Sian Claire Owen, medical journalist for Cardio Debate, UK


A recent editorial published in JAMA Cardiol in December 2017 argues that cardiovascular drug development is grinding to a halt.

Milton Packer, MD, from the Baylor Heart and Vascular Institute, Baylor University Medical Centre, Dallas, Texas, writes that “the development of new cardiovascular drugs is at its deepest nadir in decades.” [1]

Heart disease affects millions of people, and remains the biggest killer in the US, if not worldwide. Therefore the cost of new drugs is likely to have a significant impact on healthcare budgets simply by virtue of the large numbers of people who suffer from CVD.

Packer writes that factors outside the immediate scope of therapeutic benefit – including issues with health insurance, and health care systems introducing barriers to prescribing new drugs – are having an impact on drug development. Also, the high cost of running large-scale clinical trials is having a dampening effect.

These problems may be getting worse over time, but they are by no means new. In 2015, a review paper published in the Journal of the American College of Cardiology describes the same issues – that despite the increase in prevalence of CVD, investment in CVD drug development has stagnated. [2]

Furthermore, advances in areas such as genomics and systems biology that, for example, have paved the way for the identification of new therapeutic targets have not correlated with an increase in new drug development.

Experts have offered a range of possible solutions, many of which focus on ensuring new clinical trials are efficient and cost-effective. Some of these solutions include reducing the amount of “extraneous data” in order to reduce costs; encouraging future trialists to focus on the quality of the trial design to improve efficiency; and to consider large, simple trials – such as the successful PARADIGM-HF study – which was provided by the authors as a good example. [2]

A number of leading cardiologists shared their thoughts on the matter in a 2016 CardioBrief article published in MedPage Today. [3] Dr Sanjay Kaul from Cedars-Sinai Medical Centre, Los Angeles, US, says: “Not only does drug development follow science, but also the return on investment. It has become increasingly difficult to show incremental treatment benefits in the cardiovascular space relative to other disciplines such as oncology and neuroscience. All the low hanging fruit has been picked!” [3]

In the same article, Steve Nissen, Cleveland Clinic, Ohio, US adds that: “We’ve had a […] tremendous run with a series of extraordinary therapies like ACE inhibitors and statins and they have markedly reduce mortality and morbidity from cardiovascular disease.” However, he adds that as CVD continues to be the leading cause of death in the developed world, he doesn’t believe it is “prudent to abandon cardiovascular disease as a drug target, although the challenges for industry are higher than they have ever been.” [3]

Clearly there is no easy or straightforward answer to this problem. In the meantime, recent news reports describe how life expectancy in the US has decreased over two consecutive years, in part because of the prevalence of CVD. [4] Do we really want to decrease investment in CVD drug research at this point in time?

References

  1. Packer M. The imminent demise of cardiovascular drug development. JAMA Cardiol 2017; 2(12): 1293 – 4.
  2. Fard, Roe MT, Ahmad T, et al., Cardiovascular drug development: Is it dead or just hibernating? JACC 2015; 65(15): 1567-82.
  3. https://www.medpagetoday.com/cardiology/cardiobrief/59979
  4. http://edition.cnn.com/2017/12/21/health/us-life-expectancy-study/index.html