The hidden side of clinical trials

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'The Ugly Truth'

by Tracey Brown, director of Sense About Science

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Big Libel Week

Libel stories

Over Big Libel Week, we put together a series of case studies, showing the use of libel laws to silence public debate and discussion.

In some countries, criminal defamation laws are being used to silence scientists. Find out more about criminal defamation laws and the case of a Peruvian scientist.

Libel’s Cost to Consumers

What Satellite and Digital TV is a consumer technology magazine published monthly in the UK since 1986. It covers news, technical advice, equipment reviews, and other developments in the digital TV industry.

Editor Alex Lane describes the difficulty he has covering stories that are important to his readers: “It’s almost impossible to cover the poor manufacturing standards of set-top boxes used by millions of people daily, because of the potential legal and commercial ramifications of taking on big companies. Even a relatively large media company would baulk at the prospect of the most limited legal exchange with these giants.”

Lane believes that the outcome wouldn’t improve even if his writing was supported by enough evidence to defend a libel case.

“Sheer cost means the battle would be lost long before it ever reached the courts.”

The New York Academic vs. The Saudi Billionaire

Rachel Ehrenfeld is a New York-based author and director of the American Center for Democracy with a Ph.D. in criminology. In her 2003 book Funding Evil How Terrorism is Financed and How to Stop It, she alleged that Saudi billionaire Khalid bin Mahfouz “transferred some 74 million US Dollars to at least two front charities for terrorism.”

Though neither party lives in England and the book was not published or marketed there, bin Mahfouz was able to file a libel suit in London because 23 copies of Funding Evil arrived in the country via online purchases.

“Mahfouz was a one-man wrecking crew of Americans’ free speech rights, who after 9/11 sued or threatened to sue dozens of American writers in plaintiff-friendly English courts,” Ehrenfeld wrote. “When Mahfouz came after me, I refused to acknowledge the British court, asserting my rights as a U.S. citizen.”

The courts gave bin Mahfouz a default judgement, demanding Ehrenfeld pay more than 100,000 pounds and destroy existing copies of her book. Ehrenfeld countersued in New York claiming she was protected by US defamation law, but the suit was dismissed as the courts did not have jurisdiction over bin Mahfouz.

This litigation led the New York legislature to unanimously approve a bill to protect New Yorkers from libel suits “in countries whose laws are inconsistent with the freedom of speech granted by the United States Constitution.” A similar bill to protect US citizens from England’s libel laws was unanimously approved by the US House of Representatives and is expected to pass into law soon.

Silencing the Anti-Aging Critics

As experts on geriatrics and aging, Professor S. Jay Olshansky and Dr Thomas Perls are outspoken critics of unproven anti-aging products. At a conference in Australia they helped award the American Academy for Anti-Aging Medicine (A4M) a “Silver Fleece,” a dubious honour meant to shame the company for claiming to have invented a way to reverse aging.

A4M’s founders, Robert Goldman and Ronald Klatz filed a 120 million US Dollar (75 million pounds) lawsuit for damaged credibility in 2004. They alleged that Olshansky cost them an important business deal in 2003 when he met with the executive vice president of Market America, a company considering partnering with A4M. When Olshansky pointed out the lack of scientific evidence for A4M’s claims, Market America pulled out.

“It was a friendly inquiry, trying to evaluate the evidence, just as it should be in science,” said Olshansky.

A4M chose to sue Olshansky and Perls instead of their respective universities, University of Illinois at Chicago and Boston University, a move that some critics think was designed to intimidate the professors. “Even the cost of the discovery process can be extremely expensive,” said Sandra Baron of the Media Law Center in New York.

The University of Illinois at Chicago decided to back Olshansky anyway. “The university has become involved because it is an issue of academic freedom,” said a spokesperson. “Professor Olshansky is doing his job … to search for the truth and speak it. That is the purpose of a research university. The university is defending its purpose.”

Olshansky responded to A4M with a countersuit. In 2006, A4M agreed to drop its suit if Olshansky dropped his.

“It's my job to protect public health, and inform the public about the truth of what we know and what we don’t know,” said Olshansky.

Diluting Homeopathy Reporting 

Nick Miller is Health Editor for Australia’s The Age newspaper. In July 2009 he interviewed British science writer Simon Singh about homeopathy. The interview covered the lack of scientific evidence for the treatment and the potentially dangerous consequences of choosing it over conventional medicine.

The night before Miller’s article was published, he discovered that his publisher’s lawyers “diligently removed some significant directly and indirectly quoted comments about homeopathy from the first paragraph and main body.” His editor explained that the purpose was to protect the writer and the paper from becoming a target for homeopaths who might sue for libel.

