ Health Board, which represents 18 tribal communities in South Dakota and three other states. “We allow ourselves to continue to not have enough, and it impacts so many people.”

    ProPublica examined what the federal government has done to manage the crisis and the ways in which experts say it has fallen short.

    The government could pressure Pfizer to be more transparent.

    Twenty years ago, there were at least three manufacturers of the syphilis shot. Then Pfizer, one of the manufacturers, purchased the other two companies and became the lone U.S. supplier.

    Pfizer’s supply has fallen short since then. In 2016, the company announced a shortage due to a manufacturing issue; it lasted two years. Even during times when Pfizer had not notified the FDA of an official shortage, clinics across the country told ProPublica, the shots were often hard to get.

    Several health officials said they would like to see the government use its power as the largest purchaser of the drug to put pressure on Pfizer to produce adequate supplies and to be more transparent about how much of the drug they have on hand, when it will be widely available and how stable the supply will be going forward.

    In response to questions, Pfizer said there are two reasons its supply is falling short. One, the company said, was a surge in use of the pediatric form of the drug after a shortage of a different antibiotic last winter. Pfizer also blamed a 70% increase in demand for the adult shots since last February, which it described as unexpected.

    Public health experts say the increase in cases and subsequent rise in demand was easy to see coming. Officials have been raising the alarm about skyrocketing syphilis cases for years. “If Pfizer was truly caught completely off guard, it raises significant questions about the competency of the company to forecast obvious infectious disease trends,” a coalition of organizations wrote to the White House Drug Shortage Task Force in September.

    Pfizer said it is consistently communicating with the CDC and FDA about its supply and that it has been transparent with public health groups and policymakers.

    The FDA has a group dedicated to addressing drug shortages. But Valerie Jensen, associate director of that staff, said the FDA can’t force manufacturers to make more of a drug. “It is up to manufacturers to decide how to respond to that increased demand.” she said. “What we’re here to do is help with those plans.”

    Pfizer said it had a target of increasing production by about 20% in 2023 but faced delays toward the end of the year. The company did not explain the reason for those delays.

    The company said it has invested $38 million in the last five years in the Michigan facility where it makes the shots and that it is increasing production capacity. It also said it is adding evening shifts at the facility and actively recruiting and training new workers. Pfizer said it also reduced manufacturing time from 110 to 50 days. By the end of June, the company expects the supply to recover, which it described as having eight weeks of inventory based on its forecast demands with no disruptions in sight.

    The government could manufacture the drug itself.

    Having only one supplier for a drug, especially one of public health importance, makes the country vulnerable to shortages. With just one manufacturer, any disruption — contamination at a plant, a shortage of raw materials, a severe weather event or a flawed prediction of demand — can put lives at risk. What’s ultimately needed, public health experts say, is another manufacturer.

    Congressional Democrats recently introduced a bill that would authorize the U.S. Department of Health and Human Services to manufacture generic drugs in exactly this scenario, when there are few manufacturers and regular shortages. Called the Affordable Drug Manufacturing Act, it would also establish an office of drug manufacturing.

    This same bill was introduced in 2018, but it didn’t have bipartisan support and was never taken up for a vote. Sen. Elizabeth Warren, the Massachusetts Democrat who introduced the bill in the Senate, said she’s hopeful this time will be different. Lawmakers from both parties understand the risks created by drug shortages, and COVID-19 helped everyone understand the role the government can play to boost manufacturing.

    Still, it’s unlikely to be passed with the current gridlock in Congress.

    The government could reserve syphilis drugs for infected patients.

    Responding to the shortage of shots to treat the disease, the CDC in July asked health care providers nationwide to preserve the scarce remaining doses for people who are pregnant. The shots are considered the gold standard treatment for anyone with syphilis, faster and with fewer side effects than an alternative pill regimen. And for people who are pregnant, the pills are not an option; the shots are the only safe treatment.

    Despite that call, the military is giving shots to new recruits who don’t have syphilis, to prevent outbreaks of severe bacterial respiratory infections. The Army has long administered this treatment at boot camps held at Fort Leonard Wood, Fort Moore and Fort Sill. The Army has been unable to obtain the shots several times in the past few years, according to the U.S. Army Center for Initial Military Training. But the Defense Health Agency’s pharmacy operations center has been working with Pfizer to ensure military sites can get them, a spokesperson for the Defense Health Agency said.

