WHA Agrees on "Major Review" of Smallpox Virus Research

By Lim Li Lin*
South-North Development Monitor #6255
May 22, 2007

Geneva, 21 May - The World Health Assembly has decided to ban genetic engineering experiments on the smallpox virus but postponed a decision on the destruction of the virus until 2010, when a "major review" of the research results on smallpox will be held.

This review is to assist the WHA in 2011 to reach a consensus on the timing of the destruction of the smallpox virus stocks.

The WHA is meeting in Geneva for its 60th session. The issue of the eradication of the smallpox variola virus stocks has been on its agenda for many years. In 1999, the remaining stocks of smallpox virus were slated for destruction.

But the two countries that still hold stocks of the virus, the US and Russia, instead decided that the virus stocks should not be destroyed and have since accelerated research on smallpox. Destruction was re-scheduled for 2002. But in 2002, the WHA agreed to an indefinite extension of the destruction order until the US and Russia complete their research agenda on the smallpox virus.

The US then submitted proposals to the WHO Advisory Committee on Variola Virus Research, which has the mandate to oversee smallpox studies in the interim period before the destruction date, to genetically engineer smallpox and to insert smallpox genes in other poxviruses. This came before the WHA in 2005.

Many countries then expressed concern about allowing genetic engineering research on the smallpox virus, and asked for a review of the proposed research. Despite taking note of the concerns and caution expressed, and the requests to revisit and review the recommendations, the WHO Secretariat issued a press release that implied that four of the five research activities proposed had been approved by the WHA members, while one activity (transferring genes from the smallpox virus and inserting them into other pox viruses) would be reviewed. The WHO Secretariat also undertook to study the issue but to date has not yet released its full report.

At the WHA last year, no agreement could be reached on setting a date for the destruction of the smallpox virus stocks, mainly because of the US refusal. Many developing countries, led by Africa, also asked for a prohibition on genetic engineering, annual substantive WHA review of the virus research, and strengthened WHO oversight.

The issue was then pushed to the WHO's Executive Board in January 2007, which produced a draft resolution. This draft had unresolved issues on the destruction date, and the major review of the research, which have now been agreed at the 60th WHA.

The smallpox resolution, which was approved by a WHA committee at the end of last week, strongly reaffirms the decisions of prior WHAs that the remaining stocks of the smallpox variola virus should be destroyed, and reaffirms the need to reach consensus on a new date for its destruction when research outcomes "crucial to an improved public-health response to an outbreak so permit".

The resolution states that a "major review" of the results of the research will be undertaken in 2010 in order for the World Health Assembly to reach global consensus on the timing of the destruction of the existing smallpox virus stocks in 2011. However, it is not clear what a "major review" entails.

Importantly, the resolution also states that any research undertaken does not involve genetic engineering of the variola virus. This would include the genetic engineering of the smallpox virus itself, and of other viruses with smallpox genes.

NGOs campaigning on the smallpox issue had called for the resolution to explicitly prohibit the insertion of smallpox genes into other poxviruses and prohibit the use of synthetic smallpox virus genes in genetic engineering experiments. However, the resolution remains silent on this.

Recently, it had come to light that Sandia National Laboratory, part of the US Department of Energy, had initiated experiments with synthetic smallpox genes engineered into other organisms.

Sandia had claimed that WHO approval for its research and experiments was not necessary because WHA resolutions do not apply to synthetic versions of the virus. The research may also be illegal as it was conducted without WHA approval, whose approval criteria is research that is essential for public health, and in any event the research involved a laboratory outside of the WHO authorized repository system.

The resolution also requested the WHO Director-General to submit a report to the 61st WHA on the legal status of the variola virus strains held at the two repositories with respect to their ownership.

The Director-General is also requested to maintain biannual inspections of the two authorized repositories "in order to ensure that conditions of storage of the virus and of research conducted in the laboratories meet the highest requirements for biosafety and biosecurity". Thailand proposed changes to the resolution that requested that the reports of those inspections be made publicly available.

The WHO Secretariat joined the fray and suggested that the US proposal that the inspection mission reports should be made available to the public after appropriate redaction, should be inserted into the text. Thailand had wanted that the report should be made public without redaction, and stressed that the report should be scientific and not political.

