The late nineties and early 2000’s were marked by an unprecedented wave of drugs like Rezulin, Lipobay or Vioxx gone wrong. Pharmaceutical companies faced huge losses and damage to their reputations. Johannes Klose of Allianz Global Corporate & Specialty explains why today’s medicines are safer than ever.
 | Johannes Klose, Scientific Advisor, Allianz Global Corporate & Specialty"New drugs have probably never been as safe as today." (Photo: Allianz) |
What went wrong in the nineties?
On the one hand, pharmaceutical companies had a lot of new products, which may be a cause that more products failed after market launch. On the other hand, regulatory hurdles were not as high as today. The introduction of fast track approvals may also have entailed new risks.
In recent years, there has been a lot of effort put into the development and implementation of risk evaluation and mitigation strategies by regulators and pharmaceutical companies.
Regulatory actions - especially in the U.S. - have a crucial impact on losses for pharmaceutical companies and insurers worldwide. Finally, there were lots of well-prepared lawyers just waiting for new drugs to go wrong.
What is different today?
There was one case that can be considered as a turning point. Vioxx, an anti-inflammatory pain reliever from Merck Incorporated was launched in 1999 and generated billions of dollars of revenues. But it was withdrawn from the market in 2004 due to alleged cardiovascular safety issues.
The Vioxx case prompted a lot of initiatives to improve drug development, approval and post-marketing surveillance processes. For example, risk evaluation and mitigation strategies for new and already approved products have been improved. Resources, funding, and power for some important regulatory authorities have been increased and they have enhanced risk communication and transparency.
Higher regulatory hurdles imply that more safety data and dedicated safety studies are requested. A lot of new laws were passed and today patients are also better informed about the risks of drugs.
In recent years fewer new drugs have entered the market. Is this the pay off for safer drugs?
The hurdles for new drugs have increased. Many companies reacted by completely redesigning their drug development process to prevent failure at a late stage of drug development. At this time they have usually invested hundreds of millions of dollars already.
All this led to many drugs being eliminated at an early stage. On the other hand, drugs have definitely become safer. New drugs have probably never been as safe as today.
 | Medical Breakthroughs Gallery (click on the image to start)Ten of the biggest medical breakthroughs that have helped make the world a healthier place (Photo: Reuters) |
Is there something patients can do to be on the safe side?
The best patients can do, is to get into an educated dialog with their physicians. Many patients, especially those with chronic diseases like epilepsy, are extremely well informed about their disease and the treatment options. They are very demanding patients, but extremely good and compliant partners for their physicians.
This can only be recommended generally. But patients should be careful with information from the internet. There are very good sites, but many blogs are also very biased and sometimes even plain wrong.
From the insurer’s perspective, how did your business change after the big losses in the 90s?
The first change was, when other companies completely withdrew from liability insurance in this sector. We didn’t want to disappear from the market, so we adopted a very restrictive approach. Looking back it was a good approach for some years.
We used this time to learn more about the risks, built up a sophisticated system of risk identification and assessment. As a consequence, two years ago we decided to become a more important player in this segment.
What are the most important trends for the pharmaceutical market in the years to come?
One trend is the increasing cost pressure, which is already big in Europe but will increase in the U.S. as well. Some pharmaceutical manufacturers are considering partial outsourcing. Furthermore, regulatory hurdles will be higher.
Recently, a lot of research has started on so-called biomarkers which make it easier to understand how new drugs work and affect the body.
There are also a lot of biotech products in the pipeline. Many of the first biotech companies failed, but in the last five years pharmaceutical companies have bought a lot of biotech start-ups. So proteins, hormones, or antibodies produced from genetic engineering will become much more important in the future.
editor: Thilo Kunzemann
publishing date: February 23, 2009
Do you have something interesting to add? Write a comment and discuss this topic with other readers. Comments should be on-topic, non-commercial, and not contain abuse of any kind.
Comment Policy
