Humana quietly funded 40 Iora primary care clinics

New doctor's office for people on Medicare opens in Lawrenceville | News |  gwinnettdailypost.com

Health insurer Humana quietly funded 40 of Iora Health’s 47 primary care clinics, according to a Securities and Exchange Commission registration statement obtained by Business Insider.

The filing also showed the Humana-funded clinics exclusively served Humana members until July 2020.

Humana CEO Bruce Broussard told Business Insider earlier this year that the company had begun investing in other startup healthcare companies to see which would succeed. He also said the payer sees better outcomes and lower costs among members who go to clinics focused on providing care to older populations.

Iora Health serves 38,000 patients in eight states, according to the article.

Health And Economic Outcomes Of A Workplace Wellness Program

Workplace wellness programs yield unimpressive results in short term –  Harvard Gazette

The goal of workplace wellness programs is twofold: improve employee health and lower health care costs for employers and insurers.

A workplace wellness program was implemented at a random subset of worksites within BJ’s Wholesale Club from 2015 to 2017. Zirui Song and Katherine Baicker looked into its effects.

While the program led to better self-reported health behaviors, notably active weight management, the authors found that it did not produce significant differences in clinical measures of health, health care spending and use, or employment outcomes between treatment and control.

“To the extent that these results are representative of other wellness programs, they temper expectations of substantial improvements in health outcomes or financial returns on investment from wellness programs,” wrote Song and Baicker.

Deepening the role of Big Tech in analyzing clinical data

How Big Tech Is Changing the Way Hospitals Are Run | Technology Networks

HCA Healthcare, the nation’s largest for-profit hospital chain, which operates 185 hospitals and more than 2,000 care sites across 20 states, announced a landmark deal with search giant Google this week, aimed at extracting and analyzing data from more than 32M annual patient encounters.

The multiyear partnership will involve data scientists from both companies working together to develop care algorithms and clinical alerts to improve outcomes and efficiency. Data from HCA’s electronic health records will be integrated with Google’s cloud computing service, and the companies have pledged to adhere to strict limitations to protect individual patient privacy—a key concern raised by regulators after Google announced a similar partnership with another national health system, Ascension, at the end of 2019.

Despite those assurances, some experts pointed to this week’s announcement as further evidence that existing privacy protections are insufficient in the face of the deepening relationships between tech companies, like Google and Microsoft, and healthcare providers, who manage the sensitive health information of millions of patients.
 
We’d agree—we’re overdue for a major rethink of how patient privacy is handled. The healthcare industry spent much of the last decade “wiring” the health system, converting from paper records to electronic ones, and building vast storehouses of clinical data along the way. We’ve now reached a new phase, and the primary task ahead is to harness all of that data to actually improve care. That will require extensive data sharing, such as a recently announced initiative among several major health systems, and will also entail tapping the expertise of “big data” companies from beyond healthcare—the very same companies whose business practices have sometimes raised privacy concerns in the broader social context. But health information is different—more personal and more sensitive—than data about shopping preferences and viewing habits, requiring more rigorous regulation. 

As more big data deals are inked in healthcare, the question of patient privacy will become increasingly pressing.

Private equity acquisitions targeted large, high-margin hospitals over 15-year period

Private-Equity Cash Piles Up as Takeover Targets Get Pricier - WSJ

From 2003 to 2017, private equity firms focused their acquisition crosshairs on larger hospitals with higher operating margins and greater patient charge-to-cost ratios, according to a new review of healthcare investments published in Health Affairs.

These private equity (PE)-owned hospitals also saw greater increases to their operating margins and charge-to-cost ratios over the course of the 15-year study period than their non-PE-owned counterparts.

Combined with a decrease in all-personnel staffing ratios, the study’s researchers said these data make a case for further investigation into how PE investment may be influencing operational decisions to boost profits and secure favorable exits.

“[Short-term acute care] hospitals’ large size, stable cashflow environment and prevalence of valuable fixed assets (that is, properties) make them highly desirable targets for acquisition, researchers wrote in Health Affairs. “Broadly speaking, PE acquisition of hospitals invites questions about the alignment of the financial incentives necessary to achieve high-quality clinical outcomes.”

