Drug Testing Provides Care, Hope for Some

Sherri Lynn Correll was new to San Diego, hadn’t found a personal physician yet and was deeply depressed. She also didn’t have much money.

“Normally, I was on the go all the time and people couldn’t keep up with me,” Correll said. “Then all of a sudden I quit doing everything. I would go home and just sit there. I went to work only because I knew I had to.”

One of her friends told her about Feighner Research Institute in La Mesa. She checked it out.

Several weeks as part of a drug experiment conducted last fall by Feighner turned out to be what Correll considers a good investment. She received a thorough physical, an antidepressant medication and supportive counseling--about $1,800 worth of care--and it was all free.

“I couldn’t have afforded it,” Correll said. “I don’t know what would have happened to me if I hadn’t gone there.”

It is that kind of experience that makes patients like Correll talk highly about the pluses of taking advantage of San Diego’s position as a key research area to gain access to promising new drugs and treatments--and to cut down on health care costs.

But it is a strategy not without medical risks, because patients could also wind up stuck in a placebo group.

Still, as medical costs mount and insurance companies and the state cut back on the services they will finance, turning oneself into a human guinea pig may be just what the doctor ordered, these patients and their researcher physicians contend.

“For somebody who doesn’t have insurance, or is on Medi-Cal, it works out great,” said Dr. Ronald H. Miller, associate director of Sharp Memorial Hospital’s cardiac center. “Everyone wins: The doctor is paid in full--finally. The patient gets good care. And the company gets its research done and its questions answered.”

The lion’s share of research on human subjects is done at academically oriented centers such as UCSD School of Medicine and Scripps Clinic. Together they test new drugs or treatments on about 2,000 patients a year.

At least twice that many people also participate in the experiments but receive standard treatments or placebos.

There is a growing number of patients involved in privately funded research--most of it on behalf of drug companies--at doctors’ offices throughout San Diego, physicians say. The Feighner Institute alone plans to do research on nearly 800 volunteer patients over the next year.

In addition to Feighner, several other major San Diego groups test drugs for companies that use the results later to seek U.S. Food and Drug Administration marketing approval.

Smaller medical practices also offer their patients the chance to be part of studies of everything from diabetes pills to anti-hay fever nasal sprays and cornea-sculpting lasers.

Private hospitals are also getting into the act. Doctors affiliated with Scripps Memorial Hospitals will do more than $3 million in tests this year of drugs and medical devices for private firms. At Sharp, two full-time nurses are needed to oversee the two dozen research projects that cardiologists funnel patients into every year.

However, although all the different types of specialists involved in this sort of work are enthusiastic about their own contribution, they raise some quiet concerns about the programs run by the others.

“There is some very reasonable work done in private institutes that are highly tied in to drug companies. But you’re much more likely at a place like that to fall into an entrepreneurial situation where the thing that’s making the system work is money,” said Dr. Orville Kolterman, director of the UCSD Clinical Research Center, a federally funded facility to promote medical research.

“Those are basically businesses . . . and the goal is to move people through and get numbers down on paper,” Kolterman said. “Medical care falls by the wayside sometimes.”

On the contrary, says Dr. Robert Pambakian, a psychiatrist who has worked in Feighner Institute studies for the last decade, Feighner is a large operation but it is decentralized, with offices throughout the county.

“It’s very individualized service. It’s not like a mass of patients all going through the same investigator,” Pambakian said.

Stephen G. Thein Jr., clinical director of an up-and-coming private research center in San Diego, worries about others moving into the contract-research field who have been lured by the income but “who don’t have a clue what research is about.”

From the patient’s perspective, perhaps the biggest practical drawback to obtain medical care through research lies simply in finding them.

It can require several calls to an institution before a prospective volunteer knows whether there is any research project there regarding his disease or condition. (Both UCSD and Scripps Clinic have a medical hot-line service that can help in this process.)

Thein’s firm, Pacific Research Network, recently began trying to spread the health-care benefits of clinical trials into low-income San Diego by recruiting patients at two Southeast San Diego clinics.

More commonly, a patient must rely on his or her personal physician for a referral to another doctor conducting research. If he is lucky, his own physician may have a research contract.

That’s how University of San Diego student Robert Salinardo, a patient of Dr. Daniel Einhorn, began taking part in a study of a new drug against diabetic retinopathy. This retinal deterioration can blind diabetics.

“I’m in school. I don’t have any money, and it’s a good way for me to get a doctor and a controlled medical routine,” said Salinardo of the research.

The study will last at least four years and cover the costs of his diabetes-related medical care the whole time.

As is standard in clinical trials of drugs, some of the pills supplied by the drug company contain the medication, Tolrestat in this case, and some do not. In such a “double blind” study, neither doctor nor patient knows which version the patient is taking.

Salinardo doesn’t see how he can lose. Einhorn agrees, because of the drug trial’s rigid requirements for monitoring experimental subjects:

“The screening is more careful than it would ordinarily be. So if someone develops retinal disease while on the study, that disease is pointed out to the person and is treated,” Einhorn said. “So even if you’re on placebo, you will be discovered earlier and treated earlier than if you weren’t in any study at all.”

