This article is a summary of the recent, thought-provoking book by NOHA Professional Advisory Board Member Samuel S. Epstein, MD: What's in Your Milk?An Exposé of Industry and Government Cover-Up on the DANGERS of the Genetically Engineered (rBGH) Milk You're Drinking, Trafford Publishing, 2006.*
Dangers from the milk we drink
from cows treated with rBGH
Despite the many efforts of the US Food and Drug Administration (FDA), the US Department of Agriculture, and the biotechnology industry to assure the public of the safety of genetically engineered milk, such claims have never been backed up by proper scientific short or long-term safety tests. Instead of carefully conducting many preliminary safety tests on their own (and at their own expense) before releasing a new potentially dangerous product for widespread treatment of cows and for wide consumer consumption, they prefer to use all of us consumers (and cows) in a massive world-wide "laboratory test," while pocketing much profit during the wait for long-term effects to show up and be proven by others.
Milk from rBGH cows has much higher levels of the natural Insulin-like Growth Factor-1 (IGF-1). . . . Over thirty publications dating back to 1985 report a strong association between increased IGF-1 blood levels and increased risks of breast, colon, and prostate cancer.
Dr. Epstein has documented and released
many articles and letters on the dangers of milk from cows that have been treatedto
increase milk production by about ten percentwith Monsanto's genetically
engineered recombinant bovine growth hormone, rBGH (sold commercially as "POSILAC").
These dangers include:
Specific information about
genetic engineering (GE) and BGH
There are two types of bovine growth hormone (BGH)natural and genetically engineered. The natural hormone (nBGH) in the cow does, as its name implies, promote growth in the animal and also does increase milk production. It was extracted in the 1930s. However, the process was so expensive that it was abandoned. Then, in the 1980s companies found that they could genetically engineer bacteria cheaply and manufacture recombinant bovine growth hormone rBGH. Monsanto's version of the drug, with the trade name POSILAC, won the FDA approval. Sometimes, the same genetically engineered hormone is called recombinant somatotropin rBSTthis is the term most often used outside the USA.
Industry does not have any test to detect rBGH in milk. All FDA evidence of BGH safety is based on an old 1950 study where human dwarfs were given natural BGH. Due to the difference, this does not even begin to support claims of rBGH safety in humans.
Although the natural and the genetically engineered bovine growth hormones are basically quite similar, there is a definite difference. Even the FDA has admitted a three percent molecular difference. Specifically, rBGH contains up to eight additional amino acid groups at one end of the molecule. This greatly alters the way the rBGH behaves biologically in our bodies.
Industry does not have any test to detect rBGH in milk. All FDA evidence of BGH safety is based on an old 1950 study where human dwarfs were given natural BGH. Due to the difference, this does not even begin to support claims of rBGH safety in humans. While n-BGH is metabolically active and gets used similarly to a human growth hormone, rBGH fragments formed during pasteurization or in the human digestive tract can be absorbed and have a wide range of adverse effects.
Genetically engineered (GE) milk is banned in the European Union (24 nations), Canada, Australia, New Zealand, and Japan. Other nations, including South Africa, object to it and are working to ban it too.
In May, 1990 in Bonn Germany, thirty German organizations represented by the Campaign Against BGH, ten European organizations in the European Farmers' Coalition, thirty US organizations in the National Family Farm Coalition, and Dr. Epstein representing independent US scientists and the Rachel Carson Counsel, all met and agreed to: (1) an immediate international ban on BGH, (2) an immediate international ban on the manufacture of all BGH products, (3) an immediate ban on the international shipment of all BGH products, (4) an immediate ban on the sale of milk from cows treated with BGH, (5) an immediate identification of all herds treated with BGH with independent assurances their milk will not be sold to the public and will be destroyed, (6) there is already adequate evidence BGH causes harm to cows and can have potential human health effects. Many more points were made including the listing of all the misleading statements by Monsanto, plus the right to act despite prohibition by the General Agreement on Tariffs and Trade (GATT).
. . . a Canadian scientific team released a "Gaps Analysis" citing the many gaps in scientific data on the dangers of rBGH. It also showed that rBGH was absorbed along with many antibodies.
The FDA granted an Investigative New Animal Drug (INAD) exemption for synthetic hormones on the basis of allegedly confidential data. This allows the sale of GE milk without labeling. Despite Austria's concern about genetically modified (GM) food, Monsanto had its GM milk hormone rBST exclusively manufactured there under a 1998 license. From the Sandoz plant in Kundl, Austria, over 100 million doses of this GM hormone were exported to the US and to sixteen third world countries in 1998. The European Parliament supports the "Precautionary Principle" whichdue to the scientific uncertainty of public health hazards from GM milkcould be used to support a labeling requirement or a complete ban of all GM products. The following objection to the production of rBST in Austria was reported to the European Parliament in December, 1999: ". . . It does not make sense for a product whose use is considered irresponsible to be manufactured in the EU . . ." [bold in the original].
