Two years ago in a conference room in the Randolph hotel in Oxford, Henrik Thomsen gave his inside account of a medical “nightmare”.
In a presentation to about 30 colleagues, Thomsen, one of Europe’s leading radiologists, revealed how patients treated at his hospital had subsequently contracted a rare and potentially fatal disease.
Thomsen and other doctors at his Copenhagen University hospital were baffled as to why 20 kidney patients who had been given routine scans were afflicted by a disorder — nephrogenic systemic fibrosis (NSF) — in which the skin gradually swells, thickens and tightens. Some sufferers were confined to wheelchairs. At least one died. There was no known cure.
Then, in March 2006, there was a breakthrough. It was confirmed that all those who had fallen ill with NSF had been given the same drug in advance of a magnetic resonance imaging (MRI) scan.
Omniscan was used to enhance the images produced by the scan. The product was sold around the world and was manufactured by GE Healthcare, a subsidiary of General Electric, one of the world’s largest corporations.
Thomsen’s presentation lasted no more than 15 minutes, with the final slide reading: “I hope none of you meets a similar medical hurricane.”
The quietly spoken 56-year-old, director of the department of diagnostic sciences at the University of Copenhagen, is part of a small group of clinicians credited with alerting patients and regulators to the potential risks of Omniscan for renal patients.
The Medicines and Healthcare Products Regulatory Agency this weekend said there had been 20 reports in the UK of NSF after patients were given Omniscan. Five of the patients died.
Last month, European medical regulators recommended that anybody who needed an MRI scan should be given a check to ensure their kidneys were healthy if they were to be given Omniscan or two similar products. In America, the Food and Drug Administration (FDA) is reviewing its advice.
Thomsen, however, now refuses to speak anywhere in England on the possible risks of Omniscan. The reason is that he faces another kind of storm: GE Healthcare is suing him in the High Court for libel.
The company claims his presentation in Oxford, entitled Management Aspects of NSF, was highly defamatory.
GE has already racked up costs of more than £380,000 pursuing the respected academic, who has authored or co-authored nearly 400 papers and delivered countless presentations to his peers. Thomsen will have to pay the firm’s costs if he loses the case.
In recent weeks, The Sunday Times has highlighted how London’s draconian libel laws are being used to silence critics of the rich and the powerful.
In a number of cases, both claimants and defendants have little apparent connection with Britain.
Campaign groups have warned that vital scientific and medical work is being threatened because of the danger of libel actions.
Thomsen, who was in London last week meeting Carter-Ruck, his lawyers, has no doubt about the driving force behind his case. “I believe that the lawsuit is an attempt to silence me,” he said.
IN October 2003 General Electric, one of the most watched companies on Wall Street, made a successful £5.7 billion bid for Amersham, the British healthcare company that had been privatised by Margaret Thatcher.
GE has a finger in many corporate pies, from manufacturing lightbulbs to insurance sales, but this appeared a particularly good business fit. GE Medical Systems made scanning equipment and Amersham made the products used to make medical imaging more effective. The combined business — GE Healthcare — had its headquarters in Buckinghamshire and was expected to generate about $13 billion (£8 billion) annually, representing about 10% of GE’s revenue at that time.
One of its products was Omniscan, which is among a small group of products administered to patients before an MRI scan. It is a so-called “contrast agent” whose properties enhance the differences between fluids and structures in the body when they appear on scans, making diagnosis easier. To date, it has sold more than 48m doses worldwide, including 620,000 in the UK. Such products sell at about $30 a dose.
There was, however, a problem. A small number of kidney patients injected with Omniscan and other products were falling ill with NSF, a horrific disease that first attacks the skin and can then attack organs. Those with healthy kidneys were unaffected and the product has been safe for more than 99% of patients.
NSF was first identified in the United States in 1997, more than five years after the contrast agents were introduced, and doctors were initially mystified as to what caused it.
One victim, Celeste Castillo Lee, from North Carolina, who gave evidence earlier this month to a FDA hearing, described how the disease migrated through her body, causing agony. “Seventy-five per cent of us [NSF victims] are in wheelchairs,” she said. “It’s actually a torture.”
She said swelling, which started in her ankles, moved through her limbs and then attacked her insides. Her bones, she said, felt like they were in a vice.
In British hospitals doctors were also finding cases of the new and strange condition. Giles Roditi, a consultant radiologist at Glasgow Royal Infirmary, said his hospital had 16 cases of NSF in renal patients.
What was causing it? In early 2006 Thomsen had turned clinical detective to try to answer this question.
After he was told that every kidney patient at his hospital who was diagnosed with the disease had been given a drug for a MRI scan, he and his colleagues alerted the medical authorities and then embarked on a review of all known cases of NSF.
Every patient out of the 150 cases that he found had been given a contrast agent for an MRI. About 90% had been given Omniscan. It was not proof that the drug caused NSF, but it was enough evidence for Thomsen never again to give it to any kidney patient.
Omniscan is one of several competing MRI agents that contain the rare-earth metal gadolinium, which is potentially toxic. The metal is chemically protected in its various drug forms and is quickly flushed out of the body by patients with healthy kidneys.
