Drug firms rely on psychologists' expertise

Increasingly, drug companies look to behavioral researchers before bringing their drugs to market.

By Bruce Beans

© Peter Olson

In today's hyper-competitive, high-stakes world of pharmaceutical research, how effectively a new drug treats a psychological or mental disorder is no longer the only yardstick for success. Anxious to distinguish their prospective drugs from competing compounds, pharmaceutical companies are now asking psychologists to explore whether prospective drugs may also enhance or diminish patients' quality of life.

Does a drug make a patient more or less lethargic? Does it affect reaction time while driving a car? Does a medication have a positive or negative impact on sexual function or memory?

Interest in such issues is so high that, according to psychologist Ivan Barofsky, PhD, associate professor of psychiatry and behavioral sciences at Johns Hopkins University, all major drug companies have incorporated quality-of-life evaluations into their clinical research programs.

But studying quality-of-life issues is just one segment of research in which psychologists are forging ahead. Behavioral researchers are also looking at developing human models to screen potential drugs and examining whether certain drugs have the potential to be abused.

Quality of life

Research psychologists have been involved in quality-of-life issues for decades. Barofsky, for example, has investigated such issues as whether women with breast cancer enjoy a better quality of life after conservative or radical breast surgery, and how cancer medications impact quality of life, for nearly a quarter century.

But, says Barofsky, who recently was elected president of the International Society for Quality of Life Research, "What's different now is that quality of life is being formally assessed using psychometrical standards."

Combined sometimes with economic considerations, such evaluations add a more complex dynamic to drug analyses.

Any aspect of a person's normal activities that can be affected by a drug is under study-how he or she function's physically, psychologically and socially, from the ability to wash floors to how a person values his or her life. Some of these effects can be so subtle, and sometimes so unforeseen, that it takes the unique training of a psychologist to understand the consequences, of which even the subjects themselves are often unaware.

Currently, for example, Irwin Lucki, PhD, a professor in the departments of psychiatry and pharmacology at the University of Pennsylvania, is the principal investigator of a study comparing the behavioral and cognitive side effects on elderly patients of two Prozac-like drugs-paroxetine and sertraline-used for treating depression. Marketed as Paxil by SmithKline Beecham, paroxetine was also approved in May by the FDA for treating social phobia. Sertraline is sold by Pfizer, Inc., as Zoloft.

One of the manufacturers-Lucki cannot say which one-has given him funding to investigate such side effects as memory impairment, inability to perform tasks adequately and reduction of motor response speed. If your memory is impaired or you cannot operate a car safely, your quality of life is obviously compromised, he says.

"Often drugs can produce effects on memory that the subjects themselves aren't even aware of, even though such effects certainly affect quality of life," says Lucki. "To the extent that one drug would have an advantage in terms of quality of life or lack of impairments, its manufacturer could make claims that others couldn't make."

Laurie Burke, a branch chief in the FDA's Division of Drug Marketing, Advertising and Communications, agrees: "The marketing departments of pharmaceutical companies have a great interest in using these claims."

The FDA is now developing review and submission guidance suggestions for pharmaceutical firms that wish to make quality-of-life claims in labeling or advertising. Currently, the FDA recommends that firms interested in making such claims conduct validation studies as early as the initial clinical trials. And that's where psychologists come in.

Other types of research

Much newer than forays into quality-of-life issues are nascent efforts by psychologists to develop human models to screen potential drugs. The models would be similar to the animal behavior models used regularly in preclinical trials. (See also: www.apa.org/monitor/nov99/sc1.html.)

Lucki and his colleagues at Penn, for example, have explored whether people without anxiety problems could be used to study the effectiveness of anti-anxiety drugs for treating people wracked by anxiety. Their proposed model would determine if a drug under investigation made normal subjects more relaxed while speaking in public.

So far, says Lucki, there has been little federal or pharmaceutical industry support for devising such human screening models.

"But if some psychologists developed a successful track record," he says, "they could make a career out of it."

Some research psychologists also see an expanding role for the profession in performing diagnoses in clinical drug trials.

"Over the last few years, more pharmaceutical companies are amenable to allowing psychologists to perform diagnostic assessments," says Rafael Rivas-Vazquez, PsyD, a clinical psychologist who is co-director of the Neuroscience Division of Miami Research Associates in Miami, Fla.

Earlier this year, for example, SmithKline Beecham (SB) determined that psychologists or psychiatrists could be principal investigators involved in a multisite clinical trial of a drug it's developing for post-traumatic stress disorder (PTSD). Because clinical psychologists treat many Americans with PTSD, they are ideally suited to make diagnoses and devise rating scales to assess the drug's effectiveness, reasons Rajinder Kumar, MD, vice president of SmithKline Beecham's central nervous system/gastrointestinal group in Collegeville, Pa.

SB determines which professionals will be its principal investigators depending on each drug's target condition. It uses psychiatrists in its international depression drug trials because, Kumar contends, they treat most of the world's cases of serious depression. In its dementia investigations, Kumar says, psychologists ascertain changes in cognition and memory during the clinical drug trials. Meanwhile, psychiatrists conduct the diagnoses-both before the drug regimen commences, to determine if the subjects are suffering from some form of dementia, and again at the conclusion of the drug trial to determine the effect the drug had on the dementia.

In clinical drug trials, psychologists and physicians often work together.

"I always pair myself with an MD because I always do clinical trials with humans," says Helen Pettinati, PhD, an associate professor in the department of psychiatry at the University of Pennsylvania School of Medicine, who has been a principal investigator or co-principal investigator on addiction-related and depression drug trials for 15 years.

"I'm responsible for the data analysis and I'm wise enough to be a team-player working with someone else with different expertise," she says.

Pharmaceutical companies are also funding extensive research by psychologists to determine whether a drug has the potential to be abused. Originating with studies of narcotic addicts who were inmates of federal prisons during the 1960s, the field now utilizes human volunteers-often active addicts-to test new drugs for their abuse potential.

"Better abuse-liability tests are being developed all the time, and psychologists are playing a key role in that," says Robert L. Balster, PhD, the director of the Institute for Drug and Alcohol Studies at Virginia Commonwealth University in Richmond, Va., and the former chairman of the FDA's Drug Abuse Advisory Committee.

In fact, say some researchers, the entire field of clinical drug research represents significant growth potential for psychologists.

"I think psychologists are learning more about the methodology of doing clinical trials," says Balster, "and more pharmaceutical companies are interested in getting behavioral indications for their drugs."

Bruce Beans is a writer in Warrington, Pa.

Psychologists interested in making suggestions to the FDA regarding its proposed quality-of-life guidance should write to Laurie Burke at the FDA, HFD 40, 5600 Fishers Lane, Rockville, MD 20857, e-mail: BURKEL@cder.fda.gov.



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