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Home : Information on Endocrine and Metabolic Diseases : National Hormone and Pituitary Program: Information for People Treated with Human Growth Hormone (Summary)
 

National Hormone and Pituitary Program: Information for People Treated with Human Growth Hormone (Summary)

How many people treated with hGH in the U.S. got Creutzfeldt-Jakob Disease (CJD)?

The Public Health Service has identified 26 cases of CJD among the 7,700 people in the United States who received NHPP hGH. As of October 2005, none of these people began treatment with hGH after 1977, when Dr. Albert Parlow's laboratory began producing NHPP GH and a new purification step was added.

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How many people treated with hGH got CJD in other countries?

People treated with hGH in other countries also got CJD:

  • In France, 89 people got CJD out of the 1,700 people treated with hGH.
  • In England, 38 people got CJD out of 1,848 people treated.
  • In New Zealand, 5 people got CJD.
  • Two people got CJD in Holland.
  • One person got CJD in both Brazil and Australia.
The New Zealand patients and the patient from Brazil received hormone made in the U.S., but it was not identical to hormone distributed by the NHPP. France, Britain, Holland, and Australia produced their own hormone.

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What about other diseases?

Many people treated with hGH also have problems with other pituitary hormones. A pituitary hormone tells the adrenal gland to make cortisol, a hormone needed for life. People lacking this hormone are at risk of death from adrenal crisis, but this can be prevented. More hGH recipients have died from adrenal crisis than from CJD. Please read the enclosed yellow sheet and discuss the information with your doctor.

"Mad Cow" Disease

"Mad Cow" Disease in cattle is the same kind of disease as CJD from hGH. People who ate beef from animals infected with "mad cow" disease got a form of CJD called "variant CJD" (vCJD). This has happened mostly in Britain. One British woman living in the U.S. was diagnosed with vCJD, but she lived in Britain during the 1980s, when people were at highest risk. Almost surely she was infected at that time. CJD from hGH and vCJD are two similar but separate diseases. People who received hGH are not at higher risk for vCJD.

AIDS

hGH does not cause AIDS. Although it's very hard to destroy the CJD infectious agent, this is not true of HIV, the virus that causes AIDS. HIV would be destroyed by the process used to make hGH.

Low levels of growth hormone (GH) in adults

Some people who needed hGH as children may benefit from GH as adults. People with this problem may have symptoms or changes like these:

  • more body fat
  • less muscle
  • less bone mass
  • less muscle strength
  • less energy

If you have these problems ask your doctor whether they might be due to low GH. Since these conditions are common in lots of people, they are not always due to low GH.  Studies have shown that GH administration in adults with low GH results in reductions in fat and increments in muscle mass.  Effects on strength, energy and bone fractures in GH-deficient adults receiving GH replacement are not as clear.

Today GH is completely synthetic. It poses no threat of contamination. The Human Growth Foundation is one source of information about growth-related disorders. The Foundation can be reached at 1–800–451–6434.

Cancer

Our studies of people treated with NHPP hGH show no increased risk of cancer in those who did not have tumors before hGH treatment. Many people who received NHPP hGH had brain tumors that caused their lack of hGH. People who have had one tumor have an increased risk for getting other tumors.

Researchers recently reported that two people treated with hGH in Britain developed colon cancer. Two U.S patients who received hGH also died of colon cancer. This small number of cases isn't enough for us to say if there is an increased risk for all those treated with hGH. We are asking the FDA to tell us if other people treated with hGH report colon cancer. We also ask that you report colon cancer if it occurs so we can learn if there really is increased risk.

We told you in previous updates that Japanese doctors reported in 1988 that some people who received hGH seemed to have a higher rate of leukemia. We studied those who got hGH in the U.S. and found no higher rate of leukemia in those who had not had tumors before getting hGH. A more recent study by Japanese researchers found no increase in leukemia in people who did not have tumors or radiation before hGH treatment.

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What about other problems?

We have no evidence that hGH causes changes in personality, emotional problems, or suicide.

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What are the symptoms of CJD?

Symptoms of CJD can vary. People who got CJD from hGH had difficulty with walking, balance, dizziness, or clumsiness. Later some began to slur words and have jerky movement. They also had trouble seeing, remembering, or thinking clearly. The disease becomes worse very quickly. If you have had some symptoms like this over a long period of time such as a year, without getting much worse, you don't have CJD. Don't worry about CJD if you are occasionally forgetful or clumsy or have headaches.

