Mainely Tipping Points 48: Is Dr. Russell Blaylock a Quack?

Mainely Tipping Points 48:  July 2, 2013 

 

Is Dr. Russell Blaylock a Quack?

 

 

Wikipedia says Dr. Blaylock is a quack because he does not follow “science based medicine.”

On the basis of a Wiki page, which is anonymously written, a Facebook page on my news feed discussing Dr. Blaylock was removed by a FB friend yesterday without allowing the benign discussion taking place to go forward to its conclusion—which amounts to silencing and censorship, which means a refusal to dig deeper into the issue at hand to see what science actually says, which means a policing of the status quo, which means fear is present.

Science based medicine…

Well, that’s something I’ve been researching and writing about for the past five years or so.  And, living, since my husband fell into the hands of “science-based” medicine practices during a time when the oversight boards for prostate cancer were saying that doing nothing was the best course to take since the treatments did not affect the outcome.  I will go to my grave believing that the treatments did affect the outcome in that they hastened John’s death.  How could they not since they assaulted his body in countless ways.  It never had a chance.

I am sympathetic with our local doctors, most of whom are caring people who wanted to make a difference for John.  The problem is that their tool box did not contain what John needed, so they just recommended the tools they had, regardless of the shift in the science.  These doctors built their careers on these tools—such a shift threatened their ability to support themselves.  That’s a grave place to be in.   

What do we know about Dr. Russell Blaylock?

His own web site details his medical credentials (http://www.russellblaylockmd.com/). I do not doubt them since they would have long since been debunked if he were not telling the truth.  You can go there for the whole list of his medical credentials.

The pertinent information is that Dr. Blaylock is a board certified neurosurgeon who practiced for 25 years before he retired.  He worked with the eminent neurosurgeon Dr. Ludwig Kempe.  Together they developed the transcallosal removal of intraventricular tumors, which he claims is still used today, and the ventriculolymphatic shunt in treatment of hydrocephalus.  Their personal relationship continues to this day.

A turning point for Dr. Blaylock came when he started using “high-intensity nutritional supplementation in craniocerebral trauma patients” which “met with great success.”  Eventually, Blaylock retired in order to spend more time studying and researching nutrition and healing with nutrition. 

In that regard Blaylock is part of the current and growing movement which seeks to understand the connections between foods and human health.  Some stars in this arena are Dr. Mary Enig (fats), Dr. Natasha Campbell-McBride (GAPS), Dr. Joseph Mercola (amazing general blog), Dr. Kaayla T. Daniels (soy), Dr. William Davis (WHEAT BELLY), Dr. Chris Masterjohn (vitamins A, D, and K), Michael Pollen, Sally Fallon Morell, all the scientists now working on the integrity of the gut and gut health and its connections to behavior, and so forth.  Blaylock’s work in this arena led to The Weston A. Price Foundation giving him their Integrity in Science Award in 2004.

Blaylock is a member of the International and American Associations of Clinical Nutritionists, the American College of Nutrition, the Price-Pottenger Nutrition Foundation, and many other health-related organizations.  (Pottenger did the famous cat studies involving the generational effects of malnutrition.)     

Dr. Blaylock is on the editorial staffs of the Journal of American Physicians and Surgeons and of the Journal of the American Nutraceutical Association.  He is on the board of Fluoride.  He is, or was if he’s retired from there, a visiting professor in the department of biological sciences at Belhaven College in Jackson, Mississippi—a conservative Christian college for those of you who think you are dealing with a liberal.

His web site lists his publications and his three books—the first being EXCITOTOXINS:  THE TASTE THAT KILLS.  (Aspartame is an excitotoxin.)  It makes sense to me that Blaylock’s interest in the impact of excitotoxins on the brain lines up with the fact that he was a practicing neurosurgeon.

Is this a “star” resume?

I do not know, medically speaking.  It is the resume of a working neurosurgeon of twenty-five years who got interested in the relationship of healing and food nutrition and acted on it.  It is the resume of someone who went on to study nutrition, to put himself in the nutritional arena with his associations, and to write about nutrition.

