Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care.

Author: JohnsonDavid A, SchillerLawrence R

Paper Details 
Original Abstract of the Article :
Several high-profile drug withdrawals for safety issues have brought into focus the FDA's process for approving drugs and monitoring adverse experiences with those agents after marketing has begun. Gastroenterologists and their patients have been affected adversely by removal from the marketplace of...See full text at original site
Dr.Camel IconDr.Camel's Paper Summary Blogラクダ博士について

ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。

* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。


引用元:
https://doi.org/10.1111/j.1572-0241.2008.01818.x

データ提供:米国国立医学図書館(NLM)

Balancing drug risk and benefit: A critical look at FDA decisions

The process of approving drugs and monitoring their safety after they hit the market is a complex one. It's like navigating the shifting sands of evidence, trying to find the right balance between risk and benefit. This article examines the FDA's decision-making process in light of several high-profile drug withdrawals, highlighting the need for a more collaborative approach.

The FDA's role in ensuring drug safety

The FDA plays a crucial role in ensuring the safety and effectiveness of drugs, but the process is not without its challenges. It's like a shepherd trying to keep a flock of sheep in line, ensuring that all the drugs are safe and effective. This article points out that the FDA's decision-making process can be affected by a number of factors, including the availability of data, the severity of the risks, and the potential benefits of the drug.

The importance of collaboration in drug safety

The authors argue that the FDA should engage more closely with clinicians who treat patients with the drugs in question. This is like creating a dialogue between the shepherd and the sheep, ensuring that all perspectives are considered and that the best decisions are made for the safety of the flock.

Dr. Camel's Conclusion

This article raises important questions about the FDA's decision-making process and the need for greater collaboration with clinicians. It's a reminder that drug safety is a shared responsibility, and that we must continue to work together to ensure that patients receive the best possible care.
Date :
  1. Date Completed 2008-06-03
  2. Date Revised 2013-11-21
Further Info :

Pubmed ID

18397418

DOI: Digital Object Identifier

10.1111/j.1572-0241.2008.01818.x

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

This site uses cookies. Visit our privacy policy page or click the link in any footer for more information and to change your preferences.