A bill, SB-852, opens the door for California to make its own generic drugs in the future. Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.
This article was published on Tuesday, September 1, 2020 in Kaiser Health News.
SACRAMENTO — California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed pharmaceutical companies.
The Democratic-controlled legislature overwhelmingly approved a measure Monday that would direct the state's top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs — including the diabetes medicine insulin — that are cheaper than brand-name products.
The bill, SB-852, also opens the door for California to make its own generic drugs in the future.
Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.
"People need these drugs, but prices are through the roof, so we're saying there's a role for the state to bring prices down," said the bill's author, state Sen. Richard Pan (D-Sacramento).
He argued the measure is more important than ever because COVID-19 has exposed "glaring gaps" in the ability of public and private entities — from major hospitals to government drug purchasers — to maintain adequate supplies of drugs, medical equipment and devices.
"This also creates a model to address drug shortages and other supply chain issues during COVID and future pandemics," he said.
Newsom, a Democrat, floated his own generic drug proposal in January as part of his broader drug agenda to reduce pharmaceutical costs, but was forced to abandon his plan in May as he and lawmakers sought to address a pandemic-induced $54 billion budget deficit.
Though it could take years to successfully bring a new California generic product to the market, the move would put the nation's most populous state in direct competition with major generic and brand-name drug manufacturers that dominate the market, and potentially allow California to use its massive purchasing power to drive down drug prices.
"Other legislative efforts in Congress and in other states have focused on government negotiating with pharmaceutical companies to lower prices on generic drugs," said Edwin Park, research professor at the Health Policy Institute at Georgetown University.
The Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, has taken a neutral position on the bill and declined to comment.
But Brett Michelin, lead lobbyist for the Washington, D.C.-based trade group that represents generic drugmakers, the Association for Accessible Medicines, said generic companies aren't threatened by the possibility of California entering the market — and even welcome it.
"Generic manufacturers are more than open to doing this kind of partnership," Michelin said. "I think having a fair and open process to sell drugs and compete for customers is what the generic industry is very used to and comfortable with."
Under the measure, state-developed generics would be "widely" available to public and private purchasers within California. Taxpayers would pick up the costs, roughly $1 million to $2 million in startup funding, plus ongoing staff costs estimated in the low hundreds of thousands of dollars annually, according to a state fiscal analysis.
It's unclear which drugs the state would make or procure, though it would target drugs that could produce the biggest cost savings for the state and consumers.
But the bill specifically calls for the production of "at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings."
Insulin is a biologic drug, made with living cells. Once a biologic hits the market, rival copycat products that follow are called biosimilars.
Three major drug companies — Eli Lilly and Co., Sanofi and Novo Nordisk — have long controlled the lucrative insulin market in the U.S. The state of California would be the first entity to produce a biosimilar version of one of the newer, fast- and long-acting insulins on a not-for-profit basis, said Jane Horvath, a health policy consultant in Washington, D.C.
Although it would be costly and could take years, the Utah-based nonprofit drug company Civica Rx, which has consulted with Pan on his bill, is discussing partnering with California to produce generic or biosimilar drugs. It has already hammered out deals with major health systems running short on critical drugs, including the Department of Veterans Affairs, and is producing lower-cost generics for insurers, including Blue Shield of California.
"There's no doubt insulin would be a more complex and expensive drug to develop, but it's certainly possible," said Allan Coukell, the company's senior vice president of public policy. "We are watching how the biosimilar market develops."
Patients who need insulin have faced huge cost spikes. A 2019 report by the Healthcare Cost Institute concluded that average prices for insulin doubled from 2012 to 2016. And California health insurance regulators found last year that diabetes medications accounted for nine of the 25 costliest brand-name drugs sold in the state.
"It's a big deal — diabetes affects a lot of people who rely on insulin for their very lives," said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. "And insulin has probably been the poster child for unreasonable drug pricing." (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)
Laura Marston, a Washington, D.C.-based lawyer and diabetic who advocates for lower insulin prices, said she's excited about California's idea.
Marston has been on the same insulin, Humalog, since 1996. At that time, the price was $21 a vial, but has since ballooned to more than $275 a vial, she said.
"If there was a lower-cost option and the price wasn't going to be raised, I would absolutely switch from Humalog," she said. "I feel held totally hostage to these pharmaceutical companies."
Marston said she'd like the federal government to do the same thing, "so it could apply to all patients."
Congressional efforts to tackle rising prices for insulin and other drugs fizzled last year in the face of opposition from the influential pharmaceutical lobby. So states have increasingly sought ways to regulate a for-profit industry in which brand-name manufacturers hold near-monopoly power.
Colorado last year becamethe first state to cap out-of-pocket insulin costs at $100 for a 30-day supply. It was followed by at least nine other states, from New Mexico to New York, whose cost-sharing caps vary.
California had already capped out-of-pocket drug costs at $250 to $500 for a 30-day supply, but a measure that would have lowered the cap for insulin to $100 a month stalled this year — a casualty of a pandemic-shortened legislative calendar.
Newsom's office declined to comment on the generic drug legislation. But recent changes to the proposal reflect direct negotiations with the administration, Pan's office said.
Newsom spokesperson Jesse Melgar said in a statement that "the governor's goal of a sustainable system of universal coverage has not changed and making prescription drugs affordable is one more step toward that goal."
Should Newsom sign the bill into law, the state Health and Human Services Agency would have 18 months to identify a list of drugs the state could manufacture, with a report due to the legislature by July 2022. By July the following year, the state would be required to assess whether it can manufacture its own generics and biosimilars.
The bill calls for state health officials to prioritize development of generics for chronic and high-cost health conditions, and urges production of those that can be delivered through mail order.
California could emerge as a leader in the national drug debate, Levitt said.
"If California can pull it off, it would be a model for other states and federally," he said. "For it to pull this off means it can be done at scale."
The problem is most acute for medical students in their third and fourth years of study. Year three is when most medical students do their "core clinical clerkships."
This article was first published on Monday, August 31, 2020 in Kaiser Health News.
COVID-19 is disrupting just about every student’s 2020 education, but medical students have it particularly hard right now.
“It’s a nightmare scenario for the class of 2021,” said Jake Berg, a fourth-year student at the Kentucky College of Osteopathic Medicine in Pikeville. In March, students were abruptly pulled out of hospitals and medical offices, where they normally work with professionals to learn about treating patients. Over the space of less than two weeks, he said, medical students in “pretty much the entire country” transitioned from seeing patients in person to learning online.
“Everyone goes along with the idea that we’re all in the same boat together,” he said. “But, really, it’s like we’re all on the Titanic and it’s sinking.”
Megan Messinger, in her fourth year at the Western University of Health Sciences in Pomona, California, calculates she has lost about 400 hours of patient time. She worries “the class of 2021 is going to be the dumb class of interns,” said Messinger, who hopes to do a combined residency in pediatrics and psychiatry. “I feel very behind.”
The problem is most acute for medical students in their third and fourth years of study. Year three is when most medical students do their “core clinical clerkships.” These are one- or two-month stints in hospitals and clinics, through which they get the flavor of specialties such as internal medicine, pediatrics, surgery and obstetrics/gynecology.
Fourth-year students tend to spend time in more specialized options, often traveling to get experience in specialties in short supply at their own medical school’s affiliated hospitals, and also to informally “audition” at places they might like to apply to for residency. Because of the coronavirus pandemic, however, “away rotations” have been suspended, and residency interviews for next year’s graduating class will be done virtually.
Schools and hospitals are trying to restore the core clerkships but, in many areas, this is a work in progress. The uncertainty adds considerably to students’ stress levels.
“I have no idea how I will learn about the culture of the hospitals I’m applying to,” said Garrett Johnson, a fourth-year student at Harvard Medical School. On one hand, this year’s class of doctors-to-be will save a lot of money — typically, travel and housing costs for away rotations and in-person residency interviews are paid by the students. On the other hand, he said, “you don’t get to meet any of the people or get a feel for the place.”
Karissa LeClair, a fourth-year student at the Geisel School of Medicine at Dartmouth, agreed. “I was looking forward to getting to know places I had not been to previously,” she said.
