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Award Damages Commensurate with Costs, Compensate Swiftly and Increase Medical Research Funding: Comments on SB 852

We are concerned citizens, an alliance of doctors and patients, brought together by our mission to defeat mesothelioma as a life-ending disease. We are intimately familiar with the financial, medical, physical and psychological hardships to which mesothelioma patients and their families are subjected.

Mesothelioma is a cancer that arises from the cells lining the chest and/or abdominal cavity. It typically develops 20-40 years after exposure to asbestos. This deadliest of all asbestos-related diseases is almost uniformly fatal. It strikes indiscriminately, afflicting construction workers, housewives, Olympic Gold Medalists, Hollywood actors like Steve McQueen, U.S. servicemen and women (as many as a third of all cases, including Navy Admiral Elmo Zumwalt, Jr.), and even U.S. congressmen (Minnesota Rep. Bruce F. Vento). Its victims are often in the prime of their lives.

The average person with mesothelioma lives only 6-18 months after diagnosis. A minority (40 to 45 per cent) responds to the most effective chemotherapy, which lengthens survival by only 3 to 6 months. A small number are candidates for radical surgery, which along with radiation, chemotherapy, heat, and experimental therapies may slow disease progression further. Very few live more than three years.

We applaud our government's recognition of the need to jointly fund with industry and their insurers a comprehensive mesothelioma treatment and research program. Funding for mesothelioma research has been proportionately much lower than that for other cancers.

The proposed Asbestos Trust Fund Bill, SB 852, is an important first step towards framing the asbestos cancer epidemic as a public health crisis, as opposed to a litigation crisis. While a complete review of SB 852 is beyond the scope of our expertise, we are concerned about the following components of the proposed law:

1. The $1.1 million cap does not adequately address the needs of mesothelioma patients.

The cap is insufficient to meet the medical, hospital, travel, lodging and other costs of mesothelioma patients who receive the best treatment, which includes surgery, chemotherapy radiation, or a combination of therapies. Moreover, it is insufficient to address the ongoing medical costs of patients who survive long enough to outlive the median survival time but who remain disabled and unable to earn a living. The bill therefore discriminates against early stage, usually younger, patients whose life-long medical costs are certain to exceed the $1.1 million cap.

Moreover, we do not believe the pre-determined awards adequately compensate mesothelioma patients for the extraordinary pain and suffering they must endure. This is especially true for those patients who pursue aggressive treatment instead of opting for palliative treatment only.

2. Delays in the distribution of compensation will hurt patients.

Under S 852, civil claims by mesothelioma patients, even those with imminent trial dates, will be terminated. Patients will not be eligible to collect any compensation from the Trust Fund until it is up and running. Legal experts predict it may take years for the new federal bureaucracy to begin making partial payments on claims.

Mesothelioma patients have a life expectancy of between 6 and 18 months on average. As the Trust Fund is currently established in S 852, most patients are likely to pass away before they receive compensation. It is vital that the Trust Fund distribute awards to mesothelioma patients while they are still alive, so they can invest the money in life-extending treatment.

3. Defendant companies should fund the National Mesothelioma Research and Treatment Program (NMRTP) at higher levels than outlined in S 852.

We commend Senators Herb Kohl, Patrick Leahy and Arlen Specter for laying the foundation for a mesothelioma research and treatment program. As written, S 852 would authorize $29 million per year to go toward basic and translational research, a registry and tissue/blood bank and educational center. However, we are deeply concerned that, unless the above Senators take action today to insure the additional funding to the NIH, this vital program is destined to become another "unfunded mandate."

This legislation presents an historic opportunity to ensure that the parties responsible for the great harm caused by asbestos exposure are held accountable for funding research that will mitigate the damage. Currently, industry would contribute only $17 million per year, or 58% of the program. SB 852 would allocate only .2% of the $140 billion trust fund towards research on the prevention, detection, treatment and cure of mesothelioma.

While we believe that this program is a good starting point, we strongly encourage Congress to consider other measures that will force asbestos manufacturers and insurers to provide more funding for research. At least 1% of the value of the projected $140 billion Trust Fund should be set aside for medical research. Moreover, the program should be funded separately from the money earmarked for compensation. Patients with asbestosis, other asbestos-related cancer, and mesothelioma should not be taxed for curing a disease they did not cause.

