Needed: closer scrutiny of clinical trials.
نویسنده
چکیده
How many people know that eight patients in Hyderabad who were administered recombinant streptokinase to test its efficacy and safety have died? According to the Genetic Engineering Approval Committee (GEAC), the trial was being conducted by the drug’s manufacturer Shantha Biotechnics without taking clearance. Not surprisingly, the company denies the allegation claiming that it had taken permission from the Drugs Controller General, India (DCGI). In this game of passing the buck, no one is shedding any tears on the lives lost or compensating the families of those whose loved ones have died. Without any independent enquiry, the death of ‘trial subjects’, as they are impersonally called, has been attributed to ‘causes other than the use’ of the drug!
منابع مشابه
How To Use Clinical-Trial Data In Court
Multiple stakeholders in the U.S. health care system are also paying closer attention than ever to the safety and efficacy of treatments and monitoring how pharmaceutical companies report the results of their clinical trials. A consequence of this scrutiny is the number of mass tort and product liability cases in which pharmaceutical companies’ analyses, interpretations and reporting of biologi...
متن کاملEvidence Based Medicine: Clinical Trials
Evidence based medicine is very important for success of modern medicine. It is the ongoing process of using the most reliable evidence from clinical studies, scientific understanding and medical practice to make the best possible medical choice for patients. Evidence based medicine is how medicine advances and how we get improvements in life expectancy and quality of life. It not only identifi...
متن کاملThe Effect of Fennel on Pain Relief in Primary Dysmenorrhea: A Systematic Review of Clinical Trials
Background and aims: Fennel is often advocated for primary dysmenorrhea. Whether this herb has areal effect on pain relief is still a matter of debate in medicine. Therefore, this study was conducted toevaluate the effect of fennel on primary dysmenorrhea.Methods: This systematic review was conducted on clinical trials (non-randomized, randomized,historical study with co...
متن کاملLinking quality indicators to clinical trials: an automated approach.
Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials, is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of 522 quality of care indicators for 22 co...
متن کاملACE inhibitors after myocardial infarction: patient selection or treatment for all?
It is now clear that angiotensin-converting enzyme (ACE) inhibitors have an important role in the management of patients after myocardial infarction. Several clinical trials have shown statistically significant reductions in mortality (SAVE, AIRE, GISSI-3, ISIS4).1-4 Some may argue that the weight of evidence favours wide, if not universal, use of ACE inhibitors among post-infarct patients. Doe...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- Indian journal of medical ethics
دوره 1 1 شماره
صفحات -
تاریخ انتشار 2004