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What is my risk for getting CJD?

No one can say what each person's risk is. Of about 7,700 Americans who received NHPP hGH, 26 people have gotten CJD. The two things that seem to be connected with getting CJD are:

  • How long a person has been treated with hGH: The average treatment time with hGH was 3 years. People who got CJD typically were treated with hGH for about 9 years.
  • When a person was treated with hGH: All the people who got CJD had been given hGH before 1977.

Overall, 1 in about 300 people treated with hGH got CJD. All CJD patients received some hGH before 1977. Of those treated before 1977, 1 in 104 got CJD.

In 1977, the NHPP changed the way it made hGH. Scientists added a new purification step that greatly reduced and may have removed the risk of CJD. So far, no patient who started hGH after 1977 has become ill with CJD. Since CJD takes so long to develop, we still don't know for sure that those who started treatment after 1977 are safe.

The longest reported time from the start of hGH treatment to first signs of CJD is 33 years in U.S. patients. One person in Holland got CJD attributed to hGH 38 years after a very brief use of hGH. This is the longest incubation period on record.

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Can you tell me when I was treated and for how long?

The best person to tell you about your treatment is the doctor or center who gave you hGH. To protect patient privacy, the PHS did not ask for names of those being treated until 1985 when we learned of CJD. In 1985, we asked doctors and centers for names and addresses so we could tell people of the risk of CJD, but we do not have information on treatment for most recipients. If your doctor is not available, we can check our records to see if we have any information on your treatment. Call us at 1–800–472–0424 or email us at NIDDK_Inquiries@nih.gov

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Did the hormone I took cause CJD?

To try to find the hGH that could have caused CJD, we did two things:

  • We set up a test in animals: We injected samples of all available hGH directly into the brains of monkeys. Doctors gave brain injections to shorten the time it would take for illness to develop.
  • We studied people treated with hGH to see who got CJD and which hormone preparation they received.

Results: The animal tests did not help us find the hGH that might have caused CJD. After 10 years, only one test animal got sick with CJD. Two other animals received the same hormone and did not get sick. In addition, the hGH that made the animal sick was different from the hGH given to people who had gotten CJD. The animal tests did not prove that any specific hormone preparation caused CJD.

The NHPP kept records of hGH preparations sent to each doctor. We used these records to learn which preparation could have been given to people who later got CJD. We could not find any specific preparation that caused CJD. We believe that more than one hGH preparation carried low levels of infection. Most of the people who got CJD received hGH for long periods of time and received many different preparations.

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If I develop CJD, will my family get it? If I get pregnant, will my baby get it?

No. Scientists do not believe that CJD is transmitted through day-to-day contact or through sexual contact. Neither your spouse nor your children are in danger. Except for rare genetic forms of CJD, a pregnant woman does not pass CJD to her unborn baby. CJD from hGH treatment doesn't affect the genes. It won't be passed on to your child.

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Is there a test I can take to tell if I will get CJD?

Researchers are working hard on this, but today there is no test that can tell someone whether they will get CJD. Once a person has symptoms that may be due to CJD, a test on a spinal fluid sample can help doctors decide if that person has CJD. Another test, magnetic resonance imaging (MRI), may be useful in diagnosing CJD, but this needs more study.

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Why can't I give blood or donate organs?

There have been two reports of the agent that causes variant CJD (vCJD) being transmitted through blood. Variant CJD is the disease that occurs in people who ate tainted beef or were exposed to products from cattle with “mad cow” disease. Variant CJD is different from the classic type of CJD that occurred in hGH recipients. We do not know if the type of CJD that occurred in GH recipients can be transmitted by blood. Nevertheless, doctors want to be especially careful because there is no test they can use to screen blood supplies.

Until we know more, the following people should not donate blood:
  • anyone who received GH made from human pituitaries
  • family members who have a relative with a rare, genetic form of CJD
  • anyone who has lived in Europe when cattle products may have spread the agent responsible for vCJD

Family members of hGH recipients can donate blood. People who only received biosynthetic GH (bGH), after 1985 can also donate blood.