The Secretariat insisted that this was not possible as this may make public information that could be used by terrorists. Finally, the US and the Secretariat got its way and the text requires that the inspection mission reports be made publicly available after appropriate scientific and security redaction.

The approved research proposals, outcomes and benefits of the research are also to be made available to all Member States.

The annual reporting on progress in the research programme, biosafety, biosecurity and related issues to the WHA is to continue.

A report is to be submitted to the next WHA on measures that promote in Member states the widest and most equitable access possible to the outcomes of the research, including antiviral agents, vaccines and diagnostic tools.

The Director-General is requested to ensure that the two authorized repositories and "any other institution" that has fragments of variola virus DNA, only distribute such DNA for purposes of research on diagnostics, treatment and vaccines in accordance with the recommendations of the WHO Advisory Committee on Variola Virus Research.

This part of the resolution is worrying to the NGOs because it implies that other institutions outside of the two authorized repositories may be allowed to hold fragments of variola virus DNA, and could be allowed by the WHO Advisory Committee on Variola Virus Research to distribute it for research.

The resolution also states that membership of the WHO Advisory Committee on Variola Virus Research and the representation of advisers and observers at meetings of this Committee is to be reviewed in order to ensure balanced geographical representation, with the inclusion of experts from developing countries, and representation from public health experts, and the independence of the members of the Committee from any conflict of interest.

This is important as the Committee has in the past been severely criticized for being unbalanced because the majority of its members and advisors are from developed countries, and the composition of the Committee and its advisors is weighted towards scientists with personal interests in conducting smallpox research, and seeing restrictions relaxed.

The resolution disappointed the NGOs, particularly because it did not set a date for the destruction of the virus stocks. Nevertheless, they welcomed some good points such as the ban on genetic engineering and the report of the legal status of the virus strains held in the US and Russia.

In the debate on the draft resolution, South Africa, speaking for the Africa region, said that 26 years ago the WHA adopted a resolution declaring the global eradication of smallpox. It said that the "major review" will allow the WHA to reach global consensus on the timing of the destruction of existing variola virus stocks. It emphasized that WHO should ensure that the major review is wide ranging and covers all elements of the research being conducted, including gaining assurance that no country keeps any stocks without the knowledge of the WHO.

Kenya said that the rational for retention due to bio-terror threats does not make it safer. If we respond to those fears, it would only encourage more people to acquire more viruses, it stated.

Germany, on behalf of the European Union, welcomed the advances made in new research and said that retention of the live virus is necessary and recommended its retention.

The US said that it strongly supports research on smallpox. It said that eminent scientists are yet to exhaust the research and more work was necessary. The US said that it did not wish inspection reports on visits to authorized repositories to "fall into the wrong hands" and supported the view that the report be made public after redaction.

Lebanon, on behalf of the Eastern Mediterranean Region (EMRO), said that there has been a very broad research agenda since 1999 which has been of limited public health importance. It recalled that in its 7th meeting, the Advisory Committee on Variola Research reported that the live virus was no longer needed for sequencing, diagnostics and vaccines. It recommended that a time limit be set for the conduct of research and that a deadline for the destruction of the virus be set.

Iran said that the 52nd WHA opted for temporary retention of the stocks for research purposes and "compelling reasons" convinced the WHA to decide not to let the activity go beyond 2002.

Iran said that "there seems to be a shift, a temporary retention of almost permanent nature, has become the rule and destruction the exception; this needs to be reversed." It noted that "to make the exception become the rule, the story has tediously been dragged out by a few." It explained that the risky research agenda, despite confirmation by independent experts that all essential research has been accomplished including vaccines and diagnostic tools, "the conclusion favoured by the minority continues to dominate the agenda."

Iran challenged the WHA to revive its leadership by deciding upon a "clear, targeted and time bound road-map" for a fixed date for destruction of the virus stocks. Iran appealed to the WHA and said that nothing justifies WHO being dragged into addressing issues beyond its competencies and mandate or taken hostage to provide justification in the interest of non-health related agendas.

