Here we go again - another drug with false and misleading marketing that downplays risks. Gee, another set of lawsuits waiting to happen :o)
Keywords: jnj, johnson and johnson, johnson + johnson, J&J, xarelto, FDA, marketing, violation
Date Created/Edited: July 21, 2013
Gee, here we go again. Xarelto is a Johnson & Johnson drug approved for certain conditions by the FDA since introduced in 2011. On June 6, 2013, the United States Food and Drug Administration (USFDA) sent Johnson & Johnson a warning letter for false advertising. In 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."
This was also the case withLevaquin, Risperdal and even Exelon - all with FDA violations of false or misleading claims in their advertising material and all under the direct control of current CEO Alex Gorsky. Our doctors are literally being lied to regarding the safety and effectiveness of J&J pharmaceutical products and medical devices. How do you think that might affect your physician's choices for your treatment?
If you look at the information from the first article I wrote on Xarelto, you'll realize that if a doctor knew the truth they'd never prescribe the drug. For example, Xarelto is not proven to effectively treat the conditions for which it is prescribed. Xarelto costs more than known effective and currently available drugs. Xarelto has more side effects than currently available, proven-effective drugs. So basically, the insert should state that it is not proven, is more expensive and has more side effects. Yeah, I can see docs rushing to prescribe this based on the truth.
But then again, this is another drug slammed though a corrupt USFDA by The King of Corruption, JNJ Alex Gorsky. Xarelto is another drug brought to you by a corporation, Johnson & Johnson that used Freedom of Speech, or a Constitutional right to lie, as a defense with regard to the Arkansas verdict of $1.2 BILLION in restitution for Risperdal.
I wonder, if Johnson & Johnson products are so great, why do they have to lie about them to sell them? Would they be able to sell their products if they told the truth? With yet another product that safety data was not submitted to the FDA, less effective than existing products, more expensive than existing products and has more side effects than existing products, well, I doubt it.
Original Article, "Xarelto by Johnson & Johnson is Likely Another OverHyped Dud"
UPDATE: MAY 24, 2012
The FDA showed intelligence for a change and did not approve Xarelto for expanded use explaining that Agency advisers say there's not enough data in company trials on benefit for high-risk patients. The article contains additional information regarding the missing data of the outcome of a 15,000 patient clinical study. One of the FDA reviewers suggested that the missing data may indicate that Xarelto is not effective as J&J claims for expanded use in treating acute coronary syndrome.
Here we go again - another supposed blockbuster drug with issues but will get pushed through FDA anyway. Xarelto is a blood thinner used during major surgeries to reduce the risks of blood clots. It is now being pushed through FDA for regular use to reduce the risk of blood clots in people with acute coronary syndrome. However, due to missing data, "The staff appeared united in the view that the data did not prove Xarelto reduced the risk of death in patients with acute coronary syndrome..." according to Reuters.
In the same article, it is clearly stated that 12% of those in clinical trials dropped out. ANNNND - there were three deaths while on the drug that were excluded from information submitted to the FDA. Gee, what's this? If the people in the clinical trial DIE from the drug, they don't count? OMG. No wonder there are so many lawsuits against J&J!
According to the available FDA information, Xarelto was not demonstrated to be more effective than currently available drugs - but has more side effects as well as a higher cost. And we all know what more side effects means, they can sell more drugs to deal with the side effects.
Missing data, 12% dropout rate (or lost track of) and three deaths should be a sure sign that J&J knows there are issues with the drug. In addition, the expectation of such a large number of recipients to total over a billion in sales, although the drug should not be prescribed to those under 18, over 65, anyone with high blood pressure, etc, as well as the known and published side effects - um, how, exactly, could this be a 'blockbuster'? What I see is more off-label marketing to meet the sales goals and more harm with the resulting lawsuits. Oh, joy. Higher health care costs to pay for yet another 'blockbuster'. More like 'economy buster'.
1. 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
2. Emily Patterson (2013, May 8). List of Reasons Johnson & Johnson CEO Alex Gorsky Should Immediately Resign. Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/alex_gorsky_resignation.shtml
3. Emily Patterson (2012, November 9). Johnson & Johnson CEO Alex Gorsky's Career Long Cloud of Corruption. Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/alex_gorsky_corruption.shtml
4. Emily Patterson (2013, June 20). Johnson & Johnson Defense Against $1.2 Billion Arkansas Risperdal: We Have a Constitutional Right to Lie. Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/right_to_lie.shtml
5. Emily Patterson (2012, April 13). Johnson & Johnson Risperdal: Broken Laws and Side Effects. Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/risperdal.shtml
6. Emily Patterson (2012, May 23). Xarelto by Johnson & Johnson is Likely Another OverHyped Dud. Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/xarelto.shtml
7. HealthDay Correspondent (2012, May 23). FDA Panel Votes Against New Use for Blood Thinner Xarelto. US News and World Report. Retrieved from http://health.usnews.com/health-news/news/articles/2012/05/24/fda-panel-votes-against-new-use-for-blood-thinner-xarelto
8. Anna Yukhananov (2012, May 21). FDA staff sends mixed message on J&J drug Xarelto. Reuters. Retrieved from http://www.reuters.com/article/2012/05/21/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