    “Until we think about public health the way we think about our military, we’re not going to see a difference,” said Dr. John Vanchiere, chief of pediatric infectious diseases at Louisiana State University Health Shreveport.

    Some public health officials, including Alaska’s chief medical officer, Dr. Anne Zink, questioned whether the military should be using scarce shots for prevention.

    “We should ask if that’s the best use,” she said.

    Using antibiotics to prevent streptococcal outbreaks is a well-established, evidence-based public health practice that’s also used by other branches of the armed services, said Lt. Col. Randy Ready, a public affairs officer with the Army’s Initial Military Training center. “The Army continues to work with the CDC and the entire medical community in regards to public health while also taking into account the unique missions and training environments our Soldiers face,” including basic training, Ready said in a written statement.

    The government isn’t stockpiling syphilis drugs.

    In rare instances, the federal government has created stockpiles of drugs considered key to public health. In 2018, confronting shortages of various drugs to treat tuberculosis, the CDC created a small stockpile of them. And the federal Administration for Strategic Preparedness and Response keeps a national stockpile of supplies necessary for public health emergencies, including vaccines, medical supplies and antidotes needed in case of a chemical warfare attack.

    In November, the Biden administration announced it was creating a new syphilis task force. When asked why the federal government doesn’t stockpile syphilis treatments, Adm. Rachel Levine, the HHS official who leads the task force, said officials don’t routinely stockpile drugs, because they have expiration dates.

    In a written statement, an HHS spokesperson said that Bicillin has a shelf life of two years and that the Strategic National Stockpile “does not deploy products that are commercially available.” In general, the spokesperson wrote, stockpiles are most effective before a national shortage begins and can’t overcome the problems of limited suppliers or fragile supply chains. “There is also a risk that stockpiles can exacerbate shortages, particularly when supply is already low, by removing drugs from circulation that would have otherwise been available,” the spokesperson wrote.

    Stephanie Pang, a senior director with the coalition of STD directors, said that given the critical role of this drug and the severe access concerns, she thinks a stockpile is necessary. “I don’t have another solution that actually gets drugs to patients,” Pang said.

    The government could declare a federal emergency.

    Some public health officials say the federal government needs to treat the syphilis crisis the way it did Ebola or monkeypox.

    Declare a federal emergency, said Dr. Michael Dube, an infectious disease specialist for more than 30 years. That would free up money for more public health staff and fund more creative approaches that could lead to a long-term solution to the near-constant shortages, he said. “I’d hate to have to wait for some horrible anecdotes to get out there in order to get the public’s and the policymakers’ minds on it,” said Dube, who oversees medical care for AIDS Healthcare Foundation wellness clinics across the country.

    Citing an alarming surge in syphilis cases, the Great Plains Tribes wrote to the HHS secretary last week asking that the agency declare a public health emergency in their areas. In the request, they asked HHS to work globally to find adequate syphilis treatment and send the needed medicine to the Great Plains region.

    During the 2014 outbreak of Ebola in West Africa, Congress gave hundreds of millions of dollars to HHS to help develop new rapid tests and vaccines. Facing a global outbreak of monkeypox in 2022, a White House task force deployed more than a million vaccines, regularly briefed the public and sent extra resources to Pride parades and other places where people at risk were gathered.

    Levine, leader of the federal syphilis task force, countered that declaring an emergency wouldn’t make much of a difference. The government, she said, already has a “dramatic and coordinated response” involving several agencies.

    The FDA recently approved an emergency import of a similar syphilis treatment made by a French manufacturer that had plenty on hand. According to the company, Provepharm, the imported shots are enough to cover approximately one or two months of typical use by all people in the U.S. (The FDA would not say how many doses Provepharm sent, and the company said it was not allowed to reveal that number under the federal rules governing such emergency imports.)

    Clinics applaud that development. But many of them can’t afford the imported shots.

    The government could do more to rein in the cost.

    Clinics and hospitals that primarily serve low-income patients often qualify for a federal program that allows them to purchase drugs at steeply discounted prices. Pharmaceutical companies that want Medicaid to cover their outpatient drugs must participate in the program.

