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The Bezos-Buffett-Dimon health care venture: Eliminate the middlemen


The Bezos-Buffett-Dimon health care venture: Eliminate the middlemen
Warren Buffett of Berkshire Hathaway, Jeff Bezos of Amazon and Jamie Dimon of JPMorgan Chase created a health venture in January. AP File Photos.

The new health care venture formed by Amazon, Berkshire Hathaway and JPMorgan Chase announced June 20 that Harvard professor and well-known author Atul Gawande would be the company’s CEO. The idea for the new company is to innovate by cutting costs from the health care system, starting with the more than 1 million employees of the three companies behind the venture.

Previous efforts to contain health care spending – from managed care to high deductible health plans to alternative payment models – shared the goal of eliminating unnecessary and overly expensive services. But these practices are very hard to change, since they’re based on physicians’ clinical judgment and patient preferences.

The new joint venture may find it is easier to start with a different question entirely: Can we reduce spending by 15 to 20 percent just by cutting out unnecessary middlemen?

As business school professors, we know that cutting the unnecessary transactions costs generated by unneeded middlemen is the classic first step. We expect it will quickly be seen as the low-hanging fruit for this new organization.

Tackling inefficient health care arrangements

The Bezos-Buffett-Dimon health care venture: Eliminate the middlemen
Amazon has built a worldwide empire by selling goods online. Eric Broder Van Dyke/Shutterstock

In its main business, Amazon cuts out everyone except the original supplier of what they sell – and the post office. That’s how they have cut prices of other consumer products.

There’s ample room to replicate that success in health care, because the system in the U.S. has long been plagued by excessive transaction costs – the expenses incurred when buying or selling goods and services. These include irrational pricing, as evidenced by the price of services varying wildly for hospitals, insurers and patients. This, along with unnecessarily complicated billing systems, creates the need for extensive bureaucracies to manage all the varied relationships.

Businesses like Amazon try to fix this sort of mess and make shopping for services more convenient and transparent. Imagine an easy-to-use platform where patients can readily assess the price and quality of competing providers and quickly schedule appointments or perhaps even initiate an online consultation. We bet Dr. Gawande is imagining it.

There are also several less visible sources of unnecessary transactions costs that are vulnerable to disruption. Two of these center on pharmacy benefit management companies (PBMs) and insurance brokers and consultants.

Lately, the big pharmaceutical firms have pointed at PBMs to deflect the blame for their sky-high drug prices. President Donald Trump seems to share this view. However, PBMs are just middlemen whose only purpose is to lubricate the relationship between insurers, Big Pharma and pharmacy chains. They let pharmacies know what your plan covers and what you owe – a valuable service worth a nominal payment.

But PBMs also work the system by collecting rebates of up to 25 percent from drug manufacturers as an agent for insurers. They then pass some, but not all, of them on to the insurance companies and their customers. We believe these rebates should be understood for what they really are: bribes that Big Pharma pays in an attempt to bias insurers to favor their higher-priced products over others.

Health insurers, such as the plan one of us ran as CEO, receive these higher rebates based on volume – but only for drugs with a competitive alternative where there is a choice of what to cover. The growth of drug rebates clearly indicates these bribes work independent of clinical appropriateness and input from doctors.

The Bezos-Buffett-Dimon health care venture: Eliminate the middlemen
Customers sometimes have coupons they present at checkout at their pharmacies, which shields them from the high costs of drugs. Pikselstock/Shutterstock

Furthermore, Big Pharma’s use of coupons and donations to reduce what patients pay permits huge increases in drug prices, which more than offsets these rebates. The patient is insulated from higher prices at the pharmacy but still ultimately pays more. The cost of these coupons and donations shifts to the insurer, and the insurer then gets it back in premium hikes. This whole mess rests on rebates as an unproductive transaction cost that has little real reason to exist at all.

Insurers are not blameless. They also try to buy business, creating unnecessary transaction costs in the process. For instance, employers typically hire brokers and consultants to advise them on coverage for their employees. Given the complexity of insurance plans, seeking such help is usually a rational decision. But the hidden fact is that these middlemen, in addition to fees from their clients, are taking side payments from insurers up to 16 percent of the premium – clearly designed to bias their recommendations to employers. These payments are another case of unproductive transactions costs that can be eliminated by bargaining directly with insurers and drug companies.

More targets for the joint venture

Efforts to remove the middlemen won’t stop with PBMs and brokers. Insurers, the biggest middlemen, are certainly vulnerable with their high administrative costs ranging from 12 percent to 18 percent. And this new joint venture might also ask why they would pay wildly variable prices for similar health care services when they can dictate package prices for a given episode of care and channel employees to higher-quality providers willing to bargain. Employers like these three can even hire their own clinicians and save another layer of overhead. And if they can do it for their own employees, they can share these efficiencies with others.

Ron Coase, who won the Nobel Prize in economics in 1991, demonstrated that industries are organized ultimately to minimize transactions costs. This is obvious in the history of other sectors where fragmented producers gradually transformed into integrated organizations, and then into assemblers as labor and transportation costs changed. In a similar way, the internet has allowed radical restructuring of many businesses as transaction costs have fallen.

So far, the health care system has largely avoided such transformations. The Amazon, Berkshire Hathaway and JPMorgan Chase venture suggests their time is coming.

A sudden and lasting separation from a parent can permanently alter brain development

Leer en español.

At birth, the brain is the most underdeveloped organ in our body. It takes up until our mid-20s for our brains to fully mature. Any serious and prolonged adversity, such as a sudden, unexpected and lasting separation from a caretaker, changes the structure of the developing brain. It damages a child’s ability to process emotion and leaves scars that are profound and lifelong.

That’s bad news because, although President Trump has ended his “zero-tolerance” immigration policy of separating parents and children at the border, there are some 2,300 children whose reunification with parents remains uncertain.

In my psychiatric and therapeutic practice, I work with children and adults who as children experienced unexpected and lasting separation from their parents. Some fare better than others. Some struggle with major psychiatric disorders, whereas others have no psychiatric diagnosis. Yet, their feeling of safety and trust in others is compromised. The impact of separation trauma is everlasting.

Born to be nurtured

Altricial species, such as humans, are dependent upon parental care for survival and development after birth. The parent is necessary to regulate the offspring’s temperature and to provide food and protection against environment threats. This is accomplished through parent bonding with the offspring that nurtures a deep attachment. The newly born learn quickly that signs of parental presence, such as an image, voice, touch or smell, signal safety.

A sudden and lasting separation from a parent can permanently alter brain development
Mother’s embrace makes the world seem safe. By GWImages/shutterstock.com

Studies in mammals show that infants naturally conform to parental emotions. The presence of a calm and caring parent produces the feeling of safety in a child. On the contrary, parental distress and fear activate the infant’s brain circuits that are responsible for processing stress, pain and threat. The ability of a caretaker to regulate the offspring’s emotions is an adaptive function encoded in our genes. Before people have our own independent experiences, we start learning what is safe and what is dangerous in the surrounding environment through observing and interacting with our parents. This increases our chances of survival and success in the world.

