Gregory Gordon is the renowned UPI Investigator who brought out all the facts on how aspartame got approved and we do have the entire UPI Investigation on http://www.dorway.com and http://www.wnho.net
Some of the details are incredible that a company who should have been indicted for fraud got away with murder and mass poisoning the world with aspartame. We know Sam Skinner was the first US Prosecutor asked to indict them and then Conlon. Both went to work for the defense team. But note that between them was another by the name of Sullivan recommended by Skinner. No wonder he didn't do his job.
Look at the rewards like Hayes who over-ruled the Board of Inquiry who said no, being given a job with Burson Marsteller, the PR Agency of the manufacturer. I've often asked what an FDA Commissioner does at a PR Agency, and answered "send postcards home from Bermuda". Here is the admission of the like 15 days he was there but was paid $1,000 a day on a ten year contract. That's what was paid to Arthur Hull Hayes for putting a deadly poison on the market causing millions of deaths and a global plague ( Aspartame Disease: An Ignored Epidemic, http://www.sunsentpress.com by H. J. Roberts, M.D., Excitotoxins: The Taste That Kills by neurosurgeon Russell Blaylock, M.D., http://www.russellblaylockmd.com ) The story of the misery and the suffering and what Don Rumsfeld did to get it on the market can be seen in the aspartame documentary: "Sweet Misery: A Poisoned World", http://www.soundandfury.tv One of the articles even gives the testimony of the woman who worked for Searle and was there when Don Rumsfeld said he would "call in his markers" and no matter what get aspartame on the market, and he did. How wicked and evil to knowingly work to poison the world. Being an abortifacient millions of babies are murdered in their mother's womb by Rumsfeld's Plague. Others are born with birth defects and mental retardation because its a teratogen. This addictive excitoneurotoxic carcinogenic drug simply destroys the brain, the immune system, the central nervous system and optic nerve, and ravages every organ in the body.
Read about the Pathology Group that was paid $500,000 by Searle to review their studies. In Dr. H. J. Roberts books on aspartame he explains they were sworn to silence, and certainly paid well for their silence. Things Searle did border on the Twilight Zone because of what they were willing to do to poison the world, the gall and the arrogance.
There were three heros at the FDA, Dr. Adrian Gross, toxicologist and pathologist, FDA toxicologist, Dr. Jacqueline Verrett and Jerome Bressler who wrote the FDA audit, the Bressler Report. They all spoke out and Doctors Gross and Verrett exposed the FDA in Congress. Recently FDA destroyed the worse 20% of the Bressler Report because they knew they were covering up illegally incriminating records: http://www.mpwhi.com/fda_gate.htm Dr. Verrett even wrote a book published in 1973 called "Eating May Be Hazardous To Your Health: The Case Against Food Additives" She talks about damage showing up after the fact when you have a legacy of deformed children or cancerous adults. That's what we have and more but in this case all the reports show they knew it would happen before approval. Searle studies were so fraudulent, the reason Dr. Gross wanted them indicted for fraud, that Dr. John Olney insisted they do studies in his laboratory where he could see what was going on. The brain damage was proven so Dr. Olney thought it would never be approved. Searle simply didn't give the results to the FDA causing the legacy of horrors we have reported from the ends of the earth from neurodegenerative diseases, diabetes, cancer, obesity, birth defects, blindness, psychiatric and behavioral problems and even male sexual dysfunction (also ruining female response) so marriages can be destroyed. DNA in many cases has been heinously damaged for generations to come. It also embalms living tissue from the formaldehyde.
We continue to get information from informants, its just one horror story after another.
