That Old Devil Sugar

It is surely no secret that the United States, and, increasingly, the rest of the world, is wallowing in an epidemic of diabetes (the CDC says that one of every four American teenagers has type 2 diabetes, with the expectation that by 2040, it will one in three.Teenagers!), and that many doctors and other healthcare providers consider sugar to be at least one culprit. It is therefore somewhat surprising that Gary Taubes, in his latest book, The Case Against Sugar(Knopf: 2016), takes the position that there is a serious debate, if not a war, raging about this, and that he must therefore prosecute sugar as responsible for just about every major ill we have, including cancer and Alzheimer’s. For my purposes, though, I’d just like to see agreement that sugar is clearly responsible for a few: diabetes, metabolic syndrome, heart disease, and hypertension (high blood pressure). That’s because I have been diagnosed late in life with two of those at least: type 2 diabetes, and high blood pressure. I have both more or less under control, but anything that can bring clarity to what causes either or both is welcome. 

            For Taubes, the case is crystal clear. The culprit is sugar, especially the refined sugar called sucrose (half glucose, half fructose) andthe ingredient that seems to be in just about every prepared food one buys these days, high-fructose corn syrup(55% fructose, 45% glucose). These are the empty calories that Americans and inhabitants of all advanced industrial countries have been consuming in ever greater amounts for a few hundred years (Americans in 1999 were consuming an average of 158 pounds of sugar per year). And according to several studies that Taubes cites, it is this major dietary change that accounts for the damage wrought to our bodies. Humans have simply not had time to evolve fast enough for our bodies and organs (particularly the liver and pancreas) to handle the huge increase in refined sugars we now consume. This evolutionary argument is one of the best Taubes makes. For example, he notes that yearly per capita consumption of sugar “more than quadrupled in England in the eighteenth century, from four pounds to eighteen pounds, and then more than quadrupled again in the nineteenth,” while in the United States “sugar consumption increased sixteen-fold over that same century” (42). But the real argument comes in studies done more recently on indigenous populations like American Indians and Africans who have changed to Western-style living more recently and more rapidly. Among the Indians of Arizona, for example, the Pima, along with other Native Americans, have seen diabetes rates explode from almost nothing when eating their native diet to over 50% and more now, after changing to a Western diet laced with sugar and immense quantities of soda. Another major study, Western Diseases(1981) by Denis Burkitt and Hugh Trowell on indigenous populations in Africa, saw tooth decay, gout, obesity, diabetes, and hypertension skyrocket with Westernization (229). Another study of natives from Tokenau, an island near New Zealand, saw the same phenomenon: from a diet of coconut, fish, pork, chicken, and breadfruit (a high-fat diet, Taubes notes), the Tokenau people shifted to western ways in the 1970s. Some migrated to the big island of New Zealand, while some simply stayed on Tokenau, but both adopted western ways and foods. Diabetes shot up to engulf almost 20% of the women and 11% of the men, with corresponding increases in hypertension, heart disease, and obesity. To sum up, Taubes quotes one of his heroes, John Yudkin, a University of London nutritionist, who wrote in 1963: “We now eat in two weeks the amount of sugar our ancestors of two-hundred years ago ate in a whole year” (154). 

            But many of us have heard these stories and statistics before. What is surprising and even shocking in Taubes’s arguments are the supportive and historical facts. As one might guess from his argumentative title, not everyone agrees with Taubes. In fact, for the major arbiters of American eating policy like the FDA and the NIH (National Institutes of Health), sugar has remained a kind of untouchable, on the list of GRAS (generally recognized as safe) foods until virtually the present day (a quick Google search revealed that the latest FDA recommendations concerning sugar only warn that sugar can cause tooth decay!). This contrasts with FDA decisions on the sugar substitutes saccharin and cyclamates, which, with urging from scientists sponsored by the sugar industry, have been listed as possibly carcinogenic. But the major thrust of the scientists like Ancel Keys of the University of Minnesota and Fred Stare of Harvard (both funded handsomely by the sugar industry, Taubes points out) has been twofold: first, that it is the fats in our diets that kill us prematurely in the West, via heart disease and diabetes; and second, that “we get obese or overweight because we take in more calories than we expend or excrete” (107-9). Taubes calls this “the gift that keeps on giving,” because it essentially exonerates sugar from any role in obesity or diabetes or the host of other diseases plaguing Western societies. It doesn’t make any difference what you eat, goes this mantra, because “a calorie is a calorie.” Eat too much food (too many calories), and exercise too little, and you get fat, which causes you to get diabetes and die early. Period. End of discussion. Forget about the impact of refined foods (white flour, white sugar) on one’s metabolism. 

