Kaiser Health News

President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy.

Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.

The documents reveal behind-the-scenes discussions that are influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.

To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.

The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. In addition to OMB, the working group includes officials from the White House National Economic Council, the Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.

According to the documents – the latest of which is dated June 1– the working group focused on the following “principles” and “talking points”:

1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.” Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year. That policy would push up global drug prices, according to Médecins Sans Frontières.

2. Promoting competition in the U.S. drug market – both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents. The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:

3. Value-based pricing, under which pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve, is one option. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them, and who would receive the rebates. Grogan invited Robert Shapiro – an adviser for Gilead and former secretary of Commerce under President Bill Clinton – to brief the working group on value-based pricing on May 18. Shapiro is the chairman and cofounder of Sonecon, a Washington, D.C., firm that consulted with Gilead, Amgen, and PhRMA, according to his curriculum vitae.

4. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that, though Medicaid spent more than $1 billion on Sovaldi, just 2.4% of Medicaid patients with hepatitis C were treated.

After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on options for expediting generic drug approvals, creating a new tax credit “of up to 50%” for investments in generic drug manufacturing, distribution, and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.

Most of these policies would not ease patient costs, and at least one would increase prices, said experts who reviewed the documents at the request of Kaiser Health News.

“This six-page document contains the kinds of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them ‘What sort of token gestures can we do?’ ” said Vinay Prasad, MD, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.

The pharma-friendly recommendations appear to clash with earlier press reports indicating that OMB Director Mick Mulvaney was considering requiring drug makers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.

Brand-name drug prices – which account for 72% of drug spending – go untouched in the handouts, said Fiona Scott Morton, PhD, a Yale economics professor and former attorney with the Justice Department’s antitrust division.

“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.

Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby – Pharmaceutical Research and Manufacturers Association (PhRMA).

Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.

The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval” and recommends the FDA implement less rigorous clinical trial standards.

These recommendations would not lower drug prices, experts say. Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.

Another section – which recommends giving the FDA more discretion to evaluate generic copies of complex drugs – closely resembles a National Law Review article written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drug makers.

The handouts further recommend allowing drug makers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.

That’s a “terrible idea,” said Jerry Avorn, MD, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy.

Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.

The documents reveal behind-the-scenes discussions that are influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.

To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.

The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. In addition to OMB, the working group includes officials from the White House National Economic Council, the Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.

According to the documents – the latest of which is dated June 1– the working group focused on the following “principles” and “talking points”:

1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.” Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year. That policy would push up global drug prices, according to Médecins Sans Frontières.

2. Promoting competition in the U.S. drug market – both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents. The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:

3. Value-based pricing, under which pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve, is one option. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them, and who would receive the rebates. Grogan invited Robert Shapiro – an adviser for Gilead and former secretary of Commerce under President Bill Clinton – to brief the working group on value-based pricing on May 18. Shapiro is the chairman and cofounder of Sonecon, a Washington, D.C., firm that consulted with Gilead, Amgen, and PhRMA, according to his curriculum vitae.

4. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that, though Medicaid spent more than $1 billion on Sovaldi, just 2.4% of Medicaid patients with hepatitis C were treated.

After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on options for expediting generic drug approvals, creating a new tax credit “of up to 50%” for investments in generic drug manufacturing, distribution, and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.

Most of these policies would not ease patient costs, and at least one would increase prices, said experts who reviewed the documents at the request of Kaiser Health News.

“This six-page document contains the kinds of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them ‘What sort of token gestures can we do?’ ” said Vinay Prasad, MD, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.

The pharma-friendly recommendations appear to clash with earlier press reports indicating that OMB Director Mick Mulvaney was considering requiring drug makers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.

Brand-name drug prices – which account for 72% of drug spending – go untouched in the handouts, said Fiona Scott Morton, PhD, a Yale economics professor and former attorney with the Justice Department’s antitrust division.

“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.

Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby – Pharmaceutical Research and Manufacturers Association (PhRMA).

Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.

The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval” and recommends the FDA implement less rigorous clinical trial standards.

These recommendations would not lower drug prices, experts say. Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.

Another section – which recommends giving the FDA more discretion to evaluate generic copies of complex drugs – closely resembles a National Law Review article written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drug makers.

The handouts further recommend allowing drug makers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.

That’s a “terrible idea,” said Jerry Avorn, MD, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy.

Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.

The documents reveal behind-the-scenes discussions that are influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.

To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.

The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. In addition to OMB, the working group includes officials from the White House National Economic Council, the Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.

According to the documents – the latest of which is dated June 1– the working group focused on the following “principles” and “talking points”:

1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.” Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year. That policy would push up global drug prices, according to Médecins Sans Frontières.

2. Promoting competition in the U.S. drug market – both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents. The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:

3. Value-based pricing, under which pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve, is one option. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them, and who would receive the rebates. Grogan invited Robert Shapiro – an adviser for Gilead and former secretary of Commerce under President Bill Clinton – to brief the working group on value-based pricing on May 18. Shapiro is the chairman and cofounder of Sonecon, a Washington, D.C., firm that consulted with Gilead, Amgen, and PhRMA, according to his curriculum vitae.

4. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that, though Medicaid spent more than $1 billion on Sovaldi, just 2.4% of Medicaid patients with hepatitis C were treated.

After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on options for expediting generic drug approvals, creating a new tax credit “of up to 50%” for investments in generic drug manufacturing, distribution, and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.

Most of these policies would not ease patient costs, and at least one would increase prices, said experts who reviewed the documents at the request of Kaiser Health News.

“This six-page document contains the kinds of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them ‘What sort of token gestures can we do?’ ” said Vinay Prasad, MD, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.

The pharma-friendly recommendations appear to clash with earlier press reports indicating that OMB Director Mick Mulvaney was considering requiring drug makers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.

Brand-name drug prices – which account for 72% of drug spending – go untouched in the handouts, said Fiona Scott Morton, PhD, a Yale economics professor and former attorney with the Justice Department’s antitrust division.

“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.

Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby – Pharmaceutical Research and Manufacturers Association (PhRMA).

Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.

The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval” and recommends the FDA implement less rigorous clinical trial standards.

These recommendations would not lower drug prices, experts say. Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.

Another section – which recommends giving the FDA more discretion to evaluate generic copies of complex drugs – closely resembles a National Law Review article written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drug makers.

The handouts further recommend allowing drug makers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.

That’s a “terrible idea,” said Jerry Avorn, MD, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Pediatricians and public health researchers know they have to be on the lookout for lead exposure from paint chips and contaminated drinking water. A new report suggests food – particularly baby food – could be a problem, too.

The Environmental Defense Fund, in an analysis of 11 years of federal data, found detectable levels of lead in 20% of 2,164 baby food samples. The toxic metal was most commonly found in fruit juices such as grape and apple, root vegetables such as sweet potatoes and carrots, and cookies such as teething biscuits.

The organization’s primary focus was on the baby foods because lead can be so detrimental to child development.

“Lead can have a number of effects on children, and it’s especially harmful during critical windows of development,” said Aparna Bole, MD, pediatrician at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, who was not involved with the report. “The largest burden that we often think about is neurocognitive that can occur even at low levels of lead exposure.”

Lead can cause problems with attention and behavior, cognitive development, the cardiovascular system, and immune system, Dr. Bole said.

The samples studied were not identified by brand, and the levels of lead are thought to be relatively low. Still, according to the Centers for Disease Control and Prevention, no safe blood lead level in children has been identified.

In a draft report released earlier this year, the Environmental Protection Agency estimated that over 5% of children consume more than 6 micrograms per day of lead – the maximum daily intake level set by the Food and Drug Administration in 1993 – in their diet.

This surprised Tom Neltner, JD, Environmental Defense Fund’s chemicals policy director, who has spent 20 years researching and working to reduce lead exposures. His further analysis of the EPA report was that food is the major source of lead exposure in two-thirds of toddlers.

This spurred the organization to examine data from the FDA’s Total Diet Study for specific sources of exposure for kids.

In the resulting report, releasedThursday, Mr. Neltner found that the baby food versions of apple juice, grape juice, and carrots had detectable lead more often than the regular versions. Researchers could determine how frequently contamination occurred, but not at what levels.

According to the FDA, lead makes its way into food through contaminated soil, but Mr. Neltner suspects that processing may also play a role.

“I can’t explain it other than I assume baby food is processed more,” Mr. Neltner said.

The Environmental Defense Fund report notes that more research on the sources of contamination is needed.

FDA has set guidance levels of 100 parts per billion (ppb) for candy and dried fruit and 50 ppb for fruit juices. The allowable level for lead in bottled water is 5 ppb.

Concern over fruit juices flared up in 2012 when Consumer Reports found that one in four samples of apple and grape juices had lead levels higher than the FDA’s bottled-water limit of 5 ppb.

“The FDA is continuing to work with industry to further limit the amount of lead in foods to the greatest extent feasible, especially in foods frequently consumed by children,” read an agency statement in response to the report. “The agency is in the process of reevaluating the analytical methods it uses for determining when it should take action with respect to measured levels of lead in particular foods, including those consumed by infants and toddlers.”

Mr. Neltner said he’s glad the FDA is working on the issue but wants them to “get it done. Move quicker.”

The Environmental Defense Fund isn’t recommending that parents avoid certain foods or brands for their children but does advise that they consult their pediatricians about all means of lead exposure.

“In many American communities, the most significant route of lead exposure is from paint and soil,” Dr. Bole said. “Avoiding all sources of exposure of lead poisoning is incredibly important … but the last thing I would want is for a parent to restrict their child’s diet or limit their intake of healthy food groups.”

She added that pediatricians recommend limiting or eliminating fruit juices from children’s diets, anyway, for nutritional reasons. “There are good reasons to limit juice other than this particular report,” Dr. Bole said.

But she said she wouldn’t want parents to avoid root vegetables altogether. “The benefits of those nutritious foods far outweigh any risk,” she said, especially in the context of where kids are most exposed to lead.

In response to a request for comment, Gerber said that samples of its baby foods and juices “consistently fall well within the available guidance levels and meet our own strict standards.” And samples of Gerber juices were all below the EPA standard for drinking water.

“We know parents may be concerned about a recent report on lead in foods and want to reassure them that Gerber foods and juices are safe,” the statement read.

The Environmental Defense Fund report was ultimately directed at the food industry and FDA in the hopes of getting limits and standards updated.

But lead in paint and drinking water shouldn’t fall by the wayside, Mr. Neltner said. “You’ve got to deal with this issue on multiple fronts.”
 

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Pediatricians and public health researchers know they have to be on the lookout for lead exposure from paint chips and contaminated drinking water. A new report suggests food – particularly baby food – could be a problem, too.

The Environmental Defense Fund, in an analysis of 11 years of federal data, found detectable levels of lead in 20% of 2,164 baby food samples. The toxic metal was most commonly found in fruit juices such as grape and apple, root vegetables such as sweet potatoes and carrots, and cookies such as teething biscuits.

The organization’s primary focus was on the baby foods because lead can be so detrimental to child development.

“Lead can have a number of effects on children, and it’s especially harmful during critical windows of development,” said Aparna Bole, MD, pediatrician at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, who was not involved with the report. “The largest burden that we often think about is neurocognitive that can occur even at low levels of lead exposure.”

Lead can cause problems with attention and behavior, cognitive development, the cardiovascular system, and immune system, Dr. Bole said.

The samples studied were not identified by brand, and the levels of lead are thought to be relatively low. Still, according to the Centers for Disease Control and Prevention, no safe blood lead level in children has been identified.

In a draft report released earlier this year, the Environmental Protection Agency estimated that over 5% of children consume more than 6 micrograms per day of lead – the maximum daily intake level set by the Food and Drug Administration in 1993 – in their diet.

