Coffee / Health Myths and Facts: Why We Need a Risk-Benefit “Holistic” Approach for Carcinogens”

James R. Coughlin, Ph.D.President, Coughlin & Associates

Aliso Viejo, Californiajrcoughlin@cox.net

www.linkedin.com/in/jamescoughlin

Pacific Coast Coffee Association82nd Annual Convention

Aptos, CaliforniaSeptember 20, 2013

Presentation Outline Coffee / Health Myths & Facts: 30+ Year History

Acrylamide Background – Animal Carcinogenicity– Human Epidemiologic Evidence

Heat-produced Carcinogens in Foods

California Proposition 65 and Acrylamide

Benefit-Risk Evaluation of Coffee – The “Holistic Approach”– The “Coffee-Cancer Paradox”

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A 30+ Year Coffee/Health Perspective

…on Rats, Mice and Humans

…on “Good” and “Bad” Science

…on “Good” and “Bad” Media Coverage

…on Coffee’s Beneficial Health Effects

…on “Holistic” Risk-Benefit Evaluation

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Coffee / Health Conclusions: 1980 - 2013

… First 20 Years:

Mostly Bad News! Coffee and Caffeine were linked to almost every known animal and human disease!

… Last 15 Years, a Big Turn Around:

The “Good News” is that almost all of the Bad News was WRONG!

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Why have Coffee/Caffeine been so maligned?

• Dramatically increased interest in health and nutrition; much consumer worry about enjoying too much of a good thing!

• What we eat…or don’t eat…is always being linked to disease, and there is so much Consumer Anxiety from dietary headlines

• AVOID or REDUCE: salt, fat (fries and chips), red meat, carbs, soft drinks, coffee and caffeine!!

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What Science Allowed the Bad Myths to Happen and Why Do a Few Still Persist?

… Acute vs. Chronic effects:

Partial / full tolerance to caffeine develops in humans consistently consuming caffeine and coffee daily

… Most of the Myths and Fears are based on:

Acute effects testing of non-coffee consuming subjects Massive doses of individual coffee chemicals fed to

animals for a lifetime Smaller poorly done human studies.

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Much Confusion over Coffee and Caffeine

“Perhaps no substance has been the subject of more conflicting media and scientific reports in recent years than caffeine. So, is a cup of coffee bad for you or not?”

Los Angeles Times, September 11-13, 1994 risk series

- But no one was even asking back then -

“So, is a cup of coffee good for you or not?”

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But since 2000 or so…

The “Good News” is that almost all of the earlier Bad News about Coffee was WRONG!

Medical evidence has been building strongly that coffee may actually be GOOD for us!!!

Let’s briefly examine the evidence for some myths and facts…

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The “Maligning” Started in the Late 1970’s and Ballooned in the 1980’s and Early 1990’s

• Coffee and heart attacks

• Coffee and bladder & pancreatic cancer

• Caffeine and birth defects in rats (U.S. FDA, 1978)

• Caffeine and osteoporosis

• Caffeine “Addiction”

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Coffee and Pancreatic Cancer -My Personal “Baptism by Fire”…

• Dr. MacMahon (Harvard) study – New Engl J Med, 1981

• Intense media coverage and months of lost coffee sales

• His methodology & results were severely criticized by university and industry scientists

• MacMahon eventually retracted his conclusions almost completely in 1986, but only in a brief letter in the NEJM

• This study’s limitations have become famous teaching points in human dietary epidemiology coursework.

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Paracelsus (1493-1541)

THE basic tenet of all Toxicology:

“The dose alone makes the poison.”

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As we entered the 21st Century…

The preponderance of medical and scientific

evidence clearly supported the conclusion that

moderate coffee consumption (3 - 4 cups per day),

as part of a varied, balanced diet, was safe and

was not associated with any adverse human health

consequences.

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Caffeine’s Beneficial Physiological Effects

• Mild central nervous system (CNS) stimulant

• Improves cognitive performance and mental processing; increases wakefulness; improves work performance and enhances mood

• Increases capacity for physical work & exercise; improves muscular performance and endurance sports

• Relaxes smooth muscle, especially bronchial (opens airways), and increases blood flow in heart and kidneys

• Produces a slightly higher metabolic rate (some evidence of an ergogenic “fat burning” effect).

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Cardiovascular Disease

• Endpoints: heart attack, hypertension (with stress), blood cholesterol from boiled coffee, cardiac arrhythmias

• Andersen et al., 2006 – Iowa Women’s Health Study, decreased risk of cardiovascular death

• Lopez-Garcia et al., 2006, 2008 (Harvard) – big cohort study in men & women, no increased risk seen, even modest benefit for all-cause and cardiovascular disease

• Freedman et al., 2012 (NIH-AARP) – cohort study of over 400,000 men & women showed coffee consumption reducedtotal mortality and cause-specific mortality.

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Caffeine and Reproductive Effects

• Began with birth defects in rats force-fed very high-doses(FDA, 1978)

• Then human studies followed: delayed conception; premature birth; low birth weight babies; fetal death; spontaneous abortion (miscarriage), congenital defects

• But now there are more than 25 Published Reviews:• Peck, Leviton, Cowan (Food & Chemical Toxicology,

October 2010):“The weight of evidence does not support a positive relationship between caffeine consumption and adverse reproductive or perinatal outcomes.”

