Sunday, June 23, 2002
By Scott North
STANWOOD -- When Elaine DeLack was growing up on her parents' Montana cattle ranch, she needed only to step outside to see just how challenging the world can be.
She lived through winters cold enough to freeze the ears off a newborn Hereford calf. She endured summer sun so fierce that sometimes she would stand in a field and pray for a puff of breeze to stir air that had become too hot to breathe.
A descendant of people who pioneered ranching in Montana's Helena Valley, DeLack was driving a tractor by age 8 and rose most days before sunrise to help her father with the chores. She never let her age or her gender or what others might say limit what she thought she could accomplish.
"If somebody told me I couldn't do something, that was like putting a fire behind me," DeLack said.
Now 43 and a registered nurse living near Lake Goodwin, DeLack is still meeting challenges head on. The question is whether she should be.
In 1988, DeLack was diagnosed with multiple sclerosis, a degenerative neurological disorder for which there is no cure. Instead of simply going home and trying to live with debilitating fatigue and temporary paralysis, she began researching treatments, looking for hope that might have been overlooked by the experts.
The search led DeLack to develop Prokarin, a treatment that combines histamine and caffeine delivered through a patch worn on the skin. She's been using the compound for nearly four years and reports she has been virtually symptom free.
She's also become controversial.
Over the past three years, DeLack has been spreading the word about Prokarin, filing a patent on the compound and running a company that has collected up to $80,000 a month in royalties on prescriptions.
Her compound, which has not undergone the rigorous scientific study necessary to win Food and Drug Administration approval, nevertheless can legally be prescribed by doctors because its components are FDA approved. MS patients need only find a doctor willing to write a prescription and a pharmacist willing to mix the ingredients.
The ethics and efficacy of using Prokarin for MS have been the focus of often-bitter debate on the Internet and at seminars for sufferers of the disease. In recent months, the controversy has received high-profile media attention, including an article in USA Today and an appearance by DeLack on "The Montel Williams Show." The attention came after a scientific journal published results of a small study that suggested Prokarin can safely produce what researchers termed a "modest-sized statistical effect" in reducing fatigue among people with MS.
Williams, who has been diagnosed with MS, was supportive of DeLack's efforts to bring another MS treatment to market.
Many of the region's top MS specialists are less enthusiastic.
Dr. Craig Smith, a Seattle neurologist and director of the Swedish Medical Center regional MS center, fears that hype about anecdotal results with Prokarin could prompt patients to abandon scientifically proven treatments. Those attempt to limit the damage MS does to the nervous system by suppressing the body's immune response.
It's difficult enough to help patients manage their disease, and "all of a sudden voodoo science is thrown into the mix," Smith said.
DeLack's supporters are just as adamant that she's on the right track.
Bill Brayer, 69, of Edmonds is a Prokarin user who also heads MS Helping Hands, a support group that has gained national attention for his advocacy on behalf of MS sufferers. He's convinced DeLack and Prokarin are being dismissed by a medical establishment hard-wired to ignore alternative therapies and too beholden to drug companies.
"We call her the Erin Brockovich of multiple sclerosis," Brayer said.
MS hits DeLack stealthily
DeLack didn't go looking for the fight. MS came for her in the dark in 1984. She was in her mid-20s and pregnant with the younger of her two children, living in a home she and her husband, Marvin, had made on her parents' ranch.
She woke in the night and couldn't move one of her legs. By morning, the problem was gone. Her doctor told her not to worry, that the paralysis likely was caused by pregnancy and a pinched nerve. But the numbness came back and spread.
She was taking piano lessons one day when the instructor asked her why she wasn't playing with her left hand. She thought she had been. The message was going from her brain, but the hand was just lying there.
Before long, DeLack began to experience crushing fatigue. On the worst days, it took her hours to perform simple tasks, such as making a bed.
Her problems were transient, coming and going without any apparent pattern. Her doctor was perplexed, suggesting her symptoms could be psychosomatic. DeLack feared she was going insane.
Then, in 1988, during a family visit to Alberta, Canada, DeLack climbed into a hotel hot tub. The sudden temperature change triggered a reaction that left her unable to move or speak. Her breath was so shallow her husband feared she was dying.
She saw a neurologist. He performed a spinal tap and other tests, including magnetic resonance imaging, or MRI.
The machine, which allows doctors to peer inside the body similar to an X-ray, found two lesions on her brain -- little dots that on the film looked as if someone had shot her through the head with BBs. The doctor said they were places where her nerves had been damaged. He diagnosed MS, a progressive disease in which the body's natural defenses turn on the nervous system, stripping away myelin, the fatty sheath that surrounds the nerves.
DeLack got a second opinion, traveling from Montana to Seattle. The neurologist said her symptoms fit the classic presentation of MS. Her age, sex, race and where she lived also followed the most common pattern for the disease, which statistically appears most often among young, white women living in northern climes.
"He said there's really nothing we can do for you. Go home. Get your sleep and eat well," DeLack recalled.
