There’s no denying that America’s healthcare system is broken. The United States spends three times more per person on medical expenses than the average developed country does, and yet our life expectancy is lower and costs for the patients are higher. What’s more, we have no cost transparency, poor access to care, glaring inequity in treatment, and mediocre outcomes.

There’s no easy way out of this mess, even with the massive amounts of innovation being driven by the private sector, adoption is moving far too slow. While discouraging, the landscape isn’t hopeless, with forward-thinking legislation and increased pressure from the public, we can begin to fix the system.

Here are five relatively simple things the government can do now to get U.S. healthcare on the right track:

1. Reimburse telehealth visits at the same rate as in-person care. At the onset of the pandemic, CMS expanded telehealth reimbursements to beneficiaries across the country and observed extraordinary increases in telehealth services. These expanded payments accelerated telemedicine use by about 10 years but are set to expire at the end of this year. We need to make this equal reimbursement permanent.

Studies show that telemedicine improves patient outcomes through advanced monitoring and increased clinical decision support systems. The result is shorter hospital stays and decreased mortality. With investments and technology in place, we’re set for a future of telemedicine that serves a wider network of patients with more accessible care. Removing those expansions would be a foolhardy step backward.

2. Institute a virtual-first approach for primary and chronic care. When patients have more convenient access with fewer barriers to care, providers can take a more preventative approach.

Virtual-first care gives consumers more control over their health. With a shortage of primary care providers in the US, appointment wait times can be prohibitive — not to mention the logistical challenges of calling, confirming, and traveling to appointments. As a result, many patients avoid seeking care until their symptoms become unbearable and then resort to high-cost options like emergency rooms. When consumers can easily access a provider from the comfort of their home, they’re more likely to seek care sooner and avoid drastic, costly consequences.

Similarly, evidence suggests that virtual care is more efficient when it comes to chronic disease management. Patients are more likely to attend regular appointments when they can do so virtually, and greater patient adherence leads to better outcomes with more cost savings.

Chronic diseases like diabetes, obesity, depression, COPD, and hypertension are especially well-suited for a virtual continuous care approach. These conditions often require adjustments on a weekly, daily, or even hourly basis which can be hard to manage when a patient is only visiting their PCP once or twice a year. With continuous virtual care a patient and their provider can quickly adjust things like medication, blood pressure control, and diet.

3. Establish parity for mental and physical health. For centuries, philosophers and healers have exhorted the mind and body connection, and modern scientific studies consistently prove the impact of emotional stress on the body. But investment remains low in mental healthcare, so the roots of many common chronic illnesses are left untreated. It’s time that our healthcare system reflects the science and provides equal access to mental and physical care.

The Mental Health Parity and Addiction Act of 2008 was a step in the right direction, but we’re far from meeting its standards. A 2019 Milliman report shows increased disparities between mental healthcare and physical healthcare, signifying a lack of compliance among insurance carriers. In 24 states, the reimbursement rates for primary care office visits were more than 30% higher than those for mental health office visits.

Despite lower reimbursement rates, the demand for mental healthcare remains high. Americans have reported significantly higher rates of anxiety and depression since the start of the pandemic, with potentially disastrous effects on long-term health. Nearly 75% of practitioners who treat anxiety disorders are reporting an increased demand for treatment and 88% of Americans suffered at least one symptom of depression last year. We should be meeting that need with increased coverage of mental healthcare.

4. Provide universal mental health screening. Regular mental health screenings allow for early identification and treatment. When easier access to screening is available, we work toward eliminating the stigma associated with mental illness. Unfortunately, stigma and discrimination often exacerbate a person’s mental health problems and delay them from getting the help they need, especially in men.

We know +, digestive disorders, and chronic pain among other ailments. With early screening and treatment, we can avoid the long-term effects of many chronic diseases, saving patients from years of suffering.

While addressing the need for mental health screening we also need to address our lack of mental health providers in the US to meet national demand. According to a new access report, only 12% of therapists are accepting new patients and those who are taking patients have an average wait time of 19 days. While waiting nearly three weeks to be seen might be okay for certain conditions, it’s unacceptable for someone suffering from depression or anxiety. While we absolutely do need more licensed therapists in the field, we also need to do a better job of triaging less severe cases to trained mental health coaches. Just like not all conditions need to be treated by a doctor, not all mental health ailments need to be treated by a therapist.