Numerous studies show that parental presence is more important than the surrounding environment for the emotional well-being of an infant or a very young child. As long as the parent is present and remains calm and caring, the child is able to endure many threats and adversities. Metaphorically speaking, the caretaker is the world for the young child.

Separation alters the brain’s structure

The parents’ presence is also necessary for a person’s harmonious growth and development. That includes the development of our psychological and social functions, such as our ability to respond to stress and self-regulate our emotions or our ability to trust others and function in a group.

Any serious and prolonged disruption of parental care, especially in infants and very young children, alters how the young brain develops. Very young children, younger than five years old, separated from their parents cannot rely on their presence and care anymore, which causes their stress levels to spike. As stress hormones like cortisol, epinephrine and norepineprhine rise, they alter physiological functions of our bodies to better prepare us to cope with threat. However, prolonged increases in the levels of stress hormones disrupt physiological functions and induce inflammation and epigenetic changes – chemical alterations that disrupt the activity of our genes. Turning genes on or off at the wrong time alters the developmental trajectory of the brain, changing how neural networks are formed and how brain regions communicate.

Studies of children who were separated from their parents or neglected by their parents, and experimental research on animals, consistently show that the disruption of parental presence and care causes a precocious and rapid maturation of brain circuits responsible for processing stress and threat. This fast-track development alters the brain’s wiring and changes the way how emotions are processed.

Short, sharp separation quickly causes harm

Laboratory studies show that it doesn’t take long for separation to hurt these infants and children.

A sudden and lasting separation from a parent can permanently alter brain development
On Monday, June 18, 2018, Akemi Vargas, 8, cried as she described being separated from her father during an immigration family separation protest in front of the Sandra Day O’Connor U.S. District Court building in Phoenix. Ross D. Franklin/AP Photo

In laboratory rodents these changes in brain wiring are triggered when a pup is separated from its mother for a mere two to three hours a day for a several consecutive days. We know the stress to the pups is caused by the mother’s absence, not by other changes in the environment, because the researchers continued to feed the pups and maintain their body temperature during the experiment.

Premature maturation of stress and threat processing networks in the brains of children separated from parents stunts the child’s development and leads to loss of flexibility in responding to danger. For example, most of us are able to “unlearn” what we may have initially considered threatening or scary. If something or someone is not dangerous anymore, our defense responses adapt, extinguishing our fear. This ability to unlearn threat is compromised in maternally separated animals.

The subsequent reunification with a parent, or the replacement with a new caretaker, may not reverse the changes caused by this early separation stress.

Pictures of the brain reveal altered brain structures

Brain imaging studies demonstrate structural and functional changes in the brains of children separated from their parents. Specifically, the stress of separation increases the size of the amygdala, a key structure in threat processing and emotion, and alters amygdala connections with other brain areas. On the molecular level, separation alters the expression of receptors on the brain cell’s surface involved in stress response and emotion regulation. Without the right number of receptors, the communication between neurons is disrupted.

The trauma of either permanent or temporary separation poses general health risks and affects academic performance, success in career and personal life. In particular, the loss or separation from parents increases the likelihood of various psychiatric disorders, including post-traumatic stress, anxiety, mood, psychotic or substance use disorders.

The feeling of safety and the associated ability to bond with others, the ability to detect and respond to threat, as well as the ability to regulate one’s own emotions and stress are vital. Early reprogramming of neural circuits underlying these functions can directly or indirectly alter the child’s physical, emotional and cognitive development and causes lifelong changes.

What the US can learn from other countries in dealing with pain and the opioid crisis

With all the recent news on opioid overuse in the U.S., it’s not surprising that Americans consume the vast majority of the global opioid supply. Daily opioid use in the U.S. is the highest in the world, with an estimated one daily dose prescribed for every 20 people. That rate is 50 percent higher than in Germany and 40 times higher than in Japan.

As former U.S. Surgeon General Vivek Murthy once said, the U.S. “arrived here on a path that was paved with good intentions,” but “the results have been devastating.” “We have nearly 250 million prescriptions for opioids written every year. That’s enough for every person in America to have a bottle of pills and then some,” he added.

Has the U.S.‘s heavy reliance on prescription opioids caused more harm than good? And, likewise, have other countries’ low use of opioids caused more pain than good?

I have been pondering these issues at Texas A&M Health Science Center, where I am the chair of a newly established Opioid Task Force, an initiative that emphasizes a multifaceted approach to the opioid epidemic. To me, it seems like most countries need to find a happy balance between the American attitude that all pain needs to be cured – and the ethos in other countries that pain is to be endured.

Differing views on pain

In investigating this issue, I came across two reasons that might explain the worldwide differences in pain management strategies.

First, while pain is universal, pain is fundamentally a subjective phenomenon. People from different countries experience pain differently, based on traditional beliefs rooted in social and cultural values.

For example, people in Africa, especially men, may be reluctant to admit to pain, as doing so would be a sign of weakness. In contrast, Americans report more pain than people from any other country, with about a third of adults reporting pain “often” or “very often.”

In traditional African society, pain is viewed as something to be endured and pain medication has often been a luxury for those who could afford it. Self-medication with simple analgesics and traditional herbs are often the first -— but not necessarily effective – strategies to reduce pain.

Secondly, many countries have much stricter regulations than the U.S. regarding when opioids may and should be prescribed.

For example, until the past few years, there were few U.S. regulations for the medical prescription of opioids. With the goal of eliminating pain, physicians generously prescribed opioids after most surgical procedures or for routine patient complaints of pain. (It’s worthwhile to note that, thanks to new restrictions, opioid prescriptions in the U.S. decreased by more than 20 percent between 2013 and 2017.)

Conversely, in Europe, opioids are dispensed by specialists and more tightly regulated, including restrictions on advertisements. It’s less common to dispense opioids for non-cancer related pain such as chronic back or musculoskeletal pain.

What the US can learn from other countries in dealing with pain and the opioid crisis
Alternative and complementary treatments like acupuncture could help people manage pain. Leonardo da/shutterstock

Many countries have traditionally treated pain with other approaches. With a view of pain as a condition, Chinese medicine has long incorporated the use of herbs, acupuncture and lifestyle changes to manage pain. Acupuncture has been adopted in many clinical settings around the world, including in the U.S., and is considered effective for certain pain conditions and safe when performed by an experienced practitioner.

With a similar aversion to narcotics and concerns about addiction, Japanese health care providers have traditionally avoided opioid prescriptions, recommending non-pharmacological treatments for dealing with pain such as acupressure, massage and relaxation techniques. Yet, with the aging of the population, there has been a greater demand for opioids and growing concerns about abuse.

In Europe, there are positive attitudes among both the medical profession and the public alike about complementary and alternative medicine – or the use of natural products or mind and body practices developed outside of mainstream Western medicine. These approaches are increasingly integrated into primary care, with reimbursement through national health care systems. For example, German physicians often prescribe physical therapy, exercise, massage and relaxation therapies, all of which have been associated with pain relief. However, there’s some concern about the use of unregulated natural health practitioners, as well as the need for better communication among certified medical providers, natural health practitioners and patients.

