Lauran Neergaard

Panel debates bioterrorism protection for children

WASHINGTON (AP) — The Obama administration is asking a presidential commission to help decide an ethical quandary: Should the anthrax vaccine and other treatments being stockpiled in case of a bioterror attack be tested in children?

“We can’t just assume that what we have for adults works for children,” Health and Human Services Secretary Kathleen Sebelius told the panel Thursday.

Controversy over whether to open pediatric studies of the anthrax vaccine led Sebelius to ask the Presidential Commission for the Study of Bioethical Issues to tackle the question. The commission began its deliberations Thursday; recommendations are expected by year’s end.

Sebelius made clear that the question is far broader than anthrax.

“There are serious ethical issues around the development of medical countermeasures for children” in general, she said.

Developing protections for youngsters is critically important, but in a way that puts “our children’s safety as our highest priority,” Sebelius said.

A decade after the anthrax attacks in the United States, the government has a multibillion-dollar stockpile of tools to fight back against some of the threats that worry defense experts. Notably missing is information on how to treat children in various emergencies — whether the same drugs their parents will get will work or be safe for them, and even what dose youngsters should receive.

Thus the debate on whether to conduct studies now, before millions of children might need to try an untested product in an emergency. Even if those studies were offered, there’s no way to know how many parents would agree to enroll their children.

Testing medications in children always requires extra safeguards. It’s fairly straightforward to test a potential treatment for cancer or some other childhood disease. But if a child won’t receive a direct medical benefit, federal regulations say studies are allowed only if testing adults can’t provide the answers and if the risks to participating children are minimal.

Anyone exposed during an anthrax attack would require 60 days of powerful antibiotics, or antibiotics until a vaccine could kick in. Last fall, the National Biodefense Safety Board, which advises the government, recommended child testing of the anthrax vaccine, but only if outside ethical experts agreed such studies could be done appropriately.

The shots have been widely used in adults, including U.S. troops, and are considered safe for them, said the board chairman, Dr. John Parker, a retired Army major general who has been vaccinated.

Side effects include shot-site soreness and redness, muscle aches, fatigue and headache. Rare but serious allergic reactions have been reported.

The bioethics commission wrestled with how to define “minimal risk” when there is no imminent emergency, and the chairwoman, Dr. Amy Gutmann, wondered whether people urging such testing would enroll their own children.

Parker responded that he’s discussed that with first-responders and some in the military. “There are groups out there that would want their families protected as much as they are protected as they do their job, in fear of bringing something home,” he said.

Other doctors told the panel that 60 days of antibiotics can cause bad side effects for children, including diarrhea, other infections and dangerous allergic reactions. Plus there’s concern that many people wouldn’t take the full course, Parker said.

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Online:

Presidential Commission for the Study of Bioethical Issues: http://www.bioethics.gov

National Biodefense Safety Board: http://tinyurl.com/7c79bbd

More doctors are ditching the old prescription pad

WASHINGTON (AP) — Doctors increasingly are ditching the prescription pad: More than a third of the nation’s prescriptions now are electronic, according to the latest count.

The government has been pushing doctors to e-prescribe, in part because it can be safer for patients. This year, holdouts will start to see cuts in their Medicare payments.

Thursday’s report from Surescripts, the largest network for paperless prescribing, shows more doctors are signing up fast.

At the end of 2011, 36 percent of all prescriptions were electronic — the doctor wrote it by computer and sent it directly to the pharmacy with the push of a button, the report found. That’s up from 22 percent of prescriptions that were paperless a year earlier.

For patients, the convenience is obvious — shorter drugstore waits. Pharmacists like not having to squint at the doctors’ messy handwriting. And computerized ordering systems allow doctors to easily check that a new drug won’t interact badly with one the patient’s already taking.

New research by Surescripts and some pharmacies and pharmacy benefit managers uncovered another benefit: More patients pick up a new prescription when it’s filed electronically.

Doctors know that too often, patients never fill some of their prescriptions. Maybe they lose the slip of paper, or forget to drop it off, or decide they can’t afford it.