5. Shift pricing to a value-based model. We need to move away from our outdated fee-for-service reimbursement model that actually rewards providers for not focusing on outcomes. This model has resulted in providers taking on heavier patient loads and doesn’t hold providers accountable to outcomes.

Value-based initiatives can improve the quality and lower the cost of care. When pricing is based on patient outcomes instead of service fees, it helps align incentives between payers, providers, employers, and consumers.

The industry should follow the lead of CMS’s expanded Medicare Advantage benefits, which allow for flexibility to build on social determinants of health. Covered benefits like personalized nutrition coaching, therapeutic massage, and fitness training promote and sustain long-term health. These integrated care teams allow everyone to work at the top of their license and enable a comprehensive mind and body approach. Even with these expanded benefits, the overall costs decrease for all parties.

We have a long way to go, but new machine learning and artificial intelligence technology is helping us connect the dots between physical and mental health in a way that hasn’t been possible before now. If we can continue to expand telemedicine by emphasizing a virtual-first care approach and shifting pricing to a value-based model, we’ll improve patient outcomes while cutting excess costs. Now that’s a healthcare system for the future.

In 1993, a SWAT team equipped with night-vision goggles and assault rifles surrounded Mel Gibson’s mansion under the cover of darkness. They burst into the home, eventually finding the movie star wearing a bathrobe in his kitchen. Gibson put his hands up and the agents cuffed him immediately, over protestations that he had done nothing wrong, and certainly nothing dangerous. His crime? The possession of vitamin C tablets. “You know, like in oranges,” Gibson reminded the agents—and the viewers.

This was a television commercial. In a dead-serious voice-over, the ad, which was backed by the dietary-supplement industry’s advocacy arm, claims that the federal government wants to classify your humble multivitamin capsules as drugs, a word loaded enough in the early ’90s to evoke crack instead of ibuprofen. The ad ends with a stark warning on a black screen: Viewers should contact the United States Senate to protect their freedoms. If they didn’t, their home could be raided next.

The campaign was a huge success, according to Catherine Price, the author of Vitamania: How Vitamins Revolutionized the Way We Think About Food. At the time, the government was considering a bill to loosen the FDA’s regulatory reins on supplements, ensuring, among other things, that their makers would never have to prove their products’ safety or efficacy before marketing them to the public. People really did contact their senators en masse, Price told me, and the bill passed easily. The change rewrote the future entirely for the makers of dietary supplements—a category of products commonly referred to as vitamins but that also includes minerals, herbs, amino acids, and other “dietary substances.” From 1994 to 2016, the number of products on the American supplement market grew from about 4,000 to about 80,000; by one estimate, the market was worth more than $43 billion in 2019. As people have looked for ways to fortify their immune system during the coronavirus pandemic, the industry has grown even faster.

When you walk down the vitamin aisle at Walmart or type your symptoms into Google, you’re now met with the infinite constellation of marketing opportunities this law created. This is true no matter what ailment you’re trying to address or corporeal obstacle you’re trying to overcome. Synthetic vitamins are combined with one another and with a slew of other substances in seemingly limitless permutations, sold by familiar consumer brands or movie stars or venture-backed start-ups in many different dosages and formats. There are now dietary-supplement blends advertised for focus, for combatting fatigue, for hair growth, for weight loss, for sexual potency, for surviving a hangover. The variety is overwhelming, as are the promises in all of those little capsules. But if you’re confused, don’t be: There’s a pretty good chance that whatever is lurking underneath all that promise is pretty similar to your average multivitamin.

For the average person, vitamin is a slippery term. It denotes an invisible thing hiding in your food, a type of aisle at the drugstore, a product hawked by bland women on Instagram and angry men on YouTube. Multivitamin is similarly slippery, and more a term of art than a term of science. On an etymological level, it refers to any supplement that contains more than one vitamin. But according to Carol Haggans, a dietician and consultant at the National Institute of Health’s Office of Dietary Supplements, there is no regulatory standard for what multivitamin means, for what one must contain, or for what should be labeled as such. What the buying public tends to think of as a multivitamin usually contains all or part of a person’s recommended daily intake of actual vitamins (researchers have identified 13 essential to human health, and they’re the familiar ones: C, D, all the Bs), in addition to a number of minerals (iron, zinc, magnesium), and sometimes other non-vitamin substances such as ginger and ginkgo.

