February 19, 2010

Biotechnology research is no trial-and-error approach

By Tom Greene

Biotechnology research is no trial-and-error approach



By Tom Greene

As Georgia struggles to climb out of the economic morass, it will take a new breed of leaders to recognize that the economic future of the state lies not in manufacturing, agriculture or military contracting but in biotechnology research.

Clinical trials of new medications or cutting-edge medical device technology offer unparalleled opportunities to bring research dollars, venture capital funds, free health care and, most importantly, jobs to our region.

Georgia ranks 17th in the nation for active recruiting of Phase I clinical trials. According to the Kaiser Family Foundation, 17.8 percent of Georgians have no health insurance. While Georgia watches Washington try to determine the fate of health care reform, the state can provide health care to its citizens by becoming the epicenter of biotechnology research.  

Consider clinical trials, for example. In most trials, patients with or without medical insurance are recruited to participate based on their medical history or disease state. These volunteers receive full physical examinations and thorough diagnostic screening and evaluation from credentialed professionals. Trials may last many years, during which the participant's health is closely monitored. This health maintenance byproduct is provided at no cost to the participant. 

Marietta resident Debra Skurski was unemployed when she volunteered to participate in a trial of blood pressure medication already on the market; the pharmaceutical company's ongoing tests maintain current statistics on the possible side effects of a blood pressure medication.

"It was a great way to have free meds and regular monthly checkups," Skurski says. "My regular cost of blood pressure meds runs about $75 a month, so that was a huge savings. Monthly checkups at my doctor would have been about $65."

The pharmaceutical company covered colonoscopies at the beginning and end of the trial, because one possible (statistically insignificant) side effect was colon cancer. She was paid a $400 stipend and transportation costs, and she would have received medical care at no cost in the event of complications caused by a side effect.

"Since then I've heard from several people, including doctors, who recommend clinical trials as a great way for patients to save on some of their health care costs," Skurski notes.

Of course, clinical trials also have a tremendous economic impact far beyond the simple health care advantage. While biotechnology research may seem like a big-city idea, consider also the impact to the state's rural and non-metropolitan communities.

Georgia can attract industry and academic trial sponsors for several reasons:

• The state is rich with ethnic diversity, allowing sponsors to report demographics that more broadly reflect America.

• As the ninth-largest state in the union, Georgia boasts a significantly lower cost of care than other states of similar population. If you're looking for a place to host a clinical trial, Albany, Ga., for instance, wins on a pure cost comparison. The cost of a typical EKG at Albany's Phoebe Putney Memorial Medical Center for instance is $1,300. Develop chest pains in Detroit, Mich., and that test will cost you $2,175 at St. John Hospital and Medical Center.

• Georgia provides excellent access to existing medical resources, including 16 geographically diverse teaching hospitals and one of the nations leading children's hospitals.

In order to brand Georgia as the epicenter of biotechnology research, leadership under the Gold Dome must act to attract more clinical trials. Despite the state's impressive attributes, the critical ingredient for driving industry and academic trial sponsors to favor one region over another is simple: patients.

The speed at which a clinical trial can be conducted is largely driven by the availability of qualified, pre-screened volunteer patient populations. Shortened recruitment time translates into a study that finishes sooner, potentially allowing a product to reach the market faster.  As a tool for providing access to qualified applicants, the state should act now to create a non-profit research institute that combines the talent of successful clinical research leaders to act as ambassadors for Georgia.

More importantly, this non-profit venture must use technology to advance the cause. The creation of a state-wide clinical trial portal will provide Georgia patients and researchers with a tool to increase patient education and self-education on available clinical trials. Using technology in this manner would be a first of its kind in the United States. It could provide an online tool for Georgia residents to match with the national archive of clinical trials, www.clinicaltrials.gov. The cost of this type of project is approximately $4.2 million over a three-year period. 

Increasing access to clinical trials in Georgia is a creative way to improve access to health care, improve options for patients seeking clinical trials, enhance the state's reputation in the research community and provide a much-needed boost to the state's lagging economy.



Tom Greene, co-founder of a Marietta-based medical device company and a national consultant on employee health and productivity, wrote this commentary for the Georgia Public Policy Foundation. The Foundation is an independent think tank that proposes practical, market-oriented approaches to public policy to improve the lives of Georgians. Nothing written here is to be construed as necessarily reflecting the views of the Foundation or the Center for Health Transformation or as an attempt to aid or hinder the passage of any bill before the U.S. Congress or the Georgia Legislature.