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Date: Thu, 10 Feb 2000 17:13:12 -0500 (EST)
From: Richard Wolfson
By Deborah Nelson, Washington Post Staff Writer, Tuesday, February 8, 2000; Page A02
A Harvard-affiliated medical center and two patient advocacy groups have temporarily halted gene therapy experiments because of concerns raised by the September death of a Tucson teenager undergoing treatment at the University of Pennsylvania.
Beth Israel Deaconess Medical Center in Boston decided last week to suspend its gene therapy program, while the Cystic Fibrosis Foundation and Muscular Dystrophy Association have placed a hold on three human gene experiments they are sponsoring.
Representatives of all three institutions cited general safety concerns about gene therapy that surfaced in the months following the death of Jesse Gelsinger at Penn, rather than any specific problems with their own experiments.
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Date: Thu, 10 Feb 2000 17:13:12 -0500 (EST)
From: Richard Wolfson
By Bill Lambrecht, Wednesday, February 9, 2000 | St. Louis Post-Dispatch Washington Bureau
WASHINGTON - Sen. John Ashcroft told Secretary of State Madeleine Albright on Tuesday that the United States made a bad deal worse by announcing that it will abide by the new Biosafety Protocol. Grilling Albright in a Senate Foreign Relations Committee hearing, Ashcroft, R-Mo., argued that the protocol gives Europe the sort of trade restrictions on genetically modified food that it has demanded for years in the World Trade Organization. "We stood up to them in Seattle, but apparently not in Montreal," Ashcroft said, referring to the trade organization meeting in Seattle in December in which European demands were rebuffed.
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Date: Thu, 10 Feb 2000 17:13:12 -0500 (EST)
From: Richard Wolfson
PRESS RELEASE - FOR IMMEDIATE RELEASE
February 3/2000
Truro, NS * Montreal, QC * Lucknow, ON
A group of scientists, farmers and organic food industry supporters met to network at last weekend's Guelph Organic Conference.
They declared their unequivocal support for Dept. of Plant Agriculture scientist, Dr. Ann Clark, as well as for all other scientists at Guelph University, to be allowed freedom of speech on the subject of genetically engineered foods.
In a Toronto Star article on January 19, 2000, University of Guelph Dean Rob McLaughlin stated that Dr. Ann Clark was "unethical" to speak out about genetically modified foods since she was not seen as an expert in this area of study.
The above-mentioned delegates who met at the Conference believe Dean McLaughlin went too far in saying "I think her behaviour is unethical." The group is requesting that Dean McLaughlin make an apology to Dr. Clark. He is also asked to affirm the right of University faculty to speak freely about genetically engineered foods and other topics.
The University of Guelph is one of Canada's largest recipients of funding from the agricultural biotechnology industry and has a biotechnology research centre on campus.
For more information about the issues contained in this Release, please contact the individuals from the networking session:
BACKGROUNDER:
The Conference which the delegates attended welcomed over
1000 paid guests as well as 90 trade show booths. The event is thought to
be the largest Conference ever held in Canada on organic farming and
related topics. Its Eco-Trade Show is one of the Canadian organic sector's
most important trade Expos.
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Date: Thu, 10 Feb 2000 17:13:12 -0500 (EST)
From: Richard Wolfson
next article posted by Barbara.Kuepper@greenpeace.de :
Greenpeace International Press release:
Hong Kong/Amsterdam, February 10, 2000 – Greenpeace today welcomed Nestle Hong Kong's announcement to phase out genetically engineered (GE) food, but called on the company to commit to GE free production world-wide in a demonstration organised in front of the Nestle offices in Hong Kong.
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Date: Sat, 12 Feb 2000 09:59:32 -0500 (EST)
From: Richard Wolfson
People undergoing experimental gene therapy treatment for brain cancer might have been exposed to the AIDS virus. Researchers reportedly waited weeks to inform the patients.
see
http://www.wired.com/news/technology/0,1282,34289,00.html
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Date: Sat, 12 Feb 2000 09:59:32 -0500 (EST)
From: Richard Wolfson
By Rick Weiss and Deborah Nelson,
02/10/00
http://live.altavista.com/scripts/editorial.dll?efi=931&ei=149530....
Researchers discovered in December that they may have accidentally exposed more than two dozen young cancer patients to the virus that causes AIDS in a gene therapy experiment, but did not inform federal regulators until last week.
Only when it became clear that the potential problem was about to become public yesterday did the researchers at St. Jude Children's Research Hospital in Memphis and Baylor College of Medicine in Houston start contacting patients and their parents about the possible infections.
Preliminary tests on the gene-based medicine that was administered to young volunteers suggest that the treatment may have been contaminated with HIV-1, the virus that causes AIDS, and HCV, which causes hepatitis C, the researchers and federal officials acknowledged yesterday.
Although two successive tests have so far found evidence of contamination, scientists and government officials emphasized yesterday that the scare might prove to be a false alarm. The tests that have been performed so far are extremely sensitive and prone to giving "false positive" results on the kinds of samples used. New and more reliable tests are now being conducted by the Food and Drug Administration. In the meantime, the study has been terminated.
In the wake of several other recent revelations about the failure of several gene therapy research institutions to report patient deaths and illnesses properly, the incident again raises questions about the fledgling field's ability to protect patients adequately and comply with federal regulations.