LeClair, who wants to become an ear, nose and throat specialist, said clerkships she applied to in New York City, Ann Arbor, Michigan, and Boston were all canceled.
Since she was not planning to be in New Hampshire for most of this year, LeClair now has no place to live near Dartmouth. “I’m piecing together sublets and staying with friends,” she said. Unless something changes, she will spend her final year of medical school only in facilities formally affiliated with Dartmouth.
Messinger is facing similar problems in Southern California. “I’m at Cedars right now, and loving it,” she said, referring to Los Angeles’s Cedars Sinai medical center. “But you can only do one rotation there. I don’t have anything scheduled after this. My only audition rotation, at Tulane, was canceled.”
Administrators are sympathetic. “They have had major disruption,” said Dr. Alison Whelan, chief medical education officer for the Association of American Medical Colleges, which oversees M.D.-degree programs. “Medical school is stressful, and with COVID it’s even more stressful.”
“I feel for the students, they’re really in a tough position,” said Dr. Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine, which oversees osteopathy programs. About 1 in 4 U.S. medical students pursue a doctorate in osteopathy, which is similar to an M.D. degree but includes training in hands-on manipulative techniques and more emphasis on whole-body health.
Starting this year, M.D. and D.O. students are competing for the same residency training programs and work side by side, a change planned before the pandemic.
One hurdle is that all these students, in order to become well-rounded doctors, need to see a broad mix of patients with a diverse group of medical issues. But even at hospitals and clinics that have resumed general care, patients with ailments other than those associated with COVID-19 are not showing up, because they are afraid of catching the coronavirus. Elsewhere elective procedures have been canceled or postponed.
“That has become a challenge,” Whelan said. In areas with high COVID-19 rates, hospitals and other facilities often do not have enough personal protective equipment for even essential health personnel, so students are kept out.
The AAMC in August updated its guidance on student participation in clinical rotations. It continued to leave decisions about allowing students into patient care areas up to individual teaching hospitals and medical schools. But it also noted that while students are not technically essential in day-to-day care activities, “medical students are the essential, emerging physician workforce” whose learning is necessary to prevent future medical shortages.
“The progression of students over time for relatively on-time graduation is essential to the physician workforce,” Whelan said. Enabling students to finish their education in the COVID-19 era “is an ongoing, complex, jigsaw puzzle.”
Both the M.D. and D.O. organizations said third-year students can still complete most of their required rotations, although perhaps not in the usual order, and schools have dramatically increased their use of online teaching of diagnostics and care.
“A fair amount of what students do is observation,” she said. “So schools have created step-by-step videos.”
And some educators are confident these students will catch up — eventually. “Most learning goes on during your residency,” said Dr. Art Papier, who teaches dermatology at the University of Rochester medical school. “I think it can all be made up.”
In addition to losing in-person patient contact, medical students face obstacles in taking required national board examinations — there are several types and are not always conveniently offered near their training sites.
After having one required test canceled on short notice, student Jake Berg had to reschedule. The first open seat was three hours away and a couple of weeks later; then his canceled test was reinstated.
The exam that tests clinical skills has been postponed for all M.D. students but is expected to be rescheduled.
The comparable exam for osteopathic students, however, has been made optional. That’s partly because D.O. students must demonstrate not only clinical skills, but also proficiency in physical manipulation techniques, which means they need to work with patients under the supervision of doctors as part of their test. But the D.O. clinical skills exam is offered only in two places: Chicago and outside Philadelphia.
“If there’s a self-isolation period, who can afford to spend two weeks in a hotel in Chicago or Philadelphia?” asked Messinger, of Western University.
While the travel may be a burden, the exams are needed “to protect the public” from doctors who have not demonstrated competence, said Cain, of the osteopathic colleges’ association.
Whelan and Cain said details are being worked out and changes are possible as the COVID situation evolves.
In the end, Cain said, this crop of students may emerge from COVID as better doctors than those who didn’t face such challenges.
“Hopefully, we’ll look back and see them as the class of resilience,” he said. “That they were able to work through some very hard times.”
OVID-19 is disrupting just about every student's 2020 education, but medical students have it particularly hard right now.
"It's a nightmare scenario for the class of 2021," said Jake Berg, a fourth-year student at the Kentucky College of Osteopathic Medicine in Pikeville. In March, students were abruptly pulled out of hospitals and medical offices, where they normally work with professionals to learn about treating patients. Over the space of less than two weeks, he said, medical students in "pretty much the entire country" transitioned from seeing patients in person to learning online.
"Everyone goes along with the idea that we're all in the same boat together," he said. "But, really, it's like we're all on the Titanic and it's sinking."
Megan Messinger, in her fourth year at the Western University of Health Sciences in Pomona, California, calculates she has lost about 400 hours of patient time. She worries "the class of 2021 is going to be the dumb class of interns," said Messinger, who hopes to do a combined residency in pediatrics and psychiatry. "I feel very behind."
The problem is most acute for medical students in their third and fourth years of study. Year three is when most medical students do their "core clinical clerkships." These are one- or two-month stints in hospitals and clinics, through which they get the flavor of specialties such as internal medicine, pediatrics, surgery and obstetrics/gynecology.
Fourth-year students tend to spend time in more specialized options, often traveling to get experience in specialties in short supply at their own medical school's affiliated hospitals, and also to informally "audition" at places they might like to apply to for residency. Because of the coronavirus pandemic, however, "away rotations" have been suspended, and residency interviews for next year's graduating class will be done virtually.
Schools and hospitals are trying to restore the core clerkships but, in many areas, this is a work in progress. The uncertainty adds considerably to students' stress levels.
"I have no idea how I will learn about the culture of the hospitals I'm applying to," said Garrett Johnson, a fourth-year student at Harvard Medical School. On one hand, this year's class of doctors-to-be will save a lot of money — typically, travel and housing costs for away rotations and in-person residency interviews are paid by the students. On the other hand, he said, "you don't get to meet any of the people or get a feel for the place."
Karissa LeClair, a fourth-year student at the Geisel School of Medicine at Dartmouth, agreed. "I was looking forward to getting to know places I had not been to previously," she said.
LeClair, who wants to become an ear, nose and throat specialist, said clerkships she applied to in New York City, Ann Arbor, Michigan, and Boston were all canceled.
Since she was not planning to be in New Hampshire for most of this year, LeClair now has no place to live near Dartmouth. "I'm piecing together sublets and staying with friends," she said. Unless something changes, she will spend her final year of medical school only in facilities formally affiliated with Dartmouth.
Messinger is facing similar problems in Southern California. "I'm at Cedars right now, and loving it," she said, referring to Los Angeles's Cedars Sinai medical center. "But you can only do one rotation there. I don't have anything scheduled after this. My only audition rotation, at Tulane, was canceled."
Administrators are sympathetic. "They have had major disruption," said Dr. Alison Whelan, chief medical education officer for the Association of American Medical Colleges, which oversees M.D.-degree programs. "Medical school is stressful, and with COVID it's even more stressful."
"I feel for the students, they're really in a tough position," said Dr. Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine, which oversees osteopathy programs. About 1 in 4 U.S. medical students pursue a doctorate in osteopathy, which is similar to an M.D. degree but includes training in hands-on manipulative techniques and more emphasis on whole-body health.
Starting this year, M.D. and D.O. students are competing for the same residency training programs and work side by side, a change planned before the pandemic.
One hurdle is that all these students, in order to become well-rounded doctors, need to see a broad mix of patients with a diverse group of medical issues. But even at hospitals and clinics that have resumed general care, patients with ailments other than those associated with COVID-19 are not showing up, because they are afraid of catching the coronavirus. Elsewhere elective procedures have been canceled or postponed.
"That has become a challenge," Whelan said. In areas with high COVID-19 rates, hospitals and other facilities often do not have enough personal protective equipment for even essential health personnel, so students are kept out.
