Monday, June 14, 2010

Drugmakers Agree to Share Alzheimer's Research Data in Search of Breakthrough

a dozen drug companies agreed to share data on Alzheimer's patients
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 (JNJ) pushed back results from a much anticipated Alzheimer's trial to 2012, and Medivation's (MDVN) and Pfizer's (PFE) 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 (AZN), Roche's (RHHBY) Genentech, GlaxoSmithKline (GSK), Abbott (ABT), Sanofi-Aventis (SNY), Novartis (NVS), Eli Lilly (LLY), 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.

Ottawa doctor to study blocked veins in MS patients

A scan displayed by Italian Dr. Paolo Zamboni shows a partially blocked vein in an MS patient.
A scan displayed by Italian Dr. Paolo Zamboni shows a partially blocked vein in an MS patient.

An Ottawa doctor is one of seven in North America to receive a grant to study a new theory linking blocked veins to multiple sclerosis, a chronic and often disabling disease targeting the brain and spinal cord.
The MS Society of Canada and the National MS Society in the United States have announced more than $2.4 million to fund research looking into the theory, which grabbed international headlines when an Italian physician found abnormalities in the veins of people who suffer from MS.
Dr. Paolo Zamboni's research suggests some of the symptoms of MS may be caused by blocked veins in the neck or spine, which he believes leads to a higher density of iron deposits on the brain. He dubbed the condition Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Now, four research projects will get underway in Canada to determine if blocked veins in the neck and spine are common among MS patients.
In Ottawa, Dr. Carlos Torres of the Ottawa Hospital is receiving $100,000 over two years to use MRI technology to explore whether vein structure and iron deposits on the brain are unique to people who have MS.
The study will investigate both MS patients and healthy volunteers of the same age to determine if there are any differences.
If vein blockages are found in MS patients, the MS Society says the research could speed up treating the condition.
The MS Society hopes the research will help determine if blocked or narrow veins are the cause of MS, or related to the disease in some other way. The studies are also aimed at identifying the best way to screen for the condition.
The MS Society of Canada has committed $700,000 to the Canadian research. The two-year grants will begin on July 1.

Miracle Twins Joined at Head, Share a Brain

Our plan for tonight includes a report from Neal Karlinsky about a pair of 3-year-old twin girls conjoined at the head -- two children who share parts of the same brain and cannot be separated.
Tatiana and Krista Hogan, of British Columbia, Canada, are craniopagus twins. According to their pediatric neurologist, Dr. Dog Cochrane, they may be the only twins to share a common neurological connection.
Their mother, Felicia, believes the unique connection may give the children special powers, like the ability to see through each other's eyes.
What we found on our visit with them, and as you will see tonight, is two girls who have learned ways to play together and live together in coordination.
There are, of course, major health concerns, particularly Tatiana's enlarged heart that pumps blood to her twin's shared brain.

Sex addiction may be caused by neurological damage: Study

New research suggests sex addiction is a dysfunction in a critical brain region that controls decision-making.
  New research suggests sex addiction is a dysfunction in a critical brain region that controls decision-making.
Sex addiction is more than the latest celebrity disorder du jour, but a dysfunction in a critical brain region that controls decision-making, new research suggests.
Dr. Lique Coolen, Canada Research Chair in the Neurobiology of Motivation and Reward, and colleagues have found that rats with a damaged prefrontal cortex become compulsive sex seekers.
Coolen says the prefrontal cortex, located in the front part of the brain, normally acts as a break on self-destructive behaviour.
"We're always very cautious to draw parallels between studies in rodents with human behaviours," she says. But Coolen believes hyper-sexuality doesn't deserve the bad press it has recently attracted.
"My concern is with all these celebrities claiming they have sex addiction. I read the newspaper just like everyone else. A first gut reaction is to say, 'Oh, come on, this is just an excuse that people are using.'
"I think that that really damages or hurts people who really truly suffer from hyper-sexuality. They may feel even more inhibited to talk to their physicians about it and ask for help."
"Hyper-sexual disorder" is being recommended for inclusion in psychiatry's official manual of mental illness. The disorder would refer to men and women with recurrent "out-of-control" sexual behaviours. They may be consumed by pornography or cybersex, for example, or repeatedly engage in one-night stands or affairs, according to the criteria being developed for inclusion in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.
The brain's prefrontal cortex appears to play a role in many addictions or compulsive behaviours, says Coolen, a professor in the department of anatomy and cell biology at the University of Western Ontario in London.
For their study, she and her colleagues taught male rats to associate mating with "a very negative consequence:" Every time the animals copulated, the male rodents were injected with a compound that made them sick to their stomachs.
"The animal really learns to associate, 'I'm going to mate and I know I'm going to get sick afterwards," Coolen says.
Normally, it takes about four association trials for the rodents to stop initiating sex. "They see the female and try to get as far away from her as they can," Coolen says.
But when the researchers made lesions in the prefrontal cortex, the rats continued to copulate, "even though they knew the mating was associated with illness."
It may not be damage, per se, that's needed to affect the brain's inborn break on compulsive behaviour. Rather, it could be caused by a irregularity or change in the expression of certain proteins, or changes in the connections between brain cells.
"That has to be the next step in this research," Coolen says, "understanding what are the actual chemicals that are important for the function of the prefrontal cortex in inhibiting these behaviours."
It's too early to know whether prefrontal cortex dysfunction causes hyper-sexuality in humans. "But I do think that this research indicates that this is something we should look for," Coolen says.

Harmless Brain Abnormalities in Kids Pose Disclosure Dilemmas

Doctors need guidelines for discussing anomalies found in 'routine' MRIs, researchers say

MONDAY, June 14 (HealthDay News) -- Unexpected but benign anomalies are often detected in children who undergo "routine" brain MRIs, and guidelines need to be developed to help pediatricians handle these findings, a new study suggests.
"Doctors need to figure out what, if anything, they want to share with parents about such findings because they seldom require urgent follow-up," senior investigator Dr. John Strouse, a hematologist at Johns Hopkins Children's Center, said in a Hopkins news release.
The most common reasons for MRI testing in children are seizures and headaches, or as a requirement for enrollment in certain medical studies.
Strouse and colleagues looked at 953 children, predominantly black and aged 5 to 14, who underwent brain MRIs before enrolling in a study about sickle cell disease, which they all had. Of those children, 63 (6.6 percent) had a total of 68 abnormal brain findings, none of which were related to their underlying condition. None of those 63 children required emergency treatment and only six children (0.6 percent) required urgent follow-ups.
Because unexpected findings often lead to unnecessary tests and fear, pediatricians need to be prepared to deal with such findings, Strouse said. But many feel at such a loss that they either don't have a discussion with the parents or simply refer the child to a neurologist or neurosurgeon for consultation.
"Helpful as it is, imaging technology can open a Pandora's box, sometimes showing us things we didn't expect to see and are not sure how to interpret," lead investigator Dr. Lori Jordan, a pediatric neurologist, said in the news release.