WASHINGTON – House Democrats are looking at big health care changes, including federal aid to help families earning up to $88,000 pay for insurance and a requirement that all must carry coverage.

A document obtained by The Associated Press shows the plan being developed by the House Energy and Commerce Committee would also require employers to offer coverage to their full-time workers, or pay a percentage of their payroll to the government.

The committee summary is a first look at where House Democrats are headed as leaders try to meet an ambitious goal of passing a health care overhaul by the end of July. Energy and Commerce Chairman Henry Waxman, D-Calif., is expected to play a leading role in crafting the plan and steering it through negotiations with the Senate later in the year.

The three-page summary broadly tracks with the type of plan President Barack Obama outlined during the political campaign. The summary does not include any cost estimates, but independent experts have put the price tag for such a plan at $1.2 trillion to $1.5 trillion over 10 years, with some estimates ranging as high as $1.7 trillion.

Obama has said the final legislation must rein in costs, guarantee choice of health plans and medical providers, and ensure that all Americans have access to affordable coverage. The president has proposed a downpayment of $634 billion over 10 years to pay for expanding coverage. He’s also promising to hold hospitals, doctors, drug makers and other providers to their recent offer of $2 trillion in savings over 10 years.

The Energy and Commerce plan would build on the current system in which employers, government and individuals share responsibility for the cost of health insurance. But it would make major changes in the way Americans get and pay for coverage. Workers and employers would have new obligations to obtain coverage. Insurers would have to abide by new consumer protections to prevent sick people from being denied coverage.

The subsidies for health insurance would be offered on a sliding scale to those earning up to four times the federal poverty level, or $88,200 for a family of four, according to the document.

The House plan would set up a new insurance purchasing pool called an “exchange” to help make private coverage more affordable for individuals and small businesses. In its first year, the exchange would be open only to employers with fewer than 10 workers.

Health insurance plans that participate in the exchange would have to follow the same consumer protection rules. They would not be able to deny coverage to the sick, or charge them exorbitant rates.

The document also calls for creation of a new government insurance plan to compete with private companies. The government plan would probably be run by the Health and Human Services department, but it would have to compete on its own. The government insurance plan would be financed by premium payments, not taxpayer dollars.

By Erica Werner, Ricardo Alonso-Zaldivar

WASHINGTON – The White House trumpeted the news: health care providers taking a $2 trillion scalpel to their costs and pushing the U.S. toward President Obama’s vision of health coverage for all. But don’t line up yet for those insurance cards.

First, a reality check for the nation’s 50 million uninsured.

Medical providers have a long track record of avoiding fiscal constraints, as witnessed by the government’s efforts to tamp down Medicare costs.

And none of the groups that went to the White House can actually dictate prices to itsr members. Doctors in New York or hospitals in Los Angeles are free to charge what the market can bear.

There’s one more catch: Even if every penny of the promised savings shows up, not all of it would be used to help cover uninsured Americans. Actual savings to the government are all that can be counted as Congress tries to pay for subsidies that will be needed to help make health insurance affordable for everyone.

Costs could still turn out to be the greatest obstacle to Obama’s health care plan.

Outside experts estimate the taxpayers’ tab could total between $1.2 trillion and $1.5 trillion over 10 years. Some go as high as $1.7 trillion. Obama’s budget proposal includes a down payment that may cover less than half the bill.

Pledging restraint on costs Monday at the White House were groups representing hospitals, doctors, drug makers, medical device manufacturers and a major health care labor union – a Who’s Who of health care interests. The president posed proudly with them and called it “a watershed event.”

Obama wants to build on the current system in which most people get coverage through private insurers. But he wants to change the rules so the sick can’t be turned down. And he wants to provide subsidies to help low-wage workers and even some in the middle class afford their premiums.

House Republican leader John Boehner of Ohio isn’t impressed. “Today’s announcement promises savings with no concrete plan to achieve them and no enforcement mechanism if they don’t,” he said Monday.

Indeed, it’s too early to tell whether the White House meeting will be remembered as a turning point or as a political mirage.

The administration is projecting an image of a new coalition for health care, with Obama and most of the health care industry and consumer interest groups claiming the political center.

Left out, for now, are conservative Republicans, who oppose Obama’s direction but have yet to articulate their own vision, and liberal Democrats who have been hoping to move toward a nationalized system like Medicare for all. As the debate heats up, the voices from both ends of the political divide will get louder – and the pressure on the center will increase.

By joining Obama, providers are acknowledging at least some responsibility for a bloated and dysfunctional system that economists say is unaffordable.

“I think the reason all these groups want to actively participate in the process is they don’t want to see a blunt instrument used to get spending down,” said Mark McClellan, who ran Medicare for President George W. Bush. “This is an opportunity to get everyone behind a better approach to improve the way health care works.”

That’s just what the groups say they want to do. Their proposals include coordinating care for people with chronic illnesses, rewarding quality not quantity, and using technology to root out waste and prevent errors that get patients sicker.

But it’s hard to put numbers next to any of those ideas. For example, what if better care for chronically ill patients turns out to increase costs? None of the groups has set a target for how much its members should have to pony up.

Congress is going to need hard numbers to pass Obama’s plan this year.

