JOINT HEARING OF

THE HOUSE COMMERCE COMMITTEE SUBCOMMITTEE ON

HEALTH AND ENVIRONMENT AND THE SENATE LABOR AND

HUMAN RESOURCES COMMITTEE

 

"PUTTING PATIENTS FIRST: RESOLVING ALLOCATION

OF TRANSPLANT ORGANS"

 

Testimony of

Clive 0. Callender, M.D.

June 18, 1998

 

SUPPORT FOR HHS REGULATIONS WITH

OPTN PARTNERSHIP AND MINORITY INCLUSION

SUPPORT FOR HHS REGULATIONS WITH 

OPTN PARTNERSHIP AND MINORITY INCLUSION 

Testimony Submitted by: 

Clive 0. Callender M.D. 

June 18, 1998 

This testimony is presented to the joint hearing on proposed organ allocation rules on June 18, 1998. The joint committee is chaired by U.S. Senator Bill Frist (R‑TN) and congressman Mike Bilirakis (R‑FL). This is a joint hearing of the Senate Labor and Human Resources Committee and the House Commerce Subcommittee on Health and Environment. This is to examine the regulations proposed by the Department of Health and Human Services (HHS) for the allocation of organs. The testimony is prepared by Dr. Clive 0. Callender, M.D., The LaSalle D. Leffall, Jr. Professor, Chairman of the Department of Surgery, Howard University Hospital, The Transplant Center Director, Howard University Hospital, Vice Chair, Chairman Elect (July 1998), Of the Minority Affairs Committee, The United Network for Organ Sharing. (UNOS), Principal Investigator and Founder of the National Minority Organ/Tissue Transplant Education Program (MOTTEP).

Dear Senator Frist and Congressman Bilirakis, thank you for the opportunity to present this testimony. 

   I am Doctor Clive Callender and I wear many hats as my titles which follow indicate. The LaSalle D. Leffall, Jr. Professor, Chairman of the Department of Surgery, Howard University Hospital, The Transplant Center Director, Howard University Hospital, Vice Chair, Chairman Elect (July 1998), Of the Minority Affairs Committee, The United Network for Organ Sharing (UNOS) Principal Investigator and Founder of the National Minority Organ/Tissue Transplant Education Program (MOTTEP). The MOTTEP hat is the major hat I wear today. 

National MOTTEP in response to the release of the HHS regulations March 26, 1998 on April 1, 1998 released a statement which strongly supported the HHS Regulations which were designed to shorten patient waiting times. It further articulated the desire that UNOS provide a response to the regulations that would allow for the implementation of a plan that would result in an even more equitable and fair system so that needless deaths could be prevented. National MOTTEP's primary concern was that the plan be patient focused and benefit all who wait for organs including minorities. This statement concluded by emphasizing that the number one problem in transplantation today is the shortage of donors. 

I was present by telephone conference at the secretaries press release of the regulations and have since thoroughly reviewed the HHS regulations. I have chosen to focus on the following critical areas* 

1.      The Secretary's response and release of the regulations followed days of testimony and public comment on the need for proposed rule making on organ allocation policies of the Organ Procurement and Transplantation Network (OPTN).the United Network of Organ Sharing (UNOS), The discussions accompanying the regulations revealed that the secretary took into consideration every single testimony presented and that her office was responding to a great public outcry and need for change! 

2.      I was the only African American on the National Organ Transplant Task Force which met in 1983‑1984 under the Chair, Dr. Olga Jonasson and Vice Chair, Dr. James Childress and recommended the creation of the OPTN to the Congress of the United       States along with its raison D'etre and the need for the oversight responsibility of the       Secretary of Health and Human Services. It was my testimony regarding the minority perspective of transplantation before Senator Kennedy's subcommittee in 1983 which led to my selection to that Task Force. 