So, where does he begin to fall afoul of the Wiki author of his page?  The following list lies at the juncture of where many folks are asking “where’s the science?”—vaccines, aspartame, mercury in dental amalgams, fluoride, and aluminum cookware.

Which takes us back to “science-based” medicine…

Vaccines:  Would it surprise you to know that there have been NO LONG TERM gold-standard studies on the efficacy of vaccines?  That renders all we “know” about vaccines in the correlation camp.  There is not solid cause and effect scientific data in this country.  None.  Period.   

Would it surprise you to know that many scientists are now thinking that smallpox was tamed by sanitation and that polio may have been caused by DDT?

Would it surprise you to know that there is a government organization that pays off parents of children who have been harmed by vaccines?  Or that you can’t sue a vaccine maker if you or your child is harmed?

Recently, two young women died after a Gardasil vaccine.  Researchers examined their brain tissues and discovered that the vaccine had breached the blood-brain barrier, which in turn triggered the fatal autoimmune response that killed the girls—which vaccines are not supposed to do (Pharmaceut Reg Affairs 2012, S12:001).  What if other vaccines are making this leap? Could that account for the undeniable vaccine damage in children?  Leslie Mannookian’s documentary THE GREATER GOOD addresses the lack of science in the vaccine debates.  It is being shown all over the country in many venues, including to medical personnel.  I, for one, am going to see this film, which I think is available online, as soon as possible.

Fluoride:  I wrote three essays on this blog (Tipping Points Essays 34-36) that attempted to summarize the book THE CASE AGAINST FLUORIDE—written by three senior, well-established scientists with impeccable biographies in chemistry, toxicology, medical biophysics, and biological sciences.  There never was any science supporting putting fluoride in the water.  The most recent mandated government-sponsored assessment raised dozens of red flags about fluoride.  It was the first panel that contained nonbiased scientists.  The dose isn’t controllable, and even the American Dental Association warns not to feed infants formula made with fluoridated tap water.  Studies from all over the world show that fluoride is dangerous:  it harms bones and affects IQ in developing infants.  Countries that do not fluoridate do not have worse cavity rates than the U.S. does.  The stronger correlation with healthy teeth is good diet.

Mercury amalgams:  The mercury in your fillings off-gasses for the rest of your life and can make you sick.  Mercury is very, very toxic.  Europe is banning mercury fillings.  In our country dentists are quietly switching to non-mercury fillings.  I and many of my family members have had old mercury fillings removed.  (Be careful doing that and find a dentist who knows the danger of what s/he is doing.)

Aspartame:  Aspartame has, famously, never undergone third-party independent and objective assessment.  Industry supplies the “proof” of safety and the government (with staff assessment by actual scientists saying no about aspartame) allowed its use.  That’s a nasty, nasty story—and I covered it in Tipping Points Essay No. 19 on this blog.  The approval was a political decision, not a scientific one.  If you go to www.snopes to check on claims that aspartame is dangerous, you will see that the story is “false” and you will see a letter written by a government staffer claiming it was tested.  Don’t you believe that because the studies were all industry produced.  That’s the kind of corrupt system our government is running now, and we have got to get the foxes out of the regulatory henhouses and put in some laws with teeth if we want our government to actually protect us. 

Aluminum cookware:  Aluminum is a toxic metal.  If you cook with it or use a lot of aluminum foil, it will reside in your body.  Our bodies have enough environmental burdens without having to cope with aluminum toxicity.  I don’t use it any more—either cookware or foil.  Parchment paper works just as well in most cases. 

So, you decide about Dr. Blaylock. 

He’s not a saint.  He’s got quirks—like most of us he is a complex figure, not a cartoon all bad/all good character.

He’s asking “where’s the science” behind a number of mainstream medical practices and recommendations that he (and I, after researching them) believe are quite dangerous.  He’s looking for ways to effect healing by giving the body the healthy nutrient dense food it requires.

The response from the mainstream—as it almost always is—is to demonize him as a quack.  Devra Davis, a premier scientist, described this industry-driven process brilliantly in THE SECRET HISTORY OF THE WAR ON CANCER.  And make no mistake about it, too much of science and medicine today is industry driven, with little relationship to actual science and a huge relationship to profit making. 