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Why should people treated with hGH know about CJD?

Some parents did not tell their child about the possible risk of CJD. CJD is very painful to talk about, but these children are now adults. Some have learned about the risk of CJD from newspaper stories. Others heard about it when they tried to give blood. This is a very upsetting way to learn about risk. Those who were not told before are often angry when they hear of it outside the family. Also, if parents are no longer available to receive these mailings, their adult children may have no access to important new information. If you are the parent of someone who got NHPP hGH and who is not receiving these mailings, please share your child's address so we can send this information. We are glad to answer any questions that you or your child may have.

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How can the Public Health Service help me?

If you have questions, please call our toll-free number, listed below. A recording will ask you to leave your name, phone number, and a good time to reach you. A staff member will call you back promptly. You can call, write, or have your doctor contact us at:

National Institutes of Health
NIDDK Office of Communications and Public Liaison
Building 31 Room 9A06
31 Center Dr MSC 2560
Bethesda, MD 20892–2560

301–496–3583
1–800–472–0424
Email: NIDDK_Inquiries@nih.gov

We have a web site, http://endocrine.niddk.nih.gov/pubs/creutz/creutz.htm, where you can also find out more about hGH and CJD. The site contains this update and a list of articles about the health issues of people treated with hGH. The web site will be updated when we have new information to provide.

We will mail a new update only if there is significant new information. For example, we will let you know if:

  • we find a test to diagnose CJD before there are symptoms
  • we discover how to prevent or treat CJD
  • we learn about cases of CJD in people who began treatment after 1977

We will continue to provide new information on the web site. If you do not have Internet access, please let us know and we will mail the information from the web site. Scientists at the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control will continue to study this problem. They are available if you have questions.

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How can I get support and information?

The Creutzfeldt-Jakob Disease Foundation, Inc. [See www.cjdfoundation.org/] was created in 1993 by two families who lost loved ones to CJD and the neurologist who treated their family members. This nonprofit corporation promotes research, education, and awareness of CJD and reaches out to those who have lost relatives to this illness. The NIH has CJD information at www.ninds.nih.gov.

The Human Growth Foundation (HGF) is a nonprofit organization concerned with children's growth disorders and adult GH deficiency. HGF has published a brochure on adult GH deficiency. To obtain a copy, call 1–800–451–6434. HGF also supports an Internet mailing list to help the exchange of information about adult GH deficiency and adult GH replacement therapy. To subscribe, go to the HGF web page at http://www.hgfound.org.

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How can I help with the follow-up study?

Patients, their families, and their doctors can help by telling us of any deaths, especially if anyone suspects CJD. The following information is also very important:

  • Tell us about death from any cause in someone who got hGH.
  • Tell us about colon cancer in someone who got hGH.
  • Give PHS doctors permission to review medical records if a recipient dies.
  • Send us your address changes so we can share new information with you.

To report health information or to ask questions, please write or call:

National Institutes of Health
NIDDK Office of Communications and Public Liaison
Building 31 Room 9A06
31 Center Dr MSC 2560
Bethesda, MD 20892–2560

301–496–3583
1–800–472–0424
Email: NIDDK_Inquiries@nih.gov

National Endocrine and Metabolic Diseases Information Service

6 Information Way
Bethesda, MD 20892–3569
Phone: 1–888–828–0904
TTY: 1–866–569–1162
Fax: 1–703–738–4929
Email: endoandmeta@info.niddk.nih.gov
Internet: http://endocrine.niddk.nih.gov/

The National Endocrine and Metabolic Diseases Information Service is an information dissemination service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK is part of the National Institutes of Health (NIH), which is part of the U.S. Department of Health and Human Services.

The NIDDK conducts and supports biomedical research. As a public service the NIDDK has established information services to increase knowledge and understanding about health and disease among patients, health professionals and the public.

Publications produced by the NIDDK are carefully reviewed by both NIDDK scientists and outside experts.

This publication is not copyrighted. The NIDDK encourages users of this publication to duplicate and distribute as many copies as desired.


February 2004

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Bethesda, MD 20892–3569
Phone: 1–888–828–0904
TTY: 1–866–569–1162
Fax: 1–703–738–4929
Email: endoandmeta@info.niddk.nih.gov
Internet: http://endocrine.niddk.nih.gov/


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