The new research examined 40 million prescriptions, a mix of paper, phoned, faxed or electronic ones — and found a 10 percent increase in patients who fill a prescription when it’s e-prescribed.

The main reasons: Drugstores receive every paperless prescription, and they can call patients to come in and pick up their waiting medicine, said Surescripts’ researcher Seth Joseph. Also, e-prescribing programs automatically show the doctor which brands are covered by the patient’s insurance with the lowest out-of-pocket cost.

For several years, the government has run incentive programs to encourage doctors to adopt e-prescribing and other computerized health records, offering payments to help defray the costs of adopting the systems. Now Medicare is beginning to cut some reimbursements to certain doctors who don’t e-prescribe at least a little bit.

Surescripts’ report counted 390,000 doctors who were e-prescribing at least some of the time in 2011, and its records show an additional 10,000 had begun by the end of February. That translates into just over half of office-based physicians, a big jump since 2008, when only about 12 percent of doctors were e-prescribing.

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Scientists hunt ways to stall Alzheimer’s earlier

WASHINGTON (AP) — Look for a fundamental shift in how scientists hunt ways to ward off the devastation of Alzheimer’s disease — by testing possible therapies in people who don’t yet show many symptoms, before too much of the brain is destroyed.

The most ambitious attempt: An international study announced Tuesday will track whether an experimental drug can stall the disease in people who appear healthy but are genetically destined to get a type of Alzheimer’s that runs in the family. If so, it would be exciting evidence that maybe regular Alzheimer’s is preventable too.

A second study will test whether a nasal spray that sends insulin to the brain helps people with very early memory problems, based on separate research linking diabetes to an increased risk of Alzheimer’s.

The new focus emerges as the Obama administration adopts the first national strategy to fight the worsening Alzheimer’s epidemic — a plan that sets the clock ticking toward finally having effective treatments by 2025.

“We are at an exceptional moment,” with more important discoveries about Alzheimer’s in the last few months than in recent years, Dr. Francis Collins, director of the National Institutes of Health, declared Tuesday.

But a meeting of the world’s top Alzheimer’s scientists this week made clear that meeting the 2025 deadline will require developing a mix of treatments to attack the different ways that Alzheimer’s damages the brain — much like it can take a cocktail of drugs to treat high blood pressure or the AIDS virus.

Perhaps more importantly, it will require testing possible drugs before full-blown Alzheimer’s sets in, when it may be too late to do much good. After all, Alzheimer’s starts ravaging the brain at least a decade before memory problems appear. And doctors don’t wait until the worst symptoms appear before treating heart disease, cancer or diabetes, noted Dr. Reisa Sperling of Harvard Medical School.

“Once the train leaves the station of degeneration, it might be too late to stop it,” Sperling said. “We need to define the critical window for intervention.”

Future therapy is far from the only goal of the first National Alzheimer’s Plan. It’s a two-pronged approach, promising to provide better and support for overwhelmed families along the way.

“A lot more needs to be done and it needs to be done right now, because people with Alzheimer’s disease and their loved ones and caregivers need help right now,” Health and Human Services Secretary Kathleen Sebelius said in announcing the plan.

Among the first steps: A new website — www.alzheimers.gov — that Sebelius called a one-stop shop for families offers easy-to-understand information about dementia and links to resources in their own communities. The government will offer free training to doctors and other health providers on how to spot the early signs of Alzheimer’s and care for those patients. This summer, a campaign will begin to improve public awareness of Alzheimer’s, important in reducing the stigma that helps fuel late diagnosis and the isolation that so many affected families feel.

Patient advocates applauded the move, and country music legend Glen Campbell, who has Alzheimer’s, appeared on Capitol Hill to urge more research.

Alzheimer’s “has been in the shadows for far too long,” said Eric J. Hall of the Alzheimer’s Foundation of America. The plan “provides solid stepping stones toward substantial change.”

Already, 5.4 million Americans have Alzheimer’s or related dementias. Barring a research breakthrough, those numbers will jump by 2050, when up to 16 million Americans are projected to have Alzheimer’s.

There is no cure, and the five medications available today only temporarily ease some symptoms. Finding better ones has been a disappointing slog: Over the last decade, 10 drugs that initially seemed promising failed in late-stage testing, Sperling said.

