Entries in Kathleen Sebelius (7)


Critics Call Government's Alzheimer's Plan Unrealistic

Tom Williams/Roll Call(WASHINGTON) -- The Obama administration and the National Institutes of Health have homed in on Alzheimer's disease, setting an ambitious goal to have an effective treatment for the brain-wasting disease by 2025.

The plan is intended to give a "clear, national focus and attention on Alzheimer's that we've given to other diseases," said Health and Human Services Secretary Kathleen Sebelius in a meeting at the NIH Tuesday.

But Alzheimer's disease experts' reactions to the pledge are less optimistic: Some say giving more attention to the disease can only help, while others call the goal unrealistic.

Most say it is helpful to focus the nation's lens on Alzheimer's, which currently ravages the brains of about 5.4 million Americans and strains 15 million caregivers, numbers that will surely climb as the population ages.

But for some experts, the scope of the government's effort is only a fraction of what is needed to make a difference.

"It's great to have the attention drawn to the disease and have a temporary blip in funding," Dr. Samuel Gandy, a professor of Alzheimer's disease research at Mount Sinai School of Medicine, told ABC News. "But this is at least an order of magnitude off the figure that is likely to have meaningful impact."

The NIH devoted $448 million in fiscal year 2011 for Alzheimer's disease research, compared with the nearly $5.5 billion for cancer research and $3.1 billion for HIV/AIDS. So far, progress against Alzheimer's has been disappointing. There is no cure for the disease, and the treatments that are available only temporarily relieve its symptoms.

Much of the research so far has focused on amyloids in the brain, and whether targeting these protein tangles can prevent or reverse the disease. But answers have been tantalizingly out of reach, despite much research.

"We have had good reason to focus therapies on amyloid, yet they have failed to date. That is discouraging," Dr. Richard Caselli, a professor of neurology at the Mayo Clinic, told ABC News. "So challenge No. 1 is finding good alternative targets."

Dr. Peter Whitehouse, a professor of neurology at Case Western Reserve University in Cleveland, said if the government plan is to succeed, the NIH should broaden its focus on research against Alzheimer's to include more that will help patients cope with the disease or prevent it altogether, such as community design, diet and exercise.

"The field of Alzheimer's research is getting a little distorted. There's a constant need to focus on magic bullets and single molecules," Whitehouse told ABC News. "It really requires a public health focus. The most effective interventions are not going to be drugs."

Other experts defend the government's efforts, saying the plan can only improve current efforts to fight the disease.

"No doubt it's an ambitious goal. What's different now is that we have a goal," said Harry Johns, president and chief executive officer of the Alzheimer's Association.

Sebelius announced new steps in the government's strategy to develop treatments for the disease and provide better support to patients, families and caregivers in the next 13 years.

The first steps include millions in NIH funding devoted to research on Alzheimer's. Two trials will begin immediately -- $8 million for a clinical trial of a potential treatment for early Alzheimer's (an insulin nose spray), and $16 million to study the potential for a treatment to target amyloid, the brain hallmark of Alzheimer's disease, in Colombian people who are healthy but have a genetic mutation that puts them at high risk for developing the disease.

The initiative is part of the National Alzheimer's Plan Act, signed into law by President Obama in January, which marks $50 million for Alzheimer's research in fiscal year 2012 and another $100 million in fiscal year 2013.

According to the Alzheimer's Association, caring for people with dementia cost $200 billion this year alone, and could reach $1 trillion by 2050. The disease is physically and mentally devastating, not just for patients but for families and caregivers who struggle to care for them.

To help embattled caregivers, the government launched, an online resource for patients, families and caregivers looking for information on dementia and where they can get help, and is assigning $26 million to provide resources for patients and caregivers, including support in local communities and a public awareness campaign with TV, radio, online and outdoor ads.

Sebelius said she hoped the government's effort would lead to a strikingly different picture of Alzheimer's disease in the U.S. by 2025.

Copyright 2012 ABC News Radio


HHS Secretary Addresses Contraceptive Mandate, Drug Shortages

Tom Williams/Roll Call(WASHINGTON) -- The president’s controversial contraceptive mandate and ongoing national drug shortages were just two of the off-budget topics presented to embattled Health and Human Services (HHS) Secretary Kathleen Sebelius at Wednesday’s Senate Finance Committee hearing.

Sen. Orrin Hatch, R-Utah, and Sen. Charles Grassley, R-Iowa, both expressed criticism and concern about the contraceptive mandate.  Hatch questioned whether Sebelius had consulted with any Catholic bishops on the matter prior to last week’s reversal on the mandate that would require religious employers to cover certain preventable health services, such as contraception.

