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The oiling of America Part #2

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Part 1

Part 2Enig speaks out

When Mary Enig, a graduate student at the University of Maryland, read the

McGovern committee report, she was puzzled. Enig was familiar with Kummerow’s

research and she knew that the consumption of animal fats in America was not on

the increase—quite the contrary, use of animal fats had been declining steadily

since the turn of the century. A report in the Journal of American Oil

Chemists—which the McGovern Committee did not use—showed that animal fat

consumption had declined from 104 grams per person per day in 1909 to 97 grams

per day in 1972, while vegetable fat intake had increased from a mere 21 grams

to almost 60.14 Total per capita fat consumption had increased over the period,

but this increase was mostly due to an increase in unsaturated fats from

vegetable oils—with 50 percent of the increase coming from liquid vegetable oils

and about 41 percent from margarines made from vegetable oils. She noted a

number of studies that directly contradicted the McGovern Committee’s

conclusions that “there is . . . a strong correlation between dietary fat intake

and the incidence of breast cancer and colon cancer,” two of the most common

cancers in America. Greece, for example, had less than one-fourth the rate of

breast cancer compared to Israel but the same dietary fat intake. Spain had only

one-third the breast cancer mortality of France and Italy but the total dietary

fat intake was slightly greater. Puerto Rico, with a high animal fat intake, had

a very low rate of breast and colon cancer. The Netherlands and Finland both

used approximately 100 grams of animal fat per capita per day but breast and

colon cancer rates were almost twice in the Netherlands what they are in

Finland. The Netherlands consumed 53 grams of vegetable fat per person compared

to 13 in Finland. A study from Cali, Columbia found a fourfold excess risk for

colon cancer in the higher economic classes, which used less animal fat than the

lower economic classes. A study on Seventh-Day Adventist physicians, who avoid

meat, especially red meat, found they had a significantly higher rate of colon

cancer than non-Seventh Day Adventist physicians. Enig analyzed the USDA data

that the McGovern Committee had used and concluded that it showed a strong

positive correlation with total fat and vegetable fat and an essentially strong

negative correlation or no correlation with animal fat to total cancer deaths,

breast and colon cancer mortality and breast and colon cancer incidence—in other

words, use of vegetable oils seemed to predispose to cancer and animal fats

seemed to protect against cancer. She noted that the analysts for the committee

had manipulated the data in inappropriate ways in order to obtain mendacious

results.

Enig submitted her findings to the Journal of the Federation of American

Societies for Experimental Biology (FASEB), in May, 1978, and her article was

published in the FASEB’s Federation Proceedings15 in July of the same year—an

unusually quick turnaround. The assistant editor, responsible for accepting the

article, died of a heart attack shortly thereafter. Enig’s paper noted that the

correlations pointed a finger at the trans fatty acids and called for further

investigation. Only two years earlier, the Life Sciences Research office, which

is the arm of FASEB that does scientific investigations, had published the

whitewash that had ushered partially hydrogenated soybean oil onto the GRAS list

and removed any lingering constraints against the number one ingredient in

factory-produced food. The food giants fight back

Enig’s paper sent alarm bells through the industry. In early 1979, she received

a visit from S. F. Reipma of the National Association of Margarine

Manufacturers. Short, bald and pompous, Reipma was visibly annoyed. He explained

that both his association and the Institute for Shortening and Edible Oils

(ISEO) kept careful watch to prevent articles like Enig’s from appearing in the

literature. Enig’s paper should never have been published, he said. He thought

that ISEO was “watching out.”

“We left the barn door open,” he said, “and the horse got out.”

Reipma also challenged Enig’s use of the USDA data, claiming that it was in

error. He knew it was in error, he said, “because we give it to them.”

A few weeks later, Reipma paid a second visit, this time in the company of

Thomas Applewhite, an advisor to the ISEO and representative of Kraft Foods,

Ronald Simpson with Central Soya and an unnamed representative from Lever

Brothers. They carried with them—in fact, waved them in the air in indignation—a

two-inch stack of newspaper articles, including one that appeared in the

National Enquirer, reporting on Enig’s Federation Proceedings article.

Applewhite’s face flushed red with anger when Enig repeated Reipma’s statement

that “they had left the barn door open and a horse got out,” and his admission

that Department of Agriculture food data had been sabotaged by the margarine

lobby.

