TED Danielle Allen: Here’s how we might save both lives and the economy

Harvard professors take a lively look at love and politics ...

As the coronavirus pandemic sweeps the globe, it’s hard to know where to turn or what to think. TED Connects is a free, live, daily conversation series featuring experts whose ideas can help us reflect and work through this uncertain time with a sense of responsibility, compassion and wisdom.

Danielle Allen serves as Director of the Edmond J. Safra Center for Ethics at Harvard University. The Center seeks to advance teaching and research on ethical issues in public life. Widespread ethical lapses of leaders in government, business, and other professions prompt demands for more and better moral education. More fundamentally, the increasing complexity of public life – the scale and range of problems and the variety of knowledge required to deal with them – make ethical issues more difficult, even for men and women of good moral character. Not only are the ethical issues we face more complex, but the people we face them with are more diverse, increasing the frequency and intensity of our ethical disagreements.

Given these changes in the United States and in societies around the globe, the Center seeks to help meet the growing need for teachers, scholars, and leaders who address questions of moral choice across many of the professions and in public life more generally, and promotes a perspective on ethics informed by both theory and practice. We explore the connection between the problems that professionals confront and the social and political structures in which they act. More generally, we address the ethical issues that all citizens face as they make the choices that profoundly affect the present and future of their societies in our increasingly interdependent world.

https://scholar.harvard.edu/danielleallen/edmond-j-safra-center-ethics

 

 

 

Hospitals consider universal do-not-resuscitate orders for coronavirus patients

https://www.washingtonpost.com/health/2020/03/25/coronavirus-patients-do-not-resucitate/?utm_campaign=wp_post_most&utm_medium=email&utm_source=newsletter&wpisrc=nl_most

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Worry that ‘all hands’ responses may expose doctors and nurses to infection prompts debate about prioritizing the survival of the many over the one.

Hospitals on the front lines of the pandemic are engaged in a heated private debate over a calculation few have encountered in their lifetimes — how to weigh the “save at all costs” approach to resuscitating a dying patient against the real danger of exposing doctors and nurses to the contagion of coronavirus.

The conversations are driven by the realization that the risk to staff amid dwindling stores of protective equipment — such as masks, gowns and gloves — may be too great to justify the conventional response when a patient “codes,” and their heart or breathing stops.

Northwestern Memorial Hospital in Chicago has been discussing a do-not-resuscitate policy for infected patients, regardless of the wishes of the patient or their family members — a wrenching decision to prioritize the lives of the many over the one.

Richard Wunderink, one of Northwestern’s intensive-care medical directors, said hospital administrators would have to ask Illinois Gov. J.B. Pritzker for help in clarifying state law and whether it permits the policy shift.

“It’s a major concern for everyone,” he said. “This is something about which we have had lots of communication with families, and I think they are very aware of the grave circumstances.”

Officials at George Washington University Hospital in the District say they have had similar conversations, but for now will continue to resuscitate covid-19 patients using modified procedures, such as putting plastic sheeting over the patient to create a barrier. The University of Washington Medical Center in Seattle, one of the country’s major hot spots for infections, is dealing with the problem by severely limiting the number of responders to a contagious patient in cardiac or respiratory arrest.

Several large hospital systems — Atrium Health in the Carolinas, Geisinger in Pennsylvania and regional Kaiser Permanente networks — are looking at guidelines that would allow doctors to override the wishes of the coronavirus patient or family members on a case-by-case basis due to the risk to doctors and nurses, or a shortage of protective equipment, say ethicists and doctors involved in those conversations. But they would stop short of imposing a do-not-resuscitate order on every coronavirus patient. The companies declined to comment.

Lewis Kaplan, president of the Society of Critical Care Medicine and a University of Pennsylvania surgeon, described how colleagues at different institutions are sharing draft policies to address their changed reality.

“We are now on crisis footing,” he said. “What you take as first-come, first-served, no-holds-barred, everything-that-is-available-should-be-applied medicine is not where we are. We are now facing some difficult choices in how we apply medical resources — including staff.”

The new protocols are part of a larger rationing of lifesaving procedures and equipment — including ventilators — that is quickly becoming a reality here as in other parts of the world battling the virus. The concerns are not just about health-care workers getting sick but also about them potentially carrying the virus to other patients in the hospital.

R. Alta Charo, a University of Wisconsin-Madison bioethicist, said that while the idea of withholding treatments may be unsettling, especially in a country as wealthy as ours, it is pragmatic. “It doesn’t help anybody if our doctors and nurses are felled by this virus and not able to care for us,” she said. “The code process is one that puts them at an enhanced risk.”