            Taubes goes into most of the studies and white papers that chart this, to him, massive fraud, but it’s not necessary to repeat that here. Suffice it to say that the sugar industry has used its massive profits and political clout to pretty much cloud the issue of sugar’s deadly effects in much the same way the tobacco industry clouded, for years, the dangers of tobacco smoke. Indeed, one of the really surprising roles of the sugar devil is in flavoring tobacco. Yes, that’s right. Tobacco growers and cigarette makers learned around the turn of the twentieth century that tobacco in cigars and pipes wasn’t really selling enough product (getting enough people hooked). So, in 1914, R.J. Reynolds introduced Camels, “the first brand of cigarettes made of multiple tobacco types (basically flue-cured Virginia, and Burley tobacco) blended together” (64). Sugar entered in two ways. First, flue-curing the Virginia tobacco turned a natural sugar content of about 3% to one of 22% sugar. That higher sugar content makes the tobacco more inhalable, because the smoke becomes acidic, not alkaline (alkaline smoke irritates the mucous membranes and stimulates coughing, which is why pipe smokers rarely inhale). Second, the nicotine-rich Burley tobacco was “sauced” with sugars from honey, molasses, licorice and so on. This was first done for chewing tobacco, but Reynolds put it in Camels, and this really did the trick. Why? Because by blending “sauced” Burley tobacco with already-sweetened flue-cured Virginia, Camels were able to deliver a sweet-tasting and -smelling cigarette that was easier to inhale, and thus “maximized the delivery of nicotine—and carcinogens—to the human lungs” (69). Most other tobacco companies and brands wasted no time following Camels to the point that “by 1929, U.S. tobacco growers were saucing Burley tobacco with 50 million pounds of sugar a year” (69). That this is not fiction is evidenced by Taubes’s quoting of a 2006 report from the Netherlands: “Consumer acceptance of cigarette mainstream smoke [what’s directly inhaled] is proportional to the sugar level of the tobacco” (70). In other words, sugar’s key role in making cigarettes palatable (inhalable) to both men and women worldwide contributed in a major way to the epidemic of lung cancers that are still with us. 

            Taubes has endless data on the role of sugar in diseases, but a couple stand out. First, he cites studies showing that sugar may well be addictive (as anyone with children knows). It elicits a response in the brain’s “reward center,” e.g. the nucleus accumbens, that closely resembles the response from nicotine, cocaine, heroin, and alcohol. This may help explain why its rise has been so spectacular in every society where it was introduced. More important, to me at least, is the connection Taubes tries to make between sugar and what is now generally conceded to be a key factor in diabetes and a host of other diseases that cluster with it—insulin resistance. Insulin, of course, is the hormone produced in the pancreas that acts to combat high blood sugar. Basically, when blood sugar (glucose) levels rise, the pancreas responds by secreting insulin, which “signals the muscle cells to take up and burn more glucose.” Insulin also induces cells to store some of the glucose as fat (insulin is said to be “lipogenic” or fat-forming). Then, when blood glucose falls, the insulin level falls too, and the stored fat can be burned instead of glucose. The problem is that some people (and increasing numbers in Western societies) exhibit a condition known as “insulin resistance”: their cells do not accept the insulin, and hence the glucose levels in the blood, and the levels of insulin, remain high or get higher. 

The question is: what causes insulin resistance in the first place? 

This would appear to be the 64-million-dollar question (the fight over this is quite active even today, with one side blaming the “drop in insulin sensitivity” on a fat, “intramyocellular lipid” said to block cell receptors from accepting insulin; and another blaming insulin resistance on excess carbohydrate [especially sugar] consumption and too much insulin production). Oddly, Taubes himself does not give a conclusive answer. He strongly suggests that insulin resistance is caused by too much sugar consumption, but he hedges. He says that in contrast to the sugar industry’s old mantra that insulin resistance and diabetes are caused by obesity, i.e. eating too much or consuming too many calories, another possibility 

is that these elevated levels of insulin and the insulin resistance itself were caused by the carbohydrate content of our diets, and perhaps sugar in particular. Insulin is secreted in response to rising blood sugar, and rising blood sugar is a response to a carbohydrate-rich meal. That somehow this system could be dysregulated such that too much insulin was being secreted and that this was causing excessive lipogenesis—fat formation—was a simple hypothesis to explain a simple observation. (120-1). 

But because insulin resistance is so important as a causal factor in diabetes, obesity, metabolic syndrome, heart disease, and so on, we would like something firmer. Taubes doesn’t give it to us, partly, he explains, because the NIH decided long ago not to fund long-term studies on the effects of sugar in the American diet because it would cost too much. It would also take a long time, since diabetes does not manifest overnight; like tobacco, sugar’s effects usually take years to manifest. But still, we want more. And Taubes does cite one study from Switzerland that seems to provide some scientific proof. Luc Tappy of the University of Lausanne studied fructose (fructose is metabolized without the need of insulin) in the mid-1980s. What his study found is crucial, even though it was short-term:

When Tappy fed his human subjects the equivalent of the fructose in 8 to 10 cans of Coke or Pepsi a day—a “pretty high dose” as he says—their livers would start to become insulin-resistant and their triglycerides would elevate in just a few days. With lower doses, the same effects would appear but only if the experiment ran for a month or more (205). 

This would seem to be a sound study, indicating insulin resistance and elevated triglycerides, both key markers for diabetes and for heart disease, from excess sugar. But again, its effects derived only from the use of fructose—though that is the main ingredient in most sugared drinks and lots more, via that demon invention, high-fructose corn syrup. 

