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Efficacy, We Don ' t Need No Stinking Proof of Efficacy - Says Apparent Trump Candidate to Lead FDA
DiscussionWe could do our usualrant about the revolving door here. Obviously, the revolving door pheonomenon is a serious conflict of interest, if not form of corruption, that should have no place in our government, particularly in its agencies that are concerned with health care. But there is a bigger issue here.So add anyone who might have to receive any medical treatment to the long list of people who should be worried about a future Trump administration. Maybe we would all be better off if Mr Tump finds something else to do for the next four years. Maybe he should stick tobeing executive p...
Source: Health Care Renewal - December 9, 2016 Category: Health Management Tags: adverse effects Donald Trump evidence-based medicine FDA revolving doors Source Type: blogs
Destroying the FDA to save it? No, more like just destroying it.
Yesterday, I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding that basically said: You can have an increase in the NIH budget. You can have the Cancer Moonshot. You can have President Obama’s Precision Medicine Initiative and his…
Source: Respectful Insolence - December 9, 2016 Category: Surgery Authors: Orac Tags: Cancer Clinical trials Medicine Politics Popular culture Skepticism/critical thinking Donald Trump fda Food and Drug Administration Jim O'Neill libertarian Mithril Capital Management Peter Thiel Source Type: blogs
The Latest on Chimeric Antigen Receptor Therapy for Leukemia
The use of chimeric antigen receptors (CAR) to create engineered T cells to attack specific varieties of cancer cell, identified by their surface chemistry, is so far proving to be effective for leukemia, a cancer of the immune system. Researchers are also making inroads in adapting the therapy for use in solid tumors. While an initial group of patients treated several years ago with the first pass at CAR T cell therapy remain in remission, the news here focuses on the results from a more recent trial:
The 24 patients had undergone most standard therapies available to them and yet their chronic lymphocytic leukemi...
Source: Fight Aging! - December 6, 2016 Category: Research Authors: Reason Tags: Daily News Source Type: blogs
21st Century Cures Update - Includes Exemption for Education in Open Payments
When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures bill, legislation that is intended to spur the development of new medical treatments. The bill was updated the Friday after Thanksgiving, leaving many of the provisions of previous versions intact, but also adding language intended to improve America’s mental health system and dedicates $1 billion over the course of two years to help combat the opioid epidemic.
The updated package directs $4.8 billion in funding over a decade to the National Institutes of Health and includes $1.4 billi...
Source: Policy and Medicine - November 28, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
21st Century Cures Update
When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures bill, legislation that is intended to spur the development of new medical treatments. The bill was updated the Friday after Thanksgiving, leaving many of the provisions of previous versions intact, but also adding language intended to improve America’s mental health system and dedicates $1 billion over the course of two years to help combat the opioid epidemic.
The updated package directs $4.8 billion in funding over a decade to the National Institutes of Health and includes $1.4 billi...
Source: Policy and Medicine - November 28, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Congress Shouldn ’t Pass FDA Reform Bills Without Addressing Patient Safety and Drug Prices
By DIANA ZUCKERMAN
A major proposed law that alters the way the Food and Drug Administration (FDA) approves drugs and medical devices has been wending its way through Congress since 2014. Momentum is building on Capitol Hill to pass the legislation in the current “lame-duck” session of Congress.
That shouldn’t happen.
The House passed its version of the legislation—the 21st Century Cures Act (hereafter the Cures bill) —in July 2015. The Senate health committee created and passed 19 related bills, under the banner “Innovation for Healthier Americans,” this past spring.
Sen. Lamar Alexander (R-Tenn) pu...
Source: The Health Care Blog - November 23, 2016 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized Source Type: blogs
The Future Of The Affordable Care Act In A Trump Administration
This segment originally aired on The Diane Rehm Show on November 14, 2016.
The HealthCare.gov website, where people can buy health insurance, is displayed on a laptop screen. AP PHOTO/ANDREW HARNIK
Republicans in Congress have voted more than 50 times to repeal the Affordable Care Act without success. Now, they have an ally in President-elect Donald Trump, who promised on the campaign trail to “repeal and replace” the law. But over the weekend, Trump seemed to soften his stance. He told the Wall Street Journal he would consider leaving in place some provisions, including one that prohibits insurers from denying covera...
Source: Disruptive Women in Health Care - November 15, 2016 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Affordable Healthcare Act Consumer Health Care Cost Coverage Policy Election 2016 Health Reform Source Type: blogs
Hotshot. A supplement scam with a difference?
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The "supplement" industry is a scam that dwarfs all other forms of alternative medicine. Sales are worth over $100 billion a year, a staggering sum. But the claims they make are largely untrue: plain fraudulent. Although the industry’s advertisements like to claim "naturalness". in fact most of the synthetic vitamins are manufactured by big pharma companies. The pharmaceutical industry has not been slow to cash in on an industry in which unverified claims can be made with impunity.
When I saw advertised Hotshot, "a proprietary formulation of organic ingredients" that is...
Source: DC's goodscience - October 25, 2016 Category: Science Authors: David Colquhoun Tags: Academia supplements Bruce Bean cramp dietary supplements DSHEA Harvard Hotshot Muscle cramp Rockefeller university Rod MacKinnon TRP receptors Source Type: blogs
Encouraging Integrative, Non-opioid Approaches To Pain: A Policy Agenda
The United States is struggling to deal with an opioid epidemic that is damaging lives, resulting in overdoses, and yet not reducing chronic pain. National initiatives are underway to dramatically reduce access to prescription opioids, but these efforts lack a systematic approach to provide alternative treatments for these patients. Policy changes are urgently needed to provide better care for patients with chronic pain, and in this post, we outline three feasible policy initiatives.