This surprised Tom Neltner, JD, Environmental Defense Fund’s chemicals policy director, who has spent 20 years researching and working to reduce lead exposures. His further analysis of the EPA report was that food is the major source of lead exposure in two-thirds of toddlers.

This spurred the organization to examine data from the FDA’s Total Diet Study for specific sources of exposure for kids.

In the resulting report, releasedThursday, Mr. Neltner found that the baby food versions of apple juice, grape juice, and carrots had detectable lead more often than the regular versions. Researchers could determine how frequently contamination occurred, but not at what levels.

According to the FDA, lead makes its way into food through contaminated soil, but Mr. Neltner suspects that processing may also play a role.

“I can’t explain it other than I assume baby food is processed more,” Mr. Neltner said.

The Environmental Defense Fund report notes that more research on the sources of contamination is needed.

FDA has set guidance levels of 100 parts per billion (ppb) for candy and dried fruit and 50 ppb for fruit juices. The allowable level for lead in bottled water is 5 ppb.

Concern over fruit juices flared up in 2012 when Consumer Reports found that one in four samples of apple and grape juices had lead levels higher than the FDA’s bottled-water limit of 5 ppb.

“The FDA is continuing to work with industry to further limit the amount of lead in foods to the greatest extent feasible, especially in foods frequently consumed by children,” read an agency statement in response to the report. “The agency is in the process of reevaluating the analytical methods it uses for determining when it should take action with respect to measured levels of lead in particular foods, including those consumed by infants and toddlers.”

Mr. Neltner said he’s glad the FDA is working on the issue but wants them to “get it done. Move quicker.”

The Environmental Defense Fund isn’t recommending that parents avoid certain foods or brands for their children but does advise that they consult their pediatricians about all means of lead exposure.

“In many American communities, the most significant route of lead exposure is from paint and soil,” Dr. Bole said. “Avoiding all sources of exposure of lead poisoning is incredibly important … but the last thing I would want is for a parent to restrict their child’s diet or limit their intake of healthy food groups.”

She added that pediatricians recommend limiting or eliminating fruit juices from children’s diets, anyway, for nutritional reasons. “There are good reasons to limit juice other than this particular report,” Dr. Bole said.

But she said she wouldn’t want parents to avoid root vegetables altogether. “The benefits of those nutritious foods far outweigh any risk,” she said, especially in the context of where kids are most exposed to lead.

In response to a request for comment, Gerber said that samples of its baby foods and juices “consistently fall well within the available guidance levels and meet our own strict standards.” And samples of Gerber juices were all below the EPA standard for drinking water.

“We know parents may be concerned about a recent report on lead in foods and want to reassure them that Gerber foods and juices are safe,” the statement read.

The Environmental Defense Fund report was ultimately directed at the food industry and FDA in the hopes of getting limits and standards updated.

But lead in paint and drinking water shouldn’t fall by the wayside, Mr. Neltner said. “You’ve got to deal with this issue on multiple fronts.”
 

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Pediatricians and public health researchers know they have to be on the lookout for lead exposure from paint chips and contaminated drinking water. A new report suggests food – particularly baby food – could be a problem, too.

The Environmental Defense Fund, in an analysis of 11 years of federal data, found detectable levels of lead in 20% of 2,164 baby food samples. The toxic metal was most commonly found in fruit juices such as grape and apple, root vegetables such as sweet potatoes and carrots, and cookies such as teething biscuits.

The organization’s primary focus was on the baby foods because lead can be so detrimental to child development.

“Lead can have a number of effects on children, and it’s especially harmful during critical windows of development,” said Aparna Bole, MD, pediatrician at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, who was not involved with the report. “The largest burden that we often think about is neurocognitive that can occur even at low levels of lead exposure.”

Lead can cause problems with attention and behavior, cognitive development, the cardiovascular system, and immune system, Dr. Bole said.

The samples studied were not identified by brand, and the levels of lead are thought to be relatively low. Still, according to the Centers for Disease Control and Prevention, no safe blood lead level in children has been identified.

In a draft report released earlier this year, the Environmental Protection Agency estimated that over 5% of children consume more than 6 micrograms per day of lead – the maximum daily intake level set by the Food and Drug Administration in 1993 – in their diet.

This surprised Tom Neltner, JD, Environmental Defense Fund’s chemicals policy director, who has spent 20 years researching and working to reduce lead exposures. His further analysis of the EPA report was that food is the major source of lead exposure in two-thirds of toddlers.

This spurred the organization to examine data from the FDA’s Total Diet Study for specific sources of exposure for kids.

In the resulting report, releasedThursday, Mr. Neltner found that the baby food versions of apple juice, grape juice, and carrots had detectable lead more often than the regular versions. Researchers could determine how frequently contamination occurred, but not at what levels.

According to the FDA, lead makes its way into food through contaminated soil, but Mr. Neltner suspects that processing may also play a role.

“I can’t explain it other than I assume baby food is processed more,” Mr. Neltner said.

The Environmental Defense Fund report notes that more research on the sources of contamination is needed.

FDA has set guidance levels of 100 parts per billion (ppb) for candy and dried fruit and 50 ppb for fruit juices. The allowable level for lead in bottled water is 5 ppb.

Concern over fruit juices flared up in 2012 when Consumer Reports found that one in four samples of apple and grape juices had lead levels higher than the FDA’s bottled-water limit of 5 ppb.

“The FDA is continuing to work with industry to further limit the amount of lead in foods to the greatest extent feasible, especially in foods frequently consumed by children,” read an agency statement in response to the report. “The agency is in the process of reevaluating the analytical methods it uses for determining when it should take action with respect to measured levels of lead in particular foods, including those consumed by infants and toddlers.”

Mr. Neltner said he’s glad the FDA is working on the issue but wants them to “get it done. Move quicker.”

The Environmental Defense Fund isn’t recommending that parents avoid certain foods or brands for their children but does advise that they consult their pediatricians about all means of lead exposure.

“In many American communities, the most significant route of lead exposure is from paint and soil,” Dr. Bole said. “Avoiding all sources of exposure of lead poisoning is incredibly important … but the last thing I would want is for a parent to restrict their child’s diet or limit their intake of healthy food groups.”

She added that pediatricians recommend limiting or eliminating fruit juices from children’s diets, anyway, for nutritional reasons. “There are good reasons to limit juice other than this particular report,” Dr. Bole said.

But she said she wouldn’t want parents to avoid root vegetables altogether. “The benefits of those nutritious foods far outweigh any risk,” she said, especially in the context of where kids are most exposed to lead.

In response to a request for comment, Gerber said that samples of its baby foods and juices “consistently fall well within the available guidance levels and meet our own strict standards.” And samples of Gerber juices were all below the EPA standard for drinking water.

“We know parents may be concerned about a recent report on lead in foods and want to reassure them that Gerber foods and juices are safe,” the statement read.

The Environmental Defense Fund report was ultimately directed at the food industry and FDA in the hopes of getting limits and standards updated.

But lead in paint and drinking water shouldn’t fall by the wayside, Mr. Neltner said. “You’ve got to deal with this issue on multiple fronts.”
 

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

In back-to-back appearances on Capitol Hill Wednesday, Health and Human Services Secretary Tom Price sparred with Democrats over the Trump administration’s budget cuts for his department and the coming troubles in the individual health insurance market.

“President Trump’s budget does not confuse government spending with government success,” Price said, defending a spending plan that calls for substantial funding reductions to Medicaid, the Centers for Disease Control and Prevention, the National Institutes of Health, and other HHS agencies.

The problem with many federal programs “is not that they are too expensive or too underfunded. The real problem is that they do not work – they fail the very people they are meant to help,” Price said in testimony before the Senate Finance Committee and the House Ways and Means Committee.

He cited Medicaid, the federal-state insurance program for low-income people, as an example of an area in which rising costs require reforms. The administration’s budget would reduce federal Medicaid funds to states by $610 billion over a decade. Under its proposal, states would gain latitude over how to spend those funds, which Price said would lead to innovations and efficiencies.

Sen. Sherrod Brown (D-Ohio) questioned whether HHS is budgeting enough money under Medicaid to fight the opioid-abuse epidemic. Of the $939 million that Ohio spent on opioid treatment in 2016, 70% came from federal Medicaid dollars, he said.

“You would never propose we fight cancer with a $50 million increase to a grant program,” Brown said. “How does this possibly work if you’re going to cut the biggest revenue stream to treat people?”

Price pushed back, pointing out that more than 52,000 Americans died of overdose deaths in 2015.

“We continue to tolerate a system that allows for overdose deaths, and I simply won’t allow it,” Price said.

Trump’s budget has come under heavy attack in Congress since its release last month and is expected to undergo much rewriting. The budget would take effect for the fiscal year starting Oct. 1.

Democratic senators and representatives on the committees repeatedly challenged Price on his testimony and the administration’s health care policies, sometimes using strong words and loud voices.

“It’s mean-spirited. It’s not good for America. We can do much better,” thundered Rep. John Lewis (D-Ga.).

With insurers facing looming deadlines to decide whether to participate in the Affordable Care Act’s online marketplaces next year, lawmakers also pressed Price on whether the Trump administration will pay insurers about $7 billion in “cost-sharing subsidies” for 2018. The White House has sent mixed signals, but many insurers’ decisions about next year’s premiums and where they will offer health plans hinge on the verdict.

Sen. Debbie Stabenow (D-Mich.) repeatedly asked Price if he would commit to making subsidy payments, but Price refused to answer beyond reiterating that the budget includes payments through 2018. Price said he could not elaborate because he is the defendant in a lawsuit regarding these subsidies – a still-pending case brought by the Republican-led House of Representatives during the Obama administration.

Democrats accused Price of doing little to stabilize the individual insurance marketplace as insurers have announced withdrawal plans. But, Sen. Pat Roberts (R-Kan.) said the market was failing and it wasn’t Price’s fault.

“We are in the Obama car and it’s like being in the same car as Thelma and Louise going into the canyon,” he said. “We need to get out of the car.”

Price was also asked about a draft rule from HHS that would scale back the ACA’s mandate requiring nearly all employers to offer health insurance covering birth control. The HHS proposal would allow more types of employers to claim moral or religious exemptions to the mandate. “I think that, for women who desire birth control, it should be available,” Price said.

When Sen. Maria Cantwell (D-Wash.) pressed him to answer whether birth control should be available to women through their employers, Price reiterated that it should be available to women who want it.

“This is a very big problem,” she said. ”Women cannot be discriminated against by their employers who want to cherry-pick women’s health.”

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

In back-to-back appearances on Capitol Hill Wednesday, Health and Human Services Secretary Tom Price sparred with Democrats over the Trump administration’s budget cuts for his department and the coming troubles in the individual health insurance market.

“President Trump’s budget does not confuse government spending with government success,” Price said, defending a spending plan that calls for substantial funding reductions to Medicaid, the Centers for Disease Control and Prevention, the National Institutes of Health, and other HHS agencies.

The problem with many federal programs “is not that they are too expensive or too underfunded. The real problem is that they do not work – they fail the very people they are meant to help,” Price said in testimony before the Senate Finance Committee and the House Ways and Means Committee.

He cited Medicaid, the federal-state insurance program for low-income people, as an example of an area in which rising costs require reforms. The administration’s budget would reduce federal Medicaid funds to states by $610 billion over a decade. Under its proposal, states would gain latitude over how to spend those funds, which Price said would lead to innovations and efficiencies.

Sen. Sherrod Brown (D-Ohio) questioned whether HHS is budgeting enough money under Medicaid to fight the opioid-abuse epidemic. Of the $939 million that Ohio spent on opioid treatment in 2016, 70% came from federal Medicaid dollars, he said.

