For someone facing the daily specter of death, Randy Wakefield is feeling pretty good these days.
As a child, Wakefield, now 42, was diagnosed as a hypopituitary dwarf and given human growth hormone (hGH) injections to help him grow. At that time, during the 1960s and 1970s, hGH was naturally derived — that is, it was made by processing pituitary glands taken from cadavers. An arm of the National Institutes of Health then distributed the growth hormone, free of charge, to hGH-deficient children around the country.
Wakefield and the others grew taller, but in 1985 the experiment was found to have a fatal flaw. Three hGH recipients contracted a rare neurological illness called Creutzfeldt-Jakob disease (CJD), otherwise known as the human equivalent of “mad cow” disease.
Scientists still haven’t determined exactly what causes CJD, but they do know that it’s a horrible way to die. CJD literally eats sponge-like holes in the brain. Initially, victims experience balance problems and memory loss. Soon, they’re unable to walk or to care for themselves. CJD is always fatal, usually within a year.
Since 1985, a total of 22 US hGH recipients have contracted CJD. Over 100 more hGH recipients have contracted CJD world-wide. And, because the disease can incubate in the body for as long as 30 years, many hGH recipients are still at risk to contract CJD.
Wakefield has so far dodged the CJD bullet, but he has been plagued with myriad health problems, including chronic depression and obesity. His adult life has been a series of failed diets and unrealized career expectations: until getting a position with a web-design company in Utah last month, he hadn’t held down a full-time job in years.
His life began turning around last September, when Wakefield began receiving daily injections of an unlikely new treatment, which helped him lose approximately 60 pounds and find the energy to go out and look for a job. The treatment? A new, synthetic version of human growth hormone.
Wakefield thus finds himself in the peculiar position of taking the synthetic version of the very thing that has caused him so much grief.
“Certainly my improved vitality, my improving strength and part of the weight loss can be credited to the growth hormone,” he says. “Life is more than being a fat blob on a couch.”
But he has, of course, learned to temper his excitement. “As a child, I received a product thought to be benign and wonderful. and yet it had this evil backside we didn’t know about until years later,” Wakefield says. “Now I take a product that doesn’t have that particular risk, but may be risky for some unforeseen problem. I guess you’re damned if you do, and damned it you don’t.”
Good intentions, bad science
The little-known story of the hGH experiments began with great optimism. In 1958, Tufts University physician Dr. Maurice Raben first reported success injecting hGH into human subjects. Recognizing that short-statured adults often live “lesser” lives than their normal-sized counterparts vis-à-vis marriage and employment, pediatric and endocrine doctors were hopeful that hGH would enable their short patients to gain “normal” lives.
Their enthusiasm led to the first of a series of fatal errors. The doctors never followed strict scientific protocol — creating a double-blind clinical study with placebos — to prove the efficacy of hGH. Nor did they follow the rules of “informed consent” and explain to their patients about possible health risks.
In response to the frenzied demand for hGH, the National Pituitary Agency was created under the auspices of the National Institutes of Health. From 1963-1977, the NPA collected thousands upon thousands of pituitaries while Raben and two other scientists (Emory University’s Dr. Alfred Wilhelmi and Cornell University’s Dr. Brij Saxena) handled the extraction and purification chores. From 1963-1985, the NPA’s hGH was distributed to approximately 8,000 children.
In the rush of excitement over hGH’s possibilities, the NPA issued only perfunctory collection guidelines. And this is where the second flaw in the process occurred. Pituitaries from those suffering from known systemic infections were banned, but pituitaries taken from those who died of chronic neurological diseases and other illnesses were accepted.
Worse, the extraction and purification methods used by Drs. Raben, Wilhelmi and Saxena didn’t eliminate CJD. Indeed, their sloppy medicine is considered the experiment’s third fatal flaw. Writing in the New England Journal of Medicine shortly after the CJD outbreak, Dr. Clarence Gibbs and his team concluded, “Neither method used procedures that would have excluded the agent of Creutzfeldt-Jakob disease from the final product or sterilized the Creutzfeldt-Jakob disease virus.”
(Wilhelmi and Raben are deceased. Saxena referred all questions to Cornell University’s attorneys; they didn’t respond to numerous interview requests.)
Even as the National Pituitary Agency unknowingly distributed contaminated hGH, no one publicly linked it to Creutzfeldt-Jakob disease. Certainly, there were warning signs. The transmissibility of CJD was recognized as early as 1968. In 1974, writing in the New England Journal of Medicine, Columbia University’s Dr. Philip Duffy warned about CJD transmission after a patient contracted the disease following a corneal transplant. “Aside from the importance of this report to the transmission of Creutzfeldt-Jakob disease, there are wider implications to be considered in all transplantation programs with relation to the transmission of slow-virus diseases,” wrote Dr. Duffy. And in 1976, British geneticist Dr. Alan Dickinson warned the agencies in charge of Britain’s hGH program about the dangers of transmissibility. Dickinson was ignored, as were his suggestions to improve the purity of the hGH.
But no one warned the 8,000 US hGH recipients that the “miracle growth compound” they were taking might be contaminated. “There may have been a certain amount of hubris in this,” admits one pediatrician. “CJD had been suggested as a vague possibility, but most physicians thought hGH was absolutely safe.”
