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Government Appropriation Of Breakthrough Drug Patent Rights Would Deter Biopharmaceutical R&D And Innovation
In the May 2016 issue of Health Affairs, Amy Kapezynski and Aaron Kesselheim propose that the federal government invoke its patent use authority under Section 1498 to lower drug prices and increase access for breakthrough medicines in government-funded health care programs. Section 1498 allows the government eminent domain-type powers to circumvent an inventor’s patent exclusivity rights in exchange for “reasonable and entire compensation” — in effect a royalty on sales which would be determined through negotiation or by the courts. To date, application of Section 1498 has been limited to selective military and...
Source: Health Affairs Blog - June 20, 2016 Category: Health Management Authors: Henry Grabowski Tags: Costs and Spending Drugs and Medical Technology Big Pharma Cooperative Research and Development Agreements eminent domain hepatitis C Section 1498 Sovaldi Source Type: blogs

Ex-Pharma Sales Staff Arrested on Anti-Kickback Charges
It was recently announced that Jonathan Roper, a former District Manager at Insys Therapeutics, and Fernando Serrano, a former sales representative at Insys Therapeutics, were arrested and charged with violating the Anti-Kickback Statute. The allegations are made as a result of their participation in a scheme to pay doctors thousands of dollars to participate in sham educational programs, in order to induce those doctors to prescribe millions of dollars' worth of a fentanyl spray. The fentanyl spray at issue was approved by the FDA around January 2012, solely for the management of breakthrough pain in cancer patients who...
Source: Policy and Medicine - June 14, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Obama Administration Acts To Stabilize Marketplaces, Implement Expatriate Coverage Legislation
On June 8, the federal departments tasked with implementing the Affordable Care Act (ACA) released a barrage of regulatory issuances, including fact sheets, guidances, a blog post, and a notice of proposed rulemaking (NPRM). These issuances serve two major purposes. First, several of them, as summarized in a press release and fact sheet released by the Centers for Medicare and Medicaid Services (CMS), are intended to stabilize the marketplace risk pool. They are, that is, intended to draw healthy as well as unhealthy enrollees into the market and to discourage potential gaming on the part of insurers or enrollees that migh...
Source: Health Affairs Blog - June 9, 2016 Category: Health Management Authors: Timothy Jost Tags: Following the ACA Insurance and Coverage Medicaid and CHIP Medicare ACA Marketplaces Essential Health Benefits expatriate coverage minimum essential coverage risk pools special enrollment periods Source Type: blogs

DOJ Announces Genentech and OSI Pharmaceuticals, LLC Settlement
The Department of Justice (DOJ) has announced that pharmaceutical companies Genentech and OSI Pharmaceuticals, LLC, will pay $67 million to resolve allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat lung cancer. This settlement resolves allegations "that between January 2006 and December 2011, Genentech OSI Pharmaceuticals made misleading representations to physicians and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show that Tarceva was effective to treat those...
Source: Policy and Medicine - June 6, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Dear Provider – Your Image Matters!
It’s been almost eight years since my mastectomy – since then I’ve dealt with an array of side issues and preventative health procedures.  As someone who helped launch one of the nation’s first case management models 25 years ago – the “ROSE” program – my sensitivities to the communication, behavior and appearance of my physicians and allied healthcare professionals have become more acute – especially through my journey with cancer. ROSE taught us that in order for patients to comply and to flourish, they needed to trust whomever they worked with – and the keys were civility and self care.  It’s...
Source: Disruptive Women in Health Care - May 24, 2016 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Cancer Women's Health Source Type: blogs

Why is the American Cancer Society Lying to Its Members About the E-Cigarette Regulations?
In an urgent action alert, the American Cancer Society (through its Cancer Action Network) is encouraging its members to write their federal legislators and demand that Congress not strip the FDA of its authority to regulate electronic cigarettes.The "suggested" letter which the ACS pre-populates for its members states: "Congress should not strip FDA of its oversight authority when electronic cigarette use by high school students has jumped to 16 percent in a very short time... ."This action alert seems to be clearly informing ACS members that Congress is considering stripping the FDA of its authority to oversee the regula...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - May 19, 2016 Category: Addiction Source Type: blogs

Will silicone ruin a coconut oil hair treatment? Episode 133
Is the “Remedy” hair treatment by Rita Hazan really magic? Lizzy asks…Does the Rita Hazan Remedy have any magic in it? My hair feels soft and shiny after I use it, but it didn’t do anything for my sister. I must say I’ve never seen a product quite like this before. It’s a two part system involves something like 60 different ingredients. (See below.) Just having a lot of ingredients doesn’t mean it’s a better product (a lot of the ingredients are just botanical extracts that are primarily there for show) but the product is packed with a LOT of different conditioning agents. Some of these are very s...
Source: thebeautybrains.com - May 17, 2016 Category: Consumer Health News Authors: Randy Schueller Tags: Conditioners and treatments Hair coloring products Makeup and Perfume Podcast Shampoo Styling Source Type: blogs

A Physician Looks on the "Bright Side" of Metastatic Breast Cancer Survival and a Patient Advocate Looks On the Other Side
According to Forbes contributor Elaine Schattner, a physician who is writing a book on public perception of cancer, there is a "bright side" to metastatic breast cancer survival rates.Dr. Schatter cites a paper by Dr. Patricia Steeg of the National Cancer Institute (NCI) that calls out an “alarming” but debatable decline in survival in other advanced cancers and a general lack of progress against metastatic disease. But Dr. Schatter focuses (here) on the "bright side" by offering as evidence these graphs of median survival (left) and 5-year relative survival (right) after an initial diagnosis of met...
Source: Pharma Marketing Blog - May 15, 2016 Category: Pharmaceuticals Tags: breast cancer metastatic breast cancer Source Type: blogs