A happy balance

What’s the best strategy for dealing with pain? There are no simple answers.

What does seem clear is that pain management strategies are slowly converging in the face of the opioid crisis. Countries that have been overprescribing are now putting the brakes on uncontrolled prescriptions through increased regulation and continuing education. Meanwhile, in counties with limited access to pharmacological treatments, there’s increased recognition of the rampant suffering and the need for increased access to opiates as part of an overall approach that includes traditional non-pharmacological strategies too.

I’m heartened to see physicians start to emphasize alternatives to opioid prescriptions as a first step in pain management, in line with Centers for Disease Control and Prevention guidelines, and practices in other countries. To go even further will require better education of both health care professionals and patients regarding complementary and alternative treatments, as well greater access to and payment for them.

For me, the issue goes beyond the simplistic characterizations of pain management often seen in different countries and cultures. Pain isn’t just to be cured – or to be endured. Rather, all Americans, whether providing or receiving care, need to understand what can be learned from best practices in pain management around the world.

Sitting and diabetes in older adults: Does timing matter?

Adults are sitting more than ever, and few pay attention to how they sit throughout the day.

Take a moment to think about all the reasons we sit. First off, you’re probably sitting while reading this. Some of the most common sitting activities include eating meals; driving; talking on the phone; using a computer, television, or small device; and reading. Now take another moment to think about all the sitting done across your lifetime.

Sitting and diabetes in older adults: Does timing matter?
Older Americans spend a lot of time sitting. Matthew Mclaughlin/Figshare, CC BY-SA

The fact is, the amount of time spent sitting has increased over time. And with innovations such as Alexa, delivered groceries, and pre-made meal services, we expect many older adults will sit longer, and will do it more often. As of today, the average older adult spends between 56 percent and 86 percent of their waking day sedentary. That’s a lot of sitting.

Our research team studies healthy aging and is interested in how sitting too much might contribute to heart disease and diabetes. Our recent study suggests that the way older adults accumulate their sitting time might be important for aging without diabetes.

What happens while sitting?

When you sit for long periods without getting up, the large weight-bearing muscles of the legs remain dormant. With no action, these muscles are unable to efficiently use the sugars and fats that float around in your blood – and in theory, this could lead to weight gain and metabolic diseases such as diabetes.

At the same time, reduced blood flow in your arteries leads to hostile conditions that promote injury to the blood vessel walls. Over a lifetime, this injury likely contributes to heart disease and to peripheral artery disease. Furthermore, when your leg muscles remain shut off for long periods, blood collects in your veins which leads to an increased risk for blood clots, or deep venous thrombosis. Standing up and moving around can stop these processes, but all too often, we just keep sitting.

Sitting and diabetes in older adults: Does timing matter?
Blood flow can become ‘turbulent,’ causing damage to arteries. www.pexels.com

Sitting patterns

Sitting patterns describe how people sit throughout the day. Some people commonly sit for long periods at a time, rarely getting up. They are said to have prolonged sitting patterns. Others rarely sit still. They regularly get up after sitting for just short periods. These sitters are said to have interrupted sitting patterns. Where do you fit on the sitting pattern spectrum?

Sitting and diabetes in older adults: Does timing matter?
Sitting can be accumulated in different patterns. John Bellettiere/figshare.com, CC BY-SA

Are sitting patterns important for metabolic health?

Emerging evidence suggests yes. From observational studies, we learned that adults with prolonged sitting patterns had larger waistlines, higher BMI, and in their blood had less good fats, more bad fats, and higher levels of sugar compared to adults with interrupted sitting patterns.

To test whether problems with fat and sugar metabolism were being caused by sitting patterns, researchers around the world conducted experiments. They brought adults into a laboratory at least two times each, having them sit continuously for about eight hours (an extreme prolonged pattern. On the second day, the participants were asked to get up every 20-30 minutes (a highly interrupted pattern). The interruptions lasted for two to five minutes and included standing still, light walking, simple resistance exercises or moderate-intensity walking, depending on the study.

When researchers synthesized evidence from most of the laboratory studies, the results were clear. On days with prolonged patterns, our bodies are not able to metabolize fats or sugar as well as they are on days with interrupted patterns. Blood pressure and fatigue were also higher on days with prolonged sitting compared to days with interrupted patterns.

These groundbreaking laboratory studies provided strong evidence that sitting patterns had an immediate effect on how the body processes fats and sugar, otherwise known as metabolism. This led to the idea that prolonged sitting patterns over a lifetime could contribute to metabolic diseases such as diabetes in later life. Since diabetes can take a long time to develop, this question cannot be feasibly tested in a laboratory. Instead, we turned to an observational study of the population to help answer the question.

Are sitting patterns related to diabetes?

We recruited over 6,000 women aged 65-99 from the Women’s Health Initiative and measured their sedentary patterns for seven days using research-grade activity monitors. We also had over 20 years of detailed health records, which included information on whether the women had ever been diagnosed by a physician with diabetes.

As expected, the group with the most prolonged sedentary patterns had the most women with diabetes. The group with the most interrupted patterns had the fewest women with diabetes.

We used advanced statistical procedures to account for differences in other factors such as dietary habits, physical activity, medication use, weight, age, alcohol and cigarette use, and overall health, giving us more confidence that the sitting patterns were in fact driving the findings. We should caution, however, that since we did not measure sitting patterns before the women were first diagnosed with diabetes, we do not know whether the sitting patterns contributed to diabetes or whether the diabetes changed their sitting patterns. We ran additional statistical tests to try to untangle that, which indicated that sitting patterns contributed to diabetes. However, additional studies specifically suited to answer the question of causation are needed.

While this was the first study of sedentary patterns and diabetes exclusively in older adults, our results were remarkably similar to recent findings in a younger cohort. Researchers from the Netherlands studied 2,500 adults ages 40-75 and found that prolonged sitting patterns were associated with Type 2 diabetes and with metabolic syndrome.

Conclusions and words of advice

Based on the findings from our study and those of the Dutch researchers, when viewed with the earlier epidemiologic data and findings from the laboratory experiments, it seems that sitting patterns may contribute to the growing international diabetes epidemic.

With that said, as with all science, these first few studies are only the beginning of the story. Much more work lies ahead. For the time being, there is a possibility that changing your sitting patterns might provide protection against diabetes, especially if long sitting bouts were always broken with light activity or even better, moderate-intensity activity, as recommended by the American Diabetes Association.

Sitting and diabetes in older adults: Does timing matter?
Recommendations from the American Diabetes Association. Matthew Mclaughlin/figshare.com, CC BY-SA

The authors wish to sincerely thank Dr. Jonathan Unkart for his help with this story.

