C Greg Guyer 4/27/94 Director Division of Chemistry Center for Drug Evaluation DHHS Food and Drug Administration Rockville, MD 20857 Dear Dr. Guyer: On May 3rd, we will invalidate the SCIENCE article which you co-authored with Dr. Juskevich. This will be done before legal counsel of the City of New York. I invite you and the Monsanto people, please also bring Mr. Mike Taylor (the former Monsanto attorney, now Deputy Director FDA) to come and explain the following: 1. The reasons for the errors between your Ann. Rich. Vet. article and the SCIENCE article. Please bring a copy of the original notebook. There are four differences. 2. Why in the summary of your paper statistically significant oral effects were not mentioned but noted as significant in the Table 5 data. 3. Why no teratogenic [fetal development hazards] data were reported or done 4. Why no long term exposure data and two year feeding studies were done on zinc rBGH and rBGH milk, and why the liver effects cited by Groenewegen brom rBGH milk fed 90 days were ignored (J. Nutrition 120, 514) 5. Why IGF-I was tested only about two weeks when it showed a statistically significant oral effect during this period of exposure in some tests. 6. As a policy I invite the Policy Director, Mr. Taylor, to explain to the public how short term tests are being used to clear chemicals for long term exposure. Please explain how epidemiology can be replaced by short term tests. Also explain how we can go from 30 rats to 240 million people using a 90 days test. 7. Please ask Commissioner Kessler to give you a note saying to the people of New York why no quality assurance test is in the public domain as for antibiotics imported and so forth. We look forward to hearing your explanations and also to see the actual data which were used in the Ann. Rech. Vet. article. [signed Dr. William C. von Meyer] Fairview Industries ----------------------------------------------------------------------- Invalidation of Scientific Publication(s) Ann. Rech. Vet. 21, Suppl. 1, 107s, 1990 and SCIENCE 249, 875, 1990 by Hammond and Juskevich et. al, respectively, as Documentation for Determination of Safety of Bovine Growth Hormone Derived Milk and Components of the Milk Process. Whereas, documents in health research concerning the safety of materials to large number of consumers must be accurate and precise; and, Whereas, large numbers of people are contacted by milk and milk process products over a life span, and Whereas, Monsanto Corporation of St. Louis and others propose to change the process for the manufacture of milk using new h ormone chemicals, signified as rBGH and rBST from recombinant genetic processes involving fermentation; and Whereas, data have been submitted to the F.D.A. on the safety of the milk and the process and its components, and Whereas, the data as published show errors and clever deviations from standard and well established safety practice which would be detected only by an experienced scientist as given in Attachment 1, and Whereas, the editor of the publication SCIENCE has shown a bias which is not permitted in strict science data reviews (Attachment 2) such that this bias may permit the propagation of errors and misinterpretation; and, Whereas, data concerning the residual action and occurrence of forms of IGF-I (insulin-like growth factor -I, a material not well understood as to its actions) may involved the biochemistry and development of or enhancement of cancer cell growth, and Whereas, several experiments show an increase in IGF-I in raw rBGH milk such that long term feeding tests are mandatory, and Whereas, a report of off-grad rBGH has leaked to the public as reported in letters to Dr. Kessler and Ms. Browner (E.P.A.) and the City Council of New York, and we lack a public quality control methodology for rBGH, a subject omitted in the SCIENCE paper; Now, therefore, the SCIENCE and Ann. Rech. Veg. 21, suppl 1 107s documents defined in the title above are declared invalid as careful reviews of the health and safety data concerning rBGH milk as provided in Attachment 1. [signed] Dr. William C. von Meyer 5/1/94 C.E.O., Member N.Y. Academy of Science and Am. Association of Adv. of Science [signed] Notary ---------------------------------------------------------------------- Attachment 1. The figures in Table 4. of SCIENCE 249, 875, 1990, derived from the same animals as reported in an article in Ann. Rec. Vet. 21, suppl. 1, 107s lack numerical agreement. All publications of the health review of rBGH milk lack any long term or chronic toxicological data in standard animal models; no test longer than 90 days. The summary of the SCIENCE article indicates no oral effects were noted while the tables of data reported indicate, by symbols indicating statistical significance at P.05 or P.01, oral activity was observed. Reproduction and teratogenicity data have not been published in SCIENCE and critical tests were not conducted, however, reports of reproductive disturbances in cow have come to the public's attention and concern (Montpelier Chronicle Nov. 20, 1991 and comments from Mr. Kurtz, Lewiston, MN.) In the former report animals receiving a growth hormone preparation showed retained placenta and skipped generation teratogenic effects. In the Minnesota report, 19% of the cows died from stress including hip breakdown after two lactations on rBGH. These kinds of data have been omitted from the reviews and freedom of information documents issued to date. A short term oral feeding test in rat of rBGH milk showed effects on liver in J. Nutrition 120, 514. The SCIENCE article failed to alert the public that a 90 day test on 30 rats at a given dose is the longest test which has been conducted on rBGH milk. Normal tests and publications regarding chronic safety involve a minimum of two years exposure and careful observation. In this case the American public would be asked to accept a product, without a label in many states, which lacks long term tests, quality control in public labs, and with only short term test on potenial orally active by-product hormones like IGF-I. The data review of rBGH milk fails to relate for its value in quality control concerns that other proteins are very toxic at low dosage and/or orally active such as botulinin, cholera toxin, and even such vaccines as polio vaccine. The SCIENCE article assumes digestion of all putative rBGH milk toxins because they are proteins but fails to cite any well known stable and orally active proteins. Long term, or slow diseases, like diabetes and arthritis were not examined. The Report in SCIENCE fails to related to the public the role of zinc in the product and process. Of concern is the formation of stable zinc derivatives which may have unique toxicology and chemistry. A well known form of zinc protein is the zinc loop protein which can bind to DNA. Also there is lacking a discussion involving the problem of women and children contacting raw milk on the farm which is higher in IGF-I. ----------------------------------------------------------------------- Question by Walter McCaffrey, City of New York, to Robert Collier of Monsanto, "Is Dr. von Meyer's testimony that the longest test on rBGH milk is 90 days true?" Reply by Robert Collier, Director Animal Health Research, Monsanto. "Yes." (Hearing 194, City of New York, May 3, 1994) Just prior to this testimony the FDA's publication of the safety data on rBGH and IGF-I was invalidated by Fairview Industries, Inc. of Middleton, Wisconsin.