Posts tagged with "FDA"

Above, Narcan nasal spray for the treatment of opioid overdoses. (Photo source: The Dallas Morning News)

FDA approves over-the-counter sales of lifesaving opioid overdose treatment Narcan nasal spray

March 30, 2023

On Wednesday, March 29, the Food and Drug Administration approved sales without a prescription of the nasal spray Narcan to reverse opioid overdoses—a decision that promises to significantly expand access to the life-saving treatment, reports CNBC.

The FDA’s decision means people will be able to buy the 4 milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines, and online. Emergent BioSolutions, the manufacturer, has said Narcan should be available without a prescription by late summer.

In a formal statement, FDA Commissioner Dr. Robert Califf, noted that the agency is encouraging the company to make the nasal spray available as soon as possible at an affordable price.

Narcan reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray must be administered as soon as an overdose is suspected.

Two nasal spray devices typically come in a single package. The first dose should be administered in one nostril of the person suffering an overdose and then 911 should be called, according to the instructions. If the person is still unresponsive after two to three minutes, the second dose should be administered.

After the FDA’s decision, Walgreens said it will offer over-the-counter Narcan later this year in-store and online nationwide.

“Delivering access to this lifesaving medication that can reverse the effects of an overdose if administered in time is imperative and Walgreens is already working with suppliers to bring this OTC medication to shelves,” said Zoe Krey, a Walgreens spokesperson.

The FDA said in November that it was considering approving naloxone products, the generic name for medications that reverse opioid overdoses, for use without a prescription. The push to make naloxone easier to access is part of the agency’s efforts to fight the opioid crisis.

More than 564,000 people died from opioid overdoses between 1999 and 2020, according to the Centers for Disease Control and Prevention. The first wave of the epidemic began in the 1990s with prescription opioids, followed by an increase in deaths from heroin starting in 2010.

Deaths from synthetic opioids such as fentanyl have increased significantly since 2013. More than 71,000 people died from synthetic opioids in 2021—an 18% increase over the year prior, according to CDC estimates.

Research contact: @CNBC

Above, after weight loss, these women detest their 'diet faces.' (Photo source: Daily Mail Online)

Losing face: Weight loss drugs may cause facial aging

January 26, 2023

How many injections are you willing to endure to preserve the structural integrity of your face and derrière? For a certain segment of the 1%, there’s no such thing as too many pricks, reports The New York Times.

After giving birth to her first child at 41, Jennifer Berger struggled to lose the last 20 pounds of the 50 she gained during her high-risk pregnancy. “I was doing a mix of cardio and weights three to five times a week—tracking everything I ate—and I still couldn’t lose that last bit of baby weight,” said Berger, a fashion merchandiser in New York City.

At her wits’ end, Berger visited a doctor who suggested she try tirzepatide, marketed under the brand name Mounjaro, a buzzy new diabetes drug approved by the Food and Drug Administration in May 2022. Mounjaro regulates blood sugar, suppresses appetite, and—if one is to believe the hushed accounts recently exchanged at an Upper East Side hair salon—makes excess pounds disappear into thin air.

“Everybody is either on it or asking how to get on it,” said Dr. Paul Jarrod Frank, a cosmetic dermatologist in New York. “We haven’t seen a prescription drug with this much cocktail and dinner chatter since Viagra came to the market.”

The once-a-week injection works in a similar way to semaglutide treatments like Wegovy and Ozempic—the drug rumored, without evidence, to have helped Kim Kardashian fit into the tiny Marilyn Monroe gown she wore to the Met Gala; Kardashian has denied those rumors. In recent months, these drugs have been prescribed so frequently off-label that shortages prevented some diabetics and obese people from getting their medication.

Many doctors worry that the drugs’ current popularity, fueled in part by social media, has resulted in people taking them without sufficient medical supervision — a risky move considering the possibility of rare but serious side effects like thyroid cancer, pancreatitis, and kidney failure. And drugs like Ozempic can also cause less serious but still debilitating symptoms including nausea, vomiting, and racing heartbeat, as many videos on TikTok attest (see: #ozempic).

Some of the side effects are “extremely rare if the medication is being prescribed at the right dose and with careful medical supervision,” said Dr. Rocio Salas-Whalen, an endocrinologist in New York, who said she has prescribed this family of medication and its predecessors to more than 8,000 patients since 2005.

