Austin Frakt

A recent study of patients at 10 academic hospitals in the United States found that just over half care about what their doctors wear, most of them preferring the traditional white coat.

Some doctors prefer the white coat, too, viewing it as a defining symbol of the profession.

What many might not realize, though, is that health care workers’ attire — including that seemingly “clean” white coat that many prefer — can harbor dangerous bacteria and pathogens.

A systematic review of studies found that white coats are frequently contaminated with strains of harmful and sometimes drug-resistant bacteria associated with hospital-acquired infections. As many as 16% of white coats tested positive for methicillin-resistant Staphylococcus aureus, and up to 42% for the bacterial class Gram-negative rods.

Both types of bacteria can cause serious problems, including skin and bloodstream infections, sepsis and pneumonia.

It isn’t just white coats that can be problematic. The review also found that stethoscopes, phones and tabletscan be contaminatedwith harmful bacteria. One study of orthopedic surgeons showed a 45% match between the species of bacteria found on their ties and in the wounds of patients they had treated. Nurses’ uniforms have also been found to be contaminated.

Among possible remedies, antimicrobial textiles can help reduce the presence of certain kinds of bacteria, according to a randomized study. Daily laundering of health care workers’ attire can help somewhat, though studies show that bacteria can contaminate them within hours.

Several studies of American physicians found that a majority go more than a week before washing white coats. Seventeen percent go more than a month. Several London-focused studies had similar findings pertaining both to coats and ties.

A randomized trial published last year tested whether wearing short- or- long-sleeved white coats made a difference in the transmission of pathogens. Consistent with previous work, the study found short sleeves led to lower rates of transmission of viral DNA. It may be easier to keep hands and wrists clean when they’re not in contact with sleeves, which themselves can easily brush against other contaminated objects. For this reason, the Society for Healthcare Epidemiology of America suggests clinicians consider an approach of “bare below the elbows.”

With the use of alcohol-based hand sanitizer — often more effective and convenient than soap and water — it’s far easier to keep hands clean than clothing.

But the placement of alcohol-based hand sanitizer for health workers isn’t as convenient as it could be, reducing its use. The reason? In the early 2000s, fire marshals began requiring hospitals to remove or relocate dispensers because hand sanitizers contain at least 60% alcohol, making them flammable.

Fire codes now limit where they can be placed — a minimum distance from electrical outlets, for example — or how much can be kept on site.

Hand sanitizers are most often used in hallways, though greater use closer to patients (like immediately before or after touching a patient) could be more effective.

One creative team of researchers studied what would happen if dispensers were hung over patients’ beds on a trapeze-bar apparatus. This put the sanitizer in obvious, plain view as clinicians tended to patients. The result? Over 50% more hand sanitizer was used.

Although there have been fires in hospitals traced to alcohol-based hand sanitizer, they are rare. Across nearly 800 American health care facilities that used alcohol-based hand sanitizer, one study found, no fires had occurred. The World Health Organization puts the fire risk of hand sanitizers as “very low.”

An article in The New York Times 10 years ago said the American Medical Association, concerned about bacteria transmission, was studying a proposal “that doctors hang up their lab coats — for good.” Maybe one reason the idea hasn’t taken hold in the past decade is reflected in a doctor’s comment in the article that “the coat is part of what defines me, and I couldn’t function without it.”

It’s a powerful symbol. But maybe tradition doesn’t have to be abandoned, just modified. Combining bare-below-the-elbows white attire, more frequently washed, and with more conveniently placed hand sanitizers — including wearable sanitizer dispensers — could help reduce the spread of harmful bacteria.

Until these ideas or others are fully rolled out, one thing we can all do right now is ask our doctors about hand sanitizing before they make physical contact with us (including handshakes). A little reminder could go a long way.

This article originally appeared in <a href="https://www.nytimes.com/2019/04/29/upshot/doctors-white-coat-bacteria.html" id="958d275b-a19d-3f75-ae0c-7878a73ecb0b">The New York Times</a>.

Why Your Doctor's White Coat Can Be a Threat to Your Health

(The Upshot) ; (The New Health Care)

People rarely follow a doctor’s orders to the letter.

We often seek treatments that meet our preferences, and adapt them to our personal routines and responsibilities.

This isn’t necessarily a problem. A treatment you don’t (or can’t) follow won’t help you, so the odds are better if you pick one you can.

In addition, not every treatment works for everyone — sometimes the best treatment we have works for just 1 of 10 people.

