"The doctor of the future will give no medicine, but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease."
- Thomas Edison
Cancer is a political problem more than it is a medical problem.
"Monsanto should not have to vouchsafe the safety of biotech food," said Phil Angell, Monsanto's director of corporate communications. "Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job."
- New York Times, October 25, 1998
"What the FDA is doing and what the public thinks it's doing are as different as night and day." - Dr. Herbert Ley, Former FDA Commissioner
"The FDA serves as the pharmaceutical industry's watchdog, which can be called upon to attack and destroy a potential competitor under the guise of protecting the public." - Dr. James P. Carter
|The following information courtesy of Richard Wolfson, PhD, Consumer Right to Know Campaign for Mandatory labeling and long-term testing of genetically engineered food.|
11:30 AM - Oct 30, 2000 EDT 10/30 Dutch study: Starlink protein stimulated antibodies in lab rats
Selected by Pro Farmer Editors
United Press International October 29, 2000
CHICAGO, Oct. 29 (UPI) -- Who would have thought such a small percentage of the U.S. corn crop could create so big a controversy.
StarLink, planted on just 352,000 acres and representing just 0.5 percent of the 10.4 billion bushel U.S. corn crop, was supposed to be just for animal feed or industrial use. Instead it has turned up in taco shells distributed by three companies including Kraft and sent ripples through the food processing industry.
It also has shown up in corn meal and chicken feed in Japan even though it was not supposed to be shipped overseas.
Now StarLink's developer Aventis CropScience, a subsidiary of the French firm Aventis SA, is asking the U.S. Environmental Protection Agency to reconsider its earlier misgivings about approving StarLink for human use.
StarLink produces a protein - Cry9C - that is difficult for humans to digest.
Think of this as a giant clinical trial. Susan Hazen, deputy director of the EPA's Office of Pesticide Programs, said Aventis submitted new data last week to support a request to allow the portion of the 4.8 million bushels of StarLink that remain unaccounted for to work their way through the food chain without forcing a recall.
"The data suggests three ways of looking at the problem," Hazen said. "First, they don't believe Cry9C is an allergen. They also suggested that even if it is an allergen, it would be present at such low volume that it would not be able to trigger an allergic response. You need a certain level.
"Their third argument is that for something to become a food allergen it has to be present long enough in the food supply for people to build up potential for an allergic reaction."
Hazen said all known food allergens exhibit certain characteristics. Among them are stability under heat and a lack of digestibility. Unlike other biotech proteins that are digested within seconds. Cry9C can hang around for 30 minutes, Hazen said.
At a meeting Oct. 20 of the EPA's Scientific Advisory Panel, Dutch scientist Hubert Noteburn presented a study indicating rats fed StarLink begin producing antibodies.
Hazen said she had not yet examined the data but that it would be taken into consideration in examining Aventis' request.
Hazen said the conditional registration granted Aventis in 1997 for StarLink made it clear it was the company's responsibility to track its corn and keep it out of the food supply.
"In cases where our registrant has not complied with terms and conditions, policy is to revoke or take away that license," Hazen said. "In this case, we strongly urged Aventis that they should voluntarily request that their registration be canceled or the agency would take action.
"In all cases because Aventis is the registrant for this product it is Aventis who is the ultimate entity who is responsible. If this were mislabeled (as some farmers claim), that was a breach of the agreement."
Though no penalties have yet been imposed against Aventis, the case still is under investigation by the EPA's Office of Enforcement.
The investigation so far has determined some 2,600 farmers planted StarLink and about 9.6 million bushels were shipped to 260 grain elevators. Of those 9.6 million bushels, Aventis has tracked 4.8 million that were shipped for feed.
Stewart Reeve of the National Corn Growers Association said the EPA should never have given StarLink a limited registration.
"This is a decision that should have been made two years ago. It should have gotten food and feed approval at the same time - or not," he said.
Half Iowa Corn Contaminated
"This could be a tough lesson for Aventis and for all of us."
