A seemingly small mistake in an article The New England Journal of Medicine ( NEJM ) landed a Danish physician and researcher in hot water last month after a German company threatened to sue for potential losses that could run into the millions of dollars. The exchange prompted consternation media in Denmark about whether academic freedom was censored, but the researcher Anders Perner of Copenhagen University Hospital has corrected the error, which occurred in the publication of a study of a drug widely used to prevent shock and avoided a lawsuit. Still, the episode has shone a light on a therapy that some researchers say may do more harm than good, despite its widespread use.
The question is hydroxyethyl starch (HES), a synthetic derivative of ordinary starch that has been used worldwide for decades to avoid shock in patients who have lost large amounts of blood. It is also used to treat patients with sepsis, the blood leaking out of their hair. "HES binds liquid, and the idea is that it continues the volume of blood," says Tobias Welte, a pulmonologist at the Hannover Medical School in Germany, who studied the compound.
27 June Perner
On July 9, however, Perner received an email from the German pharmaceutical company Fresenius Kabi, one of the largest manufacturers of HES, saying that in NEJM article he had misidentified the compound used in the study. Perner had used Tetraspan, produced by B. Braun Melsungen, Germany, and often described as HES 130 / 0.42. (The first number gives the molecular weight of the chemical, the second is an indication of the number of hydroxyethyl starch in.) While section names methods of society and drugs, it is called HES 130 / 0.4 in the original article and its title. These are the specifications of the product HES Fresenius, Voluven.
The e-mail, Perner says, included a threat by Fresenius to take legal action to recover the financial losses of the company would suffer because of misinformation. In a market worth billions which could be a lot of money, says Welte. Perner says Fresenius also demanded an explicit declaration that the first version of the document was incorrect.
Perner and NEJM changed the online version accordingly and Fresenius said it's the end of the story. "Our goal was to have the scientific misinformation in the title and text of the article in NEJM corrected," wrote a company spokesperson in an email. "This is . happened if we see no need for action "
Fresenius said his product is different from that used Perner not only in the report hydroxyethyl, but in other ways as well; for example, contrasted with the test compound in the test, it was not produced using potato starch.
But Perner maintains it was not a error, claiming that the differences are inconsequential, and the data of the study are likely to apply to Voluven well. the change is minimal compared hydroxyethyl and unlikely to affect the drug action he argued. "We rounded up to 0.4 because the product lines HES is less relevant details," he said, stressing that the hydroxyethyl ratio is 0.4 to 0.44 in Tetraspan and 0.38 to 0.45 Voluven. "Paper is more accurate now," he admits, "but from a scientific point of view, I think it makes no difference." Welte agrees. "For all practical purposes, these compounds are identical. If you do a test with aspirin, you should not write if you used the drug produced by Bayer or anyone else either," he said.
The debate on security and the effectiveness of various forms of HES has been ongoing for some time. Welte was involved in a 08 study, also published in NEJM , which concluded that HES solutions should be avoided "until the end of the long-term studies with a sufficient number of patients show that HES solution is particularly safe in critically ill patients. "this study unused another compound (HES 0 / 0.5)," but you can take the data from the new study on top of ours and they are almost identical, "says Welte.
HES compounds were first developed by Fresenius in 1974, and others soon followed. Although the compounds have received regulatory approval in the United States and throughout Europe, Perner argues that their safety has not been assessed adequately by modern standards. "When side effects occurred, companies have made new smaller molecules, but launched on the back of products older, "he said. Others share his concern. "For me, there is sufficient evidence of adverse effects with starch solutions in sepsis to restrict the use of all starches until additional safety and efficacy data are available" said Martin. regulators ignored evidence of potential side effects and failed to act, says Welte.
Although there has been concern about the compounds since 01, benefit analysis risk years remained positive, the regulatory body of the German BfArM medicine said in a statement to science Insider. the new study results from Perner are being evaluated, a spokesman the agency said, but no decision will likely be made until the results of another clinical trial, expected in August, are presented. the study, led by John Myburgh at the George Institute for global Health in Sydney in Australia, the compound of Fresenius
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