Guest guest Posted December 22, 2004 Report Share Posted December 22, 2004 Drug Companies Make BILLIONS Testing Adult Drugs on Kids By Rachel Zimmerman Mary Robinson, a Philadelphia X-ray technologist, received $300 and a $50 gift certificate to Toys " R " Us as an incentive to enroll her seven-month-old daughter in a drug trial to treat a form of indigestion babies can get. Merck & Co., the maker of the medicine, also received an incentive: about $290 million. That's the estimated revenue Merck will pocket from six months of additional marketing exclusivity it won. Its drug, Pepcid™, was slated to lose its patent protection last October, opening the way to low-priced generic competition. But, as a reward for conducting the first formal studies of Pepcid in infants, the federal government has given Merck a half-year of extra protection from generics. And the gains are even greater for some of the other companies rushing to take advantage of a 1997 law meant to encourage pediatric trials of adult medicines. That law, by giving drug makers an incentive to test on children, is producing important new prescribing information for pediatricians, the Food and Drug Administration says. Labels have been changed on 14 drugs to reflect new data. Some pediatricians are delighted with the results and are lobbying to extend the law past its scheduled expiration at year end. But a close look at the law shows that it is also producing an unintended consequence: a drug-industry financial bonanza. Stronger Sales The studies required to gain six more months of marketing exclusivity are relatively small and inexpensive, costing anywhere from $200,000 to $3 million. But the extended exclusivity that results can be very valuable. It will boost drug-company sales by more than $4 billion, by the Wall Street Journal's calculations, which compare six months of sales while a drug has marketing exclusivity against typical six-month sales of the drug after generic competition hits. Generics typically knock a strong-selling brand-name drug's sales down roughly 75%. Benefits of Pediatric Testing Here are six of the drugs granted extended marketing exclusivity under a 1997 law and estimates of how much extra revenue the extensions could produce. Manufacturer/Drug Type One-Year Revenue* 6-Mo. Addition to Revenue** Schering-Plough (Claritin™) Antihistamine $2.60 billion $975 million Eli Lilly (Prozac™) Antidepressant $2.21 billion $831 million Bristol-Myers Squibb (Glucophage™) Diabetes $1.73 billion $648 million Merck (Pepcid™) Antiulcer/heartburn $775 million $290 million Merck (Vasotec™) Hypertensive $850 million $318 million Bristol-Myers Squibb (Buspar™) Antianxiety $759 million $284 million The $4 billion of projected extra revenue is just for the first 26 drugs tested under the program. About 200 proposals to test more drugs on children or infants are pending at the FDA. If they get an FDA go-ahead, they could add $6 billion more revenue to drug-company coffers, says Chris Milne of the Tufts Center for Drug Development in Boston. And over the next 20 years, if the law remains in effect, producers of brand-name drugs could gain added revenue of nearly $30 billion, according to an FDA analysis. Big Ones First As the numbers suggest, companies are first testing mainly their big-selling drugs, where extended market exclusivity is a potent lure. Only now are some companies moving to test lesser-selling drugs about which pediatricians have long wanted data. Critics complain that drug companies are sometimes gaining the six-month bonus by testing drugs that treat conditions uncommon in children, such as arthritis, ulcers and hypertension. Another complaint is that the law sometimes lets companies win extra exclusivity without doing much new testing. At the same time, the law does nothing to promote child testing of drugs that are already off-patent or no longer marketed by a sponsoring company. An example is dopamine hydrochloride, which neonatal nurseries rely on to stabilize blood pressure in critically ill babies, but which has never been subjected to formal pediatric trials. Meanwhile, makers of generic drugs come out losers. They could lose $10.7 billion in sales over 20 years as a result of the six-month extensions, the FDA estimates. The agency sees ill effects for retail pharmacies, too, because their markup on brand-name drugs isn't as large as on generics. The six-month extensions could cost pharmacies $4.9 billion in revenue over 20 years, the FDA estimates. Public-Health Cost There is a public-health impact, as well. The longer a drug maker fends off generic competition, the longer patients -- particularly the poor and the uninsured -- will be burdened by premium prices for their medicines. The FDA estimates that the incentive law will raise the cost of prescription drugs $695 million a year, or one-half of one-percent of the nation's $100 million annual pharmaceuticals bill. " Pediatric exclusivity has created a system of bribing companies into doing what the government deems scientifically and medically necessary, " contends Abbey Meyers, president of the National Organization for Rare Disorders. 'Win for Industry' For their part, drug makers say they are being appropriately compensated for meeting FDA requests under the 1997 law. They didn't seek this law. But since its passage, pediatric trials have become a key part of strategies to squeeze every dollar out of strong-selling drugs nearing patent expiration, some drug-company executives acknowledge. " I won't deny it's been a win for industry, " says Ian Spatz, Merck's executive director of public policy. The law arose from frustration by pediatricians and regulators who for decades couldn't persuade drug companies to test many adult medicines on children. Doctors often prescribed them anyway, cutting pills in half or grinding medicines into applesauce, hoping to come up with doses for children that were both safe and effective. Between 70% and 80% of medicines have never been formally tested in a pediatric population. Attempts at requiring testing have been largely unsuccessful. Twenty years ago, the FDA ruled that drug makers had to submit substantial safety and efficacy evidence to label a medicine for use in children. The result, instead of more pediatric trials, was more labels with disclaimers saying effectiveness in children hadn't been established. To the industry, testing drugs on children is risky and burdensome. You're talking about a small population where you have to take a lot of care and pay a great deal of attention to the design, documentation and monitoring and have adequate staff resources to ask and answer the right questions. The obstacles also include liability concerns and the challenge of getting informed consent. And if a child in a clinical trial reacts badly, negative publicity could batter the drug's sales in every age group. Dr. Kessler, the former FDA commissioner, announced an FDA rule he hoped would finally move the drug industry. It said that to get drugs labeled for use in children, companies in many cases no longer had to conduct large, expensive efficacy trials with children. They could do simpler tests to establish safety and dosing ranges. Despite the relaxation, companies continued to forgo label changes rather than pursue pediatric clinical trials. With few options, Congress and regulators warmed to the notion of financial incentives. " We were stuck. We had tried everything possible, every kind of other incentive, and nothing worked, " says Dr. Kessler, now dean of Yale medical school. Congress took up a bill to give companies extended market exclusivity in return for studying medicines in children. According to people involved in the effort, lobbyists for the drug industry initially wanted five extra years of marketing exclusivity, then two years and then one year, eventually agreeing to six months. Law's Flaws The law's critics say it has loopholes that undermine a laudable intent, such as allowing a financial benefit for studies that would probably be done anyway. For instance, Eli Lilly & Co. is winning Prozac™ six more months of defense against generics -- worth an estimated $831 million in added revenue -- by submitting a clinical study that had already been completed in 1995, two years before the law was passed, plus results of three studies that had already been initiated. A Lilly spokesman, Ed West, says that while protocols for those three studies had been written before the law passed, the final decision to proceed with them came only after the financial incentive was in place. He won't comment on the estimate of added sales. In any case, Lilly couldn't have gained credit for the tests if the FDA hadn't let it. The agency interprets the law as permitting a company to submit certain already-conducted tests -- and gain more marketing exclusivity -- as long as the test results provide important new data. In other cases, companies are doing pediatric testing with drugs for conditions that aren't common in juveniles. Consider Bristol Myers-Squibb Co.'s Glucophage™ for adult-onset diabetes and Merck's Vasotec™ hypertension pill. Both have carried labels saying safety and effectiveness hadn't been established in children. According to market-research firm IMS Health, of 24 million Glucophage™ prescriptions in the U.S. in the past year, just 133,000 were written by pediatricians. For Vasotec™, the numbers were 11 million in all, 70,000 of them from pediatricians. But makers of both drugs tested them in children and won extra marketing exclusivity, potentially worth nearly $1 billion in added revenue. Critics from the generic-drugs industry find another aspect of the incentive law troubling. A predecessor company to GlaxoSmithKline won added exclusivity for the ulcer drug Zantac™ by doing a study that gave an injectable form of it to newborns with a condition called acid reflux. The tests didn't involve the Zantac™ pill. But they yielded a six-month extension for that blockbuster pill anyway, because the FDA interprets the law as applying to a drug's active ingredient. Even the FDA acknowledges that there are still some flaws in the process, which begins when a company or the FDA expresses interest in a clinical trial. At that point, the agency gives the company a written request for studies. In a majority of cases, companies initially propose studies that are unacceptable to the FDA, the agency's Dr. Murphy says, or the companies reject FDA-proposed studies as too large and costly. Some of the sharpest criticism is that companies use the law to extend their exclusivity on hot-sellers, while often not testing other drugs that could help children but aren't large revenue producers. The American Academy of Pediatrics says there are still hundreds of drugs, on patent