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Friday, February 24, 2012


GREG GORDON, UPI INVESTIGATIVE REPORT ON ASPARTAME 10/87:

Part One of Three:

UPI Investigative Report 1987
NutraSweet:Questions Swirl
Part 1:   DID SEARLE IGNORE EARLY WARNING SIGNS ?
By GREGORY GORDON
 WASHINGTON (UPI) ≠ A University of Illinois scientist says he warned
the G.D.Searle Co. years before NutraSweet swept the diet food and soft
drink markets that the companyís new artificial sweetener could heighten
risks of brain damage in fetuses and small children.
 Dr. Reuben Matalon, a pediatrician and geneticist, said that between
1976 and 1984, he prodded Searle officials several times to do more
research on the issue, but Searle never performed the studies suggested.
 The Chicago-based company did, however, pursue U.S. government approval
for the low-calorie sugar substitute, and got it in a controversial
ruling in 1981.
 Today, tens of millions of Americans guzzle diet soft drinks stamped
with the NutraSweet "Swirl", dump packets of the NutraSweet  tabletop
sweetener, "Equal" in their coffee and consume NutraSweet-flavored
cereal, puddings, gelatins, cheesecake, chewing gum or vitamin tablets.
 The Food and Drug Administration, despite receiving more than 3,600
consumer complaints, is so confident of the sweeteners safety that it
recently expanded uses to frozen and chilled fruit juices.
 Matalon, however, has remained skeptical. In May, he reported that his
initial, federally funded tests on 51 adults suggests heavy NutraSweet
consumption may increase blood levels of a key amino acid enough to
affect attention span, memory and concentration in some people,
particularly small children. Pregnant women who are sensitive to the
sweetenerís main component, the amino acid phenylalanine, also may face
heightened risk that their infants will have birth defects, Matalon
said.
 More than a dozen other scientists, some of whom are conducting
clinical studies, also say they suspect that subtle effects of the sweet
powder could pose a major health problem. They believe NutraSweet ≠
known generically as aspartame, is linked to brain damage, epileptic
seizures, eyesight problems, allergic reactions, headaches or dizziness.
 "The likelihood is very strong that aspartame does produce serious and
potentially damaging brain effects in a number of people", said Richard
Wurtman, a neuroscientist at the Massachusetts Institute of Technology
who is studying scores of people who suffered seizures after using
NutraSweet.
 Facing continuing controversy, The NutraSweet Co., the name adopted by
Searleís NutraSweet Division following its 1985 sale to the giant
Monsanto Co., vouches for the sweetener.
 The firmís president, Robert Shapiro, rejects criticism voiced by
Matalon and others, saying, "The fact is that the world scientific
community has considered these very specific allegations repeatedly, and
has come to the same conclusion as the FDA."
 An eight-month United Press International investigation not only turned
up scientific concerns, but also raised questions about the way the
product was approved, about the independence and depth of the industry-
funded research efforts into its safety, and about "revolving door"
relationships between FDA officials including former FDA commissioner
Arthur Hull Hayes Jr. and the food and drink industries.
 Shapiro, who obtained an advance copy of this UPI report, said, "Taken
as a whole, the effect of the article is likely to be a thoroughly
misleading impression of the state of knowledge of the subject." Company
spokesman Thym Smith said the firm is contemplating litigation.
 Senator Howard Metzenbaum, D-Ohio, a leading skeptic of the FDAís
approval who plans to hold a hearing on NutraSweet in the next few
weeks, said, "I don't have hard evidence that the product is not safe.
But, I am convinced that there is no hard evidence...that the product is
safe."
 FDA officials stress they have yet to see hard data disproving the
sweeteners safety. For that reason, the agency last year rejected a
consumer groupís petition to ban it on grounds that 140 users suffered
seizures and eye problems.
 NutraSweet has been at the center of intense controversy almost since
July 18, 1981, the day Hayes approved its use in dry foods. Indeed, in
rendering his decision, Hayes overrode six of the nine scientists on two
agency review panels who felt studies on itís possible links to brain
tumors in rats has been inadequate.