To inform that discussion, the researchers reviewed PE deal data collected by Pitchbook, CB Insights and Zephyr. They also collected information on hospital characteristics and financials from the Centers for Medicare and Medicaid Services’ (CMS) Healthcare Provider Cost Reporting Information System database and the American Hospital Association’s Annual Survey.

Their efforts yielded 42 PE acquisitions involving 282 different hospitals during the 15-year time period. These deals were most frequent among hospitals in Mid-Atlantic and Southern states.

Of note, 161 of the acquired hospitals were tied to a single deal: Bain Capital, Kohlberg Kravis & Roberts and Merrill Lynch Global Private Equity’s roughly $33 billion (more than $21 billion cash, $11.7 billion debt) acquisition of HCA Healthcare in 2007.

The study outlined differences between the PE-acquired hospitals and others that were not acquired before any of the deals (in 2003) and after (in 2017).

Nearly three-quarters of hospitals acquired by PE were for-profit in 2003, versus about a quarter of those that were not acquired, the researchers wrote. By 2017, those respective proportions had increased to 92.3% and 25.3%.

Acquired hospitals were significantly larger in terms of beds and total discharges both in 2003 and in 2017. In fact, while acquired hospitals increased in size during the 15-year window, other hospitals decreased in beds and discharges by 2017.

Nurse staffing ratios were similar on both ends of the study period for both categories of hospitals. However, all-staff ratios were lower among the soon-to-be-acquired hospitals in 2003 and saw a slight decrease over the years, whereas hospitals that had not been acquired instead recorded an increase over time.

In terms of financials, the researchers reviewed measures including net patient revenue per discharge, total operating expenses per discharge and the percentage of discharges paid out by Medicaid. Differences among these three areas were not significant with the exception of a larger 15-year increase in total operating expenses per discharge among non-PE hospitals.

The primary financial differences between the PE and non-PE hospitals were instead found among the organizations’ percent operating margins and charge-to-cost ratio, the researcher wrote.

In 2003, both measures were higher among the soon-to-be acquired hospitals. By 2017, the percent operating margin and charge-to-cost ratio increased 66.5% and 105% among the PE-acquired hospitals, respectively, versus changes of -3.8% and 54.2% for the non-PE hospitals.

These and the study’s other findings outline the playbook an investor could follow to identify a profitable hospital and increase its margins, the researchers wrote.

“Post-acquisition, these hospitals appeared to continue to boost profits by restraining growth in cost per patient, in part by limiting staffing growth,” they wrote.

The trends affirm findings published in a 2020 JAMA Internal Medicine study, which similarly tied PE acquisition to moderate income and charge-to-cost ratio increases over the same time period, the researchers wrote.

The data also contrast “the prevailing narrative” that PE investors target distressed businesses to extract value for a quick turnaround sale, they wrote. Outside of a few outlier acquisitions, the researchers said that PE’s goal for short-term acute care hospitals appears to be the opposite—operations refinement and further profit improvements among potential top performers.

Still, the differing structure of PE investments warrants questions as to whether these groups are promoting high-quality outcomes alongside their high margins, Anaeze Offodile II, M.D., an assistant professor at the University of Texas MD Anderson Cancer Center and the study’s lead author, said during an accompanying Health Affairs podcast.

In contrast to the public market, PE investments often lean on leveraged buyouts that are higher risk and higher reward, he said. Partners are targeting a three-to-seven-year exit window for their investments and often need to hit 20% to 30% annualized returns.

More investigation is needed to determine whether these economic incentives come in tandem with better care or are instead hindering patient outcomes, he said.

“The question becomes ‘Are there unintended consequences or tradeoffs invited due to pursuit of profitability?’” Offodile said during the podcast. “I think someone could make the same argument that if there is a value enhancement strategy by PE firms, then it behooves them to actually raise the level of care delivery up because that enhances the value and engineers a better sale.

“In seeing that sort of exploratory result and how it challenged the prevailing narrative, we’re glad that we took this sort of [setting the] stage approach, and I look [forward] to seeing what we find—which we’re doing now—with respect to quality, spending, access domains,” he said.