Again we thank Lane Shore, Mission Possible Chicago for his continued research so the public will know beyond any shadow of a doubt what went into poisoning the world with Rumsfeld's Plague! At the end you'll see the whines of the manufacturer over the release of the facts. Know the history of this biochemical warfare weapon and save somebody's life today: http://www.mpwhi.com/ecologist_september_2005.pdf Also read NutraPoison on the front page of http://www.dorway.com
Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
E-Mail: BettyM19@mindspring.com
http://www.wpwhi.com
http://www.whno.net
http://www.dorway.com
Aspartame Toxicity Center: http://www.holisticmed.com/aspartame
DOCUMENTS:
HOW SWEET IT ISN'T -- NUTRASWEET'S SANCTION WAVERED AS OFFICIALS INVESTIGATED CHARGES OF FLAWED TESTS, CONFLICT OF INTEREST:[THIRD Edition]
GREGORY GORDON
Seattle Times. Seattle, Wash.
Oct 13, 1987. p. F1
Abstract (Summary)
The ruling, one of the first regulatory actions of the Reagan presidency, came at a time of growing concern that the most widely used low-calorie sweetener, saccharin, was linked to cancer. Thus Hayes' approval of NutraSweet profoundly changed the eating habits of millions of Americans, handing Searle a financial bonanza.
On July 26, 1974, just 15 months after Searle petitioned for approval, FDA commissioner Alexander Schmidt approved aspartame use in dry foods, allowing a 30-day period for public hearings and comment. He acted on a strong endorsement from the Bureau of Foods, now called the Center for Food Safety and Applied Nutrition.
Philip Brodsky, the unit's since-retired lead investigator, said aspartame was included in a broad inquiry into Searle animal studies. The task force assailed Searle's conduct of research, in a searing, 84-page report.
Copyright Seattle Times Oct 13, 1987
Gregory Gordon, UPI investigative reporter, spent eight months examining industry research into the artificial sweetener NutraSweet and the Food and Drug Administration's handling of the approval of the product.
WASHINGTON - Poring over laboratory-rat studies in the spring of 1981 in the government's final safety review of a new artificial sweetener, senior statistician Satya Dubey of the Food and Drug Administration was troubled.
Dubey, a member of a special FDA ``commissioner's team'' formed to help decide the fate of the product to be known as NutraSweet, wrote in an internal memo that brain-tumor data from rat tests was so ``worrisome'' he could not recommend approval.
Two other statisticians on the six-member team agreed that the Chicago-based G.D. Searle Co. had not proved with ``reasonable certainty'' the safety of the sweetener, known generically as aspartame. A 1980 Public Board of Inquiry had voted 3-0 to ban aspartame because of similar fears.
But a few weeks later, on July 18, 1981, new FDA Commissioner Arthur Hull Hayes Jr., a pharmacologist who had been in office less than three months and had little background in food additives, overturned the board and approved the use of aspartame in dry foods.
The ruling, one of the first regulatory actions of the Reagan presidency, came at a time of growing concern that the most widely used low-calorie sweetener, saccharin, was linked to cancer. Thus Hayes' approval of NutraSweet profoundly changed the eating habits of millions of Americans, handing Searle a financial bonanza. It also climaxed a topsy-turvy, eight-year FDA review process in which the agency approved the sweetener, then banned it and demanded a grand-jury investigation of its manufacturer, only to reverse course again after re-examining the issue at least five times.
Now, six years after Hayes' ruling, its uses expanded, the sweetener is widely consumed in diet sodas, puddings, cereal, drink mixes and even chewing gum and vitamins. Yet NutraSweet and its FDA approval remain at the center of controversy, the sweetener's safety questioned by a small corps of independent scientists; defended by its manufacturer and the diet-food-and-drink industry.
United Press International has learned that more than 10 federal officials involved in the NutraSweet review have taken private-sector jobs linked to the industry - among them Hayes, an acting FDA commissioner and former chiefs and acting chiefs of the agency's Bureau of Foods.
In addition, many of the scientists who have produced favorable studies or served as outspoken advocates of NutraSweet's safety have received grants or consulting fees from Searle and the industry.
APPROVAL ON HOLD
G.D. Searle began to study the artificial sweetener aspartame soon after a company laboratory chemist, James Schlatter, stumbled on the compound when he licked it off his finger while conducting ulcer research in 1965.
