Overstating benefits, downplaying (or not disclosing) risks. Xarelto by Johnson and Johnson Janssen killing people left and right. Lovely, eh?
Keywords: false, marketing, death, dead, xarelto, FDA, lawsuit, Janssen
Date Created/Edited: July 8, 2016
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I've already written three pieces regarding the bullshit-based approval of this drug, the known-from-the-beginning risk of patients bleeding out while doing nothing more harmful than eating popcorn while watching a movie. The drug is less effective, more costly and has a higher risk of adverse events - such as stroke and bleeding to death - either downplayed or not disclosed to United States Food and Drug Administration, the Europeans Medicines Agency, The New England Journal of Medicine as well as doctors and patients around the world.
[Xarelto by Johnson & Johnson is Likely Another OverHyped Dud (2012, May 23) hm, seems I was correct, eh?]
[ Johnson & Johnson Janssen Xarelto Marketed In Violation of FDA Regulations (2013, July 21)]
[Johnson & Johnson Xarelto, False Marketing, Lawsuits and FDA Says THREE TIMES, "NO EXPANDED USES!" (2014, September 14)]
(As of this printing, there are over 7,000 lawsuits filed against Johnson & Johnson / Janssen, which includes 500 dead.)
The ROCKET AF study of 15,500 patients using Xarelto, Warfarin or placebo was conducted December 2006 to September 2010. The study results included 3 deaths and 12% dropped out or Johnson & Johnson 'lost track' of them.
Helping drive up flood of lawsuits and body count was another wonderful false marketing scam, downplaying risks overstating benefits. On June 6, 2013, the United States Food and Drug Administration (USFDA) sent Johnson & Johnson a warning letter for false advertising. The FDA letter to Johnson & Johnson states,
"The print ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim."As the flood of victims grew, the United States Food and Drug Administration stepped in and requested labeling changes for consumer safety. However, most consumers don't re-read (if they even read) consumer safety inserts for drugs after they've already begun a daily dose.
Thanks to reporting by the New York Times, it was made public knowledge that there are accuracy concerns regarding the inRatio device used to monitor blood levels throughout the study.
I did a quick search in MAUDE - Manufacturer and User Facility Device Experience database for any possible reports of issues with the inRatio device used to monitor blood of patients in the study. I used the parameters: inRatio from December 1, 2005 to December 1, 2006. In the year before the study, over 500 complaints regarding the inRatio device were submitted to MAUDE.
Curious as to WHEN anyone realized there was a flood of reported problems with the device? Or, I think kind of sick and twisted, was this specific device chosen because the accuracy issues would present the results needed to get Xarelto approved? Hm. Twisted - but from a company that continues to sell talc, increasing risk of ovarian cancer by over 30%, to use on baby girls in this country, well, I wouldn't put anything past them at this point.In 2009, nine United States Food and Drug Administration scientists sent a letter to Barack Obama stating that the medical devices unit of FDA was corrupt,
The purpose of this letter is to inform you that the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.- they weren't kidding, eh? This is a clear example of depending on accuracy from defective devices with massive complaints that NO ONE did anything about leading to a massive number of deaths and 7,100 (and climbing) lawsuits.
As the United States Food and Drug Administration starts asking questions regarding the faulty blood monitor, it comes to light that the leader of the ROCKET AF Study of 15,500 patients was the obviously incompetent or corrupt (either way, get the asshole OUT OF FDA) United States Food and Drug Administration Commissioner: Robert 'Xarelto Killer' Califf. Oh boy. Bit of a problem for us, eh?
Without any clue that Califf was the leader of the ROCKET AF study which used faulty results from defective equipment to pass a drug he promoted for payment, nominated by President Barack Obama our incredibly dippy senate confirmed Robert Califf as the new United States Food and Drug Administration Commissioner.
The New England Journal of Medicine people and victims of Xarelto are a wee bit miffed at Johnson & Johnson for concealing data regarding blood tests done for patients on Warfarin at two points during the ROCKET AF trial. At this point, I haven't found much mention regarding the analysis of that data - if it was ever turned over to regulatory authorities for re-review of approval, or disapproval, of Xarelto. All I got from this is another circle-jerk pointing fingers, Johnson & Johnson claiming they don't know about any data, Bayer claiming they don't know anything about any data, and Duke University whining they just, uh, gee, kinda, sorta forgot about the missing data. Typical, jah?
Oh, wait, lest we forget the leader of the Duke University study that sorta forgot about the data regarding additional blood tests, is now the current United States Food and Drug Commissioner; a moron who didn't check the history of the devices chosen for the study and kinda, sorta, forgot about the data has the highest rank in the United States Healthcare System...
Isn't that uh, kinda scary to anyone? Wow. just wow.
Let's do a quick review of the approval of Xarelto...
The review of data:
- removed three deaths from any consideration
- ignored 12% drop-out or 'lost' patients (data not available for review? hm.)
- study was conducted with data from a device with over 500 complaints in the year prior to the study
- data regarding two blood tests of Warfarin patients with-held from New England Journal of Medicine for review
And we wonder why we have yet another killer drug by Johnson & Johnson on the market causing pain and suffering, even death, around the world?
Examples of harm by Johnson & Johnson Janssen Xarelto:
Xarelto Lawsuit Filed By Ohio Couple Alleges Damages And Anemia
Plaintiff in Xarelto Lawsuit Suffers Stroke, Dosage may be an Issue
Lawsuit Alleges Xarelto Caused Fatal Internal Bleeding
Fatal internal bleeding from a drug to save your life, is, well, a bit excessive when a far safer product, Warfarin, is available.