These truths came to mind as I recently addressed my plantar fasciitis — an injury to the tissue in the underside of the foot causing heel pain and afflicting about 10% of the population. I’d unwisely been trying for about six months to ignore the condition in both my feet. I kept walking to work and standing once I got there (by choice — I have a desk job) despite the discomfort.

Predictably, this rigid adherence to my lifestyle caused only more harm. Yielding a bit to my screaming feet, I stopped standing at work and cut my walking to a minimum, swimming for exercise instead.

This helped, but not enough to heal fully. The pain diminished but didn’t cease. Clearly, I needed to bend a little more, but which way and how much? Those are questions medical science and doctors cannot answer precisely.

Although somewhat disappointing, this is also empowering. There are dozens of therapies for the condition. I prioritized those that were recommended by doctors and for which there is good evidence, and that I felt I could stick with.

Although sometimes more invasive approaches are necessary with some modification of activity, most soft tissue injuries heal themselves in time. For 90% of patients, nonsurgical approaches to plantar fasciitis heal in four to six months. After that, you are looking at years to a lifetime of maintenance to avoid relapse. “Treatment” is really “lifestyle change.”

To help me commit to the long haul, I made a log to track progress. I gave myself credit each day I did what my selected regimen required. Not wanting to break my streak enhanced my motivation. I rated my pain and function daily. Healing is slow and often with setbacks, but it’s gratifying to look back over the weeks and months and see that there is, nonetheless, gradual progress.

And what does one do over this duration? As with other soft-tissue injuries, addressing plantar fasciitis usually includes a mix of reducing and replacing injuriously repetitive body mechanics (which I had already done), calming inflammation or repairing tissue micro tears, and increasing flexibility and strength.

To choose an approach, I listened to my doctor’s advice. I also searched online and talked to friends who’d had the condition. And I consulted medical research to see if what was recommended had any validity. Finally, I targeted and stuck with treatments I felt I could fit into my life, always knowing that if they didn’t work, I could make a bigger change later. For example, though some studies support it, I did not pursue acupuncture because of the time involved in going to appointments.

There are several noninvasive or home-based remedies for plantar fasciitis. Among the most common are orthotics, night splints (which hold your foot flexed to stretch the plantar fascia and Achilles’ tendon) and physical therapy (or at-home stretching/strengthening).

What does the research say about these? Orthotics help. Evidence shows that over-the-counter ones are just as effective as custom-made ones, and cost about one-tenth. They’re a set-it-and-forget-it approach. Unless they’re a bad fit, you won’t notice them, and there’s nothing to do to use them but stick them in your shoes. This was easy to work into my life. I bought some.

To provide additional support, you can also apply kinesiology tape, a stretchable athletic tape. A few studies suggest a benefit. I tried this, but only when I could not avoid long walks. At a few dollars per application to your foot, the tape is expensive. It also takes a few minutes to apply. Although perhaps a bit helpful, I didn’t perceive it worth it for daily use.

Night splints also work. Combining them with orthotics can accelerate healing. They can be difficult to sleep with, however. There are lots of types, but for each one there are at least some patients who say they disrupt rest. I used them as much as I could (about three hours per night) and abandoned them as I felt better so that I could more easily sleep. To a large extent, lifestyle considerations (adequate sleep) triumphed over this therapeutic approach.

The evidence on the effectiveness of stretching for plantar fasciitis is not strong. Nevertheless, it is frequently recommended, and I did find that it helped relieve discomfort in the short term. There are dozens of stretches. A study that compared two popular ones — a standing calf stretch and a seated foot stretch — found the foot stretch to be superior. Whatever stretching I did, I made sure to include that one.

At three times per day for about 10 minutes, a full stretching regimen takes considerable time. To fit it in without much disruption, I often did the foot stretching under the table during meetings and on conference calls. As for the calf stretch, I could do some of it while brushing my teeth or waiting for the train during my commute.

Trigger point therapy — massage, basically — can also help. If nothing else, it feels good. I threw that into my therapeutic mix, too, working my feet with massage balls as I typed and my calves with my hands as I read.

Finally, there’s strengthening. Here, there is good evidence that some approaches are very helpful, including a heel-raising variant. It’s very tiring and time consuming, particularly if done according to the clinical trial (three or more sets per session), and requires a step off which to hang one’s heel.

The “short foot” exercise — pulling your toes toward your heels and arching the foot upward — may also be helpful. It requires no equipment and can be done surreptitiously anywhere. Now pain free, I’m doing both. I brought a yoga block to work so I could do heel raises during calls.

There is a lot of gray area in medicine. This mix of approaches worked for me, in large part because I found a way to fit its elements into my day, abandoning those I could not. Your approach — for this or any condition — may be different from mine. But one similarity may be that it is shaped not just by medical science, but also by the realities of life.