 Since then, some independent scientists have become unusually
outspoken.
Drs. Louis Elsas of Emory University and William Pardridge of the UCLA
Medical School charged that the diet food and drink industry has engaged
in a "whitewash" by rejecting health concerns, manipulating research
studies and wining and dining scientific critics.
 These and other researchers describe a world of subtle, high-stakes
strategy in which the availability of corporate funds and the design of
research protocols may have influenced the course of a multibillion-
dollar industry and potentially affected the safety of millions of
people.
 The NutraSweet Co. and a non-profit industry group reject these
allegations, asserting they have commissioned scores of studies to test
the product's safety and that decisions on research funding are made
solely on merit. Company spokesman Smith said NutraSweetís "phenomenal
safety record is the result of the well known nature of the product
rather than manipulations of management." Consumer complaints about
NutraSweet surged in 1983, after Hayesí deputy, Mark Novitch, with the
commissioners support, approved its use in soft drinks such as "Diet
Coke" and "Crystal Light", sending consumption soaring.
 UCLAís Pardridge noted in a letter to the American Medical Association
Journal last year that, with aspartame, the food industry now is adding
about five million pounds of phenylalanine ≠ "a known neurotoxin" to the
food supply every year.
 Roy Burry, an analyst with Kidder-Peabody, Inc., said the exploding
diet market now accounts for 24 percent of soft drink sales, compared
with 10 percent in the 1970ís, and is growing at 20 to 25 percent a
year.
 The NutraSweet Co.ís sales are no longer public, but last year revenues
were believed to have exceeded previously stated levels of $700 million.
 So intense has been the NutraSweet advertising campaign that the diet
food and beverage industry created a "NutraSweet World Professional
Figure Skating Championship."
 "Taking good care of oneself makes life a little better- and NutraSweet
makes it a little sweeter!" boasted one ad during a TV fitness program.
 The NutraSweet Co. also has paid up to $3 million a year for a 100-
person public relations effort by the Chicago offices of Burson,
Marsteller, a former employee of the New York PR firm said. The employee
said Burson Marsteller has hired numerous scientists and physicians,
often at $1,000 a day, to defend the sweetener in media interviews and
other public forums. Burson Marsteller declines to discuss such matters.
 Dismissing safety fears, The NutraSweet Co. stresses that its product,
which in raw form, is 180 times sweeter than sugar, has been endorsed by
the AMA and other scientific bodies worldwide. Actually, the AMAís
Council of Scientific Affairs gave a qualified endorsement based on
"available evidence", including company-funded studies that were
challenged by FDA task forces during investigations of the firmís
laboratory practices in the 1970ís.
 Of 69 scientists who responded to a recent General Accounting Office
survey, 28 said they felt more research was needed on NutraSweet and a
dozen of those questioned considered it a major health problem.
 An "aspartame victims" group has formed, a consumer group has pressed
legal challenges and the company faces at least three personal injury
suits. In one suit, Jim Stoddard, 32, a diabetic in Grand Rapids,
Michigan, charged that his heavy NutraSweet consumption triggered a
dozen seizures-the last one so violent he dislocated his shoulder and
fractured his collar bone.
 Stoddardís lawyer, and his sister, Cynthia, alleged he suffered brain
damage and now has trouble understanding words because he consumed a
product inadequately tested by Searle. She said she withdrew the suit
recently for tactical reasons but would refile it early next year. The
company denies the allegations.
 Wurtman, who quit his job as a Searle consultant and became a vocal
NutraSweet opponent, said he has been contacted by more than 200 persons
who suspect they suffered seizures as a result of NutraSweet use.
 He said Dr. Gerald Gaull, a Searle vice president, visited his
laboratory in 1985 and threatened to veto funding by ILSI(International
Life Sciences Institute), the Washington-based tax-exempt foundation,
for his planned study into whether NutraSweet changes brain chemistry,
lowering some humansí seizure thresholds.
