Biotechnology

Dispatches from BIO 2001

Biotechies defend genetically modified food, stem cells, and cloning at their annual meeting.

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Biofizzle

San Diego, Calif. June 24. Cops. Lots of cops. That's the first impression when registering for the annual convention of the Biotechnology Industry Organization (BIO) at the harborside San Diego Convention Center. The cops are here to protect the convention from disruption threatened by anti-biotech activists, who are holding a counter demonstration that they dubbed "Beyond Biodevastation."

Today, the Alliance for Better Foods (ABF), a pro-biotech coalition of industry and farmer groups, held a morning press conference in advance of the formal sessions (which begin on Monday) to address some of the claims about the alleged risks posed by biotech-enhanced crops. Nutritionist Karen Kafer insists that foods made using biotech crops are "as safe and as nutritious as conventional foods and organic foods." She adds, with regard to food safety, that she is a lot more concerned about how people who handle food wash their hands. Mike Phillips from BIO pointed out that biotech food products "are the most scrutinized food products in our history. They are all looked at by the FDA (Food and Drug Administration), EPA (Environmental Protection Agency), and the USDA. (U.S. Department of Agriculture)" before they are put on the market.

The ABF speakers addressed the biggest public controversy so far over biotech food: the StarLink hysteria whipped up last fall by the anti-biotechies. StarLink is the corn approved only for animal feed that an anti-biotech lab found in some Taco Bell taco shells. The Centers for Disease Control tested some 20 people who claimed they had had adverse reactions after eating products like the tacos, but found no evidence that anyone had been harmed. A StarLink-type problem should not arise again because both the relevant government agencies and industry have agreed that in the future all biotech crops will be approved for both human and animal consumption before being marketed.

Gene Grabowski, communications director of the Grocery Manufacturers of America, pointed out that despite posturing by European governments over banning imports of American genetically enhanced corn and soybeans, Europeans are not even testing shipments because Europe's beef producers need the corn and soy to feed their herds.

In the afternoon, the anti-biotech activists marched through the largely deserted streets of downtown San Diego. Protest organizers had predicted a crowd of 8,000, but there were no more than 750. The marchers dressed in the usual cliche street theater costumes such as ears of GE corn, killer tomatoes, and monarch butterflies. A rather bedraggled giant Gaia Earth Mother street puppet led the parade. Besides placards demanding biotech food labeling and opposing biotech crops, a curiously large contingent of marchers carried "Free Mumia" placards. The hapless marchers were completely surrounded by phalanxes of police on motorcycles and horses. San Diego's city mothers and fathers were clearly determined to avoid a debacle like the one Seattle suffered during the anti-World Trade Organization protests in November 1999.

The anti-biotech marchers eventually arrived at the fenced-in protest area in front of the convention center, where they were met by a small contingent from the anti-abortion group, Operation Rescue, who were there protesting human embryonic stem cell research. The ideological incompatibility of the strange protesting bedfellows was highlighted when one of the more conventional left-wing protesters started bellowing through a bullhorn, "Born-again bigots go away!" The anti-biotech rally at the convention center petered out by mid-afternoon.

Biotech Gets Personal

San Diego, Calif. June 25. Some 14,000 or so BIO 2001 participants milled through the halls attending seminars and symposia with titles like "Challenges in Public-Private Partnerships," "Developing AIDS Drugs for the New Millennium," "Biocatalysis," and "Glycosylation in the Era of Proteomics."

The first session I attended was "Golden Rice: Public/Private Cooperation to Battle Malnutrition," which featured University of Freiburg biotechnologist Peter Beyer, who collaborated with Swiss biotechnologist Ingo Potrykus to create golden rice. They added two genes taken from daffodils and one from a bacterium to rice so that the crop produces beta-carotene, the precursor to vitamin A, which colors the rice yellow–hence "golden rice."

