Warning Is Sent to AIDS Vaccine Volunteers

By Craig Timberg
Washington Post Foreign Service
October 25, 2007

JOHANNESBURG, Oct. 24 -- South African AIDS researchers have begun warning hundreds of volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV in the midst of one of the world's most rampant epidemics.

The move stems from the discovery last month that an AIDS vaccine developed by Merck & Co. might have led to more infections than it averted among study subjects in the United States and other countries. Among those who received at least two doses of the vaccine, 19 contracted HIV compared with 11 of those given placebos.

Researchers shut down the trial on the grounds that the vaccine was proving ineffective, but the surge in infection among vaccinated volunteers prompted intense scientific debate and anxiety among researchers. The failure of the Merck vaccine is the latest in a series of disappointing results for research projects aimed at curbing AIDS.

"This is my worst nightmare," said Glenda Gray, the lead South Africa investigator for the vaccine study. "I haven't slept for days. I have a headache. I'm ready to resign from trials for the rest of my life."

Researchers in Soweto, Cape Town, Durban and two other sites began contacting South Africa's 801 trial participants on Tuesday, mainly by cellphone text message. The goal is to tell each one individually whether they had received a placebo or the vaccine, a process called "unblinding" the trial. Researchers are telling the roughly half who received the vaccine that it might have increased their risk of contracting HIV.

"It's quite shocking," said Nelly Nonoise, 26, who had received three injections of the vaccine in her left shoulder.

She added, "I probably wouldn't have joined the study knowing there's a risk."

Another participant, Nonhlanhla Nqakala, 22, said she thought the text message urging her to visit the vaccine test site meant she had tested positive for HIV. Her brother and a close friend had the disease and died, she said.

Nqakala said she was relieved when a doctor explained that she was not infected, but the news of a possible problem with the vaccine -- she had received three doses, not placebos -- left her distressed. "I thought the trial would help us find a cure for HIV," she said.

Merck developed the vaccine in conjunction with the U.S. National Institutes of Health, and until September's announcement, researchers worldwide considered it the most promising candidate yet in a multibillion-dollar quest for an AIDS vaccine dating to the 1980s.

Scientists crafted the vaccine by genetically altering a common virus to include elements of HIV. They hoped that it would trigger an immune response that would make recipients less likely to contract HIV, or at least delay the onset of full-blown AIDS.

The vaccine could not have caused infection, researchers say, but it could have caused immunological changes that made it easier for the virus to take hold during a later exposure.

The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men.

In South Africa -- where an estimated 5.5 million people are infected with HIV, more than in any other country -- the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual.

The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck.

Continuing research could be compromised, he said, if participants were told immediately whether they received the placebo or the vaccine. Vaccine researchers are scheduled to meet in Seattle on Nov. 7.

"Given the complexity of the issue, we feel the best conclusions will be reached when all the data are analyzed in their entirety," Feinberg said from Atlanta, where he was traveling.

He added that individual participants who want to know whether they received the vaccine will be told. Researchers also are counseling all study participants that the vaccine may have increased HIV risk for those who received it.

Other AIDS studies also have had unexpected results. Trials of two vaginal microbicide gels to prevent HIV led to more infections among those using the products instead of placebos. A massive study in Zimbabwe of the ability of HIV counseling and testing to prevent the spread of the epidemic found more infections among those with expanded access to testing.

GMO Products as a Condition for Ukraine to Enter WTO

Ukrayinska Pravda
October 25, 2007

On October 25 in Geneva final round of negotiations on Ukraine joining World Trade Organization will take place; however, the issue of obligatory marking of products containing genetically modified organisms remains unsolved.

Liga website published an article "Gene Engineering May Obstruct Ukraine's Way to WTO" drawing the readers' attention to this problem.

The author of the article reminds that the Cabinet of Ministers decided to introduce an obligation of marking genetically modified foodstuffs starting from November 1, 2007.

"However, the American side of WTO holds a firm stand against such actions," runs the article.

"It is common knowledge that the USA is among the biggest exporters of this kind of foodstuffs. That is why their actions can perhaps be interpreted as unwillingness to lose markets for their products," notes the author.

