Thirty years ago, two Bay Area
scientists demonstrated that a piece of DNA extracted from one species
could be spliced into the genome of a different species.This revolutionary
technique, discovered by Stanley Cohen of Stanford University and Herb
Boyer of UCSF, soon made it possible to turn living cells into
factories that could produce therapeutic proteins and industry enzymes.
The discovery marked the birth of biotechnology.
Gene splicing, or recombinant DNA technology, as it was then called,
was controversial from the start because it tinkered with the
fundamentals of life.
Cities banned it. States held public hearings. Scientists themselves
agreed to a moratorium on gene splicing while they worked out
self-regulatory mechanisms to oversee recombinant DNA research.
Three decades later, biotech has become a global industry with more than 550 public companies employing upward of 190,000 people and generating more than $41 billion in revenue. In addition to these public firms, thousands of privately held companies and university laboratories are developing biotech products and techniques.
This week, San Francisco is hosting the annual meeting of the Biotechnology Industry Organization. Approximately 20,000 scientists, executives and financiers from across the country and around the world are attending the event, which runs through Wednesday.
And just as in the beginning, biotechnology remains controversial, particularly the re-engineering of foods and experimenting with material from human embryos. In addition, biotech is one of the world's most thoroughly globalized industries, making it a target of protests.
Here are five people representing a spectrum that includes biotech critics and boosters, plus the insurers who grapple with the cost of new medicines. Their voices may help answer a simple question that has no simple answer: Why is biotech so controversial?
THE organic FOODS ACTIVIST
At age 59, Els Cooperrider has a certainty about her own convictions and the determination to live by them to the greatest extent practicable. So when her son, Bret, suggested that the Cooperrider family open a beer-making restaurant, the Ukiah (Mendocino County) woman insisted that the entire operation be organic, "right down to the pepper on the table.''
"Organics have become important to me when I'm looking at the health of my family and, as a restaurant owner, to the health of my customers,'' said Cooperrider, who helps preside over the Ukiah Brewing Co.
In March, Cooperrider took her all-natural approach to Mendocino County voters by pushing a ballot initiative to ban the growing, propagating or cultivating of genetically engineered foods. This ban would include corn plants that contain foreign genes to kill pests, and salmon engineered to grow faster. The measure passed with 57 percent of the vote, despite a $700,000 campaign by biotech interests against the initiative.
Now activists in other California counties are considering similar measures.
Why is Cooperrider so strongly opposed to gene-modified foods, when U.S. regulatory agencies have said they are generally recognized as safe? When they are endorsed by academic researchers from coast to coast and around the world? And when many farmers embrace the plants when given the opportunity?
Cooperrider doesn't trust the authorities. A botanist and ecologist by training, she did animal research at a university lab before she went into brewing. She has no objection to biotech medicines, but she thinks genetically modified organisms should be more thoroughly tested.
"We don't know how these things will interact with our environment. We can't engineer everything,'' she said, "It's a basic and a cultural and an ethical problem: Do we really want to remake what God created for us?''
As president of product development for Genentech Inc., Susan Hellmann oversees about 2,000 people who are developing 30 new medicines. While she knows the industry generates controversy, she wishes more people understood what her South San Francisco company and the vast majority of biotech firms do for a living.
"When people are negative about the industry, I sometimes feel frustrated that there's not a clear understanding of what we're trying to do for patients, '' said Hellmann, 46. "Harnessing the power of biotechnology to make new drugs for people who are sick is what we do every day.''
Genentech has been a pioneer in the business and medical sides of biotech. It was the first biotech company to go public in 1980. It was the first firm to use gene-splicing to make a medicine, bioengineered human insulin, which was approved for use in 1982.
In 1997 and 1998, it developed a new class of anti-cancer medicines called monoclonal antibodies. They targeted diseased cells with greater specificity, thus causing fewer side effects, than chemotherapy.
In February, Genentech led the field again by winning clearance for a new colon cancer treatment that chokes off the blood supply tumors need to grow, opening a new therapeutic approach.
"We feel that in today's world, it's our job more than ever to make valuable medicines,'' Hellmann said, a reference to the controversy brewing in the nation's capital.
Medical expenses are rising faster than overall inflation. The increase is being blamed in part on higher costs and greater use of drugs. Biotech medicines are particularly expensive because they're complex to make. Policy- makers in government and the insurance industry wonder how to rein in drug costs without throttling innovation.
Hellmann said Genentech addresses the cost controversy in two ways: by focusing on medicines for the most serious conditions and by creating diagnostic tests that determine which breast cancer patients will benefit from its new therapy, Herceptin.
"We think it's good for the (insurance) folks to challenge us,'' Hellmann said, adding, "I don't think we'll overwhelm the system.''