Robert Laszewski, a former health insurance executive turned policy consultant, said he’s betting the consensus won’t last.

“When Congress comes up with mechanisms to reduce costs that actually take money out of the hands of doctors, hospitals and insurance companies, that’s when we’re going to find out if things are really different this time,” he said.

President Obama leaves the State Dining Room of the White House after speaking about health care reform Monday.

The White House trumpeted the news: health care providers taking a $2 trillion scalpel to their costs and pushing the U.S. toward Barack Obama’s vision of health coverage for all. But don’t line up yet for those insurance cards.

First, a reality check for the nation’s 50 million uninsured.

Medical providers have a long track record of avoiding fiscal constraints, as witnessed by the government’s efforts to tamp down Medicare costs.

And none of the groups that went to the White House can actually dictate prices to their members. Doctors in New York or hospitals in Los Angeles are free to charge what the market can bear.

There’s one more catch: Even if every penny of the promised savings shows up, not all of it would be used to help cover uninsured Americans. Actual savings to the government are all that can be counted as Congress tries to pay for subsidies that will be needed to help make health insurance affordable for everyone.

The medical groups’ pledge is “a very hopeful sign,” said economist Robert Reischauer, head of the Urban Institute. “But when we get down to hammering out the details, health care reform remains both complex and philosophically and politically difficult to accomplish.”

Costs could still turn out to be the greatest obstacle to Obama’s health care plan.

Outside experts estimate the taxpayers’ tab could total between $1.2 trillion and $1.5 trillion over 10 years. Some go as high as $1.7 trillion. Obama’s budget proposal includes a down payment that may cover less than half the bill.

Pledging restraint on costs Monday at the White House were groups representing hospitals, doctors, drug makers, medical device manufacturers and a major health care labor union – a who’s who of health care interests. The president posed proudly with them and called it “a watershed event.”

Obama wants to build on the current system in which most people get coverage through private insurers. But he wants to change the rules so the sick can’t be turned down. And he wants to provide subsidies to help low-wage workers and even some in the middle class afford their premiums.

House Republican leader John Boehner of Ohio isn’t impressed. “Today’s announcement promises savings with no concrete plan to achieve them and no enforcement mechanism if they don’t,” he said Monday.

Indeed, it’s too early to tell whether the White House meeting will be remembered as a turning point or as a political mirage. The administration is projecting an image of a new coalition for health care, with Obama and most of the health care industry and consumer interest groups claiming the political center.

Left out, for now, are conservative Republicans, who oppose Obama’s direction but have yet to articulate their own vision, and liberal Democrats who have been hoping to move toward a nationalized system like Medicare for all. As the debate heats up, the voices from both ends of the political divide will get louder – and the pressure on the center will increase.

Still, the sight of health care industry leaders volunteering to hold back spending is pretty unusual.

By joining Obama, providers are acknowledging at least some responsibility for a bloated and dysfunctional system that economists say is unaffordable.

In the 1990s, when President Bill Clinton attempted to overhaul health care, the battle lines quickly hardened. Obama, who has gone out of his way to woo the interest groups, praised their willingness to sacrifice on Monday.

The groups don’t just have the national interest in mind. Industry is worried that Congress will create a government health plan to compete with private insurers.

Such a plan would quickly become the biggest in the country and could use its power to set lower payment rates, driving costs down on the backs of medical providers.

“I think the reason all these groups want to actively participate in the process is they don’t want to see a blunt instrument used to get spending down,” said Mark McClellan, who ran Medicare for President George W. Bush. “This is an opportunity to get everyone behind a better approach to improve the way health care works.”

That’s just what the groups say they want to do. Their proposals include coordinating care for people with chronic illnesses, rewarding quality not quantity, and using technology to root out waste and prevent errors that get patients sicker.

But it’s hard to put numbers next to any of those ideas. For example, what if better care for chronically ill patients turns out to increase costs? None of the groups has set a target for how much its members should have to pony up.

Congress is going to need hard numbers to pass Obama’s plan this year.

Robert Laszewski, a former health insurance executive turned policy consultant, said he’s betting the consensus won’t last.

“When Congress comes up with mechanisms to reduce costs that actually take money out of the hands of doctors, hospitals and insurance companies,” he said, “that’s when we’re going to find out if things are really different this time.”

Ricardo Alonso-Zaldivar reports on health care policy for The Associated Press.

President Barack Obama speaks about health care reform on Monday in the State Dining Room of the White House in Washington.

WASHINGTON – President Barack Obama on Monday portrayed the health care industry’s promise to cut $2 trillion in costs over 10 years as “a watershed event” in the long search for a solution to the millions of uninsured.

Whether that is true won’t be readily known as debate begins in Congress over sweeping health care legislation. What is known now is that the move puts the industry groups involved firmly inside the process of expanding coverage, with the hope they can steer the final product toward something that doesn’t restrict their profitability.

“I will not rest until the dream of health care reform is achieved in the United States of America,” Obama declared in the White House’s State Dining Room as he announced the voluntary offer made to the White House Monday by a consortium of hospitals, insurance companies, drug makers and doctors.

They told Obama they would slow rate increases by 1.5 percentage points a year by improving coordination, focusing on efficiency and embracing better technology and regulatory reform.

