Cardiovascular studies are on the decline

In the arena of drug development, cardiovascular medicine is no longer the favorite therapeutic area. This is according to a study published in the August issue of Nature, which analyzed the number of clinical trials registered at ClinicalTrials registery during the last two years, as reported by heartwire. Cardiology, which used to occupy the top priority position in research and development in the pharmaceutical industry, only now ranked 3^rd. The top two places are occupied by cancer oncolgy and neurodegenerative medicine, respectively. This is despite the fact that lipid regulators which brought in US$ 35.2 billion worth of drug sales in 2006. The complete list of the six highest-ranked therapeutic/disease areas is given below:

• Oncology
• CNS disorders
• Cardiology
• Infectious diseases
• Endocrinology
• Respiratory diseases

The Nature review paper which surveyed Phase II to IV interventional studies sponsored by pharmaceutical companies and registered with the clinical-trials registry between October 2005 and September 2007 showed the same trend.

Does this mean that the incidence of cardiovascular diseases has decreased significantly that they are no longer a major health threat? Unfortunately, this is not the case. Many pharmaceutical companies feel that the profitable days of statins and beta-blockers are coming to an end as one drug after another, including the blockblusters Coreg and Lipitor, lost or will soon be losing its patent. With each drug going off patent, generic versions are already waiting at the sidelines to grab the market.

An as example of the lack of enthusiasm for cardiology, I reported in an earlier post about an internal memo from Pfizer which some how leaked which stated

“…an Integrated Strategic Plan (ISP) that focuses and prioritizes our R&D investments. Alzheimer’s Disease, Diabetes, Inflammation/Immunology, Oncology, Pain and Psychoses (Schizophrenia) are confirmed as our higher priority areas.“

Several clinical phase drugs which showed blockbuster potential fell short of expectations and many are facing safety issues. Results from the ENHANCE trial which tested ezetimbe (Zetia) in combination simvastatin were disappointing as well as controversial. More recently, all clinical development programs of rimonabant (Acomplia), earlier thought to be the next bestseller, were halted when the European Medicines Agency (EMEA) announced that “it had asked the company [sanofi-aventis] to suspend marketing of the drug, on the grounds that its benefits no longer seemed to outweigh its risks.” The APPROACH study failed to show that rosiglitazone (Avandia) prevents atherosclerosis progression in diabetes patients, thus probably putting a stop to the drug’s use in cardiovascular medicine. Late last year, the US FDA added a black box warning to Avandia’s label due to increased heart attack risks.

As previously discussed in a previous post, maybe it’s time to look more towards lifestyle change strategies for prevention and treatment of cardiovascular treatment. And I think it’s worth repeating some practical tips here:

• Wellness and fitness in the workplace.
• Better nutrition and fitness in schools.
• Legislation regulating smoking.
• Better access to health care.
• Increased health awareness and education.

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