Presentation on theme: "RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST)"— Presentation transcript:
1 RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST) Slides prepared byRick North, Oregon Physicians for Social ResponsibilityHealth Care Without Harm rBGH CoordinatorTHE PROBLEM IS RECOMBINANT BOVINE GROWTH HORMONE. THE OREGON CHAPTER OF PHYSICIANS FOR SOCIAL RESPONSIBILITY IS VERY CONCERNED ABOUT THIS ISSUE AND IS COMMITTED TO PROVIDING INFORMATION TO THE PUBLIC AND TAKING ACTION.
2 RECOMBINANT BOVINE GROWTH HORMONE (rBGH) Or rBST · Genetically engineered drug developed by Monsanto, sold to Elanco (Eli Lilly) Oct. ‘08· Increases milk production 5-15%· Estimated 15% of dairy cows injected nationwide; 0-5% in Oregon, WashingtonRECOMBINANT BOVINE GROWTH HORMONE IS ALSO KNOWN AS RBGH OR RBST. IT’S A GENETICALLY ENGINEERED DRUG PRODUCED BY THE MONSANTO CORPORATION.IT INCREASES MILK PRODUCTION TYPICALLY 10-15%IT’S ESTIMATED THAT 20-25% OF OREGON DAIRY COWS ARE INJECTED WITH IT. OUT OF THE 320 DAIRY FARMS IN OREGON, AN ESTIMATED 15% USE IT.(NOTE: THIS MAY NOW BE LESS SINCE MONSANTO CUT PRODUCTION AND DISTRIBUTION TO CUSTOMERS BY 50% ON MARCH 1, 2004, OSTENSIBLY BECAUSE OF MANUFACTURING PROBLEMS.)
3 OUR GOAL Discontinue the production of any dairy products from cows treated with rBGH
4 OUR METHOD Grassroots education campaign so that citizens can make an informed decisionTHIS IS OUR METHOD – GOING DIRECTLY TO THE PUBLIC AND SHOWING GROUPS LIKE YOU WHAT WE’VE FOUND, MOST OF WHICH IS A MATTER OF PUBLIC RECORD, BUT LARGELY UNKNOWN.WE’RE NOT GOING TO THE LEGISLATURE TO TRY TO ENACT A LAW AND IN FACT ARE NOT USING ANY POLITICAL MEANS.OUR AIM IS THAT ENOUGH PEOPLE WILL SWITCH TO NON-RBGH DAIRY PRODUCTS, EITHER ORGANIC OR CONVENTIONAL NON-RBGH. THEN DAIRIES CURRENTLY USING THE HORMONE WILL SEE THE ECONOMIC ADVANTAGE TO KEEPING THEIR CUSTOMERS AND DISCONTINUE ITS USE. THIS IS A MARKET-BASED APPROACH. IT’S NOT LEGISLATIVE, BUT YOU HAVE AN ENORMOUS AMOUNT OF POWER BY “VOTING WITH YOUR DOLLARS.”
5 THE PROBLEMS WITH rBGHIncreases rates of 16 medical conditions occurring in cows – reduced pregnancy rates and birth weight of calves, increased diarrhea, foot disorders, lesions, somatic cell counts (pus), mastitis. Condemned by:Humane Society of U.S.Humane Farming AssociationFarm SanctuaryMastitis/antibiotic resistance connection in humansIGF-1 and cancer in humans
6 IGF-1 survive digestion? rBGH, IGF-1 AND CANCERNOT IN DISPUTEIGF-1 is present and identical in cows and humansrBGH increases IGF-1 in cows’ milkElevated IGF-1 promotes cancer in humansPromotes cancer in humansTHE OTHER MAJOR HUMAN HEALTH CONCERN IS IGF-1. LET’S START WITH WHAT IS NOT IN DISPUTE. FIRST, IGF-1 IS PRESENT IN BOTH COWS AND HUMANS AND HAPPENS TO BE CHEMICALLY IDENTICAL.SECOND, RBGH INCREASES IGF-LEVELS IN COWS’ MILK. FINALLY, ELEVATED LEVELS OF IGF-1 PROMOTES INCREASED CANCER RATES IN HUMANS. ALL THREE OF THESE POINTS ARE WELL KNOWN AND ACKNOWLEDGED BY BOTH MONSANTO AND THE FDA.WHAT’S IN DISPUTE IS WHETHER THE IGF-1 IN MILK SURVIVES DIGESTION IN HUMANS TO ENTER THE BLOOD STREAM WHERE IT CAN CAUSE TROUBLE. MONSANTO AND THE FDA MAINTAIN THAT WE DON’T HAVE TO WORRY ABOUT IT BECAUSE IT’S DESTROYED BY DIGESTION.WE DISAGREE – HERE’S WHY.Elevated IGF-1In humansIncreases IGF-1in cows’ milkrBGHIGF-1 survive digestion?