“Mounjaro is like the Apple 14 of these drugs,” Dr. Salas-Whalen, who did not treat Berger, recently told the Times. Dr. Salas-Whalen said it has the same ability to control blood sugar as Wegovy and Ozempic, but that in her practice, she had seen “almost double the weight loss and close to none of the side effects.”

The FDA has reported that in its clinical trials—which were done on diabetics—patients taking Mounjaro lost, on average, 12 pounds more than those taking drugs like Ozempic. Dr. Salas-Whalen, who has done work for Novo Nordisk, the maker of Wegovy and Ozempic, said she has seen similar results in non-diabetic patients.

While Mounjaro may sound like the closest thing to a weight loss magic bullet since gastric bypass surgery was first performed in 1954, it is not without risk. The Mounjaro packaging contains a black box warning about thyroid C-cell tumors. Like the first generation of these drugs, Mounjaro increased the risk of a rare type of thyroid cancer called medullary thyroid carcinoma when it was tested on rodents.

None of these drugs come cheap: Unless a patient is obese and has at least one other “weight-related condition” (such as high cholesterol, hypertension, diabetes), insurance usually won’t cover the medications, which can cost upward of $1,000 for a month’s supply. (Mounjaro is $975 per month; Ozempic, $892; Wegovy, $1,350.)

The rise of the ‘Ozempic face’

Berger, who had undergone fertility treatments to get pregnant, said she didn’t think twice about sticking a needle in her abdomen once a week—or shelling out nearly $1,000 a month for the drug. And Mounjaro lived up to its expectations. Within three months, she had lost those last stubborn 20 pounds.

“It was like flipping a switch,” she said. “I would look at food and it wasn’t even appealing, and I am someone who loves food! I almost had to remind myself to eat. It just took away all the cravings.”

Berger was thrilled with her new body. There was, however, a major downside to losing the weight so quickly. Her face suddenly looked gaunt.

“I remember looking in the mirror, and it was almost like I didn’t even recognize myself,” she said. “My body looked great, but my face looked exhausted and old.”

Dr. Oren Tepper, a plastic surgeon in New York, said that it’s common for weight loss to deflate key areas of the face, leading to a more aged appearance. “When it comes to facial aging, fat is typically more friend than foe,” he said. “Weight loss may turn back your biological age, but it tends to turn your facial clock forward.”

Indeed, as Catherine Deneuve is purported to have said: “At a certain age, you have to choose between your face and your ass.” But these days, in certain moneyed circles, that adage no longer seems to apply, with the now common combination of weight-loss drugs and volume-restoring filler.

“I see it every day in my office,” said Dr. Frank, who said he coined the term “Ozempic face” to describe the condition. “A 50-year-old patient will come in, and suddenly, she’s super-skinny and needs filler, which she never needed before. I look at of the time. It’s the drug of choice these days for the 1 percent.”

Dr. Dhaval Bhanusali, a dermatologist in New York whose famous patients include Martha Stewart, has observed the same trend in his office. “We are seeing more and more patients on the medications coming in,” he said. “Generally, it’s people in their 40s and 50s who are losing significant amounts of weight and are concerned about facial aging and sagging that occurs as a result.”

While noninvasive procedures like Fraxel can improve skin texture and wrinkles, Dr. Frank said that fillers are the only noninvasive way to restore volume (cost: $5,000 to $10,000). To bring back a youthful fullness to Berger’s face, Dr. Frank injected Radiesse and hyaluronic acid-based fillers in strategic places all over her face — around the temples, under the eyes, in the buccal hollows and around the jawline, the mouth and lips.

To restore volume, Dr. Bhanusali uses Radiesse in combination with Sculptra, an injectable that stimulates collagen production and can last for up to 24 months. (Dr. Bhanusali has been a consultant to Galderma, the maker of Sculptra.) “The idea is to balance the face to offset the hollowing and downward projections at the cheeks, jowls and other areas,” he said.

‘A high-end luxury drug’

Some people suffering from facial wasting caused by rapid weight loss—40 to 50 pounds, say—may require a more radical approach. “When there is this much weight loss, plastic surgery is sometimes the only way to restore the volume loss,” Dr. Tepper said, noting that more than half of the patients he sees for weight-loss-related surgery are taking these drugs.

