FDA Approves Sixth United States Biosimilar
Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira and sixth biosimilar in the United States. “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo h...
Source: Policy and Medicine - November 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff 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
DaVita Settles Another Lawsuit Amidst Accusations of "Managing Witnesses to Provide False Testimony," After Justice Department Lost Interest in Participating
The Latest Case Less than a year since its last big settlement (look here), DaVita HealthCare Partners, the big for-profit dialysis provider, has to settle again. The basics, according to the Denver Post, were:DaVita HealthCare Partners said Monday it will pay up to $495 million to settle a whistle-blower lawsuit accusing the Denver company of defrauding the federal Medicare program of millions of dollars. The company, which said it does not admit any wrongdoing, has now settled its third whistle-blower lawsuit since 2012, with payouts totaling nearly $1 billion.The civil suit, filed in Atlanta in 2011, ...
Source: Health Care Renewal - May 8, 2015 Category: Health Management Tags: DaVita fraud impunity legal settlements 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
A "Bag of Money," but Executive Says Don't "Give Me Any of that Ethics Cr*p" - DaVita's Latest Settlement for $400 Million
A striking story of a large recent legal settlement, with reminders of previous related settlements, quietly slipped out in the midst of the ruckus about the Ebola virus.A $400 Million Settlement The basics were in a news release by the US Department of Justice.DaVita Healthcare Partners, Inc., one of the leading providers of dialysis services in the United States, has agreed to pay $350 million to resolve claims that it violated the False Claims Act by paying kickbacks to induce the referral of patients to its dialysis clinics,...This amount was augmented by a Civil Forfeiture in the amount of $39 million based u...
Source: Health Care Renewal - October 28, 2014 Category: Health Management Tags: corporate integrity agreements crime DaVita deception dialysis providers fraud health care corruption kickbacks legal settlements restraint of competition Source Type: blogs
Corporate Welfare Comes in Different Flavors
Tad DeHaven
An issue with my paper on corporate welfare in the federal budget is that cases can be made for other expenditures not on the list. A prime example would be Pentagon weapons procurement. I’ll simply say that deciding what counts and what doesn’t is complicated.
The New York Times has another example of what could be considered a form of corporate welfare: excessive federal reimbursement rates for anti-anemia drugs used by dialysis centers. This snippet provides the background:
The multibillion-dollar dialysis industry has been accused by medical researchers and former employees of putting...
Source: Cato-at-liberty - August 29, 2013 Category: Health Medicine and Bioethics Commentators Authors: Tad DeHaven Source Type: blogs
Evidence Based Medicine - Why we can’t trust clinical guidelines (BMJ)
This article has a correction
Please see: Why we can’t trust clinical guidelines
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Jeanne Lenzer, medical investigative journalist
Author Affiliations
jeanne.lenzer@gmail.com
Despite repeated calls to prohibit or limit conflicts of interests among authors and sponsors of clinical guidelines, the problem persists. Jeanne Lenzer investigates
On 13 April 1990, in an unprecedented action, the US National Institutes of Health faxed a letter to every physician in the US on how to correctly prescribe a breakthrough treatment for ...
Source: PharmaGossip - June 23, 2013 Category: Pharma Commentators Authors: insider 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
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
U.S. Supreme Court Rejects Amgen Challenge to Securities Suit | Fox Business
via foxbusiness.com The suit, brought by Connecticut pension funds on behalf of purchasers of Amgen stock, alleged the Thousand Oaks, Calif., company repeatedly reassured investors about the safety of anti-anemia drugs Aranesp and Epogen even as clinical trial data raised concerns that the drugs could harm cancer patients who were taking them. Amgen's statements led to inflated share prices, the suit alleged. Read more: http://www.foxbusiness.com/news/2013/02/27/us-supreme-court-rejects-amgen-cha... Posted via email from Jack's posterous (Source: PharmaGossip)
Source: PharmaGossip - February 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
A Mystery About Affymax & Its Anemia Drug Recall
Late yesterday, the FDA disclosed that Affymax and its marketing partner, Takeda Pharmaceuticals, issued a so-called voluntary recall of their Omontys medication, which is used to treat anemia in adult dialysis patients, after there were 19 reports of anaphylaxis, a serious and life-threatening allergic, at dialysis centers in the US. Three of the cases ended in death and several other patients required hospitalization (here is the FDA statement).
Not surprisingly, the recall is killing Affymax (AFFY) stock, since the drugmaker was hoping to penetrate a huge market dominated by billion-dollar-sellers such as Epogen and Ara...
Source: Pharmalot - February 25, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Affymax Amgen Anemia Aranesp Biosimilars Epogen FDA JJ Johnson & Johnson Omontys Procrit Takeda Pharmaceuticals Source Type: blogs
Drug Costs In Hospitals & Clinics To Rise 4 Percent
The cost of medications administered by clinics and hospitals are expected to rise by as much as 4 percent this year, which is less than in previous years, thanks to the increasing availabitily of lower-cost generics, according to a study in the American Journal of Health-System Pharmacy.
Specifically, medication expenditures are projected to rise between 1 percent and 3 percent across all clinics and hospitals not run by the federal government. But medication costs are forecast to increase between 2 percent and 4 percent in clinics, while there will be a 1.5 percent gain ih hosptials.
“In the aggregate, drug expenditur...
Source: Pharmalot - February 19, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Affordable Care Act Contraceptives Epogen Lovenox Procrit Prolia Remiicade Rituxan Xgeva Source Type: blogs
Amgen Settlement and Corporate Integrity Agreement
Adding to the long list of pharmaceutical settlements involving off-label promotion, Amgen Inc., the world’s largest biotechnology company, recently entered into a settlement agreement with the U.S. Department of Justice to resolve criminal liability and false claim act allegations involving its improper promotion of certain drugs. Amgen, a biotechnology company, agreed to pay $762 million—the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history, according to the announcement.
Amgen entered a guilty plea before U.S. District Judge Sterling Johnson of the...
Source: Policy and Medicine - February 19, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
How the "Revolving Door" and Other Aspects of Corporatism Benefited Amgen Just After its Settlement and Guilty Plea
At least here in these United States, our health care corporatism is bipartisan. Here we present a sorry story of how a company that should have been shamed by dishonest behavior that likely harmed patients instead apparently was awarded special treatment through its cozy relationships with top government leaders Accusations of Kickbacks and Deceptive Marketing of Aranesp Last month, biotechnology giant pleaded guilty to a charge of misbranding and settled civil charges with the US government for $762 million (look here). Soon after, New York Times article described the unethical practices the comp...
Source: Health Care Renewal - January 23, 2013 Category: Health Medicine and Bioethics Commentators Tags: Amgen deception kickbacks stealth health policy advocacy crime revolving doors corporatism adverse effects Source Type: blogs