This article originally appeared in <a href="https://www.nytimes.com/2019/04/15/upshot/plantar-fasciitis-healing-feet.html" id="b5930f92-0f05-3b1b-a97b-72d7f654ec76">The New York Times</a>.

(The Upshot: The New Health Care)

Healing Your Feet, and Finding a Balance in Following Doctor's Orders

Sometimes the seemingly small things in life can be major stressors.

Nobody likes sitting in traffic, for example. According to one study, commuting is one of the least pleasant things we do. But it is not just an annoying time waster — there is a case that it is a public health issue.

According to analysis by the Texas A&amp;M; Transportation Institute, the average American commuter spends 42 hours per year stuck in rush-hour traffic. In the Los Angeles area, the figure is nearly twice that, equivalent to more than three days. A 2015 Los Angeles Times poll found that among residents of that city, traffic concerns exceed those pertaining to personal safety, finances or housing costs.

The total cost of traffic associated with lost time and wasted fuel exceeds $100 billion per year. As time slips away, idling vehicles add pollution, which has environmental and health consequences, including contributions to climate change. Long-term exposure to vehicle exhaust is associated with respiratory problems, especially in children.

Another toll is to psychological well-being, stemming from the sense of helplessness we experience in traffic, and its unpredictability. This, too, can be quantified. One study found that to save a minute of time spent in traffic, people would trade away five minutes of any other leisure activity. Another study found that we deal better with the commuting delays that we can anticipate.

Stressed-out people can take out their frustration on others. We have probably all experienced or seen road rage, but aggressive behavior can carry over beyond a commute.

A recent analysis of Los Angeles traffic, published in the Journal of Public Economics, documented a link between congestion and domestic violence. From 2011 to 2015, the study found, extreme evening traffic on two major highways — Interstate 5 and Interstate 10 — increased the incidence of nighttime domestic violence by about 9 percent.

What the researchers, Louis-Philippe Beland, an economist at Louisiana State University, and Daniel Brent, an economist at Penn State, mean by “extreme traffic” in their study is best explained with an example: The average evening commute along I-10 for residents of Santa Monica in their study was 45 minutes. Extreme traffic would increase this to 87 minutes.

“Life stressors act as emotional cues,” Beland said. “What our work shows is that in extreme cases some people’s responses to those cues can be quite large, leading to violence.”

Teaching children how to manage stress and traumatic events from a young age can be important.

“Throughout life, mindfulness, healthy eating, sleeping and exercise, and hobbies that blow of steam all help,” said Rebecca Mooney, director of Melrose Alliance Against Violence, which raises awareness about domestic violence and related issues in and around Melrose, Massachusetts.

Officials are not powerless before the problems that stressful commutes can cause. Los Angeles has put in a system that charges solo drivers more to use certain lanes of the I-10 and I-110 highways during periods of heavy traffic. This encourages drivers to move their commutes to less congested times or routes. A study of congestion pricing on Seattle’s State Route 520 Bridge found that drivers using the route and its alternatives were less stressed and more satisfied with their commutes after the pricing change.

In addition, many states have been replacing tollbooths with electronic and cashless tolling systems like E-ZPass. More employers are allowing people to work remotely. Troubled transit systems in some cities may be partly behind an increase in car ownership in those areas, but certain West Coast cities are making sweeping expansions of their public transit systems and many cities are adding bike lanes.

Those who can walk or bike to work tend to have a double advantage. Not only do they avoid the harmful consequences of traffic, but they can also improve their health through exercise. Younger people are more likely to prefer that style of commutingand are driving less than previous generations.

There may be more good news in coming decades for those who loathe gridlock. Although self-driving cars will not cure traffic woes on their own — the way that economics-based approaches like congestion pricing can — they may be able to reduce stress.

If you are crawling along in traffic and are late to an appointment, but are allowed to take a nap, play video games, watch your favorite TV show or sip on a cocktail, will that reduce your stress? We don’t know for sure, but we look forward to the studies on that.

This article originally appeared in <a href="https://www.nytimes.com/2019/01/21/upshot/stuck-and-stressed-the-health-costs-of-traffic.html" id="967a43c6-af93-380f-a5c6-240a208499d3">The New York Times</a>.

(The New Health Care)

Stuck and Stressed: The Health Costs of Traffic

Some significant expenses decline as we age: Most mortgages are eventually paid off, and ideally children grow up and become self-supporting.

But health care is one area in which costs are almost certain to rise. After all, one of the original justifications for Medicare — which kicks in at age 65 — is that older people have much higher health care needs and expenses.