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Caffeine and Osteoporosis

• Excess calcium loss & bone loss in post-menopausal women causes millions of bone fractures (mostly hip)

• Earlier acute, 24-hour human studies on non-caffeine consuming subjects were originally misinterpreted

• Many longer-term, human clinical studies have shown little excess calcium loss or bone loss and no increased risk of osteoporosis.

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Caffeine and “Addiction”

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Caffeine and “Addiction”• Dependence, tolerance and withdrawal headache were cited in

many published studies (mostly among psychiatric patients)

• Headlines since the late 1980’s:• “Caffeine Addiction More Than Just Java Jive -- Caffeine

Junkies”• “Study Finds Caffeine Has Qualities of Addictive Drug”

• Current view is very reassuring: • Caffeine is not classified as an addictive drug (APA, DSM-5

psychiatric “bible” May 2013) • Addiction over-warnings trivialize dangers of real drugs of

abuse.

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Coffee and Cancer Risk

• Coffee contains dozens of animal carcinogens, many produced by the “Maillard Browning Reaction” in the presence of heat, including acrylamide

• Over 500 human epidemiology studies have been published since the 1970’s on many human organs

• But, after 3 decades of human research, most health authorities across the globe now agree that coffee drinking is NOT a cancer risk!

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“FOR MOST CANCER SITES, THERE IS A SIGNIFICANT AMOUNT OF EVIDENCE SHOWING NO DETRIMENTAL EFFECT OF CONSUMPTION OF UP TO 6 CUPS OF COFFEE/DAY IN RELATION TO CANCER OCCURRENCE. IN FACT, SOME OF THE EVIDENCE…SUGGESTS THAT COFFEE MIGHT PREVENT SOME CANCERS.”

[REVIEW BASED ON OVER 500 PUBLICATIONS]24

Conclusions on the “Bad” Health Effects

• Long established history of safe global coffee consumption

• But more animal, clinical & epidemiologic studies and continued media attention are sure to come

• More recent studies and re-examinations of older disease issues have been quite reassuring

• Consumers can be assured that their health will not be adversely affected by the enjoyment of coffee and caffeine as currently consumed.

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“Risk Reductions” with Coffee Consumption

• Some cancers (already reviewed)

• Type 2 diabetes

• Chronic liver disease

• Parkinson’s Disease

• Alzheimer’s Disease

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Coffee and Type 2 Diabetes

• Diabetes “epidemic” in Western societies with links to obesity and premature death

• Human epidemiological studies have all shown a substantial reduction in risk with coffee consumption

• Research is underway on promising coffee constituents, and longer term human clinical trials are needed

• Identification of coffee constituents with beneficial effects on glucose metabolism may lead to the selection of coffees with more positive health effects.

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Liver Cancer and Liver Cirrhosis

• Liver cancer is 5th most common cancer in the world, and liver cirrhosis is a major risk factor for it

• Coffee inhibits liver enzymes and produces a liver-protective effect that seems to reduce the risk of both cirrhosis and liver cancer by as much as 45%

• This is coffee’s strongest cancer-protective effect

• Physiological studies are also providing strongbiological support.

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Coffee Consumption and Reduced Risk of Parkinson’s Disease (PD)

• 9 human studies found regular coffee consumers were 50-80% less likely to develop PD

• In 2007, two large cohort studies also showed a graded decrease in risk with more cups consumed

• Further studies on caffeine’s neuroprotective effects are required to demonstrate cause-effect conclusion.

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Coffee and Reduced Risk of Alzheimer’s Disease (AD)

• Several human cohort studies have shown that coffee consumption is associated with a reduced risk of AD

• Caffeine has shown neuroprotective effects after chronic administration in animals, possibly via changes in neurotransmitter and receptor systems

• Dr. Gary Arendash’s studies (U. of South Florida) in animals and humans continue to support this good news

• Wouldn’t we all love to avoid this disease?

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Antioxidants (AOX) in Foods (Wine, Tea, Chocolate)

Extensive media coverage of AOX health benefits in all these other foods and beverages, but coffee seems to get mentioned so much less

The media know that the positive health effects are mainly due to their polyphenol AOX content

However…Coffee is now known to be a much better source of AOX than all of the others combined!

Not just coffee’s naturally occurring polyphenols (the chlorogenic acids)

The brown melanoidin polymers are heat-produced AOX from the Maillard Browning Reaction.

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BEVERAGE - PER CAPITA AOX’S

Coffee provides 64% of per capita AOXs from beverages

0

100

200

300

400

500

600

700

800

Coffee

Black Tea (bag)

Beer (Lager)

Wine (Red)

Orange Juice

Grape Juice (Red)

Apple Juice

Grapefruit J

uice

Cranberry Juice

Pineapple Juice

mg

AOX/

day

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So with all this good news, why are we still concerned?