The AAMC in August updated its guidance on student participation in clinical rotations. It continued to leave decisions about allowing students into patient care areas up to individual teaching hospitals and medical schools. But it also noted that while students are not technically essential in day-to-day care activities, "medical students are the essential, emerging physician workforce" whose learning is necessary to prevent future medical shortages.
"The progression of students over time for relatively on-time graduation is essential to the physician workforce," Whelan said. Enabling students to finish their education in the COVID-19 era "is an ongoing, complex, jigsaw puzzle."
Both the M.D. and D.O. organizations said third-year students can still complete most of their required rotations, although perhaps not in the usual order, and schools have dramatically increased their use of online teaching of diagnostics and care.
"A fair amount of what students do is observation," she said. "So schools have created step-by-step videos."
And some educators are confident these students will catch up — eventually. "Most learning goes on during your residency," said Dr. Art Papier, who teaches dermatology at the University of Rochester medical school. "I think it can all be made up."
In addition to losing in-person patient contact, medical students face obstacles in taking required national board examinations — there are several types and are not always conveniently offered near their training sites.
After having one required test canceled on short notice, student Jake Berg had to reschedule. The first open seat was three hours away and a couple of weeks later; then his canceled test was reinstated.
The exam that tests clinical skills has been postponed for all M.D. students but is expected to be rescheduled.
The comparable exam for osteopathic students, however, has been made optional. That's partly because D.O. students must demonstrate not only clinical skills, but also proficiency in physical manipulation techniques, which means they need to work with patients under the supervision of doctors as part of their test. But the D.O. clinical skills exam is offered only in two places: Chicago and outside Philadelphia.
"If there's a self-isolation period, who can afford to spend two weeks in a hotel in Chicago or Philadelphia?" asked Messinger, of Western University.
While the travel may be a burden, the exams are needed "to protect the public" from doctors who have not demonstrated competence, said Cain, of the osteopathic colleges' association.
Whelan and Cain said details are being worked out and changes are possible as the COVID situation evolves.
In the end, Cain said, this crop of students may emerge from COVID as better doctors than those who didn't face such challenges.
"Hopefully, we'll look back and see them as the class of resilience," he said. "That they were able to work through some very hard times."
Flu season will look different this year, as the country grapples with a coronavirus pandemic that has killed more than 172,000 people. Many Americans are reluctant to visit a doctor's office and public health officials worry people will shy away from being immunized.
Although sometimes incorrectly regarded as just another bad cold, flu also kills tens of thousands of people in the U.S. each year, with the very young, the elderly and those with underlying conditions the most vulnerable. When coupled with the effects of COVID-19, public health experts say it's more important than ever to get a flu shot.
If enough of the U.S. population gets vaccinated — more than the 45% who did last flu season — it could help head off a nightmare scenario in the coming winter of hospitals stuffed with both COVID-19 patients and those suffering from severe effects of influenza.
Aside from the potential burden on hospitals, there's the possibility people could get both viruses — and "no one knows what happens if you get influenza and COVID [simultaneously] because it's never happened before," Dr. Rachel Levine, Pennsylvania's secretary of health, told reporters this month.
In response, manufacturers are producing more vaccine supply this year, between 194 million and 198 million doses, or about 20 million more than they distributed last season, according to the Centers for Disease Control and Prevention.
As flu season approaches, here are some answers to a few common questions:
Q: When should I get my flu shot?
Advertising has already begun, and some pharmacies and clinics have their supplies now. But, because the effectiveness of the vaccine can wane over time, the CDC recommends against a shot in August.
Many pharmacies and clinics will start immunizations in early September. Generally, influenza viruses start circulating in mid- to late October but become more widespread later, in the winter. It takes about two weeks after getting a shot for antibodies — which circulate in the blood and thwart infections — to build up. "Young, healthy people can begin getting their flu shots in September, and elderly people and other vulnerable populations can begin in October," said Dr. Steve Miller, chief clinical officer for insurer Cigna.
The CDC has recommended that people "get a flu vaccine by the end of October," but noted it's not too late to get one after that because shots "can still be beneficial and vaccination should be offered throughout the flu season."
Even so, some experts say not to wait too long this year — not only because of COVID-19, but also in case a shortage develops because of overwhelming demand.
Q: What are the reasons I should roll up my sleeve for this?
Get a shot because it protects you from catching the flu and spreading it to others, which may help lessen the burden on hospitals and medical staffs.
And there's another message that may resonate in this strange time.
"It gives people a sense that there are some things you can control," said Eduardo Sanchez, chief medical officer for prevention at the American Heart Association.
While a flu shot won't prevent COVID-19, he said, getting one could help your doctors differentiate between the diseases if you develop any symptoms — fever, cough, sore throat — they share.
And even though flu shots won't prevent all cases of the flu, getting vaccinated can lessen the severity if you do fall ill, he said.
You cannot get influenza from having a flu vaccine.
All eligible people, especially essential workers, those with underlying conditions and those at higher risk — including very young children and pregnant women — should seek protection, the CDC said. It recommends that children over 6 months old get vaccinated.
Q: What do we know about the effectiveness of this year's vaccine?
Flu vaccines — which must be developed anew each year because influenza viruses mutate — range in effectiveness annually, depending on how well they match the circulating virus. Last year's formulation was estimated to be about 45% effective in preventing the flu overall, with about a 55% effectiveness in children. The vaccines available in the U.S. this year are aimed at preventing at least three strains of the virus, and most cover four.
It isn't yet known how well this year's supply will match the strains that will circulate in the U.S. Early indications from the Southern Hemisphere, which goes through its flu season during our summer, are encouraging. There, people practiced social distancing, wore masks and got vaccinated in greater numbers this year — and global flu levels are lower than expected. Experts caution, however, not to count on a similarly mild season in the U.S., in part because masking and social distancing efforts vary widely.
Q: What are insurance plans and health systems doing differently this year?
Insurers and health systems contacted by KHN say they will follow CDC guidelines, which call for limiting and spacing out the number of people waiting in lines and vaccination areas. Some are setting appointments for flu shots to help manage the flow.
Health Fitness Concepts, a company that works with UnitedHealth Group and other businesses to set up flu shot clinics in the Northeast, said it is "encouraging smaller, more frequent events to support social distancing" and "requiring all forms to be completed and shirtsleeves rolled up before entering the flu shot area." Everyone will be required to wear masks.
Also, nationally, some physician groups contracted with UnitedHealth will set up tent areas so shots can be given outdoors, a spokesperson said.
Kaiser Permanente plans drive-thru vaccinations at some of its medical facilities and is testing touch-free screening and check-in procedures at some locations. (KHN is not affiliated with Kaiser Permanente.)
Geisinger Health, a regional health provider in Pennsylvania and New Jersey, said it, too, would have outdoor flu vaccination programs at its facilities.
Additionally, "Geisinger is making it mandatory for all employees to receive the flu vaccine this year," said Mark Shelly, the system's director of infection prevention and control. "By taking this step, we hope to convey to our neighbors the importance of the flu vaccine for everyone."
Q: Usually I get a flu shot at work. Will that be an option this year?
Aiming to avoid risky indoor gatherings, many employers are reluctant to sponsor the on-site flu clinics they've offered in years past. And with so many people continuing to work from home, there's less need to bring flu shots to employees on the job. Instead, many employers are encouraging workers to get shots from their primary care doctors, at pharmacies or in other community settings. Insurance will generally cover the cost of the vaccine.
Some employers are considering offering vouchers for flu shots to their uninsured workers or those who don't participate in the company plan, said Julie Stone, managing director for health and benefits at Willis Towers Watson, a consulting firm. The vouchers could allow workers to get the shot at a particular lab at no cost, for example.
Some employers are starting to think about how they might use their parking lots for administering drive-thru flu shots, said Dr. David Zieg, clinical services leader for benefits consultant Mercer.
Although federal law allows employers to require employees to get flu shots, that step is typically taken only by healthcare facilities and some universities where people live and work closely together, Zieg said.
Q: What are pharmacies doing to encourage people to get flu shots?
Some pharmacies are making an extra push to get out into the community to offer flu shots.
