THIS winter, a couple of dozen British farmers have been spraying their fields with a herbicide called glufosinate ammonium. It sounds unremarkable. But in May the herbicide will be at the centre of a courtroom battle that, depending on who you talk to, represents either an unprecedented attack on the competitiveness of big business, or a timely warning of a looming threat to the freedom to share information鈥攐ne of the mainstays of modern science and public reassurance about safety.
The case pits the British government against the multinational company Aventis and an agrochemicals industry body called the Crop Protection Association (CPA). At issue is not whether the farmers are breaking the law鈥攅verybody agrees they鈥檙e not鈥攂ut rather the secrecy surrounding the herbicide, including crucial information about its safety. For once, the British government, no stranger to secrecy, is saying it鈥檚 in the public interest to disclose the evidence. Aventis, which carried out the research, says it鈥檚 commercially sensitive and must therefore stay under wraps.
Commercial secrecy, of course, is nothing new. Companies everywhere argue that sharing certain kinds of information poses a direct danger to their business. To that end, firms routinely delay publishing their research findings, and their lawyers have never shied away from using the courts to gag people threatening to disclose proprietary information. In response, environmentalists, patient groups and other interested parties fight a paper war to gain access to such facts.
Advertisement
But the hearing in May will break new ground. Aventis and the CPA fear that the level of disclosure demanded by the government will set a precedent that could affect an entire industry.
Throughout the 1990s, glufosinate was licensed in Britain to be sprayed on fields鈥攂ut only between early spring and autumn. In wetter winter conditions, regulators feared, the chemical might leach into groundwater in amounts exceeding the legal threshold for pollutants. Three years ago, however, Aventis wanted to test a genetically modified variety of oilseed rape in British farm trials. The crop is resistant to the herbicide, so farmers could spray their fields after planting. But oilseed rape is often grown over the winter. So before the trials began, Aventis pressed the government to relax the winter restriction, backing up its argument with 鈥渃onfidential鈥 scientific evidence countering the safety fears.
This inside knowledge swayed the government, and it agreed to lift the restriction. Angered by the decision, Friends of the Earth warned the government that withholding the documents could put it in breach of its own environmental information regulations. Reluctantly, therefore, the government agreed to disclose them鈥攁nd Aventis threatened it with an injunction.
Since then nothing has been published, and in May the company will argue in court that it should stay that way. 鈥淭he data involved requires substantial economic and intellectual investment,鈥 the company says in a written statement it forwarded to 快猫短视频 in response to our enquiries. 鈥淚ts free availability to third parties could result in substantial losses to Aventis.鈥
The case is about far more than just a herbicide. In the past, British officials would have downed hemlock before daring to antagonise a major company by breaking the code of commercial confidentiality. Not any more. In effect, the government is warning companies that regulators will no longer automatically keep secret the scientific evidence that crosses their desks. If the evidence concerns the environment, they may have no option but to publish it. Meanwhile, industry critics, including many researchers, see the case as a wake-up call on the growing commercialisation of science.
Across the world, university labs are spawning start-up companies or signing contracts with industry. Two-thirds of research is now financed by companies (see Graph). And much of this 鈥減rivatised鈥 science is falling into the hands of ever fewer鈥攁nd ever bigger鈥攇lobal corporations. For instance, drugs firm Pfizer Warner Lambert has the world鈥檚 largest private biomedical R&D operation, investing $4.7 billion in 2000. That鈥檚 70 per cent more than the British government鈥檚 annual science budget.
Many would argue that the rise of multinationals is a necessary consequence of an increasingly competitive global market. But to some it amounts to nothing less than a wholesale takeover of science. If access to information produced by the private sector is unduly restricted, the result will be unprecedented scientific secrecy.
And the turf war is going to be fiercest in Britain. In the US, freedom of information is enshrined in legislation. Many argue that the system is flawed, but the assumption is that if companies want to keep data secret, they鈥檇 better have a good reason. In Britain the reverse has been true鈥攊f you want such information, you have to fight for it.