Miller explained the situation in a blog post on TheAge.com.au, which also had to be written carefully to avoid controversy. “The legal advice - which I have come to grudgingly accept - could be summed up as ‘Back off a bit - look what happened in the UK, we might get sued.’” he wrote.

Miller described the “gut-sinking, career and family-financial-security-threatening process” of a libel case, but acknowledged the importance of defending free expression.

“I’m worried a precedent has been set,” he wrote, “and I’m worried that fear has chalked up a point against reason.”

Libel Tourism Affecting Developing Nations

The Centre for Investigative Reporting (CIN) is a Bosnian non-profit organisation that investigates organised crime and corruption. Spokesman Drew Sullivan recently addressed the Culture Media and Sport Committee inquiry into press standards, privacy, and libel.

Sullivan described the the practice of libel tourism in the UK, which he says “has been a boon to developing world crime figures who have sued developing world media and civil society organization in your courts,” taking advantage of England’s “draconian civil awards” and “the most media-unfriendly libel laws relative to the rest of the developed world.”

As an example, Sullivan told of a Serbian oligarch who took control of the local energy market:

“We reported, based on prosecution and auditor records, how this man had a pattern of getting state electrical companies to give him sweetheart deals that cost taxpayers millions of dollars, and how he bought state electricity at below production costs only to sell it at handsome profits.”

The expose won an international investigative prize, but the oligarch’s UK lawyers began sending threatening letters. CIN had to hire a UK-based lawyer, though Sullivan noted “the cost of only a few hours of a UK lawyer’s time will buy an organization such as ours a one year retainer for a lawyer in Bosnia and Herzegovina.”

Though CIN’s lawyer handled the threats, the oligarch’s firm did not stop there.

“Reminiscent of the despicable, underhanded practices of organized crime figures, the UK law firm contacted all of our donors,” Sullivan said. “They made a series of inaccurate, slanderous statements attempting to damage our reputation.”

CIN spent valuable time and money to defend against these attacks, which gained greater credibility since they originated from a UK law firm. Eventually they were able to convince their donors to continue to support them.

“UK courts should not be misused,” said Sullivan, “and they should not be a tool that forces organizations to avoid printing the truth or journalists to self-censor, and that allows organized crime figures to harass the innocent.”

Football Club Sues Supporters

Owlstalk is an online forum for fans of Sheffield Wednesday Football Club (SWFC). Members can anonymously post their thoughts, which at times can be passionate. SWFC felt that eleven of the members were posting defamatory remarks and pursuing “a sustained campaign of vilification.”

SWFC sued Neil Hargreaves, the owner of Owlstalk, to force him to reveal the identities of eleven members so they could pursue those members in libel suits. Judge Richard Parkes QC ordered Hargreaves to turn over the email addresses of four of the members, ruling that the claimants’ right to reputation “outweighs, in my judgement, the right of the authors to maintain their anonymity and their right to express themselves freely.”

The Judge ruled that the other members’ comments were “trivial” and therefore they could stay anonymous. He also ruled that Hargreaves did not bear any responsibility for the comments, and thus would not be at risk of a libel suit.

The people in the media who stand up for free speech, like newspapers, have money and experience to fight these cases,” said solicitor Ian de Freitas. “The vast majority of online companies don’t have this luxury and their business models can’t cope with defamation claims. The libel laws in the UK are claimant friendly, not defendant friendly.”

Defamatory Science?

Xytis Inc is a Swiss biotech firm that funded a clinical trial at the London School of Hygiene and Tropical Medicine (LSHTM) to test a new drug designed as a treatment for traumatic brain injury. During the study, Xytis found that the data being collected was not supportive of the drug’s efficacy, and requested that the trial end early.

 “They requested the trial be terminated but quickly moved onto using a court injunction, which in essence prevented researchers . . . from publishing any of the trial results - which they felt would jeopardise the future of the drug,” said Iain Hrynaszkiewicz of BioMed Central, publishers of the journal Trials where the trial was eventually published.

The injunction was used to prevent publication of potentially libellous or defamatory material. In this case, the material in question was a scientific study that might keep a drug from being released onto the market.

LSTM defended the study in court and won the right to publish the results a year later. Chief investigator Ian Roberts and trial manager Haleema Shakur wrote in a letter to BioMed Central:

“After a long and expensive legal battle we are pleased that Trials has published the results of the BRAIN trial thus allowing us to meet our ethical obligations to the trial participants that the data are made publicly available.”

