Clinical Trials grow--Industry Investment Key to a Healthy Future

The march toward healthcare reform continues with the Biotech and Pharma industries in the crosshairs. Several initiatives target the industry. Discussion continues on allowing drug importation as a mechanism to lower drug costs. Fortunately the rider to the Tobacco Bill, allowing for importation was removed on June 9, with the caveat that the issue would soon be brought up for a congressional vote. The rallying cry for Follow on Biologics continues as President Obama is reminded of his commitment to create "generic competition" for biologic agents. 

The industry remains a key target and a poster child for greed in a healthcare system that seems to grow unchecked. Unfortunately little attention is paid to the continued investment made by the industry to advance healthcare. An overlooked barometer for investment is the quantity of clinical trials that are ongoing in both the US and around the world. All studies that are in Phases II-IV, which are essentially all clinical studies conducted in patients, must be registered with the National Institutes of Health (NIH). These trials can be found on the database  at http://www.clinicaltrials.gov/. The quantity of these trials is astounding.

As of June 10, there are a total of 74,235 trials registered. As of April 13 the database contained 71,398 studies according to Deborah Zarin of NIH (FD&C Reports, April 27,2009). In a period of 8 weeks, 2,837 new studies were added, a rate of 350 per week! Of these studies 62% are interventional studies conducted with drugs and biologics. The industry itself accounts for 31% of the studies. Federal agencies are responsible for 26% of the studies and the majority are from Universities/other at 43%. Many of these University sponsored studies are funded through non-restricted grants provided by the Pharma industry. 

These studies are a considerable investment in our health future. Not only do we hope to find the next breakthrough in mitigating disease, these trials increase the knowledge base of disease mechanisms and provide crucial information on the safe and effective utilization of current therapies. Many of these studies increase the understanding of cost-effectiveness and how to efficiently utilize the drugs and devices being studied. 

Who benefits from all of these clinical studies? We all do. We should therefore be wary of the unintentional consequences of squeezing drug prices. If the industry is forced to decrease expenditures, this type of investment will be scrutinized and potentially scaled back. We should not expect or desire that the government offset such a decline by increased funding.

As healthcare reform moves forward, let's keep in mind not to "kill the goose" that advances the future of our nation's health.