President Obama's recent nominee to head the Food and Drug Administration (FDA) is Robert Califf. Mr. Califf has received huge consulting fees from large pharmaceutical corporations to push their agenda. Worse than that, he played a significant role in the approval of an anti-coagulant medication that is literally killing people.
The prescription in question is known as rivaroxaban, manufactured by Janssen Pharmaceutica in partnership with Bayer AG and marketed by Janssen's parent company, Johnson & Johnson. Sold under the brand name Xarelto, it is one of the “new generation” anticoagulant meds designed to replace the old standby coumadin (Warfarin). Xarelto is designed to prevent blood clotting in patients at risk for thrombosis, pulmonary embolism and irregular heartbeat (arrhythmia or atrial fibrillation), all of which can contribute to stroke. However, Xarelto has a major potential side effect. Once it inhibits clotting factors in the blood, a slight cut or bump can cause the patient to bleed to death. There is no antidote for Xarelto. The only chance to save the patient in such a case is to administer emergency dialysis in order to get the medication out of the system as quickly as possible.
In 2011, Xarelto was subject to a questionable study that was the basis of an FDA advisory committee's endorsement. The study involved patients with atrial fibrillation (AF), and was known as “ROCKET-AF.” The study demonstrated that there was “no increase in overall bleeding risk and no increase in major bleeding events [caused by Xarelto] compared with warfarin.” However, that study was limited in how long test subjects were administered the drug. Furthermore, there was concern about the dosage and the amount of time the patients were given warfarin compared with Xarelto, and whether the test conditions reflected actual clinical conditions under which physicians might administer the medications. In short, the tests biased in favor of Xarelto.
One of the principal investigators and co-chairman of the study in the ROCKET-AF trial was Dr. Robert Califf. Despite serious questions about the study, Califf stated that:
In clinical studies, XARELTO® was shown to be effective in patients who are at increased risk of stroke, and especially in those with co-morbidities such as high blood pressure or diabetes, and other factors that increase the risk of stroke.
Xarelto was approved for the treatment of AF patients in November of 2011. Since then, Xarelto has become a huge seller for the company, but is currently involved in mass litigation over severe injuries and deaths caused by its use.
Dr. Califf has strong financial connections to several major pharmaceutical firms. He has been given research grants by Johnson & Johnson, Eli Lily, Merck, and Novartis Pharmaceuticals. Califf has also been paid generous consulting fees by three of the foregoing companies in addition to Boehringer Ingelheim, Glaxo-Smith Kline and Bayer. All of these companies have been targeted in legal action over defective drugs in recent years.
Why is Obama even considering Dr. Califf for the lead position of the FDA? This organization already is rubber stamping 96% of drug applications. The FDA has become a vehicle for Big Pharma with no oversight. Reports of defective medical devices and dangerous drugs are so commonplace they're almost not newsworthy anymore. At the same time, the profit motive is so powerful that it trumps all other considerations. Big Pharma has demonstrated again and again that it is willing to sacrifice lives and pay out a few million in order to preserve its billion-dollar profits. Recently, they have even begun purchasing the rights to live saving drugs that have been on the market for decades, and then increasing the price of the drugs to astronomical levels. Bernie Sanders has been investigating this practice, and will be proposing legislation to stop it.
Dr. Califf is not the right person to reign in the out-of-control drug industry. He is one of them. One certainly must ask the question, “Why is Obama doing this?”