In January, the FDA shut down the University of Pennsylvania's prestigious gene therapy program after an agency investigation uncovered multiple serious lapses in patient protections that may have contributed to the death of an 18-year-old volunteer - the first death attributed to gene therapy. National Institutes of Health officials subsequently revealed that hundreds of deaths and other "adverse events" in gene therapy trials had gone unreported to that agency, despite federal rules that require such events to be reported immediately.
The new case also adds to St. Jude's troubles with the National Institutes of Health, which was already investigating the medical center for its handling of patient deaths in a different clinical study and which has had problems with bacterial contamination of some bone marrow preparations.
Scientists involved in the new case described a series of oversights and mistakes dating to 1995 that led to the current alarm. The treatment was designed for patients with neuroblastoma, a brain cancer that is the second most common childhood malignancy. It called for a patient's own tumor cells to be removed and enhanced with an immune system gene inserted by a gene-altered virus. Those cells were then reinjected into the patient in an effort to rally the immune system against the cancer.
Laura Bowman, the study's principal investigator at St. Jude, said she was reviewing the laboratory's quality control program last fall when she discovered that the two most recent volunteers - a child and a teenager treated a year ago - received genetically engineered viruses that had not been processed correctly. That lapse could increase the odds of contamination with foreign viruses.
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Date: Sun, 13 Feb 2000 21:33:41 -0500 (EST)
From: Richard Wolfson
by Richard Wolfson, Ph.D.
In 1998 and 1999, Dr. Shiv Chopra and other scientists at Health Canada testified to the Senate Standing Committee on Agriculture and Forestry that they had been pressured by senior administrators at Health Canada to approve drugs of questionable safety, including bovine growth hormone. Following his testimony, Dr. Chopra was suspended from his job at Health Canada for five days without pay.
On Dec. 7, 1999, at the Senate Standing Committee on Privileges, Standing Rules and Orders, Dr. Chopra testified that his suspension was a retaliatory action related to his previous appearances before the Senate Standing Committee on Agriculture and Forestry. The Committee on Privileges, Standing Rules and Orders then sent out letters to other Health Canada scientists asking them whether they were aware of retaliatory action against Dr. Chopra or other scientists, with the intention to subsequently call these scientists to testify before the committee.
Meanwhile, Mr. David Dodge, the Deputy Minister of Health, wrote to the same Senate Committee and said that due to the seriousness of these charges of retaliation, Health Canada is employing a law firm to do its own internal investigation of the situation, with the possibility of disciplinary proceedings, without saying against whom. Mr. Dodge asked for a postponement of the Senate Committee's investigation until after the internal investigation by Health Canada's lawyer.
The action by Mr. Dodge appears to be damage control, to try to save the reputation of his own managers, who may be in violation of Dr. Chopra's rights as a parliamentary witness, which the Senate committee may regard as contempt of Parliament.
The Senate Committee wrote back to Mr. Dodge asking for reassurance that if the department conducts its own investigation of the charges made by Dr. Chopra, there must be no further retaliation against him or other Health Canada scientists who provide further evidence in the investigation. The Senate Committee also requested that it be able to call Mr. George Hunter, the lawyer employed by Health Canada for its investigation, as a witness in the Committee's investigation and that Mr. Hunter be free to answer all questions without invoking solicitor-client privileges to withhold information. The Senate Committee also sent to Mr. Dodge passages from the parliamentary Bill of Rights (dated back to 1867) ensuring parliamentary witnesses freedom of speech without reprisal.
At the same time, the lawyer for Dr. Chopra and the Health Canada scientists wrote to Mr. George Hunter saying that the scientists will not agree to cooperate in investigations by a lawyer who is paid by the accused department to only investigate a small range of information presented at the Dec. 7, 1999 meeting of the Senate Committee, without investigating the broader context of the concerns and allegations by the Health Canada scientists. A second letter that was sent to Mr. Dodge on behalf of the Health Canada scientists indicated that the scientists would agree to a publicly held judicial inquiry that fully investigates their allegations and is conducted under the authority of a mutually acceptable adjudicator.
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Date: Wed, 16 Feb 2000 06:42:48 -0500 (EST)
From: Richard Wolfson
|
RACHEL'S ENVIRONMENT & HEALTH WEEKLY #686 ---February 10, 2000--- SUSTAINABILITY AND AG BIOTECH http://www.rachel.org |
How will genetically modified seeds, crops and foods affect the sustainability of U.S. agriculture? During 1999, agricultural economist Charles Benbrook tried to answer that question.[1] Benbrook has a long history of analyzing all aspects of agriculture as an employee of the executive branch, the Congress, and the National Academy of Sciences, and more recently in the private sector.[2]
Benbrook defines "sustainable agriculture" as a food system that:[1]
First we should acknowledge that, by these criteria, U.S. agriculture is not sustainable now and hasn't been for many decades.[3] Loss of profitability is almost always the immediate cause of unsustainability in farming, Benbrook says. "All too often in the U.S. in recent decades, the only thing that really changes is that energetic and ambitious managers willing to accept lower returns per bushel find the capital to expand, maintaining their income only by expanding their acreage base," Benbrook says.
Of course when one farm expands its acreage, often another farm family has to move off the land. As a result, the U.S. Bureau of the Census stopped counting "farm residents" in 1993 because there were so few of them left; their numbers had dwindled to fewer than 2% of total U.S. population (4.6 million people).[4] (In contrast, in 1900, farm residents made up 35% of total population.)