    One factor in determining the discount price is whether a pharmaceutical company has raised the price of a drug by more than the rate of inflation. Because Pfizer has hiked the price of its Bicillin shots significantly over the years, the government requires that it be sold to qualifying clinics for just pennies a dose. Otherwise, a single Pfizer shot can retail for upwards of $500. The French shots are comparable in retail price and not eligible for the discount program.

    Several clinic directors also said they worried that drug distributors were reserving the limited supply of the Pfizer shot for organizations that could pay full price. For several days in January, for example, the website of Henry Schein, a medical supplier, showed doses of the shot available at full price, while doses at the penny pricing were out of stock, according to screenshots shared with ProPublica. When asked whether it was only selling shots at full price, a spokesperson for Henry Schein did not respond to the question.

    Local health departments that qualify for the discount program told ProPublica they’ve had to pay full price at other distributors, because it was the only stock available.

    The Health Resources and Services Administration, the federal agency that regulates the discount program, said that a drug manufacturer is ultimately responsible for ensuring that when supplies are available, they are available at the discounted price. When asked about this, Pfizer said that it has “one inventory that is distributed to our trade partners” and that hospitals and clinics that qualify for the discount program are “responsible for ensuring compliance with the program and orders through the wholesaler accordingly.” The company added, “Pfizer plays no part in this process.”

    In October, on Weinberg’s regular search for shots for her Mississippi clinic, she found doses of Bicillin for sale at the discounted price and purchased 40. “The idea that we’re supposed to be hoarding treatment is a horrific compact,” she said. Word got out that the clinic, called Plan A, has some shots, and other clinics began sending pregnant patients there.

    The clinic’s supply is dwindling. Weinberg is happy to get the shots to patients who need them. But she’s not sure how much longer her reserve will last — or if she’ll be able to find more when they’re gone.

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  • Live Forever? – by Dr. John Tregoning

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    The author, a research scientist, investigates our mortality, and what can (and can’t) be done about it.

    His conclusions are mostly grim and fatalistic (have a good diet and exercise, don’t drink or smoke, get your vaccines, and anything else is merely changing what you’ll die of), but the real value of the book lies in how he gets there.

    Dr. Tregoning is an immunologist, and as such he places the greatest stock in epidemiological studies, which can and if reasonable should be followed up with randomized controlled trials (RCTs). Why the “if reasonable”, you ask?

    He gives the example of a study that was undertaken precisely to illustrate this: volunteers were sought for a RCT to test the efficacy of using a parachute vs using a placebo backpack. However, given that the intervention group (parachute) is a well-established lifesaver, and the control group (placebo backpack) means a wildly unethical risk of letting half the study population die, this study being performed as an RCT is of course absurd.

    The reader who understands how that is a problem, will understand how asking for RCTs for many kinds of “…or the patient will suffer horribly and/or die” medical interventions is also the same problem.

    That illustrative parachute study was conducted, by the way; however for safety reasons (acknowledged in the “limitations” section of the paper) they used a stationary aircraft on the ground, and concluded “the results may be cautiously extrapolated to high-altitude use” (highlighting another problem—that experimental conditions often cannot usefully replicate real-world conditions).

    The point here, and indeed the main thesis of the book, is: examine the evidence for yourself and do not just trust headlines, including:

    • when there headlines say there is evidence (does the evidence really say what the headlines are saying?)
    • when the headlines are saying there is not enough evidence (are they asking for placebo-controlled trials for something that cannot be ethically placebo-controlled—like vaccines, HRT, cancer drugs, or surgeries, all of which are better suited to intervention studies without a control group?)

    The style is—for all the grim fatalism we mentioned—entertaining and personable, making this bleak topic an engaging and even enjoyable read. There’s an extensive bibliography, and separately, many per-chapter footnotes.

    Bottom line: will this book help you to live longer? If you’re currently on-the-fence about vaccines (in which case, maybe it’ll motivate you to get them as appropriate), then yes, quite possibly. Otherwise, probably not. However, what it will do is two things: 1) entertain you 2) give you a great insight into how to understand science itself, so as to not be at the mercy of headlines. For those reasons, we recommend this book.

    Click here to check out “Live Forever?”, and understand the science behind the headlines!