and off, that need to be tested in certain age groups. In the mid-1990s, Dr. Kauffman pleaded in vain with Hoffmann-La Roche Inc. to test its Toradol™ pain killer on children, and finally did such a study himself -- finding the drug to be as effective as morphine for postsurgical pain, with fewer narcotic side effects. But the manufacturer, a unit of Roche Holding Ltd., hasn't changed the label. A spokesman says Toradol™ is " not one of our promoted products. " The extra market exclusivity the law provides is especially valuable for top-selling products. By conducting pediatric tests of Vasotec™, Merck fended off generic competition for this blood-pressure drug for six more months last year, gaining about an extra $318 million in revenue. After Vasotec's™ patent and the six months of extra exclusivity finally expired in the fourth quarter, the drug's U.S. sales fell 73%, Merck says. Pepcid™ has been another big seller for Merck, and the company won an extension through pediatric testing despite having already shown Pepcid was safe and effective in children aged one to 16. Doctors could have given seven-month-old Julia Robinson an off-label Pepcid™ prescription in the form of a liquid with a cherry banana mint flavor. Instead, she became part of a clinical trial designed to test a diluted version, after a doctor at Children's Hospital of Philadelphia recruited her mother. " They explained that it hadn't been approved for kids under one and that's why she had to be in the study in order to get it, " Mrs. Robinson says. Julia's condition improved, but the trial found that in most infants, the diluted form wasn't as effective. Despite those results, the FDA let Merck fend off generic competition for an added six months for all forms of Pepcid™. Merck says the study's findings were valuable data that simply wouldn't have been produced without the six-month incentive. Even Younger Schering-Plough Corp. should receive one of the bigger boosts from the law -- an estimated $975 million in extra revenue from Claritin™. U.S. sales of the antihistamine last year were $2.6 billion. The drug is so important to Schering-Plough that the company spent millions on lobbyists and political donations in an effort to win special legislation extending its patents, which start expiring in mid-2002. That effort didn't succeed. But the company did get an extension of its marketing exclusivity through the pediatric law -- even though Claritin™ was already approved for children aged six and above and was being widely prescribed for them. Pediatricians wrote 3.6 million Claritin™ prescriptions in the 12 months through November 1999. Six extra months of protection from generics in a case like this upsets Carol Ben-Maimon, chairwoman of the Generic Pharmaceutical Industry Association. " If you're testing kids for valuable information, that's one thing, but if you're testing them just to make another half billion, that's exploitation, " she says. Schering-Plough spokesman William O'Donnell declines to comment on the projection of added revenue for Claritin™. But he says the pediatric study, by establishing that Claritin™ could be used safely in children under six and setting a proper dose, " met the intent and spirit of the provision. " At the FDA, Dr. Murphy acknowledges that a few companies will make " quite a lot of money on this. " But, she says, " that's the price you pay. " Wall Street Journal February 5, 2001 The Doors Of Perception: Why Americans Will Believe Almost Anything Page 1 of 2 (Page 2, References) by Dr. Tim O'Shea We are the most conditioned, programmed beings the world has ever known. Not only are our thoughts and attitudes continually being shaped and molded; our very awareness of the whole design seems like it is being subtly and inexorably erased. The doors of our perception are carefully and precisely regulated. Who cares, right? It is an exhausting and endless task to keep explaining to people how most issues of conventional wisdom are scientifically implanted in the public consciousness by a thousand media clips per day. In an effort to save time, I would like to provide just a little background on the handling of information in this country. Once the basic principles are illustrated about how our current system of media control arose historically, the reader might be more apt to question any given story in today's news. If everybody believes something, it's probably wrong. We call that Conventional Wisdom. In America, conventional wisdom that has mass acceptance is usually contrived: somebody paid for it. Examples: Pharmaceuticals restore health Vaccination brings immunity The cure for cancer is just around the corner When a child is sick, he needs immediate antibiotics When a child has a fever he needs Tylenol Hospitals are safe and clean. America has the best health care in the world. And many many more This is a list of illusions, that have cost billions and billions to conjure up. Did you ever wonder why you never see the President speaking publicly unless he is reading? Or why most people in this country think generally the same about most of the above issues? How This Set-Up Got Started In Trust Us We're Experts, Stauber and Rampton pull together some compelling data describing the science of creating public opinion in America. They trace modern public influence back to the early part of the last century, highlighting the work of guys like Edward L. Bernays, the Father of Spin. From his own amazing chronicle Propaganda, we learn how Edward L. Bernays took the ideas of his famous uncle Sigmund Freud himself, and applied them to the emerging science of mass persuasion. The only difference was that instead of using these principles to uncover hidden themes in the human unconscious, the way Freudian psychology does, Bernays used these same ideas to mask agendas and to create illusions that deceive and misrepresent, for marketing purposes. The Father Of Spin Bernays dominated the PR industry until the 1940s, and was a significant force for another 40 years after that. (Tye) During all that time, Bernays took on hundreds of diverse assignments to create a public perception about some idea or product. A few examples: As a neophyte with the Committee on Public Information, one of Bernays' first assignments was to help sell the First World War to the American public with the idea to " Make the World Safe for Democracy. " (Ewen) A few years later, Bernays set up a stunt to popularize the notion of women smoking cigarettes. In organizing the 1929 Easter Parade in New York City, Bernays showed himself as a force to be reckoned with. He organized the Torches of Liberty Brigade in which suffragettes marched in the parade smoking cigarettes as a mark of women's liberation. Such publicity followed from that one event that from then on women have felt secure about destroying their own lungs in public, the same way that men have always done. Bernays popularized the idea of bacon for breakfast. Not one to turn down a challenge, he set up the advertising format along with the AMA that lasted for nearly 50 years proving that cigarettes are beneficial to health. Just look at ads in issues of Life or Time from the 40s and 50s. Smoke And Mirrors Bernay's job was to reframe an issue; to create a desired image that would put a particular product or concept in a desirable light. Bernays described the public as a 'herd that needed to be led.' And this herdlike thinking makes people " susceptible to leadership. " Bernays never deviated from his fundamental axiom to " control the masses without their knowing it. " The best PR happens with the people unaware that they are being manipulated. Stauber describes Bernays' rationale like this: " the scientific manipulation of public opinion was necessary to overcome chaos and conflict in a democratic society. " Trust Us p 42 These early mass persuaders postured themselves as performing a moral service for humanity in general - democracy was too good for people; they needed to be told what to think, because they were incapable of rational thought by themselves. Here's a paragraph from Bernays' Propaganda: " Those who manipulate the unseen mechanism of society constitute an invisible government which is the true ruling power of our country. We are governed, our minds molded, our tastes formed, our ideas suggested largely by men we have never heard of. This is a logical result of the way in which our democratic society is organized. Vast numbers of human beings must cooperate in this manner if they are to live together as a smoothly functioning society. In almost every act of our lives whether in the sphere of politics or business in our social conduct or our ethical thinking, we are dominated by the relatively small number of persons who understand the mental processes and social patterns of the masses. It is they who pull the wires that control the public mind. " Here Comes The Money Once the possibilities of applying Freudian psychology to mass media were glimpsed, Bernays soon had more corporate clients than he could handle. Global corporations fell all over themselves courting the new Image Makers. There were dozens of goods and services and ideas to be sold to a susceptible public. Over the years, these players have had the money to make their images happen. A few examples: Philip Morris Pfizer Union Carbide Allstate Monsanto Eli Lilly tobacco industry Ciba Geigy lead industry Coors DuPont Chlorox Shell Oil Standard Oil Procter & Gamble Boeing General Motors Dow Chemical General Mills Goodyear The Players Though world-famous within the PR industry, the companies have names we don't know, and for good reason. The best PR goes unnoticed. For decades they have created the opinions that most of us were raised with, on virtually any issue which has the remotest commercial value, including: pharmaceutical drugs vaccines medicine as a profession alternative medicine fluoridation of city water chlorine household cleaning products tobacco dioxin global warming leaded gasoline cancer research and treatment pollution of the oceans forests and lumber images of celebrities, including damage control crisis and disaster management genetically modified foods aspartame food additives; processed foods dental amalgams Lesson #1 Bernays learned early on that the most effective way to create credibility for a product or an image was by " independent third-party " endorsement. For example, if General Motors were to come out and say that global warming is a hoax thought up by some liberal tree-huggers, people would suspect GM's motives, since GM's fortune is made by selling automobiles. If however some independent research institute with a very credible sounding name like the Global Climate Coalition comes out with a scientific report that says