With demonization, Blaylock joins any number of folks who have said “where’s the science” and been attacked and smeared in an attempt to erase what he’s asking as it falls into the realm of “an inconvenient truth.”  Dr. Mary Enig, for instance, tried to tell us about the danger of trans fats and about the healthy nature of high-quality saturated fats.  She lost all her research money and was demonized and not published for years.  But, she was right all along.  

Follow the money.  Vaccines, aspartame, and fluoride are big, big money.  Under our economic system, it is entirely logical that industry would fight to continue making that money and that it enslaves us all to its purpose, doctors included.    

Demonization is how a system of cultural power maintains the status quo.  But that status quo is not ultimately healthy for you. Today, one in two people will get cancer.  That’s 50 percent.  That’s a plague.  So, think twice, investigate, learn how to find and read reputable sources, and choose not to participate in practices that will make you sick. 

Ultimately, this issue isn’t about Blaylock personally.  It’s about “where’s the science?”  It’s about your health.   

Interesting Information: Chewing Gum Disaster

Interesting Information:  March 27, 2013

Chewing Gum Disaster

I love chewing gum.

Always have.

I probably got that love from my mother.  She used to read in bed at night, and you could always tell how excited the book was by the speed with which she popped the gum in her mouth.

Gum today has some exciting flavors and names, like Wrigley’s “Rain…a tingling spearmint.”  And the packages are colorful and beg to be picked up and chewed.

The other day, though, I noticed that “Rain” had a warning on the cellophane wrapper (NOT on the actual box) that the package contained a chemical called phenylalanine.  Hmmmm.  What is that?

That’s when I looked closer at the label.

Aspartame.  Soy Lecithin.  Sorbitol.  Natural and artificial flavors.

Where was the plain old sugar?

This was not a sugarless gum…

OK.  I’ll just get Juicy Fruit or one of the “normal” older gums.

Aspartame.

Aspartame is in ALL THE GUMS AT THE DRUGSTORE.

I had to go to a health food store to get a plain old gum with plain old sugar.

Aspartame is a neurotoxin.  Dr. Russel Blaylock calls it an excitotoxin and puts it right alongside MSG.  Blaylock claims excitotoxins promote cancer growth and the metastasis of cancer cells.  He cites a life time Italian study that links leukemia and aspartame.  The internet is full of testimonials from people whose health issues had reduced them to wheelchairs and who stopped drinking diet drinks filled with aspartame and who got their health back.  Military pilots are cautioned not to use it before flying planes.

I wrote about the history of aspartame and how it got FDA approval and what it does to humans in Tipping Points 19 and 20.  It’s another shoddy, terrible tale of regulatory agencies bought off by industry and of a total disregard for science or for the health of humans.  Aspartame has NEVER BEEN SHOWN TO BE SAFE.  There is plenty of information showing that IT IS DANGEROUS.

ALL the gum in the stores…

And what about phenylalanine?  In its natural form, it’s an amino acid that shows up in places like breast milk.  It can really harm people who can’t process it.  There have been enough of those folks that the gum is labeled for it.  The pheylalanine is gum has got to be a synthetic chemical brew, so who knows what effect it has on us.  Phenylalanine is reputed to be an analgesic and an antidepressant, so it kills pain and makes you feel happy.  The FDA allows it in foods as an additive and as a NUTRITIONAL SUPPLEMENT, which just shows you how far gone our food system is now.   So, the chewing gum industry is using it because it’s addictive and can kill pain, aren’t they?

And what’s soy lecithin doing in gum???

EVERY SINGLE GUM IN A MAINSTREAM STORE…

Chemical brews, not real food.

Don’t buy it.  Don’t chew it.  Understand what’s gone so terribly wrong with our food system.

Tipping Points 20: Chemical Brews: Non-Nutritive Sweeteners

Chemical Brews:  Non-Nutritive Sweeteners

The American Dietetic Association groups sweeteners into two major categories:  nutritive and non-nutritive.   Nutritive sweeteners provide energy to the body; non-nutritive sweeteners do not, which means they sweeten without calories.  Thus, non-nutritive sweeteners have been the backbone of the diet industry. 