            Unfortunately, this is as much as Taubes provides concerning insulin resistance. And that is a shame. 

            Still, Taubes’s book is well worth reading, if only for the disgraceful history it unfolds, a history of sugar that has scarred this nation from its very beginnings (slavery and sugar are intimately intertwined) and which still, in 2018, thanks to the power of the sugar industry in shielding its product from blame, continues its devilish work. 

Lawrence DiStasi

Sugar is Toxic

The title of this blog says essentially what Dr. Robert Lustig (a pediatric endocrinologist at University of California at San Francisco who specializes in childhood obesity) conveys in Fat Chance: Beating the Odds Against Sugar, Processed Food, Obesity, and Disease, (Hudson Street Press: 2013). To anyone in the least familiar with foods and nutrition, that sugar is a poison should come as no surprise, but the real value of Lustig’s book lies in the biochemical science he cites. Fat Chance contains all the latest scientific information you need (and, one would think, our regulating agencies, FDA and USDA would need as well) to convince you that America’s food industry and the resultant food consumption habits in this most “advanced” of countries are idiotic, sick, and sickening to an entire population and now, because of globalization, the world.

            To begin with, Lustig cites the statistics on obesity in America, and specifically, how the last 30 years have been a disaster in this regard. In 2001, for example, Newsweek reported that 6 million American children were seriously overweight. Those numbers tripled in a decade, and America now boasts more than 20 million obese children, including even an epidemic of obese 6-month olds! Over 40% of American deaths now list diabetes as the cause, up from only 13% two decades ago. And the epidemic has become a worldwide pandemic: the World Health Organization (WHO) says the percent of obese humans globally has “doubled in the past 28 years,” and the UN General Assembly in 2011 asserted that “non-communicative diseases (diabetes, cancer, and heart disease) are now a greater threat to world health than infectious diseases” (such as malaria, etc.). One would think these statistics would be enough to impel government agencies to rush to control the causes of obesity and its traveling companion, metabolic syndrome (a cluster of five diseases: obesity, diabetes, lipid problems, hypertension, and cardiovascular disease). But one would be wrong. Since the mega-corporations that produce foods worldwide depend on persuading consumers to eat their junk (processed foods that cause obesity), their power has crippled national and international organizations and prevented them from warning the public of the slow death lurking in the consumption of these products. Just one example: in 2002, the WHO and FAO (Food and Agriculture Organization of the UN) jointly produced a report (TRS 916) titled “Diet, Nutrition, and the Prevention of Chronic Diseases.” It called for “limiting added sugar to less than 10% of total calories in the diet.” The food industry went ballistic, pushed its lobbying into overdrive, and eventually got U.S. Secretary of Health and Human Services, Tommy Thompson, to threaten “to withhold the $406 million annual United States contribution to WHO” unless TRS 916 was repealed. Not only was TRS 916 scuttled, but so was, ever since, even a hint of a Daily Recommended Intake for sugar. Instead, the official line of all politicians and food industry groups is that obesity is a question of personal responsibility: if you eat too much, you get fat. Not our problem. Period.  

            What Robert Lustig shows us is that this is simply a ploy to take the spotlight off the real threat: the ubiquity of processed foods, laced with sugar to cover up the horrors done to the whitened calories that have come to replace REAL FOOD. The real key to “the obesity pandemic,” in other words, is  “our altered biochemistry,” which is due to loading us up with sugar and salt and additives that literally change how our bodies respond to hunger. One key is insulin. “We’re all hyperinsulimic,” says Lustig, with most humans today releasing double the insulin that we did a mere 30 years ago. And what does insulin do? It’s the energy storage hormone: eating a carbohydrate causes blood glucose to rise, and this signals the pancreas to release insulin to deal with this rise in glucose;

Insulin then tops off the liver’s energy reserve by making liver starch (called glycogen), and shunts any amino acids from the blood into muscle cells. Excess fatty acids, or blood lipids, are cleared into fat cells for storage for a “rainy day,” where they get turned into greasy triglycerides (such as the fat surrounding your steak). p. 35.

In brief, insulin makes fat, the more insulin the more fat. Another hormone, only discovered in 1994, comes into play as well. It’s called leptin and its job is to “signal the hypothalamus that you’ve got enough energy stored up in your fat,” i.e. that you’re full. But sometimes the VMH (ventromedial hypothalamus in the brain) can’t see or is resistant to the leptin signal. The brain then interprets this as “starvation” and directs the body to both increase energy stores (eat more), and conserve energy by reducing activity. Simultaneously, more insulin and more leptin is called for as well. Though few people are leptin deficient (from a mutation), billions, according to Lustig, exhibit leptin resistance. They have plenty of leptin, but “their hypothalami can’t see their leptin, so their brains think they’re starving.” The command is then to eat more (gluttony) and conserve energy (sloth). This is the key to the obesity epidemic, says Lustig. And studies suggest that it is the increased insulin production (hyperinsulemia), acting in the brain, that is blocking normal leptin signaling.