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  • Self-Care That’s Not Just Self-Indulgence

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Self-Care That’s Not Just Self-Indulgence

    Self-care is often seen as an excuse for self-indulgence. Worse, it’s often used as an excuse for self-indulgence—in ways that can end up making us feel worse.

    It’s a bit like dietary “cheat days”. If your diet needs cheat days, your diet probably isn’t right for you!

    How to recognize the difference between self-care and self-indulgence?

    Statistically, the majority of our subscribers are parents (whose children are now mostly grown up, but still, the point is that parenting experience has been gleaned), and/or are or have been caregivers of some form or other.

    When a small child is ill, we (hopefully!) look after them carefully:

    • We don’t expect too much of them, but…
    • …we do expect them to adhere to things consistent with their recovery.

    Critically: an important part of self-care is that it actually should be care.

    Let’s spell something out: neglect is not care!

    How this works for physical and mental health

    If you overdo it in physical exercise, it’s right and correct to take a break to recover, and during that time, do things that will hasten one’s recovery. For example:

    Overdone It? How To Speed Up Recovery After Exercise

    But it’s well-known that if you just do nothing, your condition will likely deteriorate. Also, “a break to recover” is going to be as short as is necessary to recover. Then you’ll ease back into exercise, but you will get back to it.

    For mental health it’s just the same. If we for whatever reason need to take a step back, it’s right and correct to do take a break to recover, and during that time, do things that will hasten one’s recovery.

    Sometimes, if for example it’s just a case of burnout, rest is the best medicine, and even rest can be an active process. See for example:

    How To Rest More Efficiently (Yes, Really)

    So the question to ask, when it comes to self-care vs self-indulgence, is:

    “Is this activity helping me to get better?”

    Some examples:

    Probably not great self-care activities:

    • Oversleeping (unless you were sleep-deprived, in which case, it’s better to get an earlier night than a later morning, if possible)
    • Overeating (comfort-eating is a thing, but your actual problems will still be there)
    • Mindless activities (mindless scrolling, TV-watching, game-playing, etc)

    Probably better self-care activities:

    • Enjoyable physical activity (whatever that may be for you)
    • Preparing your favorite food, and then enjoying it mindfully
    • Engaging in a personal project that might not be that important, but it’s fulfilling to you (hobbies etc can fall into this category)
    • Scheduling some time, and committing some resources, to tackling whatever problem(s) you are facing that’s prompting you to need this self-care.
    • Doing the tasks you want to hide away from, but making them fun.

    What’s your go-to self-care? We love to hear from you, so feel free to hit “reply” to this email, or use the handy feedback form at the bottom!

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  • ‘I keep away from people’ – combined vision and hearing loss is isolating more and more older Australians

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Our ageing population brings a growing crisis: people over 65 are at greater risk of dual sensory impairment (also known as “deafblindness” or combined vision and hearing loss).

    Some 66% of people over 60 have hearing loss and 33% of older Australians have low vision. Estimates suggest more than a quarter of Australians over 80 are living with dual sensory impairment.

    Combined vision and hearing loss describes any degree of sight and hearing loss, so neither sense can compensate for the other. Dual sensory impairment can occur at any point in life but is increasingly common as people get older.

    The experience can make older people feel isolated and unable to participate in important conversations, including about their health.

    bricolage/Shutterstock

    Causes and conditions

    Conditions related to hearing and vision impairment often increase as we age – but many of these changes are subtle.

    Hearing loss can start as early as our 50s and often accompany other age-related visual changes, such as age-related macular degeneration.

    Other age-related conditions are frequently prioritised by patients, doctors or carers, such as diabetes or heart disease. Vision and hearing changes can be easy to overlook or accept as a normal aspect of ageing. As an older person we interviewed for our research told us

    I don’t see too good or hear too well. It’s just part of old age.

    An invisible disability

    Dual sensory impairment has a significant and negative impact in all aspects of a person’s life. It reduces access to information, mobility and orientation, impacts social activities and communication, making it difficult for older adults to manage.

    It is underdiagnosed, underrecognised and sometimes misattributed (for example, to cognitive impairment or decline). However, there is also growing evidence of links between dementia and dual sensory loss. If left untreated or without appropriate support, dual sensory impairment diminishes the capacity of older people to live independently, feel happy and be safe.