Walgreens, which has nearly 9,100 pharmacies nationwide, is continuing a partnership begun in 2015 with community organizations, churches and employers that has offered about 150,000 off-site and mobile flu clinics to date.
The program places a special emphasis on working with vulnerable populations and in underserved areas, said Dr. Kevin Ban, chief medical officer for the drugstore chain.
Walgreens began offering flu shots in mid-August and is encouraging people not to delay getting vaccinated.
Both Walgreens and CVS are encouraging people to schedule appointments and do paperwork online this year to minimize time spent in the stores.
At CVS MinuteClinic locations, once patients have checked in for their flu shot, they must wait outside or in their car, since the indoor waiting areas are now closed.
"We don't have tons of arrows in our quiver against COVID," Walgreens' Ban said. "Taking pressure off the healthcare system by providing vaccines in advance is one thing we can do."
President Donald Trump told the American people this week that convalescent plasma is a potential new treatment for COVID-19. His announcement followed the Food and Drug Administration's decision Sunday to grant fast-track authorization for its emergency use as a treatment for hospitalized COVID patients.
This "emergency use authorization" triggered an outcry from scientists and doctors, who said the decision was not supported by adequate clinical evidence and criticized the FDA for what many perceived as bowing to political pressure.
With all the news swirling around convalescent plasma this week, we thought we'd break it down for you.
1. Convalescent plasma contains antibodies against disease. Donations are being promoted as a potential COVID-19 treatment.
"Convalescent" refers to recovery from a disease. And plasma is the yellowish, liquid part of blood in which blood cells are suspended.
When someone is infected with a virus, the body generates antibodies to fight off the viral particles. Enter COVID-19. If an individual who has recovered from this virus donates their plasma, scientists can isolate the antibodies from the plasma and give it to patients who are still in the early stages of their COVID-19 infection. This infusion, in theory, should help people fight off the virus while their own body catches up and makes its own supply of antibodies.
It's not a new concept. An infusion of antibodies via plasma has been used as a treatment for other types of diseases, such as rabies.
2. Some experts took issue with the data presented to approve the treatment and thought the FDA action crossed a political line.
An FDA emergency use authorization allows companies and medical providers to deploy unapproved treatments or medical products in a crisis. The FDA said healthcare providers would be authorized to distribute COVID convalescent plasma to treat suspected or confirmed patients with COVID-19 while in the hospital.
Before the authorization, some top researchers and clinicians at the National Institutes of Health felt there was not sufficient scientific evidence to support pushing the treatment forward.
"A randomized placebo control trial is the gold standard," said Dr. Howard Koh, who was an assistant secretary at the Department of Health and Human Services from 2009 to 2014 under President Barack Obama. "If you don't have that standard and don't have some evidence from a high-quality study or [a randomized controlled trial], you are left with suboptimal science and treatments in the long run that may not prove to work."
Koh also said that for other COVID-19 treatments including the medication remdesivir, a randomized clinical trial had been done before the FDA OK'd it for emergency use.
When the emergency authorization for convalescent plasma was announced, HHS officials pointed to findings from a Mayo Clinic preliminary analysis as the rationale. The analysis has not been reviewed by other scientists and doctors.
Suspicions of a political motive behind the decision were heightened because the authorization came one day before the start of the Republican National Convention.
"The timing raises so many questions," said Koh, also a professor of the practice of public health leadership at Harvard University. "I think this announcement shakes the confidence of the medical community in the rigor of the FDA decision-making process."
Trump tweetedjust a day before the FDA's action, "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!"
Scott Gottlieb, a former Trump administration FDA commissioner, offered his take in a tweet the day after the announcement: "Plasma may provide a benefit, and it could be meaningful for certain patients, but we need more evidence to prove it. The data FDA had supports an authorization for emergency use, where the standard is 'may be effective' but we need better studies to confirm preliminary findings."
3. Dr. Stephen Hahn, the current FDA commissioner, misrepresented the data on the treatment's effectiveness during Sunday's press conference. Hahn later corrected himself.
The Mayo Clinic analyzed outcomes of patients who were given a low dose of plasma and those given a high dose. Those who got the high dose had a lower seven-day mortality rate (8.9%) compared with the seven-day mortality rate of those given a low dose (13.7%).
Dr. Adam Gaffney, a critical care doctor and instructor in medicine at Harvard Medical School, said these two variables were used to calculate what is known as a "relative risk reduction," or the percent difference between the risk of two different treatment outcomes. In this case, the risk reduction between the high dose and low dose of plasma is 35%.
That's the number Hahn misrepresented.
"Many of you know I was a cancer doctor before I became FDA commissioner, and a 35% improvement in survival is a pretty substantial clinical benefit," said Hahn. "What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma."
But, that was an incorrect statement. Hahn had confused relative risk with absolute risk, as many members of the medical community later pointed out. Absolute risk reduction refers to the number of people who experienced reduced mortality from a treatment compared with the rest of the entire population who didn't get the treatment. The absolute risk reduction in this situation is probably closer to 3-5 cases out of 100.
On Monday night, Hahn issued a tweetto set the record straight: "I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction."
Hahn also noted in the Twitter thread that the agency's decision was not political, but "made by FDA career scientists based on data submitted a few weeks ago." He also said the approval was not final and the FDA could revoke authorization if needed.
4. President Trump referred to the use of blood plasma during the RNC, and is likely to do so throughout the remainder of his presidential campaign.
During the first night of the Republican National Convention, in a meeting with a group of first responders, Trump told a police officer who had recovered from COVID-19 that her blood was "valuable."
"Once you're recovered, we have the whole thing with plasma happening. That means your blood is very valuable, you know that, right?" Trump said. Vice President Mike Pence also mentioned it in his Wednesday night speech.
5. Critics of the convalescent plasma treatment say there must be randomized clinical trials to prove its effectiveness.
Koh said receiving convalescent plasma doesn't appear to be dangerous, but a recent study in Chinadid report that 2 in about 100 people experienced adverse events associated with the treatment.
And multiple experts said a randomized clinical trial is necessary to ensure that the mortality outcomes shown in the Mayo Clinic analysis weren't confounded by other factors.
A randomized clinical trial would involve one group receiving a placebo and another group receiving the treatment. Who is assigned to each group would be completely random to eliminate bias.
Gaffney said he noticed that patients in the low-dose plasma group seemed to be sicker than those in the high-dose plasma group — which could have affected the Mayo Clinic's findings.
"To ensure that the effect we see is the effect of the intervention, and not a manifestation of differences in how sick the two groups are," the trial has to be randomized, said Gaffney.
The Mayo Clinic analysis also reported that some patients who received plasma also took remdesivir or steroids, which could have influenced their mortality outcomes.
Dr. Eric Topol, director of the Scripps Research Translational Institute, said, at best, he sees the outcomes of this analysis as a hypothesis that needs to be tested in a randomized clinical trial. "No survival benefit has been proven," he wrote in an email.
In the 2014 elections, Republicans rode a wave of anti-Affordable Care Act sentiment to pick up nine Senate seats, the largest gain for either party since 1980. Newly elected Republicans such as Cory Gardner in Colorado and Steve Daines in Montana had hammered their Democratic opponents over the healthcare law during the campaign and promised to repeal it.
Six years later, those senators are up for reelection. Not only is the law still around, but it's gaining in popularity. What was once a winning strategy has become a political liability.
Public sentiment about the ACA, also known as Obamacare, has shifted considerably during the Trump administration after Republicans tried but failed to repeal it. Now, in the midst of the COVID-19 pandemic and the ensuing economic crisis, which has led to the loss of jobs and health insurance for millions of people, healthcare again looks poised to be a key issue for voters this election.
With competitive races in Colorado, Montana, Arizona, North Carolina and Iowa pitting Republican incumbents who voted to repeal the ACA against Democratic challengers promising to protect it, attitudes surrounding the health law could help determine control of the Senate. Republicans hold a slim three-vote majority in the Senate but are defending 23 seats in the Nov. 3 election. Only one Democratic Senate seat — in Alabama, where incumbent Doug Jones is up against former Auburn University football coach Tommy Tuberville — is considered in play for Republicans.