“You would never propose we fight cancer with a $50 million increase to a grant program,” Brown said. “How does this possibly work if you’re going to cut the biggest revenue stream to treat people?”

Price pushed back, pointing out that more than 52,000 Americans died of overdose deaths in 2015.

“We continue to tolerate a system that allows for overdose deaths, and I simply won’t allow it,” Price said.

Trump’s budget has come under heavy attack in Congress since its release last month and is expected to undergo much rewriting. The budget would take effect for the fiscal year starting Oct. 1.

Democratic senators and representatives on the committees repeatedly challenged Price on his testimony and the administration’s health care policies, sometimes using strong words and loud voices.

“It’s mean-spirited. It’s not good for America. We can do much better,” thundered Rep. John Lewis (D-Ga.).

With insurers facing looming deadlines to decide whether to participate in the Affordable Care Act’s online marketplaces next year, lawmakers also pressed Price on whether the Trump administration will pay insurers about $7 billion in “cost-sharing subsidies” for 2018. The White House has sent mixed signals, but many insurers’ decisions about next year’s premiums and where they will offer health plans hinge on the verdict.

Sen. Debbie Stabenow (D-Mich.) repeatedly asked Price if he would commit to making subsidy payments, but Price refused to answer beyond reiterating that the budget includes payments through 2018. Price said he could not elaborate because he is the defendant in a lawsuit regarding these subsidies – a still-pending case brought by the Republican-led House of Representatives during the Obama administration.

Democrats accused Price of doing little to stabilize the individual insurance marketplace as insurers have announced withdrawal plans. But, Sen. Pat Roberts (R-Kan.) said the market was failing and it wasn’t Price’s fault.

“We are in the Obama car and it’s like being in the same car as Thelma and Louise going into the canyon,” he said. “We need to get out of the car.”

Price was also asked about a draft rule from HHS that would scale back the ACA’s mandate requiring nearly all employers to offer health insurance covering birth control. The HHS proposal would allow more types of employers to claim moral or religious exemptions to the mandate. “I think that, for women who desire birth control, it should be available,” Price said.

When Sen. Maria Cantwell (D-Wash.) pressed him to answer whether birth control should be available to women through their employers, Price reiterated that it should be available to women who want it.

“This is a very big problem,” she said. ”Women cannot be discriminated against by their employers who want to cherry-pick women’s health.”

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

In back-to-back appearances on Capitol Hill Wednesday, Health and Human Services Secretary Tom Price sparred with Democrats over the Trump administration’s budget cuts for his department and the coming troubles in the individual health insurance market.

“President Trump’s budget does not confuse government spending with government success,” Price said, defending a spending plan that calls for substantial funding reductions to Medicaid, the Centers for Disease Control and Prevention, the National Institutes of Health, and other HHS agencies.

The problem with many federal programs “is not that they are too expensive or too underfunded. The real problem is that they do not work – they fail the very people they are meant to help,” Price said in testimony before the Senate Finance Committee and the House Ways and Means Committee.

He cited Medicaid, the federal-state insurance program for low-income people, as an example of an area in which rising costs require reforms. The administration’s budget would reduce federal Medicaid funds to states by $610 billion over a decade. Under its proposal, states would gain latitude over how to spend those funds, which Price said would lead to innovations and efficiencies.

Sen. Sherrod Brown (D-Ohio) questioned whether HHS is budgeting enough money under Medicaid to fight the opioid-abuse epidemic. Of the $939 million that Ohio spent on opioid treatment in 2016, 70% came from federal Medicaid dollars, he said.

“You would never propose we fight cancer with a $50 million increase to a grant program,” Brown said. “How does this possibly work if you’re going to cut the biggest revenue stream to treat people?”

Price pushed back, pointing out that more than 52,000 Americans died of overdose deaths in 2015.

“We continue to tolerate a system that allows for overdose deaths, and I simply won’t allow it,” Price said.

Trump’s budget has come under heavy attack in Congress since its release last month and is expected to undergo much rewriting. The budget would take effect for the fiscal year starting Oct. 1.

Democratic senators and representatives on the committees repeatedly challenged Price on his testimony and the administration’s health care policies, sometimes using strong words and loud voices.

“It’s mean-spirited. It’s not good for America. We can do much better,” thundered Rep. John Lewis (D-Ga.).

With insurers facing looming deadlines to decide whether to participate in the Affordable Care Act’s online marketplaces next year, lawmakers also pressed Price on whether the Trump administration will pay insurers about $7 billion in “cost-sharing subsidies” for 2018. The White House has sent mixed signals, but many insurers’ decisions about next year’s premiums and where they will offer health plans hinge on the verdict.

Sen. Debbie Stabenow (D-Mich.) repeatedly asked Price if he would commit to making subsidy payments, but Price refused to answer beyond reiterating that the budget includes payments through 2018. Price said he could not elaborate because he is the defendant in a lawsuit regarding these subsidies – a still-pending case brought by the Republican-led House of Representatives during the Obama administration.

Democrats accused Price of doing little to stabilize the individual insurance marketplace as insurers have announced withdrawal plans. But, Sen. Pat Roberts (R-Kan.) said the market was failing and it wasn’t Price’s fault.

“We are in the Obama car and it’s like being in the same car as Thelma and Louise going into the canyon,” he said. “We need to get out of the car.”

Price was also asked about a draft rule from HHS that would scale back the ACA’s mandate requiring nearly all employers to offer health insurance covering birth control. The HHS proposal would allow more types of employers to claim moral or religious exemptions to the mandate. “I think that, for women who desire birth control, it should be available,” Price said.

When Sen. Maria Cantwell (D-Wash.) pressed him to answer whether birth control should be available to women through their employers, Price reiterated that it should be available to women who want it.

“This is a very big problem,” she said. ”Women cannot be discriminated against by their employers who want to cherry-pick women’s health.”

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

As a drug salesman, Mike Courtney worked hard to make health care expensive. He wined and dined doctors, golfed with them and bought lunch for their entire staffs – all to promote pills often costing thousands of dollars a year.

Now he’s on a different mission. When Mr. Courtney calls on doctors these days, he champions generic drugs that frequently cost pennies and work just as well as the kinds of pricey brands he used to push.

Instead of Big Pharma, he works for Capital District Physicians’ Health Plan (CDPHP), an Albany, N.Y., insurer. Instead of maximizing pill profits, his job is to save millions of dollars by educating doctors about expensive prescriptions and the stratagems used to sell them.

“Having come from Big Pharma, I do really feel my soul has been cleansed,” laughs Mr. Courtney, who formerly worked for Pfizer and Johnson & Johnson. “I do feel like I’m more in touch with the physicians” and plan members, he added.

Costs for prescription drugs have been rising faster than those for any other health segment, marked by high-profile cases such as the reported 400% increase for Mylan’s EpiPen and 5,000% spike for Turing Pharmaceuticals’ Daraprim.

Health plans and others paying those costs are fighting back. Many have tried to give doctors academic research on pill effectiveness or simply removed high-cost drugs from coverage lists.

Consumer groups and medical societies have tried to spread the word about expensive drugs. Startup GoodRx lets patients compare retail prices online.

CDPHP is one of the few insurers to have taken the battle against pricey pills a step further. It is recruiting across enemy lines, hiring former pharma representatives and staffing what may be a new job category: a sales force for cost-effective medicine.

“Insurers are taking matters into their own hands,” said Lea Prevel Katsanis, a marketing professor at Canada’s Concordia University who specializes in the pharmaceutical industry. “They’re saying, ‘We can’t really rely on drug companies to talk to doctors about what’s cost-efficient.’ ”

If insurance companies can curb drug costs, premiums paid by employers, taxpayers, and consumers need not rise as fast.

Two years ago, when one company increased the cost of a common diabetes medicine to 20 times what it had been a few years earlier, Mr. Courtney and five other former pharma and medical-device reps working for CDPHP knew what to do.

Valeant Pharmaceuticals had cranked up the price of one common dosage of its Glumetza medicine for lowering blood sugar to an astonishing $81,270 a year, according to Truven Health Analytics, a data firm. Meanwhile a similar, generic version can be bought for as little as a penny a pill.

Because Glumetza was on CDPHP’s list of approved drugs, the insurer and its members had to pay for it when doctors prescribed it, resulting in millions in extra costs and stinging copayments for patients.

Eric Schnakenberg, MD, an upstate New York family medicine doctor, was shocked when patients began complaining about what he assumed was an inexpensive prescription. Doctors are famously unaware about the cost of the care they order, a situation exploited by drug sellers and other vendors.

While physicians’ electronic prescribing programs and even pharmaceutical guides like the Physicians’ Desk Reference contain prescribing information – some are even peppered with ads – they contain no specific information about prices. Drug sales reps who visit their offices don’t highlight high prices as they drop off free samples, and drug makers can quietly, but substantially, hike the price of a drug from one year to the next.

“As physicians, we’re blindsided by that,” Dr. Schnakenberg said. “We get patient complaints saying, ‘Hey, I can’t afford this,’ and we say: ‘It’s cheap!’ ”

After Mr. Courtney and his colleagues alerted doctors to what Valeant was up to, all but a handful of the 60 plan members who were taking Glumetza switched to metformin, the generic alternative. That saved about $5 million in a year.

Following an outcry over its practices, Valeant agreed last year to raise annual prices by no more than single-digit percentages, the company said through a spokesman. But such hikes could still outpace the inflation rate.
 

Using ‘Those Powers For Good’

Cardiologist John Bennett got the idea to hire pharma reps a few years ago, after he became CDPHP’s chief executive. He knew reps are smart, genial, and motivated. Overhiring by pharma had put many back on the job market.

His sales pitch to them, he says half-jokingly, was: “You know everything they taught you in Big Pharma? How would you like to use those powers for good?”

Pharma companies spend billions on TV ads, doctor blandishments, and expensive salespeople to keep prescriptions flowing.

Pfizer, Johnson & Johnson, and other sellers responded to critics a few years ago by restricting gifts of entertainment, coffee mugs, and some meals. But the industry’s ethics code still allows lavish consulting contracts for doctors and sponsorship of physician conferences as well as meals for doctors and their staffs who listen to an “informational presentation” from sales reps touting expensive pills.

“When those products go generic, nobody’s promoting them anymore,” Mr. Courtney said. Generics makers lack big marketing budgets. CDPHP’s remedy: The insurer promotes generics with its own reps.

“It’s a great idea,” said Alan Sorensen, an economist at the University of Wisconsin who has studied drug prices. “Even a small moving of the needle on their [doctors’] prescribing behavior can have a pretty big impact on costs.”

At first the team concentrated on educating doctors about cheaper alternatives to Lipitor, a widely prescribed cholesterol-lowering medicine, and Nexium, for stomach problems. That saved around $10 million the first year, much in the form of copayments that would have been owed by plan members.

Recently the plan has focused on Seroquel, a branded antipsychotic that costs far more than a similar generic. Switching to the generic saves $600 to $1,000 a month, estimates Eileen Wood, the insurer’s vice president of pharmacy and health quality.

CDPHP’s repurposed reps have helped keep the insurer’s annual drug-cost increases to single-digit percentages, whereas without them and other measures “we would certainly be well into double-digit” increases, she said.

Educating doctors about drug costs is part of a larger push for “transparency” in an industry where Princeton economist Uwe Reinhardt says consumers face the same experience as somebody shopping in Macy’s blindfolded.

Current research by the University of Wisconsin’s Mr. Sorensen finds physicians with access to data about drug prices and insurance coverage are more likely to prescribe generics.

That gives Mr. Courtney and his colleagues a fighting chance, even if, he said, “we don’t have the freewheeling, unlimited green Amex card like I did back in the day.”
 

