Obama's Alzheimer's plan focuses on treatment, care

CHICAGO (Reuters) - The Obama administration's plan to fight Alzheimer's disease aims to harness the nation's expertise to find real treatments by 2025 and improve the care and treatment of the 5.1 million Americans already afflicted with the brain-wasting disease.

The draft plan, issued by the Department of Health and Human Services on Wednesday, makes treatment a top priority, but it also focuses on the burden the disease places on families and caregivers.

"Alzheimer's disease burdens an increasing number of our nation's elders and their families, and it is essential that we confront the challenge it poses to our public health," President Barack Obama said in a statement marking the plan's unveiling.

The White House earlier this month said it would divert an additional $50 million this year from HHS projects to Alzheimer's research, and seek an extra $80 million in new research funding in fiscal 2013.

"These investments will open new opportunities in Alzheimer's disease research and jumpstart efforts to reach the 2025 goal," HHS said in the draft document.

Obama also plans on an additional $26 million in spending on programs to support people who care for Alzheimer's patients.

Current drugs help manage symptoms but so far no therapy can stop the progression of Alzheimer's, which can start with vague memory loss and confusion before progressing to complete disability and death.

Some researchers have criticized the plan and its 2025 target, saying it is too ambitious given that researchers are still just beginning to understand the disease, which develops silently for 15 to 20 years before any memory problems begin to show.

The best hopes for a treatment at this stage lie with two drugs under development: one from Eli Lilly and another from Johnson & Johnson and Pfizer. But some experts worry these drugs are being tested in patients whose disease has already progressed too far for them to benefit from the treatments.

Experts predict that without effective drugs, the number of Americans with Alzheimer's will double by 2050 and related healthcare costs could soar to more than $1 trillion a year.

HHS is planning a scientific summit in May to set research priorities. It seeks to increase participation in Alzheimer's clinical trials, with a special focus on ensuring minority representation, and to shorten the time it takes to develop drugs.

Eric Hall, president and chief executive of the Alzheimer's Foundation of America and a member of the advisory council that has been working with HHS, said it addresses many of the concerns that have been expressed by the panel.

"Given the current economic environment that limits much-needed resources and the scientific unknowns of this disease, we believe that defeating Alzheimer's disease will likely happen in a series of small victories," Hall said in a statement.

He was especially pleased that the plan focuses on educating healthcare providers on how to detect early signs of cognitive impairment and linking newly diagnosed families with appropriate support services.

But George Vradenburg, chairman of USAgainstAlzheimer's and a member of the advisory panel, said the draft plan did not go far enough.

"This first draft fails to present a strategy aggressive enough to achieve the goal of preventing and treating Alzheimer's within 13 years," he said, noting that the plan lacks specific timelines and does not hold any high-level officials accountable for meeting the plan's goals.

The plan is open for public comment through the end of March.

(Reporting by Julie Steenhuysen; Editing by Eric Walsh)

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Men opting for costly new prostate cancer treatment, study shows

Lindsey Konkel

NEW YORK (Reuters Health) - Men diagnosed with localized prostate cancer are more likely to be treated with proton beam therapy, a novel form of radiation therapy, if the technology is available nearby, a new study found.

Prostate cancer is the most common cancer in men -- the National Cancer Institute estimates that more than 240,000 men in the U.S. were diagnosed in 2011.

About nine out of 10 of those cases were localized prostate cancer, meaning the cancer hasn't spread outside the prostate gland. Nearly all men diagnosed with localized tumors survive at least five years after diagnosis.

In the study, researchers examined the treatment choices of nearly 20,000 men living inside or outside of a regional market for Loma Linda University, a hospital in Southern California with a proton beam facility. All men were diagnosed with low- to intermediate-risk prostate cancer between 2003 and 2006.

Currently, there are nine proton centers in operation in the United States and eight more in development, according to the National Association for Proton Therapy.

Touted as a technological advancement over other forms of radiation therapy, proton beam therapy allows radiated particles to more tightly target and destroy tumor cells, leaving more of the surrounding tissue intact.

The treatment is often billed as having lower impotence and incontinence rates than other radiation treatment options, but there's a lack of evidence to support this, according to Dr. David Aaronson, a urologist at Kaiser Permanente Medical Group in Oakland, California, and lead author of the study.