In a memo on Dec. 28, 1970, a Searle official laid out a plan for winning FDA approval for the sweetener. ``We must create an affirmative atmosphere in our dealing with them,'' Herbert Helling wrote senior company executives.
Helling suggested that Searle representatives carefully order proposals to the FDA to put Bureau of Foods officials ``into a yes-saying habit.''
On July 26, 1974, just 15 months after Searle petitioned for approval, FDA commissioner Alexander Schmidt approved aspartame use in dry foods, allowing a 30-day period for public hearings and comment. He acted on a strong endorsement from the Bureau of Foods, now called the Center for Food Safety and Applied Nutrition.
At that point, consumer attorney James Turner, author of a 1970 book about food additives who has unsuccessfully pressed petitions for a NutraSweet ban as part of an 11-year campaign against the sweetener, objected to the short comment period. Turner was joined in his protest by Dr. John Olney, a Washington University neuropathologist who had linked aspartame to brain lesions in mice.
Schmidt promptly froze the approval. In an action that was the first of its kind, he ordered that a Public Board of Inquiry be named to look into aspartame.
Philip Brodsky, the unit's since-retired lead investigator, said aspartame was included in a broad inquiry into Searle animal studies. The task force assailed Searle's conduct of research, in a searing, 84-page report.
"At the heart of the FDA's regulatory process,'' the report said, "is its ability to rely upon the integrity of the basic safety data submitted by sponsors of regulated products. Our investigation clearly demonstrates that, in the G.D. Searle Co., we have no basis for such reliance now.''
The task force charged, for example, that instead of performing autopsies on rhesus monkeys that suffered seizures after being fed aspartame, the company had financed a new monkey seizure study with a different methodology that showed no problems.
INVESTIGATION ASKED
For the next seven years, Searle's petition was tied up in reviews by the task force and other sharply critical FDA panels.
At the task force's request, Richard Merrill, the FDA's general counsel, demanded in a letter that Samuel Skinner, the U.S. attorney in Chicago, open a grand-jury investigation of Searle and three of its employees.
One Searle official named by Merrill was Robert McConnell, who had been director of Searle's Department of Pathology and Toxicology and oversaw most of the company's aspartame research.
McConnell's Detroit lawyer, Gerald Wahl, said that as the inquiries heated up, his client suddenly was awarded a $15,000 bonus and asked to take a three-year sabbatical by director Wesley Dixon. Wahl said Dixon told McConnell he had become a ``political liability,'' a remark Dixon later denied making.
McConnell received his annual salary of more than $60,000 during the sabbatical at the Massachusetts Institute of Technology, but he never got his job back and ended up suing the company, Wahl said.
Wahl said McConnell had felt pressure to hurry his research because of the "profit motive,'' but that the company never ordered him to alter test results.
Chief investigator Brodsky said that "politicized'' handling of the task-force disclosures, at hearings chaired by Sen. Edward Kennedy, D-Mass., was one reason he retired in 1977. He said the main witnesses, Searle executives and top FDA officials uninvolved in the investigation, gave "the wrong answers to the wrong questions. . . . They didn't even let the experts answer the questions.''
The FDA, rocked by the controversy, established a set of "good laboratory practices'' - minimum standards for future corporate research work.
Richard Ronk, deputy Bureau of Foods chief, stressed that Searle's practices were typical of the industry at the time, not ``the worst on the block.''
Searle's fortunes did not begin to change until 1977, when Donald Rumsfeld, White House chief of staff under Gerald Ford, was named its new president.
Turner alleged that Searle chose, with Rumsfeld's hiring, not to redo the questioned studies on the belief he could handle aspartame as "a legal problem rather than a scientific problem.''
The company also hired another Ford White House official, William Timmons, as a Washington lobbyist.
Before deciding on Merrill's grand-jury request, U.S. Attorney Skinner and an aide agreed in February 1977 to meet with lawyers for Searle, including Newton Minow, a partner in the law firm of Sidley & Austin.