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

As a drug salesman, Mike Courtney worked hard to make health care expensive. He wined and dined doctors, golfed with them and bought lunch for their entire staffs – all to promote pills often costing thousands of dollars a year.

Now he’s on a different mission. When Mr. Courtney calls on doctors these days, he champions generic drugs that frequently cost pennies and work just as well as the kinds of pricey brands he used to push.

Instead of Big Pharma, he works for Capital District Physicians’ Health Plan (CDPHP), an Albany, N.Y., insurer. Instead of maximizing pill profits, his job is to save millions of dollars by educating doctors about expensive prescriptions and the stratagems used to sell them.

“Having come from Big Pharma, I do really feel my soul has been cleansed,” laughs Mr. Courtney, who formerly worked for Pfizer and Johnson & Johnson. “I do feel like I’m more in touch with the physicians” and plan members, he added.

Costs for prescription drugs have been rising faster than those for any other health segment, marked by high-profile cases such as the reported 400% increase for Mylan’s EpiPen and 5,000% spike for Turing Pharmaceuticals’ Daraprim.

Health plans and others paying those costs are fighting back. Many have tried to give doctors academic research on pill effectiveness or simply removed high-cost drugs from coverage lists.

Consumer groups and medical societies have tried to spread the word about expensive drugs. Startup GoodRx lets patients compare retail prices online.

CDPHP is one of the few insurers to have taken the battle against pricey pills a step further. It is recruiting across enemy lines, hiring former pharma representatives and staffing what may be a new job category: a sales force for cost-effective medicine.

“Insurers are taking matters into their own hands,” said Lea Prevel Katsanis, a marketing professor at Canada’s Concordia University who specializes in the pharmaceutical industry. “They’re saying, ‘We can’t really rely on drug companies to talk to doctors about what’s cost-efficient.’ ”

If insurance companies can curb drug costs, premiums paid by employers, taxpayers, and consumers need not rise as fast.

Two years ago, when one company increased the cost of a common diabetes medicine to 20 times what it had been a few years earlier, Mr. Courtney and five other former pharma and medical-device reps working for CDPHP knew what to do.

Valeant Pharmaceuticals had cranked up the price of one common dosage of its Glumetza medicine for lowering blood sugar to an astonishing $81,270 a year, according to Truven Health Analytics, a data firm. Meanwhile a similar, generic version can be bought for as little as a penny a pill.

Because Glumetza was on CDPHP’s list of approved drugs, the insurer and its members had to pay for it when doctors prescribed it, resulting in millions in extra costs and stinging copayments for patients.

Eric Schnakenberg, MD, an upstate New York family medicine doctor, was shocked when patients began complaining about what he assumed was an inexpensive prescription. Doctors are famously unaware about the cost of the care they order, a situation exploited by drug sellers and other vendors.

While physicians’ electronic prescribing programs and even pharmaceutical guides like the Physicians’ Desk Reference contain prescribing information – some are even peppered with ads – they contain no specific information about prices. Drug sales reps who visit their offices don’t highlight high prices as they drop off free samples, and drug makers can quietly, but substantially, hike the price of a drug from one year to the next.

“As physicians, we’re blindsided by that,” Dr. Schnakenberg said. “We get patient complaints saying, ‘Hey, I can’t afford this,’ and we say: ‘It’s cheap!’ ”

After Mr. Courtney and his colleagues alerted doctors to what Valeant was up to, all but a handful of the 60 plan members who were taking Glumetza switched to metformin, the generic alternative. That saved about $5 million in a year.

Following an outcry over its practices, Valeant agreed last year to raise annual prices by no more than single-digit percentages, the company said through a spokesman. But such hikes could still outpace the inflation rate.
 

Using ‘Those Powers For Good’

Cardiologist John Bennett got the idea to hire pharma reps a few years ago, after he became CDPHP’s chief executive. He knew reps are smart, genial, and motivated. Overhiring by pharma had put many back on the job market.

His sales pitch to them, he says half-jokingly, was: “You know everything they taught you in Big Pharma? How would you like to use those powers for good?”

Pharma companies spend billions on TV ads, doctor blandishments, and expensive salespeople to keep prescriptions flowing.

Pfizer, Johnson & Johnson, and other sellers responded to critics a few years ago by restricting gifts of entertainment, coffee mugs, and some meals. But the industry’s ethics code still allows lavish consulting contracts for doctors and sponsorship of physician conferences as well as meals for doctors and their staffs who listen to an “informational presentation” from sales reps touting expensive pills.

“When those products go generic, nobody’s promoting them anymore,” Mr. Courtney said. Generics makers lack big marketing budgets. CDPHP’s remedy: The insurer promotes generics with its own reps.

“It’s a great idea,” said Alan Sorensen, an economist at the University of Wisconsin who has studied drug prices. “Even a small moving of the needle on their [doctors’] prescribing behavior can have a pretty big impact on costs.”

At first the team concentrated on educating doctors about cheaper alternatives to Lipitor, a widely prescribed cholesterol-lowering medicine, and Nexium, for stomach problems. That saved around $10 million the first year, much in the form of copayments that would have been owed by plan members.

Recently the plan has focused on Seroquel, a branded antipsychotic that costs far more than a similar generic. Switching to the generic saves $600 to $1,000 a month, estimates Eileen Wood, the insurer’s vice president of pharmacy and health quality.

CDPHP’s repurposed reps have helped keep the insurer’s annual drug-cost increases to single-digit percentages, whereas without them and other measures “we would certainly be well into double-digit” increases, she said.

Educating doctors about drug costs is part of a larger push for “transparency” in an industry where Princeton economist Uwe Reinhardt says consumers face the same experience as somebody shopping in Macy’s blindfolded.

Current research by the University of Wisconsin’s Mr. Sorensen finds physicians with access to data about drug prices and insurance coverage are more likely to prescribe generics.

That gives Mr. Courtney and his colleagues a fighting chance, even if, he said, “we don’t have the freewheeling, unlimited green Amex card like I did back in the day.”
 

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

As a drug salesman, Mike Courtney worked hard to make health care expensive. He wined and dined doctors, golfed with them and bought lunch for their entire staffs – all to promote pills often costing thousands of dollars a year.

Now he’s on a different mission. When Mr. Courtney calls on doctors these days, he champions generic drugs that frequently cost pennies and work just as well as the kinds of pricey brands he used to push.

Instead of Big Pharma, he works for Capital District Physicians’ Health Plan (CDPHP), an Albany, N.Y., insurer. Instead of maximizing pill profits, his job is to save millions of dollars by educating doctors about expensive prescriptions and the stratagems used to sell them.

“Having come from Big Pharma, I do really feel my soul has been cleansed,” laughs Mr. Courtney, who formerly worked for Pfizer and Johnson & Johnson. “I do feel like I’m more in touch with the physicians” and plan members, he added.

Costs for prescription drugs have been rising faster than those for any other health segment, marked by high-profile cases such as the reported 400% increase for Mylan’s EpiPen and 5,000% spike for Turing Pharmaceuticals’ Daraprim.

Health plans and others paying those costs are fighting back. Many have tried to give doctors academic research on pill effectiveness or simply removed high-cost drugs from coverage lists.

Consumer groups and medical societies have tried to spread the word about expensive drugs. Startup GoodRx lets patients compare retail prices online.

CDPHP is one of the few insurers to have taken the battle against pricey pills a step further. It is recruiting across enemy lines, hiring former pharma representatives and staffing what may be a new job category: a sales force for cost-effective medicine.

“Insurers are taking matters into their own hands,” said Lea Prevel Katsanis, a marketing professor at Canada’s Concordia University who specializes in the pharmaceutical industry. “They’re saying, ‘We can’t really rely on drug companies to talk to doctors about what’s cost-efficient.’ ”

If insurance companies can curb drug costs, premiums paid by employers, taxpayers, and consumers need not rise as fast.

Two years ago, when one company increased the cost of a common diabetes medicine to 20 times what it had been a few years earlier, Mr. Courtney and five other former pharma and medical-device reps working for CDPHP knew what to do.

Valeant Pharmaceuticals had cranked up the price of one common dosage of its Glumetza medicine for lowering blood sugar to an astonishing $81,270 a year, according to Truven Health Analytics, a data firm. Meanwhile a similar, generic version can be bought for as little as a penny a pill.

Because Glumetza was on CDPHP’s list of approved drugs, the insurer and its members had to pay for it when doctors prescribed it, resulting in millions in extra costs and stinging copayments for patients.

Eric Schnakenberg, MD, an upstate New York family medicine doctor, was shocked when patients began complaining about what he assumed was an inexpensive prescription. Doctors are famously unaware about the cost of the care they order, a situation exploited by drug sellers and other vendors.

While physicians’ electronic prescribing programs and even pharmaceutical guides like the Physicians’ Desk Reference contain prescribing information – some are even peppered with ads – they contain no specific information about prices. Drug sales reps who visit their offices don’t highlight high prices as they drop off free samples, and drug makers can quietly, but substantially, hike the price of a drug from one year to the next.

“As physicians, we’re blindsided by that,” Dr. Schnakenberg said. “We get patient complaints saying, ‘Hey, I can’t afford this,’ and we say: ‘It’s cheap!’ ”

After Mr. Courtney and his colleagues alerted doctors to what Valeant was up to, all but a handful of the 60 plan members who were taking Glumetza switched to metformin, the generic alternative. That saved about $5 million in a year.

Following an outcry over its practices, Valeant agreed last year to raise annual prices by no more than single-digit percentages, the company said through a spokesman. But such hikes could still outpace the inflation rate.
 

Using ‘Those Powers For Good’

Cardiologist John Bennett got the idea to hire pharma reps a few years ago, after he became CDPHP’s chief executive. He knew reps are smart, genial, and motivated. Overhiring by pharma had put many back on the job market.

His sales pitch to them, he says half-jokingly, was: “You know everything they taught you in Big Pharma? How would you like to use those powers for good?”

Pharma companies spend billions on TV ads, doctor blandishments, and expensive salespeople to keep prescriptions flowing.

Pfizer, Johnson & Johnson, and other sellers responded to critics a few years ago by restricting gifts of entertainment, coffee mugs, and some meals. But the industry’s ethics code still allows lavish consulting contracts for doctors and sponsorship of physician conferences as well as meals for doctors and their staffs who listen to an “informational presentation” from sales reps touting expensive pills.

“When those products go generic, nobody’s promoting them anymore,” Mr. Courtney said. Generics makers lack big marketing budgets. CDPHP’s remedy: The insurer promotes generics with its own reps.

“It’s a great idea,” said Alan Sorensen, an economist at the University of Wisconsin who has studied drug prices. “Even a small moving of the needle on their [doctors’] prescribing behavior can have a pretty big impact on costs.”

At first the team concentrated on educating doctors about cheaper alternatives to Lipitor, a widely prescribed cholesterol-lowering medicine, and Nexium, for stomach problems. That saved around $10 million the first year, much in the form of copayments that would have been owed by plan members.

Recently the plan has focused on Seroquel, a branded antipsychotic that costs far more than a similar generic. Switching to the generic saves $600 to $1,000 a month, estimates Eileen Wood, the insurer’s vice president of pharmacy and health quality.

CDPHP’s repurposed reps have helped keep the insurer’s annual drug-cost increases to single-digit percentages, whereas without them and other measures “we would certainly be well into double-digit” increases, she said.

Educating doctors about drug costs is part of a larger push for “transparency” in an industry where Princeton economist Uwe Reinhardt says consumers face the same experience as somebody shopping in Macy’s blindfolded.

Current research by the University of Wisconsin’s Mr. Sorensen finds physicians with access to data about drug prices and insurance coverage are more likely to prescribe generics.

That gives Mr. Courtney and his colleagues a fighting chance, even if, he said, “we don’t have the freewheeling, unlimited green Amex card like I did back in the day.”
 

