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Factory Farms, Antibiotics and Anthrax:. Putting Profits Before Public Health Martin Donohoe, MD, FACP. Outline. Factory Farming Agricultural Antibiotics Cipro and Anthrax Bayer Conclusions. Factory Farming.

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  1. Factory Farms, Antibiotics and Anthrax: Putting Profits Before Public Health Martin Donohoe, MD, FACP

  2. Outline • Factory Farming • Agricultural Antibiotics • Cipro and Anthrax • Bayer • Conclusions

  3. Factory Farming • Factory farms have replaced industrial factories as the # 1 polluters of American waterways • Large CAFOs make up 5% of livestock operations but produce more than 50% of food animals • 9,900 CAFOs in U.S. • Flourished thanks to indirect federal subsidies • Not subject to Clean Air Act Standards

  4. Factory Farming • 1.4 billion tons animal waste generated/yr in U.S. (13 billion tons worldwide) • 130 x human waste (in U.S.) • Cattle manure 1.2 billion tons • 16kg livestock feces and urine produced for every 0.3kg steak • Pig manure 116 million tons • Chicken droppings 14 million tons

  5. Factory Farm Waste • Overall number of hog farms down from 600,000 to 157,000 over the last 15yrs, while # of factory hog farms up 75% • 1 hog farm in NC generates as much sewage annualy as all of Manhattan

  6. Factory Farm Waste • Most untreated • Ferments in open pools • Seeps into local water supply, estuaries • Kills fish • Causes human infections - e.g., Pfisteria pescii,Chesapeake Bay

  7. Factory Farm Waste • Creates unbearable stench • Foul odors and contaminated water caused by CAFOs reduce property values in surrounding communities an estimated $26 billion nationally • Widely disseminated by floods/hurricanes

  8. Risks to Farm Workers, Marine Life • Antibiotic-resistant infections • Carriage of antibiotic-resistant organisms • Antibiotic-resistant land-based pathogens increasingly found in marine organisms

  9. Risks to Farm Workers • Aerosolized pig brains associated with immune polyradiculoneuropathy (progressive inflammatory neuropathy) in pork processing plant workers • ?Other similar illnesses?

  10. Agricultural Antibiotic Use • Agriculture accounts for 80% (29 million lbs) of U.S. antibiotic use • Use up 50% over the last 15 years • Only 10% used to actually treat infections • Almost 9 billion animals per year “treated” to “promote growth” • Claim: Larger animals, fewer infections in herd

  11. Agricultural Antibiotic Use • 84% of beef cattle, 83% of pigs, and 40-50% of poultry given non-therapeutic antibiotics • Arsenic used in chicken and pork feed (banned in Europe; roxarsone [major arsenic contributor] voluntarily withdrawn from U.S. market, but still sold overseas; Poison-Free Poultry Act pending in U.S. Congress)

  12. Consequences of Agricultural Antibiotic Use • Campylobacter fluoroquinolone resistance • Infections/carriage by swine farmers associated with inflammatory neuropathies • VREF (due to avoparcin use in chickens) • Gentamycin- and Cipro-resistant E. coli in chickens • Linked to E.coli UTIs in humans • 2009: Campylobacter found in 62%, Salmonella in 14%, and both in 8% of store-bought chickens

  13. Consequences of Agricultural Antibiotic Use • MRSA in pork, chickens • 49% of pigs and 45% of pig farmers harbor MRSA • MRSA from animals throught to be responsible for more than 20% of human MRSA cases in the Netherlands • H1N1 carriage rates very high in CAFO workers

  14. Antibiotic Resistant Pathogens • CDC: “Antibiotic use in food animals is the dominant source of antibiotic resistance among food-borne pathogens.” • CDC: 76 million people suffer foodborne illnesses each year in the U.S. • 325,000 hospitalizations • 5,000 deaths • > $156 billion/yr in medical costs, lost wages, and lost productivity

  15. Antibiotic Resistant Pathogens • EU bans use of all antibiotic growth promoters effective 1/1/06 • FDA bans off-label use of cephalosporins in food animals (2008) • Preservation of Antibiotics for Medical Treatment Act – awaiting vote in Congress

  16. Alternatives to Agricultural Antibiotic Use • Organic farming • Decrease overcrowding • Better diet/sanitation/living conditions • Control heat stress • Vaccination • Increased use of bacterial cultures and specific antibiotic treatment in animals when indicated

