The Obama administration asked a federal judge on Tuesday to lift an injunction halting human embryonic stem cell research, saying it would irreparably harm research and cost more than 1,300 jobs.

The Justice Department also appealed against the injunction by Judge Royce Lamberth in which he ruled National Institutes of Health funding of human embryonic stem cell research violated a law called the Dickey-Wicker Amendment, which bars federal funding of work that involves destroying embryos.

The administration said Lamberth’s ruling was overly broad and was having a significant negative impact on embryonic stem cell research, arguing that there was “serious doubt” Congress intended the legislation to be so encompassing.

“Numerous ongoing projects will likely not survive even a temporary gap in funds, jeopardizing both the potential benefit of the research and the hundreds of millions of dollars of taxpayer funds already invested in it,” the filing said.

The Justice Department asked Lamberth to rule by September 7 on the request to lift his injunction.

Lamberth’s injunction was a setback for President Barack Obama and the issue could become a theme in November elections where his fellow Democrats who control both chambers of Congress are facing tough races.

One of Obama’s first acts after taking office in 2009 was to broaden federal funding of human embryonic stem cell research — a controversial decision because some people oppose any destruction of human embryos, even for medical research.

Dr. James Sherley, a biological engineer at Boston Biomedical Research Institute, and Theresa Deisher of Washington-based AVM Biotechnology sued, saying Obama’s policy violated Dickey-Wicker and harmed their own chances of getting funding for similar research not involving embryos.

SELF-INTEREST

Sherley and Deisher’s “remote economic self-interests do not outweigh the harm the injunction will cause NIH, the hundreds of affected human embryonic stem cell researchers, and the millions of individuals who hold out hope that human embryonic stem cell research will lead to the cure for, or treatment of, their currently incurable illnesses,” the Justice Department said.

The administration pointed to 24 projects up for renewed federal funding between now and the end of September and said the benefits from the research could be lost. If the projects ended, it would waste $64 million already invested, the administration said.

Overall, the injunction could put 1,300 jobs at risk, NIH Director Francis Collins said in a declaration to the court.

Earlier on Tuesday, Democratic Representative Diana DeGette said she would push to revive legislation specifically allowing federal funding of the research by the end of September.

“We need to pass legislation in September to fix this problem,” she told Reuters in a telephone interview.

DeGette co-sponsored bipartisan legislation that passed both the House and Senate twice and was twice vetoed by then-President George W. Bush.

DeGette said she believed there was support in the House and Senate, as well as in both parties, to push through legislation quickly.

Source: Reuters

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The National Institutes of Health named a committee on Monday to help guide research into the environmental and genetic causes of breast cancer.

The 19-member Interagency Breast Cancer and Environmental Research Coordinating Committee will meet in September to help decide where research money will be best spent.

“The broad range of expertise and insight of these individuals will ensure the federal research portfolio continues to advance our understanding of the critical links between our environment, our genes, and our health,” said Linda Birnbaum, director of the NIH’s National Institute of Environmental Health Sciences.

Members of the panel include experts at federal agencies, doctors and advocates.

Congress mandated the panel last year, said Gwen Collman of the NIEHS, who will help facilitate the committee’s work.

“It was Congress who decided there was a need for some oversight and strategic organization of breast cancer research,” Collman said in a telephone interview.

Scientists realized the importance of including advocacy groups when discussing research and where best to spend money, she said.

“I think this experience of having advocates speak to scientists and vice versa has begun a process where there is education on both ends on what’s important here.”

One in eight U.S. women will be diagnosed with breast cancer, the second-leading cause of cancer death among American women after lung cancer. It kills 500,000 people globally every year and is diagnosed in close to 1.3 million people.

The risk rises as a woman gets older and several genes are linked with breast cancer. Obesity, use of hormones, and childbearing also affect the risk but a significant percentage of cases cannot be explained yet.

Death rates from cancer are falling in the United States, but many people fear chemicals or other outside factors may cause a variety of cancers, and researchers are keen to ensure that scarce research dollars are spent in the best way.