Iran proposed that a new destruction date for the virus stocks be fixed; all genetic engineering of the virus should be prohibited; the WHA should examine if the WHO Advisory Committee on Variola Virus Research has fulfilled its mandate; and in the interim, live virus stocks should be considered a global public good; these stocks should come under global jurisdiction; and global ownership of the research achievements should be ensured.

The Philippines said that the discussions on the destruction date of the virus must be concluded as early as 2010. It said that it did not recommend further rescheduling of the date for concluding discussions.

(* With additional reporting by Edward Hammond.)

Monsanto Violated Patents, ISU Says

By Abby Simons
Des Moines Register
May 23, 2007

The Iowa State University Research Foundation is suing Monsanto Co. for patent infringement, claiming that the St. Louis corporation has developed and sold soybeans with the same low-fat characteristics as soybeans developed and patented by two ISU professors.

The lawsuit, filed Monday in federal court in Des Moines, alleges that Monsanto began selling its Vistive soybeans, which are used to make a low-fat cooking oil, "without any license or authority from (the foundation) and now licenses Iowa State's technology to others."

According to the lawsuit, Iowa State professors Walter Fehr and Earl Hammond have been awarded several U.S. patents relating to soybeans with low linolenic acid content.

University officials asked for an injunction against Monsanto's infringement of the patents, monetary damages and a declaratory judgment that there has been no settlement agreement between the two entities.

Monsanto introduced its Vistive soybeans to farmers in 2005. In January, Omaha-based cooperative Ag Processing Inc. said it would begin processing Vistive soybeans at four more of its nine processing plants this year: those in Eagle Grove, Emmetsburg and Manning in Iowa and in Hastings, Neb. Vistive beans were already being processed at plants in Mason City and Sheldon.

Repeated telephone calls to Monsanto representatives for comment were not returned. ISU's Fehr declined to comment, as did the research foundation's attorney, Edmund Sease.

Ken Kirkland, executive director of the research foundation, said in a prepared statement that officials of the organization had "reached a stalemate in our attempt to resolve a patent dispute with Monsanto over low linolenic acid soybeans. We remain hopeful that we will be able to work out our differences, and this has been communicated to Monsanto."

Kirkland declined to answer questions but confirmed that Monsanto had not given financial endowments to the research foundation.

In contrast, Monsanto competitor Pioneer Hi-Bred International Inc. of Des Moines, has had a long, warm relationship with Iowa State, extending back to Henry A. Wallace, a 1910 graduate of the school who developed hybrid seed corn and founded Pioneer, then began a political career that included eight years as U.S. agriculture secretary and four years as vice president under President Franklin D. Roosevelt.

Through the years, Pioneer has endowed several professorial chairs at ISU and has been a regular benefactor to the university's agricultural, engineering and business programs.

In 1991, Iowa State and Pioneer reached an agreement that gave the company "exclusive commercialization rights" to soybean genetic traits developed by ISU researchers.

Pioneer and Monsanto have been prime rivals in the seed market since the late 1990s, when Monsanto spent more than $8 billion to buy several U.S. and foreign seed companies.

In 1999, Pioneer was sold to DuPont for $7.7 billion.

Pioneer spokesman Pat Arthur said Tuesday that "we don't think we can add anything to a lawsuit that does not involve us."

According to court documents, Iowa State professors began developing the low linolenic acid soybeans and their producing methods as early as 1968. The documents say the research foundation currently owns at least eight U.S. patents covering the products, breeding and manufacturing methods.

The lawsuit says that Iowa State confronted Monsanto in February about the patent claim and that at a subsequent meeting, "settlement terms were discussed, but no agreement was reached."

The lawsuit says the research foundation told Monsanto that any settlement terms would have to be cleared with Fehr.

After Monsanto was confronted again, the company's representatives sent a letter to ISU saying Monsanto "stands ready to perform under the agreement reached with the university at our meeting of February 28th." However, Iowa State contends no agreement was reached.