  17. Alternatives to Agricultural Antibiotic Use: Vegetarianism • ↓ water/grain needs • ↓ animal fecal waste • ↓ rendering/mad cow disease • ↓ rBGH (→ ↑IGF-1 in milk) • Health benefits • Meatpacking = most dangerous job in US

  18. Agricultural Antibiotics • Three years after a Danish ban on routing use of antibiotics in chicken farming, the prevalence of antibiotic-resistant bacteria in chickens dropped from 82% to 12%

  19. Agricultural Antibiotics • 2008: USDA allows E. coli-tainted meat to be sold as pre-cooked hamburger patties, taco meat, pizza toppings, etc. • Multiple other food recalls since • Almost 9 million lbs of meat and poultry recalled in 2010

  20. Agricultural Antibiotics • 2010: AMA, AAP, APHA, IDS all oppose non-therapeutic antibiotic use in livestock • 2010: FDA urges phasing out antibiotic use

  21. Campylobacter • Most common food-borne infection in US • 2.5 million case of diarrhea and 100 deaths per year

  22. Campylobacter Resistance to Fluoroquinolones Increasing • 13% in 1998, 18% in 1999, 20-80% currently • Fluoroquinolone use up dramatically • Continues to increase • FDA proposed ban on fluoroquinolone use in poultry • Supported by APHA, PSR and others

  23. Fluoroquinolones • Animal Use • Sarafloxacin (Saraflox) – Abbott Labs – voluntarily withdrawn from market • Enrofloxacin (Baytril) – Bayer – FDA withdraws approval (7/05), ban effective 9/05 • Human Use • Ciprofloxacin (Cipro) - Bayer

  24. Anthrax • Cipro – patent expired 2004 • Doxycycline – generic • Penicillin - generic • Huge potential profits • 300 million Americans, others • 20-25% increase in Cipro sales one month after 2001 anthrax mailings, per the nation’s largest PBM

  25. Cipro • Was best selling antibiotic in the world for almost a decade • Sales down since off patent, lower than levofloxacin and moxifloxacin • Gross sales (first quarter of 2008) = $242 million

  26. Bayer and Cipro • 1997 onward – Bayer pays Barr Pharmaceuticals and two other competitors $200 million not to manufacture generic ciprofloxacin, despite a federal judge’s 1995 decision allowing it to do so • Ultimately absolved of wrongdoing: “anticompetitive effects … were within the exclusionary zone of the patent, and thus could not be redressed by federal antitrust law.”

  27. Cost of Cipro • Drugstore = $4.50/pill • 2002: US government agreed to buy 100 million tablets for $0.95 per pill (twice what is paid under other government-sponsored public health programs) • A full course of ciprofloxacin for postexposure prophylaxis (60 days) would then cost the government $204 per person treated, compared with $12 per person treated with doxycycline

  28. Cost of Cipro • US government has the authority, under existing law, to license generic production of ciprofloxacin by other companies for as little as $0.20/pill in the event of a public health emergency • It did not, but it cut a deal with Bayer to reduce the price of Cipro • Canada did override Bayer’s patent and ordered 1 million tablets from a Canadian manufacturer

  29. Why? • Weakening of case at WTO meetings that the massive suffering consequent to 25 million AIDS cases in Sub-Saharan Africa did not constitute enough of a public health emergency to permit those countries to obtain and produce cheaper generic versions of largely unavailable AIDS drugs

  30. Other Consequences • Opens door to other situations involving parallel importing and compulsory licensing • Threatens pharmaceutical industry’s massive profits • the most profitable industry in the US

  31. Other Consequences • Weakens pharmaceutical industry’s grip on legislators • $110 million dollars spent on lobbying in the first half of 2010 • 1,228 lobbyists (2.3 for every member of Congress) • Revolving door between legislators, lobbyists, executives and government officials

  32. Bayer • Based in Leverkusen, Germany • 107,000 employees worldwide (2008) • Revenue: €31.16 billion (2009) • Pre-tax profits: €6.47 billion (2009) • US = largest market

  33. Bayer • Consists of Bayer HealthCare, Bayer MaterialScience, and Bayer CropScience • Pharmaceuticals • World’s leading pesticide manufacturer • One of world’s largest seed companies • Manufacters bis-phenol A (BPA)

  34. Bayer • Number one biotech company in Europe (after 2001 purchase of Aventis CropScience) • Controls over half of genetically-modified crop varieties up for approval for commercial use • Risks of GMOs