Study: Higher Death Rates and Taxpayer Costs at Nursing Homes Owned by Private Equity

About 1 in 10 nursing homes in California and nationwide are owned by private equity (PE) investors, and new research suggests that death rates for residents of those facilities are substantially higher than at institutions with different forms of ownership.

Essential Coverage

Researchers from New York University, the University of Chicago, and the University of Pennsylvania found that the combination of subsidies from Medicare and Medicaid alongside incentives for PE owners to increase the value of their investments “could lead high-powered for-profit incentives to be misaligned with the social goal of affordable, quality care [PDF].” The researchers — Atul Gupta, Constantine Yannelis, Sabrina Howell, and Abhinav Gupta — reported that nursing homes owned by private equity entities were associated with a 10% increase in the short-term death rate of Medicare patients over a 12-year period. That means more than 20,000 people likely died prematurely in homes run by PE companies, according to their study, which was published in February by the National Bureau of Economic Research (NBER).

In addition to the higher short-term death rates, these homes were found to have sharper declines in measures of patient well-being, including lower mobility, increased pain intensity, and increased likelihood of taking antipsychotic medications, which the study said are discouraged in the elderly because the drugs increase mortality in this age group. Meanwhile, the study found that taxpayer spending per patient episode was 11% higher in PE-owned nursing homes.

Double-Checked, Triple-Checked, Quadruple-Checked

The researchers were stunned by the data. “You don’t expect to find these types of mortality effects. And so, you know, we double-checked it, triple-checked it, quadruple-checked it,” Atul Gupta, a coauthor of the NBER study, told NPR reporter Gabrielle Emanuel.

There’s nothing new about for-profit nursing homes, but private equity firms are a unique subset that in recent years has made significant investments in the industry, Dylan Scott reported in Vox. PE firms typically buy companies in pursuit of higher profits for shareholders than could be obtained by investing in the shares of publicly traded stocks. They then sell their investments at a profit, often within seven years of purchase. They often take on debt to buy a company and then put that debt on the newly acquired company’s balance sheet.

They also have purchased a mix of large chains and independent facilities — “making it easier to isolate the specific effect of private equity acquisitions, rather than just a profit motive, on patient welfare.” About 11% of for-profit nursing homes are owned by PE, according to David Grabowski, professor of health care policy at Harvard Medical School. The NBER study covered 1,674 nursing homes acquired in 128 unique transactions.

While the owners of many nursing homes may not be planning to sell them, they also have strong incentives to keep costs low, which may not be good for patients. A study funded by CHCF, for instance, found that “early in the pandemic, for-profit nursing homes had COVID-19 case rates five to six times higher than those of nonprofit and government-run nursing homes. This was true of both independent nursing homes and those that are part of a corporate chain.”

Nationallyabout 70% of nursing homes are operated by for-profit corporations, 24% of nursing homes are nonprofit, and 7% are government-owned. Corporate chains own 58%. In California, 84% of nursing homes are for-profit, 12% are nonprofit, and 3% are government-owned, according to the CHCF report.

Growing PE Investment in Health Care

Given the dramatic increase in PE ownership of nursing facilities coming out of the COVID-19 pandemic, the higher death rates are troubling. The year-over-year growth between 2019 and 2020 is especially striking. Before the pandemic, 2019 saw 33 private equity acquisitions of nursing homes valued at just over $483 million. In 2020, there were 43 deals valued at more than $1.5 billion, according to Bloomberg Law reporter Tony Pugh.

And PE interest in health care is not restricted to nursing homes, explained Gretchen Morgenson and Emmanuelle Saliba at NBC News. “Private equity’s purchases have included rural hospitals, physicians’ practices, nursing homes and hospice centers, air ambulance companies and health care billing management and debt collection systems.” Overall, PE investments in health care have increased more than 1,900% over the past two decades. In 2000, PE invested less than $5 billion. By 2017, investment had jumped to $100 billion.

Industry advocates argue that the investments are in nursing homes that would fail without an influx of PE capital. The American Investment Council said private equity firms invest in “nursing homes to help rescue, build, or grow businesses, often providing much-needed capital to strengthen struggling companies and employ Americans,” according to Bloomberg Law.

