Claim: New drug ‘may turn back the clock on heart disease’
Verdict: REFUTES

Retrieved passages:
title: Rosiglitazone
text: after the story first broke in 2007, dropping from $2.5 billion in 2006 to less than $408 million in 2009 in the US. In response to the rise in risk of heart attacks, the Indian government ordered GSK to suspend its research study, called TIDE, in 2010. The FDA also halted the TIDE study in the United States. Three doctors' groups, the Endocrine Society, the American Diabetes Association and the American Association of Clinical Endocrinologists, urged patients to continue to take the drug as it would be much worse to stop all treatment, despite any associated risk, but that patients

title: Tamas Bartfai
text: for 'heartburn', as a consultant to Roche, the catechol-O-methyltransferase inhibitor (Tasmar-tolcapone) used in Parkinson's Disease, the first benzodiazepine–antagonist (flunitrazepam) for treatment of benzodiazepine overdoses, and as a consultant to Novartis the sphingosine 1-phosphate agonist gilenya-fingolimod as the first oral multiple sclerosis drug. He has also worked on four current drug candidates that as of 2015, are in phase 2 and 3 clinical trials. One of the most promising ones is the amyloid Αβ antibody that the Banner Alzheimer's Institute, Roche and the U.S. government are testing in Colombia for prevention of Alzheimer's disease in a large cohort with a familial

title: Peter Davies (scientist)
text: currently approved drugs for Alzheimer’s disease: Aricept, Exelon, and Razodyne. Davies is interested in the pathway of Alzheimer’s disease and has said that the disease may be a process of cell cycle division gone wild. He has evidence that the switch that drives the cell cycle of neurons, which is a one-time event when the neuron is born, is somehow tripped and reactivated late in life. He and his team designed an experiment to turn on the cell cycle in laboratory models. They put a viral oncogene into differentiated neurons and watched as pathological events unfolded. Davies and his collaborators

title: Giovanna Mallucci
text: over-activated a natural defence mechanism, ‘switching off’ the vital production of new proteins in brain cells. Switching protein production back on with an experimental drug halted neurodegeneration but the drug tested was toxic to the pancreas and not suitable for testing in humans. But in a study published in Brain, the researchers revealed how they identified a number of suitable candidates after testing 1,040 compounds from the National Institute for Neurological Disorders and Stroke, initially in worms, which have a functioning nervous system. Testing on mice with prion disease and a form of familial tauopathy or frontotemporal dementia (FTD) identified

title: Catecholaminergic polymorphic ventricular tachycardia
text: the heart, reducing the chance of abnormal heart rhythms developing. Of all the beta blockers, Nadolol may be the most effective for treating CPVT. This drug lowers the heart rate to a greater extent than other beta blockers and only needs to be taken once daily, reducing the chance of missed doses. Nadolol may be difficult to obtain and is not available in all countries, and an alternative beta blocker suitable for use in CPVT is Propranolol. Flecainide is a class 1c antiarrhythmic drug that is recommended for those with CPVT who experience abnormal heart rhythms despite taking a beta

title: Regeneron
text: will help reduce cholesterol up to 72% more than the leading brands. The new drug targets the PCSK9 gene. In July 2015, the company announced a new global collaboration with Sanofi to discover, develop, and commercialise new immuno-oncology drugs, which could generate more than $2 billion for Regeneron, with $640 million upfront, $750 million for proof of concept data and $650 million from the development of REGN2810. REGN2810 was later named cemiplimab. ARCALYST (rilonacept) for specific, rare autoinflammatory conditions. Approved by the FDA in February 2008. EYLEA (aflibercept injection) Approved by the U.S. Food and Drug Administration (FDA) in November

title: Rosiglitazone
text: of the heart risks of its drug, and that the FDA knew of the dangers months before it informed the public." It reports, "the FDA is investigating whether GSK broke the law by failing to fully inform the agency of Avandia's heart risks", according to deputy FDA commissioner Dr. Joshua Sharfstein. GSK threatened academics who reported adverse research results, and received multiple warning letters from the FDA for deceptive marketing and failure to report clinical data. The maker of the drug, GlaxoSmithKline, has dealt with serious backlash against the company for the drug's controversy. Sales on the drug dropped significantly

