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Xarelto Coverage
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U.S. Senate Nears Final Vote on Califf’s FDA Nomination
Feb 23, 2016 | Drug Discovery and Development
By Stephanie Guzowski
Dr. Robert Califf, President Obama’s nominee to head the U.S. Food and Drug Administration, faced a procedural vote Monday afternoon, in which Califf won the support of Senate, in a vote of 80 to 6. He will now move on to a final confirmation vote, and his Senate opponents will lose leverage to block his nomination. -
Morning Read: Valeant loses $6 billion in value, the digital health drumbeat hits Harvard
| MedCity News
By Chris Seper
The FDA turns its attention to a faulty blood-testing device that effected the clinical data around Xarelto. – The New York Times -
New FDA Chief Nears Confirmation With Crucial Senate Vote
Feb 22, 2016 | Bloomberg
By Anna Edney
The U.S. Senate agreed to end debate on President Barack Obama’s nominee to lead the Food and Drug Administration, setting the stage for confirmation as early as Tuesday of former Duke University researcher Robert Califf as the agency’s commissioner. -
Questions about the reliability of ROCKET-AF anticoagulation data
Feb 23, 2016 | BMJ :Letter to the Editor
By Constantinos Christopoulos
Like Cohen, I also worry about the quality of evidence of the ROCKET-AF trial that led to regulatory approval of rivaroxaban for stroke prevention in non-valvular atrial fibrillation.1 -
Safety status of rivaroxaban remains unchanged — EMA
Feb 23, 2016 | Irish Medical Times
The European Medicines Agency (EMA) has said that the use of a defective device in a pivotal clinical trial of the oral anticoagulant rivaroxaban (Xarelto) does not change its overall safety status or risk-benefit.
New York Times Follow-on Coverage
Other Traditional Coverage
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U.S. Senate Nears Final Vote on Califf’s FDA Nomination
Feb 23, 2016 | Drug Discovery and Development
By Stephanie Guzowski
Dr. Robert Califf, President Obama’s nominee to head the U.S. Food and Drug Administration, faced a procedural vote Monday afternoon, in which Califf won the support of Senate, in a vote of 80 to 6. He will now move on to a final confirmation vote, and his Senate opponents will lose leverage to block his nomination.
At least 60 votes were needed to move forward. According to Senate rules, senators can continue to debate Califf’s nomination for up to 30 hours before a final vote.
Several senators — including Sen. Bernie Sanders of Vermont, who is running for the Democratic presidential nomination; Edward Markey of Massachusetts; and Joe Manchin of West Virginia — oppose Califf’s nomination, citing concerns about his close ties to the pharmaceutical industry and the FDA’s response to the opioid epidemic, which they’ve said has not been ‘strong enough.’ Sanders, however, did not leave the campaign trail to register his vote.
“We can’t filibuster, but we are going to use up all of the 30 hours to make our case as to why we feel that Dr. Califf is not the right person to lead the FDA,” said Manchin’s spokesperson Jonathan Kott, in a STAT article.
Califf joined the FDA as a deputy commissioner in February 2015, after having worked at Duke University as a cardiologist, where he led a clinical research center that received a large share of its funding from the pharmaceutical industry. Califf, however, testified that the center’s scientific results were reached independently.
Califf led the clinical trial, known as ROCKET-AF, which serves as the backbone for the approval of rivaroxaban (Xarelto). Currently, there are questions about the validity of the trial’s data, specifically a portable device used to gain approval that appears to have been defective.
Sen. Lamar Alexander of Tennessee showed his support for Califf: “[He’s] the right person for the job. We need a leader who can manage a large and complex organization, not just on big policies that make headlines but on day-to-day matters.”
Senators Manchin and Markey said Califf is a “good man,” but that his work as a consultant for large drug companies makes him a poor fit, especially in light of the opioid epidemic. “Enough is enough,” Markey said. “This whole culture has to change.”