The Debate Over Staffing

A bare-bones nursing staff is implicated in poorer quality at PE-owned nursing homes, both before and during the COVID-19 pandemic. Staff is generally the greatest expense in nursing homes and a key place to save money. “Labor is the main cost of any health care facility — accounting for nearly half of its operating costs — so cutting it to a minimum is the fastest profit-making measure owners can take, along with paying lower salaries,” journalist Annalisa Merelli explained in Quartz.

Staffing shrinks by 1.4% after a PE purchase, the NBER study found.

The federal government does not set specific patient-to-nurse ratios. California and other states have set minimum standards, but they are generally “well below the levels recommended by researchers and experts to consistently meet the needs of each resident,” according to the journal Policy, Politics, & Nursing Practice.

According to nursing assistant Adelina Ramos, “understaffing was so significant [during the pandemic] that she and her colleagues . . . often had to choose which dying or severely ill patient to attend first, leaving the others alone.”

Ramos worked at the for-profit Genesis Healthcare, the nation’s largest chain of nursing homes, which accepted $180 million in state and federal funds during the COVID-19 crisis but remained severely understaffed. She testified before the US Senate Finance Committee in March as a part of a week long look into how the pandemic affected nursing homes.Before the pandemic, we had this problem,” she said of staffing shortages. “And with the pandemic, it made things worse.”

$12.46 an Hour

In addition, low pay at nursing homes compounds staffing shortages by leading to extremely high rates of turnover. Ramos and her colleagues were paid as little as $12.46 an hour.

“The average nursing home in the US has their entire nursing home staff change over the course of the calendar year. This is a horrible way to provide good, quality nursing home care,” Grabowski told NPR, speaking of his March 2021 study in Health Affairs.

Loss of front-line staff leads to reductions in therapies for healthier patients, which leads to higher death rates, according to the NBER study. The effect of these cuts is that front-line nurses spend fewer hours per day providing basic services to patients. “Those services, such as bed turning or infection prevention, aren’t medically intensive, but they can be critical to health outcomes,” wrote Scott at Vox.

Healthier patients tend to suffer the most from this lack of basic nursing. “Sicker patients have more regimented treatment that will be adhered to no matter who owns the facility,” the researchers said, “whereas healthier people may be more susceptible to the changes made under private equity ownership.”

Growing Interest on Capitol Hill

In addition to the Senate Finance Committee hearings, the House Ways and Means Committee held a hearing at the end of last month about the excess deaths in nursing homes owned by PE. “Private equity’s business model involves buying companies, saddling them with mountains of debt, and then squeezing them like oranges for every dollar,” said Representative Bill Pascrell (D-New Jersey), who chairs the House Ways and Means Committee’s oversight subcommittee.

The office of Senator Elizabeth Warren (D-Massachusetts) will investigate the effects of nursing-home ownership on residents, she announced on March 17.

The hope is that the pandemic’s effect on older people will bring more attention to the issues that lead to substandard nursing home care. “Much more is needed to protect nursing home residents,” Denise Bottcher, the state director of AARP’s Louisiana office, told the Senate panel. “The consequence of not acting is that someone’s mother or father dies.”

Millions more smokers and ex-smokers should receive free annual screenings for lung cancer, a federally appointed task force says

Millions more smokers and ex-smokers should receive free annual screenings  for lung cancer, a federally appointed task force says - The Washington Post

The recommendation would double the number of people eligible, but some experts worry about possible false positives and follow-up tests.

A federally appointed task force recommended a major increase in the number of Americans eligible for free screening for lung cancer, saying expanded testing will save lives and especially benefit Black people and women.

The U.S. Preventive Services Task Force, an independent group of 16 physicians and scientists who evaluate preventive tests and medications, said people with a long history of smoking should begin getting annual low-dose CT scans at age 50, five years earlier than the group recommended in 2013. The group also broadened the definition of people it considers at high risk for the disease.

The changes mean that 15 million people, nearly twice the current number, will be eligible for the scans to detect the No. 1 cancer killer in the United States. Under the Affordable Care Act, private insurers must cover services, without patient cost-sharing, that receive “A” or “B” recommendations from the task force. The lung-cancer screening recommendation received a “B” rating. Medicare also generally follows the group’s guidance.

