Guidance for persons with CFS regarding blood donation

Guidance for Persons With CFS Regarding Blood Donation

Updated most recently on Sept. 23, 2011

The CFIDS Association of America has long advised against CFS patients donating blood or making organ transplants. On May 18, 2010, the Association’s Board of Directors affirmed this guidance to the CFS community:

“The CFIDS Association of America reiterates its long-standing recommendation urging that individuals with CFS voluntarily not donate blood or organs. This recommendation is based on issues of blood donor safety and blood recipient safety. Research has demonstrated that orthostatic intolerance, low blood volume and infections are common in CFS. Until more is known about the role of various infectious agents in CFS, it is prudent for individuals with a past or present diagnosis of CFS to refrain from giving blood and donating organs to protect the safety of the blood and transplant organ supply for all recipients.”

Recent Action

On June 18, 2010 the AABB (formerly the American Association of Blood Banks) issued a bulletin to its member organizations advising that “blood collectors actively discourage potential donors who have been diagnosed by a physician with chronic fatigue syndrome (CFS), chronic fatigue and immune dysfunction syndrome (CFIDS) or myalgic encephalomyelitis (M.E.) from donating blood.” This interim recommendation to U.S. blood collection centers originated with the AABB’s Interorganizational XMRV Task Force, formed in December 2009. The CFIDS Association of America, represented on the Task Force by CEO Kim McCleary, issued a June 18, 2010 statement commending AABB for its action. The AABB bulletin is accompanied by educational materials for use in blood donation centers to educate potential blood donors about CFS and to address questions arising from the recommendation to discourage CFS patients from donating blood. These recommendations have been implemented by the American Red Cross and America's Blood Centers, which combined collect 95% of the nation's blood supply. In the first two months of implementation, the American Red Cross deferred 34 individuals out of approximately one million donors, based on this policy.

At a Dec. 14, 2010 meeting of the FDA's Blood Products Advisory Committee (BPAC), the committee heard nine presentations on XMRV research and testimony from several public witnesses. The Committee was asked to vote on the following question: "Do the scientific data support asking donors about a medical history and/or diagnosis of CFS as a basis for indefinite deferral?" Nine members voted "yes" while four voted "no." The 9-4 vote reflects opinion on the issue of whether asking a question was better than using the AABB educational materials to elicit donor disclosure of past/present CFS diagnosis. All BPAC members have indicated that they agree with the indefinite deferral of CFS patients based on all evidence that it will promote donor and recipient safety. The FDA strongly considers guidance from its advisory committees when making policy. No date has been provided for a decision by FDA.

The National Cancer Institute has reinforced the need for CFS patients to refrain from making blood donations in its interim guidelines and more recent Q&A on XMRV.

Other countries have varying policies about CFS patients donating blood. Canadian Blood Services revised its guidelines for persons with a history of CFS on April 7, 2010. Persons with a history of our current symptoms of CFS will be "indefinitely deferred" by Canadian Blood Services whose centers serve all provinces and territories outside of Québec, (Hema-Québec serves Québec.) The Australian Red Cross announced on April 28, 2010 that it would indefinitely defer CFS patients from donating blood and that it will re-evaluate its policy in two years. New Zealand will follow Canada's new guidelines. As of Nov. 1, 2010, blood donors who report that they have had ME/CFS will be permanently excluded from giving blood in the U.K. According to the U.K. Director of Health Protection, this change was made on the grounds of donor safety as ME/CFS is a relapsing condition. It brings practice for ME/CFS into line with other relapsing conditions of neurological conditions of unknown origin. Later correspondence from officials in the U.K.'s Department of Health indicates that the decision to ban individuals with CFS/ME was based solely on concern for the donor. Norway issued a clarification to its blood centers that individuals with ME/CFS should not be accepted as blood donors. The Flemish Red Cross has asked a question on its donor form about CFS for several years. Its rate of deferral for CFS is about the same rate as reported by the American Red Cross.

None of the policies recently instituted regarding CFS require additional testing.