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.

In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.

One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.

Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.

“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.

“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”

In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”

CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.

“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”

“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”

But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.

That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.

There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.

And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”

That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.

There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”

So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.

At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
 

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.

In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.

One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.

Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.

“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.

“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”

In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”

CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.

“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”

“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”

But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.

That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.

There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.

And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”

That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.

There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”

So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.

At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
 

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Back in January, Republicans boasted they would deliver a “repeal and replace” bill for the Affordable Care Act to President Donald Trump’s desk by the end of the month.

In the interim, that bravado has faded as their efforts stalled and they found out how complicated undoing a major law can be. With summer just around the corner, and most of official Washington swept up in scandals surrounding Trump, the health overhaul delays are starting to back up the rest of the 2018 agenda.

One of the immediate casualties is the renewal of the Children’s Health Insurance Program. CHIP covers just under 9 million children in low- and moderate-income families, at a cost of about $15 billion a year.

Funding for CHIP does not technically end until Sept. 30, but it is already too late for states to plan their budgets effectively. They needed to know about future funding while their legislatures were still in session, but, according to the National Conference of State Legislatures, the local lawmakers have already adjourned for the year in more than half of the states.

“If [Congress] had wanted to do what states needed with respect to CHIP, it would be done already,” said Joan Alker of the Georgetown Center for Children and Families.

“Certainty and predictability [are] important,” agreed Matt Salo, executive director of the National Association of Medicaid Directors. “If we don’t know that the money is going to be there, we have to start planning to dismantle things early, and that has a real human toll.”

In a March letter urging prompt action, the Medicaid directors noted that while the end of September might seem far off, “as the program nears the end of its congressional funding, states will be required to notify current CHIP beneficiaries of the termination of their coverage. This process may be required to begin as early as July in some states.”

CHIP has long been a bipartisan program – one of its original sponsors is Sen. Orrin Hatch (R-Utah), who chairs the Finance Committee that oversees it. It was created in 1997, and last reauthorized in 2015, for 2 years. But a Finance hearing that was intended to launch the effort to renew the program was abruptly canceled this month, amid suggestions that Republicans might want to hold the program’s renewal hostage to force Democrats and moderate Republicans to make concessions on the bill to replace the Affordable Care Act.

“It’s a very difficult time with respect to children’s coverage,” said Ms. Alker. Not only is the future of CHIP in doubt, but also the House-passed health bill would make major cuts to the Medicaid program, and many states have chosen to roll CHIP into the Medicaid program.”

“We’ve just achieved a historic level in coverage of kids,” she said, referring to a new report finding that more than 93% of eligible U.S. children now have health insurance under CHIP. “Now all three legs of that coverage stool – CHIP, Medicaid, and ACA – are up for grabs.”

But it’s not just CHIP at risk because of the congested congressional calendar. Congress also can’t do the tax bill Republicans badly want until lawmakers wrap up the health bill.

That is because Republicans want to use the same budget procedure, called reconciliation, for both bills. That procedure forbids a filibuster in the Senate and allows passage with a simple majority.

There’s a catch, though. The health bill’s reconciliation instructions were part of the fiscal 2017 budget resolution, which Congress passed in January. Lawmakers would need to adopt a fiscal 2018 budget resolution in order to use the same fast-track procedures for their tax changes.

And they cannot do both at the same time. “Once Congress adopts a new budget resolution for fiscal year 2018,” said Ed Lorenzen, a budget-process expert at the Committee for a Responsible Federal Budget, that new resolution “supplants the fiscal year 2017 resolution and the reconciliation instructions in the fiscal year 2017 budget are moot.”

That means if Congress wanted to continue with the health bill, it would need 60 votes in the Senate, not a simple majority.

There is, however, a loophole of sorts. Congress “can start the next budget resolution before they finish health care,” said Mr. Lorenzen. “They just can’t finish the new budget resolution until they finish health care.”

So the House and Senate could each pass its own separate budget blueprint, and even meet to come to a consensus on its final product. But they cannot take the last step of the process – with each approving a conference report or identical resolutions – until the health bill is done or given up for dead. They could also start work on a tax plan, although, again, they could not take the bill to the floor of the Senate until they finish health care and the new budget resolution.

At least that’s what most budget experts and lawmakers assume. “There’s no precedent to go on,” said Mr. Lorenzen, because no budget reconciliation bill has taken Congress this far into a fiscal year. “So nobody really knows.”
 

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
 

KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Despite days of intense negotiations and last-minute concessions to win over wavering GOP conservatives and moderates, House Republican leaders Friday failed to secure enough support to pass their plan to repeal and replace the Affordable Care Act.

House Speaker Paul Ryan pulled the bill from consideration after he rushed to the White House to tell President Donald Trump that there weren’t the 216 votes necessary for passage.

“We came really close today, but we came up short,” he told reporters at a hastily called news conference.

When pressed about what happens to the federal health law, he added, “Obamacare is the law of the land. … We’re going to be living with Obamacare for the foreseeable future.”

President Trump laid the blame at the feet of Democrats, complaining that not one was willing to help Republicans on the measure, and he warned again that the Obamacare insurance markets are in serious danger. “Bad things are going to happen to Obamacare,” he told reporters at the White House. “There’s not much you can do to help it. I’ve been saying that for a year and a half. I said, look, eventually, it’s not sustainable. The insurance companies are leaving.”

But he said the collapse of the bill might allow Republicans and Democrats to work on a replacement. “I honestly believe the Democrats will come to us and say, ‘Look, let’s get together and get a great health care bill or plan that’s really great for the people of our country,’” he said.

Mr. Ryan originally had hoped to hold a floor vote on the measure Thursday – timed to coincide with the 7th anniversary of the ACA – but decided to delay that effort because GOP leaders didn’t have enough “yes” votes. The House was in session Friday, before his announcement, while members debated the bill.

House Democratic leader Nancy Pelosi (Calif.) said the speaker’s decision to pull the bill “is pretty exciting for us … a victory for the Affordable Care Act, more importantly for the American people.”

The legislation was damaged by a variety of issues raised by competing factions of the party. Many members were nervous about reports by the Congressional Budget Office showing that the bill would lead eventually to 24 million people losing insurance, while some moderate Republicans worried that ending the ACA’s Medicaid expansion would hurt low-income Americans.

At the same time, conservatives, especially the hard-right House Freedom Caucus that often has needled party leaders, complained that the bill kept too much of the ACA structure in place. They wanted a straight repeal of Obamacare, but party leaders said that couldn’t pass the Senate, where Republicans don’t have enough votes to stop a filibuster. They were hoping to use a complicated legislative strategy called budget reconciliation that would allow them to repeal parts of the ACA that only affect federal spending.

The decision came after a chaotic week of negotiations, as party leaders sought to woo more conservatives. The president lobbied 120 members through personal meetings or phone calls, according to a count provided Friday by his spokesman, Sean Spicer. “The president and the team here have left everything on the field,” Mr. Spicer said.

On Thursday evening, Mr. Trump dispatched Office of Management and Budget Director Mick Mulvaney to tell his former House GOP colleagues that the president wanted a vote on Friday. It was time to move on to other priorities, including tax reform, he told House Republicans.

“He said the president needs this, the president has said he wants a vote tomorrow, up or down. If for any reason it goes down, we’re just going to move forward with additional parts of his agenda. This is our moment in time,” Rep. Chris Collins (R-N.Y.), a loyal Trump ally, told reporters late Thursday. “If it doesn’t pass, we’re moving beyond health care. … We are done negotiating.”

Trump’s edict clearly irked some lawmakers, including the Freedom Caucus chairman, Rep. Mark Meadows (R-N.C), whose group of more than two dozen members represented the strongest bloc against the measure.

“Anytime you don’t have 216 votes, negotiations are not totally over,” he told reporters who had surrounded him in a Capitol basement hallway as he headed in to the party’s caucus meeting.

President Trump, Speaker Ryan, and other GOP lawmakers tweaked their initial package in a variety of ways to win over both conservatives and moderates. But every time one change was made to win votes in one camp, it repelled support in another.

The White House on Thursday accepted conservatives’ demands that the legislation strip federal guarantees of essential health benefits from insurance policies. But that was another problem for moderates, and Democrats suggested the provision would not survive in the Senate.

Republican moderates in the House – as well as the Senate – objected to the bill’s provisions that would shift Medicaid from an open-ended entitlement to a set amount of funding for states that also would give governors and state lawmakers more flexibility over the program. Moderates also were concerned that the package’s tax credits would not be generous enough to help older Americans – who could be charged five times more for coverage than would their younger counterparts – afford coverage.

The House package also lost the support of key GOP allies, including the Club for Growth and Heritage Action. Physician, patient and hospital groups also opposed it.

But Mr. Ryan’s comments made clear how difficult this decision was. “This is a disappointing day for us,” he said. “Doing big things is hard. All of us. All of us – myself included – we will need time to reflect on how we got to this moment, what we could have done to do it better.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Despite days of intense negotiations and last-minute concessions to win over wavering GOP conservatives and moderates, House Republican leaders Friday failed to secure enough support to pass their plan to repeal and replace the Affordable Care Act.

House Speaker Paul Ryan pulled the bill from consideration after he rushed to the White House to tell President Donald Trump that there weren’t the 216 votes necessary for passage.

“We came really close today, but we came up short,” he told reporters at a hastily called news conference.

When pressed about what happens to the federal health law, he added, “Obamacare is the law of the land. … We’re going to be living with Obamacare for the foreseeable future.”

President Trump laid the blame at the feet of Democrats, complaining that not one was willing to help Republicans on the measure, and he warned again that the Obamacare insurance markets are in serious danger. “Bad things are going to happen to Obamacare,” he told reporters at the White House. “There’s not much you can do to help it. I’ve been saying that for a year and a half. I said, look, eventually, it’s not sustainable. The insurance companies are leaving.”

But he said the collapse of the bill might allow Republicans and Democrats to work on a replacement. “I honestly believe the Democrats will come to us and say, ‘Look, let’s get together and get a great health care bill or plan that’s really great for the people of our country,’” he said.

Mr. Ryan originally had hoped to hold a floor vote on the measure Thursday – timed to coincide with the 7th anniversary of the ACA – but decided to delay that effort because GOP leaders didn’t have enough “yes” votes. The House was in session Friday, before his announcement, while members debated the bill.

House Democratic leader Nancy Pelosi (Calif.) said the speaker’s decision to pull the bill “is pretty exciting for us … a victory for the Affordable Care Act, more importantly for the American people.”

The legislation was damaged by a variety of issues raised by competing factions of the party. Many members were nervous about reports by the Congressional Budget Office showing that the bill would lead eventually to 24 million people losing insurance, while some moderate Republicans worried that ending the ACA’s Medicaid expansion would hurt low-income Americans.

At the same time, conservatives, especially the hard-right House Freedom Caucus that often has needled party leaders, complained that the bill kept too much of the ACA structure in place. They wanted a straight repeal of Obamacare, but party leaders said that couldn’t pass the Senate, where Republicans don’t have enough votes to stop a filibuster. They were hoping to use a complicated legislative strategy called budget reconciliation that would allow them to repeal parts of the ACA that only affect federal spending.

The decision came after a chaotic week of negotiations, as party leaders sought to woo more conservatives. The president lobbied 120 members through personal meetings or phone calls, according to a count provided Friday by his spokesman, Sean Spicer. “The president and the team here have left everything on the field,” Mr. Spicer said.

On Thursday evening, Mr. Trump dispatched Office of Management and Budget Director Mick Mulvaney to tell his former House GOP colleagues that the president wanted a vote on Friday. It was time to move on to other priorities, including tax reform, he told House Republicans.

