For years, Johnson & Johnson’s anticoagulant, Xarelto was the market leader of blood thinners. Now, Eliquis, marketed by Bristol-Myers Squibb and Pfizer is leading Xarelto based upon prescription data. Eliquis brought in 667,000 prescriptions last September while Xarelto had 711,000.
This isn’t a surprise since Bristol-Myers Squibb and Pfizer spent double the amount of Johnson & Johnson to woo doctors. This included paying $185,000 to fly 25 specialists to Vienna for medical conferences.
Bristol-Myers Squibb and Pfizer are spending millions on advertising to distract consumers from the dangers of their anticoagulant. Researchers have linked Eliquis, and other newer generation oral anticoagulants (OACs) like Pradaxa and Xarelto, to an increased risk of uncontrolled bleeding (hemorrhaging). This is because the drug prevents stroke by inhibiting the blood clotting mechanism.
Warfarin, an older anticoagulant in use for over 50 years in the U.S., also prevents blood from clotting. However, doctors can reverse warfarin with a single dose of vitamin K. No such antidote exists with Eliquis, so once a bleeding event starts, it is nearly impossible to stop.
The FDA should have never approved Eliquis in the first place. Approval for Eliquis hinged on a trial called ARISTOTLE (Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation). The trial spanned over 1,000 locations and 40 different countries. This included 36 sites and 18,000 patients in Asia. Independent researchers uncovered 18 of these Asian sites had altered records to cover up numerous violations of good clinical practice guidelines. This could mean a whole host of troubling misconduct such as wrongful selection of subjects, not monitoring procedures and even not reporting adverse drug reactions.
Additionally, there were data discrepancies. Patient names and dates did not match. English and Chinese data reports showed completely different numbers. Even entire reports disappeared. The FDA did step in to investigate but determined that the Asian sites didn’t change the trial results.
The discrepancies in the Asian sites weren’t the only flaw in the ARTISTOLE trial. A large number of participants in the trials conducted all over the world received incorrect medications and even the wrong dosages. Some received a double dose or none at all. In fact, this changed the entire outcome of the results.
An appalling fact is that neither manufacturer believed the ARISTOTLE trial cover up, the missing data nor the inaccurate distribution of medicine to patients affected the trial’s integrity.
As manufacturers keep pushing Eliquis to be the most popular blood thinner on the market, more people will be victimized. It is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one has developed a compulsive behavior after taking Eliquis, you should demand accountability from Bristol-Myers Squibb. Why weren’t you told?
The Michael Brady Lynch Firm is on the forefront of litigations like Eliquis. We provide a free consultation. Contact us today.