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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Experimental TB vaccine a ‘game changer’ that offers new hope - Business Day

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The Bacille Calmette Guérin (BCG) vaccine, routinely given to babies around the world, was developed more than 90 years ago, and provides limited protection that wanes by adolescence. GSK’s candidate vaccine M72/AS01E was tested in 3,300 HIV negative adults in Kenya, SA and Zambia who had latent TB, and the results of the phase 2b trial were published in the New England Journal of Medicine this week.  

Participants were either given two doses of the vaccine or a placebo, and followed for three years to see if they developed pulmonary TB. Only 13 people who received the shots got TB, compared to 26 who did not.

“The trial is a game changer because it is the first time a TB vaccine candidate has been shown to offer protection to people who are already infected with the Mycobacterium tuberculosis bacillus. Those people, about two thirds of SA adults, are at risk of progression to TB disease,” said the study’s principal investigator Mark Hatherill, director of the SA Tuberculosis Vaccine Initiative.

GSK’s experimental vaccine contains TB proteins that trigger an immune response, but the mechanism is not yet fully understood, said Hatherill.

Further research was needed to determine whether the vaccine protected people who had not yet been infected with TB and those living with HIV, and to determine whether the protection was durable. Ideally a vaccine should confer protection for at least 10 years, he said.

“These questions must be asked and answered in a bigger confirmatory trial or trials, which will need a funding commitment from government and non-governmental stakeholders worldwide. These answers will be critical in getting the vaccine to a broad market,” he said.

In a separate development, French pharmaceutical manufacturer Sanofi announced on Thursday that it had slashed the price of its TB antibiotic rifapentine by two thirds, to a net ex-factory price of $15 for eligible countries in low and middle-income countries, including SA.



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