Moreover, scientists still don’t know exactly what causes Alzheimer’s. The chief suspects are a sticky gunk called beta-amyloid, which makes up the disease’s hallmark brain plaques, and tangles of a protein named tau that clogs dying brain cells. One theory: Amyloid may kick off the disease while tau speeds up the brain destruction.

Previous studies of anti-amyloid drugs have failed, but that new international study will test a different one, in a different way: About 300 people from a huge extended family in Colombia who share a gene mutation that triggers Alzheimer’s in their 40s will test an experimental drug, Genentech’s crenezumab, to see if it delays onset of symptoms. The study also will include some Americans who inherit Alzheimer’s causing gene mutations.

Meanwhile, there are brain-protective steps that anyone can take that just might help, Dr. Carl Cotman of the University of California, Irvine, told Tuesday’s NIH meeting.

“It’s just a well-kept secret,” he said.

The advice:

–Your brain is like a muscle so exercise it. Intellectual and social stimulation help build what’s called “cognitive reserve,” the ability to withstand declines from aging and dementia.

—Getting physical is crucial also. Clogged arteries slow blood flow to the brain, and people who are less active in middle age are at increased risk of Alzheimer’s when they’re older. “Any time your heart is healthier, your brain is healthier,” said Dr. Elizabeth Head of the University of Kentucky.

–Don’t forget diet, she added. The same foods that are heart-healthy are brain-healthy, such as the omega-3 fatty acids found in fish.

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Lauran Neergaard covers health and medicine for The Associated Press in Washington.

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Clock ticking with new plan to fight Alzheimer’s

WASHINGTON (AP) — The clock is ticking: The first National Alzheimer’s Plan sets a deadline of 2025 to finally find effective ways to treat, or at least stall, the mind-destroying disease.

The Obama administration finalizes the landmark national strategy on Tuesday, laying out numerous steps the government and private partners can take over the coming years to fight what is poised to become a defining disease of the rapidly aging population.

But some of the work is beginning right away.

Starting Tuesday, embattled families and caregivers can check a new one-stop website — www.alzheimers.gov — for easy-to-understand information about dementia and where to get help in their own communities.

The National Institutes of Health is funding some major new studies of possible therapies, including a form of insulin that’s squirted into the nose.

“These actions are the cornerstones of an historic effort to fight Alzheimer’s disease,” Health and Human Services Secretary Kathleen Sebelius said in a statement. She was announcing the steps Tuesday at the NIH.

The first National Alzheimer’s Plan comes as the world’s top Alzheimer’s scientists are gathered at the NIH this week to debate what research needs to be given priority in order to meet that ambitious 2025 deadline. They said it may be time to start testing potential therapies differently, before people have full-blown Alzheimer’s symptoms, when it may be too late to help.

“There’s a sense of optimism” thanks to some new discoveries, Dr. Francis Collins, director of the National Institutes of Health, told scientists at the Alzheimer’s Research Summit on Monday.

But, “we need to figure out exactly where is the best window of opportunity” to battle back Alzheimer’s, Collins said. He noted that cardiologists don’t test cholesterol-lowering drugs on people already near death from heart failure.

It’s clear that Alzheimer’s quietly brews in the brain, killing off cells, for 10 years or more before symptoms appear, Dr. Reisa Sperling of Harvard Medical School told the meeting. She called that time period an important opportunity to try to stave off the disease, at least postponing the memory loss and other symptoms.

Already, 5.4 million Americans have Alzheimer’s or related dementias. Barring a research breakthrough, those numbers will rise significantly by 2050, when up to 16 million Americans are projected to have Alzheimer’s. Already, it’s the sixth-leading killer, and there is no cure. Treatments only temporarily ease some symptoms.

Beyond the suffering, it’s a budget-busting disease for Medicare, Medicaid and families. Caring for people with dementia will cost the U.S. $200 billion this year alone, and $1 trillion by 2050, the Alzheimer’s Association estimates. Even that staggering figure doesn’t fully reflect the toll. Sufferers lose the ability to do the simplest activities of daily life and can survive that way for a decade or more. Family members provide most of the care, unpaid, and too often their own health crumbles under the stress.