In England, the government has taken responsibility for that hubris, by compensating families who’ve lost relatives to CJD. British courts have also awarded claims to “well-but-worried” hGH recipients — people who’ve suffered psychological damage because they fear that they might contract CJD.
In the US, however, none of the several families that have attempted to sue for damages over loved ones lost to CJD have won. The latest case is currently pending in New York, filed by the young widower of an hGH recipient who died of CJD in 1998.
“Every time I feel a new twinge, I wonder…”
Randy Wakefield is reminded of the threat of CJD every year, when the NIH sends an update to the approximately 6,000 hGH recipients it’s been able to contact. (In yet another miscue, the agency has been unable to locate approximately 2,000 hGH recipients to inform them of their potential health risk.) “Every time I feel a new twinge,” he says, “I wonder if it’s starting.”
Wakefield is resigned to living with the specter of CJD, and he accepts the fact that mistakes were made in the interest of helping short-statured children. What angers him is the lack of support he’s received from the NIH.
“All we get is that letter,” he says. “We’ve gotten no help, no offer of counselling services, no information about the challenges specifically for this. It’s the Clinton syndrome — complete denial.”
Wakefield complains that, for years, the NIH refused to enable the 8,000 hGH recipients to communicate with one another. (The NIH has, however, recently changed that policy; it now encourages hGH recipients to go through a third party, the Illinois-based Magic Foundation, for such contact.)
Dr. Judith Fradkin, deputy director of the division of diabetes, endocrinology and metabolic diseases, a part of the NIH, defends the agency. “We’ve tried to take responsibility by giving out information in the updates,” she says. “The hGH wasn’t made in NIH labs and it wasn’t distributed by government scientists.”
Fradkin also believes that the NIH shouldn’t be the conduit for contact among hGH recipients. “I think that it’s a privacy issue,” she says. “People don’t necessarily want to be contacted. People don’t like getting letters from us because it reminds them [of the dangers of CJD]. That’s why we never send updates during major holidays.”
The explanations don’t placate Wakefield and others. “You would think that they’d want to know how we’re doing, physically and psychologically, if only for the sake of science,” says another hGH recipient who spoke on condition of anonymity. “Well, they don’t. It’s like we don’t exist for them — we’re still treated as if we’re little children. In the meantime, they make their professional reputations off us by publishing papers in scientific journals that we never see, while the drug companies that benefited from the research on us make millions upon millions of dollars.”
The debate about adult growth hormone replacement therapy symbolizes the discontent many hGH recipients express about the NIH’s lack of support. Evidence suggests that hGH-deficient adults suffer chronic health problems. An article in the October 1999 New England Journal of Medicine reported that those adults have “increased fat mass, reduced msucle mass and strength, smaller hearts and lower cardiac output (as well as) decreased vitality, energy, and physical mobility; emotional lability; feelings of social isolation; and disturbances in sexual function.”
In 1996, the FDA approved hGH for adults with a pituitary disease or a tumor causing growth-hormone deficiency. It has also developed a wide popularity as a reputed anti-aging drug. And while additional testing is needed — there is evidence that it may be a cancer risk — the results of such therapy have been encouraging. According to Dr. Vance, “In some studies, quality-of-life measures, including energy level, mood, sensitivity to pain, emotional lability, and physical mobility … improved with growth hormone therapy.”
Norma Carter, 50, can attest to the potency of adult growth hormone replacement therapy. Like Randy Wakefield, she had injections of naturally derived hGH when she was young. Like Wakefield, she grew — in her case, from 4-foot-4 to her present height of 5-foot-2.
But shortly after she turned 32, Carter began having difficulty functioning. She had to give up her job at K-Mart because she didn’t have the energy to leave the house. Indeed, Carter says she was bed-ridden for years. “I feel like I lost 17 years of my life,” she says. “My mind was so impaired that when I tried to say anything, it was like each word was being erased after I said it.”
In 1998, Carter began taking adult growth hormone replacement therapy, and she claims she’s a new woman. “I can clean my house and I’m not dropping things anymore,” she says. “It restored my sleep and my mind works so much better.”
Carter says she never received any correspondence from the NIH (making her one of the 2,000 hGH recipients the agency has been unable to contact). After she was contacted for this article, she took it upon herself to get in touch with them. She questions why, if adult growth hormone replacement therapy is so beneficial, the agency doesn’t encourage testing for such treatment. “I wonder how many other people suffer from depression because they don’t have [replacement therapy],” she asks. “I had to spend a whole year doing my own research about this. Nobody had any answers for me.”
“It’s not so easy to decide what constitutes adult growth hormone deficiency,” says Dr. Fradkin. “What we’ve said is that is very important to be under the care of an endocrinologist.”
Randy Wakefield also says that the NIH didn’t help him with adult growth hormone replacement therapy; his endocrinologist told him about it. He’s thankful that his insurance covers the expenses, but notes that he uncovered a program (administered by drug company Eli Lilly) that supplies hGH, free of charge, for those hGH deficient adults without health insurance.
“Every year we get a letter stating that some more of us have kicked the bucket — and have a nice day,” he says. “Now, I feel that there’s hope for the future.”
David Davis is a free-lance journalist based in Los Angeles. He received hGH injections from 1974 to 1977.