7 CASEIN PROTECTS IGF-1“ Casein (was) effective in preserving IGF-1 structural integrity (80%) and receptor binding activity. . .”(C.J. Xian et al, “Degradation of IGF-1 in the adult rat gastrointestinal tract is limited by a specific antiserum or the dietary protein casein,” Journal of Endocrinology, v. 146, 1995.) “This paper clearly showed that IGF-1 can survive digestion (67%) when in the presence of casein.”(Michael Hansen, Consumer Policy Institute, Letter to Maine Attorney General G. Steven Rowe, Feb. 11, 2003, citing T. Kimura et al, Journal of Pharmacology and Experimental Therapeutics, v. 283, 1997.))“Casein greatly enhanced the stability of IGF ”(P. Anderle et al, “In Vitro Assessment of Intestinal IGF-1 Stability,” Journal of Pharmaceutical Sciences, v. 91, 2002.)ALL DAIRY PRODUCTS HAVE A PROTEIN CALLED CASEIN. SO WHILE IGF-1 IN ISOLATION IS DESTROYED BY DIGESTION, MOST OF IGF-1 IN THE PRESENCE OF CASEIN IS PROTECTED AND CAN ENTER THE BLOODSTREAM.SEVERAL LABORATORY STUDIES HAVE INDICATED THIS. HERE ARE EXAMPLES OF THREE OF THEM. AFTER THOROUGHLY SEARCHING THE MEDICAL LITERATURE, WE COULD NOT FIND ONE. STUDY THAT INDICATED CASEIN DOESN’T PROTECT IGF-1.
8 FDATHIS PRESENTATION IS QUITE CRITICAL OF THE FDA, SO WE’D LIKE TO STOP HERE BEFORE PROCEEDING. THIS IS NOT A BLANKET CONDEMNATION OF THE AGENCY. WE THINK IT HAS A LOT OF GOOD PEOPLE AND HAS DONE A LOT OF GOOD THINGS. MOREOVER, IT HAS AN ENORMOUS JOB REGARDING FOOD SAFETY AND IS OFTEN SHORT OF THE PEOPLE AND MONEY IT NEEDS TO DO EVERYTHING THAT NEEDS TO BE DONE. SO, WE WANT TO KEEP THINGS IN PERSPECTIVE.BUT HAVING SAID THAT, AFTER SPENDING LITERALLY HUNDREDS OF HOURS RESEARCHING SCIENTIFIC AND HISTORICAL RECORDS, WE COULD ONLY CONCLUDE THAT FDA MADE A SERIOUS MISTAKE AND DID NOT PROPERLY PROTECT THE PUBLIC’S HEALTH WHEN IT APPROVED RBGH.WHY? IN THE 1980’S, THE U.S. GOVERNMENT, DECIDED THAT GENETIC ENGINEERING WOULD BE GOOD FOR THE U.S.ECONOMY AND SHOULD BE PROMOTED. PLEASE NOTE THAT THIS WAS COMING RIGHT FROM THE TOP, THE WHITE HOUSE, AND WAS NOT A PARTISAN ISSUE. IT HASN’T MADE MUCH DIFFERENCE WHETHER A DEMOCRAT OR REPUBLICAN WAS IN OFFICE. IF YOU TRIED TO STAND IN THE WAY OF GENETIC ENGINEERING, NO MATTER HOW GOOD YOUR ARGUMENTS, YOU WERE GOING AGAINST THE BIOTECH INDUSTRY AND OUR GOVERNMENT SUPPORTING THEM.ALONG WITH A GENETICALLY ENGINEERED TOMATO, RBGH WAS THE FIRST TEST CASE, SO IT HAD A PIVOTAL PLACE IN THE FUTURE APPROVAL OF ALL GE PRODUCTS.