            In sum, insulin (which most humans now produce twice as much of) produces a double whammy: in the body it causes increased energy storage in fat cells; in the brain it causes leptin resistance and the feeling of starvation. It thus drives gluttony and sloth, weight gain, and obesity worldwide. Most important, none of this is under the individual’s control. That is to say, since the biochemical process is primary and the behaviors result from the biochemistry, then the clear conclusion is: “Obesity is a biochemical alteration in the brain promoting leptin resistance with resultant weight gain.” This means that obesity is not a question of personal responsibility as corporations and the government agencies under their control would have us believe. It is a question of what has happened to human biochemistry as a result of the environmental changes caused by the types of foods we have all been inundated with in the last half century. And the correlation with “fast foods” and “processed foods” is almost perfect. For example, Lustig points out that in the U.S. in the 1950s, only 4% of the foods consumed outside the home came from fast foods (I can testify to this personally; all foods I ate growing up were cooked from scratch). In 1997, the percentage was 34%. Put another way, every day “30% of U.S. adults eat at a fast food outlet,” with McDonald’s feeding 46 million of them every day. The highly refined carbohydrates (including sugar) from such fast and/or highly processed (white bread, white rice, sodas, soy products, instant meals) foods not only cause obesity, but will also eventually make the liver sick by building up fat in the liver and other organs. This is the kind of fat, called visceral fat, that kills you.

            Sugar is a chief culprit in all of this, and much of the damage has been done in the last 30 or 40 years. That’s because in the 1970s, Ancel Keys convinced American agencies like USDA and FDA that dietary fat from red meat was responsible for our health problems, mainly heart disease. In response, food manufacturers took the fat out of most foods, but without the fat, the food tasted like cardboard. To disguise this disastrous taste, processed food manufacturers upped the carbohydrate content, especially sugar. The result is our current sugar and carbohydrate glut: compared to 100 years ago, American consumption of sugar has increased 5-fold, and doubled in the last 30 years. Of that sugar consumption, 33% comes from beverages like Coke and even orange juice (containing 1.8 grams of fructose per ounce compared to only 1.7 grams for soda). Lustig sums it up thus: “The inescapable reality is that 20-25% of all the calories we consume, a total of 22 tsp/day, comes from some variation of sugar. Some adolescents consume 40% of calories as sugar.” And how much of our food contains sugar? Nearly all of it. Barry Popkin of No. Carolina University surveyed 600,000 food items for sale in the United States, and found that “80% are laced with added sugar” (234). Moreover, fully 90% of food sold in the U.S. comes from 10 food conglomerates including Coca Cola, Con Agra, Dole, General Mills, Pepsico, Kraft and Nestle—purveyors all of fast or ‘convenience’ food. And what is the definition of fast food? “It’s fiberless food,” because fiber can’t be frozen. Freezing turns fiber to mush, so it can’t be stored forever, shipped globally, and cooked quickly. So food processors remove the fiber— precisely that which is the key to a healthy gut, and thereby to a healthy human. Foods with fiber—like whole grains, or fruits and vegetables in their whole form—not only slow digestion and increase absorption of the vital nutrients in food, but also slow “the rate of flux from the intestine crossing into the bloodstream” and into the liver. The liver then gets the time to fully metabolize what’s coming into it. But when the liver is hit quickly with heavy loads of fiberless starch or sugar, the glucose level peaks higher and faster, and that translates to a higher insulin peak demand. And more insulin means more fat, more obesity, and more of the diseases associated with it.

            There is more in this vital book, complete with charts and tables that are revelatory. The point, though, is what my title suggests: sugar is slowly killing us. And its increased use is the product of the policies of government agencies that have abdicated their historic role of protecting the consumer, and shifted to the role of protecting the profits of major corporations. Sugar, for example, got the highly-sought-after GRAS (Generally Recognized as Safe) status from the FDA in 1958, based on no science whatever. The same status was bestowed on High Fructose Corn Syrup in 1983. This means, quite simply, that there is no limit on its use in any food. An FDA report commissioned in 1986 put the dogma in writing:

“fructose is a valuable, traditional source of food energy, and there is no basis for recommending increases or decreases in its use in the general food supply or in special dietary use products” (242).

End of story. The fact that when this report was written, average U.S. sugar consumption was 40 pounds per person per year, and now is 130 pounds/person/year, seems to make no difference. The FDA has reaffirmed its 1986 stance twice, most recently in 2004. The same holds true in Europe. Then in 2000, in response to lawsuits brought against McDonald’s for causing obesity and heart disease (which was true), our lobby-subservient Congress came up with the Personal Responsibility in Food Consumption Act (aka the “Cheeseburger Bill”). Following the old pattern, Congress was saying—and Rep. Jim Sensenbrenner of Wisconsin said specifically—don’t blame fast foods or food companies. Blame yourself:

This bill says ‘Don’t run off and file a lawsuit if you are fat.’ It says, ‘Look in the mirror because you’re the one to blame…If a person knows or should know that eating copious orders of super-sized McDonald’s products is unhealthy and could result in weight gain, it is not the place of the law to protect them from their own excesses’” (246).

