One of the final processes in translating pharmaceutical research into medications that are available to the public is clinical trials, and closely monitored scientific tests that determines if the medication is effective and if it has side effects by testing it in human patients.
Louisiana Research Associates (4460 Gen. Meyer Ave., Algiers, 363-7448) helps to move the process along by recruiting participants for last-stage studies on pharmaceutical products or new forms and combinations of drugs seeking approval from the U.S. Food & Drug Administration (FDA). The year-old company, which also follows and monitors patients through the trial period, now is conducting five ongoing trials on drug regimens to alleviate panic disorder, depression in the elderly, general anxiety, attention deficit, and weight problems in patients with psychotic disorders. The studies are being conducted for major international pharmaceutical companies such as Lily and Pfizer.
The research firm was founded by Dr. Robert Detrinis, a psychiatrist and the primary investigator of trials; Suzanne Chabaud, a clinical psychologist and trials coordinator; and Timothy Kemery, a clinical social worker who handles much of the management. They also brought Connie Johnson on board as case manager to help with recruitment and retention, and three other full-time staff members help to keep the business going.
"You can never guarantee results to participants," Chabaud says, "but we do our best to make sure they are happy and content with the study."
That's not always easy, because participants who sign up for the trials are suffering from conditions for which they haven't heretofore found relief. As is the standard in scientific studies of the effects of medication, the clinical trials conducted by Louisiana Research Associates are double-blind investigations, meaning half the participants are placed on the medication being studied and half are placed on a placebo and neither the researchers nor the patients know who is taking what. Such an assay allows for more objective observations, Chabaud says, adding that it is not unusual for all participants to show improvement at first because of the psychological aspects of believing they are on a drug that works. As time goes by, however, the improvement generally diminishes in the group taking placebos and the results become more meaningful.
Study participants not only have an opportunity to try a new medication for their malady, the medical staff also monitors their general health.
"We have a fully functional lab here," Chabaud says. "We can do EKGs, blood work, blood pressure, check weight, and all participants get physicals at the beginning and end. Most of the medical needs associated with the study are done in this building so they don't have to go out somewhere else."
Not all the medications undergoing trials at the West Bank company are new, however. Some are being administered in conjunction with other approved drugs, some have been developed in a different form such as drops instead of pills, and others that have been on the market for one condition now are being tested for efficacy in alleviating a different ailment.
"For depression in the elderly, the medication we're testing isn't in the traditional pill form," Chabaud says. "It can be put in the mouth and dissolved, for people who have swallowing disorders. For attention deficit disorder ... we're testing a medication that would be time-release, so they'd only have to take it once a day. Another is adding a medication to one already used for psychotic patients to help them from gaining weight. It's one of the major side effects and one of the reasons people quit taking the medication."
The pulse of the clinical trials, however, is the patients who sign up for the studies, which can last from six weeks to two years.
"A main concern for us is the patients," says case manager Johnson. "We have to be sure we don't coerce them in any way to stay in the study. We're here for them 24 hours a day, any time they have a problem or need to talk to us. Sometimes the treatment they receive in the clinical trials really helps them. We like to see that."
In addition to all-hours help during the trials, Louisiana Research Associates also continues to follow their progress afterwards, and will make their medical records available to them for more than a decade after the research is completed. Louisiana Research also will contact study participants after the trials if anything adverse is discovered about their medication. In some cases where the trials are completed and a patient has improved on a drug but it has not been approved for general sale by the FDA, the pharmaceutical companies will make the medication available to the patient until such approval is complete.
"We see most of the patients once a week, so we get attached to them," Johnson says. Chabaud agrees: "We're all people people ... with a high degree of ethics and a lot of experience in patient care. We want the best for them."