Opioids don’t have to be addictive – the new versions will treat pain without triggering pleasure

The problem with opioids is that they kill pain – and people. In the past three years, more than 125,000 persons died from an opioid overdose – an average of 115 people per day – exceeding the number killed in car accidents and from gunshots during the same period.

America desperately needs safer analgesics. To create them, biochemists like myself are focusing not just on the opioids, but on opioid receptors. The opioids “dock” with these receptors in the brain and peripheral nervous system dulling pain but also causing deadly side effects.

My colleagues and I in Bryan Roth’s lab have recently solved the atomic structure of a morphine-like drug interacting with an opioid receptor, and now we are using this atomic snapshot to design new drugs that block pain but without the euphoria that leads to addiction.

What has caused the opioid epidemic?

In the U.S., more than one-third of the population experiences some form of acute or chronic pain; in older adults this number rises to 40 percent. The most common condition linked to chronic pain is chronic depression, which is a major cause of suicide.

To relieve severe pain, people go to their physician for powerful prescription painkillers, opioid drugs such as morphine, oxycodone and hydrocodone. Almost all the currently marketed opioid drugs exert their analgesic effects through a protein called the “mu opioid receptor” (MOR).

MORs are embedded in the surface membrane of brain cells, or neurons, and block pain signals when activated by a drug. However, many of the current opioids stimulate portions of the brain that lead to additional sensations of “rewarding” pleasure, or disrupt certain physiological activities. The former may lead to addiction, or the latter, death.

Which part of the brain is activated plays a vital role in controlling pain. For example, MORs are also present in the brain stem, a region that controls breathing. Activating these mu receptors, not only dulls pain but also slows breathing. Large doses stop breathing, causing death. Activating MORs in other parts of the brain, including the ventral tegmental area and the nucleus accumbens, block pain and trigger pleasure or reward, which makes them addictive. But so far there is no efficient way to turn these receptors “on” and “off” in specific areas.

Opioids don't have to be addictive – the new versions will treat pain without triggering pleasure
Locations of the mu opioid receptor (MOR) in the brain. The red areas are locations where MOR is present and active. Labeled locations are only approximate. Tao Che, CC BY-ND

But there is another approach because not all opioids are created equal. Some, such as morphine, bind to the receptor and activate two signaling pathways: one mediating pain cessation and the other producing side effects like respiratory depression. Other drugs favor one pathway more than the other, like only blocking pain – this is the one we want.

“Biased opioids” to kill pain

But MOR isn’t the only opioid receptor. There are two other closely related proteins called kappa and delta, or KOR and DOR respectively, that also alter pain perception but in slightly different ways. Yet, currently there are only a few opioid medications that target KOR, and none that target DOR. One reason is that the function of these receptors in the brain neurons remains unclear.

Recently KOR has been getting attention as extensive studies from different academic labs show that it blocks pain without triggering euphoria, which means it isn’t addictive. Another benefit is that it doesn’t slow respiration, which means that it isn’t lethal. But although it isn’t as dangerous as MOR, activating KOR does promote dysphoria, or unease, and sleepiness.

This work suggests it is possible to design a drug that only targets the pain pathway, without side effects. These kind of drugs are called “biased” opioids.

Discovering and designing drugs to target KOR

So far, there are two popular ways to discover new drugs. The first involves using existing commercially available libraries of compounds and testing them on cells or animals to find one that has the required characteristics. This hit-and-miss approach is straightforward but time-consuming, running anywhere from three months to two years to screen between 3,000 to 20,000 compounds.

The other strategy is called “structure-based drug design.” With this approach, you first need a high-resolution photograph of the receptor – showing the arrangement of every atom in the molecule. Then, using a computer program, you can examine up to 35 million molecules from a virtual chemical library called ZINC 15 to find a molecule that will precisely interact – lock-and-key style – with the receptor. It is like having the precise dimensions of the International Space Station so that you can design a spacecraft that can fits perfectly in the docking site.

Opioids don't have to be addictive – the new versions will treat pain without triggering pleasure
The receptor and drug are like a lock and key. The drug needs to fit the receptor perfectly to trigger a signal. Tao Che, CC BY-ND

I’m a crystallographer, which means I specialize in taking atomic resolution photographs of proteins. I became interested in solving the structure of KOR – when the protein is in its active state bound to a drug.

Structure is considered the gold standard for figuring out how a drug interacts with a receptor and produces a signal. To solve the KOR structure, I first manufactured the KOR protein to make KOR crystals, which consists of hundreds of millions of KOR molecules stacked in the same way, just like salt molecules in a salt crystal. Then I blasted the crystals with X-rays to generate an image of the receptor at atomic level. The key to these pictures was that I “froze” the KOR proteins in their active state to understand how these receptors interact with a drug.

Opioids don't have to be addictive – the new versions will treat pain without triggering pleasure
X-ray crystallography. These action shots of KOR show how the receptor (blue) and drug (pink) fit together to trigger a signal that blocks pain. Tao Che, CC BY-ND

With an action shot of KOR, we recognized what parts of the molecule are critical for blocking pain signals. We are now using this structural data to construct a “biased” molecule that only activates the pain-blocking parts of the protein without triggering side effects.

Opioids don't have to be addictive – the new versions will treat pain without triggering pleasure
Now that we have an ultra high-resolution picture of the KOR receptor interacting with an opioid, we can now design a new, safer version that fits snugly in the receptor and only blocks pain. Tao Che, CC BY-ND

Deciphering the structure of a protein is also valuable for creating a drug that interacts only with only one receptor. All the members of the opioid receptor family – MOR, KOR and DOR – look similar, like siblings. Therefore, these high-resolution photos are essential for designing drugs that will only recognize and target KOR.

Our structure is now used for virtual drug screening where the computational program randomly inserts millions of compounds into the structure and ranks each of them based on how well they fit. The better the score, the more likely that compound will yield a drug.

The exciting news is that researchers in the Roth lab have discovered several promising compounds based on the KOR structure that selectively binds and activates KOR, without cavorting with the more than 330 other related protein receptors.

Now our challenge is to transform these molecules into safer drugs.

A way around opioids: Target the type of pain for better pain relief

In the old days, pain was pain, and there was not a lot of differentiating on the best way to treat it. Then came along powerful morphine in the late 1800s, and more than a century later, powerful opioid painkillers. Marketing by opioid manufacturers led many people to believe, several lawsuits claim, that there were few downsides to using powerful opioids to treat pain. Well, we know differently now.

At the same time we saw the rise of deaths due to opioids in the past decade, research revealed the nuances of pain. A modern medical approach, emphasized even more in the wake of new Centers for Disease Control and Prevention recommendations on prescribing opioids for pain, is to consider non-opioid painkillers first.

As a physician and pain researcher, I can say this is not as easy as it sounds, because there are different kinds of pain and because people experience pain differently. As a pain specialist, I’ve learned to use a broad array of treatments, including dozens of non-opioid pain medications, to treat the type of pain my patients describe and what I diagnose. Now, we need every clinician to practice this way, and to do so, we need to start at the beginning. An essential part of treating pain is to first identify what type of pain a person is having and then use a targeted treatment.

