Posted by dj on July 30, 2000, at 16:26:42
In reply to Drug Trials Hide Conflicts for Doctors, posted by dj on July 30, 2000, at 16:17:32
June 22, 1999
STOPGAP MEDICINE
For the Uninsured, Experiments May Provide the Only Treatment--------------------------------------------------
By GINA KOLATA and KURT EICHENWALD
NY Timesarole Danforth's asthma had gotten the best of her. No longer did she have the energy for activities she loved, like playing with her grandchildren or doing yardwork. Some days, her breathing was so labored she could not get up from the couch. And there seemed little she could do about it: Ms. Danforth, a 51-year-old housecleaner in Taunton, Mass., had no insurance and little money for doctors or the inhalers she needed when her condition was at its worst.
Then, two years ago, her life changed. Friends told her of a doctor who was offering free examinations and drugs as part of a study of an experimental asthma medication. Perhaps, the friends suggested, the doctor could help her.
The doctor, Michael Lawrence, was soon providing Ms. Danforth with free diagnostic tests -- including a chest X-ray she could never have afforded -- to determine if she was eligible. Ms. Danforth was accepted for the study and within days Dr. Lawrence gave her a free, but unapproved, medication for asthma. Her breathing returned to normal.
Ms. Danforth had finally found her access to health care -- albeit one where a medicine she finds effective lasts only as long as the study. As a result, she has become one of a growing number of drug-trial nomads, wandering from study to study as they become available.
"I can't keep track of them all," Ms. Danforth said of the drug studies in which she has participated. "But I haven't felt this good in a long time."
In recent years, the need for test subjects in experimental drug trials has exploded as the industry has brought to market an ever-increasing number of new products. In response, drug companies have developed new methods of finding participants for the trials by turning to private-practice doctors who recruit from their lists of patients. But even that influx of participants has not been enough to satisfy the demand.
Filling the gap, according to industry officials and researchers, are people like Ms. Danforth: chronically ill with limited or no health insurance, relying on clinical trials by private doctors as their primary source of medical care. For these people, experiments have become treatments; clinical investigators are their specialists.
Medical experts recognize the shortcomings of this system. On the one hand, the doctors are white knights, providing a critical service that such patients cannot obtain any other way. Patients "are better off getting experimental therapy than no therapy at all," Paul Menzel, a philosophy professor at Pacific Lutheran University in Tacoma, Wash., said.
But the benefit can be fleeting or nonexistent. Chronically ill patients with no other options can be treated with an experimental medication that does not work or that even worsens their condition. Or they can end up with a placebo -- a dummy pill or treatment -- rather than the medication itself. And once the study is over, usually in a matter of weeks, they are left to their own devices. They can be barred by the rules of one clinical trial from participating in another study for months, forcing them to rely on samples of medications provided by drug companies or to go without treatment altogether.
That leaves many patients in a sad position: Having tasted, for a moment, how good life can be when their conditions are controlled, they are plunged back into a life of disabling symptoms.
"Studies are becoming like a stopgap" with the private doctors, said Dr. Richard A. Friedman, director of the psychopharmacology clinic at New York Hospital-Cornell Medical Center in Manhattan. "And that's pretty bad, taking from them what they need and then tossing them back."
That description underscores a hard fact of medical research: The subjects of drug trials are not, technically speaking, being treated for a disease. Rather, they are participating in an experiment.
"One will often hear from physicians and economists that there is always a way for them to get medical care, so this must be one of the ways," said Norman Daniels, a professor of philosophy at Tufts University who specializes in ethics and health policy. "In my view, it does not count as medical care."
THE TREND
Uninsured Pursue Unaffordable Care
obody tracks how many uninsured people seek health care from clinical studies, but researchers agree that they number in the thousands and that their ranks are growing.The result is that researchers in areas with many poor people often have the best chance of attracting research subjects. "That's one of the reasons that we have been so successful," Dr. Paul Chervinsky, medical director at New England Clinical Studies in New Bedford, Mass., said. "New Bedford has always been an economically deprived area."
Even people with insurance plans that impose significant restrictions -- like managed care programs that require pre-approval to visit a specialist -- are circumventing the gatekeepers by seeking out clinical trials, researchers said.
"A lot of patients tell me that they feel frustrated with the care that they receive from the H.M.O.," said Dr. Norman Zinner, a Los Angeles doctor who heads Affiliated Research Centers, an organization of private-practice urologists who do drug studies. "They want to know if they might be eligible for a drug study so that they could get relief."
Of course, the poor have long been participants in drug studies, usually through university medical centers. But once a study is completed those institutions often direct the patients to other university programs that provide health care to the poor -- programs that private doctors who normally see only paying patients have few dealings with.
The benefits for test subjects are obvious.
For many, a clinical trial offers a rare opportunity for a full diagnostic workup by a medical specialist as well as access, at no charge, to the latest treatments.
"Arkansas is not a wealthy state, and most of the drug studies that we do provide the patient with free medication," said Lin Richardson, director of practice management at Baptist Health Systems, which operates a network of private practices in Little Rock that conduct drug studies involving a large number of uninsured patients. "It is amazing what I have seen happen for some of our patients."
THE ETHICS
Right and Wrong on the Frontierthical qualms arise from the fact that clinical trials are not intended to be medical care. In this context, the doctors are investigators, not personal physicians. The drugs are often experimental, and no one knows for sure whether they work. On top of that, because many clinical trials compare an active drug with a placebo, the patients often stand as good a chance of receiving no treatment.
Clinical trials also raise a problem never experienced in true patient care: Even if a test medication improves the health of a chronically ill person, the drugs will no longer be supplied once the study ends.
Some researchers and study co-ordinators strive to avoid that outcome.
