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National report shines light on lupus 50-year treatment drought
October 05, 2009Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years - since the Eisenhower Administration. The recommendations are included in the report, "Overcoming Barriers to Drug Development in Lupus," which is the outcome of a 9-month study commissioned by the Lupus Foundation of America, Inc. (LFA). The recommendations highlight the need for a national collaborative and coordinated effort among key stakeholders, including the FDA, the National Institutes of Health (NIH), researchers and scientists from academia, the LFA, and industry, to implement a range of initiatives that would create a path forward to develop a robust arsenal of safe, effective, and more tolerable treatments for this difficult to treat and devastating disease.
The report provides recommendations for each of the key stakeholders, which include expanding federal support for medical research on lupus, assessing the existing standard of care used in clinical trials, examining the interpretation of regulations pertaining to clinical trial design and related standards of evidence used to evaluate investigational drugs for lupus, expediting the discovery and validation of lupus biomarkers, and more.
As part of the research conducted to prepare this independent report, in June 2009 more than 40 international lupus experts and thought leaders from government, industry, and the scientific community convened in Washington, DC to discuss the barriers to lupus drug development. This groundbreaking effort represents the first time leaders from all sectors with a broad range of informed opinions were brought together to address the unique challenges of lupus drug development and ways to overcome them.
Lupus is a chronic, severe autoimmune disease that affects approximately 1.5 million Americans − primarily women in their childbearing years. In its more severe form lupus can lead to kidney failure, heart attack, atherosclerosis, or even death. According to the report, lupus "stands apart" from other chronic autoimmune diseases because the majority of therapies currently used to effectively manage lupus have not been approved by the FDA for the disease. Many of these medications often have side effects that can be worse than the primary disease, including osteoporosis, weight gain, high blood pressure, diabetes, sterility, liver damage, and the increased risk of infection.
"The recommendations are a call to action requiring the efforts of all key stakeholders," said Sandra C. Raymond, LFA President and CEO. "They provide the foundation for developing and obtaining approval for the arsenal of therapies and personalized treatment that people with this perilous disease require."
The report states that the persistent lack of success of lupus clinical trials has consequences for the willingness of drug manufacturers to pursue FDA approval and indicates "some in industry perceive no clear pathway or system in place for the development of lupus therapies."
"The report findings demonstrate that the pharmaceutical and biotechnology industries cannot develop lupus treatments in a vacuum," said Rick Goulburn, Executive Vice President - Global Autoimmune Therapy Area at Vifor Pharma. "We need more collaboration and partnership across all sectors of the field, greater investment by the federal government in basic lupus research, and continued leadership from the LFA and the entire scientific community."
Lupus drug development has had many setbacks in recent years including the failure of several promising new treatments. However, much has been learned from these trials and potentially greater insight can be gained if the data is evaluated collectively.
An immediate outgrowth of the expert panel meeting held in June is the LFA Collective Data Analysis Initiative (LFA CDAI), chaired by Kenneth Kalunian, M.D., Professor of Medicine, Division of Rheumatology, Allergy and Immunology, at the University of California, San Diego, to advance the knowledge of lupus and optimize clinical trial design by researching data from previous and existing lupus clinical trials.
"The lupus community certainly recognizes the urgent need for collaboration," said Dr. Kalunian. "Following the expert panel meeting, working groups were immediately established to begin tackling the recommendations that were identified. When fully implemented, these initiatives will help gain needed insight on the issues which have plagued lupus clinical trials and develop more effective ways to design them, so ultimately lupus trials can be completed successfully."
Lupus Foundation of America, Inc.
Lupus is a chronic, severe autoimmune disease that affects approximately 1.5 million Americans − primarily women in their childbearing years. In its more severe form lupus can lead to kidney failure, heart attack, atherosclerosis, or even death. According to the report, lupus "stands apart" from other chronic autoimmune diseases because the majority of therapies currently used to effectively manage lupus have not been approved by the FDA for the disease. Many of these medications often have side effects that can be worse than the primary disease, including osteoporosis, weight gain, high blood pressure, diabetes, sterility, liver damage, and the increased risk of infection.
"The recommendations are a call to action requiring the efforts of all key stakeholders," said Sandra C. Raymond, LFA President and CEO. "They provide the foundation for developing and obtaining approval for the arsenal of therapies and personalized treatment that people with this perilous disease require."