global warming is really a fiction, people begin to get confused and to have doubts about the original issue. So that's exactly what Bernays did. With a policy inspired by genius, he set up " more institutes and foundations than Rockefeller and Carnegie combined. " (Stauber p 45) Quietly financed by the industries whose products were being evaluated, these " independent " research agencies would churn out " scientific " studies and press materials that could create any image their handlers wanted. Such front groups are given high-sounding names like: Temperature Research Foundation Manhattan Institute International Food Information Council Center for Produce Quality Consumer Alert Tobacco Institute Research Council The Advancement of Sound Science Coalition Cato Institute Air Hygiene Foundation American Council on Science and Health Industrial Health Federation Global Climate Coalition International Food Information Council Alliance for Better Foods Sound pretty legit don't they? Canned News Releases As Stauber explains, these organizations and hundreds of others like them are front groups whose sole mission is to advance the image of the global corporations who fund them, like those listed on page 2 above. This is accomplished in part by an endless stream of 'press releases' announcing " breakthrough " research to every radio station and newspaper in the country. (Robbins) Many of these canned reports read like straight news, and indeed are purposely molded in the news format. This saves journalists the trouble of researching the subjects on their own, especially on topics about which they know very little. Entire sections of the release or in the case of video news releases, the whole thing can be just lifted intact, with no editing, given the byline of the reporter or newspaper or TV station - and voilá! Instant news - copy and paste. Written by corporate PR firms. Does this really happen? Every single day, since the 1920s when the idea of the News Release was first invented by Ivy Lee. (Stauber, p 22) Sometimes as many as half the stories appearing in an issue of the Wall St. Journal are based solely on such PR press releases.. (22) These types of stories are mixed right in with legitimately researched stories. Unless you have done the research yourself, you won't be able to tell the difference. The Language Of Spin As 1920s spin pioneers like Ivy Lee and Edward Bernays gained more experience, they began to formulate rules and guidelines for creating public opinion. They learned quickly that mob psychology must focus on emotion, not facts. Since the mob is incapable of rational thought, motivation must be based not on logic but on presentation. Here are some of the axioms of the new science of PR: technology is a religion unto itself if people are incapable of rational thought, real democracy is dangerous important decisions should be left to experts when reframing issues, stay away from substance; create images never state a clearly demonstrable lie Words are very carefully chosen for their emotional impact. Here's an example. A front group called the International Food Information Council handles the public's natural aversion to genetically modified foods. Trigger words are repeated all through the text. Now in the case of GM foods, the public is instinctively afraid of these experimental new creations which have suddenly popped up on our grocery shelves which are said to have DNA alterations. The IFIC wants to reassure the public of the safety of GM foods, so it avoids words like: Frankenfoods Hitler biotech chemical DNA experiments manipulate money safety scientists radiation roulette gene-splicing gene gun random Instead, good PR for GM foods contains words like: hybrids natural order beauty choice bounty cross-breeding diversity earth farmer organic wholesome It's basic Freudian/Tony Robbins word association. The fact that GM foods are not hybrids that have been subjected to the slow and careful scientific methods of real crossbreeding doesn't really matter. This is pseudoscience, not science. Form is everything and substance just a passing myth. (Trevanian) Who do you think funds the International Food Information Council? Take a wild guess. Right - Monsanto, DuPont, Frito-Lay, Coca Cola, Nutrasweet - those in a position to make fortunes from GM foods. (Stauber p 20) Characteristics Of Good Propaganda As the science of mass control evolved, PR firms developed further guidelines for effective copy. Here are some of the gems: dehumanize the attacked party by labeling and name calling speak in glittering generalities using emotionally positive words when covering something up, don't use plain English; stall for time; distract get endorsements from celebrities, churches, sports figures, street people - anyone who has no expertise in the subject at hand the 'plain folks' ruse: us billionaires are just like you when minimizing outrage, don't say anything memorable, point out the benefits of what just happened, and avoid moral issues Keep this list. Start watching for these techniques. Not hard to find - look at today's paper or tonight's TV news. See what they're doing; these guys are good! PAGE 2 The Doors Of Perception: Why Americans Will Believe Almost Anything Page 2 of 2 (Page 1, References) Science For Hire PR firms have become very sophisticated in the preparation of news releases. They have learned how to attach the names of famous scientists to research that those scientists have not even looked at. (Stauber, p 201) This is a common occurrence. In this way the editors of newspapers and TV news shows are often not even aware that an individual release is a total PR fabrication. Or at least they have " deniability, " right? Stauber tells the amazing story of how leaded gas came into the picture. In 1922, General Motors discovered that adding lead to gasoline gave cars more horsepower. When there was some concern about safety, GM paid the Bureau of Mines to do some fake " testing " and publish spurious research that 'proved' that inhalation of lead was harmless. Enter Charles Kettering. Founder of the world famous Sloan-Kettering Memorial Institute for medical research, Charles Kettering also happened to be an executive with General Motors. By some strange coincidence, we soon have the Sloan Kettering institute issuing reports stating that lead occurs naturally in the body and that the body has a way of eliminating low level exposure. Through its association with The Industrial Hygiene Foundation and PR giant Hill & Knowlton, Sloane Kettering opposed all anti-lead research for years. (Stauber p 92). Without organized scientific opposition, for the next 60 years more and more gasoline became leaded, until by the 1970s, 90% of our gasoline was leaded. Finally it became too obvious to hide that lead was a major carcinogen, and leaded gas was phased out in the late 1980s. But during those 60 years, it is estimated that some 30 million tons of lead were released in vapor form onto American streets and highways. 30 million tons. That is PR, my friends. Junk Science In 1993 a guy named Peter Huber wrote a new book and coined a new term. The book was Galileo's Revenge and the term was junk science. Huber's shallow thesis was that real science supports technology, industry, and progress. Anything else was suddenly junk science. Not surprisingly, Stauber explains how Huber's book was supported by the industry-backed Manhattan Institute. Huber's book was generally dismissed not only because it was so poorly written, but because it failed to realize one fact: true scientific research begins with no conclusions. Real scientists are seeking the truth because they do not yet know what the truth is. True scientific method goes like this: 1. Form a hypothesis 2. Make predictions for that hypothesis 3. Test the predictions 4. Reject or revise the hypothesis based on the research findings Boston University scientist Dr. David Ozonoff explains that ideas in science are themselves like " living organisms, that must be nourished, supported, and cultivated with resources for making them grow and flourish. " (Stauber p 205) Great ideas that don't get this financial support because the commercial angles are not immediately obvious - these ideas wither and die. Another way you can often distinguish real science from phony is that real science points out flaws in its own research. Phony science pretends there were no flaws. The Real Junk Science Contrast this with modern PR and its constant pretensions to sound science. Corporate sponsored research, whether it's in the area of drugs, GM foods, or chemistry begins with predetermined conclusions. It is the job of the scientists then to prove that these conclusions are true, because of the economic upside that proof will bring to the industries paying for that research. This invidious approach to science has shifted the entire focus of research in America during the past 50 years, as any true scientist is likely to admit. Stauber documents the increasing amount of corporate sponsorship of university research. (206) This has nothing to do with the pursuit of knowledge. Scientists lament that research has become just another commodity, something bought and sold. (Crossen) The Two Main Targets Of " Sound Science " It is shocking when Stauber shows how the vast majority of corporate PR today opposes any research that seeks to protect public health the environment It's a funny thing that most of the time when we see the phrase " junk science, " it is in a context of defending something that may threaten either the environment or our health. This makes sense when one realizes that money changes hands only by selling the illusion of health and the illusion of environmental protection. True public health and real preservation of the earth's environment have very low market value. Stauber thinks it ironic that industry's self-proclaimed debunkers of junk science are usually non-scientists themselves. (255) Here again they can do this because the issue is not science, but the creation of images. The Language Of Attack When PR firms attack legitimate environmental groups and alternative medicine people, they again use special words which will carry an emotional punch: outraged sound science junk science sensible scaremongering responsible phobia hoax alarmist hysteria The next time you are reading a newspaper article about an environmental or health issue, note how the author shows bias by using the above terms. This is the result of very specialized training. Another standard PR tactic is to use the rhetoric of the environmentalists themselves to defend a dangerous and untested product that poses an actual threat to the environment. This we see constantly in the PR smokescreen that surrounds genetically modified foods. They