David vs. Myeloma
In 1994 David Emerson, then just 34 years old, was diagnosed with multiple myeloma, an incurable cancer of the bone marrow. Between 1994 and 1997 David combated three relapses of his myeloma with radiation therapy, chemotherapy, and a stem cell transplant. On his third relapse his doctors told him there was nothing more that could be done and that he had 6-12 months to live.
Not accepting his fate, David did extensive research and sought out alternative therapies to survive. In 1997 he traveled to the Burzynski Research Institute in Houston, Texas where he underwent antineoplaston therapy, a non-FDA recommended therapy his health insurance deemed unnecessary. His myeloma slowly retreated and he has been cancer free since April of 1999.
David learned from his experience and although he knows that the specific therapy he chose will not work for everyone, he believes strongly that people facing chronic disease have a right to information about a full spectrum of approaches to cancer therapy. The information about multiple myeloma David found on the internet helped to save his life, and he is passionate about helping others succeed in their battles against chronic disease of all kinds.
Read more about David and his battle against myeloma and the health system in the following article, reprinted from theCleveland Plain Dealer Sunday Magazine from 4/13/03
A Bitter Pill to Swallow
David Emerson beat back his cancer with unconventional therapies. Then he took on the health system that abandoned him in his fight
By Diane Solov
When conventional therapy failed to halt his aggressive cancer and a string of doctors had written him off, David Emerson took his medical care into his own hands.
He brewed herbs prescribed by a Chinese doctor he couldn't understand, swallowed shark cartilage because sharks don't get cancer, saw a massage therapist and started working out. He traveled coast to coast to consult with top research doctors and mulled last-hope therapies in places as suspect as Tijuana and Bermuda.
When he had been bounced to his fourth cancer specialist in a year - and the doctor dozed off during their first appointment - Emerson boarded a plane for Houston. He took a treatment offered there by an unconventional and highly controversial Poland-trained doctor named Dr. Stanislaw Burzynski, who pumped his body full of urine laced with peptides that purportedly shrank tumors.
By all appearances, the treatment saved his life.
With his cancer in abeyance, Emerson launched the second biggest fight of his life.
Emerson sued his HMO and the doctors' group that had the contract to care for him. His purpose: To exact a reckoning of how bureaucrats could declare the therapy that saved him "medically unnecessary."
With a common-man sensibility evocative of Mr. Smith Goes to Washington, Emerson dared to challenge a health system unwilling to fight for his survival. Stung by the indifference of some of his doctors and an erratic series of insurance denials and approvals, he took aim at the rubric of managed care that has enraged patients for a decade.
How could his rare cancer be managed by a succession of oncologists? How could he trust a physician group that repeatedly denied its own doctors' recommendations to consult with out-of-town specialists? How does someone unschooled in the health system's complexities negotiate the ever shifting line between accepted treatments and promising new therapies?
Mostly, Emerson asked how a reasonably intelligent person could be expected to keep faith in a system that was better off if he were dead.
"The whole system is fundamentally flawed," Emerson says. "I should have died because of it."
In bouts with insurance companies, most cancer patients do die before the first round. Win or lose, Emerson's lawsuit may be the elixir that continues to keep him alive.
David Emerson is not a crank. He is smart, well educated and articulate, despite the lingering effect of his early cancer treatment that he calls "chemo brain," a list of deficits topped by short-term memory lapses. The youngest of four children of an affluent Shaker Heights family, he graduated from University School, an exclusive private school in Shaker, and Bowdoin College, a small liberal arts college in Maine, where he studied government and art history.
After trying a few jobs on for size, Emerson returned home and in 1991 took over the commercial printing business that his father, Oliver Emerson - founding publisher of Cleveland Magazine - started in the 1960s. He was working on his MBA nights and weekends, dating casually and living with the vigor you'd expect of a man with the world at his feet when he learned he had a disease that could kill him well before his 40th birthday.
A nagging pain in the neck launches Emerson's journey in 1993.