title: Ezetimibe/simvastatin
text: small and unique patient population, 720 patients in an Amsterdam hospital with heterozygous familial hypercholesterolemia. Merck and Schering Plough have reported that they have three trials underway to focus on outcomes, measuring the drug's effect on heart attacks and strokes in patients. These results were presented in full at the American College of Cardiology meeting on 30 March 2008, two years after the last patient completed the study. The House Committee on Energy and Commerce conducted an inquiry into the delayed disclosure of the study data. In the United States, Vytorin featured a television advertising campaign showing a series of

title: Rosiglitazone
text: Medicines Control Council of South Africa on July 5, 2011 stated that it had resolved on July 3, 2011 to withdraw all rosiglitazone-containing medicines from the South African market due to safety risks. It disallowed all new prescriptions of Avandia. Following the reports in 2007 that Avandia can significantly increase the risk of heart attacks, the drug has been controversial. A 2010 article in "Time" uses the Avandia case as evidence of a broken FDA regulatory system that "may prove criminal as well as fatal". It details the disclosure failures, adding, "Congressional reports revealed that GSK sat on early evidence

title: James Black (pharmacologist)
text: beta adrenergic receptor antagonist that revolutionised the medical management of angina pectoris, is considered to be one of the most important contributions to clinical medicine and pharmacology of the 20th century. Propranolol has been described as the greatest breakthrough in heart disease treatments since the 18th century discovery of digitalis and has benefited millions of people. Black's method of research, his discoveries about adrenergic pharmacology, and his clarification of the mechanisms of cardiac action are all strengths of his work. He was greatly involved in the synthesis of cimetidine, at the time a revolutionary drug for the treatment and prevention

title: PCSK9
text: circulating LDL particle concentrations. Since LDL particle concentrations are thought by many experts to be a driver of cardiovascular disease like heart attacks, it is plausible that these drugs may also reduce the risk of such diseases. Clinical studies, including phase III clinical trials, are now underway to describe the effect of PCSK9 inhibition on cardiovascular disease, and the safety and efficacy profile of the drugs. Among those inhibitors under development in December 2013 were the antibodies alirocumab, evolocumab, 1D05-IgG2 (Merck), RG-7652 and LY3015014, as well as the RNAi therapeutic inclisiran. PCSK9 inhibitors are promising therapeutics for the treatment of

title: Cardiovascular Cell Therapy Research Network
text: clinical trials studying treatments for heart disease and peripheral artery disease. These sites include: In July 2008, the CCTRN opened enrollment in two studies in patients who had recently suffered heart attacks: TIME () and LateTIME (). The purpose of these studies was to determine if stem cells safely taken from an individual’s bone marrow could be transplanted back into the injured heart muscle of the individual and improve the heart’s ability to pump following a heart attack, as well as to determine the best time for transplanting the cells following a heart attack. The results of both studies were

title: Steven Nissen
text: the Bristol-Myers Squibb drug Pargluva (muraglitazar), an experimental type 2 diabetes drug. When an U.S. Food and Drug Administration (FDA) advisory panel charged with reviewing the clinical trial data approved the drug, he immediately began an in-depth analysis. In 2007, the meta-analysis by Nissen and his co-investigator Kathy Wolksi, published in the Journal of the American Medical Association online on October 20, found that the diabetes drug rosiglitazone (Avandia) produced by GlaxoSmithKline carried high cardiovascular risks. The FDA issued an alert on May 21, 2007, leading to a warning by the Food and Drug Administration and a sales loss of

