How Many Physicians Have Opted Out of the Medicare Program?

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peter doshi :: Article Creator New Research Reports On Financial Entanglements Between FDA Chiefs And The Drug Industry An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating. Regulations prohibit FDA employees from holding financial interests in any FDA "significantly regulated organization" and the FDA says it takes conflicts of interest seriously, but Peter Doshi, senior editor at The BMJ, finds that financial interests with the drug industry are common among its leaders. Doshi reports that nine of the FDA's past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company. That includes Margaret Hamburg, who led FDA between 2009 and 2015, but whose story is less well known. Like her colleagues, Margaret Hamburg h
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Candidate vaccine shows sustained protection against pulmonary TB - European Pharmaceutical Review

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A candidate TB vaccine’s efficacy level and acceptable safety profile have been confirmed in a three-year clinical trial.

It has been reported that GlaxoSmithKline’s (GSK’s) M72/AS01E  candidate vaccine has significantly reduced the incidence of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection.

These results demonstrate an overall vaccine efficacy of 50 percent during the three years after vaccination and the candidate vaccine has an acceptable safety and reactogenicity profile. The final results are consistent with the primary analysis done after two years of follow-up.

“These results demonstrate that for the first time in almost a century, the global community potentially has a new tool to help provide protection against TB,” said Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines. “I want to thank our scientists for their dedicated effort and scientific innovation in developing this impactful vaccine candidate in partnership with IAVI and other key organisations.”   

The trial was conducted in TB-endemic regions (Kenya, South Africa and Zambia) and involved 3,573 HIV-negative adults between the ages of 18 and 50 years. Participants who received two doses of either M72/AS01E or placebo 30 days apart were followed for three years to detect evidence of pulmonary TB disease.

We have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause TB”

In the final analysis, 13 participants in the vaccine group developed active pulmonary TB compared to 26 participants in the placebo group. Among participants who received the vaccine, an increased M72-specific immune response was sustained through three years.  

“These final results show that M72/AS01E could be an important tool in the fight against pulmonary TB,” added Dr Mark Feinberg, President and CEO of IAVI. “While additional trials need to be conducted to confirm these findings in other populations, we have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause TB.”

The results of the study were published in the New England Journal of Medicine.



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