“The success rates are astonishing,” he said of the drug treatments. “For many patients, it’s like suddenly winning a lottery Mega Millions. But then they realize there’s a tax that comes with it—the loss of fat in the face—so it may not be quite the windfall they imagined.”

Dr. Tepper said he can eliminate any vestige of “Ozempic face” with a deep plane face-lift, which costs $75,000. He typically combines this with a procedure in which fat is transferred from other parts of the body to the face (an additional $8,000 to $12,000).

While the jaw-dropping prices of these treatments are clearly beyond the reach of the average person, for patients like Berger, who stopped taking Mounjaro after she returned to her pre-baby weight, feeling healthy and confident again is worth every penny she spent.

“I can’t tell you how good I feel about myself now,” she said. “I used to hide from my husband when I came out of the shower. I would literally walk backward so he wouldn’t see my backside. Now I don’t care. Because I feel good. I feel like myself again.”

Some doctors say that most patients who are taking these drugs need to stay on them indefinitely to keep the weight off, but Berger maintained the same strict portion control after she stopped taking Mounjaro. It also helped her ease off wine, which some other people taking the drug have noticed as well.

“I learned to find other ways to deal with my stress because I just didn’t have the taste for it,” she said.

Perhaps most important, the drug allowed her to stop obsessing about food and exercise. “Sure, it was expensive,” Berger said. “But you know what? I saved a lot of money on trainers and not buying wine! To be honest, the most expensive thing so far has been buying new clothes.”

Research contact: @nytimes

Above, Mifepristone (Mifeprex) and Misoprostol are the two medical abortion drugs that CVS and Walgreens plan to sell. (Photo source: USA Today)

CVS and Walgreens say they plan to sell the abortion pill

January 9, 2023

Walgreens and CVS on Wednesday said they plan to sell the abortion pill after the U.S. Federal Drug Administration relaxed its rules on January 5 on where patients can buy the drug. In addition, Rite Aid it is reviewing the FDA action and will comply with federal and state law, reports USA Today.

The announcements from the pharmacy chains come one day after the FDA said any certified mail and brick-and-mortar pharmacy can dispense the abortion pill mifepristone. Patients will still need a prescription but will no longer be required to pick it up in person at a doctor’s office or clinic.

Mifeprex (mifepristone) and its generic Mifepristone Tablets, 200 mg (collectively mifepristone) are approved, in a regimen with Misoprostol, to end an intrauterine pregnancy through ten weeks gestation (70 days or less since the first day of a patient’s last menstrual period). The FDA first approved Mifeprex in 2000 and approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg in 2019.

Mifepristone is used to dilate the cervix and block the hormone needed to sustain a pregnancy. Mifepristone is followed up with a second medication called Misoprostol that causes the uterus to contract and expel tissue.

CVS and Walgreens will need to get certified in the FDA’s program before they can begin selling the drug, and the new rule won’t change access for those in states where abortion is restricted.

Independent pharmacies also have expressed interest in dispensing the abortion pill, according to Ronna Hauser, senior vice president of policy and pharmacy affairs at the National Community Pharmacists Association, which represents about 19,400 independent pharmacies nationwide.

Research contact: @USATODAY

Above, NARCAN is a potentially lifesaving medication designed to help reverse the effects of an opioid overdose in minutes. (Photo source: NARCAN)

A major drugmaker plans to sell overdose-reversal nasal spray NARCAN over the counter

December 15, 2022

Drug maker Emergent BioSolutions is seeking approval from the Food and Drug Administration to sell NARCAN over the counter (OTC), without need for a prescription, reports NPR.

The medication, an easy-to-use nasal spray version of the drug naloxone, has a strong track record reversing deadly opioid overdoses, which have soared in recent years largely because of the spread of fentanyl.

“I think it’s a wonderful thing,” says China Darrington, an addiction counselor in Ohio who was, herself, addicted to heroin for 16 years, adding, “The potency of the drugs nowadays is just so unfair. Naloxone has got to be around. People have got to have access to it.”

Darrington tells NPR she survived addiction because people happened to have NARCAN on hand when she overdosed. “I’ve experienced being NARCANed, I want to say, about a half dozen times in my life. It kept me alive. You have to give people a chance to stay alive,” she says.