According to the World Health Organization, some 124 million poor children in developing countries suffer from vitamin A deficiency. Nearly half a million go blind from lack of the vitamin annually. In addition, nearly 2 million children whose immune systems are weakened by vitamin A deficiency die annually from infectious diseases they would otherwise survive. Anti-biotech groups like Greenpeace have charged that golden rice won't help eliminate vitamin A deficiency because people would have to eat a couple of pounds of golden rice per day to get the recommended daily allowance (RDA) of the nutrient. Beyer responds that RDAs are relatively luxurious standards, and that research is needed to identify the minimum amount of vitamin A needed to avoid disease. He and Potrykus are also working to boost the beta-carotene content of golden rice by a factor of three to five.

If Greenpeace and other anti-biotechies are not enthusiastic about the prospects of golden rice, Ronald Cantrell, the head of the International Rice Research Institute (IRRI) in the Philippines, is. This past January, IRRI began working on cross-breeding golden rice with other varieties that it will make available to poor farmers in the next five years. Cantrell describes rice cultivation as the single most important economic activity on the planet, and points out that half the world's people get more than half their daily calories from eating rice. He reminded the audience of the tremendous success of the Green Revolution in boosting rice production in Asia from 199 million tons a year in 1961 to 540 million tons a year in 2000. Cantrell also cited the creation of golden rice as the first major cooperative effort between the public and private sectors in agricultural biotechnology. "Poor farmers and consumers need and deserve the best technologies available," said Cantrell.

Next up was the session on "Getting Personal: The Development and Practice of Personalized Medicine." Today pharmaceutical companies develop drugs that they believe will benefit large numbers of people, but in the future drugs will be tailored to your specific genetic makeup. This will improve drug efficacy and avoid side effects.

Elma Hawkins of Antigenics Inc. told the audience about her company's success with autologous cancer vaccines. "There are as many different cancers as there are people with cancer," explained Hawkins. Genetic differences influence individual responses to medicines and most current cancer drugs are effective in only 30 to 50 percent of patients. Antigenics treats cancer by taking malignant cells from the patient and producing certain proteins that are made into a vaccine based directly on the patient's particular cancer. Hawkins showed us MRI scans of a melanoma patient whose cancer had metastasized throughout his viscera. Since being vaccinated with Antigenics' Oncophage vaccine, his cancer has disappeared. He has been disease-free for two years. Another patient had melanoma lesions covering most of one leg. After vaccination, the lesions disappeared. He also has been disease-free for two years. Although the vaccines are still in clinical trials, some 250 patients have been treated with Antigenics' autologous cancer vaccines and the company is developing vaccines for renal cell carcinoma, colorectal and pancreatic cancer, and sarcoma.

Dr. Anthony Atala, a surgeon at Harvard University's Children's Hospital, gave a talk called "Tissue Engineering, Stem Cells, and Cloning: Current Concepts." Dr. Atala's labs are creating tissues for transplantation by taking a few of a patient's cells and then growing them outside their bodies on molds (like plastics) shaped like the structures and organs they need to replace. For example, Atala has created ureters (the tubes that drain the kidneys into the bladder) using cells taken from 80 patients, growing them on tubular molds, and then transplanting them into patients. Unlike donor organs, tissues made using a patient's own cells will not be rejected by the patient's immune system. Dr. Atala is doing experimental work on growing arteries. He has also successfully created and transplanted whole bladders for dogs.

Atala also described how therapeutic cloning could one day create human embryonic stem cells that would be used to grow immunologically compatible tissues for patients. Basically, a physician would take the nucleus from one of your skin cells, insert it into a human egg whose nucleus has been removed, and then let it divide into 32 cells. At that point stem cells, which can become any tissue in your body, would be harvested and grown to make whatever tissue you needed, like brain cells to cure Parkinson's disease, islet cells to cure diabetes, or heart cells to repair the damage done by a heart attack. Again the advantage is that your body would not reject these cells since they are, after all, your cells in the first place. Atala said that his lab has already tested this procedure in cows, where cloned cow embryonic stem cells were used to create muscle cells that were then transplanted into a cow. The transplant was accepted and after a year there have been no complications.