She attempted to follow the advice, mourning the loss of her former, healthy self. But one day her leg suddenly went lifeless, and she pitched down a stairway while carrying her young son. The boy needed five stitches to close a gash on his head.
DeLack began her search for something better.
She found relief not far from home when she learned that a respected physician in Helena, Dr. Ray Bjork, also suffered from MS and had been managing his symptoms for years with injections of vitamin B-12 and other substances. Although retired, Bjork wrote DeLack a prescription for his concoction, and she began using it herself. Her symptoms, especially the fatigue, faded.
In 1990, the DeLacks moved to Washington, where her husband had brought his construction company to cash in on the building boom. DeLack had her ups and downs, but she felt well enough to finish off a nursing degree she had begun working on in the late 1970s.
She graduated in 1993, and continued her studies at the University of Washington's Bothell campus.
While researching at the UW library, DeLack came across studies showing doctors in the 1940s and 1950s had tried to use histamine to treat MS. The naturally occurring compound plays a role in a number of bodily functions, from dilation of blood vessels to muscle contractions to allergic reactions.
Although DeLack didn't know it then, a Tacoma doctor, Hinton Jonez, had made headlines years earlier by treating people with MS and other neurological disorders with histamine injections. Some of his patients reportedly got back on their feet after years in wheelchairs.
DeLack thought there was more work to do with histamine and MS, and for a class assignment prepared a proposed research protocol. She said her instructors were impressed enough that she was encouraged to seek support for a study.
In 1995 she decided to pursue a research grant. She got a glimpse of the road ahead when she contacted a doctor who is a national figure in MS research. She said he hung up on her after she told him she was a nurse.
Medical backlash stings
Prokarin was born out of three years of DeLack using her own body as a laboratory. She found a doctor willing to prescribe the compound -- a difficult task because most didn't want the risk. Then she had to find a pharmacist willing to prepare the concoction.
There were false starts and errors, some of which left her body aching and with painful abscesses from injecting compounds the body rejected. It wasn't until September 1998 that she eventually hit upon what she believes is the proper dosage.
DeLack said she approached drug companies, urging them to take it from there. None stepped forward. They wanted more research, and some said they didn't believe she could get a patent, a necessary step to protect an investment in the drug's development.
DeLack said she responded by forming her own company to raise money for research, and also began seeking a patent. It was during research for the patent that similar work done by Jonez years earlier was discovered.
In 1999, DeLack paid half the cost of an $89,000 pilot study of Prokarin, tracking fatigue in 10 MS patients who used the compound over a 90-day period. Seven out of the nine participants who stuck with the study reported improvement.
DeLack went public with the results in a story that aired in July 1999 on a Seattle TV station.
"The patients saw it and started calling," DeLack said. She told them how to get Prokarin, which costs about $250 a month and is not covered by insurance companies that refuse to pay for treatments not approved by the FDA.
There also were thunderbolts from the medical community.
As the buzz about Prokarin grew, the clinical advisory committee for the Greater Washington Chapter of the National MS Society issued a statement signed by Smith and six other doctors, saying there was no scientific merit to claims the drug was effective in treating MS. Moreover, the doctors said, DeLack's underlying hypothesis was not new and already had been abandoned by MS experts.
Some criticism was more personal. Dr. Ted Rothstein, a neurologist from Seattle, wrote in the November 1999 issue of the King County Medical Society bulletin that the evidence had only convinced him Prokarin was "just one more suspect therapy that falsely raises the hopes of a vulnerable public."
"Has our nurse, in conjunction with the pharmacist, discovered a treatment that has eluded the hundreds of scientists who have been searching out effective treatments of MS for decades?" Rothstein wrote.
The criticisms stung, reducing DeLack to tears. She believed she was doing the right thing, trying to help others in the same way she believed she had helped herself. There were times she told her family she was ready to quit.
"And every single time I said that, the phone would ring," DeLack said. "It was somebody with MS who had heard about my research."
Many become believers
Karen Redmon, 39, of Centralia was one of those seeking out DeLack. Her battle with MS began in 1995, when she woke up one morning to discover one side of her body numb.
At the time, her life was filled with the stress of being a parent and managing a corporate career. As her symptoms progressed, Redmon said fatigue forced her to leave her dream job. She began losing her eyesight. Her skin felt like it was on fire. Redmon tried traditional treatments for MS, but was sickened by the side effects. By August 2000, she had lost partial use of one of her hands, was paralyzed in one leg and got around using a motorized scooter.
Redmon looked into Prokarin after hearing about it in an Internet chat room for MS patients. Her doctor said it was false hope, but wrote her a prescription when she insisted.
Redmon kept a diary. The first month there was no improvement. But by the sixth week, her burning sensation started lifting.
"By week eight, I could walk," Redmon said. "I felt like it was a miracle. I felt like I had my life back."
She rejects suggestions that her improvement could be just a manifestation of MS, a disease notorious for symptoms that spontaneously come and go.