That the bill only passed the House and is not yet law doesn’t change the real message: as a consumer, you’re on your own. The fact that we (the food industry) spend billions to persuade you to eat crap, and more billions making that crap deadly to your health, and more billions lobbying your elected representatives to abdicate their responsibility to protect your health, has no bearing on the case.

            If this sounds familiar, it’s because it is: tobacco companies for years used exactly the same strategy to protect themselves from any responsibility for the illness and death of smokers. We can only hope that in time, as in the tobacco case, enough people will wake up to the dangers in their fake food to force the people’s representatives to act in their behalf. Until then, we can only watch as Americans get sicker, and the skyrocketing health bills for this pandemic of obesity and metabolic syndrome continue to ravage the world—mainly, unfortunately, in poorer communities where the choices are so reduced that people would rather drink sugar-loaded beverages than the water that in many places cannot be trusted. It’s a deadly trap whose pernicious effects differ from most of ours only in degree.

Lawrence DiStasi

Michael Taylor, Monsanto's Revolver

I have been reading Foodopoly (New Press: 2012), Wenonah Hauter’s (head of Food and Water Watch) new study of the consolidation of food power, and though it can be a difficult read at times—mainly because of the thoroughness of Hauter’s research—it is critical material for all Americans. Its main thrust is this: the corporate food industry in America has been working diligently for years to achieve the level of dominance they now have: Monsanto, for instance, has bought up virtually every seed company in the world and now controls most seeds necessary for agricultural plant life, upon which human life depends; many supposedly organic products are now owned by the likes of Nestle, General Mills and Coca Cola. The corporate food giants have been able to do this because of the intimate collusion between them and the regulatory agencies (including presidents of both parties) charged with controlling them. American corporate food has become as much a part of American hegemony as the Department of “Defense,” and the ability of these international outlaws to promote (force) the planting of American-designed crops (GMOs) in foreign nations—like Mexico, like India, like Argentina and Paraguay—is interconnected with American military power. The American Empire is an empire of designer crops and the chemicals that enable them as much as it is an empire of military hardware.

It is impossible to go through Hauter’s entire book here; I heartily recommend it to everyone. To give some idea of the collusion between government and corporate food giants in Foodopoly, however, the case of one individual, Michael Taylor, can be taken as emblematic. The material on Taylor comes not only from Hauter’s book, but also from several videos and articles devoted to him by the likes of Jeffrey Smith (see his numerous pieces at Huffington Post about Monsanto and Taylor, specifically “You’re Appointing Who?” Huff Post July 23, 2009) and a video available on Top Documentary Films, “The World According to Monsanto” http://topdocumentaryfilms.com/the-world-according-to-monsanto/).

So who is Michael Taylor? At this writing, he’s the Deputy Commissioner for Foods in Barack Obama’s FDA (Food and Drug Administration.) Like at least one of his other posts (Deputy Commissioner for Policy, also at the FDA, in 1991), this one was newly created, tailored, as it were, to Taylor himself. He has been said to epitomize the “revolving door” in Washington, wherein government officials trade on their government experience to obtain lucrative positions in industry and/or lobbying. His brief vita will explain why. Taylor began as a staff attorney at the FDA in 1976. He stayed there for a few years until 1981, when he left government to become an attorney with the Washington law firm of King & Spaulding, a major legal player in DC specializing in regulatory law. One of King & Spaulding’s clients was Monsanto, and Taylor is said to have “established and led the firm’s food and drug law practice.” Not surprising, since he had just come from the FDA. One of his notable achievements while at King & Spaulding, was an article, “The De Minimis Interpretation of the Delaney Clause.” The Delaney Clause of 1958 had for years prohibited any chemical additive found to be carcinogenic in any amount from entering foods. And for years this seemed a reasonable precaution: why would anyone want to eat cancer-causing material? Taylor thought otherwise, however, especially because, with modern methods, more and more food additives were being found to be carcinogenic. In his article, Taylor argued for a less stringent approach—one which stated that if a carcinogen was present at levels below 1 part in 1 million, the risk was minimal and so the carcinogenic product could be allowed on the market. This was said by Taylor and his supporters to be “reasonable” regulation; organic food advocates argued that this rule was promoted by Taylor to benefit his client, Monsanto, and other large food corporations, with consumers, as usual, taking the risks.

