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Posted: November 9th, 2012 | Filed under: Genetic Crimes, Press | Tags: Bernard Sanders, Bernie Sanders, Bill Goold, Bioethics, biotechnology, bST, Center for Veterinary Medicine, Conflict of Interest, Cows, David A. Kessler, David R. Obey, drug, Ethics, FDA, GAO, George E. Brown Jr., gmo, historical, Jack M. Kress, Jeremy Rifkin, Jim O'Hara, King and Spalding, Margaret A. Miller, Michael Taylor, Milk, Monsanto, old news, Public Citizen Health Research Group, rBST, recombinant bovine somatotropin, Regulatory Capture, Research, Resignation, Revolving Door, Senate, Sidney Wolfe, Susan Sechen, Toxic, Washington Post |
Probe of 3 FDA Officials Sought
Industry Ties Before Approval of Bovine Growth Hormone Are at Issue
By John Schwartz, Washington Post Staff Writer, April 19, 1994
Three members of Congress have called for a federal investigation into possible conflicts of interest involving three officials of the Food and Drug Administration, which approved a controversial genetically engineered Monsanto Corp. drug last year. All three agency officials had some ties to Monsanto before coming to the FDA, but an agency spokesman denied there was any misconduct.
In a letter Friday to the General Accounting Office, Reps. George E. Brown Jr. (D-Calf.), David R. Obey (D-Wis.) and Bernard Sanders (I-Vt.) asked the watchdog agency to conduct a 30-day review of the FDA’s approval of recombinant bovine somatotropin (bST), a substance that increases milk yields in cows.
“A troubling pattern of unanswered questions is emerging that suggests an altogether too cozy relationship between some FDA officials central to this food safety decision and their close dealings with the Monsanto Company,” Sanders said in a statement.
The letter- which cites an anonymous March 16 complaint ostensibly written by members of the FDA’s Center for Veterinary Medicine (CVM)- asks the GAO to probe the roles of three “key” FDA officials in the approval of the Monsanto drug.
The highest ranking is Michael Taylor, deputy commissioner for policy, a past FDA employee who rejoined the agency in 1991 from the Washington law firm King and Spalding, which represents Monsanto. Also named was Margaret A. Miller, deputy director of the agency’s office of new animal drugs. The letter characterized her as “a former Monsanto company employee” who wrote the FDA’s opinion on why milk from bST-treated cows should not require special labeling.
A third staff member, Susan Sechen, was described as a data reviewer at the FDA who had worked as a graduate student for a Cornell University professor who conducted Monsanto-sponsored research on bST.
Anti-biotechnology activist Jeremy Rifkin first made the charges about Taylor in February, when he petitioned the FDA to rescind the approval of bST and investigate the three staff members’ role in the agency’s policy.
On March 15, FDA Commissioner David A. Kessler sent Rifkin a four-page letter stating that “none of the activities of Mr. Taylor cited in your petition were in violation of any applicable law or regulation, or were otherwise inappropriate … I believe that Mr. Taylor’s behavior adhered to all applicable ethical standards.”
Kessler said that Taylor had not been “intimately” involved in Monsanto’s efforts to obtain approval, as Rifkin charged, and that he was involved in the FDA’s bST policy only in the final stages of review.
Kessler attached a nine-page memo by FDA ethics official Jack M. Kress supporting that position. Upon arrival at the FDA in the summer of 1991, Taylor recused himself for one year from taking part in any agency action dealing directly with Monsanto or any other King and Spalding clients.
Some longtime agency critics found the charges against Taylor misplaced. Sidney Wolfe, a physician who heads the Public Citizen Health Research Group here has filed complaints with the FDA about revolving door ethics issues concerning other officials. But he said yesterday that “It’s barking up a silly kind of tree to be going against Mike Taylor.”
Wolfe said that “as far as we’re concerned, he’s done a perfectly good job.” Wolfe compared Rifkin’s charges to saying that anyone who worked for a drug company and began working for the FDA should not be allowed to say anything about drugs in general- a stance that Wolfe characterized as “preposterous.”
As for the two other FDA employees named in the House members’ letter, agency spokesman Jim O’Hara said there was no impropriety. “As we have learned of these allegations, we have looked at them. The appropriate safeguards against conflict of interest have been taken,” O’Hara said.
Miller was no involved in the decision to approve bST, and Sechen’s involvement with the bST review was approved at the outset by the FDA’s ethics and program integrity division, which “determined that there was no a conflict of interest based on the information they were provided,” O’Hara said.
Although reluctant to comment in the face of a possible investigation, Taylor said yesterday that “I would welcome any scrutiny of my actions.”