 Gaull said, "thereís no way" Searle, with one of 12 votes on the ILSI
panel, could veto a grant decision, but he did not deny making the
threat.
 ILSI ultimately turned away Wurtman on grounds that Searle already had
arranged for seizure studies at Yale University and New Yorkís Mount
Sinai Hospital ≠  studies that have drawn criticism because human
volunteers were given aspartame only once or twice.
 Wurtman said he is now tapping his laboratoryís budget, which is
extremely limited, slowing progress on his own studies. "Aspartame may
be a serious health hazard," he said, "Itís critically important that
high quality research now be done to assess this hazard." In his letter
to the AMA Journal,  Pardridge said no one has fully researched the
degree to which aspartame raises phenylalanine levels on the brain and,
if so, what the possible effects are. He said in an interview, after he
raised questions about the sweetenerís effects on children, that ILSI
rejected his two grant proposals in 1985. Last year, he said, Gaull
pressed him at a conference in Colorado to prove that phenylalanine, one
of twenty-one amino acids, causes brain damage.
 "It was incredible for him to ask that," Pardridge said. "That was the
basis for my ILSI grant (proposal)."
 "Thereís an internal conflict of interest," he said, "when a company,
which has profit at the bottom line, is charged with finding out the
true safety of its product."
 Elsas, who publicly assailed NutraSweet in 1985, said he was put off
for a year before ILSI rejected his proposal without stating a reason.
ILSIís executive director, Jack Filer, asserted research proposals were
rejected because they cost too much or lacked scientific merit.
 While denying funding for these aspartame skeptics, the company
(G.D.Searle/NutraSweet Co.) and ILSI have financed researchers with whom
they have long-running relationships. A number of industry-funded
scientists acknowledged that company and ILSI officials originated ideas
for their studies or participated in the research design. These studies
generally have reported the sweetener is safe.
 Consumer lawyer Turner said, "The notion that an industrial company
would take large sums of money and parcel it out to scientific
consulting firms and university departments, who they consider to be
personal and commercial allies is an unconscionable way to ensure the
safety of the American food supply."
 He said the NutraSweet experience shows that "the entire system of the
way scientific research is done needs to be carefully investigated,
evaluated, and revamped."
 Food industry officials also said most studies financed by Searle or
the NutraSweet Co. have been arranged as contracts, rather than grants.
Smith said the company often uses contracts "to accomplish a specific
research task."
 James Scala, former director of health sciences for the General Foods
Corp., a major NutraSweet user, said that a scientist working under
contract became "more of an arm of the Searle research group than a
grantee."
 Scala, now with the Shaklee Corp., also said that most early NutraSweet
research consisted of short-term studies that ignored possible "subtle,"
long-term effects.
 Matalon said, "Let us say cigarettes were invented today, and you give
20 people two packs a day and after six weeks, no one has cancer, would
you say that it was safe? Thatís what they did with NutraSweet."
 Dr. Martha Freeman, who was a medical officer at the FDAís Bureau of
Drugs in the early 1970ís, argued in 1973 that the substance (aspartame)
was "a new chemical...that doesn't occur naturally" and should only be
approved after long-term clinical studies, as if it were a new drug. Her
arguments were rejected.
 Despite these complaints, the NutraSweet Co. has insisted that the
company-funded studies prove that except for people with the rare
disease, phenylketonuria, the human body processes phenylalanine in
aspartame just like any other food, Thomas Stenzel, a spokesman for the
International Food Information Council, a public relations arm for
NutraSweetís manufacturers and biggest customers, contended scientific
adversaries comprise a small minority.
 He said he found it "very important that the leading professional
health organizations" have found NutraSweet to be safe.
 For example, the American Academy of Pediatrics concluded in 1985 that
studies on people given massive aspartame doses showed no dangerous rise
in blood phenylalanine levels; the Epilepsy Institute has reported the
sweetener "to be safe for people with epilepsy."
 Filer, executive director of the industryís main organ, the
International Life Sciences Institute, suggested that problems blamed on
aspartame may stem from "water load" on the brain resulting from over-
consumption of liquids.
