Biotech Ethics Launch Researcher on Difficult Quest : Science: Ex-professor seeks funds for a center that would wrestle with the human and ethical questions raised by the fast-growing industry.
It’s not everyone who would give up a $120,000-a-year job for a dream, especially one that, at the moment, is devoid of salary.
But those who know Solana Beach scientist Ed Golub, a confident, adventurous man whose career path has wended through academic science to industry, aren’t surprised.
The 57-year-old Golub walked away from his job as research director at R. W. Johnson Pharmaceutical Research Institute in La Jolla, where he worked for three years, to give shape to his dream of an ethics center focused on the vagaries inherent in biotechnology.
At Golub’s proposed center, scientists would navigate through the growing thicket of ethical dilemmas made possible by advances in science:
* Should it be possible to purchase, for instance, a gene that will give a child superior mathematical ability?
* Is it right to genetically engineer an animal to live with a painful disease so scientists can test different drugs?
* If there is no treatment, is it useful to have a diagnostic test that can tell when a baby will develop a fatal or debilitating disease?
* Should scientists be able to patent genes?
* Is it right to extend how long a patient will live without improving the quality of his or her life?
“The role of science has changed--it used to be that scientists were able to worry just about pure science. But with advances in biotechnology, scientists at the start should know there are social consequences to research. They should think: ‘Down the line, am I going to be causing as many problems as I am curing?’ ” Golub said. “But there has been little in the training of scientists to prepare them.”
Some say such a facility is much needed by an industry that grows in leaps, transforming what once seemed like the stuff of science fiction into possible reality.
“We definitely need this. The questions in some ways are similar to questions we had previously, but they are going to come at an accelerated rate and with more urgency,” said Robert Bohrer, a professor at California Western School of Law who specializes in biotechnology-related issues.
“The world is big enough for more than one,” said Gary Varner, assistant professor of philosophy and a research associate at the Center for Biotechnology and Ethics at Texas A & M University, which is believed to be the first center to focus solely on these issues.
Varner acknowledges that many in the industry believe biotechnology doesn’t raise fresh ethical questions, but, he says, it does raise considerable concern among the public.
In part, he attributes that discomfort to the fact that biotechnology inevitably involves gene engineering, which makes many people queasy as they envision mutated animals.
“Certainly the reception of biotechnology by the public raises a lot of public policy questions that scientists need to be thinking about,” Varner said.
Today, Golub’s center has little more than an idea, a name--the Pacific Center for Ethics and Applied Biology--and a director: Golub.
It has no funding yet--though Golub has spoken with officials from the Kellogg Foundation, National Institutes of Health and the federal Department of Energy. And he has given himself one year to raise enough money to float his dream; he figures $250,000 a year would operate the center.
Nonetheless, Golub hopes that one day the center will help educate researchers, broaden their perspectives so they view how their research will affect the world.
To do this, Golub plans to set up an educational program to work with molecular biology departments at colleges and universities to rejigger their curricula to include courses that make would-be scientists more aware of the consequences of their work.
In addition, the center would also host a variety of seminars and courses. Though the nonprofit operation is currently being run out of Golub’s home, he hopes it will one day be housed in a separate building that would draw visiting fellows who spend a year in residence. It would be a West Coast version of the East Coast think-tank Hastings Center, he says.
Golub, an author of immunology textbooks, plans to draw on his own connections to the industry and academic sciences to launch the center. Prior to joining the La Jolla biotech firm, he worked as director of research at Ortho Biotech in Raritan, N. J.
But before his career in industry, Golub was strictly an academic scientist, for two decades, teaching at the biological science department of Purdue University in Indiana. He still evokes an image of a professor as he thoughtfully strokes his chin. A lean-framed man, Golub chooses his words carefully and pauses with a dramatic flair.