The other thing Reipma told Enig during his unguarded visit was that he had

called in on the FASEB offices in an attempt to coerce them into publishing

letters to refute her paper, without allowing Enig to submit any counter

refutation as was normally customary in scientific journals. He told Enig that

he was “thrown out of the office”—an admission later confirmed by one of the

FASEB editors. Nevertheless, a series of letters did follow the July 1978

article.16 On behalf of the ISEO, Applewhite and Walter Meyer of Procter and

Gamble criticized Enig’s use of the data; Applewhite accused Enig of

extrapolating from two data points, when in fact she had used seven. In the same

issue, John Bailar, Editor-in-Chief of the Journal of the National Cancer

Institute, pointed out that the correlations between vegetable oil consumption

and cancer were not the same as evidence of causation and warned against

changing current dietary components in the hopes of preventing cancer in the

future—which is of course exactly what the McGovern Committee did.

In reply, Enig and her colleagues noted that although the NCI had provided them

with faulty cancer data, this had no bearing on the statistics relating to trans

consumption, and did not affect the gist of their argument—that the correlation

between vegetable fat consumption, especially trans fat consumption, was

sufficient to warrant a more thorough investigation. The problem was that very

little investigation was being done.

University of Maryland researchers recognized the need for more research in two

areas. One concerned the effects of trans fats on cellular processes once they

are built into the cell membrane. Studies with rats, including one conducted by

Fred Mattson in 1960, indicated that the trans fatty acids were built into the

cell membrane in proportion to their presence in the diet, and that the turnover

of trans in the cells was similar to that of other fatty acids. These studies,

according to J. Edward Hunter of the ISEO, were proof that “trans fatty acids do

not pose any hazard to man in a normal diet.” Enig and her associates were not

so sure. Kummerow’s research indicated that the trans fats contributed to heart

disease, and Kritchevsky—whose early experiments with vegetarian rabbits were

now seen to be totally irrelevant to the human model—had found that trans fatty

acids raise cholesterol in humans.17 Enig’s own research, published in her 1984

doctoral dissertation, indicated that trans fats interfered with enzyme systems

that neutralized carcinogens and increased enzymes that potentiated

carcinogens.18 How much trans fat is " normal " ?

The other area needing further investigation concerned just how much trans fat

there was in a “normal diet” of the typical American. What had hampered any

thorough research into the correlation of trans fatty acid consumption and

disease was the fact that these altered fats were not considered as a separate

category in any of the data bases then available to researchers. A 1970 FDA

internal memo stated that a market basket survey was needed to determine trans

levels in commonly used foods. The memo remained buried in the FDA files. The

massive Health and Human Services NHANES II (National Health and Nutrition

Examination Survey) survey, conducted during the years 1976 to 1980, noted the

increasing US consumption of margarine, french fried potatoes, cookies and snack

chips—all made with vegetable shortenings—without listing the proportion of

trans.

Enig first looked at the NHANES II data base in 1987 and when she did, she had a

sinking feeling. Not only were trans fats conspicuously absent from the fatty

acid analyses, data on other lipids made no sense at all. Even foods containing

no trans fats were listed with faulty fatty acid profiles. For example,

safflower oil was listed as containing 14% linoleic acid (a double bond fatty

acid of the omega-6 family) when in fact it contained 80%; a sample of butter

crackers was listed as containing 34% saturated fat when in fact it contained

78%. In general, the NHANES II data base tended to minimize the amount of

saturated fats in common foods.

Over the years, Joseph Sampagna and Mark Keeney, both highly qualified lipid

biochemists at the University of Maryland, applied to the National Science

Foundation, the National Institutes of Health, the US Department of Agriculture,

the National Dairy Council and the National Livestock and Meat Board for funds

to look into the trans content of common American foods. Only the National

Livestock and Meat Board came through with a small grant for equipment; the

others turned them down. The pink slip from National Institutes of Health

criticized items that weren’t even relevant to the proposal. The turndown by the

National Dairy Council was not a surprise. Enig had earlier learned that Phil

Lofgren, then head of research at the Dairy Council, had philosophical ties to

the lipid hypothesis. Enig tried to alert Senator Mettzanbaum from Ohio, who was

involved in the dietary recommendations debate, but got nowhere.