9 THE MONSANTO-FDA REVOLVING DOOR Michael TaylorFDA Deputy Commissioner For Policy ( ). Previously a partner at King & Spalding representing Monsanto.Margaret MillerFDA Branch Chief for Hormones and Pharmacological Agents, other positions ( ). Worked for Monsanto fromHERE ARE SOME SPECIFICS ON RBGH. YOU’VE ALL HEARD ABOUT THE REVOLVING DOOR IN WASHINGTON, WHERE INDIVIDUALS GO BACK AND FORTH BETWEEN REGULATORY AGENCIES AND THE INDUSTRIES THEY’RE SUPPOSED TO REGULATE.MICHAEL TAYLOR WAS A LAWYER AT KING & SPALDING IN WASHINGTON REPRESENTING MONSANTO BEFORE BEING BROUGHT IN AS DEPUTY COMMISSIONER AT FDA. HE WAS THE ONE THAT MADE THE FINAL DECISION THAT RBGH MILK DIDN’T HAVE TO BE LABELED.MARGARET MILLER WORKED FOR MONSANTO ON RBGH BEFORE BEING BROUGHT IN TO FDA TO HOLD A VARIETY OF POSITIONS DEALING WITH ITS APPROVAL.SUZANNE SECHEN WAS A GRAD STUDENT AT CORNELL WORKING ON RBGH RESEARCH UNDER A PROFESSOR THAT HAD BEEN PREVIOUSLY FUNDED BY MONSANTO BEFORE BEING BROUGHT IN AS PRIMARY REVIEW OFFICER FOR THE DRUG AT FDA.Suzanne SechenFDA Primary Review Officer for rBGH ( ). Previously a graduate student at Cornell doing rBGH research.
10 DISSENT WITHIN THE FDAAlexander Apostolou, Director of Toxicology: “Sound scientific procedures for evaluating human food safety of veterinary drugs have been disregarded.”- Forced to quit FDAJoseph Settapani, Chemist in charge of quality control : Described “a systematic human food-safety breakdown at the Center for Veterinary Medicine. Dissent is not tolerated if it could seriously threaten industry profits.”– Reprimanded, threatened with dismissal, stripped of duties as supervisor(Craig Canine, “Hear No Evil,” Eating Well, July/August 1991.)TAKE A LOOK AT WHAT SOME OF THE SCIENTISTS REVIEWING RBGH AT FDA HAD TO SAY AND WHAT HAPPENED TO THEM (ALLOW TIME FOR AUDIENCE TO READ).AGAIN, GOVERNMENT AND INDUSTRY PRESSURE TO PUSH GENETIC ENGINEERING WAS VERY EVIDENT.
11 DISSENT WITHIN THE FDARichard Burroughs, Reviewer for rBGH for nearly five years: “. . . the Center decided to cover up inappropriate studies and decisions.” Officials “suppressed and manipulated data . . .”– Fired (Jeffrey Smith, Seeds of Deception, Chelsea Green Publishing, 2003.)RICHARD BURROUGHS WAS A VETERINARIAN AND LEAD REVIEWER FOR RBGH IN FDA. HE’S QUITE CLEAR THAT HE BELIEVES THE SCIENTIFIC INTEGRITY OF THE REVIEW WAS SERIOUSLY COMPROMISED TO APPROVE THIS DRUG NO MATTER WHAT.HE WAS FIRED.WE REALIZE THAT ANY ORGANIZATION, WHETHER IT’S THE GOVERNMENT, PRIVATE BUSINESS OR A NON-PROFIT, CAN HAVE DISGRUNTLED EMPLOYEES.HOWEVER, IT WASN’T JUST THESE THREE. THIS SITUATION BECAME SO BAD THAT OTHER EMPLOYEES AT FDA, SEEING WHAT WAS GOING ON, WROTE A LETTER TO CONGRESS EXPRESSING THEIR OUTRAGE.
