Will the data safety-monitoring boards of these studies have to meet in order to make sure squamous cell patients are safe?
Merck spokesman Tony Plohoros says that Merck's statement at the analyst meeting referred to its plan to gather and combine heart-safety data from three other studies, whose primary aim was to show Vioxx could prevent or treat cancer.
But the panel dashed the company's hopes, saying there wasn't enough long-term safety data.
Sincere thanks to all of the participants in the first-ever Safety Data Jam!
WHITEHOUSE: Safety Data Jam connects Tech Innovators with Public Safety Officers | The White House
James Stein of the University of Wisconsin-Madison calls the cholesterol suppressor "the hottest drug on the horizon, " although he cautions that longer-term safety data are needed.
Indeed, in America, the Tourette Syndrome Association felt it necessary to issue a statement warning of the paucity of long-term safety data, especially in children, and the potential interactions of nicotine with drugs given to treat the syndrome.
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The data showed the average forces of a soccer-ball header were similar to those exerted on the head by punches from amateur boxers, according to Daniel Plant, a researcher in Imperial's department of mechanical engineering, who presented the data Friday at a helmet-safety science conference at the university.
Last month, OSTP and the Department of Transportation co-hosted a Safety Data Jam at the Eisenhower Executive Office Building that brought together 40 leaders from technology, public safety, and government communities to discuss public safety challenges and to brainstorm creative new solutions that leverage open government safety data.
WHITEHOUSE: Safety Data Jam connects Tech Innovators with Public Safety Officers | The White House
In September, the Safety Data Initiative will host a Safety Datapalooza at which a cross-section of the most innovative safety applications submitted will be highlighted.
WHITEHOUSE: Administration Safety Data Initiative Challenges App Developers | The White House
Any data that questions the safety of a widely-used product needs to be as solid as it can get.
The lack of a data safety monitoring board is "sub-optimal, " says Steven Joffe, a bioethicist and researcher at the Dana Farber Cancer Center.
In the U.S. generic companies can sell off-patent products immediately, but they have to compensate the company that originally registered the chemical with the Environmental Protection Agency--Monsanto in this case--for the data showing the product's safety and efficacy.
Schering-Plough is expected to present new safety data to address this on Tuesday.
This fraction is likely to decrease further as FDA demands ever-larger, ever-more expensive clinical trials to accumulate data on the safety of drugs in development.
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The weaker-than-expected housing data helped push some investors towards the relative safety of Treasury bond.
Like all major outcome studies, the IMPROVE-IT trial is being monitored by an independent data safety monitoring board (DSMB).
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"The post-coronary bypass data raise new issues about Bextra's safety that require a closer look, " says Steven Nissen, a cardiologist at the Cleveland Clinic who provides unpaid consulting services for Pfizer, Merck, and other drug companies.
Certainly it makes sense for fire, police and other public-safety officials to be able to talk and share data with each other.
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The first, the increased push for drug safety, calls for an ever-increasing mountain of data before a new medicine is approved.
"If the goal of employing red-light camera systems is to improve driver safety, the data suggest that the program has failed, " New Jersey state Sen.
From 2005 to 2009, it had the highest accident rate of any big Japanese nuclear plant, according to data collected by the Japan Nuclear Energy Safety Organization, a mainly government-funded group.
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In a letter sent Wednesday to the company, the agency alleged that data submitted from the Ranbaxy plant contained falsified information -- including lies that safety tests were conducted, lies that drugs had been kept at room temperature when in fact they had been stored in refrigerators, and lies about the shelf life of some drugs.
For arthritis drugs, data is most likely to come from a Pfizer-sponsored study comparing the heart safety of Celebrex with ibuprofen and naproxen.
However, Vasella says he doubts the drug will make it through the FDA until the agency gets a glimpse at data from an 18, 000-patient study that will test Prexige's safety for the heart and stomach.
Nissen has said that observational data needs to be in the safety equation, but also favors big trials--he is conducting one, paid for by Pfizer, that will compare the heart safety of Celebrex, naproxen, and ibuprofen.
Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped.
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But drug safety experts say that the problem is that this is the best data available--and that the FDA, because of lack of authority to force drug firms to do anything, has not been able to mandate large studies that would answer safety questions.
In an interview before the release of the Genentech data, Eyetech chief executive DavidGuyerDavid Guyer emphasized that his drug may have safety advantages over Lucentis--although many of those are still hypothetical.
In an interview before the release of the Genentech data, Eyetech chief executive David Guyer emphasized that his drug may have safety advantages over Lucentis--although many of those are still hypothetical.
Merck withdrew the FDA application for Arcoxia, its follow-up to Vioxx, saying it needed to add more data, including some information regarding cardiovascular safety.
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