Eat It! – by Jordan Syatt and Michael Vacanti
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One of the biggest challenges we often face when undertaking diet and exercise regimes, is the “regime” part. Day one is inspiring, day two is exciting… Day seventeen when one has a headache and some kitchen appliance just broke and one’s preferred exercise gear is in the wash… Not so much.
Authors Jordan Syatt and Michael Vacanti, therefore, have taken it upon themselves to bring sustainability to us.
Their main premise is simplicity, but simplicity that works. For example:
- Having a daily calorie limit, but being ok with guesstimating
- Weighing regularly, but not worrying about fluctuations (just trends!)
- Eating what you like, but prioritizing some foods over others
- Focusing on resistance training, but accessible exercises that work the whole body, instead of “and then 3 sets of 12 reps of these in 6-4-2 progression to exhaustion of the anterior sternocleidomastoid muscle”
The writing style is simple and clear too, without skimping on the science where science helps explain why something works a certain way.
Bottom line: this one’s for anyone who would like a strong healthy body, without doing the equivalent of a degree in anatomy and physiology along the way.
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Zuranolone: What to know about the pill for postpartum depression
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In the year after giving birth, about one in eight people who give birth in the U.S. experience the debilitating symptoms of postpartum depression (PPD), including lack of energy and feeling sad, anxious, hopeless, and overwhelmed.
Postpartum depression is a serious, potentially life-threatening condition that can affect a person’s bond with their baby. Although it’s frequently confused with the so-called “baby blues,” it’s not the same.
The baby blues include similar, temporary symptoms that affect up to 80 percent of people who have recently given birth and usually go away within the first few weeks. PPD usually begins within the first month after giving birth and can last for months and interfere with a person’s daily life if left untreated. Thankfully, PPD is treatable and there is help available.
On August 4, the FDA approved zuranolone, branded as Zurzuvae, the first-ever oral medication to treat PPD. Until now, besides other common antidepressants, the only medication available to treat PPD specifically was the IV injection brexanolone, which is difficult to access and expensive and can only be administered in a hospital or health care setting.
Read on to find out more about zuranolone: what it is, how it works, how much it costs, and more.
What is zuranolone?
Zurzuvae is the brand name for zuranolone, an oral medication to treat postpartum depression. Developed by Sage Therapeutics in partnership with Biogen, it’s now available in the U.S. Zurzuvae is typically prescribed as two 25 mg capsules a day for 14 days. In clinical trials, the medication showed to be fast-acting, improving PPD symptoms in just three days.
How does zuranolone work?
Zuranolone is a neuroactive steroid, a type of medication that helps the neurotransmitter GABA’s receptors, which affect how the body reacts to anxiety, stress, and fear, function better.
“Zuranolone can be thought of as a synthetic version of [the neuroactive steroid] allopregnanolone,” says Dr. Katrina Furey, a reproductive psychiatrist, clinical instructor at Yale University, and co-host of the Analyze Scripts podcast. “Women with PPD have lower levels of allopregnenolone compared to women without PPD.”
How is it different from other antidepressants?
“What differentiates zuranolone from other previously available oral antidepressants is that it has a much more rapid response and a shorter course of treatment,” says Dr. Asima Ahmad, an OB-GYN, reproductive endocrinologist, and founder of Carrot Fertility.
“It can take effect as early as on day three of treatment, versus other oral antidepressants that can take up to six to 12 weeks to take full effect.”
What are Zurzuvae’s side effects?
According to the FDA, the most common side effects of Zurzuvae include dizziness, drowsiness, diarrhea, fatigue, the common cold, and urinary tract infection. Similar to other antidepressants, the medication may increase the risk of suicidal thoughts and actions in people 24 and younger. However, NPR noted that this type of labeling is required for all antidepressants, and researchers didn’t see any reports of suicidal thoughts in their trials.
“Drug trials also noted that the side effects for zuranolone were not as severe,” says Ahmad. “[There was] no sudden loss of consciousness as seen with brexanolone or weight gain and sexual dysfunction, which can be seen with other oral antidepressants.”