On August 16, 2010, the CFIDS Association hosted a webinar featuring Dr. Louis M. Katz who addressed the topic of XMRV & Blood Safety. Dr. Katz, executive vice president, Medical Affairs, Mississippi Valley Regional Blood Centers, described the measures currently employed to protect the nation's blood supply and the current state of knowledge about XMRV and CFS.

Background on XMRV-Related Activities
Following the October 2009 publication of research linking CFS to a retrovirus, XMRV, and a 4 percent XMRV-positive rate among healthy controls, concerns surfaced about the safety of the general blood supply. Dr. Jerry Holmberg of the Department of Health & Human Services (DHHS) Office of Public Health and Safety spoke at the Oct. 30, 2009 meeting of the CFS Advisory Committee. He provided an update on U.S. blood safety studies at the May 10, 2010 meeting of the CFS Advisory Committee and the committee recommended to the Secretary of Health that, “Given the concerns for patient health, that the Secretary ask the government and non-government organizations responsible for the US blood supply to indefinitely defer individuals with a current or past history of CFS from donating blood and that a screening question about CFS be asked of all donors.”

The AABB Board of Directors and the AABB Interorganizational XMRV Task Force will continue to monitor activity and research associated with XMRV and, as appropriate, will provide further communication and guidance to the blood banking and transfusion medicine community. AABB’s Transfusion Transmitted Diseases Committee has created a fact sheet about XMRV. A DHHS Blood XMRV Scientific Research Working Group is conducting a four-phase study to ascertain risks to the general blood supply that XMRV might pose and to standardize tests for XMRV. Sample collection for phase III of the study is presently under way. Results of participating labs' tests for XMRV and polytropic MLVs are expected this summer.

On Dec. 17, 2010, the CFIDS Association hosted a webinar featuring Graham Simmons, PhD, Michael Busch, MD, PhD and Steven Kleinman, BSc, MD to provide an update on the activities of the HHS Blood XMRV Scientific Research Working Group, including results of the Phase II study that were presented to the FDA's Blood Products Advisory Committee on Dec. 14.

The March 2011 issue of Transfusion included four articles about XMRV, including an editorial by Hua Shan, MD, PhD, of Johns Hopkins University titled, “What is XMRV and Should We Be Worried About It?,” A detailed description of the Blood XMRV Scientific Research Working Group's four-part study and an update from the AABB Interorganizational XMRV Task Force (for blood) were included in the issue as well.

The New York Academy of Sciences will host a half-day symposium on March 29, 2011 titled, “Pathogens in the Blood Supply,” including a presentation about XMRV by Dr. Judy Mikovits.

General Blood Supply Information for U.S.
The United States’ blood supply is regulated by the Food and Drug Administration (FDA), but it is dependent on donations of blood from healthy volunteers collected at community blood centers, hospitals, by the Red Cross and, in some areas, for-profit entities. Most of these organizations are members of the AABB. Blood donors are required to be “healthy,” over age 16 and at least 110 pounds. “Healthy” is defined by the Red Cross as: “feeling well and able to perform normal activities. If you have a chronic condition such as diabetes or high blood pressure, ‘healthy’ also means that you are being treated and the condition is under control.” Taking various medications can also be a barrier to blood donation. The Food and Drug Administration (FDA) maintains a list of prohibited medications.

Blood is perishable and the need for blood donations is perpetual and increases in times of disaster and war. Although the safety of the blood supply relies on proper collection measures, including screening for health conditions at the time of donation through an interview and health history, tightly controlled testing measures further strengthen blood safety, even after it leaves the collection center.

After blood is drawn, it is tested for blood type (ABO) and RH type, as well as for any unexpected red blood cell antibodies that may cause problems for the recipient. Screening tests performed are listed below:

Hepatitis B surface antigen (HBsAg)
Hepatitis B core antibody (anti-HBc)
Hepatitis C virus antibody (anti-HCV)
HIV-1 and HIV-2 antibody (anti-HIV-1 and anti-HIV-2)
HTLV-I and HTLV-II antibody anti-HTLV-I and anti-HTLV-II)
Serologic test for syphilis
Nucleic acid amplification testing (NAT) for HIV-1 and HCV
NAT for West Nile virus (WNV) (this test is not required by FDA)
Antibody test for Trypanosoma cruzi, the agent of Chagas’ disease (this test is also not required by FDA)

If the test result from a donated unit of blood is abnormal for any of these disease markers, the unit is discarded and the donor is notified. The donor’s name is then added to a donor deferral list and is prohibited from donating blood indefinitely.

