Anemia in cardiac failure : Needs little more attention
HF is the inability (or reduced ability) to supply oxygen and other nutrients to fulfill the body’s demands. In the process, the heart either fights or flights, and results in symptoms due to hemodynamic alterations, or adversities of neuro-hormonal activation.
Now, what is Anemia? Anemia is a condition with reduced or dysfunctional RBCs. that directly interferes with oxygen delivery to tissues. It is not at all a coincidence, the core functions of the heart and blood are strikingly similar and intertwined. While the heart is the powerhouse of the circulatory system, without good-quality blood, the greatness of th...
Source: Dr.S.Venkatesan MD - November 19, 2022 Category: Cardiology Authors: dr s venkatesan Tags: Uncategorized anemia in cardiac failure Source Type: blogs
Northwestern Upholds its "Brand," Never Mind Free Speech and Academic Freedom
Threats to free speech and academic freedom in health care were a major concern when we started Health Care Renewal. Such threats may now be less anechoic, but do not seem to have diminished.Censorship and the Resignation of Alice Dreger The latest example was at Northwestern University. The basics of the case appeared in the Chronicle of Higher Education. Alice Dreger just resigned her position of 10 years as "a clinical professor of medical humanities and bioethics."What prompted her departure was the fallout over an article by William Peace, who at the time was a visiting professor in the humanities at Syracuse...
Source: Health Care Renewal - September 2, 2015 Category: Health Management Tags: academic freedom anechoic effect bioethics censorship free speech mission-hostile management Northwestern University Source Type: blogs
The Real Dark Side of Health Care: Health Care Corruption
The editors of the prestigious Annals of Internal Medicine just stated they they were shocked, shocked to find out that physicians occasionally express disrespect for patients when the patients cannot hear or see them. The occasion was an editorial signed by three editors whose title included the phrase, "shining a light on the dark side of health care."(1) The editorial referred to an anonymous narrative that recounted two incidents from the past.(2)Two Alleged Incidents of Physicians' Expression of Disrespect for Patients The first incident, discussed second hand, was of a obstetrician who made a sexist comme...
Source: Health Care Renewal - August 25, 2015 Category: Health Management Tags: anechoic effect Annals of Internal Medicine health care corruption medical journals professionalism 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
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
New Guideline Recommends Conservative Treatment for Heart Patients with Anemia
The American College of Physicians (ACP) is recommending more conservative use of transfusions and erythropoiesis-stimulating agents (ESAs) in anemia patients with heart disease. But the authors of the new clinical practice guidelines, published in the Annals of Internal Medicine, acknowledge that the evidence base is too flimsy to support firm conclusions. “Overall,” wrote the authors, “despite the epidemiologic and biologically plausible association of anemia with poor outcomes, we did not find consistent evidence that anemia correction improves outcomes in patients with heart disease…” ...
Source: CardioBrief - December 2, 2013 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes American College of Physicians Amgen anemia Annals of Internal Medicine bloodtransfusion Cardiovascular disease Darbepoetin alfa Source Type: blogs
You Call That Efficacy? FDA Warns Amgen For Aranesp Promotion
For the past dozen years, Amgen has been marketing Aranesp to treat anemia caused by chronic kidney disease. So by now, one might expect the biotech to know how to successfully compile promotional material that is distributed to physicians. But apparently not, at least according to the FDA, which last week sent a letter chastising Amgen for committing some basic mistakes.
What went wrong? The Amgen mailer omitted important risk information, suggested that Aranesp is useful in a broader range of conditions or patients than has been demonstrated by evidence and made unsubstantiated efficacy claims, according to the November ...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Why Do People Think US Health Care is Corrupt? - The Examples of Amgen, Mallinckrodt Settling Charges of Giving Kickbacks to Doctors to Induce them to Prescribe Their Products, While No Individual Suffers Negative Consequences
We recently posted a discussion of the results of Transparency International's 2013 corruption barometer, focusing on the US results. 43% of survey respondents thought US health care is corrupt. Our coverage, apparently the only substantial discussion of the US results published in the US, got star ranking for a while on Reddit. But many anonymous commentators dismissed the survey results as coming from a naive public who does not understand health care economics.I submit that one can recognize corruption without a degree in economics. In fact, as we discussed in the initial post, there is a lot of ...
Source: Health Care Renewal - July 25, 2013 Category: Health Medicine and Bioethics Commentators Tags: Amgen deception kickbacks health care corruption Covidien legal settlements Mallinckrodt Source Type: blogs
Summary of Recent Settlements Novartis, Amgen and Boehringer Ingelheim
Discussion
In light of these cases, and in particular, the Novartis kickback case, Jose Sierra, a white collar lawyer who writes for the blog pharmarisc, proposed several factors for companies to consider.