A USDA official confided to the Maryland research group that they “would never

get money as long as they pursued the trans work.” Nevertheless they did pursue

it. Sampagna, Keeney and a few graduate students, funded jointly by the USDA and

the university, spend thousands of hours in the laboratory analyzing the trans

fat content of hundreds of commercially available foods. Enig worked as a

graduate student, at times with a small stipend, at times without pay, to help

direct the process of tedious analysis. The long arm of the food industry did

its best to put a stop to the group’s work by pressuring the USDA to pull its

financial support of the graduates students doing the lipid analyses, which the

University of Maryland received due to its status as a land grant college.

In December of 1982, Food Processing carried a brief preview of the University

of Maryland research19 and five months later the same journal printed a

blistering letter from Edward Hunter on behalf of the Institute of Shortening

and Edible Oils.20 The University of Maryland studies on trans fat content in

common foods had obviously struck a nerve. Hunter stated that the Bailar,

Applewhite and Meyer letters that had appeared in Federation Proceedings five

years earlier, “severely criticized and discredited” the conclusions reached by

Enig and her colleagues. Hunter was concerned that Enig’s group would exaggerate

the amount of trans found in common foods. He cited ISEO data indicating that

most margarines and shortenings contain no more than 35% and 25% trans

respectively, and that most contain considerably less.

What Enig and her colleagues actually found was that many margarines indeed

contained about 31% trans fat—later surveys by others revealed that Parkay

margarine contained up to 45% trans—while many shortenings found ubiquitously in

cookies, chips and baked goods contained more than 35%. She also discovered that

many baked goods and processed foods contained considerably more fat from

partially hydrogenated vegetable oils than was listed on the label. The finding

of higher levels of fat in products made with partially hydrogenated oils was

confirmed by Canadian government researchers many years later, in 1993.21

Final results of Enig’s ground-breaking compilation were published in the

October 1983 edition of the Journal of the American Oil Chemists Society.22 Her

analyses of more than 220 food items, coupled with food disappearance data,

allowed University of Maryland researchers to confirm earlier estimates that the

average American consumed at least 12 grams of trans fat per day, directly

contradicting ISEO assertions that most Americans consumed no more that six to

eight grams of trans fat per day. Those who consciously avoided animal fats

typically consumed far more than 12 grams of trans fat per day. Cat and mouse

games in the journals

The ensuing debate between Enig and her colleagues at the University of

Maryland, and Hunter and Applewhite of the ISEO, took the form of a cat and

mouse game running through several scientific journals. Food Processing declined

to publish Enig’s reply to Hunter’s attack. Science Magazine published another

critical letter by Hunter in 1984,23 in which he misquoted Enig, but refused to

print her rebuttal. Hunter continued to object to assertions that average

consumption of trans fat in partially hydrogenated margarines and shortenings

could exceed six to eight grams per day, a concern that Enig found puzzling when

coupled with the official ISEO position that trans fatty acids were innocuous

and posed no threat to public health.

The ISEO did not want the American public to hear about the debate on

hydrogenated vegetable oils—for Enig this translated into the sound of doors

closing. A poster presentation she organized for a campus health fair caught the

eye of the dietetics department chairman who suggested she submit an abstract to

the Society for Nutrition Education, many of whose members are registered

dietitians. Her abstract concluded that “. . . meal plans and recipes developed

for nutritionists and dieticians to use when designing diets to meet the Dietary

Guidelines, the dietary recommendation of the American Heart Association or the

Prudent Diet have been examined for trans fatty acid content. Some diet plans

are found to contain approximately 7% or more of calories as trans fatty acids.”

The Abstract Review Committee rejected the submission, calling it “of limited

interest.”

Early in 1985 the Federation of American Societies for Experimental Biology

(FASEB) heard more testimony on the trans fat issue. Enig alone represented the

alarmist point of view, while Hunter and Applewhite of the ISEO, and Ronald

Simpson, then with the National Association of Margarine Manufacturers, assured

the panel that trans fats in the food supply posed no danger. Enig reported on

University of Maryland research that delineated the differences in small amounts

of naturally occurring trans fats in butter, which do not inhibit enzyme

function at the cellular level, and man-made trans fats in margarines and

vegetable shortenings which do. She also noted a 1981 feeding trial in which

swine fed trans fatty acid developed higher parameters for heart disease than

those fed saturated fats, especially when trans fatty acids were combined with

added polyunsaturates.24 Her testimony was omitted from the final report,

although her name in the bibliography created the impression that her research

supported the FASEB whitewash.25

In the following year, 1986, Hunter and Applewhite published an article

exonerating trans fats as a cause of atherosclerosis in the prestigious American

Journal of Clinical Nutrition26, whose sponsors, by the way, include companies

like Procter and Gamble, General Foods, General Mills, Nabisco and Quaker Oats.

