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Improving the way drugs are tested and marketed


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Sometimes there is good news and not-so-good news in a trial that tests the effectiveness and safety of a potential new drug. When the sponsor of the trial either downplays or disregards the unflattering information about an unreasonable health risk, it’s the patient and the patient’s family who get the worst news of all.

Victims in Xarelto lawsuits are cases in point. But the larger issue in regard to the treatment of clinical trial data is not new. Medical science and academia have been discussing for decades what to do about deficiencies in the disclosure of health risk information by the marketers of the drugs.

Suffolk University Law School Professor Dr. Marc Rodwin, who earned a doctorate from Brandeis University in Health and Social Welfare Policy, has written and has lectured extensively on this topic. At a 2011 seminar conducted at the Edmond J. Safra Lab at Harvard University, Rodwin recommended reforms in the following areas:

  • Pharmaceutical industry funding and control of clinical trials on which the U.S. Food and Drug Administration relies to determine whether to approve a drug
  • Dearth of research into how the drugs affect people after they are on the market
  • Use of a drug for purposes not FDA-approved, which is known as “off label”

Rodwin proposed that independent entities conduct Phase 3 clinical trials at the drug maker’s expense, so that the drug company cannot control the outcome. He also proposed that manufacturers be required to share with the U.S. government any post-market data on drug purchases and uses. Finally, Rodwin recommended that research into the health impact of off-label uses be conducted by independent labs and be funded from a portion of the proceeds that the drug company nets from the off-label sale of the drug.

This is a healthy discussion, the criticality of which, unfortunately, is reaffirmed every time a drug company is accused of concealing important and relevant data derived from its own clinical trials and otherwise is accused of depriving patients of fair warning about the side effects of a drug.

Xarelto, which Johnson & Johnson-owned Janssen Pharmaceuticals markets, is an anticoagulant linked to serious and oft-uncontrollable bleeding. To date, there is no antidote to reverse the drug’s anticoagulant effects, thus making it difficult to stop someone from internally bleeding. Patients generally take Xarelto after they undergo hip replacement or knee replacement surgery.

Janssen relied on a few studies to help convince the FDA that Xarelto was safe and effective. Those studies include the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism, or RECORD, studies; the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study, which is known as the ROCKET AF study; and a cluster of so-called EINSTEIN studies.

A patient who in 2014 suffered a “gastrointestinal bleed” that required blood transfusions filed a Xarelto lawsuit at a Philadelphia trial court in March. The lawsuit, one of hundreds, claimed that important information about Xarelto side effects appeared to have been sidestepped.

For instance, according to the suit, “The findings of the RECORD studies showed that rivaroxaban [the generic for Xarelto] was superior to enoxaparin for thromboprophylaxis after total knee and hip arthroplasty (based on the Defendants’ definition), and that use of these two treatments was accompanied by similar rates of bleeding. However, the RECORD studies also showed a greater incidence of bleeding, with Xarelto, leading to decreased hemoglobin levels and the need for blood transfusion.”

Additionally, as the petition reads, “The ROCKET AF study’s findings showed that rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation, with a similar risk of major bleeding. However, ‘bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.'”

Here, as the plaintiff asserts, is Strike 3: “The EINSTEIN-DVT study tested Xarelto versus a placebo, and merely determined that Xarelto offered an option for treatment of DVT, with obvious increased risk of bleeding events as compared to placebo.”

Hundreds of victims of Xarelto side effects – as well as the families of decedents – have decided to come forward and to hold the manufacturer accountable. Anyone else who wants to do that should contact an experienced pharmaceutical injury attorney.

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