title: ERT (company)
text: approval by the U.S. Food and Drug Administration (FDA). In 1979, the company analyzed 4,500 Holter readings for the National Institutes of Health’s Beta Blocker Heart Attack Trial. The study resulted in the recommendation to use the drug propranolol for at least three years in patients who have had a recent heart attack and who need to have their heart rate slowed down. In 1987 Cardio Data Systems, Ltd. expanded to the United Kingdom to extend its business services internationally. They based their operations in Peterborough, Cambridgeshire. In 1990, now known as CDSResearch, they initiated a computer analysis for cardiologists

title: Masato Tanabe
text: A compound discovered in a previous contract from NIH showed potential - it acted like "anti-estrogen" in the breasts and uterus but like normal estrogen elsewhere in the body, and were thus more "tissue-selective". A contract was proposed to Taiho Pharmaceutical in July 1996, and within six years and slightly under $3 million (an unusually short amount of time) two new drugs were discovered and tested on people (particularly people for which tamoxifen has failed): SR16234 and SR16287. The first of those, SR16234, also inhibited the growth of blood vessels (angiogenesis) and accelerated the death of cancer cells (apoptosis) and

title: PCSK9
text: The first two PCSK9 inhibitors, alirocumab and evolocumab, were approved as once every two week injections, by the U.S. Food and Drug Administration in 2015 for lowering LDL-particle concentrations when statins and other drugs were not sufficiently effective or poorly tolerated. The cost of these new medications, , was $14,000 per year at full retail; judged of unclear cost effectiveness by some. While these medications are prescribed by many physicians, the payment for prescriptions are often denied by insurance providers. In February 2003, Nabil Seidah, a scientist at the Clinical Research Institute of Montreal in Canada, discovered a novel human

title: Raymond L. Woosley
text: co-director of the landmark NIH-sponsored Cardiac Arrhythmia Suppression Trial (CAST) that found arrhythmia suppression by drugs to be an invalid biomarker for the prediction of drug therapy that prevents sudden death. Dr. Woosley's research at Georgetown contributed substantially to the recognition that non-cardiovascular drugs, such as antihistamines (e.g., terfenadine (Seldane)), may have arrhythmogenic effects. Dr. Woosley's invention, fexofenadine (Allegra), resulted from this research and is today marketed as a safer non-sedating antihistamine replacing Seldane. His research on drug safety led Dr. Woosley to champion the development of the Centers for Education and Research on Therapeutics (CERTs), until 2016, a network

title: Pharmaceutical industry
text: Novello of Merck and Co. discovered and developed chlorothiazide, which remains the most widely used antihypertensive drug today. This development was associated with a substantial decline in the mortality rate among people with hypertension. The inventors were recognized by a Public Health Lasker Award in 1975 for "the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension". A 2009 Cochrane review concluded that thiazide antihypertensive drugs reduce the risk of death (RR 0.89), stroke (RR 0.63), coronary heart disease (RR 0.84), and cardiovascular events (RR 0.70) in people with high blood

title: Thrombolytic Science International
text: and heart attacks. The company completed a Phase I trial in The Netherlands in 2017. The company raised $8 million by 2012 mostly from an undisclosed angel investor. Thrombolytic Science International Thrombolytic Science, LLC (TSI) is a private, clinical stage biopharmaceutical company that was founded in 2006 based on the research of Harvard scientist Victor Gurewich into the potential use of prourokinase to break up blood clots. Gurewich co-founded the company and the founding CEO is business person Alexis Wallace. TSI's lead drug candidate is a synergistic sequential dual therapy combination of mutant prourokinase (the precursor form of urokinase) and

title: Migalastat
text: a total of about 110 subjects were conducted between 2009 and 2015, one double-blind comparing the drug to placebo, and one comparing it to recombinant α-GalA without blinding. Migalastat stabilised heart and kidney function over the 30-months period of these trials. In September 2015, Amicus announced that it would submit a new drug application (NDA) for accelerated approval of migalastat to the FDA by the end of 2015. The CHMP recommended approval in April 2016, but the FDA rejected the application in November for having insufficient data in November 2016. The drug was approved in the European Union in May