Saving billions of dollars in health care: The story of Avastin and Lucentis
I sometimes worry that my wife Paula won’t be able to see me grow old. Not that I expect to outlive her. She is four years my junior and has the blood pressure of a 17-year-old track star. It’s her eyesight I’m worried about, because she is at risk for a form of blindness called macular degeneration. Paula is the youngest in a long line of redheads, several of whom have been diagnosed with this illness. Her fair-haired grandmother developed macular degeneration and was eventually unable to see her bridge hand and had to give up her golf game, just when she was threatening to score below her age. Fortunately, Paula sh...
Source: Kevin, M.D. - Medical Weblog - July 17, 2016 Category: Journals (General) Authors: Tags: Meds Medications Source Type: blogs

Abort, Retry, Fail - Billionaire Bill Gates Opines, Sans Evidence, on ... the Efficacy of Hepatitis C Treatment?
Conclusions So maybe Bill Gates' seemingly ill-informed apologia for the extremely high drug prices charged in the US, and his lack of understanding of the evidence about the efficacy, or lack thereof, of some of these high priced drugs is a small humorous story that indicates just the tip of the iceberg.  It appears that in our current market fundamentalist, neoliberal world, foundations may be more about promoting the commercial interests of their board members and officers than about improving the lot of humanity.  Yet for the most part they may succeed in obfuscating what they are doing through the haze of ma...
Source: Health Care Renewal - July 14, 2016 Category: Health Management Tags: conflicts of interest Gates Foundation Genentech Gilead global health health care foundations hepatitis C Sovaldi Source Type: blogs

Proposed Drug and Device Laws Should Be Pushed to 2017
By PAUL BROWN, TRACY RUPP, and STEVEN FINDLAY Senate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay.  Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress. We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar.   That way, lawmakers can debate the implications of the propos...
Source: The Health Care Blog - July 14, 2016 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized 21st Century Cures Act Consumer's Union FDA User Fees Medical Devices Steven Findlay Source Type: blogs

Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush
The full Senate may in the next few days consider companion legislation to the 21st Century Cures Act that passed the House last year. The legislation—currently 19 separate bills—makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices. Set to adjourn for an extended election-year summer recess on July 15, the clock is ticking. The congressional calendar in the fall is full and the Senate may simply not have the time to take up the complex legislation, and reconcile it with the House version, before the November elections. We believe that’s a good thing. The legi...
Source: Health Affairs Blog - July 11, 2016 Category: Health Management Authors: Paul Brown, Tracy Rupp and Steven Findlay Tags: Drugs and Medical Technology Featured Public Health Quality 21st Century Cures Act Congress FDA NIH regulation Source Type: blogs

Four Ways To Address The Ethical Tensions Around Expedited Approval Of New Prescription Drugs
The Food and Drug Administration (FDA) requires a new drug’s manufacturer to present affirmative evidence of its efficacy and safety before it can be marketed. Because testing new drugs requires a delay between identification of an important, novel prescription drug and FDA approval, some patients with serious or life-threatening illnesses and no satisfactory options will not live to see a potentially life-saving medication approved for public use. To address this concern, the FDA and Congress have established several programs—with the support of pharmaceutical manufacturers and some patient advocacy groups—t...
Source: Health Affairs Blog - June 23, 2016 Category: Health Management Authors: Aaron Kesselheim, Spencer Phillips Hey, Dalia Deak and Bernard Lo Tags: Drugs and Medical Technology Featured Population Health Public Health Quality Bioethics breakthrough drugs Drug approval FDA priority review Risk Evaluation and Mitigation Strategies Source Type: blogs

A Controversial New Demonstration In Medicare: Potential Implications For Physician-Administered Drugs
According to an August 2015 survey, 72 percent of Americans find drug costs unreasonable, with 83 percent believing that the federal government should be able to negotiate prices for Medicare. Recently, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS) Andy Slavitt commented that spending on medicines increased 13 percent in 2014 while health care spending growth overall was only 5 percent, the highest rate of drug spending growth since 2001. Some of the most expensive drugs are covered under Medicare’s medical benefit, Part B, because they are administered by a physician. They are often admini...
Source: Health Affairs Blog - May 3, 2016 Category: Health Management Authors: Kavita Patel and Caitlin Brandt Tags: Costs and Spending Featured Medicare Payment Policy Quality Avastin CMMI Lucentis Medicare Part B oncology care model prescription drug coverage Source Type: blogs

We want access to safe and effective Avastin. Here’s a solution.
Recently, two states in India halted all use of Avastin for the treatment of eye disease following the report of 15 patients who underwent emergency surgery for potentially blinding infections at the C.H. Nagri Municipal Eye Hospital in Ahmedabad.  Though further investigations are ongoing, there is worry that the cluster of infections centered around a tainted lot of compounded Avastin. This most recent event serves as a reminder of the risk that we take every time we inject Avastin into our patients eye. Recent cluster infections have led to greater oversight:  A good thing. In the U.S., great measures have been taken...
Source: Kevin, M.D. - Medical Weblog - February 15, 2016 Category: Journals (General) Authors: Tags: Conditions Medications Surgery Source Type: blogs