Three broad categories of pain

Broadly speaking, the medical community now knows there are three types of pain: nociceptive pain, neuropathic pain and inflammatory pain.

Nociceptive pain is experienced when pain receptors, called nociceptors, are activated. For example, go ahead and pinch your skin right now. The pain happens because pressure receptors are being activated on nerves, and pain signals travel quickly to your brain. Some pain nerves have these special receptors, and others have bare nerve endings that can be activated by pressure, stretch, extreme temperature, chemicals or movement. The activated nerve endings send pain signals to the spinal cord and up to the brain. Nociceptive pain is a normal response to insult or injury because it tells the person to protect themselves from further injury.

A way around opioids: Target the type of pain for better pain relief
The pain from a broken arm is an example of nociceptive pain. PRESSLAB/Shutterstock.com

Nociceptive pain can be divided into two types – somatic, with receptors that monitor the musculoskeletal system, or visceral, with receptors that exist in the lining of intestines. Somatic nociceptive pain results from a broken arm, for example. If a person holds really still and doesn’t move the arm, the pain is not intense. But if a person moves, all the somatic nerve receptors in the bone and muscle are activated and pain is severe.

A stomach ulcer is an example of visceral pain. If the stomach and intestines are quiet, there may be little or no pain, but as soon as the stomach and intestines start moving, the pain receptors around the ulcer are activated and severe sharp, burning pain is felt.

Neuropathic pain is felt when nerve fibers are damaged or malfunctioning. A classic example is diabetic peripheral neuropathy, where patients with diabetes feel like pins and needles are stabbing them in their fingers and toes. That is because nerves have been damaged by high levels of sugar. Think of it like a fallen electric power line that has lost its insulation and is now sparking and zapping randomly on the ground. Those random zaps are injured nerves spontaneously firing and sending false signals to the brain that there is something causing pain. Neuropathic pain is pathologic pain, which means that it is considered abnormal. It is not a protective response, as is nociceptive pain; it is a malfunction.

Inflammatory pain is caused by inflammation, the body’s response to injury or infection. In inflammatory diseases, such as infection, traumatic injury, burns, cuts, arthritis, inflammatory bowel disease or autoimmune diseases, the region around the nerve is inflamed. There, an inflammatory soup of pain signal molecules, such as TGN-alpha, IL-1, IL-6 and ATP, lower the threshold for nerve firing, so even the slightest thing sets them off. Inflammation causes nerves to signal pain much easier than they otherwise would.

It makes sense to use pain medicines if the pain is severe, in all three types. If it isn’t really that bad, then non-medicine treatments are better. Elevate your leg, stretch your muscles, put ice on that charley horse. All that works well. Often, movement, coping strategies, and time for the body to heal are truly the best remedy.

If medication is needed, there are medications geared for each type.

Different pain, different treatment

Let’s look again at the example of the broken arm. If you don’t move it, it doesn’t hurt as much because the pain receptors are not being activated. So protect the arm, stabilize it, and get it fixed. Treat nociceptive pain by looking for the cause and treating the cause. If you stop the cause, the acute pain will resolve. So, immobilize the arm, realign the bone in surgery, and put a cast on it until it heals. In many instances, no pain medicine is needed. But it’s okay to use medicine for moderate and severe pain. Medications in this case can help you tolerate the fix and speed up rehabilitation and recovery.

Severe nociceptive pain can be controlled by starting with non-opioids and adding other medications as needed. Don’t stop the non-opioid pain medicines. You may think they weren’t working because the pain was too severe, but when used in combination with opioids, medicines like Tylenol and ibuprofen are what we doctors call opioid-sparing. This means that if a person needs more than Tylenol or ibuprofen, a smaller amount of opioid will be needed to control the pain if opioids are combined with non-opioids. This significantly lowers the risk of using opioids.

Nerve pain caused by damaged nerves is targeted by nerve pain medicines. Gabapentin is probably the most common, but again, there are several options. Finding the one that works best with the fewest side effects for an individual person is the key.

Inflammatory pain best responds to drugs called anti-inflammatories. There are non-steroidal anti-inflammatory drugs (NSAIDs), and steroids used to treat inflammation and reduce inflammatory pain. Aspirin, ibuprofen and naproxen are NSAIDs. Steroids, such as cortisone, have side effects of their own.

Many of these drugs were not originally developed to treat pain, so they are used by doctors “off-label” because doctors and other clinicians noticed that they were beneficial for targeted pain treatment.

For example, gabapentin’s traditional use is to stop seizures. If I prescribe it for pain, I explain it like this: Gabapentin can be used at really high doses, and is strong enough to prevent a seizure. I compare that dose to a very high volume, like listening to music so loud it might give you a headache. On the other hand, a low dose of gabapentin, like playing a stereo quietly in the background so the music is barely noticeable, calms overexcited nerves. This is how I and others use it to treat diabetic neuropathy, sciatica and even nerves injured from normal surgery.

All of this may seem complicated, and brings up many good questions that providers and patients have. Let me respond to the questions with a series of answers.

Can all three pain types occur together?

A way around opioids: Target the type of pain for better pain relief
A patient after surgery may feel three kinds of pain at once. gpointstudio/Shutterstock.com

Yes, people can have only one pain type or all three pain types at the same time. After surgery, a patient will have nociceptive, neuropathic and inflammatory pain. So in this case, using a combination of medications is more effective and safer than trying to treat all the pain types with one drug.

This means that a person with all three types of pain may take multiple medicines to most effectively treat it all. Low doses of combinations of medications are often more effective and safer. This is why when drugs become generic, they often are combined into combo pills for the best effect. This is known as synergism. But, this also means that if a person only has one type of pain, a single targeted prescription may be all they need.

Are opioids still good medicines to use?

Yes, targeted pain treatment with non-opioid pain medicines may not be enough, and some patients will still need opioids. The severity of pain may be overwhelming, and opioids indiscriminately block pain sensation. Opioids are still an indispensable tool in the doctor’s toolkit for many diseases.

Are newer pain medicines being developed?

Yes, because of the opioid crisis, alternative options that are safer and have fewer side effects are appropriately being sought out. Many old drugs are being revived, reformulated and re-evaluated with new research methods. While researchers discover new benefits of ketamine and its cousin memantine for treatment of depression and memory loss respectively, each is finding resurgent use for treatment of pain.

Does marijuana treat pain?

A way around opioids: Target the type of pain for better pain relief
Marijuana can treat pain, but researchers need to understand the mechanisms better. BestStockFoto/Shutterstock.com

Yes, marijuana can treat pain. The active ingredients in marijuana are similar to fat molecules our own body makes, called endocannabinoids. Endocannabinoids are retrograde messengers, meaning they travel backwards from one nerve to the nerve upstream to turn it off. But, turning off nerves indiscriminately can have some pretty horrible side effects, so researchers are trying to identify exactly which cannabinoids work best in specific body areas and for specific disease types. Once we have better research data, using marijuana-like molecules may become a targeted pain treatment.

