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How Do We Protect Patients From False Promises In Right-To-Try Laws?
My sister Gale had exhausted every option. Metastatic cancer raged through her body, defeating all conventional treatments. She faced a final decision: succumb to the disease, or wage one last battle with an experimental bone marrow transplant known to kill 20 percent of patients. Gale chose to fight, opting to use the unproven therapy at a time when institutional review boards and scientific peer review regulated experimental therapies rather than the Food and Drug Administration (FDA). Now, three decades later, the FDA has an expanded access policy, also known as “compassionate use,” that seeks to ensure the quality ...
Source: Health Affairs Blog - March 14, 2017 Category: Health Management Authors: Ellen Sigal Tags: End of Life & Serious Illness Quality Compassionate Use experimental therapies right to try terminal illness Source Type: blogs
Chimeric Antigen Receptor Cancer Immunotherapies Continue to Look Promising
Cancer treatments based on the use of chimeric antigen receptors are one of the more promising of present forms of immunotherapy. In trials they are producing good results in patients with late stage leukemia and lymphoma, who lack any other options, and are comparatively fragile and beaten down by the combination of disease and prior aggressive treatments. They should do even better once deployed earlier, for patients who have not run this gauntlet. In cancer, as in many things, the earlier the intervention the better the prognosis.
Six months after receiving infusions of their own T cells - genetically engineere...
Source: Fight Aging! - March 3, 2017 Category: Research Authors: Reason Tags: Daily News Source Type: blogs
The Future Of Precision Medicine: Great Promise, Significant Challenges
Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23rd, 2017. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come.
In his 2015 State of the Union address, President Obama launched the Precision Medicine Initiative (PMI), which is intended to help move medicine from the traditional “one-size-fits-all” approach where treatments are designed for the “average” patient, to one that “takes into account individual diffe...
Source: Health Affairs Blog - February 28, 2017 Category: Health Management Authors: Jonathan Darrow, Aaron Kesselheim and Jessica Lasky-Su Tags: Costs and Spending Featured Quality 21st Century Cures Act cancer moonshot cancerr Precision Medicine Research The Health Law Year in P/Review Source Type: blogs
Can Employers Take A Bigger Role In Controlling Drug Costs?
An estimated 150 million Americans receive insurance through their employer — and employees and employers alike continue to suffer from “sticker shock” for prices for new drugs, despite several years of debate and threatened congressional action to control the high prices of pharmaceutical products. While considerable attention has been paid to potential actions by Medicare or the Food and Drug Administration (FDA), there has been less focus on the role of private payers to solve the issue. Employers sponsoring health benefits are not bound by the same statutory constraints that apply to Medicare and can ...
Source: Health Affairs Blog - February 17, 2017 Category: Health Management Authors: Robert Galvin and Troyen Brennan Tags: Costs and Spending Drugs and Medical Innovation Drugs and Medical Technology Insurance and Coverage employer coverage launch prices pharmacy benefit managers prescription drug prices QALY Source Type: blogs
21st Century Cures Act Lowers Confidence In FDA-Approved Drugs And Devices
President Barack Obama signed the 21st Century Cures Act on December 13, 2016, bringing into law a piece of health care policy legislation that some describe as landmark. The Act is the result of years of debate on how best to approach a wide range of health care policy goals, from funding for and approval of new drugs to the growing nationwide problem of opioid abuse.
First introduced in the House in January 2015, the new law went through seven iterations and grew to more than 1,000 pages before landing on the President’s desk. The final version invests in new therapies, injects money into health research and named ini...
Source: Health Affairs Blog - February 14, 2017 Category: Health Management Authors: Deborah Mazer and Gregory Curfman Tags: Drugs and Medical Innovation Drugs and Medical Technology Quality 21st Century Cures Act Drug approval FDA medical devices off-label promotion Patient Safety Source Type: blogs
Tucked Away In The Cures Act, A Better Option For Addressing Readmission Penalties For Safety-Net Providers
Along with accelerating the Food and Drug Administration (FDA) approval processes, funding the Cancer Moonshot, and strengthening mental health and substance abuse treatment programs, the wide-ranging 21st Century Cures Act, signed into law on December 13, 2016, also directs the Secretary of Health and Human Services (HHS) to change the way pay-for-performance penalties are applied to safety-net hospitals. This is a move in the right direction.
The Hospital Readmissions Reduction Program (HRRP), authorized by the Affordable Care Act, aims to improve care and outcomes for patients by assessing hospitals’ risk-standardize...
Source: Health Affairs Blog - February 7, 2017 Category: Health Management Authors: Susannah Bernheim and Karen Dorsey Tags: Costs and Spending Health Equity Hospitals Payment Policy Quality Hospital Readmissions Reduction Program safety-net providers Source Type: blogs
Will Trump ' s Leadership Picks Smack Down Health Care? - A Drug Company Lobbyist, an Entrepreneur Who Wants to Weaken Drug Testing, and a Mysterious Billionaire Who Settled Fraud Charges
President Trump in hisinauguration speech promised to reach out to " struggling families " and to benefit " American workers and American families, " and promised all Americans " you will never be ignored again. " Yet the Trump transition team, and now presidential administration continues to consider individuals for health care policy leadership roles remarkable for theirconflicts of interest, which often did not merely arise from small financial transactions but from their roles as corporate insiders, and in some cases, association with dubiously ethical practices. They are particularly unremarkable for their...