The FDA currently approves five non-nutritive sweeteners:  aspartame, saccharin, acesulfame K, sucralose, and neotame.  The FDA banned cyclamate in 1969 and has never approved alitame, which is similar to aspartame.

Aspartame, or 1-aspartyl 1-phenylalanine methyl ester, was discovered by accident when James Schlatter, while working on creating new drugs to treat ulcers, accidentally licked his fingers in order to pick up a piece of paper.  Aspartame is 80 times sweeter than sucrose, or table sugar.  And, according to Jim Earle in “Sugar-Free Blues:  Everything You Wanted to Know About Artificial Sweeteners,” February 2004 (http://www.westonaprice.org/modern-foods/570-sugar-free-blues.html ), aspartame            is the most widely used non-nutritive sweetener.  By 1992, Earle writes, Americans were using 8.4 million pounds of aspartame yearly, which represents 80 percent of world demand.  About 70 percent of aspartame is used in soft drinks, but it is added also to “more than 6,000 foods, personal care products, and pharmaceuticals.”  Aspartame is sold under several brand names, including NutraSweet, Equal, Spoonfuls, Canderel, Bienvia, NatraSweet, and Miwan.

Earle explains that during digestion, aspartame degrades into methanol, or wood alcohol, and two amino acids:  phenylalanine, the largest component by weight, and aspartic acid.  Methanol is a known, lethal poison that can cause, Devra Davis notes in THE SECRET HISTORY OF THE WAR ON CANCER (2007), blindness and brain damage.  And, she notes that methanol content of aspartame is “a thousand times greater than most foods under FDA control” (421). 

Phenylalanine, Earle notes, is dangerous to people with phenylketonuria (PKU), an inherited condition.  And, he notes that the FDA recommends that pregnant and lactating women, people with advanced liver disease, and phenylketonurics avoid aspartame.   

The FDA admits also, writes Earle, that “aspartic acid has the potential to cause brain damage,” but the FDA limits the danger to very high doses.  Earle notes that Dr. Christine Lydon, an aspartame researcher, explains that phenylalanine and aspartic acid are amino acids found naturally in foods, but in foods they are eaten alongside other amino acids.  Separated, each enters “the nervous system in abnormally high concentrations, causing aberrant neuronal firing and potential cell death”—which, in turn, is linked to “headaches, mental confusion, balance problems and possibly seizures.” 

Earle notes that Dr. Lydon warns that phenylalanine decomposes into diketopiperazine (DKP) a known carcinogen, when exposed to warm temperatures or prolonged storage.  At cold temperatures, methanol “spontaneously gives rise to a colorless toxin known as formaldehyde.”  Jim Turner’s timeline detailing the history of aspartame’s approval by the FDA notes that aspartame’s unstable nature prompted The National Soft Drink Association (NSDA) to petition the FDA in July 1983 to delay approval “pending further testing because aspartame is very unstable in liquid form” (http://www.swankin-turner.com/hist.html).     

Dr. Mary Enig and Sally Fallon Morell, in NOURISHING TRADITIONS (2000), write that “aspartame…is a neurotoxic substance that has been associated with numerous health problems including dizziness, visual impairment, severe muscle aches, numbing of extremities, pancreatitis, high blood pressure, retinal hemorrhaging, seizures and depression.  It is suspected of causing birth defects and chemical disruptions of the brain.”  And, Enig and Morell report that in 1992 Utah State University researchers reported “that even at low levels aspartame induces adverse changes in the pituitary glands of mice.  The pituitary gland is the master gland upon which the proper function of all biochemical processes depend” (51).     

Davis notes that the U.S. military, in two publications, “warned that aspartame can cause serious brain problems in pilots” (422).  And, Davis points to the flaw in tests that kill and exam rats before they have lived out their natural lifespans—an important factor since cancer can often take decades to develop and killing rats early derails detection of cancer formation.  She cites test results in 2001 showing the development of cancer in multiple organs of rats allowed to live out their natural life spans–even though dosages were well under those allowed in America (50 mg daily).  Davis notes that one can of diet soda contains 200 mg of aspartame (424-425).  She further notes that there is “no evidence at all” that those who use aspartame actually lose weight.  Actually, there is “some indication” that aspartame “creates a sugar deficit” which leads “people to seek more sugar from other sources” (423). 

