Tag: FDA

Interesting Information: BIG NEWS: Feds Finally Release Burzynski Cancer Cure Treatment

Interesting Information:  July 28, 2014

BIG NEWS

Feds Finally Release Burzynski Cancer Cure Treatment

 

I’d be willing to bet that none of you were aware of the news that Dr. Stanislaw Burzynski recently won another legal (and moral and ethical) round in our government’s war against his many-times successful cancer treatment.

I’d be willing to bet that many of you have never heard his name.

Yet, his work is important, exciting, real, should be celebrated, and is, instead, a huge threat to the $$$$ of the established cancer industry–you know, that industry that has failed to “cure” cancer in the past 50 or so years.

Burzynski’s treatments are NON TOXIC (for the most part–sometimes he combines them with some chemotherapy) and have been, as near as I can determine, the most successful with brain tumors–which is a good thing since we’re about to have an epidemic of brain tumors from cell phone usage according to the experts who have been studying this issue for some time now.

 

Here’s Jeffrey Phelps, writing in The Examiner:

 

But once again, another huge victory against the medical establishment for a Houston-based doctor that has been using a breakthrough technology he invented to literally cure cancer on many occasions, who for all-intents-and-purposes should be a household name by now and an easy Nobel Prize winner, is instead nowhere to be found, as if it never even happened.

That’s because Dr. Stanislaw Burzynski and his cancer-curing discovery, “Antineoplastons,” including a remarkable, relatively new gene-targeted therapy, threatens the very way of life to which the Western medical cancer and sick-care industry has become accustom. Raking in billions a year off of the desperate backs of people suffering from debilitating and deadly diseases in which the Western medical industry does not truly want to find a cure.

What’s really terrible, but predictable in our industry/profit-driven society, is the collusion between the greedy and the FDA.  At the same time the federal government and the state of Texas medical folks were trying to not only shut Burzynski down but to send him to jail, they were trying to steal his work.  Here’s Phelps again:

Because even as the skeptics and trolls do everything they can to shoot down the discovery on every single article and video released in support of the technique’s proven successes, for reasons that include the subconscious fears of real answers to questions regarding why this treatment isn’t already widely used, if it truly didn’t work better than what Western-trained doctors are still being forced to do, then why did the agents of deceit in the US government, BigPharma and related individuals collude with one of Burzynski’s own research scientists to file 11 different patents on the very same, non-toxic, Antineoplastons AS2-1 medical technology? #6,037,376, #5,635,532, #5,605,530, #5,852,056, #5,654,333, #5,661,179, #5,635,533, #5,710,178, #5,843,994, #5,877,213, #5,881,124. Only failing to accomplish the patent hijacking after a Grand Jury acquitted Burzynski of any wrongdoing, during the establishment’s 4th and most recent attempt to put him in prison for the very same technology they were trying to patent.

There are TWO documentaries telling this sorry tale:  Burzynski 1 and 2.

Part of the tale is that Burzynski has had to defend himself in the courts at his own expense–while the deep pockets of industry and the government mounted charge after charge against him.  HE HAS WON EVERY SINGLE TIME.

 

Feds finally release Burzynski cancer cure treatment – National Holistic Health | Examiner.com.

Health Freedom Alliance » Feds Finally Release Burzynski Cancer Cure Treatment.

 

Here’s an article from 2011 on one of the more recent attacks on Dr. Burzynski.

Breaking News: Outrageous New Attack on Dr. Burzynski—New Action Alert! | The Alliance for Natural Health USA.

And, here’s an article on how the mainsteam media, in this case, USA TODAY, attempted to smear Dr. Burzynski.  Note that when industry and the status quo control the media, this kind of event is possible.  Dr. Burzyski attempted with great politeness, according to this story, to give USA TODAY some data on his revolutionary treatment, but they refused to print it.

Exclusive: Inside USA Today’s Smear Campaign Against Dr. Burzynski | The Alliance for Natural Health USA.

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.