First IBD-Related Legislation is Considered by Congress
This landmark legislation would expand and enhance IBD research at the National Institutes of Health (NIH); establish an IBD prevention and epidemiology program at the Centers for Disease Control and Prevention (CDC); and require federal studies to identify barriers that IBD patients encounter when seeking insurance coverage and applying for Social Security disability.
"This bill will benefit millions of Americans who suffer from or who are at risk of developing Inflammatory Bowel Disease," said Sen. Harry Reid. "It promises to alleviate much suffering, to assist patients in accessing sound and effective medical treatment, and to benefit those who are debilitated by IBD."
Rodger L. DeRose, CEO of the Crohn's and Colitis Foundation of America (CCFA), testified May 9 before Congressional Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies on behalf of IBD sufferers nationwide. A major goal of the CCFA's government affairs committee is to increase IBD research at the NIH. The CCFA supports efforts to double the overall budget of the NIH over the next five years, and, concurrently, the foundation supports a doubling of the research for IBD over the same time span. CCFA also supports efforts to increase funding for programs run by the CDC, including their colon cancer surveillance program.
This year's testimony included three requests:
- To enact a 16 percent increase for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Allergy and Infectious Diseases (NIAID) and a corresponding increase for inflammatory bowel disease research at both institutes
- To earmark $1 million for the establishment of a national inflammatory bowel disease epidemiological program at the CDC
- To earmark $20 million for the CDC's national colorectal cancer screening awareness program
"Crohn's disease and ulcerative colitis are chronic disorders of the gastrointestinal tract which represent the major cause of morbidity and mortality from digestive illness," DeRose testified. "Because they behave similarly, these disorders are collectively known as inflammatory bowel disease (IBD). IBD can cause severe diarrhea, abdominal pain, fever, and rectal bleeding. Moreover, IBD related complications can include: arthritis, osteoporosis, anemia, liver disease and colon cancer. Crohn's disease and ulcerative colitis are not fatal, but they can be devastating. We do not know their cause, and we have no cure."
DeRose added that last year, a team of investigators from NIDDK, CCFA and private industry announced that they had identified the first gene for Crohn's disease. "This historic breakthrough opens up exciting new pathways of research focused on the development of improved therapies for Crohn's disease patients. The research that led to the discovery of the gene would not have been possible without the strong support that Congress has provided to the NIDDK in recent years."
In his testimony, DeRose supported the establishment of a nationwide IBD epidemiological program in partnership with the CDC. He commented, "This much-needed program will further our understanding of both the prevalence of IBD in the U.S. and the demographic characteristics of this unique patient population. The cultivation of patient demographic information is critically important to our biomedical research efforts given that environmental factors are believed to play a major role in the development and progression of IBD. If we are able to generate an accurate analysis of the geographic makeup of the IBD patient population, it will provide us with invaluable clues about the potential causes of IBD."
"The CCFA is grateful that the Committee again last year encouraged CDC to initiate an IBD epidemiological program in collaboration with the IBD community," DeRose continued. "The CCFA scientific leadership recently began working with the CDC to develop the parameters of the study. However, it is important to note that despite three consecutive years of congressional encouragement, CDC has yet to commit any significant resources toward the establishment of this program. Although we have resisted requesting a direct line of funding in years past, we ask that in fiscal year 2003 the Committee provide CDC with a specific appropriation of $1 million to facilitate the establishment of this important initiative."
DeRose wrapped up his testimony with a plea for support for creating greater colorectal awareness among the general public. "In addition to coping with either Crohn's disease or ulcerative colitis, many IBD patients are at high risk for developing colorectal cancer. It is the third most commonly diagnosed cancer for both men and women in the United States and the second leading cause of cancer-related deaths. Because people who have suffered from IBD for more than eight years are susceptible to this disease, CCFA has a long history of actively promoting the benefits of colorectal cancer screening. Although colorectal cancer is almost entirely curable when detected early, studies have shown a tremendous need to inform the public about the availability and advisability of screening and educate healthcare providers about screening guidelines. CDC's National Colorectal Cancer Roundtable is actively working to address these challenges by partnering with organizations like CCFA to implement a national public awareness campaign emphasizing the importance of screening and early detection. CCFA encourages the subcommittee to provide CDC with $20 million in fiscal year 2003 (an increase of $8 million) for this vital campaign."