A month later, Skinner, a Republican appointee who was looking for a job as a result of Jimmy Carter's election, informed aides in a memo that he had begun preliminary employment discussions with the law firm.
Withdrawing from the Searle matter, Skinner suggested his designated successor, Thomas Sullivan, be left to decide whether to open a grand-jury inquiry - a move that delayed action for at least four months. Sullivan took office just 12 weeks before expiration of the statute of limitations for prosecuting alleged false statements on aspartame. While a grand-jury inquiry ultimately was convened, those allegations were not explored.
Skinner has denied any conflict of interest.
Assistant U.S. Attorney William Conlon worked with the grand jury until Oct. 12, 1977, two days after the statute of limitations expired on the aspartame allegations. No indictments were brought on the few matters investigated. Conlon, who declined comment, joined Sidley & Austin 15 months later.
STUDIES ARE ANALYZED
Following issuance of the task-force report in March 1976 and facing a dilemma as to how to proceed, the FDA sought new reviews of several "pivotal'' studies - long-term animal tests to see whether aspartame causes cancer.
A new, five-member internal FDA task force analyzed three of these studies, and Universities Associated for Research and Education in Pathology Inc., a consortium formed by 15 universities, was contracted to look at another dozen. Much like the earlier team, the five-member FDA task force, headed by veteran Chicago inspector Jerome Bressler, assailed the quality of animal tests into whether the substance might cause birth defects and tumors.
The report said Searle laboratory employee Raymond Schroeder, who worked on related research, first told investigators the feed in a study of the aspartame breakdown product DKP was so inadequately mixed it appeared the rats could "discriminate'' and avoid eating the DKP.
Schroeder, who has worked for another company since 1975, later backed off. He told UPI, "I just didn't feel qualified to speak on something I didn't work on. . . . There's no one twisting my arm.''
Bressler criticized the company's ``sloppiness'' on all three studies.
"The question you've got to ask yourself,'' he said in an interview, "is: Because of the importance of this study, why wasn't greater care taken? The study is highly questionable because of our findings.''
Howard Roberts, acting director of FDA's Bureau of Foods, appointed a five-person task force to review the Bressler team's findings pending a decision on whether to throw out the three tumor and birth-defect studies.
Jacqueline Verrett, the senior scientist on the review team, said members were barred from stating opinions about the research quality.
"It was pretty obvious that somewhere along that line they (bureau officials) were working up to a whitewash,'' she said. "I seriously thought of just walking off of that task force.''
On Sept. 28, 1977, the panel reported that deviations between Searle's raw data and its FDA submissions were ``not of such magnitude'' as to alter its conclusions.
(In October, 1978, a year after ordering the review that helped get Searle's petition back on track, Roberts quit to become a vice president at the National Soft Drink Association. The NSDA's members later marketed a stream of NutraSweet-flavored diet soft drink products.
(Reached at NSDA, Roberts dismissed Verrett's criticism, asserting the task-force report ``really was of no importance.'' He said he had no concerns about the appearance of his taking an industry job, stressing he does not represent NSDA before the FDA.)
ANOTHER REVIEW
Negotiations for an additional, outside review of Searle's studies had begun with an Aug. 4, 1976, meeting between Searle and 10 FDA officials. During the meeting, Searle officials said they desired to help pick the consultant to perform the review, an internal FDA memo said.
Agency memos show the FDA soon was negotiating with the Universities Associated for Research and Education in Pathology for a half-million-dollar, company-funded "validation'' of a dozen Searle studies.
The pathology organization's review concluded that Searle's studies were authentic and the discrepancies largely inconsequential.
Adrian Gross, an investigative consultant to the 1975 task force, later said the 16-month review was "at best irrelevant'' because the group was limited to analyzing "whether Searle lied about the data in its tests.''
"It was not our task to challenge the validity of the experimental methods, since the FDA had itself already accepted the methodology,'' the group's executive director, Kenneth Endicott, said.
