DAR ES SALAAM, Tanzania (AP) ? President Barack Obama is encouraging embattled Egyptian President Mohammed Morsi (MOHR'-see) to respond to concerns being voiced by throngs of protesters seeking his removal from office.
The White House confirmed in a statement Tuesday that Obama called Morsi on Monday while traveling in Africa. The call came as Egypt's military said Morsi must meet the demands of millions of protesters who have taken to the streets.
The statement said Obama told Morsi that the United States is committed to the democratic process in Egypt and does not support any single party or group. The statement also said Obama underscored to Morsi that the current crisis can only be resolved through a political process.
Obama also told Morsi he's particularly concerned about violence in the demonstrations, especially sexual assaults against women.
Fidaxomicin in Clostridium difficile infection: added benefit not provenPublic release date: 2-Jul-2013 [ | E-mail | Share ]
Contact: Dr. Anna-Sabine Ernst presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Drug manufacturer did not submit studies on mild cases, and processed data in an unusable way for severe cases and recurrences
The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults who have diarrhoea caused by Clostridium difficile. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the added benefit of fidaxomicin in comparison with current standard therapy. According to this, there is currently no proof of an added benefit. The manufacturer did not submit any studies on non-severe cases. It cited studies on severe courses of disease and recurrences, but did not process the results in a way that would make it possible to draw reliable overall conclusions on benefit and harm of fidaxomicin.
G-BA distinguished between three treatment situations
For this benefit assessment, the Federal Joint Committee (G-BA) distinguished between three treatment situations, and hence also specified different drugs as appropriate comparator therapy: in courses of the disease that were not severe, but required treatment, fidaxomicin was to be compared with the antibiotic metronidazole; in severe cases and in patients with recurrence, with vancomycin, another antibiotic.
No studies on comparison with metronidazole
Results of two randomized controlled trials (RCTs), both approval studies on fidaxomicin, were available for IQWiG's assessment (studies 101.1.C.003 and 101.1.C.004). In these studies, fidaxomicin was tested against the drug vancomycin in patients with all courses of the disease, i.e. including patients who were not severely affected.
Moreover, the manufacturer did not cite any additional studies for patients with non-severe course of the disease, in whom fidaxomicin was to be compared with metronidazole. So no data were available for this appropriate comparator therapy. Hence an added benefit for this subpopulation is not proven - however, this was not claimed by the manufacturer either.
Severe cases and recurrences: advantage of fidaxomicin in global cure
The two approval studies provided usable data on the outcome "global cure" for the two subpopulations "patients with severe course of disease" and "patients with recurrence". According to these studies, patients treated with fidaxomicin have better chances of cure than those treated with vancomycin. Here IQWiG derives a proof.
Data on side effects were not analysed appropriately
Side effects were also recorded in both approval studies. However, the manufacturer did not process these data in an appropriate way: The dossier contained information on severe adverse events only for the total study population, including non-severe cases. The manufacturer failed to analyse the data separately for the subpopulation defined by the G-BA. It cannot be excluded that, in a severe course of disease and recurrences, severe side effects are more frequent under fidaxomicin treatment than under vancomycin treatment.
Overall, the pharmaceutical company did not provide sufficient proof in its dossier that the positive effects (global cure) outweigh the negative effects (side effects). Hence an added benefit of fidaxomicin is not proven also in comparison with vancomycin on the basis of the manufacturer's dossier.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on fidaxomicin.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book V and specific German-language information on the assessment of fidaxomicin.
###
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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Fidaxomicin in Clostridium difficile infection: added benefit not provenPublic release date: 2-Jul-2013 [ | E-mail | Share ]
Contact: Dr. Anna-Sabine Ernst presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Drug manufacturer did not submit studies on mild cases, and processed data in an unusable way for severe cases and recurrences
The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults who have diarrhoea caused by Clostridium difficile. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the added benefit of fidaxomicin in comparison with current standard therapy. According to this, there is currently no proof of an added benefit. The manufacturer did not submit any studies on non-severe cases. It cited studies on severe courses of disease and recurrences, but did not process the results in a way that would make it possible to draw reliable overall conclusions on benefit and harm of fidaxomicin.
G-BA distinguished between three treatment situations
For this benefit assessment, the Federal Joint Committee (G-BA) distinguished between three treatment situations, and hence also specified different drugs as appropriate comparator therapy: in courses of the disease that were not severe, but required treatment, fidaxomicin was to be compared with the antibiotic metronidazole; in severe cases and in patients with recurrence, with vancomycin, another antibiotic.