12 CONGRESSIONAL INVESTIGATION – GAO On human food safety risks:“. . . we were unable to acquire the data from either the University of Vermont or from Monsanto . . .”(Eleanor Chelimsky, “rBGH Vermont Review, Chronology of Events,” Memorandum from the U.S. General Accounting Office to U.S. Rep. Bernard Sanders, Oct. 27, 1992.)“These risks are not covered by the FDA guidelines and have not been addressed for rBGH.”(GAO, “Recombinant Bovine Growth Hormone, FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved,” August 6, 1992.) THE INVESTIGATIONAL ARM OF CONGRESS, THE GENERAL ACCOUNTING OFFICE, BECAME INVOLVED. IN THE FIRST PLACE (FIRST QUOTE), THEY WERE NOT ABLE TO GET ALL THE INFORMATION THEY WANTED FROM THE U. OF VERMONT, WHERE SOME OF THE RBGH TESTS WERE BEING CONDUCTED, OR FROM MONSANTO.HOWEVER, FROM THE DATA THEY WERE ABLE TO OBTAIN, THEY CAME TO THE SAME CONCLUSION: HUMAN FOOD SAFETY RISKS WERE NOT BEING ADEQUATELY ADDRESSED.IN SPITE OF THESE FINDINGS, HOWEVER, NOTHING FURTHER CAME OUT OF CONGRESS AND RBGH WAS APPROVED IN NOVEMBER 1993.
13 FDA 1994 RULING ON LABELING FDA does not require labeling of any product from cows treated with rBGH – it is voluntary.FDA recommendation for dairies not using rBGH: “No significant difference has been shown between milk derived from cows treated with rBGH and those not treated with rBGH.”THE FDA’S QUESTIONABLE DECISION THAT RBGH IS SUBSTANTIALLY EQUIVALENT LED TO THEIR DECISION IN NOVEMBER 1993 APPROVING RBGH AND NOT REQUIRING LABELING IF USED, SAYING LABELING WAS VOLUNTARY. IN THE DECADE SINCE ITS APPROVAL, WE’RE NOT AWARE OF ANY DAIRY THAT HAS VOLUNTARILY TOLD ITS CUSTOMERS THAT ITS MILK CAME FROM COWS GIVEN THIS HORMONE.FURTHERMORE, THE FDA RECOMMENDED THAT ANY DAIRY LABELING ITS PRODUCTS AS RBGH-FREE ADD THIS STATEMENT OR ONE SIMILAR TO IT. PLEASE NOTE THIS IS A RECOMMENDATION, NOT A REQUIREMENT, SO SOME RBGH DAIRIES ADD IT AND SOME DON’T.
14 CANADIAN SCIENTISTS QUESTION rBGH SAFETY “Both procedural and data gaps were found which fail to properly address the human safety requirements of this drug . . .”“. . . sterility, infertility, birth defects, cancer and immunological derangements were not addressed.” “IGF-1 also can survive the GI tract The full significance of this finding also was not investigated.” (“rBST ‘Gaps Analysis’ Report,” Internal Review Team, Health Canada, April 21, 1998.)BUT WHEN MONSANTO APPROACHED CANADA FOR APPROVAL, THINGS TURNED OUT DIFFERENTLY. A SPECIAL COMMITTEE OF HEALTH CANADA, THEIR COUNTERPART TO THE FDA, DID AN INTENSIVE REVIEW OF THE FDA’S SCIENCE AND APPROVAL PROCESS AND WERE VERY TROUBLED BY WHAT THEY FOUND (READ QUOTES).NOTE THAT EVEN AS FAR BACK AS 1998, THEY WERE ALSO SAYING THAT IGF-1 COULD SURVIVE DIGESTION, IN CONTRAST TO WHAT FDA AND MONSANTO CONTINUE TO SAY TO THIS DAY.THEY FOUND THE IMPROPRIETIES OF THE FDA RESEARCH SO SERIOUS THAT THEY EVEN NAMED THEIR STUDY THE “GAPS” REPORT.CANADA BANNED USE OF THE DRUG, OFFICIALLY ON THE GROUNDS OF THE HARM IT DOES TO THE COWS, BUT YOU CAN SEE ALSO THE HUMAN HEALTH CONCERNS THEY HAD.
15 EU SCIENTISTS QUESTION rBGH SAFETY “. . . an association between IGF-1 and breast and prostate cancer is supported by epidemiological studies.”“An increased use of antimicrobial substances in the treatment of rBST related mastitis which might lead to an increased risk of residue formation in milk and to the selection of resistant bacteria.” (The European Commission, Report on Public Health Aspects of the Uses of Bovine Somatotropin, “Food Safety: From the Farm to the Fork,” March 15-16, 1999.)THE OPPOSITION TO RBGH WENT FURTHER THAN JUST THE FDA AND CANADIAN SCIENTISTS. WHEN THE EUROPEAN SCIENTISTS REVIEWED RBGH, THEY HAD THE SAME CONCERNS WITH IGF-1 AND ANTIBIOTIC RESISTANCE. THE UNDERSCORING IS OURS.THE EUROPEAN UNION ALSO BANNED RBGH.