3.      Institutional Racism is alive and well and thriving in America. While race is irrelevant       as we are all Homo sapiens and members of the same race: this practice of organized racism exacts a severe price. The price minorities pay for this abominable practice is that this may well be the major reason people of color die 10‑ 15 years before their time. Yet, while the gap between people of color (minorities) and the majority widens we continue to not allow minorities to sit at the discussion table. Yet, just last week, data released revealed that African Americans continue to wait twice as long as other Americans for kidney transplants while constituting More than fifty percent (50%) of those waiting for kidney transplants. This debate on allocation of organs and the Secretary's proposed regulations rapes and once again the minority population is excluded from the table of discussion. The Minority Affairs Committee of‑UNOS listened to an impassioned presentation by a UNOS representative and resolved that a representative for the Minority Affairs Committee participate in the negotiations between UNOS and DHHS because the deliberations for the most part relate to allocation of organs regarding a group of recipients who are not represented at the discussion table! It further resolved that the Congressional Black Caucus be placed in the loop regarding the operations of the OPTN and the impact of the regulations on minorities of disadvantaged potential transplant candidates. This was done in an attempt to address the issues that the Secretary has attempted to address and that UNOS has thus far unsuccessfully addressed, which is having adequate minority representation at the highest level of UNOS administration and in fact at all levels of UNOS activity. For emphasis, I must restate the need for the support of the perpetuation of the national minority strategic plan which requests that institutionalized racism be treated by involving minorities at all levels of research, resource allocation, and problem resolution from start to finish. (1-4) 

4.      The Green Screen s a term I have used to identify what happens in extra‑renal transplantation. Renal transplantation is covered by Medicare and Medicaid, therefore, 97% of patients in America can have dialysis and transplantation. This does not yet exist in extra renal transplantation, especially for Ever and heart transplantation candidates. Some states do not pay for extra renal transplantation, therefore, patients who are uninsured or underinsured or without cash, the green, will never be placed on the extra renal transplant waiting list. This is the explanation for why, in End Stage Liver Disease, which is 24 times more common in African Americans than Whites as a cause for mortality, there is under representation of African Americans on Ever transplant waiting lists. African Amen‑cans constitute 12% of the American population and 35% of patients on ESRD transplant waiting lists. On liver transplant waiting fists, however, they rarely account for more than 10% of patients. This figure should be closer to 20%. This under-­representation I believe is related to the presence of the Green Screen. This means if one does not have the fiscal resources one will never get on the transplant waiting list and therefore will never receive a transplant. The price exacted when this occurs in extra renal transplant is death! While Secretary Shalala's plan does not solve the green screen problem, it places it on the agenda so that we may no longer "sweep it under the rug" and identifies it as alcohol and major causes of End Stage Liver Disease, as there has been placed on smoking, a major cause of lung cancer and other illness? One thing that is certain is that if we don't address it we will never solve it. While it is an example of our society's unwillingness to solve this problem. don't we make up society? 

5.      Equitable Allocation ‑ the purpose of the regulations are to accomplish equitable allocation. The closer we get to an equitable allocation system the louder we can speak when we go into the community to educate and empower. In order to maximize community participation in all aspects of  transplantation especially – organ and tissue donation, this must be done. The regulations which are drafted to accomplish this can do so only with the collaboration and participation of the OPTN. This participation and the presentation of a proposed implementation plan has been sorely lacking, as of this writing. 

Many have constructively criticized the Secretary's allocation regulation. Who among us is capable of coming up with a flawless plan? None of us! We all are, painfully aware that united we stand, divided we fall (fail). The Secretary's regulations with the cooperation and participation of the OPTN as a participating team member cannot fail. On the other hand without the OPTN's participation, cooperation, and expertise her plan cannot succeed! The need then is for the two to work together "Putting Patients First" so that we can resolve the inequities that exist today, and are inherent in our current allocation of transplant organs plan! 

6a. The Donor Shortage‑ This is the number one problem in transplantation today and the number one reason for the allocation dilemma. The following are presented to recommend ways in which this can be done in conjunction with the other allocation efforts. It is reemphasized that they must be addressed simultaneously. The major impediments to organ donation are:

1)     Inequitable organ allocation

2)     Suboptimal use of the community as a change, agent for organ tissue donation and transplantation.

3)     Lack of optimization of community input at all levels of problem resolution, research, and resource allocation.

4)     Lack of transplantation awareness.

5)     Religious myths and misperceptions.

6)     Distrust of the health care system and health care professionals.

7)     Fears that signing donor cards will lead to premature declaration of death.

8)     Inadequate emphasis on behavior modification toward health promotion and disease prevention along with increasing donor card signing, family discussions and giving organ/tissues in life and after death.

9)     Lack of adequate use of recipients, donors, transplant candidates as community messengers. 

