JAMA Study Reveals Clinical Trial Misconduct for Xarelto

February 20, 2015

On February 9th, 2015, JAMA Internal Medicine published an article stating that although the U.S. Food and Drug Administration (FDA) frequently finds problems with the way in which clinical sites perform biomedical research on human participants, this information is hardly ever distributed properly or adequately addressed when trials are published. Scientists who run these trials may be failing to adhere to good clinical practices and the proper research conduct. These violations may include any of the following: a failure to adhere to clinical trial protocols, inadequate or inaccurate record keeping, falsification of reports, or a failure in ensuring the safety of a patient.

Unfortunately, because the FDA has no adequate system in place to communicate these findings to others in the scientific community, other scientists are not properly notified, let alone the general public. Even more astounding is the fact that, out of all these questionable situations, only 4% of these unacceptable conditions and practices are ever revealed. In other words, 3 out of 78 publications actually make clear that within their study, violations were found and what those violations are. For patients, this means that not only are they being treated by a potentially dangerous drug, they may also have no accurate and factual information available to them.

One such case is in regards to the drug Xarelto (generic: rivaroxaban), a blood thinner that has been recently introduced into the pharmaceutical market. Charles Seife, the researcher heading the JAMA study, found that the FDA conducted 16 inspections of the drug and found 8 undisclosed instances of wrongdoing. During these trials, scientists – among other things – falsified data, discarded medical records, and knowingly revealed which patients were receiving the actual drug or a placebo. Although FDA considered the studies unreliable, they were still published, minus the above violations listed.

Unfortunately, even though this new study shows clear problems with the way in which the Xarelto clinical trials were conducted, the drug is still on the market and still harming consumers. The drug, developed and distributed by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer Healthcare, has recently come under fire because of its potentially deadly side effects. The drug is prescribed to patients as an anticoagulant but has no reversal agent. This means that patients are at an increased risk of developing unstoppable internal bleeding that may result in death. If the JAMA study is any indication, it is no surprise that this drug has caused a number of problems for doctors and patients and as such, should not be on the market.


Legal Commentary

Many patients and their attorneys argue that the manufacturers of Xarelto, which include Bayer, Janssen Pharmaceutical and Johnson & Johnson, have withheld information and have not properly warned the public about the risks of this dangerous drug. The above JAMA study only serves to show that the manufacturers of Xarelto have acted negligently in producing this drug. If you or a loved one has fallen victim to any of the side effects of Xarelto, then seeking legal advice may provide you with the ability to hold the manufacturers accountable. Our attorneys have years of experience battling big pharmaceutical corporations. If you would like free legal information about your Xarelto case, call us for a free case evaluation. You can reach us at 1.866.705.7584 or by email at mn@fnlawfirm.com.

About the Author
Majed Nachawati is a preeminent Xarelto Lawyer with a focus on representing Xarelto victims and families harmed by this dangerous drug on a nationwide basis. Mr. Nachawati has resolved numerous cases through trial and settlement that have resulted in seven and eight figure confidential settlements. He is on the Grievance Committee for the State Bar of Texas. He is licensed to practice in the Northern, Southern, and Eastern Districts of Texas. Mr. Nachawati is a member of the Board of Directors of the Texas Trial Lawyers Association, the Board of Directors for Public Justice, a Leaders’ Forum and PAC member of the American Association for Justice. Mr. Nachawati has been recognized as a Super Lawyer in Texas Monthly Magazine for the past six consecutive years for legal excellence, in connection with pharmaceutical injury cases. Mr. Nachawati is also a member of The Million Dollar Advocates Forum. Mr. Nachawati can be reached by email
 

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