30 September 2002
THE GENETICS REVOLUTION HAS FAILED TO DELIVER
"20 years later and how many breakthrough products has biotech produced? Gene therapy may actually have harmed more people than it's helped. Genetically engineered (GE) crops haven't aided hard-pressed farmers, improve the quality of our food or fed the hungry. The few drugs derived from GE such as insulin simply replace existing products while creating new risks."
Biotech hope and hype
The genetics revolution has failed to deliver, says Stephen Leahy
MACLEAN'S, September 30, 2002
COME TO CANADA. We have lovely scenery, low crime, industry-friendly regulators and low corporate taxes. That, in essence, was the sales pitch Industry Minister Allan Rock gave the 15,565 biotechnonauts from 52 countries attending the world's largest biotech nology industry convention in Toronto this summer. And if that wasn't enticement enough, Rock announced $200 million in new funding for biotech start-ups to go with Ontario's $51 million in new funding initiatives.
Federal and provincial governments have long had a love affair with genetics, pumping billions into the biotech biz since the early 1980s. And who wouldn't love a new technology that promises to feed the hungry, cure intractable diseases, clean up the environment and, thanks to patent rights, usher in the Golden and Profitable Age of Biotechnology?
So, 20 years later and how many breakthrough products has biotech produced? Gene therapy may actually have harmed more people than it's helped. Genetically engineered (GE) crops haven't aided hard-pressed farmers, improve the quality of our food or fed the hungry. The few drugs derived from GE such as insulin simply replace existing products while creating new risks. And Canadians remain nervous about the technology.
With good reason. The industry consistently overhypes the benefits and downplays the potential risks of a revolutionary new technology. Genetic engineering is revolutionary because its products incorporate genes from unrelated species. The process of evolution and traditional plant and animal breeding is an incestuous, only-with-close-relatives affair -- a vertical gene exchange.
The between-species aspect of biotechnology, a horizontal gene exchange, is a whole new ball game. Only through GE can a gene from a soil bacterium that makes a toxin become part of a corn plant's DNA. Now this exchange is not easily done. First a DNA package has to be built that contains the toxin-producing bacterial gene as well as elements known as promoters and vectors of bacterial viruses, antibiotic-resistance marker genes and other assorted bits of DNA. These packages are "glued" onto thousands of tiny metal pellets and blasted into corn plant cells with a device called a gene gun. A few will hit the right place, and the bacterial virus promoters and vectors will stitch the foreign gene into the corn's DNA. The process will produce many freakish, non-functional plants.
The odd corn plant will produce the bacterial toxin in every cell. Known as Bt corn, it kills any moth or butterfly larvae that nibble on it. One major reason to proceed with caution on bioteck innovation: the pedal-to-the-metal attitude in an industry where even the biggest players concede that many vital questions remain unanswered. "My view of biology is, we don't know shit," the U.S. geneticist Craig Venter told a magazine writer.
Yet the company he founded heralded its successful decoding of the human genome (the total DNA package) two years ago as a key step in ushering in the Biotech Age. It discovered -- surprise! -- that the human genome contains just 35,000 genes instead of the expected 100,000. So, rather than performing single duties, genes appear to multi-task and work in combination with other genes. In other words, pluck a gene from an organism because it performs one desired function, place it in another organism -- and who knows what unanticipated business it will get up to. Besides, genes are just a small part of DNA. Biotech critics like geneticist David Suzuki say it's much too soon to have planted GE crops and used them in food and drugs.
"Scientists just don't know enough about the technology right now," argues Suzuki. Not surprisingly, the biotech business says it's high time to move forward. "People don't realize that biotech nology is starting to transform the world," says Janet Lambert, president of the industry trade association, BIOTECanada. "Is it too soon to feed the starving in Africa?" Canada's first GE crops were planted in 1996. Three patented versions -- canola, corn and soy -- are now found in 60 to 70 per cent of our food. Yet they don't improve food quality or boost yields appreciably -- in fact, critics argue both quality and yield are poorer.
The main reason farmers plant something like Monsanto's Round-Up Ready canola is that it offers them the convenience of using a single herbicide -- made by Monsanto, natch -- to control weeds, rather than a whole bunch. But the jury is still out as to whether GE farmers actually spray less. The economics are also iffy. Although GE seeds cost more that the seeds they replace, some farmers, mainly those with large operations, make a couple more dollars per acre using them. Others, however, are being badly hurt. First it was the loss of export markets for formerly GE-free crops in GE-shy Europe. Now, because GE plants are living creatures that reproduce, disperse and evolve, there's genetic pollution and contamination. Thanks to winds and insects, engineered genes are travelling long distances in pollen and seeds, turning up in non-GE crops across the Prairies. Given those concerns, it's not surprising there was an uproar in Prairie farm communities last year when Agriculture Canada announced that Monsanto's GE wheat will be submitted to regulators for approval this fall. While the company stands to make as much as $7 billion from that crop, a University of Saskatchewan study showed Canadian farmers would end up losing $185 million a year through lost sales. Monsanto says it is sensitive to the contamination concerns. "We are not going to sell it," says company spokesperson Trish Jordan, "until a segregation system is in place to keep it separate from non-GE wheat."