Government economists say the shaved costs would create breathing room to help provide health insurance to an estimated 50 million Americans who now do not have it.

It’s a substantial change from the time in the early 1990s when President Bill Clinton took on health care reform, only to see industry leaders fight back hard, ultimately killing the White House proposal before it could gain any traction.

Still, even Obama acknowledged that the step announced Monday would be meaningful into the future only if it is not a singular event, but part of a larger and successful effort toward universal health care coverage for Americans. He said the country “can, will and must” accomplish this goal by the end of the year.

“There’s so much more to do,” he said.

“We can’t continue down the same dangerous road we’ve been traveling for so many years,” Obama said. “Reform is not a luxury that can be postponed, but a necessity that cannot wait.”

He indirectly criticized some of the groups at his side for killing the effort last time.

“All too often, efforts at reform have fallen victim to special interest lobbying aimed at keeping things the way they are, to political point-scoring that sees health care not as a moral issue or an economic issue, but as a wedge issue, and to a failure on all sides to come together on behalf of the American people,” the president said.

The industry letter said “these and other reforms will make our health care system stronger and more sustainable.”

Although the offer from the industry groups doesn’t resolve thorny details of a new health care system, it does offer the prospect of freeing a large chunk of money to help pay for coverage. And it puts the private-sector groups in a good position to influence the bill Congress is writing.

The industry groups are trying to get on the administration bandwagon for expanded coverage now in the hope they can steer Congress away from legislation that would restrict their profitability in future years.

Insurers, for example, want to avoid the creation of a government health plan that would directly compete with them to enroll middle-class workers and their families. Drug makers worry that in the future, new medications might have to pass a cost-benefit test before they can win approval. And hospitals and doctors are concerned the government could dictate what they get paid to care for any patient, not only the elderly and the poor.

It’s unclear whether the proposed savings will prove decisive in pushing a health care overhaul through Congress. There’s no detail on how the savings pledge would be enforced. And, critically, the promised savings in private health care costs would accrue to society as a whole, not just the federal government. That’s a crucial distinction because specific federal savings are needed to help pay for the cost of expanding coverage.

Costs have emerged as the most serious obstacle to Obama’s plan. The estimated federal costs range from $1.2 trillion to $1.5 trillion over 10 years, and so far Obama has only spelled out how to get about half of that.

By Philip Elliott, Ricardo Alonso-Zaldivar

WASHINGTON – The health insurance industry offered Tuesday to end its practice of charging higher premiums to women.

It was the latest concession from health insurers as Congress works to overhaul the nation’s $2.5 trillion health care system.

Insurers are trying to head off creation of a government insurance plan that would compete with them — something many Democrats favor but which private insurers say would drive them out of business.

Instead health insurers have offered to submit to a series of restrictions they contend would add up to a fairer marketplace and cut into the ranks of the 50 million uninsured.

The latest came Tuesday as the head of the leading private insurance group told senators that women should no longer be charged more than men in the individual market, as long as all Americans are required to get insurance coverage. Health care costs for women tend to be higher during childbearing years.

“We don’t believe gender should be a subject of rating,” Karen Ignagni, president of America’s Health Insurance Plans, said as the Senate Finance Committee convened a roundtable on covering the uninsured.

“We are ready to be accountable to those rules,” she said.

“I do not accept the premise that to keep the plans honest you need a public program.”

Insurers last year offered to end the practice of denying coverage to sick people, and earlier this year they went still farther by offering to stop charging sick people more.

They still haven’t done enough to convince many Democrats.

“The bottom line is you need somebody who is not a private insurance company to be in the mix and there are many of us who feel very strongly about that,” Sen. Charles Schumer, D-N.Y., told Ignagni and a panel of witnesses from the insurance industry, labor unions, business groups and others. “It would be giving all of you in the insurance industry an unfair advantage not to have a public plan.”

For some Democrats, particularly liberals in the House, support for a public plan is already a compromise because their real preference is for a “single-payer” plan — an entirely government-run program like some European countries have.

Underscoring the strong feelings about that, Tuesday’s meeting began with Capitol Police ejecting protesters who interrupted senators by shouting in favor of a single-payer plan. Finance Committee Chairman Max Baucus, D-Mont., has said that’s not on the table.

“We want a seat at the table,” shouted one protester.

“We want police,” Baucus responded.

Capitol Police removed eight people.

Baucus and many others, including President Barack Obama, say single-payer is not practical or politically feasible. They want to build on the current setup of employer-based care, which is how most Americans under age 65 get their health care.

Associated Press writer Erica Werner contributed to this report.

WASHINGTON – Kansas Gov. Kathleen Sebelius, President Barack Obama’s choice for health secretary, told senators Thursday that she wants to transform Medicare and Medicaid with a focus on prevention and primary care.

It’s imperative to steer resources “toward wellness rather than sickness,” Sebelius said in prepared testimony for the Senate Finance Committee, where senators were expected to ask more questions about her policies and politics than about $7,000 worth of mistakes she made on her taxes.

Overseeing the giant government-run insurance programs for the elderly, disabled and poor would be a major responsibility, and Sebelius said improvements are needed.

Sebelius said that, if confirmed, she hopes to use technology to better align Medicare and Medicaid payments with quality care. The payments to health care providers are often criticized as alternately inadequate or excessive.