At a Southeast low-income clinic, gonorrhea patients participating in a Pacific Research Network drug test receive a much more thorough medical monitoring than otherwise would be the case, Thein said. The program also pays patients, $10 for the first visit and $40 for a follow-up to make sure they return for tests to see how the drug worked.

In conditions that are more immediately life-threatening, U.S. Food and Drug Administration standards for drug trials set limits on placebo controls for experiments. A new heart medication, for instance, will be tested not against a regime of no drug at all, but against another existing heart drug.

At Feighner, the study design frequently involves a double-blind crossover--patients may start on a conventional drug for their mental illness but later are switched to the new drug so the two can be compared in the same patients.

Still, in some drug tests, volunteers are warned that they might receive nothing but placebos. In that case, doctors point out, the only real advantage of being in the study would lie in the intensive screening and monitoring that doctors do on prospective research subjects.

Even people who have health insurance would have to pay for such tests themselves because insurance commonly does not cover preventive medical procedures.

“Usually there’s a pretty sizable general medical evaluation that you get going into the study, including chest X-rays and cardiograms,” said Dr. Ronald A. Simon, chairman of the Human Subjects Committee at Scripps Clinic. “So that, if nothing else, is worth these days probably in the neighborhood of $1,000.”

Dr. Murray Rosenthal, who conducts tests of psychiatric drugs, says some people choose the studies not just because of money or reimbursement problems but because they want to keep mental health problems off their insurance company’s records.

Another issue that research volunteers face is what happens to them after the drug trial is over. Most research groups provide some sort of transitional period in which patients can be switched to conventional medication for their conditions.

If patients cannot be helped by conventional drugs, doctors sometimes apply to the drug company for a “compassionate need” waiver allowing the patient to continue on the experimental drug.

The ultimate down side to all this research is that experiments are just that.

No one really knows how a new treatment will work or what side effects a drug may have until many people are tested, doctors say. (Toxicology tests in animals and the first phase of drug tests in humans are used to establish maximum safe dosages; most of the later tests at private research offices test only efficacy.)

The consent forms doctors give patients make this risk to the volunteers clear, and they also attempt to limit the testing firm’s liability if the patient is harmed.

In addition, to avoid any birth defects, many tests exclude women if there is any chance that they might get pregnant during the study.

Other requirements for test subjects can also be limiting. At UCSD’s Division of Reproductive Medicine, for instance, many studies exclude women if they take any medication, including birth control pills.

In the end, doctors say, financial pressures on private physicians ensure that San Diegans will see a continued growth in contract research at their doctors’ offices.

A medical practice that successfully solicits such work has a built-in cushion against a highly competitive medical marketplace and cutbacks in reimbursement from insurance firms.

The Allergy & Asthma Medical Group and Research Center, a five-physician practice in Kearny Mesa, gets about half of its income from conducting research for drug companies, said Dr. James P. Kemp of that group.

Einhorn points out, though, that he believes private physicians who take on research often do so not just as a moneymaker but also as a way of keeping on the cutting edge of their field. These doctors also keep sight of individual patients’ needs, Einhorn said.

“The drug company is very specific about what it pays for. It pays for a certain number of visits, it pays for their medicines, it pays for their blood tests. Other things come in a sense out of our pocket--our time on the telephone and in the office.

But spending that extra time with someone is not a problem, Einhorn said.

“Once someone’s in one of your studies, you feel personally responsible for them.”

How to Find Researchers

These are some of the centers in San Diego County where residents can find research experiments to join. Other medical facilities may also conduct tests. Requirements for participation are often quite specific, so prospective volunteers can expect to be questioned extensively.

* UCSD Medical Center: Various departments, as well as the federally funded Clinical Research Center, have ongoing studies in many areas. Current studies include tests of diabetes treatment, postmenopausal hormone supplements and asthma medications. Call UCSD Healthline, 543-5820.

* Scripps Clinic: Has about 250 research studies in many areas. Call Scripps Healthline, 554-8585.

* Feighner Research Institute: Concentrates on tests of psychiatric drugs. Currently recruiting volunteers with panic attacks or depression. Call 464-4300.

* Pacific Research Network: Has studies of drugs for anxiety, depression, Alzheimer’s disease symptoms, chronic pain, ulcers, gonorrhea. Call 294-4302.

* Dr. Murray Rosenthal: Has studies of drugs for treating anxiety, stress, depression and Alzheimer’s disease symptoms. Call 571-1166.

* Allergy & Asthma Medical Group & Research Center: Tests medications for hay fever, asthma and other allergies. Call 292-1144.

* Dr. Milan Brandon: Tests of drugs for allergies, pain, gastric problems, angina, sinusitis, anxiety, depression (over age 65), arthritis. Call 291-2321.

* Diabetes and Endocrine Associates: Testing oral diabetes medication and drugs to block diabetes-related kidney and retina damage. Call 224-9530.

* Dr. Laurence G. Yellen: Clinical trials of a variety of cardiac drugs. Call 582-2404.

* Harbor View Medical Center: Current studies include test of a drug for enlarged prostate. Call 235-3145.

* Scripps Memorial Hospitals: Clinical trials in ophthalmology, diabetes, growth hormone deficiency, migraine headaches, allergy and cardiology. Call 457-4123.

* Sharp Memorial Hospital: Several studies of cardiac drugs. Call 541-3133.