talk about how GM foods are necessary to grow more food and to end world hunger, when the reality is that GM foods actually have lower yields per acre than natural crops. (Stauber p 173) The grand design sort of comes into focus once you realize that almost all GM foods have been created by the sellers of herbicides and pesticides so that those plants can withstand greater amounts of herbicides and pesticides. (The Magic Bean) Kill Your TV? Hope this chapter has given you a hint to start reading newspaper and magazine articles a little differently, and perhaps start watching TV news shows with a slightly different attitude than you had before. Always ask, what are they selling here, and who's selling it? And if you actually follow up on Stauber & Rampton's book and check out some of the other resources below, you might even glimpse the possibility of advancing your life one quantum simply by ceasing to subject your brain to mass media. That's right - no more newspapers, no more TV news, no more Time magazine or Newsweek. You could actually do that. Just think what you could do with the extra time alone. Really feel like you need to " relax " or find out " what's going on in the world " for a few hours every day? Think about the news of the past couple of years for a minute. Do you really suppose the major stories that have dominated headlines and TV news have been " what is going on in the world? " Do you actually think there's been nothing going on besides the contrived tech slump, the contrived power shortages, the re-filtered accounts of foreign violence and disaster, and all the other non-stories that the puppeteers dangle before us every day? What about when they get a big one, like with OJ or Monica Lewinsky or the Oklahoma city bombing? Do we really need to know all that detail, day after day? Do we have any way of verifying all that detail, even if we wanted to? What is the purpose of news? To inform the public? Hardly. The sole purpose of news is to keep the public in a state of fear and uncertainty so that they'll watch again tomorrow and be subjected to the same advertising. Oversimplification? Of course. That's the mark of mass media mastery - simplicity. The invisible hand. Like Edward Bernays said, the people must be controlled without them knowing it. Consider this: what was really going on in the world all that time they were distracting us with all that stupid vexatious daily smokescreen? Fear and uncertainty -- that's what keeps people coming back for more. If this seems like a radical outlook, let's take it one step further: What would you lose from your life if you stopped watching TV and stopped reading newspapers altogether? Would your life really suffer any financial, moral, intellectual or academic loss from such a decision? Do you really need to have your family continually absorbing the illiterate, amoral, phony, uncultivated, desperately brainless values of the people featured in the average nightly TV program? Are these fake, programmed robots " normal " ? Do you need to have your life values constantly spoon-fed to you? Are those shows really amusing, or just a necessary distraction to keep you from looking at reality, or trying to figure things out yourself by doing a little independent reading? Name one example of how your life is improved by watching TV news and reading the evening paper. What measurable gain is there for you? Planet of the Apes? There's no question that as a nation, we're getting dumber year by year. Look at the presidents we've been choosing lately. Ever notice the blatant grammar mistakes so ubiquitous in today's advertising and billboards? Literacy is marginal in most American secondary schools. Three fourths of California high school seniors can't read well enough to pass their exit exams. (SJ Mercury 20 Jul 01) If you think other parts of the country are smarter, try this one: hand any high school senior a book by Dumas or Jane Austen, and ask them to open to any random page and just read one paragraph out loud. Go ahead, do it. SAT scales are arbitrarily shifted lower and lower to disguise how dumb kids are getting year by year. At least 10% have documented " learning disabilities, " which are reinforced and rewarded by special treatment and special drugs. Ever hear of anyone failing a grade any more? Or observe the intellectual level of the average movie which these days may only last one or two weeks in the theatres, especially if it has insufficient explosions, chase scenes, silicone, fake martial arts, and cretinesque dialogue. Radio? Consider the low mental qualifications of the falsely animated corporate simians they hire as DJs -- they're only allowed to have 50 thoughts, which they just repeat at random. And at what point did popular music cease to require the study of any musical instrument or theory whatsoever, not to mention lyric? Perhaps we just don't understand this emerging art form, right? The Darwinism of MTV - apes descended from man. Ever notice how most articles in any of the glossy magazines sound like they were all written by the same guy? And this guy just graduated from junior college? And yet he has all the correct opinions on social issues, no original ideas, and that shallow, smug, homogenized corporate omniscience, which enables him to assure us that everything is going to be fine... All this is great news for the PR industry - makes their job that much easier. Not only are very few paying attention to the process of conditioning; fewer are capable of understanding it even if somebody explained it to them. Tea In the Cafeteria Let's say you're in a crowded cafeteria, and you buy a cup of tea. And as you're about to sit down you see your friend way across the room. So you put the tea down and walk across the room and talk to your friend for a few minutes. Now, coming back to your tea, are you just going to pick it up and drink it? Remember, this is a crowded place and you've just left your tea unattended for several minutes. You've given anybody in that room access to your tea. Why should your mind be any different? Turning on the TV, or uncritically absorbing mass publications every day - these activities allow access to our minds by " just anyone " - anyone who has an agenda, anyone with the resources to create a public image via popular media. As we've seen above, just because we read something or see something on TV doesn't mean it's true or worth knowing. So the idea here is, like the tea, the mind is also worth guarding, worth limiting access to it. This is the only life we get. Time is our total capital. Why waste it allowing our potential, our personality, our values to be shaped, crafted, and limited according to the whims of the mass panderers? There are many important issues that are crucial to our physical, mental, and spiritual well-being. If it's an issue where money is involved, objective data won't be so easy to obtain. Remember, if everybody knows something, that image has been bought and paid for. Real knowledge takes a little effort, a little excavation down at least one level below what " everybody knows. " References DR. MERCOLA'S COMMENT: As I said in February when I posted an earlier piece on Trust Us We're Experts: One of the reasons I write this newsletter is to provide you, the reader, with the truth so you can weed through much of the nonsense that the media throws at you. I know that it is difficult to do and that is one of the main reasons for the newsletter. This book will help explain the details of how the media deceives you through the manipulation of PR by the large corporations who do not have your best interest at heart. My goal is to change the entire system. The way that will be done is through the Internet, which is the world's cheapest printing press. By passing this newsletter on to as many of your friends and relatives as possible along with a strong endorsement to , you will play a major role in helping to lift the veil of deceit that these corporations try to hide the truth with. We can change the traditional paradigm and in the process save hundreds of thousands of people from premature death and disability. Related Articles: How The Media Deceives You About Health Issues by Tate Metro Media Think about how many times you've heard an evening news anchor spit out some variation on the phrase, " According to experts .... " It's such a common device that most of us hardly hear it anymore. But we do hear the " expert " - the professor or doctor or watchdog group - tell us whom to vote for, what to eat, when to buy stock. And, most of the time, we trust them. Now ask yourself, how many times has that news anchor revealed who those experts are, where they get their funding, and what constitutes their political agenda? If you answered never, you'd be close. That's the driving complaint behind Trust Us, We're Experts, a new book co-authored by John Stauber and Sheldon Rampton of the Center for Media and Democracy. Unlike many so-called " experts, " the Center's agenda is quite overt - to expose the shenanigans of the public relations industry, which pays, influences and even invents a startling number of those experts. The third book co-authored by Stauber and Rampton, Trust Us hit bookstore shelves in January. There are two kinds of " experts " in question--the PR spin doctors behind the scenes and the " independent " experts paraded before the public, scientists who have been hand-selected, cultivated, and paid handsomely to promote the views of corporations involved in controversial actions. Lively writing on controversial topics such as dioxin bovine growth hormone genetically modified food makes this a real page-turner, shocking in its portrayal of the real and potential dangers in each of these technological innovations and of the " media pseudo-environment " created to hide the risks. By financing and publicizing views that support the goals of corporate sponsors, PR campaigns have, over the course of the century, managed to suppress the dangers of lead poisoning for decades, silence the scientist who discovered that rats fed on genetically modified corn had significant organ abnormalities, squelch television and newspaper stories about the risks of bovine growth hormone, and place enough confusion and doubt in the public's mind about global warming to suppress any mobilization for action. Rampton and Stauber introduce the movers and shakers of the PR industry, from the " risk communicators " (whose job is to downplay all risks) and " outrage managers " (with their four strategies--deflect, defer, dismiss, or defeat) to those who specialize in " public policy intelligence " (spying on opponents). Evidently, these elaborate PR campaigns are created for our own good. According to public relations philosophers, the