After taking into account factors such as tumor stage and year of diagnosis, Aaronson's team found that patients living near a proton beam facility were more than five times more likely to receive proton beam treatment than those living outside of the hospital's referral region.

Nearly nine percent of the patients living within the referral region for the facility received proton beam therapy, compared to less than two percent of patients throughout the rest of the state.

The researchers also found that younger and non-Hispanic white men were also slightly more likely to receive proton beam treatment.

"It's not surprising that men are more likely to be treated with a certain technology in an area where that technology is offered," Aaronson told Reuters Health.

While most insurers, including Medicare, cover proton beam therapy, it comes at a hefty price.

Previous studies have estimated that proton beam therapy costs twice as much as intensity-modulated radiation therapy, another form of external radiation therapy and about five times more than radioactive seed implants.

And side-by-side comparisons of proton beam therapy and other prostate cancer treatments have not been done, according to Dr. Leonard Lichtenfeld, chief medical officer for the American Cancer Society.

Despite the added costs, there's no evidence to suggest that proton beam therapy results in better outcomes than other forms of prostate cancer treatment, including other forms of radiation, surgery or hormone therapy.

Although proton beam therapy has been shown to be superior in targeting tumors of the brain, eye and spine, those cancers are rare.

Institutions with proton beam facilities often look to pad their numbers by treating prostate cancer, according to Dr. Anthony Zietman, a radiation oncologist at Massachusetts General Hospital in Boston who was not involved in the new study.

"People often think that technology is synonymous with 'better,' but in some cases, it's not," said Aaronson.

"With the healthcare crisis looming and multiple treatment options available, newer, more expensive procedures for prostate cancer should be validated before they are implemented," he said.

SOURCE: http://bit.ly/yHdxqN Archives of Internal Medicine, February 13, 2012

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Diet Treatment, Already in Use, to Get F.D.A. Review

The F.D.A. rejected the drug under review, Qnexa, in 2010, amid safety concerns, and the drug’s manufacturer is now presenting additional data to argue its case.

But thousands of people here in central California, where Qnexa’s inventor ran a weight-loss clinic, and others across the country have not had to wait for the drug’s approval. Through a regulatory loophole of sorts, many obesity doctors prescribe two separate drugs that, when taken together, are essentially the same medicine.

The widespread use of the unsanctioned combination reflects the often desperate desire for a medicine to help overcome the nation’s epidemic of obesity, doctors and patients say.

The experience in this idyllic coastal community about midway between San Francisco and Los Angeles also provides a look at what might happen if Qnexa were approved. Use of the close substitute grew as word spread that some patients had experienced substantial weight loss. Some people here regained weight after stopping the treatment, and some experienced unpleasant side effects such as memory loss.

“I can’t tell you how many people I sent to him because they saw the success I had,” said Lynn Adams, a retired teacher, referring to Dr. Thomas Najarian, the inventor of Qnexa who opened a weight-loss clinic here in 2001.

Ms. Adams said she took the two drugs for a year and lost about 80 pounds. She has taken the drugs from time to time since then but is off them now and has gained about half the weight back.

Qnexa, developed by the company Vivus, is a combination of two already approved drugs — a stimulant called phentermine and an anticonvulsant called topiramate — that seem to work together to quell appetite. Even though the F.D.A. declined to approve Qnexa two years ago, citing the risks of birth defects and cardiovascular problems, doctors are allowed to prescribe the components off-label as they see fit.

Many do. Dr. Christopher D. Still, director of the obesity institute at Geisinger Health System in Danville, Pa., estimated that 70 percent of obesity specialists prescribed the combination. “There is a subgroup of individuals that really feel satiated” when treated with the two drugs, said Dr. Still.

Only one drug, Roche’s Xenical, is currently approved for long-term use in treating obesity, and it is unpopular because of embarrassing digestive side effects. The F.D.A. rejected three obesity drugs, including Qnexa, in 2010 and 2011, citing different safety concerns for each.

The F.D.A.’s staff is expected to release its analysis of the new Qnexa data on Friday. On Wednesday, an advisory panel will review the drug and make its recommendation, and the F.D.A. will have until April 17 to make a decision about it.

