Are overseas drug companies looking for cardiovascular health solutions or flicking the next deregulation domino?
The website Science 2.0 recently featured an interesting item: They examined a report called “Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology.” Notice that nowhere in the title is there any hint that the pharmaceutical industry occupied some of the seats at that table. Neither does it intimate anything about doing away with randomized controlled trials (RCTs), which is at the heart of their suggested “improvements.”
The authors acknowledge that the randomized controlled trial has transformed the practice of medicine and particularly of cardiovascular medicine, but add that “it has become bloated and inefficient and may be hindering cardiovascular drug development.” They point to several aspects of cardiovascular medicine which they say “make investment into cardiovascular drugs less attractive than other fields of medicine,” including that:
1) Many cardiovascular therapies require long term treatment to see any effect. Demonstrating incremental risk reduction often requires very large sample sizes.
2) Cardiovascular disease encompasses a diverse range of mechanisms, not all of which are influenced by the agent studied making it difficult to identify patients likely to benefit.
3) Clinical trials are complex and subject to at times contradicting national and regional regulations.
Other obstacles according to the authors of the position paper include the high cost when drugs fail in late stage clinical trials. The Science 2.0 article says the round table purports “solutions to reinvigorate industry investment in cardiovascular research including targeted drug development and evaluation in defined patient populations, and simplifying large randomised trials.” Indeed, lest pharmaceutical companies profiting nearly $75 billion yearly be forced to take a financial risk!
“We propose a streamlined pre-approval evaluation process for new cardiovascular medicines,” said a lead author, describing the scheme. “We envision that a novel agent may initially be tested and approved for a smaller target population, underpinning the emerging concept of personalised cardiovascular medicine, and that further safety and efficacy data can be collected after the initial (conditional) approval. This will mitigate the risk for drug developers, and provide earlier access to novel therapies for patients.” Mitigating risks for drug developers while aggravating risks for patients? It is true that RCTs need to be improved. This means, however, taking them out of the hands of pharmaceutical corporations, not handing them blanket approval.
Sounding much like their political partners, the group carefully parsed out these words: “Cardiovascular drug development is partially a victim of its own success, where mortality benefits are the accepted benchmark in the field, and new therapies have traditionally been evaluated in large cohorts. We have developed ever more robust systems to conduct such trials, and are now faced with a total cost that seems prohibitive for some of the novel developments. Progress in prevention of cardiovascular diseases may require more stratified or personalized management approaches in the future. It costs up to $12 billion to bring a single drug to market and delays such as long regulatory reviews leave a short window to recoup costs before a patent expires.” Not to mention their “window to recoup” before the patient expires.