Benbrook believes that genetically modified seeds, crops and foods will amplify recent trends and will have the following effects on farms:
This has, in fact, been happening, Benbrook shows. In the midwestern farm belt, corn and soybeans are the major crops. Since 1975, for soybean farmers, the share of the farmer's gross income per acre devoted to seed plus chemicals has risen more than 50%, from 10.8% to 16.3%. For corn farmers, the increase has been even larger (from 9.5% of gross income to 16.9%, 1975-1997).
Roundup Ready crops offered farmers a modest reduction in costs per bushel if everything worked as advertised. However, the reality is different from what Monsanto promised in its ads. Farmers using Roundup Ready crops find they have to use two or three applications of two or more herbicides to control weeds. Some farmers are finding they must use as many as four different herbicides after planting a seed that supposedly makes weed management easier. This disappointing trend is putting more of farmers' income into the pockets of the seed and chemical giants. As Charles Benbrook points out, the full Roundup Ready system is now costing farmers "an amazing $68.77 per acre in 1999, about 50% more than the cost of [other] seed plus weed management systems in the Midwest in recent years." This trend promises to deliver "significantly lower average returns to growers," Benbrook predicts.
There are additional reasons why genetically modified crops are likely to produce economic surprises and setbacks for farmers:
Bt is a naturally-occurring killer of lepidopterans. As such, it is a priceless gift from nature to row-crop farmers who need to control outbreaks of lepidopterans. Charles Benbrook makes this comparison: Bt is to the control of lepidopterans what antibiotics are to the control of human diseases. If Bt loses its effectiveness, it will have major consequences for vegetable farmers across the U.S., many of whom use Bt (in one form or another) as a foliar spray.
By inserting a gene from the Bt bacterium into plants, Monsanto and others have created crops that are themselves pesticidal to lepidopterans. For example, Monsanto's "New Leaf" potato, which is now sold in U.S. grocery stores, is itself a registered pesticide because every cell in every potato contains the Bt gene.[8] (Notably, it is one of the few registered pesticides that is not labeled as such.)
From the beginning, Monsanto and others have acknowledged that their Bt-containing crops might conceivably induce Bt resistance among lepidopterans, but they have insisted that the likelihood is "remote." Resistance is a well-understood phenomenon. When a group of insects is sprayed with a poison, those that are least affected survive and reproduce. Soon the only remaining insects are unaffected by that poison –they have developed resistance to it.
When Monsanto approached EPA [U.S. Environmental Protection Agency] for permission to market Bt-containing plants, they came armed with numerous studies showing that resistance to Bt might take 30 years to develop, if indeed it developed at all. Because genetically-engineered Bt-containing crops had been developed in almost total secrecy, when EPA asked for public comment on Monsanto's proposal, the nation's agricultural experts had little to say. EPA assumed their silence meant all was well.
Traditionally, farmers get reliable information from the land grant colleges that Congress created in 1862. However, beginning with the Freedom to Farm Act of 1996, Congress has systematically reduced the role of the public sector in U.S. agriculture. Now development of genetically engineered crops is largely in private hands and the new technology is cloaked in secrecy. The veil of secrecy "raises an important public policy issue," says Benbrook. "When scientists are unwilling to share data, are constrained in what they can report, and/or have no opportunity to study new technology, public institutions and regulators have to fly blind for a period of time." So, flying blind and basing its decision on Monsanto's science, EPA approved crops with the Bt gene inserted into them.
Now it turns out that Monsanto's science was woefully weak and incomplete. New studies show that resistance to Bt is not nearly as rare in lepidopterans as Monsanto claimed it was, so resistance can be expected to develop much more rapidly than Monsanto initially projected. Furthermore, it is now clear that Bt-corn can adversely impact populations of key beneficial insects. Lacewing larvae, which eat lepidopteran larvae, are killed by Bt, thus removing a natural control on lepidopterans. It now seems clear that farmers who become reliant upon genetically modified crops containing the Bt gene can expect unpleasant surprises in the short term and loss of the effectiveness of Bt in the medium term.[9] It will be a grave loss indeed.
In sum, genetically modified crops seem poised to reduce diversity on farms, reduce farm profits, and make U.S. farms even less sustainable than they already are. For the U.S. food system, this hardly seems like progress.
We owe an apology to the Los Angeles Safe Schools Coalition (LASSC) who did the work that resulted in the path-breaking new pesticide policy adopted last year by the Los Angeles Unified School District, which we described in Rachel #684.
The new policy says Los Angeles schools will look for the least damaging way to control pests, in accord with the precautionary principle, and that the goal is to control pests by non-chemical means whenever possible. The policy represents a major step forward in environmental decision-making.
LASSC is a coalition of 20 organizations, including Pesticide Watch, Physicians for Social Responsibility, United Teachers Los Angeles, the Parent Teachers Association, and Action Now.
Six individuals made up the core group that successfully persuaded the Los Angeles Unified School District that "better safe than sorry" is the best pest management philosophy:
We implied in Rachel #684 that the new pesticide policy in Los Angeles resulted from efforts by Californians for Pesticide Reform (CPR). CPR and Pesticide Watch jointly raised the funds that paid the community organizer who helped build LASSC, and CPR generated support and publicity for the new policy at a crucial moment, just as it came up for a vote. But LASSC worked tirelessly for two years to make the new policy a reality and it is they who deserve the credit for this important public policy innovation. –.M.