Regardless, the pathology group's findings carried major weight in the final approval decision. The chairman of the 1980 Public Board of Inquiry, Dr. Walle Nauta of MIT said the board had to rely on those findings because it was denied access to the task-force reports by FDA officials.
"There was absolutely no way in which we could decide who was right here,'' Nauta said. "We simply had to accept the data as they stood.''
TAKING INDUSTRY JOBS
Between 1979 and 1982, four more FDA officials who participated in the approval process took jobs linked to the NutraSweet industry: Pape; acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was associate director of the Bureau of Foods for toxicology, and Mike Taylor, an FDA lawyer who represented the bureau before the Board of Inquiry. All four denied any conflict of interest.
After the Board of Inquiry ruled against NutraSweet on Sept. 30, 1980, Searle waited until Jan. 21, 1981, the day after President Reagan's inauguration, to press for a reversal of the FDA commissioner - assuring the new administration would decide the issue.
Jere Goyan, Hayes' predecessor as FDA commissioner, said he found the delay curious because, after eight years of legal battles, financially struggling Searle "obviously was most anxious to have this thing approved.''
Robert Dormer, a lawyer for The NutraSweet Co., said there was nothing special about the Jan. 21 date.
But with Reagan's election, it was virtually assured that a Republican-appointed commissioner would replace Goyan and decide the appeal - and Searle had strong GOP connections with Rumsfeld at the helm.
On May 18 and 19, 1981, a month after Hayes took office, scientists Satya Dubey, Douglas Park and Robert Condon each laid out concerns about the sweetener's safety in memos to team lawyer Joseph Levitt.
Dubey not only expressed reservations about the reported incidence of brain tumors in one key Searle rat study, but also said key data in another study appeared to have been altered. Dubey, who still works at FDA, refuses to discuss the matter.
Condon, another statistician on the team, and Park, staff science adviser in the agency's Office of Health Affairs, each said the available evidence failed to prove NutraSweet's safety or lack of safety.
Park said that Levitt hurried the panel to decide the issue.
Sources have said the office of Sen. Howard Metzenbaum, D-Ohio, has received allegations of political influence in Hayes' final decision-making process.
In a letter written after the FDA cleared NutraSweet, one former Searle saleswoman, Patty Wood-Allott, asserted that Rumsfeld told his sales force after Reagan took office that "he would call in all his markers and that no matter what he would see to it that aspartame would be approved that year.'' Rumsfeld declined to return phone calls.
Levitt, who normally would have been expected to draft an options paper spelling out scientific evidence on key issues, took an unusual tack. He circulated an approval recommendation - and only backed off when Dubey, Park and Condon objected, team members said.
Levitt said he was not directed to draft the approval memo, but did so as a "tactical'' step to break the team's weeks-long impasse by forcing each scientist to state his views.
Hayes' July 1981 approval decision came in the face of a Searle threat to file a suit challenging the regulatory delays.
His ruling relied in part on a late rat study of brain tumors submitted by Ajinomoto, a Japanese company that manufactures aspartame for Searle. That study, however, tested Wistar rats, a strain that some scientists said is more tumor resistant than the Sprague-Dawley rats used in earlier research.
HAYES RESIGNS
In late 1982, Searle petitioned for FDA approval to use the sweetener in diet soft drinks and children's vitamins. On a day when Hayes was away, Novitch approved the petition, increasing the acceptable daily intake level for humans by nearly half, from 34 to 50 milligrams per kilogram of body weight.
Novitch, now in private industry, said he and Hayes had worked together on the matter, but declined to say why he was left to sign the approval.
Just weeks later, Hayes resigned under the cloud of an internal Department of Health and Human Services investigation into his acceptance of gratuities from FDA-regulated companies - including free rides aboard jets owned by a major NutraSweet user, the General Foods Corp.
Shortly after being named dean of the New York Medical School, Hayes also became a consultant to the New York-based public relations firm of Burson Marsteller, which represents the NutraSweet Co. and several major users.
