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Total 341 results found since Jan 2013.
Cochlear Implants and MRI: Growth Trend Leads to Design Revolution
By Darla Franz, MA, & Rebecca Novak Tibbitt, MPH MED-EL
Cochlear implants (CIs) are an increasingly common option for people with severe to profound hearing loss. Approximately 324,200 people worldwide had received implants as of December 2012, according to the U.S. Food and Drug Administration (FDA). In the United States, an estimated 58,000 adults and 38,000 children have received cochlear implants (National Institute on Deafness and Other Communication Disorders; bit.ly/NIDCD-CI). Recent research has shown that the number of older adults in the United States who are potential candidates for cochlear implantatio...
Source: R&D Blog - May 4, 2015 Category: ENT & OMF Tags: Blog Posts Source Type: blogs
To Spur Medical Innovation, Make Corporate Cheaters Pay
The past decade has seen a relatively constant rate of newly approved drugs every year. The number has even jumped in the past few years. Yet, despite such encouraging trends, we are actually facing a crisis in drug innovation today. That is because many of these new products do not offer substantial improvements over already available alternatives.
At the same time, novel and effective treatments for many diseases---both rare and common---remain elusive. For example, there is widespread concern over the lack of development of new antibiotics aimed at multidrug-resistant infections. Therapeutic innovation for central nerv...
Source: Health Affairs Blog - April 30, 2015 Category: Health Management Authors: Aaron Kesselheim Tags: Drugs and Medical Technology Health Policy Lab Medicaid and CHIP Medicare corporations Cost FDA legislation Marketing medical innovation Medical Innovation Act NIH Pharma price Source Type: blogs
Weighing the Risks of Hormone Therapy
The post below originally ran on Huffington Post’s Healthy Living blog on February 19. To see the original post click here.
For over a decade, hormone therapy (HT) has been a hot topic in medicine. Unfortunately, women are still confused and concerned about using HT after two federally-funded studies linked HT to potentially serious health risks. Even decades after these studies, information on HT is seriously muddied, and not much is still fully known or understood about the treatment. It’s time to clear up the confusion and debunk the false reports surrounding its risks.
HT is used to primarily treat menopaus...
Source: Disruptive Women in Health Care - April 28, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Aging Women's Health Source Type: blogs
FDA Announces Consent Decree with Medtronic Over Alleged Quality Violations, Deal Limits Pain Pump Manufacturing and Sales
Yesterday, the Food and Drug Administration (FDA) announced the filing of a consent decree with Medtronic and two executives “for repeatedly failing to correct violations” related to the manufacture of Synchromed II Implantable Infusion Pump Systems, a medical device for chronic pain. The announcement comes after FDA had issued several Warning Letters to the company over the product—targeting the company’s insufficient quality controls and delay in correcting certain manufacturing problems. Though the decree does not come with a monetary fine, Medtronic has agreed to a long list of stringent terms regarding future ...
Source: Policy and Medicine - April 28, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
As Vaccination Rates Dip, Parents Walk A Tightrope Between Doubt And Risk
The recent re-emergence of measles in the United States following a 15-year period of occasional cases provides a compelling example of an unresolved societal tension in public health: that between the value of autonomous decision-making and the need for social responsibility. The outbreak---more than 700 cases since January 2014---reveals not only this tension, which also plagues other arenas of health care reform.
It also reveals the tenacity of doubt about vaccine safety that has led to a tipping point in undermining herd immunity. (That is, within a community, high rates of immunization protect both individuals and th...
Source: Health Affairs Blog - April 23, 2015 Category: Health Management Authors: Sharon Kaufman Tags: Featured Population Health Public Health autism risk awareness vaccines Source Type: blogs
FDA Acting Commissioner Ostroff Addresses the "State of the FDA"
The 2015 FDLI Annual Conference kicked off yesterday in Washington, DC. The conference hosted a variety of impressive speakers from the Food and Drug Administration, as well as FDA lawyers and in-house counsel. Dr. Stephen Ostroff, the Acting Commissioner at FDA, spoke as the conference's keynote speaker. After congratulating previous Commissioner Margaret Hamburg on an impressive tenure as FDA Commissioner, Ostroff ran through a long list of recent FDA accomplishments--"hitting the highlights," as he called it. Following Ostroff's address, a panel of industry experts provided a "to do list" for the agency for the co...
Source: Policy and Medicine - April 21, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
New Cures Require New Pricing Policies
One critical incentive for ongoing drug discovery and development is the temporary monopoly pricing that manufacturers can command for novel drugs. Yet this incentive, embedded in current patent and regulatory policy, does not guarantee that manufacturers will deliver novel products with clinically meaningful benefits. Indeed there are many diseases---including Alzheimer’s disease and Amyotrophic lateral sclerosis (ALS)---that pose significant patient, family, and societal burden but have not benefited from meaningful treatment advances.
