The Trial Lawyer Winter 2018 - Page 40

LEGALBRIEFS Prominent Medical Researcher Falsified Data on Stem Cell Therapy In 2001, Dr. Piero Anversa, a prominent and well-respected scientist specializing in regenerative medicine, published a report indicating that certain stem cells found in bone marrow could be used to repair damaged heart tissue. However, further research failed to confirm his findings, casting aspersions on his claims. Harvard Medical School announced the results of an investigation, which determined that Dr. Anversa falsified the data. Officials are now calling for the retraction of over 30 of his scientific papers. Based on his studies, Anversa and his colleagues claimed that a certain group of stem cells, known as “c-kit” progenitor cells, could be used to heal and regenerate hearts damaged by disease and adverse myocardial events. His findings attracted millions of dollars in federal research grants and led to a major clinical trial underwritten by the National Institutes for Health. Anversa’s research also encouraged entrepreneurs to form start-up companies for the development of new treatments — despite the fact that other researchers were unable to reproduce his results. According to Anversa, stem cells from bone marrow could be injected directly into the heart muscle, where they would transform and repair injuries caused by heart attacks and stroke. He even started his own company, intending to profit from his work. However, later studies at Stanford University and the University of Washington came to different conclusions. Those immature 38 x The Trial Lawyer By Top Class Actions & Drug Safety News cells, known as hematopoietic stem cells, while able to grow into different types of cells are limited in their ability to differentiate (unlike embryonic stem cells, which can develop into virtually any other kind of cell). In short, bone marrow stem cells injected into the heart remain unchanged and do nothing. Despite growing evidence to the contrary, Anversa continued to defend his results, suggesting that others’ methods were flawed. He then went on to claim discovery of a method using stem cells from the heart muscle itself. According to Anversa, these stem cells could be removed, allowed to reproduce in the lab and injected back into the heart, where they could repair damaged tissue. However, a subsequent study published in 2014 found that while heart stem cells were indeed capable of growing cardiac muscle cells (known as cardiomyocytes), their ability to do so was limited to a “functionally insignificant level.” All of this cast such a shadow of doubt over Anversa’s research that he finally stepped down from his position at Brigham and Women’s Hospital (BWH) in 2015. Last year, the Harvard investigation conclusions led to BWH having to pay $10 million in order to settle allegations that Anversa and his colleagues had obtained federal research grants under false pretenses by manipulating and falsifying lab results. Officials at Harvard Medical School announced that 31 of Anversa’s studies should be retracted. Appallingly, a clinical study on the use of cardiac stem cells in regenerative heart treatment is continuing to enroll volunteers, despite the discrediting of Anversa’s research. Predictably, startup companies are continuing to seek profits by marketing what has now been proven to be useless treatments to desperate heart patients, eager to find a miracle — and willing to pay the price. FDA Approves New Indication for Xarelto New Jersey-based drugmaker Johnson & Johnson (JNJ) and its partner, Bayer AG, received approval for a new indication for the controversial anti-coagulant medication Xarelto (rivaroxaban). As of mid-October, it is the sole prescription medication in its class that has been approved to reduce the risk of “major cardiovascular events” (i.e., heart attacks) in patients suffering from chronic coronary or peripheral artery disease. Both of these conditions result from the buildup of plaque on the arterial walls (more commonly known as “hardening of the arteries”), causing reduced blood flow to the heart muscle. The FDA’s decision was based on data from the 2017 COMPASS clinical trial, demonstrating that patients who took Xarelto in conjunction with aspirin therapy were up to 42 percent less likely to die from a major cardiac event than those who took aspirin alone. This approval follows a similar decision by the European Medicines Agency (EMA) in August. Xarelto is what is known as a Novel Oral Anticoagulant, or NOAC. Other drugs in this class include Pradaxa (Boehringer Ingelheim), Savaysa (Daiichi Sankyo), and Eliquis (Bristol- Meyer Squibb). They are also labeled as “non-Vitamin K antagonists.” While warfarin, the standard treatment for over 65 years, prevents the action of Vitamin K (an important component in blood clotting), NOACs work by disabling the upstream biological mechanisms that allow blood clots to form in the