But there are a few common misunderstandings about health costswhen people are older, including the idea that money can easily be saved by reducing wasteful end-of-life spending.

No, Medicare will not cover it all. There are gaps.

Half our lifetime spending on health care is in retirement, even though that represents only about 20 percent of a typical life span. Total health care spending for Americans 65 and older is about $15,000 per year, on average, nearly three times that of working-age Americans.

Don’t expect Medicare to provide complete protection from these expenses.

Traditional Medicare has substantial gaps, leaving Americans on the hook for a lot more than they might expect. It has no cap on how much you can pay out of pocket, for example. Such coverage gaps can be filled — at least in part — by other types of insurance. But some alternatives, such as Medicare Advantage, are not accepted by as many doctors or hospitals as accept traditional Medicare.

On average, retirees directly pay for about one-fifth of their total health care spending. Some spend much more.

One huge expense no Medicare plans cover is long-term care in a nursing home.

Over half of retirement-age adults will eventually need long-term care, which can cost as much as $90,000 per year at a nursing home. Although most who enter a nursing home do not stay long, 5 percent of the population stays for more than four years. You can buy separate coverage outside the Medicare program for this, but the premiums can be high, especially if you wait until near retirement to buy.

Medicaid plays a bigger role than expected

Although Medicare is thought of as the source of health care coverage for retirees, Medicaid plays a crucial role.

Medicaid, the joint federal-state heath financing program for low-income people, has long been the nation’s main financial backstop for long-term care. Over 60 percent of nursing home residents have Medicaid coverage, and over half of the nation’s long-term care is funded by the program.

That is not because most people who require long-term care have low incomes. It is because long-term care is so expensive that those needing it can frequently deplete their financial resources and then must turn to Medicaid.

A recent working paper from the National Bureau of Economic found that, on average, Medicaid covers 20 percent of retiree health spending. The figure is larger for lower-income retirees, who are more likely to qualify for Medicaid for more of their retirement years.

It is really hard to predict when someone will die

A widely held view is that much spending is wasted on “heroic” measures taken at the end of life. Are all the resources devoted to Medicare and Medicaid really necessary?

First, let’s get one misunderstanding out of the way. The proportion of health spending at the end of life in the United States is lower than in many other wealthy countries.

Still, it is a tempting area to look for savings. Only 5 percent of Medicare beneficiaries die each year, but 25 percent of all Medicare spending is on individuals within one year of death. However, the big challenge in reducing end-of-life spending, highlighted by a recent study in Science, is that it is hard to know which patients are in their final year.

The study used all the data available from Medicare records to make predictions: For each beneficiary, it assigned a probability of death within a year. Of those with the very highest probability of dying — the top 1 percent — fewer than half actually died.

“This shows that it’s just very hard to know in advance who will die soon with much certainty,” said Amy Finkelstein, a Massachusetts Institute of Technology economist and an author of the study. “That makes it infeasible to make a big dent in health care spending by cutting spending on patients who are almost certain to die soon.”

That does not mean that all the care provided to dying patients — or to any patient — is valuable. Another study finds that high end-of-life spending in a region is closely related to the proportion of doctors in that region who use treatments not supported by evidence — in other words, waste.

“People at high risk of dying certainly require more health care,” said Jonathan Skinner, an author of the study and a professor of economics at Dartmouth. “But why should some regions be hospitalizing otherwise similar high-risk patients at much higher rates than other regions?”

In 2014, for example, chronically ill Medicare beneficiaries in Manhattan spent 73 percent more days in the hospital in their last two years of life than comparable beneficiaries in Rochester, New York.

“There absolutely is waste in the system,” said Ashish Jha, director of the Harvard Global Health Institute. But, he argues, waste is present throughout the life span, not just at the end of life: “We have confused that spending as end-of-life spending is somehow wasteful. But that’s not right because we are terrible at predicting who is going to die.”

Of course, beyond any statistical analysis, there are actual people involved and wrenching individual decisions that need to be made.

“We should do all we can to push waste out of the system,” Jha said. “But spending more money on people who are suffering from an illness is appropriate, even if they die.”

This article originally appeared in <a href="https://www.nytimes.com/2018/12/24/upshot/misconceptions-about-health-costs-when-youre-older.html" id="dfc17311-8cb4-3f69-abd2-9e4ad2cecfaf">The New York Times</a>.

Misconceptions About Health Costs When You're Older

Americans are generally uncomfortable with pharmaceutical prices — which are the highest for brand drugs among wealthy nations — and with drug companies’ profits. But if policies were adopted to reduce drug prices, could there be negative consequences? On balance, would such policies be good or bad?