“I did not,” she said, adding that the president has, “spoken to the bishops on several occasions,” but she was unsure if it was about the compromise in the requirement.

The comprimise touted by the administration after a firestorm erupted over the mandate did little to quell the controversy. This week, the nation’s Roman Catholic bishops rejected the Obama administration's compromise on birth control coverage and said they would continue to fight President Obama's plan to force employees of Catholic hospitals, universities and other institutions to provide free contraceptive coverage in their health insurance plans for their employees. 

Hatch also pressed her on whether HHS had conducted or requested any, “analysis of the constitutional or statutory religious freedom issues” surrounding the mandate.  Sebelius replied that she never spoke to anyone, but that HHS did, “look at a whole host of legal issues.”

Pressing the issue, Hatch asked if HHS consulted anyone at the Justice Department, to which Sebelius said “no.”

“I think you’ve got it very wrong the first try,” Grassley said, before turning his attention to whistle-blower protection.  “You have a lot more work to do.”

But it wasn’t all negative surrounding the mandate.  Sen. Jeff Bingaman, D-N.M., commended the “reasonable position” HHS has taken.

“I think that it adequately protects religious liberty and it at the same time protects the right of women to obtain contraceptive services when they choose to,” Bingaman said.

The recent drug shortages making headlines across the nation were also a topic of discussion.

Citing a 3-year-old in his district who can’t get her leukemia medication, Sen. Ron Wyden, D-Ore., questioned why the government can’t, “fix this and stop playing catch-up ball.”

“The FDA did announce yesterday that they feel that in the next two weeks the leukemia drug shortage will indeed be resolved,” Sebelius said. “It’s resolved because what we can do at the FDA is accelerate alternatives, if we have notification.”

Sebelius cited a “market glitch” as the main cause of the problem.

“The market capacity for drugs has not increased,” she said.  “Currently, we have the same manufacturing capacity and drug marketers choosing which line of drugs to produce at which time.”

A bill currently pending in the House and Senate would make it a requirement for drug companies to notify the government of an impending shortage -- a process Sebelius said was “key” for the government’s role in preventing shortages.

Copyright 2012 ABC News Radio


Pharmacy Apologizes for Refusing to Sell Man Morning After Pill 

Joe Raedle/Getty Images(HOUSTON) -- CVS Pharmacy offered  a mea culpa Thursday after a pharmacist denied the sale of the morning-after pill to Isaac Kurtz of  Houston. The pharmacist told Kurtz she was acting on “personal belief” and not store policy.

“She tells me she needs to speak with the woman,” Kurtz told the Houston Press. “I’m taken back by this and ask her what she needs to talk to her about. I bought them here before without issue. She then tells me she won’t sell it to me.”

CVS store policy does not prohibit men from buy the morning-after pill, and under federal law, anyone over the age of 17 can buy Plan B without a prescription.

“We apologize for the isolated incident in our Houston pharmacy in which a male customer was unable to purchase this item,” CVS spokesman Michael DeAngelis said in a statement. “We are following up on the pharmacy staff to ensure that our policies are properly followed to prevent a recurrence of this incident.”

Last week, the Food and Drug Administration deemed Plan B One-Step a safe and effective nonprescription medication for all women of childbearing years. The decision would have allowed the product to be available over-the-counter to people of all ages, but, in an unprecedented move, U.S. Department of Health and Human Services Secretary Kathleen Sebelius blocked the pill from hitting drug store shelves.

"Last week’s decision added confusion to Plan B,” said Susan Wood, director of the Jacobs Institute of Women’s Health in Washington D.C. 

"It made people think there was a safety issue or it somehow affected younger teens’ desire to participate in risky sexual behavior. Of course, neither of those are true, and those who don’t know all the information now have misinformation.”

Because Plan B  is not sold on store shelves, Woods said pharmacists end up acting as gatekeepers for the product.

“It’s so important that this product be compared to other products like condoms, tampons and pregnancy tests,” said Wood.

“Some of these might be considered male- or female-oriented, but clearly, anyone 17 or older can purchase these products for themselves or someone else. This would be better than having a gatekeeper who may not approve or understand the reason for providing it to the customer.”

Copyright 2011 ABC News Radio


Plan B: 'Morning After Pill' Blocked from Hitting Drug Store Shelves

Joe Raedle/Getty Images(WASHINGTON) -- U.S. Department of Health and Human Services Secretary Kathleen Sebelius has blocked the Plan B "morning after" birth control pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

"Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional," Sebelius wrote in a statement.