A Physician Looks on the " Bright Side " of Metastatic Breast Cancer Survival and a Patient Advocate Looks On the Other Side
According to Forbes contributor Elaine Schattner, a physician who is writing a book on public perception of cancer, there is a & quot;bright side & quot; to metastatic breast cancer survival rates. Dr. Schatter cites a paper by Dr. Patricia Steeg of the National Cancer Institute (NCI) that calls out an “alarming” but debatable decline in survival in other advanced cancers and a general lack of progress against metastatic disease. But Dr. Schatter focuses ( here ) on the & quot;bright side & quot; by offering as evidence these graphs of median survival (left) and 5-year relative survival (right) after an initial diagno...
Source: Pharma Marketing Blog - May 15, 2016 Category: Pharmaceuticals Tags: breast cancer metastatic breast cancer Source Type: blogs

HHS Issues Health Equity Final Rule
On May 13, the Office of Civil Rights (OCR) of the Department of Health and Human Services (HHS) issued a final rule implementing section 1557 of the Affordable Care Act. The rule finalizes a proposed version issued in September of 2015, analyzed in this blog at that time. The final rule was accompanied by a press release, summary, and series of fact sheets. Section 1557 of the ACA provides that an individual shall not, on the basis of race, color, national origin, sex, age, or disability, be excluded from participation in, denied the benefits of, or subjected to discrimination under any health program or activity of whi...
Source: Health Affairs Blog - May 14, 2016 Category: Health Management Authors: Timothy Jost Tags: Equity and Disparities Featured Following the ACA Insurance and Coverage Medicaid and CHIP Medicare age discrimination disability discrimination health equity national origin discrimination racial discrimination sex discrimination Source Type: blogs

Would A Wider Variety Of Vial Sizes Reduce The Cost Of Chemotherapy? Not Likely
The high prices of many patented pharmaceuticals, especially chemotherapy drugs, pose substantial challenges to the budgets of public programs, private insurers, and patients and their families. Addressing this problem in the US context, through changes in drug negotiating rules, reimportation, price controls, or patent reform is pragmatically daunting and politically fraught. It’s natural, then, to seek ways around the problem — options that might reduce the price of drugs while sidestepping that charged territory. Vial Size In a March 1, 2016 article published in BMJ, Peter Bach and colleagues propose one such st...
Source: Health Affairs Blog - May 11, 2016 Category: Health Management Authors: Sherry Glied and Bhaven Sampat Tags: Costs and Spending Drugs and Medical Technology Featured Health Professionals Hospitals Quality Big Pharma chemotherapy vial sizes Source Type: blogs

We Need To Fill The Gap Between What We Know And Don’t Know About E-cigarettes
Cigarettes. Roll-your-own tobacco. Smokeless tobacco. Cigars. Cigarillos. Pipe tobacco. Electronic cigarettes. Gels. Water pipes. The evolution of nicotine delivery systems has raised as many new questions for public health as it has brought new products to market. But none is more controversial than e-cigarettes. The ongoing debate over the public health implications of e-cigarette use is full of passion. Some argue that e-cigarettes could be the beginning of the end of smoking in the U.S. Others claim e-cigarettes may erase the hard-won progress achieved over the last half-century in reducing nicotine and tobacco addicti...
Source: Health Affairs Blog - May 5, 2016 Category: Health Management Authors: Sudip Parikh Tags: Drugs and Medical Technology Featured Public Health Quality e-cigarettes FDA smoking cessation Tobacco Control Act Source Type: blogs

Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates
Last July, Harvard Medical School and its Cambridge Health Alliance accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility to create an endowed chair in behavioral sciences research at Harvard Medical School and the Cambridge Health Alliance. The Dean of the Harvard Medical School proudly announced the acceptance of this money and praised the Foundation for Advancing Alcohol Responsibility, while acknowledging a long-standing alliance between the two entities: "The Foundation for Advancing Alcohol Responsibility has long been a strong supporter of the research program at Cambridge Health Alliance, p...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - May 4, 2016 Category: Addiction Source Type: blogs

Anheuser Busch "Smart Drinking" Initiative is a Complete Farce
Last December, Anheuser-Busch InBev (AB InBev) announced its commitment of more than $1 billion over ten years to promote "Smart Drinking," whose major purported purpose is to "reduce the harmful use of alcohol" by reducing "binge drinking, underage drinking and drink-driving." The company claims that this represents "Doing Right, While Doing Well." A major goal is to reduce the "harmful use of alcohol" by at least 10% in six cities within 10 years.The Rest of the StoryThe truth is that this initiative is essential a huge scam designed to promote alcohol use, to divert attention away from the alcohol industry's culpability...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - May 3, 2016 Category: Addiction Source Type: blogs

Unlucky Charms
Are there any HEALTHY breakfast cereals? Simple answer: No. Let’s consider the most common ingredients in breakfast cereals: wheat flour, corn, high-fructose corn syrup, sugar. In effect, they therefore contain sugar, sugar, sugar, and sugar. That ain’t good. It explains why the glycemic index of breakfast cereals are all exceptionally high, usually 70 and above. (Sucrose is 59-65, depending on which study you look at.) How about those coarser cereals with whole grains like oats, millet, buckwheat, etc., such as muesli? Same issues. Followers of the Wheat Belly conversation understand that whole grains are wro...
Source: Wheat Belly Blog - April 27, 2016 Category: Cardiology Authors: Dr. Davis Tags: Wheat Belly Lifestyle cereal gluten grains Source Type: blogs