Reaching out for more research
Werschler affiliate currently has 50 trials underwayMay 7th, 2015
Cosmetic dermatology pioneer Dr. W. Philip Werschler is leading an effort to expand clinical trials for drugs, treatments, and devices here, just as many medical practices and health care organizations have cut back on clinical research.
Premier Clinical Research LLC, an affiliate of Werschler’s longtime practice Spokane Dermatology Clinic PS, currently is participating in 50 clinical trials.
Premier Clinical Research moved into the Sherman Medical Plaza, at 324 S. Sherman, in October, following extensive renovations at the 14,200-square-foot former Discovery School complex.
Spokane Dermatology Clinic, and another affiliate, Werschler Aesthetics, also have moved there from the Fifth & Browne Medical Center building, at 104 W. Fifth. The operations have some 50 employees combined, Werschler says.
Werschler, a Spokane-area native, received his medical training through George Washington University and the University of Arizona, and had participated in clinical research before he returned to Spokane in the early 1990s and joined Dr. Michael Ryan’s dermatology practice.
Within a few years, Ryan retired, and Werschler took over the practice.
Werschler’s research here started with tiny trials for products such as acne cream.
“Little studies grew into bigger studies,” he says.
One of those bigger studies centered on a neurotoxin that has changed cosmetic medicine over the last decade.
“Botox was kind of a fluke,” Werschler says. Berkeley, Calif.-based Oculinum Inc. had been using a botulinum toxin to treat an eye-muscle disorder, when researchers observed that the toxin also appeared to smooth facial lines near the injection site.
Werschler was one of 12 investigators selected to lead trials for the “wrinkle poison,” he says.
The Food and Drug Administration approved Botox to treat wrinkles in 2002, making it the first approval of a neurotoxin for cosmetic purposes.
Now it’s one of the most widespread cosmetic treatments in the world, Werschler says.
“It built the house of Allergan, which developed into a $70 billion company,” he says.
Dalyn Boehm, research director at Premier Clinical Research, says the research center and Spokane Dermatology Clinic each account for about 40 percent of the combined revenue for the affiliated operations, and Werschler Aesthetics brings in about 20 percent.
Werschler Aesthetics is a medical spa that offers advanced skin care and cosmetic treatments.
Premier Clinical Research has 20 employees and six partner physicians, including Dr. Richard Gower, of Marycliff Allergy Specialists, and Dr. Gary Gleason, who’s also setting up a direct-care family medicine practice in the Sherman Medical Plaza, Boehm says.
“Areas in this building are specifically designed for research,” she says. “We had been limited by space. We’re not limited anymore.”
The research space includes labs, offices, rooms for monitors and auditors, and a drug room secured with a fingerprint scanner and backed up with its own power generator.
The range of studies under way at Premier Clinical Research is more than skin deep, Boehm says.
Research includes trials for medications that could help reduce heart risks for patients with Type 2 diabetes, Boehm says.
“Some very promising drugs have been approved, but there’s been no long-term studies on them,” she says. “We’re hoping new medications not only are better for blood sugar, but heart disease.”
Another drug showing some promise appears to be effective in reducing circulatory inflammation for people with heart attacks and strokes, she says.
Other research is looking at new ways to treat asthma by trying to treat the cause rather than the symptoms, she says.
Premier Clinical Research also is participating with other practices in research projects relating to treatments for Parkinson’s disease and multiple sclerosis.
Some trials have been almost immediately life changing for participants, Boehm says.
One such breakthrough involved patients in a trial for a treatment for psoriasis, an inflammatory skin disease.
“New biologic medications clear it,” she says.
One such medication, with the trade name Enbrel, was approved in 1997 to treat certain forms of arthritis, she says. “We didn’t know it worked for psoriasis until 2004 and 2005.”
Psoriasis used to be thought of as just a skin condition, with the problem of red, scaly patches being mostly cosmetic, Boehm says.
“It’s not just skin. A lot of people with psoriasis have psoriatic arthritis,” she says. “Researchers have found what’s going on outside is also going on inside.”
People with psoriasis also are more likely to have heart conditions, weight problems, and depression issues, Boehm says.
Each clinical trial at Premier Research Clinic has 10 to 150 subjects. Most studies are conducted through multiple research centers and are commissioned by drug and device companies.
“We may have 10 patients, but the full study can have around 600 patients,” she says.
The Spokane area provides a lot of willing volunteers for research trials.
“I’ve worked in Los Angeles, Chicago, and Tacoma,” Boehm says. “We get more participation here.”
Participants receive stipends to reimburse them for their time and expenses, but payments aren’t intended to be the main incentive to participate.
Most trials involve adults between 18 and 65 years old.
Some studies, however, specifically target older adults, and some target younger subjects.
Acne studies, for example, are popular with youths who want to participate in the latest treatments, she says.
When a new drug is developed, it goes through four phases of human trials, Boehm says.
The first phase of trials looks into the safety and side effects of a new drug.
The second phase begins to look at the effectiveness of the drug under a range of doses.
The third stage involves larger pools of participants to help determine if the drug is effective for the proposed treatment.
After a product is initially approved for marketing, the fourth stage gathers long-term data regarding the drug’s safety, effectiveness, and best use.
Most studies in which Premier Clinical Research is involved are in the second or third stage of trials.
“When we get involved, the treatment is at the stage that some degree of effectiveness has been shown,” Boehm says.
Each study comes with its own protocols, and staff is assigned to certain trials and keep track of patients and trials.
Up until 10 or 15 years ago, clinical trials were conducted widely through “mom and pop” medical practices, Werschler says.
Current regulations require practices that conduct trials to provide specialized facilities and personnel, forcing many practices to choose not to participate in trials.
“If you want to survive doing trials, you can’t just do one or two a year,” Werschler says. “You have to purpose-build like we did or acquire facilities. We made the decision to become a bigger trial center and branch out beyond dermatology.”
Marycliff Allergy’s Gower is a nationally recognized opinion leader with a robust practice, Werschler says.
“He was facing the same (regulatory) dilemma,” Werschler says. “We offered him support through a relationship that started three years ago.”
Premier Clinical Research also works on specific trials with other practices and service providers, he says, adding, “We can supply support services for any outpatient trial. We provide the infrastructure, personnel and expertise.”
It took a leap of faith to develop the Sherman Medical Plaza, Werschler says, adding that one adviser told him the development site was in a bad location.
“I saw this as a perfect location,” Werschler says. The site is centrally located between the University District and the medical district on the lower South Hill, he says.
“The hospital systems have run out of room on the South Hill,” he says, asserting that Sherman Medical Plaza is within in the next logical growth area for medical services.
“We’re positioned well to take advantage of the growth of health care,” Werschler says. “I want the Spokane medical community to be known as a great place to do clinical studies.”
Werschler claims the Premier Clinical Research center will stand up to any multispecialty outpatient research center in the Pacific Northwest, including centers in Seattle and Portland.
“About 20 years ago, we went to them to see what we could aspire to be,” Werschler says. “Now, they come to us.”
Spokane is the right size with the right resources to be a major population center for clinical studies, he says. “We have the demographics and certainly have the level of expertise,” he says.