Today, in this decade, targeted pain treatment is modern medical practice. I believe future decades will look different, as newer medicines are developed and non-medicine options are emphasized. Already, even major surgeries are being done using targeted pain treatment with improved pain control and with safer outcomes. Non-medicine pain control options coupled with targeted pain medicine treatments when needed, is what the doctor should be ordering today.

Opiate addiction and the history of pain and race in the US

“I have had little or no sleep, owing to the tooth ache or rather stump ache,” Elizabeth Drinker wrote in her diary one night in 1796. “One of my Eye teeth very sore, my face much swelled and painful.”

Drinker, a white woman from a prominent family in Philadelphia, filled her diary with comments like this. Disease was rampant in those days, and injuries often didn’t heal properly. Food was frequently spoiled, leading to painful stomach problems. Cavities and severe gum disease were common. These and other problems meant that pain – severe, intractable pain – was an ordinary part of daily life.

Of course, many people suffered far more than Elizabeth Drinker. Slaves, in particular, were forced to perform long hours of grueling work, and their injuries and illnesses were often left untreated. They also suffered from brutal physical punishment. In his 1845 autobiography, Frederick Douglass described how the overseer on his plantation whipped his aunt: “No words, no tears, no prayers, from his gory victim, seemed to move his iron heart from its bloody purpose. The louder she screamed, the harder he whipped; and where the blood ran fastest, there he whipped longest.”

It is worth considering this history in the current opiate crisis. I am a researcher who has closely studied drug use in the U.S. in the 19th century. I see many parallels between the past and today in the shameful way people of different races are treated when it comes to pain and to drug addiction.

Rise of narcotics

When Drinker was alive, people did not have many options for treating pain. The only really effective treatment was opium, taken as a tincture in an alcohol solution. Opium could dull minor and perhaps moderate pain, but if you crushed your foot in an accident, nothing could be done for your agony.

Plus, since opium also caused constipation, nausea and vomiting – all of which could be serious medical problems in their own right – people only used it in modest amounts.

Slaves were rarely given opium for their pain. Their illnesses and injuries were often left untreated. But it was also widely assumed that different types of people felt pain more or less strongly. The poor supposedly felt less pain than the rich, while men felt less pain than women and blacks felt less than whites. Physicians and slave owners therefore believed that when slaves claimed to be hurt, they were probably lying. They also believed that whippings had to be severe to be effective.

Opium was not particularly helpful for severe pain, but injected morphine was. Morphine was first isolated from opium around 1805, but it was rarely used for the next five decades, because it was difficult to tolerate when taken by mouth. In 1856, Scottish physician Alexander Wood invented the hypodermic needle. He discovered that injected morphine gives fast and highly effective relief for even excruciating pain.

Injected morphine was first widely used during the Civil War. After the war, it was used to help wounded veterans cope with their injuries, and then became a popular way to treat acute pain of all kinds.

Responses to addiction

For many people, morphine was a godsend. However, serious problems accompanied its widespread use. People began to inject morphine for recreational purposes and to escape despair. Suicide and overdoses became common. Others became addicted to morphine as well as other intoxicating drugs at the time, including cocaine and hashish.

By the end of the century, physicians were debating whether or not addiction should be considered a disease. Reformers passed the first wave of laws intended to control narcotics and other drugs. They also established treatment facilities to help people recover from their addiction.

Opiate addiction and the history of pain and race in the US
Clear glass shop round for liquid morphine. Science Museum, London, CC BY

According to historian Timothy Hickman, these efforts divided drug users into two types. People who became addicted after using morphine or other drugs to treat their pain were often described as sympathetic victims and given help. People who used drugs for recreational reasons, however, were considered “degraded” and put in prison.

In practice, of course, the difference between the two categories was often blurry. People who became addicted trying to control their pain were frequently incarcerated under the faulty assumption that their continued use was a personal choice. They were also mistaken for people who took drugs solely for recreational reasons.

There was also an important racial component to all this. After the Civil War, the widespread suffering of freed slaves was ignored by policymakers and the media as part of the effort to reunite the nation. It was also ignored by white physicians. Although statistics from the period are unreliable, it appears that blacks were prescribed morphine significantly less often than whites – in part because they received less medical care and in part because white physicians assumed that they suffered less physical pain.

Like whites, blacks sometimes used other drugs that authorities found concerning. Unlike whites, however, blacks were rarely offered sympathy or treatment for their addiction. White authorities almost always assumed that blacks used these substances for “degraded” reasons. Although whites were sometimes given sympathy and treatment even if they were considered degraded, blacks rarely were. Black addicts simply were not understood as sympathetic victims in the same way as many whites. They were seen only as dangerous criminals and often described in racist terms.

Lessons for today

Today, Americans live with the consequences of this history. We all benefit from the ability of physicians to relieve serious pain by prescribing narcotics. Yet these drugs also cause immense harm, just as injected morphine did more than a century ago. And many still have a deeply confused reaction to addiction, mistaking people who cannot control their drug habits with people who take drugs for other reasons.

The mistaken belief that blacks suffer from less physical pain than whites still persists among medical students and physicians. So does the assumption that black people are more likely to seek narcotics for supposedly illegitimate reasons. Black people receive less treatment for both acute and chronic pain than whites.

Prescription practices by physicians are only one cause for opiate addiction in this country. Illegal drug use also plays an important role in both white and black communities. Blacks use illegal drugs at roughly the same overall rate as whites, yet their rate of incarceration is three to four times higher. They also receive less effective treatment for drug addiction than whites.

The lessons here are stark. As a country, the U.S. responds to drug epidemics in very different ways depending on the skin color of the communities involved. At the same time, we have historically treated the pain of whites far more seriously than we have that of blacks. In my view, the country needs more treatment, and less prison, for people who struggle with addiction. We also need effective pain relief for everyone.

Drug shortages pose a public health crisis in the US

On June 12, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.

The Food and Drug Administration defines a drug shortage as a “period of time when the demand or projected demand for a medically necessary drug in the U.S. exceeds its supply.” All too often, a shortage means that doctors cannot give the right drugs to patients when needed.

Serious drug shortages are not a new phenomenon. The FDA recognized their prevalence and established a Drug Shortage Program back in 1999. The problem, however, persists.

In short supply

Currently, the U.S. is short on 182 drugs and medical supplies, according to the American Society of Health-System Pharmacists. The list includes IV bags, injectable morphine and other powerful painkillers, anesthetics, antibiotics, electrolytes, cancer drugs and much more. All of these are of critical importance to patients with serious illnesses.

Why do drug shortages occur? The AMA blames the current crisis in part on the damage caused to production facilities in Puerto Rico by hurricanes Irma and Maria in 2017. Furthermore, the government’s efforts to combat the opioid crisis by reducing the availability of opioids has hampered the ability for hospitals to obtain necessary painkillers. Production delays at manufacturing plants or delays in procuring raw materials from suppliers can also contribute to shortages.