There’s a sense that the Senate needs to act quickly on Sebelius’ nomination so lawmakers can push ahead with the ambitious schedule they have set for health reform legislation this year. The Finance Committee votes on whether to send the nomination to the full Senate.

Sebelius told senators that “health reform would be my mission,” a pledge she also made earlier this week to the Senate Health, Education, Labor and Pensions Committee.

Sebelius, 60, would run a department of 67,000 employees and a budget of more than $700 billion. Medicare, Medicaid, the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health would be in her purview.

In her appearance Tuesday before the other Senate committee, Sebelius stuck closely to the administration’s line. She supports giving all Americans the option of joining a government-sponsored health care plan, something the insurance industry and most Republicans strongly oppose. She said she would prefer health care legislation that both parties can support, but she wouldn’t rule out using a parliamentary strategy to pass a bill with Democrats only.

For the most part, the hearing was a low-key affair.

That evening, the administration disclosed that Sebelius had filed amended tax returns for three years. An accountant she’d hired found “unintentional errors” and Sebelius and her husband, Gary, a federal magistrate judge in Kansas, paid a total of $7,040 in back taxes and $878 in interest to amend returns from 2005-07.

Sebelius said the tax mistakes involved charitable contributions, the sale of a home and business expenses. She said she filed the amended returns as soon as the errors were discovered.

Sen. Charles Grassley of Iowa, the top Republican on the Finance Committee, told reporters Wednesday he felt Sebelius made “a good-faith effort” to pay her taxes correctly in the first place and the errors should not count against her.

Grassley suggested he’s more concerned with Sebelius’ views on Medicare and Medicaid, and how her support for abortion rights might influence policies at the Health and Human Services Department.

Several Obama administration nominees have run into tax troubles, notably the president’s first pick for HHS secretary, former Senate Democratic leader Tom Daschle. He withdrew from consideration while apologizing for failing to pay $140,000 in taxes and interest.

Finance Committee Chairman Max Baucus, D-Mont., issued a statement supporting Sebelius.

Associated Press writer Erica Werner contributed to this report.

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ON THE WEB

Health and Human Services Department: www.hhs.gov/

WASHINGTON – The nation can’t afford to wait for the economy to recover before tackling out-of-control medical costs, President Barack Obama is telling some of the most powerful players in the health care reform debate.

“If we want to create jobs and rebuild our economy, then we must address the crushing cost of health care this year, in this administration,” Obama says in remarks prepared for delivery to a White House forum on the issue Thursday. Excerpts were released by the White House.

“Making investments in reform now, investments that will dramatically lower costs, won’t add to our budget deficits in the long term — rather, it is one of the best ways to reduce them,” Obama said.

Obama has invited to the forum more than 120 people who hold a wide range of views on how to fix the world’s costliest health care system, one that still leaves an estimated 48 million people uninsured. Doctors, patients, business owners, insurers and drug industry representatives were to gather in hopes of building support for big changes. Republicans are invited, and they’re expected to speak up.

“The president wants to engage with Congress in a transparent and bipartisan fashion,” said Melody Barnes, who heads White House domestic policy.

Among the invitees are some who helped kill the Clinton administration’s health care overhaul in the 1990s. Everyone is supposed to be on his best behavior, but will that last?

“This is a different day, ” said Chip Kahn, a hospital lobbyist who opposed President Bill Clinton’s plan and was to attend Thursday’s gathering. “I think among most of the stakeholders, everyone wants to see this work. There is a tremendous feeling that it’s time.”

Now president of the Federation of American Hospitals, Kahn worked for the insurance industry in the Clinton years.

The difference this time, Obama argues, is that health care costs have become unsustainable, particularly in a sinking economy. The U.S. spends $2.4 trillion a year on health care, yet an estimated 48 million Americans lack coverage. Obama’s goal is health coverage for everyone.

Barnes said Obama is determined to pass health care legislation this year, and while he wants it to be bipartisan, he will not be deterred by obstruction from interest groups or ideological partisans.

“The president will make clear this has to be a bipartisan effort,” Barnes said. “As for people who are there to set up hurdles, from his perspective that isn’t tolerable. It’s crucial to families, businesses and our nation’s budget that we address the issue of exploding costs.”

Senate Republican leader Mitch McConnell of Kentucky released a letter to Obama, saying his party is ready to work with the administration on health care, but warning that reforms should not lead to a government-run system, and must balance coverage expansions with curbs on costs.

Barnes said that Obama “walks into this conversation being pragmatic, being open. He knows that the American people are hurting” and are seeing their premiums rise.

But Barnes, interviewed Thursday on NBC’s”Today” show, also said that “we have to be transparent about it. … We will also hear the voices of the American people … to make sure that health care reform gets before the president for his signature before the end of the year.”

In support of Obama’s efforts, liberal activists have mobilized to keep the pressure on Congress to pass legislation this year.

“It would be a mistake to dismiss this as a gabfest,” Drew Altman, president of the Kaiser Family Foundation, said about Obama’s meeting. “It’s an effort to keep the momentum going. The details are not going to be worked in two or three hours at a White House summit.”

There were concerns Wednesday about some of those details.