The recommendation was welcomed by many lung-cancer specialists but drew a more cautious reaction from some physicians who noted that the test can produce false positives — flagging a spot or growth that is benign — and lead to potentially costly and invasive follow-up tests such as biopsies.

Lung cancer killed more than 135,000 people in the United States last year, according to the National Cancer Institute. Smoking and increasing age are the biggest risk factors, although nonsmokers also develop the disease, sometimes as a result of genetic mutations.

Overall, the five-year survival rate for lung cancer is about 20 percent, but it is higher when the disease is caught at the earliest stages. In recent years, the death rate for non-small cell lung cancer — the most common form — has declined, partly reflecting decreases in smoking but also new treatments targeted at specific genetic mutations or alterations.

To update its 2013 recommendation, the task force commissioned a study of the latest data on lung-cancer screening and did modeling on the best age to start the screening.

The conclusion was that broadening eligibility would save a substantial number of lives, the task force said in an article Tuesday in the Journal of the American Medical Association.

The new recommendation applies to adults ages 50 to 80 who have smoked about a pack of cigarettes a day for 20 years. The 2013 version, which had the higher age threshold, was for those who smoked the equivalent of a pack a day for 30 years. In both cases, the policy applies to current smokers or those who have quit within the past 15 years. Someone who stopped smoking 20 years ago would not be eligible.

The task force said the changes will increase the number of Black people and women who will be eligible for screening and who tend to smoke fewer cigarettes than White men yet still are vulnerable to lung cancer. African Americans, the group said, have a higher risk of lung cancer than White men even with lower levels of smoking exposure. It said it hopes the new recommendation will increase the use of the test; estimates are that fewer than 5 percent of eligible Americans have been screened for lung cancer.

Roy S. Herbst, a lung-cancer specialist at the Yale Cancer Center, was enthusiastic about the recommendation. He said more screening would mean more cancer caught at an earlier stage, when there is a better chance of treating or curing it.

“We have to find these lung cancers early,” he said. “It’s a very minimal test.”

Some physicians and researchers were more cautious. Daniel S. Reuland, a professor of medicine at the University of North Carolina School of Medicine, co-wrote an updated analysis of benefits and harms that also ran in JAMA. Screening high-risk people with low-dose CT, the article said, “can reduce lung cancer mortality but also causes false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, increases in distress, and, rarely, radiation-induced cancers.”

Reuland noted that follow-up tests can be nerve-racking and costly. For that reason, he and other physicians, in a third JAMA article, called on the Centers for Medicare and Medicaid Services to continue to require doctors and patients to undergo “shared decision-making” — an in-depth discussion about the pluses and minuses of the screening.

Otis Brawley, an oncologist at Johns Hopkins University who has raised questions about lung-cancer screening, said he does not object to expanding the criteria but argued that all the tests should be performed at hospitals with extensive experience, to minimize the likelihood of false positives.

“You have to have a good program,” Brawley said. “A number of centers that are offering it should not be offering it. So those centers are perpetuating disparities, not reducing them.”

John Wong, a member of the task force and an internist at Tufts Medical Center in Boston, countered that the benefits of screening — and of finding a potentially lethal malignancy at an early, curable stage — far outweigh the harms.

Although follow-up tests involving what turns out to be a benign growth might cause short-term anxiety and be costly, he said, “if you miss a lung cancer, then it might spread and shorten your life.”

Risking lives in pursuit of profits

https://mailchi.mp/05e4ff455445/the-weekly-gist-february-26-2021?e=d1e747d2d8

Benefit of Private Equity in Healthcare? Lessons from Nursing Homes

Finding a good long-term care facility for a loved one has always been a difficult process. A new National Bureau of Economic Research working paper suggests that families should also be paying attention to who owns the facility, finding a significant increase in mortality in nursing homes owned by private equity investors.

Examining Medicare data from over 18,000 nursing homes, 1,674 of which were owned by private equity (PE) firms, researchers found that PE ownership increased Medicare patient mortality by 10 percent—translating to a possible 20,150 additional lives lost. PE-owned facilities were also 11 percent more expensive.

Counterintuitively, lower-acuity patients had the greatest increase in mortality. Researchers found staffing decreased by 1.4 percent in PE-owned facilities, suggesting that shorter-staffed facilities may be forced to shift attention to sicker patients, leading to greater adverse effects on patients requiring less care.

