A report from the independent, public-interest news organization ProPublica indicates that in 2015 drug makers spent more money on physician payments connected to Xarelto than for any other drug.
ProPublica’s Dollars for Docs database shows how much money physicians receive from drug and device makers. Dollars for Docs now includes payments made from August 2013 through December 2015. The payment disclosures were required under the Physician Payments Sunshine Act, a part of the 2010 Affordable Care Act. The goal of the law was to increase the transparency of financial relationships between health care providers and pharmaceutical and device manufacturers and to uncover potential conflicts of interest.
The payments were for such things as promotional speaking, consulting, meals, travel, gifts and royalties, but not for research. Earlier ProPublica studies have shown that doctors receiving payments from manufacturers tend to prescribe more brand-name drugs than those who do not receive payments.
Payments Influence Prescribing Practices
Pharmaceutical and medical device companies are required by law to released details of payments to doctors and U.S. teaching hospitals for things like promotional talks, and travel. ProPublica gathers this information and provides an annual analysis.
Drug and device makers made about $2 billion in payments to more than 600,000 physicians in 2014 and 2015, and an additional $600 million a year to teaching hospitals. The companies spent the most on the blood-thinning drug Xarelto. The other drugs in the top five were the rheumatoid arthritis drug Humira, the diabetes drug Invokana, the hepatitis C drug Viekira and the blood thinner Eliquis.
Parker Waichman notes that drug companies compete fiercely for market share for their products, especially during the period when a manufacturer holds exclusive rights to sell a new drug. Once cheaper generic versions of a drug are permitted to enter the market, profits from sales of the brand-name version can drop significantly.
ProPublica’s analysis shows that doctors who receive payments prescribe the drug involved more often; this is confirmed by other studies.
In a 2016 study, Harvard Medical School researchers that payments to doctors in Massachusetts were associated with higher rates of prescribing brand-name cholesterol drugs. For every $1,000 a doctor received, the rate of prescribing the brand-named drug increased by 0.1 percent. Lead study author Dr. James S. Yeh noted that doctors should use objective criteria in prescribing a drug, “rather than doing something because there is financial gain, whether it be subconscious or conscious.”
Another study analyzed payments from August 1, 2013 through December 31, 2013, as well as the prescribing data for individual physicians for four classes of drugs: statins, beta-blockers, ACE inhibitors, and antidepressants. Nearly 280,000 physicians received over 63,000 payments associated with these drugs. Physicians who received a single meal promoting a particular drug had higher rates of prescribing that drug over others. Physicians who received additional meals costing more than $20 had higher relative prescribing rates.
The researchers concluded: “Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted.” Dr. R. Adams Dudley, one of the study authors, noted that they were surprised that it “took so little” to influence a doctor’s prescribing.
Plaintiffs Claim Xarelto Manufacturers Downplayed Risks
The U.S. Food and Drug Administration (FDA) approved Xarelto (rivaroxaban) in 2011 to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery. In November 2011, the approval was extended to include the use of Xarelto to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).
Xarelto is one of a “new generation” of anticoagulants. These drugs have been heavily marketed as better, more convenient, alternatives to warfarin, the leading blood-thinner for more than 50 years. The drug makers claimed that Xarelto was more convenient than warfarin because it did not require regular blood monitoring, or a restrictive diet, and the drug is taken in a once daily dose.
But Xarelto, unlike warfarin, Xarelto, has no antidote that will restore the blood’s clotting ability in the event of a bleeding episode. If a patient experiences internal or external bleeding, or needs emergency surgery, it is important to be able to restore the patient’s clotting ability. When a bleeding episode cannot be stopped, the patient faces the risk of permanent injury or death.
More than 11,000 Xarelto bleeding lawsuits are currently pending in courts throughout the U.S. Many plaintiffs allege that Janssen Pharmaceuticals, the maker of Xarelto, overplayed the benefits of Xarelto while downplaying potentially life-threatening side effects. Plaintiffs claim Janssen rushed Xarelto to market before making sure it was safe.
The lawsuits allege that Janssen chose not to warn doctors or the public about Xarelto’s risks. Instead, the company has heavily promoted Xarelto’s convenience compared to warfarin. Television ads feature celebrity Xarelto users like golf legend Arnold Palmer and NBA All-Star Chris Bosh, who happily promote Xarelto’s lack of restrictions but do not mention the bleeding risks. Patients who have filed Xarelto lawsuits say Janssen deliberately used misleading marketing and advertising to sell the drug.
Plaintiffs also dispute the lack of monitoring and the once-a-day dose. Independent studies have indicated that it would have been better, particularly for the elderly and some other populations, if blood monitoring had been done, to help identify those individuals at greater risk for excessive bleeding.
A 2015 study found with Japanese patients showed that many vulnerable to “peaks and troughs,” meaning that the drug was more effective at some times, less at other times. During the times Xarelto was more effective, their bleeding risk was higher. The researchers concluded that blood monitoring would be valuable in these cases. Some plaintiffs allege that the uniform daily dose of Xarelto does not take into account differences in patients’ size and weight. The same dose is not equally effective for every patient, they say.
Legal Help for Xarelto Bleeding
If you or a Xarelto user you know has experienced a serious bleeding episode, you may have important legal rights. Please contact the attorneys at Parker Waichman LLP for a free, no obligation case evaluation. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).