FDA Sued in Federal Court ------------------------- Robert Cohen reported that refusal to release under the Freedom of Information Act one of the references upon which rBGH approval was based. The reference is #42 which appeared in the Juskevich and Guyer paper (Science, 24 August, 1990, Volume 249, pp. 875-884). There is a strong possibility that this paper will verify the health problems current being experienced by cows that have received rBGH injections. Update ------ Monsanto filed a motion to intervene in the above-mentioned lawsuit (CIV-95-6140) as a third party defendant. Monsanto claims that the release of "secret" data would cause harm to their company. Many people believe it will cause harm because the data shows just how dangerous rBGH really is. Scanned Text of the Lawsuit --------------------------- UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY NEWARK, NJ 07101-0419 Robert Cohen, Citizen of the United States of America FILED ON DEC. 4, 1995 Plaintiff V. David Kessler in his official capacity as Commissioner, U.S. Food and Drug Docket No. Administration, and Philip Lee in his official capacity as Assistant Secretary of Health of the Department of Health and Human Services, Defendants COMPLAINT Plaintiff, ROBERT COHEN, (PRO SE ATTORNEY), P.O. Box 36, Oradell, New Jersey, 07649 (201-599-0325), complaining of Defendants, DAVID KESSLER, Commissioner of the U.S. Food and Drug Administration, and PHILIP LEE, Assistant Secretary of the U.S. Department of Health and Human Services, respectfully alleges as follows: Purpose of Action 1) This action is for declaratory judgment, and for injunctive relief agai nst the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services, who by their action of refusing to release research data which were submitted to FDA as part of a 53,000 page application by Monsanto Agricultural Company for approval of recombinant bovine somatotropin (RBST) continue to suppress the key evidence which will prove that laboratory animals ingesting RBST developed CANCER. This Action, filed on behalf of the health and safety of the American Public which now consumes milk and dairy products containing this new genetically engineered hormone, was filed because FDA denied a Freedom of Information Act request and the Department of Health and Human Services upheld that denial in a subsequent appeal. The actual request was for an unpublished paper that was cited as reference #42 and note #45 in an FDA paper published in the Journal, SCIENCE (August 24, 1990, Juskevich & Guyer, 875-883). ANECDOTAL NOTE: A recent movie, I Love Trouble (Nick Nolte & Julia Roberts) had as the basic premise two reporters who attempted to "steal" the secret report that a genetically engineered cow hormone caused cancer and should not have been approved. FDA possesses the REAL LIFE report authored by D. Richard, G. Odaglia and P. Deslex which will reveal the weights of 32 organs and tissue samples from rBST-treated laboratory animals. These data, which were never properly reviewed by FDA, will result in a ban on RBST which has been implicated by numerous scientists and institutions as a key factor in human cancer. Americans have a right to know! FDA and Department of Health and Human Services incorrectly lends "TRADE PROTECTION" to Monsanto by not releasing these data in this one experiment. FDA and the Department of Health and Human Services correctly state that Monsanto will suffer financial harm if this paper is released. Monsanto hides behind this powerful protective legal veil which is being incorrectly applied and which violates FDA statues regarding "Trade Protection." -2- 2) The provisions of the Federal Food, Drug, and Cosmetic Act and regulati ons and actions thereunder pertaining to TRADE PROTECTION are incorrectly being interpreted and implemented as policy and are short of statutory right. Plaintiff 3) Plaintiff, Robert Cohen, resides in Oradell, New Jersey. He filed a Freedom of Information Act request with FDA on October 3, 1994 (9439274) (EXHIBIT #1) which was denied on December 23, 1994 (EXHIBIT #2) and then filed an appeal on December 24, 1994 with The Department of Health and Human Services (EXHIBIT #3) which was denied on April 4, 1995. (EXHIBIT #4). 4) Cohen then FAXED a letter on July 17, 1995 to Linda Kalm, Esq., Chief Counsel for the Center for Veterinary Medicine. (EXHIBIT #5). That letter contained specific provisions in the Administrative Code (Section 514.11) which allowed for the release of said data contained in the FOFA request of October 3, 1994. 