Innovative reimbursement initiatives by the Centers for Medicare and Medicaid Services (CMS) could frame and stimulate use of evidence-based ...
Source: Health Affairs Blog - October 4, 2016 Category: Health Management Authors: Jason Doctor, Penny Cowan, Daniella Meeker, Patricia Bruckenthal and Joan Broderick Tags: Drugs and Medical Technology Health Professionals Public Health Quality chronic pain Opioid Addiction opioids Source Type: blogs
The Proposed Federal ‘Right-To-Try’ Law Is Not The Answer For Critically Ill Patients
Currently, patients have two main options to access experimental therapies that may treat their conditions but that have not yet been approved by the Food and Drug Administration (FDA): enrolling in a clinical trial or applying to FDA’s expanded access (also known as compassionate use) program. But because FDA’s expanded access program has been viewed as cumbersome and overly restrictive, 31 states have passed “Right-To-Try” laws in the past two years. Based on model legislation created by the Goldwater Institute, a public policy think tank, right-to-try laws are intended to authorize use of experimental, not-yet-a...
Source: Health Affairs Blog - September 27, 2016 Category: Health Management Authors: Jonathan Friedlaender Tags: Drugs and Medical Technology Featured Health Professionals Narrative Matters Quality clinical trials Compassionate Use right-to-try laws Trickett Wendler Right to Try Act Source Type: blogs
Not Everyone Wants to Ban Kratom: Here Are Some Issues to Consider
Never heard of kratom? The media has been so focused on the ongoing opioid epidemic that it’s easy to miss a less frequently used or abused substance, like kratom. But a movement to ban or restrict the sale of kratom in cafes, at head shops and on the internet is gaining momentum across the country and states are taking legal action to curtail the public’s use of this drug. So what exactly is kratom, and why are people divided about its use?
Common in the United States for almost ten years before catching the attention of the federal government, kratom is a plant grown in Southeast Asia and cultivated as a kin...
Source: Cliffside Malibu - September 21, 2016 Category: Addiction Authors: Constance Scharff, PhD Tags: Abuse Addiction Recovery Addiction to Pharmaceuticals Addiction Treatment and Program Resources Alcoholism Behavioral Addictions Current Events Drug Rehab Information Drug Treatment Mental Health drug addiction drug treatment center Source Type: blogs
Rapid Biomedical Innovation Calls For Similar Innovation In Pricing And Value Measurement
Advances in foundational science, technology, and clinical knowledge are driving a revolution in patient care. Minimally invasive surgery has reduced rates of post-surgical complications, reduced hospitalization, and dramatically accelerated recovery; direct-acting antivirals have brought a cure for hepatitis C; and novel immunotherapies have brought the promise of increased survival to late-stage cancer patients. The list goes on.
At the same time, spending on these innovative drugs and devices has increased dramatically. Between 1980 and 2010, overall personal health care expenditures in the US grew nearly four-fold, dri...
Source: Health Affairs Blog - September 15, 2016 Category: Health Management Authors: Dana Goldman, Samuel Nussbaum and Mark Linthicum Tags: Drugs and Medical Innovation Featured Comparative Effectiveness health technology assessment National Health Service National Institute for Health and Care Excellence PCORI Source Type: blogs
The Women ’s Health Amendment Is Getting An Update. What Should It Include?
The Affordable Care Act (ACA) requires most private health plans in the United States to cover four sets of recommended preventive services without copayments, deductibles, or other out-of-pocket costs. One of those four sets of services focused on women’s preventive care needs. It was called for under the law’s Women’s Health Amendment, developed by an Institute of Medicine panel, and officially incorporated by the federal government into health plans’ requirements in 2012. Taken as a whole, the ACA’s preventive services provision requires coverage of a wide array of sexual and reproductive health services, from...
Source: Health Affairs Blog - September 14, 2016 Category: Health Management Authors: Adam Sonfield Tags: Costs and Spending Equity and Disparities Public Health Quality ACA contraceptive coverage HIV/AIDS sexually transmitted infections Women's Health Source Type: blogs
Health Affairs ’ September Issue: Payment Reforms, Prescription Drugs, And More
The September issue of Health Affairs, a variety issue, includes a number of studies examining aspects of payment reform, the impact of certain ACA provisions, the value of some high-cost anticancer drugs, and more. It also includes a DataGraphic examining aging and health.
DATAWATCH: New evidence of rapid physician practice consolidation, 2013–15
In the past few decades, group physician practices have become more of the norm, and the proportion of physicians in larger groups has grown. David Muhlestein and Nathan Smith, with Leavitt Partners in Salt Lake City, Utah, looked at Medicare’s Physician Compare data for the ...
Source: Health Affairs Blog - September 7, 2016 Category: Health Management Authors: Lucy Larner Tags: Elsewhere@ Health Affairs Featured Health Affairs journal Source Type: blogs
How the System is Rigged - Johnson and Johnson Board Member Pretends to be Independent Brookings Institution Scholar
DiscussionIt is hardly news that US health care is broadly dysfunctional, that it suffers from ever rising costs, and questionable quality, while access has only somewhat improved after the 2009 Affordable Care Act. The big question is why these problems seem so intractable.Our latest case illustrates that the problem may be that health policy making is dominated by people withconflicts of interest. In the current case, one of the more influential voices on health care policy turns out not to have just a garden variety conflict of interest. He actually has a duty to uphold the corporate interests of one o...
Source: Health Care Renewal - August 10, 2016 Category: Health Management Tags: boards of directors Brookings Institution hepatitis C Johnson and Johnson revolving doors You heard it here first Source Type: blogs