Wunderink said all of the most critically ill patients in the 12 days since they had their first coronavirus case have experienced steady declines rather than a sudden crash. That allowed medical staff to talk with families about the risk to workers and how having to put on protective gear delays a response and decreases the chance of saving someone’s life.

A consequence of those conversations, he said, is that many family members are making the difficult choice to sign do-not-resuscitate orders.

Code blue

Health-care providers are bound by oath — and in some states, by law — to do everything they can within the bounds of modern technology to save a patient’s life, absent an order, such as a DNR, to do otherwise. But as cases mount amid a national shortage of personal protective equipment, or PPE, hospitals are beginning to implement emergency measures that will either minimize, modify or completely stop the use of certain procedures on patients with covid-19.

Some of the most anxiety-provoking minutes in a health-care worker’s day involve participating in procedures that send virus-laced droplets from a patient’s airways all over the room.

These include endoscopies, bronchoscopies and other procedures in which tubes or cameras are sent down the throat and are routine in ICUs to look for bleeds or examine the inside of the lungs.

Changing or eliminating those protocols is likely to decrease some patients’ chances for survival. But hospital administrators and doctors say the measures are necessary to save the most lives.

The most extreme of these situations is when a patient, in hospital lingo, “codes.”

When a code blue alarm is activated, it signals that a patient has gone into cardiopulmonary arrest and typically all available personnel — usually somewhere around eight but sometimes as many as 30 people — rush into the room to begin live-saving procedures without which the person would almost certainly perish.

“It’s extremely dangerous in terms of infection risk because it involves multiple bodily fluids,” explained one ICU physician in the Midwest, who did not want her name used because she was not authorized to speak by her hospital.

Fred Wyese, an ICU nurse in Muskegon, Mich., describes it like a storm:

A team of nurses and doctors, trading off every two minutes, begin the chest compressions that are part of cardiopulmonary resuscitation or CPR. Someone punctures the neck and arms to access blood vessels to put in new intravenous lines. Someone else grabs a “crash cart” stocked with a variety of lifesaving medications and equipment ranging from epinephrine injectors to a defibrillator to restart the heart.

As soon as possible, a breathing tube will be placed down the throat and the person will be hooked up to a mechanical ventilator. Even in the best of times, a patient who is coding presents an ethical maze; there’s often no clear cut answer for when there’s still hope and when it’s too late.

In the process, heaps of protective equipment is used — often many dozens of gloves, gowns, masks, and more.

Bruno Petinaux, chief medical officer at George Washington University Hospital, said the hospital has had a lot of discussion about how — and whether — to resuscitate covid-19 patients who are coding.

“From a safety perspective you can make the argument that the safest thing is to do nothing,” he said. “I don’t believe that is necessarily the right approach. So we have decided not to go in that direction. What we are doing is what can be done safely.”

However, he said, the decision comes down to a hospital’s resources and “every hospital has to assess and evaluate for themselves.” It’s still early in the outbreak in the Washington area, and GW still has sufficient equipment and manpower. Petinaux said he cannot rule out a change in protocol if things get worse.

GW’s procedure for responding to coronavirus patients who are coding includes using a machine called a Lucas device, which looks like a bumper, to deliver chest compressions. But the hospital has only two. If the Lucas devices are not readily accessible, doctors and nurses have been told to drape plastic sheeting — the 7-mil kind available at Home Depot or Lowe’s — over the patient’s body to minimize the spread of droplets and then proceed with chest compressions. Because the patient would presumably be on a ventilator, there is no risk of suffocation.

In Washington state which had the nation’s first covid-19 cases, UW Medicine’s chief medical officer, Tim Dellit, said the decision to send in fewer doctors and nurses to help a coding patient is about “minimizing use of PPE as we go into the surge.” He said the hospital is monitoring health-care workers’ health closely. So far, the percentage of infections among those tested is less than in the general population, which, he hopes, means their precautions are working.

‘It is a nightmare’

Bioethicist Scott Halpern at the University of Pennsylvania is the author of one widely circulated model guideline being considered by many hospitals. In an interview, he said a blanket stop to resuscitations for infected patients is too “draconian” and may end up sacrificing a young person who is otherwise in good health. However, health-care workers and limited protective equipment cannot be ignored.

“If we risk their well-being in service of one patient, we detract from the care of future patients, which is unfair,” he said.

Halpern’s document calls for two physicians, the one directly taking care of a patient and one who is not, to sign off on do-not-resuscitate orders. They must document the reason for the decision, and the family must be informed but does not have to agree.