Senate Finance Committee Chairman Max Baucus, D-Mont., who will play a leading role in writing health care legislation, raised questions about the proposed $634 billion “down payment” for expanded coverage that Obama included in the 2010 budget he released last week.

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ON THE WEB

White House: www.whitehouse.gov/agenda/health—care/

President Barack Obama wants to rescind a Bush administration rule that strengthened job protections for doctors and nurses who refuse for moral reasons to perform abortions.

A Health and Human Services official said Friday the administration will publish notice of its intentions early next week, opening a 30-day comment period for advocates, medical groups and the public. The official spoke on condition of anonymity because the notice has not been completed.

The Bush administration instituted the rule in its last days, and it was quickly challenged in federal court by several states and medical organizations. As a candidate, President Barack Obama criticized the regulation and campaign aides promised that if elected, he would review it.

The news that he was doing so drew praise from abortion-rights supporters and condemnation from groups opposed to abortion.

“It would be a horrible move. These regulations were a long time coming,” said Tom McClusky, a vice president at Family Research Council. “What they seek to do is protect patients, nurses, doctors and other health care professionals from being forced to violate their consciences.”

McClusky and other abortion opponents said the Bush regulation clarified federal policies and raised awareness about the rights of medical providers to follow their consciences. But abortion rights advocates said it was vague and overly broad, and could reduce access to other services — allowing a drug store clerk to refuse to sell birth control pills, for example.

“I think it’s a wonderful step,” Rep. Diana DeGette, D-Colo., who co-chairs the Congressional Pro-choice Caucus and has introduced legislation to overturn the regulation, said of Obama’s move.

“That rule was actually a poorly drafted last-minute attempt to, I think, restrict health care access and I think it would have had far-reaching and unintended consequences.”

Federal law has long forbidden discrimination against health care professionals who refuse to perform abortions or provide referrals for them on religious or moral grounds. The Obama administration supports those laws, said the HHS official.

The Bush administration’s rule adds a requirement that institutions that get federal money certify their compliance with laws protecting the rights of moral objectors. It was intended to block the flow of federal funds to hospitals and other institutions that ignore those rights.

But the Obama administration was concerned that the Bush regulation could also be used to refuse birth control, family planning services and counseling for vaccines and transfusions.

“The administration supports a tightly written conscience clause,” said the HHS official. “While we are concerned about the Bush rule, we also understand there might be a need to clarify existing laws.”

The administration will review comments from the public before making a final decision. Options range from repealing the regulation to writing a new one with a narrower scope.

The administration’s move was first reported by the Los Angeles Times.

WASHINGTON – The blockbuster asthma drug Advair does not appear to have an increased risk of serious respiratory complications seen with similar new medicines, federal health officials said Friday.

But a less widely used medication, Serevent, had a significantly higher rate of complications when compared to older treatments, the Food and Drug Administration said. Both medicines are made by the same company, GlaxoSmithKline.

The FDA is concerned about asthma drugs known as LABAs, which already carry warnings. The long-acting medications relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.

But LABAs, for reasons that are still being debated, can increase risks of death and respiratory complications in some patients. The risk is lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways.

Advair combines both kinds of medicine in one inhaler. But Serevent is a LABA-only product, although medical treatment guidelines call for patients taking the medication to also use a steroid.

The FDA analyzed reams of clinical data on four drugs: Advair, Foradil, Serevent and Symbicort. All four already carry the FDA’s strongest warning, but the findings could lead to more specific instructions for patients and greater restrictions on some of the medications. The agency has called a special two-day meeting of outside advisers next week to discuss the data and make recommendations.

GlaxoSmithKline said the analysis underscored its confidence in Advair, its best-selling medication, with U.S. sales of $2.9 billion in the first nine months of this year. But a spokeswoman declined to comment on whether the data could lead to a withdrawal of Serevent, which had U.S. sales of $97 million in the same period. About 4 million U.S. patients now use the Glaxo medications.

Asthma is a chronic respiratory illness that leaves patients short of breath, wheezing, and can sometimes send them to the emergency room because of difficulty breathing. Some 22 million people in the United States suffer from asthma, and children account for nearly one out of every three patients. Nearly 3,600 people still die from asthma in this country each year, although symptoms can be controlled with medication to prevent the most serious complications.

“We don’t believe LABAs are inherently unsafe or toxic,” said Dr. Kate Knobil, a Glaxo executive who oversees asthma drugs. “What we do know is that poorly treated asthma is what is causing the increase in asthma-related complications. If you don’t also treat the inflammation inside the airways (with a steroid) patients are going to have worse outcomes.”

For patients, the advantage of using LABAs is that they have to take medications less often, usually once every 12 hours. But some doctors believe that the convenience and relief LABAs offer can mask problems that develop slowly. Deep inside airways in the lungs, passages can become inflamed or clogged with mucus unless patients are also taking a steroid. At some point, that congestion can become acute, leaving patients to gasp for air.

The FDA analysis compared patients taking a LABA drug to those using steroids alone to control their asthma. It compared the number of deaths, hospitalizations and cases where a patient had to have a breathing tube inserted. The agency analyzed findings from 110 clinical trials involving nearly 61,000 patients.

