21-02-2008

The company behind the Omniscan had knowledge of a serious problems. Prominent Danish professor in Radiology is shaken. » Why was Omniscan even approved for use on humans, ' he asks
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Manufacturer of MRI contrast agent Omniscan-— biotech company Salutar, which is now owned by one of the world's largest companies, GE Healthcare — knew already before the Omniscan was sent on the market that product was unstable and dangerous.Nevertheless, it was marketed in Europe and the United States in 1993-1994. And the result today is that somewhere between 1000 and 5000 kidney patients worldwide has developed the debilitating and often deadly disease nefrogen systemic fibrosis, NSF. In Denmark, assesses the 1. reserve doctor Peter Marckmann, nefrologisk Department at Odense University hospital, that at least 60 kidney patients is invaliderede or died because of Omniscan. Peter Marckmann is internationally known as one of the researchers who first was able to link the contrast product Omniscan, together with disease nefrogen systemic fibrosis. Before Omniscan was placed on the market, had American researchers in 1992 documented in Mosby Yearbook 1992, Contrast agents. Magnetic resonance imaging 2. nd edition, that the risk of poisoning with the hazardous heavy metal gadolinium was much larger with Omniscan than with most other types of MRI contrast agents. One of the researchers were from Salutar and the same, which helped to develop the Omniscan. Professor Henrik Thomsen, radiological Department on Herlev Hospital, is one of the Danish researchers who most inbound to examine the consequences of giving Omniscan and other cardiovascular contrast means for kidney patients. He is not in doubt, the company behind Omniscan withholding important information about product hazards and thereby led both doctors and patients. ' They had a knowledge of that product was unstable and thus be able to release the toxic gadolinium in the body. And the knowledge they had, even before the Omniscan was placed on the market. As doctors we

thought that the product was safe, stable and non-hazardous, and it has shaken me to discover that the company had a knowledge of the contrast product hazards to which they held for the medical world, "says Henrik Thomsen. He is within the past year been aware that the chemists from both the laboratories, which in its time was behind the development of Omniscan, and from other laboratories, advised against that product was applied to humans. » Chemists writes directly, that these funds are more unstable, and that they do not stand on the toxic effect. The knowledge producer had. It makes me angry, of course, to be withheld from the knowledge. I have in his time even helped to get Omniscan approved for kidney disease patients.Because we all believed that it was a good alternative to the old iodine contrast agents, and because we believed that it was safe, "says Henrik Thomsen. Rejects criticism GE Healthcares representative, global safety officer Hugo Flaten, rejects Henrik Thomsens criticism. Hugo Flaten recognises that GE Healthcare is aware of the warnings, Henrik Thomsen refers. But according to Hugo Flaten, there was talk about the results of laboratory tests, that the company not attributed clinical importance. Hugo Flaten and Henrik Thomsen has previously had a long-standing collaboration on research projects at Herlev and a technical cooperation in the ESUR, European Society of Urogenital Radiology. The relationship between the two is now cooled down. «» Henrik Thomsen driver a personal crusade against our product, which is not based on scientific evidence, and as I find it difficult to understand why. We have in the period 1998-2000 had a collaboration with Henrik Thomsen on a series of experiments in which it appears that gadolinium is stable and secure for kidney patients. Henrik Thomsen said good for Omniscans security, and his studies is an essential reason why Omniscan has been more used for patients with low kidney function than other contrast agents, ' believes Hugo Flaten. Ten times more married Omniscan provides as well as a number of other cardiovascular contrast products in the extremely toxic heavy metal gadolinium. The difference in contrast funds lies, inter alia, in the way in which producers have chosen to encapsulate gadolinium by means of so-called chelater, so that the toxic substances not when to be released in the body before they separated.However, unlike the so-called cyclic Mr.-contrast agents, which are considered the most stable and secure to use – especially for kidney disease patients – belongs to the so-called linear Omniscan funds. The linear products regarded as chemically more unstable than the cyclic, and international register of studies linking, therefore, not surprising use of Omniscan with 85 percent of all registered cases of NSF. Another linear agent, Magne shown stands for the majority of the other known cases of NSF. That is until now not registered a single case of NSF after use of cyclic contrast agents. When Henrik Thomsen langer out after the manufacturer of the Omniscan is due to the fact that there has already been granted prior to and at the same time as placing the contrast product existed warnings about the risk by using the product: Already in 1992, a year before the Omniscan was approved – writes American researchers in Mosby Yearbook 1992that means linear contrast increases the risk that the toxic heavy metal gadolinium is released in the body. Up to ten times larger quantities of toxic gadolinium is released from the linear substances as Omniscan. And in 1994 a research group writes in an article in the magazine Investigative Radiology that linear mrcontrast products is molecular unstable. It increases the risk of harmful heavy metal compounds are released in the body, researchers warn. The article is written by researchers from the company Salutar, the company which, at the time, developed Omniscan. But at the same time winner Omniscan quickly plow on radiological departments and cardiovascular devices all over the world. Proceedings under way in the United States ' Why were warnings ignored? We must as radio directories ask ourselves today. Why was the linear, unstable and potentially toxic contrast agents as Mr.-Omniscan even approved for use on humans? And why did you choose the same laboratory, which could have chosen a cyclic and safer product, a linear and unstable product? Linear substances are cheaper to produce than cyclical, so there may have been an