Source: Reuters

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A gene linked with the immune system may play a role in developing Parkinson’s disease, researchers said on Sunday, marking a possible advance in the search for effective treatments.

They said a gene in the human leukocyte antigen region or HLA — which contains a large number of genes related to immune system function — was strongly linked with Parkinson’s disease.

“That means the immune system probably plays a role in your body developing Parkinson’s disease,” said Dr. Cyrus Zabetian of the University of Washington and Veteran’s Administration Puget Sound Health Care System, whose study appears in the journal Nature Genetics.

Zabetian said there had been hints that the immune system may be linked to Parkinson’s disease, a neurodegenerative disease that affects 1 to 2 percent of people over age 65.

“This is the best evidence we’ve seen so far,” Zabetian said in a telephone interview.

The finding came from a large, long-term study of more than 2,000 Parkinson’s disease patients and 2,000 healthy volunteers from clinics in Oregon, Washington, New York and Georgia.

Parkinson’s sufferers have tremors, sluggish movement, muscle stiffness and difficulty with balance.

Researchers looked at clinical, genetic and environmental factors that might contribute to the development and progression of Parkinson’s disease and its complications.

“We found strong evidence that a gene within the HLA region is associated with Parkinson’s disease,” Zabetian said.

HLA genes play an important role in helping the body discern between foreign invaders and the body’s own tissues.

“We don’t know specifically which gene because there is a cluster of genes in that region, but it is the first really strong link that the immune system plays a role,” he said.

That may mean infections, inflammation or an auto-immune response play some role in the development of Parkinson’s disease, Zabetian said.

“What this allows us to do is to hone in on the immune system,” he said.

Although current medical treatments may improve symptoms, none can slow or halt the progression of the disease.

The study was funded in part by the National Institute of Neurological Disorders and Stroke, one of the National Institutes of Health.

Source: Reuters

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We like taking potshots at Big Pharma, and often deservedly so. But critics may take a break when they consider the recent move by a dozen competing drug companies, which have agreed to share data on thousands of Alzheimer’s patients who participated in failed clinical trials. The idea behind the move is that the shared data will help accelerate new treatment research on brain diseases.

Alzheimer’s disease is a progressive, incurable and fatal brain disease that destroys brain cells, causing memory loss and problems with thinking and behavior severe enough to affect all aspects of life.

Roughly 6.5 million people in the U.S. are afflicted with Alzheimer’s and Parkinson’s diseases, with costs reaching as much as $175 billion annually. The number of those afflicted is growing as the population ages.

Challenging Scientific Research

Alzheimer’s has been a particularly tough area of research, with little to show for the millions spent. Just in March, Johnson & Johnson pushed back results from a much anticipated Alzheimer’s trial to 2012, and Medivation’s and Pfizer’s late-stage trial for the Alzheimer’s drug Dimebon failed to hit its efficacy goals.

Not only that, but over the past few months, some new research has suggested that drugs being investigated for Alzheimer’s disease may be causing further neural degeneration and cell death. The new theory is that brain plaque has a protective role, rather than a destructive one, which would explain the failure of so many drugs.

With the National Institutes of Health concluding that none of the methods attempted to prevent, delay or reduce the severity of Alzheimer’s disease have proved to work, and with no treatment progress to speak of, the situation seems bleak.

Sharing Failed Drug Trials Data

A new database may offer some hope. In it, data on more than 4,000 Alzheimer’s patients who have participated in 11 industry-sponsored clinical trials of failed drug candidates will be released by the Coalition Against Major Diseases (CAMD). The database will be shared by pharmaceutical companies and researchers around the world in the hopes it will assist in making progress against Alzheimer’s, Parkinson’s, Huntington’s and other neuro-degenerative diseases.

Of course, still unable to take the leap to full transparency, the secretive pharmaceuticals will only share data on those patients in the placebo arm, the Financial Times reported. Still, the data should help provide researchers with valuable information, especially in developing biomarkers, or biological measurements that can be used to assess progress in tackling Alzheimer’s. The shared data will be detailed, including memory tests, brain scans and blood samples, the Associated Press reported.

