Area a hotbed for medical research
378 clinical studies being done in Fort Myers alone
BY MICHELLE L. START Florida Weekly correspondent
More than 15,000 women will die this year because their ovarian cancer was not detected quickly enough, according to the American Cancer Society.

Florida Gynecologic Oncology is hoping that research being conducted locally will decrease that number dramatically.

"We are doing a molecular study where we are looking at women who are diagnosed with ovarian cancer, taking their blood and looking to see if there is a protein that would perhaps ultimately work as a diagnostic test," said Cami Kulwicki, research coordinator at Florida Gynecologic Oncology.

The office is also conducting several other studies, including one that involves infusing antibodies into patients after they finish chemotherapy that target the cancer cells and help keep patients in remission. It is in the third phase of study and the drug may soon be ready for market.

The studies are two of 378 National Institutes of Health clinical research studies being conducted in Fort Myers. Of those 120 are still recruiting participants.

In comparison, Gainesville has 842 National Institutes of Health studies of which 322 are still recruiting participants and Pittsburgh has 2182, Cleveland 2385. All three of those cities are home to medical schools while Fort Myers is not.

And there are likely additional studies being conducted locally by drug companies in physicians offices, according to Pam Fowler, registered nurse and administrator of Lee Memorial Health System's Institutional Review Committee. Studies conducted within the system must receive approval through the 12 person review committee, which includes clergy, nurses, community members and doctors.

Fowler said the government funded studies seldom meet the entire cost because patients are frequently followed for years and require additional testing. There is also a significant amount of documentation required. Fowler said the government reimbursement levels amount to about half of the overall cost.

"You do these studies because you want to offer cutting edge treatment," Fowler said.

There have been studies that the Institutional Review Committee has stopped because the risks outweighed the potential benefits, she said.

While the majority of local studies being conducted deal with various forms of cancers, some are geared toward heart disease, HIV and bipolar disorder. Another study going on locally involves a Merck drug that is geared toward lowering the plaque in the legs.

"We do a lot of cardiovascular and oncology studies," Fowler said. "At any given time, we do a lot implants for hips and knees. Or we're testing a pacemaker, but using it in a different way."

Within the last three months, at least two products that were tested locally have hit the open market. One was a game for teenage cancer patients called Re-Mission and the other was a drug called Tykerb that is aimed at stalling breast cancer.

"What happens in our community is that we just have some physicians who do a lot," said Fowler.

In order to participate in a study, patients have to meet the criteria, agree to be followed throughout the study, sign a consent form and follow specific directions.

To find out which government studies are being conducted locally, go to www. clinicaltrials.gov and enter Fort Myers in the search box.
CLINICAL TRIALS:
Clinical trials are conducted in a series
of steps, called phases - each phase is
designed to answer a separate research
question.:
>>Phase I: Researchers test a new drug or
treatment in a small group of people for the
first time to evaluate its safety, determine a
safe dosage range, and identify side effects.
>>Phase II: The drug or treatment is given to
a larger group of people to see if it is effective
and to further evaluate its safety.
>>Phase III: The drug or treatment is given
to large groups of people to confirm its effectiveness,
monitor side effects, compare
it to commonly used treatments, and collect
information that will allow the drug or treatment
to be used safely.
>>Phase IV: Studies are done after the drug
or treatment has been marketed to gather
information on the drug's effect in various
populations and any side effects associated
with long-term use.