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Organised crime, the business model of big pharma
Published in Peter C. Gøtzsche, Richard Smith, Drummond Rennie, Deadly Medicines and Organised Crime, 2019
Peter C. Gøtzsche, Richard Smith, Drummond Rennie
The payment concerned criminal and civil liability arising from the illegal marketing of Trileptal (oxcarbazepine, an epilepsy drug approved for the treatment of partial seizures, but not for any psychiatric, pain or other uses).28 The company unlawfully marketed Trileptal and five other drugs, causing false claims to be submitted to government healthcare programmes. The agreement resolved allegations that the company paid kickbacks to healthcare professionals to induce them to prescribe Trileptal and five other drugs, Diovan (valsartan, for hypertension), Zelnorm (tegaserod, a drug for irritable bowel syndrome and constipation, which was removed from the market by the FDA in 2007 because of cardiovascular toxicity), Sandostatin (octreotide, a drug that mimics a natural hormone), Exforge (amlodipine + valsartan, for hypertension) and Tekturna (aliskiren, for hypertension).
Efficacy and effectiveness of valsartan/amlodipine and valsartan/amlodipine/hydrochlorothiazide in hypertension: randomized controlled versus observational studies
Published in Current Medical Research and Opinion, 2018
Jorge Sison, Rosa María Ríos Vega, Hu Dayi, Giovanni Bader, Patrick Brunel
Hypertension, one of the important risk factors for cardiovascular diseases, is estimated to affect globally more than one billion individuals and is leading to an estimated 9.4 million deaths every year5. Despite the wide availability of medications, hypertension is not managed well, even though it is controllable. Many patients may benefit from combination therapy to achieve blood pressure (BP) control6 and nearly two-thirds of them take multiple antihypertensive therapy7. Recommended effective combination therapies include blockers of the renin–angiotensin–aldosterone system such as angiotensin-receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) administered together if BP levels require it with calcium channel blockers (CCBs) and/or diuretics for lowering BP8. The efficacy of Val/Aml has been widely studied in several RCTs, conducted in more than 40 countries across the world and including diverse subgroups such as elderly and obese patients, patients with diabetes, and patients with isolated hypertension (ISH)9–13. In addition, the effectiveness of Val/Aml has been confirmed in several RWE studies. To date, 13 large RWE studies have been carried out with Exforgea (Val/Aml) in more than 60,000 patients across 26 countries worldwide (Bahrain, Bangladesh, Belgium, China, Egypt, Germany, Kuwait, Lebanon, Malaysia, Middle East Countries, Oman, Pakistan, Qatar, Russia, Saudi Arabia, Turkey, United Arab Emirates, Indonesia, India, Hong Kong, Pakistan, Philippines, South Korea, Thailand, Taiwan, South-Central US)14–26. Similarly, the efficacy of the Val/Aml/HCTZ single pill combination (SPC) has been studied in approximately 1500 patients in five studies worldwide, including diverse subgroups such as elderly and obese patients, patients with diabetes, and patients across various ethnicities and races27–31. With Exforge HCTa (Val/Aml/HCTZ), two larger RWE studies, EXforge Clinical evaluation of AmlodIpine and valsarTan in hypertension (EXCITE) and SIMPLIFY had been carried out in over 8000 hypertensive patients across 14 countries (Bahrain, Egypt, Germany, Kuwait, Lebanon, Oman, Qatar, United Arab Emirates, Indonesia, Hong Kong, Pakistan, Philippines, South Korea and Taiwan)14,32.