public reacts emotionally to topics related to health and safety and is incapable of holding rational discourse. Needless to say, Rampton and Stauber find these views rather antidemocratic and intend to pull back the curtain to reveal the real wizard in Oz. Metro Media: What was the most surprising or disturbing manipulation of public opinion you reveal in your book? John Stauber: The most disturbing aspect is not a particular example, but rather the fact that the news media regularly fails to investigate so-called " independent experts " associated with industry front groups. They all have friendly-sounding names like " Consumer Alert " and " The Advancement of Sound Science Coalition, " but they fail to reveal their corporate funding and their propaganda agenda, which is to smear legitimate heath and community safety concerns as " junk-science fear-mongering. " The news media frequently uses the term " junk science " to smear environmental health advocates. The PR industry has spent more than a decade and many millions of dollars funding and creating industry front groups which wrap them in the flag of " sound science. " In reality, their " sound science " is progress as defined by the tobacco industry, the drug industry, the chemical industry, the genetic engineering industry, the petroleum industry and so on. Metro Media: Is the public becoming more aware of PR tactics and false experts? Or are those tactics and experts becoming more savvy and effective? Stauber: The truth is that the situation is getting worse, not better. More and more of what we see, hear and read as " news " is actually PR content. On any given day much or most of what the media transmits or prints as news is provided by the PR industry. It's off press releases, the result of media campaigns, heavily spun and managed, or in the case of " video news releases " it's fake TV news - stories completely produced and supplied for free by former journalists who've gone over to PR. TV news directors air these VNRs as news. So the media not only fails to identify PR manipulations, it is the guilty party by passing them on as news. Metro Media: What's the solution for the excesses of the PR industry? Just more media literacy and watchdog organizations like yours? Or should the PR industry be regulated in some way? Stauber: In our last chapter, " Question Authority, " we identify some of the most common propaganda tactics so that individuals and journalists and public interest scientists can do a better job of not being snowed and fooled. But ultimately those who have the most power and money in any society are going to use the most sophisticated propaganda tactics available to keep democracy at bay and the rabble in line. There are some specific legislative steps that could be taken without stepping on the First Amendment. One is that all nonprofit, tax-exempt organizations - charities and educational groups, for instance - should be required by law to reveal their institutional funders of, say, $500 or more. That way when a journalist or a citizen hears that a scientific report is from a group like the American Council on Science and Health, a quick trip to the IRS Web site could reveal that this group gets massive infusions of industry money, and that the corporations that fund it benefit from its proclamations that pesticides are safe, genetically engineered food will save the planet, lead contamination isn't really such a big deal, climate change isn't happening, and so on. The public clearly doesn't understand that most nonprofit groups (not ours, by the way) take industry and government grants, or are even the nonprofit arm of industry. Detroit Metro Times February 6, 2001 DR. MERCOLA'S COMMENT: One of the reasons I write this newsletter is to provide you, the reader, with the truth so you can weed through much of the nonsense that the media throws at you. I know that it is difficult to do and that is one of the main reasons for the newsletter. This book will help explain the details of how the media deceives you through the manipulation of PR by the large corporations who do not have your best interest at heart. My goal is to change the entire system. The way that will be done is through the Internet, which is the world's cheapest printing press. By passing this newsletter on to as many of your friends and relatives as possible along with a strong endorsement to , you will play a major role in helping to lift the veil of deceit that these corporations try to hide the truth with. We can change the traditional paradigm and in the process save hundreds of thousands of people from premature death and disability. The Doors Of Perception: Why Americans Will Believe Almost Anything References Stauber & Rampton, " Trust Us, We're Experts " , Tarcher/Putnam 2001 Ewen, Stuart PR!: A Social History of Spin 1996 ISBN: 0-465-06168-0 Published by Basic Books, A Division of Harper Collins Tye, Larry The Father of Spin: Edward L. Bernays and the Birth of Public Relations Crown Publishers, Inc. 2001 King, R Medical journals rarely disclose researchers' ties Wall St. Journal, 2 Feb 99. Engler, R et al. Misrepresentation and Responsibility in Medical Research New England Journal of Medicine v 317 p 1383 26 Nov 1987 Black, D PhD Health At the Crossroads Tapestry 1988. revanian Shibumi 1983. Crossen, C Tainted Truth: The Manipulation of Fact in America 1996. Robbins, J Reclaiming Our Health Kramer 1996. O'Shea T The Magic Bean 2000 www.thedoctorwithin.com. Inhibitory effect of conjugated dienoic derivatives of linoleic acid and beta-carotene on the in vitro growth of human cancer cells CANCER LETT. (Ireland) , 1992, 63/2 (125-133) Inhibition of Listeria monocytogenes by fatty acids and monoglycerides APPL. ENVIRON. MICROBIOL. (USA) , 1992, 58/2 (624-629) Fatty acids and monoglycerides were evaluated in brain heart infusion broth and in milk for antimicrobial activity against the Scott A strain of Listeria monocytogenes. C(12:0), C(18:3), and glyceryl monolaurate (monolaurin) had the strongest activity in brain heart infusion broth and were bactericidal at 10 to 20 microg/ml, whereas potassium (K)-conjugated linoleic acids and C(18:2) were bactericidal at 50 to 200 microg/ml. C(14:0), C(16:0), C(18:0), C(18:1), glyceryl monomyristate, and glyceryl monopalmitate were not inhibitory at 200 microg/ml. The bactericidal activity in brain heart infusion broth was higher at pH 5 than at pH 6. In whole milk and skim milk, K-conjugated linoleic acid was bacteriostatic and prolonged the lag phase especially at 4degreeC. Monolaurin inactivated L. monocytogenes in skim milk at 4degreeC, but was less inhibitory at 23degreeC. Monolaurin did not inhibit L. monocytogenes in whole milk because of the higher fat content. Other fatty acids tested were not effective in whole or skim milk. Our results suggest that K-conjugated linoleic acids or monolaurin could be used as an inhibitory agent against L. monocytogenes in dairy foods. Recognition of cervical neoplasia by the estimation of a free-radical reaction product (octadeca-9,11-dienoic acid) in exfoliated cells CLIN. CHIM. ACTA (NETHERLANDS) , 1987, 163/2 (149-152) lar ratio between a diene-conjugated linoleic-acid isomer (18 : 2(9,11)) and the parent linoleic acid (18 : 2(9,12)), both esterified as phospholipids, was significantly different in exfoliated cells from normal cervices and from cervices with colposcopic and cytological evidence of precancer. The measurement may provide a simple and perhaps improved alternative to cytological screening. Feeding conjugated linoleic acid to animals partially overcomes catabolic responses due to endotoxin injection BIOCHEM. BIOPHYS. RES. COMMUN. (USA) , 1994, 198/3 (1107-1112) The ability of conjugated linoleic acid to prevent endotoxin-induced growth suppression was examined. Mice fed a basal diet or diet with 0.5% fish oil lost twice as much body weight after endotoxin injection than mice fed conjugated lineoleic acid. By 72 hours post injection, mice fed conjugated linoleic acid had body weights similar to vehicle injected controls; however, body weights of basal and fish oil fed mice injected with endotoxin were reduced. Conjugated linoleic acid prevented anorexia from endotoxin injection. Splenocyte blastogenesis was increased by conjugated linoleic acid. Conjugated linoleic acid (9,11- and 10,12-octadecadienoic acid) is produced in conventional but not germ-free rats fed linoleic acid J. NUTR. (USA) , 1994, 124/5 (694-701) Conjugated linoleic acid (CLA) is an anticarcinogen in several model animal systems. Conjugated linoleic acid occurs naturally in food and is present at higher concentrations in products from ruminant animals. Given that certain rumen microorganisms produce CLA from free linoleic acid, we studied the effect of feeding free or esterified linoleic acid on tissue CLA a 5% (wt/wt) corn oil control diet alone or supplemented with 5% free linoleic acid or 8.63% corn oil (equivalent to 5% linoleic acid in triglyceride). Germ-free rats were fed autoclavable nonpurified diet alone or supplemented with 5% free linoleic acid. Analyses of CLA concentrations were performed on lipids extracted from liver, lung, kidney, skeletal muscle and abdominal adipose tissue, and on liver phospholipid and neutral lipid fractions. Tissue CLA concentrations were higher in conventional rats fed free linoleic acid (the major isomers were cis-9, trans-11 and trans-9, cis- 11) than in control animals. Conjugated linoleic acid concentrations in free linoleic acid-fed rats were maximal at 4 wk, and levels were 5-10 times higher than those of controls. Elevated CLA concentrations were also observed in liver phospholipid and neutral lipid fractions. In contrast, CLA concentrations in the tissues of germ-free rats were not affected by diet. Feeding the corn oil-fortified diet to conventional rats did not increase CLA concentration in the tissues. We conclude that the intestinal bacterial flora of rats is capable of converting free linoleic acid (but not linoleic acid esterified in triglycerides) to cis-9, trans-11 and trans-9, cis-11 CLA isomers. Conjugated linoleic acid and atherosclerosis in rabbits ATHEROSCLEROSIS (Ireland) , 1994, 108/1 (19-25) Conjugated linoleic acid (CLA) consists of a series of positional and geometric dienoic isomers of linoleic acid that occur naturally in foods. CLA exhibits antioxidant activity in vitro and in vivo. To assess the effect of CLA on atherosclerosis, 12 rabbits were fed a semi-synthetic diet containing 14% fat and 0.1% cholesterol for 22 weeks. For 6 of these rabbits, the diet was augmented with CLA (0.5 g CLA/rabbit per day). Blood samples were taken monthly for lipid analysis. By 12 weeks total and LDL cholesterol and triglycerides were markedly lower in the CLA-fed group. Interestingly, the