1. Provide the title of your story or series and the names of the journalists involved.
The AJT Report by Sue Pondrom.
The four submitted articles are titled:
"Best Intentions Gone Awry: Pancreas acquisition costs hamper islet transplantation"
"Can Generics Be Trusted? Anecdotal reports question the safety of generic immunosuppression"
"Survival Rates Increase in Bowel Transplantation: Seldom-done procedure comes of age"
"AMR: A Difficult Problem with No Easy Solution: Food and Drug Administration recruits opinions from clinicians, scientists, industry and labs to fight acute antibody-mediated rejection in transplant patients"
The AJT Report is a news section in the American Journal of Transplantation, the No. 1 rated academic transplant journal in the world and the No. 2 surgical journal in the world. Readers include transplant surgeons, physicians and transplant coordinators.
2. List date(s) this work was published or aired.
October 2010, April 2010, March 2010 and November 2010.
3. Provide a brief synopsis of the story or stories, including any significant findings.
"Best Intentions Gone Awry": Although Congress attempted to support experimental trials of islet transplantation for Type 1 diabetes, the unintended consequences of their action are fewer islet recipients and increasingly fewer islet transplant centers in the U.S. This article explores what happened, the reasons why and potential future options.
"Can Generics Be Trusted?" Transplant physicians are concerned about the safety of generic versions of the mainstay immunosuppressant drugs organ recipients need to stay alive. However, concerns have been based on anecdotes, not published studies. In this article, I learned from the FDA that generics don't go through a rigorous validation for use in transplantation the same way that the name brands do. Additionally, drugs are considered "bioequivalent" to name brands if they fall within limits of 80 percent to 125 percent. Because pharmacists will often shift from one generic to another each month, depending upon where they get the best profits, a transplant patient's needed immunosuppressant drug can vary each month by 40 percent.
"Survival Rates Increase in Bowel Transplantation": The field of bowel transplantation has remained relatively unknown by both the public and medical professionals who could potentially refer patients. During the past few years, bowel transplant outcomes have improved so much that intestine-patient survival is on a par with pancreas, lung and liver. However, it is still difficult to get referrals. And, one of the biggest problems in managing patients with intestinal failure is that there are so few patients that it is difficult to have enough data to establish best practices in pre- and post-transplant patients.
"AMR: A Difficult Problem With No Easy Solution": Acute antibody-mediated rejection is the primary cause of organ rejection in transplant recipients. Although there are new clinical trials to test new drugs, problems have arisen primarily due to the variability of lab test results and variances in manufacturers' products. The FDA recently held a meeting with physicians, pharmaceutical company reps and immunosuppressant drug manufacturers to discuss these problems and potential solutions. This article reported on that meeting and comments from attendees.
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
Data from the Scientific Registry of Transplant Recipients (a data gathering and analysis arm of the United Network for Organ Sharing/Organ Procurement and Transplantation Network), the 2003 Medicare.
Modernization Act, transplant patient comments on the website TransplantCafe.com, and various other websites.
5. Explain types of human sources used.
Interviews with FDA officials, pharmaceutical representatives, a spokesperson from the Centers for Medicare & Medicaid, the CEO of the Association of Organ Procurement Organizations, a spokesperson for the American Pharmaceutical Association, and numerous transplant surgeons and physicians.
6. Results (if any).
The AJT Report is a news section that informs the transplantation community. There has been considerable talk at professional meetings about the stories referenced above – because they contain information of great concern to transplant professionals. A survey of American Journal of Transplantation readers shows that most readers have read The AJT Report. In addition. it is the most frequently downloaded article from the AJT website.
7. Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
No clarifications or corrections were needed, nor requested.
8. Advice to other journalists planning a similar story or project.
Find the most knowledgeable people in the field. These are often the doctors who are speakers at major conferences or editors of journals. Also be sure to search the internet and talk with officials from organizations and government agencies. Finally, trust but verify!