50% of corn may be impure
Problem could cost 'hundreds of millions'
By JERRY PERKINS
Des Moines Register Farm Editor
As much as half of the 2 billion bushels of corn in Iowa could contain traces of StarLink, a genetically modified corn not approved for human consumption. The mixing of conventional and StarLink corn could cost farmers and elevators "hundreds of millions of dollars," said Ed Beaman, executive vice president of the Agribusiness Association of Iowa, based in Des Moines.
A Regulatory Maize
Critics Say Bio-corn Debacle Points Up Flaws in Splintered Regulatory Scheme for Biotech Foods
By Deirdre Davidson
Monday, October 30, 2000
Legal Times, 30 Oct 2000
To some, it seemed inevitable.
First, bioengineered corn unapproved for human consumption was discovered in taco shells in the United States. Then it showed up in U.S. corn shipments to Japan. And for more than a week, millions of bushels of high-tech corn went unaccounted for.
Who's at fault? No one - at least no one government agency. Regulation of biotech foods is spread among three federal agencies, leading to a system of oversight that critics say is too thin and disorganized to keep pace effectively with the rapidly changing field.
"The regulatory system is so fragmented and full of holes and inconsistencies that it's a stretch to call it a system," says Jean Halloran, director of the Consumer Policy Institute at Consumers Union. "There is a lot of smoke and mirrors to suggest there is real review when there isn't."
The article below deals with a lawsuit after a death in a gene therapy experiment. I think that criminal charges should have been laid in the case and cases like it.
Nature Biotechnology Business and Regulatory News
November 2000 Volume 18 Number 11 p 1136
Gene-therapy death prompts broad civil lawsuit
Jeffrey L. Fox
One year since the death of a volunteer in a gene therapy clinical trial at the University of Pennsylvania (UP; Philadelphia, PA), a broadly framed wrongful death lawsuit has been brought against the university, two local hospitals with which it is associated, and its private sector biotechnology collaborator, Genovo (Sharon Hills, PA). The lawsuit was filed by the patient's father and uncle in mid September in the Philadelphia County Court of Common Pleas. It not only names several UP faculty members who were directly involved in its gene therapy program, but unusually also singles out a bioethicist on the faculty who advised them as well as university trustees and specific administrators for alleged negligence and conflicts of interest.
As a civil action, the lawsuit seeks to collect both compensatory and punitive damages in excess of $50,000 on all of several claims that, besides wrongful death, include "assault and battery," "lack of informed consent," "infliction of emotional distress," and "fraud on the Food and Drug Administration." However, in the broad sweep of the lawsuit, it in effect demands higher standards for safety during such clinical trials, insists on more detail and candor when disclosing risks to volunteers who participate in them, and calls for sharply restricting the kinds of conflict of interest that would be permitted among corporate and university partners that undertake gene therapy and other high-risk clinical trials. The demands coincide with espousals from Greg Koski of the new federal Office for Human Research Protections (Washington, DC) of stronger standards, and the American Society of Gene Therapy's (Milwaukee, WI) recent adoption of similarly stringent standards as a way of minimizing conflicts of interest (Nat. Biotechnol. 18, 1029;MEDLINE).
Jesse Gelsinger had a mild form of a rare inherited nitrogen metabolism disorder called ornithine transcarbamylase (OTC) deficiency. He died inSeptember 1999 while participating in the phase I clinical trial that was testing an engineered adenovirus vector carrying a gene intended to correct the defect. UP principal investigator James Wilson and other members of the UP team attributed Gelsinger's death to an acute respiratory system collapse and subsequent multiorgan failure induced, at least in part, by his immune system's response to the engineered viral vector (Nat. Biotechnol. 18, 377, 2000; 18,143, 2000; 17, 1153, 1999; MEDLINE).