Then there are the other multivitamins—the pills that make all the promises. These products, which claim to naturally “support” (we’ll talk about this word later) an even skin tone or jump-start productivity or calm nerves, almost always seem separate from the Centrum Silver that Grandad takes or the Flintstones chewable that appeared next to your childhood cereal bowl every morning; rarely will you find the word multivitamin on their labels or in their product descriptions online. But at a nutritional level, it’s often hard to see where these sorts of products are distinct.

The luxury wellness company Moon Juice markets a hair-growth supplement that includes all 13 essential vitamins in doses similar to or exceeding those of common multivitamins, as well as minerals that are almost always present in such vitamins: iron, iodine, zinc. (Moon Juice did not respond to a request for comment.) H-Proof, a supplement that claims to proactively ameliorate the effects of hangovers, contains significant levels of nine vitamins, plus zinc and potassium. (Rachel Kaplan, H-Proof’s co-founder, told me that the company’s supplement is patented and therefore distinct from others on the market. She said the supplement is safe to take with multivitamins.) The list goes on and on: Boost your immune system! Support your digestive health! Increase productivity! Even dietary products like 5-Hour Energy shots have a significant ingredient overlap with multivitamins—although, presumably, your multi doesn’t also include more than 200mg of caffeine.

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Other companies take a different path to a similar destination, with vast product lineups that are positioned as complementary and customizable—an alternative to one-size-fits-all traditional health care. Hum Nutrition, whose products are sold at Sephora and Bloomingdale’s, offers a cover-your-bases multivitamin as well as a broad assortment of products that shoppers can use to build their own personal health routines. These ancillary products have names like Uber Energy and Hair Sweet Hair, and many of them include blends of vitamins and minerals already found in the company’s multivitamin, sometimes with other herbs or extracts mixed in. Other add-ons are just standard-issue vitamin D or biotin supplements, rebranded as Here Comes the Sun or Killer Nails. Care/of, a line of dietary supplements available at Target, offers a smaller but structurally similar setup, with a standard multi for men or women and add-ons for focus or energy or immunity. You can buy a multivitamin, and then build your own multivitamin, perhaps unwittingly, to take on top of it.

Graham Rigby, Care/of’s chief innovation officer, told me via email that the brand’s mix-and-match line is formulated to fall below any known safety limits for its ingredients. Shauna Aminzadeh, a spokesperson for Hum Nutrition, told me that the company’s build-your-own vitamin regimen is “targeted to very specific health and beauty concerns” and that “key ingredients are backed by clinical trials.”

Cross-referencing products’ ingredients against one another is an exhaustingly detailed process. The print is tiny, the numbers are very close together, and different manufacturers list the same ingredients in different orders and under different names. If you’re shopping online, some websites won’t let you zoom in far enough to easily read the ingredient lists. Nothing about how supplements are marketed or packaged makes them easy to understand or compare for the people buying them. The regulatory changes passed in 1994 mean manufacturers are not required to disclose much at all, including potential side effects and drug interactions. If they claim clinical proof of their products’ efficacy, they are not required to make that proof available for scrutiny, or even to demonstrate that it exists. This system is how you end up with people stacking supplements on top of one another with no real understanding of what’s in them, and no real understanding of what to expect.

According to Tod Cooperman, the founder and president of ConsumerLab.com, which conducts independent lab testing on retail dietary supplements, the end experience for buyers often looks similar, even if they select different products from different brands: They are taking at least one multivitamin, and maybe the equivalent of several. “What you typically see is that marketers are formulating products based on the smallest scraps of evidence for an ingredient that might relate to a condition,” he told me. “There’s the expectation that the products are going to contain many ingredients if there’s some magic to the formula, and obviously, that is what [the marketers] are shooting for.”