DeLack said she has responded to Prokarin critics by inviting them to discuss her ideas. She has copies of invitations sent via registered mail to doctors and MS researchers who have ignored her.
She's also moved forward in subjecting her compound to more scientific research. That's been difficult because DeLack has been unsuccessful in securing grants, even though studies are under way on a variety of substances, including aspirin and marijuana.
Her biggest study was completed last year and tracked fatigue among 29 MS sufferers over three months. A total of 22 people in the study received Prokarin, while seven were given a placebo that would have no effect.
The study found a 37 percent reduction in fatigue among MS patients who received Prokarin. No serious side effects were reported.
It cost DeLack and investors $187,000 for the research, which was conducted by a team of doctors who treat MS, in conjunction with a longtime MS research scientist who works in the radiology department at the UW. Results were reported in Multiple Sclerosis, a peer-reviewed scientific journal. The report's authors suggested Prokarin was worthy of additional evaluation.
Todd Richards, the MS researcher at the UW who helped conduct the study, said he's been shocked by how it has been received.
"I think there are a lot of political things going on with this study, and I don't understand what is going on," Richards said.
Among other things, Richards said, critics appear to be ignoring the study's results, and attributing the reduction in fatigue solely to the caffeine component of the Prokarin patch. But the caffeine in the patch is less than that in a single cup of coffee, Richards said. Moreover, the study found caffeine levels actually tested higher among people receiving the placebo.
Richards believes larger, longer and more costly studies are warranted.
"I think it is worth pursuing," he said. "I don't think any firm conclusions can be reached."
The Boston-based Tufts Center for the Study of Drug Development in November released a report showing it costs on average $802 million in research and development to bring a new drug from the laboratory to FDA-approved distribution at pharmacies. That takes 10 to 15 years.
Although others put the cost lower -- say $200 million -- there is little doubt that studying new drugs is tremendously expensive. The FDA requires three phases of clinical studies, starting with small trials like those DeLack has already completed, and growing to include large-scale studies in several locations.
Smith, the MS expert, said he has little patience for people who market treatments without doing the research first. That's one of his biggest problems with Prokarin and other alternative therapies.
"I'm vocal, and I'm a rabid dog when it comes to patient care," Smith said. "This is a treatment that does not provide good patient care for a number of reasons," especially the risk that it is providing people with false hope.
DeLack said her company is paid about $48 a month from every Prokarin prescription. When she adds up her monthly operating expenses, including her $2,000 phone bill and the costs of a lawsuit she's brought against an East Coast man using the Internet to market what he bills as a less-expensive alternative to Prokarin, there's a slim chance she'll ever be able to afford long-term scientific testing. In any case, DeLack is doubtful that she'll win over her detractors.
"The underlying tone I keep hearing is, 'This crazy nurse. This idiot nurse,' " she said.
In her heart, DeLack is convinced she is doing right. For her, right now, that is enough.
Multiple sclerosis is a chronic disease that affects an estimated 350,000 people in the United States. Its cause is not completely understood, and there is no known cure.
An MS patient's body turns against itself, attacking the myelin, or fatty sheath that surrounds nerves. The result is the neurological equivalent of what happens when insulation is stripped from electrical wires.
Patients' symptoms vary widely, from fatigue and tingling in the limbs to paralysis and blindness. The symptoms can come and go. MS is up to three times more common in women than men.
Washington state has one of the highest MS incidence rates in the country. Nationally, 57 to 78 people per 100,000 population have MS. In Washington, the rate is 150 to 220 per 100,000.
Overall, 10,000 people in Washington have been diagnosed with the disease. Snohomish County has a high number of people diagnosed with MS, in part because of its proximity to treatment clinics, said Dr. Craig Smith, a Seattle-based neurologist.
Elaine DeLack, a registered nurse from Stanwood, has been marketing a compound called Prokarin (previously Procarin) as an alternative therapy for MS. It is a combination of histamine and caffeine delivered through a skin patch. A recent study showed Prokarin reduced fatigue in some MS patients.
Many MS experts are skeptical and say that anecdotal reports aside, there isn't enough scientific information to warrant using Prokarin to treat MS.
MS is now most commonly treated with the so-called ABC drugs - Avonex, Betaseron and Copaxone. Those drugs attempt to limit the neurological havoc linked to MS by controlling the body's immune response.
The National Multiple Sclerosis Society said this after the Prokarin study:
"Fatigue is a very troubling symptom for many people with MS. It is treated by a number of therapies, and Prokarin may be useful in this regard. Because of its ingredients, Prokarin may have an impact on fatigue, even though the design of the current study makes this difficult to interpret. Individuals concerned about MS and fatigue should consult with their physician about Prokarin and other fatigue treatments."
For more information:
National Multiple Sclerosis Society Greater Washington Chapter: www.nationalmssociety.org/was/home/
EDMS LLC (Elaine DeLack's Web site): www.edmsllc.com/
MS Helping Hands Foundation: www.procarinreach.org/
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