    A dearth of specific resources to educate and support older Australians with their dual sensory impairment means when older people do raise the issue, their GP or health professional may not understand its significance or where to refer them. One older person told us:

    There’s another thing too about the GP, the sort of mentality ‘well what do you expect? You’re 95.’ Hearing and vision loss in old age is not seen as a disability, it’s seen as something else.

    Isolated yet more dependent on others

    Global trends show a worrying conundrum. Older people with dual sensory impairment become more socially isolated, which impacts their mental health and wellbeing. At the same time they can become increasingly dependent on other people to help them navigate and manage day-to-day activities with limited sight and hearing.

    One aspect of this is how effectively they can comprehend and communicate in a health-care setting. Recent research shows doctors and nurses in hospitals aren’t making themselves understood to most of their patients with dual sensory impairment. Good communication in the health context is about more than just “knowing what is going on”, researchers note. It facilitates:

    • shorter hospital stays
    • fewer re-admissions
    • reduced emergency room visits
    • better treatment adherence and medical follow up
    • less unnecessary diagnostic testing
    • improved health-care outcomes.

    ‘Too hard’

    Globally, there is a better understanding of how important it is to maintain active social lives as people age. But this is difficult for older adults with dual sensory loss. One person told us

    I don’t particularly want to mix with people. Too hard, because they can’t understand. I can no longer now walk into that room, see nothing, find my seat and not recognise [or hear] people.

    Again, these experiences increase reliance on family. But caring in this context is tough and largely hidden. Family members describe being the “eyes and ears” for their loved one. It’s a 24/7 role which can bring frustration, social isolation and depression for carers too. One spouse told us:

    He doesn’t talk anymore much, because he doesn’t know whether [people are] talking to him, unless they use his name, he’s unaware they’re speaking to him, so he might ignore people and so on. And in the end, I noticed people weren’t even bothering him to talk, so now I refuse to go. Because I don’t think it’s fair.

    older woman looks down at table while carer looks on
    Dual sensory loss can be isolating for older people and carers. Synthex/Shutterstock

    So, what can we do?

    Dual sensory impairment is a growing problem with potentially devastating impacts.

    It should be considered a unique and distinct disability in all relevant protections and policies. This includes the right to dedicated diagnosis and support, accessibility provisions and specialised skill development for health and social professionals and carers.

    We need to develop resources to help people with dual sensory impairment and their families and carers understand the condition, what it means and how everyone can be supported. This could include communication adaptation, such as social haptics (communicating using touch) and specialised support for older adults to navigate health care.

    Increasing awareness and understanding of dual sensory impairment will also help those impacted with everyday engagement with the world around them – rather than the isolation many feel now.

    Moira Dunsmore, Senior Lecturer, Sydney Nursing School, Faculty of Medicine and Health, University of Sydney, University of Sydney; Annmaree Watharow, Lived Experience Research Fellow, Centre for Disability Research and Policy, University of Sydney, and Emily Kecman, Postdoctoral research fellow, Department of Linguistics, University of Sydney

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • The Mind-Gut Connection – by Dr. Emeran Mayer

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    We’ve reviewed books about the mind-gut connection before, so what makes this one stand out?

    Firstly, it’s a lot more comprehensive than the usual “please, we’re begging you, eat some fiber”.

    And yes, of course that’s part of it. Prebiotics, probiotics, reduce fried and processed foods, reduce sugar/alcohol, reduce meat, and again, eat some greenery.

    But where this book really comes into its own is looking more thoroughly at the gut microbiota and their function. Dr. Mayer goes well beyond “there are good and bad bacteria” and looks at the relationship each of them have with the body’s many hormones, and especially neurotransmitters like serotonin and dopamine.

    He also looks at the two-way connection between brain and gut. Yes, our gut gives us “gut feelings”, but 10% of communication between the brain and gut is in the other direction; he explores what that means for us, too.

    Finally, he does give a lot of practical advice, not just dietary but also behavioral, to make the most of our mind-gut connection and make it work for our health, rather than against it.

    Bottom line: this is the best book on the brain-gut connection that this reviewer has read so far, and certainly the most useful if you already know about gut-healthy nutrition, and are looking to take your understanding to the next level.

    Click here to check out The Mind-Gut Connection, and start making yours work for your benefit!

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