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A Rapid-Learning Initiative For Cholesterol-Lowering Drugs
In late July, the Food and Drug Administration (FDA) approved selective use of Praluent, the first of a new class of cholesterol-lowering drugs (PCSK9 inhibitors). A similar drug, Repatha, is expected to be approved this month. The reported results so far for Praluent, e.g. 50-70 percent lowering of cholesterol levels, are very promising — particularly for patients who are unable to control their cholesterol with statins. The new drugs may be uniquely valuable for a million or more persons with genetic conditions that cause high cholesterol. However, there is considerable uncertainty and debate about how broadly Pral...
Source: Health Affairs Blog - August 25, 2015 Category: Health Management Authors: Lynn Etheredge Tags: Costs and Spending Drugs and Medical Technology Featured Population Health Public Health Quality cholesterol-lowering drugs FDA genetic conditions Praluent rapid learning regulation Repatha Source Type: blogs

Once More with Feeling - Amgen Again Settles Allegations of Misbranding, But Why Bother?
DiscussionIn the case of Amgen, the large 2012 settlement for misbranding resulted in the only guilty plea made and the largest fine paid by the company.  From my informal perusal of legal settlements made by drug, biotechnology and device companies, misbranding seems to be one of the more frequent allegations, and often the only one resulting in admissions of guilt.  It may be that it is easier to prove misbranding than other charges, and companies may admit to misbranding in settlements because the charge is not well understood by the general public and hence may carry less of a stigma than other charges, for e...
Source: Health Care Renewal - August 20, 2015 Category: Health Management Tags: Amgen bribery deception kickbacks legal settlements marketing Source Type: blogs

A Food Safety Test We Have Yet To Pass
Back in 1987 The Wall Street Journal shocked health care consumers and awakened the U.S. clinical community with these headlines: “Lax Laboratories: The Pap test misses much cervical cancer through labs’ errors” (Walt Bogdanich, November 2, 1987) “Physician’s carelessness with Pap tests is cited in procedure’s high failure rate” (Walt Bogdanich, December 29, 1987) “Medical labs, trusted as largely error-free, are far from infallible” (Walt Bogdanich, February 2, 1987) “Risk Factor: inaccuracy in testing cholesterol hampers war on heart disease” (Walt Bogdanich, February 3, 1987) It took this...
Source: Health Affairs Blog - August 20, 2015 Category: Health Management Authors: Robin Stombler Tags: Featured Public Health Quality FDA Food Laboratory Alliance food safety Food Safety Modernization Act FSMA Source Type: blogs

TBT: Blind to women’s sexual health
Today’s TBT post ran over two years ago and addressed female dysfunction. Given the FDA’s recent approval of flibanserin, a pill that aims to increase a woman’s desire for sex, we thought it would be helpful to review some of the early conversations on the issue. A recent article published in partnership with The Investigative Fund and Newsweek questioned the existence of “female dysfunction,” as if to say, who cares about women’s sexual health? If you can’t “see” it, apparently it doesn’t exist. This is one-sided, inaccurate and disparaging of women. Why is it that when men are impotent it ...
Source: Disruptive Women in Health Care - August 20, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Aging Choice gender Women's Health Flibanserin Food and Drug Administration Sexual desire Sexual dysfunction Source Type: blogs

Amgen Pays $71 Million to States For Off-Label Allegations In Violation of Consumer Protection Laws
  Earlier this week, Amgen Inc. agreed to pay $71 million to 48 states to settle allegations that it violated state consumer protection laws by promoting its anemia drug Aranesp and plaque psoriasis drug Enbrel off-label. Amgen pleaded guilty in 2012 to a federal criminal charge related to similar off-label allegations related to Aranesp, paying $762 million, then the “single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history,” stated DOJ.  Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells.  En...
Source: Policy and Medicine - August 20, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

Inside Baseball: The DoD EHR
By MARGALIT GUR-ARIE The health information technology (HIT) world has been hit by a watershed event like no other. The Department of Defense (DoD), widely respected for its indiscriminate generosity to contractors, has awarded the most coveted prize in recent HIT memory – the Defense Healthcare Management Systems Modernization (DHMSM) contract. And the winner is… Leidos, the contractor formerly known as SAIC. A couple of years ago, when the race for the DoD contract began, Leidos/SAIC selected Cerner as its EHR of choice for this contract. The smart money though was on Epic and its Big Blue partner because they ar...
Source: The Health Care Blog - August 6, 2015 Category: Consumer Health News Authors: John Irvine Tags: Tech Uncategorized Source Type: blogs

Spending Growth Trends: Keeping An Eye On Spending Per Person
New health spending data for 2014 and spending projections over the next decade from the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary were just published in Health Affairs. They show that total growth in health spending picked up in 2014; this was expected given the significant expansion of insurance coverage and the release of expensive new drugs for hepatitis C.¹ But all of the evidence points to continued modest growth in per capita/enrollee spending. This low growth in per enrollee costs is a strong signal that we may be in an era where the “new normal” is more restrained growth in the us...
Source: Health Affairs Blog - July 28, 2015 Category: Health Management Authors: Melinda Buntin Tags: Costs and Spending Drugs and Medical Technology Featured Health Professionals Hospitals Insurance and Coverage Medicaid and CHIP Medicare Altarum symposium CMS Office of the Actuary Consumers Health IT Melinda Buntin transparency Source Type: blogs

Majority of House of Representatives Support 21st Century Cures
The Energy and Commerce Committee has announced that two hundred and thirty bipartisan members of Congress have added their names as co-sponsors of H.R. 6, the 21st Century Cures Act, signaling the continued support for the bill. On May 21, 2015, the House Energy and Commerce Committee unanimously approved the 21st Century Cures Act—a 300 page bill reflecting a year-long legislative process to bring drug and device regulations up-to-date with current medical innovation. Co-sponsored by House Commerce Committee Chair Fred Upton (R-Texas) and Rep. Diana DeGette (D-Colo.), the bill focuses on the life-cycle of getting...
Source: Policy and Medicine - June 29, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

