- The Washington Times - Sunday, April 20, 2003

The human immune system is wonderful when it works. It attacks and destroys invaders that want to harm us ranging from the common cold virus to cancer cells.
The immune system produces antibodies, proteins that scout out malicious invaders and neutralize them. Sometimes, however, the immune system doesn't work properly. It needs help in the form of drugs.
Cancer patients, for example, have defective immune systems, which are incapable of warding off invading cancer cells. Until fairly recently, most cancer drugs have been chemical-based. Some are very good at controlling the invading cancer cells but unfortunately they cannot discern between the bad cells and the body's own cells. These chemical treatments which we have termed chemotherapy can have serious side effects. Some forms of cancer, as well as other diseases, have seemed incurable because safe and effective drugs have not been discovered.
Recently, however, there is increased optimism, thanks to the development of protein-based pharmaceuticals, including monoclonal antibodies. Through genetic research, we have learned which proteins the immune system uses to ward off specific diseases. By increasing the level of these proteins in the body, physicians are discovering an exciting new way to fight some of mankind's worst maladies.
Protein-based drugs offer new hope to victims of lymphoma, leukemia, diabetes, certain forms of breast cancer, arthritis, AIDS and many other conditions.
There are, however, two major hurdles cost and availability. We don't mine proteins or create them in beakers in a laboratory; proteins are normally produced by living organisms. Getting enough proteins to sustain the development of a drug product is a complicated and costly process. There is great optimism, however, that we might be able to produce large amounts of these proteins very economically in plants such as corn, rice or tobacco.
Currently, biologics manufacturers introduce human proteins into the cells of hamsters or other mammals. Through a series of complicated and costly processes, which involve large reactors and fermentation tanks, eventually these cells can be produced in quantities for drug manufacture.
Because of the cost, drug companies are very selective in the diseases they target and the potential lifesaving drugs they develop. For some patients, the costs may be prohibitive, and even worse, drugs for uncommon diseases may never be developed because of the costs.
Now biotechnology scientists have learned to introduce these lifesaving proteins into plants, which can produce them season after season in quantities sufficient to meet any imaginable demand. By some estimates, a few acres of corn could duplicate the protein output of a fermentation facility costing hundreds of millions of dollars.
Some people have expressed concern about the continued development of pharmaceuticals produced in plants. They have questioned whether genetic traits could be transferred to food crops.
The U.S. Department of Agriculture and the Food and Drug Administration have proposed new regulations aimed at preventing the commingling of pharma crops and food crops.
People skilled in agriculture are better judges as to whether those regulations are sufficient. As a physician and cancer researcher, however, I can vouch for the potential benefits of plant-made pharmaceuticals. This innovative technology offers great promise for the economical and efficient production of novel proteins that could potentially save many lives and provide hope where little hope has existed.

Oliver W. Press, M.D. and Ph.D., is a professor and oncologist at the University of Washington and at the Fred Hutchinson Cancer Research Center.

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