Some companies choose to stop manufacturing a drug in order to focus on newer, more lucrative medicines. If a manufacturer is one of only a few producers or the primary producer, even a temporary stoppage can have harmful market effects. For example, only seven companies make most of the sterile injectable drugs sold in the U.S. If one of these has difficulty or discontinues production, it would be very hard for the others to make up the difference.

Dangerous outcomes

Drug shortages have serious consequences. Most importantly, they often endanger patients’ lives. When health care providers cannot administer needed drugs, they cannot provide proper treatment.

The Institute for Safe Medication Practices conducted a survey of almost 300 health care providers in 2017. A majority of participants felt that drug shortages had affected their patients. Seven in 10 stated shortages made them unable to provide some patients with recommended treatments. Almost half believed that as a result, their patients received less effective therapies.

In addition, 75 percent of participants stated that they were forced to delay patient treatments because of shortages. In one case, a delay in treating sepsis with sodium bicarbonate may have contributed to a patient’s death. Other poor outcomes included more pain or discomfort during procedures because appropriate drugs were unavailable.

Drug shortages also contribute to increased health care costs. Medical staff must spend time managing drug shortages. They must track inventory, identify alternatives and make decisions about rationing scarce resources.

In addition, some vendors engage in price gouging when selling drugs in short supply. The cost of this deplorable practice may reach over US$400 million a year.

Drug shortages can have other consequences for doctors and patients. Physicians face the unenviable task of explaining to patients that they cannot receive needed drugs. This can be demoralizing for patients and make them lose trust in the medical profession. Additionally, insurers may refuse to pay for a treatment that is substituted for a drug in shortage. They may insist the alternative medication is not standard therapy and therefore will not be covered.

Finally, drug shortages can adversely affect medical research. If drugs that are being studied are unavailable, research projects may have to be postponed, suspended or canceled.

Tackling the problem

By law, manufacturers are required to report the expected duration of shortages and the reasons for them to the FDA. They must also provide notifications of production discontinuances and temporary interruptions.

FDA states that it posts information about drug shortages on its website. However, it is not clear where on the website this data is placed. Indeed, many health care providers indicate that they do not consistently receive information that could help them prepare for shortages.

The FDA states that it works with manufacturers to resolve drug shortages as quickly as possible.

Fortunately, in recent years, there have been fewer drug shortages than earlier in the decade. However, the number still hovers around 200 annually. In my view, this figure remains unacceptably high and all too often compromises patient care. The drug shortage crisis must remain a priority for the government, the health care industry and the public at large.

As Venezuela’s public health system collapses, mosquito-borne viruses re-emerge

The ability to predict which virus will cause the next epidemic is a science, an art and a gamble. We have learned through our work in Venezuela that it’s always a good idea to pay attention to the cryptic viruses.

During our work on the Zika virus epidemic in Venezuela, we may have spotted the emergence of a potentially dangerous virus that appears to be crossing from horses to humans: Madariaga virus. By using a diverse toolkit of approaches, we were able to look behind the curtains of the Zika virus epidemic to see what might be coming next. Time will tell if Madariaga virus will spread across Venezuela’s borders, but continued research will allow us to be prepared if it does.

As scientists, we aim to learn from past outbreaks and hope those lessons are applicable to future situations. We try to be proactive, because being caught unprepared and having to react to an outbreak comes at a cost that is often paid in human lives.

Being prepared includes keeping a close watch on human and animal viruses in circulation. This is referred to as virus surveillance. We pay attention to animal viruses because many of today’s deadly viruses such as Ebola virus and Middle East respiratory syndrome coronavirus (MERS-CoV) are animal viruses that now affect humans. Surveillance is especially important for mosquito-transmitted viruses, particularly when public health systems are overburdened and mosquito control is limited.

Moreover, viruses frequently mutate, and it is important to track whether they are changing into more virulent versions. Billions of dollars and countless hours in the laboratory have been invested toward developing vaccines to protect humans and other animals such as horses and livestock against mosquito-transmitted viruses, but vaccines are not available for many of the important viruses.

We began working on mosquito-transmitted viruses during the 2016 outbreak of Zika virus in Venezuela, along with Dr. J. Glenn Morris of the Emerging Pathogens Institute and with Dr. Alberto Paniz-Mondolfi, a physician based in Barquisimeto, Venezuela. We teamed up with the Incubadora Venezolana de la Ciencia, a group of Venezuelan medical students, interns and physicians based in Barquisimeto.

As a native Venezuelan, G. Blohm had watched the country’s public health system collapse under the weight of an unprecedented economic crisis. She had watched hundreds of people leave the country. She, too, had left the country with a heavy heart after her family suffered repeated assaults and threats of kidnapping. She had seen better days in this beautiful place and has not stopped believing in the potential of its land and of its people. She knew that Venezuela’s crisis could affect neighboring countries and hoped to assist in monitoring the spread of mosquito-transmitted diseases within and across Venezuela’s borders.

Because the study of mosquito-transmitted diseases involves an element of chance, we could not have predicted what we would find.

Viruses are often puzzling

Mosquito-transmitted viruses can be deceiving. The illnesses they cause are often misdiagnosed or the virus is not detected. They can hide behind similar early clinical symptoms, yet there can be vast differences in long-term consequences to the patient.

This is true for dengue, Chikungunya, Zika and other mosquito-transmitted viruses, which can elicit similar symptoms during the early phase of infection in those affected, yet the long-term effects can vary significantly. It is therefore important to have the capacity to detect and identify these viruses in diagnostic laboratories.

In preparing for outbreaks of mosquito-transmitted viruses, it’s important also to understand the biology of each virus, its genetic makeup, proper methods for diagnosis and the clinical symptoms it can cause.

The genetic code of a virus contains information about its geographic origins and its relatedness to other viruses. Knowing its relatedness to other viruses can sometimes – but not always – give clinicians some clues about the symptoms it may cause. Uncovering the genetic code of a virus requires detection and isolation of the virus in the laboratory.

How to detect a virus

There are several ways to detect a virus: One can look for antibodies in the patient, or if the laboratory has the capacity and the timing is just right, one can actually retrieve (i.e., isolate) the virus from the patient. Some laboratory tests rely on antibodies to discern whether a patient has been infected with a particular virus in the past.

These tests, although common, are less precise and can be misleading: Antibodies to closely related viruses react against similar viruses. This cross-reactivity can confound diagnosis in countries wherein many of the viruses co-exist.

Isolation of a virus is more precise, and it is as much a science as it is an art. The patient’s specimen needs to be collected properly, during the right time of infection, and the procedures used need to be just right for each type of virus. Ascertaining the correct procedures for isolating viruses requires years of training and experience. And the processes used require special equipment, instruments and facilities, making them impractical or impossible in resource-strapped laboratories.