  35. History of Bayer • Trademarked heroin in 1898 • Marketed as cough syrup for children “without side effects”, despite well-known dangers of addiction • Patented acetylsalicylic acid as aspirin in 1899

  36. History of Bayer • WW I: invented modern chemical warfare; developed “School for Chemical Warfare” • WW II: part of IG Farben conglomerate, which exploited slave labor at Auschwitz, conducted unethical human subject experiments (including funding Mengele) • Manufactured and supplied Zyklon B (without usual odorant) to the SS for use in gas chambers

  37. History of Bayer • 24 board members and executives indicted in Nuremberg Trials • 13 received prison sentences • Longest sentence to Fritz Meer • Convicted for plunder, slavery, and mass murder • Released from prison in 1952 • Chairman of supervisory board of Bayer 1956-1964

  38. History of Bayer • Early 1990s – admitted knowingly selling HIV-tainted blood clotting products which infected up to 50% of hemophiliacs in some developed countries • US Class action suits settled for $100,000 per claimant • European taxpayers left to foot most of bill

  39. History of Bayer • 1995 onward - failed to follow promise to withdraw its most toxic pesticides from the market • Failed to educate farmers in developing nations re pesticide health risks • 2 to 10 million poisonings / 200,000 deaths per year due to pesticides (WHO)

  40. History of Bayer • 1998 –pays Scottish adult volunteers $750 to swallow doses of the insecticide Guthion to “prove product’s safety” • Sued the FDA to lift moratorium on human-derived data • 2000 – cited by FDA and FTC for misleading claims regarding aspirin and heart attacks/strokes

  41. History of Bayer • 2000 – fined by OSHA for workplace safety violations related to MDA (carcinogen) exposures • 2000 – fined by Commerce Dept. for violations of export laws

  42. History of Bayer • 2001 – FDA-reported violations in quality control contribute to worldwide clotting factor shortage for hemophiliacs • 2002 - Baycol (cholesterol lowering drug) withdrawn from market • Linked to 100 deaths and 1600 injuries • Accused by Germany’s health minister of failing to inform government of lethal side effects for 2 months

  43. History of Bayer • 2006: Bayer CropScience genetically-modified, herbicide-tolerant “Liberty Link” rice contaminates U.S. food supply • Bayer keeps contamination secret for 6 months, then US government takes another 18 days to respond • Places $1.5 billion industry at risk

  44. History of Bayer • Worldwide cost estimates range from $740 million to $1.3 billion • Bayer loses first three cases for total $53.5 million • Later agrees to pay up to $750 million to farmers in Missouri and 4 other states

  45. History of Bayer • “Liberty Link” rice contamination: • 9/06: 33/162 EU samples tested positive for Liberty Link contamination • EU initially requires testing of all imported rice, then stops in response to US pressure • Japan ban imports of US rice • Over 1,200 lawsuits

  46. History of Bayer • 2007: Member of rubber cartel fined $356 million by European Commission • 2007: Bayer suspends sales of Traysol (aprotinin) 2 years after data show increased deaths in heart surgery patients (Bayer withheld data) • 2008: FDA warns Bayer re unapproved marketing claims for Bayer Women’s Low Dose Aspirin plus Calcium and Bayer Heart Advantage

  47. History of Bayer • 2008: Explosion at Bayer CropScience plant in Institute, WV, kills 2 workers • Above-ground storage tank that can hold up to 40,000 lbs of methyl isocyanate) located 50-75 ft from blast area • Underground storage tank at plant site can store an additional 200,000 lbs

  48. Comparison: Bhopal • 50,000 to 90,000 pounds of methylisocyanate released in Union Carbide Bhopal, India explosion • 7000-10,000 dead within 3 days, 15,000-20,000 more over next 10 years; tens of thousands injured • Persistent water and soil contamination

  49. History of Bayer • 2009: $4 million settlement reached re 2006 release of chemical odorant propyl mercaptan and organophosphate pesticide Mocap from Bayer Cropscience plant in Alabama in 2006, which caused 2 deaths • 2009: Sued by CSPI for false claims about selenium in its “One A Day Men’s Health Formula” multivitamin reducing prostate cancer risk

  50. History of Bayer • 2009: Bayer ordered by FDA and a number of states attorneys general to run a $20 million corrective advertising campaign about its birth control pill Yaz • Failed to inform FDA and public re risks of VTE • Facing thousands of personal injury lawsuits