LA BioMed recognized for high standards of clinical trials

LA BioMed was recently accredited for various research programs. Dr. Matthew Budoff is leading one such study on testosterone and its effect on the hearts of patients. (Robert Casillas / Staff Photographer)
 
Carlos Portillo visited LA BioMed this week, just as he has done regularly for two years, for a round of blood tests and probing questions.

Portillo, who is HIV-positive, is participating in one of the research center’s 200 ongoing clinical trials, testing a combination of medications so doctors can determine what pairings work best.

Like all human research participants, Portillo gets a small stipend for each visit and free treatment.

“I was told it would create many benefits for other people,” Portillo said in Spanish, through a translator. “That the research was going to improve treatment for everyone.”

It was for these types of human research programs that Los Angeles Biomedical Research Institute at County Harbor-UCLA Medical Center near Torrance earned the highest national standards in its recent accreditation. This is the kind of research that commonly seeks participants through late-night television commercials, fliers at community centers and radio spots with highly specific personal health questions like: “Do you have depression? Trouble sleeping? Nerve pain? Psoriasis?”

LA BioMed researchers are seeking answers to questions about the effects of testosterone and diabetes on the heart, the best way to prevent early Alzheimer’s disease in HIV patients, new forms of therapy to prevent teen suicide, among many others. One recent trial found that exercise improves chronic obstructive pulmonary disease (COPD).

Clinical trials require a limitless supply of brave test subjects, willing to be on the front lines of treatments before they are approved by the Federal Drug Administration.

Safety, of course, is a primary concern with such experimentation on humans.

The federal government regulates research institutions that utilize clinical trials to ensure tests are not too risky and that patients are well-informed. But the main regulator comes in the form of volunteer Institutional Review Boards that approve clinical trials at hospitals and research centers. Those boards are made up of physicians and concerned community members.

CAT scans give doctors at LA BioMed views of arteries and blood flow through the heart. (Robert Casillas / Staff Photographer)
The Association for the Accreditation of Human Research Protection Programs Inc. recently accredited LA BioMed for having excellent protections in place for their clinical trial programs. The AAHRPP provides a greater level of oversight and a peer-review system than that of the federal government.

AAHRPP accreditation “is becoming the standard by which institutions that do human research are judged,” said Stewart Laidlaw, LA BioMed’s chief compliance officer. “You’re asked to develop standard operating procedures according to a set of guidelines. When they’re satisfied you’ve got the right standards in place, they send out a team of your peers to compare what you said you’d do with what you’re actually doing.”

Dr. Matthew Budoff oversees clinical research into the little-understood relationship between heart disease and testosterone use.

His study includes 800 participants, half of which are given testosterone and half a placebo. Researchers incrementally measure the plaque buildup in their coronary arteries through angiograms.

“A lot of older men are taking testosterone because it makes them feel better, gives them more vitality,” Budoff said. “But we have no idea if it hurts the heart.”

Dr. Matthew Budoff is leading a study on testosterone and its effect on the hearts of patients. (Robert Casillas / Staff Photographer)
Participants receive the medical treatments for free and physicians go over the results with them, Budoff said. Dr. Eric Daar oversees LA BioMed’s extensive HIV and AIDS research. Now that the virus’ effect on the immune system has been largely contained with medications that can allow those infected to live long, healthy lives, the focus of HIV research is on how it harms organs, Daar said.

“Now that we have good treatments to protect immune systems from the virus, it’s gotten a lot more complicated,” Daar said. “The focus is on how HIV affects the brain, kidneys, liver, causes hepatitis infections – a broad scope of activities.”

Daar currently has two ongoing clinical trials investigating the correlation between HIV and brain-related diseases like dementia and Alzheimer’s. Since researchers can’t do biopsies on the brains of living sufferers because of major health risks, they are using spinal taps to test the fluid that surrounds the brain.

These clinical trials were approved by the center’s Institutional Review Board because they had relatively low risks compared to the social benefits, he said. Risks include the rare possibility of infection from the needle and bruising or pain from the puncture.

“We explain the risks to the board, and then they look at it to make sure they really believe we can answer the question” we are researching and if the risks are comparatively small, Daar said. Once the board approves the research, they make sure a detailed patient consent form is completed.

Daar’s research has found that a subset of HIV sufferers do not have any detectable amounts of the virus in their blood, but do have it in the fluid around their brain. That may cause inflammation and damage to brain cells, ultimately leading to brain disorders, he said. The next phase of these clinical trials will focus on finding drugs that attack the virus in brain fluid.

Clinical trial participants are given a small stipend for their time and trouble, but Daar said that most do it because they want to find better treatments.

“People are altruistic, they want to contribute to eradicating disease,” he said. “These patients are exposed to risks and it’s very important that (the Institutional Review Board) looks at what are the risks to the patient from each particular study and what are the gains to society.”