"The fall election will significantly revolve around people's belief about what [candidates] will do for their health coverage," said Dr. Daniel Derksen, a professor of public health at the University of Arizona.
The Affordable Care Act has been a wedge issue since it was signed into law in 2010. Because it then took four years to enact, its opponents talked for years about how bad the not-yet-created marketplace for insurance would be, said Joe Hanel, spokesperson for the Colorado Health Institute, a nonpartisan nonprofit focused on health policy analysis. And they continued to attack the law as it took full effect in 2014.
Gardner, for example, ran numerous campaign ads that year criticizing the ACA and, in particular, President Barack Obama's assertion that "if you like your healthcare plan, you'll be able to keep your healthcare plan."
But now, Hanel said, the ACA's policies have become much more popular in Colorado as the costs of health exchange plans have dropped. Thus, political messaging has changed, too.
"This time it's the opposite," Hanel said. "The people bringing up the Affordable Care Act are the Democrats."
Despite Gardner's multiple votes to repeal the ACA, he has largely avoided talking about the measure during the 2020 campaign. He even removed his pro-repeal position from his campaign website.
Democratic attack ads in July blasted Gardner for repeatedly dodging questions in an interview with Colorado Public Radio about his stance on a lawsuit challenging the ACA.
His opponent, Democrat John Hickenlooper, fully embraced the law when he was Colorado governor, using the measure to expand Medicaid eligibility to more low-income people and to create a state health insurance exchange. Now, he's campaigning on that record, with promises to expand healthcare access even further.
Polling Data
Polling conducted by KFF for the past 10 years shows a shift in public opinion has occurred nationwide. (KHN is an editorially independent program of KFF, the Kaiser Family Foundation.)
"Since Trump won the election in 2016, we now have consistently found that a larger share of the public holds favorable views" of the health law, said Ashley Kirzinger, associate director of public opinion and survey research for the foundation. "This really solidified in 2017 after the failed repeal in the Senate."
The foundation's polling found that, in July 2014, 55% of voters opposed the law, while 36% favored it. By July 2020, that had flipped, with 51% favoring the law and 38% opposing it. A shift was seen across all political groups, though 74% of Republicans still viewed it unfavorably in the latest poll.
Public support for individual provisions of the ACA — such as protections for people with preexisting conditions or allowing young adults to stay on their parents' health plans until age 26 — have proved even more popular than the law as a whole. And the provision that consistently polled unfavorably — the mandate that those without insurance must pay a fine — was eliminated in 2017.
"We're 10 years along and the sky hasn't caved in," said Sabrina Corlette, a health policy professor at Georgetown University.
Political Messaging
Following the passage of the ACA, Democrats didn't reference the law in their campaigns, said Erika Franklin Fowler, a government professor at Wesleyan University and the director of the Wesleyan Media Project, which tracks political advertising.
"They ran on any other issue they could find," Fowler said.
Republicans, she said, kept promising to "repeal and replace" but weren't able to do so.
Then, in the 2018 election, Democrats seized on the shift in public opinion, touting the effects of the law and criticizing Republicans for their attempts to overturn it.
"In the decade I have been tracking political advertising, there wasn't a single-issue topic that was as prominent as healthcare was in 2018," she said.
As the global health crisis rages, healthcare concerns again dominate political ads in the 2020 races, Fowler said, although most ads haven't explicitly focused on the ACA. Many highlight Republicans' support for the lawsuit challenging preexisting condition protections or specific provisions of the ACA that their votes would have overturned. Republicans say they, too, will protect people with preexisting conditions but otherwise have largely avoided talking about the ACA.
"Cory Gardner has been running a lot on his environmental bills and conservation funding," Fowler said. "It's not difficult to figure out why he's doing that. It's easier for him to tout that in a state like Colorado than it is to talk about healthcare."
Similar dynamics are playing out in other key Senate races. In Arizona, Republican Sen. Martha McSally was one of the more vocal advocates of repealing the ACA while she served in the House of Representatives. She publicly acknowledged those votes may have hurt her 2018 Senate bid.
"I did vote to repeal and replace Obamacare," McSally said on conservative pundit Sean Hannity's radio show during the 2018 campaign. "I'm getting my ass kicked for it right now."
She indeed lost but was appointed to fill the seat of Sen. Jon Kyl after he resigned at the end of 2018. Now McSally is in a tight race with Democratic challenger Mark Kelly, an astronaut and the husband of former Rep. Gabby Giffords.
"Kelly doesn't have a track record of voting one way or another, but certainly in his campaign this is one of his top speaking points: what he would do to expand coverage and reassure people that coverage won't be taken away," said Derksen, the University of Arizona professor.
The ACA has proved a stumbling block for Republican Sens. Thom Tillis of North Carolina and Joni Ernst of Iowa. In Maine, GOP Sen. Susan Collins cast a key vote that prevented the repeal of the law but cast other votes that weakened it. She now also appears vulnerable — but more for her vote to confirm Brett Kavanaugh's nomination to the Supreme Court and for not doing more to oppose President Donald Trump.
In Montana, Daines, who voted to repeal the ACA, is trying to hold on to his seat against Democratic Gov. Steve Bullock, who used the law to expand the state's Medicaid enrollment in 2015. At its peak, nearly 1 in 10 Montanans were covered through the expansion.
As more Montanans now face the high cost of paying for healthcare on their own amid pandemic-related job losses, Montana State University political science professor David Parker said he expects Democrats to talk about Daines' votes to repeal cost-saving provisions of the ACA.
"People are losing jobs, and their jobs bring healthcare with them," Parker said. "I don't think it's a good space for Daines to be right now."
"President Trump marshaled the full resources of our federal government from the outset. He directed us to forge a seamless partnership with governors across America in both political parties," said Vice President Mike Pence, during his speech at the Republican National Convention on Aug. 26.
This article was published on Thursday, August 27, 2020 in Kaiser Health News.
Vice President Mike Pence portrayed his boss, President Donald Trump, as a leader who has reached out across the aisle to help during the coronavirus pandemic.
“President Trump marshaled the full resources of the federal government and directed us to forge a seamless partnership with governors across America in both parties,” Pence said during his speech Wednesday night at the Republican National Convention.
Clearly, the federal government has provided supplies and funding to states led by both parties in response to the pandemic, and Pence himself has held regular conference calls with governors in both parties. But Pence was speaking about the actions of Trump, not his own.
Pence’s comments ignored Trump’s multiple feuds, frequently with Democratic governors, about state-federal responsibilities and the pandemic response.
A Trump campaign spokesperson sent us a list of dozens of teleconferences and meetings that Trump or Pence had with governors, including Democrats such as New York’s Andrew Cuomo and Michigan’s Gretchen Whitmer. In March, Trump sent a letter to governors thanking them for “stepping up to help America confront this unprecedented global pandemic.” The campaign pointed to actions by administration officials to brief governors about making available supplies, such as testing swabs, utilizing the National Guard, and reopening state economies.
Trump Argued With Governors Over COVID-19 Supplies, Tests
After declaring a national emergency over the health crisis on March 13, Trump directed governors to order their own ventilators, respirators and supplies, saying the federal government is “not a shipping clerk.” Governors in both parties shot back that Trump’s stance, and the lack of coordination from Washington, left states bidding against one another and the federal government for access to critical equipment.
Cuomo said it was akin to competing on eBay with all the other states plus the Federal Emergency Management Agency.
Whitmer and Maryland Gov. Larry Hogan, a Republican and then chair of the National Governors Association, were among those pleading for better coordination from FEMA to ensure that supplies were distributed based on need.
“The lack of any centralized coordination is creating a counterproductive competition between states and the federal government to secure limited supplies, driving up prices and exacerbating existing shortages,” they wrote in a joint March 30 op-ed in The Washington Post.
A couple of days earlier, Trump said during a White House briefing that governors should be “appreciative” toward him and the federal government.
Speaking of Pence, Trump said: “He calls all the governors. I tell him — I mean, I’m a different type of person — I say, ‘Mike, don’t call the governor of Washington. You’re wasting your time with him. Don’t call the woman in Michigan.’” On Twitter, Trump said Whitmer was “way in over her head, she doesn’t have a clue.”
