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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: jttmab who wrote (904)	1/16/1999 8:11:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

Thanks, James, for digging up the papers. It answered my question of how they managed to get the drug for the study before the drug was approved by the FDA: The current study was performed with Celebrex, the COX-2 compound from G. D. Searle and Co. that was approved for sale on December 31, 1998, by the Food and Drug Administration. FitzGerald notes, however, that the potential risk factor identified in the experiments done in his laboratory is not a property solely of Celebrex. Results of a study involving Vioxx, a COX-2 inhibitor from Merck & Co., have shown similar results, he says. The lead author on the study is B. F. McAdam, MD. In addition to senior author FitzGerald, the remaining authors are F. Catella-Lawson, MD; I. A. Mardini, MD; S. Kapoor, PhD; and J. A. Lawson, BS. Funding for the study was provided by G. D. Searle and Co.

To: jttmab who wrote (904)	1/16/1999 8:34:00 AM
From: Anthony Wong	Respond to of 2539

GENE CRITICS PUZZLE MONSANTO By Robert Steyer Of The Post-Dispatch Wednesday, January 13, 1999 Section: BUSINESS Monsanto Co. Chairman Robert B. Shapiro said Tuesday that he is puzzled by loud criticism of the "terminator gene" technology, an opposition that he said is based on "concept rather than reality." Even though Monsanto has had nothing to do with developing the technology, which renders a plant sterile, the terminator has become a proxy for anti-biotechnology and anti-Monsanto protests in several countries. The experimental technology, developed by the U.S. Agriculture Department and a U.S. cotton seed company, is many years away from any commercial development. Its formal name is "control of plant gene expression"; the nickname was penned by an anti-biotechnology activist. Shapiro likened the technology to copyright protection for a recording artist or a developer of computer software. Without a copyright for a recording, "Anybody can make a million copies and I don't get paid," Shapiro said in a meeting with Post-Dispatch editors and reporters. The same principle applies to biotechnology. "One of the hardest issues in biotech has always been, given you're investing all this money, will you get paid for the product?" Shapiro said. Anti-biotechnology groups portray the "terminator," which is really three genes, as enabling giant multinational corporations to control worldwide agriculture by preventing farmers from saving seed. That's the practice by which farmers use seed from one year's crop for the next year's planting. One developer of the technology, Delta & Pine Land Co., says the tech nology would be used only to protect biotechnology traits inserted into new seed. And Shapiro said it is ridiculous to think that Monsanto or any corporation would spend the money to stop Third World farmers from replanting seed that "basically is not very good." "We wouldn't have any interest in preventing farmers from saving seed that they haven't purchased [and] that doesn't have any of our traits," Shapiro said. "If you want to continue to use seed that doesn't contain any of our traits, you are free to do that." Monsanto will become more involved with the technology when it acquires Delta & Pine Land, the biggest U.S. cotton seed company. Monsanto, which owns 5 percent of Delta & Pine Land, made a $1.9 billion bid last May to buy the rest of the company. The proposal is under review by the Justice Department. Shapiro said the terminator technology was an issue during negotiations with Delta. "Their view was that it had a lot of value," he said. "Our view was that it didn't."

To: jttmab who wrote (904)	1/16/1999 1:35:00 PM
From: Dan Spillane	Read Replies (1) \| Respond to of 2539

Keep in mind that this study suggests a theory rather than a result. That is, the downside of the drug hasn't shown up in the clinical trials. Theories are important, but don't matter until proven. And I am still somewhat unsure of the significance of the theory until/unless there are similar comparisons made with other NSAIDs, since the article's logic keys on a factor common to all drugs in this class (i.e., "While it is true that current NSAIDs also suppress prostacyclin"). If (and only if) the theory holds true, it would seem to me the degree of risk would be different for each NSAID, COX-2 or otherwise. And logically, right now we are talking about a theoretical "base risk" which could be near-zero, and indeed seems to be such in clinical trials. ...the bottom line is this whole thing hinges on a theory... Moreover, there is another curious aspect to this whole thing. Note, the actual study (dated Jan 5th 1999) was actually available on paper in JULY OF LAST YEAR, and reviewed in OCTOBER. Surprisingly, that study DOES NOT mention Searle as a funding source at all. However, the later rehash of the study (dated Jan 14th) -- which casts the same results in a new light -- does mention Searle as a funding source. I don't get it.