==============
References:
Descriptor terms: agriculture; farming; biotechnology; pesticides;
herbiocides; resistance; genetic engineering; bt; roundup ready; monsanto;
dupont; charles benbrook; economics;
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Date: Thu, 17 Feb 2000 16:54:01 -0500 (EST)
From: Richard Wolfson
By Mary MacArthur Camrose bureau,
Western Producer,
February 10, 2000
http://www.producer.com/articles/20000210/news/20000210news01a.ht....
Seeds taken from 11 Saskatchewan canola fields are expected to turn up resistance to both Roundup and Liberty herbicides. The big question still to be answered is how much will they find.
Hugh Beckie, with the Agriculture Canada Research Centre in Saskatoon, focused his research on places where Roundup-tolerant and Liberty-tolerant canola were planted close together last year. The expectation is that bees and pollen drift will have transferred each herbicide-tolerance trait to the other. Thousands of seed samples were taken throughout the fields for greenhouse testing.
Beckie is confident the study will find that seeds taken from plants near the edges of the fields produce plants resistant to more than one herbicide.
He wants to know how far pollen has drifted into the fields and how common the problem is.
"It will give us a better handle on how many multiple-resistant weeds there are," said Beckie, who chose fields from different soil types across Alberta.
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Date: Thu, 17 Feb 2000 16:54:01 -0500 (EST)
From: Richard Wolfson
Source: Augusta Chronicle, Feb 15, 2000
Poor Economy Hurt Growers Of Genetically Altered Food Products
The companies that genetically engineer crops are bringing fewer new varieties to market amid a slumping farm economy and growing public resistance to biotech food.
Seed companies sought government approval for six genetically engineered varieties in 1999, the fewest applications since 1993, and withdrew four of them by year's end. One application has been filed this year.
By comparison, businesses filed 14 applications with the Agriculture Department in 1997 and nine in 1998. All but four were approved.
"Getting a new biotech crop approved is probably high on the dumb things to do for your stock price right now," said Alex Hittle, an industry analyst with A.G. Edwards and Sons Inc.
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.
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Date: Fri, 18 Feb 2000 09:58:20 -0500 (EST)
From: Richard Wolfson
This email may be of most significance to Canadians.
Richard
Tuesday Feb 22, 6:00 - 8:00 pm * Wed Feb 23, 12:00 - 1:30 pm
In 1998 and 1999, several Health Canada Scientists testifed before the Canadian Senate that they were being pressured by senior administration to approve drugs of questionable safety (including genetically engineered bovine growth hormone). One of the scientists, Dr. Shiv Chopra, was then suspended for five days without pay from Health Canada.
The Senate Committee on Privileges, Standing Rules and Orders, Dr. Chopra is now investigating claims that the suspension was a retaliatory action against Dr. Chopra for providing incriminating testimony against Health Canada.
Witnesses before Parliamentary Committees are protected by law. Therefore, if Health Canada is found guilty of retaliation, it could be in Contempt of Parliament.
Several Health Canada scientists are testifying before Senate hearings on whether they are aware of retaliatory actions:
Senate Hearings (Committee on Privileges, Standing Rules and Orders)
Tuesday Feb 22, 2000, Feb 6-8 pm, Centre Block 256S
Wed Feb 23, 2000 12:00 - 1:30 pm, Centre Block 160S
Witnesses to be heard on Tuesday, Feb 22: Dr. Margaret Haydon, Dr. Gerard Lambert, Dr. Rajinder Sharma
Witnesses to be heard on Wednesday, Feb 23 Dr. Dr. Arnost Vilim, Dr. Cris Basudde, Dr. S Malik
Hearings Open to the Public - Everyone Invited
Support Health Canada Whistle-Blowers, whose efforts to protect the public have put the scientists at odds with industry pressure to get their drugs and other commercial products on the market as quickly as possible.
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.
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Date: Sun, 20 Feb 2000 22:07:15 -0500 (EST)
From: Richard Wolfson
By PHILIP BRASHER AP Farm Writer,
Thursday February 17 5:26 PM ET
http://dailynews.yahoo.com/h/ap/20000217/pl/biotech_crops_1.html
WASHINGTON (AP) - The government should improve its testing and monitoring of genetically engineered crops to ensure they aren't killing butterflies and other harmless insects, a panel of scientists says.
The Scientific Advisory Panel, which makes recommendations to the Environmental Protection Agency, says the crops should be tested on a wider variety of insects than the four species currently done and that EPA should require more data from seed companies on the impact of crops in the field.
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Date: Sun, 20 Feb 2000 22:07:15 -0500 (EST)
From: Richard Wolfson
Source: Chicago Daily Herald, Feb 18, 2000
In light of recent consumer controversy about bio-engineered foods, Illinois farmers are facing crucial decisions about whether or not to plant genetically modified corn and soybeans this spring.
The risks are huge - if consumers reject food made from the genetically modified crops, farmers could experience devastating financial losses. As the market for genetically modified crops grows more volatile, many farmers are playing it safe by planting less of the modified seed than last year.