No studies on comparison with metronidazole
Results of two randomized controlled trials (RCTs), both approval studies on fidaxomicin, were available for IQWiG's assessment (studies 101.1.C.003 and 101.1.C.004). In these studies, fidaxomicin was tested against the drug vancomycin in patients with all courses of the disease, i.e. including patients who were not severely affected.
Moreover, the manufacturer did not cite any additional studies for patients with non-severe course of the disease, in whom fidaxomicin was to be compared with metronidazole. So no data were available for this appropriate comparator therapy. Hence an added benefit for this subpopulation is not proven - however, this was not claimed by the manufacturer either.
Severe cases and recurrences: advantage of fidaxomicin in global cure
The two approval studies provided usable data on the outcome "global cure" for the two subpopulations "patients with severe course of disease" and "patients with recurrence". According to these studies, patients treated with fidaxomicin have better chances of cure than those treated with vancomycin. Here IQWiG derives a proof.
Data on side effects were not analysed appropriately
Side effects were also recorded in both approval studies. However, the manufacturer did not process these data in an appropriate way: The dossier contained information on severe adverse events only for the total study population, including non-severe cases. The manufacturer failed to analyse the data separately for the subpopulation defined by the G-BA. It cannot be excluded that, in a severe course of disease and recurrences, severe side effects are more frequent under fidaxomicin treatment than under vancomycin treatment.
Overall, the pharmaceutical company did not provide sufficient proof in its dossier that the positive effects (global cure) outweigh the negative effects (side effects). Hence an added benefit of fidaxomicin is not proven also in comparison with vancomycin on the basis of the manufacturer's dossier.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on fidaxomicin.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book V and specific German-language information on the assessment of fidaxomicin.
###
[ | E-mail | Share ]
?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
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Sanford, Fla., police officer Chris Serino in Seminole circuit court, in Sanford, Fla., on Monday, July 1, 2013.
By Tom Winter, James Novogrod and Tracy Connor, NBC News
The jury in the George Zimmerman trial heard his first accounts given to investigators of the deadly confrontation with Trayvon Martin when tapes of police interrogations were played in court Monday.
The audio and video content had been made public before the trial, but this was the first time jurors heard Zimmerman ? who has still not said whether he will testify during trial ? tell his side of the story to police in his own words.
One of the officers who questioned Zimmerman, lead investigator Chris Serino, testified that he tried to bluff Zimmerman into thinking the clash had been recorded to convince him that he would be in more trouble if he lied.
?I believe his words were, ?Thank God, I was hoping somebody would videotape it,?? Serino said.
Asked by defense lawyer Mark O?Mara what he thought of that comment, Serino said, ?Either he was telling the truth or he was a complete pathological liar. One of the two.?
When questioned further, Serino said he thought Zimmerman was telling the truth and was not a pathological liar.
On Monday, the top two investigators who interviewed George Zimmerman took the stand, including the lead detective who had doubts about the story Zimmerman told police. Zimmerman has pleaded not guilty, saying he fired his gun in self-defense. NBC's Ron Mott reports.
Zimmerman, 29, has pleaded not guilty to second-degree murder in the death of the unarmed 17-year-old, who was walking in the neighborhood watch volunteer?s gated neighborhood in Sanford, Florida. He says he shot Martin in self-defense after being attacked. Martin was unarmed.
Serino testified that, while Zimmerman estimated he was hit some two dozen times, he considered the head injuries ?minor.? But pressed on cross-examination, Serino also said life-threatening injuries are not a requirement for proving self-defense.
Serino also testified that after Zimmerman heard a tape of a 911 call on which screaming can be heard, he said, ?That doesn't even sound like me."? Zimmerman had told cops he yelled for help, while the prosecution contends Martin was screaming.
Also taking the stand was Sanford police officer Doris Singleton, who took the initial statement from Zimmerman at the police station after the Feb. 26, 2012, shooting.
She recalled that at one point he noticed a small cross around her neck and asked if she was Catholic. She said she was Christian and asked him why it mattered.
She said Zimmerman told her the Catholic religion teaches ?it?s always wrong to kill somebody.? Singleton said she told him: ?If what you're telling me how it happened is true then I don?t believe that?s what God meant. He didn?t mean that you couldn?t save your own life.?
She also said that at one point in the interview, Zimmerman expressed surprise when she told him that Martin had not survived.
?He said, ?He?s dead?? ? Singleton said.
?And I said, I thought you know that I thought you knew he was dead,? she added.
?And he kind of slung his head and just shook it.?
Editor's note: George Zimmerman has sued NBC Universal for defamation. The company strongly denies the allegation
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Public release date: 2-Jul-2013
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