I asked three health policy experts to consider these questions in the context of four specific drug pricing policies.

Coverage From Private Insurers

Most Americans, including those on Medicare, get drug coverage from private insurers, which negotiate prices with drug manufacturers. (Insurers often outsource that task to pharmacy benefit management companies.)

In a competitive market, insurers that drive the hardest bargains should be able to reduce premiums and cost-sharing. That would then attract more people to enroll, increasing insurers’ revenue.

But “consumers turn out to be fairly bad at shopping and do not respond to price decreases,” said Fiona Scott Morton, an economist at the Yale School of Management. She was an author of a study showing that consumers in Medicare tend to stick with whatever plans they originally selected, even as premiums rise.

Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, said: “A key disadvantage of Medicare’s drug benefit is that it has no real system in place for holding down drug prices. Drug manufacturers with monopoly products can raise prices to whatever extent the market will bear.”

Medicare rules that require insurance plans to cover all drugs in certain classes, including for cancer, help undermine plans’ ability to negotiate prices downward. Medicare “can’t walk away from the table” and refuse to cover a drug, he said.

Nicholas Bagley, a professor of law at the University of Michigan, pointed out that for many drugs — most commonly, generics — competition has lowered prices. “But for drugs that lack clinical substitutes — including some patented drugs and complex biologics — competition doesn’t work,” he said.

This is by design. Patents that the government provides to drug companies necessarily create monopolies. Therefore “we need another solution if we want private plans to get lower prices,” Bagley said.

Direct Deals With Drug Companies

Medicare could flex its market power by negotiating directly with drug manufacturers. There have been calls for Medicare to do so and polling shows that a majority of Americans favor it.

Other government programs, including Medicaid and the Department of Veterans Affairs, obtain steeper discounts than Medicare drug plans. In part this is because of government regulations that mandate price reductions. But those programs also negotiate directly with manufacturers, obtaining additional discounts. For example, the VA pays about 40 percent less for drugs than Medicare drug plans do.

“The VA obtains larger discounts in part because it can — and does — institute a more restrictive formulary than Medicare, meaning some drugs that are more costly but no better than alternatives are not as easily obtained in the VA as they are from a Medicare plan,” Kesselheim said.

Scott Morton said: “Direct negotiation by Medicare would only be effective if it could say, ‘No, we won’t cover your product’ to a drug manufacturer. Is that really plausible? I’m not sure that’s what Medicare beneficiaries would want.”

Medicare could save money if it could negotiate with manufacturers and exclude high-priced drugs. That would benefit taxpayers, but it would mean reduced access to drugs for the program’s current beneficiaries and slower innovation of drugs in the future.

“If Medicare doesn’t pay attention to a drug’s benefits during those negotiations, the pharmaceutical industry won’t have the right incentives to develop the drugs we need most,” Bagley said.

How Some Other Countries Do It

One way to better align a drug price with its clinical value is to follow the lead of other countries. Some simply refuse to pay if a drug is considered too expensive relative to the benefits it delivers. In Britain, for example, the National Institute for Health and Care Excellence advises the country’s National Health Service about which drugs to cover.

The institute considers a drug’s cost-effectiveness, as well as the type of condition it addresses and whether it is for a particularly vulnerable population. There is more leeway for drugs administered toward the end of life, for example.

Drug manufacturers have cut prices to get their products covered in Britain. In April 2014, NICE initially did not recommend Eli Lilly’s lung cancer drug Alimta on cost-effectiveness grounds. But when Eli Lilly dropped Alimta’s price, it gained NICE’s approval.

“If we stopped covering drugs that are 1 percent better but 1,000 percent more expensive, drug manufacturers would steer their research investments toward more effective drugs,” Bagley said. “The obstacle is political.”

Scott Morton said: “The main reason we do not have a NICE-like system in the U.S. is that drug manufacturers lose when insurers know which drug is most cost-effective. It is in pharma’s interest to protect their profits and lobby vigorously against any government body that would reveal which drugs have the highest value.”

Another consideration, according to Kesselheim: “We still might be willing to pay a lot for extremely effective new drugs.”

That is, if we are willing to pay according to value, some very high-value medications will command very high prices.

“A system with less wasteful drug spending for many other conditions should be able to better afford high prices in those circumstances,” he said.

‘Value-Based Insurance Design’

There is a more nuanced variation on Britain’s take-it-or-leave-it approach. An insurer or public program could use information about the price-benefit trade-off to establish not whether to cover a drug, but how generously.