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Date: Sun, 20 Feb 2000 22:07:15 -0500 (EST)
From: Richard Wolfson
By Julie Vorman, Reuters Story - February 17, 2000
WASHINGTON, Feb 17 (Reuters) - U.S. farmers will cut plantings of genetically modified crops this year by 15 to 25 percent because of growing uncertainty in the market, according to separate estimates on Thursday by a Washington environmental group and a corn grower group.
This spring is viewed as a crucial test for genetically modified soybeans, corn and other crops which have met with growing resistance from food makers, retailers and grain importers.
Frito-Lay Inc, the world's biggest snack food maker, said recently it would stop buying bioengineered corn and soybeans.
It followed the lead of a number of food companies including Gerber baby foods, Japan's Asahi Breweries Ltd and British supermarket chain Tesco Plc in bowing to consumer demand for non-biotech food or ingredients.
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Date: Sun, 20 Feb 2000 22:07:15 -0500 (EST)
From: Richard Wolfson
By Reuters news reporters
http://194.200.85.10/sources/154/621/4004943/000218c.htm
Farmers in the United States, Canada and Argentina will slash plantings of genetically modified crops this year by as much as 25% because of growing uncertainty in the market, a Washington environmental group has claimed.
The Worldwatch Institute said global bioengineered crop plantings, which peaked last year at nearly 40 million hectares, could drop to about 30 million hectares this year.
"After four years of stupendous growth, farmers are expected to reduce their planting of genetically engineered seeds by as much as 25% in 2000, as spreading public resistance staggers the once high-flying biotech industry," the Washington-based group said in a new report.
The cuts will mostly occur in the United States, Canada and Argentina, which account for virtually all global plantings of biotech crops, the group said.
A growing number of food manufacturers and retailers, first in Europe and now in the United States, have said they would stop selling foods containing genetically altered ingredients.
"If more American manufacturers hop on the bandwagon, the drop in demand would be devastating for transgenic growers and seed producers," Worldwatch said.
Last month, a Reuters straw poll of 400 US farmers found they planned sharp reductions in spring plantings of genetically modified crops. The survey indicated a decline of 24% for sowings of Bt corn, 22% for RoundUp Ready corn, and 15% in RoundUp Ready soybeans.
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.
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Date: Sun, 20 Feb 2000 22:10:48 -0500 (EST)
From: Richard Wolfson
By SHERYL GAY STOLBERG, New York Times: , February 20, 2000
Financial Ties in Biomedicine Get Close Look
Dr. H. Kirk Hammond, a cardiologist at the University of California in San Diego, never envisioned himself an entrepreneur. "I'm a blue jeans-wearing, tieless character," he said.
But when he invented a gene therapy technique to treat heart disease, he did what any self-respecting academic scientist does these days: he started a biotechnology company.
Today, he has one foot in academia and the other in industry. On campus, he trains doctors and runs a gene therapy lab, financed in part by his company, Collateral Therapeutics. As its chief scientist, he has drummed up support for a public offering of stock, and helped design clinical trials for his therapy.
But there is one bright line that Dr. Hammond says he will not cross: He will not treat patients who are enrolled in studies of his invention. "I think it would look bad for me to be involved in any direct way," he says.
With the biomedical revolution in full swing, academic scientists who lack industry ties have become as rare as giant pandas in the wild. But as Congress begins to investigate lapses in federal oversight of gene therapy experiments, lawmakers, bioethics experts and federal regulators say they are troubled that so many researchers have a financial stake in companies testing their discoveries – companies whose fortunes, with those of the scientist, can rise and fall on a single product.
The fear is that the lure of profit could color scientific integrity, prompting researchers to withhold information about potentially dangerous side effects or push for experiments that might not be quite safe.
Of particular concern are doctors who enroll and treat patients in clinical studies that are paid for by the companies they own, a practice that the Food and Drug Administration says is growing in gene therapy.
Some universities, including the University of California at San Diego, simply do not allow it. Even if Dr. Hammond wanted to test his own invention, he could not do so and keep his university job. But the rules are not the same across the board.
Dr. Ronald G. Crystal, a gene therapy researcher at Cornell University's Weill Medical College, has treated patients in small studies paid for by the company he founded, Gen-Vec. So has Dr. Jeffrey M. Isner, a scientist at St. Elizabeth's Medical Center in Boston. Dr. Isner, along with the medical center and two other partners, founded a company called Vascular Genetics, of which he owns 20 percent. Both doctors declined to be interviewed for this article.
But both have drawn the attention of members of the Recombinant DNA Advisory Committee, the National Institutes of Health panel that oversees gene therapy research. Dr. Crystal was criticized for asking the panel not to disclose that a heart disease patient had died of an underlying illness during a gene therapy experiment. And before the panel learned that most gene therapy researchers were failing to comply with its guidelines to report patient side effects, Dr. Isner was singled out for failing to do so.
Dr. Ruth Macklin, a member of the advisory panel and professor of bioethics at Albert Einstein College of Medicine in the Bronx, said she worried that researchers with financial conflicts would try to keep information about risks a secret for fear it would hurt investment in their companies.
Dr. Macklin said she would like the panel to require doctors who own stock or have other financial interests in companies to disclose those interests on the consent forms distributed to patients.
Others, like Dr. David Blumenthal, who directs the Institute for Health Policy at the Massachusetts General Hospital, would ban the practice outright. "I'm not comfortable with scientists' owning substantial equity in small firms that are sponsoring their clinical research," Dr. Blumenthal said. "I think it creates a conflict of interest, and the conflict is particularly difficult to justify in cases where patients' welfare may be affected."
