TRIO Public Policy Commentary
Docket number CDC-2011-0011
'Draft 2011 Public Health Service (PHS) Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation
The CDC has presented new proposed guidelines for organ transplantation and we have until November 21, 2011 to make out comments known. I have discussed this with more than six hundred people inclusive of several transplant surgeons and directors of transplant at various Transplant Centers. While many transplant surgeons originally consulted with the CDC and offered their names as part of the draft's list of authors, most have demanded that their name be removed from the list of authors and supporters of the document once they saw the completed draft of the document ready to be released to the public for public comment.
The draft concerns infections such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) and recommends adding HBV and HCV to the list of organisms to be screened.
There are two sides to every story and then there is the truth (or what I like to think of as a compromise in this case):
It's important to read the whole document which the CDC seems to (accidentally) keep hidden i.e. there are many articles and announcements about the public comment period and many articles about what the guidelines are trying to do but many have reported that it was difficult or impossible to find the document with so many links no working at the federal register, CDC and the regulations.gov website where thousands of articles refer people to seek more information and the document itself.
It was also pointed out by many other transplant surgeons and those who read the document that while there are currently shortages of organs (to say the least), this document's guidelines contain references to issues like same sex partner, and whether a donor had more than two sexual partners in the past year, and it was those issues among others that many people at our TRIO meeting reacted to during our vibrant discussions of the CDC draft.
The Nuclear Acid Test is not always currently used for screening organ donors; organ procurement groups and transplant centers rely more often on a serology, which detects in the blood antibodies against the virus within three to eight weeks of infection.Though there is no data on the risk from living donors in particular, the CDC’s data suggest that the risk of HIV transmission is about one in 20,000 deceased donors. The NAT can detect an HIV infection within eight to ten days.
One case:
A transplant recipient contracted the virus that causes AIDS from a kidney donor in an unnamed New York City hospital. The CDC issued a report on the case, in which the male organ donor engaged in unprotected sex with another male after he was initially screened for HIV but before he donated the organ. The CDC says the 2009 incident is the nation’s first documented case of HIV transmission via a living-donor transplant since a sensitive test for the virus was approved in 1985,
A Quote from press of ASTS
“We support guidelines which help to decrease disease transmission, but we want them to be evidence-based and balanced by the risks of dying without an organ transplant,” says Henry.
Guidelines were last updated in 1994, when the more sensitive tests weren’t yet in use, and covered only HIV.
Again, Nucleic-acid testing, or NAT, can detect an infection acquired seven days before testing. Standard blood tests, known as serologic testing, measure antibodies to an infection that may take months to appear. Only about half of procurement labs in the country voluntary use the newer test, but it can double screening costs.
Henry also stated that NAT isn’t always feasible — for example, if an organ has to be flown to a transplant center from a remote location where no labs are available.
Should they be available?
The proposed guidelines also broaden the types of donors considered to be at increased risk of spreading an infection. Henry says his group believes they now classify too many segments of the population as riskier donors even though they might be good candidates, such as anyone who has had sex with two or more different partners in the last year. “That could cover three quarters of college kids in America,” Henry notes.
Matthew Kuehnert, who oversees blood and organ safety for the CDC, stresses that the guidelines are meant to give potential recipients and their doctors as much information as possible about risks of any organ, so they can make an informed decision about using it.
Organs that are positive for infections other than HIV can still be transplanted, “but we just want to make sure we are aware so the recipient can be treated and we can mitigate complications of infections when they do occur,” Kuehnert says.
While the federal guidelines are not enforceable, the CDC guidelines almost always become mandatory standards of care.
Guidelines from the CDC do become law:
Comments can be submitted until November 21, 2011 and many surgeons are against the guidelines.
Suggestion that anyone discuss this via email and in person with chapter members and have anyone and everyone register their comments for or against as an individual who has a relationship with transplantation; that is - a transplant recipient, living donor, caregiver et. al.
Comment for or against- there will not be any editing of the document at this time:
I met with a surgeon last week and he felt that it is most urgent that these guidelines not be implemented and that anyone with an interest in transplantation should speak out against the document. I feel that you should have people make that choice individually and I personally feel there could be a compromise (eventually) where NAT testing would be more available and at the same time some of the other provisions of the document do not have to be included in the guidelines at this time.
Some of my sources for the content herein included the CDC, regulations.gov,PHS guidelines, WSJ, and cdc.gov media announcements
Details and comment info:
Comments must be identified by Docket No.
CDC-2011-0011. Please follow directions at
http://wwww.regulations.gov
to submit comments.