The AABB and the Plasma Protein Therapeutics Association (PPTA) have issued statements about XMRV linked below.

These guidelines are intended to help you make decisions about whether to donate blood and/or organs while more research is conducted that may lead to new restrictions. Staff or volunteers at local blood drives or collection centers are unlikely to be as informed as you are about the general health risks associated with CFS or XMRV, and you may have to decline participation more than once.

Organ Donation
There is little data available about the safety of individuals with a past or present diagnosis of CFS donating solid organs (liver, kidney, heart) either during their lives or at the time of their death. In the April 15, 2011 issue of the journal Transplantation, Rajeev Desai and James Neuberger of the NHS Blood and Transplant (United Kingdom) report the results of a retrospective study of 10 deceased solid organ donors who had been diagnosed with CFS (as defined by Fukuda) and the health of the recipients of their organs. In a Letter to the Editor, Desai and Neuberger state that none of the 18 organ recipients had developed CFS in the post-transplant follow-up period (average 38 months, range 15-71 months). The donors had donated a total of 27 organs: 17 kidneys, 6 livers, 2 lungs, 1 heart and 1 pancreas. They conclude with the suggestion that there is no justification for excluding those with CFS from organ donation, due to the shortage of organs and significant mortality of those awaiting transplants.

The authors acknowledge the conflicting evidence for XMRV infection in CFS and indicate that transmission of viruses by solid-organ transplantation is well-recognized in cases of hepatitis B and C and HIV. There is generally more aggressive disease in the recipient than there was in the donor due to immunosuppression. This study was aimed at whether organ transplants could transmit CFS. There is no mention in the report of testing either donors or recipients for XMRV. In this particular study, the CFS patients who donated organs were deceased, so the impact of transplantation on the donor was not evaluated or addressed.

Guidelines for organ donation are different than blood donation and they vary by state, country and are different for donation of organs by individuals during their lifetime and after death. In the U.S. "living donation" of organs or partial organs is limited to healthy individuals. Guidelines for organ donation at the time of death varies in the U.S. by state, but DonateLifeAmerica's FAQ states, "Anyone can be a potential donor regardless of age, race, or medical history."

The CFIDS Association's recommendation states, “Until more is known about the role of various infectious agents in CFS, it is prudent for individuals with a past or present diagnosis of CFS to refrain from giving blood and donating organs to protect the safety of the blood and transplant organ supply for all recipients.” (See top of page for complete recommendation.)

RESOURCES

Specific to CFS:

Risk assessment of XMRV implications for blood donation (Sept. 9, 2011)

Donor Fatigue: Should Blood Banks Reject Chronic Fatigue Sufferers? By Nina Bai, Scientific American (July 4, 2011)

"Safety of Solid-Organ Transplantation From Donors With CFS," Transplantation (March 26, 2011)

"What is XMRV and should we be worried about it?" Transfusion (March 9, 2011)

"XMRV and the Blood Supply: More Study Needed," by Amy Dockser-Marcus, Wall Street Journal (March 7, 2011)

"The Blood Xenotropic Murine Leukemia Virus–Related Virus Scientific Research Working Group: mission, progress, and plans," Transfusion (March 1, 2011)

"XMRV and Blood Transfusion: Report of the AABB Interorganization Task Force," Transfusion (Jan. 14, 2011)

FDA Blood Products Advisory Committee Dec. 14, 2010 Meeting Transcript (posted Jan. 11, 2011)

Recording from webinar, "Update of Blood XMRV Working Group" (Dec. 17, 2010)

Slides from webinar, "Update of Blood XMRV Working Group" (Dec. 17, 2010)

AABB report on Blood Products Advisory Commitee Meeting (Dec. 15, 2010)

Wall Street Journal article about rates of diagnosed CFS patients donating blood
(Dec. 15, 2010)