Food and Drug Administration officials are also uncomfortable. Dr. Jesse Goodman, deputy director of the agency's Center for Biologics Evaluation and Research, said that in a typical clinical trial sponsored by a large drug company, the company served as a check on the researcher, ensuring that information about side effects was properly disclosed and that patients were given clear information about the benefits and risks.
But when the company and the researcher are one and the same, he said, that check is absent. He said the agency was trying to decide whether additional oversight was needed to protect patients in such studies. Yet the issue of just what is a conflict can get murky. A case in point is the University of Pennsylvania, where an 18-year-old patient, Jesse Gelsinger, died in a gene therapy experiment last fall, bringing the current wave of scrutiny. The principal investigator of the study was Dr. James Wilson, director of the university's Institute for Human Gene Therapy. He is also the founder of a biotechnology company, Genovo, in which both he and the university hold stock.
The relationship is so entangled, said Peter Erichsen, the university's general counsel, that it set up two committees to oversee it. Dr. Wilson cannot sit on Genovo's scientific advisory board and his work as a company consultant is unpaid. He may not participate in clinical studies paid for by the company.
In an interview shortly after Mr. Gelsinger's death, Dr. Wilson said he agreed with the restrictions. "I think it gets a little bit concerning when the person who has responsibility for enrolling patients is the scientist who is driving" the research, he said then. "I think that's a conflict."
But Genovo contributes one-fifth of the $25 million annual budget at the gene therapy institute, and in return has exclusive rights to develop Dr. Wilson's discoveries into commercial products.
So while the company did not pay for the study that cost Mr. Gelsinger his life – it was financed by the National Institutes of Health – Genovo does have an indirect interest in all of Dr. Wilson's work. Indeed, Dr. Wilson was required to disclose his connection to Genovo on the "informed consent" document that explained the study's benefits and risks to patients.
What effect, if any, such relationships have on the outcome of clinical studies is difficult to evaluate, said Dr. Mildred Cho, a bioethicist at Stanford University who has studied conflict-of-interest policies at the 100 largest research institutions in the country. "There is almost never a smoking gun," she said. "You can't say Jesse Gelsinger died because Jim Wilson had stock in Genovo."
Evidence is beginning to emerge, however, that industry ties do color scientific judgment. In a 1996 analysis of 789 articles in medical journals, Dr. Sheldon Krimsky, a professor of urban and environmental policy at Tufts University, found that 34 percent of the authors had a financial interest – most frequently a patent pending – in the subject matter being studied.
In a later study, Dr. Krimsky interviewed the authors of articles in medical journals about calcium channel blockers, commonly prescribed for high blood pressure and chest pain from angina. Among those who supported the use of the drugs, 96 percent had a relationship with the pharmaceutical industry, compared with 60 percent who were neutral toward the drugs and 37 percent who were critical of them.
No federal regulations govern the specifics of scientists' relationships to the companies they create. The National Institutes of Health require universities to set their own policies, but experts say the rules vary widely. Some researchers can sit on the scientific advisory boards of their own companies; others must maintain a greater distance. Some can have only a small investment. Others can have a significant equity stake. Dr. Hammond owns 15 percent of Collateral Therapeutics. Dr. Wilson's equity in Genovo is not public, but Mr. Erichsen, the university lawyer, said that Dr. Wilson and his family could own no more than 30 percent of the company, and Dr. Wilson said half of his holdings were in a blind trust for his children.
Twenty years ago, before the revolution in genetics, academia was academia and industry was industry, and rarely was there any overlap.
Now, so many university scientists have started their own companies that deans of medical schools no longer talk about eliminating conflict of interest; the current buzzword for dealing with conflicts is "management." The primary management tool, university officials say, is disclosure. But that means disclosure to supervisors – not to the public.
Congress has helped fuel the trend of scientists' starting their own companies. In 1980, it passed the Bayh-Dole Act, a law designed to speed up the commercialization of academic discoveries. It encouraged universities to patent inventions, and then assign the rights to those patents to private companies that could develop them into products. Instead of relying on existing companies, scientists like Dr. Hammond began raising venture capital and starting businesses of their own.
Universities like the Bayh-Dole Act because it generates income from licensing fees and royalties, and because it gives their best scientists incentive to stay in academia. Scientists like it because it helps them carry discoveries from the laboratory to the bedside, and because they no longer have to leave the prestige of academia to earn the money available in industry.
For some, it has been quite lucrative. Dr. William Haseltine, the chief executive of Human Genome Sciences in Rockville, Md., founded seven biotech companies while a professor at Harvard University. "I don't even know how many millions I've made," Dr. Haseltine said. But, he insisted, "the motivation was not primarily money."
"The motivation was the joy of conceiving ideas and reducing them to practical reality to make a difference in people's lives," he said.
That, said Dr. Hammond of the University of California at San Diego, was precisely why he started Collateral Therapeutics. In the late 1980's, he said, he began looking at patients with heart disease whose bodies had grown new blood vessels to do the work of the blocked ones. It struck him that there must be a gene that would promote this beneficial blood vessel growth, and that "it would be really nice just to be able to put those genes into patients."
By 1993, he said, he had figured out how to do it. "Back then, I was completely ignorant of business, and to be honest, quite alienated by business," he said. "But I had two young daughters and not a lot of money, a retirement in my future and I had sense enough to know that what I had discovered was important."