6b. Other ways to improve current efforts to promote organ donation. Allocation of additional funds of 50 million dollars over the next 5 years (5,6) for national organ/tissue programs such as: The National Minority Organ/Tissue Transplant Education Program (MOTTEP), the National Marrow Donor Program (NMDP), the National Medical Association (NMA) and the Transplant Recipient International Organization (TRIO). 

6c. Further initiatives which are necessary to ensure that members of racial and ethnic minority groups are appropriately apprised regarding such matters as the role of organ transplantation within the health care system, the unique health benefits that can ensue from successful transplantation, the limitations associated with transplant procedures, and the challenges involved in recruiting organ donors, follow: 

The National Medical Association (NMA), the American Society of Minority Transplant Health Related Professionals (ASMTHP) and MOTTEP ‑ The National Minority Organ/Tissue Transplant Education Program and minority community representatives at all levels of research, resource allocation and problem resolution must be involved from start to finish. These groups are involved with grassroots efforts and have designed models for increasing donation rates, but need more resources to complete a job recently begun. 

From 1978-1996 we have participated in a community based minority research program that when subjected to statistical analysis produced significant minority donation rate improvements! (4) These programs ‑ the D.C. Organ Donor Programs (DCODP) the Dow Chemical Companies "Take Initiative Program (DOW TIP) have demonstrated that a strategy utilizing face to face dialogue,

       ethnically similar messages and culturally sensitive messengers made a significant impact on how       minorities responded to the call for the need to have minorities sign donor cards, have family    discussions and eventually become donors. (31 In 199 1, this technique was employed in the founding    of MOTTEP which targets all minority populations: Hispanics/Latinos, Asian/Pacific Islanders,            Alaska Native, and Native Americans as well as African Americans. In 1995 this program was funded        to include 15 cities but sufficient funding to include a total of 25‑30 cities now seems essential along with an additional 2 million dollars for 5 years (10 million dollars). to adequately prevent the need for organs and to increase the donor rate among these disproportionately afflicted populations. An   increase in 5 organ donors/million in each of these ethnic groups in 5 years would save the    government 50 million dollars for kidneys alone and more than one billion dollars for life saving     organs like livers and hearts! These programs, working along‑with OPO's, the National Medical    Association (NMA), and TRIO, are an idea, whose time has come when adequate funding is included! (5-6) 

In conclusion, the number one problem in transplantation today is the shortage of donors. In order to successfully address this problem we must have an allocation scheme that is as fair as possible along with adequate resources. When this is combined with a strategic plan and a coordinated OPTN team effort all of these obstacles can be overcome. The OPTN has done a remarkable job in its nearly 10 years of existence however, input from the public sector and a private sector/public sector partnership is desirable for success. To the extent that. it is a partnership and oversight is the role of DHHS and day to day policy making is the role of the OPTN, this must be done in the best interest of all Americans. It is equally imperative however, that minority community participation be included from top to bottom in all decision making, research and resource allocations. This must be done throughout all of the processes so that all of these efforts are as fair as possible to all. 

Bibliography

 

1)     Callender, C.O., Kidney Transplantation Allocation in American: An African American Transplant Surgeon's Perspective, Clinical Transplant, 1995: 355‑357, Edited by Cecka and Terasaki.

2)     Office of the Inspector General, The Distribution of Organs for Transplantation. Expectations and Practices (HHS) Publication No. OE‑1‑01‑89‑0050). Office of Analysis and Inspections­ Washington, D.C., 1991.

3)     Callender C.O,Bey, A.s. Miles, Yeager, C.L., A National Minority Organ Tissue Transplant Education Program. The First Step in the Evolution of a National MinorityStrategy      Transplant Equity in America Transplant Proceedings 1995, 27:1441.

4)     Callender, CO., Burston, B., Yeager, C.L., Miles, P.V., A National Minority Transplant Program for Increasing Donation Rates, Transplant Proceeding, 1997 at Press.

5)     Recommendation for support of the National Minority Transplant Strategy presented to the NIDDK Strategic Planning Committee, May 26, 1992 at National Institute of Health (NIH), Bethesda, Maryland, Clive 0. Callender, M.D.

6)     The Surgeon General's Workshop on Increasing Organ Donations: The Minority Subcommittee Recommendation; July 8‑10, 1991, Oscar Salvatierra, Jr., M.D., Chairperson.