Much of the material used in the lawmakers’ letter, including the anonymous CVM letter alleging Miller’s conflict of interest, came from Rifkin, a long-standing opponent of bST. Bill Goold, a spokesman for Sanders, said the search of scientific literature relied upon by Sander’s staff in drafting the letter came from Rifkin’s organization.
Rifkin has fought against the approval of bST for more than seven years as a part of an all-fronts assault against biotechnology. He called his ethical charges “a significant scandal” that he said showed moral weakness at the top of the organization. “We want Kessler’s resignation,” Rifkin said yesterday. He said that the nine-page ethics memo by FDA’s Kress was “people in government trying to protect their own.”
Sanders and Obey have previously taken stands against the approval of bST and its use without consumer labels that identify the milk as coming from cows treated with the drug.
But many Capitol Hill staff members were surprised to see Brown- who chairs the Science, Space, and Technology Committee- as a signer of the letter.
Sources familiar with the process said key committee staff members felt they had been end-run by activists. One congressional aide said staff members who normally would be informed of such an action were unaware that Brown had signed the letter.
“George’s issue is with the process of approval. He wants to make sure people are squeaky-clean,” the aide said. Brown did not see the FDA response to the Rifkin petition before signing the Sanders letter, an aide said. Obey said yesterday that he had seen the FDA response and “I’m frankly not impressed.”
Some acquaintances of Taylor were incredulous that the official would be the object of ethical scrutiny. “There’s no more ethical person in this town than Mike Taylor,” said Wayne Pines, a former FDA official who now consults with companies on FDA matters. “Mike would never get involved in a situation in which there’s a conflict- that’s such a no-brainer.”
Source: Washington Post, April 19, 1994
Posted: October 1st, 2012 | Filed under: Press | Tags: Atrazine, bacillus thuringiensis, bacteria, Belt Road, Big Island, Big Island Dairy, BT, Bt toxin, Cows, DNA, Dominic Yagong, Dominique Cellier, Dr. James Brubaker, Dr. Robert Kremer, Eden Peart, elephant grass, European Journal of Agronomy, François Roullier, Genetic Roulette, Gilles-Eric Séralinis, Glyphosate, GM Corn, GM Crops, GM papaya, GMO Free Hawaii, grain, Hamakua, Hawaii, HI, Hilo, Honokaa People's Theater, Institute for Responsible Technology, Joël Spiroux de Vendômois, kalo, Kauai, Kona Coffee, livestock, Loeffler Farms, Milk, Nancy Redfeather, Non-GMO, Ookala, papaya, Pepe‘ekeo, Pioneer Hi-Bred, pollen, Puna, RoundUp, scientists, Scott Enright, Silage, Soil, Steve Whitesides, studies, sweet corn, Toxic, toxicity, University of Hawaii at Manoa |
By Alan D. McNarie, October 1, 2012 – The Big Island Chronicle
There’s a new crop growing in O‘okala and Pepe‘ekeo on the North Hilo/Hamakua coast—well, a new crop for the Big Island, anyway. Big Island Dairy, formerly Island Dairy, has planted field corn in O‘okala and Pepe‘eke‘o to help feed its cows. The corn will be fed as ensilage—“silage” as most farmers call it: green stalks that are cut, chopped and stored in a low-oxygen environment so that they ferment in a process similar to the making of sauerkraut. The silage is one solution to a problem that plagues all livestock farmers in Hawai‘i: the high cost of imported feed. Since the islands grow little grain, farmers are forced to rely on Matson and Young Brothers to bring in feed from outside, often at ruinous prices. The home-grown silage could be a major aid in the survival of one of the state’s only two remaining dairies.
But the new crop has still become a matter of concern for some local residents and farmers, because of one fact: Big Island Dairy is growing genetically modified corn.
The corn was already in the ground when the dairy was recently purchased by Steve Whitesides, who also runs Whitesides Dairy in Rupert, Idaho. But the reason that the GM varieties were planted, Whitesides says, is simple: “The way crops grow there, if you don’t have something planted that can control the weeds, they can overtake it.”
Whitesides didn’t specify what varieties of corn were being grown, but given that weed control is the object, the corn is probably one or more of Monsanto’s “Roundup Ready” varieties. Monsanto has long touted both the GM corn and the herbicide Roundup, which is also makes, as safe. But in recent years, some studies have begun to challenge that assumption. And the company has drawn fire for its heavy-handed tactics in dealing with farmers—it’s sued farmers, for instance, for patent infringement when pollen from GM crops drifted into non-GM farmer’s fields. The company has also been accused of tampering with science and with the agencies that regulate it.