For more information, log on to www.ccfa.org.
Letter to the Editor
Olympus Officials Refute EndoNurse Article
Olympus America would like to correct several errors that appeared in the article "Bronchoscope Pseduomonas Outbreak Rattles Johns-Hopkins - Officials Cite Poor Recall Notification," published in the April/May 2002 issue of EndoNurse.
The article repeatedly refers to a "design flaw" or "design error" in certain Olympus bronchoscopes. The bronchoscopes were recalled because of a manufacturing non-conformance in the amount of adhesive-sealant and torque used to secure the biopsy port in place. Olympus determined that on some instruments an inadequate amount of this adhesive-sealant and torque was applied during the manufacturing process, allowing this part to loosen. As soon as Skyline Medical Center (officials) discovered this loose port, and Olympus determined that there was a potential for the biopsy port to loosen on bronchoscopes at other sites as well, Olympus initiated a voluntary, nationwide recall of all affected models. The article, at times, refers to the part that could become loose as a "valve." The part is not a valve, but a cover or housing that surrounds the biopsy port. You report "The Food and Drug Administration (FDA) was reportedly notified of the recall in December, even though Olympus learned of the problem in September. FDA officials are reviewing the recall and their response." However, there was no delay in informing FDA about either the unfolding events at Skyline, or the initiation of the recall mailing. The moment we learned of a single set of circumstances involving our bronchoscopes at one hospital, we began an immediate inquiry that led to a voluntary nationwide recall. In accordance with the Medical Device Reporting regulations, Olympus informed FDA of the data it had available regarding the Skyline incident on October 17, 2001. In mid-November Olympus concluded that the potential for a loose biopsy port was not isolated to the bronchoscopes at Skyline Medical Center, and decided to initiate a nationwide recall. The investigation into the incident at Skyline Medical Center was not concluded until mid to late-November. Certified recall letters dated November 30, 2001 were sent out on the following Tuesday, and the FDA was informed of this recall action. The article quotes Johns Hopkins as stating that Olympus sent the recall notice to the wrong address. In fact, as with every customer, Olympus mailed the recall notice to the address the customer provided to Olympus for receiving their bronchoscopes. The recall letters were sent via certified, return-receipt mail, addressed to the attention of the "Bronchoscopy Program Manager/Risk Manager" with "Urgent Recall" printed in large capital letters on both the envelope and letter. Please review our (enclosed) recall letters. In the initial recall letter, dated November 30, 2001, we clearly stated "If you detect any looseness in the biopsy channel port, please discontinue use of this bronchoscope, and return the bronchoscope to Olympus's repair facility as noted below." It did indicate that if no looseness is detected in the biopsy channel port, you may continue to utilize the bronchoscope, however, Olympus would like you to return the bronchoscope at your convenience so that we can upgrade the biopsy port housing." Although there was no indication at that time, and to date there still is no evidence, that instruments with tight biopsy ports pose any contamination risk, Olympus nevertheless instructed users to return these instruments to Olympus at their convenience. The second notice, dated February 27, 2002, sent to those which had not responded to the first letter, reiterated that even, "if no looseness is detected in the biopsy channel port, you are still required to return the bronchoscope so that Olympus can upgrade the biopsy port housing." As of July 31, 2002 97 percent of the units have been returned to Olympus America, modified, and returned to the customers. We have had telephone contact with 100 percent of the purchases of record of the remaining units, and we are working aggressively to ensure the remaining units are returned and repaired.
Laura Storms-Tyler
Director of Regulatory Affairs and Quality Assurance
Medical Systems Group
Olympus America Inc.
Talk Back!
"At Massachusetts General Hospital, we follow Universal Precautions for all patients. We also use a "needleless" system for our syringes and we have a negative pressure room in our unit that we use for TB patients, or with patients with that type of respiratory precautions."
Jane D. Harker, RN, MS, CGRN
Massachusetts General Hospital, Boston
Next issue's question: Do you treat more women or men in your endoscopy suite?
Email editor Kelli Donley with your answers, kdonley@vpico.com.