Mostrando las entradas con la etiqueta research. Mostrar todas las entradas
Mostrando las entradas con la etiqueta research. Mostrar todas las entradas

29 febrero, 2012

US seeks new review of easier-to-spread bird flu

English: This Map shows the Spread of H5N1/ Bi...
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Source: http://www.cbsnews.com
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WASHINGTON — A scientist who created an easier-to-spread version of the bird flu said his work isn't as risky as people fear. The U.S. government is asking its biosecurity advisers to reconsider if the research should be made public.

Bird flu only occasionally sickens people, mostly after close contact with infected poultry, but it can be deadly when it does. Scientists have long feared it might mutate to spread more easily and thus spark a pandemic. Researchers in the Netherlands and Wisconsin were studying how that might happen when they created bird flu strains that at least some mammals — ferrets — can spread by coughing or sneezing.

The work triggered international controversy. U.S. health officials urged the details be kept secret so would-be terrorists couldn't copy the strains, and critics worried that a lab accident might allow deadly viruses to escape.

But contrary to public perceptions, the airborne bird flu didn't kill the ferrets, Dr. Ron Fouchier of the Netherlands' Erasmus University told a meeting of U.S. scientists Wednesday. In fact, he said those previously exposed to regular flu were protected from severe disease.

Fouchier said publishing the research would help other scientists monitor the so-called H5N1 bird flu for similar mutations in the wild, and to test vaccines and treatments.

A federal biosecurity panel first sounded the alarm about the research, concerned about the easier mammal-to-mammal spread. The U.S. is asking that panel to conduct another review of the two laboratories' work, Dr. Anthony Fauci of the National Institutes of Health said Wednesday. He said the board should hear some new data that came to light at a recent closed-door meeting of the World Health Organization, where international flu experts concluded the research eventually should be published.
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19 septiembre, 2011

Porque la mayoria de los resultados de investigacion publicados son falsos?

Existe una creciente preocupación de que los resultados de investigación más recientes publicados son falsos. La probabilidad de que una reivindicación de la investigación es cierto puede depender de la energía y el sesgo del estudio, el número de otros estudios sobre la misma cuestión, y, más importante, la proporción de fieles a ninguna relación entre las relaciones investigado en cada campo científico. En este marco, un hallazgo de investigación es menos probable que sea cierto cuando los estudios realizados en el campo son más pequeños, cuando son más pequeños tamaños del efecto, cuando existe un número mayor y menor prueba de preselección de las relaciones, donde existe una mayor flexibilidad en los diseños, definiciones, resultados, y los modos de análisis, cuando los intereses financieros y de otro no es mayor y los prejuicios, y cuando más equipos están involucrados en un campo científico a la caza de la significación estadística. Las simulaciones muestran que la mayoría de los diseños de estudio y configuración, sean más probable que los resultados de una investigación sean más falsos que verdaderos. Además, para muchos campos científicos actuales, los resultados de la investigación puede ser a menudo una medición simplemente precisa de la tendencia imperante. En este ensayo, se discuten las implicaciones de estos problemas para la realización e interpretación de la investigación.
El articulo completo puede encontrarse en http://dx.doi.org/10.1371/journal.pmed.0020124

Why Most Published Research Findings Are False. by: John P. A. Ioannidis

Ioannidis JPA. Why Most Published Research Findings Are False. PLoS Med. 2005 August;2(8):e124
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14 septiembre, 2011

A cure for the disease of hate

BMJImage via Wikipedia
BMJ 2011; 343:d5715 doi: 10.1136/bmj.d5715 (Published 14 September 2011)
Cite this as: BMJ 2011; 343:d5715
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A cure for the disease of hate

  1. Iain McClure, consultant child and adolescent psychiatrist, Royal Hospital for Sick Children, Edinburgh
  1. imcclure@nhs.net
A Gazan doctor working in Israel describes his life and extraordinary tragedy, with a determination that good must come from bad. Iain McClure recommends his book to all doctors
On 16 January 2009 three Palestinian sisters were killed when an Israeli tank fired two shells into their bedroom. They were the daughters of Dr Izzeldin Abuelaish, a Palestinian gynaecologist, who, uniquely for a Gazan doctor, held a consultant post in an Israeli hospital. Abuelaish’s book, I Shall Not Hate, is an account of his life up to this momentous event and movingly explains his remarkable reaction. In essence, Abuelaish, who likens hate to disease and communication to cure, has drawn on his medical experience to seek a new approach to the resolution of apparently insoluble conflict.
For the three weeks prior to January 2009 the Israeli Defense Forces had been pursuing an incursion into the Gaza Strip to eradicate Quassam rocket attacks into Israel. The Israeli government had prevented Israeli or foreign journalists broadcasting from within Gaza during the operation. However, Abuelaish, a well known public figure in Gaza, had …

01 agosto, 2011

Reevaluating Studies: A CRO & A Coincidence?