Source: Health Care Renewal - January 27, 2017 Category: Health Management Tags: conflicts of interest Covidien Donald Trump executive compensation fraud Medtronic revolving doors Source Type: blogs
Interim FDA Commissioner Announced
Dr. Robert Califf’s tenure as commissioner of the United States Food and Drug Administration (FDA) is slated to come to an end ahead of the January 20th inauguration of Donald Trump as president. Deputy commissioner Dr. Stephen Ostroff is expected to take over on an interim basis after the inauguration. Ostroff has previously been acting commissioner – from April 2015 to February 2016 he served as acting commissioner. Once Califf was sworn in, Ostroff became the FDA’s deputy commissioner for foods and veterinary medicine.
Califf Permanent Replacement
Scott Gottlieb
The leading candidate to replace Califf is said t...
Source: Policy and Medicine - January 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Sympathy for the Devil - Mr Trump ' s Adviser on FDA Leadership Prefers Corruption to Boredom
Please allow me to introduce myself I ' m a man of wealth and taste I ' ve been around for a long, long year Stole many a man ' s soul and faith- Keith Richards, Mick JaggerMr Peter Theil, a Silicon Valley billionaire, apparently a man of wealth and taste, has become a major adviser to the transition team for US President-Elect Donald Trump about candidates for important government positions, including the leadership of the US Food and Drug Administration. As we notedhere, Mr Theil apparently supported the candidacy of one Jim O ' Neill, one of Mr Theil ' s business associates, for this position, despite Mr O ' Neill...
Source: Health Care Renewal - January 18, 2017 Category: Health Management Tags: conflicts of interest Donald Trump FDA health care corruption Source Type: blogs
Fighting the injustice of health disparities: Honoring the legacies of Dr. Martin Luther King Jr. & Dr. John M. Eisenberg
For the past several years I have run this post and just as it was those years, it is this year a very important message.
We, as a nation, have made progress and I believe Dr. King would be proud. But our work is far from complete – particularly where health care is concerned. Another doctor, Dr. John M. Eisenberg, a physician of tremendous stature whose life was also tragically cut short (not by an assassin’s bullet but by brain cancer) was equally passionate about the dignity of life and justice for all Americans. Dr. Eisenberg, who among other things, served as the Director of the Agency for Health Care Policy and R...
Source: Disruptive Women in Health Care - January 16, 2017 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Advocacy Choice Source Type: blogs
The Adventurous are Undergoing Enhancement Gene Therapies
As I've been saying for the past couple of years, gene therapies are straightforward enough and cheap enough to carry out that people are doing it, usually quietly, but it is happening. You only have to be connected enough to know a biotechnologist or two with the right skills, as the example here shows. The stage of the adventurous and the self-experimenters is an important part of the development of any new medical technology, helping to overcome institutional reluctance while gathering initial data on how best to approach such treatments in practice. The next part of the process, something that does requires much greate...
Source: Fight Aging! - January 10, 2017 Category: Research Authors: Reason Tags: Daily News Source Type: blogs
A Profile of UNITY Biotechnology
An accumulation of senescent cells is one of the causes of aging, and periodic removal of senescent cells is therefore one of the foundations for near future rejuvenation therapies. The first generation of these treatments will likely be available via medical tourism within the next couple of years, but we'll be waiting five years or more for comprehensive human data and passage through the regulatory systems of the US and Europe. For those who have been following events in the nascent senescent cell clearance industry, there won't be much that is new in this popular press article on UNITY Biotechnology, but it is nonethel...
Source: Fight Aging! - January 9, 2017 Category: Research Authors: Reason Tags: Daily News Source Type: blogs
The Best-Laid Plans For Health Care
Editor’s note: These issues and more will be discussed at the 5th Annual Health Law Year in P/Review conference, to be held on January 23, 2017, at Harvard Law School in Cambridge, MA. The event is free and open to the public, but registration is required. Conference presenters will participate in a blog series to follow here on Health Affairs Blog. Stay tuned. In the meantime, you can check out last year’s Health Law Year in P/Review blog series here.
“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title o...
Source: Health Affairs Blog - January 5, 2017 Category: Health Management Authors: I. Glenn Cohen Tags: Drugs and Medical Technology Following the ACA Health Policy Lab Organization and Delivery Payment Policy Public Health 21st Century Cures Act Supreme Court The Health Law Year in P/Review Source Type: blogs
The Uncertain Future of Biosimilars in the United States
Discussion
During the first panel discussion, Dr. Leah Christl, Associate Director for Therapeutic Biologics at the FDA, noted that an interchangeability designation did not necessarily signify a higher standard than a biosimilar designation. Biosimilars are approved when they are shown to be “highly similar” with “no clinically meaningful difference” from the reference product, whereas interchangeability means that a prescription written for a biologic could be substituted at the pharmacist’s discretion for a drug that was therapeutically equivalent.
Dr. Christl believes that interchangeability will have large...
Source: Policy and Medicine - December 18, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
The Most Exciting Medical Technologies of 2017
It is almost a tradition for me to publish predictions for the coming year. I do not mean to disappoint you this year either, so here you find some thoughts about the top medical technologies of 2017.
2016 was a rich year for medical technology. Virtual Reality. Augmented Reality. Smart algorithms analysing wearable data. Amazing technologies arrived in our lives and on the market almost every day. And it will not stop in the coming year.
The role of a futurist is certainly not making bold predictions about the future. No such big bet has taken humanity forward. Instead, our job is constantly analysing the trends shaping t...
Source: The Medical Futurist - December 15, 2016 Category: Information Technology Authors: nora Tags: Future of Medicine 3d printing AI artificial intelligence diabetes GC1 genetics Healthcare Innovation nutrigenomics Personalized medicine robotics wearables Source Type: blogs