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Morning Read: Valeant loses $6 billion in value, the digital health drumbeat hits Harvard
| MedCity News
By Chris Seper
TOP STORIES
The Valeant news is not good. It has now lost $6 billion in value since Thursday, as it took another big hit on Monday after announcing it had to restate its earnings. “We have made mistakes in the past and our focus today is on executing our business plan and rebuilding trust,” interim CEO Howard Schiller stated in a company press released headlined: “Valeant Ad Hoc Committee has Made Substantial Progress in Its Review of Philidor and Related Accounting Matters.” – Fortune, Bloomberg & PRNewswire
Aneesh Chopra and David Blumenthal take the case of high-tech healthcare to a bigger audience: “If we make the market for good health care work, a lot of our current technical problems will melt away as providers and vendors compete to make service and care better for their customers: the nation’s patients.” – Harvard Business Review
LIFE SCIENCES
Chase Pharmaceuticals is in the midst of raising $70 million by the middle of this year to drive its Alzheimer’s drugs through Phase II and into Phase III trials. – Washington Business Journal
A new Parkinson’s group has emerged in Britain – with members including AbbVie, Biogen, Merck Sharp, the Critical Path Institute (C-Path) and Parkinson’s UK – to share data and other resources to accelerate new treatments. – Pharma Times
The FDA turns its attention to a faulty blood-testing device that effected the clinical data around Xarelto. – The New York Times
Prcision Medical has raised $19 million as part of a strategic partnership with Consort Medical to develop ways to use the eye as a site for drug-distribution. – MassDevice
More revelations in the Insys Therapeutics-Subsys marketing case: a guilt plea by a sales rep whose doctors, in one instance, became top Subsys prescribers even though most of their patients didn’t have cancer. – STAT
Skin health company PhotoMedex is selling its consumer and professional products businesses to DS Healthcare Group for $48 million. – Philadelphia Inquirer
PAYERS-PROVIDERS
Being careful or bracing for the worst? Tenet has set aside $238 million to settle a federal kick-back investigation in a mixed earnings report (loss for Q4, but predicting more cash flow in 2016). – Atlanta Business Journal & Reuters
A much-deserved assault on ACOs continues. My favorite line: “A wish is not a definition.” – The Health Care Blog
I have to wonder whether this lawsuit route will work in a battle for reimbursement. If Exact Sciences wins, does it mean insurers can be sued into compliance? – WisBusiness.com
Silver-livings on Zika: praise for the international response to the outbreak, nearly $2 billion in emergency funding could be on the way, and the CDC launches a new study on Zika. – Reuters, The Hill & STAT
TECHNOLOGY
“Three Things The Tech Industry Has Right And The Medical Industry Has Wrong” is the headline. But, regarding No. 1: I don’t think tech is as open with data as the author thinks it is. #theranos – TechCrunch
More HIMSS 2016 advice on where to get the most out of interoperability, analytics and other “trending topics.” – Healthcare Dive
Dubai’s Health Authority has launched a “comprehensive digital health system.” – The Gulf Today
Alibaba Health Information Technology may be in trouble. China said it will stop using the drug-coding system developed and operated by Alibaba Health (a product which also makes up almost all of the company’s revenue). – Bloomberg
Toshiba continues to cut bait on more wearables (note the final paragraph for an update on its healthcare business). – Wall Street Journal
POLITICS
Robert Califf moves on. Lesson: close ties to pharma are no vice. – The Hill & MedPage Today
Funny: Donald Trump’s healthcare advisers revealed! – Politico
Ummmmm….. no. – The Hill
LITTLE BIT EXTRA
Google’s Waze GPS app just got a major competitive edge: Morgan Freeman’s voice will guide you to your destination. – Time
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New FDA Chief Nears Confirmation With Crucial Senate Vote
Feb 22, 2016 | Bloomberg
By Anna Edney
The U.S. Senate agreed to end debate on President Barack Obama’s nominee to lead the Food and Drug Administration, setting the stage for confirmation as early as Tuesday of former Duke University researcher Robert Califf as the agency’s commissioner.
The Senate voted 80-6 on Monday in favor of moving to a vote on passage of Califf’s nomination, despite some senators’ opposition, based on claims that the FDA hasn’t done enough to curb the opioid abuse epidemic in the U.S. Close to 20,000 Americans died in 2014 from overdoses on opioid prescription painkillers, which include drugs like OxyContin, according to the National Institutes of Health.
“This is an epidemic that’s devastating our entire country,” Senator Joe Manchin, a West Virginia Democrat, said on the Senate floor before the vote. “Rich or poor it makes no difference.”
Manchin said that Califf is “a qualified man” but “I just think he’s the wrong person at this time of need, for the position that we need, to shake it up. The commissioner of the agency must be someone willing to lead in a different direction.”
Manchin voted against ending debate on Califf as did Senators Ed Markey, a Democrat from Massachusetts; Kelly Ayotte, a Republican from New Hampshire; Richard Blumenthal, a Democrat from Connecticut; Bill Nelson, a Democrat from Florida; and Rob Portman, a Republican from Ohio.
Senators have focused on the FDA’s decision last year to allow OxyContin to be prescribed to children from 11 to 16 years old, which the FDA has said it did to give physicians guidance on safely prescribing the drug since they already were doing so anyway. The FDA also has taken heat for approving in 2014 a potent pure hydrocodone pill called Zohydro that wasn’t made with technology that could deter abusers from snorting or injecting the drug.
Opioid Plan
The FDA released an action plan on opioids earlier this month to address some of the opposition’s concerns. The agency said it would convene a panel of outside experts to advise it every time an application for an opioid not made with abuse-deterrent technology came up for review. It also would craft guidance to help generic drugmakers gain approval of abuse-deterrent painkillers to expand access to the drugs.
The FDA’s science board will meet March 1 to discuss the role of opioids in pain management and the scientific challenges in supporting the development of abuse-deterrent opioids, Sarah Peddicord, a spokeswoman for the FDA, said in an e-mail. It also will hold two meetings, one in April and the other in September, with a pediatric advisory committee on the use of the drugs in children in pain, she said.