16 INTERNATIONAL OPPOSITION The Codex Alimentarius Commission, the U.N.’smain food safety body, declined to declare rBGH safe in1997 and It has not been brought up since.Industrialized nations banning rBGH: European Union (27 nations), including Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United KingdomTHE CODEX ALIMENTARIUS COMMISSION IS THE UN’S MAIN FOOD SAFETY BODY.THREE TIMES THE U.S. HAS BROUGHT UP RBGH FOR APPROVAL FOR SAFETY. THREE TIMES THE CODEX HAS VOTED TO SAY IT CANNOT BE DECLARED SAFE.THESE ARE SOME OF THE COUNTRIES THAT HAVE BANNED RBGH.New ZealandJapanCanadaAustralia
17 HEALTH CARE WITHOUT HARM June 2005 Position Statement“Health Care Without Harm opposes the use of recombinant Bovine Growth Hormone, (rBGH or rBST) due to its adverse impacts on animals and potential harm to humans. We therefore encourage health care providers to purchase non-rBGH milk from suppliers.”Over 250 hospitals in 23 states pledge to go rBGH-free
18 AMA, ANA STATEMENTSAMA – No official policy; Ron Davis, MD, President: “Hospitals should use milk produced without bovine growth hormone . . .” (AMA eVoice column 4/24/08) ANA – Official resolution opposing rBGH passed by House of Delegates: “Support laws, regulations and policies that specifically reduce the use of rBGH . . .” (enacted June 2008)
19 APHA POSITION STATEMENT “APHA is therefore opposed to the use of hormone growth promoters in beef and dairy production . . .The FDA act with public health precaution to ban their use . . .Hospitals, schools and other institutions, especially those serving children, preferentially purchase food products from beef and dairy cattle produced without such hormones.”- November 2009
20 NORTHWEST rBGH-FREE RESPONSE April ‘05: Tillamook cheese, followed by ice cream, butter, yogurtJune ‘05: Eberhard totallyNov. ‘05: Alpenrose totallyNov. ’05: Darigold starts one line of milk; Feb. ’06: all yogurt; Dec. ‘08 all productsJuly ’06: Wilcox totallyJan. ’07: Safeway (NW) milk onlyJan. ’07: Starbucks asks all suppliers nationwide
21 2006-09 NATIONWIDE RIPPLE EFFECT June ’06: Darigold, Meadow Gold – Montana April ‘08: WalMartJune ’06: Garelick – New Jersey April ‘09: GlanbiaOct. ’06: Hood, Garelick – New England Aug. ‘09: YoplaitOct. ’06: Dean Foods – Texas, New Mexico Dec. ‘09: DannonFeb. ’07: Byrne – New YorkFeb. ’07: Sinton – ColoradoMar. ’07: Price Chopper – New YorkAug. ’07: California Dairies, Inc. – CaliforniaApril ’07: Publix Super Markets – FloridaSept. ’07: Southeast Milk, Inc. – FloridaOct. ‘07: Wawa, Turner - PennsylvaniaFeb. ‘08: Kroger - Ohio
22 WE’VE COME A LONG WAY57 out of Top 100 Completely or Partially rBGH-Free65% - 75% Fluid Milk Completely75% Yogurt Completely
23 NEXT STEPS WHAT DO YOU THINK? rBGH-free products in all five major categories – milk, yogurt, cheese, butter, ice creamLine-item identification for all rBGH-free products
25 WHAT YOU CAN DO Buy dairy products from dairies not using rBGH Tell people you knowStay informed – get on the PSR update list (approx. 2x per month)Set up presentations to other groupsWHAT CAN YOU DO? FIRST AND FOREMOST, BUY DAIRY PRODUCTS THAT ARE LABELED RBGH- OR ARTIFICIAL HORMONE-FREE. THIS INCLUDES ALL ORGANIC BRANDS AND NON-ORGANIC BRANDS LIKE SUNSHINE AND TRADER JOE’S. DAIRIES THAT ARE NON-RBGH BUT NOT LABELING YET INCLUDE LOCHMEAD IN JUNCTION CITY AND UMPQUA IN ROSEBURG. FOR ANY OTHERS, YOU SHOULD ASSUME THAT AT LEAST SOME OF THEIR MILK HAS COME FROM RBGH COWS.FOR ORGANIZATIONS, WE ARE ALSO LOOKING FOR ENDORSEMENTS AND HAVE A SIMPLE FORM TO FILL OUT.WE ALSO HAVE AN UPDATE THAT WE SEND OUT ABOUT TWICE A MONTH THAT GIVES THE LATEST INFORMATION ON THIS CAMPAIGN AND OUR OTHER ONE ON BIOPHARMACEUTICAL CROPS (CROPS GENETICALLY ENGINEERED TO PRODUCE DRUGS OR INDUSTRIAL CHEMICALS), PLUS HIGHLIGHTS OF OTHER NEWS ON GENETIC ENGINEERING THAT YOU TYPICALLY WILL NOT SEE IN THE MEDIA.WE HAVE A SIGN-UP SHEET FOR ANYONE THAT WOULD LIKE TO BE ON THIS UPDATE LIST.