Hayes' former top spokesman, Wayne Pines, who previously had joined the firm, said he approached Hayes because he thought him "an added value'' to clients.
Hayes, now president of the E.M. Pharmaceutical Co. in Hawthorne, N.Y., declined comment for this series of articles. He has in the past denied any impropriety in his consulting role, which sources said paid him more than $1,000 per day.
Burson Marsteller vice president Buck Buchwald stressed that Hayes was not involved in NutraSweet issues and worked but 10 to 15 days a year. But a former Burson Marsteller employee, who requested anonymity, said that Hayes was hired precisely because of his decision on NutraSweet and other issues affecting company clients.
Metzenbaum said it was ``at the very least . . . unbecoming, at the very most it probably was inappropriate'' for Hayes to accept the position.
In July 1986, Anthony Brunetti, a consumer-product officer who drafted the 1983 notice approving NutraSweet use in soft drinks, also took an industry job, joining the soft-drink association as a science adviser. Brunetti said he cleared the move with the FDA's ethics officer.
Other questions have arisen over the company and industry's funding of researchers who have invariably supported NutraSweet's safety - with the exception of people with the rare disease phenylketonuria. Independent studies have often raised health concerns.
Dr. Lewis Stegink, a pediatrics professor at the University of Iowa who repeatedly has produced studies that he says support aspartame's safety, has received more than $1.3 million in research grants and gifts from the company since the early 1970s.
Stegink's longtime research collaborator, Dr. Jack Filer, serves as executive director of ILSI, the Washington foundation that funds aspartame research.
Filer said he sees no conflict in his dual roles as ILSI's executive director and a company researcher, but declined to disclose his ILSI consulting fees. He said all the Iowa research money has gone to Stegink.
Dr. David Hunninghake of the University of Minnesota was picked to study aspartame's effect on the liver by former Searle research director Daniel Azarnoff, once Hunninghake's mentor at the University of Kansas, a Hunninghake associate said. He said Searle helped design the study.
Susan Schiffman, named to head a Searle-funded Duke University Medical School study into NutraSweet's link to headaches, is a former General Foods and Searle consultant. Her research at Duke, where the medical school has a new Searle Center, has fallen under the office of university vice president William Anlyan, a former Searle director. Schiffman said Anylan had no role in Searle's promise to cover all costs of the study, expected to cost "hundreds of thousands of dollars.'' She said she took no salary for her work.
Another industry-backed researcher has been Ann Reynolds, now chancellor of California State University at Long Beach. Olney asserted that in a 1971 study, Reynolds confirmed his findings that the sweetener destroyed nerve cells in infant mice, but Searle did not notify the FDA until 1975 or 1976 - after the agency's initial review. Dr. Daniel Azarnoff, Searle's former science director, and other Searle officials have denied withholding any studies from the government
. Next: Sweet corporate victories.
Nutrasweet responds
WASHINGTON - The NutraSweet Co. yesterday issued a statement in response to the United Press International series on the artificial sweetener. Here is an excerpt from the statement:
A series of articles released this week by UPI seriously misrepresents the vast body of scientific evidence which establishes the safety of aspartame.
Contrary to the impression created by these articles, the scientific record has been carefully reviewed by independent and official scientific and regulatory agencies around the world.
Without exception, each of these agencies has concluded that aspartame is a safe sweetener which can be used as a normal part of the daily diet.
The UPI articles also seek to discredit the process by which aspartame was reviewed and approved by the FDA. These charges have been conclusively rebutted by both the FDA itself and by the General Accounting Office, the investigative agency of the Congress. A full GAO report on the approval process concluded that the FDA had properly followed the appropriate procedures and had adequately addressed the scientific issues.
The UPI series is replete with misstatements and distortions which convey a totally misleading impression of the scientific facts.
Any concern or anxiety by consumers who read these articles is absolutely unwarranted. Aspartame is safe as approved by FDA and regulatory authorities around the world. Any contrary impression created by the UPI articles is a serious disservice to the public.