Evaluating the Safety and Effectiveness of New Drugs

Abstract

Prescribers seek to provide their patients with access to the latest innovations in medicine to maximize their health status. When a new drug comes to market, it often has not been as widely tested as other available therapies, and its effectiveness and safety cannot be fully evaluated. To address this problem, physicians can use the STEPS (Safety, Tolerability, Effectiveness, Price, and Simplicity) mnemonic to provide an analytic framework for making better decisions about a new drug's appropriate place in therapy. A key element is to base this evaluation on patient-oriented evidence rather than accept disease-oriented evidence (which may be misleading), while avoiding inappropriate reliance on studies that report only noninferiority results or relative-risk reductions. The primary question to ask for each new drug prescribing decision is, "Is there good evidence that this new drug is likely to make my patient live longer or better compared with the available alternatives?"

How Silencing of Dissent in Science Impacts Woman. The Gardasil® Story

“…It is hoped that instead of looking at parents who question the safety and efficacy of a vaccine such as Gardasil ® as "kooks" that the physician, when deciding to vaccinate or not will ask the question; "Is there good evidence that this new vaccine is likely to make my patient live longer or better compared with the available alternatives?" [112] We do not know how long the vaccine will last, the HPV types covered by the vaccine are limited, and the very safe alternative of Pap screening with early detection and treatment is a proven successful program. Although Gardasil® may allow a woman to experience fewer abnormal Pap tests it is not likely to extend a woman's life in countries where cytology screening is readily available [113] [114].…”

Review of Gardasil

“…The primary question to ask about the decision to vaccinate with Gardasil is, “Is there good evidence that this new vaccine is likely to make my patient live longer or better compared with the available alternatives?” [74]. We do not know how long the vaccine will last, the HPV types covered by the vaccine are limited, and the very safe alternative of Pap screening with early detection and treatment is a proven successful program.…”

Myth: When it comes to drugs and devices, newer is always better

“…Sometimes clinical trials are short term or do not include specific groups, such as individuals above a certain age, 7 which makes it difficult to predict all of the possible outcomes that can occur when a new drug reaches the general population. 8,9 As a result, some adverse events are recognized only after a drug is released. 8 A recent study of new drugs approved in Canada between 1995 and 2010 showed that almost one in four had a serious safety issue.…”

“…8,9 As a result, some adverse events are recognized only after a drug is released. 8 A recent study of new drugs approved in Canada between 1995 and 2010 showed that almost one in four had a serious safety issue. 10…”

“…Additionally, sometimes new drugs are not new in the molecular sense. 8,11 Instead, they are existing drugs or molecular entities that have been reformulated (e.g. extended-release versions of various pharmaceuticals) or repositioned for the treatment of different conditions.…”