Claim: FDA advisory panel backs Merck's blood clot-preventing drug.
Verdict: SUPPORTS

Retrieved passages:
title: David Graham (epidemiologist)
text: Lotronex, Baycol, Seldane, and Propulsid. On November 18, 2004, Dr. Graham testified before the U.S. Senate Committee on Finance about Merck's withdrawal of the popular anti-inflammatory drug Vioxx the previous month because of serious safety concerns. In his testimony, he asserted his personal belief that the policies within the U.S. Food and Drug Administration were insufficient to protect the public from drugs which carry unacceptable risks, saying "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless." After his testimony, Graham was publicly criticized by the FDA. He contacted

title: Rofecoxib
text: carried out in older "trusted" NSAIDs such as ibuprofen, diclofenac and others. The possible exceptions may be aspirin and naproxen due to their anti-platelet aggregation properties. Due to the findings of its own APPROVe study, Merck publicly announced its voluntary withdrawal of the drug from the market worldwide on September 30, 2004. In addition to its own studies, on September 23, 2004, Merck apparently received information about new research by the FDA that supported previous findings of increased risk of heart attack among rofecoxib users (Grassley, 2004). FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30

title: Eric Topol
text: Vioxx. In a 2004 editorial in "The New York Times", he wrote that "Merck finally had to acknowledge the truth [about the drug's cardiovascular risks], but only by accident." Topol also authored an editorial in the "New England Journal of Medicine", arguing that "neither Merck nor the FDA fulfilled its responsibilities to the public" and encouraging a "full Congressional review" of the situation. In 2004, Bethany McLean, writing in "Fortune", questioned Topol's own potential financial conflicts of interest. She reported that Topol served as a scientific advisor to a hedge fund which profited substantially by short selling Merck stock, which

title: Merck Group
text: chemicals to the electronics industry. In September 2014 Merck halted the clinical development of two drug candidates in development with Oxygen Biotherapeutics. One drug candidate suffered a lack of success in patient recruitment, with its MUC1 antigen-specific cancer immunotherapy drug, tecemotide (L-BLP25), missing its Phase I/II endpoint of increasing overall survival in patients with Stage III non-small cell lung cancer. Later in September it was announced that the company would acquire Sigma-Aldrich for $17 billion. After the acquisition was completed in 2015, Merck has around 50,000 employees. In November 2014, Merck and Pfizer agreed a deal for the latter to

title: Drotrecogin alfa
text: the drug study itself and the FDA approval," wrote NEJM editor-at-large Richard P. Wenzel, MD in 2002. The FDA approved the drug despite the advisory committee's split vote (10 to 10) due to concerns about the validity of the claimed efficacy and safety findings on the basis of a single trial. Eli Lilly spokeswoman Judy Kay Moore insisted that the company did not mastermind the ethics task force or steer the guideline-writing process. It was only a coincidence, Moore says, that the ethics task force and the Surviving Sepsis Campaign used the same P.R. firm, Belsito and Company. In the

title: Betrixaban
text: with Merck. In 2011 Merck discontinued joint development. The drug has undergone human clinical trials for prevention of embolism after knee surgery and for prevention of stroke following non-valvular atrial fibrillation with promising results. Later betrixaban was studied in a large phase III clinical trial ("APEX") for extended duration thromboprophylaxis in acute medically ill patients. Previously apixaban and rivaroxaban have failed to show positive risk/benefit ratio in this indication compared to enoxaparin. APEX trial compared betrixaban with enoxaparin and included 7513 patients. Lower rate of VTE events was found in betrixaban arm with no increase in major bleedings compared to

title: COX-2 inhibitor
text: and death from a vascular event such as MI or stroke. These results led Merck to voluntarily withdraw (Rofecoxib) from the market in September 2004 and to regulatory authorities imposing a boxed warning on the label of celecoxib. Traditional NSAIDs were also found to have cardiovascular risks, leading to similar boxed warnings. The cause of the cardiovascular problems became, and remains, a subject of intensive research. As of 2012 results have been converging on the hypothesis that the adverse cardiovascular effects are most likely due to inhibition of COX-2 in blood vessels, which leads to a decrease in the production

title: Bezlotoxumab
text: prevent recurrence of "C. difficile" associated diarrhea than bezlotoxumab alone. On June 9, 2016, the U.S. FDA's Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) met to discuss bezlotoxumab. The committee voted to recommend approval of Merck's license application by a vote of 10 to 5, generally expressing a willingness to accept that the trials had proven that bezlotoxumab decreased recurrence of "C. difficile" overall. The committee tempered this acceptance with a robust discussion of whether or not the drug provide more marked benefit in some patient groups and expressed concern over a potential safety signal

title: Thrombosis prevention
text: risk of bleeding and so many surgeons start giving anti-coagulants the first 6 hours after surgery.Medications that inhibit blood clot formation include: The discontinuation of contraceptives also prevents blood clots. The therapeutic effects of warfarin may be decreased by valerian. Anticoagulants can be affected by chamomile. Dong quai, garlic, ginger, Ginkgo biloba, bilberry and feverfew can increase bleeding time. These same herbal supplements taken with warfarin increased prothrombin time. By containing significant content of vitamin K, some foods act as antagonists to antiplatelet and anticoagulant medications; these include green leafy vegetables, like spinach, legumes, and broccoli. Preventing blood clots with