The authors once again stressed that the average per capita consumption of trans

fatty acids did not exceed six to eight grams. Many subsequent government and

quasi government reports minimizing the dangers of trans fats used the 1986

Hunter and Applewhite article as a reference.

Enig testified again in 1988 before the Expert Panel on the National Nutrition

Monitoring System (NNMS). In fact she was the only witness before a panel, which

began its meeting by confirming that the cause of America’s health problems was

the overconsumption of “fat, saturated fatty acids, cholesterol and sodium.” Her

testimony pointed out that the 1985 FASEB report exonerating trans fatty acids

as safe was based on flawed data.

Behind the scenes, in a private letter to Dr. Kenneth Fischer, Director of the

Life Sciences Research Office (LSRO), Hunter and Applewhite charged that “the

University of Maryland group continues to raise unwarranted and unsubstantiated

concerns about the intake of and imagined physiological effects of trans fatty

acids and . . . they continue to overestimate greatly the intake of trans acids

by typical Americans.” “No one other than Enig,” they said, “has raised

questions about the validity of the food fatty acid composition data used in

NHANES II and. . . she has not presented sufficiently compelling arguments to

justify a major reevaluating.”

The letter contained numerous innuendos that Enig had mischaracterized the work

of other researchers and had been less than scientific in her research. It was

widely circulated among National Nutrition Monitoring System agencies. John

Weihrauch, a USDA scientist, not an industry representative, slipped it

surreptitiously to Dr. Enig. She and her colleagues replied by asking, “If the

trade association truly believes ‘that trans fatty acids do not pose any harm to

humans and animals’. . . why are they so concerned about any levels of

consumption and why do they so vehemently and so frequently attack researchers

whose finding suggest that the consumption of trans fatty acids is greater than

the values the industry reports?”

Maryland researchers argued that trans fats should be included in food nutrition

labels; the Hunter and Applewhite letter asserted that “there is no documented

justification for including trans acids . . . as part of nutrition labeling.”

During her testimony Enig also brought up her concerns about other national food

databases, citing their lack of information on trans. The Food Consumption

Survey contained glaring errors—reporting, for example, consumption of butter in

amounts nearly twice as great as what exists in the US food supply, and of

margarine in quantities nearly half those known to exist in the food supply.

“The fact that the data base is in error should compel the Congress to require

correction of the data base and reevaluation of policy flowing from erroneous

data,” she argued, “especially since the congressional charter for NHANES was to

compare dietary intake and health status and since this data base is widely used

to do just that.” Rather than “correction of the data base,” [The] National

Nutritional Monitoring System officials responded to Enig’s criticism by

dropping the whole section pertaining to butter and margarine from the 1980

tables.

Enig’s testimony was not totally left out of the National Nutritional Monitoring

System final report, as it had been from the FASEB report three years earlier. A

summary of the proceedings and listing of panelists released in July of 1989 by Kenneth Fischer announced that a transcript of Enig’s testimony could

be obtained from Ace Federal Reporter in Washington DC.27 Unfortunately, his

report wrongly listed the date of her testimony as January 20, 1988, rather than

January 21, making her comments more difficult to retrieve.

The Enig-ISEO debate was covered by the prestigious Food Chemical News and

Nutrition Week 28—both widely read by Congress and the food industry, but

virtually unknown to the general public. National media coverage of dietary fat

issues focused on the proceedings of the National Heart, Lung and Blood

Institute as this enormous bureaucracy plowed relentlessly forward with the

lipid hypothesis. In June of 1984, for example, the press diligently reported on

the proceedings of the NHLBI’s Lipid Research Clinics Conference, which was

organized to wrap up almost 40 years of research on lipids, cholesterol and

heart disease.