The patent was filed in 1995, but the university could not get any companies interested in licensing it. So Dr. Hammond met with some venture capitalists and started Collateral Therapeutics, which quickly licensed the patent rights. Within months, the company was working with a German pharmaceutical firm, Schering A.G., which began human tests of Dr. Hammond's technique in May 1998.
Even without participating in the clinical trial, the arrangement has been a delicate balancing act for Dr. Hammond. He takes unpaid leave from his university job when he is traveling on company business. He accepts payment as a consultant, but his job as vice president for research is unpaid. Although Collateral Therapeutics provides research money for his laboratory, he said, the company does not hold exclusive rights to commercialize his discoveries, as is the case with Genovo and Dr. Wilson at the University of Pennsylvania. And Dr. Hammond cannot sell his shares in Collateral while human testing is under way, he said, because the Securities and Exchange Commission prohibits it.
"It's theoretical money; I can't do anything with it because I'm an insider," he said. "The university would love me to sell all of it. They think that makes me less contaminated in some way. I think that's nonsense."
© Copyright 2000 The New York Times Company
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.
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Date: Wed, 23 Feb 2000 21:40:01 -0500 (EST)
From: Richard Wolfson
posted by
nlpwessex@bigfoot.com
By PHILIP BRASHER,
AP Farm Writer,
February 21, 2000
http://www.btinternet.com/~nlpwessex
WASHINGTON (AP) via NewsEdge Corporation -
Government officials say they are considering recommendations by a panel of scientists for more testing and monitoring of genetically engineered crops to ensure they aren't killing butterflies and other harmless insects.
The panel, which advises the Environmental Protection Agency, says the crops should be tested on a wider variety of insects than the four species currently done and that EPA should require more data from seed companies on the impact of crops in the field.
About 30 percent of the corn grown in the United States last year was genetically altered to produce its own toxin, known as Bt, that kills the European corn borer, a major pest. Concerns were raised about the corn last spring when a Cornell University study said its pollen could be harmful to the monarch butterfly.
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Date: Wed, 23 Feb 2000 21:40:01 -0500 (EST)
From: Richard Wolfson
posted by
nlpwessex@bigfoot.com
"I have spent the last several weeks reviewing as much varietal information as I could find. Consistency is a factor I emphasize, and it should be a major criteria as you formulate your selections...
After 3 years of large-scaled planting of Roundup Ready varieties, a lot of mixed thinking still exists. Although some good varieties are available, Roundup Ready varieties, as a whole, have been more variable in yield and disease reactions; key in on consistency.....
The U.S. farmer may find that he or she is at a serious disadvantage when [harvested crop GM/NON-GM]segregation begins. After what I have seen over the last 3 years in the area of quality control and mass production of many new varieties, it would not surprise me if many conventional lines are mixed with Roundup Ready seed. This is not the grower's fault, not the end-purchaser's fault, but an overall disregard for high-quality seed production. "
Dr. Alan Blaine
January 11, 2000
agronomy notes
Mississippi State University Extension Service
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Date: Wed, 23 Feb 2000 21:40:01 -0500 (EST)
From: Richard Wolfson
posted by
nlpwessex@bigfoot.com
As Monsanto is merging with the pharmaceutical group Pharmacia&UpJohn, one might wonder what Pharmacia&UpJohn is up to:
By Eamon Timmins, Irish Times February 10, 2000
A pharmaceutical company, Pharmacia & Upjohn, confirmed last night that it had removed glands from dead children and adults in Irish hospitals for 11 years, until 1985. The practice of removing pituitary glands came to light as part of an investigation into organ removal and retention procedures at Our Lady's Hospital for Sick Children in Dublin.
The multinational firm confirmed yesterday that the glands were provided by a number of hospitals in Ireland between 1974 and 1985, and it did not confine its search to children's glands.
Then called Kabi Vitrum, the company used the pituitary glands to produce a growth hormone for children of short stature. They were flown by the firm to its parent company in Sweden, which processed them to manufacture the drug, which was then sold globally.
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Date: Wed, 23 Feb 2000 21:40:01 -0500 (EST)
From: Richard Wolfson
Is Monsanto's biotech worth less than a hill of beans?
http://www.pathfinder.com/fortune/2000/02/21/bio.html
"The Voice of Reason in the Global Food Fight," - Gordon Conway, Rockefeller Foundation
http://www.pathfinder.com/fortune/2000/02/21/bio3.html
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Date: Wed, 23 Feb 2000 21:40:01 -0500 (EST)
From: Richard Wolfson
February 23, 2000, WASHINGTON, Feb. 22 /U.S. Newswire/ via NewsEdge Corporation
U.S. Sen. Barbara Boxer (D-Calif.) today introduced legislation that would require labeling of genetically engineered (GE) foods on supermarket shelves.
The legislation affects foods with genetically engineered ingredients, or foods processed with genetically engineered material. Popular products that would likely require labeling include Frosted Flakes (GE corn), Coca-Cola (GE corn syrup), Hershey's chocolate (GE soy used in lecithin), Heinz ketchup (GE tomatoes, GE corn syrup).
"Sen. Boxer just gave voice to over 30 million more Americans who want to know if the food they are eating has been manipulated," said Larry Bohlen, director of Friends of the Earth's Safer Food-Safer Farms Campaign. "As long as this stuff is on the shelf, citizens should be able to choose whether or not they want to promote biopollution like genetically engineered corn."
