A Customized Approach to Cancer Care
To those who are healthy, the idea may sound preposterous. Pay a private, for-profit cancer research center $20,000--which may or may not be reimbursed by medical insurance--for a customized cancer treatment as yet unapproved by the Food and Drug Administration, which may or may not save your life.
Among many physicians, the idea has stirred controversy ever since Dr. Robert K. Oldham, a former National Cancer Institute researcher, founded Biotherapeutics in 1984. The Franklin, Tenn.-based research center contracts with patients to develop customized therapies with biological response modifiers, substances that aim to enhance the immune system’s natural ability to prevent tumors. Critics charge that asking patients to pay for such investigational therapy is unfair, unethical and exploitative.
Oldham and other Biotherapeutics proponents counter, however, that not all patients qualify for NCI-sponsored clinical trials of biologicals and that the Biotherapeutics model--in which the center invites physicians nationwide to join its study group and treat its patients--also makes it possible for patients to obtain treatment in their own community.
If Florence Fruhwirth had to choose sides in this controversy, it would be no contest. The 53-year-old Cypress, Calif., secretary thinks the idea neither preposterous nor unethical. If she had to choose a word to describe the concept, it would be lifesaving.
Grim Cat-and-Mouse Game
Diagnosed with kidney cancer in 1983, Fruhwirth underwent surgery for removal of the malignant right kidney, and for a time was healthy. But a year after the surgery, an X-ray showed that the cancer had spread to the right lung--a common site of metastasis for kidney cancer. Ever since, the growth has played a grim cat-and-mouse game, disappearing and reappearing with a variety of approved and investigational treatments. In early 1986, Fruhwirth’s local oncologist, Dr. Mark Janis of Los Alamitos, gave her a dismal prognosis. “He told me, ‘You need tomorrow’s medicine today,’ ” Fruhwirth recalled recently.
Now, she believes she has found it. Early last year, she contracted with Biotherapeutics to customize her treatment with biological response modifiers. Two treatments and $20,000 later, her disease has not progressed.
“Purely from a disease or medical standpoint, she has had what we would call stabilization of disease,” said Dr. Neil Barth, a Newport Beach medical oncologist and a member of the Biotherapeutics’ national study group, who oversees Fruhwirth’s treatment.
Fruhwirth’s therapy is called IL-2/LAK--short for interleukin-2/lymphokine-activated killer cell therapy. In the treatment, a patient’s white blood cells, or lymphocytes, are removed and combined with interleukin-2 to transform them into “killer cells.”
A key concept in the Biotherapeutics’ approach is the belief that each tumor in each patient is different and demands customized therapy.
‘Just Stopped Growing’
“She was treated in July with IL-2/LAK and the pulmonary lesions just stopped growing,” Barth said. The treatment schedule was interrupted in late summer when a routine brain scan showed a metastasis on the right posterior side of the brain, Barth said. Fruhwirth received radiation therapy before entering the hospital for another round of treatment.
“There is some improvement in the lesion on the brain,” Barth noted, “and a very slight regression of pulmonary nodules. In clinical terms, she’s stable.”
This month, Fruhwirth is scheduled to begin monthly maintenance treatments of IL-2 alone, Barth said. For the next four months, she will check into the hospital for five days each time to receive the treatment. If she shows continued regression, Barth said, he may administer another round of IL-2/LAK treatments.
Fruhwirth sees herself as a pioneer--and a believer in the investigational treatment. “The method makes sense--when they pump up your own cells,” she said. “It’s a treatment for me ,” she added. “And cancer, from what I’ve been reading, is so individualized it has to be treated individually.”
The optimism of Fruhwirth and her husband, Matt, a 55-year-old engineer in the flight-test division at Douglas Aircraft Co. in Long Beach, is bounded by realism. “We’re working on hope,” said Matt during a recent interview in the Wedgwood-blue home the Fruhwirths share on a quiet Cypress cul-de-sac. They have four grown daughters, a son-in-law and two grandchildren.
Florence Fruhwirth is predicting she will return to her secretarial job at Aerojet Ordnance in Tustin sometime this year. Slowly, she is trying to build up the strength in her legs by taking five-minute rides on the exercise bicycle that sits in a corner of her living room.
Unpleasant Side Effects
Looking ahead to the good times offsets the struggles that Fruhwirth has endured during the last four years. Side effects with the biologicals can be unpleasant, she admitted. After the first treatment with IL-2/LAK, she recalled, she had severe fluid retention, gaining about 14 pounds, and skin problems. “I peeled all over my body,” she said.
