EFPIA Files Complaint Against French Law Promoting Off-Label Avastin Use
Earlier this week, EFPIA, Europe's pharmaceutical industry association, announced it had filed a complaint with the European Commission against the French “RTU Regime.” promoting the use of Roche's cancer drug Avastin for the off-label treatment of wet age-related macular degeneration (AMD). The decree allows the French medicines regulator (ANSM) to issue a temporary authorization for use of a product in an unauthorized indication, purely for economic purposes, notwithstanding the existence of an authorized alternative treatment. This development is troubling and contravenes European Community law and jurisprudence, wr...
Source: Policy and Medicine - September 3, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Inside the Open Payments Data: Two-Thirds of Transactions Worth $20 or Less; Research and Royalties Account for Majority of Total Value
Yesterday, the Centers for Medicare and Medicaid Services published the second year of Open Payments data, detailing the transfers of value made from pharmaceutical and device manufacturers to physicians and teaching hospitals in 2014. The top line total has received most of the headlines—“docs get $6.5 billion from drug and device companies.” Here, with data courtesy of Open Payments Analytics, we break down some of those payments in detail, with more to follow in subsequent articles.
Small Payments Fill the General Database:
Overall, there were 11.41 million records published, covering 607,000 physicians and ...
Source: Policy and Medicine - July 2, 2015 Category: American Health Authors: Thomas Sullivan 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
Top stories in health and medicine, March 31, 2015
From MedPage Today:
Nephrologists Iffy About Dialysis in Expectant Moms. A third of nephrologists reported being somewhat to very uncomfortable caring for a pregnant patient on hemodialysis despite a growing number having to do so.
What Makes an Opioid Stronger or Weaker Than Morphine? A February 2015 report from the Centers for Disease Control and Prevention provided updated estimates of prescription opioid analgesic use among adults ages 20 and over.
Mixed Results for Avastin Plus Chemo in Ovarian Cancer. Women with recurrent, platinum-sensitive ovarian cancer obtained an unprecedented survival benefit with a chemother...
Source: Kevin, M.D. - Medical Weblog - March 31, 2015 Category: Journals (General) Authors: MedPage Today Tags: News Cancer Nephrology Source Type: blogs
How Open Data Can Reveal—And Correct—The Faults In Our Health System
We examined sites of service for non-complex office visits across gastroenterology, cardiology, and oncology — three specialties that tend to deliver care across a range of sites. Medicare reimbursement is higher for hospital visits as compared to those in a physician office. Overall, we found that most doctors bill regular, level 3 evaluation and management visits in non-hospital settings. Oncologists have the highest percentage billed in hospital-type facilities — 15 percent of non-complex office visits. In this case, we were limited in our analysis because the dataset does not include the additional amount t...
Source: Health Affairs Blog - February 18, 2015 Category: Health Management Authors: Kavita Patel, Domitilla Masi, and Caitlin Brandt Tags: All Categories Big Data Health Care Costs Medicaid Medicare Payment Policy Research Spending Source Type: blogs
Top stories in health and medicine, January 16, 2015
From MedPage Today:
Current Flu Vaccine Half as Effective as Previous Years. People receiving this year’s seasonal influenza vaccine are 23% less likely to seek medical treatment for flu-type symptoms relative to unvaccinated individuals, according to an interim CDC estimate based on reports submitted so far for the current season.
New Board Offers New Recert Route. The American Board of Medical Specialties (ABMS) has competition for the board recertification process: the newly established National Board of Physicians and Surgeons (NBPAS).
Post TIA Microbleed Signals Recurrent Risk. The presence of cerebral microbl...
Source: Kevin, M.D. - Medical Weblog - January 16, 2015 Category: Journals (General) Authors: MedPage Today Tags: News Cancer Infectious disease Neurology Source Type: blogs
Top stories in health and medicine, November 17, 2014
From MedPage Today:
Ebola: Signs of Progress, CDC says. The response to the Ebola outbreak in Liberia is showing encouraging signs of progress, with downward trends in new cases especially in two regions of the country that had been hot spots.
Millions Of Medicaid Kids Missing Regular Checkups. Millions of low-income children are failing to get the free preventive exams and screenings guaranteed by Medicaid, and the Obama administration is not doing enough to fix the problem.
Some Pregnancy Risks for Young Kidney Donors. Young women who donate a kidney may be at higher risk of gestational hypertension and preeclampsia wh...