I talked with Atala after the session about the legislation being proposed by Senator Sam Brownback (R-Kan.) that would criminalize embryonic stem cell research by banning therapeutic cloning. Atala was incredulous that anyone could think that using human embryonic stem cells to treat patients this way is immoral. "If they are going to argue that stem cells produced this way are potential babies, then they should worry about showering since the skin cells that go down the drain are also potential babies," Atala says. He seemed to have great difficulty imagining that Congress might try to ban research on therapeutic cloning.

Still pursuing the theme of personalized medicine, Paul Oestreicher of Genaissance Pharmaceuticals said that his company's aim is "to revolutionize health care by customizing treatments based on each person's DNA. Our goal is to eliminate trial and error prescribing." Genaissance identifies genetic variations among individuals, which are organized into haplotypes. Genetic variations affect drug response, so Genaissance can classify patients as to whether they will respond or not to a specific medicine and/or experience side effects. Oestreicher gave an example of tests for response to the asthma drug albuterol. These tests check patients for genetic variations in a particular receptor. Genaissance found that they could divide patients into four different haplotypes and that two of the haplotypes simply did not respond to albuterol. One day doctors could test for these haplotypes and avoid prescribing albuterol to those who will not benefit from it. Haplotyping would also be very useful in clinical trials of new drugs, because the drugs could be targeted to patient populations that are likely to benefit. Drug companies know that they have many drugs on their shelves that work for some patients but not for others. Until now they had no way of finding those patients who are likely to benefit. With haplotyping they do.

Agricultural biotech was again on the agenda when Leonard Gianessi of the National Center for Food and Agricultural Policy held an afternoon press conference to issue a preliminary report on the economic impact of ag biotech on 30 different crops. Gianessi found that if soybeans genetically modified to resist the herbicide Roundup were eliminated, farmers would have to spend an additional $735 million annually on alternative pesticides to control weeds. He also found that farmers planting insect-resistant cotton reduced their pesticide use by 2.7 million pounds in 1999. Gianessi also pointed out that genetically engineering virus protection into crops is the only effective way to protect plants from disease. His bottom line: Genetically modified crops "save several billion dollars per year for farmers."

I dropped by the Xenotransplantation Symposium later in the afternoon. There Barry Solomon, president of Circe Biomedical, described the HepatAssist bioartificial liver his company has developed. "Xenotransplantation" is using cells and organs from animals to treat human diseases. The HepatAssist bioartificial liver is composed of pig liver cells enclosed in a bioreactor outside the body. The plasma of a patient suffering from acute liver failure is pumped through the bioartificial organ, which inactivates impurities. The bioartificial liver is used chiefly as a bridge to keep a patient alive until a suitable donor liver can be transplanted. Some 170 patients have been treated using the bioartificial liver. Solomon told the audience that there is no evidence that endogenous retroviruses found in the pig genome have become active or infected patients, despite some initial concerns.

"Those Who Protest Biotechnology Do So with a Full Belly"

San Diego, Calif. June 26. That headline comes from the mouth of Kenyan biotechnologist Florence Wambugu, who works on creating virus-resistant sweet potatoes suitable for poor farmers to grow in Africa. Wambugu held a press conference at the BIO convention to release her new book, Modifying Africa: How Biotechnology can Benefit the Poor and Hungry, A Case Study from Kenya. "Without this technology there will be people in Africa who will not make it," Wambugu says. "This technology will change the face of Africa." Wambugu was dismayed by the activities of anti-biotech non-governmental organizations (NGOs) like Greenpeace in Africa. "They are taking Africa hostage," she says. "Because of them, we may not realize these opportunities [offered by crop biotech] in Africa." Wambugu worries that European bans on importing genetically enhanced food crops will harm Africa's efforts to join the world economy. She told the audience that an NGO had declared that food aid delivered last year from the United States to ward off a famine was not fit for human consumption, and that Kenyans were being used as experimental subjects, because the food contained genetically modified crops. A Kenyan minister quelled the furor by pointing out that Americans had been consuming genetically enhanced crops for the past five years with no ill effects.