LDL cholesterol to HDL cholesterol ratio and total cholesterol to HDL cholesterol ratio were significantly reduced in CLA-fed rabbits. Examination of the aortas of CLA-fed rabbits showed less atherosclerosis. Conjugated linoleic acid is a growth factor for rats as shown by enhanced weight gain and improved feed efficiency J. NUTR. (USA) , 1994, 124/12 (2344-2349) We studied the effect of conjugated linoleic acid (CLA) on rat development and growth. Primigravid female Fischer rats were fed control or CLA- supplemented (0.25% or 0.5% CLA) diets during gestation and/or lactation. Conjugated linoleic acid was incorporated into milk fat and tissue lipids proportional to the level of CLA fed and the duration of CLA feeding. Conjugated linoleic acidas incorporated into fetal and neonatal tissues; it did not affect litter size nor induce apparent abnormalities. To the contrary, feeding CLA to the dams during gestation and lactation improved the postnatal body weight gain of pups (P & lt; 0.05), measured on d 10 of lactation. Pups that continued to receive the CLA-supplemented diet after weaning had significantly greater body weight gain and improved feed efficiency relative to control animals (P & lt; 0.05). Cows' milk fat components as potential anticarcinogenic agents Journal of Nutrition (USA) , 1997, 127/6 (1055-1060) The optimum approach to conquering cancer is prevention. Although the human diet contains components which promote cancer, it also contains components with the potential to prevent it. Recent research shows that milk fat contains a number of potential anticarcinogenic components including conjugated linoleic acid, sphingomyelin, butyric acid and ether lipids. Conjugated linoleic acid inhibited proliferation of human malignant melanoma, colorectal, breast and lung cancer cell lines. In animals, it reduced the incidence of chemically induced mouse epidermal tumors, mouse forestomach neoplasia and aberrant crypt foci in the rat colon. In a number of studies, conjugated linoleic acid, at near-physiological concentrations, inhibited mammary tumorigenesis independently of the amount and type of fat in the diet. In vitro studies showed that the milk phospholipid, sphingomyelin, through its biologically active metabolites ceramide and sphingosine, participates in three major antiproliferative pathways influencing oncogenesis, namely, inhibition of cell growth, and induction of differentiation and apoptosis. Mice fed sphingomyelin had fewer colon tumors and aberrant crypt foci than control animals. About one third of all milk triacylglycerols contain one molecule of butyric acid, a potent inhibitor of proliferation and inducer of differentiation and apoptosis in a wide range of neoplastic cell lines. Although butyrate produced by colonic fermentation is considered important for colon cancer protection, an animal study suggests dietary butyrate may inhibit mammary tumorigenesis. The dairy cow also has the ability to extract other potential anticarcinogenic agents such as beta- carotene, beta-ionone and gossypol from its feed and transfer them to milk. Animal studies comparing the tumorigenic potential of milk fat or butter with linoleic acid-ricless tumor development with dairy products. Suppression of voltage-gated L-type Ca2+ currents by polyunsaturated fatty acids in adult and neonatal rat ventricular myocytes Proceedings of the National Academy of Sciences of the United States of America (USA) , 1997, 94/8 (4182-4187) Our recent data show that in cardiac myocytes polyunsaturated fatty acids (PUFAs) are antiarrhythmic. They reduce I(Na), shorten the action potential, shift the threshold for excitation to more positive potentials, and prolong the relative refractory period. In this study we use patch-clamp techniques in whole-cell mode and confocal Ca2+ imaging to examine the effects of PUFAs on the voltage-gated L-type Ca2+ current (I(Ca,L)), elementary sarcoplasmic reticulum Ca2+-release events (Ca2+-sparks), and (Ca2+)(i) transients in isolated rat ventricular myocytes. Extracellular application of eicosapentaenoic acid (EPA; C20:5 n - 3) produced a prompt and reversible concentration-dependent suppression of I(Ca,L). The concentration of EPA to produce 50% inhibition of I(Ca) was 0.8 microM in neonatal rat heart cells and 2.1 microM in adult ventricular myocytes. While the EPA induced suppression of I(Ca,L), it did not significantly alter the shape of the current-voltage relation but did produce a small, but significant, negative shift of the steady-state inactivation curve. The inhibition of I(Ca,L) was voltage- and time-dependent, but not use- or frequency-dependent. Other PUFAs, such as docosahexaenoic acid, arachidonic acid, linolenic acid, linoleic acid, conjugated linoleic acid, and eicosatetraynoic acid had similar effects on I(Ca,L) as EPA. All-trans-retinoic acid, which had been shown to suppress induced arrhythmogenic activity in rat heart cells, also produced a significant inhibition of I(Ca,L). The saturated stearic acid and sarcoplasmic reticulum Ca2+-release underlie many cardiac arrhythmias, we examined the effects of EPA on I(Ca,L) and Ca2+-sparks. While EPA suppressed both, it did not change the temporal or spatial character of the Ca2+-sparks, nor did it alter the ability of I(Ca,L) to trigger Ca2+- sparks. We conclude that PUFAs may act as antiarrhythmic agents in vivo in normal and Ca2+-overloaded cells principally because they reduce Ca2+ entry by blocking I(Ca,L). Furthermore, PUFAs act directly to decrease I(Na) and I(Ca,L), but indirectly to reduce the (Ca2+)(i) transients and (Ca2+)(i)-activated membrane current. Although a negative inotropic action is associated with application of PUFAs, it is clear that by reducing I(Ca,L), I(Na) and Ca2+-sparks, PUFAs can reduce spontaneous extrasystoles in the heart. The mechanisms by which PUFAs act are discussed. Effects of dietary conjugated linoleic acid on lymphocyte function and growth of mammary tumors in mice Anticancer Research (Greece) , 1997, 17/2 A (987-993) We studied the effects of conjugated linoleic acid (CLA) on lymphocyte function and growth of a transplantable murine mammary tumor. In experiment 1, eig(n = 8/group) were fed 0.1%, 0.3% or 0.9% CLA for 3 or 6 wk. Lymphocyte proliferation, interleukin-2 production and lymphocyte cytotoxicity were assessed using splenic lymphocytes. Plasma CLA concentrations increased in a dose-dependent manner with CLA feeding. Lymphocyte proliferation in mice fed 0.3% and 0.9% CLA was enhanced in phytohemagglutinin-induced but not in concanavalin A- or lipopolysaccharide-stimulated cultures. Production of IL-2 also was stimulated by CLA. In contrast, CLA had no effect on lymphocyte cytotoxicity. In experiment 2, mice (n = 20/treatment) were fed the same diets for 2 wk before being infused with 1 x 106 WAZ-2T metastatic mammary tumor cells into the right inguinal mammary gland. Tumor volume and latency were recorded for 45 d. Dietary CLA did not affect mammary tumor growth. Tumor latency, tumor incidence and tumor lipid peroxidation activity also were unaffected by CLA. Body weight and feed intake were similar among treatments. Therefore, dietary CLA modulated certain aspects of the immune defense but had no obvious effect on the growth of an established, aggressive mammary tumor. Conjugated linoleic acid suppresses the growth of human breast adenocarcinoma cells in SCID mice Anticancer Research (Greece) , 1997, 17/2 A (969-973) Conjugated linoleic acid (CLA), which is mainly derived from dairy products, has been shown both in vitro and in animal models to have strong anti-tumor activity. Particular effects were observed on the growth and metastatic spread of transplantable mammary tumors. In this study, we examined the effect of dietary CLA on the growth of human breast adenocarcinoma cells in severe combined immunodeficient (SCID) mice. Mice were fed 1% CLA for two weeks prior to subcutaneous inoculation of 107 MDA-MB468 cells and throughout the wth by 73% and 30% at 9 and 14 weeks post-inoculation, respectively. Moreover, CLA completely abrogated the spread of breast cancer cells to lungs, peripheral blood, and bone marrow. These results indicate the ability of dietary CLA to block both the local growth and systemic spread of human breast cancer via mechanisms independent of the host immune system. Lymphatic recovery, tissue distribution, and metabolic effects of conjugated lioleic acid in rats Journal of Nutritional Biochemistry (USA) , 1997, 8/1 (38-43) Apparent lymphatic recovery of conjugated linoleic acid (CLA) in rats was considerably lower than for linoleic acid, approximately 55% versus 80% for 24 hr, although the distribution in lymph lipoproteins was similar. Not all the CLA constituents were recovered equally, and more tt-isomers were recovered than ct- or tc-isomers in relation to the composition of CLA given. When rats were fed CLA or linoleic acid at the dietary level of 1% for 2 weeks, there were detectable differences in the incorporation of CLA in various tissues, and adipose tissue and lung contained the highest proportion, whereas a limited amount was incorporated into the brain. In general, 9c, 11t/9t,11c isomers were the predominant CLA followed by tt-isomers. Also, CLA was differently incorporated into individual phospholipids in the liver. No effects were observed on serum and liver lipid levels, but the concentration of prostaglandin E2 (PGE2) in serum anhe for mer was statistically significant. CLA did not increase tissue TBA values. Thus, the metabolic effect of CLA may not be attributed to a single entity. Proliferative responses of normal human mammary and MCF-7 breast cancer cells to linoleic acid, conjugated linoleic acid and eicosanoid synthesis inhibitors in culture Anticancer Research (Greece) , 1997, 17/1 A (197-203) Potential mechanisms for the stimulation or inhibition of cell growth by linoleic acid (LA) and conjugated linoleic acid (CLA) were investigated by using eicosanoid linoleic acid (CLA) were investigated by using eicosanoid synthesis inhibitors. Normal human mammary epithelial cells (HMEC) and MCF-7 breast cancer cells were incubated in serum-free medium supplemented with LA or CLA and cyclooxygenase (indomethacin; INDO) or lipoxygenase (nordihydroguaiaretic acid; NDGA) inhibitors. Linoleic acid stimulated the growth and (3H)thymidine incorporation of normal HMEC and MCF-7 cancer cells, while CLA was inhibitory. Supplementation with LA increased intracellular lipid peroxide concentrations in normal HMEC and MCF-7 cancer cells, whereas CLA did not affect lipid peroxide formation. Normal HMEC and MCF-7 cells supplemented with LA and INDO or NDGA resulted in growth inhibition. The treatment of normal HMEC with CLA and INDO or NDGA, and MCF-7 cells with CLA and INDO stimulated