Earle reports that as of 1995 over 75 percent of the adverse reactions reported to the Adverse Reaction Monitoring System (ARMS) of the FDA were due to aspartame.  Davis notes that the FDA stopped gathering adverse reaction reports in 1995 (422). 

Saccharin, from the Latin for “sugar,” is 300 times sweeter than sugar.  Saccharin, Earle notes, was also discovered by accident in 1879 when a Johns Hopkins scientist spilled some and noticed the sweet taste.  Saccharin, until 1915, was first used as an antiseptic agent and food preservative.  In 1901, John F. Queeny, started the Monsanto corporation, manufactured saccharin, and shipped it to a Georgia company,  Coca-Cola. 

Saccharin is “the holy grail of the artificial sweetener industry,” writes Earle, because it “is not metabolized by the human body and is excreted rapidly through the urine.”  This kind of compound, Earle explains, tastes sweet, is stable in prepackaged foods and beverages, is thought to be “so foreign to the human diet that our digestive systems cannot metabolize them to create any dietary calories,” and is “dirt cheap to produce in bulk.

World War II brought sugar shortages, but cyclamate, discovered in 1937 when a graduate student at the University of Illinois working on anti-fever drugs accidentally tasted it, came to the rescue and was the chemical of choice.  Saccharin’s original chemical classification lists it as an O-toluene sulfonamide derivative.  Toluene is a colorless liquid hydrocarbon distilled from coal tar, which may, Earle suggests, account for saccharin’s “bitter, metallic aftertaste.”  In 1958, Maryin Eisenstadt mixed saccharin with cyclamate and introduced Sweet’n Low, which we have today, without the cyclamate.    

Dr. Nathanael J.  McKeown, a medical toxologist, writes that “toluene (methylbenzene, toluol, phenylmethane) is an aromatic hydrocarbon (C7 H8) commonly used as an industrial solvent for the manufacturing of paints, chemicals, pharmaceuticals, and rubber. …Toluene is found in gasoline, acrylic paints, varnishes, lacquers, paint thinners, adhesives, glues, rubber cement, airplane glue, and shoe polish.  At room temperature, toluene is a colorless, sweet smelling, and volatile liquid” whose fumes are highly toxic (“Toluene, Toxicity,” http://emedicine.medscape.com/article/818939-overview).  (These fumes, sniffed by some to get high, as with glue, affect the Central Nervous System.) 

Saccharin is now, Earle explains, manufactured by a more cost-effective method developed in 1950 that begins with synthetically produced methyl anthranilate.  Wikipedia explains that anthranilic acid successively reacts with nitrous acid, sulfur dioxide, chlorine, and then ammonia to yield saccharin.  Another route, Wikipedia continues, begins with o-chlorotoluene

And, Wikipedia notes that saccharin is also known as ortho sulfobenzoic acid.  Earle notes that as saccharin is a sulfonamide, some people have allergic reactions to it.  Further, saccharin-sweetened infant formula has produced severe, largely muscle, reactions in some babies. 

In 1969, the FDA proposed banning saccharin with cyclamate until its safety was proved, but, Earle notes, significant opposition from a public now concerned with calories saved saccharin.  Canada, however, did ban saccharin in 1977 as a carcinogen.  The US Congress put a two-year moratorium on any ban, but mandated a cautionary label warning of possible health hazards, including cancer.  For the next 26 years, numerous studies (2374) have been performed to prove or disprove saccharin safety until, in 1991, the FDA gave saccharin, as Earle notes, “something of a probationary status,” though the FDA still classifies saccharin as an“anticipated human carcinogen.” 