So the National Alzheimer’s Plan, required by Congress, takes a two-pronged approach: focusing on future treatments plus help for families suffering today.

“There is a reinvigorated focus on this disease,” Donald Moulds of HHS told The Associated Press.

Among the first steps:

—A planned $8 million study of an insulin nasal spray that pilot-testing suggests could help Alzheimer’s. It’s based on growing evidence that diabetes and Alzheimer’s are related, damaging how the brain is fueled. The insulin nasal spray can reach the brain without affecting blood-sugar levels.

—Also, NIH was contributing $16 million to an international study of whether a treatment targeting amyloid, Alzheimer’s hallmark brain plaque, could prevent the disease. The study will include people at highest risk, genetically, of the disease, including Americans and a unique group in Colombia.

—The government will begin offering training to doctors and other health providers on the best ways to care for patients and their families.

Beyond the initial steps, the plan lays out ways that federal and state governments plus private and nonprofit organizations can collaborate to battle Alzheimer’s — from improving early diagnosis to creating more resources to help families with long-term care of their loved ones at home.

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Govt adopts landmark strategy to fight Alzheimer’s

WASHINGTON (AP) — The Obama administration adopts a landmark national strategy to fight Alzheimer’s on Tuesday, setting the clock ticking toward a deadline of 2025 to finally find effective ways to treat, or at least stall, the mind-destroying disease.

But work is beginning right away: Starting Tuesday, embattled families and caregivers can check a new one-stop website for easy-to-understand information about dementia and where to get help. The National Institutes of Health is giving the green light to some major new studies of possible therapies, including a form of insulin that’s squirted into the nose.

And the world’s top Alzheimer’s scientists gathered this week to decide what other research should take place next in order to meet that ambitious 2025 deadline.

“These actions are the cornerstones of an historic effort to fight Alzheimer’s disease,” Health and Human Services Secretary Kathleen Sebelius said in a statement. She was announcing the steps Tuesday at the meeting of researchers.

The first National Alzheimer’s Plan comes at what many scientists think is a pivotal moment. Alzheimer’s is poised to become a defining disease of the rapidly aging population. But researchers are pushing for a big change in how potential therapies are tested, by trying them in people who don’t yet have full-blown Alzheimer’s symptoms, when it may be too late to help.

“There’s a sense of optimism” thanks to some new discoveries, Dr. Francis Collins, director of the National Institutes of Health, told scientists at the Alzheimer’s Research Summit on Monday.

But, “we need to figure out exactly where is the best window of opportunity” to battle back Alzheimer’s, Collins added. He noted that cardiologists don’t test cholesterol-lowering drugs on people already near death from heart failure.

It’s clear that Alzheimer’s quietly brews in the brain, killing off cells, for 10 years or more before symptoms appear, Dr. Reisa Sperling of Harvard Medical School told the meeting. She called that time period an important opportunity to try to stave off the disease, at least postponing the memory loss and other symptoms.

Already, 5.4 million Americans have Alzheimer’s or related dementias. Barring a research breakthrough, those numbers will rise significantly by 2050, when up to 16 million Americans are projected to have Alzheimer’s. Already, it’s the sixth-leading killer, and there is no cure. Treatments only temporarily ease some symptoms.

Beyond the suffering, it’s a budget-busting disease for Medicare, Medicaid and families. Caring for people with dementia will cost the U.S. $200 billion this year alone, and $1 trillion by 2050, the Alzheimer’s Association estimates. Even that staggering figure doesn’t fully reflect the toll. Sufferers lose the ability to do the simplest activities of daily life and can survive that way for a decade or more. Family members provide most of the care, unpaid, and too often their own health crumbles under the stress.

So the National Alzheimer’s Plan, required by Congress, takes a two-pronged approach: focusing on future treatments plus help for families suffering today.

“There is a reinvigorated focus on this disease,” Donald Moulds of HHS told The Associated Press.