The analysis found 20 asthma-related deaths, of which 16 were in patients taking a LABA drug. All of those deaths were among patients treated with Serevent.

In terms of overall risk of complications, Foradil, Serevent and Symbicort had a higher rate when compared to treatment with steroids. But the FDA said the difference was statistically significant only in the case of Serevent.

WASHINGTON – BPA — a chemical used in food containers — is so widespread that most people have traces of it in their bodies.

But health officials can’t decide if that’s a problem, or something we all can live with.

Bisphenol A is useful for hardening plastics to make all sorts of consumer products, from CDs to baby bottles. And the canning industry uses it for coatings that prevent leaks and bacterial contamination in metal food containers.

Some scientists are concerned that BPA could be harmful, since it mimics some of the effects of a powerful hormone, estrogen. Infants may be particularly vulnerable because their bodies are developing and cannot eliminate the chemical as quickly.

Earlier this year, the Food and Drug Administration issued a scientific assessment that BPA is safe and asked independent scientists to review its conclusion. That report — made public Tuesday — found that the FDA’s science was badly flawed. The FDA did not consider all the evidence and its margin of safety for human exposure to BPA could be off by a factor of ten times or more, the outside scientists said.

While the experts sort out the issue, what are the options for worried consumers? Here are some questions and answers:

Q: It sounds like BPA is everywhere, how can people avoid it?

A: “Get to know your plastics,” says Urvashi Rangan, a senior scientist with Consumers Union, which publishes Consumer Reports. Avoid polycarbonate plastic containers, those imprinted with the recycling number “7″ and the letters “PC.” Don’t microwave foods in these containers. Don’t use polycarbonate plastic baby bottles. Consider powdered infant formula instead of liquid formula in cans. Cut down on canned foods.

“If you the consumer want to take matters into your own hands while the science is being sorted out here, those are the things you can do that will directly reduce your level of exposure to BPA,” said Rangan.

One thing mothers should not do is stop giving their infants proper nutrition because of fears about BPA, says acting Surgeon General Steven Galson. “While the best source of nutrition for babies is the mother’s breast milk, infant formula remains the recommended alternative when breast milk is not an option,” he said.

Q: Wait a minute, aren’t some people overreacting here? Has anybody died from BPA?

A: No direct cause-and-effect relationship has been established to show that exposure to small amounts of BPA harms people.

But many scientific studies have raised that possibility, and some government scientists believe it should not be dismissed lightly. Chemical exposures that cause harm over a long time are hard to detect.

The National Toxicology Program conducted its own BPA assessment earlier this year, and differed with the FDA. The toxicology program found “some concern” for BPA effects on the brain, behavior and prostate gland in fetuses, infants and children at current exposure levels. “Some concern” is right in the middle of the toxicologists’ five-level scale for ranking the possible harmful effects of chemicals.

The independent panel that reviewed the FDA’s assessment said the agency needs to go back and take a second look at several studies it earlier dismissed.

Q: What’s going to happen now?

A: On Friday, the FDA’s Science Board will meet to discuss the controversy in public. It was a subcommittee of the Science Board that issued the report criticizing FDA’s safety analysis. But FDA officials say it could take two to five years to complete additional research and reach a final conclusion.

If scientific evidence against BPA mounts and U.S. regulators don’t act, Congress may try to restrict some uses for the chemical.

“If FDA continues to dismiss independent scientific evaluations of BPA, correcting the issue legislatively is an option,” said Rep. Rosa DeLauro, D-Conn., chairwoman of a committee with jurisdiction over the FDA budget.

Q: What would be the downside of just banning BPA altogether?

A: The canning industry thinks there would be unintended consequences. The chemical is used to make epoxy resins that coat and seal the inside of cans. That prevents leaks and keeps bacteria from contaminating the foods inside.

“Although we are looking for alternatives, they are not readily available, and there is no ‘drop-in’ replacement for these uses,” said John Rost, chairman of the North American Metal Packaging Alliance, a trade group. “Quick changes that have not been evaluated could impact the real safety issue: food poisoning.”

Short of a ban on all BPA in food containers, Canada has banned it in baby bottles as a precaution.

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On the Web

Scientific advisers report to the FDA: http://tinyurl.com/5mfmm7

WASHINGTON – Parents wondering whether to give cold and cough medicines to their kids may not get help from the government anytime soon.

Food and Drug Administration officials at a public hearing Thursday said they need to gather more data on whether over-the-counter remedies are safe and effective for children ages 2-6. The FDA is also worried that a ban — as sought by leading pediatricians’ groups — might only drive parents to give adult medicines to their youngsters.

“That is a concern for us,” said Dr. John Jenkins, who heads the FDA’s Office of New Drugs. “We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation.”

With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never scientifically established, critics say, and problems with the drugs send thousands of kids to the emergency room every year.

“When a treatment is ineffective, its risks — unless zero — always exceed its benefits,” Dr. Michael Shannon of Children’s Hospital in Boston told the FDA panel.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers — and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The industry says OTC medicines have been used for decades in treating kids’ colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said children older than 2 could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

“The data clearly show a majority of adverse events are direct result of misuse of our products,” said Linda Suydam, who heads the industry group.