More irritating than alarming, Emerson shrugs it off as muscle strain. But a few months later, he stands at the mirror and notices that his right shoulder has shrunk. It is decidedly smaller than the left. Emerson, a lean 6 feet 6, can no longer grip the ball at his weekly basketball game. The strength has drained from his arm so it feels like a worn-out rubber band.
On the way home from work one Thursday afternoon in January 1994, Emerson swings by the urgent care center he passes every day on the way to the office. An X-ray shows an unmistakably substantial mass on his spine, and he is on the operating table within a week. Moments after the tube is pulled from his throat in University Hospitals' recovery room, one of his doctors delivers the diagnosis.
"You have cancer," he says.
Emerson, who is 34, starts to cry.
At first, there is just one tumor, called a plasmacytoma, at the fifth cervical vertebra. Doctors remove it and saw out a slice of his hip to bridge the fourth and sixth vertebrae. Emerson is given a brace for his back, some radiation treatments and returns to work at Emerson Press, hoping the cancer is behind him.
But just 13 months after his initial surgery, on Valentine's Day 1995, Emerson learns the cancer has returned. The progression changes the diagnosis to multiple myeloma, a rare and incurable cancer.
Multiple myeloma is a cancer of the plasma cells, which are vital to the disease-fighting immune system. With this cancer, unregulated plasma cells run rampant. They congregate in the bone marrow and hard bone, then bore through bones like termites in an old clapboard house, leaving holes, collapsing bones and gumming up vital organs with the calcium dispersed from disintegrating bone. The cancer accounts for just 1 percent of all cancer deaths, and is particularly unusual in young white men. The typical victim is twice Emerson's age, and blacks are twice as likely as whites to get it, although no one knows why.
Emerson's myeloma is of a particularly unusual variety. His disease is counted among the 1 to 5 percent of multiple myeloma cases that refrain from emitting proteins in the urine that signal cancer activity. Instead, Emerson is the sentry for his cancer. He knows it has returned when aching pressure deep in his bones becomes undeniably real.
Because the new diagnosis confirms that cancer is now coursing through his body, Emerson receives targeted radiation treatments and standard chemotherapy, then in December 1995, the most aggressive treatment his doctors can offer - high-dose chemotherapy and a bone marrow transplant. Before his first treatments, he's optimistic enough about his future that he follows one of his physicians' suggestions to harvest sperm before it is damaged by the radiation.
If Emerson is lucky, the standard treatment will let him beat the median remission of three years. He hopes for five.
The bone marrow transplant is brutal and the recovery long and hard. Emerson no longer can manage the family business, which has declined since his illness. He sells it the day before the transplant, essentially breaking even once the debt is paid.
Before he becomes unemployed, he applies for new medical coverage through HMO Health Ohio, a managed care plan offered by Medical Mutual of Ohio. Physician services are provided to HMO members through a contract with Mednet, a large doctors' group in the eastern suburbs that its owner, University Hospitals, recently disbanded.
Then Emerson gets on with his life.
In September 1996, he marries Dawn White, the woman who, to his amazement, has endured waking up in bed sheets filled with hair the chemo has freed from every part of his body. But while honeymooning in Europe, Emerson again begins to feel the deep ache in his bones, and he knows the cancer is back.
New X-rays confirm the cancer is raging. Emerson has tumors in his skull, and lesions in the sacrum and the top of his hip bone have returned. Less than two years have passed since his first tumor was discovered, and Emerson already has run through his doctors' bag of tricks.
"I realize my five-year plateau is gone," he says. "I need to do something."
Emerson sells his life insurance policies to a firm that buys them from the terminally ill. He nets $720,000 for the $1 million coverage - a high percentage of the policies' face value that confirms expectations for a quick death.
Since he became sick, Emerson has pursued wellness therapies outside the medicine cabinet that he hopes will boost his immune system. He works out most days at the Cleveland Racquet Club, gives up wine, beer and caffeine, receives a weekly massage and brews the concoctions of herbs prescribed by the Chinese doctor he found at Asia Plaza.