Companies must ensure close monitoring of speaker programs to ensure compliance with internal policies and CIA requirements
For "front-end" controls, he recommends that companies should adopt a system in which no speaker program is scheduled without 6-10 "RSVPs" from invited doctors. "You need this many RSVPs because half the doctors never show up and 3-5 attendees are needed to pass the laugh test....
Source: Policy and Medicine - July 19, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
FDA Expanding Role of Office of Criminal Investigations
Over the last year or two, the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) has grown to play a crucial role in protecting the public health from fraudulent or counterfeit drugs, devices, cosmetics and other FDA regulated products. Increasingly, OCI has also played a large role in several recent high-profile settlements involving off-label marketing or deceptive promotional practices.
Several recent posts on the FDAVoice blog, written by OCI's director, John Roth, explain the work OCI has done in the past and what the future holds.
OCI consists of numerous federal agents, who have t...
Source: Policy and Medicine - June 20, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Summer Reading contd. Blood Medicine by Kathleen Sharp
http://www.bloodmedicine.info/The StoryAbout Blood Medicine:Blood Medicine is Kathleen Sharp’s superbly reported, breathtakingly true story of Big Pharma’s power, the terrifying vulnerability of innocent patients, and what it takes to stand up for what is right.The Drug: Called a “wonder drug,” this early biotech invention is a blood booster that spawned three lucrative brands: Procrit, Epogen and Aranesp. No one claimed the drugs would cure a disease. But they did give sick people more energy and stamina. Yet, marketeers quickly expanded that into unproven claims of more zest, sex, and “happi...
Source: PharmaGossip - June 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Amgen CEOs Prosper Despite (or Because of) Continuing Ethical Questions
This is becoming a familiar narrative on Health Care Renewal: top health care leaders continue to enrich themselves while their organizations' behavior continues to raise ethical questions.For our latest example we return to the ongoing adventures of biotechnology giant Amgen.CEOs Get Richer An AP story (via the LA Times) documented the continuing enrichment of its current CEO:Amgen Inc's new chief executive, Robert A. Bradway, received total compensation of $13.6 million in 2012, more than his predecessor, according to an analysis of a company regulatory filing.Bradway, who was promoted from chief operating officer to ...
Source: Health Care Renewal - May 2, 2013 Category: Health Medicine and Bioethics Commentators Tags: Amgen executive compensation kickbacks legal settlements adverse effects Source Type: blogs
Amgen settles kickback allegations for $24.9M
Biotechnology company Amgen Inc. has agreed to pay $24.9 million to resolve charges under the False Claims Act that it was involved in a kickback scheme with long-term care pharmacy providers, the U.S. Department of Justice said.
The settlement with Thousand Oaks, Calif.-based Amgen, announced Tuesday, settles charges it paid kickbacks to Cincinnati-based Omnicare Inc., and PharMerica Corp. and Kindred Healthcare Inc., both based in Louisville, Ky., in return for implementing “therapeutic interchange” programs designed to switch Medicare and Medicaid beneficiaries from a competitor drug to its own product, the Justice...
Source: PharmaGossip - April 18, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Another Negative Trial With Darbepoetin Alfa
Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine. A total of 2278 patients with systolic heart failure and mild-to-moderate anemia were randomized to darbepoetin alfa (Aranesp, Amgen) or placebo. As expected, treatment with darbepoetin alfa significantly improved hemoglobin levels. However, no significant improvements in outcomes were associated ...
Source: CardioBrief - March 10, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Prevention, Epidemiology & Outcomes anemia Darbepoetin alfa new england journal of medicine Source Type: blogs
Securities Fraud Suit Against Amgen Can Proceed
The US Supreme Court handed Amgen a setback by ruling that shareholders can proceed with a lawsuit accusing the biotech of providing misinformation between 2004 and 2007 about its best-selling Aranesp and Epogen anemia treatments in order to boost its stock price. A federal appeals court last fall also sided with a Connecticut pension fund that is pressing a class-action complaint.
As we wrote previously, the 9th US Circuit Court of Appeals last year upheld a lower court ruling that an ‘element of reliance’ was common to all investors and ‘fraud on the market’ had been committed. The court ruled that, to win class ...
Source: Pharmalot - February 27, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen Aranesp Class-Action Lawsuit Epogen Securities Fraud US Supreme Court Source Type: blogs
