Senator Lucio's Letterhead

CAPITOL UPDATE FROM SEN. EDDIE LUCIO, JR.

FOR IMMEDIATE RELEASE
July 10, 2008
CONTACT: Doris Sanchez , Press Secretary
Phone: (512) 463-0385

Clinical Trials Critical to Successful Treatment and Research

Clinical trials are proving to be miracles for many people afflicted with life-threatening diseases like cancer.

Often paid by medical company sponsors, clinical trials are research studies of people that follow a pre-defined plan involving investigational treatment, tests and extra doctor visits.

Besides insufficient clinical trials, particularly in South Texas, another of the problems with these programs that we are addressing at the Legislature is determining who should pay for "routine costs" associated with clinical trials that frequently aren't covered by either the sponsor company nor the health insurance provider. Routine costs involve doctor visits, tests and treatments that generally are covered by health insurance when associated with standard treatment.

Only 3 percent of all cancer patients enroll in clinical trials statewide, meaning that 97 percent of cancer patients have no access to novel treatment.

With a goal of lowering the cancer rate and finding a cure, during the 80th Legislature we passed legislation giving voters the opportunity to approve $3 billion in general obligation bonds over ten years (on the ballot as Proposition 15) to fund grants for cancer prevention and research that includes clinical trials.

Lt. Gov. David Dewhurst recently appointed three members to the Cancer Prevention and Research Institute Oversight Committee, (including Mr. Lionel Sosa from San Antonio), created by Proposition 15 to oversee the Institute.

The Institute will begin investing these funds in a number of areas that will decrease the incidence of cancer in South Texas, including education and prevention programs and research grants focused on basic, translational and clinical cancer research.

Basic research is usually performed in a laboratory and is the earliest process scientists use to create new knowledge. Translational research uses animal models to determine if the new knowledge found through the basic science investigative process has a beneficial impact on animals with cancer. If the translational research studies are successful, then the new therapies are tested in human subjects (clinical trials).

Clinical trials occur in four phases and involve different numbers of human subjects depending on the clinical trial phase. Clinical trials at phase one normally enroll 10-50 human subjects, hundreds at phase two, and thousands at phases three and four.

"We certainly expect that the Regional Academic Health Science Center (RAHC) will, through the University of Texas Health Science Center-San Antonio (UTHSCSA), become the recipient of some of this money to conduct clinical trials in South Texas," says Dr. Brian Herman, Vice President for Research at UTHSCSA.

"The goal," he continues, "is for the RAHC campus in Harlingen to conduct clinical research, while cancer related basic and translational research supported by funds will occur primarily in the UTHSCSA Edinburg research campus."

Currently UTHSCSA performs research at the Edinburg campus to determine if certain genes can predispose Hispanic individuals to certain types of mental illness and diabetes, and what if any may be the relationship between obesity and cancer. Clinical trials are also being conducted by Valley Baptist Hospital and some of the private physicians in the South Texas region.

Dr. Gabriel Hortobagyi with the University of Texas M.D. Anderson Cancer Center reminds us that in the 1950s every child with acute leukemia died, and today thanks to clinical trials, more than 80 percent survive.

And while many medical experts and patients believe that health insurers should cover clinical trial costs, the insurance industry resists any state mandates to do so.

The Texas Association of Health Plans (TAHP) takes a neutral position on this issue, while still expressing concerns regarding efficacy and safety, and questioning whether the financial burden for the costs of clinical trials should fall to trial sponsors who they feel reap the benefits. The organization believes that standards for clinical trials should be set, and that "mandates to cover services that are essentially public good constitute a tax, of sorts, on the insured."

Furthermore, TAHP notes that since clinical trials are by definition experimental, they are generally not covered by insurers. Yet there are exceptions. Some insurers cover routine costs if determined to be the usual care that the member would have received outside of the trial.

Dr. Gabriel Hortobagyi defends the efficacy of clinical trials, explaining that they represent the final common pathway to validate and to test the progress in laboratory research to assure that they are effective, that they deliver what they are supposed to deliver and are safe for patients.

We in South Texas anxiously await funding from the Cancer Prevention and Research Institute to expand clinical trials. As a member of the State Affairs Committee, my colleagues and I will work with the insurance industry on a compromise for coverage of routine costs.

As always, if you have any input or questions regarding these or other matters, please do not hesitate to contact Doris Sanchez, my press secretary, 512-463-0385.

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