In April, Trump said that testing “is a local thing” and that states should turn to commercial labs for help. After he was blasted by governors from both parties, Trump said the federal government would step up efforts to get testing supplies.
Governors also called on Trump early on to enact the Defense Production Act, a law that gives the president authority to expedite the supply of materials for national defense, in order to ramp up production of personal protective equipment and COVID-19 testing supplies. While the president did eventually invoke the act to produce ventilators and medical equipment, he delayed efforts to do so and did it sparingly. Washington Gov. Jay Inslee and Arkansas Gov. Asa Hutchinson called for him to broaden its use.
Trump’s justification for slow-rolling the act was that he didn’t want the government to intervene in the private sector.
“You know, we’re a country not based on nationalizing our business,” Trump said at a coronavirus task force press briefing on March 22. “Call a person over in Venezuela, ask them how did nationalization of their businesses work out? Not too well.”
In April, Trump said that Georgia Gov. Brian Kemp, a Republican, had reopened Georgia “too soon.” In May, he criticized Pennsylvania Gov. Tom Wolf, a Democrat, for keeping parts of his state closed that Trump said were “barely affected.”
Trump said in mid-April that it was up to him — not the governors — to decide when to reopen states on lockdown.
Some Governors Bypassed the Federal Government to Work Together
Frustrated with the responses from the Trump administration, some governors teamed up with one another to get needed supplies.
In May, a coalition of governors from seven Northeastern states, including New York, Connecticut, New Jersey, Rhode Island, Pennsylvania and Delaware, joined together to buy personal protective equipment and ventilators and create a unified reopening strategy.
As late as July, some governors were calling on the feds for help and not getting what they needed. There were shortages of testing supplies, as well as personal protective gear. Washington state asked for 4.2 million N95 respirators. It received a bit under 500,000. It asked for about 300,000 gowns. It got about 160,000.
On Aug. 18, a bipartisan group of governors — five Democrats and five Republicans — announced they would be partnering with the Rockefeller Foundation to create a national testing strategy in the absence of federal action. The 10 states are Louisiana, Maryland, Massachusetts, Michigan, Ohio, North Carolina, Utah, Arkansas, Rhode Island and Virginia. Their goal is to buy and deploy 5 million COVID-19 antigen tests.
Feuds Between Trump Administration and States Continue
The Trump administration sought to pressure states to reopen schools for in-person instruction. In July, Trump threatened to cut off funding if schools didn’t reopen.
This summer, the Trump administration reduced the federal share of National Guard assistance to the states to help with pandemic response, despite pleas from governors in both parties. An Aug. 3 memo said that the federal government would no longer continue to pay for 100% of the tab for most states and that it would be reduced to 75% as of Aug. 21.
And when the CDC unveiled new testing guidelines that downplayed the need to test people who don’t show symptoms — about 40% of those infected — Cuomo and California Gov. Gavin Newsom said that they wouldn’t follow it. Asymptomatic people are thought to be significant spreaders of the virus. Both governors at times praised certain responses by the Trump administration to help their states respond to the pandemic.
Our Ruling
Pence said, “President Trump marshaled the full resources of our federal government from the outset. He directed us to forge a seamless partnership with governors across America in both political parties.”
Trump and top administration officials have communicated with governors of both parties for months in meetings, phone calls and written communication. But Pence’s comment ignores that Trump has feuded with governors over state-federal responsibilities, supplies and policies for shutting down or reopening. Trump also has suggested a lesser role for the federal government and said that the handling of COVID-19 should be left to the states.
Doctors have noted a troubling phenomenon associated with some COVID cases: Even after extubation, some patients remain unconscious for days, weeks or longer.
This article was published on Thursday, August 27, 2020 in Kaiser Health News.
Leslie Cutitta said yes, twice, when clinicians from Massachusetts General Hospital in Boston called asking whether she wanted them to take — and then continue — extreme measures to keep her husband, Frank Cutitta, alive.
The first conversation, in late March, was about whether to let Frank go or to try some experimental drugs and treatments for COVID-19. The second call was just a few days later. Hospital visits were banned, so Leslie couldn't be with her husband or discuss his wishes with the medical team in person. So she used stories to try to describe Frank's zest for life.
"Frank used to joke that he wanted to be frozen, like Ted Williams, until they could figure out what was wrong with him if he died," said Leslie Cutitta. It wasn't a serious end-of-life discussion, but Cutitta knew her husband would want every possible lifesaving measure deployed.
So the Cutittas hung on and a small army of ICU caregivers kept working. On April 21, after 27 days on a ventilator, Frank's lungs had recovered enough to remove the breathing tube.
After the removal, it typically takes hours, maybe a day, for the patient to return to consciousness. The body needs that time to clear the drugs that keep the patient sedated and comfortable — able to tolerate intubation and mechanical ventilation.
But doctors across the U.S. and in other countries have noted a troubling phenomenon associated with some COVID cases: Even after extubation, some patients remain unconscious for days, weeks or longer. There's no official term for the problem, but it's being called a "prolonged" or "persistent" coma or unresponsiveness.
Frank Cutitta, 68, was one of those patients. He just didn't wake up.
"It was a long, difficult period of not — just not knowing whether he was going to come back to the Frank we knew and loved," said Leslie Cutitta. "It was very, very tough."
Doctors studying the phenomenon of prolonged unresponsiveness are concerned that medical teams are not waiting long enough for these COVID-19 patients to wake up, especially when ICU beds are in high demand during the pandemic.
As Frank's unresponsive condition continued, it prompted a new conversation between the medical team and his wife about whether to continue life support. Although he no longer needed the ventilator, he still required a feeding tube, intravenous fluids, catheters for bodily waste and some oxygen support.
Leslie Cutitta recalled a doctor asking her: "If it looks like Frank's not going to return mentally, and he's going to be hooked up to a dialysis machine for the rest of his life in a long-term care facility, is that something that you and he could live with?"
She struggled to imagine the restricted life Frank might face. Every day, sometimes several times a day, she would ask Frank's doctors for more information: What's going on inside his brain? Why is this happening? When might something change?
Their candid and consistent answer was: We don't know.
"Because this disease is so new and because there are so many unanswered questions about COVID-19, we currently do not have reliable tools to predict how long it will take any individual patient to recover consciousness," said Dr. Brian Edlow, a critical care neurologist at Mass General.
Given all the unknowns, doctors at the hospital have had a hard time advising families of a patient who has remained unresponsive for weeks, post-ventilator. Some families in that situation have decided to remove other life supports so the patient can die. Edlow can't say how many.
"It is very difficult for us to determine whether any given patient's future will bring a quality of life that would be acceptable to them," Edlow said, "based on what they've told their families or written in a prior directive."
Theories abound about why COVID-19 patients may take longer to regain consciousness than other ventilated patients, if they wake up at all. COVID-19 patients appear to need larger doses of sedatives while on a ventilator, and they're often intubated for longer periods than is typical for other diseases that cause pneumonia. Low oxygen levels, due to the virus's effect on the lungs, may damage the brain. Some of these patients have inflammation related to COVID-19 that may disrupt signals in the brain, and some experience blood clots that have caused strokes.
"So there are many potential contributing factors," Edlow said. "The degree to which each of those factors is playing a role in any given patient is still something we're trying to understand."
One of the first questions researchers hope to answer is how many COVID-19 patients end up in this prolonged, sleeplike condition after coming off the ventilator.
"In our experience, approximately every fifth patient that was hospitalized was admitted to the ICU and had some degree of disorders of consciousness," said Dr. Jan Claassen, director of neurocritical care at New York's Columbia University Medical Center. "But how many of those actually took a long time to wake up, we don't have numbers on that yet."
An international research group based at the University of Pittsburgh Medical Center expects to have in September some initial numbers on COVID-19 brain impacts, including the problem of persistent comas. Some COVID patients who do eventually regain consciousness still have cognitive difficulties.