Meanwhile, hundreds of millions of North Americans are eating foods made from GE crops without any documented ill effects. But then, how could we document any harm without data on who is eating those foods and in what quantities? That would require food labelling and a tracking system for GE crops. But while the vast majority of Canadians want foods with GE ingredients to be labelled, that's not going to happen. The reason: it would spell the end of agricultural biotech. Food processors admit they'd insist on GE-free crops from farmers because if people could easily identify GE foods, some, perhaps many, wouldn't buy them. As for global hunger, no one can deny it's a major economic and social problem. But the GE crops that the large multinationals have brought to developing countries so far are cotton, corn and soy -- all engineered to resist herbicides, and all affordable only by large commercial farmers. If biotech nologists really want to feed the poor, notes Sakiko Fukuda-Parr of the United Nations Development Program, they need to create virus-resistant, drought-tolerant, nutrient-enhanced versions of such staple crops as millet, sorghum and cassava. "Of course," she adds, "farmers living on less than a dollar a day don't represent much of a market."
Perhaps that's why fewer companies are now involved in "green" (agricultural) biotech and many more in "red" (medical/health) biotech . With one blockbuster health product capable of bringing in billions in revenue, the big drug companies are quickly transmogrifying into biopharmaceutical corporations. Today, something like 100 medical products are derived from genetic engineering.
Thousands more are being tested. The first, and likely the most profitable, GE product is "human-derived" insulin.
Approved for use in Canada in 1983, it rapidly replaced the more expensive insulin traditionally made from the pancreas of cows and pigs. It also produced biotech's first human casualties. Hundreds of Canadian diabetics have reported reactions to GE insulin, says Vancouver health policy expert Colleen Fuller, spokesperson for Society for Diabetic Rights. Using access-to-information law, that new group has associated the deaths of eight Canadians with use of synthetic insulin as of January, 2001. Fuller, a diabetic who has reacted badly to GE insulin, has also heard from more than 400 people complaining of bad responses to the medication. Hundreds of deaths and thousands of unwanted side effects have also been noted in the U.S., Britain and elsewhere. Problems clear up quickly when diabetics return to animal insulin, says Fuller. What really makes her angry, she says, is that she and thousands like her have paid a high price so insulin manufacturers could make more money. The financial successes of GE insulin and another multi-billion dollar product, GE erythropoietin (EPO), an anti-anemia drug made by placing a human gene in the ovarian cells of a Chinese hamster, jump-started the production of "biofactories." The term refers to bacteria, plants and animals engineered to produce human proteins of all kinds. Wisconsin dairy cows produce a blood-clotting agent called fibrinogen in their milk. Sheep, rabbits, goats and even mice make human proteins in their milk. While the mammary gland is the biofactory of choice, TGN Biotech of Quebec City produces complex proteins in pig semen. Plants are the bargain-basement biofactories with the potential for manufacturing material at just a fraction of the traditional costs. Molecular farmers at Medicago Inc. of Sainte-Foy, Que., have genetically engineered alfalfa to produce human hemoglobin proteins for blood transfusions.
Tobacco fields outside London, Ont., produce Interleukin-10, a human immune system modulator, for treating Crohn's disease. In the U.S. there are experimental fields of corn containing anti-sperm and anti-herpes antibodies, an HIV protein for a future vaccine, and an enzyme that may help cystic fibrosis patients digest food. While none of these products are in general use yet, some are in human trials. Critics worry about the possibility of contamination of other crops or the altered items getting into food. Joe Cummins, a retired University of Western Ontario geneticist, is concerned about the effects human proteins may have on bugs and micro-organisms in the soil and water. There is a danger, he says, that by incorporating a human protein, a common soil virus could become a health threat. Gene therapy is a more direct route to solving medical problems -- introducing engineered genes straight into human cells.
While billions of dollars have been invested and some 3,500 clinical trials conducted worldwide since 1990, there have been few claims of cures. But there are substantial risks. In 1999, 18-year-old Jesse Gelsinger died while undergoing gene therapy at the University of Pennsylvania.
Researchers have since reported hundreds of adverse reactions among patients in gene therapy trials, 691 in the U.S. alone. In Canada, where more than 30 human trials have been approved, one man, James Dent, died while undergoing gene therapy for a brain tumour. Human trials continue. The heart of the problem with gene therapy and genomic medicine in general is the complexity of the human body. Single-gene diseases, the kind most likely to be treatable by gene therapy, are very rare. And nearly all ailments, including cancer, diabetes and cardiovascular disease, are the result of many factors: lifestyle, diet, exposure to toxins, stress, hygiene and, yes, genes. The current focus and fascination with genes produces a fix-it mentality toward disease and health, rather than a better examination of the conditions that create illness. Currently 99 per cent of genomic research is about making money, not curing people, says Dr. Nancy Olivieri, head of the thalassemia and sickle cell anemia research programs at Toronto's Hospital for Sick Children. Moreover, Olivieri questions huge investments in biotech research that may never yield results when that money could be put to good use improving conventional treatments or the distribution of existing medicines, particularly in emerging countries. The current passion for all things genetic has blinded many to biotech 's faults and limitations. The hard-hearts of Canadian business continue to pump billions into an industry where only a small number of companies has ever made a profit.
Last year, the publicly traded firms netted a collective loss of $784 million. Perhaps, in the end, genetics is a numbers game. Canadian biotechs have 17,000 new products in the pipeline. Undoubtedly some will earn substantial profits and benefit some people. But at what cost, and at what risk to the public and the planet?
Stephen Leahy is a Brooklin, Ont. writer specializing in technology and the environment.
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