Because consuming a minimum amount of certain vitamins and minerals is essential to human life, there are studies linking all of them to a slew of bodily processes. That means supplement marketers can advertise their products as supporting or encouraging (importantly, not causing) healthy immune function or clear skin or good mood, even if there’s no proof that taking large amounts of these substances leads to any additional effect. Vitamin C, for example, is indeed important for your immune system, and it figures prominently in many of the immunity-boosting supplements that have become especially popular during the pandemic. But as with all vitamins and essential minerals, infinite Vitamin C is not infinitely beneficial. Consuming it is helpful only to a point that most people hit through their diets, Haggan, the NIH dietician, told me. That point is far lower than the megadoses included in many immunity supplements.

Where supplements make a real difference is in people with genuine nutritional deficiencies or with specific health conditions, Haggan said. For example, pregnant people need to get more folic acid than the average person in order to prevent some birth defects, and vegans often don’t get enough B12. People with enough money to build bespoke personal supplement regimens rarely have deficiencies. Most Americans, for that matter, get everything they need by eating and going outside. Beyond the known essential nutrients, we have even less understanding of what—if anything—other supplement ingredients do, and in what amounts they might do it. Small studies abound, many of them conducted on rodents instead of humans. Although this type of research is crucial to scientists, Haggan said, it in no way proves that a particular effect can be extrapolated to humans through use of any particular consumer product.

This is the part where discussion of supplements gets tricky. Most dietary supplements are unlikely to hurt an otherwise healthy person in the short term, Haggan said, even if they contain megadoses of certain ingredients. In a country where the health-care system is so often inaccessible and unreliable, isn’t it good that lots of people want to do what’s in their power to shore up their personal health outside of that system? Isn’t it good that vital nutrients are widely available and pretty affordable? Who cares if some people treat vitamins like edible astrology? Americans, as Mel Gibson told us all those years ago, want the opportunity to decide for themselves what goes in their bodies.

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The problem is that the supplement industry, as it stands currently, ensures that making good personal choices with its products is almost impossible. Because even the most basic proof of a product’s efficacy and safety isn’t required in order to start selling, that research isn’t done. Cooperman told me that about one in five of the supplements that ConsumerLab tests is substantially different than what it claims to be. The ingredient levels are much too low or much too high. The pills don’t break apart to allow their ingredients to be absorbed by the body. The oil-based capsules go rancid. Some supplements are tainted with pesticides, metals, or actual pharmaceuticals. Price recounted an anecdote she heard from a chemist during her Vitamania reporting: While evaluating a male-enhancement supplement that was supposed to contain a traditional mix of Chinese herbs, the chemist cracked open a capsule and a chunk of a blue Viagra tablet fell out. (In the male-enhancement world, this kind of thing is more common than you might expect.)

Supplements can be dangerous. If you pile a few different types on top of one another, and then pile those on top of the vitamins and minerals you’re already getting from food—itself commonly fortified or enriched with extra vitamins in the United States—you could very well be megadosing lots of different substances without realizing it. In the short term, with most supplement ingredients, that’s probably fine—they are water-soluble, which means you’ll excrete the excess in urine. But for fat-soluble vitamins such as A, D, and E, as well as minerals such as calcium and iron, according to Price, the overage can accumulate in bodily tissues over time. That helps make multivitamins an overdose risk and can cause serious problems—hair loss, fainting, cardiac issues, seizures, coma, and even death. One recent survey found that one in eight people said either they or a member of their immediate family had experienced a severe side effect after taking a dietary supplement.

These conditions attract bad actors. Multilevel marketing schemes, conspiracy theorists, and celebrities looking to diversify their revenue streams are all serious players in the American supplement market, many of them hawking products that are extraordinarily similar to one another, just with different packaging and a different pitch. Caveat emptor doesn’t seem to cut it, but maybe this will: Whatever it is that sounds so promising might just be a multivitamin, and when was the last time one of those changed your life?

Nov. 22, 2021

With Thanksgiving almost here, the U.S. Centers for Disease Control and Prevention has issued tips on the safest way to prepare your turkey.

First of all, you should not wash or rinse your bird. That may seem counterintuitive, but washing the turkey can spread germs and bacteria all over your kitchen.