Meanwhile, the American public appears increasingly wary of the unintended conseque...
Source: Health Affairs Blog - April 16, 2015 Category: Health Management Authors: Rena Conti Tags: Health Policy Lab costs drugs Pharma pricing Source Type: blogs
More Trials
So I've added a couple more trials to an ever growing list. At last count I've had 12 different regimens over the last 10+ years half of which were clinical trials. There is definitely a "Aren't you special." feedback from all the attention clinical trial patients get.The ABT-199 trial ended after 5 cycles with evidence of progression seen via imaging (PET/CT). I have a tough clone to clobber. Illusive secretive beast that stops expressing any evidence of progression in the blood. Instead it just munches away at my bones with a relentlous incideous appetite.There is no doubt that the Oprozomib trial was not worth the extra...
Source: Laughing Plasma Cells - April 16, 2015 Category: Cancer & Oncology Source Type: blogs
Doctor's Article Counters The "Myths That Undermine Medical Research"
Thomas Stossel, American Cancer Society Professor of Medicine at Harvard Medical School and a visiting scholar at the American Enterprise Institute, recently wrote an article entitled “Myths that undermine medical research.” Stossel raises important points to counter three prevailing myths about the drug and device industry. View the article, as published in the hill.com
If you or a loved one suffers from a serious and debilitating disease and hope for improved treatment or—even better—a cure, the recent history of medical progress should be encouraging. Over the years I have practiced medicine, U.S. longevi...
Source: Policy and Medicine - April 14, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Public Citizen Urges FDA To Penalize Drug Makers Over Diabetes Ads, Criticizes the Agency’s “Dismal Record” on Issuing Warning Letters
Consumer advocacy group Public Citizen is calling on the Food and Drug Administration (FDA) to “stop the apparently violative off-label promotional statements” in various Type 2 Diabetes advertisements, which the group argues are being advertised as weight-loss drugs. “[N]one of the drugs is approved for weight loss and, despite the presence of disclaimers that the medications are not weight-loss drugs, the implication is clearly that weight loss is an additional potential benefit of the drugs,” Public Citizen states.
This request comes in the midst of a “drastic reduction” in the past few years of direct-to-co...
Source: Policy and Medicine - April 3, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Ensuring Timely Approval Of Generic Drugs
Having saved US consumers over $1.5 trillion in the past decade, generic drugs are one of the most cost-effective interventions in our entire health care system. Using generic drugs instead of brand-name drugs, when a generic is available, has been shown to increase medication adherence and improve health outcomes for chronic conditions.
Importantly, generic drugs offer these advantages without sacrificing quality; the Food and Drug Administration’s bioequivalency standards are met and often exceeded by generic-name manufacturers, and no randomized controlled trials—the gold standard of medical evidence—have identifi...
Source: Health Affairs Blog - March 24, 2015 Category: Health Management Authors: Ameet Sarpatwari and Aaron Kesselheim Tags: All Categories Competition Health Care Costs Pharma Policy Source Type: blogs
Continued Interest in Drugs that Might Slightly Slow Aging
Research institutions are willing to pour comparatively large sums into the pursuit of existing already developed and approved drugs that might, possibly, have some marginal, tiny effect on the course of degenerative aging. This is one manifestation of a large and harmful issue that plagues medical research as a whole, which is that there is very little interest in pursuing radical new improvements to the state of therapies. Rather the larger investments nowadays often go towards mining the existing catalog of approved drugs in search of different uses and slight gains that might have been overlooked in the past. Other gro...
Source: Fight Aging! - March 17, 2015 Category: Research Authors: Reason Tags: Medicine, Biotech, Research 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
Health Affairs’ March Issue: The Benefits And Limitations Of Information
This study is part of Health Affairs’ DataWatch series.
Another study examining different kinds of health plan benefits:
Comparing Employer-Sponsored And Federal Exchange Plans: Wide Variations In Cost Sharing For Prescription Drugs; Christine Buttorff of the RAND Corporation and coauthors.
From England, lessons learned by the National Health Service in paying for value.
In England, as is the case in the United States, containing health spending is a major focus of current health policy. A flattening budget coupled with growing service demand drove the country’s National Health Service (NHS) to seek cumulative effici...
Source: Health Affairs Blog - March 2, 2015 Category: Health Management Authors: Chris Fleming Tags: All Categories Consumers Coverage Employer-Sponsored Insurance Europe Health Law Health Reform Hospitals Pharma Policy Quality Spending Workforce Source Type: blogs