Baltimore health commissioner Dr. Joshua Sharfstein sought to reassure FDA officials worried about unintended consequences if the government moves to restrict the medications and parents start dispensing adult drugs to their preschoolers. Sharfstein said the state of Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

“The feared increases in poisonings simply did not happen,” said Sharfstein. “In fact, the opposite occurred.”

WASHINGTON – If John McCain is elected and goes on to win a second term, there’s as much as a one-in-four chance America could see its first woman president – Sarah Palin. It’s actuarial math.

The odds highly favor either McCain or Barack Obama completing a first term in good health. After that, McCain’s odds still are still fairly solid, but his chances of dying or being in poor health go up faster than Obama’s, mainly because of his age.

An Atlanta actuarial company specializing in individualized estimates of life and health expectancy has run the numbers for McCain, 72, and Obama, 47. The firm, Bragg Associates, calculated the odds of the candidates dying in office, adjusted for their known health problems.

McCain would be the oldest president to begin a first term in office. By the end of a second term, Jan. 20, 2017, he would have a 24.44 percent chance of dying, compared with 5.76 percent for Obama, the firm estimates.

“Can either candidate expect to serve two terms in a healthy state? The answer is yes,” says James C. Brooks, Jr., an actuary with the firm. “They’re both in outstanding health for people of their age.”

Illness is another issue.

Because chances of developing a serious ailment are higher for any person than are the chances of dying, Bragg used the candidates’ medical information to estimate how many years of good health might be in store for each. An illness could force a president to step down.

The firm estimates that McCain has a health expectancy of 8.4 years, while Obama can expect another 21.9 years of good health. The calculations are from January 2009, covering two terms in office for either candidate. McCain, if he’s like others in his age group, would have a cushion of about five months.

But no one really knows. Actuaries such as Brooks make statistical calculations for insurance companies, based on numbers culled from large databases. No matter how sophisticated, they can’t predict anyone’s future.

“There a randomness to it that we don’t know,” said Ron Gebhardtsbauer, who directs the actuarial science program at Penn State’s Smeal College of Business. For example, he said, “if McCain is president, he’ll get the best health care in the world. I can’t crank that into any of my numbers.”

In the spring, the Obama campaign released a letter from the candidate’s doctor declaring him to be in excellent health. He had very good cholesterol levels, his EKG was normal, his pulse was 60 beats per minute, and his blood pressure was an outstanding 90 over 60. Obama also exercises regularly and has quit smoking since the spring, with the help of nicotine gum.

But Obama has a family history of cancer. His mother died of ovarian cancer and his maternal grandfather died of prostate cancer. Obama’s PSA screening test for prostate cancer showed no sign of abnormalities.

For the Republican, Brooks took into account a history of skin cancer, degenerative arthritis from his Vietnam war injuries, moderately high cholesterol, mild vertigo and that McCain is a former smoker who quit in 1980.

Eight years of McCain’s medical records show that he is cancer-free, has a strong heart and is generally in good health. As a three-time melanoma survivor, his biggest health worry is a recurrence of that cancer.

McCain maintains a healthful weight and blood pressure, and takes medication for his cholesterol.

WASHINGTON – If John McCain is elected and goes on to win a second term, there’s as much as a one-in-four chance America could see its first woman president — Sarah Palin.

It’s actuarial math.

The odds highly favor either McCain or Barack Obama completing a first term in good health. After that, McCain’s odds are still fairly solid, but his chances of dying or being in poor health go up faster than Obama’s, mainly because of his age.

An Atlanta actuarial company specializing in individualized estimates of life and health expectancy has run the numbers for McCain, 72, and Obama, 47. The firm, Bragg Associates, calculated the odds of the candidates dying in office, adjusted for their known health problems.

McCain would be the oldest president to begin a first term in office. By the end of a second term, Jan. 20, 2017, he would have a 24.44 percent chance of dying, compared with 5.76 percent for Obama, the firm estimates.

“Can either candidate expect to serve two terms in a healthy state? The answer is yes,” says James C. Brooks, Jr., an actuary with the firm. “They’re both in outstanding health for people of their age.”

Illness is another issue.

Because chances of developing a serious ailment are higher for any person than are the chances of dying, Bragg used the candidates’ medical information to estimate how many years of good health might be in store for each. After all, a debilitating illness could force a president to step down.

The firm estimates that McCain has a health expectancy of 8.4 years, while Obama can expect another 21.9 years of good health. The calculations are from January 2009, covering two terms in office for either candidate. McCain, if he’s like others in his age group, would have a cushion of just about five months.

But no one really knows. Actuaries like Brooks make statistical calculations for insurance companies, based on numbers culled from large databases. No matter how sophisticated, they can’t predict anyone’s future.

“There a randomness to it that we don’t know,” said Ron Gebhardtsbauer, who directs the actuarial science program at Penn State’s Smeal College of Business.

For example, he said, “if McCain is president, he’ll get the best health care in the world. I can’t crank that into any of my numbers.”

Health expectancy calculations, although relatively new, are becoming increasingly important as people buy long-term-care insurance.

“We’ve done thousands of these health expectancy calculations for financial planners,” said Brooks. “People, especially those with high net worth, are concerned more about the risk of living too long than about what happens if they die prematurely. What if they need long-term care?”