In April, 1998, a Canadian scientific team released a "Gaps Analysis" citing the many gaps in scientific data on the dangers of rBGH. It also showed that rBGH was absorbed, inducing specific antibodies. Due to the diligence of its leaders and backed with Dr. Epstein's documentation, the Gaps Analysis was presented to the Canadian Parliament that requested the Canadian Veterinary Medical Association and the Royal College of Physicians to investigate these concerns. "Based on conclusions on the adverse veterinary effects of rBGH, particularly an increased incidence of mastitis, lameness, and reproductive problems, Health Canada reluctantly broke ranks with the U.S." In January 1999 it banned future sales of rBGH.
Despite the many efforts of the US Food and Drug Administration (FDA), the US Department of Agriculture, and the biotechnology industry to assure the public of the safety of genetically engineered milk, such claims have never been backed up by proper scientific short or long-term safety tests.
In October, 2005, the South African Milk Processors Organization (SAMPRO) decided to formally oppose the use of rBST in dairy herds. Even though most cows in South Africa are not treated with rBST, the fact that it is legal concerns consumers and the export markets. In order to ban rBST, the banning would have to be scientifically proved to the World Health Organization. SAMPRO is now collecting a wide range of scientific data supporting its ban of all rBST.
Industry and government cover-ups
In 1982, at the time the FDA first approved the use of BGH in cows whose milk would go unlabeled to the public, there was at least a five to fifteen day waiting period before the milk could be processed and sold publicly. Researchers had known for twenty-five years that BGH fragments could be active in humans. However, in 1986 the FDA lifted the waiting period requirement. An elevated serum hormone level in BGH-treated cows was one reason the FDA originally required the fifteen day waiting period. Just why the FDA lifted it in 1986 is not available from current documents.
Dr. Susan Sechen requested the industry measure blood hormone levels immediately after a BGH injection. Replies indicate that the industry feared testing blood hormone levels in treated cows would raise public health/safety issues.
In October, 1988, Dr. Susan Sechen requested that the industry measure blood hormone levels immediately after a BGH injection. Replies indicate that the industry feared testing blood hormone levels in treated cows would raise public health/safety issues.
The FDA Center for Veterinary Medicine (CVM) has never conducted proper tests on BGH. Monsanto and other corporate lobbyists "enjoy almost unlimited access" to CVM officials. The Production Drugs Division (PDD) sequestered the BGH data and did not allow anyone from the Division of Toxicology, the Biometrics Branch of the Division of Biometrics and Information, or any experienced veterinary pathologist from the CVM free access to the BGH data. The PDD personnel were not qualified to review the BGH data. They did not seek advice from any qualified veterinary or animal science experts.
With very little (and no long range) testing, the US FDA approved the use of genetically engineered rBGH to increase milk production in 1985. They did one short two-week test on rats, and a small trial group of only seven to ten cows. This is a pitifully small and insignificant statistical sample size for any meaningful test. "At least 2,423 cows would be needed in each group to detect an increase in disease frequency from 5 to 10 percent, and at least 11,773 cows in each group for a change from 1-2%" (Kronfield, D.S., "The Challenge of BST," Large Animal Veterinarian, November/December, 1987). Despite a citizens' petition to the FDA in August, 1989, citing Dr. Kronfield's publications on the adverse veterinary effects of rBGH by the Foundation on Economic Trendsacting on behalf of 42 organizations and citizensdemanding: (1) the immediate halting of all sales of milk from rBGH-treated cows, and (2) funding for long-term research on the economic, veterinary, and human health effects from milk from rBGH treated cows, the FDA failed to respond to the petition.
. . . the US FDA approved the use of genetically engineered rBGH to increase milk production in 1985. They did one short two-week test on rats, and a small trial group of only seven to ten cows. This is a pitifully small and insignificant statistical sample size for any meaningful test. "At least 2,423 cows would be needed in each group to detect an increase in disease frequency from 5 to 10 percent . . .
A 1986 Congressional report concluded:
FDA has consistently disregarded its responsibility. . . . repeatedly put what it perceives are the interests of veterinarians [who use drugs] and the livestock industry ahead of its legal obligations to protect consumers. . . . jeopardizing the health of consumers.
