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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CDC Panel Votes to Recommend Shingrix for Immunocompromised Adults - Monthly Prescribing Reference

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The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of herpes zoster (shingles) and its complications in adults 19 years of age and older who are, or will be immunodeficient or immunosuppressed due to disease or therapy.

Shingrix is intended for intramuscular injection in 2 doses separated by 2 to 6 months in immunocompetent adults. In adults who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose may be administered 1 to 2 months after the first dose.

The recommendation was based on data from clinical studies that assessed the efficacy and safety of Shingrix in adults 18 years of age and older who previously had an autologous hematopoietic stem cell transplant (auHSCT; N=1721) and in those undergoing treatment for hematologic malignancies (N=515; post-hoc analysis).

Shingrix was found to be 68.2% (95% CI, 55.5-77.6) effective against the development of herpes zoster in immunocompromised adults who received an auHSCT 50 to 70 days prior to the first dose and who were expected to receive prophylactic antiviral therapy for at most 6 months post-transplant. In the hematologic malignancy study, post hoc analysis showed Shingrix was 87.2% (95% CI, 44.2-98.6) effective against herpes zoster development.

The approval was further supported by safety and immunogenicity data in adults who were, or were anticipated to be immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.

The recommendations will be reviewed for approval by the director of the CDC and the US Department of Health and Human Services. Following approval, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR).

"Today's recommendation is an important clinical advancement in providing protection from shingles and its complications to adults with immunodeficiency or immunosuppression," said Sabine Luik, Chief Medical Officer & SVP Global Medical Regulatory & Quality, GSK. "The ACIP's vote helps to address an existing unmet need as individuals who are immunocompromised are at an increased risk of the disease."

Shingrix is currently approved for the prevention of herpes zoster in adults 50 years of age and older. It is also approved for the prevention of herpes zoster in adults 18 years of age and older who are or who will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.

Reference

US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices votes unanimously to recommend Shingrix for immunocompromised adults aged 19 and up. News release. GlaxoSmithKline. October 20, 2021. Accessed October 21, 2021. https://www.gsk.com/en-gb/media/press-releases/votes-unanimously-to-recommend-shingrix-for-immunocompromised-adults-aged-19-and-up/. 

Topics:

Herpes Zoster Virus Immunization Infectious Disease Vaccines Viral Infections

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