Antipsychotic use, which carries a higher risk in the elderly, was also a whopping 50 percent higher.

Nursing homes are low-margin businesses, with profits of just 1-2 percent per year—and PE ownership did not improve financial performance.

Researchers found private equity profited from three strategies: “monitoring fees” paid to services also owned by the PE firm, lease payments after real estate sales, and tax benefits from increased interest payments, concluding that PE is shifting operating costs away from patient care in order to increase return on investment. Private equity investment in care delivery assets has skyrocketed over the past decade.

This study draws the most direct correlation between PE investment and an adverse impact on patient outcomes that we’ve seen so far, highlighting the need for increased regulatory scrutiny to ensure that patient safety isn’t sacrificed for investor returns.

The growth of “pharmacy deserts”

https://www.axios.com/pharmacy-deserts-cities-prescriptions-45c32271-37ac-4105-b1bb-e2d2436b88c1.html

Neighborhoods in cities like Chicago are rapidly becoming places where people can’t fill medical prescriptions locally because their drugstores have shuttered or don’t accept Medicaid.

Why it matters: The pandemic has accelerated the growth of “pharmacy deserts” as unprofitable and less-profitable stores have closed. It’s a worrisome trend for the urban poor, who are less likely to try online pharmacies and more likely to let their drug regimens lapse when they can’t get medication locally.

Driving the news: Effective Dec. 1, Medicaid patients in Illinois — of which there are 400,000, per the Chicago Tribune — could no longer get their prescriptions filled at Walgreens, a prevalent chain headquartered in a Chicago suburb.

  • The change came because Aetna, which provides contracts with the state of Illinois to serve Medicaid recipients, dropped Walgreens as a provider. CVS — a top Walgreens rival — owns Aetna as well as the pharmacy benefits manager CVS Caremark.
  • CVS “has no pharmacies in five key West Side neighborhoods,” per the Tribune.
  • Illinois state Rep. La Shawn Ford called Aetna’s decision “pathetic” and told the Tribune, “It’s an attack not just on Black people, but on those that are struggling during the pandemic.”

The backstory: Researcher Dima Qato coined the term “pharmacy desert” in a 2014 article that found there were far fewer pharmacies in Chicago’s Black neighborhoods than in white and mixed neighborhoods.

  • Medicaid policies like the one in Illinois “are all over the country, where Medicaid dictates where and where you can go fill your medication,” Qato tells Axios. “And that leads to certain pharmacies having less patients in them, which leads to less profits, which leads to closures.”
  • Qato — who recently took a post as a professor at the University of Southern California, and is in the process of moving from Chicago — said that the new Medicaid policy in Illinois is generating “a lot of outrage in the community right now.”
  • Per Qato’s definition, people live in a “pharmacy desert” if they can’t fill a prescription within a half-a-mile of their homes (for low-income people without cars), and a mile for others.
  • “We’ve estimated it for Chicago at a third of the city’s population, with substantial difference by racial composition,” Qato says.

Between the lines: Because pharmacies get the lowest reimbursements for filling Medicaid prescriptions, they’re more likely to close stores in low-income neighborhoods and open them in wealthy ones, notes Antonio Ciaccia, chief strategy officer of 3 Axis Advisors, a consultancy focused on the drug supply chain.

  • “We’re seeing a general retreat from impoverished areas,” said Ciaccia, who serves as an adviser to the American Pharmacy Association.

Of note: Studies draw a direct line between pharmacy closures and people stopping their vital medications — with terrible health outcomes.

  • Adults over 50 were more likely to drop their cardiovascular pills after their local drug store closed, according to a study published in the Journal of the American Medical Association in 2019 (of which Qato is the lead author). 
  • Benjy Renton, the Middlebury College senior who has been closely tracking the COVID-19 outbreak, noted on Twitter that pharmacy deserts could hold back the administration of vaccines.

What’s next: While “food deserts,” where inner-city residents lack access to fresh and healthy groceries, are a bigger problem in places like New York City, pharmacy access is a growing concern. The number of drugstores has declined 20% in NYC since 2016, according to Jonathan Bowles, executive director of the Center for an Urban Future.