 Maj. Michael Collings, who was an Air Force F-16 pilot in top physical
condition, said he often drank up to a gallon of aspartame-sweetened
products when he finished his daily, five-to-eight mile jogs in Nevadaís
desert heat. After noticing slight trembling in his hands over several
weeks, he collapsed unconscious with a seizure on Oct.4, 1985, a lawyer
for Collings said.
 Because of the seizure, Collings is grounded as a pilot for life, is on
medication and was ordered transferred to Maxwell Air Force Base in
Alabama at a $400-a-month pay reduction, said attorney Bryan Gould, who
charged in a state court suit last year that NutraSweet caused the
seizure.
 "He tells me thereís no way to describe the feeling of flight," Gould
said. "He loves to fly and now he can't." The NutraSweet Co. denies any
link between the sweetener and Collings medical problems.
 FDA officials, while publicly endorsing aspartame, are watching the
situation closely. In late 1985, the agency took the unusual step of
asking doctors nationwide to report adverse reactions to NutraSweet, and
another food additive, sulfites ≠ a move normally reserved for drugs.
Sulfites since have been banned from the market. A FDA spokesman said
about 25 doctors filed reports suggesting aspartame links to varying
health problems.
 The FDA approved NutraSweet products on the condition they carry a
compulsory warning to phenylketonurics, individuals sensitive to its
phenylalanine component. But Matalon, Elsas and others worry about
millions of "carriers" of the disease who are unaware of their
sensitivity. They say NutraSweet could damage fetuses of pregnant women
whose bodies have trouble processing the amino acid.
 Matalon, on releasing his new study, urged that products be labeled
with the amount of NutraSweet they contain so consumers can monitor
their intake. In Canada, aspartame is the only food additive for which
such quantity food labeling is required.
 With consumption soaring, Sanford Miller, chief of FDAís Bureau of
Foods, has acknowledged considering a labeling requirement in this
country.
 Dr. Gary Flamm, the FDAís top toxicologist overseeing food additives,
said that beyond labeling, once a food additive such as NutraSweet has
won approval, it is far more difficult to restrict its marketing.
 "If...our approval of it was a mistake, we couldn't rectify that
without data showing that aspartame was unsafe," said Flamm, an
aspartame defender.
 Even then, he said, the agency would face a new regulatory thicket
unless it could be shown NutraSweet posed "an imminent hazard." Consumer lawyer James Turner, who has campaigned for more than a decade for a
NutraSweet ban, assailed the FDAís treatment of such safety issues.
"Once a product is on the market, whether there by nefarious or honest
means," he said, "it is impossible to get it off the market until it has
caused severe, undeniable damage that has probably lasted over many
years."
 Several independent scientists have alleged that the industry has
steered research money to allies in the scientific community, while
denying funding to those who have raised health concerns.
 A number of scientists who pressed for more studies into possible brain
damage told UPI they were turned away by Searle and the International
Life Sciences Institute, a tax-exempt industry foundation supported by
the company, its Japanese aspartame-manufacturing partner and 10 sellers
of NutraSweet-flavored products.
 In interviews, Drs. Matalon, Wurtman, Elsas, Pardridge, and John Olney
of Washington University in Illinois charged that the industry has paid
millions of dollars for studies that have skirted the real issues about
NutraSweet.
 "There are virtually no studies," Turner said, "that have been done by
individuals using resources other than the industryís that have given a
clean bill of health to aspartame."
 University of Illinois researcher Matalon recalled that he couldnít
persuade Searle to do the kind of research necessary to put to rest
lingering health concerns, neither on his first approach in 1976 nor
when he submitted specific grant proposals to more four more company
officials beginning in late 1980.
 After NutraSweet won FDA approval and began changing the dietary habits
of millions of Americans, Matalon said he lost patience in 1984 with the
usual encouragement from Searle officials about prospects for future
funding. "I felt they were just stringing me along," said Matalon, who
obtained a $180,000 grant from the National Institutes of Health.