Dr. Najarian, who sold his clinic in 2010, said Vivus would not allow him to talk about his experience treating patients with phentermine and topiramate. While doctors can prescribe drugs off-label, drug companies cannot promote such use. Dr. Najarian has been a part-time employee of Vivus since 2006.

Timothy E. Morris, the chief financial officer of Vivus, said Dr. Najarian’s practice did not constitute off-label promotion because Qnexa was “a separate product,” often with different doses, from the two components.

The weight-loss clinic, called Najarian Center, “certainly treated thousands of patients,” said Carol Rowsemitt, a nurse practitioner who worked at the clinic. Besides the drugs, the regimen involved modest exercise, a low-calorie diet and nutritional supplements, some sold by the clinic.

Ms. Rowsemitt said patients had been informed that the drugs were being used off-label and that Dr. Najarian had a financial stake in the combination.

She said side effects were carefully monitored, and she knew of no birth defects. She said, however, that some other doctors in the region had also started using the phentermine-topiramate combination “without being educated on how to use it.”

Phentermine, a stimulant, is approved for short-term use for weight loss. Part of the once popular fen-phen diet pill combination, it remained on the market after two other drugs were withdrawn in 1997 for damaging heart valves.

Topiramate, or Topamax, is approved for epilepsy and migraines, although half of the obesity specialists in one academic survey said they had prescribed it for weight loss. Critics say that using drugs for weight loss does little to change the underlying behavior leading to obesity.

“Everyone wants a quick fix,” said Dr. Sidney M. Wolfe, director of health research at Public Citizen. “But it’s also dangerous.”

Melané Lange of Los Osos once thought that way as well. When she worked for Weight Watchers here, she recommended diet and exercise and used those methods herself.

But it was hard work. So last October, she had her doctor prescribe the two drugs and lost more than 10 pounds in time for a vacation.

“Taking a pill in the morning, taking a pill at night, that’s not a lot of work,” Ms. Lang said. “I was losing patience this time. I didn’t want it to take six months.”

Dr. Philip A. Borgardt, who bought Dr. Najarian’s practice and moved it to nearby San Luis Obispo, Calif., said weight loss was not simply a matter of willpower.

“If it was that easy, they wouldn’t have come to see us,” he said. “The biggest barrier we have to treating obesity is we blame the patient.”

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New Blood Thinner May Prevent Blood Clots During Cancer Treatment

WEDNESDAY, Feb. 15 (HealthDay News) -- A new blood-thinning medication called semuloparin reduces the risk of blood clots in people undergoing certain cancer treatments, new research shows.

When people with cancer are treated with chemotherapy, they have an increased risk of developing blood clots (venous thromboembolism). These clots can be dangerous, and have the potential to cause heart attacks or strokes.

This new drug reduced the risk of blood clots by 64 percent, according to the study, which was funded by Sanofi, the drug's manufacturer. Sanofi was also responsible for the analysis of the study's results.

Semuloparin, which is not currently approved by the U.S. Food and Drug Administration, didn't appear to increase the risk of excessive bleeding, which can be a side effect of blood thinners.

"Thromboembolism and the effects are very significant," said Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City. Even if blood clots don't cause life-threatening complications, they can cause lifelong problems, such as pain and a decreased ability to exercise, she explained.

"What's interesting about this paper is that they're decreasing the rate of thromboembolism without increasing bleeding. This needs to be confirmed in other studies, but this drug may play an important role for cancer patients in the future," said Bernik, who was not involved with the research.

The current study included more than 3,000 people from 47 countries. All had been diagnosed with cancer, including cancers of the lung, pancreas, stomach, colon, rectum, bladder or ovary.

The study volunteers were randomly assigned to one of two groups. One group received treatment with semuloparin, which is a type of heparin, while they were undergoing chemotherapy. The other group received a placebo.

The medication or the placebos were given as an injection once a day. Treatment lasted an average of 3.5 months.

Blood clots occurred in just 1.2 percent of those taking semuloparin compared to 3.4 percent of those on the placebo, according to the study.

