Miami Herald - Monday, August 3, 1998
Michele Chandler, Herald Business Writer

Her doctor told her she could have conventional surgery, or undergo an experimental treatment using a stent -- a tiny, mesh coil that resembles the spring found in ballpoint pens and is used to prop open damaged blood vessels.

Salman, 69, opted for the experimental procedure, in part because traditional surgery would have left a sizable scar. Through a half-inch-long incision in her groin, the stent was placed on a flexible wire and threaded through a network of arteries to her neck.

"I didn't feel like a guinea pig, because it was explained to me that the surgery was being done in five hospitals across the nation," Salman said about the hourlong procedure she underwent in January at North Ridge Medical Center in Oakland Park. "I took a chance."

She's far from alone.

With more medical companies than ever eyeing profits as they race to develop new devices and drugs, a flood of clinical trials is going on in South Florida.

Nearly 3 percent of all clinical trials in the United States conducted by nongovernment groups last year took place in South Florida, according to DataEdge, an organization that tracks the industry. South Florida ranked fourth, behind New York, Los Angeles and Philadelphia.

Problems and opportunities

Since 1995, South Florida's share of trials has risen steadily. Those in the industry say the region is a magnet for drug researchers because of the community's large population of elderly residents: indispensable patients for companies developing medicines for heart disease, postmenopausal problems, vascular troubles, Alzheimer's disease and other afflictions of aging.

A culturally diverse population and high proportion of AIDS patients also has made South Florida a hot spot for clinical trials.

It's an industry that last year generated an estimated $87 million for South Florida physicians, hospitals and researchers who were hired to evaluate potential cures being developed by pharmaceutical firms, biotechnology companies and medical-device makers.

That's not counting clinical studies overseen by contract research groups -- outside companies hired by drug firms to select and monitor doctors, analyze study results and otherwise oversee the testing process. Those groups aim to speed an experimental medicine's journey through the federal drug-approval process, which saves development costs and gives pharmaceutical companies more time to capture sales before competitors introduce similar drugs.

About 468 contract research organizations exist in the United States, according to the Association of Clinical Research Professionals trade organization. By the end of 1998, those groups will receive an estimated $3.7 billion from medical firms, up from $3.1 billion last year , according to UBS Securities LLC.

So many drugs

Of all clinical trial delays, half are blamed on sponsors being unable to find enough patients. It's estimated that less than 6 percent of the eligible patient base participates in clinical research, according to CenterWatch, which also tracks the industry. Other snags result from problems collecting and analyzing data from various research locations. Sometimes, it's just plain hard to get review boards at hospitals or other sites to make up their minds on whether to sign on with a particular study.

Still, the number of trials of experimental medicines and devices is expected to continue to climb, since President Clinton and congressional leaders of both parties vowed earlier this year to boost federal spending on research to find new treatments for cancer and other illnesses.

The number of clinical investigators, including physicians, has more than doubled in four years. There were 24,000 investigators in 1996, up from only 11,000 in 1992, according to DataEdge. The increased supply of investigators has created a buyer's market, giving drug firms and others that oversee clinical research the ability to use competition as a lever to lower grant payments. The average contract amount dropped from $50,000 in 1994 to $43,000 in 1996, a DataEdge survey found. Some companies give researchers stock options in lieu of cash.

To compete, investigative sites that are efficient and cost effective are selected to conduct tests and can command the highest prices. The drug testing industry is changing because pharmaceutical firms, which sponsor the bulk of drug trials, want to bring their medicines from test tube to drug-store shelf more quickly. Drug companies want to shave development costs by quickly halting work on money-draining duds and concentrating on compounds holding more promise.

Even more trials

Another major source of clinical trial funding is the federal government's National Institutes of Health. The NIH paid out $1.3 billion in 1996, mainly to academic medical centers -- including the University of Miami -- to conduct trials of experimental medicines.

As more drugs progress through the development pipeline, South Florida will continue to see a rising number of drug trials, said Mark Hovde, vice president of DataEdge. "I think South Florida will benefit because a greater proportion of diseases have to do with the elderly, and South Florida has favorable demographics of those patients," he said.

