Current legal intervention regarding "experimental" treatments must be changed: an analysis of high doses of chemotherapy with autologous bone marrow transplantation for breast cancer patients.

• Author: Smayda, Emily

1. INTRODUCTION

   A 35-year old woman, mother of three children, suffers from Stage IV metastatic breast cancer.(1) After finding a suspicious mass in her right breast, she underwent a mastectomy.(2) Nine months of chemotherapy and radiation followed, making the woman extremely ill.(3) Despite efforts to battle the disease, the cancer was found to have progressed.(4) The woman's doctor told her that with conventional treatment the "disease will continue to progress and she will die."(5) Given her situation, the woman's doctor suggested a relatively new approach to standard chemotherapy called High Dose Chemotherapy with Autologous Bone Marrow Transplantation

   ("HDC-ABMT").(6) The procedure involves the extraction of bone marrow, followed by near lethal doses of chemotherapy, finalized by the replacement of the damaged bone marrow, essentially rescuing the patient.(7) Many doctors were "encouraged by the promising preliminary data from HDC-ABMT research."(8) HDC-ABMT was not considered a cure for this woman's breast cancer. Instead, the procedure gave her a better chance of remission, a significantly less amount of time in a hospital and a shortened term of chemotherapy with its unavoidable side effects, that had previously plagued her.(9) The treatment provided an extension of time to the woman's life and ensured a modicum of comfort.(10)

   At this point, the woman felt that HDC-ABMT was her only chance of survival from a disease that was literally taking over her body. She decided to go though with the procedure. Before being admitted into the health care facility, however, the institution required pre-secured financing or pre-certification from a prospective patient's insurance company, guaranteeing that the treatment costs would bere imbursed.(11) The procedure costs between $100,000 and $150,000 per patient.(12) She automatically assumed that her insurance coverage would cover the expense.

   Her insurance company denied her request, deeming High Doses of Chemotherapy with Autologous Bone Morrow Transplantation ("HDC-ABMT") as being "experimental" and "investigative", thus falling outside of coverage.(13) The woman not only faced the emotional distress of realizing that conventional treatment could no longer help her, but now had to deal with the reality that her only course of action was now unattainable.(14) When she signed her health insurance contract she thought she would be covered for anything. She had no idea that a provision, a simple sentence of text, would essentially cost her her life. As she paid her premiums every month, she felt secure, protected from any possible health conditions that she would encounter.

   She had undergone treatments that had proven ineffective.(15) She had been told that death was inevitable without HDC-ABMT.(16) The health care institution which promised to provide her with such treatment required pre-paymen, that her insurance company denied. Her options looked bleak. She decided to turn to the law for remedy.

   Instead of entering into a personal injury lawsuit, she found herself involved in a contracts dispute. The language of the insurance contract was being scrutinized, instead of the injustice of the denial of coverage. The way in which the word "experimental" was defined became more important then how young this woman was and the number children she would leave behind if she was not able to receive HDC-ABMT treatment. The more ambiguous the term, the more likely she would receive a possible preliminary injunction, allowing her to have the amount of money to proceed with treatment.(17)

   Unfortunately, the woman's law suit against her insurance company was also preempted by the Employment Retirement Income Security Act of 1974 (ERISA).(18) ERISA contains a vague preemption provision that supersedes "any and all State laws insofar as they may relate to any employee benefit plans."(19) The woman could not bring any further state common law claims, such as emotional distress, against her insurance company under ERISA.(20) She was also bound by the remedies provided by ERISA.(21)

   Litigation lingered and the woman died before trial. The woman's legal attempts proved futile. Her husband sued her insurance company for breach of contract, infliction of emotional distress, fraud and wrongful death, but ERISA preempted all four claims.(22) The husband's claims were preempted because they stemmed from the denial of benefits to his wife.(23) Further, under ERISA the husband could not personally bring a suit against the insurance company because he lacked standing.(24) Due to the fact that the woman died, an award of benefits no longer existed.(25)

   The hypothetical above combines the facts of numerous cases, that had developed between 1988 and 1997 regarding HDC-ABMT, and proceeds to bring to life the real issues that the legal community must face with insurance companies' coverage of revolutionary treatments. "It is a society-wide problem of how to provide last-chance health care to a person who may have a small chance at survival if provided an expensive cutting edge treatment that she cannot afford out of her own resources.(26) This Note is not trying to solve this problem. Instead, the purpose of this Note is to recognize the flaws with the legal system's dealings with insurance benefit denial.