She adds: “Given the lower incidence of side effects and more rapid-acting onset, zuranolone could be a viable option for many,” including those looking for a treatment that offers faster symptom relief.
Can someone breastfeed while taking zuranolone?
It’s complicated. In clinical trials, participants were asked to stop breastfeeding (which, according to Furey, is common in early clinical trials).
A small study of people who were nursing while taking zuranolone found that 0.3 percent of the medication dose was passed on to breast milk, which, Furey says, is a pretty low amount of exposure for the baby. Ahmad says that “though some data suggests that the risk of harm to the baby may be low, there is still overall limited data.”
Overall, people should talk to their health care provider about the risks and benefits of breastfeeding while on the medication.
“A lot of factors will need to be weighed, such as overall health of the infant, age of the infant, etc., when making this decision,” Furey says.
How much does Zurzuvae cost?
Zurzuvae’s price before insurance coverage is $15,900 for the 14-day treatment. However, the Policy Center for Maternal Mental Health says insurance companies and Medicaid are expected to cover it because it’s the only drug of its kind.
Less than 1 percent of U.S. insurers have issued coverage guidelines so far, so it’s still unknown how much it will cost patients after insurance. Some insurers require patients to try another antidepressant first (like the more common SSRIs) before covering Zurzuvae. For uninsured and underinsured people, Sage Therapeutics said it will offer copay assistance.
The hefty price tag and potential issues with coverage may widen existing health disparities, says Ahmad. “We need to ensure that we are seeking out solutions to enable wide-scale access to all PPD treatments so that people have access to whatever treatment may work best for them.”
If you or anyone you know is considering suicide or self-harm or is anxious, depressed, upset, or needs to talk, call the Suicide & Crisis Lifeline at 988 or text the Crisis Text Line at 741-741. For international resources, here is a good place to begin.
For more information, talk to your health care provider.
This article first appeared on Public Good News and is republished here under a Creative Commons license.
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A Therapeutic Journey – by Alain de Botton
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We’ve often featured The School of Life’s videos here on 10almonds, and most of those are written by (and often voiced by) Alain de Botton.
This book lays out the case for mental health being also just health, that no person is perfectly healthy all the time, and sometimes we all need a little help. While he does suggest seeking help from reliable outside sources, he also tells a lot about how we can improve things for ourselves along the way, whether by what we can control in our environment, or just what’s between our ears.
In the category of limitations, the book is written with the assumption that you are in a position to have access to a therapist of your choice, and in a sufficiently safe and stable life situation that there is a limit to how bad things can get.
The style is… Alain de Botton’s usual style. Well-written, clear, decisive, instructive, compassionate, insightful, thought-provoking.
Bottom line: this isn’t a book for absolutely everyone, but if your problems are moderate and your resources are comfortable, then this book has a lot of insights that can make your life more easy-going and joyful, without dropping the seriousness when appropriate.
Click here to check out A Therapeutic Journey, and perhaps begin one of your own!
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Is white rice bad for me? Can I make it lower GI or healthier?
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Rice is a culinary staple in Australia and around the world.
It might seem like a given that brown rice is healthier than white and official public health resources often recommend brown rice instead of white as a “healthy swap”.
But Australians definitely prefer white rice over brown. So, what’s the difference, and what do we need to know when choosing rice?
What makes rice white or brown?
Rice “grains” are technically seeds. A complete, whole rice seed is called a “paddy”, which has multiple parts:
- the “hull” is the hard outer layer which protects the seed
- the “bran”, which is a softer protective layer containing the seed coat
- the “germ” or the embryo, which is the part of the seed that would develop into a new plant if was germinated
- the “endosperm”, which makes up most of the seed and is essentially the store of nutrients that feeds the developing plant as a seed grows into a plant.
Rice needs to be processed for humans to eat it.
Along with cleaning and drying, the hard hulls are removed since we can’t digest them. This is how brown rice is made, with the other three parts of the rice remaining intact. This means brown rice is regarded as a “wholegrain”.
White rice, however, is a “refined” grain, as it is further polished to remove the bran and germ, leaving just the endosperm. This is a mechanical and not a chemical process.