 Company spokesman Smith said the NutraSweet manufacturer has "not
discouraged Dr. Matalonís work, nor anyone elseís." While declining to
comment on the decision not to fund Matalonís study, Smith said the
company spends "between $30 million and $35 million annually on
research."
"We do make decisions based on how we understand a study will be
conducted and, reasonable scientists may disagree on study designs," he
said.
The company has alleged that a number of its critics are seeking to
pressure the industry to fund their laboratories.
  Faced with sharply differing opinions on the sweetenerís safety, the
FDA and the National Institutes of Health, the governmentís chief
funding mechanism for private research, have financed few studies on its
effects. One former ranking NIH official, Artemis Simopoulos, argued the
agency "should have a very extensive program on aspartame so people
would know" whether it is safe.
 Yet some NIH scientists have served as consultants to the ILSI
foundation, helping decide the awards of $500,000 in annual NutraSweet
research grants in recent years. Even Simopoulos was a non-paid member
of the foundationís board.
 But ILSIís "aspartame technical committee," consisting of the
NutraSweet Co. and 11 other manufacturers and users of sweetener, have
been accused of discriminating against NutraSweet critics in granting
awards.
 Represented on the ILSI committee are General Foods, the Coca Cola Co.,
PepsiCo, Inc., the Royal Crown Cola Co. and Seven-Up, Inc.
 ILSI insists that the NutraSweet Co. carries no special weight despite
its U.S. monopoly on the sweetener. "The NutraSweet Co. is one of our
members," said ILSI administrator Sharon Senzik. "Committees operate by
Robertís Rules of Order."
 Filer collaborated for several years on NutraSweet research with a
colleague at the University of Iowa, Dr. Lewis Stegink. Filer pledged
that, despite his past ties to the company, as ILSIís head he would "let
the chips fall where they may" on research results. Samuel Molinary, co-
chairman of ILSIís panel, is Searle's former director of scientific
affairs and now Pepsicoís research director. Molinary insists that ILSI
is not a "lacky and tool" of the NutraSweet Co.
 Peter Dews, a Harvard University psychobiology professor named to
ILSIís original board of trustees in 1978, has served as an ILSI
consultant since then. Dews recently took the trouble to write and
promote an article declaring that, based on scientific presentations at
an ILSI aspartame conference in Spain last year, "there is now a mass of
evidence" that NutraSweet is safe if consumed at FDA-recommended levels.
 Dews declined to discuss his ILSI consulting fees, except to say it is
"not enough to make any difference in my life." ILSIís 1984 return filed
with the Internal Revenue Service showed payments to Dews that year of
$31,000.
 A lawyer for the ILSI pledged to the IRS in obtaining tax-exempt status
for the foundation in 1983, that the organization "does not have any
plans to engage in commercially sponsored scientific research." Attorney
Roger Middlekauff advised the IRS that ILSI would "direct the research
toward benefiting the public" and would release all research results.
 But Elsas charged that ILSI "is definitely a front organization to try
to make the public believe that there is some non-directed, non-biased
research going on," when ILSI studies actually are likely to support
NutraSweetís safety.
 The industry has invited scientific critics for paid visits to company
laboratories, sometimes offering courtesy "honorariums," an industry
source said.
 The NutraSweet Co. also hosted critics at conferences in resort
settings. Matalon briefed ILSI on his research at the meeting in the
Costa del Sol region on Spainís southern coast.
 In the summer of 1985, the firm flew Wurtman, Elsas, Matalon,
Pardridge, several of their wives and other NutraSweet critics to a two-
day meeting at a luxurious home in Northeast Harbor, Maine. An afternoon
was spent on a yacht, participants said. "This was industry wooing the
concerned to shut up." Elsas said.
 Pardridge said he was the only strong aspartame critic to accept an
invitation in June 1986 to a heavily-attended Searle sponsored
conference at a picturesque ski resort in Keystone, Colo. Pardridge said
when he tried during the conference to raise his concerns about
phenylalanine, the discussion was cut off. "It was just another typical
industry whitewash," he said.