"She would give me these bags full of stuff," he says. "You boil it down, sometimes for hours, and you get kind of a tincture, this dark brown stuff."
Emerson is feeling pretty healthy. Now the return of the bone pain - the cancer - so soon after the hellish high-dose chemo sparks enduring panic.
Doctors prescribe a bone-strengthening drug for Emerson, and targeted radiation treatments tamp down new lesions centered near his sacrum. But the play book is empty between its covers for his next move.
Emerson scours the Internet, a far clumsier tool in 1997 than now, in search of new therapies. Like a business executive preparing employees for a meeting, he makes it a habit to send memos to his doctors in advance of office visits detailing possibilities he wants to discuss.
"I'm going to my doctors with any and all ideas," Emerson says. "'Let's try this, let's try that.' Some were conventional, some were less than conventional. I didn't understand the delineation at that point. I just read stuff. So you go to your oncologists and you ask them."
His second Mednet oncologist retires, and Dr. Anne Rassiga becomes the third Mednet cancer doctor Emerson has seen in the last seven months. She is keenly aware of Emerson's anxiety and seems genuine in her efforts to help Emerson find alternatives, referring him to different multiple myeloma experts across the country for consultation.
Emerson travels to Los Angeles, Seattle and Toronto to consult with three of them. Each offers a different, unproven approach, including suggestions for high doses of his bone-strengthening medicine and a second bone-marrow transplant, a procedure that carries a 40 percent chance of death. Emerson ultimately rejects them all.
Then he fumes when, one by one, Mednet's medical director stamps out denials to pay for the expert consultations his Mednet doctors recommended. Out-of-network services are not covered by his health plan, the form letter reads. "A second opinion can be done within Mednet."
Time is becoming a factor for Emerson - and for the harried doctors assigned to his care. In a September 9, 1997, chart note, Rassiga comments that she has spent about two hours on Emerson's care, and a Mednet staffer a month later confirms Emerson's feeling that his caregivers are growing weary of his fight.
"Every time he comes in it takes 45 to 60 minutes to bring our doctor up to speed on the patient's research of his disease," a staffer notes. "Time is a problem as the doctor cannot spend an hour each visit."
In late September, a year after Emerson's honeymoon relapse, the tumors again appear to be on the move. Rassiga again discusses Emerson's limited options, then counsels him about palliative care, a treatment strategy that will manage his symptoms until his inevitable death, noting in his chart: "The patient still has difficulty accepting these as alternatives. He was supported as best we could manage."
Emerson's disease has been progressing for three years, and she expresses little hope that he will be able to outrun it. "Despite very aggressive treatment one would predict that the odds of death within probably less than several years, would be virtually 100 percent," she says later in court papers.
Rassiga's prognosis stuns Emerson like a wind-up punch to his head. Three weeks later, after Rassiga has left Mednet, Emerson is explaining his medical history to Dr. James Sabiers, his fourth Mednet oncologist in a year, then tells him about the Burzynski Clinic and antineoplaston therapy.
Sabiers is the only remaining oncologist in Mednet, and is logging between 350 and 450 patient consultations a year. When he dozes off during the appointment, Emerson resolves to do it his way.
"You know, I'm taking up his time, he's a really busy guy," Emerson says. "To try to jump into his mind, he thought I was toast, and statistically speaking I'm a goner. I truly believed that they didn't have the time or the inclination to really figure out for me the next course of action."
A couple of weeks later, Emerson is sitting in the waiting room of the Burzynski Clinic in Houston.
In his gut, he knows he has made the right choice, though many would disagree.
Burzynski has achieved national notoriety for his fight with the U.S. Food and Drug Administration over a cancer therapy he developed using a drug he calls antineoplastons. The active ingredient is a peptide - a string of amino acids - that occurs naturally in urine and is believed by some to help kill cancer cells. Burzynski initially distilled the antineoplastons from donated urine, but he holds the patent on a synthetic version produced in Houston at the Burzynski Institute, a company in which he holds more than 80 percent of the stock.