cell growth. However, the addition of CLA and NDGA to MCF-7 cells resulted in synergistic growth suppression suggesting that CLA effects were mediated through lipoxygenase inhibition. Although NDGA was more inhibitory of cell growth in the presence of LA or CLA than INDO, growth was associate with both prostaglandin and leukotriene production. Additional studies are warranted to elucidate the mechanism(s) whereby LA or CLA affect breast cell growth. Conjugated linoleic acid modulates hepatic lipid composition in mice Lipids (USA) , 1997, 32/2 (199-204) Conjugated linoleic acid (CLA) is a chemoprotective fatty acid that inhibits mammary, colon, forestomach, and skin carcinogenesis in experimental animals. We hypothesize that the ubiquitous chemoprotective actions of dietary CLA in extrahepatic tissues are dependent upon its role in modulating fatty acid composition and metabolism in liver, the major organ for lipid metabolism. This study begins to evaluate the role of CLA in lipid metabolism by determining the modulation of fatty acid composition by CLA. Female SENCAR mice were fed semipurified diets containing 0.0% (Diet A), 0.5% (Diet B), 1.0% (Diet C), or 1.5% (Diet D) CLA (by weight) for six weeks. Mice fed Diets B, C, and D exhibited lower body weights and elevated amounts of extractable total lipid in livers compared with mice fed diets without CLA (Diet A). Analyses of the fatty acid composition of liver by gas chromatography revealed that dietary CLA was incorporated into neutral and phospholipids at the expense of linoleate in Diets B, C, and D; oleate increased and arachidonate decreased in neutral lipids of CLA diet groups. In addition, increasing dietary CLA was associated with reduced linoleate in hepatic phospholipids. In an in vitro assay, CLA was desaturated to an unidentified 18:3 product to a similar extent as linoleate conversion to gamma- linolenate (9.88, and 13.63%, respectively). These data suggest that CLA may affect metabolic interconversion of fatty acids in liver that may ultimately result in modified fatty acid composition and arachidonate-derived eicosanoid production in extrahepatic tissues. In addition to determining how dietary CLA modulates eicosanoid synthesis, further work is needed to identify enzymatic products that may result from desaturation of CLA. Dietary conjugated linoleic acid modulation of phorbol ester skin tumor promotion Nutrition and Cancer (USA) , 1996, 26/2 (149-157) The fatty acid derivative conjugated dienoic linoleate (CLA) has been shown to inhibit initiation and postinitiation stages of carcinogenesis in several experimental animal models. The goal of the present study was to determine the role of increasing levels of dietary CLA in mouse skin tumor promotion elicited by 12-O-tetradecanoylphorbol-13-acetate (TPA). Mice were fed control (no CLA) diet during initiation, then switched to diets containing 0.0%, 0.5%, 1.0%, or 1.5% (wt/wt) CLA during skin tumor promotion by TPA. Body weights of mice fed 0.5%, 1.0%, or 1.5% CLA were similar to each other but were significantly lower (p & lt; 0.05) than weights of mice fed no CLA (0.0%) throughout promotion. A reduction in papilloma incidence was observed in mice fed 1.5% CLA from Weeks 8 to 24 compared with mice fed diets containing 0.0-1.0% CLA (p & lt; 0.05). Twenty-four weeks after tumor promotion was begun, diets containing 1.0% and 1.5% CLA inhibited tumor yield (4.94 and 4.35 tumors/mouse, respectively) compared with diets without CLA (0.0% CLA, 6.65 tumors/mouse, p & lt; 0.05) or 0.5% CLA (5.92 tumors/mouse, p & lt; 0.05). These data indicate that CLA inhibits tumor promotion in a manner that is independent of its anti-initiator activity. Further studies are warranted in identifying cellular mechanisms that are likely to be involved with the antipromoter effects of CLA. The efficacy of conjugated linoleic acid in mammary cancer prevention is independent of the level or type of fat in the diet Carcinogenesis (United Kingdom) , 1996, 17/5 (1045-1050) The objective of the present study was to investigate whether the anticarcinogenic activity of conjugated linoleic acid (CLA) is affected by the amount and composition of dietary fat consumed by the host. Because the anticancer agent of interest is a fatty acid, this approach may provide some insight into its mechanism of action, depending on the outcome of these fat feeding experiments. For the fat level experiment, a custom formulated fat blend was used that simulates the fatty acid composition of the US diet. This fat blend was present at 10, 13.3, 16.7 or 20% by weight in the diet. For the fat type experiment, a 20% (w/w) fat diet containing either corn oil (exclusively) or lard (predominantly) was used. Mammary cancer prevention by CLA was evaluated using the rat dimethylbenz(alpha)anthracene model. The results indicated that the magnitude of tumor inhibition by 1% CLA was not influenced by the level or type of fat in the diet. It should be noted that these fat diets varied markedly in their content of linoleate. Fatty acid analysis showed that CLA was incorporated predominantly in mammary tissue neutral lipids, while the increase in CLA in mammary tissue phospholipids was minimal. Furthermore, there was no evidence that CLA supplementation perturbed the distribution of linoleate or other fatty acids in the phospholipid fraction. Collectively these carcinogenesis and biochemical data suggest that the cancer preventive activity of CLA is unlikely to be mediated by interference with the metabolic cascade involved in converting linoleic acid to eicosanoids. The hypothesis that CLA might act as an antioxidant was also examined. Treatment with CLA resulted in lower levels of mammary tissue malondialdehyde (an end product of lipid peroxidation), but failed to change the levels of 8-hydroxydeoxyguanosine (a marker of oxidatively damaged DNA). Thus while CLA may have some antioxidant function in vivo in suppressing lipid peroxidation, its anticarcinogenic activity cannot be accounted for by protecting the target cell DNA against oxidative damage. The finding that the inhibitory effect of CLA maximized at 1% (regardless of the availability of linoleate in the diet) could conceivably point to a limiting step in the capacity to metabolize CLA to some active product(s) which is essential for cancer prevention. Dietary modifiers of carcinogenesis Environmental Health Perspectives (USA) , 1995, 103/SUPPL. 8 (177-184) Dietary components express a wide range of activities that can affect carcinogenesis. Naturally occurring substances in foods have been shown in laboratory experiments to serve as dietary antimutagens, either as bioantimutagens or as desmutagens. Dietary desmutagens may function as chemical inactivaters, enzymatic inducers, scavengers, or antioxidants .. Dietary components may also act later in the carcinogenic process as tumor growth suppressors. Examples of dietary factors acting in each of these stages of carcinogenesis are presented, and potential anticarcinogens such as the carotenoids, tocopherols, phenolic compounds, glucosinolates, metal-binding proteins, phytoestrogens, and conjugated linoleic acid are discussed. individual foods typically contain multiple potential anticarcinogens. Many of these substances can influence carcinogenesis through more than one mechanism. Some substances exhibit both anticarcinogenic and carcinogenic activity in vitro, depending on conditions. Epidemiologic research indicates that high fruit and vegetable consumption is associated with lower cancer risk. Little research has focused on the effects of single substances or single foods in man. Realization of the potential of foodborne substances to reduce the human burden of cancer will only be achieved with better measurement of dietary exposures and funding of muitidisciplinary research in this area commensurate with its importance. Effects of C18 fatty acid isomers on DNA synthesis in hepatoma and breast cancer cells Anticancer Research (Greece) , 1995, 15/5 B (2017-2021) The influence of geometrical isomerism on the growth regulatory effects of 18 carbon unsaturated fatty acids on the incorporation of (3H)thymidine into DNA was studied in 7800NJ rat hepatoma and T47D human breast cancer cells. 9 cis, 12 cis linoleic acid was more inhibitory than the trans 9, trans 12 isomer (linolelaidic acid). The monounsaturated cis isomer. In contrast to published studies on the proliferation of breast cancer cells, we observed conditions in which linoleic acid was more inhibitory than conjugated linoleic acid for thymidine incorporation into DNA. Increasing the concentration of 38 mg/ml greatly diminished inhibitory effects and favored stimulatory effects on hepatoma and breast cancer cells. The results suggested that the growth inhibitory and stimulatory effects of C18 unsaturated fatty acids on cancer cells are influenced by geometrical isomerism and the ratio of the albumin to fatty acid concentrations Effect of timing and duration of dietary conjugated linoleic acid on mammary cancer prevention Nutrition and Cancer (USA) , 1995, 24/3 (241-247) Conjugated linoleic acid (CLA) is a minor fatty acid found predominantly in the form of triglycerides in beef and dairy products. Previous work by Ip and co-workers showed that free fatty acid-CLA at less than or equal to1% in the diet is protective against mammary carcinogenesis in rats. The present study verified that the anticancer activities of free fatty acid-CLA and triglyceride-CLA are essentially identical. This is an important finding, because it rules out a nonspecific free fatty acid effect. In terms of practical implication, we can continue the in vivo research with the less-expensive free fatty acid- CLA without compromising the physiological relevance of the data. A primary objective of this report was to investigate how the timing and duration of CLA feeding might affect the development of mammary carcinogenesis in the methylnitrosourea (MNU) model. We found that exposure to 1% CLA during the early postweaning and pubertal period only (from 21 to 42 days of age) was sufficient to reduce subsequent tumorigenesis induced by a single dose of MNU given at 56 days of age. This period incidentally corresponds to a time of active morphological development of the mammary gland to the mature state. In contrast to the above observation, a continuous intake of CLA was required for maximal inhibition of tumorigenesis when CLA feeding was started after MNU administration, suggesting that some active metabolite(s) of CLA might be involved in suppressing the process of neoplastic promotion/progression. The role of phenolics, conjugated linoleic acid, carnosine, and pyrroloquinoline quinone as nonessential dietary antioxidants Nutrition Reviews (USA) , 1995, 53/3 (49-58) Oxidative reactions have been implicated in the development of numerous diseases including atherosclerosis and cancer. Oxidation t in loss of membrane integrity and function, inactivation of enzymes, modification of lipoproteins, and chemical alteration of DNA. Active oxygen species, transition metals, reducing agents, and enzymes such as lipoxygenase are all involved in the catalysis of oxidative reactions. Since lipid oxidation catalysts and active oxygen species are ubiquitous to all biological systems and since lipid oxidation products can enter the body via oxidized foods, numerous endogenous antioxidant systems have been developed. Endogenous antioxidant systems include antioxidant enzymes, free radical scavengers, and metal chelators. The purpose of this review is to examine the potential of nonessential dietary components that inhibit oxidative reactions in foods and biological tissues. Dietary conjugated linoleic acid reduces plasma lipoproteins and early aortic atharosclerosis in hypercholasterolemic hamsters Artery (USA) , 1997, 22/5 (266-277) Conjugated linoleic acid is a collective term used to designate a mixture of positional and geometric isomers of linoleic acid in which the double bonds are conjugated. Unlike linoleic acid, there is a paucity of information regarding the effect of dietary conjugated linoleic acid on plasma lipoproteins and aortic atherosclerosis. Therefore, fifty hamsters were divided into five groups of ten and fed O (Control), 0.06 (LOW), 0.11 (MEDIUM), and 1.1(HIGH) en% conjugated linoleic acid or 1.1 en% linoleic acid. Blood samples were taken at 4, 8 and 11 weeks for plasma lipid analyses and for plasma tocopherol assay at sacrifice. Animals fed the conjugated linoleic acidcontaining diets collectively had significantly reduced levels of plasma total cholesterol, non-high density lipoprotein cholesterol, (combined very low and low density lipoprotein) and triglycerides with no effect on high density lipoprotein cholesterol, as compared to CONTROLs. Linoleic acid-fed animals relative to CONTROLs also had reduced plasma total cholesterol, non-high density lipoprotein cholesterol and triglycarides, but only the latter was statistically significant. Compared to the CONTROL group, plasma tocopherol/total cholesterol ratios determined from plasma pools for the LOW, MEDIUM and HIGH conjugated linoleic acid and linoleic acid groups were increased by 48%, 48%, 86% and 29%, respectively, suggesting a tocopherol-sparing effect, at least for the conjugated linoleic acid treatment. Morphomatric analysis of aortas revealed less early atherosclerosis in the conjugated linoleic acid and linoleic acid-fed hamsters compared to the CONTROL group. Evidence of a Science Bending Group Within the CDC? Commentary by Teresa Binstock As summarized by Rosie Waterhouse's news item, a transcript of the CDC's secret meeting about thimerosal effects indicates that a small group within the CDC acknowledges major flaws within its initial study of the autism epidemic's link to vaccinal ethylmercury. Despite this awareness, this small but influential group within the CDC (i.e. the group that enacted the fatally flawed " study " ) has touted and continues to use the study's " conclusions " -- e.g. on the webpages of the American Academy of Pediatrics (spring, 2000) and at the recent Institute of Medicine (IOM) hearing (July 16, 2001). What the CDC's secret meeting transcript conveys is that the study's data about autism were insufficient. As a result, conclusions about rates of autism in the pediatric cohort from several HMOs in the study are fictional. Yet invalid findings do not stop this CDC group from continuing to disseminate misleading conclusions. Importantly, as indicated by reporters' rhetoric in recent Boston Globe and Lancet articles about the IOM hearing, a tradition of respect for the CDC enables the phony conclusions to be presented as if valid. Paragraphs that follow are an attempt to set forth a summary of what this " rogue group " within the CDC has achieved and continues to achieve. The seriously flawed CDC " study " -- initially distributed as RL Davis et al, spring 2000 -- had at least three major flaws: The HMO data had major under-reporting of autism; Data analysis by Davis et al did not include susceptible subgroups likely to be more affected by injected ethylmercury; Davis et al relied upon the EPA's " safe " limit for methylmercury, which had been derived in relation to gradually ingested mercury and which, therefore, minimized the fact that during the 1990s human infants and toddlers had been injected with bolus doses of ethylmercury, which persisted in their bodies during a post-vaccinal, extended pulse of cytokines, which alter permeability of intestinal tissue and of the blood-brain barrier. These several factors -- and others identified by analysts, e.g., Thomas Kurt, MD -- indicate that the rate of autism " documented " by Davis et al was an extreme under-representation of the actual rates of autism among children within the HMOs whose data Davis et al utilized. Despite these flaws the CDC's rogue team has continued to distribute and utilize the flawed data and the misleading conclusions derived. The CDC's rogue team has stated and continues to state that an association with autism was not found. Note: this statement is inaccurate and is quite different from what the CDC ought be stating, namely, that the study design was inadequate for evaluating a link between thimerosal (TMS; 49.6% ethylmercury by weight) and the increased incidence of autism. Yet despite the flawed study, the CDC's team continues to tout the study's " conclusions " as if valid, which they are not! At the IOM hearing (7.16.01), the CDC presented summaries of its " Phase 1 and Phase 2 " studies (i.e. several versions of what had been called RL Davis et al, spring of 2000) as if the Phase 1 and Phase 2 studies had had valid methodologies and had thereby derived valid conclusions about autism and thimerosal. In fact, during the hearing, the CDC appeared content to convey the impression that conclusions from the Phase 1 and Phase 2 studies were legitimate. At the IOM hearing, the impression conveyed by the U Washington presenter was that there was no need to study what had already been found to be non-existent. In my opinion, this requires a severe leap of faith. Even Alice in Wonderland might pause incredulously. The CDC acknowledges (off the record and in secret meetings) that the Phase 1 and Phase 2 Davis et al studies were seriously flawed in regard to autism, yet the CDC is happy to proceed with a Phase 3 study that omits autism -- because, so we were told, there was no finding of an autism/thimerosal study in the Phase 1 and Phase 2 studies. In other words, despite the fact that the CDC's Davis et al methodology was fatally flawed in regard to autism and thimerosal, the CDC's rogue team and their U of Washington allies seem quite willing to continue diverting attention away from the substantial likelihood that physician-injected ethylmercury has been an etiologic factor in many cases of autism and related disorders. If ADHD, Tourette's, PDD, and PDD/NOS are added, then the number of children adversely affected by physician-injected thimerosal is potentially huge. At the IOM hearing, presenter Mark Blaxill summarized epidemiological similarities between autism's increase and the increased use of vaccines containing TMs He also expressed dismay that the CDC group most responsible for developing and encouraging TMs-injections into neonates (via the HepB vaccine) is the group that also has been conducting and superintending studies intended to evaluate the relationship between autism and injected-ethylmercury. Given the 1990s history of injecting thimerosal and the recent history of CDC-led " studies " about thimerosal, the CDC's conflict of interest is clear. The actions by the CDC's rogue team appear to be masking and diverting attention away from thimerosal's adverse effects in hundreds of thousands of children. Excerpts from the CDC's secret meeting -- obtain via the Freedom of Information act -- were presented to IOM by representatives of SafeMinds. As an official submission to the hearing, the SafeMinds letter to IOM is to be posted on the IOM website -- as will other materials that implicate thimerosal injections as having damaged many of America's children (and those in other countries too). Having the CDC team that developed and encouraged early infant injections with TMs also be running studies about TMs is akin to having Al Capone investigate the liquor business in 1930s Chicago. That the CDC's conflict of interest is having a real effect is seen in five factors: The CDC continues to trumpet the Phase 1 and Phase 2 conclusions as if valid, which they are not; The CDC continues to utilize the EPA's so-called " safe " limit for ingested organic mercury despite the fact that vaccinal ethylmercury was injected; The CDC continues to perform data analysis while ignoring the fact that some children are more susceptible to adverse sequelae from bolus exposures to toxic metals; The CDC is allowing a major " Phase 3 " study to proceed without autism as a focus; The CDC's rogue team uses its organization's prestige as a lever whereby the flawed conclusions autism/thimerosal conclusions of Davis et al are presented as if acceptable and useful -- e.g. in allowing Phase 3 to omit autism. At the IOM hearing, an autism-parent suggested that the HMO data utilized by the CDC ought be analyzed by professionals selected by trusted autism organizations. Not surprisingly, the CDC's Dr. Chen -- apparently a leading actor in the development and use of the HepB for neonates and infants -- took the microphone and offered reasons why independent analysis ought not occur. After the meeting, Beth Clay -- assistant to Congressman Dan Burton -- commented that the CDC seems quite ready to allow new " outsiders " to view the HMO data so long as the CDC selects who those outside experts are. In my opinion, outside analysis of the CDC's primary data for Davis et al ought occur; and the analysts ought be persons not within and not hand-picked by the CDC. Furthermore, the CDC's conflict of interest already has a track record of diverting attention away from the link between injected ethylmercury and autism. A solution is needed to the CDC's conflict of interest. By continuing to misuse Davis et al conclusions -- the CDC's rogue team continues to shape public opinion and near-future research regarding the link between thimerosal and autism. Families for Early Autism Treatment (FEAT) Dress up your holiday email, Hollywood style. Learn more. Quote Link to comment Share on other sites More sharing options...
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