What’s the difference, nutritionally?
Keeping the bran and the germ means brown rice has more magnesium, phosphorus, potassium B vitamins (niacin, folate, riboflavin and pyridoxine), iron, zinc and fibre.
The germ and the bran also contain more bioactives (compounds in foods that aren’t essential nutrients but have health benefits), like oryzanols and phenolic compounds which have antioxidant effects.
But that doesn’t mean white rice is just empty calories. It still contains vitamins, minerals and some fibre, and is low in fat and salt, and is naturally gluten-free.
White and brown rice actually have similar amounts of calories (or kilojoules) and total carbohydrates.
There are studies that show eating more white rice is linked to a higher risk of type 2 diabetes. But it is difficult to know if this is down to the rice itself, or other related factors such as socioeconomic variables or other dietary patterns.
What about the glycaemic index?
The higher fibre means brown rice has a lower glycaemic index (GI), meaning it raises blood sugar levels more slowly. But this is highly variable between different rices within the white and brown categories.
The GI system uses low (less than 55), medium (55–70) and high (above 70) categories. Brown rices fall into the low and medium categories. White rices fall in the medium and high.
There are specific low-GI types available for both white and brown types. You can also lower the GI of rice by heating and then cooling it. This process converts some of the “available carbohydrates” into “resistant starch”, which then functions like dietary fibre.
Are there any benefits to white rice?
The taste and textural qualities of white and brown rices differ. White rice tends to have a softer texture and more mild or neutral flavour. Brown rice has a chewier texture and nuttier flavour.
So, while you can technically substitute brown rice into most recipes, the experience will be different. Or other ingredients may need to be added or changed to create the desired texture.
Removing more of the outer layers may also reduce the levels of contaminants such as pesticides.
We don’t just eat rice
Comparing white and brown rice seems like an easy way to boost nutritional value. But just because one food (brown rice) is more nutrient-dense doesn’t make the other food (white rice) “bad”.
Ultimately, it’s not often that we eat just rice, so we don’t need the rice we choose to be the perfect one. Rice is typically the staple base of a more complex dish. So, it’s probably more important to think about what we eat with rice.
Adding vegetables and lean proteins to rice-based dishes can easily add the micronutrients, bioactives and fibre that white rice is comparatively lacking, and this can likely do more to contribute to diet quality than eating brown rice instead.
Emma Beckett, Adjunct Senior Lecturer, Nutrition, Dietetics & Food Innovation – School of Health Sciences, UNSW Sydney
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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If I’m diagnosed with one cancer, am I likely to get another?
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Receiving a cancer diagnosis is life-changing and can cause a range of concerns about ongoing health.
Fear of cancer returning is one of the top health concerns. And managing this fear is an important part of cancer treatment.
But how likely is it to get cancer for a second time?
Why can cancer return?
While initial cancer treatment may seem successful, sometimes a few cancer cells remain dormant. Over time, these cancer cells can grow again and may start to cause symptoms.
This is known as cancer recurrence: when a cancer returns after a period of remission. This period could be days, months or even years. The new cancer is the same type as the original cancer, but can sometimes grow in a new location through a process called metastasis.
Actor Hugh Jackman has gone public about his multiple diagnoses of basal cell carcinoma (a type of skin cancer) over the past decade.
The exact reason why cancer returns differs depending on the cancer type and the treatment received. Research is ongoing to identify genes associated with cancers returning. This may eventually allow doctors to tailor treatments for high-risk people.
What are the chances of cancer returning?
The risk of cancer returning differs between cancers, and between sub-types of the same cancer.
New screening and treatment options have seen reductions in recurrence rates for many types of cancer. For example, between 2004 and 2019, the risk of colon cancer recurring dropped by 31-68%. It is important to remember that only someone’s treatment team can assess an individual’s personal risk of cancer returning.
For most types of cancer, the highest risk of cancer returning is within the first three years after entering remission. This is because any leftover cancer cells not killed by treatment are likely to start growing again sooner rather than later. Three years after entering remission, recurrence rates for most cancers decrease, meaning that every day that passes lowers the risk of the cancer returning.