A letter citing this lack of statistically significant test data, and many potential dangers from GE milk including: (1) latent viruses, including bovine immunodeficiency virus (BIV), whose relationship to AIDS (Acquired Immune Deficiency Syndrome) is of concern, and which could be released by stressing cows with the synthetic growth hormone (rBGH), (2) toxic pesticides and PCBs released into milk from the breakdown of fat in GE cows stressed by the continual injection of rBGH, and many more powerful points, was sent by Dr. Epstein to the FDA in July, 1989 with twenty-six cited scientific references. In August, 1989, Dr. Epstein received in return a short letterwith NO referencescontradicting his warnings and claiming that GE milk was perfectly safe, properly tested, and giving "proprietary information" as the excuse for a lack of specific data.
In 1990, Dr. Epstein published another article warning of the many potential dangers from GE milk in the International Journal of Health Services with thirty-four specific references. The FDA published a rebuttal later that year in Science by Ann Gibbons, again with NO references. This FDA rebuttal: (1) had been reviewed by a Monsanto consultant who manipulated and suppressed evidence of adverse veterinary effects, (2) had as a acknowledged contributor, a FDA employee who had violated the FDA's conflict-of-interest rules while on staff by publishing many articles supporting Monsanto and rBGH, (3) claimed references from unpublished data, (4) claimed that the International Journal of Health Services was a little known (and non peer-reviewed) journal when it actually is one of the largest health journals in the U.S. with a wide international audience, and it IS peer reviewed. When the Editor in Chief published a rebuttal to Ann Gibbons critique of Dr. Epstein's article in the International Journal of Health Services emphasizing point (4) and inviting Monsanto to respond, there was no reply.
In August, 1989, Dr. Epstein received in return a short letterwith NO referencescontradicting his warnings and claiming that GE milk was perfectly safe, properly tested, and giving "proprietary information" as the excuse for a lack of specific data.
These warnings by Dr. Epstein and denials by the FDA, USDA, and the National Institutes of Health have continued back and forth for over sixteen years. Other evidence of government and industry deceit and cover-up are: (1) the firing of Dr. Richard Burroughs from the FDA in October, 1989 after he expressed grave concern over the veterinary toxicology of rBGH, (2) in May, 1990, the House Committee on Government Operations charged that "Monsanto and the FDA have chosen to suppress and manipulate animal test datain efforts to approve commercial use of BGH," (3) no human data on a short and long term basis is available on rBGH, their peptide fragments, and foods contaminated with them, and (4) the only way Dr. Epstein became aware of the full dangers from rBGH, was when a large box of classified Monsanto files about rBGH classified tests was delivered (or "leaked") to him in October, 1989.
Dale Bauman was a Monsanto Consultant and on the US Office of Technology Assessment. In 1991 he claimed that even though much mastitis was postulated to occur from rBGH in cows, "no such effects have been observed in any scientific valid public studies." However, the Monsanto 1994 labels on POSILAC (the rBGH drug) listed the need for "Increased use of medication for treating mastitis, and other health problems." Over 20 toxic effects are listed on the label. "At least nine are painful and disabling diseases. Use of this drug is thus inhumane." Bauman's allegation of rBGH safety was accepted by the White House in 1994.
Congressional reactions to
Dr. Epstein's publication
In October, 1989, Senator Patrick Leahy, of the Committee on Agriculture, Nutrition, and Forestry, corresponded with Dr. Epstein about the potential dangers and incomplete testing of milk from cows treated with somatotropin, or bovine growth hormone (BGH). In January, 1990, Senator Leahy wrote to the US General Accounting Office (GAO) requesting an evaluation of the FDA's testing of BGH. He specifically requested evaluating: (1) the adequacy of the FDA risk assessment, (2) the adequacy of animal safety reviews, (3) the process by which outside comments are evaluated and considered, and (4) the development of protocols and the influence of private companies on the development of these protocols, all in regard to BGH.
Congressman [John] Conyers was distressed by learning that critical research on the safety of BGH has been withheld from the public by Monsanto and the FDA. He found it reprehensible that Monsanto and the FDA have suppressed and manipulated animal health test data.
Senator Herb Kohn of the Judiciary Committee thanked Dr. Epstein in January, 1990, for sending the article on BGH. Senator Kohn also expressed concern over potential inadequacies in the FDA testing and he and several of his colleagues requested that the General Accounting Office (GAO) do a through evaluation of the FDA's BHG safety testing.
In February, 1990, Senator Wyche Fowler, Jr., of the Committee on Agriculture thanked Dr. Epstein for his BGH article. Senator Fowler agreed this "is a very important as well as controversial issue."