FDA Commission Dr. Margaret Hamburg said in a statement that she believes there is adequate and well-supported data that shows Plan B One-Step is safe and effective for nonprescription use for all females of childbearing years -- an opinion vetoed by Sebelius.

"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women's Health, Inc.," Sebelius wrote.

The move would have landed the emergency contraceptive on drugstore shelves alongside condoms, spermicides and contraceptive sponges. Instead, women 17 and older can continue to buy the high-dose hormone pill over the counter, but girls younger than 17 still need a prescription.

Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, requested the switch in February.

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it reportedly does not pose harm to a fetus.

In 2008 the FDA ruled that women 18 and older could buy Plan B over the counter. A year later, the agency expanded the regulation to include those 17 and older.

Copyright 2011 ABC News Radio


HHS in Campaign to Cut Hospital Errors

Thomas Northcut/Thinkstock(WASHINGTON) -- Health and Human Services Secretary Kathleen Sebelius on Tuesday announced a national program to help save 63,000 lives and up to $35 billion in health care costs over the next three years by preventing hospital-related injuries.

"Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents," Sebelius said. "Working closely with hospitals, doctors, nurses, patients, families and employers, we will support efforts to help keep patients safe, improve care, and reduce costs. Working together, we can help eliminate preventable harm to patients."

Sebelius was joined by hospital leaders, employers, insurers, doctors, nurses and patient advocates.

As many as one-third of hospital visits lead to hospital-related injuries, according to an April 7 report in Health Affairs. The missteps range from hospital-acquired infections to deadly surgical mistakes.

Sebelius said under the Partnership for Patients, HHS would invest up to $1 billion in federal funding through the Affordable Care Act.

The Community-based Care Transitions Program pledged $500 million and the Centers for Medicare & Medicaid Services will pitch in up to $500 million more to achieve the partnership's two main goals: To reduce preventable injuries by 40 percent; and cut preventable hospital readmissions by 20 percent.

"Reaching those targets would save up to $35 billion over the next 10 years," Sebelius said, adding that $10 billion of that would come from Medicare savings. "That's a return of up to $10 for each dollar we're investing."

Copyright 2011 ABC News Radio


Half of Americans Have Pre-Existing Health Conditions

Photo Courtesy - Getty Images(WASHINGTON) -- As many as 129 million non-elderly Americans have a pre-existing health condition that puts them at risk of being denied affordable coverage without health care overhaul, according to a government report. The estimate represents nearly half of Americans younger than 65, and 86 percent of people 55 to 64.

Secretary of Health and Human Services Kathleen Sebelius released the report hours before the House of Representatives was set to begin debate Tuesday on a Republican-spearheaded health care repeal bill.

"The timing of the report may be political but that does nothing to diminish its accuracy," said Robert Field, professor of law at the Earle Mack School of Law and professor of health management and policy at the Drexel University School of Public Health in Philadelphia.

What constitutes a pre-existing condition -- one that exists before someone applies for a health insurance policy -- is generally defined by insurers. But ones considered to fall in "high-risk pools" were also counted in the report. So pre-existing conditions ranged from having cancer to having high cholesterol.

Under the Affordable Care Act -- part of the health care legislation passed by the last Congress and signed into law by President Obama on March 23, 2010 -- insurers can no longer base eligibility, benefits or premiums on a person's health status, starting in 2014.

Copyright 2011 ABC News Radio


Obama to Sign Food Safety Act into Law; Funding for Implementation Unclear with GOP in Control of House

Photo Courtesy - Getty Images(WASHINGTON) -- Health & Human Services Secretary Kathleen Sebelius and the head of the FDA held a conference call with reporters Monday on The Food Safety and Modernization Act, which the President will sign into law Tuesday. Secretary Sebelius said that the act would finally bring U.S. food safety laws up to date and help with efforts to keep the food supply safe as the number of foodborne diseases and outbreaks have increased in recent years. Sebelius said that in the 1990s there were about 100 foodborne outbreaks every year but that now there are an estimated 350 outbreaks every year in the United States.
Because of these increased outbreaks Sebelius said that it is estimated that one out of six Americans is struck with food-related illnesses every year and that as many as 3,000 people die each year from foodborne illness.
The key part of the act that was discussed on the call involved providing the FDA with mandatory recall authority and the ability of the FDA to access food producers' records. Asked on the call about the costs of implementing the act, FDA Commissioner Dr. Margaret Hamburg said the estimated costs over five years to implement the act was $1.4 billion. It is unclear if the new incoming Republican Congress will fully fund the act’s implementation.

Copyright 2011 ABC News Radio

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