The insurer or program could make a drug more accessible by cutting cost-sharing or by clearing away administrative hurdles. Often, for a lower price, insurers are more willing to provide easier access, which increases sales of that drug — a trade-off of volume for price.

This happened with the cholesterol medication Praluent, made by Regeneron and Sanofi and approved by the Food and Drug Administration in 2015. It was originally priced at $14,000 per year. At that price, the pharmacy benefit management firm Express Scripts — which manages drug benefits for 25 million consumers — covered the drug only if a patient went through a complex review process.

In March 2018, the Institute for Clinical and Economic Review estimated that a cost-effective price for the drug would be, at most, $8,000 per year for high-risk patients.

In exchange for more favorable coverage by Express Scripts, Regeneron and Sanofi agreed this year to lower the price of Praluent to the level the Institute for Clinical and Economic Review recommended. More patients will have access to the drug and it will cost insurers less per patient than originally priced.

“This kind of value-based insurance design is the holy grail, at least for new drugs,” Bagley said. “But we wouldn’t want to pay a value-based price for aspirin. Doing so would cause us to pay a lot more for it than we do today.”

Kesselheim said: “One reason imposing higher cost-sharing on less effective drugs isn’t as successful as it could be today is that drug manufacturers undermine the approach. They offer coupons to patients that counteract increased cost-sharing levels or provide physician offices with strategies to circumvent prior authorization paperwork.”

“Drug manufacturers offering financial assistance is an illegal kickback in Medicare,” Scott Morton said. “We would likely lower drug costs by extending that rule to the private sector.”

Ultimately, all these approaches have limitations.

“There isn’t one best model for drug pricing,” Bagley said. “What works for generics won’t work for patented drugs and we shouldn’t pay for antibiotics the same way that we pay for cancer drugs.”

That is why it is hard to boil realistic solutions down to a bumper-sticker slogan. Balancing prices and access to drugs for the patients of today with the innovation that will benefit those of tomorrow will take ingenuity, as well as a lot of political will.

This article originally appeared in <a href="https://www.nytimes.com/2018/12/10/upshot/how-to-cut-drug-prices-experts-weigh-in.html" id="7a3cc198-eef3-3e6f-a297-25d9d2909734">The New York Times</a>.

How to Cut Drug Prices: Experts Weigh In

This happened with the cholesterol medication Praluent, made by Regeneron and Sanofi and approved by the Food and Drug Administration in 2015. It was originally priced at $14,000 per year. At that price, the pharmacy benefit management firm Express Scripts — which manages drug benefits for 85 million consumers — covered the drug only if a patient went through a complex review process.

But don’t count on a single policy to address a nuanced problem.

“All low-priced drugs are alike; all high-priced drugs are high priced in their own way,” Craig Garthwaite, a health economist from Northwestern University’s Kellogg School of Management, wrote with a colleague.

Outside of a few government programs — like Medicaid and the Veterans Health Administration — low-priced drugs are alike in that competition is the sole source of downward pressure on prices. When many generic versions of a brand-name drug enter the market, competition can push their prices 80% below the brand price, or sometimes even more.

In contrast, high-priced drugs lack competition for various reasons, “not all of which imply our goal should be to reduce prices,” Garthwaite said.

Consider two drugs, Humira and Daraprim

Humira, an injectable drug from AbbVie, is a good example. It’s used to treat severe rheumatoid and other forms of arthritis, plaque psoriasis and Crohn’s disease. It’s also the best-selling prescription drug in the world, with a nearly $40,000 annual price tag per person (even accounting for rebates).

Since its approval by the Food and Drug Administration in 2002, Humira has been protected from direct competition by patents and FDA-provided market exclusivity. This government protection from competition is a source of profit intended as an incentive for innovation.

“One-size-fits-all incentives like patents and exclusivity periods may not provide the right incentive for Humira or any other drug,” said Rachel Sachs, associate professor of law at Washington University in St. Louis. “We probably are under-rewarding drug innovation for some types of diseases, such as early-stage cancers requiring long clinical trials, and over-rewarding it for others.”

Daraprim, currently manufactured by Vyera Pharmaceuticals (formerly Turing), treats a life-threatening parasitic infection. It was discovered in 1952. In 2015, Martin Shkreli, then Turing’s chief executive, increased Daraprim’s price by more than 5,000%, to $750 from $13.50 per pill.

Shkreli was able to do this because Daraprim lacked competition, but the reason was different from for Humira. Daraprim’s chemical structure and means of manufacture may be used by other drug manufacturers to make and market a generic equivalent. The obstacles to doing so aren’t governmental. They’re found in the market.