The problem with the 40 years of NHLBI-sponsored research on lipids, cholesterol

and heart disease was that it had not produced many answers—at least not many

answers that the NHLBI was pleased with. The ongoing Framingham Study found that

there was virtually no difference in coronary heart disease “events” for

individuals with cholesterol levels between 205 mg/dL and 294 mg/dL—the vast

majority of the US population. Even for those with extremely high cholesterol

levels—up to almost 1200 mg/dL, the difference in CHD events compared to those

in the normal range was trivial.29 This did not prevent Dr. William Kannel, then

Framingham Study Director, from making claims about the Framingham results.

“Total plasma cholesterol” he said, “is a powerful predictor of death related to

CHD.” It wasn’t until more than a decade later that the real findings at

Framingham were published—without fanfare—in the Archives of Internal Medicine,

an obscure journal. “In Framingham, Massachusetts,” admitted Dr. William

Castelli, Kannel’s successor “the more saturated fat one ate, the more

cholesterol one ate, the more calories one ate, the lower people’s serum

cholesterol. . . we found that the people who ate the most cholesterol, ate the

most saturated fat, ate the most calories weighed the least and were the most

physically active.”30

NHLBI’s Multiple Risk Factor Intervention Trial (MRFIT) studied the relationship

between heart disease and serum cholesterol levels in 362,000 men and found that

annual deaths from CHD varied from slightly less than one per thousand at serum

cholesterol levels below 140 mg/dL, to about two per thousand for serum

cholesterol levels above 300 mg/dL, once again a trivial difference. Dr. John

LaRosa of the American Heart Association claimed that the curve for CHD deaths

began to “inflect” after 200 mg/dL, when in fact the “curve” was a very

gradually sloping straight line that could not be used to predict whether serum

cholesterol above certain levels posed a significantly greater risk for heart

disease. One unexpected MRFIT finding the media did not report was that deaths

from all causes—cancer, heart disease, accidents, infectious disease, kidney

failure, etc.—were substantially greater for those men with cholesterol levels

below 160 mg/dL.31 Lipid Research Clinics Trial

What was needed to resolve the validity of the lipid hypothesis once and for all

was a well-designed, long-term diet study that compared coronary heart disease

events in those on traditional foods with those whose diets contained high

levels of vegetable oils—but the proposed Diet-Heart study designed to test just

that had been cancelled without fanfare years earlier. In view of the fact that

orthodox medical agencies were united in their promotion of margarine and

vegetable oils over animal foods containing cholesterol and animal fats, it is

surprising that the official literature can cite only a handful of experiments

indicating that dietary cholesterol has “a major role in determining blood

cholesterol levels.” One of these was a study involving 70 male prisoners

directed by Fred Mattson32—the same Fred Mattson who had pressured the American

Heart Association into removing any reference to hydrogenated fats from their

diet-heart statement a decade earlier. Funded in part by Procter and Gamble, the

research contained a number of serious flaws: selection of subjects for the four

groups studied was not randomized; the experiment inexcusably eliminated “an

equal number of subjects with the highest and lowest cholesterol values;” twelve

additional subjects dropped out, leaving some of the groups too small to provide

valid conclusions; and statistical manipulation of the results was shoddy. But

the biggest flaw was that the subjects receiving cholesterol did so in the form

of reconstituted powder—a totally artificial diet. Mattson’s discussion did not

even address the possibility that the liquid formula diet he used might affect

blood cholesterol differently than would a whole foods diet when, in fact, many

other studies indicated that this is the case. The culprit, in fact, in liquid

protein diets appears to be oxidized cholesterol, formed during the

high-temperature drying process, which seems to initiate the buildup of plaque

in the arteries.33 Powdered milk containing oxidized cholesterol is added to

reduced fat milk—to give it body—which the American public has accepted as a

healthier choice than whole milk. It was purified, oxidized cholesterol that

Kritchevsky and others used in their experiments on vegetarian rabbits.

The NHLBI argued that a diet study using whole foods and involving the whole

population would be too difficult to design and too expensive to carry out. But

the NHLBI did have funds available to sponsor the massive Lipid Research Clinics

Coronary Primary Prevention Trial in which all subjects were placed on a diet

low in cholesterol and saturated fat. Subjects were divided into two groups, one

of which took a cholesterol-lowering drug and the other a placebo. Working

behind the scenes, but playing a key role in both the design and implementation

of the trials, was Dr. Fred Mattson, formerly of Procter and Gamble.