title: Rofecoxib
text: to operate honestly throughout the process. Any mistakes that were made regarding the mishandling of clinical trial results and withholding of information was the result of oversight, not malicious behavior. The Martin Report did conclude that the Merck's marketing team exaggerated the safety of Vioxx and replaced truthful information with sales tactics. The report was published in February 2006, and Merck was satisfied with the findings of the report and promised to consider the recommendations contained in the Martin Report. By March 2006, there were over 10,000 cases and 190 class actions filed against Merck over adverse cardiovascular events associated

title: Value-Based Insurance Design
text: clot-inhibiting drug clopidogrel. The policy was associated with an immediate 2.8 percent increase in adherence to statins relative to controls. For clopidogrel, the policy was associated with an immediate stabilizing of the adherence rate and a four-percentage-point difference between intervention and control subjects a year later. In 2004, Mayo Clinic's self-funded health plan increased cost sharing for its employees and their dependents for specialty care visits and other services such as imaging, testing and outpatient procedures. The plan also removed all cost sharing for visits to primary care providers and for preventive services such as colorectal screening and mammography. The

title: Darbepoetin alfa
text: Public Health Advisory on March 9, 2007, and a clinical alert for doctors on February 16, 2007, about the use of erythropoeisis-stimulating agents (ESAs) such as epoetin alfa (marketed as Epogen) and darbepoetin alfa. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings. According to the 2010 update to clinical practice guidelines from the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH), use of ESAs such as darbepoetin

title: Aprotinin
text: the Food and Drug Administration issued a warning that aprotinin may have serious kidney and cardiovascular toxicity. The producer, Bayer, reported to the FDA that additional observation studies showed that it may increase the chance for death, serious kidney damage, congestive heart failure and strokes. FDA warned clinicians to consider limiting use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks. On November 5, 2007, Bayer announced that it was withdrawing Aprotinin because of a Canadian study that showed it increased the risk of death when used to

title: Thrombosis prevention
text: medication is not considered safe in the following circumstances: Adding heparin to the use of compression stockings may prevent thrombosis. An international registry and risk assessment calculator is being used to centralize data on post-surgical venous thrombosis and its prevention. Hospitals are implementing a multi-disciplinary approach to prevent of blood clots. This includes adequate assessment of the risks, follow up on missed doses of medication and instituting a 'patient-centered' approach endorsed by the Joint Commission. Recommendations regarding the prevention of blood clots vary widely between clinicians and treatment facilities. Research continues to clarify these discrepancies. The metabolic state of hypercoagulability

title: Percutaneous coronary intervention
text: or other long-term adverse events. Some DES products market a biodegradable polymer coating with the belief that the permanent polymer coatings of DES contribute to long-term inflammation. Other strategies: A more recent study proposes that, in the case of population with diabetes mellitus—a population particularly at risk—a treatment with paclitaxel-eluting balloon followed by BMS may reduce the incidence of coronary restenosis or myocardial infarction compared with BMS administered alone. After placement of a stent or scaffold, the patient needs to take two antiplatelet medications (aspirin and one of a few other options) for several months to help prevent blood clots.

title: Aprotinin
text: may benefit certain subpopulations of patients. In a Public Health Advisory Update dated October 3, 2006, the FDA recommended that "physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks" and carefully monitor patients. On October 25, 2007, the FDA issued a statement regarding the "Blood conservation using antifibrinolytics" (BART) randomized trial in a cardiac surgery population. The preliminary findings suggest that, compared to other antifibrinolytic drugs (epsilon-aminocaproic acid and tranexamic acid) aprotinin may increase the risk of death. On October 29, 2006

title: Thrombosis prevention
text: credited with the first use of thrombosis prophylaxis in the 1930s. The development of blood clots can be interrupted and prevented by the use of medication, changing risk factors and other interventions. Some risk factors can be modified. These would be losing weight, increasing exercise and the cessation of oral contraceptives. Moving during periods of travel is a modifiable behavior. Preventing blood clots includes the use of medications that interrupt the complex clotting cascade and changing the proteins that are needed for clotting. Antiplatelet drugs also have an effect in preventing the formation of clots. If a blood clot has

title: Rivaroxaban
text: (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. On November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prevention in people with non-valvular atrial fibrillation. Researchers at the Duke Clinical Research Institute have been accused of withholding clinical data used to evaluate rivaroxaban. Duke tested rivaroxaban in a clinical trial known as the ROCKET AF trial. The clinical trial, published 2011 in the New England Journal of Medicine and headed by Robert Califf, then Commissioner of the FDA) found rivaroxaban to be

title: Coagulation
text: forms of major surgery to decrease bleeding risk and need for blood products. Anticoagulants and anti-platelet agents are amongst the most commonly used medications. Anti-platelet agents include aspirin, dipyridamole, ticlopidine, clopidogrel, ticagrelor and prasugrel; the parenteral glycoprotein IIb/IIIa inhibitors are used during angioplasty. Of the anticoagulants, warfarin (and related coumarins) and heparin are the most commonly used. Warfarin affects the vitamin K-dependent clotting factors (II, VII, IX, X) and protein C and protein S, whereas heparin and related compounds increase the action of antithrombin on thrombin and factor Xa. A newer class of drugs, the direct thrombin inhibitors, is under

title: History of invasive and interventional cardiology
text: of the American College of Cardiology, preliminary results of the BASKET-LATE trial were presented, which showed a slight increase in late thrombosis associated with drug eluting stents over bare metal stents. However, this increase was not statistically significant, and further data would have to be collected. Further data published over the following year had conflicting results, and it was unclear whether stent thrombosis was truly higher when compared to bare metal stents. During this time of uncertainty, many cardiologists started extending the dual antiplatelet regimen of aspirin and clopidogrel in these individuals, as some data suggested that it may prevent