The report states that the persistent lack of success of lupus clinical trials has consequences for the willingness of drug manufacturers to pursue FDA approval and indicates "some in industry perceive no clear pathway or system in place for the development of lupus therapies."
"The report findings demonstrate that the pharmaceutical and biotechnology industries cannot develop lupus treatments in a vacuum," said Rick Goulburn, Executive Vice President - Global Autoimmune Therapy Area at Vifor Pharma. "We need more collaboration and partnership across all sectors of the field, greater investment by the federal government in basic lupus research, and continued leadership from the LFA and the entire scientific community."
Lupus drug development has had many setbacks in recent years including the failure of several promising new treatments. However, much has been learned from these trials and potentially greater insight can be gained if the data is evaluated collectively.
An immediate outgrowth of the expert panel meeting held in June is the LFA Collective Data Analysis Initiative (LFA CDAI), chaired by Kenneth Kalunian, M.D., Professor of Medicine, Division of Rheumatology, Allergy and Immunology, at the University of California, San Diego, to advance the knowledge of lupus and optimize clinical trial design by researching data from previous and existing lupus clinical trials.
"The lupus community certainly recognizes the urgent need for collaboration," said Dr. Kalunian. "Following the expert panel meeting, working groups were immediately established to begin tackling the recommendations that were identified. When fully implemented, these initiatives will help gain needed insight on the issues which have plagued lupus clinical trials and develop more effective ways to design them, so ultimately lupus trials can be completed successfully."
Lupus Foundation of America, Inc.
Lupus Current Events and Lupus News RSSSaliva proteins change as women age
In a step toward using human saliva to tell whether those stiff joints, memory lapses, and other telltale signs of aging are normal or red flags for disease, scientists are describing how the protein content of women's saliva change with advancing age.
Smokers with common autoimmune disorder at higher risk for skin damage
As if there weren't enough reasons to stop smoking, a team of researchers at the Research Institute of the McGill University Health Centre (RI-MUHC) have just found another.
Kidney transplants generally safe for lupus patients
Individuals with a history of lupus who receive a kidney transplant rarely develop the serious inflammatory condition lupus nephritis in their new organ, according to a paper being presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, CA.
Iberian wolves prefer wild roe deer to domestic animals
A Spanish researcher has analysed the preferences of wolves from the north east of the Iberian Peninsula to demonstrate that, in reality, their favourite prey are roe deer, deer and wild boar, ahead of domestic ruminants (sheep, goats, cows and horses).
OMRF scientists discover promising new path for treating traumas
A discovery by scientists at the Oklahoma Medical Research Foundation could help save lives threatened by traumatic injuries like those sustained in car crashes or on the battlefield. The work also holds potential for treating severe infectious diseases and diabetes.
Lupus patients perceive benefit from cardiovascular disease prevention counseling program
According to a new study by Hospital for Special Surgery investigators presented at the American College of Rheumatology meeting on October 21 in Philadelphia, most lupus patients are not aware that their condition puts them at a higher risk for cardiovascular disease and a counseling program is a valuable way to promote education and lifestyle change.
Stanford study identifies cellular mechanism that causes lupuslike symptoms in mice
Macrophages, the scavenger cells of the body's immune system, are responsible for disposing of dying cells. Stanford University School of Medicine researchers have identified one pathway in this important process in mice that, if disrupted, causes a lupuslike autoimmune disease.
Promising new target emerges for autoimmune diseases
University of Michigan scientists say they have uncovered a fundamentally new mechanism that holds in check aggressive immune cells that can attack the body's own cells.
McGill/JGH researchers successfully reverse multiple sclerosis in animals
A new experimental treatment for multiple sclerosis (MS) completely reverses the devastating autoimmune disorder in mice, and might work exactly the same way in humans, say researchers at the Jewish General Hospital Lady Davis Institute for Medical Research and McGill University in Montreal.
Taking the Needle's Sting Out of Diabetes
Found in 30% of all human cancer tumors, the Ras protein literally "drives cells crazy," says Prof. Yoel Kloog, the dean of the Faculty of Life Sciences at Tel Aviv University. Prof. Kloog was the first in the world to develop an effective anti-Ras drug against pancreatic cancer, currently in clinical trials.
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