By PHIL GALEWITZ
Palm Beach Post Staff Writer
Sunday, February 22, 2009

PALM BEACH GARDENS - When Joachim Lengner went to the eye doctor last year to treat his macular degeneration, a leading cause of vision loss, the ophthalmologist offered him a deal.

The Jupiter man could take a medication that's been on the market since 2006, or a drug still in clinical trials. By joining in the study, he would get the drug for free, saving thousands of dollars over the course of a two-year trial. Regular doctor visits would also be covered by the drugmaker.

Lengner, 64, opted for the study. "The doctor told me the study drug was a new and improved form of the existing drug, so I figured I had nothing to lose," Lengner said.

Neither Lengner nor his doctor knows which drug he received: Lucentis, the drug already on the market, or an investigational medicine called VEGF Trap-Eye.

Nine months into the clinical trial, though, Lengner feels his vision loss has been arrested and even slightly improved.

The study is one of about a dozen clinical trials that Palm Beach Gardens ophthalmologist Dr. Mark Michels offers his patients. Michels acknowledges he gets paid by the drugmakers for enrolling patients in the research, but says the real incentive is being able to offer the latest drugs. "I enjoy the intellectual stimulation and being at the crest of the wave of the evolution of our field," Michels said. He is one of about 150 Palm Beach County and Treasure Coast doctors offering drug trials to patients. Some of the trials done by local doctors, which can range from three months to years, involve deadly diseases such as breast cancer and Alzheimer's disease. Other trials involve finding drugs to treat problems such as obesity, insomnia and erectile dysfunction.

Twenty years ago, most trials were done in academic medical centers such as the University of Miami Miller School of Medicine, where the institution is paid for the research. Today, the majority of research is done either in physician offices or independent clinical research centers staffed by doctors and nurses.

Bringing medical research into doctors' offices has made experimental medicines available to people who don't live near the nation's 126 academic medical centers.

Two factors are driving the trend. With declining reimbursement from insurers, doctors are looking for new sources of revenue. And drugmakers realize doctors have a ready supply of patients with conditions matching investigational drugs.

The drug trials are often conducted at hundreds of physician offices nationwide and are overseen by an independent institutional review board that examines all medical records of test subjects.

Local physicians doing studies say being able to offer the investigational medications keeps them abreast of the latest breakthroughs in their field.

Michels said the per-patient fee he gets from a drugmaker for doing a study is not much more than he gets from Medicare. The extra dollars only make up for the recordkeeping and staff to handle testing. Testing for a drug company does not influence his prescribing patterns: "What influences me is seeing which drug is proven superior," he said.

Delray Beach internist Dr. Barry Seidman for years has offered his patients studies on drugs for high cholesterol, shingles and diabetes, among others. "This makes practicing medicine more exciting," he said. Seidman acknowledges that he may prescribe more of a drug that he learns about in a clinical trial, but says that's not necessarily a bad thing.

Seidman, who has a full-time research coordinator in his office, said he recommends that certain patients participate in a trial based on their health needs, but leaves the choice to them. Though all clinical trials have risks for patients, Seidman said he typically offers only later-stage testing, when issues of safety have already been addressed.

Dr. Ron Surowitz, a Jupiter family doctor, was asked 10 years ago by a drug company to test an asthma drug. He immediately was hooked on the idea of doing clinical trials from his office and has been doing multiple studies ever since. Surowitz said the trials are not easy money. He had to hire extra staff to handle the testing and the paperwork and it takes away time he might have spent treating more patients. But he still finds the testing rewarding. "It's the enjoyment of being on the cutting edge of medical treatment," Surowitz said.

But the practice also has raised questions.

Some critics say studies are a thinly disguised way for drugmakers to market their medicines to doctors. "Some community physician research is valuable, but a lot of it is marketing dressed up as research," said Ken Goodman, director of bioethics at the University of Miami medical school.

To appease such criticism, Pfizer Inc., the world's biggest drugmaker, now says said it will begin disclosing all payments over $500 to doctors who test experimental drugs in people. It's a first for the industry.

The move comes after the introduction last month of federal legislation to require such disclosures - and revelations of astronomical payments to some doctors that were not revealed to universities and hospitals that employed them.

When doctors participate in clinical trials, they have the challenge of determining whether they are enrolling a patient in the study for the patient's best interest or their own monetary gain, Goodman said. Also, community physicians may not be the best ones to oversee a clinical trial because they lack the training in conducting studies, he said. "Society may be better off to pay doctors to practice medicine and leave the research to the researchers," concludes Goodman.

And Arthur Caplan, director of Bioethics at the University of Pennsylvania School of Medicine, said doctors should tell their patients they are being paid to enroll them in clinical trials. "I do worry that patients are joining clinical trials because they don't want to let their doctor down," he said.

"Patients are under no obligations and we tell them that," says Surowitz, who emphasizes that his relationship with patients isn't changed by their participation, or lack of it, in trials.

He also says it is not difficult to find patients willing to be in drug trials. But the trials often have strict criteria, such as patients of a certain age range or health status.

Test subjects can get paid a few hundred dollars for participating in a trial. Most, though, don't cite money as the main reason for joining a study.

For example, Jordan Kleiner was tested on a new combination diabetes drug last year. The Lake Worth man's existing medication was not keeping his blood sugar under control. An added benefit: "Being in the study helped motivate me to eat better and work out and do the things to control my diabetes," he said.

Things to consider

POTENTIAL BENEFITS

Involves patients more actively in their health care.

Gives access to potentially new research treatments; test drugs are free.

Provides free access to expert medical care for the condition being studied, since investigators are often specialists in the disease being studied.

Helps others by contributing to medical research.

POSSIBLE RISKS

Potential unpleasant, serious, or even life-threatening side effects.

Treatment may not be effective.

Participants may need to visit the study site on a regular basis, be subjected to additional tests and get more treatments than normally necessary.

OTHER CONSIDERATIONS:

Payment/compensation:

Research subjects are sometimes paid for participation. The amount varies based on such factors as the time required to complete the trial or potential discomfort.

Potential conflict of interest:

Some health-care workers are paid fees for recommending, referring or enrolling patients in trials. Potential volunteers may ask if the referring health-care provider will receive monetary compensation, or if investigators have other potential conflicts of interest.

Continued treatment:

Will the treatment be stopped at the end of the trial, even if the participant feels it is beneficial? Some sponsors continue to provide the medicines; others do not.

Source: Food and Drug Administration

TESTING FOR APPROVAL

Drug trials have to pass three phases of human testing before they can seek FDA approval:

Phase 1. Usually involves fewer than 100 patients, and examines whether a drug is safe.

Phase 2. May involve a few hundred patients; continues to examine safety and begins to determine whether the drug is effective.

Phase 3. Can involve thousands of patients to confirm that the drug is both safe and effective.