Among the hospitals that have intensified involvement in clinical trials is Broward General Medical Center in Fort Lauderdale. The hospital is now conducting 108 clinical trials of medicines and devices, up from a dozen in 1992.

"We had a new group of oncologists come on board that was active in clinical trials and brought their research with them," said Dr. Jean Gordon, vice chief of the hospital's emergency department. "And with more (HIV and AIDS) drugs available, we have a large population that would qualify."

Florida leads the nation in terms of the number of elderly. About 18 percent of the state's 14.5 million residents are aged 65 or older. AIDS is also an issue for South Florida, where 3,300 people tested positive for AIDS last year, according to the Florida Department of Health.

Since winning state approval last year to treat the most serious trauma cases, Broward General has also begun doing more trauma-related research trials, Gordon said.

Besides prestige, there's sometimes money left over. A $9,000 surplus is expected from a recent trial involving a pneumonia treatment; it will be spent on the hospital's medical-education efforts.

`A lot of money to be made'

Nationwide, about 36,000 nongovernment clinical trials were conducted in 1996, involving 18,000 investigators and 400,000 patients, according to DataEdge. Medicine makers and device firms spent about $3 billion on clinical research efforts last year, according to industry estimates.

Expanding clinical-research opportunities -- and dollars -- has prompted more doctors to join in. "There's a lot of money to be made in clinical trials. No question," said Tamara Fishman, a North Miami Beach podiatrist who conducted her first clinical trial two years ago. "Could it someday replace my private practice? Absolutely."

Once signed on as an investigator, many doctors discover they make money even if they don't conduct trials. That's because people who don't qualify for a particular medical trial may opt to receive conventional treatments instead. Other patients continue under the physician's care once their experimental treatment ends.

But rushing to get in on experimental research, doctors are polishing up their resumes and courting pharmaceutical firms. Some physicians assist in conducting research trials while in medical school and use that experience to continue on.

Doctors are attending meetings of professional investigators. They're assisting other physicians who are experienced researchers to learn the ropes. They're using the Internet to tap into potential new grant opportunities and news on experimental drugs progressing through the development pipeline.

Hiring a research coordinator is a must, according to Medical Economics magazine. Those coordinators help secure research grants, recruit patients and fill out case report forms.

Handling clinical research patients gets some doctors in the forefront of medicine -- while supplementing their income.

Hunting for patients

Ask Dr. Fishman, who now receives about 15 percent of her business from medical trials. She'd like it to eventually climb to about 50 percent. Looking for more diabetic patients prone to foot problems, Fishman has contacted Native-American reservations, placed newspaper ads and visited local nursing and retirement homes.

Some trial participants, like Aventura resident Rose Rattner, first came by the medical office simply because they spied Fishman's Primary Footcare Center sign.

One recent Friday afternoon -- the day her office devotes exclusively to research patients -- Fishman's nurse gripped Rattner's hand.

The 85-year-old diabetic woman winced in pain as Fishman deftly cleaned a serious wound on one of Fishman's toes. The nurse photographed the wound and traced its size to determine whether it had shrunk from the prior week. Then Fishman applied a special bandage containing a medicated salve, the product being tested.

With the money she'll receive for conducting the study, Fishman pays her part-time research nurse, reimburses patients for travel expenses, pays overhead and places advertising.

She receives between five and 10 inquiries a week from companies developing new products. She doesn't respond to each one because they're not all looking for podiatric patients.

"To be involved on the cutting edge of research is exciting to me," she said. "And patients come in and need the help. This is about helping the patient."

Looking to win more phamaceutical trials, some doctors are banding together to increase their attractiveness to drug companies in search of multiple medical sites. That's because pharmaceutical firms may need to test an experimental drug in hundreds of people with a particular disease. By linking up and combining their patient base, those physician-consortiums may be more likely to provide enough people meeting the study's requirements.

Strength in numbers

In the early 1990s, for example, seven physician groups involved in research in several states formed a research consortium. Since then, the group has expanded and now includes 22 offices. One of the two groups in South Florida, Clinical Research of South Florida in Coral Gables, has seen its share of clinical trials rise from 10 in the early 1990s to 32 now. The group now employs eight research coordinators to keep up on trials ranging from diabetes treatments and contraceptive patches to using soy extracts to treat unpleasant symptoms of menopause.