Whatever the conclusion, Taylor thereby became a poster boy for the “de-regulation” movement. He had already proven his worth to both Monsanto and the Reagan Administration in 1984 with his strategy of coming up with an industry-friendly framework for the regulation of the biotech industry. Titled the ‘Coordinate Framework for Regulation of Biotechnology,’ it remains the basis of regulation today, and was designed to head off Congressional rules or statutes that could cause problems for the industry. Even according to Wikipedia, it was developed “to ensure the safety of the public and to ensure the continuing development of the fledgling biotechnology industry without overly burdensome regulation.” The framework policy had three basic parts—1) focus on the product of genetic modification techniques, not the process itself; 2) only regulate based on verifiable scientific risks; 3) GM products are on a continuum with existing products, and therefore, existing statutes are sufficient to review the products. Again, this framework invented by Taylor became the basis for all subsequent rules governing (or not governing) biotechnology today, and contrasted sharply with regulations in Europe and elsewhere demanding that GM foods be labeled. This contrast came into sharp focus in 1992, when Taylor, again passed through the revolving door, left King & Spalding to take a position created for him by President George H.W. Bush as Deputy Commissioner of Policy at the FDA. Here Taylor had a hand in the new FDA policy statement on genetically-engineered plant foods, which policy treats “transferred genetic material and the intended expression product or products” in food derived from GM crops as “food additives” subject to existing food additive regulation. This means that the new genetic material—creating a plant entirely new in genetic history—conveniently slips under the GRAS (generally recognized as safe) rule—whereby the producer, say Monsanto, declares that according to its tests, the material is safe. Well, sure, why not trust old Monsanto? The makers of Agent Orange and PCBs would never lie, now would they?

These two policies, both invented by Michael Taylor (or perhaps by the policy wonks at Monsanto and promoted vigorously by Taylor), have had fundamental and long-lasting consequences. First, the foreign genes used to genetically modify basic life forms were treated as simply another additive, like yellow coloring. And second, and critically, genetically modified foods created in the laboratory were treated the same as—with no substantial difference from—foods produced by nature. Hence, anyone can invent a new genetically modified product (spider genes in pigs, say) and put it out there, without having to notify consumers. It’s all biology, after all.

Taylor was not done, however. Monsanto, his former client, was having trouble with its bovine growth hormone, rBGH, marketed as Posilac. This monster hormone had been created by Monsanto in the 1980s to increase milk production in dairy cows. Monsanto submitted its materials allegedly indicating rBGH safety to the FDA, and amidst growing public concern, the FDA looked briefly at the health impacts (all provided by Monsanto and other biotech companies) of drinking milk produced this way, and concluded there were none. In 1987, Monsanto officially applied for FDA approval; and despite new data suggesting that drinking GMO milk caused increased exposure to the insulin-like growth factor-1 (IGF-1; which has been found to increase the risk of breast, colon, prostate and other cancers ), the FDA in 1989 gave rBGH its approval. Just another additive. The problem was, some milk companies were labeling their milk “rBHG-free,” and Monsanto didn’t like that at all. The label implied that something was wrong with milk containing its rBHG (which was true). Again, Michael Taylor, still at the FDA, came through for his client by writing new regulations governing milk labeling. Arguing that the “rBGH-free” label was unfairly misleading, his regulations mandated that the FDA conclusion had to also be included to “balance” the label. The required FDA statement was: “No significant difference has been shown between milk derived from rbST-treated and non rbST-treated cows” (rbST is the industry’s name for rBGH). And in days, Monsanto sued two dairy farms that had labeled their milk only “rBGH-free,” with King & Spalding weighing in with warning letters to other “non-compliant” dairies.

Most countries, including Australia and Canada, banned the use of rBGH in light of many studies proving that rBGH causes lower birth rates and weights of calves, and diseases such as mastitis (infection of the udders), cystic ovaries, and hoof and leg problems in cows treated with it. Indeed, ‘The World According to Monsanto,’ noted above, reports that milk from such cows is contaminated with pus (from mastitis) and the GMO hormone itself. Tiring of the problems, Monsanto in August 2008 got out of the artificial hormone business, and sold its rBGH operations to the giant pharmaceutical company, Eli Lilly. Lilly has now focused its sales efforts on the developing world where there is less publicity about the side effects, and more pressure to industrialize traditional agriculture.

Perhaps seeing the writing on the wall before his client did, Michael Taylor shifted jobs once again in 1994, wangling an appointment with the Clinton administration as the Administrator of the USDA’s Food Safety and Inspection Service. Maintaining his old bag of tricks (to come up with toothless regulations before Congress or nosey regulators get the chance to come up with real ones), Taylor at USDA invented and implemented the rules known as HAACP (Hazard Analysis and Critical Control Points system) for meat and poultry production. Wenonah Hauter has a great deal to say about this too, and it’s mostly bad. Basically, what HAACP does is provide meat and poultry producers with relief from those pesky meat inspectors—the ones who, since 1906 when the Food and Drug Administration was created in response to Upton Sinclair’s The Jungle, had inspected animals before they were cut up and passed through the line. This kept diseased and sick cattle from being slaughtered and entering the food supply. But it also wasted a lot of “perfectly good cows,” slowed down the slaughtering line, and required numerous inspectors. Taylor came up with the “post”-slaughter inspection-and-remediation system: under HAACP, meat was treated at the end of the line with disinfectant chemicals like ammonia, and (possibly) radiation. Thus, animals that had visibly obvious cancerous growths and sores and feces and other gross stuff on them could be simply passed through, and disinfected at the end. Much more scientific, said Taylor. And efficient.