“Federal food safety advice has recommended against washing turkey or chicken since 2005, but some habits are hard to break,” the CDC says, citing a 2020 survey that found 78% of respondents did rinse or wash their turkeys.

“Old recipes and family cooking traditions may keep this practice going, but it can make you and your family sick. Poultry juices can spread in the kitchen and contaminate other foods, utensils, and countertops.”

Next, don’t think about thawing your frozen turkey on the counter. When a turkey is left at room temperature for more than two hours, its temperature becomes unsafe and may reach “the danger zone” between 40 and 140 degrees Fahrenheit, the CDC says.

Instead, thaw the turkey in a container in the refrigerator; in a leak-proof plastic bag in a sink of cold water (making sure to change the water every half hour); or in the microwave, if you own one big enough to accommodate a turkey.

Other kitchen tips from the CDC:

Keep it clean. Wash your hands with soap for 20 seconds after handling turkey. Use a separate cutting board for raw turkey and never place other foods on a plate or cutting board that has held raw turkey. Wash cutting boards and utensils with hot soapy water.

Cook your stuffing thoroughly. Whether you cook it inside the turkey or in a casserole dish, use a food thermometer to make sure the center of the stuffing hits 165 degrees Fahrenheit. If you cook it in the turkey, wait 20 minutes after removing the bird from the oven to take the stuffing out; this allows it to cook more.

Use a food thermometer on your turkey. The thawed bird should be placed in a roasting pan inside an oven set at 325 degrees Fahrenheit or higher. Even if your turkey has a pop-up temperature indicator, use a food thermometer and make sure it at least 165 degrees at thickest portions of the breast, thigh, and wing joint. Let your turkey sit for 20 minutes before carving.

 

Neurocrine Biosciences generates the lion’s share of its revenue from a movement disorders drug, and the biotech has been an active dealmaker as it tries to broaden its portfolio and build up its drug pipeline. In the latest deal, Neurocrine is paying $100 million up front for a portfolio of preclinical and clinical-stage neuroscience compounds, including a lead program ready for Phase 2 testing in schizophrenia.

The upfront cash payment is going to Tokyo-based Sosei Heptares. Neurocrine will also fund a research collaboration in which both companies will work together to advance preclinical candidates through Phase 1 testing. Neurocrine said it plans to study the Sosei Heptares compounds for treating schizophrenia, dementia and other neuropsychiatric disorders. Depending on the progress of those drug candidates, Sosei Heptares could receive up to $1.5 billion in development and regulatory milestone payments. The Japanese company also stands to earn royalties from Neurocrine’s sales of drugs that emerge from the alliance.

The partnered drugs are based on Sosei Heptares’s work developing compounds that target muscarinic receptors. These receptors are key to brain function and have been validated as drug targets in psychosis and cognitive disorders. The receptors M1 through M5 are found in the brain and some peripheral tissues, but the challenge has been developing drugs that can target M4 and M1 receptors without sparking side effects by also activating M2 and M3 receptors.

Sosei Heptares has developed drugs that target the M4 and M1 receptors individually, as well as drugs that target both receptors simultaneously. Sosei Heptares says its drugs can selectively hit these receptors to deliver therapeutic effects. The company also contends its drugs avoid the side effects caused by non-selective drugs as well as the efficacy problems that some older patients can experience with a different class of neuro drugs called positive allosteric modulators.

Neurocrine is licensing the Sosei Heptares drugs after AbbVie gave up its chance to develop them. They were initially partnered with Allergan under an alliance signed in 2016. AbbVie inherited that partnership with its acquisition of Allergan last year. The North Chicago drugmaker pruned a number of Allergan’s drug candidates as it digested the acquisition and the Sosei Heptares alliance was among the programs that did not make the cut. The Japanese company regained full rights to the muscarinic agonist drugs earlier this year.

According to deal terms announced Monday, Neurocrine gets global rights to Sosei Heptares’ muscarinic receptor agonist drugs. Sosei Heptares retains the rights to develop M1 agonists in Japan in all indications, but Neurocrine has the option to co-develop and co-commercialize these drugs in Japan. The most advanced Sosei Heptares drug covered under the Neurocrine pact is HTL-0016878, a drug that selectively activates M4. Neurocrine said it plans to submit to the FDA an application to begin clinical testing in 2022; a placebo-controlled Phase 2 study in schizophrenia could follow later in the year.

