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

John Theurer Cancer Center launches clinical trial of personalized cancer vaccine - NJBIZ

John Theurer Cancer Center at Hackensack University Medical Center said Friday that it is the only site in New Jersey, and one of just 17 in the country, participating in a multicenter international Phase II study of an innovative personalized cancer vaccine being evaluated in combination with pembrolizumab immunotherapy in patients with melanoma that has been surgically removed but has a high risk of coming back.

The expectation is that the vaccine can prime a patient’s immune system to be more responsive to immunotherapy and reduce the risk of cancer recurrence.

Utilizing a novel and potentially revolutionary gene-based technology, the vaccine is created by comparing the patient’s normal cell DNA sequence to that of their tumor and identifying tumor-specific changes to the DNA. Once identified, the patient-specific, tumor-specific changes are turned into a messenger RNA construct to be used as a vaccine.

Pembrolizumab belongs to a class of drugs called “checkpoint inhibitors,” which have transformed the treatment of melanoma. It works by blocking a protein called PD-1 which normally shuts down the immune response. Cancer cells use PD-1 to hide from the immune system. Inhibiting PD-1 enables the immune system to find and kill cancer cells.

“Pembrolizumab and other checkpoint inhibitors have been shown to reduce disease recurrence among patients with high-risk melanoma that was surgically removed. However, in many patients, the cancer eventually comes back,” said Dr. Andrew Pecora, a nationally recognized hematologist/oncologist at John Theurer Cancer Center and associate dean, Technology and Innovation, Hackensack Meridian School of Medicine at Seton Hall University, who is a principal investigator (PI) of the study.

“Reducing the rate of relapse would address a significant unmet medical need for these patients,” Pecora said.



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