“Companies said they’re running into a stone wall with Alzheimer’s and Parkinson’s,” Ray Woosley, chief executive of the Critical Path Institute, told The Wall Street Journal. “We really believe drugs are failing because we honestly don’t understand the disease.” The data could help researchers find meaningful trends that may suggest what to study next.

While it’s no doubt going to be difficult to comb through the data, it’s better than not being able to access the data at all. And perhaps no less important, it could improve the industry’s R&D productivity as they lessen duplicate failed efforts.

The CAMD database will also allow researchers to design more efficient clinical trials. The pharmaceutical members have also agreed to use the new standard in their future submissions for drug approvals, making the FDA’s review process more efficient.

Pharmaceuticals, Government, Research and Patient Groups Collaborate

The effort is supported by the U.S. Food and Drug Administration and includes advisers such as the European Medicines Agency, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. CAMD is led and managed by the non-profit Critical Path Institute, or C-Path.

Among members of CAMD are such pharmaceutical giants as AstraZeneca, Roche’s Genentech, GlaxoSmithKline, Abbott, Sanofi-Aventis, Novartis, Eli Lilly, J&J and Pfizer. The coalition also includes research foundations and patient advocacy groups such as the Alliance for Aging Research, Alzheimer’s Association and Alzheimer’s Foundation of America, among others.

Alzheimer’s disease afflicts 30 million people worldwide, a number that may exceed 100 million by 2050, according to Alzheimer’s Disease International.

Source: DailyFinance

Popularity: 7% [?]

Johnson & Johnson, GlaxoSmithKline, AstraZeneca, Sanofi-Aventis and Abbott Labs are releasing results from 11 failed Alzheimer’s programs with the hope that the information will help researchers better understand the disease. Alzheimer’s is a difficult-to-treat condition and clinical successes are few and far between. More drugmakers, along with the National Institutes of Health, plan to join the coalition in the future. The project is backed by the FDA and Science Foundation Arizona and will be monitored by the Critial Path Institute.

“Companies said they’re running into a stone wall with Alzheimer’s and Parkinson’s,” Ray Woosley, chief executive of the Critical Path Institute, tells the Wall Street Journal. “We really believe drugs are failing because we honestly don’t understand the disease.” This first wave of data includes information on 4,000 patients. Allowing researchers to study a larger pool of patients will help them see how the disease progresses, identify subgroups, and–hopefully–develop more sophisticated computer models that could save time and money developing drugs.

The project is the FDA’s response to criticism that it does more to hinder innovation than promote it. “I think the FDA recognizes that one thing that can accelerate drug development is sharing information that is relevant to a disease,” FDA Deputy Commissioner Joshua Sharfstein noted. The coalition against Major Diseases also hopes to pool Big Pharma’s results for Parkinson’s disease and tuberculosis drugs.

Source: FierceBiotech

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Major drugmakers will share data from their clinical trials for Alzheimer’s and Parkinson’s disease in an effort to speed the development of new medicines to treat the brain disorders.

The database, a public/private partnership to be announced on Friday, will give academic and industry researchers worldwide access to information from more than 4,000 patients with neurodegenerative diseases.

Bringing the data together, rather than keeping pieces of it within each drug company, will give scientists a larger amount of information on how the diseases progress and how they differ in various patients.

Backers hope the approach will jump start research into treatments for some of the toughest and most common brain disorders. Despite decades of study, doctors still have few effective treatments for Alzheimer’s disease, which affects more than 26 million people globally. It is the most common form of dementia.

An estimated four million people worldwide have Parkinson’s disease, which causes trembling and other symptoms.

Information in the new database should help drugmakers design more efficient clinical trials of potential treatments, said Dr. Raymond Woosley, president and chief executive of the Critical Path Institute, a nonprofit organization working to improve drug development.

Some patients, for example, develop Alzheimer’s in their 80s while for others it starts in their 40s, Woosley said. The disease probably evolves differently in those groups, but companies only have small numbers in each age range to study in their own trials.

“If you have 4,000 patients (in the database), you begin to have enough data to see their real course” and can target a drug to specific types of patients, Woosley said in an interview.