A British Doctor Sued by a US Company for a Canadian Article

Dr Peter Wilmshurst is a British cardiologist who has spent more than two decades challenging misconduct in medical research. In 2003 he was awarded the HealthWatch award, given annually to the person who has done the most to expose poor clinical trials.

“Exposing this bad practice usually requires a whistleblower who thereby puts his own career in peril,” explained HealthWatch.

In 2005, Wilmshurst did just that. He was a joint principal investigator in a clinical trial testing the effectiveness of the STARFlex device, which was expected to reduce the incidence of migraines when implanted in the heart. The study failed to find any benefits. At a cardiology conference in Washington, Wilmshurst criticised the device’s American manufacturer, NMT Medical, for the way they were handling data from the clinical trial. His criticism was reported by the Canadian website Heartline, where it could be viewed online for three days. NMT launched a libel lawsuit against Wilmshurst, who has chosen to defend himself despite receiving no support from his NHS Trust. His solicitor maintains that Wilmshurst had a “social, moral, and ethical duty” to make the information public and demanded that NMT drop the suit and repay all the costs.

“We also want them to say they recognise my right to have said this,” Wilmshurst told The Times. “They should recognise that even though they don’t agree, this is an expert opinion and they shouldn’t have sued.”

Despite the potentially crippling legal costs even if he wins, Wilmshurst is defending his right publicly express his concerns to ensure that future researchers are free to speak honestly about clinical trials for the good of the public.

The One Million Pounds Per Day Lawsuit

Andy Lewis runs the Quackometer blog, where he writes about quackery, or “anything involving overpromotion in the field of health.”

Beginning in September 2006, Lewis wrote a series of articles criticising Joseph Chikelue Obi of the Royal College of Alternative Medicine (RCAM) in Dublin. Obi was charging 300 Euro an hour for health advice over the phone, and Lewis later reported that he was under investigation for taking thousands of pounds to cure a woman’s illness.

Among other revelations, he also found that RCAM did not exist at the address it claimed and that Obi was suspended from South Tyneside District Hospital for misconduct.

In January 2008, Obi’s legal representative “Tanja Suessenbach” sent Lewis’ ISP Netcetera a letter demanding the posts be removed by January 21 or else “we are instructed to hold you fully liable to the tune of 1 Million (One Million Pounds) per day, together with additional punitive damages relating to the many months during which the defamatory material had and has been globally accessible via your server.”

Lewis contacted Obi in an attempt to understand which statements were defamatory so they could be edited. In the meanwhile, Netcetera removed the posts, which were immediately posted on dozens of other websites.

A week later, Lewis wrote to Netcetera, saying, “We have now waited long enough for either Obi or his ‘legal advisor’ to respond in a meaningful and constructive manner. That has not happened, not will it happen because his case is utterly groundless and he has achieved what he wanted to do - take down those pages.”

After several days he learned that Netcetera had decided to remove the entire Quackwatch site from its servers. Lewis received an email from the company saying “We do not wish to be in a position where we could be taken to court, and incur the loss of time and expense that would involve.”

Quackwatch reappeared several days later, hosted by a new ISP.

Trafigura Silences The Guardian

In October 2009, The Guardian reported that an MP had tabled a question in Parliament, but the paper could not reveal the name of the MP, the question that was asked, or the company that was preventing the reporting.

The following day, The Guardian was allowed to explain that “[MP Paul] Farrelly’s question was about the implications for press freedom of an order obtained by Trafigura preventing the Guardian and other media from publishing the contents of a report related to the dumping of toxic waste in Ivory Coast.”

Trafigura is a Swiss oil company that was accused of dumping the waste in 2006, causing 30,000 people to seek medical attention. The company hired libel specialists Carter-Ruck to act as attorneys.

“Carter-Ruck spray threatening letters around newsrooms from Oslo to Abidjan. They launch an action against the BBC. And they persuade a judge to suppress a confidential but embarrassing document which has fallen into journalists’ hands,” wrote Guardian editor Alan Rusbridger. “A new term is coined: ‘super-injunctions’, whereby the existence of court proceedings and court orders are themselves secret.”

After Carter-Ruck stopped his paper from reporting on the Parliamentary question, Rusbridger took to Twitter. Overnight, users had figured out Farrelly’s question and deduced that Trafigura was behind the injunction.

By lunchtime the following day, Trafigura conceded the injunction did not apply to Parliamentary proceedings.

“Trafigura thought it was buying silence,” Rusbridger wrote. “A combination of old media - the Guardian - and new - Twitter turned attempted obscurity into mass notoriety.”

An injunction still prevents The Guardian from revealing information about The Minton Report, a document that purports to contain evidence of the waste dumping.