Off Our Chests: No Secrets Left Behind
By CHADI NABHAN
She was a successful corporate lawyer turned professional volunteer and a housewife.
He was a charismatic, successful, and world-renowned researcher in gastrointestinal oncology. He was jealous of all breast cancer research funding and had declared that disease his nemesis.
They were married; life was becoming a routine, and borderline predictable. Both appeared to have lost some appreciation of each other and their sacrifices.
Then, she saw a lump, and was diagnosed with breast cancer. Not any breast cancer, but triple negative breast cancer. The kind that is aggressive and potentially lethal. ...
Source: The Health Care Blog - May 27, 2021 Category: Consumer Health News Authors: Christina Liu Tags: Medical Practice Patients Physicians Book Review Breast cancer Chadi Nabhan illness narratives John Marshall Liza Marshall Off Our Chests triple negative breast cancer Source Type: blogs
Flowers, chocolates, organ donation — are you in?
Chocolates and flowers are great gifts for Valentine’s Day. But what if the gifts we give this year could be truly life-changing? A gift that could save someone’s life, or free them from dialysis?
You can do this. For people in need of organ, tissue, or blood donation, a donor can give them a gift that exceeds the value of anything that you can buy. That’s why February 14th is not only Valentine’s Day — it’s also National Donor Day, a time when health organizations nationwide sponsor blood drives and sign-ups for organ and tissue donation. Read on if you’ve ever wondered what can be donated, had reservations ...
Source: Harvard Health Blog - February 11, 2021 Category: Consumer Health News Authors: Robert H. Shmerling, MD Tags: Health Heart Health Kidney and urinary tract Lung disease Source Type: blogs
FDA Approves Sixth United States Biosimilar
Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira and sixth biosimilar in the United States. “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo h...
Source: Policy and Medicine - November 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Putting the Human in Human Services
Healing is a journey that may begin with a diagnosis and ideally, end with a positive outcome. The twists and turns that accompany it could be dizzying. In the case of Ondreah Johnson, RN who I have written about in previous articles, the voyage began when she detected a lump in her breast on Christmas night, 2016. She is open to considering it “another gift.”
As a home care nurse, she was accustomed to being the one offering the advice and instruction to her patients for most of her professional career that spans 37 years. Matter of fact medical care blended with compassion, has been her way. She is good at w...
Source: World of Psychology - March 12, 2017 Category: Psychiatry & Psychology Authors: Edie Weinstein, MSW, LSW Tags: Health-related Industrial and Workplace Personal Policy and Advocacy Professional Psychotherapy Stories Research Bedside Manner Compassion healthcare human services Social Services Source Type: blogs
Updated Medicare and Medicaid Drug Spending Data Released
On November 15, 2016, the Centers for Medicare and Medicaid Services (CMS) released updated Medicare and Medicaid drug spending data, to include information for calendar year (CY) 2015 through its online interactive dashboards for Medicare and Medicaid. The inclusion of the Medicaid drug spending data on the public dashboard is new this year, as is the addition of high-level (aggregated) Medicare drug rebate data.
CMS noted that “there is significant growth in spending on prescription drugs, representing a significant burden.” In CY 2015, total prescription drug costs amounted to roughly $457 billion – an estimated ...
Source: Policy and Medicine - December 14, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Fight Aging! Newsletter, June 13th 2016
FIGHT AGING! NEWSLETTER
June 13th 2016
Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to ...
Source: Fight Aging! - June 12, 2016 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
Immune System Destruction and Recreation Can Cure Multiple Sclerosis
The latest update for ongoing efforts to test destruction and recreation of the immune system in patients suffering from the autoimmune disease multiple sclerosis demonstrate that this approach is effectively a cure if the initial destruction of immune cells is comprehensive enough. Researchers have been able to suppress or kill much of the immune system and then repopulate it with new cells for about as long as the modern stem cell therapy industry has been underway, something like fifteen years or so. Methodologies have improved, but the destructive side of this process remains unpleasant and risky, something you wouldn'...