Published  por Ed Silverman, via Pharmalot
oh-my-flickrLast week, the FDA announced that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. In explaining its move, the agency maintained there were “significant instances” of misconduct.
The agency says Cetero failed to conduct an adequate internal investigation to determine the extent and impact of the violations, and did not take sufficient steps to assure data integrity during those five years. And so drugmakers must check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications – and may have to repeat or confirm results (back story).
For its part, Cetero subsequently issued a statement saying the CRO initiated its own internal investigation of its Houston bioanalytical laboratory in 2009 after discovering six chemists had misreported the date that samples were extracted prior to analysis. They did this to seek overtime pay for hours when they did not actually work. But the CRO insists reports were filed with the FDA and agency feedback was sought, although none was received. Cetero clients were also contacted.
“We leaned in roughly June 2009 and that’s the time at which we self reported the findings to the FDA,” Cetero ceo Troy McCall tells us. “We requested a meeting at the time that we originally provided them with our preliminary findings and during the course of our 18 month investigation. We were providing them with regular updates…They received all the information we provided to them on an interim basis.
“We took these issues so seriously that we not only terminated the employees who were responsible for these actions, but we also replaced management and ultimately the site leadership,” McCalls continues. “…That was probably another half dozen or so people.” He reiterated that all of the terminated employees were based in the Houston facility.
There is, however, an interesting tidbit concerning some other former and current Cetero employees – several of them have had experience suitable for dealing with the recent troubles. How so? They also once worked for MDS Pharma Services, another CRO that is now owned by INC Research and, notably, had rather similar problems with the validity and accuracy of test results. In fact, in January 2007, the FDAnotified drugmakers to reevaluate pharmacokinetic studies that were conducted for them by MDS from 2000 through 2004 (read here).
Which former and current Cetero employees worked at MDS? And when? Well, there wasJerry Merritt, who was MDS senior vice president and general manager from 2000 to 2006, when he left to run Cetero, although he was succeeded as ceo early last year by McCall. And Murray Ducharme, the chief scientific officer at Cetero, was previously an MDS vice president from 2000 to 2006, although his Cetera bio neglects to mention this (look here).
Then there was John Capicchioni, who was the MDS senior vice president of business development from 1994 to 2006, when he joined Cetero as vice president of business development, although his bio also overlooks time spent at MDS (see this).
There was also Herb Smith, who was MDS senior director of quality assurance from 1999 to 2007, when he became vp of quality assurance at Cetero, although he retired in April. Finally, there is April Johnson, who worked at MDS as a marketing manager from 1999 to 2005 and as a marketing director of early clinical research and bioanalysis from 2005 to 2007, when she joined Cetero as vp, business relationship management (see this). And, yes, her bio fails to mention MDS.
In other words, several current and former members of the Cetero managerial team arrived from another CRO that experienced similar breakdowns affecting the validity of bioequivalence data, which caused regulators to question the ability to conduct a proper audit (read a sample letter the FDA sent to drugmakers with pending ANDAs).
The problems at MDS, by the way, factored into growing concern a few years ago about oversight of CROs. The rise in the number of clinical trials prompted a corresponding growth in the number of such companies, along with complaints about quality and competency. In February 2007, for instance, Gilead reported that the FDA had found “certain irregularities” in studies conducted by MDS (read this).
We asked Cetero for comment about the experience some of their executives brought with them from MDS. Johnson, who also acts as the Cetero spokesperson, declined to comment

14 octubre, 2008

Ethical and Practical Issues Associated with Aggregating Databases

By Richard Wheeler (Zephyris) 2007. Lambda rep...Image via WikipediaThe goal of “personalized medicine” relies upon defining the genetic variation responsible for disease susceptibility and response to therapy [1]. For most common human diseases, the contribution of a single sequence variant to disease susceptibility is typically small, and can only be detected with data from large numbers of people [2]. Practically, this necessitates collaboration among investigators who either have DNA and phenotypic information previously collected, or have access to populations from which to recruit participants. It also requires that data be shared among the collaborators. Modern bioinformatics platforms have the capacity to combine datasets and store them for re-analysis. This is scientifically advantageous since it makes possible studies with enhanced validity in a cost-effective fashion. However, this data storage can complicate the already vexing practical, scientific, and ethical issues associated with gene and tissue banks. Research participants' data may have been collected without authorization that meets today's standards for informed consent. Research participants may not have consented to participation in genetics research in general, to inclusion in genetics databases specifically, or to use of their samples in genetic analyses that were unanticipated, unknown, or nonexistent at the time samples were collected [3]. Participants who consented to the collection of their data for use in a particular study, or inclusion in a particular database, may not have consented to “secondary uses” of those data for unrelated research, or use by other investigators or third parties [4]. There is concern that institutional review boards (IRBs) or similar bodies will not approve of the formation of aggregated databases or will limit the types of studies that can be done with them, even if those studies are believed by others to be appropriate, since there is a lack of consensus about how to deal with re-use of data in this manner............read more inn PLoS Medicine.