Genetically modified organisms are those organisms the genetic material of which changed not as a consequence of replication and/or natural recombination but because of a modified gene or a gene of other biological species or kind added.

According to Kateryna Kartava, Ph.D., doctors don't know which diseases a person can face after consuming gene engineering products.

After consuming such products the anti-gene composition of body tissues will be changing; as a result the immune system will start to destroy its own organism, notes the expert.

The author cites the Minister of Economy Anatoliy Kinakh according to whom the issue of GMO products should be dealt with by prioritizing health of Ukrainian citizens and strictly controlling the quality of foodstuffs imported into Ukraine nowadays.

Meanwhile State Commission of Consumption Standards of Ukraine insists on compulsory marking of at least children's food. As Mr. Kinakh noted, it is an obligatory norm in all EU countries.

According to the data of All-Ukrainian Ecological League, 90 per cent of Ukrainian foodstuffs do not contain genetically modified organisms, notes the author.

Time for a Fresh Start on GM

The Independent
October 28, 2007

One of Gordon Brown's many chances for a fresh start, after the high-pitched certainties of his predecessor, is the Government's policy on genetically modified food. In truth, the battle is already over. Those who urged caution, including this newspaper which launched a campaign against GM food in 1999, have won. Those who advocated a rush towards the white heat of a biotechnological future, including Tony Blair, have lost. What is required now is for Mr Brown to accept that outcome and to take the debate on to more level ground.

When we began our campaign, 60 per cent of the food on British supermarket shelves contained GM ingredients. Today there are only two products. Public opinion has spoken and the market has responded. Few people want to eat GM. They have made up their minds even though its safety is still in dispute, with little firm evidence on either side of the argument. And there are other reasons for opposing the growing of GM crops - the loss of biodiversity shown by the Government's trials and the likelihood that genes will escape to contaminate organic and conventional produce. In the absence of a compelling argument to set against these important drawbacks we think that British consumers have made the right choice. If we do not need it, why have it?

That logic has killed off GM as a commercial proposition in this country and most of the rest of Europe for the foreseeable future. When our campaign began, it was widely assumed that consultation and trials were a formality, that GM crops would soon be planted all over Britain and that protests were futile. Mr Blair was enthusiastic about the possibilities, and how Britain could take a leading role on this frontier of human knowledge. Since then, that frontier has become a less exciting place. The hype of "feeding the world", or "super-crops" that do not need weedkiller or pesticides, has given way to a more complex and prosaic reality.

Crops with higher yields have proved harder to engineer than hoped and tend to be overtaken by gains in the traditional technology of selective breeding. And instead of developing crops that might help the world, the biotech companies have concentrated on ones that benefit only their own bottom lines, for example by having to be cultivated with their own proprietary pesticides.

So: people do not want it; the great predicted benefits have failed to materialise; the GM juggernaut has stalled. Campaigners for GM have not given up, however. Dick Taverne, a member of the House of Lords Science and Technology Committee, writes (again) in next month's Prospect about how "moralising" about GM in the West is costing millions of lives in the poor world. But his argument is unconvincing. Development charities, who know better than most how things work in the often complex Third World grassroots, oppose the technology because it increases, rather than reduces, hunger.

Yet the Blairite mission seems to be carried on by inertia, even after the former Prime Minister and David Sainsbury, his science minister and biotech cheerleader, have gone. As we report today, public funding is still skewed in favour of this one vision of the future of food. Funding for research into GM science seems to be about 20 times that devoted to organic methods. Yet people want organic not GM food, while the emphasis of policy in other parts of the Government machine is on biodiversity and environmental sustainability. (This month the Treasury even published targets for "wild breeding bird populations" and "plankton status".)

What is more, the secrecy with which the Government treats GM policy bears all the defensive hallmarks of the Blair period, when public policy was bent to promoting an unpopular cause on the quiet in the hope that opinion would turn. Geoffrey Lean, our Environment Editor, describes today how difficult it proves to obtain what ought to have been straightforward information on spending on GM research.