However, regulators believe the chemical structure of Omniscan, and another similarly constructed product, make them less stable and potentially dangerous for those suffering from renal problems.
The Danish Medicines Agency was the first to sound the alarm, highlighting 25 cases linked to Omniscan in a notice in May 2006.
Many of the Danish patients filed claims with a Danish government insurance agency, which pays benefits if it decides that a drug was a likely cause of inquiry or death.
In one of those cases, involving a 55-year-old woman who died from a lung embolism in 2003, the insurance agency concluded the side effects of Omniscan had “caused” her immobilisation, which, in turn, “caused” her deadly embolism. GE declined to comment on this case last week.
In June 2007, the Commission on Human Medicines in the UK advised doctors not to use Omniscan in patients with severe renal problems along with two other products, Magnevist, manufactured by Bayer HealthCare, and Optimark, produced by Covidien. It advised that other products containing gadolinium should not be used for kidney patients unless essential.
GE Healthcare appears to have reacted promptly to concerns about its product, but it objects to some of Thomsen’s work and the decisions by the European regulators. While it does not deny that there is an association between its product and NSF, it felt that to classify its drug as particularly risky was unfair.
It insists that a causal link to NSF has “not been established”. It believes a reporting bias may account for the high number of NSF cases linked to its product.
GE’s arguments helped sway regulators in the US, the biggest market for Omniscan. Doctors there have been warned of an association between contrast agents and NSF, but the FDA until recently said the data was too limited to classify some of the products as more risky than others.
The FDA has also not so far recommended doctors to stop using any of these products in kidney patients, but has simply issued safety warnings.
FDA’s staff has been revisiting the evidence. This month the FDA said it now believes that Omniscan, Optimark and Magnevist pose higher risks. An FDA advisory panel went further: they recommended that Omniscan and Optimark should not be given to patients with severe kidney disease.
This represents a victory of sorts for Thomsen and may mean less chance of kidney patients suffering from this disease in the future. But his mind is now on another looming battle with GE in the High Court.
Academics and radiologists who attended Thomsen’s presentation say it is “ludicrous” that he faces a potentially ruinous legal action and are writing letters of support for him in the action. His PowerPoint presentation is summarised in the writ and appears to be an objective analysis of the association between Omniscan and NSF.
GE Healthcare said this weekend it believed the presentation was defamatory because it accused the firm of suppressing information and marketing its product when it was aware of possible problems.
Last week, however, a spokeswoman was unable to highlight any part of Thomsen’s presentation in which this allegation was made. The writ says the defamation may have been “by way of innuendo”.
Carter-Ruck, defending Thomsen on a no-win, no-fee basis, says the action should be struck out because the words complained of in the writ are clearly not defamatory.
GE Healthcare is also suing over an article that appeared under Thomsen’s name in Imaging Management, a medical journal, published in Belgium, which referred to rumours that the company had been warned about possible problems with its product.
Thomsen says he did not “write or publish” the words that are the subject of the complaint and that they were written by a journalist. He denies libel.
The GE Healthcare spokeswoman said the company supported scientific debate and sued Thomsen only as a “last resort” because it felt it was being defamed. It says it always reacted quickly and in the best interests of patients to any possible side-effects of Omniscan. It reiterated that the product was still safe to use for the vast majority of patients.
THOMSEN’S case, however, is merely the latest example of the courts being used against scientists who scrutinise drugs and treatments. Simon Singh, a science writer, is being sued by the British Chiropractic Association for describing some of their treatments as “bogus”.
Another victim of the libel laws is Peter Wilmshurst, a consultant cardiologist at Shrewsbury hospital. He is being sued by an American company, NMT Medical, after he questioned the effectiveness of a new heart implant device.
The Libel Reform Campaign is now urging capped damages, stricter controls on costs and a stronger public interest defence. John Kampfner, chief executive of Index on Censorship, which is among a number of groups supporting the campaign, said: “[Thomsen’s case] appears to be yet another shocking example of multinational corporations going after academics and scientists working in the public interest.”
Sir Ken Macdonald, the former director of public prosecutions, has already called for reform. “The idea that we are becoming an international haven for people to attack scientists is something that we should not be proud of,” he said.
The culture, media and sport committee of the House of Commons is compiling a report that is expected to recommend change in the country’s libel laws. Jack Straw, the justice secretary, has already announced a review.
Colin Blakemore, professor of neuroscience at Oxford University and an adviser to Sense about Science, which promotes the use of good science in public debates, said any review should ensure the libel courts are never used as forum for assessing the risks of a treatment. “The risk is that the party with the most money will always win in what should be a dispassionate assessment of evidence,” he said.
GE, along with other manufacturers of contrast agents, now faces action in the American courts over its drug. A writ filed in the northern district of the Ohio federal court by lawyers acting for almost 500 plaintiffs says Omniscan was “routinely administered to kidney patients for years without warnings”.
These actions mean the debate over the side-effects of Omniscan and other products is likely to continue for many years to come.
Thomsen’s concern is about medical researchers who will need to highlight possible risks from drugs in the future. He says it is essential that they are not cowed by the prospect of appearing before the libel courts in London.
“It’s dangerous for the patient if we can’t frankly exchange views,” he said.
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