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.
Continue Reading CloseScientists 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.
Continue Reading CloseClock 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.
Continue Reading CloseGovt 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.
Continue Reading CloseFDA 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.
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