To try to get a handle on this problem at Columbia, Claassen and colleagues created a "coma board," a group of specialists that meets weekly. Claassen published a study in 2019 that found that 15% of unresponsive patients showed brain activity in response to verbal commands. A casereported by Edlow in July described a patient who moved between a coma and minimal consciousness for several weeks and was eventually able to follow commands.
This spring, as Edlow observed dozens of Mass General COVID-19 patients linger in this unresponsive state, he joined Claassen and other colleagues from Weill Cornell Medical College to form a research consortium. The researchers are sharing their data to determine the cause of prolonged coma in COVID-19 patients, find treatments and better predict which patients might eventually recover, given enough time and treatment.
The global research effort has grown to include more than 222 sites in 45 countries. Prolonged or persistent comas are just one area of research, but one getting a lot of attention.
Dr. Sherry Chou, a neurologist at the University of Pittsburgh Medical Center, is leading the international effort.
Chou said families want to know "whether a patient can wake up and be themselves." Answering that question "depends on how accurate we are at predicting the future, and we know we're not very accurate right now."
A CT scan of Frank Cutitta's brain showed residue from blood clots but was otherwise "clean."
"From what they could tell, there was no brain damage," Leslie Cutitta said.
And then, on May 4, after two weeks with no signs that Frank would wake up, he blinked. Leslie and her two daughters watched on FaceTime, making requests such as "Smile, Daddy" and "Hold your thumb up!"
"At least we knew he was in there somewhere," she said.
It was another week before Frank could speak and the Cutittas got to hear his voice.
"We'd all be pressing the phone to our ears, trying to catch every word," Leslie Cutitta recalled. "He didn't have a lot of them at that point, but it was just amazing, absolutely amazing."
Frank Cutitta spent a month at Spaulding Rehabilitation Hospital. He's back home now, in a Boston suburb, doing physical therapy to strengthen his arms and legs. He said he slurs words occasionally but has no other cognitive problems.
While he was in the ICU, Cutitta's nurses played recorded messages from his family, as well as some of his favorite music from the Beach Boys and Luciano Pavarotti. Frank Cutitta said he believes the flow of these inspiring sounds helped maintain his cognitive function.
The Cutittas said they feel incredibly lucky. Leslie Cutitta said one doctor told the family that during the worst of the pandemic in New York City, most patients in Frank's condition died because hospitals couldn't devote such time and resources to one patient.
"If Frank had been anywhere else in the country but here, he would have not made it," Leslie Cutitta said. "That's a conversation I will never forget having, because I was stunned."
Frank Cutitta credits the Mass General doctors and nurses, saying they became his advocates.
It "could have gone the other way," he said, if clinicians had decided "'Look, this guy's just way too sick, and we've got other patients who need this equipment.' Or we have an advocate who says, 'Throw the kitchen sink at him,'" Frank said. "And we happened to have the latter."
Many hospitals use 72 hours, or three days, as the period for patients with a traumatic brain injury to regain consciousness before advising an end to life support. As COVID-19 patients fill intensive care units across the country, it's not clear how long hospital staff will wait beyond that point for those patients who do not wake up after a ventilator tube is removed.
Joseph Giacino, director of rehabilitation neuropsychology at Spaulding, said he's worried hospitals are using that 72-hour model with COVID-19 patients who may need more time. Even before the coronavirus pandemic, some neurologists questioned that model. In 2018, the American Academy of Neurology updated its guidelines for treating prolonged "disorders of consciousness," noting that some situations may require more time and assessment.
Some patients, like Frank Cutitta, do not appear to have any brain damage. Whatever caused his extended period of unconsciousness cleared.
Unless a patient has previously specified that she does not want aggressive treatment, "we need to really go slow," said Giacino, "because we are not at a point where we have prognostic indicators that approach the level of certainty that is necessary before making a decision that we should stop treatment because there is no chance of meaningful recovery."
Doctors interviewed for this story urged everyone to tell their loved ones what you expect a "meaningful recovery" to include. If confronted with this situation, family members should ask doctors about their levels of certainty for each possible outcome.
Some medical ethicists also urge clinicians not to rush when it comes to decisions about how quickly COVID-19 patients may return to consciousness.
"A significant number of patients are going to have a prolonged recovery from the comatose state that they're in," said Dr. Joseph Fins, chief of medical ethics at Weill Cornell Medical College. "This is a time for prudence because what we don't know can hurt us and can hurt patients."
Leslie and Frank Cutitta have a final request: Wear a mask.
"This disease is nothing to be trifled with," Leslie Cutitta said. "It's a devastating experience."
Frank Cutitta worries about all of the patients still suffering with COVID-19 and those who have survived but have lasting damage.
"I'm not considering myself one of those," he said, "but there are many, many people who would rather be dead than left with what they have after this."
This story is part of a partnership that includes WBUR, NPR and KHN.
However, those executive orders are far from being implemented, and multiple experts told us it’s unlikely the measures would pass along drug-pricing discounts to a majority of Americans.
This article was first published on Wednesday, August 26, 2020 in Kaiser Health News.
President Donald Trump has long considered lowering the high cost of prescription drugs to be one of his signature issues, and it is likely to be a talking point he relies on throughout the upcoming campaign.
During his afternoon speech Monday ― delivered on the first day of the Repubublican National Convention after delegates had unanimously renominated him to seek reelection ― he returned to this theme.
“Now, I’m really doing it,” he said, referring to a series of four executive orders he issued in July. These orders touched on a range of issues, including insulin prices and drug importation. He focused on two specifically.
“But the fact is that we signed a favored nations clause and a rebate clause, and your numbers are going to come down 60, 70%,” he said.
However, those executive orders are far from being implemented, and multiple experts told us it’s unlikely the measures would pass along drug-pricing discounts to a majority of Americans. And the text of one, the favored nation executive order, has not yet been made public ― making it hard to know how exactly the initiative would work.
“Details are a bit murky,” Matthew Fiedler, a health care fellow with the Brookings Institution, wrote in an email.
We checked in with the White House to find out more details about the favored nation order and when the text might be released. However, we did not get a response. Still, we decided to dig in.
What We Know
The favored nation executive order was supposed to match U.S. prices for a certain class of drugs with the lower amount paid in certain European countries, which negotiate drug prices. It reportedly would have applied only to drugs covered by Medicare Part B ― those that patients receive at their doctors’ offices, such as infused cancer drugs ― but not those purchased at the pharmacy counter. Drug companies criticized the executive order, and the Trump administration offered to consider an alternative plan if the firms offered it by Aug. 24. So far, the industry has not made a counter offer.
A spokesperson for PhRMA, the lobbying group that represents major drugmakers, said in a statement that “the most favored nation executive order is an irresponsible and unworkable policy that will give foreign politicians a say in how America provides access to treatments and cures for seniors and people struggling with devastating diseases.” The group did not confirm on the record whether an alternative drug-pricing plan had been discussed with the White House.
The Trump administration floated a similar idea in 2018, which met with swift criticism from some of its usual supporters, such as Americans for Tax Reform, a right-leaning advocacy group that opposes tax increases. The criticism was marked by TV ads warning that this approach to drug costs was a step toward socialism. We found that claim to be Mostly False. The Centers for Medicare & Medicaid Services estimated at that time the resulting savings from such a plan would be 30%, but it was never enacted.
Multiple experts questioned Trump’s claims about how much costs would come down as a result of the more recent proposal.
That’s in part because the full text of the executive order has not been published, and so classifying the president’s statement as true “requires a leap of faith,” said Benedic Ippolito, a resident scholar who studies health care costs at the American Enterprise Institute.
Ippolito allowed that because some drug prices in other countries are far below those in the U.S., a reduction of 60% or 70% could be plausible for an individual product. But, in order for that to happen, the policy would have to be implemented.
Seeing this 60% to 70% decrease “relies on the idea that this policy ever happens. And I think there is reason to be very skeptical there,” Ippolito wrote in an email.
Rachel Sachs, an associate professor of law at Washington University in St. Louis, who has analyzed the drug-pricing executive orders, agreed there’s no solid foundation to support those percentages.