During severe opioid overdoses, people stop breathing and die. Narcan and other forms of naloxone quickly reverse those harmful effects. But right now the medication is often hard to get, with access complicated by a dizzying patchwork of state and federal laws.

Speaking at a press conference this month, Dr. Rahul Gupta, head of the White House Office of National Drug Control Policy, pointed out that last year alone roughly 80,000 Americans died from opioid overdoses. With naloxone on hand, many of those deaths would have been avoided.

“There is today no excuse, no excuse absolutely for not having it everywhere available, when we know that’s one medication that can save tens of thousands of lives right now,” Gupta said.

Emergent BioSolutions CEO Bob Kramer says the FDA has now agreed to fast track its application to sell NARCAN over the counter without a prescription, with an answer expected by the end of March.

Kramer says that the goal is to have NARCAN so widely available that it’s everywhere, ready in people’s purses, in school classrooms, in shops and businesses, whenever someone overdoses.

“It’s very easy to administer,” he says. “You place the device in the nostril in the nostril and you deploy the mechanism with a puff.”

Research contact: @NPR

Photo source: Glamour

Federal regulations are finally taking aim at the ‘Wild West’ of clean beauty

July 18, 2022

Three years ago, several makeup products at Claire’s, the national retail chain beloved by teenagers, tested positive for the presence of asbestos—a mineral that has been known for decades to be linked to several types of cancer and lung disease, reports Fortune.

The Food and Drug Administration did what it could legally do about the fact that teenagers had been applying asbestos to their faces and possibly absorbing it through their pores: It recommended Claire’s recall the products. Claire’s disputed the test results, but ultimately recalled the products, even though the FDA had no further authority to act.

“To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety,” then-FDA Commissioner Scott Gottlieb wrote candidly in a March 2019 statement with Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the agency.

Not much has changed since then. Federal law regulating the beauty industry hasn’t been updated since 1938—the year that Adolf Hitler marched into Austria and set off the Second World War.

“Cosmetics is the least regulated category in the marketplace: There are more restrictions on the pesticides that we spray on crops to kill weeds than the stuff we spray on our bodies every day,” said Scott Faber, head of Government Affairs at the Environmental Working Group (EWG).

All the same, Congress, where several female legislators—including Sen. Dianne Feinstein of California, Sen. Susan Collins of Maine, Rep. Jan Schakowsky of Illinois, and Sen. Patty Murray of Washington—have introduced bipartisan proposals to update the laws, expand FDA authority to oversee beauty brands, and ban the most harmful chemicals.

At the same time, several states including California, Maryland, Maine, and Colorado have already moved to increase supply-chain transparency in an industry known for its opacity.

Last month, those proposals were tucked into the FDA Safety and Landmark Advancements Act—legislation that would reauthorize the agency’s user fee agreements related to prescription drugs and medical devices. Since this reauthorization needs to pass, the ride-on cosmetics regulations have their best chance in over eight decades to move through a gridlocked Congress.

The proposals have widespread support from the beauty industry, including Unilever, Johnson & Johnson, L’Oréal, Sephora, and Procter & Gamble, because many mainstream brands and retailers have already started moving into the clean-beauty space.

Olivia Tong, an equity analyst at Raymond James who follows Ulta Beauty, Estée Lauder, Sally Beauty, and other cosmetics and personal care companies, said regulations could establish some consistency in what “clean beauty” means.

“It’s a little bit of the Wild Wild West right now with anything that has a label of ‘clean,’” Tong said. “Investors along with consumers are typically on board with some consistency in terms of what everybody is talking about.”

David Swartz, equity analyst at Morningstar who covers Ulta, said big retailers don’t have much to fear when it comes to proposed regulations. “If anything, it would allow Ulta to promote its brands and bolster its links with the key suppliers,” Swartz said. “There could be some negative impact on Amazon and others that sell counterfeit and unauthorized beauty products, which could benefit Ulta, Sephora, and other stores.”

Indeed, while not everyone in the industry welcomes stricter regulation, it’s clear that current law has fallen far behind global industry standards and consumer preferences. Clean beauty was the fastest-growing segment as of May, according to NPD Group. Clean-beauty market revenues are up 19% from last year, while vegan makeup revenue is up 27%, and vegan skin care 23%, the market research firm told Fortune.

“There’s way more concern for what goes into products today than there was even ten years ago,” said Larissa Jensen, industry adviser and vice president at NPD Group.