An interesting feature of the study was the fact that a good part of the trial’s

one-hundred-and-fifty-million-dollar budget was devoted to group sessions in

which trained dieticians taught both groups of study participants how to choose

“heart-friendly” foods—margarine, egg replacements, processed cheese, baked

goods made with vegetable shortenings, in short the vast array of manufactured

foods awaiting consumer acceptance. As both groups received dietary

indoctrination, study results could support no claims about the relation of diet

to heart disease. Nevertheless, when the results were released, both the popular

press and medical journals portrayed the Lipid Research Clinics trials as the

long-sought proof that animal fats were the cause of heart disease. Rarely

mentioned in the press was the ominous fact that the group taking the

cholesterol-lowering drugs had an increase in deaths from cancer, stroke,

violence and suicide.34

LRC researchers claimed that the group taking the cholesterol-lowering drug had

a 17% reduction in the rate of CHD, with an average cholesterol reduction of

8.5%. This allowed LRC trials Director Basil Rifkind to claim that “for each 1%

reduction in cholesterol, we can expect a 2% reduction in CHD events.” The

statement was widely circulated even though it represented a completely invalid

representation of the data, especially in light of the fact that when the lipid

group at the University of Maryland analyzed the LRC data, they found no

difference in CHD events between the group taking the drug and those on the

placebo.

A number of clinicians and statisticians participating in a 1984 Lipid Research

Clinics Conference workshop, including Michael Oliver and Richard Krommel, were

highly critical of the manner in which the LRC results had been tabulated and

manipulated. The conference, in fact, went very badly for the NHLBI, with

critics of the lipid hypothesis almost outnumbering supporters. One participant,

Dr. Beverly Teter of the University of Maryland’s lipid group, was delighted

with the state of affairs. “It’s wonderful’” she remarked to Basil Rifkind,

study coordinator, “to finally hear both sides of the debate. We need more

meetings like this” His reply was terse and sour: “No we don’t.” National

Cholesterol Consensus Conference

Dissenters were again invited to speak briefly at the NHLBI-sponsored National

Cholesterol Consensus Conference held later that year, but their views were not

included in the panel’s report, for the simple reason that the report was

generated by NHLBI staff before the conference convened. Dr. Teter discovered

this when she picked up some papers by mistake just before the conference began,

and found they contained the consensus report, already written, with just a few

numbers left blank. Kritchevsky represented the lipid hypothesis camp with a

humorous five-minute presentation, full of ditties. Edward Ahrens, a respected

researcher, raised strenuous objections about the “consensus,” only to be told

that he had misinterpreted his own data, and that if he wanted a conference to

come up with different conclusions, he should pay for it himself.

The 1984 Cholesterol Consensus Conference final report was a whitewash,

containing no mention of the large body of evidence that conflicted with the

lipid hypothesis. One of the blanks was filled with the number 200. The document

defined all those with cholesterol levels above 200 mg/dL as “at risk” and

called for mass cholesterol screening, even though the most ardent supporters of

the lipid hypothesis had surmised in print that 240 should be the magic cutoff

point. Such screening would, in fact, need to be carried out on a massive scale

as the federal medical bureaucracy, by picking the number 200, had defined the

vast majority of the American adult population as “at risk.” The report

resurrected the ghost of Norman Jolliffe and his Prudent Diet by suggesting the

avoidance of saturated fat and cholesterol for all Americans now defined as “at

risk,” and specifically advised the replacement of butter with margarine.

The Consensus Conference also provided a launching pad for the nationwide

National Cholesterol Education Program, which had the stated goal of “changing

physicians’ attitudes.” NHLBI-funded studies had determined that while the

general population had bought into the lipid hypotheses, and was dutifully using

margarine and buying low-cholesterol foods, the medical profession remained

skeptical. A large “Physicians Kit” was sent to all doctors in America, compiled

in part by the American Pharmaceutical Association, whose representatives served

on the NCEP coordinating committee. Doctors were taught the importance of

cholesterol screening, the advantages of cholesterol-lowering drugs and the

unique benefits of the Prudent Diet. NCEP materials told every doctor in America

to recommend the use of margarine rather than butter.

Part 3

Part 4

References

 

 

 

 

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