As Venezuela's public health system collapses, mosquito-borne viruses re-emerge
The author preparing to work in the lab in Gainesville, Fla., June 12, 2018. Caroline Stephenson, CC BY-SA

Viruses do not cause epidemics in a vacuum. In many cases, there are social and environmental conditions that set the stage for an outbreak. In Venezuela, the deterioration of the political and economic infrastructure, and the destruction of the country’s public health system have created conditions that make the inhabitants of this once prosperous country susceptible to outbreaks. Venezuela, which in the 1950s was the world’s fourth wealthiest nation per capita, currently has the highest inflation rate in the world.

Mosquito-transmitted diseases that were once under control such as Dengue Fever have reached record high levels, with no signs of receding. Other less well-known viruses are on the rise in Venezuela: some are inching their way across the barrier between domestic animals and humans. Madariaga virus (MADV) is one such virus which we suspect has crossed this barrier.

Madariaga virus

Madariaga virus is a South American virus that is genetically similar to Eastern equine encephalitis virus (EEEV). Scientists know much more about EEEV, which is a mosquito-transmitted virus that infects horses, humans and other animals. Although rare in humans, EEEV causes severe infections wherein up to 33 percent of those infected die, usually due to encephalitis, or inflammation of the brain. Those that survive have significant brain damage. There is no vaccine to protect humans against EEEV or cure for the illnesses it causes.

Recent genetic studies reveal that MADV is distinct from but nevertheless closely related to EEEV, and is found in Central and South America. Antibody tests suggest the virus infects humans and caused an outbreak among Panamanians in 2010, but until now, the virus itself only had been isolated from or detected in horses, rodents and mosquitos.

During our work on the Zika outbreak in Venezuela, we may have unveiled a more cryptic outbreak of MADV in humans. We detected the virus in the blood of a Venezuelan child who had initially been thought to have Zika. The child had developed a fever, rash and joint pains, but his infection did not progress. And, he did not develop encephalitis. The child developed an infection at a time when veterinarians reported cases of neurologic disease among horses in the locality of the patient’s area of residence; the horses were thought to be infected with EEEV. Whereas laboratory confirmation of EEEV or MADV was not possible due to the situation in Venezuela, it is plausible that the horses were infected with MADV. The presence of the virus in this child, though, provides evidence that MADV infects humans.

We scientists have learned repeatedly that viruses like MADV and their mosquito vectors do not honor national borders, and that preventing their spread into surrounding areas requires international efforts. Preparedness and continued research will allow us to come out ahead of the next epidemic, which may very well have its origins in a country whose public health infrastructure is in disrepair. The entire global community needs continued research on the biology, the genetics and the clinical symptoms of MADV.

Fathers forgotten when it comes to services to help them be good parents, new study finds

Fathers have a significant impact on their children’s well-being – an impact that begins even before the child is born. In fact, studies have shown that fathers who are involved during pregnancy have healthier children.

During the early years of life, emotionally nourishing father-child relationships lay the foundation for lifelong health and well-being for children. Fathers who are involved during pregnancy also tend to stay involved over the long term. Indeed, the positive influence of father involvement can be felt throughout adolescence and young adulthood.

Our research lab studies father-child relationships, and we recently looked at the question: What early parent education programs are out there to support fathers during the prenatal and postnatal periods? Our study, published on June 14 in the journal Pediatrics, suggested that there are not that many.

Not many father-friendly early parent education programs

Fathers forgotten when it comes to services to help them be good parents, new study finds
Studies suggest that fathers want to be involved but may not know how to do so. Antonio Guillem/Shutterstock

Specifically, our systematic review examined U.S.-based parent programs for men during the perinatal period, i.e., pregnancy through the first year of life. We could identify only 19 programs (out of a total of 1,353 studies reviewed) that were considered “father-friendly.” Father-friendly was defined as involving or targeting fathers and including outcomes related to fathering, such as father involvement, father-infant interaction and father’s parenting knowledge.

Most programs were offered in clinic or hospital settings. Programs ranged from general education programs (on childbirth, infant care and infant development) to relationship and co-parenting programs to clinical and case management programs.

In addition to the small number of existing programs for fathers, most programs reviewed in the systematic review lacked evidence of improving key fathering outcomes. Relatedly, only three studies were considered high quality. These findings demonstrate the dearth of father-inclusive programs that yield promising outcomes.

Overall, when it comes to education and support during the perinatal period, research shows that there are few parenting programs to prepare men for the magic moment when they welcome their new baby, even though this time has been identified as a critical window of opportunity to intervene to support fathers during their transition to fatherhood.

Most existing programs are designed primarily for mothers. This is a missed opportunity, because fathers in the U.S. are increasingly involved in their children’s lives. And fathers today want to be involved not just as breadwinners, but also as caregivers who provide nurturing and responsive parenting.

Father-friendly practices by health care professionals

Fathers forgotten when it comes to services to help them be good parents, new study finds
A father and newborn. Fathers have reported that they feel neglected in obstetric and pediatric settings. ESB Studios/Shutterstock

In obstetrics and pediatrics settings, fathers participating in research have reported feeling neglected. They are often viewed as playing a secondary role to mothers. This may entail the father seeing himself as a “helper” of the mother instead of a “co-parent” alongside the mother.

This neglect persists for several reasons. For instance, health care professionals may be unwilling or inadequately trained to work with fathers. Clinical services may not be sensitive to men’s parenting needs. Further, mothers might limit men from being engaged in prenatal and postnatal services.

Yet, men have a vital role to play during infancy. To help address the above barriers, Michael Yogman and Craig Garfield, pediatric faculty at the Harvard Medical School and Northwestern Feinberg School of Medicine respectively, recommended that health care professionals engage in father-friendly practices. These include acknowledging fathers’ presence at health care visits, welcoming fathers directly, educating fathers about parenting, and encouraging fathers to assume childcare roles early on.

Innovative early parent education programs for fathers

Although there aren’t many yet, innovative parent education programs targeting men during the perinatal period are emerging. One example is Dads Matter, a father-friendly home visitation program that may improve fathers’ engagement with their babies among socioeconomically disadvantaged families.

Another emerging program is Baby Elmo. This is an interactive program that helps fathers understand their babies’ emotional needs to support positive father–child interactions. Baby Elmo is currently being tested for its effectiveness within low-income communities.

Our research lab is implementing a father engagement program for low-income fathers, in collaboration with Healthy Start home visitation programs in Michigan.

Yet another promising program is Supporting Father Involvement by Philip Cowan, emeritus professor of psychology at the University of California, Berkeley. Supporting Father Involvement is a group-based relationship program that has been successful in promoting father involvement with young children.

On the whole, these programs help ensure that American children – especially those at the highest risk of living apart from their fathers – grow up in households where their fathers or father figures are positively involved from the very beginning.

Fathers play a key role in children’s lives, starting from the very beginning of life. Their involvement in pregnancy is just as important as the involvement of mothers. We celebrate mothers on Mother’s Day and offer multiple programs and resources for helping women navigate motherhood.

We also celebrate our fathers on Father’s Day. However, we leave them with almost no resources for navigating the transition to fatherhood. This disparity in services is inevitably hurting not only fathers, but also their children. It’s time to change this narrative.