Trials are conducted by two of the group's six physicians; the rest handle nontrial patients. Tapping into the popularity of drug trials among independent doctors, Clinical Research also handles day-to-day drug research details for physicians from outside its network. So far, two outside doctors are signed on and Clinical Research wants to provide that service to more physicians, said medical director Jeffrey Rosen.

With their large base of patients and technology for data collection, some physician practice management firms see themselves as naturals to compete for the $3 billion a year in outsourced clinical trials. In October, PhyMatrix of West Palm Beach, which manages doctors' practices, spent $10 million to buy Clinical Studies, a Providence, R.I., company that directs investigational studies. Clinical Studies has 34 research-only sites, including an inpatient center in Fort Lauderdale and reported $25 million in revenues last year.

By combining with PhyMatrix's network of community physicians, the number of trials is expected to increase to 150 by the end of this year, up from 98 trials before PhyMatrix purchased the group.

Continuecare of Miami, another physician practice management firm, reported that nearly 2 percent of total revenues -- $855,000 for the first six months of the year -- came from studies conducted by the company's growing roster of doctors.

The specialists

Responding to the pharmaceutical research outsourcing trend, a variety of groups has emerged. Some handle only the administrative side of clinical trials, such as monitoring data and conveying that information to the sponsor drug firms. Others perform those duties, plus find patients and sign on doctors and other investigators. Some one-stop-shopping companies even own a network of doctor's practices, enabling them to handle the entire drug - testing process.

Contract research firms, some of them publicly traded companies, took hold about a decade ago when many pharmaceutical companies were downsizing. Now, those firms are hired by drug companies to help in 59 percent of all pharmaceutical trials, according to CenterWatch.

Site management organizations, which oversee several clinical research sites and sometimes own physicians' practices, now conduct about 3 percent of all clinical trials, industry data show.

Academia's losess

All the competition for drug trials hasn't played out well for the nation's academic medical centers. While home to the brightest scholars, foremost specialists and the latest technology, pharmaceutical firms sometimes perceive academic centers as expensive, bureaucratic and slow. So more trials sponsored by private companies are being done in lower-cost and more nimble community hospitals and private doctors' offices.

In 1996, academic institutions were involved in only 48 percent of all clinical trial projects placed by drug firms and contract research groups. That's down from 79 percent in 1991, according to CenterWatch.

But when it comes to trials funded by the government as well as private industry, academic medical centers still hold the lead. They conducted 48 percent of all studies last year. Independent sites conducted 35 percent. Research-only sites handled 14 percent, while site mangement organizations conducted 3 percent, says the Association of Clinical Research Professionals.

To compete in the changing testing landscape, several medical schools have established central offices focused only on shortening research turnaround time and otherwise smoothing the way for private companies looking for clinical trial sites.

Last year, UM received $25 million to conduct 1,880 clinical trials, a 10 percent increase from 1996.

Still, said Norman Altman, associate dean for research, UM may have conducted even more trials, had community hospitals and private doctors' offices not moved in. In response, UM plans to centralize its clinical trial efforts next year.

CUTLINESNURI VALLBONA / Herald Staff HOLD STILL: North Miami Beach podiatrist Tamara Fishman, aided by nurse Marie Delgado, figures 15 percent of the revenues for her practice comes from clinical drug trials. Here, she examines the feet of patient Elsa Gon Calves.

CHARLES TRAINOR JR. / Herald Staff `TOOK A CHANCE:' When she needed surgery, Lila Salman opted for an experimental procedure that would leave no telltale scar on her neck unlike a conventional operation. Dr. Michael Rush re-examined her six months later.

CAPTION: color photo: podiatrist Tamara Fishman aided by nurse Marie Delgado examine patient Elsa Gon Calves (a); photo: Lila Salman being examine by Dr. Michael Rush (a); chart: how long it takes, Cost to develop new drug, pharmaceutical sales, Research & Development spending, Testing 1,2,3, Top 5 Cities for drug trials
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