Medicine by Design: The Practice and Promise of Biomedical Engineering

CHAPTER 13. The Business

Chapter 13 The Business For more than two decades, Theodore Hersh was a professor of medicine at Emory University in Atlanta, living a full life of teaching and treating patients. In 1980, however, at the height of his career, Hersh—a gastroenterologist—noticed that his night vision, which had been poor for years, was getting worse. He also was losing the peripheral vision in his right eye.Visiting his ophthalmologist, Hersh learned that he had retinitis pigmentosa, a disease marked by the deterioration of the retina’s photoreceptor cells, which pick up and process light signals sent to the brain. He quit driving in 1982, as the disease ate away at his peripheral vision and left him, particularly in the right eye, with the sensation that he was looking through a tunnel . Hersh continued teaching and practicing medicine until 1989, when, legally blind, he could no longer read X-rays well or master other small tasks of the job. His position as a professor was so intimately bound with his clinical work that he had to stop teaching, as well, a one-two blow that turned his world upside down. “It was very hard for me, because I loved to see patients and I loved to teach,” said Hersh, who also spent twenty-three years as chairman of Emory’s Human Investigations Committee, which oversees clinical trials conducted at the university. “But having taken care of patients with so many illnesses and physical limitations, I knew I had to rise to the occasion and do the best I could. I was also fortunate to have the best partner in the world, my wife, and she has become my eyes.”
148 MEDICINE BY DESIGN Hersh continued working as an administrator at the Emory Clinic until 1995 and then founded a company with his wife, Rebecca, that manufactures antioxidant compounds and skin care products. Still, there was little he could do about the progression of his retinitis pigmentosa , a heretofore incurable disease, caused by various genetic mutations, that afflicts roughly 1 million people worldwide, many of them young and middle aged. In late 2003, however, Hersh, then 70, was given some reason for hope, in the form of a tiny, fifteen-person biomedical engineering start-up company from Rhode Island. Driven by its resolute chief scientific officer, Weng Tao, the company—Neurotech—had overcome hurdle after hurdle before creating a potential treatment for people with retinitis pigmentosa and other degenerative retinal diseases . The therapy consists of a tiny device—about one-quarter of an inch long and as thin as pencil lead—inserted into the eye’s gel-like vitreous humor and anchored to the wall of the eyeball. Inside the porous capsule are about 200,000 lab-grown human retinal cells that have been genetically modified to produce a protein called ciliary neurotrophic factor (CNTF) and release it slowly over time. Through years of research and many dead ends, Tao and Neurotech scientists had discovered that the device had the ability to stave off the death of retinal photoreceptors. Building on the work of two former Brown University scientists, they had worked out a method to keep the CNTF-producing cells alive in a capsule and implant that capsule inside the eye. In short, Neurotech seemed to have achieved one of the great goals of twenty-first-century biomedical engineering: producing a cellfilled device—“a little factory to make protein,” as Neurotech molecular biologist Paul Stabila put it—that could be implanted in the body to treat disease. Experiments on specially bred dogs and rabbits with retinitis pigmentosa showed that the so-called encapsulated cell technology (ECT) slowed or halted the death of photoreceptor cells. And so, through the stubborn efforts of Tao and Neurotech vice president William Tente, the company was able to persuade the National Eye Institute—part of the National Institutes of Health—to conduct a limited trial of ten patients on the device’s safety and efficacy. Hersh got wind of the trial, applied, met the qualifications to be included, and prepared to see whether somebody had finally come up with something to halt the progression of his retinitis pigmentosa, which will eventually leave him almost totally blind in both eyes. The physician who had overseen so many human trials was about to become a guinea pig himself. “I spent so many years approving people to go into so many research studies,” said Hersh. “People...