26 . . . GARFIELD THE CAT. BUT TAKE A LOOK (ALLOW TIME TO READ). I THINK ALL OF US HUMANS, TO ONE DEGREE OR ANOTHER, FEEL THE SAME WAY AS GARFIELD. OUR LIVES ARE TOO BUSY, WE’RE OVERLOADED WITH TOO MUCH INFORMATION, AND IF WE DO GET MORE, WE WANT GOOD NEWS, NOT SOMETHING WE DIDN’T WANT TO HEAR.REGARDING FOOD SAFETY, WE ALL WANT TO COUNT ON THE FDA TO PROTECT US, SO WE WON’T HAVE TO WORRY ABOUT IT. WE REALIZE THAT THIS PRESENTATION HAS EXPRESSED THE OPINION THAT THE FDA’S PROTECTION ISN’T ADEQUATE.BUT EVEN THOUGH WE DIDN’T DELIVER HAPPY NEWS, WE HOPE THAT ON BALANCE, YOU’LL BE VERY GLAD YOU RECEIVED IT. THIS INFORMATION IS QUITE EMPOWERING AND PUTS YOU IN THE DRIVER’S SEAT OF THAT CAR AT THE FORK IN THE ROAD. YOU CAN TURN YOUR STEERING WHEEL ANY DIRECTION YOU WANT.THANK YOU.
27 THE rBGH DIFFERENCE IN MILK Monsanto’s rBGH adds one amino acid to the cow’s natural growth hormone protein.rBGH is twice as immunogenic for certain antibodies than natural BGH.IGF-1 levels in milk from rBGH-treated cows significantly increased (Michael Hansen, Senior Research Associate, Consumer Policy Institute, Letter to Maine Attorney General G. Steven Rowe, Feb. 11, 2003, citing M.H. Erhard et al, Journal of Immunoessay, v. 15, 1994 and four Monsanto studies from ) ALL COWS HAVE GROWTH HORMONE. RBGH IS PRODUCED BY ADDING ONE AMINO ACID TO THIS GROWTH HORMONE PROTEIN. ONE AMINO ACID MAY NOT SOUND LIKE MUCH, BUT IT CAN HAVE A PROFOUND EFFECT. FOR INSTANCE, ONE ADDITIONAL AMINO ACID CAN RESULT IN SICKLE-CELL ANEMIA.FOR CERTAIN ANTIBODIES, RBGH IS TWICE AS IMMUNOGENIC, WHICH MEANS THAT THE BODY IS RECOGNIZING A FOREIGN SUBSTANCE THAT HAS GAINED ENTRY AND IS REACTING TO IT.FINALLY, RBGH INCREASES LEVELS OF ANOTHER GROWTH HORMONE CALLED IGF-1(INSULIN-LIKE GROWTH FACTOR-1). VARIOUS STUDIES HAVE SHOWN INCREASES RANGING FROM %, BUT ALL HAVE BEEN STATISTICALLY SIGNIFICANT. BOTH COWS AND HUMANS NATURALLY HAVE A CERTAIN LEVEL OF IGF-1, BUT ELEVATED LEVELS OF THE HORMONE HAVE BEEN ASSOCIATED WITH CANCER. WE’LL RETURN TO THIS IN A FEW MINUTES.