The patient and medical communities believe that much ground has been lost in finding effective treatments and cures for mesothelioma, a cancer that has been known for over 55 years. The National Cancer Institute spends only 1/10 of 1% of its annual budget on mesothelioma-related research. While it is an uncommon disease, affecting about 3,500 individuals a year on average, mesothelioma is funded at much lower levels than other cancers of similar incidence rates. The federal government currently spends only $933 of research funds per mesothelioma patient, while it devotes $17,300 (nearly 20 times as much) for each patient with cervical cancer, a disease which kills roughly the same number of persons each year.

This legislation presents an opportunity to demand that the responsible parties fully and fairly compensate victims of asbestos exposure and ensure that they have the best hope for treatment and survival through innovative research. We ask that Congress strongly consider concerns outlined above when debating the future of S 852.

The following pages provide background on mesothelioma and justification for our stated concerns .

* Mesothelioma is an uncommon but deadly cancer associated with exposure to asbestos. Mesothelioma is a cancer, or malignant tumor, arising from mesothelial cells, which are found primarily in the linings of the chest, abdomen, and heart. Mesothelioma is the deadliest of all asbestos-caused illnesses. Although there is no safe threshold for asbestos exposure, studies show that those groups with the highest occupational exposures suffer the greatest mortality.

Once the diagnosis is made, the prognosis is always grim. A fatal outcome is considered "uniform" and "nearly inevitable." Median survival rates are in the range of 6 to 18 months, and most patients who are diagnosed in the later stages of the disease are given only supportive or palliative treatment.

Even the most successful chemotherapy regimen increases the median survival by only 3 months, and only about 40% of the patients who take the "standard care" chemotherapy regimen show any response. Patients who have their tumors surgically debulked are virtually certain to suffer a recurrence within the next 12 months. During treatment, patients experience chronic fatigue and shortness of breath, making it nearly impossible to continue their chosen craft or profession. Mesothelioma is a permanent disability that results in death.

* Without a national registry, a precise estimate of mesothelioma incidence cannot be established. Public health figures report that about 2,500 to 3,500 individuals are diagnosed with mesothelioma in the United States per year.

The latency between asbestos exposure and the diagnosis of mesothelioma is a confounding factor in establishing the current incidence and projecting future rates. We do know that the incidence of mesothelioma is rising. Even with the asbestos mitigation efforts initiated 20 to 25 years ago in this country, mesothelioma incidence is expected to peak sometime in the next 15 to 25 years. Over 27 million Americans have been occupationally exposed to asbestos and are thus at substantial risk for lung cancer and mesothelioma.

A national registry would also help track mesothelioma cases and establish geographic or other factors related to asbestos exposure. Mesothelioma does not respect the color of one's collar, their military rank, age, political power, influence or physical fitness. At-risk populations not only include workers directly or indirectly exposed, but also housewives, children, and schoolteachers who were exposed second-hand or environmentally. Additional research funding will help to identify new markers of asbestos-related cancers so that tumors can be detected early enough to allow life-extending medical interventions.

* A commitment to fund research into effective treatment and cures will help to reverse overwhelming hopelessness in the medical and research communities.

While patients often present with a myriad of clinical symptoms, from chest pain to shortness of breath to abdominal distention, there are new diagnostic imaging tools that help facilitate a definitive diagnosis, such as the PET-CT scan. Pathological analysis will confirm the diagnosis, through the presence or absence of specific markers in tissue taken from the tumor. New technologies may provide early detection of mesothelioma based on the presence of biomarkers in blood, serum and tissue. These techniques should be refined and validated immediately, so that they can be offered to populations at high risk.

Limited funding has resulted in little research attention to early detection, and the paucity of effective treatments has resulted in fewer numbers of doctors willing to treat the disease, with many simply making an immediate and hope-depriving recommendation for hospice care. Only a handful of doctors in a few hospitals nationwide currently have the expertise to offer the newest treatment options.

A commitment of research funding will help to reverse this trend by attracting new investigators to the field, providing hope to both medical professionals and patients that effective treatments are on the horizon.

* Physician education through a national education center is critical in disseminating information to the medical community. Given the rarity of the disease, the likelihood is high that a patient's primary care physician has not seen a mesothelioma patient. Even physicians who practice in areas where former asbestos workers are concentrated may only encounter one new case a year. Many are unaware of national protocols for surgical and novel chemotherapeutic regimens, or they may feel that the standard of care should be symptom palliation only.