If a competitor entered the market, it’s likely that Vyera would drop Daraprim’s price — exactly what we’d expect and want from competition. But the cost of starting production of the drug, relative to the return on that cost, may prove a deterrent.

“At a lower price level, a competitor may not be able to recoup its investment,” said Aaron Kesselheim, a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School. “That, coupled with the small market for this drug, makes it relatively unappealing to a for-profit company.”

Daraprim isn’t alone. Other drugs that have lost their patents have had rapid price increases for similar reasons. The price for captopril, a drug for hypertension and heart failure, rose 2,800% in 2013.

The same year, the price for clomipramine, which treats depression and obsessive-compulsive disorder, increased 3,700%. And the antibiotic doxycycline hyclate’s price jumped 2,000 to 5,000% (depending on formulation) in six months, from October 2013 to April 2014.

Some ideas to push down prices

The FDA has already taken action to increase generic competition. A 2012 law authorized the FDA to charge generic drug manufacturers user fees, and those funds enabled it to speed up generic approvals. But this doesn’t address barriers in the market that keep some prices high for drugs whose patents have expired.

“We could do more through importation to respond to sudden price increases of off-patent drugs,” Kesselheim said. “Manufactures serving markets overseas might be willing to sell in the U.S. if we were to acknowledge regulatory approvals in other developed countries with high standards.”

Not requiring those manufacturers to undergo approvals in the United States would reduce barriers to market entry, potentially increasing competition.

The duration of market exclusivity varies by type of drug. Until recently, the vast majority of new drugs were so-called small-molecule drugs produced through chemical processes. A manufacturer can expect to be granted about five years of market exclusivity from the FDA for these kinds of drugs, though some — like those that treat rare conditions — can obtain longer exclusivity.

Some companies find elaborate ways to effectively achieve much longer periods of exclusivity.

“One way is to build up a so-called thicket of patents, claiming ownership of often minor characteristics of a drug or its manufacture,” Kesselheim said. “Many are trivial, but collectively they slow down competition.”

For example, some pertain to small changes in packaging or formulations.

When the FDA treats these as “new” drugs, it can buy a company additional years of protection from competition and high prices.

“More could be done to scrutinize drug patent applications and throw them out if the modifications are trivial,” Kesselheim said.

Competition doesn’t work well with biologic drugs

An increasing share of new drugs are biologics, which are much more complex and are regulated differently. They’re made up of proteins produced by living organisms and can cost 20 times more to manufacture than small-molecule drugs.

Some of today’s most expensive drugs are biologics, including Humira. The first biologic, a human formulation of insulin, was marketed in 1982. By 2016, they accounted for half of FDA approvals.

Humira owes its popularity to its effectiveness. The same could be said of many other expensive biologic drugs, like Herceptin for certain kinds of breast cancer.

To encourage investment in them, biologics get longer market exclusivity — 12 years — than small-molecule drugs. As with the small-molecule drugs, the exclusivity can be extended in various ways.

But even after that, biologics are protected from competition to an extent because they are harder to duplicate than small-molecule drugs. A biosimilar — a drug intended to mimic the therapeutic effect of a specific biologic — is not like a small-molecule generic drug. A generic drug can exactly duplicate the chemical structure of the brand drug it is intended to mimic, but that’s not easily achieved for biosimilars. Because they rely on living organisms, their structure and clinical performance depend on many subtleties of manufacturing.

This means biosimilars may not behave exactly like original biologics, giving those original drugs a leg up in the market.

Reflecting this, some of today’s drug pricing proposals focus on biologics. A recently proposed change to Medicare would link the prices of many biologics to those in other countries, which are lower. Another proposal has been to automatically reduce prices once their market exclusivity period has expired.

Lower drug prices could lead to shortages

A final complication in addressing prices is that, for some drugs, it may not be a good way to achieve the pace of innovation we may want. Here, antibiotics offer a good example. Although we desperately need new antibiotics to combat resistant superbugs, few pharmaceutical companies are willing to invest in their development. The problem is that they would serve a market we would want to be as small as possible. Ideally, nobody would need a powerful antibiotic, and there is no price at which a manufacturer would make a product that is never purchased.

“We should not pay for antibiotics by the dose, like other drugs,” said Kevin Outterson of Boston University School of Law. “Instead, buying access to new antibiotics — a Netflix model — could encourage innovation even if they’re rarely used.”

Policy ideas to push drug prices downward are summarized by the Drug Policy Lab at the Memorial Sloan Kettering Cancer Center, at which Peter Bach is director of the Center for Health Policy and Outcomes.

In some cases, lowering drug prices could invite shortages.