Every day that passes also increases the numbers of new discoveries, and cancer drugs being developed.
What about second, unrelated cancers?
Earlier this year, we learned Sarah Ferguson, Duchess of York, had been diagnosed with malignant melanoma (a type of skin cancer) shortly after being treated for breast cancer.
Although details have not been confirmed, this is likely a new cancer that isn’t a recurrence or metastasis of the first one.
Australian research from Queensland and Tasmania shows adults who have had cancer have around a 6-36% higher risk of developing a second primary cancer compared to the risk of cancer in the general population.
Who’s at risk of another, unrelated cancer?
With improvements in cancer diagnosis and treatment, people diagnosed with cancer are living longer than ever. This means they need to consider their long-term health, including their risk of developing another unrelated cancer.
Reasons for such cancers include different types of cancers sharing the same kind of lifestyle, environmental and genetic risk factors.
The increased risk is also likely partly due to the effects that some cancer treatments and imaging procedures have on the body. However, this increased risk is relatively small when compared with the (sometimes lifesaving) benefits of these treatment and procedures.
While a 6-36% greater chance of getting a second, unrelated cancer may seem large, only around 10-12% of participants developed a second cancer in the Australian studies we mentioned. Both had a median follow-up time of around five years.
Similarly, in a large US study only about one in 12 adult cancer patients developed a second type of cancer in the follow-up period (an average of seven years).
The kind of first cancer you had also affects your risk of a second, unrelated cancer, as well as the type of second cancer you are at risk of. For example, in the two Australian studies we mentioned, the risk of a second cancer was greater for people with an initial diagnosis of head and neck cancer, or a haematological (blood) cancer.
People diagnosed with cancer as a child, adolescent or young adult also have a greater risk of a second, unrelated cancer.
What can I do to lower my risk?
Regular follow-up examinations can give peace of mind, and ensure any subsequent cancer is caught early, when there’s the best chance of successful treatment.
Maintenance therapy may be used to reduce the risk of some types of cancer returning. However, despite ongoing research, there are no specific treatments against cancer recurrence or developing a second, unrelated cancer.
But there are things you can do to help lower your general risk of cancer – not smoking, being physically active, eating well, maintaining a healthy body weight, limiting alcohol intake and being sun safe. These all reduce the chance of cancer returning and getting a second cancer.
Sarah Diepstraten, Senior Research Officer, Blood Cells and Blood Cancer Division, Walter and Eliza Hall Institute and Terry Boyle, Senior Lecturer in Cancer Epidemiology, University of South Australia
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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Metabolic Health Roadmap – by Brenda Wollenberg
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The term “roadmap” is often used in informative books, but in this case, Wollenberg (a nutritionist with decades of experience) really does deliver what can very reasonably be described as a roadmap:
She provides chapters in the form of legs of a journey [to better metabolic health], and those legs are broadly divided into an “information center” to deliver new information, a “rest stop” for reflection, “roadwork” to guide the reader through implementing the information we just learned, in a practical fashion, and finally “traveller assistance” to give additional support / resources, as well as any potential troubleshooting, etc.
The information and guidance within are all based on very good science; a lot is what you will have read already about blood sugar management (generally the lynchpin of metabolic health in general), but there’s also a lot about leveraging epigenetics for our benefit, rather than being sabotaged by such.
There’s a little guidance that falls outside of nutrition (sleep, exercise, etc), but for the most part, Wollenberg stays within her own field of expertise, nutrition.
The style is idiosyncratic; it’s very clear that her goal is providing the promised roadmap, and not living up to any editor’s wish or publisher’s hope of living up to industry standard norms of book formatting. However, this pays off, because her delivery is clear and helpful while remaining personable and yet still bringing just as much actual science, and this makes for a very pleasant and informative read.
Bottom line: if you’d like to improve your metabolic health, as well as get held-by-the-hand through your health-improvement journey by a charming guide, this is very much the book for you!
Click here to check out the Metabolic Health Roadmap, and start taking steps!
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Syphilis Is Killing Babies. The U.S. Government Is Failing to Stop the Disease From Spreading.
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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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