   The specific analysis of HDC-ABMT will help the reader to realize that the medical procedures being dealt with by litigation are not necessarily wildly innovative. Insurance companies are hiding behind the guise of words such as "experimental" to avoid paying for treatments that are both feasible and needed. Further, HDC-ABMT being used for breast cancer patients, suggests a possible discriminatory aspect that cannot be reached with current legal intervention.

   This Note suggests ways of dealing with insurance coverage denial on a more direct level. Instead of being bogged down by contract language and ERISA preemption, proposals for national standards and expert committees would rectify the injustice of benefit denial by taking away insurance company discretion. Then Courts could deal with case by case scenarios according to the actual denial, not the language of a provision in a contract.

2. MEDICAL BACKGROUND

   Based on medical studies, one out of eight or nine women today will be diagnosed with breast cancer.(27) This is a dramatic increase from the 1940's where only one out of twenty women were diagnosed with the disease.(28) The sudden escalation of victims has greatly heightened public fear.(29) This heightened fear has put pressure on the medical field to produce a treatment to combat breast cancer. Currently, there is no curative approach to stage IV breast cancer.(30) Conventional uses of chemotherapy and radiation, used in other cancers, proved to be not extremely effective with advance stage patients.

   The increasing of dose intensity has been a successful way of improving the effect of many drugs.(31) In the past ten years there has been a sudden interest in dose intensity of chemotherapy in breast cancer treatment.(32) Most studies showed a higher complete and total response rate to high-dose chemotherapy then lower amounts.(33) Higher dosages of chemotherapy produces a larger amount of toxicity, rendering the immune system defective.(34) Escalating treatment doses causes irreversible bone marrow suppression.(35) Bone marrow transplantation, however, allows improvement with response rates without the toxic level ramifications.(36)

   Autologous bone marrow transplantation (ABMT) was first tested in humans in the 1950s.(37) The procedure involves the harvesting of a patient's own bone marrow and later reinfusing the substance back into the person's system.(38) "Bone marrow is placed into a heparinized tissue culture medium, passed through wire mesh to remove aggregates, and infused intravenously," where hematopoietic stem cells produce new cells.(39) Autologous bone marrow transplants allow higher doses of chemotherapy. The return of bone marrow rescues a patient's immune system from the serious life threatening effects of aggressive chemotherapy treatments.(40)

   As with other treatments there are complications with HDC-ABMT that could cause patients problems. About 5% of patients will die of infections and other complications during the time period where bone marrow is growing back to support their immune system.(41) Long-term survivors have a greater risk of developing secondary leukemias.(42) Infertility and difficulties with sexual functions further damage the procedures' success.(43)

   The real question that counters the treatment, however, is whether HDC-ABMT is truly superior to conventional chemotherapy for later stage breast cancer patients. The medical advisory board of Chicago's Technology Evaluation Center found HDC-ABMT a "viable option for some women with advanced metastatic breast cancer" based on new assessments of the procedure done in 1996.(44) Yet the procedure fails to be considered a "standard treatment" for advanced staged breast cancer patients because of the "lack of controlled studies and the presence of numerous biases" when compared to standard chemotherapy.(45) Randomized controlled trials comparing HDC-ABMT and conventional-dose chemotherapy are needed to prove HDC-ABMT's effectiveness.(46) One of the reasons that clinical trials are not being administered as often as they are needed to standardize the treatment is that patients refuse to be randomized.(47) The chance of not receiving high-dose chemotherapy is preventing many women from entering into clinical trials.(48) Further, insurance companies are less likely to cover involvement with clinical trials because of the "experimental" nature of the programs.

   Essentially, HDC-ABMT is not being covered by insurance because it is deemed "experimental". The procedure is considered "experimental" because the treatment has not gone through enough clinical trials comparing HDC-ABMT to standard dose...