Wyese, the Michigan ICU nurse, said his own hospital has been thinking about these issues for years but still is unprepared.

“They made us do all kinds of mandatory education and fittings and made it sound like they are prepared,” he said. “But when it hits the fan, they don’t have the supplies so the plans they had in place aren’t working.”

Over the weekend, Wyese said, a suspected covid-19 patient was rushed in and put into a negative pressure room to prevent the virus spread. In normal times, a nurse in full hazmat-type gear would sit with the patient to care for him, but there was little equipment to spare. So Wyese had to monitor him from the outside. Before he walked inside, he said, he would have to put on a face shield, N95 mask, and other equipment and slather antibacterial foam on his bald head as the hospital did not have any more head coverings. Only one powered air-purifying respirator or PAPR was available for the room and others nearby that could be used when performing an invasive procedure — but it was 150 feet away.

While he said his hospital’s policy still called for a full response to patients whose heart or breathing stopped, he worried any efforts would be challenging, if not futile.

“By the time you get all gowned up and double-gloved the patient is going to be dead,” he said. “We are going to be coding dead people. It is a nightmare.”

 

 

 

 

Bill Gates says we can’t restart the economy soon and simply “ignore that pile of bodies over in the corner”

https://www.vox.com/recode/2020/3/24/21192638/coronavirus-bill-gates-trump-reopen-business?fbclid=IwAR3j7XzP_Mf3i9VhZwzYk2jTesqLjr9SAtmb4B-xLy0KXaeyZ2zK4lUWjdU

Image result for Bill Gates says we can’t restart the economy soon and simply “ignore that pile of bodies over in the corner”

Bill Gates rebuked proposals, floated over the last two days by leaders like Donald Trump, to reopen the global economy despite the Covid-19 coronavirus outbreak, saying that this approach would be “very irresponsible.”

Gates did not mention Trump by name, but the American president has said that he may decide to relax some of the country’s “social distancing” in order to jumpstart the country’s shut-down economy. Gates, the country’s leading philanthropist, has been among the most active tech leaders in using his resources to try and contain the virus.

“There really is no middle ground, and it’s very tough to say to people, ‘Hey, keep going to restaurants, go buy new houses, ignore that pile of bodies over in the corner. We want you to keep spending because there’s maybe a politician who thinks GDP growth is all that counts,’” Gates said in an interview with TED Tuesday. “It’s very irresponsible for somebody to suggest that we can have the best of both worlds.”

Trump has suggested that this middle ground would indeed be possible — by letting some healthy people return to work, for instance, while keeping more vulnerable workers in their homes. Experts have said that drastic and widespread social distancing is required to keep the pandemic from spreading further. Trump has said he would make a decision at the end of the month but has said that he believes the “cure” could be worse than the “problem itself.”

Asked what he would do if he were president, Gates returned to his concerns about reopening the economy.

“The economic effect of this is really dramatic. Nothing like this has ever happened to the economy in our lifetimes,” Gates said. “But bringing the economy back … that’s more of a reversible thing than bringing people back to life. So we’re going to take the pain in the economic dimension — huge pain — in order to minimize the pain in the diseases-and-death dimension.”

The Bill and Melinda Gates Foundation has put up $100 million for programs to fund testing and science around the pandemic, and he has begun using his public profile, too, to shape the coronavirus conversation. This month, Gates himself resigned from the board of Microsoft, which he founded, and is now effectively a full-time philanthropist — and the country’s most famous one.

And Gates has tried to cast himself as an optimist. He has said that the social distancing measures might need to last as little as six weeks, but said that “we have no choice,” despite the economic impacts.

“It’s disastrous for the economy,” Gates said. But “the sooner you do it in a tough way, the sooner you can undo it and go back to normal.”

 

 

 

High-priced specialty drugs: Exposing the flaws in the system

https://theconversation.com/high-priced-specialty-drugs-exposing-the-flaws-in-the-system-129598

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My husband, Andy, has Parkinson’s disease. A year ago, his neurologist recommended a new pill that he was to take at bedtime. We quickly learned that the medication would cost US$1,300 for a one-month supply of 30 pills. In addition, Andy could obtain the drug from only one specialty pharmacy and would have to use mail order.

This was our introduction to specialty drugs.

These medications are becoming increasingly common, though many Americans are unfamiliar with the term. In 2018, the Food and Drug Administration approved 59 new medications, of which 39 are considered specialty drugs.

Specialty drugs are generally high-cost drugs requiring special handling such as refrigeration or injection, though Andy’s did not. They treat complex conditions such as cancer and multiple sclerosis.