The firm’s estimates for McCain and Obama relied on medical information disclosed by the candidates. Bragg Associates has no partisan agenda, said Brooks: “We don’t have a dog in this hunt.”

He classified the Democrat as a smoker with minor upper respiratory problems, probably linked to his smoking. Obama announced in February that he was trying to quit smoking again, with the aid of nicotine gum.

“We don’t consider you a nonsmoker until you stay quit for 12 months,” said Brooks.

In the spring, the Obama campaign released a letter from the candidate’s doctor declaring him to be in excellent health. He had very good cholesterol levels, his EKG was normal, his pulse was 60 beats per minute, and his blood pressure was an outstanding 90 over 60. Obama also exercises regularly.

But Obama has a family history of cancer. His mother died of ovarian cancer and his maternal grandfather died of prostate cancer. Obama’s PSA screening test for prostate cancer showed no sign of abnormalities.

For the Republican, Brooks took into account a history of skin cancer, degenerative arthritis from his Vietnam war injuries, moderately high cholesterol, mild vertigo and that McCain is a former smoker who quit in 1980.

McCain allowed reporters to review eight years of medical records, more than 1,000 pages. They show that he is cancer-free, has a strong heart and is generally in good health. As a three-time melanoma survivor, his biggest health worry is a recurrence of that cancer. But he is closely watched by his dermatologist, and any future melanoma should be caught in time to be treated successfully. McCain maintains a healthy weight and blood pressure, and takes medication for his cholesterol.

To underscore his chances of long life, he’s campaigned with his mother, 96 and going strong.

Vice presidential candidates Joe Biden and Sarah Palin have not released their medical records, although Biden has promised to. Biden, 65, had surgery 20 years ago to repair a life-threatening brain aneurysm. He was out of the Senate for seven months while he recuperated but says he’s fine now. Palin, 44, a mother of five, gave birth earlier this year to a son, Trig, who was born with Down syndrome.

WASHINGTON – Super Chicken strutted a step closer to the dinner table Thursday.

The government said it will start considering proposals to sell genetically engineered animals as food, a move that could lead to faster growing fish, cattle that can resist mad cow disease, or perhaps heart-healthier eggs laid by a new breed of chicken.

The Food and Drug Administration issued a proposed legal framework for how it would resolve such questions as whether the altered animals are safe for human consumption and pose no serious environmental risks. FDA officials said they are focusing on animals that will be used as food, or to produce medications that would then be consumed by people or other animals. The agency is not interested in reviewing genetically engineered mice already widely used in lab experiments.

“Genetic engineering of animals is here and has been here for some time, ” said Larisa Rudenko, a science policy adviser with the FDA’s veterinary medicine center. “We intend to provide a rigorous, risk-based regulatory path for developers to follow to help ensure public health and the health of animals.”

Reaction from consumer groups was mixed. On one hand, they welcomed the government’s decision to regulate genetically altered animals. But they cautioned that many crucial details remain to be spelled out. For example, the FDA does not plan to require in all cases that genetically engineered meat, poultry and fish be labeled as such for consumers.

“They are talking about pigs that are going to have mouse genes in them, and this is not going to be labeled?” said Jean Halloran, director of food policy for Consumers Union. “We are close to speechless on this.”

Nonetheless, Gregory Jaffe, who heads the biotechnology project at the Center for Science in the Public Interest called the FDA action a “good first step.”

“This is the first time the federal government is announcing a comprehensive regulatory system that addresses the concerns from these animals,” said Jaffe. “But it may not have addressed all the environmental concerns.”

Genetically engineered animals are not clones, which the FDA has already said are safe to eat. While clones are exact copies of an animal, genetically engineered animals are manipulated by scientists to bring about a change in their characteristics. In years past, this was done by breeding animals with desirable traits. But now the changes can be made directly in the lab.

Genetically engineered animals are created when scientists insert a gene from one species of animal into the DNA of another animal to reprogam some of its characteristics. For example, fish could be made to grow faster, or pigs might be re-engineered to produce less waste. Animals can also be engineered to produce substances in their milk and blood that can later be used for human drugs.

Genetic engineering is already widely used in agriculture to produce higher-yielding or disease-resistant crops. But it’s unclear how consumers will react to altered animals, even if they come with a government seal of approval.

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On the net

FDA: http://tinyurl.com/4pv795

WASHINGTON – When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot.

When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written.

The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.

Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects.

What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.

Drug companies are forbidden to promote medications for uses that have not been validated by the Food and Drug Administration on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.

The situation has raised concerns for Sen. Charles Grassley, R-Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.

The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

The FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Grassley said in a statement. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

Instead, the job is handled by the office that oversees all drug advertising, including television commercials and magazine ads. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements.

The office tries to set priorities, by focusing first on misrepresentations that could have a damaging impact on human health. But the report found that the FDA lacks a system for tracking all the material it receives.

From 2003-2007, the office issued 42 notices of possible violations, which usually prompted the drug maker to drop its promotional claims. The cases included a drug approved for breast cancer and rectal cancer that also was being promoted for treatment of gastric, cervical, uterine, ovarian, renal, bladder, thyroid and liver cancers.

An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify – approved to treat schizophrenia and bipolar disorder – for treatment of dementia-related psychosis and for use in treating children.