Mr Brown has the chance to be more open; to balance policy so that, at the very least, it is more even-handed between GM and organic. And he has the chance to move the debate about the future of biotechnology on to a sounder footing. We are not opposed to genetic manipulation on principle. We do not share Prince Charles's view that it is interfering in matters that are the province of God. If GM technology was really designed to help to feed the world, or produce drought-resistant or salt-resistant crops to help humankind adapt to global warming, then there would be reason to welcome it.

But this has to be subject to transparent assessment of all the environmental impacts, including on human health, without the Government seeking to pick winners and advocating any particular technological fix - especially one that the people of the country reject so overwhelmingly.

GM: The Secret Files

By Geoffrey Lean
The Independent
October 28, 2007

Ministers are secretly easing the way for GM crops in Britain, while professing to be impartial on the technology, startling internal documents reveal.

The documents, obtained through the Freedom of Information Act, show that the Government colluded with a biotech company in setting conditions for testing GM potatoes, and gives tens of millions of pounds a year to boost research into modified crops and foods.

The information on funding proved extraordinarily difficult to get, requiring three months of investigation by an environmental pressure group, a series of parliamentary questions, and three applications for the information.

Friends of the Earth finally obtained still partial information last week which shows that the Government provides at least £50m a year for research into agricultural biotechnology, largely GM crops and food. This generosity contrasts with the £1.6m given last year for research into organic agriculture, in spite of repeated promises to promote environmentally friendly, "sustainable" farming.

Publicly ministers claim to be neutral over GM. Four years ago, at the height of controversy about plans to introduce modified crops to Britain, Prime Minister Tony Blair insisted that the Government was "neither for nor against" them. The then Environment minister, Elliot Morley, added: "There is an open and transparent process for their assessment and all relevant material will be put in the public domain." Last month the Environment Secretary, Hilary Benn, reiterated: "There is no change in the Government's position."

But the documents show that ministers have been far from even-handed. One set, obtained by the campaigning group GM Freeze, clearly demonstrate that the Department of Environment, Food and Rural Affairs (Defra) allowed the biotech giant BASF to help to set the conditions for field trials it has conducted on modified potatoes. On 1 December last year the company was given permission to plant 450,000 modified potatoes in British fields over the next five years, in a series of 10 trials. The set of emails and letters between Defra and the company reveal that officials repeatedly went to remarkable lengths to make sure the trial conditions, supposed to protect the environment and farmers, were "agreeable" to BASF.

On 29 September a department official emailed BASF to inform it of a recommendation by the Advisory Committee on Releases to the Environment (Acre), its official advisers on risks to health and the environment from GM, that "the land should be left fallow for two years following each trial" and added "I would like to know whether you think that this is workable for you". The official pointed out that other EU countries had specified that "berries/true seed should be removed from the trial" but that Acre had "not specified this because the committee believes that this would be a very big job". The email went on: "If you think this is completely unworkable, I think the committee may be prepared to accommodate a reduction of this fallow period to one year but there may be other conditions (eg removal of flowers/berries)."

The writer added: "In addition to this, Acre has recommended a particular tillage regime, hopefully you are able to accommodate this."

On 6 October Defra sent BASF a draft of the consent to the trials, adding: "Please let me know whether or not the conditions as they stand would be agreeable to BASF or whether there are any conditions that would be difficult to meet."

BASF replied on 26 October that it believed that the "probable conditions" were "very agreeable to us", adding: "We hope that the final conditions will not change too much."

On 9 November Defra again emailed BASF to check that one of the conditions "does not affect your plans", and five days later was in touch again to say that it had "redrafted" another "in response to your concerns".

Yet the department insisted in a written statement last week: "There is no truth in any allegation that Defra was in any way influenced by BASF in relation to the terms under which BASF could conduct trials on GM potatoes in the UK."

Pete Riley, the campaign director of GM Freeze, said: "That is simply not correct. The documents clearly show that Defra colluded with BASF to ensure that Acre's conditions for growing their GM crop were to their liking. Its role is to protect the environment and public health. It is supposed to be a watchdog, but the documents reveal it to be the industry's lapdog."