5) Cohen received no response to that letter. Defendants 6) Defendant David Kessler, M.D., J.D., is the Commissioner of the U.S. Fo od and Drug Administration (FDA), and is responsible for its supervision. 7) Defendant Philip Lee, M.D., is the Assistant Secretary of the U.S. Department of Health and Human Services (HHS), and is the officer charged with the administration of Freedom of Information Act appeals which have been denied by FDA. Subiect Matter 8) The subject matter of this action is the necessity for public disclosur e and independent review of data from newly approved -3- pharmaceuticals in which adverse reaction problems are indicated. FDA correctly offers trade protection to drugs that are currently under review or drugs which have been turned down for commercial use. These trade secrets "protect" pharmaceutical companies from unfair competition and the validity of this protection is well founded. However, according to FDA, after an approval is published in the Federal Register, data must be made available for public disclosure. Cohen does not seek secret formulas or experimental techniques. Cohen seeks only raw data of organ and tissue samples of 360 laboratory rats which were treated with RBST. It is unfortunate that the American public can no longer trust FDA to impartially review data in a rigorous manner. Cohen will demonstrate under the section BACKGROUND examples of how Monsanto and FDA manipulated data and committed scientific fraud which led to the approval of RBST. Jurisdiction and Venue 9) The jurisdiction of this Court is invoked pursuant to Title 28 U.S.C. Sections 1331 and 1337. This action arises under the laws of the United States, namely the Federal Food, Drug and Cosmetic Act, Title 21, U.S. Code. The actions described herein are reviewable by this Court pursuant to Section 10(c) of the Administrative Procedure Act, 5 U. S. C. Section 704. 10) This action is authorized by 28 U.S.C. Sections 2201 and 2202. The Plaintiff is suffering legal wrong because of the agency actions of the FDA Commissioner and Assistant Secretary of HSS hereinabove referred to, and is aggrieved by such actions. There is now existing between the parties hereto an actual, justiciable controversy in respect to which plaintiff is entitled to have a declaration of his right and further relief, of releasing the data requested in his FOIA request, because of the facts, conditions and circumstances herein set out. 11) Venue in this judicial district is proper by virtue of 28 U.S.C . Section 1391(e). Background 12) RBST is the most controversial drug application in FDA history. -4- In order to answer some of the questions in that controversy, FDA (August 24, 1990) published an article in SCIENCE which was intended for "peer review" by an estimated weekly readership of 500,000 individuals in the scientific community. That article was written by Judy Juskevich and Grey Guyer, two FDA scientists. At the same time that article appeared, an article was published in the Journal of American Medican Association (JAMA) written by two "independent" doctors. Both articles stressed the safety of rBST. 13) When Cohen first read these articles in July of 1994 he noted some problems. The JAMA article, for example was not written by independent doctors at all. Both authors were on the Monsanto payroll. That information was revealed on page 1003 of the JAMA article (EXHIBIT #6) although that conflict was not revealed in subsequent FDA comments on that article. 14) When FDA wrote that wholesome milk and genetically engineered milk were exactly the same, indistinguishable, Cohen read the abstract of that Juskevich and Guyer FDA article which indicated otherwise. (EXHIBIT #7). That abstract indicated that a powerful growth hormone, insulin-like growth factor (IGF) increased in rBST-treated milk. Yet, FDA continued to misstate the facts. That misrepresentation was repeated by the national press and appeared in newspapers and magazines. That lie became part of the public's basic understanding. 15) When Cohen applied simple math and observed that the spleens of laboratory animals grew enormously after rBST treatment (male spleens grew over 39% and female spleens grew 46%!) and FDA stated that there were no biological effects, Cohen requested in telephone conversations with Richard Teske, Ph.D. at FDA, and Robert Collier, Ph.D., at Monsanto, copies of the actual "raw data" so that he could perform actual statistical analyses of said data. Both parties refused this request. 