“I don’t know about the 60 or 70%,” she said. “I don’t know what he’s talking about.”
Another executive order attempted to address the rebates paid to pharmacy benefit managers within Medicare by directing that these payments instead be used as discounts for beneficiaries within the Part D program, the plans that pay for prescription medications.
However, experts pointed out that those discounts usually go toward lowering insurance premiums for seniors. Without applying the discount there, premiums would likely go up. And, in order to keep premiums down, the federal government would need to spend more on subsidies.
Analyses from the Congressional Budget Office and other groups predicted that Trump’s rebate proposal would lower drug prices for some seniors, but would also increase federal spending and increase seniors’ premiums.
There is also a stipulation in the text of the order, which says the order cannot be implemented if it leads to increased government spending or higher premiums for beneficiaries. Thus, it’s unclear how such a proposal would be implemented.
“The executive order on the rebate is internally contradictory, which makes you wonder how they can do this,” said Sachs.
Why It Matters
Trump is likely to continue saying he has reduced drug prices, not only during the Republican National Convention but for the remainder of the 2020 campaign.
Trump likes to present proposals in the works as having been implemented, and we’ve fact-checked him twice before on similar drug-pricing statements.
In May 2019, he claimed he brought down drug prices for the first time in 51 years, which we found to be Mostly False. And in early August of that year, we fact-checked a claim about another of his drug-pricing executive orders that inflated his efforts to reduce insulin prices, which we also found to be Mostly False.
This time, Trump referenced two different drug-pricing executive orders. While it is true that he signed both of them (though the text of only one is publicly available), experts have expressed skepticism about whether these proposals will be implemented, as well as whether they would lower drug prices significantly for Americans.
And this isn’t the first time Trump has made this promise to the American people.
“He promised to lower drug prices as part of his campaign in 2016 and has done absolutely nothing of substance about drug prices at all while he’s been in office,” Aaron Kesselheim, a professor of medicine at Harvard, wrote in an email.
Harbor-UCLA wants to recruit most, if not all, of the trial's 500 participants from among the high-risk patients it already treats.
This article was published on Wednesday, August 26, 2020 in Kaiser Health News.
By Arthur Allen The patients at Dr. Eric Daar's hospital are at high risk for serious illness from COVID-19, and he's determined to make sure they're part of the effort to fight the disease.
He also hopes they can protect themselves in the process.
When Daar and his colleagues at Harbor-UCLA Medical Center on Wednesday announce the start of enrollment for a trial to test a COVID-19 vaccine produced by AstraZeneca, they will also unveil the hospital's community-based recruitment strategy.
Harbor-UCLA wants to recruit most, if not all, of the trial's 500 participants from among the high-risk patients it already treats: people over 65, those with chronic illnesses and members of underserved racial and ethnic groups. Hospital officials also expect that the recruitment task will not be easy.
"It's a priority and obligation to make sure our community is well represented in these trials," said Daar, chief of HIV medicine at Harbor-UCLA and a researcher at the UCLA-affiliated Lundquist Institute, who dropped his other research projects last spring to focus on a COVID-19 vaccine.
The safety-net hospital in Torrance, California, serves patients in the South Bay area of Los Angeles County who are predominantly Black, Latino and Pacific Islander. Many live in crowded homes and do "essential" work that requires them to expose themselves to the virus to make a living: They're orderlies and cooks and house cleaners, day laborers and bus drivers and sanitation workers.
The area has high rates of heart disease and stroke.
"If you don't have a community represented in the trial, it's hard to extrapolate your results to the community," said Dr. Katya Corado, one of Daar's colleagues. "We want to find something to protect our patients and loved ones."
Latinos and Blacks in the United States are nearly three times more likely than non-Hispanic whites to be diagnosed with COVID-19 and nearly five times more likely to be hospitalized with the disease. In Los Angeles County, Latinos in particular have been disproportionately stricken by the virus.
Eight of 10 COVID-19 deaths nationwide occur among people 65 and older, according to the Centers for Disease Control and Prevention.
Historically, Blacks and Latinos have been less likely to be included in clinical trials for disease treatment, despite federal guidelines that urge minority and elder participation.
The National Institutes of Health and the Food and Drug Administration have urged infectious disease researchers to focus on these vulnerable populations in the large phase 3 trials that will test how well vaccines prevent COVID-19.
Harbor-UCLA, a public teaching hospital owned and operated by Los Angeles County, is one of roughly 100 sites nationwide testing the AstraZeneca vaccine candidate, which was developed in collaboration with Oxford University in Britain. Phase 3 trials of about the same size for vaccine candidates produced by Moderna and Pfizer are already underway. Each of the three companies seeks to recruit 30,000 people, 20,000 of whom will get the vaccine and 10,000 a placebo, or harmless saline solution, to test whether the vaccine prevents coronavirus disease.
Recruitment at Harbor-UCLA will include patients with well-controlled chronic diseases such as diabetes and hypertension, and people with HIV who've kept the virus under control with medication, Daar said.
According to the AstraZeneca trial protocol, patients will get up to $100 for each of 15 to 20 visits during the two-year trial. The Harbor-UCLA team will also offer car services to bring people to the hospital through L.A. traffic.
To reach its targeted recruits, the hospital will distribute leaflets to clinics and community organizations and create targeted social media campaigns, in addition to taking any free publicity it can get, Daar said.
Recruitment of high-risk patients in other COVID-19 trials so far has been mixed. Moderna, which began the first phase 3 trial of the experimental vaccines on July 27, announced Friday that 18% of its 13,000-plus enrollees so far were Black, Latino or Native American — a high percentage as clinical trials go, but only about one-third of the goal set by NIH officials.
Other AstraZeneca trial sites have also publicized their efforts to reach those most at risk from the virus. The University of Southern California's Keck School of Medicine placed one of its AstraZeneca recruitment sites in Vernon, south of downtown Los Angeles in an area with many factories and meatpacking plants, which have experienced high COVID-19 infection rates.
Clinicians suspect that the higher rates of disease and hospitalization in minority groups are due both to health conditions — such as undertreated diabetes and heart disease — and to higher exposure to the virus in workplaces and crowded housing. Environmental factors like polluted neighborhoods may also have an impact.
While there's little evidence that vaccines affect Blacks or Latinos differently than white people, the subject hasn't really been studied, said Dr. Akilah Jefferson Shah, an allergist/immunologist and bioethicist at the University of Arkansas for Medical Sciences. That's another reason for making sure these groups are well represented in trials, she said.
"We know now there are subgroup responses to drugs by sex, but no one figured it out until they started including women in these studies," Jefferson Shah said. "Race is not genetic. It's a social construct. But there are genetic variants more prevalent in certain populations. We won't know until we look."
Perhaps most important, diversity in the research will be needed to build trust and uptake of the vaccine, Corado said. In a May poll from the Associated Press-NORC Center for Public Affairs Research, just 25% of Blacks and 37% of Hispanics said they would definitely seek vaccination against the coronavirus, compared with 56% of whites.
In July, the Harbor-UCLA vaccine team began holding weekly Zoom meetings with about 25 activists and clergy members to learn what their communities were saying about the vaccine and get tips on how to design educational materials for the trial.
What they've heard suggests they'll have an uphill recruitment battle.
One member of the community council, HIV activist Dontá Morrison, noted that people frequently say on social media that the vaccine is designed to give them COVID-19 as part of a plot to get rid of Black voters. (None of the vaccines contains infectious COVID virus.)
"It may seem far-fetched, but those are the conversations because we have an administration that has not shown itself to be trustworthy," Morrison said.
He noted that the first challenge UCLA researchers face is to convince community leaders, particularly clergy members, of the vaccine's safety. Church leaders worry they'll be blamed for supporting the trial if the vaccine ends up making their congregants sick, he said.
If done right, the trial could build trust in medical science while helping minorities help themselves — and the rest of us — find a way out of the current mess, Morrison said.
Dr. Raphael Landovitz, another UCLA scientist working on the trial, agreed.
"We're hoping that people understand this is a chance — if we succeed — to take back some power and control in this situation that has made so many of us feel so powerless," he said.