"I believe it's a violation of human rights" to keep patients dangling untreated between studies, said Maria Lopez, a study coordinator for Dr. Herbert Rubin, a gastroenterologist in Beverly Hills, Calif.
Dr. Rubin provides his uninsured test subjects with drug company samples between tests, a practice that Ms. Lopez said was frowned upon by the companies.
"Drug company representatives will be like: 'Remember, you have to give these to patients who will actually buy,' " Ms. Lopez said.
Other researchers refuse to allow the uninsured to use drug studies for medical care.
"It's not right that some people would give the patient the false impression that they are getting full medical care when they are not," said Dr. Thomas Littlejohn, who directs Piedmont Medical Group in Winston-Salem, N.C.
Told of the trend, medical ethicists were divided.
Some expressed concern, saying that vulnerable patients were being coerced through the lure of medical care to put their bodies on the line.
"It becomes a further exploitation of the poor," John Paris, an ethics professor at Boston College, said.
But others were less certain, noting that the trend presented new options for getting care to people whose choices were limited.
"It is a nasty dilemma," Professor Menzel said. "There is no way you can win on this one."
THE PATIENTS
A Roller Coaster Without Relief
hen Victor Miranda saw Dr. Rubin's ad in La Opinion, a Spanish language newspaper in Los Angeles, he did not even call ahead for an appointment.Instead, Miranda, a 37-year-old house painter from Guatemala, hopped on a bus in the morning and traveled an hour and a half to Dr. Rubin's office. He said through a translater that he had suffered from heartburn and agonizing stomach pain for two years but had not seen a doctor because he could not pay for it.
Dr. Rubin determined that he had an inflamed esophagus, an easily treatable condition, and enrolled Miranda in a study comparing drugs developed by Astra Pharmaceuticals.The paradoxes of such experiences are not lost on patients. While most praise the doctors who conduct the research, many also resent the compromises they have to make.
"The health care they give you is really specific for what they're testing for," said Elizabeth Elder, a 52-year-old uninsured woman in Albuquerque, N.M., who has participated in a number of studies, "so it isn't really health care."
Others are simply grateful for whatever medical attention they can get.
In Lemoyne, Ohio, Roland and Linda Gladieux were looking for drug studies to get relief from a host of medical problems. They could not afford insurance; the cheapest policy they could find cost $500 a month with a $2,500 deductible and paid only 70 percent of medical costs above that.
Gladieux, a burly 51-year-old who manages a car-repair shop, has a chronic wheezing cough. He had gone to a doctor who wanted to test him for emphysema, but Gladieux declined, unable to afford the tests. So when he saw an advertisement on television late last year seeking people with chronic bronchitis, he jumped at the chance.
The ad was placed by Dr. John Winder, an asthma and allergy specialist in Sylvania, Ohio, who does drug studies alongside his private practice. The bronchitis study was already fully enrolled when Gladieux called. But Dr. Winder's recruiters told him of studies for other ailments. Learning that a heartburn study was opening, Gladieux offered his wife, who has had severe heartburn for 20 years. She got into the study.
"It was a godsend," Mrs. Gladieux said. The experimental medication cleared up her heartburn and for the first time in years she could eat foods like lasagna without suffering.
Now the heartburn study is over and the Gladieuxes are looking for other drug studies to join -- bronchitis for him, heartburn for her. Or almost anything.
"I have arthritis real bad," Mrs. Gladieux said. When she saw Dr. Winder for her last visit in the heartburn study she asked him to keep her in mind. "I told him if anything comes up, give me a call," she said.
The financial difficulties that lead patients to choose experiments for their health care are not limited to people with little or no insurance. Adriana Medina, a 24-year-old medical assistant in Tucson, Ariz., has health insurance through a health maintenance organization. The plan paid for her 8-year-old daughter, Gabriela Garcia, to see a pediatrician for her asthma. But when that failed to help, the plan would not pick up the cost of a specialist.
"She was on so many medications, and she was constantly sucking on the breathing machine," Ms. Medina said. "It was just a roller coaster ride. She was never well."
Unable to afford the specialist, Ms. Medina enrolled Gabriela in a drug study conducted by a local asthma expert, Dr. Jay Grossman.
"Just hearing that it was an asthma specialist I said, 'Hey, what do I have to lose?' " she said.
The experimental asthma drug changed Gabriela's life. The trial "is allowing her to have a normal childhood," Ms. Medina said.
"My only worry," she added, "is that the study will be over and she'll be back where she started from."
The completion of a study can be a poignant moment, several doctors said, especially when the subjects, like Gabriela Garcia, finally received medical help that had eluded them. The subjects spent weeks or months sitting in waiting rooms with private patients, filling out the same forms and looking through the same magazines as everyone else. Their diagnostic tests were done in the usual exam rooms, and they received drugs just like private patients. Then the study ended and the subjects had to leave.
"They have had more medical care from me than they have had from anybody for years," Dr. Winder said. "It is hard for them to understand that they are not my patients."
In the end, if no new clinical trials are available to them, that reality can leave patients feeling frightened and abandoned. Josette Good, a 60-year-old widow, used to count on Dr. Winder to keep her enrolled in study after study for asthma. But last year, she moved to Lake Milton, Ohio, near her children but 200 miles from Dr. Winder's office.
Now, medical care has become an issue; adequate health insurance is beyond her budget, and Dr. Winder could not help her find a study in her area. She has only one inhaler left, from the last study she participated in, so she uses it sparingly, at times borrowing another from a friend. Hoping to make her inhaler last through the summer, she limits her activities, avoiding yardwork and even short walks.
"It's just so tough," Mrs. Good said. "I pray nothing happens."
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