The lawsuit claims that Gelsinger died because the members of the UP medical team and other defendants were "careless, negligent, and reckless" and that they failed to "properly and adequately evaluate [Gelsinger's] condition and eligibility for the gene transfer trial." Moreover, it claims that the adenoviral vector that "ultimately caused the death" was "defective" and "unreasonably dangerous." Among other specific claims, it contends that Genovo and UP researchers "allowed vectors to sit and/or be stored on lab shelves for 25 months before being tested on animals, making them less potent than they could have been." Moreover, the way the vector was stored "may have resulted in underestimation of [its] potency in humans.
By popular demand, we have gathered together and better organized various items on the StarLink episode on Ag BioTech InfoNet. Access the new section at --
We will be posting new items as they become available.
BIOTECH-CORN PROBLEMS LEAD TO RECALL OF 300 PRODUCTS
November 2. 2000
Sarah Lueck And Scott Kilman , Staff Reporters of The Wall Street Journal
WASHINGTON-The flap over StarLink corn, a biotechnology product not approved for human consumption, has, according to this story, led to the recall of nearly 300 food products and caused major disruptions in parts of the Farm Belt.
The story says that the recall involves companies ranging from restaurants such as Wendy's and Applebee's to small food companies. The products are included on a list released yesterday by the Food and Drug Administration, and its length suggests the costs of the recall are growing. The list, which includes more than 70 types of taco chips, more than 80 taco shells and nearly 100 foods served in restaurants, is the first opportunity for consumers to see a comprehensive roster of products affected by the recall. It is available on the FDA's Web site at <http://www.fda.gov/>
Mission, which said it isn't sure how much the recall will cost, is telling consumers to take the products back to where they bought them for a refund or a replacement.
Thanks to "NLP Wessex" <email@example.com> for forwarding this:
http://www.biotech-info.net/buried_data.html "Buried Data in Monsanto's Study on Roundup Ready Soybeans"
How often have you heard that GE foods are extensively studied for safety? These "extensive" safety studies make an interesting read. The titles sound reassuring. For example: "The composition of glyphosate-tolerant [read Roundup Ready] soybean seeds is equivalent to that of conventional soybeans." That study was presented to the FDA in 1994 during the approval process for Roundup Ready Soybeans. Except that part of it was buried. And it failed to prove equivalence.
Even what Monsanto scientists presented to FDA and subsequently published in the JOURNAL OF NUTRITION shows significant differences between GE beans and controls in 3 of the 6 macronutrients measured and in one fatty acid. The researchers did not perform statistical analysis on even larger differences in Roundup Ready beans, such as 29% less choline. They found raw Roundup Ready meal contained 27% more trypsin inhibitor, an allergen that inhibits protein digestion, can retard growth in animals fed raw soybeans, and has been connected to enlarged cells in rat pancreases.
The most glaring flaw is a "file drawer" problem: the data on one out of 3 experiments, conducted on beans grown in Puerto Rico, was omitted from the published study and the data submitted to the FDA. In fact, none of the prominent dissenting scientists I consulted had seen the data on this experiment until I obtained it from journal archives and showed it to them.
In the unreported Puerto Rico trials, Roundup Ready beans were significantly lower in protein and the amino acid phenylalanine.
More disturbing were levels of the allergen trypsin inhibitor in toasted Roundup Ready meal, WHICH exceeded the highest levels per Levels were 18% higher in Roundup ready meal than in regular meal. And in the retoasted meal, levels of allergens called lectins In Roundup Ready beans almost doubled the levels in controls.
What might be the result of consuming foods with high levels of trypsin inhibitor and lectin? Well, maybe slower and lower growth, say scientists. And slower growth with less weight gain was observed in rats fed Roundup Ready beans. Cows eating Roundup Ready meal gave milk with higher levels of fat than controls. The improbable name of the feeding study is "The feeding value of soybeans fed to rats, chickens, catfish and dairy cattle is not altered by genetic incorporation of glyphosate [Roundup] tolerance." Go figure.
Richard Wolfson, PhD
Consumer Right to Know Campaign
for Mandatory labelling and long-term
testing of genetically engineered food
In accordance with Title 17 U.S.C. Section 107 this material is distributed without profit to those who have expressed a prior interest in receiving it for research and educational purposes.