The incidence of any type of excessive bleeding was 2.8 percent for the semuloparin group and 2.0 percent in those on placebo. Major bleeding occurred in 1.2 percent of those on semuloparin and 1.1 percent of those on placebo.

Results of the study are published in the Feb. 16 issue of the New England Journal of Medicine.

In addition to preventing clots, heparin medications may also help fight cancer tumors, according to the authors of an accompanying editorial in the same issue of the journal.

"This study by itself did not show any effect on mortality, but when we included it in a meta-analysis, we found that there is a likely survival benefit," said one of the editorial's authors, Dr. Elie Akl, an associate professor of medicine at the State University of New York at Buffalo.

The meta-analysis done by Akl and his co-author reviewed 11 studies including more than 6,000 people taking heparin medications during chemotherapy. They concluded that for every 1,000 people being treated with chemotherapy for cancer, there would be 30 fewer deaths if people were also treated with heparin during their chemotherapy. They also estimated that there would be 20 fewer blood clots. And, they estimated that there would be one more major bleeding episode and five more minor bleeding episodes if everyone on chemotherapy were to receive heparin treatment.

"Patients with cancer, who have a low risk of bleeding and who have no problem with injecting themselves with heparin, are likely to benefit in terms of survival from heparin treatment," he said.

What isn't yet clear, Akl said, is if heparin would provide more or less benefit depending on the type of cancer someone has, and how far advanced the cancer is. He said that there are currently six different studies under way to help answer those questions. The cost of the medication is also unclear, since it has not been approved for use in the United States yet.

More information

To learn more about blood clots and cancer, read this information from the American Society of Clinical Oncology.

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Talk Therapy Eases Hot Flashes After Breast Cancer Treatment

It was a bad dream that prompted 38-year-old Sheryl Alberico of Los Angeles to demand the mammogram that saved her life.

Although it was small, the pea-size tumor in Alberico's left breast was aggressive. Within weeks, doctors would remove both breasts and pump toxic drugs throughout her body "just in case."

Now, one day after her fourth and final round of chemotherapy, something else is haunting Alberico's sleep: Unrelenting hot flashes.

"Last night I woke up every hour," said Alberico, who is currently on disability leave from her job as an architect. "It just hits you. It feels like there's a fire inside you."

Up to 85 percent of women treated for breast cancer experience hot flashes and night sweats, the often debilitating symptoms of menopause brought on by the hormone-disrupting cancer treatments.

"I wake up my husband kicking off the covers. Neither of us gets any sleep," said Alberico, who routinely irons the cotton sheets to keep them "crisp and cold." "Sometimes I have to get up and take a shower just to cool down."

Certain drugs can provide some relief, but they don't work for everyone.

"Hormone therapy generally isn't recommended for these women because of its association with breast cancer," said Myra Hunter, a professor of clinical health psychology at King's College London's Institute of Psychiatry. "And many women want to take a non-medical approach."

Hunter and colleagues investigated whether group cognitive-behavioral therapy, a psychotherapy aimed at changing perceptions rather than physical symptoms, could help breast cancer survivors cope with hot flashes and night sweats by changing the way they think about them.

"There is some evidence that cognitive-behavioral therapy can help well women [who do not have breast cancer] cope with hot flashes and night sweats related to menopause," said Hunter. "If we can help them to counter their negative thoughts, they can learn to really let the flash flow over them."

In a study of 96 breast cancer survivors, women who received six 90-minute cognitive-behavioral therapy sessions reported significantly fewer problems with hot flashes and night sweats than women who received the usual care. The findings were published Tuesday in the Lancet Oncology.

"They're still having hot flashes, but they don't notice them as much," said Hunter.

Using relaxation techniques such as "paced breathing," the women learned to counteract the stress, embarrassment of hot flashes and their effects on mood and sleep.

Holly Prigerson, director of psychosocial oncology at the Dana-Farber Cancer Institute, said the study "demonstrates the power of the mind as medicine."

"By encouraging someone to think about physical symptoms in a different way -- a way that's less stigmatizing and more normalizing -- you can substantially improve her quality of life," said Prigerson, who wrote an editorial accompanying the study. "Just like anxiolytics or antidepressants, how you think about something can have a dramatic influence on how you feel physically and mentally."