Now something has to give. After the BSE crisis, the government promised transparency in scientific decision making. This newfound enthusiasm for openness reached new heights last year when its Chief Scientific Adviser published a code of practice for government advisory panels and agencies. The code stipulates that such bodies should disclose not just their reports and policy statements, but 鈥渁ccurate minutes鈥 of their meetings and 鈥渟upporting papers鈥. In effect, the sort of information Aventis and the CPA think should remain hidden.
The government鈥檚 credibility on scientific openness is on the line and the British courts aren鈥檛 helping. The chemicals giant Amvac recently won an injunction preventing government experts from disclosing information, including safety concerns, about an insecticide it manufactures called dichlorvos.
For decades this organophosphate has been the active ingredient of household flea and fly sprays. Last July, acting on new evidence from animal experiments, the British government鈥檚 Advisory Committee on Pesticides warned ministers that 鈥渢here could be a small risk of cancer from the substance in those people who used it over prolonged periods鈥. The committee recommended the substance be withdrawn from sale.
It wasn鈥檛. Instead, Amvac lodged an appeal claiming regulators hadn鈥檛 looked at all the relevant data. The company also obtained a court order restraining the government from acting on or publishing the advice of its experts. It took six months to get the restraining order overturned, during which time the public remained in the dark about the safety concerns. The expert pesticides committee was forbidden even from publishing the minutes of one of its meetings.
Dichlorvos continues to be sold in Britain pending a judicial review of the evidence. In response to 快猫短视频鈥檚 enquiries, Amvac forwarded us a statement saying the chemical 鈥渄oes not present a carcinogenic risk to humans鈥, and that the proposed suspension 鈥渨as without scientific basis and would do nothing but create unwarranted concerns鈥. The statement also says the company is 鈥渇ully supportive of the precautionary principle and transparency in regulatory issues鈥.
But David Coggon, chair of the expert committee 鈥渞estrained鈥 by the company, finds that hard to swallow. He says that the prospect of further legal action from companies prevents his committee from publishing detailed minutes of its meetings. 鈥淭here is a feeling that we ought to make these open because people shouldn鈥檛 feel anything is being hidden,鈥 he says. 鈥淏ut a small minority of the companies would not be happy, and if one or two make legal challenges you could have problems.鈥
So why are British courts granting companies these gagging orders? Partly it鈥檚 because there are no clear legal boundaries on what should be classed as commercially sensitive or damaging information. Companies can use the phrases to justify withholding or censoring not just legitimate trade secrets and intellectual property but virtually anything they like, says Charles Medawar of Social Audit, a London-based consumer watchdog.
Another reason is that despite the government鈥檚 rhetoric about openness, Britain鈥檚 statute books are still stuffed with 鈥渟ecrecy clauses鈥 designed to ensure regulators and expert advisers do not leak confidential information. Section 118 of the Medicines Act, for example, makes it an offence for drugs regulators to disclose company information to a third party. And as yet, Britain has no counterbalancing 鈥渄isclosure laws鈥 compelling companies to publish all their information about their products, including evidence relating to safety.
Even when those products are drugs, companies can pick and choose what they publish or pass on to independent experts. The confusion this can create is seen in the long-running controversy over the safety of Prozac-type antidepressants.
When launched, these drugs were hailed as a safe, non-addictive alternative to older drugs like Valium. But in recent years there have been claims that they can trigger suicidal or violent thoughts in a small minority of patients (see 鈥淩eputations at stake鈥), and marked physical dependency in a larger group. The industry denies both problems, but has so far been unwilling to disclose all its raw data. The result has been a rash of speculation about a cover-up.