Sharon Levine spends an increasing amount of time worrying about the cost of biotech medicines. As associate executive director of the Permanente Medical Group in Northern California, the doctor half of the Kaiser-Permanente HMO, her duties include drug policy.
"We're prescribing drugs, and we're watching the cost increase. The issue for us is: How do we make access to these drugs sustainable?'' said Levine, 58.
"The biotech drugs and the prices at which they are being introduced is a challenge to that,'' she said, adding, "There are drugs in this category that are in the hundreds of thousands of dollars a year.''
The most expensive biotech medicines are those aimed at rare conditions such as enzyme deficiencies. Not only is it costly to make the enzyme for replacement therapy, but the expense can be spread over only a few patients, which means a high unit cost.
Because these diseases are rare, Levine said, the clinical trials of the drug are done on small groups. Levine said these tiny trials don't necessarily prove that the patients will get a lasting benefit. What makes all of this particularly heartbreaking is that the patients are often children. Levine, a pediatrician, though sympathetic, looks at the big picture.
"The process of putting a price on hope is a societal issue,'' she said. "Eventually, the cost is borne by all of us who pay for insurance.''
Levine has another gripe with the biotech industry. Biotech medicines are so new that, as a class, their patents are just beginning to expire. That should open the way for generics, but there are no clear rules to govern the creation of generic versions.
"There is no framework for generic equivalents to biotech drugs and very little progress on a regulatory scheme to get competition on the horizon,'' Levine said.
Biotech remedies now account for between 1 and 1 1/2 cents of every dollar Kaiser spends. While that may not seem like much, Levine said her payout for biotech treatments has increased 600 percent since 1998.
"Some of them are great drugs,'' she said. "But I think we have a right to question the price we pay.''
After 18 years as a pediatric critical care nurse, Jennifer Lahl took a break in the 1990s to get a master's degree in bioethics from Trinity International University, a Christian college north of Chicago.
Now, in addition to being a wife and a home-schooling mother of three, she's executive director of the Center for Bioethics and Culture in Oakland.
"I founded the nonprofit as my thesis project,'' said Lahl, 46.
She is opposed to the biotech industry's research on human embryonic stem cells. When a sperm fertilizes an egg, forming an embryo, the embryo divides into stem cells. These are all-purpose cells that develop into muscles, bones, nerves and, if allowed to proceed undisturbed, a baby.
Scientists have extracted stem cells from embryos frozen after in vitro fertilization and have kept them growing in this all-purpose state. They hope one day to manipulate these flexible cells to grow replacement tissue to repair diseased hearts or treat Alzheimer's disease.
Lahl opposes this research on principle. "Once the sperm and egg are united, and the DNA double helixes are raveled and unraveled, you have a human, '' she said. "If you put that embryo into a woman, you're going to get a baby in nine months' time. What else are we going to call it, a tree?''
In August 2001, President Bush approved limited human embryonic stem cell research. Last week, the California secretary of state certified an initiative for the November ballot asking voters to approve a $3 billion bond issue to fund a stem cell research institute in the state.
Lahl supports research on the medical uses of stem cells from adult tissues. Scientists have also found multi-purpose cells in blood, nerve and other tissues. Trying to turn them into remedies doesn't bother her. But experiments on cells taken from embryos are, to her, morally impermissible.
"That to me is the bright line,'' said Lahl.
industry ASSOCIATION head
Carl Feldbaum, president of the Biotechnology Industry Organization, said he first sensed the controversial nature of his post when the movie "Jurassic Park" opened not long after he assumed office.
Its fictional treatment of genetic engineering kindled concerns that Feldbaum has dealt with periodically ever since, whether the subject involved modifications to crops, human cloning or stem cell research.
"Every major advance in science has been controversial,'' said Feldbaum, 60. He said the association's officials knew that presenting the conference in San Francisco meant it would probably face protests, but they were not deterred.
"We're not put off by people expressing their First Amendment rights,'' he said. "It's part of doing business in America.''
He noted that this convention is the most international ever, with delegations from China and Russia joining the familiar European and other non- U.S. attendees. The industry's global nature, a source of alarm to some protesters, strikes Feldbaum as a plus.
"You have a very unusual global mix, which I think is a very good thing to have at this point in history,'' he said, adding, "science knows no boundaries.''
He said media coverage of the biotech industry cuts both ways. Public interest in medical research has generated stories that tend to boost the field. But the tendency of the media to focus on conflict means that a lot of coverage is on research -- stem cells for instance -- in which few biotech firms are involved.
"Where's the controversy over a new therapy for cancer?'' he said.
Feldbaum believes the public will eventually become comfortable with biotechnology even if it takes a generation. For instance, he said, high school students today often do gene-splicing experiments the way their parents once tinkered with chemistry sets.
"You have the beginnings of a generation who have grown up with this
technology and are familiar and comfortable with it, and they also
understand the ethical implications,'' Feldbaum said.