“I’m not arrogant enough to say that now Ed Golub is going to ride in on a white horse and he’s going to be listened to,” he said as he sat in the den of his home by the ocean in Solana Beach. But clearly, Golub believes he stands a chance of wooing and winning the ear of industry and academic scientists.
So do others. Polio vaccine pioneer Jonas Salk (or, as Golub says, “my friend Jonas”) is on the center’s board of advisers.
“It’s a very good idea. I’m looking forward to seeing if it can be made to work,” Salk said.
“I think it’s a creative idea, a bold one. It takes a kind of maverick to pull something like that off, and I think Ed Golub’s got the commitment,” said Bryna Kranzler, associate director of CONNECT, the UC San Diego program to promote high-tech entrepreneurship. “I can’t predict the reaction from industry. Everybody is going to look at it as ‘Is there anything in it for me.’ If they don’t see anything positive, they are going to say, ‘Why do we need it?’ ”
In fact, many in the industry say they have been able to effectively regulate themselves.
“We have a pretty good moral rudder--I don’t expect any kind of (Joseph) Mengele (the Nazi who performed gruesome experiments on prisoners) to emerge, but there are fine lines to be drawn,” said William Repress, vice president and general counsel of Ligand Pharmaceutical, which develops pharmaceutical alternatives to natural hormones and vitamins.
“There are always ethical questions, but I don’t feel the industry is wrought with problems and needs to be policed,” said Lionel Simon, vice president of licensing at Genta Inc. “I think the pharmaceutical industry is one of the most misunderstood; people feel they are making inordinate profits, and nothing could be further from the truth.”
But in recent years, critics charge, there have been examples of unethical abuses. They often cite the drug Ceradase, which can cost as much as $300,000 for one year of treatment in battling Gaucher’s disease, an inherited enzyme disorder. But since this is a treatment, not a cure, the expense is an ongoing one.
“At these prices, ask yourself how many American families can afford these miracle drugs?” Sen. Howard Metzenbaum (D-Ohio) said during a congressional hearing in January.
Gaucher’s disease is a rare and painful disorder in which victims lack a specific enzyme to break down and dispose of the accumulation of fatty substances in cells. As a result, the fatty material collects in the liver, spleen and bone marrow, usually causing gross enlargements of these organs. It can also cause swelling of the joints and render bones so brittle that they easily break.
The drug, made by Boston-based Genzyme Corp., was developed under the umbrella of the Orphan Drug Act, which gives exclusive marketing rights for new drugs that battle diseases affecting less than 200,000 people. Legislators hoped the law would encourage companies to develop drugs previously viewed as offering little commercial value.
At a congressional hearing to change the law, Metzenbaum said, “The prices being charged for some drugs strike me as something akin to ransom.”
Metzenbaum advocates altering the law so drug manufacturers would lose exclusive marketing rights once sales of the drugs reach $200 million. Those in favor of the change say drug companies, like the biotech firm Genzyme, enjoy a captive audience that allows them to reap obscene profits.
Drug companies, however, counter that they lose a lot of money on research for all the drugs that never reach the marketplace, and that they need to be able to make money on the successful ones.
To Golub, this case provides fertile ground and one he’d like his center to cover.
“Is it ethical for a treatment to be so expensive that no one can afford it? Should we do it? How do we do it? Are there alternative ways of doing this?” he said. “We are walking into an era where we as scientists are going to be changing the way drugs are developed and made--that’s going to change the way medicine is done.”
Golub believes that scientists must take more responsibility for their actions, that they should think about whether their research will result in a drug that few can afford.
Some say Golub is posing an age-old, albeit worthy, question.
“It’s a question that new developments in biotechnology intensify but do not create,” said Jim Nelson, an associate for ethical studies at the Hastings Center, a New York-based bioethics think tank.
“That kind of question--what we should study--all those questions were much debated by Einstein and physicists,” he said. “It’s a perennial of the science and technology era. Science has this power over nature, and that immediately invites the question of how do we use that power?”