Congressman John Conyers wrote to the Inspector General of the Department of Health and Human Services in May, 1990. Congressman Conyers was distressed by learning that critical research on the safety of BGH has been withheld from the public by Monsanto and the FDA. He found it reprehensible that Monsanto and the FDA have suppressed and manipulated animal health test data.
In June, 1990 Congressman Conyers wrote the Secretary of the US Department of Health and Human Services requesting that the FDA delay final approval of BGH until investigations and evaluations of the adverse health effects on animals and humans can be completed. He was very troubled that the FDA approved BGH before many important safety questions could be answered.
Confidential Monsanto research
files dispute BHG safety claims
Before these confidential files were leaked to Dr. Epstein in October, 1989, all industry reports and industry funded "scientists" claimed: (1) no increase in hormone levels, (2) no adverse reproductive or other toxic health effects in treated cows, and (3) milk from BGH cows is safe for humans.
The confidential Monsanto files revealed the following:
The truth finally slows POSILAC
The news began to come out slowly in 2003 with hardly a whisper from the mainstream media. Monsanto was not taking any new customers. Domestic and international farmers would see their POSILAC supplies cut in half through the end of 2004. What was happening? Was there a bacterial contamination? Monsanto had been manufacturing POSILAC with an abnormal DNA sequence, which was not the one on which the FDA test had been made. One of the contaminants at the Sandoz plant in Kundl, Austria, plant was Staphylococcus, an antibiotic-resistant bacteria, which had been contaminating hospitals at an alarming rate, infecting children, professional athletes, and Hurricane Katrina evacuees. Another contaminant at the Austria plant was Propionibacterium acnes, a common cause of pimples (acne). It has also caused more serious and intractable infections.
The FDA was concerned that the manager of the Sandoz plant in Austria did not understand the causes of the contamination. They were also tired of translating from German so they insisted all future replies to them be in English.
One of the contaminants at the Sandoz plant in Kundl, Austria, plant was Staphylococcus, an antibiotic-resistant bacteria, which had been contaminating hospitals at an alarming rate, infecting children, professional athletes, and Hurricane Katrina evacuees.
In January, 2005, Monsanto declared that all POSILAC was up to "full scale production." This could hardly be further from the truth. A loyal Florida farmer who always used POSILAC complained that no new customers could get it, only old users. The Milkweed Journal believed that many farmers had weaned their herds from POSILAC during the 2004-05 shortage. Others are turning to a POSILAC "black market" to keep their cows from getting drug withdrawal symptoms. Monsanto is in double violation of its sales contracts by both raising the price and cutting the supply.
In June 2004 Monsanto fired many POSILAC sales personnel, along with the industry-funded "hit squad," and the website attacking all food biotechnology critics.
Monsanto's only other plant to manufacture POSILAC is in Augusta, Georgia, but it has been slow getting built and approved. The Austria plant decided to terminate Monsanto's contract without cause in December 2008. In 2006 POSILAC supplies are running low. The FDA finally approved the Georgia plant in March, 2006. Before that, they had to manufacture POSILAC in Georgia while all the packaging, including filling the syringes, was done in Austria.
This book is an amazing story of the fight by Dr. Epstein and other independent scientists against the deceptions and false claims of safety for consumers and for the injected animals. The story of "Monsanto's Hit Squad" is scary.
Finally, consumers are becoming concerned about the dangers of rBGH milk. Some claim that the huge growth in sales of organic milk is due to the continued use of hormones and rBGH injected into cows.
ENDORSEMENTS of his book include the following two:
"As evidenced in his new book, What's in Your Milk?, Dr. Samuel Epstein has again made a very persuasive and important case about hidden dangers in every day consumer products. And not only does Epstein raise our awareness about possible carcinogens in our milk supply, but also about how special corporate interests seek to keep the public in the dark about documentation relating to health hazards of their products.
"This book is a must read for every American consumer."
Rep. John Conyers
House Judiciary Committee
"Timely and pertinent, What's in Your Milk? is the most comprehensive review of the dairy industry's plunge into the darkness of bio-engineering of what we drink and eat. Epstein describes a massive international experiment including hundreds of millions of adults and children as unknowing subjects. The book's documentation of the cancer and other risks of rBGH milk make a compelling case for recognition of the role of public interest science in protecting the public interest."
Quentin D. Young,
Chairman, Health and Medicine Policy Research Group
Past President, American Public Health Association
*The book is available from Trafford Publishing, www.trafford.com/06-0676, or by calling Trafford's Order Desk at 888-232-4444 or 250-383-6864, and at amazon.com and main bookstores. $24.95 USD
For overseas orders, contact national Amazon sites or other major bookstores and on-line retailers. £14.35 GPB, 20.49 Euros