16) When Cohen noted (EXHIBIT #8) in the Conclusion section of that ar ticle that FDA believed 90% of BST was destroyed when milk is pasteurized, Cohen searched for the reference. The FDA authors were quite sloppy and incorrectly cited J.A. Moore as the scientist who did this research. -5- (They cited Moore, reference #47). The work was actually performed by Groenewegen, reference #49, who was not cited. (EXH.#8) 17) When Cohen examined Groenewegen's work he discovered SCIENTIFIC FRAUD. Groenewegen, then an undergraduate student at the University of Guelph, Ontario, pasteurized milk at a high temperature for 30 minutes. The temperature used was normally reserved for a 15 second pasteurization process. No wonder the BST was destroyed. Or was it? 18) Cohen carefully reviewed Groenewegen's data. (EXHIBIT #9). Groenewegen 's data revealed that only 19% of the BST was destroyed by this high heat! Somebody obviously lied. Somebody knew the lie and incorrectly cited the reference. 19) This was an important lie. FDA Commissioner Kessler, Director of Cente r for Veterinary Medicine Steven Sundlof, and Deputy Regulatory Commissioner Michael Taylor (Monsanto's ex-attomey who was appointed into this position of power) all testified before Congress as to the safety of RBST. These respected gentlemen repeated this pasteurization fraud which resulted in the following: 1) No further toxicology studies were required of Monsanto 2) A zero-day withdrawal period was determined for RBST making it safe for human consumption 3) No assay was required (identification tool) to measure the amounts of t his genetically engineered hormone. All of these things occurred because FDA investigators created this fraud. 20) On April 21, 1995, Cohen met with a group of FDA scientists at The Center for Veterinary Medicine in Rockville, Maryland. At that time it became clear that the original Richard, Deslex and Odaglia study was not rigorously reviewed. Dr. Robert Condon agreed to "re-analyze" the data. This work was performed in late summer, 1995. -6- 21) A number of contraindications surfaced as a result of that review. It became clear to Cohen that any conflicts of 'interest could best be eliminated by an independent review of said data. The actual reference (#45 in the Juskevich and Guyer paper) revealed that data existed for 32 organ and tissue samples. The last citation 'indicated that data existed for "all gross lesions." The scientific terminology "all gross lesions" 'indicates tumors and/or cancers. 22) Inspector General Richard Kusserow (EXHIBIT 10) 'in 1992 commented: ,,Because FDA is constrained from fully disclosing data undergoing review (emphasis added), complete disclosure of bST data will not occur unless and until FDA approves the drug for commercial use." FDA has approved the drug for commercial use. The data should now be released. 23) Section 514.11 of the FDA administrative Code which allows for release of such data states (in section e): "After an approval has been published 'in the Federal Register, the following data and information in the NADA file are immediately 'Table for public disclosure unless extraordinary c' aval ircumstances are shown." Section 4 - "Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information after deletion of.." (names, ingredients, methods) 24) In upholding the importance of releasing any adverse reaction report, F DA guidelines state in section f of 514: "All safety and effectiveness data and information not previously disclosed to the public are available for public disclosure at any time one of the following events occurs unless extraordinary circumstances are known:" -7- #5 "...a final determination has been made that the animal drug may be marketed without submission of such safety and/or effectiveness data and information." The pasteurization SCIENTIFIC FRAUD (described in paragraphs 16-19) indicate that an incorrect determination was made to not require additional safety documentation. Monsanto was relieved of its responsibility. The data indicating such problems existed must at this time be released. Every day that passes exposes Americans to increased levels of this new genetically engineered growth hormone which has replaced wholesome milk with a dangerous chemical. These data must be reviewed. By no stretch of the imagination can any lawyer or scientist argue that Monsanto will be compromised by exclusivity of trade secrets when Cohen has opportunity to review the actual weights of spleens, stomach, thymus, pancreas, testes, ovaries and brain tissues. Trade protection for these data is an unconscionable and wanton abuse of the legal system and provides a legal veil which has been incorrectly offered for Monsanto to hide behind. 