50 Years is a Long Time to Wait for a Drug

Lupus, a chronic, severe automimmune disease that effects 1.5 million Americans, primarily women in their childbearing years, can lead to kidney failure, heart attack, atherosclerosis or death. According to a report issued yesterday by the Lewin Group, a health care consulting firm, 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. There has been no new drug approval for lupus in more than 50 years, since the Eisenhower Administration.

“Overcoming Barriers to Drug Development in Lupus,” the report, is the result of a nine-month study commissioned by the Lupus Foundation of America (LFA). The report recommends the need for FDA, NIH, academic researchers and scientists, and industry to work together on initiatives to develop safe, effective, and more tolerable treatments.

In light of this report, we refer back to a blog last month about DSG’s role in Phase III trials for  BENLYSTA, a drug that looks very promising for systemic lupus sufferers. DSG was instrumental in providing EDC expertise and direction for Human Genome Sciences, the sponsor of the trial.

While DSG Vice President of Data Management, Suzanne Lamerand, presents on both the necessity of 100% EDC and the site and monitor perspective on CRF/eCRF design at this years Society of Clinical Data Management (SCDM) annual meeting currently in progress in Seattle, those who suffer from lupus and their advocates at the LFA can be assured that while drug development may turn slowly, it turns positively with integrated relationships.