Bio-Tech U, Version 2 - Current Board Member of Four Biotechnology Companies, Fomer Pfizer Director, Former Genentech Executive to be President of Stanford
DiscussionTo summarize, the incoming president of Stanford, on of the most prestigious American universities, one of the foremost US sites for biomedical research, and home to an equally prestigious medical school and academic health center, spent most of the last 15 years heavily involved with the pharmaceutical and biotechnology industries.  He was a top Genentech executive for eight of those years, served as a director of the then biggest US pharmaceutical company, and currently is a member of the boards of directors of four biotechnology companies, and is chairman of one of them.  He earned nearly $2.5 millio...
Source: Health Care Renewal - February 11, 2016 Category: Health Management Tags: boards of directors conflicts of interest Genentech Stanford Source Type: blogs

European Medicines Agency: Framework for Interaction with Industry
The European Medicines Agency's (EMA) Management Board has adopted a new framework to govern interaction between the Agency and industry stakeholders. The framework covers interactions involving human and veterinary medicine, however there are still unanswered questions about specific products and procedures that will be resolved by internal EMA departments. The adopted framework seeks to facilitate and streamline communication, structure interactions, increase accountability and transparency, and includes a plan to monitor and report on interactions. According to the EMA's minutes, comments by the European Commission on...
Source: Policy and Medicine - February 2, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Was Martin Shkreli Arrested For Hiking Drug Prices?
By SAURABH JHA, MD I don’t subscribe to conspiracy theories. I never believed a second shot was fired. Nor do I believe that Bill Clinton was stalked on the grassy knoll. So I won’t speculate that Martin Shkreli’s arrest for alleged securities fraud that happened years ago is related to his raising Daraprim’s price by 5500 %. Just because something isn’t suspicious doesn’t mean that it isn’t odd. Shkreli is a perfect poster child for rapacious pharmacocapitalism – so perfect that it’s odd. He openly admits “I have a sworn duty to my shareholders to maximize profit.” Shkreli’s admission is odd not f...
Source: The Health Care Blog - December 22, 2015 Category: Consumer Health News Authors: Simon Nath Tags: THCB Saurabh Jha Source Type: blogs

Martin Shkreli and Pharmacocapitalism’s Inconvenient Truth
By SAURABH JHA, MD I don’t subscribe to conspiracy theories. I never believed a second shot was fired. Nor do I believe that Bill Clinton was stalked on the grassy knoll. So I won’t speculate that Martin Shkreli’s arrest for alleged securities fraud that happened years ago is related to his raising Daraprim’s price by 5500 %. Just because something isn’t suspicious doesn’t mean that it isn’t odd. Shkreli is a perfect poster child for rapacious pharmacocapitalism – so perfect that it’s odd. He openly admits “I have a sworn duty to my shareholders to maximize profit.” Shkreli’s admission is odd not f...
Source: The Health Care Blog - December 22, 2015 Category: Consumer Health News Authors: Simon Nath Tags: THCB Saurabh Jha Source Type: blogs

Marcia Angell writes
By Marcia AngellIn 1953, a new drug was released by Burroughs Wellcome, a pharmaceutical company based in London. Pyrimethamine, as the compound was named, was originally intended to fight malaria after the microorganisms that cause the disease developed resistance to earlier therapies. The drug was used against malaria for several decades, often in combination with other compounds. It ’s mostly used now to treat toxoplasmosis, a parasitic infection that can be life-threatening in people whose immune systems are suppressed, for example, by HIV/​AIDS or cancer.More than 40 years later, Burroughs Wellcome merged with the...
Source: PharmaGossip - October 4, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs

Marcia Angell writes
By Marcia AngellIn 1953, a new drug was released by Burroughs Wellcome, a pharmaceutical company based in London. Pyrimethamine, as the compound was named, was originally intended to fight malaria after the microorganisms that cause the disease developed resistance to earlier therapies. The drug was used against malaria for several decades, often in combination with other compounds. It’s mostly used now to treat toxoplasmosis, a parasitic infection that can be life-threatening in people whose immune systems are suppressed, for example, by HIV/​AIDS or cancer.More than 40 years later, Burroughs Wellcome merged with the ...
Source: PharmaGossip - October 3, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs

The 21st Century Cures Act: More Homework To Do
In July, the US House of Representatives approved the 21st Century Cures Act, which heads to the Senate for a vote this fall. While no one can complain about the Act’s purported goal of “bring[ing] our health care innovation infrastructure into the 21st Century,” or increasing funding for the National Institutes of Health, the optimism surrounding the legislation obscures measures buried within that many agree will make newly approved drugs and medical devices less safe and effective, increase the cost of medical products, and discourage innovation in biomedical research. Long-term value to the public’s health is b...
Source: Health Affairs Blog - September 24, 2015 Category: Health Management Authors: Susan Molchan, James Rickert and John Powers Tags: Costs and Spending Drugs and Medical Technology Featured Health Professionals Hospitals Public Health Quality 21st Century Cures Act Big Pharma Drug approval Fred Upton Research funding Thurgood Marshall Source Type: blogs

Are Medicare Prescription Benefits Too Stingy?
The bill she received in the mail revealed a staggering figure — $9,225 for one infusion of Avastin, a chemotherapy drug. And she would need many more such infusions. Fortunately, the dollar amount is what medical experts call a “charge,” … Continue reading → The post Are Medicare Prescription Benefits Too Stingy? appeared first on PeterUbel.com. (Source: blog.bioethics.net)
Source: blog.bioethics.net - September 23, 2015 Category: Medical Ethics Authors: Peter Ubel Tags: Health Care healthcare costs Medicare Peter Ubel syndicated Uncategorized Source Type: blogs