Some of Wambugu's concerns about activists was amply illustrated by a morning symposium on "Safety and Regulatory Oversight of Novel Crops." One particularly low point was when Doug Gurian-Sherman, co-director of the Biotechnology Project at the Center for Science in the Public Interest, warned biotech food producers that "consumers will see through their optimistic scenarios and the environmental community will help them to do so." Gurian-Sherman seems completely unfazed by the fact that there is not a single documented case of any one of the millions who have eaten genetically enhanced foods suffering so much as a sniffle, a cough, or a stomach ache as a result. Despite showing no evidence that anyone has been harmed, Gurian-Sherman demanded that the United States establish a "comprehensive regulatory system based on mandatory approvals" for all genetically enhanced crops.

Susan Ferenc from the Grocery Manufacturers of America gamely responded that "we don't think that the current system needs to be overhauled." She pointed to the oversight exercised currently by the EPA, USDA, and the FDA. Ferenc also said that her organization strongly opposed "process-based labels" like "GMO-free" or "Non-GM" because they potentially could mislead consumers with an implication that such foods are superior or safer when that is simply not true.

"The Rhetoric Was Very, Very Anti-Biotech"

San Diego, Calif. June 27. Those words were spoken by Michael Werner, who heads up bioethics at the Biotechnology Industry Organization. Werner was not talking about Jeremy Rifkin or the ragtag protesters outside the convention hall. No, Werner was talking about the United States House of Representatives. Specifically, Werner was talking about recent hearings held on Capitol Hill on anti-stem cell bills proposed by Congressman David Weldon (R-Fla.) and Senator Sam Brownback (R-Kan). [House bill; Senate bill] President Bush has hinted that he supports the bills. "This legislation is anti-biotech," declared Werner during an afternoon panel discussion on the stem cell controversy. "The folks who are pressing this case are extremely hostile to our industry." Werner's bottom line? "BIO cannot stand for any legislation that turns researchers into criminals."

What Werner and other panel members are concerned about is an effort being led by conservative members of Congress and a group of neoconservative policy intellectuals, including University of Chicago philosopher Leon Kass and Weekly Standard editor William Kristol, to ban and criminalize all research that uses somatic cell nuclear transfer (SCNT), the technique that famously produced the cloned sheep Dolly in 1997. SCNT could be used for the reproductive cloning of humans, just as it was used to create Dolly, but researchers believe that the human embryonic stem cells produced by using SCNT, also called therapeutic cloning, will be essential in helping cure many devastating degenerative diseases. Such cells can potentially be turned into any tissue in the body, such as nerve cells, heart cells, liver cells, or pancreatic cells. Opponents of human embryonic stem cell research claim that recently discovered adult stem cells can substitute for embryonic cells, making the research unnecessary. However, as panelist Doros Platika, CEO of the biotechnology company Curis, pointed out, adult stem cells do not propagate as efficiently nor do they differentiate into various cell types as efficiently as embryonic cells do. Furthermore, Platika argued that it is not an either/or situation. Researchers need to study embryonic stem cells in order to find out how adult stem cells work. "Blocking embryonic stem cell research is the surest way to make sure that adult stem cells don't happen [as therapies]," Platika says.

Peter Van Etten from the Juvenile Diabetes Research Foundation passionately argued against the proposed criminalization of embryonic stem cell research, arguing that "the most likely supply of transplantable islet cells [the pancreatic cells that make insulin] comes from embryonic stem cells." Islet cells made using a person's own DNA would be a perfect match, and would not be rejected by a patient's immune system. Such islet cells produced using stem cells would be a complete cure for diabetes.

Simon Best from the British biotech company Ardana Bioscience, and vice-chairman of the British Biotech Industry Association, explained how the British government passed legislation permitting the creation of embryos up to 14 days for stem cell research. Van Etten mentioned that one California-based diabetes researcher (whom he declined to name) has gone to work at Cambridge University because he cannot do his research on stem cells here. Others may do the same.

At the end of the session, one audience member objected to the using the term "pro-life" to describe opponents of stem cell research. "The biotech community is pro-life. Every company here is pro-life," she declared. Especially after exposure to all the potentially life-enhancing and life-preserving possibilities of biotech presented at this conference, all I can say is, hear! hear!

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