“Though Daraprim’s price could be lower and Vyera would still make a profit, if it was pushed too low, there could be a shortage,” Bach said. “For drugs prone to shortage, it might make sense to subsidize the price.”

Although there appears to be a mandate to lower drug prices, it’s an issue that defies a simple solution.

This article originally appeared in <a href="https://www.nytimes.com/2019/07/15/upshot/lower-drug-prices-no-one-cure.html" link="null" target="_blank">The New York Times</a>.

There is no single, best policy for drug prices

(The Upshot) ; (The New Health Care): A majority of Americans prefer greater regulation of prescription drug prices, meaning government intervention to lower them.

<h1>(The Upshot: The New Health Care): The idea that legal cannabis can help address the opioid crisis has generated much hope and enthusiasm.</h1>

Opioid misuse has declined in recent years at the same time that cannabis use has been increasing, with many states liberalizing marijuana laws.

Based on recent research, some advocates have been promoting this connection, arguing that easier access to marijuana reduces opioid use and, in turn, overdose deaths.

A new study urges caution. Sometimes appearances — or statistics — can be deceiving.

— Why people were so hopeful

It’s plausible that marijuana can help reduce pain. Systematic reviews show that certain compounds found in marijuana or synthetically produced cannabinoids do so, at least for some conditions. So some people who might otherwise seek out opioid painkillers could use medical marijuana instead.

Regulations in some states, including New York, that streamline access to medical marijuana are based on the idea that it can substitute for opioids in pain treatment.

In 2014, a study published in JAMA gave further hope that liberalizing marijuana laws might alleviate the opioid crisis.

The study examined the years 1999 through 2010, during which 10 states established medical marijuana programs. It compared changes in the rates of opioid painkiller deaths in states that passed medical marijuana laws with those that had not. The results? Researchers found that the laws were associated with a nearly 25% decline in the death rate from opioid painkillers.

Since publication of the JAMA study, others have produced similar findings. One posted last fall at the Social Science Research Network found that counties with medical marijuana dispensaries have up to 8% fewer opioid-related deaths among non-Hispanic white men, and 10% fewer heroin deaths.

Other studies have documented marijuana laws associated with reduced opioid prescribing in Medicaid and Medicare.

— Why you should be skeptical

None of this proves that marijuana liberalization causes lower opioid-related mortality, something the authors of the 2014 JAMA study pointed out.

Correlation does not mean causation, of course. A particular challenge in interpreting correlations in social science has its own name — the ecological fallacy. It’s the erroneous conclusion that relationships observed at the wider level (like state or region) necessarily hold true at the individual level as well.

“It’s possible that relationships get strengthened, weakened or even reversed when going from the individual to aggregate level,” said Mark Glickman, senior lecturer on statistics at Harvard. This was documented in a classic paper in 1950 and underlies many erroneous conclusions from research.

A new study revisited the JAMA-published analysis with more data. Its conclusions cast doubt on the idea that medical marijuana helps reduce opioid deaths — at least as far as we can tell with state-level data.

Between 2010 — the final year of analysis in the JAMA study — and 2017, 32 more states legalized medical marijuana, and eight legalized recreational use. A new study published in the Proceedings of the National Academy of Sciences (PNAS) reassessed the relationship between these laws and opioid deaths using the same approach as the JAMA study, but extending the years of analysis through 2017.

Over the years analyzed in the JAMA study, 1999 to 2010, the new PNAS study produced similar findings: Medical marijuana legalization was associated with reduced opioid painkiller overdose deaths. But in an expanded analysis through 2017, the results reversed — the laws are associated with a 23% increase in deaths.

This doesn’t necessarily mean that the laws first saved lives and then, in later years, contributed to deadly overdoses.

“If there is a relationship between medical cannabis use and opioid overdose on an individual level, this kind of study can’t reveal it,” said epidemiologist Chelsea L. Shover, lead author of the PNAS study and a postdoctoral research fellow at Stanford School of Medicine.

Glickman said: “Other sources of potential bias are possible in all these studies. As states were liberalizing their marijuana laws, they could have been changing other policies that also affected opioid overdoses.” We could be misled by analyses that don’t also control for those.

For example, efforts to expand treatment for opioid abuse could reduce deaths. Or, imprisoning more opioid users could increase it, because studies have found that overdoses are likelier after a prison stay.

Other evidence suggests it’s unlikely that easier access to marijuana could significantly reduce opioid painkiller death rates. For one thing, medical marijuana users make up only about 2.5% of the adult population, a small proportion of the 38% that receive a prescription for an opioid painkiller each year.

Austin Frakt

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