Acesulfame-K, or acesulfame potassium, or 5,6-dimethyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide, or ACK, was also discovered by a German chemist in 1967 when he licked his fingers to pick up a piece of paper.  ACK is, Earle writes, 200 times sweeter than sugar and is thought not metabolized by the body so is excreted unchanged in the urine.  The FDA approved ACK  in 1988 for use in” baked goods, frozen desserts, alcoholic beverages and candies” and, in 1998, for “all other general sweetening purposes.”  ACK has been marketed under the brand names Sunett, Sweet One, Swiss Sweet, and Sweet & Safe.  Pepsi used it in Pepsi One upon its FDA approval.  And, ACK is often blended with aspartame, as it is in Twinsweet. 

Earle notes that there is very little information about ACK.  The Center for Science in the Public Interest (CPSI), he writes, concluded that the safety tests were of mediocre quality.  And, that “large doses of acetoacetamide, a breakdown product, have been shown to affect the thyroid in rats, rabbits and dogs.  ACK, he notes, stimulates insulin secretion which can possibly aggravate hypoglycemia, or low-blood sugar.    

Sucralose, or 1,6-dichloro-1,6-dideoxy-BETA-D-fructofukranosyl-4-chloro-4-deoxy-alpha-D-galactopyranoside, was discovered, Earle writes, as a sweetener in 1976 when a grad student misunderstood “testing” for “tasting” and discovered that “many chlorinated sugars are hundreds or thousands of times sweeter than sucrose.”  Splenda is the brand we know. 

Johnson & Johnson claims sucralose is exceptionally stable and that sucralose passes through the body without being broken down.  But, Earle notes, sucralose “has the fewest independent scientific tests to its credit of all non-nutritive sweeteners.”  And, “independent reviewers of Johnson & Johnson’s tests have found them to be inadequate and methodologically flawed.”

Earle notes that “several pre-approval tests still indicated potential toxicity.”  And, research is now showing some alarming physical reactions, including  shrinking of the thymus gland, enlargement of the liver and kidneys, decreased red blood cell count, and decreased fetal body weights.   Earle notes that the FDA’s “own research has shown that 11 to 27 percent of sucralose is absorbed in humans.”  Japanese tests show that as much as 40 percent of sucralose is absorbed.  And, the FDA considers sucralose to be “weakly mutagenic” in some mouse studies.

These effects, Earle notes, are “not fully understood.”  But, detractors are pointing to the chlorinated molecules, which are also “used as the basis for pesticides such as DDT” and which “tend to accumulate in body tissues.” 

Nor is sucralose stable.  Prolonged storage, especially at high temperatures, causes breakdown into chemicals which have not been “specifically tested in terms of safety for human ingestion.” 

Neotame is produced by The NutraSweet Company and is known as “superaspartame.”  It is synthesized from a base of aspartame and 3,3-dimethylbutyraldehyde.    It’s chemical name is N-[N-(3,3-dimethylbutyl)-L-a-aspartyl]-L-phenylalanine 1-methyl ester.  It is 8000 times sweeter than sugar.  Earle poses that The NutraSweet Company is positioning neotame to replace aspartame whose patent rights expired in the 1990s. 

None of these accidentally discovered chemical brews have been shown to be safe for humans.  Many may be, in fact, quite dangerous.  The pattern of FDA approval fits the pattern Davis establishes in THE SECRET HISTORY OF THE WAR ON CANCER:   a profitable but potentially dangerous product appears; industry denies and demonizes science pointing to problems; industry produces flawed studies that obfuscate the safety issues; industry manipulates the legal and political mechanisms meant to protect citizens; industry buys massive advertising to sell the product; and industry achieves a profitable status quo.

Here’s three things you can do.    Stop eating these products.  Buy local, organic, whole foods and cook them yourself.  And recognize that we have to change the values that put profit before people.

Mainely Tipping Points 19: The History of Aspartame: An American Story

The History of Aspartame:  An American Story 

 The Food and Drug Administration (FDA) approved aspartame in 1981.  The decision was made solely by a political appointee, Dr. Arthur Hayes, Jr., despite the fact that since 1973 FDA scientists had consistently and repeatedly refused to recommend aspartame because industry safety studies were inadequate.  Indeed, since the early 1970s the research of scientists not connected to industry has demonsed that aspartame is seriously dangerous for humans in multiple ways.    

