Researchers Distressed by Overregulation of Drug Development

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Overregulation of new drug development has driven up the cost of care and resulted in significant loss of human life by delaying the approval of effective medications. David J. Stewart presented these findings at the 2015 World Conference on Lung Cancer, a meeting of over 7,000 oncology professionals.

"The huge cost of driving clinical research is rising much faster than the rate of inflation, and it is all about complying with regulation," Stewart, head, Division of Medical Oncology, University of Ottawa/The Ottawa Hospital, said during a press briefing. "For people with a 100 percent percent largely by the costs of doing the research. We're going to bankrupt ourselves."

At the conference, Stewart presented an analysis of 21 drugs that were shown to significantly prolong overall survival (OS) in phase 3 clinical trials between 2000 and 2015 across 10 incurable malignancies. The analysis excluded adjuvant trials and those for uncommon diseases. The number of life-years potentially lost was assessed by multiplying the improvement in OS in years seen with each treatment by the estimated number of patients who died annually from the relevant indication.

For each therapy, the median time from drug discovery to approval was 12 years. Across all indications worldwide, the median number of life-years lost per year was 2.54 million. From discovery until approval, there was a total loss of 31.54 million years of life. By reducing the average time of development to five years, the authors predicted that 19.4 million life-years could be saved.

In North America, 29 life-years were lost for every hour that approval was delayed. Taking this into account, each year of development equated to 251,626 life-years or slightly over three million life-years over the full 12-year course of development.

Added safety measures that were a byproduct of regulation were not without their merit. These measures were found to save less than 700 life-years for each drug. However, when looking at the two figures in contrast, there were approximately 50,000 life-years lost due to delays for every one life-year saved through greater clinical research safety.

While the exact costs associated with the development of each agent were not explored, some reports have placed the cost of development for a drug from discovery to approval at over $1 billion.

"We need to take the speed of approval and the expense of approval and make that our top priority for lethal diseases," Stewart said. "Regulation is absolutely essential but we need something that is equivalent to the autobahn in Germany — unlimited speed limits but yet one of the lowest traffic fatality rates in Europe — it's because they have smart regulations: not too much, not too little. Right now, our regulation is not smart."

While accelerated approvals and breakthrough designations have made strides toward improving the speed of new drug approvals, additional changes are still needed. Many of the speed bumps toward rapid drug development involve documentation, preclinical studies, and delays associated with setting up clinical trial locations. Not only can these processes slow down development but they can also add considerable costs, Stewart said.

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