The FDA pursued Burzynski for years for refusing to subject his antineoplastons to the government's drug approval process. When Emerson arrives at the Houston clinic, a judge has just acquitted Burzynski and declared a mistrial on a sum of 75 federal criminal charges, including shipping unapproved drugs across state lines.
A loyal battery of patients has made Burzynski an icon in the alternative medicine movement and marshaled supporters to stage sign-wielding demonstrations for patient choice. The doctor also has become a target for conventional cancer researchers on the far side of the chasm. A chorus of critics insists Burzynski has flouted good science and blown any credibility by taking a direct financial interest in his innovation. To them, he is a white-coated charlatan preying on cancer's most desperate victims.
Emerson unapologetically admits his desperation. But he is encouraged by journalists' accounts of patients treated with Burzynski's antineoplastons who defied death warrants issued by mainstream doctors.
"I've got to try," he says. "What's the alternative? To wait for the tumors to take over my body?"
Because of a 1996 court order, Burzynski administers antineoplastons only in FDA-approved clinical trials. Before Burzynski can start treatments, Emerson must find a hometown "monitor." Sabiers offers to follow his disease and treat his symptoms but refuses to cooperate in the Burzynski therapy, noting in the chart that Emerson told him it is "non-FDA."
Emerson denies he characterized the treatment as non-FDA and claims the Mednet oncologist told him he didn't have time, which Sabiers later denies. "It didn't meet my professional standards," Sabiers says in court papers. Sabiers did not return Plain Dealer calls.
With a single phone call, a family friend finds an oncologist at MetroHealth willing to help. "He was so full of hope for himself, and everyone was telling him he was hopeless," says Dr. Susan Gear Carter, who has since retired from MetroHealth.
Emerson knows he is stepping outside the circle of mainstream medicine, but Burzynski's FDA trial seems no less credible than the unproven therapies multiple myeloma specialists offered at renowned medical centers.
Emerson's medical status does not fit the criteria for Burzynski's study, but Burzynski successfully petitions the FDA to grant approval to treat Emerson under a regulation that permits "compassionate use" exceptions for gravely ill patients without alternatives.
So in November 1997, Emerson joins 962 other cancer patients Burzynski will treat with antineoplastons that year. A port is installed in a vein in Emerson's chest to convey the antineoplastons that are pumped from a bag he will wear around his waist for the next 10 months. Treatment for the subsequent seven months takes the form of 60 antineoplaston capsules that Emerson swallows each day. For much of the treatment, he emits a peculiar smell his family politely likens to garlic.
Emerson arrives at his regular appointments with Carter, then head of MetroHealth's cancer center, hopeful that she will document a miracle. Carter is highly skeptical of Burzynski's unproven treatment, but she supports Emerson with routine care, the MRIs Burzynski requires and a quiet compassion he missed in the serial oncologists at Mednet.
There are no simple tests to definitively determine the status of his disease. Carter deems him "stable," but Burzynski interprets what he sees on the MRIs as evidence of a steady but certain retreat of his cancer. In September 1998, Emerson receives his best affirmation of life yet: The birth of his son, Alexander, conceived in Dawn's womb with his rescued sperm.
"You know there is a bias about this odd Polish doctor giving urine to people," Emerson says. "It almost sounds comical. But I'm alive today."
Paying for a full course of antineoplaston therapy is like buying a four-bedroom colonial in the suburbs - without a mortgage.
From what he's seen so far, Emerson knows his HMO is unlikely to pay for Burzynski's antineoplaston treatment. Medical Mutual provides benefits for a network of physicians and requires authorization to go beyond it. Emerson went outside the network, and he did not receive authorization before he flew to Houston. The existence of a referral made midway through his therapy is in dispute.