economic motive, but we have hardly any answers to the questions before the trials in the United States against manufacturers of the linear resources is decided, "assesses Henrik Thomsen. According to Hugo Flaten from GE Healthcare, he has no knowledge of the economy in the production of the different substances, and he therefore wishes not to comment on the question of possible economic reasons for choosing linear rather than cyclical substances. Henrik Thomsen also serves as an adviser to an American lawyer on behalf of a large number of American victims has raised the Omniscan-action for damages against the GE Healthcare. These damages pending currently a judicial assessment and decision. In other American damages under lawyers ' reasoning, treatment is that GE Healthcare knew or earlier should have been aware of the danger which Omniscan constituted for the kidney disease patients. Henrik Thomsen make no secret of the fact that confidence in the GE Healthcare has suffered a serious blow. "I can well live without an apology from the company, although they are on a scientific Congress last year called me a liar and attempted to influence the editor of the magazine Urology to bring a fix for one of my scientific articles that linked Omniscan and NSF together. But they should at least apologise to the many seriously ill kidney patients who now live with the consequences of serious adverse reactions, and to the bereaved.And the Bill for the substitutions should be forwarded to the company. ' Hugo Flaten: ' neither I nor others in the GE Healthcare has used the word ' liar ' on Henrik Thomsen. But it is true that I wrote to the editor of Urology, because we had a comment to an article by Henrik Thomsen. He had published an article on the new guidelines from the ESUR (European Society of Urogenital Radiology, ed.), but had added a paragraph with a number of his own allegations of Omniscan and NSF. He has abused ESUR to promote their own views, ' believes Hugo Flaten. Want long-term studies Peter Marckmann, 1. reserve physician at nefrologisk Department, Odense universitetshospital, share Henrik Thomsens anger against the people of GE Healthcare. Peter Marckmann has published a wide range of scientific articles, which describes a probable link between the use of Omniscan to strong kidney weakened patients and the risk for the development of NSF. Marckmanns work was the direct cause for the Herlev Hospital in March 2006, on its own initiative chose to stop using Omniscan – not only for kidney disease patients, but to all patients. He believes that the manufacturer is not investigated thoroughly enough for adverse reactions to the product, before it was sent on the market. ' They must have known in advance that the product was especially risky for people who do not may excrete the substance normally – in other words, serious kidney weakened patients – and that they thus exposed patients for a hazard. When we, in our studies can show that as many as one in every three of the worst kidney patients that have been scanned with Omniscan, after the following developer NSF, so it will show that the product has not been investigated thoroughly enough with regard to the possible side effectsbefore it was placed on the market, "says Peter Marckmann. He has several years of study of the scientific literature not seen a single study where the longer term effect of Omniscan is tested by experiments on the kidney diseased animals. » Company can blame, that they have not done the long-term studies. And if they had made them, they should also have discovered the problem, "he said. Chief physician in the pharmaceutical administration's Department of consumer safety Doris Stenver ascertains that a pharmaceutical producer always have an obligation to inform the authorities if they become aware of problems with the use of the product. ' The manufacturer is per definition the party at most about the product and should therefore also be the first to react, if there proves to be unforeseen side-effects, "says Doris Stenver. Hugo Flaten insists that GE Healthcare not previously could have warned about the dangers of using Omniscan to kidney weak patients: ' today, we know that there is no need to use Omniscan to patients with impaired kidney function. We knew it was not previously. We went out with a warning, as soon as we

discovered it, "says Hugo Flaten. He believes that the pharmaceutical authorities for unilaterally focus has been on the Omniscan as the cause of the NSF: "We still don't know what gadolinium means for the development of NSF.Gadolinium is a part of, but not all of the legend. My point is that we must be careful to use all funds for kidney patients contrast. ' Niels-Bjørn Albinus nba@dagensmedicin.dk

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