Peter Ainsworth, the Conservative environment spokesman, added: "This is a government department that claims to be objective and science-based in its approach to biotechnology, but clearly it has bent over backwards to model its conditions on the requirements of BASF."

A spokesman for BASF said: "I do not think that they granted us any concessions that would not normally have been granted."

The funding disclosure came when the Biotechnology and Biological Sciences Research Council (BBSRC) - which is funded by the Department for Innovation, Universities and Skills - revealed that it gave £39.3m to its seven sponsored institutes for research on "agricultural biotechnology" in 2006-07.

The sum has more than doubled, from £15.5m, since 1997, even though the prospects for GM crops in Britain have been declining in this period, with ministers admitting three years ago that none would be grown commercially "for the foreseeable future".

Besides this "core strategic grant", the BBSRC also gives tens of millions of pounds a year for similar research to universities and other institutes.

In 2003-04 this sum totalled £27.1m. The BBSRC told Friends of the Earth that it could not provide it with up-to-date information until January, unless it paid a fee of £750, because this "would take considerable effort, beyond the appropriate limit" to assemble. But the figure is believed not to have fallen over the past three years. On top of the BBSRC funding, Defra provided £12.6m for agricultural biotechnology research in 2005-06, the last year for which figures are available.

Nor is it clear how much money goes to genetic modification, since the BBSRC defines agricultural biotechnology as "the application of molecular genetic and other modern biological techniques to crops, livestock and disease-causing organisms".

It says it is not yet able to provide information on the proportion that has recently been devoted to GM, as opposed to other techniques. But figures on its website show that in 2000-01 about half of its core strategic grant to the seven institutes was spent on the technology.

In contrast, Defra spent £1.6m on research "relating to organic farming", while BBSRC refuses to provide any funds at all, saying it "does not fund applied work on entire farming systems".

It justifies spending so much taxpayers' money on GM before, as it admits, "there is any clear evidence that the public wants them" by saying that research must retain "the flexibility to remain competitive and to respond to changing global situations and changes in consumer demand".

Yet when the Government officially asked the public, four years ago, about their preferences, 86 per cent said they would not be happy to eat GM foods. By contrast, sales of organic produce rose by 22 per cent last year to break through the £2bn barrier. More than half of Britons now buy it, at least from time to time.

The BBSRC says that its funding for the research on GM crops would continue even if there was "a Europe-wide ban" on growing them commercially.

Kirtana Chandrasekaran, Friends of the Earth's food campaigner, said: "The Government's support for GM crops and foods is out of all proportion to its non-existent benefits, let alone the public's non-existent desire to consume them.

"Despite continually promising to support sustainable agriculture, it is spending tens of millions on a technology that has fallen flat on its face while starving organic farming, which is producing food that people want to buy.

"It is also staggering that there is no clear information in the public domain on exactly how much money is going into GM research, and that it has proved so hard to get even partial figures out into the light of day."

A farmer's story: 'It's all about control of food production'

The spectre of GM contamination has cost John Turner dear. A succession of trials near his 250 acre farm in Little Bytham, south Lincolnshire, between 2000 and 2002 forced him to stop growing certain crops - suffering heavy financial losses as a result.

"It was a nightmare and we just felt absolutely powerless to do anything over it at all," he recalled. "Without any real protection against contamination, we were forced to stop growing crops like maize that could be vulnerable to cross-pollination. It wasn't easy but it was preferable to the damage that could have been done if our crops were no longer GM-free. We feel that we are in remission at the moment, but every few months there seems to be a new PR push from the GM lobby."

The facts are being twisted to fit a commercial agenda, according to Mr Turner: "There is no sound science behind the push for GM crops. It's all about money and control of not only the seeds but also food production from one end to the other. The more I find out about it the less I understand why there has been this impetus to force this technology on farming. It has been hugely over-hyped by those trying to promote it. There are plenty of ways of improving crops that don't involve swapping genes around.

"But farmers could sleepwalk into using GM crops and by the time they realise the proposed benefits just aren't there they will not be in a position to go back to a GM-free style of agriculture - that's the danger and that's been the experience of farmers in other parts of the world."

Jonathan Owen

top of page