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Good morning and I do not want to get up today! (Washington, DC) Today, the U.S. Food and Drug Administration (FDA) approved the drug, BENLYSTA®, for the treatment of lupus, an autoimmune disease.
Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA), has issued the following statement regarding the FDA’s decision:
“This is a historic day for the millions of people with lupus and their families around the world who have waited more than 52 years for a treatment breakthrough for lupus. We at the LFA applaud the FDA’s decision to approve BENLYSTA®. BENLYSTA is the first drug ever to be specifically developed to treat lupus, and is a significant first step toward reaching our goal of developing an arsenal of new, safe, effective, and tolerable treatments. Today marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease.
“The LFA wishes to thank the physicians, researchers, industry leaders, and the many study volunteers who made this day possible. We also extend a special thank you to BENLYSTA®’s developers, the staff of Human Genome Sciences and GlaxoSmithKline, who have long been committed to the research and development process. These efforts will go a long way in elevating the profile of this disease that remains a significant national public health problem.
“There are a number of pioneering biotechnology and pharmaceutical companies, involved in the research and development of new treatments for lupus, and our hope is that today’s decision will further stimulate additional companies to invest in new therapies for lupus. To build on this momentum and encourage the development of new treatments, the LFA has launched new initiatives that help to strengthen clinical trials. These programs include the launch of a Web-based program designed to train clinical investigators on the instruments used in trials. As well, the LFA recently implemented the LFA Lupus Research Registry which enables individuals to be notified about new clinical trials in their geographic area. The Registry is part of the LFA’s Center for Clinical Trials Education.
“The LFA also is partnering with key stakeholders from industry, government, and the scientific community to evaluate data from previous lupus clinical trials with the goal to improve the design of future studies.”
About the LFA’s National Research Program
The LFA’s National Research Program: Bringing Down the Barriers®, is dedicated to addressing research issues that have for decades obstructed basic biomedical, clinical, epidemiological, behavioral, and translational lupus research. The LFA’s approach to research is unique because it directs its funding to areas of research where gaps exist in the understanding of lupus, and to promising areas of study in which other public and private organizations have not focused their efforts. Using a three-pronged strategy, the LFA and its national network are committed to advancing the science and medicine of lupus by: directly funding research to close the gaps in lupus research; advocating for expanded investment in research from public and private sources; leading special initiatives and forging collaborative efforts among stakeholders to address critical issues to advancing the science and medicine of lupus. For more information about the LFA’s National Research Program, visit www.lupus.org/research.
"Flannery O'Connor is considered one of America's greatest fiction writers and one of the strongest apologists for Roman Catholicism in the twentieth century. Born ofthemarriageof two of Georgia's oldest Catholic families, O'Connor was a devout believer whose small but impressive body of fiction presents the soul's struggle with what she called the "stinking mad shadow of Jesus."
Life and Literary Education
Mary Flannery O'Connor was born in Savannah on March 25, 1925, to Regina Cline and Edward F. O'Connor. She began her education in the city's parochial schools. After the family's move toMilledgeville in 1938, she continued her schooling at the Peabody Laboratory School associated with Georgia State College for Women (GSCW), now Georgia College and State University. When she was fifteen, O'Connor, an only child, lost her father to systemic lupus erythematosus, the disease that would eventually take her own life at age thirty-nine. Devastated by the loss of this close relationship, O'Connor elected to remain in Milledgeville and attend GSCW as a day student in an accelerated three-year program.
In 1945 O'Connor received a scholarship in journalism from the State University of Iowa (now the University of Iowa). In her first term, she decided that journalism was not her metier and sought out Paul Engle, head of the now world-famous Writers' Workshop, to ask if she might enter the master's program in creative writing. Engle agreed, and O'Connor is now numbered among the many fine American writers who are graduates of the Iowa program. While there she got to know several important writers and critics who lectured or taught in the program, among them Robert Penn Warren, John Crowe Ransom, Austin Warren, and Andrew Lytle. Lytle, for many years editor of the Sewanee Review, was one of the earliest admirers of O'Connor's fiction. He later published several of her stories in the Sewanee Review, as well as critical essays on her work. Engle years after declared that O'Connor was so intensely shy and possessed such a nasal southern drawl that he himself read her stories aloud to workshop classes. He also asserted that O'Connor was one of the most gifted writers he had ever taught. Engle was the first to read and comment on the initial drafts of what would become Wise Blood, her first novel, published in 1952.
O'Connor's master's thesis was a collection of short stories entitled The Geranium, the title work having already become her first published story (Accent, 1946). Most stories in this collection, however, are the work of an apprentice in search of her own territory and voice; they suggest only faintly the sharp wit, finely honed style, and spiritual scope of O'Connor's mature work. "The Turkey" most genuinely represents the significant connection between language and belief that came to pervade O'Connor's work. This story also reveals her ear for southern dialect and marks one of her first attempts at the literary irony for which she later became famous.
Following the completion of her M.F.A. in 1947, O'Connor won the Rinehart-Iowa Fiction Award for a first novel (for her submission of a portion of Wise Blood) and was accepted at Yaddo, an artists' retreat in Saratoga Springs, New York. There she continued to work on the novel and became friends with the poet Robert Lowell. In 1949, after several months at Yaddo and some time in New York City and Milledgeville, O'Connor moved into the garage apartment of Sally and Robert Fitzgerald in Ridgefield, Connecticut, where she boarded for nearly two years. In the Fitzgeralds, O'Connor found devout Catholics who provided her with the balance of solitude and communion necessary to her creativity and her intellectual and spiritual life.
This stabilizing and productive time was interrupted in 1950, however, when O'Connor was stricken with lupus, the incurable, autoimmune disease that was then treated only by the use of steroid drugs. O'Connor survived the first life-threatening attack, but she was forced to return to Milledgeville permanently. Remaining in this historic central Georgia town for the rest of her life, from 1951 until 1964, O'Connor lived quietly at Andalusia, the family farm just outside town. In spite of the debilitating effects of the drugs used for treating lupus, O'Connor managed to devote a good part of every day to writing, and she even took a surprising number of trips to lecture and read from her works."
I was thrilled to find such a remarkable woman who accomplished so much in her relatively short life, in spite of her Lupus, a disease that followed her from her childhood (with the death of her father from SLE Lupus) to her own in 1964. It is important to note that she was inducted into the Georgia Writer's hall of fame in 2000, and in my opinion is an incredible individual, who achieved a great deal while living with her Lupus.
For more information check out the New Georgia Encyclopedia at www.georgiaencyclopedia.org