Among the first steps:

—NIH’s Collins on Tuesday will announce an $8 million study of an insulin nasal spray that pilot-testing suggests could help Alzheimer’s. It’s based on growing evidence that diabetes and Alzheimer’s are related, damaging how the brain is fueled. The insulin nasal spray can reach the brain without affecting blood-sugar levels.

—Also, NIH was contributing $16 million to an international study of whether a treatment targeting amyloid, Alzheimer’s hallmark brain plaque, could prevent the disease. The study will include people at highest risk, genetically, of the disease, including Americans and a unique group in Colombia.

—The government will begin offering training to doctors and other health providers on the best ways to care for patients and their families.

—A government website — http://www.alzheimers.gov — will offer one-stop information, in plain English about the disease and the challenges for families, including the financial burden. It also will link families to local resources near them, such as where to find the nearest adult day care, Moulds said.

A $4 million advertising campaign this summer will spread word of the website. “Questions. When you’re caring for a loved one with Alzheimer’s, not a day goes by that you don’t have them,” the ad says. “The answers start here.”

Beyond the initial steps, the plan lays out ways that federal and state governments plus private and nonprofit organizations can collaborate to battle Alzheimer’s — from improving early diagnosis to creating more resources to help families with long-term care of their loved ones at home.

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FDA delays rules meant to ease sunscreen confusion

WASHINGTON (AP) — Sunscreen confusion won’t be over before summer after all. The government is bowing to industry requests for more time to make clear how much protection their lotions really offer.

The Food and Drug Administration ordered changes to sunscreens last summer but gave their makers a year — until this June — to get revised bottles on the shelf.

The changes aimed to finally distinguish which brands protected against both sunburn-causing ultraviolet B rays and the deeper-penetrating ultraviolet A linked to skin cancer and premature aging. They also couldn’t claim to be waterproof or sweatproof, only water- or sweat-resistant — so that people know sunscreens have to be reapplied frequently.

But sunscreen manufacturers said they were having a hard time meeting the deadline. And Friday, the FDA said it would give major sunscreen makers another six months to make the changes — until December, beyond sunbathing season in most of the country. Smaller companies will have even longer, until December 2013.

“The FDA took a major step backwards today and as a result, more consumers will likely get burned this summer,” said Sen. Jack Reed, D-R.I., who had long urged the FDA to tighten its regulation of sunscreens. The regulations had been in limbo for years.

But FDA officials worried that holding companies to the original deadline might lead to a temporary shortage of some types of sunscreen this summer, spokeswoman Shelly Burgess said in an email.

Still, the FDA said companies could go ahead and put the new relabeled bottles on store shelves as soon as they’re ready — and encouraged them not to waste time.

There is a mix already in stores, as some companies have found it easier to re-label certain brands and bottles than others, said Farah Ahmed of the industry’s Personal Care Products Council.

But neither she nor the FDA could estimate how many of the new consumer-friendly sunscreens have made it to the market so far.

Ahmed, who chairs the council’s sunscreen task force, said sunscreens aren’t having to be reformulated as a result of new testing requirements from the FDA’s pending rules. The real problem was the time it takes to revise package labeling, especially on smaller packages that now will have to fit extra information about just what protection is offered, she said.

So what should consumers look for today?

—You want protection against both UVA and UVB rays, explained Dr. Joshua Zeichner, a dermatologist at Mount Sinai Medical Center in New York. Once the new rules are in place, any sunscreen labeled “broad spectrum” will offer both, but until then, there’s no guarantee behind that wording.

To check for UVA protection now, look on the ingredient list for any of these names: zinc, titanium, avobenzone or ecamsule. Zeichner said.

—Once the new rules are in place, sunscreens with less than an SPF of 15 or that aren’t “broad spectrum” will have to carry a warning label: “This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

—Zeichner advises using a sunscreen with an SPF of 30 or higher.

—If it still says “waterproof,” it was bottled under the old rules. Once the new rules are in place, the sunscreens will have to say how long they’re water-resistant.

—A good rule of thumb is to apply about a shot-glass full of sunscreen and to reapply often, Zeichner said

And experts say to avoid direct sun between 10 a.m. and 4 p.m. or to cover up. Even if you’re conscientious about sunscreen, it’s easy to miss a spot.

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