Still, Emerson goes through the motions of working the long shot to have his HMO pay for the antineoplastons treatment. Before he started the treatments, Emerson asked Sabiers for a referral but was refused.
"I knew that was the process," Emerson says. "You get your doctor to buy into this, otherwise the HMO won't pay for it, even though there was confusion in my mind as to why I got all those referrals before and they won't pay for [them]."
Emerson knows he is lucky to have access to the cash necessary to start the treatment regardless of the HMO's position. His parents write a $110,000 check to Burzynski, and Emerson pays the $7,200 monthly charge. To his great surprise, Medical Mutual soon starts writing checks to Burzynski,too.
Medical Mutual denies charges for office visits and medical supplies at the Houston clinic, as well as claims for office visits and MRIs at MetroHealth. But the insurer writes Burzynski checks for more than $6,000 in April 1998 to pay for blood tests and "chemotherapy infusion" - the antineoplaston treatment.
As Medical Mutual's explanations pour in, Emerson is as gleeful as a child who took a handful of cookies. But he doesn't discount the possibility that a newfound sensibility has dawned on Medical Mutual. His insurance rulebook clearly covers therapy with "chemical or biological antineoplastic agents," and antineoplastons are antineoplastic - or anticancer.
But soon, the insurer's denials outnumber its approvals. Some cite lack of physician authorization or out-of-network service. Some are denied simply as "not a covered benefit," an apparent reference to the policy exclusion for experimental therapies. Some say the services are not approved by the medical director or are medically unnecessary - an explanation Emerson finds particularly maddening once Burzynski documents the treatments are working. How could they be unnecessary?
In two years of medical claims, Emerson can discern no pattern. Medical Mutual periodically pays Burzynski claims, some as late as January 2000, chipping in $25,254.78 altogether toward his antineoplaston treatment, according to Burzynski Clinic records. Medical Mutual says in court papers the payments were made by mistake.
Dr. Linda Peeno, a managed-care medical director who converted to patient advocacy, says if Emerson's HMO is like most managed care plans, he stood a slim chance of persuading it to pay for the Burzynski therapy.
Peeno, whose story as an HMO whistleblower was told in the 2002 Showtime movie Damaged Care, draws on her personal experience when she decrees that managed care plans often are designed to skirt payment of high-ticket services.
"The basic strategy is anybody that's expensive, there's going to be a strategy to avoid paying for it," says Peeno, who may testify as an expert witness if Emerson's lawsuit proceeds to trial. "The decision is already made and then the rationale is done after the fact."
Emerson faces an uphill battle to prove that case. The lawsuit against Mednet and Medical Mutual was filed in July 2001, and Emerson lost a critical first round in January, when a Hamilton County Common Pleas judge granted the defendants' motion for summary judgment without comment. Emerson has filed an appeal.
But Emerson believes that finances drove denial decisions. His lawyer, Robert Perez, learned that HMO Health Ohio capped Mednet's fees at a set per-patient rate to cover all services delivered outside a hospital.
"There was a financial disincentive to make referrals," says Perez, who works in Cincinnati. "That he's alive demonstrates in a very vivid way why it should have been paid for. It worked."
Mednet and Medical Mutual both say they cannot discuss the case because it is still in the courts. "Generally speaking, the company has an obligation to its members to effectively manage the payment of benefits according to the subscriber's policy," Medical Mutual said.
All insurance policies are different. But few would flatten the mountain Emerson likely would have had to climb to overcome coverage issues for an investigational therapy.
The domain of experimental therapies is loaded with ambiguity and nuance in the world of medicine. Novel, innovative, experimental, let's-give-it-a-try therapies - all are stretched along a continuum of treatments, from those well-established as the standard of care to acknowledged research experiments to clear digressions from accepted regimens.
The concepts are dear to the medical community, but they are not absolute. "Standard of care" boils down to physician consensus about the best medical treatment given the evidence available to establish safety and effectiveness. Perhaps the most clear-cut is recognized clinical research, which is marked by controlled studies that undergo peer reviews and require patients' informed consent.