Source: Kevin, M.D. - Medical Weblog - November 17, 2014 Category: Journals (General) Authors: MedPage Today Tags: News Cancer Infectious disease Nephrology Source Type: blogs
The Darker Days of Fall
Autumn is usually my favorite season. It's the time of year when the chill that I so love comes back into the air, when everything feels crisp, and rich colors dress the trees. I am one of those people who's into pumpkin spice lattes and chai, fresh seasonal apples and of course, cider. Halloween is usually a treat for me because I adore dressing up in costumes. But you may notice I've been absent from blogging about how it's okay to eat candy at Halloween with diabetes. You haven't yet seen any silly posts wherein I dress up my insulin vials. Actually, you haven't seen any posts from me at all since mid-September.I'm...
Source: Dorkabetic - October 27, 2014 Category: Endocrinology Authors: Hannah McDonald Source Type: blogs
EFPIA Disapproves of French Off-Label Initiative
On July 8, 2014, the French National Assembly voted a draft law proposal that would potentially allow healthcare professionals to prescribe off-label drugs, even if there is an approved drug available for treatment. The draft law specifically references Avastin, a Roche cancer drug, as an alternative eye treatment for wet age-related macular degeneration, an indication for which the drug is not approved and for which two authorized alternatives exist.
EFPIA, the European Federation of Pharmaceutical Industries and Associations, harshly criticized the proposal. Richard Bergström, EFPIA Director General, said: "A worrying ...
Source: Policy and Medicine - July 17, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)
The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2)Two Somewhat Redundant Lancet Articles Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1)After returning from Uganda, Desmond-Hellmann joined the nascent Taxol development programme at Bristol-Myers Squibb, before being poached by Arthur Levin...
Source: Health Care Renewal - May 5, 2014 Category: Health Management Tags: anechoic effect boards of directors conflicts of interest Gates Foundation Genentech health care foundations health care prices Lancet medical journals Procter and Gamble UCSF Source Type: blogs
Novartis and Roche fined over 180 mn euros by anti-trust
Italy's Antitrust authority said Wednesday that it had fined Swiss pharmaceutical companies Novartis and Roche a total of over 180 million euros for alleged collusion to manipulate the market in Italy."The two companies made an illegal agreement to hamper the spread of the use of a very cheap pharmaceutical, (Roche's) Avastin, in the treatment of the most widespread eye pathology among the elderly and other serious eye diseases, to favour a much more expensive product, (Novartis's) Lucentis, artificially differentiating the two products," read an Antitrust statement. It added that this had cost the Italian national health ...
Source: PharmaGossip - March 5, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Top stories in health and medicine, December 17, 2013
From MedPage Today:
Breast Cancer: Adding Avastin Boosts Toxicity. Beleaguered bevacizumab (Avastin) has failed another test in breast cancer.
FDA Wants Proof of Anti-Bacterial Soap Claims. Manufacturers of nonprescription anti-bacterial hand soaps and body washes will soon be required to show their products are safe for long-term daily use and are more effective than plain soap in stopping the spread of infections.
AACE Rejects Heart Groups’ Guidelines. The American Association of Clinical Endocrinologists said it doesn’t endorse the latest lipid and obesity guidelines from the American Heart Association and...
Source: Kevin, M.D. - Medical Weblog - December 17, 2013 Category: Family Physicians Tags: News Cancer Heart Infectious disease Source Type: blogs
Literally gouging
In conclusion, we found no evidence of increased risks of mortality, myocardial infarction, bleeding, or stroke,” their research paper said.The other danger to using Avastin, however, has attracted a lot of publicity in recent years.The fact that the drug needs to be repackaged into smaller doses introduces an element of risk because it opens the possibility that the drug could be tainted during the repackaging process. (Genentech says because the FDA has not approved it for use in the eye, the company cannot legally distribute Avastin in doses appropriate for the eye.Indeed, in three cases that made the news — in Sout...
Source: PharmaGossip - December 16, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit
The Food and Drug Administration (FDA) sent a WARNING letter to the CEO of 23andMe because the company is illegally marketing its 23andMe Saliva Collection Kit and Personal Genome Service (PGS). "This product," says FDA, "is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." Recall that Genentech teemed up with 23andMe -- a personal genetics firm -- to collect spi...
Source: Pharma Marketing Blog - November 25, 2013 Category: Pharma Commentators Tags: 23andMe Avastin Genentech warning letter Source Type: blogs
Orphan Drugs - The Seattle Times explains
The mining of rare diseasesThirty years ago, Congress acted to spur research on rare diseases. Today, we have hundreds of new drugs — along with runaway pricing and market manipulation, as drugmakers turn a law with good intentions into a profit engine.By Michael J. Berens and Ken ArmstrongHer vision failed first.Then she fell asleep at school from inexplicable fatigue. Even walking proved difficult, often impossible, as she knocked into furniture and walls. It was like an electrical switch in her body toggled without warning. Some days she was in control, most she was not.Specialists were s...
Source: PharmaGossip - November 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