“He said the president needs this, the president has said he wants a vote tomorrow, up or down. If for any reason it goes down, we’re just going to move forward with additional parts of his agenda. This is our moment in time,” Rep. Chris Collins (R-N.Y.), a loyal Trump ally, told reporters late Thursday. “If it doesn’t pass, we’re moving beyond health care. … We are done negotiating.”

Trump’s edict clearly irked some lawmakers, including the Freedom Caucus chairman, Rep. Mark Meadows (R-N.C), whose group of more than two dozen members represented the strongest bloc against the measure.

“Anytime you don’t have 216 votes, negotiations are not totally over,” he told reporters who had surrounded him in a Capitol basement hallway as he headed in to the party’s caucus meeting.

President Trump, Speaker Ryan, and other GOP lawmakers tweaked their initial package in a variety of ways to win over both conservatives and moderates. But every time one change was made to win votes in one camp, it repelled support in another.

The White House on Thursday accepted conservatives’ demands that the legislation strip federal guarantees of essential health benefits from insurance policies. But that was another problem for moderates, and Democrats suggested the provision would not survive in the Senate.

Republican moderates in the House – as well as the Senate – objected to the bill’s provisions that would shift Medicaid from an open-ended entitlement to a set amount of funding for states that also would give governors and state lawmakers more flexibility over the program. Moderates also were concerned that the package’s tax credits would not be generous enough to help older Americans – who could be charged five times more for coverage than would their younger counterparts – afford coverage.

The House package also lost the support of key GOP allies, including the Club for Growth and Heritage Action. Physician, patient and hospital groups also opposed it.

But Mr. Ryan’s comments made clear how difficult this decision was. “This is a disappointing day for us,” he said. “Doing big things is hard. All of us. All of us – myself included – we will need time to reflect on how we got to this moment, what we could have done to do it better.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Despite days of intense negotiations and last-minute concessions to win over wavering GOP conservatives and moderates, House Republican leaders Friday failed to secure enough support to pass their plan to repeal and replace the Affordable Care Act.

House Speaker Paul Ryan pulled the bill from consideration after he rushed to the White House to tell President Donald Trump that there weren’t the 216 votes necessary for passage.

“We came really close today, but we came up short,” he told reporters at a hastily called news conference.

When pressed about what happens to the federal health law, he added, “Obamacare is the law of the land. … We’re going to be living with Obamacare for the foreseeable future.”

President Trump laid the blame at the feet of Democrats, complaining that not one was willing to help Republicans on the measure, and he warned again that the Obamacare insurance markets are in serious danger. “Bad things are going to happen to Obamacare,” he told reporters at the White House. “There’s not much you can do to help it. I’ve been saying that for a year and a half. I said, look, eventually, it’s not sustainable. The insurance companies are leaving.”

But he said the collapse of the bill might allow Republicans and Democrats to work on a replacement. “I honestly believe the Democrats will come to us and say, ‘Look, let’s get together and get a great health care bill or plan that’s really great for the people of our country,’” he said.

Mr. Ryan originally had hoped to hold a floor vote on the measure Thursday – timed to coincide with the 7th anniversary of the ACA – but decided to delay that effort because GOP leaders didn’t have enough “yes” votes. The House was in session Friday, before his announcement, while members debated the bill.

House Democratic leader Nancy Pelosi (Calif.) said the speaker’s decision to pull the bill “is pretty exciting for us … a victory for the Affordable Care Act, more importantly for the American people.”

The legislation was damaged by a variety of issues raised by competing factions of the party. Many members were nervous about reports by the Congressional Budget Office showing that the bill would lead eventually to 24 million people losing insurance, while some moderate Republicans worried that ending the ACA’s Medicaid expansion would hurt low-income Americans.

At the same time, conservatives, especially the hard-right House Freedom Caucus that often has needled party leaders, complained that the bill kept too much of the ACA structure in place. They wanted a straight repeal of Obamacare, but party leaders said that couldn’t pass the Senate, where Republicans don’t have enough votes to stop a filibuster. They were hoping to use a complicated legislative strategy called budget reconciliation that would allow them to repeal parts of the ACA that only affect federal spending.

The decision came after a chaotic week of negotiations, as party leaders sought to woo more conservatives. The president lobbied 120 members through personal meetings or phone calls, according to a count provided Friday by his spokesman, Sean Spicer. “The president and the team here have left everything on the field,” Mr. Spicer said.

On Thursday evening, Mr. Trump dispatched Office of Management and Budget Director Mick Mulvaney to tell his former House GOP colleagues that the president wanted a vote on Friday. It was time to move on to other priorities, including tax reform, he told House Republicans.

“He said the president needs this, the president has said he wants a vote tomorrow, up or down. If for any reason it goes down, we’re just going to move forward with additional parts of his agenda. This is our moment in time,” Rep. Chris Collins (R-N.Y.), a loyal Trump ally, told reporters late Thursday. “If it doesn’t pass, we’re moving beyond health care. … We are done negotiating.”

Trump’s edict clearly irked some lawmakers, including the Freedom Caucus chairman, Rep. Mark Meadows (R-N.C), whose group of more than two dozen members represented the strongest bloc against the measure.

“Anytime you don’t have 216 votes, negotiations are not totally over,” he told reporters who had surrounded him in a Capitol basement hallway as he headed in to the party’s caucus meeting.

President Trump, Speaker Ryan, and other GOP lawmakers tweaked their initial package in a variety of ways to win over both conservatives and moderates. But every time one change was made to win votes in one camp, it repelled support in another.

The White House on Thursday accepted conservatives’ demands that the legislation strip federal guarantees of essential health benefits from insurance policies. But that was another problem for moderates, and Democrats suggested the provision would not survive in the Senate.

Republican moderates in the House – as well as the Senate – objected to the bill’s provisions that would shift Medicaid from an open-ended entitlement to a set amount of funding for states that also would give governors and state lawmakers more flexibility over the program. Moderates also were concerned that the package’s tax credits would not be generous enough to help older Americans – who could be charged five times more for coverage than would their younger counterparts – afford coverage.

The House package also lost the support of key GOP allies, including the Club for Growth and Heritage Action. Physician, patient and hospital groups also opposed it.

But Mr. Ryan’s comments made clear how difficult this decision was. “This is a disappointing day for us,” he said. “Doing big things is hard. All of us. All of us – myself included – we will need time to reflect on how we got to this moment, what we could have done to do it better.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.

The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)

Kenishirotie/Thinkstock.com

By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.

Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”

The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.

As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).

Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.

The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.

This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.

The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)

Kenishirotie/Thinkstock.com

By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.

Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”

The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.

As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).

Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.

The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.

This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.

The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)

Kenishirotie/Thinkstock.com

By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.

Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”

The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.

As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).

Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.

The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.

This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

MADISON, WIS.— Something astonishing has happened in the past year to outpatient treatment at the Veterans Affairs hospital here.

Vets regularly get next-day and even same-day appointments for primary care now, no longer waiting a month or more to see a doctor as many once did.

The reason is they don’t all see doctors. Clinical pharmacists — whose special training permits them to prescribe drugs, order lab tests, make referrals to specialists and do physical examinations — are handling more patients’ chronic care needs. That frees physicians to concentrate on new patients and others with complex needs.

A quarter of primary care appointments at the Madison hospital are now handled by clinical pharmacists since they were integrated in patient care teams in 2015. Several VA hospitals — in El Paso, Texas, and Kansas City, Mo., among them — have followed Madison’s approach and more than 36 others are considering it, according to hospital officials.

“It’s made a tremendous positive impact in improving access,” said Dr. Jean Montgomery, chief of primary care services at the Madison hospital.

That’s critical for the VA, the focus of a national scandal in 2014 after news reports revealed the Phoenix VA hospital had booked primary care appointments months in advance, schedulers falsified wait times to make them look shorter and dozens had died awaiting care. Further investigations uncovered similar problems at other VA facilities. More than two years later, tens of thousands of vets are still waiting a month or two for an appointment, according to the latest data from the VA.

The Obama administration has allowed some veterans to seek care in the private sector if they choose, but VA wait times remain long and more action is needed, theGeneral Accountability Office reported in April.

Expanding clinical pharmacists’ role is a solution.

They receive two more years of education than regular pharmacists and they can handle many primary care needs for patients, particularly after physicians have diagnosed their conditions.

The VA has had them for more than 20 years, but their growing involvement in patient care is more recent. This year it employs 3,185 clinical pharmacists with authority to prescribe medications, order lab tests and perform physical assessments — nearly a 50 percent increase since 2011.

“It’s having a significant impact on reducing wait times and our office is trying to expand more of them nationally to increase access,” said Heather Ourth, national clinical program manager for VA Pharmacy Benefits Management Services.

In 2015, VA clinical pharmacists wrote 1.9 million prescriptions for chronic diseases, according to a report co-authored by Ourth and published in September in the American Journal of Health-System Pharmacy.

A goal is to increase the use of clinical pharmacists to help patients with mental health needs and pain management.

“This helps open up appointment slots for physicians to meet patients with acute care needs,” Ourth said.

Clinical pharmacists’ authority is determined at each VA hospital based on their training and knowledge.

The Madison VA allowed clinical pharmacists to take over management of patients with chronic diseases such as diabetes and high blood pressure, participate in weekly meetings with doctors and other members of patients’ care teams and handle patients’ calls about medications.

They typically see five patients in their office each day, usually for 30 minutes each, and they talk to another 10 by telephone, said Ellina Seckel, the clinical pharmacist who led the changes at the hospital.

Many issues involve adjusting medication dosages such as insulin, which do not require a face-to-face visit. When Seckel sees patients, she often helps them lower the number of drugs they take because they may cause unnecessary complications.

Expanding clinical pharmacists’ role in primary care has cut readmission rates and helped more patients keep their diabetes under control, Seckel said.

VA hospital officials in both Madison and El Paso said they faced challenges initially in persuading doctors to delegate some duties to qualified pharmacists.

“Some physicians feel like it’s a turf war and don’t want to refer their patients because they feel the clinical pharmacist is trying to practice medicine,” said Lanre’ Obisesan, a clinical pharmacist and assistant chief of pharmacy at the El Paso VA.

Even so, the El Paso VA’s average wait time fell from two months to two weeks, he said, after it added several clinical pharmacists and gave them independence to help patients. About 30 percent of the VA patients in El Paso have used clinical pharmacists, Obisesan said.

That share will rise. The hospital now has one clinical pharmacist for every six physicians, but it aims to add more pharmacists to reduce the ratio to 1 to 3.

The Madison VA is close to that ratio now after adding four clinical pharmacist positions in the past year.

Patients there can choose whether to see a doctor or a pharmacist. With approval from primary care physicians, pharmacists took over 27 percent of the follow-up appointments for patients with chronic illnesses, Seckel said.

That shift yields benefits for both doctors and patients, said Montgomery, the head of primary care services at the Madison VA.

Many VA doctors only have time to deal with patients’ acute care issues, such as knee or back pain, with little time to focus on a patient’s multiple chronic illnesses and often a dozen or more medications they may be taking for them.

“The more we can have members of the team to do routine things that do not require a physician’s time the better the quality of the visit and the better patient outcomes,” he said.

Patients seem to like what the hospital is doing.

Stephen Howard Foster saw a clinical pharmacist  recently who told him he could stop taking one heartburn medication and switched him to another medicine to reduce side effects. He said he was comfortable with the pharmacist advising him without first consulting his physician and he saved time.

“This is a good idea rather than put up with normal delays,” said Foster, 51.

Another Madison VA patient, Mike Fonger, 71, saw clinical pharmacist Anita Kashyap recently to get a blood pressure check, lab test results, a review of his medications and to change an ointment he was taking for back and shoulder pain. Kashyap also helped him ease the side effects from the cholesterol-lowering drug he takes by cutting his dosage in half.

