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40 Years Ago, GMO Insulin Was Controversial Also

Aug 30, 2017

It may seem like olden days to Millennials, but the late 1970s were a lot like today. America was divided due to an unpopular President, gas was expensive, the movie industry was at death's door...and genetic engineering was a big concern.

GMOs were a worry 40 years ago? Yes, though GMO insulin today is regarded as a gigantic success story for public health in this century, by 1977 the same political forces and activists still aligned against science now were present then. Just the names have changed. Today, it is Senator Bernie Sanders, back then it was Senator Ted Kennedy. Today, activists universally call all genetic engineering a GMO, but back then the public knew a broader term, Recombinant DNA - which is what a GMO is, the transfer of genetic material from one organism to another plant or animal. Some of the states against it then, like Massachusetts and California and New York, are the same, though they have gotten a new addition in Vermont while Pennsylvania has switched to the pro-science camp. In 1975, Senator Kennedy called for hearings to tightly regulate recombinant DNA research, and he wanted any federally-funded scientist who did not agree to lose their NIH grant. Any other scientist would be fined $10,000 per day. The mayor of Cambridge banned what Kennedy called high-risk research from being done at Harvard and MIT, unless the scientists installed two sets of self-closing doors, sealed seams in the floors, walls, and ceilings and installed a ventilation system like is used in labs working with tuberculosis, SARS and West Nile virus. Just to work with E. coli that couldn't spread.

Super-activist Jeremy Rifkin organized protests against biologists, with his followers chanting, "We shall not be cloned." Then, as now, they didn't actually know any science or they would have known recombinant DNA is not cloning any more than Frankenstein was a GMO.

Being assaulted on both sides, by activists and government, some scientists came to the horrible realization that being dependent on government money actually did not give them more independence than they had in the corporate world, they had less and began to call from disentangling themselves from federal funding. Others simply persevered, voluntarily making sure everything was done safely, before Kennedy and the administration could find a reason to shut them down. Scientists agreed to use specific bacteria (e-coli strain K12) genetically engineered so that even if they got to the outside world, they would die quickly and have no chance to colonize the human digestive tract.

By 1982, we got the first high-profile breakthrough for recombinant DNA research. The first GMO insulin product was ready so Eli Lilly & Co. submitted NDA 18-790 for Biosynthetic Human Insulin (BHI) - Humulin. Though many FDA scientists were unsure why they were considering it a New Molecular Entity, since the amino acid sequence of Humulin occurs naturally in humans, FDA took the conservative approach and it was still quickly approved. No more chopped up pork and beef pancreases, E. Coli and yeast cells, with the help of the gene for human insulin production, were suddenly tiny insulin factories. Insulin is cheap.

But all of that caution led to a bigger problem we have now. Because scientists were so proactive in the 1970s, proactively taking steps to prevent problems that might not even be scientifically possible, and publicizing their efforts to assure people that recombinant DNA research was not opening up a new world of problems, the next generation of activists began to promote the belief that scientists were being so cautious because their research was risky. They began to raise money on the idea that science was placing us all in imminent danger. Because even something that FDA scientists said was not a New Molecular Entity was treated as such, activists, including those who have wormed their way into FDA, insist all similar science must be regarded as such.

That is the legacy they have left us. Two generations of activists have further convinced a giant swath of Americans and the politicians that represent them that science "must be proven 100 percent safe" before it can be on the market - a test no product can withstand. One popular anti-science documentary features a guy who won't let his kids stand in a field of corn without a haz-mat suit. Center for Science in the Public Interest, Center for Food Safety, Sourcewatch, Organic Consumers Association, Consumer Reports, Dr. Oz, they all parrot that belief for financial gain.

Yet the success of GMO insulin shows there is no reason to give up hope. Things change. In 1980, an unpopular President was swept out of office after one term, gas became affordable again and genetic engineering led to such a boom in food that no one in America is worried about starvation now like we were in the 1970s. Instead, we are worried Americans are too fat. Diabetes, once a death-sentence, is now the archetype for what managed disease looks like.

Forty years from now, we may regard the controversy over GMOs and Gene Drives and RNAi and whatever else activists try to scare us about as being just as quaint and naive as Rifkin and Michael Jacobson and Ralph Nader were about insulin.

Source: Hank Campbell, American Council on Science and Health