TCS Daily

Regulate Cloning With Science, Not Fear

By Duane D. Freese - July 9, 2001 12:00 AM

Here's a bit of news you probably haven't heard much about.

Last month, Nature Biotechnology reported that researchers at Scotland's Roslin Institute, the same folks who kicked off the big cloning debate with their delivery of the now late Dolly the Sheep, established that they could "target" in sheep either the alpha (1,3) protein galactosyl transferase or the prion protein.

What does this mean? A lot, really, if you are interested in ultimately raising cattle, say, that are immune from hoof-and-mouth disease or that other graver threat to human health, Mad Cow disease, that can be transferred to people as the degenerative and fatal Creutzfeld-Jacob disease. Together, gene targeting and then cloning the embryos could spread immunities against such animal pestilences that will protect both food supplies and human health.

Similar manipulation, it is hoped, will lead to animal models that make discovery of drug treatments less costly; provide higher protein, less fatty meat and greater milk production; and furnish animal organs and skin for human transplant, and new therapies for emphysema, Parkinson's and other diseases.

Before raising the roof with a loud Eureka! it is worth noting that of 120 implanted gene-targeted embryos in the experiment, only four made it to birth, and the longest surviving sheep lasted but 12 days. Cloning Dolly required implantation of nearly 300 eggs, in which only one led to a birth. Subsequent success rates hovered at only about one in 20 implants. That low success rate is why a yet to be born clone of a prized Holstein milk cow called Mandy fetched $82,000 at an auction last fall at the World Dairy Expo in Madison, Wis. But new techniques promise to drop the cost dramatically, encouraging its usage. Last month, University of Georgia scientists announced that they had brought eight cattle to term at a success rate of one in seven implantations. These most recent experiments provide not only a glimpse at the hopes for genetic modification and cloning but also the hurdles they face. As such, government regulation needs to deal with such advances with care. To ensure safety, it must follow a sound-science model for its regulation, but not succumb to the scare-mongering about genetically modified food that has plagued American producers of corn and soybeans in the European market.

The Food and Drug Administration's request last month to biotech companies that they keep their cloned animals, their offspring or the meat and milk they produce out of the food chain walks a fine line.

The agency says it was caught off guard by the fast pace of change in agriculture since Dolly was born in 1997. Insofar as the agency hopes only to get scientific understanding ahead of this curve by allowing the National Academy of Sciences time to complete a review of the safety of cloned animal products, there is no real problem.

None of the cloned animals created by the biotech firms will be ready for either milk production or slaughter until 2003. And most in the industry understand that the only way to gain public acceptance of their products is through proof that the products are safe, the animals are normal and animal welfare isn't ignored in the process.

Still, the FDA's good intentions again risk raising false fears that these techniques are more dangerous than others commonly used in agriculture, even when there is no evidence that they are. When regulatory agencies singled out genetically modified plants for scrutiny - at the behest of industry -- they fed the uproar about their safety. Opponents of high-tech farming - including not merely those concerned with safety but European farmers whose subsidies are threatened by foreign producers' efficiency and organic farmers seeking a leg up against competitors - latched onto the regulation to claim GM foods were somehow less safe, even though they were more.

Some critics of cloning already are raising safety concerns about GM animals, based on a study published in Science last week by scientists at the Whitehead Institute for Biomedical Research and the University of Hawaii. The study found even grown, normal-looking mice born from cloned embryonic stem cells suffer subtle aberrations that aren't easily detected.

Such findings hold particular relevance about the safety if anyone were to attempt human cloning, which President Clinton banned after Dolly. The concern for animal husbandry, though, isn't safety so much as simply efficiency. It was hoped that using embryonic stem cells might make cloning easier than using the DNA from ears and other parts of mature animals as is done now. If the embryonic cells prove too unstable, it simply means other methods need to be tried.

The only concern for regulators, though, ought to be whether the actual composition of the products produced by cloned cattle, pigs or sheep pose problems for humans who consume or otherwise make use of them. The NAS study may shed light on that. But the federal government should fund field tests to produce the data necessary to determine whether there is a significant and detectable difference in safety with products from uncloned animals. Otherwise, the government's role should be minimal, supporting the basic research that underlies this potentially life-saving technology. In the case of cloning, bring on the science, but don't open new doors to scare-mongering critics.


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