Source: Fight Aging! - June 9, 2016 Category: Research Authors: Reason Tags: Medicine, Biotech, Research Source Type: blogs
IMS Releases 2016 Report on Prescription Drug Spending – Net Price Growth 2.8% in 2015
Discussion on Medicare Part B Drug Payment Model Demonstration (Source: Policy and Medicine)
Source: Policy and Medicine - May 1, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Being a Cancer Treatment Partner
Recently my wife was asked to advise one of our friends about the process of cancer treatment. As I wrote in my 2011 post about our family's experience with cancer, the treatment involves everyone close to the patient. Here are Kathy's notes for families of cancer patients, which I post in the hope that they will help others."I promised to pencil out tips for how you can best serve as a cancer treatment partner.Here is a great resource to read on the general way to help.At the treatment planning visit, you should take notes so the patient can remember things later more clearly. Also, if you have a...
Source: Life as a Healthcare CIO - April 27, 2016 Category: Information Technology Source Type: blogs
Top Policy and Medicine Stories for 2015
At the end of each year, we attempt to give you an overview of what happened in previous year and give some spin on predictions for the coming year, much like an end-of-the-year family newsletter. For those who are a bit more nostalgic, here is a link to our 2014 story.
Perhaps the End of Off Label Lawsuits?
With the Amarin Injunction, Caronia standing for two years without any pushback from the government, and the recent settlement with Pacira, there seems to be a trend of the FDA pulling away from off-label citations. Perhaps this trend is a signal of the end of cases against manufacturers for off label pr...
Source: Policy and Medicine - December 30, 2015 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes New Identifiers For All Biologic Products
Yesterday, the Food and Drug Administration (FDA) released much anticipated guidance on how they plan to address nonproprietary naming of biologics and biosimilars. In it, FDA proposed that all biologics—both reference products and biosimilars—will share a core drug substance name and also a new “FDA-designated suffix” that is unique for each product. While brand-biologic manufacturers pressed FDA to ensure biosimilars carry unique names, the agency’s proposal in fact places a large burden on these manufacturers and prescribers to adopt the new naming model.
In March, FDA approved the fir...
Source: Policy and Medicine - August 28, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Approves Sandoz's Zarxio, The First Biosimilar Approved in the U.S.
Today, the Food and Drug Administration approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. The approval comes two months after an FDA advisory committee recommended Zarxio as biosimilar to Neupogen for all five of the intended indications.
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product--in this case Neupogen. The biosimilar a...
Source: Policy and Medicine - March 6, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Postpones Advisory Committee Review of Celltrion's Remicade Biosimilar
Celltrion will have to wait longer than expected for FDA's Advisory Committee to review its application for Remsima, a biosimilar for Johnson and Johnsons’ Remicade (infliximab). Yesterday, FDA announced that they would be postponing the meeting of the Arthritis Advisory Committee scheduled for March 17, 2015 where they were going to review the product.
View FDA's announcement here.
"The postponement is due to information requests pending with the sponsor of the application. A future meeting date will be announced in the Federal Register," states the Agency.
The A...
Source: Policy and Medicine - February 26, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Accepts Apotex's Neupogen Biosimilar Application: Raises Issues of How the Agency Will Address Exclusivity, Previous Warning Letters to Apotex
Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim, a biosimilar version of Amgen's Neupogen. The product was jointly developed with Intas Pharmaceuticals Ltd. Filgrastim is used to help cancer patients taking chemotherapy to fight infections and fever by boosting white blood cell count. This is the fifth application submitted through the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA), and the second biosimilar submitted by Apotex.
This latest Neupogen biosimilar application is not...
Source: Policy and Medicine - February 19, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Biosimilars Update: FDA Staff Recommends Approval of First Biosimilar in U.S.; Agency Accepts Third Biosimilar Application For Review
FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading, which would state imitation products deemed “highly similar” next to the listed reference. That may change soon. Tomorrow, the FDA will consider whether the Agency should approve Novartis AG's copy of Neupogen, Amgen Inc.'s successful injectable biologic used to prevent infection in patients on chemo therapy. FDA staff reviewers recommended approval for the copy on all five of its proposed indications yesterday.
View the FDA Briefing Document in advance of the Oncologic Drugs...
Source: Policy and Medicine - January 6, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
