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.