How Institutional Conflicts of Interest Exacerbate the Anechoic Effect - the Example of ASCO Fearing "Biting the Hand that Feeds You"
As we recently discussed (here, here, here and here), in May, 2015, the New England Journal of Medicine, arguably the world's foremost medical journal, published an editorial and a three-part commentary arguing that current concerns about the effects of financial conflicts of interest (COI) on health care are overblown(1-4).  On June 1, the Wall Street Journal published a report on the 2015 meeting of the American Society of Clinical Oncology (ASCO) that provided a vivid example of why these concerns should not be dismissed.Questioning Drug Prices at the ASCO MeetingThe main issue in the article was:In a sign of growi...
Source: Health Care Renewal - June 26, 2015 Category: Health Management Tags: American Society of Clinical Oncology anechoic effect conflicts of interest health care prices institutional conflicts of interest medical societies You heard it here first Source Type: blogs

Skin Cancer Myths, Busted: Part 1
The following post first ran on HuffPost’s Healthy Living blog and can be accessed here. With summer’s arrival and more time spent outdoors everyone should take a minute to read the information below. Did you know 10,000 people in the U.S. will die from a preventable cancer this year alone? That preventable cancer is skin cancer. And yes, we know you’re tired of being told to wear sunscreen, put on a hat, and hang out in the shade, but these practices can be life-saving. About 3.5 million cases of basal and squamous cell skin cancer are diagnosed in the U.S. each year. Melanoma, the most dangerous form of...
Source: Disruptive Women in Health Care - June 26, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Cancer American Academy of Dermatology Food and Drug Administration skin cancer Sunburn Sunscreen Ultraviolet Source Type: blogs

Skin Cancer Myths, Busted: Parts 1 & 2
The following post first ran on HuffPost’s Healthy Living blog and can be accessed here. With summer’s arrival and more time spent outdoors everyone should take a minute to read the information below. Did you know 10,000 people in the U.S. will die from a preventable cancer this year alone? That preventable cancer is skin cancer. And yes, we know you’re tired of being told to wear sunscreen, put on a hat, and hang out in the shade, but these practices can be life-saving. About 3.5 million cases of basal and squamous cell skin cancer are diagnosed in the U.S. each year. Melanoma, the most dangerous form of...
Source: Disruptive Women in Health Care - June 26, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Cancer American Academy of Dermatology Food and Drug Administration skin cancer Sunburn Sunscreen Ultraviolet Source Type: blogs

Government backs down on some requirements for digital medical records
EHR utopian dreams have taken some pronounced hits in recent years.In recent months, the hyper-enthusiasts and their government allies have had to eat significant dirt, and scale back their grandiose but risible - to those who actually have the expertise and competence to understand the true challenges of computerization in medicine, and think critically - plans.(At this point I'll give them the benefit of the doubt and not call the utopians and hyper-enthusiasts corrupt, just stupid.) USA Today published this article today outlining the retreat:Government backs down on some requirements for digital medical recordshttp://w...
Source: Health Care Renewal - May 27, 2015 Category: Health Management Tags: Bob Wachter David Blumenthal healthcare IT difficulties healthcare IT dissatisfaction Healthcare IT experiment Jayne O ' Donnell Sally Murphy USA Today Source Type: blogs

Media Outlets Using 2013 Open Payments Data To Imply Misconduct
Open Payments, a public list of the transfers of value made from pharmaceutical and device manufacturers to physicians and teaching hospitals, has yet to be the basis for a government enforcement action. The Justice Department has not, for example, explicitly used the Centers for Medicare and Medicaid Services’ database as the foundation for bringing kickback allegations against a company. That day may be a ways off—after all the database currently lists only five months of payment data covering September through December of 2013, and a large portion of that data is aggregated, meaning it doesn't list the physician rec...
Source: Policy and Medicine - May 25, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

Addressing the risks of indoor tanning
With May being Skin Cancer Awareness Month and in tandem with our event Wednesday co-hosted with the Congressional Families Cancer Prevention Program, The Hazards and Allure of Indoor Tanning Beds on College Campuses we are running a series on skin cancer. Be sure to check back daily for posts on skin cancer including how you prevent and detect it. Enjoy! It is not the kind of selfie we usually expect to see on Facebook. A young woman looks forlornly away from the camera, her face covered from top to bottom with bloody scabs—the result of treatment for skin cancer. The therapy is aggressive; but it is necessary, because ...
Source: Disruptive Women in Health Care - May 19, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Advocacy Cancer Source Type: blogs

In ‘Ensuring Timely Approval Of Generic Drugs,’ Safety Must Come First
If there was ever a time for an informed discussion about the purpose and use of Risk Evaluation and Mitigation Strategies (REMS), it is now. Rather than impeding the arrival of more effective treatments to the market, Congress gave the Food and Drug Administration (FDA) authority to require REMS as a way to approve needed medicines that are also known to carry severe risks. As a result, patients now have access to new treatments for asthma, chronic obstructive pulmonary disease, blood disorders, multiple myeloma, thyroid cancer, irregular heartbeat, hypertension, multiple sclerosis, seizures, schizophrenia, bipolar disord...
Source: Health Affairs Blog - May 14, 2015 Category: Health Management Authors: Stacey Worthy and Stephanie Curtis Tags: Drugs and Medical Technology Featured Population Health FAST Act FDA FDAAA Patient Safety REMS Source Type: blogs