25) The respected industry journal, Food Chemical News,(October 9, 1995, p.4-6) recently obtained evidence of errors in the Richard, Odaglia and Deslex report which Cohen has requested in the entirety. (EXHIBIT #11) THE FOLLOWING PRINTED TEXT IS REPRODUCED EXACTLY AS IT APPEARS IN THE 1O/9/1995 ISSUE OF FOOD CHEMICAL NEWS. According to this report, Dr. Condon ofFDA "did uncover some errors in the in-formation as it was presented in Table 2 of the Science paper." He noted that the heading of table 2 states that 30 rats per sex per treatment group were utilized in the study. "While the 90-day study did involve the use of 30 rats per sex per treatment group, only 15 rats per sex treatment were sacrificed to obtain organ weight data, " Teske said, noting that 1O rats per sex per treatment were used for blood analyses and the remaining 5 animals per sex per treatment were scheduled for an effect reversal phase of the study. Noting that the weight of one heart in the negative control male rat was given as being almost 3.5 grams, Teske said no other heart weight was over two grams for this control group or any of the RBST oral groups. "In Dr. Condon's opinion, this heart weight is an impossible value." There is an unresolved issue regarding the average spleen weight for the female negative control group. Teske said, "The -8- available data are not sufficient to determine the correct value. In either case, the effect on spleen weight is not considered to be biologically meaningful, " he added. Cohen charged that Dr. Condon's reanalyses "demonstrates that the data from the study were never reviewed by FDA, saying FDA was guilty of blindly accepting data and conclusions from Monsanto. As Dr. Condon discovered error after error (including the grossly increased heart weight of3.5 grams which you dismiss as 'an impossible value,' ) it becomes clear that independent review of these data is appropriate," Cohen wrote. 26) Plaintiff realleges and incorporates herein by reference the allegation s contained in Paragraphs 1 through paragraphs 25. 27) By not releasing the article referenced in the Landmark Juskevich and Guyer FDA publication in the Journal, SCIENCE, FDA and HHS denies proper peer review to scientists and the American people. By not releasing the data from that experiment, FDA violates its own statute as written in Code 514.11. COUNT I 28) The illegal, improper, arbitrary and excessive actions by the defendant FDA Commissioner and his subordinates, hereinabove set forth, have and will, unless corrected,interfere with the rights of all Americans to their physical well being, livelihoods, and quality of life, denying them right to review truthful accounts of cancer in laboratory animals from ingestion of RBST. COUNT II 29) The illegal and improper interpretation of a Congressional Act, the Delaney Amendment (1958) which has now become standard operating procedure at FDA as a result of Michael Taylor's (Monsanto's attorney turned FDA regulator) paper, "A De-Minimus interpretation of the Delaney Amendment," has allowed FDA procedural and operational jurisdiction, but not legal Justification, in allowing a food additive to be approved which caused cancer in laboratory animals. Release of this paper will demonstrate -9- the ontogeny of this scientific fraud. Release of this paper will demonstrate and invalidate an attempt at covering up this fraud. Release of this paper is consistent with applicable code and is in the best interests of the health and of the American people. PRAYER FOR RELIEF WHEREFORE, Plaintiff respectfully requests the following relief- A. As to Count I, that the Court instruct defendants and all persons actin g on their behalf to release the scientific experiments and papers which were the basis of a Freedom of Information Act request (94-39274) filed on October 3, 1994. B. As to Count II, that the Court enter a judgment finding that FDA and HH S acted in an arbitrary manner, abusing their authority and discretion by offering trade protection to a pharmaceutical company at the expense of the health and safety of the American public. C. For such other further relief as this Honorable Court may deem proper. Respectfully submitted, Robert Cohen -10-