  • “I for one will miss the 70 Duane Reades that closed this year,” was the headline of an an article that New York Magazine’s “Curbed” ran on Dec. 30. (Duane Reade is owned by Walgreens.)

What makes a Bad Vaccine?

A Covid-19 vaccine, amazingly, is close. Why am I so worried?

A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a having a vaccine to fight it. Moderna and the National Institutes of Health recently announced the start of a Phase 3 clinical trial, joining several others in a constructive rivalry that could save millions of lives.

It’s a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements.

I’m optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a bit of angst. Behind the proud declarations, many science and medical professionals have been whispering concerns. These whispers have escalated into a murmur. It’s time to cry them loudly:

Hey, Food and Drug Administration: Don’t be rash! Premature approval of a sub-standard Covid-19 vaccine could have dire implications, and not just for this pandemic. It could harm public health for years, if not generations, to come.

Unfortunately, elements now in place make such a disastrous outcome not only possible but in fact quite likely. Specifically, the FDA and its staff of chronically overworked and underappreciated regulators will face enormous public and political pressure to approve a vaccine. Whether or not one worries about an “October surprise” aimed at the upcoming election, regulators will be pressed hard. Some will stand firm. Some may resign in protest. But others could break and allow a bad vaccine to be released.

What makes a “bad vaccine”? Insufficient protection against the disease it is designed for, unwanted side effects, or some combination of the two. If an approved Covid-19 vaccine turns out to be ineffective, this could unintentionally promote wider spread of the disease by individuals who presume they were protected from it. Likewise, a negative experience with one vaccine might discourage the use of other vaccines that are far more safe and effective, whether they are for Covid-19 or other vaccine-preventable diseases.

Some things take time. Under normal circumstances, ensuring that a vaccine’s effects are safe and durable requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient, making sustained investigation all the more necessary. A merely short-term effect could encourage vaccinated individuals to resume risky behaviors, which would all but guarantee that the epidemic endures. And if unintended side effects turn out to include, for instance, chronic inflammatory or autoimmune disease, a bad vaccine could impart lifelong damage.

But wait, there’s worse! A bad Covid-19 vaccine could further undermine confidence in the many safe, reliable vaccines already in our public health arsenal. Vaccine skepticism and anti-science bias, propagated by B-list celebrities and Russian troll farms, have been gaining strength all year. Combined with disappointing Covid-19 outcomes, such malign forces could facilitate the reemergence of once-vanquished foes — polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus — that once killed multitudes of children each year.

These are enormous risks. Placing all of our bets on a small set of untried vaccine technologies would be gobsmackingly foolish. Yet this is exactly what we are now doing. Most of the high-profile names capturing headlines are pursuing comparatively minor variations on a theme of genetic vaccines (those delivered via DNA or RNA). If one approach happens to work, the odds are higher the others will work as well. Disappointing results from one candidate, though, might presage failure across the board.

Rather than investing in a balanced portfolio of vaccines with different approaches — not to mention different therapies, devices, and diagnostics for treating Covid-19 — too many observers, too many companies, and too many governmental officials seem to be narrowly focused on hopes for a “savior” vaccine. Were that savior to fail, our national morale, already low, could plummet even further.

Don’t get me wrong. I, along with millions of Americans, want a Covid-19 vaccine. But we deserve one that’s been proven to be safe and effective.

It’s not too late to take a deep breath and devise a strategy to balance short- and long-term goals, including vaccination, improved diagnostics, and existing and novel treatments. We must support the FDA and hope that its scientists and physicians retain the strength and conviction to resist approving a substandard vaccine.

For encouragement, we should look to Frances Oldham Kelsey, a veritable patron saint of the FDA. In 1960, during her first month working for the agency, Kelsey was asked to approve a sedative called Kevadon, which had the potential to generate billions in revenue. Despite enormous pressure, Kelsey spotted a risk for toxicity and dug in her heels. She refused to rubber stamp the approval. Her actions saved the lives of countless babies. Kevadon, better known as thalidomide, proved to be one of the most dangerous and disfiguring drugs in history.

Kelsey passed away in 2015 at the age of 101. We must pray that her spirit inspires a new generation of FDA leaders with the courage to say, “No.”