Elisabeth Rosenthal, Kaiser Health News

America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.

The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.

And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.

So, how about an economic argument? Get a COVID shot to protect your wallet.

Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”

Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.

In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.

More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.

For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.

A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.

But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.

The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.

The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.

Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.

That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.

Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.

KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.

But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.

The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.

And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.

So, how about an economic argument? Get a COVID shot to protect your wallet.

Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”

Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.

In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.

More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.

For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.

A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.

But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.

The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.

The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.

Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.

That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.

Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.

KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.

But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.

The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.

And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.

So, how about an economic argument? Get a COVID shot to protect your wallet.

Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”

Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.

In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.

More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.

For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.

A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.

But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.

The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.

The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.

Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.

That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.

Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.

KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.

But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed – at least for now?

Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed – at least for now?

Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed – at least for now?

Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Amazon has opened a new health care frontier: Now Alexa can be used to transmit patient data. Using this new feature – which Amazon labeled as a “skill” – a company named Livongo will allow diabetes patients – which it calls “members” – to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize health care, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties – while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free – as part of our doctor-patient relationship – though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies – maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make health care worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need – and deserve – human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring health care into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Amazon has opened a new health care frontier: Now Alexa can be used to transmit patient data. Using this new feature – which Amazon labeled as a “skill” – a company named Livongo will allow diabetes patients – which it calls “members” – to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize health care, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties – while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free – as part of our doctor-patient relationship – though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies – maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make health care worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need – and deserve – human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring health care into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Amazon has opened a new health care frontier: Now Alexa can be used to transmit patient data. Using this new feature – which Amazon labeled as a “skill” – a company named Livongo will allow diabetes patients – which it calls “members” – to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize health care, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties – while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free – as part of our doctor-patient relationship – though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies – maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make health care worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need – and deserve – human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring health care into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.