Specialty drugs are often available only through specialty pharmacies. In addition to filling prescriptions, these outlets provide educational and support services to patients. For example, they provide refill reminders and help patients learn how to inject their drugs.

In a forthcoming articleprofessor Isaac Buck and I argue that specialty drugs raise significant legal and ethical questions. These merit attention from the public and policymakers.

Specialty drug concerns

First, the term “specialty drug” is somewhat elusive and has no clear definition. In addition, government authorities and medical experts are not the ones who decide whether a medication is designated a specialty drug. Rather, the decision is entirely up to pharmacy benefit managers, or PBMs.

PBMs administer health plans’ drug benefit programs and thereby serve insurers. PBMs have been criticized for driving up health care costs. Drugs that are specialty drugs under one insurance policy are sometimes classified differently in other policies. Furthermore, some specialty drugs are simple pills that do not involve complicated instructions, and thus, it is unclear why they are categorized as specialty drugs.

The second problem is the very high cost of specialty drugs. The average price tag of the more than 300 medications that are considered specialty drugs is approximately $79,000 per year. Almost half of the dollars that Americans pay for medications are spent on specialty drugs. In fact, Medicare spent $32.8 billion on specialty drugs in 2015.

Because of these exorbitant costs, some insurers have created what they call a “specialty tier” in their health plans. In this tier, patients’ cost-sharing responsibilities are higher than they are for medications in other tiers. If your drug is placed in a specialty tier, your coinsurance payment, or the percentage of cost that you pay, may be 25% to 33% of the drug’s price.

This leads to a situation in which you may have the least generous insurance coverage for your most expensive drugs. Under some plans you might pay $10 per month for generic drugs but hundreds of dollars per month for specialty drugs. This can translate into many thousands of dollars in annual out-of-pocket costs, even for consumers with good health insurance. There are no federal regulations in the U.S. that limit drug prices or insurers’ tiering practices.

Conflict of interest and patient choice

A third problem is conflict of interest. PBMs own or co-own the top four specialty pharmacies in the U.S., which are responsible for two-thirds of nationwide specialty drug prescription revenues.

PBMs frequently require patients to purchase their medications from the specific specialty pharmacy that they own. Thus, PBMs have much to gain from designating medications as specialty drugs. Doing so may lead to significant revenues in the form of purchases at PBM-owned specialty pharmacies.

A related problem is the limiting of patient choice. Many specialty pharmacies fill prescriptions only through mail order. Consequently, patients may be restricted to using just one pharmacy and be forced to rely on the mail for delivery.

Some patients enjoy the convenience of home delivery. Others, however, prefer the traditional approach of visiting a drugstore in person. They may worry that the mail will be late, their package will be stolen, or they will be out of town when the drugs arrive. Yet, such patients do not have the option of a brick and mortar pharmacy.

Possible corrective measures

Both political parties have stated that health care costs are a priority for them. However, they have shown a limited appetite for tackling this herculean problem.

The House recently passed a bill that would enable the federal government to negotiate prices with drug manufacturers. Such negotiations could well lower specialty drug prices. The Senate, however, is unlikely to approve the bill, and Congress is unlikely to pass sweeping legislation in a divisive election year.

There has been more success at the federal level in promoting consumer choice. Medicare rules establish that Medicare plans may not force participants to use mail-order pharmacies.

In the meantime, individual states offer useful solutions. For example, some have provided patients with relief in the form of capping out-of-pocket costs. California limits consumers’ expenditures to $250 or $500 for a 30-day supply, depending on the drug type.

At least 15 states also have pharmacy choice statutes. Several ban PBM mandates that prevent patients from freely selecting their preferred qualified pharmacy. Many ban mail-order only requirements.

Some states have recognized that PBMs should not be entirely free to designate medications as specialty drugs. Because such designations can significantly disadvantage patients and may increase patients’ costs, such states have statutory definitions for the term “specialty drug.”

They generally mandate that the drug require special administration, delivery, storage or oversight. Such requirements may justify purchase from a specialty pharmacy. However, drugs without complicated instructions should not be deemed specialty drugs.

One more option that some insurers have already adopted is allowing patients to obtain just a few pills or doses for an initial trial period. Sometimes individuals quickly learn that they cannot tolerate a medication or that it is ineffective. Such “partial fill” programs can spare patients the exorbitant cost of a full 30-day specialty drug supply.

Specialty drugs contribute significantly to the American health care cost crisis. Additional state, or better yet, federal laws should be enacted to constrain PBMs’ authority over specialty drugs. We need further regulation concerning drug classification, pricing, conflicts of interest and patient choice.