The Obama administration is moving forward with an ambitious, fast-moving agenda to improve the treatment of Alzheimer’s disease and unlock a method to prevent it by 2025.

The final draft of the plan, released today, also sets up a wide-ranging effort to improve the care that Alzheimer’s patients receive and support families.

I am not alone – alzheimers.gov

As many as 5.1 million Americans are diagnosed with Alzheimer’s disease, and that number could more than double in the next few decades, said Health and Human Services Secretary Kathleen Sebelius when she unveiled the plan at a National Institutes of Health summit on Alzheimer’s-related research.

The majority of the plan’s expected funding – $130 million over the next two years – will go toward NIH research, but another $26 million will go toward Alzheimer’s care and public awareness.

Chief among those is a government website, alzheimers.gov, also launched Tuesday. The site serves as a “one-stop shop,” Sebelius said, for patients and their families.

It features information on Alzheimer’s diagnosis, caregiver support, insurance coverage and clinical trials for new treatments.

A radio, TV and print campaign will promote the site beginning this summer and encourage families to plan ahead for the care of their loved ones.

The site will also serve as a resource for health care providers, featuring up-to-date information on how to diagnose and treat Alzheimer’s.

Secretary Kathleen Sebelius

Sebelius noted that the health law requires Medicare providers to check patients for cognitive impairment during annual wellness visits, but it will be increasingly important for all providers to have guidelines for Alzheimer’s diagnosis and to look for signs of illness prior to age 65.

The online resources will complement several on-the-ground initiatives. Grants are being awarded this summer to educational centers that work with geriatricians, nurses and others to develop new curricula and training programs.

Sebelius said that the administration’s goal is to “improve the care, immediately, that people with the disease receive.”

In addition, the administration plans to evaluate how Alzheimer’s patients fare within new health care models, like the medical homes and accountable care organizations being promoted by the health law.

Reviews will focus on changes in patients’ cognitive function and on the efficiency of services provided. Work on that front is projected for completion by the end of this year.

It will take much longer, though, to find new treatments, or even a preventive treatment, for Alzheimer’s. NIH Director Francis Collins said Tuesday that study of the disease is “at an exceptional moment.”

He went on to announce two major research grants: one will evaluate a nasal spray that could improve patients’ brain function; the other will test a preventive medication among a large family in Colombia whose members have a genetic predisposition to Alzheimer’s.

Know where to turn: alzheimers.gov

The national plan for Alzheimer’s has been through several months of development since President Barack Obama signed the National Alzheimer’s Project Act in January 2011.

Funding, however, remains an issue. The administration announced in February it would devote $156 million over two years to the national plan.

Immediately, $50 million of already available NIH funds were transferred to Alzheimer’s-related projects. Another $80 million was requested as part of the president’s Fiscal Year 2013 budget, which has yet to be passed by Congress.

Much of the $26 million going toward Alzheimer’s care and awareness is also awaiting approval.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Purkinje cells (red, yellow, and green dots) in a region of the cerebellum.

The new funds will support the first four years of a 10-year plan that will double the Institute’s staff to 350 and launch three new scientific initiatives.

These projects will seek to answer three key, related questions:

• How does the brain store, encode and process information?

• What are the cellular building blocks that underlie all brain function, and are often targets of disease?

• How do those cells develop, and then create the circuits that drive behavior, thought and brain dysfunction?

The the stated goal of the Institute is to accelerate brain research by providing researchers with the most detailed information possible about the brain’s anatomy, genetics and biochemistry.

The Institute gathers this information by adapting highly automated “high-throughput” industrial production techniques to perform laboratory work that would take years, if not decades, for university researchers to complete using standard techniques.

The Institute then makes its data available on huge searchable, online databases for free at the Allen Brain Atlas data portal at www.brain-map.org

To guide these and other initiatives, the Institute had been recruiting new talent including.  Christof Koch, Ph.D. from Caltech, R. Clay Reid, M.D., Ph.D. from Harvard Medical School, and Ricardo Dolmetsch, Ph.D. from Stanford.

Mother Jones: Santorum In ’93: More Government Needed in Health Care

Rick Santorum (Photo: Gage Skidmore)

If elected president, Santorum vows, he will end the “tyranny” of President Obama’s Affordable Care Act. Yet as an up-and-coming congressman in the early 1990s, Santorum took a much different line. Then—like now—health care was one of the nation’s most divisive issues. In 1993, Republicans were up in arms about a health care reform bill spearheaded by Hillary Clinton and pushed by President Bill Clinton. … During that fiery debate, Santorum said it would be a mistake to allow the delivery of health care services to be determined only by the market. He asserted that Republicans were “wrong” to let the marketplace decide how health care works. He instead argued that government should play a “proactive” role in shaping the health care marketplace “to make it work better” (Andy Kroll and Tim Murphy, 3/5).