Schizophrenia is also part of a partnership that Neurocrine inked with Takeda Pharmaceutical last year, a deal that spans seven programs from the Japanese pharma giant’s pipeline. Other partnerships that Neurocrine science has added in recent years include agreements with Xenon Pharmaceuticals and Idorsia, both deals covering forms of epilepsy.

Sosei Heptares isn’t the only company with clinical-stage drugs designed to selectively stimulate muscarinic receptors as a way of treating neurological disorders. Anavex Life Sciences has tested its muscarinic receptor agonists in Alzheimer’s disease and frontotemporal dementia. Karuna Therapeutics is developing its lead drug for schizophrenia. Cerevel Therapeutics formed three years ago with drug candidates acquired from Pfizer including an M4-selective drug in development for schizophrenia.

Image by Jolygon, via Getty Images

Broadening Medicare coverage of vision and hearing services would significantly expand access to the most vulnerable U.S. residents at minimal cost to taxpayers, new research shows.

Medicare beneficiaries with incomes below the federal poverty level spent less than half per year on vision services and nearly three times as less on hearing services than their higher-earning peers, according to an analysis from the Urban Institute. The data suggest that there is a vast unmet need for glasses, hearing aids and other related care among low-income Medicare beneficiaries and that those items are likely lower quality.

The version of the Build Back Better Act that the House recently passed will cover hearing services for Medicare enrollees starting in 2023. But policymakers cut vision and dental services in the latest iteration of the bill to reduce costs.

“If the higher-income population serves as where the need is regarding eyeglasses, hearing aids, etc., it suggests there is an unmet need among the low-income population. The spending gap also suggests that the higher-income population has better quality frames and hearing aids,” said Anuj Gangopadhyaya, senior research associate for the Urban Institute. “There is a lot of correlation between hearing loss and the use of healthcare, quality of life and the ability to follow and listen to medical providers’ questions—it could have effects on other parts of healthcare as well.”

Spending on both vision and hearing services was relatively small compared to total Medicare expenditures of $1.1 trillion, researchers found. The cost of expanding hearing, vision and dental services for Medicare beneficiaries would cost only $358 billion over 10 years, the Congressional Budget Office estimated.

“There is a virtuous cycle created by making incremental coverage improvements in hearing and vision services,” said Dr. Harry Greenspun, chief medical officer of the consultancy Guidehouse. “Expanding benefits would produce an outsized amount of value relative to the expenditure. What is also critically important is that high out-of-pocket costs have a disproportionate impact on lower-income individuals.”

Medicare beneficiaries spent $8.4 billion on vision services in 2020, $5.4 billion of which enrollees paid for out of pocket, according to the research brief. Beneficiaries spent $5.7 billion on hearing services last year, $4.7 billion of which fell on enrollees.

Beneficiaries often have to choose between food, medication and other necessities and hearing aids or eye-wear. Although it’s hard to quantify those trade-offs, experts said.

“The purpose of Medicare as a social insurance program is to put lower-income and higher-income beneficiaries on the same platform,” Gangopadhyaya said.

As hearing and vision deteriorates, it becomes harder to socialize, read and process information. While the policy brief does not quantify the associated downstream impacts on healthcare outcomes and costs, hearing and vision loss can compound mental health issues and reduce quality of life. Access to more preventative care could stave off serious health complications and reduce healthcare spending, particularly among the most vulnerable populations, experts said.

Meanwhile, Biogen’s Alzheimer’s drug Aduhelm costs about $56,000 a year even though providers have questioned whether it even works. There would be a much bigger return on investment in incremental improvements in healthcare coverage for basic services, Greenspun said.

“All health outcomes are very dependent on being able to communicate and take in information,” he said. “We’re willing to spend trillions on drugs that have mild improvement in certain areas—and cause many side effects—but ignore the basic block-and-tackle things we can do that show a lot more value than the much more expensive therapeutics.”