Are the Europeans more open about safety?
- Author Thomas Strickland
- Published November 22, 2010
- Word count 511
As in the US with the FDA, the Europeans have a regulatory body called the European Medicines Agency (EMA). It is responsible to approving drugs for use and then monitoring their performance once released into homes and hospitals. The problem is always one of trust. How do we know either agency is doing its work properly and protecting us as consumers? The European Union has laws supposedly guaranteeing free access to information. So governments and NGAs should be proactive and release as much information as possible. If there are gaps, citizens have the right to request the release of the information. There's a European official called an Ombudsman who has the job of policing the system and ensuring all public bodies make as full a disclosure as possible. The EMA has a database of all the adverse drug reactions reported by all European hospitals, clinics and individual doctors. In 2008, an Irishman asked the EMA to release all the data on a particular drug his son had taken to treat his acne. Shortly after starting treatment, his son had committed suicide and his father wanted to discover whether there was a pattern suggesting this drug raised a risk of suicide. The EMA refused to release this information.
The EMA argued that, without understanding the context of each individual report and having the chance to evaluate the evidence, a disclosure of all the information could be very misleading. Parliament only intended the information to be disclosed after the EMA had completed an evaluation, which might show the reports did not show sufficient cause and effect to prove a "problem". The reaction of the Ombudsman is very interesting. Essentially, he dismissed all the legal arguments and said that, if the release of raw information might be misleading, all the EMA need do is add a short commentary explaining the documents and how reliable they were. He ordered disclosure of the adverse reaction data as requested.
One of the main issues with all drugs is that, once they are released on to the market, there is little incentive to the manufacturer to follow each drug's actual performance. If it turns out less than impressive, the regulator might order it withdrawn. So for any regulatory system to protect us as consumers, the FDA or EMA should have a formal plan to monitor the performance of drugs after release. Without a proactive process to collect information about drugs, real problems may go unreported and so patients may be injured or killed.
In fact, the drug involved is Accutane and, according to the FDA, there have been a limited number of case where teens have committed suicide while taking this drug. But there is no evidence showing cause and effect. Teens with acne are more likely to grow depressed and to consider suicide a way of escaping the bullying. Nevertheless, it is good to see the Europeans being insistent on all the raw data on Accutane being released. The FDA has no comparable policy of openness and never releases postmarketing surveillance information, alleging the information is commercially sensitive.
Thomas Strickland is always ready to share his professional point of view on a topic. To see what Thomas Strickland has written about other things visit [http://www.bodytreatmentsite.com/accutane-and-the-issue-of-openness.html](http://www.bodytreatmentsite.com/accutane-and-the-issue-of-openness.html).
Article source: https://articlebiz.comRate article
Article comments
There are no posted comments.
Related articles
- Tesla Lemon Law
- Mary Ferry Real Estate agent in Lakeland, Florida
- Essential Marketing Strategies for Small Businesses in 2024
- Top 10 Digital Nomad Destinations for 2024 with Cost of Living Insights
- AI and Nanotechnology: How Your Smartphone Could Soon Detect Health Issues at Home
- Top Emerging Trends in Quantum Computing for 2024 and Beyond
- Luxury Chauffeur Services: A Journey of Elegance and Convenience
- What Is Harmony in Interior Design, and Why Does It Matter?
- Acura MDX and Honda Pilot: Which one will you choose?
- How to Save Money Every Day With Promo Codes
- Fresh Paint for a Fast Sale: Here's Why You Should Paint Before Listing
- The Invisible Impact of Missing Teeth: Why Replacing Them Matters
- Detecting Dental Beauty: 5 Core Traits of a Beautiful Smile
- Timeless Toothcare: Dental Hygiene Tips for Seniors
- Saving Old Smiles: How In-House Dental Discount Plans Help Seniors
- Too Much of a Good Thing? Signs You’re Brushing Your Teeth Too Hard
- Why a Root Canal Might Be the Best News for Your Tooth
- 10 Techniques for Achieving a Lean and Efficient Supply Chain
- What is DuckDuckGo?
- The Role of Lighting Stores in Brampton: Shaping Spaces for the Future
- The Role of Commercial Cleaning Services in Auckland: A Comprehensive Guide
- Exploring the World of Chauffeur Service: Benefits, Challenges, and Best Practices
- Nerds and Geeks: They still live on!
- IQ Tests: History, Uses, and Choosing a Reliable Resource
- 8 Great Ways To Teach Kids About Oral Hygiene
- App Development as a Catalyst for Business Growth
- Costs of arranging a Mortgage in Spain
- TikTok and Instagram: Ways you will grow and learn.
- Mustang GT: Ford Motor Company is a Rising Force!
- 10 Ways to Transform Production Scheduling in Business Central