The Atlantic: Making The Best Of What Is Often The Very Worst Time Of Our Lives (Book Excerpt)

As difficult as things are now, these may turn out to be the good old days. How we die is already a public health crisis, and care for people through the end of life is poised to become a generation-long social catastrophe. … Very soon, for the first time in human history, older people will outnumber younger people on our planet. In the United States, one in five adults is 65 or older. … Those of us who are concerned about long-term care have good reasons to worry. The nursing homes of the future — our future! — may make today’s nursing homes look like luxury hotels. It doesn’t have to turn out that way (Ira Byock, 3/7).

American Medical News: Legal Risks Of Going Paperless

System breaches. Modification allegations. E-discovery demands. These issues are becoming common courtroom themes as physicians transition from paper to EMRs, legal experts say. Not only are EMRs becoming part of medical negligence lawsuits, they are creating additional liability. … Studies are mixed about how EMRs will impact liability for physicians. … Whatever the future holds for EMRs, it’s important that doctors reduce their liability risks during system implementation, legal experts say. Being aware of potential legal pitfalls prevents doctors from falling victim to technology intended to do good — not cause hardship (Alicia Gallegos, 3/5).

The Daily Beast: Talking About Sex Is the Only Way To Stop HIV

[The United States has] been stuck at about 50,000 new infections each year for more than a decade. Compared with the challenges facing places like sub-Saharan Africa, our failure is particularly galling: we have plenty of drugs that work, the money and systems to administer them, and effective, if not particularly popular, ways to interrupt the spread (condoms, clean needles, abstinence). So why aren’t we doing better? The answer is blindingly simple: sex. Almost all HIV in the U.S. is spread by sexual intercourse, yet when faced with this fact, we act like a bumbling junior-high-school kid hearing about the birds and the bees for the first time. As a result, we have before us an unabated 30-year epidemic of a sexually transmitted disease (Kent Sepkowitz, 3/5).

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

The guidelines, which were published online this week by the  American Journal of Obstetrics & Gynecology, were written to help health-care providers counsel mothers-to-be on how to avoid such toxins as lead, mercury, and a class of chemicals called “endocrine disrupters” that resemble hormones and have been linked to a number health problems including reproductive tract and neurodevelopment abnormalities.

Although the guidelines were written for health-care providers, the guidelines contain helpful information for patients, too, says Dr. Sathyanarayana.

“There are simple ways to reduce exposures to lead, mercury, pesticides and endocrine-disrupting chemicals . . .  by following the guidelines we have outlined,” Dr. Sathyanarayana said.

“Women and their partners should be aware that pregnancy is an important time for development, that environmental chemicals can cause harm to a developing fetus, and that this topic is important to discuss with health care providers,” said Dr. Sathyanarayana.

A summary of the guidelines provided by Seattle Children’s Research Institute is below:

Environmental Exposures:  

Tips for Reproductive Health Care Providers, Preconception and Prenatal Women

Mercury

• Risk factors: Exposure can come from eating fish, contact with quicksilver, and use of skin-lightening creams.  Exposure during pregnancy can lead to adverse neurodevelopmental outcomes that include lower IQ, poor language and motor development
• Reducing exposure to mercury:  Pregnant, preconception and breastfeeding women should follow U.S. Environmental Protection Agencyand state-specific fish consumption guidelines.  Avoid shark, swordfish, king mackerel, tile fish and large tuna.
• Resources:  Fish Chart and mercury guide.

Lead

• Risk factors: Risk factors for exposure include recent immigration to the U.S., occupational exposure, imported cosmetics, and renovating or remodeling a home built before 1970.  Lead is neurotoxic to a developing fetus.
• Reducing exposure:  Never eat nonfood items (clay, soil, pottery or paint chips); avoid jobs or hobbies that may involve lead exposure; stay away from repair, repainting, renovation and remodeling work conducted in homes built before 1978; eat a balanced diet with adequate intakes of iron and calcium; avoid cosmetics, food additives and medicines imported from overseas; and remove shoes at the door to prevent tracking in lead and other pollutants.
• Resources: Lead in Pregnancy/CDC and Poison Center Locator.

Pesticides

• Risk factors: Exposure can come from eating some produce and from using pesticides in your home or on your pets.  Exposure to pesticides in pregnancy has been shown to increase risk of intrauterine growth retardation, congenital anomalies, leukemia and poor performance on neurodevelopmental testing.
• Reducing exposure:  Do not use chemical tick and flea collars or dips; avoid application of pesticides indoors and outdoors; consider buying organic produce when possible; wash all fruits and vegetables before eating; and remove shoes at the door.
• Resources:  http://www.ewg.org/foodnews (focus on the “Dirty Dozen,” a list of the 12 most contaminated products published by the Environmental Working Group.

