Xarelto Researchers Deceive Top Medical Journal

Xarelto Researchers Deceive Top Medical Journal | Pintas & Mullins Law Firm

Our Xarelto lawyers know all too well that Big Pharma hides important data from the public to protect their most profitable drugs. There are thousands of death and injury claims against Xarelto federal court, where a legal briefing was just filed accusing the manufacturers of misleading editors of one of the world's most respected medical journals.

Patients injured by the popular blood thinner Xarelto are suing its manufacturers, Johnson & Johnson (J&J) and Bayer, because the drug can cause uncontrollable, fatal bleeding. These wrongful death and injury lawsuits accuse the companies of concealing important safety information and failing to test the drug fully before releasing it for sale.

To prove these claims in court, Xarelto lawyers recently pointed to a letter published in the prestigious New England Journal of Medicine (NEJM). The letter was written by Duke University researchers and led to the FDA's approval of Xarelto in 2011.

The problem: the Duke researchers were hired by J&J and Bayer. They were paid to run a three-year clinical trial comparing 14,000 patients taking Xarelto and the original blood thinner, warfarin. They compared the drugs by drawing blood from patients during their treatment, sending the blood samples to labs, and testing them.

To view the letter, follow this link.

In September 2015, J&J and Bayer told the FDA that the machine used to test patients' blood had malfunctioned. This means that many patients blood results were incorrect, causing doctors to give wrong drug doses to patients. The inaccurate device obviously compromised the trial's final results and data, and yet this information was hidden from NEJM editors, regulators, doctors, or patients.

Although the Duke researchers were aware of the malfunctioning equipment, they did not mention it at all in the 2011 report. In fact, NEJM editors said they did not know about the faulty data until a New York Times reporter asked about it in February 2016. Before the original report was published five years ago, NEJM did ask about the potential for faulty data, however Duke researchers stated such data was “not available.”

This lie led to the approval of Xarelto by American and European governments.

Fraud and Misconduct in Clinical Trials

There are supposed to be many levels of protections to prevent this type of fraud. For years, crucial safety data went "missing" from medical journal reports that were funded by Big Pharma. These scandals led to the establishment of ethics policies in medical literature, in the hope of limiting the influence of drug companies.

Despite these half-hearted attempts at regulation, Congress keeps passing laws allowing drug companies to do whatever they please in the American marketplace. In 2003, Congress actually banned Medicare from negotiating drug prices whatsoever. Big Pharma is allowed to charge whatever it wants for drugs, and Americans are not allowed to import less expensive versions of the exact same drug from, say, Canada.

Why are we at the mercy of Big Pharma? Politics. Drug companies paid about $32 million in campaign contributions in the 2014 elections, along with $229 million in lobbying. There are some politicians hoping to end this scheme. Senator Al Franken recently introduced legislation that would end the tax break drug companies get from advertising to the public. Didn’t know Big Pharma gets tax breaks for its marketing schemes? Read this.

So, the cycle of hiding evidence of devastating side effects continues. J&J is overwhelmingly guilty of this, as it aggressively markets dangerous, fatal drugs to vulnerable patients without disclosing accurate safety information.

Billion-Dollar Drugs, No Accountability

One of the most unethical and disturbing examples is Risperdal, the antipsychotic drug to treat schizophrenia and bipolar. J&J promoted this drug to young boys, even though it was not legally allowed, and it knew high percentage of young boys would develop female breasts from taking the drug.

Risperdal has caused gynecomastia (swollen male breast tissue) in thousands of adolescent males who should not have been on the drug in the first place, purely because J&J wanted to increase profits. State and federal governments finally caught on to the fraud, leading to a $6 billion fine for misconduct. By that point, however, Risperdal had already reaped in $48 billion globally for J&J. Risperdal gynecomastia lawsuits continue to be filed nationwide. More information on those claims here.

These are not isolated incidents, and they are certainly not exceptions. This type of malicious, unethical, and dangerous conduct is the norm. In 2005, NEJM published an Expression of Concern over a study on the painkiller Vioxx. Researchers deleted data on several heart attacks from trial documents just two days before being submitted to NEJM. In 2006, clinical trial data on the diabetes drug Avandia was released, showing the drug could dramatically reduce cholesterol levels. As it turned out, every author involved in that trial was paid by Avandia's manufacturer, and four were employed by the company. Avandia is now estimated to have caused more than 100,000 heart attacks in diabetic patients.

Our team of Xarelto lawyers is currently accepting incidents of stroke, severe bleeding, pulmonary embolism, or death from this drug. If you or someone you love took Xarelto, Avandia, Risperdal, or any other dangerous drug, contact our firm for a free case review. We accept clients nationwide.