Alan Haburchak asked: On 17 February 2008, television programs investigative ventilated have 60 minutes a segment on the drug to be sold on prescription aprotinin, marketing by Bayer as Trasylol. In the report, we are given the sordid history of 14 years of drugs, from the concerns prior to approval of the drug combination and the food (FDA), an aggressive marketing campaign during the first years of its introduction to the market, with many accidents fatalities resulting from the common side effects of Trasylol. Since 1980 'initial and the s, the concerns over the potentially fatal side effects of Trasylol has been discussed. Dr. Juergen Fischer, director of experimental medicine at the University of Cologne, he found the events of severe kidney damage in animals Trasylol. When he sent the results of his research at Bayer, have ignored the information, overlooking a potentially fatal side effect of Trayslol. Soon, since then, the similar effects were revealed in patients given the drug in hospitals in the United States. The most common among the side effects of Trayslol acute kidney was weakening, also known as acute kidney failure, resulting from damage to the kidneys. Prudent to it 's the continued use, Dr. Nicholas Kouchoukos, one of America' heart surgeons most important s have taken the small study on 20 patients Trasylol data. Of those given the drug, 13 had problems with kidney function after taking the drug. Ignoring these results and several other similar studies, Trasylol was approved by the FDA for use in 1993.Through a campaign of relentless marketing and intense pressure on the FDA, Bayer has had only set aside all the market Trasylol 's use in All the open heart surgeries and was promoted to the drug control bleeding in other major surgeries. The sales of the drug hit $ 300 million in 2005, with lle sales projections of $ 750 million for 2006.Dr. Dennis Mangano, a leader in the field of medical research, were finishing a study around this same time, a study that had followed the notes of 5065 patients in 17 countries Trayslol data. Published in New England Journal of Medicine in January 2006, this was the largest Trasylol study ever undertaken and, finally, the most illuminating, suggesting not only an association between Trasylol patient data and acute kidney failure, but also a tendency for increased the probability of death in hospitals. When Dr. Mangano presented his findings to a FDA advisory committee, the reaction was less dynamic, which had imagined. Mr. Mangano 's results were based on the hospital records of patients rather than a more traditional study involving a placebo, the committee was hesitant to proceed with its request to remove the drug from the market. Without the committee, Bayer has owned the results from studies undertaken by Professor employee Dr. Alexander Walker of Harvard, who has examined records of nearly 70,000 patients in the same sense that Mr. Mangano had conducted his research. Stupenti were startlingly similar results that Dr. Walker 's study found: data Trasylol patients had an increased risk of failure and death of acute kidney. Bayer 's failure to inform the panel to confirm their results led Dr. Walker to get in contact with the FDA, Bayer insistent that he had deliberately considered potentially the curse to continue sales of lucrative Trayslol. However, the FDA 's response to only the confirmation of the fatal side-effects was issuing a warning to other doctors, would be a full year before the committee to reassess ricostituisse for efficacy of drugs. Meanwhile, a functioning clinical study in Canada in 2007 was stopped when the participants in the study group began to die. The German government immediately pulled and banned Trayslol, with a combined effort between the Government of Canada and the FDA, Bayer was persauso to provisionally close the market continued on the deadly drug. It is believed that about 4.5 million people have been universally Trayslol data, one third of those patients, approximately 1.5 million people, has been given the drug in the United States during the 14 years that the drug was available. Mr. Mangano 's estimates, if, in the short time between his study and the temporary moratorium on the latest drugs, the drug had been taken off the market, it could store every month around 22,000 lives - about 1,000 people.
Posted by
Animangame 
No comments:
Post a Comment