Endocrine-disrupting chemicals

• Risk factors: Human prenatal phthalate exposure is associated with changes in male reproductive anatomy and behavioral changes primarily in young girls. Animal studies suggest prenatal exposure to BPA is associated with obesity, reproductive abnormalities and neurodevelopmental abnormalities in offspring. Endocrine-disrupting chemicals mimic or antagonize the effects of hormones in the endocrine system and can cause adverse health effects that can be passed on to future generations.
• Reducing exposure:  Decrease consumption of processed foods; increase fresh and/or frozen foods; reduce consumption of canned foods;  avoid use of plastics with recycled codes #3, #6 and #7; be careful when removing old carpet because padding may contain chemicals; and use a vacuum machine fitted with a HEPA filter to get rid of dust that may contain chemicals.
• Resources:  BPA, CDC, and EPA.

FDA Consumer Update:

If you’re one of the millions of Americans who take statins to prevent heart disease, the Food and Drug Administration (FDA) has important new safety information on these cholesterol-lowering medications.

FDA is advising consumers and health care professionals that:

• Routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, is no longer needed.

  Such monitoring has not been found to be effective in predicting or preventing the rare occurrences of serious liver injury associated with statin use.

• Cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users.

• People being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes.

• Some medications interact with lovastatin (brand names include Mevacor) and can increase the risk of muscle damage.

This new information should not scare people off statins, says Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP).

“The value of statins in preventing heart disease has been clearly established,” she says. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

FDA will be changing the drug labels of popular statin products to reflect these new concerns. (These labels are not the sticker attached to a prescription drug bottle, but the package insert with details about a prescription medication, including side effects.)

The statins affected include:

• Altoprev (lovastatin extended-release)
• Crestor (rosuvastatin)
• Lescol (fluvastatin)
• Lipitor (atorvastatin)
• Livalo (pitavastatin)
• Mevacor (lovastatin)
• Pravachol (pravastatin)
• Zocor (simvastatin).

Products containing statins in combination with other drugs include:

• Advicor (lovastatin/niacin extended-release)
• Simcor (simvastatin/niacin extended-release)
• Vytorin (simvastatin/ezetimibe).

Liver Injury Called Rare

FDA has found that liver injury associated with statin use is rare but can occur. Patients are advised to consult their health care professional if they have symptoms that include unusual fatigue, loss of appetite, right upper abdominal discomfort, dark urine or yellowing of the skin or whites of the eyes.

Statins work in the liver to reduce the production of cholesterol, a waxy substance that can form plaque on the walls of the arteries and keep the heart from getting the blood it needs.

Egan explains that there had been signals in early clinical trials of possible liver damage tied to statin use, so health care professionals were advised to regularly test their patients’ liver enzyme levels. However, she says, such damage is rare, and the tests are not effective at predicting or preventing who will develop this rare side effect.

So FDA is now recommending that liver enzyme tests be performed before statin treatment begins and then as needed if there are symptoms of liver damage.

Reports of Memory Loss

FDA has been investigating reports of cognitive impairment from statin use for several years. The agency has reviewed databases that record reports of bad reactions to drugs and statin clinical trials that included assessments of cognitive function.

The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking.

In general, the symptoms were not serious and were reversible within a few weeks after the patient stopped using the statin. Some people affected in this way had been taking the medicine for a day; others had been taking it for years.

What should patients do if they fear that statin use could be clouding their thinking? “Talk to your health care professional,” Egan says. “Don’t stop taking the medication; the consequences to your heart could be far greater.”

The Risk of Diabetes

Diabetes occurs because of defects in the body’s ability to produce or use insulin—a hormone needed to convert food into energy. If the pancreas doesn’t make enough insulin or if cells do not respond appropriately to insulin, blood sugar levels in the blood get too high, which can lead to serious health problems.

A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins.

“Clearly we think that the heart benefit of statins outweighs this small increased risk,” says Egan. But what this means for patients taking statins and the health care professionals prescribing them is that blood-sugar levels may need to be assessed after instituting statin therapy,” she says.

The Potential for Muscle Damage

Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. Egan explains that some new drugs are broken down (metabolized) through the same pathways in the body that statins follow. This increases both the amount of statin in the blood and the risk of muscle injury.

FDA is revising the drug label for Lovastatin to clarify the risk of myopathy. The label will reflect what drugs should not be taken at the same time, and the maximum lovastatin dose if it is not possible to avoid use of those other drugs.

Patients and health care professionals should report negative side effects from statin use to FDA’s MedWatch Adverse Event Reporting Program.

This article appears on FDA’s Consumer Update page, which features the latest on all FDA-regulated products.

February 27, 2011