New proposed guidelines for organ transplantation
Docket number CDC-2011-0011
- Mike Sosna
TRIO Public Policy Committee Chairman
Joint letter referenced above:
August 23, 2011
The Honorable
Howard Koh, MD, MPH Assistant Secretary
for Health
Department of Health and Human Services
200 Independence Avenue, SW Washington, DC
20201
Dear Secretary Koh:
On behalf of the transplant community, the American Society of Transplant Surgeons (ASTS), the American Society of Transplantation (AST), the Association of Organ Procurement Organizations (AOPO) and NATCO, The Organization for Transplant Professionals are writing to express our concerns with the proposed “PHS Guideline for Reducing HIV/HBV/HCV Transmission,” along with the process used to develop it.1 The process and document both fail to reflect the coordinated and cooperative approach toward transplantation that we had hoped would emerge as the result of the positive meeting that the ASTS and the AST had with you and your staff on April 27, 2011. The document has significant deficiencies, espousing firm recommendations that are impractical and not evidence-based. Most significantly, the proposed guideline has the potential to unnecessarily reduce the availability of organs for transplantation, an outcome inconsistent with HHS’ broader policy objectives and with the needs of our patients.
We support updating the 1994 PHS guideline for reducing the risks of transmission of blood borne pathogens, to more accurately reflect today’s clinical practice. For that reason, we were pleased to participate in the development of a new PHS guideline by appointing designated experts.
However, the proposed guideline deviates so completely from the input provided by our expert representatives that most of them have withdrawn their names from the document. The experts’ serious concerns with the proposed guideline are set forth in greater depth in a separate letter from them to you and Dr. Frieden.2
While our organizations have serious concerns about the proposed guideline, our broader concern is that this document, like many that are issued by various divisions within HHS, appears to reflect the relatively narrow focus of the HHS division involved, and fails to reflect any coordination of policies related to transplantation at the departmental level. More specifically, the draft guideline reflects the CDC’s focus on complete elimination of the risk of disease transmittal, without adequate consideration of the need to balance this objective against the need to increase the availability of organs for transplantation. In our view, if the guideline is finalized as proposed, organ wastage will increase and many of our patients will be unnecessarily deprived of life-saving transplants. Quite simply, as the consequence of a misguided effort to completely eliminate all risk of disease transmittal, more patients will die of organ failure than will be saved by avoiding donor-derived infection. Such a result would be inconsistent with the HHS’ overall objective of increasing the availability of organs for transplantation: misguided from the standpoint of the transplant community and nothing less than tragic for those patients unnecessarily deprived of access to life-saving transplants, not to mention the significant increase in resource expenditure to accomplish these proposed guidelines.
Under these
circumstances, we request that you
consider revising the draft guideline
prior to publication in the Federal
Register or, at the very
least, prior to publication in final
form, to achieve a more reasonable
balance of the need to prevent disease
transmission against the need to
maximize the availability of organs
for transplantation. More broadly, we
urge you to persevere with plans for
inter- divisional coordination of
transplant policy, knowing that the
transplant community stands ready to
assist you in this effort in any way
we can.
1 It is our understanding that this draft is to be published in the Federal Register in the near future.
2 Summarizing, the proposed Guideline is based on weak evidence; is inconsistent with expert opinion provided during the guideline development process; directly contradicts the conclusions of the July 28, 2011 consensus panel sponsored by the AST, ASTS, UNOS, and NATCO; and purports to provide detailed proscriptive “instruction” for specimen preparation and handling which are supported by expert opinion or by clinical evidence.
Sincerely,
Mitchell L.
Henry, MD
ASTS President
ASTS National Office
2461 S. Clark Street, Suite 640
Arlington, VA 22202
PH: 703
414-1609
Email: kim.gifford@asts.org
Tim Brown
AOPO President
AOPO National Office
8500 Leesburg Pike, Suite 300 Vienna, VA
22182
PH: 703 556-4242
Email: eeidbo@aopo.org
Robert S.
Gaston, MD
AST President
AST National Office
15000 Commerce Parkway, Suite C Mt.
Laurel, NJ 08054
PH: 856
642-4438
Email: snelson@ahint.com
Tracy
Evans-Walker, RN, CNP, CCTC NATCO
President
NATCO Executive Office
P.O. Box 15384
Lenexa, KS
66285
PH: 913 895-4612
Email: jdawson@goamp.com
Cc The
Honorable Kathleen Sebelius
Secretary, Department of Health and
Human Services
The Honorable Thomas Frieden, MD, MHP, Director, Centers for Disease Control and Prevention
Jerry A. Holmberg, PhD
Senior Advisor for Blood Policy Department of
Health and Human Services
Matthew J. Kuehnert, MD
Director, Office of Blood, Organ, and Other
Tissue Safety Centers for Disease Control and
Prevention
Debbie L. Seem, MPH, RN
Nurse Consultant, Division of Healthcare
Quality Promotion Centers for Disease Control
and Prevention
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