GM crops have generated negative publicity in the islands, as well. Pioneer Hi-Bred, for instance, is currently battling lawsuits filed by two groups of plaintiffs—one suit represents over 200 people—who claim that the company has not controlled spray drift and pesticide-contaminated dust from its GM test crop sites on Kauai. Some farmers and residents in Puna are still smarting from the state’s oft-bungled handling of GM papayas, originally developed by Cornell and UH-Manoa to fight papaya ringspot virus; small farmers claimed that the state’s “quarantine zones” set up to create a “sea of GM papayas,” isolating and protecting a few fields of non-GMO papaya for the Japanese market, discriminated against small farmers in favor of a few large export companies; organic farmers complained that their papayas have been contaminated that pollen drift from GM fields, and the GM papayas, though resistant to ringspot, have proved especially vulnerable to a fungal disease, forcing some farmers to periodically abandon their fields anyway. Native Hawaiians have taken offense at attempts to create GM versions of their beloved kalo, and Kona Coffee farmers have resisted attempts to introduce GM coffee.
That resentment boiled to a head in Honoka‘a on September 17, when a group called GMO-Free Hawai‘i sponsored a rally and reggae concert at the Honoka‘a People’s theater. The main target was Monsanto—the event was part of a world-wide “Occupy Monsanto Day”—but Big Island Dairy got some attention, too. Councilman Dominic Yagong introduced Scott Enright, the state Agriculture Department official who said he’d been “Charged by the Governor to assist Big Island Dairy.”
“He [Whitesides] is looking for varieties that will do well here,” said Enright. “He’s going to be doing his best to grow corn conventionally.”
But that clearly wasn’t enough assurance for the crowd. GMO-Free Hawai‘i spokesperson Eden Peart noted that the Hamakua Agricultural Plan “prohibits” GM crops in the district (Actually, it doesn’t prohibit them outright, but it does call for a moratorium on those crops until their possible impacts could be better assessed.)
“If there’s still GMO grown here, blowing pollen in the wind, that is a concern for us,” she said, and announced that protestors would be demonstrating along the Belt Road beside one of the dairy’s O’okala fields on Friday, September 21.
Yagong, in whose district the corn is growing, told Big Island Chronicle he shared some of the community’s concerns about GMOs with Whitesides.
Yagong had already approached Whitesides about the issue. In addition to the kalo and coffee controversies, he told the Chronicle, he had “Shared that in the leasing of [county owned] Hamakua lands, one of the conditions for leasing was no planting of GMO crops on county lands.” Yagong noted that the county’s farm lands and Island Dairy’s O‘okala corn fields were “practically neighbors.” Yagong said Whitesides would “strongly consider the community’s recommendations” but “fell short of saying that they wouldn’t grow GMO corn.”
Whitesides’ response to the Chronicle was similar. He made no commitment to replace the GMO corn with conventional varieties. But he did say his company planned to experiment with conventional varieties to “see if they could be grown at a cost that would still keep the dairy’s output competitive with mainland milk. “
He noted that 80 t0 90 percent of all corn grown in the U.S., now, was genetically modified. Even if his company did continue to grow GM corn, he said, “The product that’s coming over here from the mainland is GMO, so what’s the difference?”
How much of a difference genetically modified corn makes is very much a matter of debate. Dr. James Brubaker, the University of Hawaii at Manoa’s acknowledged authority on corn, maintains that the GM corn is perfectly safe; that the only difference between it an conventional corn was “A little piece of DNA which is very benign and only affects weeds.” He compared GMO opponents to the Creationist movement. “This is the scientific ignorance that we do face in the state of Hawai‘i,” he told BIC. “We don’t come equipped with a realistic appraisal of the achievements of science, so we’re frightened of anything scientific.” He noted that around a thousand scientific papers a year are devoted to GMOs, and that nearly a billion acres of GM corn had been raised: “We know that these are incredibly safe.”
The problem is that not all of science is in agreement with Brubaker’s assessment—and that scientific papers critical of GMOs find an instant and persistent world-wide audience. The Web is awash with stories and blogs citing those articles, but often with no direct documentation or links, and often at Web sites that make no pretense of being unbiased—sites with names like treehugger.com and naturalnews.com. A site called responsibletechnology.org,, for instance, which proclaims itself “the most comprehensive source of GMO health risk information on the Web,” ran an article entitled “65 Health Risks from GMO food,” with factoids such as “More than 20 farmers in North America report that pigs fed GM corn varieties had low conception rates, false pregnancies or gave birth to bags of water.” But the story gives no links or sources for any of its allegations.
Many of those factoids flying around the Web, however, are based on actual scientific articles that do seem to raise some basis for concern. In 2009, for instance, the International Journal of Biological Sciences published an article entitled “A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health “ by Joël Spiroux de Vendômois, François Roullier, Dominique Cellier, Gilles-Eric Séralinis, four well-credentialed scientists from French universities. The study fed three varieties of Monsanto’s genetically modified corn, including one of the Roundup Ready varieties and two containing genes from a bacteria, bacillus thuringiensis (BT), that is used as a natural insecticide. The French scientists found that rats fed the corn suffered from various symptoms, including higher liver and kidney toxicity levels and enlarged spleens and hearts.