Devra Davis, a preeminent cancer epidemiologist and environmentalist, tells the aspartame story in her book The Secret History of the War on Cancer (2007).  For Davis, the aspartame story is yet another illustration of how successful American corporations have been in their quests to sell products they know to be poisonous for humans, but which can and do make huge profits.  The story of how industry got aspartame approved without demonstrating conclusively its safety is worth reviewing because it is, unfortunately, a common story in America, though not one many Americans know since they assume wrongly that their government organizations are acting to protect them.    

Mr. James Schlatter created Aspartame in 1965 while working on new drugs to treat ulcers.  Schlatter licked his fingers to pick up some papers and tasted the intense sweetness of the chemical compound he had just created.  G. D. Searle of the pharmaceutical company G. D. Searle & Company owned the patent, and Searle’s company did the original research on aspartame—research which claimed to show aspartame to be safe for humans (Jim Earle, “Sugar-Free Blues:  Everything You Wanted to Know About Artificial GSweeteners,” February 2004, http://www.westonaprice.org/modern-foods/570-sugar-free-blues.html).      

The context surrounding the battle to win approval for aspartame includes the fact that in November 1970, cyclamate, the most commonly used low-calorie sweetener, was removed from the market because some scientists had associated it with cancer.  At the same time, the safety of saccharin was being questioned.  Aspartame, thus, could become a replacement artificial sweetener for a market searching for lucrative diet products (Jim Turner’s timeline, http://www.swankin-turner.com/hist.html). 

In February 1973, Searle applied for FDA approval of aspartame.  But, Davis reports, Martha Freeman, an FDA scientist, determined that “the information submitted on the safety of aspartame was not adequate.”  Freeman recommended that aspartame not be allowed on the market.  Nevertheless, in July 1974, the FDA gave its first limited approval to aspartame for use in dry foods (420).  Searle called the product NutraSweet. 

Immediately, in August 1974, two men filed an objection against aspartame’s approval:  Jim Turner, a consumer advocate who had helped remove cyclamate from the market, and Dr. John Olney, a research neurologist and psychiatrist whose pioneering research with monosodium glutamate (MSG) enabled removing it from baby foods.  Turner and Olney’s protest spurred an FDA investigation of the Searle studies (Turner). 

Turner’s timeline notes that Searle knew that Olney’s research had shown that aspartic acid, an ingredient in aspartame, caused holes to develop in the brains of infant mice because Olney personally told him so.  And, that one of Searle’s researchers had “confirmed Dr. Olney’s findings in a similar study.” 

Davis writes that Dr. Olney told her that in 1969 Searle asked Harry Waisman to study aspartame in seven infant monkeys.  In one year, one monkey died and five had “suffered severe epileptic seizures.” Waisman died in the spring of 1971, so his research was not completed.  Olney’s research, however, showed that aspartame paired with monosodium glutamate (MSG) produced brain tumors in rats (420).

In January 1977, the FDA Chief Counsel, Richard Merrill, formally asked the U.S. Attorney’s office to convene a Grand Jury to investigate G. D. Searle for knowingly misrepresenting the material facts about the safety of aspartame. This request marks the first time in FDA history that the FDA requested a criminal investigation of a manufacturer (Davis).  

In March 1977, Searle hired politically powerful Donald Rumsfeld as CEO of G. D. Searle & Company.  Rumsfeld had been Chief of Staff and Secretary of Defense for Gerald Ford and would become Secretary of Defense for George W. Bush.  In July, Samuel Skinner, the U.S. Attorney in charge of the Grand Jury investigation, took a job with Searle’s law firm.  His replacement, William Conlon, joined Skinner fifteen months later.        

 In August 1977, the FDA released the Bressler report on Searle’s studies claiming the safety of aspartame.  This report, notes Davis, “depicted a stunning number of irregularities”—an assessment senior FDA investigator Jacqueline Verrett, a toxicologist, later seconded in 1987 testimony to the U.S. Senate (420-421).  Verrett’s summation was that it “ `is unthinkable that any reputable toxicologist…could conclude anything other than that the study was uninterpretable and worthless, and should be repeated’ ” (Verrett in Davis, 421).  Turner writes that the “report finds that 98 of the 196 animals died during one of Searle’s studies and weren’t autopsied until as much as one year later.”  And, that growths found in the animals were neither reported nor diagnosed. 