Group Condemns Dept. of Justice Approval of Monsanto - Delta and Pine Land Merger

Bill Freese, Center for Food Safety
John Bianchi, Goodman Media International
May 25, 2007

Washington, DC - The Center for Food Safety today blasted the Dept. of Justice's (DoJ) approval of Monsanto's $1.5 billion buyout of cotton seed giant Delta and Pine Land (DPL). Monsanto holds a virtual monopoly in biotech traits deployed in genetically engineered cotton and soybeans, and is also the world's largest seed firm. Delta and Pine Land sells over half of U.S. cotton seed, and in 2004 was the world's eleventh largest seed firm. The National Black Farmers Association and the Center for Food Safety had urged DoJ to block the merger. The American Antitrust Institute and leading agricultural experts had warned DoJ the merger could seriously inhibit competition, limit choices and raise prices.

'Monsanto technology is already in 95% of biotech cotton. This merger will strengthen Monsanto's monopoly, meaning increased seed prices and reduced seed choices for American farmers,' said Bill Freese, science policy analyst at Center for Food Safety (CFS). Freese authored a report on the merger based on exhaustive analysis of USDA data that was submitted to DoJ in February of this year.

'The Department of Justice's failure to block this clearly anticompetitive merger is inexcusable,' said Joseph Mendelson, CFS Legal Director, noting that DoJ officials approved the merger despite sharp criticism from Senators on the Judiciary Committee, and that DoJ has not gone to trial to block a proposed merger since 2004.

'We often get calls from farmers being sued by Monsanto for allegedly saving the company's patented seeds. These farmers tell us that Monsanto's steep biotech fees, together with rising fuel and chemical costs, are driving them to and over the edge of bankruptcy,' added Mendelson.

CFS's report shows that cotton seed prices have risen 240% since 1995, due primarily to rising biotech fees Monsanto adds to the price of genetically engineered seeds containing its 'traits.' Over 80% of all U.S. cotton (conventional and biotech) already contains Monsanto's traits; meanwhile, the number of cheaper conventional varieties available to farmers declines every year. The report cites USDA data showing that one of five cotton farms, mostly smaller operations, went out of business from just 1997 to 2002.

The report discusses Delta and Pine Land's attempts to diversify its biotech seed offerings through recent agreements with DuPont and Syngenta, Monsanto competitors, and predicts the merger will foil DPL's pre-merger efforts to provide more seed choices to cotton farmers.

A striking graphic in the report (Appendix 6) charts Monsanto's multi-billion acquisitions of leading corn, soy, canola and vegetable seed firms over the past two decades, deals that transformed it into the world's largest seed company in 2005.

The report also explores the serious, adverse impacts Monsanto's biotech seed monopoly is having on agriculture and the environment.

'Monsanto's goal is to transform America into Roundup Nation,' said Mendelson, noting that Monsantos Roundup Ready cotton, soybeans, corn and canola, engineered for use with the company's Roundup weed killer, covered an astounding 117 million acres in 2006, an area larger than the state of California.

'Roundup use has skyrocketed since Roundup Ready crops were introduced. Excessive use of Roundup is harming soil life essential to crop health and productivity, and also breeding superweeds resistant to Roundup,' said Freese. 'One cotton expert called these Roundup-resistant weeds a threat to the cotton industry comparable to the boll weevil.'

Monsanto's biotech monopoly, strengthened by its takeover of Delta and Pine Land, is quickly leading American agriculture into a dangerous dependence on one company and its limited set of biotech traits, and poses an unprecedented threat to American agriculture, concluded Mendelson.

View Report

New Statute Protects the DNA of Wild Rice

Minneapolis Star Tribune
May 29, 2007

The DNA of Minnesota wild rice gets special protection under a new state law adopted this year with the backing of Indian tribes.

Genetic modifications to wild rice will be watched more closely, with environmental impact statements required and permits controlled by the Minnesota Environmental Quality Board. The board is also required to keep tabs on genetic modifications to wild rice throughout the country and notify wild rice farmers, Indian tribes and legislators if permits for genetically altered wild rice are issued in any state.

Meanwhile, the state Department of Natural Resources will study the status of natural wild rice and potential threats. Rep. Frank Moe, DFL-Bemidji, said it's the first time a state has voted to protect a native crop or species from genetic changes.

"Wild rice is not only historically and economically important for all Minnesotans, it's sacred to the Ojibwe people," Moe said. "It's both important food for us and prime fish and duck habitat. We need to study the declining wild rice population and protect against any genetic damage to native wild rice."

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