Is It To Expensive to Develop and Test Cardiovascular Drugs?

cardiovascular-drugsDespite the fact heart disease continues to be among the leading causes of death in the United States (and throughout the world), the number of drugs in development aimed at combating the condition continue to drop, and they have for the past two decades.

A new study, published on Monday in the JACC: Basic to Translational Science, analyzed existing data from a massive collection of commercial drug development activity database that focused on all drugs designed to treat cardiovascular disorders and had also entered Phase 1 clinical trials between Jan 1 1990 and Dec 31 2012.

The study easily found that no more than 350 drugs designed for treating cardiovascular disease went into Phase 1 trials within this time frame. The majority of these drugs were antihypertensive or lipid-lowering agents, or anticoagulants. More importantly, though, the analysis found that between 1990 and 1995, 16 percent of drugs entering into Phase 1 trails were designed specifically to treat cardiovascular diseases. Between 2005 and 2012, though, only 125 out of 2,366 drugs were designed for such purposes (and made it to Phase 1 tasting).

That equates to only 5 percent.

“These findings shed light on several important shifts in cardiovascular research and development activity over the past two decades. Importantly, while the overall number of new investigational cardiovascular drugs has declined, we also found a relative growth in the number of drugs targeting novel biological pathways ,” explains Aaron S. Kesselheim, M.D., J.D., M.P.H., who is the associate professor of medicine at Brigham and Women’s Hospital and Harvard Medical School.

The lead study author may also indicate that this number dipped even more in 2012, a time when cardiovascular drugs only accounted for 7 percent of Phase 3 tests.
and the senior author of the study.

The researchers note that cardiovascular drug development has long been funded by major pharmaceutical companies. Of late, though, smaller companies have begun to throw their hat into the fray.

As such, journal editor-in-chief Douglas Mann notes, “These findings are not entirely glass-half empty. Part of the decline in new drugs is that there are less ‘me too’ drugs that are similar to those already available. The study also refutes the premise that cardiovascular drugs are often riskier to develop than drugs in other clinical categories.”

And basically, they conclude that—at least in part—skyrocketing costs of conducting these studies is not compensating competition from low-cost generic drugs.