Deferral from blood donation of individuals who received human growth hormone

Some members have asked about the deferral from blood donation of individuals who received human growth hormone. The following summary has been provided by Dr. Cherie Evans, a member of the California Blood Bank Society. Cherie reviewed several documents, including some provided to CBBS e-network by the FDA.

In the years from 1963 to 1985, growth hormone harvested from human cadaver pituitaries (hGH) was used to treat children whose growth was significantly retarded. This human-derived material was distributed through the National Hormone and Pituitary Program (NHPP) to hundreds of physicians in the United States. In turn they treated approximately 8,000 children with the material. This distribution stopped abruptly in 1985 when it was discovered that three patients had subsequently died due to Creutzfeldt-Jakob Disease (CJD) which is a rare and incurable brain disease. Since that time another 19 confirmed or likely cases from this era have been identified in the U.S.

Since CJD is a disease with an asymptomatic period of infection that may last for decades and there is no test available to detect this asymptomatic infection, concerns were raised about the possibility that if someone in this asymptomatic stage donated blood it might transmit infection to the recipient. To avoid such risk, questions were added to the blood donor medical history asking if the potential blood donor ever received hGH. If they did, they received it two to three decades ago so the donor may not have clear recollection of the treatment and treatment records may be incomplete or nonexistent. Blood centers, therefore, struggle with the accurate evaluation of donor history information to determine if a donor received hGH.

There are a number of questions that can be asked to assist in doing this evaluation. Human-derived hGH was an injectable medication. There was no oral form. It was not produced after 1985. In general, the shots were given 3 times a week. Treatment would begin at the time the deficiency was identified and then be stopped when the patient reached puberty, as the epiphyses in the long bones close at this point and injections would no longer increase height. Another cutoff for therapy was based on reaching a specific height. For girls this was 60 inches and for boys it was 62 inches. Distribution was quite carefully controlled as this material was in extremely scarce supply.

While there is a long period of asymptomatic carriage in infected individuals, in U.S. patients, the average CJD onset was 19 years from the midpoint of hGH treatment. CJD developed as early as 4 years and as long as 25 years after stopping therapy, and from 14 to 33 years after starting therapy. As time moves on, it will be increasingly unlikely to find anyone infected prior to 1985 who has not become symptomatic. Once symptoms develop, the disease develops quickly. In 2-3 months, patients could not walk or do other simple tasks.

For those interested in further information on this subject, visit this site for the full report on the "Follow-up Study of NHPP Growth Hormone Recipients".