An online version of the therapy sessions could improve access for women limited by money, geography and busy schedules, Prigerson said. But there are advantages to sharing the experience with a group of women in the same boat.

"This study didn't really parse out the effect of sharing with a group of other breast cancer survivors -- how the social support of sisters in suffering might also prove empowering and make women more resilient," Prigerson said.

Learning to counter negative emotions can give women back some of the control they feel they lost during their cancer diagnosis and treatment, Hunter said.

"I think it's very empowering, actually, because they've been going through a process where they feel as if their bodies are being managed by other people," she said. "The cognitive-behavioral therapy approach lets them feel as though they've got some control, and think they can apply that to different areas of their life."

After a double mastectomy and aggressive chemotherapy, Alberico said she likes the sound of cognitive-behavioral therapy.

"I'm just sick of all the pills and needles," she said. "If I can do something more natural, that's better. I'm in my 30s, and this is going to go on for a while, so it can't hurt to try."

Also Read

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New study casts doubt on lung cancer treatment

NEW YORK (Reuters Health) - A controversial radiation treatment for patients who've had lung cancer surgery may not help elderly people live longer, U.S. researchers have found.

Postoperative radiotherapy, or PORT, is thought to cut the chances that a tumor will return. But it can damage the heart and lungs, which might cancel out any potential benefits -- particularly in seniors.

"Thus, these patients may be exposed to the side effects and complications of PORT without a clear benefit," lead researcher Dr. Juan Wisnivesky, of Mount Sinai School of Medicine in New York, told Reuters Health by email.

The findings fuel an ongoing debate over how much treatment older cancer patients should get. Often those treatments have been tested in younger people and it's unclear whether other age groups will reap the same benefits.

Side effects may take a higher toll on older people's health, for instance, and they may not live long enough to see the positive effects of their therapy.

"The marginal benefit of the additional treatment gets smaller and smaller as patients get older," said Dr. David J. Sher, a radiation expert at Rush University Medical Center in Chicago, who was not involved in the new work.

"Their overall fitness generally doesn't warrant postoperative radiotherapy," he told Reuters Health. "It's a fine balance."

The new study, published in the journal Cancer, analyzed data on more than 1,300 Medicare patients who'd had surgery for early-stage lung cancer.

Such patients usually don't get radiation therapy, but in this group the cancer had spread to lymph nodes in the chest. There is no agreement on what to do in that case, and earlier studies have come to mixed conclusions.

It turned out that about half of the patients, most of whom were over 70, had been treated with radiation.

It's hard to compare those who got radiation and those who didn't directly, because different factors may have influenced the individual decisions to treat or not. But in their study, Wisnivesky and his colleagues did their best to account for patient characteristics, tumor size, type of surgery, complications and other possible differences.

No matter how they analyzed the data, however, they were unable to find a survival benefit linked to radiation treatment after surgery.

According to Sher, the therapy typically costs between $10,000 and $15,000.

"That being said," he added, "if it prevents the recurrence it also saves a lot of money later."

Dr. Benjamin Smith, of the University of Texas MD Anderson Cancer Center in Houston, said the kind of patients in the new study have a grim prognosis, with at most 20 to 30 percent surviving more than five years.

"Some physicians want to try to do everything they can to get a benefit," said Smith, who wasn't involved in the research. "This data, however, makes me reconsider whether or not there truly is a benefit with respect to patient survival, which at the end of the day is the most important outcome."

He said immediate side effects of radiation include fatigue, skin reactions and pain when swallowing. Down the road, it may also weaken the heart and the lungs.

"I don't think that radiation is likely to cause life-threatening side effects, but it is certainly inconvenient and can impair a patient's quality of life," Smith told Reuters Health.

There is currently a rigorous clinical trial under way that may shed more light on whether postoperative radiation is a good idea for lung cancer that turns out to have invaded the lymph nodes in the chest -- a relatively uncommon scenario.

Meanwhile, patients and doctors should weigh the pros and cons together, said Smith.

"It's worth patients having a discussion with their surgeon and radiation oncologist about whether or not to do radiation after surgery," he said.

SOURCES: http://bit.ly/h73jcS Cancer, online February 13, 2012.

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