Taylor still hadn’t finished with the revolving door, though. In 1996, he was back at King & Spalding for a couple of years, and then, really cashing in, took a position at his old client Monsanto as Vice President for Public Policy. Whatever that means; propaganda probably. No matter. His move indicated, as nothing else could, his true colors as a creature of corporate America. What’s astonishing is that this blatantly self-serving move did not diminish his credibility in Washington, in government, one bit. It may have enhanced it, in fact. Because in July 2009, to his everlasting shame, President Barack Obama, over howls of protest from the healthy food movement, appointed Michael Taylor as Senior Advisor to the FDA Commissioner. And in January 2013, yet another new post was created for this corporate hack, once again at the FDA, this time as Obama’s Deputy Commissioner for Foods. As Jeffrey Smith said about Taylor after his initial selection by Obama: “The person who may be responsible for more food-related illness and death than anyone in history has just been made the US food safety czar.”

Now you know what Wenonah Hauter’s book is about, and it isn’t pretty. Government agencies are so thoroughly polluted with corporate money and corporate insiders that the boast of Americans about the purity of their food system has become a hollow joke. Unless and until an enraged public rises up to demand some accounting of just who gets appointed and how, and some way of getting rid of the revolving door that puts foxes in charge of the hen houses—Hauter’s material on industrial chicken farms is enough to have me reaching for a weapon—the same cozy relationships will continue to compromise and poison our food supply. Individuals buying organics are no help either. Most organic producers, as I noted at the beginning, have already been bought up by the bigs. And besides, carving out a safe haven at your local Whole Foods Market (another farce; an amazing percentage of products sold there are not even organic) only emboldens the sharks to make a killing off the desire of those who can afford it to eat healthy. No, something fundamental needs to be done, and it needs to get at the root. Organic food was introduced as a concept fifty years ago as a part of restoring a sustainable system of farming, food production and the entire relationship of consumers to food, not as a way to market boutique products to the wealthy. Until that original purpose is revitalized, foodopolies and their corporate revolvers will continue to grow, like the cancers that are their emblem.

Lawrence DiStasi

The BiDil Scam

Of all the facts and figures in Dorothy Roberts’ book, Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-First Century (New Press: 2011), the BiDil scam best gives the flavor of how this re-creation of race is being done. Targeting a serious health problem among African Americans—heart failure—the BiDil ‘inventors’ promoted a type of pill said to be specific for blacks. They thus not only tried to make a fortune on the misfortune of a downtrodden group, but also reinforced the idea that major illnesses are genetic—due to defective genes—rather than based in social and cultural deprivation. As Roberts argues tirelessly throughout the book, the current focus on genetic difference is just a new and more insidious way of establishing that racial differences, the concept of race itself, are real and biological rather than the product of societies that wish to justify their exploitation of some groups as biologically inferior.

Heart failure affects millions of Americans each year when the heart muscle, weakened by a heart attack, high blood pressure or infection, no longer pumps a sufficient supply of blood. Patients become weak, short of breath, and most die within five years of diagnosis. A cardiologist named Jay Cohn around 1970 hypothesized that vasodilators—drugs that relax blood vessels—might help as a treatment. The prevailing vasodilator, sodium nitroprusside, had to be administered by injection. Cohn came up with the idea of combining two generic vasodilators, Hydralazine and Isosorbide nitrate, into a single pill that could be taken orally. By helping the body make more nitrous oxide, the vasodilator combination would widen arteries and let more blood flow through. The key, though, is that no new drug was involved here. Cohn simply combined two already-available generics into a single pill, and patented them as a new drug for a new purpose. When he and other cardiologists ran a trial on 642 black and white patients, they found that the combination pill did lower the death rate. This was great news for Cohn initially. But then a new trial was conducted, this time comparing the effectiveness of the H-I combined pill with an “angiotensin-converting enzyme (ACE) inhibitor called enalapril.”  The study found that enalapril was even more effective than H-I at lowering the death rate, and these ACE inhibitors subsequently became the preferred treatment for heart failure.

Cohn at this point had no useful drug to peddle, but he wasn’t discouraged; after all, the era of making millions on a patented drug was in full swing. So Cohn filed a patent in 1989 for his combined H-I pill, not mentioning race, and then became partners with a biotech firm, Medco, to whom he licensed the property rights. In 1996, Medco applied to the FDA for a New Drug Application for the drug it christened BiDil, also never mentioning its efficacy or lack thereof for any particular race. Long story short, the FDA refused to approve the new drug, finding that the case for BiDil was not convincing. At this point, Medco gave up and returned the rights to Cohn, who was now in a bind. He had only 10 years left on his patent and he needed something to give it new life. Then he had another eureka moment: he decided to patent BiDil—which he had previously patented without regard to race—as a therapy specifically for African Americans. He and one of his researchers named Carson returned to the original data, broke down the statistics by race, and published the new results in the Journal of Cardiac Failure claiming that, based on their retrospective analysis of the original trial, “the H-I combination appears to be particularly effective in prolonging survival in black patients.” They also claimed that enalapril worked especially well with whites, and concluded that “therapy for heart failure might appropriately be racially tailored” (Roberts, p. 170).