~

Caffeine Issues [Congress / FDA]

Animal Carcinogens in Coffee

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Caffeine

~

Summer of 2013

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“Proposition 65”A California Law

~“Safe Drinking Water and Toxic

Enforcement Act of 1986”- Right-to-Know Warnings- Prohibition of Discharge

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Acrylamide Snapshot

Known for decades as an occupational neurotoxinin humans; genotoxic / mutagenic in cell cultures

Known rat carcinogen, classified as a “probable human carcinogen” in the 1990’s

Discovered unexpectedly by the Swedes in 2002 in hundreds of heat-processed food products [including coffee] due to the Maillard Browning Reaction between sugars and amino acids.

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Food Acrylamide Range (ppb)Baby food/biscuits ND - 442

Breads/bakery products ND - 364

Cereals 11 - 1057

Chocolate products ND - 909

Coffee (roasted, not brewed) 37 - 374

Coffee (brewed) 5 - 11

Cookies/crackers 26 - 1540

Dairy drinks ND - 43

Dried foods/mixes ND - 1184

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Food Acrylamide Range (ppb)French fries 117 - 1325

Fruits/vegetables (canned) ND - 83

Gravies/seasonings ND - 151

Infant formulas ND

Nuts/nut butters ND - 457

Potato chips 117 - 4080

Snacks (other salty) 12 - 1340

Olives 123 - 1925

Prune juice 53 - 32644

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Annu. Rev. Food Sci. Technol. (2012) 3:15–35

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Acrylamide Battleground under California Prop 65

Listed in 1990 as a carcinogen with a very low “Safe Harbor” intake level = 0.2 micrograms/day; must stay below this level to avoid cancer warnings

French fries: Attorney General sued and settled a case (2008) against frozen fries/tater tots demanding a 50% reduction in levels; fast-food restaurant fries have had cancer warnings posted for years

Potato chips: AG settled a case (2008) against chip manufacturers; agreement to cut levels to 275 ppb by end of 2011 (20 - 85% reductions) to avoid warnings; no warnings are currently being given

Cereals: Private “bounty hunter” lawyers sued cereal manufacturers in 2009; case is still pending.

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Coffee/Acrylamide Battles under Prop 65

Private “bounty hunter” (CERT, R. Metzger) sued California coffee shops in April 2010 for failure to provide cancer warnings (“brewed coffee” suit); in April 2011, the shops began posting 10 x 10 inch cancer warning placardscovering coffee, baked goods and other browned products

CERT filed a related suit in May 2011 against coffee roasters, distributors and retailers, over 120 companies are now sued (“roasted coffee” suit)

Roasters are fighting hard to avoid cancer warning labels on packaged products; levels average only about 10 ppb in brewed coffee.

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Using a Benefit-Risk Approach

for Coffee…

The “Holistic” Approach

~“Coffee - Cancer Paradox”

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Benefit-Risk Evaluation to Assess the Safety of Foods Containing Heat-produced Carcinogens

Doing it the WRONG WAY for decades, by evaluating the risk of individual chemicals in a food one by one (like Prop 65 does!)

I believe the RIGHT WAY is to evaluate the safety of the whole food by comparing its risks vs. benefits

Use the “Holistic Approach”

“Benefit-Risk” evaluations have recently been published –

U.S. FDA’s 2009 “Draft Risk and Benefit Assessment of Fish” (Methyl mercury risks vs. Omega-3 fatty acid benefits)

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“One by One” vs. the “Holistic” Approach• Foods and beverages contain huge numbers of

different chemical components that can have directly opposite health effects

• Assessing these chemicals “one by one” is highly likely to be misleading and overly conservative, especially for animal carcinogens produced in complex heated foods (no better example than coffee!)

• I believe the correct way forward for complex heated foods and beverages requires the “Holistic” Risk-Benefit approach, as opposed to the current “one by one” chemical assessments.

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Use the Holistic “Risk-Benefit” Approach

• The beneficial health effects of certain whole foods may outweigh the effects of trace levels of animal carcinogens and other toxicants – COFFEE is one of these foods!

• We must press global health and regulatory authorities to:• Use improved toxicology & risk assessment methods on

individual chemicals tested at high doses in animals• Do more research on qualitative and quantitative

assessment of the benefits of whole foods• Consider the health benefits of protective compounds

naturally occurring and produced by heating (coffee’s antioxidants)

• Assess the safety and benefits of the whole food, not just individual food carcinogens & toxicants one by one.

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The “Coffee / Cancer Paradox” Coffee contains about 2,000 identified compounds (hundreds are

flavors and aromas), including trace levels of many animal carcinogens

But global health and regulatory authorities now agree that coffee drinking is NOT causing any increased risk of human cancer

In fact, human studies show significant risk reductions for numerous cancers in spite of the presence of many animal carcinogens

How can this be? Naturally occurring antioxidants (chlorogenic acids) Heat-formed antioxidants (the brown melanoidin polymers) Chemicals that induce detoxification enzymes

So, here is the Paradox – Coffee is loaded with animal carcinogens but most likely reduces human cancer risk!

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THE Health Beverage!

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Thank You!

Questions?