FATAL internal bleeding caused by Xarelto is one of those pesky little risks that were majorly downplayed, and probably not disclosed to those who started taking the drug prior to the new, updated package insert warnings. Basically, the risk of fatal bleeding is huge, because there is no known antidote - no way to turn off the blood-thinning effects for emergencies such as a car accident or if the patient needs emergency surgery.
Although Johnson & Johnson's 275 or so subsidiaries are incapable of developing an antidote, five YEARS AFTER FDA approved Xarelto with no known antidote to flood the market, a potential reversal agent may be on the horizon. But for now, if you take Xarelto, don't cut yourself, be involved in a crash or need emergency surgery because, uh, you'll bleed out like a stuck pig on a hot summer day, eh?
As Investigations Conducted On Xarelto Clinical Trials As Lawsuit Filings Continue, if you are taking Xarelto, you might want to talk to your doctor about how to safely switch to a not-quite-so-deadly and not-based-on-bad-data-from-a-defective-device and only-if-an-antidote-is-available-please alternative, eh?
1. SEC (2016, May). Johnson & Johnson 2016 First 1/4 10-Q. Securities Exchange Commission. Retrieved from https://www.sec.gov/Archives/edgar/data/200406/000020040616000084/a1q10q4-03x16.htm
2. Laurence Banville (2016, June 17). Xarelto Lawsuit Plaintiffs Await Bellwether Trials As More Details Emerge About Clinical Trial Data. LegalExaminer. Retrieved from http://newyorkcity.legalexaminer.com/fda-prescription-drugs/xarelto-lawsuit-plaintiffs-await-bellwether-trials-as-more-details-emerge-about-clinical-trial-data/
3. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (First received: November 23, 2006; Last updated: April 10, 2014). An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation. Clinical Trials.gov, A service of the U.S. National Institutes of Health. Retrieved from https://clinicaltrials.gov/ct2/show/NCT00403767
4. Anna Yukhananov (2012, May 21). FDA staff sends mixed message on J&J drug Xarelto. Reuters. Retrieved from http://www.reuters.com/article/us-fda-johnson-xarelto-idUSBRE84K0M220120521?feedType=RSS&feedName=healthNews&utm_source=twitterfeed&utm_medium=twitter&utm_campaign=Feed%3A+reuters%2FhealthNews+%28Reuters+Health+News%29
5. Zarna Patel and Amy Toscano (2013, June 6). FDA WARNING LETTER. Office of Prescription Drug Promotion, United States Food and Drug Administration. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM357833.pdf
6. Staff Writer (2016, June 10). Xarelto (Rivaroxaban) Tablet, Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)s. U.S. Food and Drug Administration. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm367392.htm
7. KATIE THOMAS (2016, MARCH 17). Accuracy Concerns on Testing Device for Blood-Thinning Drug. New York Times. Retrieved from http://www.nytimes.com/2016/03/18/business/accuracy-concerns-on-testing-device-for-blood-thinning-drug.html?_r=0
8. MAUDE - Manufacturer and User Facility Device Experience (monitored). MAUDE search form. United States Food and Drug Administration. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm
9. MAUDE - Manufacturer and User Facility Device Experience (2016, July 10). MAUDE search results. United States Food and Drug Administration. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=&brandname=inratio&eventtype=&reportdatefrom=12%2F01%2F2005&reportdateto=12%2F1%2F2006&pagenum=10
10. Certified Letter from Food and Drug Administration to President Obama (2009). Certified Letter from Food and Drug Administration to President Obama. United States Food and Drug Administration. Retrieved from http://www.johnsonandtoxin.com/data/cert-fda-letter-to-the-president-4-2-09-and-trans-team-1-7-09.pdf
11. KATIE THOMAS (2016, February 22). F.D.A. Asks If Faulty Blood Monitor Tainted Xarelto Approval. New York Times. Retrieved from http://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0
12. Emily Patterson (2016, March 2). New United States Food and Drug Commissioner Dr. Robert Califf Responsible for KILLER Xarelto. Johnson And Toxin. Retrieved from http://www.johnsonandtoxin.com/califf_fda_commissioner.shtml
13. Emily Patterson (updated index). Obama Files. Johnson And Toxin. Retrieved from http://www.johnsonandtoxin.com/obama.shtml
14. Brady Dennisn (2016, February 24). Senate confirms Robert Califf as new FDA commissioner. Washington Post. Retrieved from https://www.washingtonpost.com/news/to-your-health/wp/2016/02/24/senate-confirms-robert-califf-as-new-fda-commissioner/
15. KATIE THOMAS (2016, MARCH 1). Document Claims Drug Makers Deceived a Top Medical Journal. New York Times. Retrieved from http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?_r=0
16. Bill Berkrot (2015, November 11). Portola reversal agent for Xarelto succeeds in late stage trial. Reuters. Retrieved from http://www.reuters.com/article/us-health-heart-portola-idUSKCN0T01WN20151111
17. Laurence Banville (2016, June 1). Investigations Conducted On Xarelto Clinical Trials As Lawsuit Filings Continue. Legal Examiner. Retrieved from http://newyorkcity.legalexaminer.com/fda-prescription-drugs/investigations-conducted-on-xarelto-clinical-trials-as-lawsuit-filings-continue/