Secret Canadian Govt. Study
Reveals Serious Faults With BGH Research;
FDA Approval Was Based on Faulty Conclusion?
By STEVE WILSON
A secret study by five senior Health Canada scientists concludes important gaps in scientific procedures and data have left legitimate human health concerns about Bovine Growth Hormone unresolved despite the drug's approval by the U.S. Food and Drug Administration.
The report was written after staff scientists reviewing data submitted by Monsanto Canada complained they were being strongly pressured to approve the drug despite their serious misgivings. A Canadian Senate committee studying BGH safety issues was never given the April 21 report, nor was it ever released publicly.
A leaked copy of the document is now available on the web at http://www.nfu.ca/gapsreport.html. It's findings are considered "explosive" by scientists who have been following the BGH issue for years.
At the heart of the report is a finding that FDA scientists misreported the results of a key test for human safety before they approved the drug in the U.S. in 1993.
Writing in the journal Science in 1990, FDA scientists reviewing Monsanto data said, "no toxicological effects (from BGH) were found (in test rats)." The Canadian scientists say that report was false. Actually, 20 to 30% of the rats developed primary antibody responses to rBGH and some developed throid cysts and infiltration in the prostate. The Canadian report says those results "should have prompted the need for long-term studies.
"Instead, the U.S. FDA took no action," says Michael Hansen, a leading scientist who works for the Consumer Policy Institute. His group is demanding a congressional investigation and immediate response from Monsanto and the FDA.
Monsanto spokesman Gary Barton was quoted as saying all rat study data was available to FDA scientists but a spokesman for the agency in Washington disputed that claim.
The Rutland (Vt.) Herald quoted FDA spokesman John Schaid as saying "We do not have the data from that study." Instead, he says the FDA relied on a summary of the data supplied by Monsanto to reach the conclusion the results were "not pivotal".
The Vermont Public Interest Research Group and Rural Vermont, another citizen activist group in the Green Mountain state, were blunt and direct in their reaction to the report. "Either the FDA or Monsanto covered up the results of the major human safety test," they said in a joint news release.
The groups pointed to concern raised in the report that infrants and young children may be most at risk from drinking rBGH milk because ti has higher lebvels of insulin like growth factor (IGF-1). High levels of IGF-1 have been linked to increased risk of breast, colon and prostate cancers.
Both Monsanto and the FDA have long held that increased quantities of IGF 1 pose no risk because they are not digested by humans. The Canadian review, however, concludes IGF-1 can survive digestion, especially when consumed with a milk protein called casein.
Questions surrounding the "90 day study on 30 rats" and increased IGF-1 levels were central to the never-aired Fox Television reports produced by this investigative reporter and colleague Jane Akre. Following pressure from a high-powered lawyer hired by Monsanto, those stories were killed and the reporters eventually fired after they say they repeatedly refused instructions to lie and slant the truth about BGH on Fox's WTVT in Tampa. A civil suit is pending in that matter.
In Ottawa, six Health Canada scientists have testified they were harassed by their Health Protection Branch managers who threatened and pressured them to approve rBGH and other drugs they consider unsafe.
The scientists filed a labor grievance and spoke out publicly after a senior government scientist ignored their human health concerns about BGH and agreed with Monsanto that "normally required long-term, toxicology experimentation and tests for human safety" were not necessary.
One of the whistleblowing scientists, Dr. Shiv Chopra, testified that one of his managers threatened to ship him and his colleagues to other department where they would "never be heard of again" if they didn't hurry favorable evaluations of rBGH.