A new drug’s effectiveness and safety are tested and verified by studies and clinical trials conducted by independent third parties such as universities and scientific labs. From a drug company’s perspective, receiving the endorsement of a successful clinical trial is essential to successfully marketing a new drug. Drug companies and their salesman use the results of these studies and trials as sales tools to market the drug to doctors. A pharmaceutical company can make billions of dollars by developing a drug that is more effective than another, providing doctors with an incentive to buy one to replace the other. In 2015 alone, Johnson and Johnson made $1.9 billion dollars selling Xarelto, an anti-clotting drug used to treat patients who are in danger of having a stroke. The future of this drug is now in question, however, because one of the testing devices used in the clinical trial has been deemed to be defective.
The FDA has challenged the results of the Rocket AF clinical trial, led by Dr. Robert M Califf because a device used in the tests, the INRatio sold by Alere may have produced faulty results that favored the newer replacement drug Xarelto. Xarelto is an anti-clotting drug developed and manufactured by Johnson and Johnson and prescribed to millions of Americans since its approval in 2011. Warfarin, the drug it replaces, is a 60-year old medication prescribed to prevent strokes in people with atrial fibrillation. With Warfarin, the margin of error in prescribing the correct dosage was deemed exceptionally thin. Doctors had to weigh the risks of the patient having a stroke from prescribing too little with the risk of catastrophic bleeding caused prescribing too much.
It was brought to the attention of the FDA that the INRatio monitoring device had been recalled in 2014 because it was underestimating a drug’s side effect, a patient’s risk of catastrophic bleeding. The FDA is investigating whether the faulty device could have caused doctors conducting the clinical trial to give patients a higher dosage of warfarin than necessary, thus giving an advantage to Xarelto.
Legal briefs filed by lawyers in federal court claiming that their clients have been injured by Xarelto raised the question of whether Johnson and Johnson knew the devices malfunctioned while the clinical trial was underway. The brief also claims that doctors for the study had been complaining about the device to the leaders of the trial during the study.
Researchers at Duke Clinical Research Institute and the European Medicines Agency, Europe’s FDA, both concluded that the faulty device did not affect the trial’s outcome. Doctors in Germany questioned whether Dr. Califf’s nomination to the FDA played a role in the heightened scrutiny of the study.
Thanks to: NY Times