GENTECH archive 8.96-97


Forbidden Knowledge?

Rick Roush wrote:
>         In any case, the crucial question is not whether companies have the
> patent rights to prohibit safety research on controversial GE organisms but
> whether they exercise those rights.  

Taken from Bio/Technology/Diversity Week
Produced by the Institute for Agriculture and Trade Policy
November 10, 1994
Volume 3, Number 21


In the October 20 issue of NATURE magazine, British researchers Erik 
Millstone, Eric Brunner and Ian White report on their investigation of 
Monsanto data and the barriers they ran into trying to publish their 
analysis.  The three were interested in examining whether the use of 
rBGH increases the somatic cell count (SCC) in milk.  They got the idea 
from an undergraduate, who concluded in his final project in 1989 
that by pooling the data from eight Monsanto SCC studies, it was 
possible to increase the sensitivity of a statistical analysis.  

Millstone requested supplementary data from Monsanto to help with 
an analysis of the pooled data and his request was fulfilled.  From 
the pooled data, the three concluded "that there was evidence that 
the milk from cows treated with BST contains statistically increased 
levels of somatic cells (or, more prosaically, pus)."  Millstone noted 
that some of Monsanto's published figures did not coincide with what 
he had been given.  He was told by Monsanto scientist Neil Craven 
that the second set had been given to the British government but 
neither set was correct due to arithmetical errors.  Millstone was 
then given a new set of data in hard copy and on a diskette.  Two 
weeks later, Dr. Craven wrote to explain why 10 cows that had begun 
the trial were omitted from the final analysis.  "We request that the 
raw data be kept confidential.  We hope that you will discuss any 
interpretation of the data with us before disclosing it to third 
parties," the letter said.  

They decided to carry out a detailed analysis of the Monsanto data 
they had in hand.  They concluded that on average, cows treated 
with rBGH produced a 19% increase in SCC relative to control cows.  
The three say they recognize their analysis is imperfect because high 
SCC and mastitis are related to high milk yield.  And they have not 
been able to distinguish between the effects of rBGH on SCC per se 
and the effect of higher milk yield as a result of the use of rBGH.  
They say until data on milk yield is available, such an analysis will 
be impossible.  

The three submitted their paper to the British Veterinary 
Association's Veterinary Record, which said it would publish the 
analysis only with Monsanto's permission.  In 1991, Dr. Doug Hard of 
Monsanto refused to allow the paper to be published, saying that it 
was up to principle investigators and their institutions to publish 
such data.  After an appeal, Hard responded in 1992, "As the raw 
data are confidential, all subsequent analyses are as well."  They 
wrote directly to the Journal of Dairy Science, inviting them to 
publish their paper alongside Monsanto articles to stimulate debate.  
The editor turned them down, saying "no papers have been 
submitted to the Journal of Dairy Science by Dr. Hard on the topic of 
BST and somatic cell counts."  They then approached the editor at 
The British Food Journal who said he would publish their paper 
without requiring Monsanto's permission if it passed their peer 
review process.  The paper passed, but the journal then asked the 
three to indemnify the journal against potential breach of copyright 
allegations.  The three researchers refused.

In March 1994, Dr. Michael Hansen of the Consumer Policy Institute 
brought up the researchers' work at a hearing on rBGH before the 
Canadian Parliament's Committee on Agriculture.  In response, Dr. 
Robert Collier of Monsanto said, "When you take someone else's data 
and you submit it without putting their names on it ... it's called 
plagiarism."  The three British researchers defend their analysis as 
original while admitting the data is someone else's.  "We entirely 
reject any suggestion that we have plagiarized the work of 
Monsanto's scientists.  Our paper simply seeks to make public results 
that Monsanto appears to be making little effort to publicize and that 
we believe are of importance to the debate over the licensing of BST."    
They say a forthcoming article in the Journal of Dairy Science by 
Hard and others addresses the SCC issue; however, the data are taken 
from 15 trials.  The authors say Monsanto refused to provide them 
the data from the other seven trials and that "some important 
questions about the effects of BST on animal health will remain 
unresolved" until the data reaches the public realm.

Monsanto says it has the right to control the publication of the data 
AND any accompanying analysis.  The Veterinary Record is still 
waiting for Monsanto's permission to publish the paper.  Said 
Monsanto spokesperson Thomas McDermott, "They (the researchers) 
have ruled themselves out of consideration by virtue of their 
behavior."  In a statement issued October 19, the company said, 
"Monsanto stands by its rights, and the rights of its investigators, to 
control the publication not only of raw data, but also of analyses of 
these data by others."  The three maintain that their agreement with 
Monsanto only covered the raw data, and not their analysis.  Cathy 
Donnelly of Cornell University said, "As an institution, we would not 
sign off on any contract that would not allow our faculty to publish 
any work, regardless of sponsorship.  Our whole business is to 
publish results of our work so we can advance knowledge."  

Source:  Erik Millstone, Eric Brunner and Ian White, "Plagiarism or 
Protecting Public Health?" NATURE, October 20, 1994; Aki Sofa, 
"Scientists Doubt BST Test Data," BURLINGTON FREE PRESS, November 
2, 1994.