“I like the extra attention I get here,” Fonger said.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

MADISON, WIS.— Something astonishing has happened in the past year to outpatient treatment at the Veterans Affairs hospital here.

Vets regularly get next-day and even same-day appointments for primary care now, no longer waiting a month or more to see a doctor as many once did.

The reason is they don’t all see doctors. Clinical pharmacists — whose special training permits them to prescribe drugs, order lab tests, make referrals to specialists and do physical examinations — are handling more patients’ chronic care needs. That frees physicians to concentrate on new patients and others with complex needs.

A quarter of primary care appointments at the Madison hospital are now handled by clinical pharmacists since they were integrated in patient care teams in 2015. Several VA hospitals — in El Paso, Texas, and Kansas City, Mo., among them — have followed Madison’s approach and more than 36 others are considering it, according to hospital officials.

“It’s made a tremendous positive impact in improving access,” said Dr. Jean Montgomery, chief of primary care services at the Madison hospital.

That’s critical for the VA, the focus of a national scandal in 2014 after news reports revealed the Phoenix VA hospital had booked primary care appointments months in advance, schedulers falsified wait times to make them look shorter and dozens had died awaiting care. Further investigations uncovered similar problems at other VA facilities. More than two years later, tens of thousands of vets are still waiting a month or two for an appointment, according to the latest data from the VA.

The Obama administration has allowed some veterans to seek care in the private sector if they choose, but VA wait times remain long and more action is needed, theGeneral Accountability Office reported in April.

Expanding clinical pharmacists’ role is a solution.

They receive two more years of education than regular pharmacists and they can handle many primary care needs for patients, particularly after physicians have diagnosed their conditions.

The VA has had them for more than 20 years, but their growing involvement in patient care is more recent. This year it employs 3,185 clinical pharmacists with authority to prescribe medications, order lab tests and perform physical assessments — nearly a 50 percent increase since 2011.

“It’s having a significant impact on reducing wait times and our office is trying to expand more of them nationally to increase access,” said Heather Ourth, national clinical program manager for VA Pharmacy Benefits Management Services.

In 2015, VA clinical pharmacists wrote 1.9 million prescriptions for chronic diseases, according to a report co-authored by Ourth and published in September in the American Journal of Health-System Pharmacy.

A goal is to increase the use of clinical pharmacists to help patients with mental health needs and pain management.

“This helps open up appointment slots for physicians to meet patients with acute care needs,” Ourth said.

Clinical pharmacists’ authority is determined at each VA hospital based on their training and knowledge.

The Madison VA allowed clinical pharmacists to take over management of patients with chronic diseases such as diabetes and high blood pressure, participate in weekly meetings with doctors and other members of patients’ care teams and handle patients’ calls about medications.

They typically see five patients in their office each day, usually for 30 minutes each, and they talk to another 10 by telephone, said Ellina Seckel, the clinical pharmacist who led the changes at the hospital.

Many issues involve adjusting medication dosages such as insulin, which do not require a face-to-face visit. When Seckel sees patients, she often helps them lower the number of drugs they take because they may cause unnecessary complications.

Expanding clinical pharmacists’ role in primary care has cut readmission rates and helped more patients keep their diabetes under control, Seckel said.

VA hospital officials in both Madison and El Paso said they faced challenges initially in persuading doctors to delegate some duties to qualified pharmacists.

“Some physicians feel like it’s a turf war and don’t want to refer their patients because they feel the clinical pharmacist is trying to practice medicine,” said Lanre’ Obisesan, a clinical pharmacist and assistant chief of pharmacy at the El Paso VA.

Even so, the El Paso VA’s average wait time fell from two months to two weeks, he said, after it added several clinical pharmacists and gave them independence to help patients. About 30 percent of the VA patients in El Paso have used clinical pharmacists, Obisesan said.

That share will rise. The hospital now has one clinical pharmacist for every six physicians, but it aims to add more pharmacists to reduce the ratio to 1 to 3.

The Madison VA is close to that ratio now after adding four clinical pharmacist positions in the past year.

Patients there can choose whether to see a doctor or a pharmacist. With approval from primary care physicians, pharmacists took over 27 percent of the follow-up appointments for patients with chronic illnesses, Seckel said.

That shift yields benefits for both doctors and patients, said Montgomery, the head of primary care services at the Madison VA.

Many VA doctors only have time to deal with patients’ acute care issues, such as knee or back pain, with little time to focus on a patient’s multiple chronic illnesses and often a dozen or more medications they may be taking for them.

“The more we can have members of the team to do routine things that do not require a physician’s time the better the quality of the visit and the better patient outcomes,” he said.

Patients seem to like what the hospital is doing.

Stephen Howard Foster saw a clinical pharmacist  recently who told him he could stop taking one heartburn medication and switched him to another medicine to reduce side effects. He said he was comfortable with the pharmacist advising him without first consulting his physician and he saved time.

“This is a good idea rather than put up with normal delays,” said Foster, 51.

Another Madison VA patient, Mike Fonger, 71, saw clinical pharmacist Anita Kashyap recently to get a blood pressure check, lab test results, a review of his medications and to change an ointment he was taking for back and shoulder pain. Kashyap also helped him ease the side effects from the cholesterol-lowering drug he takes by cutting his dosage in half.

“I like the extra attention I get here,” Fonger said.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

MADISON, WIS.— Something astonishing has happened in the past year to outpatient treatment at the Veterans Affairs hospital here.

Vets regularly get next-day and even same-day appointments for primary care now, no longer waiting a month or more to see a doctor as many once did.

The reason is they don’t all see doctors. Clinical pharmacists — whose special training permits them to prescribe drugs, order lab tests, make referrals to specialists and do physical examinations — are handling more patients’ chronic care needs. That frees physicians to concentrate on new patients and others with complex needs.

A quarter of primary care appointments at the Madison hospital are now handled by clinical pharmacists since they were integrated in patient care teams in 2015. Several VA hospitals — in El Paso, Texas, and Kansas City, Mo., among them — have followed Madison’s approach and more than 36 others are considering it, according to hospital officials.

“It’s made a tremendous positive impact in improving access,” said Dr. Jean Montgomery, chief of primary care services at the Madison hospital.

That’s critical for the VA, the focus of a national scandal in 2014 after news reports revealed the Phoenix VA hospital had booked primary care appointments months in advance, schedulers falsified wait times to make them look shorter and dozens had died awaiting care. Further investigations uncovered similar problems at other VA facilities. More than two years later, tens of thousands of vets are still waiting a month or two for an appointment, according to the latest data from the VA.

The Obama administration has allowed some veterans to seek care in the private sector if they choose, but VA wait times remain long and more action is needed, theGeneral Accountability Office reported in April.

Expanding clinical pharmacists’ role is a solution.

They receive two more years of education than regular pharmacists and they can handle many primary care needs for patients, particularly after physicians have diagnosed their conditions.

The VA has had them for more than 20 years, but their growing involvement in patient care is more recent. This year it employs 3,185 clinical pharmacists with authority to prescribe medications, order lab tests and perform physical assessments — nearly a 50 percent increase since 2011.

“It’s having a significant impact on reducing wait times and our office is trying to expand more of them nationally to increase access,” said Heather Ourth, national clinical program manager for VA Pharmacy Benefits Management Services.

In 2015, VA clinical pharmacists wrote 1.9 million prescriptions for chronic diseases, according to a report co-authored by Ourth and published in September in the American Journal of Health-System Pharmacy.

A goal is to increase the use of clinical pharmacists to help patients with mental health needs and pain management.

“This helps open up appointment slots for physicians to meet patients with acute care needs,” Ourth said.

Clinical pharmacists’ authority is determined at each VA hospital based on their training and knowledge.

The Madison VA allowed clinical pharmacists to take over management of patients with chronic diseases such as diabetes and high blood pressure, participate in weekly meetings with doctors and other members of patients’ care teams and handle patients’ calls about medications.

They typically see five patients in their office each day, usually for 30 minutes each, and they talk to another 10 by telephone, said Ellina Seckel, the clinical pharmacist who led the changes at the hospital.

Many issues involve adjusting medication dosages such as insulin, which do not require a face-to-face visit. When Seckel sees patients, she often helps them lower the number of drugs they take because they may cause unnecessary complications.

Expanding clinical pharmacists’ role in primary care has cut readmission rates and helped more patients keep their diabetes under control, Seckel said.

VA hospital officials in both Madison and El Paso said they faced challenges initially in persuading doctors to delegate some duties to qualified pharmacists.

“Some physicians feel like it’s a turf war and don’t want to refer their patients because they feel the clinical pharmacist is trying to practice medicine,” said Lanre’ Obisesan, a clinical pharmacist and assistant chief of pharmacy at the El Paso VA.

Even so, the El Paso VA’s average wait time fell from two months to two weeks, he said, after it added several clinical pharmacists and gave them independence to help patients. About 30 percent of the VA patients in El Paso have used clinical pharmacists, Obisesan said.

That share will rise. The hospital now has one clinical pharmacist for every six physicians, but it aims to add more pharmacists to reduce the ratio to 1 to 3.

The Madison VA is close to that ratio now after adding four clinical pharmacist positions in the past year.

Patients there can choose whether to see a doctor or a pharmacist. With approval from primary care physicians, pharmacists took over 27 percent of the follow-up appointments for patients with chronic illnesses, Seckel said.

That shift yields benefits for both doctors and patients, said Montgomery, the head of primary care services at the Madison VA.

Many VA doctors only have time to deal with patients’ acute care issues, such as knee or back pain, with little time to focus on a patient’s multiple chronic illnesses and often a dozen or more medications they may be taking for them.

“The more we can have members of the team to do routine things that do not require a physician’s time the better the quality of the visit and the better patient outcomes,” he said.

Patients seem to like what the hospital is doing.

Stephen Howard Foster saw a clinical pharmacist  recently who told him he could stop taking one heartburn medication and switched him to another medicine to reduce side effects. He said he was comfortable with the pharmacist advising him without first consulting his physician and he saved time.

“This is a good idea rather than put up with normal delays,” said Foster, 51.

Another Madison VA patient, Mike Fonger, 71, saw clinical pharmacist Anita Kashyap recently to get a blood pressure check, lab test results, a review of his medications and to change an ointment he was taking for back and shoulder pain. Kashyap also helped him ease the side effects from the cholesterol-lowering drug he takes by cutting his dosage in half.

“I like the extra attention I get here,” Fonger said.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

The pharmacy chain pitches started in August: Come in and get your flu shot.

Convenience is touted. So are incentives: CVS offers a 20-percent-off shopping pass for everyone who gets a shot, while Walgreens donates toward international vaccination efforts.

The start of flu season is still weeks — if not months — away. Yet marketing of the vaccine has become an almost year-round effort, beginning when the shots become available in August and hyped as long as the supply lasts, often into April or May.

Not that long ago, most flu-shot campaigns started as the leaves began to turn in October. But the rise of retail medical clinics inside drug stores over the past decade — and state laws allowing pharmacists to give vaccinations — has stretched the flu-shot season.

The stores have figured out how “to deliver medical services in an on-demand way” which appeals to customers, particularly millennials, said Tom Charland, founder and CEO of Merchant Medicine, which tracks the walk-in clinic industry. “It’s a way to get people into the store to buy other things.”

But some experts say the marketing may be overtaking medical wisdom since it’s unclear how long the immunity imparted by the vaccine lasts, particularly in older people.

Federal health officials say it’s better to get the shot whenever you can. An early flu shot is better than no flu shot at all. But the science is mixed when it comes to how long a flu shot promoted and given during the waning days of summer will provide optimal protection, especially because flu season generally peaks in mid-winter or beyond. Experts are divided on how patients should respond to such offers.