In response to growing consumer demand, the nation’s largest retailers, including Ulta, Sephora, and Target, are launching clean-beauty standards and disclosing more information about how these products are made.

There are no legal definitions for “clean,” “natural,” or “green” beauty products—so companies can use those terms as they wish without fearing legal consequences. “Organic” is the only industry label regulated in the United States.

“What’s clean to one brand might mean something different to another,” said Emily Spilman, science analyst on EWG’s Healthy Living team. “The onus is on the consumer to do that research.”

The nonprofit advocates for stronger regulation of the beauty industry and has launched the Skin Deep cosmetics database as an alternative way for consumers to check ingredients in the products they use in the interim. An accompanying mobile app makes it possible to scan barcodes in a store to see how an item rates.

Credo, a San Francisco–based clean-beauty retailer, has established a Clean Standard for the products it carries. It bans the use of 2,700 mainstream beauty ingredients that raise safety and sustainability concerns; restricts animal-derived ingredients and animal testing; and poses questions about ethics, sustainability, and transparency.

“The standard is really the nexus of how we evaluate ingredient and material safety, sourcing, sustainability, and ethics,” said Mia Davis, vice president of Environmental and Social Responsibility at Credo. The company explains on its website that it created the standard because current law is so limited.

Yet the brand does not think the standard is a stand-in for federal action. Instead, it’s one of the industry advocates pushing for Congress to act. The tide has turned in favor of regulation, and many mainstream cosmetics brands also supported an earlier bill introduced by Feinstein and Collins that is the foundation of the current proposal.

As is often the case in Congress, the extent of the regulation is the crux of debate. The Personal Care Products Council, which represents manufacturers, distributors, and suppliers of beauty products, says the industry is very responsible and responsive to consumer concerns about safety and sustainability. While critics point out that the European Union has banned over 1,600 ingredients; and the United States. fewer than a dozen, PCPC vice president Jay Ansell says the statistics are misleading.

“Nearly all of those ingredients banned in the EU have never been nor would ever be used in cosmetics, including jet fuel, radioactive substances, pesticides, pharmaceuticals like chemotherapy drugs, chloroform, hemlock, cyanide, and LSD,” Ansell said

.However, Credo’s Davis agreed that not all of the EU-banned ingredients are present in American products, but she added that the EU’s approach is demonstrably more precautionary than the one taken by U.S. regulators. Some beauty brands change the formula of their products for the European market, and she believes those versions are safer.

“This industry enjoys a lot of secrecy,” she said. “There’s very little federal information required of the industry. We need more in order to protect the consumer and the planet.”

Still, Tong of Raymond James noted that many other priorities are front and center for multinational beauty brands right now—including economic pressures, inventory and supply-chain challenges, and shifts in consumer behavior amid the pandemic. That means regulations are not the focus—at least not until current proposals advance further in Congress.

Research contact: @FortuneMagazine

Above, customers at a Chicago Walgreens. (Photo source: Phil Velasquez for The Chicago Tribune)

Walgreens to launch business that will connect customers with clinical trials

June 20, 2022

Some Walgreens customers might soon get a new kind of message from the company, asking if they’d like to participate in a clinical trial, reports The Chicago Tribune.

Deerfield, Illinois-based Walgreens announced on Thursday, June 16, that it plans to launch a clinical trials business—in which pharmaceutical companies can hire Walgreens to help them find participants for clinical trials, which are used to evaluate the safety and effectiveness of new potential types of medications and devices.

Walgreens plans to use its rosters of customers and patients to find those who may match a trial’s criteria, and then ask those people if they would like to participate, said Ramita Tandon, chief clinical trials officer at the pharmacy chain.

As part of the new business, Walgreens also may help companies carry out clinical trials by conducting visits for participants at some of its stores, during which patients may fill out surveys or have blood taken, depending on the type of trial, Tandon said. It’s possible nurses, pharmacists, pharmacy technicians or doctors could help with those visits, depending on what’s needed, she said.

Walgreens leaders believe they can help companies get more clinical trial participants, and a more diverse range of participants, because Walgreens has customers in so many different communities.

Including participants from diverse racial backgrounds has long been an issue in clinical trials. In the U.S., 75% of 32,000 participants in the trials of 53 new drugs approved in 2020 by the U.S. Food and Drug Administration were White, according to FDA. Only 8% were Black, 6% were Asian, and 11% were Hispanic.

