John Moore has me wondering about my spleen. Where is it? What's it doing? Who owns it?
Moore and I are both overweight, middle-aged men afflicted with hairy cell leukemia -- a rare, often fatal disease. And in the course of treatment, we've both had our spleens removed. That's where the similarity ends. I hope.
In recent years, Moore and his spleen have become the center of a major controversy that could have long-range legal and ethical consequences for medical research.
After being diagnosed as having this rare form of cancer in 1976, Moore had his spleen removed at the UCLA Medical Center. It was the only treatment available at the time. After surgery, Moore's oncologist, David Golde, kept the spleen. It seems that during the course of his diagnosis, Golde noticed that Moore's blood produced an unusual amount of interferon and other proteins that might be helpful in treating both cancer and AIDS.
Golde, a highly respected research scientist, began working with tissue from Moore's spleen in an effort to develop a "cell line." A cell line could produce an endless supply of cells for research as well as for commercial development.
By 1984, Golde and his colleagues, working in state-owned laboratories financed by large doses of federal grants, eventually developed a cell line from Moore's spleen and patented it. Calling his new product Mo line after Moore, Golde signed a contract with Genetics Institute Inc., an American biotech firm, to clone the cells and with Sandoz Inc., a Swiss drug company, to make medicines using the cell line. Both companies have exclusive use of the Mo cell line.
Golde, according to Moore's lawyers, received 75,000 shares of Genetics Institute stock for a penny a share. At the time, the stock was worth an estimated $3 million, according to Moore's lawyer. More important, estimates of the potential market for the medicines developed through use of the Mo cell line range as high as $3 billion.
Throughout the research period, Moore, at Golde's request, flew every six months from his home in Seattle to the UCLA Medical Center in Los Angeles for a checkup. The medical center usually picked up the tab. Each time, Golde and his colleagues drew some of Moore's blood to see how he was doing.
But Moore grew tired of making the trip and says he asked Golde if he couldn't have the blood drawn and checked in Seattle. He said he was told no and that he would have to continue making the trip to Los Angeles.
By 1983, Moore said, he became suspicious about Golde's insistence that he make the trip to Los Angeles and hired attorney Sandford Gage to find out what was going on. Gage's Beverly Hills firm specializes in medical malpractice cases.
Jonathan Zackey, a legal colleague of Gage's, said the law firm's investigation discovered that Golde was using the blood drawn from Moore during his visits twice a year as a control gauge. The blood provided them with a way to compare the lab cells with the real McCoy," Zackey said. "It also gave them a new supply."
It was through Gage's investigation that Moore said he first learned that Golde was using his cells for commercial enrichment. It was at that point that he sued for a piece of the action. Moore claims that Golde never told him about the research or the possible commercial value of his spleen.
Anthony Murray, Golde's attorney, doesn't think Moore has a legal leg to stand on. "Nothing in Mr. Moore itself had value. It was the doctors' knowledge, their ingenuity, their genius that had the value," Murray said in a recent interview on the MacNeil-Lehrer Report. "They almost literally made a silk purse out of a sow's ear. I mean, they took something that was not only useless to him, but fatal to him. And they used it, and they made some entirely different product."
Moore, according to Murray, is an ingrate. Golde saved Moore's life, Murray told MacNeil-Lehrer. "Most people would embrace the doctor with all the gratitude they have."
Moore's suit has raised the passions of the scientific community, which warns that if he is successful he will strike a blow against future medical research. Although human scrap has been used in medical research through the ages, the emergence of the biotech industry in recent years has resulted in an explosion of such research.
Because I share the same disease as Moore, I find myself wondering what I would have done if I discovered my doctor had used my discarded spleen to develop a lucrative commercial product.
When I was diagnosed in March 1984 -- just about the time Golde was patenting his cell line -- I was told that the average life span for someone with this disease was five years from the time of diagnosis, although there was a possibility I could live 25 years without having the disease progress any further.
I was also told there was no treatment other than removing the spleen if the blood counts reached danger levels. If the disease continued after that, there was nothing that could be done. It's the kind of conversation that gets your attention.
At the same time, I was told there were some very promising tests involving hairy cell leukemia patients being conducted under the auspices of the National Cancer Institute. It seems there was this new genetically engineered drug called interferon that was showing extraordinary results in large test groups of patients with hairy cell leukemia.
Although interferon was once hailed as the cure for all forms of cancers, the only disease it really seemed to work on was hairy cell leukemia. But there simply aren't enough hairy cell leukemia patients around to make much of a profit for interferon. The real commercial hope of interferon, for its backers, is that it might someday prove to be the cure for the common cold, among other things.
To bring a drug to market, however, a pharmaceutical manufacturer must first get it approved by the Food and Drug Administration by showing that it works on something. Enter hairy cell leukemia. Because interferon worked so well on this disease, it was approved in the summer of 1986 by the FDA for commercial use. And now that it's approved, the medical profession basically is free to use it for anything it wants.
Many different laboratories worked on the development of interferon. Dr. Golde's work with the Mo cell line is just part of a much larger effort that galvanized the scientific community.
Since then, the concentrated research on hairy cell leukemia has resulted in the development of a chemical drug that, according to my doctor, shows more promising results than interferon did.
Both of these drugs were developed as a result of the profit motive. Medical scientists and their corporate backers gambled on the fact that their research could lead to millions of dollars in profits. As a result, my life may be saved.
I should be grateful to the Dr. Goldes of the world for their scientific know-how and commercial zeal. But I'm not. I find something sleazy about Golde's relationship with his patient.
What bothers me is the lack of candor. As someone who has walked in John Moore's shoes, I strongly believe that Golde had the ethical if not legal responsibility to tell his patient from the start that he found his cells unique and of potential scientific and commercial value. Moore, it is hoped, would have been big enough to sign away his rights for the good of society. But he had the right to know.
The real danger of Moore's suit was summed up by medical ethicist Thomas Murray. Writing in the March 1986 issue of Discover magazine, Murray said, "The real danger from the Mo cell case and others that may follow is that they threaten to transform the nature of the relationship between scientists and the public."
Murray notes that the public has been generous to science, particularly when it comes to making gifts of organs and tissues. "If they begin to see scientists as greedy players in a biotechnology lottery with tickets provided by public generosity, this relationship stands to change," Murray said, "and not for the better."
That's something Golde and the rest of the medical profession should keep in mind. As for my own spleen? I haven't had the courage to ask about it. I trust my doctor.