“If you’re over 65, don’t get the flu vaccine in September. Or August. It’s a marketing scheme,” said Laura Haynes, an immunologist at the University of Connecticut Center on Aging.

That’s because a combination of factors makes it more difficult for the immune systems of people older than age 65 to respond to the vaccination in the first place. And its protective effects may wear off faster for this age group than it does for young people.

When is the best time to vaccinate? It’s a question even doctors have.

“Should I wait until October or November to vaccinate my elderly or medically frail patients?” That’s one of the queries on the website of the board that advises the Centers for Disease Control and Prevention on immunizations. The answer is that it is safe to make the shots available to all age groups when the vaccine becomes available, although it does include a caution.

The board says antibodies created by the vaccine decline in the months following vaccination “primarily affecting persons age 65 and older,” citing a study done during the 2011-2012 flu season. Still, while “delaying vaccination might permit greater immunity later in the season,” the CDC notes that “deferral could result in missed opportunities to vaccinate.”

How long will the immunity last?

“The data are very mixed,” said. John J. Treanor, a vaccine expert at the University of Rochester medical school. Some studies suggest vaccines lose some protectiveness during the course of a single flu season. Flu activity generally starts in the fall, but peaks in January or February and can run into the spring.

“So some might worry that if [they] got vaccinated very early and flu didn’t show up until very late, it might not work as well,” he said.

But other studies “show you still have protection from the shot you got last year if it’s a year when the strains didn’t change, Treanor said.

In any given flu season, vaccine effectiveness varies. One factor is how well the vaccines match the virus that is actually prevalent. Other factors influencing effectiveness include the age and general health of the recipient. In the overall population, the CDC says studies show vaccines can reduce the risk of flu by about 50 to 60 percent when the vaccines are well matched.

Health officials say it’s especially important to vaccinate children because they often spread the disease, are better able to develop antibodies from the vaccines and, if they don’t get sick, they won’t expose grandma and grandpa. While most people who get the flu recover, it is a serious disease responsible for many deaths each year, particularly among older adults and young children. Influenza’s intensity varies annually, with the CDC saying deaths associated with the flu have ranged from about 3,300 a year to 49,000 during the past 31 seasons.

To develop vaccines, manufacturers and scientists study what’s circulating in the Southern Hemisphere during its winter, which is our summer. Then — based on that evidence — forecast what flu strains might circulate here to make vaccines that are generally delivered in late July.

For the upcoming season, the vaccines will include three or four strains, including two A strains, an H1N1 and an H3N2, as well as one or two B strains, according to the CDC. It recommends that everyone older than 6 months get vaccinated, unless they have health conditions that would prevent it.

The vaccines can’t give a person the flu because the virus is killed before it’s included in the shot. This year, the nasal vaccine is not recommended for use, as studies showed it was not effective during several of the past flu seasons.

But when to go?

“The ideal time is between Halloween and Thanksgiving,” said Haynes at UConn. “If you can’t wait and the only chance is to get it in September, then go ahead and get it. It’s best to get it early rather than not at all.”

This Kaiser Health News story also ran on NPR. 

The pharmacy chain pitches started in August: Come in and get your flu shot.

Convenience is touted. So are incentives: CVS offers a 20-percent-off shopping pass for everyone who gets a shot, while Walgreens donates toward international vaccination efforts.

The start of flu season is still weeks — if not months — away. Yet marketing of the vaccine has become an almost year-round effort, beginning when the shots become available in August and hyped as long as the supply lasts, often into April or May.

Not that long ago, most flu-shot campaigns started as the leaves began to turn in October. But the rise of retail medical clinics inside drug stores over the past decade — and state laws allowing pharmacists to give vaccinations — has stretched the flu-shot season.

The stores have figured out how “to deliver medical services in an on-demand way” which appeals to customers, particularly millennials, said Tom Charland, founder and CEO of Merchant Medicine, which tracks the walk-in clinic industry. “It’s a way to get people into the store to buy other things.”

But some experts say the marketing may be overtaking medical wisdom since it’s unclear how long the immunity imparted by the vaccine lasts, particularly in older people.

Federal health officials say it’s better to get the shot whenever you can. An early flu shot is better than no flu shot at all. But the science is mixed when it comes to how long a flu shot promoted and given during the waning days of summer will provide optimal protection, especially because flu season generally peaks in mid-winter or beyond. Experts are divided on how patients should respond to such offers.

“If you’re over 65, don’t get the flu vaccine in September. Or August. It’s a marketing scheme,” said Laura Haynes, an immunologist at the University of Connecticut Center on Aging.

That’s because a combination of factors makes it more difficult for the immune systems of people older than age 65 to respond to the vaccination in the first place. And its protective effects may wear off faster for this age group than it does for young people.

When is the best time to vaccinate? It’s a question even doctors have.

“Should I wait until October or November to vaccinate my elderly or medically frail patients?” That’s one of the queries on the website of the board that advises the Centers for Disease Control and Prevention on immunizations. The answer is that it is safe to make the shots available to all age groups when the vaccine becomes available, although it does include a caution.

The board says antibodies created by the vaccine decline in the months following vaccination “primarily affecting persons age 65 and older,” citing a study done during the 2011-2012 flu season. Still, while “delaying vaccination might permit greater immunity later in the season,” the CDC notes that “deferral could result in missed opportunities to vaccinate.”

How long will the immunity last?

“The data are very mixed,” said. John J. Treanor, a vaccine expert at the University of Rochester medical school. Some studies suggest vaccines lose some protectiveness during the course of a single flu season. Flu activity generally starts in the fall, but peaks in January or February and can run into the spring.

“So some might worry that if [they] got vaccinated very early and flu didn’t show up until very late, it might not work as well,” he said.

But other studies “show you still have protection from the shot you got last year if it’s a year when the strains didn’t change, Treanor said.

In any given flu season, vaccine effectiveness varies. One factor is how well the vaccines match the virus that is actually prevalent. Other factors influencing effectiveness include the age and general health of the recipient. In the overall population, the CDC says studies show vaccines can reduce the risk of flu by about 50 to 60 percent when the vaccines are well matched.

Health officials say it’s especially important to vaccinate children because they often spread the disease, are better able to develop antibodies from the vaccines and, if they don’t get sick, they won’t expose grandma and grandpa. While most people who get the flu recover, it is a serious disease responsible for many deaths each year, particularly among older adults and young children. Influenza’s intensity varies annually, with the CDC saying deaths associated with the flu have ranged from about 3,300 a year to 49,000 during the past 31 seasons.

To develop vaccines, manufacturers and scientists study what’s circulating in the Southern Hemisphere during its winter, which is our summer. Then — based on that evidence — forecast what flu strains might circulate here to make vaccines that are generally delivered in late July.

For the upcoming season, the vaccines will include three or four strains, including two A strains, an H1N1 and an H3N2, as well as one or two B strains, according to the CDC. It recommends that everyone older than 6 months get vaccinated, unless they have health conditions that would prevent it.

The vaccines can’t give a person the flu because the virus is killed before it’s included in the shot. This year, the nasal vaccine is not recommended for use, as studies showed it was not effective during several of the past flu seasons.

But when to go?

“The ideal time is between Halloween and Thanksgiving,” said Haynes at UConn. “If you can’t wait and the only chance is to get it in September, then go ahead and get it. It’s best to get it early rather than not at all.”

This Kaiser Health News story also ran on NPR. 

The pharmacy chain pitches started in August: Come in and get your flu shot.

Convenience is touted. So are incentives: CVS offers a 20-percent-off shopping pass for everyone who gets a shot, while Walgreens donates toward international vaccination efforts.

The start of flu season is still weeks — if not months — away. Yet marketing of the vaccine has become an almost year-round effort, beginning when the shots become available in August and hyped as long as the supply lasts, often into April or May.

Not that long ago, most flu-shot campaigns started as the leaves began to turn in October. But the rise of retail medical clinics inside drug stores over the past decade — and state laws allowing pharmacists to give vaccinations — has stretched the flu-shot season.

The stores have figured out how “to deliver medical services in an on-demand way” which appeals to customers, particularly millennials, said Tom Charland, founder and CEO of Merchant Medicine, which tracks the walk-in clinic industry. “It’s a way to get people into the store to buy other things.”

But some experts say the marketing may be overtaking medical wisdom since it’s unclear how long the immunity imparted by the vaccine lasts, particularly in older people.

Federal health officials say it’s better to get the shot whenever you can. An early flu shot is better than no flu shot at all. But the science is mixed when it comes to how long a flu shot promoted and given during the waning days of summer will provide optimal protection, especially because flu season generally peaks in mid-winter or beyond. Experts are divided on how patients should respond to such offers.

“If you’re over 65, don’t get the flu vaccine in September. Or August. It’s a marketing scheme,” said Laura Haynes, an immunologist at the University of Connecticut Center on Aging.

That’s because a combination of factors makes it more difficult for the immune systems of people older than age 65 to respond to the vaccination in the first place. And its protective effects may wear off faster for this age group than it does for young people.

When is the best time to vaccinate? It’s a question even doctors have.

“Should I wait until October or November to vaccinate my elderly or medically frail patients?” That’s one of the queries on the website of the board that advises the Centers for Disease Control and Prevention on immunizations. The answer is that it is safe to make the shots available to all age groups when the vaccine becomes available, although it does include a caution.

The board says antibodies created by the vaccine decline in the months following vaccination “primarily affecting persons age 65 and older,” citing a study done during the 2011-2012 flu season. Still, while “delaying vaccination might permit greater immunity later in the season,” the CDC notes that “deferral could result in missed opportunities to vaccinate.”

How long will the immunity last?

“The data are very mixed,” said. John J. Treanor, a vaccine expert at the University of Rochester medical school. Some studies suggest vaccines lose some protectiveness during the course of a single flu season. Flu activity generally starts in the fall, but peaks in January or February and can run into the spring.

“So some might worry that if [they] got vaccinated very early and flu didn’t show up until very late, it might not work as well,” he said.

But other studies “show you still have protection from the shot you got last year if it’s a year when the strains didn’t change, Treanor said.

In any given flu season, vaccine effectiveness varies. One factor is how well the vaccines match the virus that is actually prevalent. Other factors influencing effectiveness include the age and general health of the recipient. In the overall population, the CDC says studies show vaccines can reduce the risk of flu by about 50 to 60 percent when the vaccines are well matched.

Health officials say it’s especially important to vaccinate children because they often spread the disease, are better able to develop antibodies from the vaccines and, if they don’t get sick, they won’t expose grandma and grandpa. While most people who get the flu recover, it is a serious disease responsible for many deaths each year, particularly among older adults and young children. Influenza’s intensity varies annually, with the CDC saying deaths associated with the flu have ranged from about 3,300 a year to 49,000 during the past 31 seasons.

To develop vaccines, manufacturers and scientists study what’s circulating in the Southern Hemisphere during its winter, which is our summer. Then — based on that evidence — forecast what flu strains might circulate here to make vaccines that are generally delivered in late July.

For the upcoming season, the vaccines will include three or four strains, including two A strains, an H1N1 and an H3N2, as well as one or two B strains, according to the CDC. It recommends that everyone older than 6 months get vaccinated, unless they have health conditions that would prevent it.

The vaccines can’t give a person the flu because the virus is killed before it’s included in the shot. This year, the nasal vaccine is not recommended for use, as studies showed it was not effective during several of the past flu seasons.

But when to go?

“The ideal time is between Halloween and Thanksgiving,” said Haynes at UConn. “If you can’t wait and the only chance is to get it in September, then go ahead and get it. It’s best to get it early rather than not at all.”

This Kaiser Health News story also ran on NPR.