People from different backgrounds can react differently to some medications and devices, which is part of the reason it’s crucial to have trial participants from a variety of backgrounds, according to the FDA. Also, a lack of diverse participants may mean that people from certain racial and ethnic groups are not getting early access, through clinical trials, to drugs that could help them.

“The therapies that are coming out today are not very representative of the U.S. population,” Tandon said. “As we at Walgreens start to tap into our local communities, (we can) educate and empower these communities on the benefits of clinical trials. Not only are they participants in research, but this is yet another opportunity as a care option, (for) patients who may he exhausted other avenues in their care journey.”

She said Walgreens will be able to “mine the vast foundation of patients and consumers who come to our stores and pharmacies on a regular basis” to match potential participants to clinical trials.

Patient data will not be shared with pharmaceutical companies unless patients give consent to share it, and participation will be voluntary. Doctors will work with Walgreens to oversee the clinical trials, and Walgreens may be able to reach out to a patient’s primary care or specialty doctors if needed, Tandon said.

Research contact: @Walgreens

Above, Helaina founder and CEO Laura Katz. (Photo source: Rebecca Greenfield for Fortune Magazine)

How the Gen Y founder of Helaina may have solved the baby formula shortage

June 2, 2022

Despite the fact that instant baby formula represents a $50 billion global market, a recent shortage shows the need for innovation in the space, reports Fortune.

America has been facing a severe—and already deadly, in several cases—shortage of formula since March, when the FDA found traces of a potentially deadly bacteria at Abbott Nutrition’s plant in Sturgis, Michigan, and shut down production. Recently, the United States imported 70,000 pounds of baby formula from Europe to ease the crisis.

However, as young entrepreneurs in the food industry innovate, an alternative to baby formula is in the works. A case in point: 29-year-old Laura Katz has always been passionate about the food industry. As she learned about its broken parts, she decided to gravitate towards innovation and advancement. Aiming to revolutionize instant formula, she launched Helaina.

Helaina uses fermentation to recreate the proteins found in breast milk. At the company, the design and build team makes sure the yeast will produce first-of-its-kind, nature-equivalent breast milk components that build immunity.

These technologies will give parents access to a healthier option than instant formula, Katz believes. However, once the product hits the market, it will look like instant formula. The founder says the product will be “powdered” and “pretty recognizable,” but it will be different because it will be composed of the proteins that the yeast creates through the fermentation process. So “instead of relying on conventional sources of agriculture,” the founder explained her product was more

Six years ago, when Katz was 23, she learned through a podcast that there was a black market for breastmilk out there, and parents would go on the internet to buy breast milk from strangers because they wanted to give their infants the benefits of baby milk.

“As a food scientist at the time, seeing all this innovation going into alternative dairy and alternative meat, ok, we can make a burger bleed, but why aren’t we channeling that technology towards making the things that are so essential for babies and for parents?” she questioned.

So she set on a quest to make a product that empowered these parents and recreated the immunity properties in breastmilk, and Helaina was born.

“The infant formula category is highly regulated” and “there are a lot of safety steps.” The company has to prove that its product is safe in many different ways, which will take time, explained the founder. This means it could take years for the product to hit the market.

The founder is proud because they are the only company putting human proteins in food. “No one has done that before,” Katz said.

While the company still has a long way to go, Katz is hopeful that innovation will give many parents and infants the immunity they desire and that the food industry will shift towards healthier options.

“I think within the category that we’re in we’re starting to see—and I’m hoping to see—people shift more from focusing a lot of their effort on figuring out how to make food taste better” to “how we can use technology to make food healthier for us and more accessible,” shared the founder.

Research contact: @fortunemagazine

Photo source: @rockmyfamily/#bottlefedbabies/Instagram

America faces baby formula ‘crisis’ as shortage worsens

May 11, 2022

Major U.S. pharmacies recently have restricted sales of baby formula in response to a spiralling shortage of the special milk. CVS and Walgreens are among the big pharmacy chains to have imposed limits on how many cans of baby formula customers can buy at a time, reports the BBC.

The shortages intensified after Abbott— which makes top brand Similac—shut a key factory and issued a recall in February after finding contamination in its supply.