The database is coordinated by the Coalition Against Major Diseases, an organization of patient groups and 13 drugmakers that is part of the Critical Path Institute.

Companies in the coalition include Pfizer Inc, GlaxoSmithKline PLC, Johnson & Johnson and Sanofi-Aventis.

Officials from the Food and Drug Administration, the National Institutes of Health and the European Medicines Agency serve as advisers.

Source: Reuters

Popularity: 5% [?]

There’s not enough evidence to suggest that medicines or dietary supplements prevent Alzheimer’s disease or cognitive decline, an independent committee of experts convened by the National Institutes of Health concluded today.

The three-day meeting of 15 experts took a critical look at the state of science surrounding the memory-robbing disease, which is now the sixth-leading cause of death in the U.S. The main conclusion: there’s not enough good research out there to show that any intervention prevents the disease.

Some factors that appear to be related to decreased risk of Alzheimer’s include “cognitive engagement” like training people in reasoning and memory, walking and a Mediterranean diet. But there’s no consistent evidence that multivitamins, gingko biloba or other supplements can do anything to stave off the disease.

The experts didn’t find evidence that Alzheimer’s drugs like Pfizer and Eisai’s Aricept and Forest’s Namenda, approved to treat memory loss and other symptoms of the disease, are also effective in slowing or preventing dementia.

The panel hopes that the results about what does and doesn’t work will reach doctors and patients to better inform decision-making. “People should know that so they can decide how they’re going to spend their money,” said Carl Bell, a panel member and a professor at the University of Illinois at Chicago.

Source: The Wall Street Journal

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Imaging tests used to screen symptom-free people for lung cancer often find suspicious growths that turn out to not be cancer, according to a U.S. government study published Monday.

Researchers say the findings point to a significant downside of using the tests — chest X-rays or spiral CT scans — to try to detect lung cancer early.

In recent years, CT scans, in particular, have been promoted by some hospitals and advocacy groups for lung cancer screening, even though studies have not yet shown whether such screening saves lives.

“The most important thing right now is to try to figure out if this lowers death rates,” Dr. Jennifer M. Croswell, the lead researcher on the new study, told Reuters Health.

The current findings, she said, add “pieces to the puzzle” by estimating how likely a person is to have a false-positive result if he or she has repeat screening tests over time.

For the study, Croswell and her colleagues at the National Institutes of Health (NIH) followed nearly 3,200 smokers and former smokers who were randomly assigned to undergo either a chest X-ray or CT scan to detect potentially cancerous abnormalities. If the first result was normal, participants had another test one year later.

Overall, the study found, the chances of having a false-positive result — a suspicious lesion that turned out not to be cancer — were 21 percent after one CT scan, and 33 percent after two.

With chest X-rays, there was a 9 percent chance of a false-positive after one test, and a 15 percent chance after two, the researchers report in the Annals of Internal Medicine.

The problem with false-positives is that they can lead to needless follow-up procedures, as well as stress and anxiety for patients and their families.

That follow-up may include invasive tests, which carry some risks. More often, false-positive become apparent when patients have a follow-up CT scan or chest X-ray anywhere from a few months to a year later.

Those extra imaging tests are a concern, according to Croswell, because of the added radiation exposure. The CT scans are known as “low-dose” CT, but a single scan still carries a much higher radiation dose than a single chest X-ray, Croswell noted.

It is not yet known, she said, what the long-term risks of radiation exposure from repeated lung cancer screening might be.

In this study, 7 percent of participants with a false-positive CT result had an invasive follow-up procedure; most commonly, that meant a bronchoscopy, where a thin, camera-bearing tube is passed through the nose or mouth and threaded into the lungs’ airways.

But some patients had more-invasive procedures, such as a lung or lymph node biopsy. Eight ended up having major surgery for what turned out to be benign conditions.

Of study participants with a false-positive chest X-ray, 4 percent went on to have an invasive procedure.