The Boxer legislation is similar to labeling legislation introduced in the House by Rep. Dennis Kucinich (D-Ohio) in November 1999. The Kucinich legislation now has more than 40 co-sponsors. Other Congressional action has included a letter to the FDA by 49 House members led by Rep. David Bonior (D-Wis.) in October calling the failure of FDA to require labeling an "important food safety and consumer protection matter." Their letter stated that the "current FDA policy regarding genetically engineered or modified food is flawed."
The Boxer bill introduction comes just as the FDA is planning to release its decision on labeling and safety testing of genetically engineered foods after a series of field hearings in November and December.
A diverse, nationwide set of organizations including religious, farm groups, consumer groups, and environmentalists has emerged to call for labeling and safety testing of GE foods.
For more information on the Safer Food-Safer Farms campaign, go to http://www.foe.org/safefood
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Date: Wed, 23 Feb 2000 21:40:01 -0500 (EST)
From: Richard Wolfson
Thanks to Dr. Robert Mann robt_m@talk.co.nz for posting the following:
ENN Multimedia
When scientists at the Roslin Institute in Scotland brought Dolly the sheep into the world, alarms went off about human cloning. Scientists have sought to reassure the public that their revolutionary techniques could have enormous benefits for medicine. Now, as the first patents are handed out, fresh controversy is brewing.
http://www.lrs.co.uk EcoWatch/London Radio Service (4:24)
Full Story: http://www.enn.com/enn-multimedia-archive/2000/02/02232000/lrs_10....
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.
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson
A Canadian fish farm wants to market genetically-altered salmon that grow bigger and faster than their wild counterparts. But this could "muck up the gene pool." Read Environmental Defense scientist Rebecca Goldburg on transgenic fish.
http://www.environmentaldefense.org/pubs/Reports/Aquaculture/tran....
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson
RAFI Communique, February/March 2000
"Weve continued right on with work on the Technology Protection System [Terminator]. We never really slowed down. Were on target, moving ahead to commercialize it. We never really backed off."
- Harry Collins, Delta & Pine Land Seed Co., January, 2000
Sections:
ISSUE:
PLAYERS:
IMPACT:
POLICY:
INTRODUCTION
After Monsanto made a public commitment not to commercialize Terminator seeds in October 1999, some governments and civil society organizations were lulled into believing that suicide seeds are "history" and that the crisis had passed. Nothing could be further from the truth.
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson
The Washington Times
BANGKOK - Despite a recent international agreement on the trade of genetically modified products, derisively named "Frankenfoods," the concept of tampering with genes continues to frighten poorer nations.
Leaders at a recent U.N. trade conference said they feared Frankenfoods - a play on the name Dr. Frankenstein, who unwittingly created one of literature's most terrifying monsters - threaten the health and prosperity of Third World nations.
"The free trade and patenting of modified plants and foods trespasses on poor states' sovereignty, puts developing world consumers' lives in danger and destroys farmers' rights," said Prasitporn Kanonsir, a leader of nongovernmental organization Assembly of the Poor.
Mr. Kanonsir and others expressed their concerns at last week's U.N. Conference on Trade and Development (UNCTAD) held in Bangkok.
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson
By Kate Kelland,
Friday February 25 4:04 PM ET
http://dailynews.yahoo.com/h/nm/20000225/wl/britain_greenpeace_1.....
LONDON (Reuters) - Five activists from the environmental group Greenpeace who stormed a ship carrying genetically modified soya off the coast of Wales on Friday vowed to cling on until the cargo is returned to the United States. They're still there – two on the anchor chain and three on board – and a spokesman for the group told Reuters.
He said two activists were positioned on the anchor chain to make it too dangerous for the ship's crew to draw up and move on from Anglesey to unload its cargo.
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
Reprinted with permission from the March 2000 issue of Alive: Canadian Journal of Health and Nutrition, 7436 Fraser Park Drive, Burnaby, BC V5J 5B9
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
Meanwhile, at the Rodale Institute in Pennsylvania, (despite one of its worst droughts on record) organic soy is producing bumper yields of 30 bushels per acre, compared to 16 bushels per acre from conventional soy.
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
The ability of industry to get their products fast-tracked through the safety evaluation puts into question the whole regulatory process. Michèle Brill-Edwards, MD, FRCPC, former senior Health Canada drug regulator, commented on Monsanto's resistance to supply the information on their products. She said, "It's like a courtroom where you don't want the evidence against you to get out."
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
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Date: Sun, 27 Feb 2000 16:20:17 -0500 (EST)
From: Richard Wolfson March 2000 issue of Alive
Biotech News, by Richard Wolfson, PhD
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.
Richard Wolfson, PhD
Consumer Right to Know Campaign,
for Mandatory Labelling and Long-term
Testing of all Genetically Engineered Foods,
500 Wilbrod Street
Ottawa, ON Canada K1N 6N2
tel. 613-565-8517 fax. 613-565-1596
email:
rwolfson@concentric.net
Our website, http://www.natural-law.ca/genetic/geindex.html contains more information on genetic engineering as well as previous genetic engineering news items. Subscription fee to genetic engineering news is $35 (USD for those outside Canada) for 12 months, payable to "BanGEF" and mailed to the above address. Or see website for details.