While opioids have been the hot-button FDA topic, the agency has some other high-profile regulatory actions coming up, including extending its oversight of tobacco to electronic cigarettes and requiring food labels to disclose the amount of added sugar in a product. The FDA also is working to modernize food safety rules meant to curtail food-borne illnesses and is improving its ability to approve generic drugs more quickly as well as figuring out the details of regulating a new type of drug called biosimilars, which are less expensive copies of biologic drugs.
Sanders Opposed
Senator Bernie Sanders, an Independent from Vermont who’s running for the Democratic presidential nomination, has opposed Califf because he says the nominee has close ties to the pharmaceutical industry and wants him to commit to do more to bring down drug prices. The FDA isn’t allowed to consider pricing when reviewing or approving a medicine. Sanders was not present for the vote.
Califf led the key clinical trial evaluating Johnson & Johnson’s blood thinner Xarelto, which the FDA approved in 2011 to prevent strokes in people with an irregular heartbeat. Xarelto generated $1.87 billion in sales last year, according to data compiled by Bloomberg.
Obama nominated Califf for the position in September after Margaret Hamburg stepped down in March 2015. Stephen Ostroff, the agency’s chief scientist, has served as acting commissioner in the interim.
Califf was appointed deputy FDA commissioner for medical products and tobacco in January 2015. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization, the FDA said. He also led the university’s efforts on translational research, or turning basic scientific discoveries into new treatments for patients.
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Questions about the reliability of ROCKET-AF anticoagulation data
Feb 23, 2016 | BMJ :Letter to the Editor
By Constantinos Christopoulos
Like Cohen, I also worry about the quality of evidence of the ROCKET-AF trial that led to regulatory approval of rivaroxaban for stroke prevention in non-valvular atrial fibrillation.1
In the warfarin treated control group, the mean time in therapeutic range (TTR) was reported to be 55%—significantly less than the 62% and 64% reported in the apixaban (ARISTOTLE) and dabigatran (RE-LY) trials, respectively. In the methods section of the published reports of all the above trials it is stated that TTR was calculated according to Rosendaal’s linear interpolation method.2 However, in the supplementary appendix (table 5) available online with the full text of the ROCKET-AF report it is stated that “Center TTR is calculated using total number of international normalized ratio (INR) values in target range from all warfarin subjects within a center divided by total number of INR values from all warfarin subjects within the center.”3 4 This percentage is a measure of anticoagulation quality entirely different from Rosendaal’s TTR and may yield values that deviate significantly from the mean of individual TTRs. This discrepancy is confusing and raises further questions about the reliability of the ROCKET-AF anticoagulation data.
All individual patients’ data should be made public for our trust in the findings of this pivotal trial to be restored. The campaign for open access to trial data should be intensified.
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Safety status of rivaroxaban remains unchanged — EMA
Feb 23, 2016 | Irish Medical Times
The European Medicines Agency (EMA) has said that the use of a defective device in a pivotal clinical trial of the oral anticoagulant rivaroxaban (Xarelto) does not change its overall safety status or risk-benefit.
The ROCKET-AF trial to prevent ischaemic stroke in non-valvular atrial fibrillation (AF) was published in the New England Journal of Medicine (NEJM) in 2011.
It compared rivaroxaban with warfarin and was used to gain regulatory approval in the US and Europe.
The device used in the trial to measure international normalised ratio (INR) was found to be defective, leading to concerns — recently reported by The BMJ — that it could have provided lower INR values in some patients in the warfarin group and led investigators to increase the dose, which could have increased their risk of bleeding and given a false impression of the safety of rivaroxaban.
The trial included more than 14,000 patients and found that rivaroxaban was non-inferior to warfarin in preventing ischaemic stroke or systemic embolism.
There was no significant difference between the groups in the risk of major bleeding, with less intracranial and fatal bleeding occurring in the rivaroxaban group.
The EMA was informed of the defect with the Alere manufactured device by rivaroxaban manufacturer Bayer in September 2015.
Further analyses by its Committee for Medicinal Products for Human Use concluded that any incorrect measurements would have had only a marginal effect on the study results and the safety of the drug remains unchanged.
“In addition, data from other large studies confirmed the comparative safety of the medicine and showed similar rates of bleeding in their warfarin groups.
“The CHMP therefore considered that the benefit-risk balance of Xarelto in patients with non-valvular atrial fibrillation remains unchanged,” it said in a statement.
Bayer’s Chief Medical Officer Dr Michael Devoy said it was very pleased with the EMA’s assessment confirming the positive benefit-risk profile of the drug.
“The re-analyses are reassuring and will provide physicians with additional confidence to prescribe Xarelto for their patients with atrial fibrillation at risk of stroke,” he said.
New York Times Follow-on Coverage
Other Traditional Coverage
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