The findings come from the pilot phase of an ongoing NIH clinical trial looking at whether CT or chest X-ray screening cuts death rates among people at increased risk of lung cancer. The trial, which began in 2002, ultimately enrolled more than 53,000 current and former smokers, and the results could become available in the next couple years, Croswell said.

Despite the current lack of proof that screening prevents deaths, certain hospitals and advocacy groups have been promoting CT scans, which cost anywhere from $300 to $1,000 per test, for lung cancer screening.

Both chest X-rays and spiral CT scans can detect small tumors in the lungs; the CT scans, which generate three-dimensional images of the lungs, are especially sensitive — detecting growths that are well below 1 centimeter in size. However, such abnormalities are frequently not cancer.

“Most professional medical societies do not recommend this (lung cancer screening) right now,” Croswell said, “and the reason is because we don’t know if it works.”

For smokers and former smokers who are nonetheless interested in lung cancer screening, Croswell said that they should be aware that there are “important downsides.” She suggested that they talk with their doctors about all the potential benefits and risks before making a decision.

However, Croswell pointed out, the most important thing a smoker can do about his or her lung cancer risk is to quit.

SOURCE: Annals of Internal Medicine, April 20, 2010.

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A brain implant made partly of silk can melt onto the surface of the brain, providing an “intimate” connection for recording signals, researchers reported on Sunday.

Tests of their device showed the thin, flexible electrodes recorded signals from a cat’s brain more accurately than thicker, stiff devices.

Such devices might help people with epilepsy, spinal cord injuries and even help operate artificial arms and legs, the researchers report in the journal Nature Materials.

John Rogers of the University of Illinois, Urbana and colleagues at the University of Pennsylvania and Tufts University in Boston made the electrode arrays using protein from silk and thin metal electrodes.

The silk is biocompatible and water-soluble, dissolving into the brain and leaving the electrodes draped over its contours, the researchers reported.

They tested them on cats who were anesthetized but whose eyes were functioning. The electrodes recorded the signals from the eyes of the cats as they were shown visual images.

“These implants have the potential to maximize the contact between electrodes and brain tissue, while minimizing damage to the brain,” said Dr. Walter Koroshetz of the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, which helped pay for the study.

“They could provide a platform for a range of devices with applications in epilepsy, spinal cord injuries and other neurological disorders.”

For instance, such a sensitive electrode could detect a seizure as it starts and deliver pulses to counter it. Brain signals might be routed to prosthetics for people with spinal cord and other injuries.

Silk is also transparent, strong and flexible, and it is possible to control the rate at which it dissolves.

Source: Reuters

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In the effort to try to delay and ultimately prevent Alzheimer’s disease, an important question needs to be answered: how to pay for the programs.

Many strategies are now in the works. At CFIT, a nonprofit program, members pay $4,000 annually. Kenneth S. Kosik, the program’s founder, helped raise more than $1 million in private donations to defray costs and offer scholarships, according to an article in today’s WSJ.

But other models are also being tried. The CDC and the Alzheimer’s Association, along with institutes that are part of the National Institutes of Health, created a public-health “road map’’ to cognitive health that would involve publicly funded programs.

In another effort, a pilot program was launched in March by SCAN Health Plan Arizona and a company called BrainSavers to reduce the risk of Alzheimer’s for 150 members of SCAN, a Medicare Advantage plan. Three times a week, the SCAN members ages 65 and older attend one-hour classes that combine cognitive exercises with strength-building and other physical exercises, stress reduction and tips on diet. The participants are evaluated for cognitive and physical fitness before the class begins, then again at three months and six months. Another 150 SCAN members not taking the classes are serving as a control group for comparison.

The pilot classes are taking place mainly at assisted living facilities in Phoenix, but Paul E. Bendheim, founder and CEO of BrainSavers, says his goal is to partner with health plans around the country that will offer the class as a member service at a network of participating health clubs.

Dr. Bendheim says that data from the Alzheimer’s Association indicates that Medicare spends three times as much for an Alzheimer’s patient as it does for someone the same age without Alzheimer’s. He says BrainSavers is in discussion with health plans in California, Utah and New Mexico, hoping they will foot the bill for classes for their members.

Source: The Wall Street Journal

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