When it comes down to it, though, even a treatment as mundane as a cold tablet is experimental, because no one can be sure it will work on an individual patient. A new surgical procedure lies somewhere on the spectrum, depending on how wide the swing from the tried and true. Prescribing drugs for conditions other than those that have been studied and approved by the FDA - the widely prevalent practice known as "off-label" pharmaceutical use - occupies another notch along the continuum. Off-label use of chemotherapy drugs is a staple of cancer care.
"The line between therapeutic innovation and experimentation is extremely thin," notes Tom Murray, executive director of the Hastings Center, a bioethics institute in Garrison, New York. "Sometimes it's no more than the intention of the physician."
For a patient like Emerson, whose disease has stubbornly resisted containment, there were no options proven to spark a response. Emerson saw no distinction between taking antineoplastons and getting an off-label, high dose of his bone-strengthening drug, a treatment recommended by an L.A. myeloma expert that a Mednet oncologist agreed could be administered in Cleveland.
There's nothing to say that Medical Mutual would have agreed to pay for that one, either. Insurance companies resist covering experimental therapies, particularly those far outside mainstream medicine. Medicare, which as the nation's largest health care payer sets the trend for benefits coverage, didn't start covering clinical trials until 2000. Even now, it picks up only routine costs of care associated with treatments.
There are sound ethical reasons not to pay for every possible intervention. "Resources are finite," Murray says. "It's a matter of justice that those resources get used to fund care that is useful and likely to make a difference. You want some minimal standards to believe it might be effective, and you want a fair process to determine that."
Evidence of effectiveness, of course, also is a patient's best shield against frauds that hawk cures made of use-less sugar water, or worse, something harmful. And a court ultimately may determine whether Emerson's process was fair.
In the eyes of government regulators, the jury is still out on Burzynski's treatment, too. The Burzynski Clinic still has 69 clinical trials open to patients for a wide assortment of cancers, but the FDA has not warmed to the therapy. An FDA spokeswoman who fielded a query about the status of the trials noted that Burzynski is a "sensitive" topic at the agency before sending along a warning statement in response: "To date, the safety and effectiveness of so-called 'antineoplaston therapy' have not been established. While the agency will continue to evaluate study results, FDA cannot verify that this therapy provides any benefits."
It has been more than five years since Emerson first walked into Dr. Stanislaw Burzynski's Houston clinic.
Emerson has not had a recent bone marrow biopsy or MRI, tests that provide clues to his cancer status. But he knows his cancer is in check. He does not feel the deep aches in his bones that have always telegraphed its forward march.
When she was caring for him, Dr. Susan Gear Carter, the MetroHealth oncologist who served as local monitor for his Burzynski treatment, saw Emerson improve. She readily concedes his survival is remarkable, but she believes there was no scientific evidence to prove that Emerson achieved remission.
"David is unusual," says Carter, who since moved to Maine. "He survived beyond so-called expectations."
Now 43, Emerson fills his days working at the small desktop publishing business he and his wife started. But the lawsuit and the issues that swirl around it often command his thoughts. He would like to re-pay his parents and Burzynski, but mostly,he wants consequences for Medical Mutual and Mednet.
"I don't believe any of these people are evil," Emerson says. "I think the system is."
The disease has left its mark on Emerson's health. He walks with a limp. Nerve damage from the intensive chemotherapy makes it hard to carry a bag of groceries up the stairs to his back door. He can no longer jog or chase his son, Alex, when they play catch in the back yard.
But these are not complaints. Emerson knows he is lucky to be alive and dares to hope he can skirt death long enough so his son, now four, will have a memory of his father.
"I had never expected to see 40," Emerson says. "I would give my left arm to see 50."
Diane Solov is a Plain Dealer medical reporter. Like virtually everyone, she has lost loved ones to cancer. She may be reached at 216-999-4133 or through firstname.lastname@example.org.