Increasingly, experts are calling for rules to compel drugs companies and their regulators to publish everything. 鈥淚t鈥檚 extraordinary,鈥 says Iain Chalmers, 鈥渢hat neither you nor I, as potential patients, have access to information held by the Medicines Control Agency on the effects of licensed drugs that we may be asked to swallow.鈥
Chalmers is director of the Cochrane Centre in Oxford, where researchers attempt to pool disparate clinical data on drugs to get a clearer view of their efficacy. This 鈥渆vidence-based鈥 approach to medicine also underpins the work of the British government鈥檚 National Institute for Clinical Excellence, a pioneering body set up to screen out drugs that are poor value for money.
It鈥檚 a revolutionary approach, but it can only work if researchers have access to all the data. And at present, says Chalmers, companies who want their drugs endorsed by NICE don鈥檛 have to pledge that all of the relevant evidence has been made available, or agree to the automatic publication of any data that they do submit.
Will any of this change? In 2005, Britain will attempt to catch up with the US by enacting a new Freedom of Information Act. Those who read its fine print, however, will discover a clause exempting information 鈥渓ikely to prejudice the commercial interests of any person鈥.
Gagged and bound
DAN LYONS knows all about gagging orders. For the past 18 months he has been silenced by an injunction.
It all started two years ago when a stash of company memos and confidential scientific findings landed on his doormat in Sheffield. Lyons is an animal welfare campaigner, and the leaked documents described animal experiments by a British biotech company called Imutran.
The company is now part of a Boston-based outfit financed by the drugs and chemicals giant Novartis. But in the mid-1990s, Imutran was attempting to use genetic engineering to turn pigs into organ donors. It paid contract researchers to transplant its pig organs into more than 400 macaques and baboons.
Technically the documents were stolen, but Lyons argues that much of what they contain is in the public interest and ought to be published. Specifically, he claims that in the papers the company published in scientific journals, it exaggerated the average survival times and health of the monkeys, and that some animals suffered unnecessary pain due to surgical blunders.
No one can verify these allegations because Lyons risks imprisonment if he discloses any part of the documents. But last year, the government鈥檚 chief inspector of animal experiments, who has seen the documents, issued a report stating that 鈥渢he decisions taken by the surgical team were taken in good faith鈥, but that 鈥渋n several instances鈥 the procedures led to 鈥渦nnecessary animal suffering鈥.
Since then experts at Britain鈥檚 Royal Society for the Prevention of Cruelty to Animals have written a fuller report on the documents. However, the authors are unable to circulate the report even to members of their own organisation without the company鈥檚 permission鈥攚hich they have not yet received.
Reputations at stake
FOUR years ago, while on a course of an antidepressant called paroxetine, Don Schell got up one night and shot dead three members of his family before turning a gun on himself. He was a retired worker from Wyoming with no history of violence. The family blamed the medication and won $8 million in compensation from its manufacturer, GlaxoSmithKline (GSK), in a US court case last summer.
The expert testimony of David Healy, a psychiatrist at the University of Wales in Bangor, helped swing the verdict. Healy was granted access to 235,000 pages of company documents, some describing early unpublished trials of paroxetine.
Healy claims the trials revealed unusually large numbers of healthy volunteers becoming agitated while taking the drug, or experiencing marked withdrawal effects afterwards. Some volunteers, he claims, even went on to attempt suicide. Healy also alleges the findings he saw are at odds with a summary of the research that the company sent to regulators at Britain鈥檚 Medicines Control Agency. Both the company and the MCA deny any disparity.
At stake is the reputation of the bestselling product of one of the world鈥檚 biggest drugs companies. And yet the obvious way to clear the air鈥攇et independent experts to analyse all the data鈥攊s barred. The MCA is forbidden by law from publishing evidence given it in confidence. And before seeing the documents, Healy had to sign a confidentiality agreement. He cannot disclose anything more than the interpretation he gave in court.
When 快猫短视频 asked GSK why it hasn鈥檛 published all its paroxetine findings, the company said: 鈥淭he raw data that Dr Healy was given access to involved identifiable patients, and is thus confidential and proprietary.鈥 When pressed on why it couldn鈥檛 publish the data on healthy volunteers and strip out the patients鈥 personal details, the company added: 鈥淲e cannot just give out our raw data.鈥