RX FOR PROGRESS: CAPE GIRARDEAU HOME TO RESEARCHERS AT WORK ON MEDICAL INNOVATIONS

Every year, physicians and health professionals in Cape Girardeau participate in dozens of clinical trials for medications, devices and procedures.

That means Southeast Missouri and Southern Illinois residents get access to medical developments they might not otherwise have for months or even years, medical experts say.

Dr. Charles H. Cozean Jr., an ophthalmologist, was one of the first physicians locally to participate in research and development (R and D).

Since the 1970s, Cozean has worked on clinical trials for a variety of intraocular implants -- lenses implanted into the eye -- as well as the ongoing development of laser technology for eye surgery to correct nearsightedness and glaucoma.

"We do a lot here, actually, despite the fact that we're in private practice," he said.

A clinical professor at St. Louis University's School of Medicine, Cozean said Cape Girardeau is a site for "a number of R and Ds, despite not being a university."

Cozean is currently participating in clinical trials for two implants manufactured by Storz: the True Vista bifocal implant and the HydroView foldable implant.

"They aren't on the market yet," he said.

Lens implants are inserted into the eye to replace patients' diseased or otherwise faulty natural lenses. Different types of implants are used to correct such conditions as nearsightedness, astigmatism or cataracts.

Dr. C.R. Talbert, a cardiovascular specialist, has participated in a number of clinical trials on pacemakers and other devices.

"We put in pacemakers that would turn off and on like a thermostat. That was 20, 25 years ago," he said.

Over the years, Talbert also worked in clinical trials for dual-chamber pacemakers to control both halves of the heart.

Most recently, he's worked in trials for activity response pacemakers, "the latest development" in the devices.

Talbert and Dr. James Chapman also participated in trials using the Excimer laser to clear plaque from coronary arteries, now an FDA-approved procedure.

He also was involved in research on the retroprofusion pump, which "back flushes" oxygenated blood from one chamber of the heart to the other.

Talbert also helped design the Hemalert, a device to help detect bleeding. The device is not yet on the market, but Talbert said a British manufacturer has expressed interest in producing it.

Dr. William K. LaFoe is currently participating in clinical trials studying the use of a stint already approved by the FDA for use in the liver to relieve blockages in the renal artery.

"It happens to be the right size for the renal artery," LaFoe said.

"We've used balloons in that area for many people, and the results have been very satisfactory," he said. So far, he added, the stints "appear to have been very successful."

LaFoe has used the stints on about six patients.

The study centers on "what we call an approved device in a non-approved location," LaFoe said. "That actually happens quite a lot."

Stints are metallic devices inserted into an artery. The devices help clear blockages to control or cure high blood pressure and preserve organ function.

Both local hospitals are participating in the National Cancer Institute's studies on two drugs which may prevent cancer: Tamoxifen and Proscare, which may prevent breast and prostate cancers, respectively, in people at risk for developing the diseases.

"Access to these research trials allows patients to have the same kind of cancer treatment they'd have to go to M.D. Anderson or Sloan-Kettering to get," said Nancy Mattingly, cancer program coordinator at Southeast Missouri Hospital.

Trials for both drugs have been in progress for three to four years, she said, and the tamoxifen study will eventually involve 16,000 women from around the U.S.

It's important for people to understand a few things about clinical research trials, Talbert said.

"The clinical research is not the basic research, with the laboratory and the animals and all that," he said. "There's few if any basic research projects going on here. Clinical research applies to medications or devices that are applied to patient care."

The Food and Drug Administration requires extensive clinical testing of all newly developed medical products before those products can be released onto the marketplace for use by the public at large.

Also, he said, during clinical trials, patients volunteer to participate in testing the products, which have already been tested on humans in smaller test groups.

The FDA requires that patients participating in the trials sign consent forms and be informed of all potential risks the product might pose.

Clinical trials usually involve thousands of patients from around the country or around the world, and can take several years to complete.

To make sure physicians and manufacturers follow all the rules for testing and documentation of test results, the FDA requires hospitals to set up Institutional Review Committees to oversee clinical research trials at the local level.

Committee members review the protocols, or procedures, for those trials to make sure the study subject will be beneficial to patients, said Karen Hendrickson, assistant administrator and chief nursing officer at Southeast Missouri Hospital.

IRCs are made up of medical professionals and laypeople, said Rev. Louis Launhardt, who chairs St. Francis Medical Center's IRC.

"We try to think of it from the point of view of the patient and to be able to be part of this clinical research where we could say, Here's an instance where the patient would need some protection," Launhardt said.

Committee members look at potential health risks the test subjects could pose for patients, cost, emotional and psychological issues and whether existing devices, procedures or medications can do the job as well or better, he said.

Orthopedic devices, medications, cancer screenings and an array of other research subjects come before IRCs regularly, Hendrickson said. "We have proposals for procedures in our cardiovascular lab, new catheters that might be available to be trialed and needing the approval of the FDA," she said.

"It doesn't have to be device-oriented," Hendrickson added. "IRCs also review research projects for other health-care professions. We've looked at protocols for nursing studies, for instance. It could be on wound management. It could be on diabetes. It could be on psycho-social aspects of nursing or hospice care."

The FDA requires extensive documentation for all clinical research trials, and if the paperwork comes up short for a particular protocol, Cozean said, "it doesn't make it."

Clinical research trials are usually conducted in conjunction with the manufacturers or developers of the study subject, and corporations may spend hundreds of millions of dollars developing a product before it is introduced to the marketplace, Cozean said.

Allowing community-based -- rather than university-based -- physicians to conduct clinical research means more patients can be signed up for the studies more quickly. If the results meet FDA standards, that means the study subject is available on the market sooner.

There are other implications, Mattingly said, in the fact that Cape Girardeau physicians are participating in so many research projects.

"It does tell people who live in this area that they can receive the best treatment, the most up-to-date care," she said. "It also gives them an indicator of the services that are provided in this area, that they have to be top-notch or we wouldn't be able to participate in these programs.

"You have to have physicians who have the knowledge and who are screened thoroughly to be able to take part."

Medical R and D at the local level also lets physicians "promote medical care on the cutting edge," Talbert said, allowing them to keep their skills sharp and their knowledge current.