28 CONGRESSMEN RESPONDRepresentatives George Brown, David Obey and Bernard Sanders: “The entire FDA review of rBGH seemingly has been characterized by misinformation and questionable actions on the part of both FDA and the Monsanto Company officials.”(Letter to GAO comptroller general Charles Bowsher, April 15, 1994.)Representative Sanders: “The FDA allowed corporate influence to run rampant in its approval of rBGH.” (Bernard Sanders, Press Release, “GAO Uncovers Appearances Of Impropriety In FDA’s Approval Of RBGH, “ Oct. 30, 1994.)
29 SCANDAL IN CANADA“The senators sat dumbfounded as Dr. Margaret Haydon told of being in a meeting when officials from Monsanto, Inc., the drug’s manufacturer, made an offer of between $1 million and $2 million to the scientists from Health Canada – an offer she told the senators could only have been interpreted as a bribe.”(“Monsanto Accused of Attempt to Bribe Health Canada for rBGH Approval,” The Ottawa Citizen, Ottawa, Canada, Oct. 23, 1998)
30 30 RATS IN 90 DAYS CPI, CANADIANS QUESTION Consumer Policy Institute: “ to 30 percent of the rats in the high dose group developed primary antibody responses to rBGH, suggesting it was being absorbed into the bloodstream. In the view of the Canadian scientists, and in our view as well, these are toxicologically significant changes, and should have triggered a full human health review . . .”(Michael Hansen, Ph. D., Research Associate, “FDA’s Safety Assessment of Rcombinant Bovine Growth Hormone,” Consumer Policy Institute, December 15, 1998)
31 BRITISH MEDICAL JOURNAL 2000 EDITORIAL “Given the increasing evidence of the risk of cancer, caution should be exercised in the exogenous use of either insulin-like growth factor-1 or substances that increase concentrations of it.”(George Smith et al, Editorial: “Cancer and insulin-like growth factor-1,” British Medical Journal, vol. 321, October 7, 2000.)(READ QUOTE)THE BRITISH MEDICAL JOURNAL IS THE PUBLICATION OF THE BRITISH MEDICAL ASSOCIATION.EXOGENOUS MEANS FROM OUTSIDE THE BODY. THEY ARE ALSO WARNING AGAINST ANY SUBSTANCES INCREASING IGF-1, WHICH OF COURSE INCLUDES RBGH. AGAIN, THE UNDERSCORE IS OURS.
32 JOURNAL OF THE NATIONAL CANCER INSTITUTE 2000 REVIEW “Laboratory studies have shown that IGF’s exert strong mitogenic and antiapoptotic actions on various cancer cells.”“The role of IGF’s in cancer is supported by epidemiologic studies, which have found that high levels of IGF are associated with increased risk of several common cancers . . .”(Herbert Yu, Thomas Rohan, “Role of the Insulin-Like Growth Factor Family in Cancer Development and Progression,” Journal of the National Cancer Institute, v. 92, Sept. 20, 2000.)THIS 2000 REVIEW WRITTEN UP IN THE JOURNAL OF THE NCI EXAMINED 350 SCIENTIFIC STUDIES. BOTH LABORATORY AND POPULATION STUDIES SHOWED IGF-1’S CONNECTION WITH CANCER. THE UNDERSCORES ARE OURS.MITOGENIC MEANS IT INCREASES CELL DIVISION, WHICH WHEN OUT OF CONTROL BECOMES CANCER. ANTIAPOPTOTIC MEANS THAT CELLS HAVE A PROGRAMMED LENGTH OF TIME TO LIVE. IF THEY DON’T DIE ON SCHEDULE, THAT CAN PROMOTE CANCER ALSO. IGF-1, IN SOME CASES, IS PREVENTING THEM FROM DYING WHEN THEY’RE SUPPOSED TO.
33 ONCOLOGY2002 REVIEW“Recent evidence from epidemiologic studies has confirmed an association between serum levels of IGF’s and several malignancies . . .” “It is now well established that IGF-1 enhances mitogenicity of breast cancer cells via a variety of mechanisms.”(S. Moschos and C. Mantzoros, “The Role of the IGF System in Cancer: From Basic to Clinical Studies and Clinical Applications,” Harvard Medical School, Oncology, v. 63, n. 4, 2002.)