“Our data strongly suggests that these GM maize varieties induce a state of hepatorenal toxicity,” concluded the article, which called for longer term studies of the three varieties.
But Brubaker said that there were already studies out refuting the French study. “[With] almost any report of that sort, you can be assured there will be immediately responding research studies to validate or invalidate it,” he noted.
There have also been scientific studies that questioned the safety of Roundup itself—and scientists who’ve gone public about their concerns. One of them is Dr. Robert Kremer of the University of Missouri—Monsanto’s home state—who has done extensive studies of glyphosate, the active ingredient in Roundup, since 1997. Glyphosate doesn’t kill weeds directly; it inhibits their ability to absorb certain nutrients, making them fatally susceptible to naturally occurring bacteria and fungi. As it turns out, Kremer discovered, glyphosate also makes crops more susceptible to diseases such as fusarium and to the toxins they produce, which can also affect animals and humans who consume those crops. And it can be toxic to some beneficial bacteria, including the ones that live in the roots of soybeans and other legumes and “fix” nitrogen in the soil—a vital function for maintaining soil fertility. Glyphosate, Kremer concluded, “is altering the whole soil biology.”
Kremer is not alone. In a 2009 article in the European Journal of Agronomy, Don Huber, emeritus professor of plant pathology at Purdue University, and Purdue botanist G. S. Johal, warned that widespread glyphosate use could “significantly increase the severity of various plant diseases, impair plant defense to pathogens and diseases, and immobilize soil and plant nutrients rendering them unavailable for plant use.” Huber has also approached the USDA with concerns about a previously unknown microorganism that has appeared in GM-based animal feeds and appears to be linked to an epidemic of livestock infertility and miscarriages.
An interviewer at the Web site nongmoreport.com asked Kremer if glyphosate was environmentally benign.
“Absolutely not,” he replied. “Glyphosate is the single most important agronomic factor predisposing some plants to both disease and toxins. These toxins can produce a serious impact on the health of animals and humans…. Toxins produced can infect the roots and head of the plant and be transferred to the rest of the plant. The toxin levels in straw can be high enough to make cattle and pigs infertile.”
Huber was among the many scientists, including agronomists, plant pathologists, veterinarians, nutritionists, pediatricians and medical doctors, featured in the documentary “Genetic Roulette,” which screened at the Honoka‘a rally before the musicians came on. Those researchers raised a host of apparent human and animal health problems, from infertility to cancer. The scientists also brought up problems in humans exposed to the GM crops/and or Roundup.
Some of the scientists also talked about pressure exerted on them, up to and including firing, by Monsanto, public officials and their peers. One Oregon researcher, for instance, talked about releasing a study critical of GMOs, then getting a call from the former president of her university, questioning whether she “belonged” at the school.
Caught in the crossfire of these scientific barrages and counter-barrages are companies like Big Island Dairy, who just want to give their corn a fighting chance against weeds such as elephant grass, which can quickly grow much higher than the corn.
“The weeds that we have are entirely different for the middle of IA, and they grow much more aggressively,” notes Brubaker, who also points out that some of those weeds themselves contain toxins that can harm cattle.
There are, in fact, non-GM varieties of corn bred specifically for Hawaii—Brubaker himself developed some of them—and it is possible to raise non-GM corn on the North Hilo/Hamakua Coast. Brubaker notes that Loeffler Farms, for instance, grows one of his conventional sweet corn varieties on that coast. But according to Brubaker, even the conventional corn may require chemical assistance from pesticides such as Atrazine, which have their own environmental consequences; they may get into groundwater if improperly applied, so they must be applied by a state-certified specialist—an additional cost for the farmer.
How the GM corn could affect those existing sweet corn crops is another issue. Corn for silage is cut green, but after the corn has tasseled—which means that pollen from it could get to other plants.
“That corn can cross with people’s sweet corn, and do people want those genes in their corn? Probably not,” local natural farming advocate Nancy Redfeather told BIC. She noted that bees carrying pollen could travel up to seven miles a day.
But aside from the dairy, GM corn is already on Hawai‘i Island, in thousands of food products imported daily. If you drink non-organic milk, whether it’s from the mainland or it’s from local cows fed with imported feed, you’re probably drinking milk from cows that have eaten GMOs. The only possible change would be if Island Dairy managed to grow conventional corn.
That’s the outcome Yagong hopes for. He notes that the number of dairies in the state has now shrunk from 24 to two, and he thinks it’s important to support the two that remain.
“I think that would make a lot of people very, very happy and may even distinguish his product further if they knew that the milk was GMO free and fed from conventional corn,” he says.
Source: Big Island Chronicle