Mark D. Gold of the Aspartame Toxicity Information Center, in a January 2003 request to withdraw approval of aspartame, covers the full range of the Searle safety studies’ irregularities:  http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt.  Gold’s history of the aspartame history is worth a look.

In December 1977 the Grand Jury investigation was dropped.  Skinner’s withdrawal and Conlon’s inactivity stalled the investigation sufficiently that the statute of limitations ran out.  Davis writes that “expert legal advice” from former FDA officials who now worked for Searle helped “Searle run out the clock.”  She notes that on October 12, 1987, United Press International reported that “more than ten American government officials who had been involved in the decision to approve aspartame were now working in the private sector with or for the aspartame industry” (422).  Davis further notes that “scientific evidence became irrelevant” in the FDA’s approval process (422).     

In June 1979, the FDA established a Public Board of Inquiry (PBOI) to rule on safety issues surrounding NutraSweet.  In September 1980, the PBOI concluded that NutraSweet should not be approved pending further investigations of brain tumors in animals (Turner, Davis 421-422). 

The turning point came in November 1980 when Ronald Reagan won the Presidential election.  Rumsfeld told a Searle sales meeting that he would get aspartame approved within the year (Davis 422, Turner Timeline).  Turner writes that Rumsfeld said he would use his political pull in Washington to get the job done rather than using scientific means.

In January 1981, Rumsfeld was part of Reagan’s transition team.  Turner writes that Rumsfeld “hand-picked” Hayes to be the new FDA Commissioner.  The day after Reagan’s inauguration, Searle reapplied to the FDA for approval for aspartame.  Hayes was appointed to the FDA in April 1981.    

In March 1981, Gold writes, a five-person FDA commissioners’ panel was created to review issues raised by the PBOI.  Three members were going to vote for disapproval, so Hayes brought in a toxicologist to the panel, and the members split 3 to 3.  Gold takes this part of the story from an investigation done by Gregory Gorden of United Press International that included the irregularities involved in this panel’s determinations. 

In July 1981, “as one of his first official acts,” Hayes overruled the PBOI and ignored the intent of the original five-member FDA commissioner’s panel.  Gold notes that Hayes ignored  ”the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C. 348), which says that a food additive should not be approved if tests are inconclusive (Federal Register 1981, Farber 1989, page 38).”  Davis writes that the initial approval is for use in dry products, but that approval was extended for liquids and vitamins within a year (422). 

Turner writes that in September 1983 Hayes resigned from the FDA “under a cloud of controversy” regarding taking ”unauthorized rides aboard a General foods jet.”   Hayes winds up at Burston-Marsteller, the chief public relations firm for both Searle and Monsanto, which, in 1985, buys Searle’s aspartame business, The NutraSweet Company.   

Turner writes that when Hayes approved aspartame for dry use, he said that aspartame “has been shown to be safe for its proposed uses” and that “few compounds have withstood such detailed testing and repeated close scrutiny.”  Davis, however, repeatedly demonstrates in her book that tests performed by industry are not reliable—which is a key factor in what is wrong with our regulatory process.  Davis describes, also, how  in 1996 Ralph G. Walton, a professor of clinical psychology at Northeastern Ohio University, for the news show 60 Minutes, surveyed 165 separate aspartame studies published in medical journals over a twenty-year period.  Walton, writes Davis, found the following:  “All of the studies that found aspartame safe happened to be sponsored by industry” and “every single one that questioned its safety was produced by scientists without industry ties” (423).

You must decide if aspartame is safe or not, if the approval process was corrupt or not, or if all of the information above is just a huge conspiracy theory, as the government and industry claim.  I’m going to believe Davis, especially after reading her book about this old, repeated American story of the collusion of our government and industry.   

(Note:  There are at least three aspartame timelines online.  The most complete—and the one the other two likely use–is Mark D. Gold’s, which was submitted to the FDA in 2003:   http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt).  Jim Turner and Rich Murray have the other two timelines.