Despite the clear problems with the small size of the test sample and the real possibility that other factors might have contributed to the different outcomes for whites and blacks, Cohn kept pushing, and in 1999 relicensed his intellectual property rights to yet another pharmaceutical company called NitroMed. The new patent submitted by Cohn and Carson stated that “the present invention provides methods for treating and preventing mortality associated with heart failure in an African American patient.” One of the great benefits of the new patent was that where his original patent was due to expire in 2007, the new one gave Cohn another 13 years, till 2020, of control over his drug. This was not because he had invented a new drug, but rather had reinvented “an existing therapy as race-specific.”

Cohn and NitroMed then went to the FDA to get approval for BiDil as a drug specifically for African Americans. The FDA said that if the applicants could prove in a specific trial that the drug worked specifically for African American patients, they might approve it. NitroMed and its CEO, Michael Loberg set out to raise the money for a drug trial, promising millions in revenues the very first year blacks started using the pill. Rather quickly, $34 million in financing showed up, with investors and even banks salivating at the prospect of such a bonanza. Thus, the African American Heart Failure Trial (A-HeFT) began in 2001. The trial included about 1000 African American men only (no whites or other groups) supplied mainly by the Association of Black Cardiologists, who were enthusiastic. Half the subjects received BiDil in addition to standard heart failure medicine, while half got only the standard therapies. The results were so positive for BiDil that the trial was stopped ahead of schedule; BiDil increased survival by as much as 43 percent. Loberg and NitroMed were ecstatic, releasing a report claiming that 750,000 diagnosed African Americans with heart failure (900,000 expected by decade’s end) would be using the drug for a projected income of nearly $1 billion.

BiDil’s chances were improved for FDA approval by the lobbying of many African American groups who saw the chance to finally have therapies, equal to white therapies, designed for black Americans. Even the Congressional Black Caucus urged approval. But the FDA was concerned about the lack of any real scientific evidence to support the claim that the drug worked specifically for blacks. Nor was there any control group of white or other groups for comparison to back up the claim. The FDA also said there was little precedent for designating a drug for any particular racial group: drugs tested on mostly whites were not designated “white drugs.” But with the chair of the FDA approval committee arguing in its favor, the FDA finally approved NitroMed’s application for BiDil, even without scientific much less genetic proof about why it worked for blacks. They were satisfied by the claim that there is an unknown physiological mechanism that explains how BiDil works, and race, blackness (specifically blacks self-identifying as African American), was perhaps a proxy or signal for that unknown factor—probably genes. Cohn and Carson in their patent application speculated along these lines, writing that “blacks, particularly with a hypertensive history, may have a greater deficiency of nitric oxide generation that is restored” (177) by their drug. In 2005, the FDA even claimed that its approval of BiDil was an important step towards the long-desired “promise of personalized medicine.”

In the end, however, even with FDA approval, BiDil failed; so did NitroMed, and so did Jay Cohn’s dream of making a fortune. Roberts says this by way of an initial explanation:

NitroMed did not make money from a drug that was developed to treat heart failure in black patients. It made money by converting a drug for heart failure into a drug for African Americans based on unsubstantiated claims about racial difference. (p. 185)

Here is how it broke down: even with the encouragement of the NAACP and the African American Cardiologist’s Association, only a mere 1% of those 750,000 black heart-failure patients bought prescriptions for BiDil. Part of it had to do with the price. BiDil pills were priced at $1.80 per pill, with a recommended dose of 6 pills daily. That would be $10.80 per day, or nearly $4,000 per year. That adds up to 4 to 7 times the price for the generic drugs of which it is made, so the insurance companies refused to pay the approximately $3,000 extra per year for BiDil compared to the identical two generics. So did Medicare part D and Medicaid. And they were right. BiDil was not a new drug; it was just a clever combination of two drugs already available in generic form! It was a drug that had not originally been targeted to black people or white people or any specific group. Only when the original FDA application failed did the ‘clever’ cardiologist named Jay Cohn come up with a new ploy: market it specifically to black people; and then show how it works; and then massage the marketing to appeal to the sense among African Americans that no one cares about their specific health problems; and Eureka, you’re a billionaire.

            Fortunately, BiDil and NitroMed crashed and burned. People of color were not so dumb after all; rather, they were suspicious from the get go. But it makes one wonder: how many other “miracle” drugs have been hatched and marketed the same way? In a pill-crazy culture like the United States, one would have to guess “a lot” (just think of all the statins taken by Americans desperate to reduce their cholesterol).  Sadly, though, the underlying problem exhaustively chronicled by Roberts is sure to recur. Race-based pharmaceuticals—what have been called pharmacogenics or pharmacoethnicity—are sure to return again and again. It’s as old as snake oil: there’s gold in them thar hills. And cardiologists—I know, having consulted them for some time now—and pharmaceutical companies are among the nation’s most avid and mercenary prospectors.

Lawrence DiStasi