And although she appears healthy and relaxed, she admits she has bad days. When the future looks dismal, though, she usually takes action.
“I went to a support group--and still go--called Cancer Conquerors. I read ‘Getting Well Again’ (a 1978 book by Dr. O. Carl Simonton, a pioneer in the use of visualization and other techniques to combat cancer).”
Fruhwirth had been symptom-free until the night of Oct. 3, 1983, she recalled. After returning from an evening exercise class in which she had attempted a new stomach exercise, Fruhwirth experienced pain in her back. “It came around to the front and I thought it was appendicitis,” she said.
When it didn’t subside, Matt drove her to a nearby emergency room, where they performed tests. “The next morning, a nephrologist determined it was a mass in my kidney and told me that 98% are cancerous,” Fruhwirth remembered. “The best thing, he said, was removal of the kidney. So they removed it and it was malignant.
“He thought he got it all,” she added. “And after about six weeks, I was back to work. I knew two people at work with kidney (cancer) problems (who were doing well) . . . so it didn’t frighten me.”
Her six-month check-up showed no evidence of cancer, she said. But the real battle began after an X-ray taken one year after the surgery revealed a spot on the right lung.
“That was my worst time,” Fruhwirth recalled. “The doctors said there’s no effective treatment for this type (of cancer). The doctors suggested I go to a UCLA trial of interferon (a type of biological response modifier). In six months, interferon got rid of the lung spot. They called it a 100% response.”
But it didn’t last. Six months later, the spot was back. And thus began Fruhwirth’s long search for relief.
The struggle with cancer, the Fruhwirths said, has made them more tolerant of each other. “He’s very positive,” said Florence of her husband as he sat next to her.
“She also uses the word hyper to describe me,” he added with a teasing look. She agreed quickly.
“My daughters have also helped immensely,” Florence said. “The best things they do is treat me as they did before. They don’t treat me as a victim.”
To finance the $20,000 fee to Biotherapeutics, the Fruhwirths took out a loan and are making payments to the company. “You write out a $6,000 check and you say ‘aaaah,’ ” said Florence Fruhwirth, gasping as she spoke.
Next, the Fruhwirths will wait on their insurance company’s decision on reimbursement. Overall, the possibility of reimbursement is getting better, noted Oldham during a Biotherapeutics-sponsored conference for physicians held last year in La Jolla.
In a study of 12 kidney-cancer patients with metastases treated with biological response modifiers by Biotherapeutics last year, three have achieved “complete remissions” with IL-2/LAK therapy, Dr. William West, Biotherapeutics’ co-founder and medical director said recently. “Five patients have had more than 50% regression of the tumor,” he added.
Cetus Corp., an Emeryville-based biotechnology firm, hopes for FDA approval of interleukin-2 soon.
“We have our filing in preparation,” said Jana Cuiper, manager of corporate communications. A few other private cancer research companies have sprung up since Biotherapeutics began, according to Edward Lanphier, vice president of corporate development for Biotherapeutics. “There are fewer than half a dozen,” he estimated.
Not Yet Profitable
As yet, Biotherapeutics is far from profitable. “Our loss for fiscal year 1987 was $3.3 million,” said Lanphier. In fiscal year 1986, he said, the loss was $1.3 million.
To date, seven Biotherapeutics labs are operational, three of them in Southern California. More than a dozen physicians have joined the study group, Lanphier said.
He expects Biotherapeutics to continue operating in the red through fiscal year 1988, but to post profits in the near future. “Analysts who follow the company predict that the company will be operating in the black within 18 months,” he said.
“I think they’ll break even in fiscal year 1989,” said Stuart Weisbrod, an analyst with Prudential-Bache Securities in New York City, who predicts profitability by April 1990.
Does the prospect of a private cancer-research center like Biotherapeutics making a profit on her cancer treatment bother Florence Fruhwirth?
“No, not at all,” she said. That’s not to say she couldn’t have used that $20,000 in other ways, she added. “The shower leaks in the main bathroom,” she noted with a laugh recently. “But that repair will have to come later.”
To her, the money spent on her cancer treatment is clearly a secondary concern. “There’s no way I would pay for a government study,” she said. “But this is more individualized (treatment) than studies (provide). If Biotherapeutics did not come out with this, where would I turn?”
In Fruhwirth’s view, the real bottom line is a rhetorical question: “What’s my life worth?”
