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News in Brief
The National Institute of Neurological Disorders and Stroke (NINDS) announced on March 22 the launch of a Phase III clinical trial of creatine, a nutritional supplement, to determine its potential to slow the progression of Parkinson’s disease. The double-blind, placebo-controlled study will enroll 1,720 people with early Parkinson’s at 51 medical centers in the US and in Canada.
The creatine trial is the first in a series of NINDS-sponsored clinical research programs called NET-PD (NIH Exploratory Trials in Parkinson’s Disease). The program is designed to determine whether certain known compounds can be used as treatments to protect the brain cells of people living with Parkinson’s disease. Some research has indicated that creatine may improve the function of mitochondria, the energy center of the cell, and may work as an antioxidant.
Participants will be enrolled for five to seven years, and eligibility is limited to people who have been diagnosed with Parkinson’s within the past five years (and only treated for two years or less with dopaminergic medications). Half of the people in the study will receive creatine, and the other half will receive a placebo.
Pergolide Pulled from Market
On March 29, the US Food and Drug Administration (FDA) announced that the manufacturer of pergolide, a dopamine agonist used for almost 20 years in treating the symptoms of Parkinson’s disease, has agreed to withdraw the drug from the market because of reports linking the drug to increased risk of heart valve damage.
Permax® (pergolide), marketed by Valeant Pharmaceuticals, and two generic versions manufactured by Par and Teva, have been used in combination with carbidopa/levodopa to treat Parkinson’s symptoms. The FDA urged pergolide users not to discontinue taking pergolide instantly, out of concern that abrupt withdrawal could be dangerous. Instead, they are being advised to contact their physicians immediately to determine alternative treatment options. Therapies that can be used in place of pergolide include three dopamine agonists that have not been associated with valve damage.
The withdrawal was prompted by two studies recently published in The New England Journal of Medicine that demonstrated a risk of heart valve damage of up to 20 percent with pergolide use. When heart valves are damaged, they no longer make a perfect seal between heartbeats. As a result, blood pumped by the heart into the circulation will leak back into the heart after each contraction, a condition known as “valve regurgitation” that increases the heart’s workload, leading to heart failure and even death.
New York State Government Approves $100 Million for Stem-Cell Research
On April 1, the New York State Legislature passed momentous legislation to fund stem-cell and regenerative medicine research, allocating $100 million for the fiscal year that began on that day. An additional $500 million was voted for the next 10 years, and advocates are hoping for more funds through annual appropriations.
This new funding will offer hope for finding cures for a number of chronic and degenerative conditions such as spinal cord injury, type 1 diabetes and Parkinson’s. The money will be administered by a new Empire State Stem Cell Fund.
In response to the restrictions placed on embryonic stem-cell research by President Bush in 2001, several states have begun providing funding of their own for this potentially groundbreaking science. This decisive act will make New York the second largest state funder of stem-cell research in the nation after California (which passed a $3 billion bond initiative in 2004).
In 2003, PDF convened New Yorkers for the Advancement of Medical Research (NYAMR) — a statewide pro-stem cell coalition of 46 universities, health advocacy groups and citizens’ organizations that is chaired by PDF’s Executive Director, Robin Elliott. NYAMR was active in helping to craft the legislation allocating funds to this critical research, as well as in submitting nominations for the proposed governing board and drafting a governance plan.
PDF thanks everyone who has helped to reach this milestone, including Governor Eliot Spitzer and Lt. Governor David Paterson, for their leadership and conviction.