Enthusiasm Over Growth Hormone's

Potential Is Strong Despite Side Effects

                  Tuesday, February 24, 1998; Page Z16

                  As recently as two decades ago, medical experts thought that growth

                  hormone didn't do much in adult bodies. They believed that once a child

                  had grown to his or her final height, the job of this protein messenger made

                  by the pituitary gland was finished.

                  That view began to change, says Marc R. Blackman of Johns Hopkins

                  School of Medicine, when researchers found that adults with pituitary

                  glands that could no longer make growth hormone seemed to grow old

                  before their time -- losing muscle and bone mass, gaining fat, and

                  developing diabetes and heart disease -- and that giving such patients

                  supplemental growth hormone could remove those hallmarks of aging.

                  Scientific and popular interest in the possible anti-aging properties of

                  growth hormone ignited with the 1990 publication of a landmark study by

                  Daniel Rudman of the Medical College of Wisconsin. Rudman treated 12

                  healthy men, aged 61 to 81, with injections of growth hormone three times

                  a week for six months and compared them with nine similar men who

                  received no treatment. Men who received the hormone showed marked

                  increases in lean body mass and skin thickness, a dramatic drop in body

                  fat, and some increase in bone density. The effects of six months of human

                  growth hormone on the body's muscle and fat content were equivalent in

                  magnitude to the changes incurred during 10 to 20 years of aging,

                  Rudman wrote.

                  In response to these findings, Blackman said, the National Institute on

                  Aging awarded eight grants for larger studies of the role of growth

                  hormone treatment -- with and without supplemental sex hormones and

                  exercise -- in preserving the health of tissues and organs in elderly people.

                  Among the many factors being measured are muscle strength, bone mass,

                  body fat content, heart function, blood sugar, cholesterol and fats in the

                  blood, immune function and psychological health. All of these studies are

                  underway, and results are expected within the next two to three years.

                  Blackman emphasized that for now, both the safety and the long-term

                  benefits of growth hormone are still uncertain. Reported side effects,

                  especially with high doses, include high blood pressure, carpal tunnel

                  syndrome (pain, weakness and tingling in the fingers caused by

                  compression of a nerve), headaches and diabetes. Such side effects can

                  usually be reversed by stopping treatment or reducing the dose, Blackman

                  said.

                  The biggest concern, he added, is that growth hormone and IGF-1, a

                  related substance made by the body that directs the growth hormone's

                  effects, may increase cancer risk. To date there is no evidence

                  whatsoever that growth hormone and IGF-1 cause cancers to increase,

                  Blackman said. On the other hand, there is clear-cut evidence in animals

                  and humans that both hormones can cause enlargement or expansion of

                  existing cancers, including breast cancer. Last month in the journal

                  Science, a study of more than 14,000 doctors reported that the quarter of

                  the group with the highest blood levels of IGF-1 had four times as great a

                  risk of prostate cancer as the quarter with the lowest levels.

                  Blackman, who is directing a federally funded hormone trial at Hopkins,

                  said anyone with possible cancer is excluded from that study, and that

                  participants are monitored closely for malignancies.

                  He said it already appears that growth hormone takes longer to produce

                  beneficial effects in some tissues than in others. Body fat content decreases

                  quickly but muscle mass and bone density take a year or longer to

                  respond. Long-term treatment may also make the heart work better and

                  improve the body's metabolism of sugar.

                  Blackman predicted that if the results of the first round of studies are

                  promising, researchers will need to continue to test the hormone in larger

                  groups of people for longer periods of time.

                  Genetically engineered human growth hormone was first approved by the

                  FDA in 1985, but only for children who had failed to grow normally

                  because their bodies didn't make enough of the hormone. Four companies

                  -- Genentech, Eli Lilly, Pharmacia/Upjohn and Serono -- make genetically

                  engineered human growth hormone. In the past two years, the FDA has

                  approved the products of the first three companies for growth hormone

                  deficiency in adults. It approved Serono's product in 1996 for the

                  treatment of weight loss and muscle wasting caused by AIDS. But none of

                  the treatments are approved for healthy elderly people who are not

                  deficient in growth hormone.

                  Nevertheless, some physicians have responded to the rising interest in

                  growth hormone by signing up to buy supplies of the product that they can

                  resell to their elderly patients, said Randall Lusson, vice president of HGH

                  Corp., a Phoenix-based company that buys the hormone from

                  Pharmacia/Upjohn and sells it to physicians for less than a pharmacy would

                  charge. The treatment, which must be injected several times a week, costs

                  patients $5,000 or more per year, depending on the dose prescribed.

                  In an interview, Lusson said his company had enrolled between 150 and

                  200 doctors during its first two months of existence. He said about four or

                  five new doctors were signing up each week. Pretty much all of the

                  doctors we sell to are taking it themselves, Lusson said. Then, if they like

                  the effect, they start prescribing it to patients. . . . I don't think any of our

                  doctors are using it for younger persons.

                  A spokesman for Pharmacia/Upjohn said the company is not studying

                  growth hormone as a treatment for non-hormone-deficient elderly people

                  and has no plans to request approval for that purpose. We know it's going

                  on out there, but it's not something we're promoting, he said.

    Medical researchers, as a group . . . always paralyze themselves with

                  caveats, he said. It's so much easier to remove the caveats and tell

                  consumers, 'This stuff works. Buy it, and buy it from me.'

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