Pressure is building on the Biden Administration to respond to the issue. Republicans—among them, Senator Tom Cotton (R-Arkansas)—have called it a “national crisis” that the White House must address.

Democratic Representative Rosa DeLauro of Connecticut said she was concerned that the Food and Drug Administration , which regulates formula makers, had responded “far too slowly” to the issue; and to the reports of problems at the Abbott factory in Michigan, which remains closed.

Abbott—the main supplier of baby formula to many of the state government programs for low-income women and children—said it was working with regulators to get the plant re-opened.

The company has been sending extra shipments from a plant in Ireland to try to address the problem—expecting shipments from the country to double this year, it added.

“We know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage,” the company said in a recent statement.

“We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.”

As of 24 April, the average out-of-stock rate across the country had jumped to 40%, up from just 30% a few weeks earlier—and 11% in November, according to Datasembly. There were 26 states with out-of-stock rates higher than 40%—compared to just seven states three weeks earlier, it said.

Due to increased demand and various supplier challenges, infant and toddler formulas are seeing constraint across the country,” the major pharmacy chain Walgreens said in a statement, adding, “We continue to work diligently with our supplier partners to best meet customer demands.”

Walgreens has limited families to buying three cans at a time—similar to other retailers. A 12.4 ounce can of formula typically lasts for about 15 bottles—or just a few days’ worth of supply.

Companies that produce items like baby formula—for which demand is typically steady over time—have trouble catching up when there is disruption, said Rudi Leuschner, director of the Masters in Supply Chain Management program at Rutgers Business School.

And as parents rush to buy as stories of empty shelves spread, that only makes the problem worse, he warned. “It’s not a situation where you can just snap out of it,” he said. “It was designed to run at one speed.”

While this year’s formula shortage may expose the fragility of the supply chain, it may not be enough to make a business case for backup inventories, Professor Leuschner added.

Overall, birth rates are falling, reaching the lowest point on record in the United States in 2020. Studies also have found that consumption of infant formula has been declining in favor of breast milk.

Research contact: @BBC

Photo source: Pfizer

Hard luck: Taking Viagra cuts the risk of Alzheimer’s by up to 69%

December 7, 2021

Now we really know it’s a man’s world: A research study conducted by the Cleveland Clinic’s Genomic Medicine Institute has found that the a drug used to counteract erectile dysfunction, Viagra, may help to boost brain health and cut levels of toxic proteins that trigger dementia, according to a report by The Sun.

Experts analyzed data on 7.2 million U.S. adults and found regular users had a 69% lower chance of being diagnosed with Alzheimer’s disease over the next six years.

Medics say the findings, published in the journal, Nature Aging, suggest that “the little blue pill” soon could be prescribed to tackle dementia.

The authors are now planning a fresh study to test the benefits of sildenafil—the generic version of Viagra—in early Alzheimer’s patients.

A team from Cleveland Clinic looked at whether any of 1,600 approved drugs could be repurposed to tackle the underlying causes of the disease.

Lead researcher Dr Feixiong Cheng, from Cleveland Clinic’s Genomic Medicine Institute, said: “Sildenafil, which has been shown to significantly improve cognition and memory in preclinical models, presented as the best drug candidate.

Two in three cases of dementia are due to Alzheimer’s.

Dr. Jack Auty, lecturer in the Medical Sciences at the University of Tasmania, said: “This is exciting stuff,” adding, ““But we need further research. In the field of Alzheimer’s disease research, we have been excited by many drugs over the years, only to have our hopes dashed in clinical trials.”

However, Dr. Susan Kohlhaas, director of Research at Alzheimer’s Research UK, was more cautious about the findings.

She said: “While sildenafil is most well-known as a treatment for erectile dysfunction, it’s also used to treat high blood pressure in the lungs. In this study, researchers also found that its use is linked with fewer cases of Alzheimer’s disease in American adults. The researchers conducted lab-based experiments to give an indication as to why the drug may have impact diseases like Alzheimer’s, but these early-stage experiments would need follow-up in more thorough tests.”

Meanwhile, health officials in the United States recently approved the first new drug for Alzheimer’s disease in nearly 20 years. Despite controversy over the trial results, the Food and Drug Administration said it granted approval to the drug developed by Biogen.

Research contact: @TheSun

Above, a Thanksgiving leftover sandwich. (Photo source: @captsafety/#thanksgivingleftovers/Instagram)