Faced with this overwhelming defeatism, many patients and family members will retreat into isolation and hopelessness, as they attempt to follow their doctors' advice to "get their affairs in order and prepare to die."

* Compensation caps do not adequately address the fact that treatment of mesothelioma is extremely difficult and expensive.

Many patients seek treatment at the handful of medical schools, teaching hospitals, and cancer centers that have developed specialized mesothelioma care. Few of these patients will be candidates for treatment, since more often than not the disease is diagnosed after there has been lymph node involvement, progression of tumor bulk or extensive metastases. For those patients who are candidates, the best treatment is a multimodality approach consisting of surgery to locally control the disease, chemotherapy or other novel drug treatment, and possibly radiation.

Surgery for mesothelioma is a serious and risky option, only performed routinely by a handful of surgical specialists in the United States. Many patients and desperate families must travel long distances to reach a medical center with specialty care in mesothelioma, causing an immediate financial, psychological, and physical burden. Once an institution is located, tests to see if the patient is functionally able to participate in the aggressive programs must be performed. This adds another layer of financial difficulty.

Moreover, there is the huge and frightening question of whether the patient's insurance carrier will pay for the out-of-state or "out-of-group" treatment necessitated by the lack of local experts. Although this cancer does not respect the color of a patient's collar, a substantial percentage of patients are poor and uninsured. Most health insurance plans do not cover treatments that they consider "experimental." Many refuse to reimburse hospitals for performing PET scans, for example, which have been shown to be valuable for diagnosing and staging mesothelioma.

These financial and psychological burdens are only a prelude to the physical pain that follows surgery of the chest. Rib resection, muscle cutting and spreading, and placement of tubes in cavities all contribute to postoperative discomfort. This can be ameliorated in the first few days after surgery with epidural analgesia, but this is not always offered. Narcotics are effective in reducing the pain, but side effects are common, including constipation, nausea, lack of appetite, and confusion. As the postoperative pain diminishes, the patient then faces the physical ordeal of chemotherapy or radiation. He or she also must adapt to living with one lung, chronically short of breath and in pain.

Recovery from this invasive, complex surgery is slow and painful. Patients are homebound, unable to work and without income (except perhaps disability), for many months afterward.

* We believe that the legislation should require the companies responsible to allocate additional funds directly towards an asbestos cancer patient assistance program.

The program would help indigent or uninsured patients pay for the travel and lodging expenses associated with seeking treatment at the handful of specialized centers for mesothelioma treatment. Not only will the money directly help patients obtain the treatments they desperately need, it will also help increase enrollment in vital clinical trials and novel treatment protocols and ensure that the registry and tissue bank capture all relevant data, which will advance the march of scientific research. This patient-friendly system is already used by the National Institutes of Health (NIH) in order to assist patients who are participating in protocols in Bethesda, Maryland.

With surgery, expensive pain medications, and weeks to months of chemotherapy or other novel drug treatment and radiation, a patient's medical expenses can range from several hundred thousand dollars to well over a million dollars. The medical bills can easily consume an entire life's savings. Table 1 outlines actual medical costs for fourteen mesothelioma patients who sought recovery for their medical bills in civil court.

VERIFIED MEDICAL COSTS FOR MESOTHELIOMA VICTIMS

(June 2005)

CLIENT NAME
GENDER
AGE AT
DIAGNOSIS
STATUS
AGE AT
DEATH
MEDICAL
COSTS
DIAGNOSIS
DATE
E.B. MALE 44 Deceased 45 $ 201,626.77 12/08/99
J.D. MALE 34 Living N/A $ 238,557.90 11/22/99
T.L. MALE 46 Deceased 48 $ 258,078.11 06/05/03
C.R. FEMALE 49 Deceased 53 $ 260,238.55 11/15/01
R.P. MALE 44 Deceased 46 $ 261,891.19 03/17/00
J.P. MALE 51 Deceased 53 $ 292,254.78 01/26/00
R.T. MALE 59 Living N/A $ 414,409.57 10/01/03
K.W. FEMALE 54 Living N/A $ 450,740.11 02/17/99
B.W. MALE 52 Living N/A $ 555,000.00 04/02/03
R.O. MALE 32 Deceased 33 $ 576,124.90 11/12/00
P.B. MALE 57 Deceased 59 $ 731,854.12 03/13/02
K.A.B. MALE 51 Living N/A $ 1,243,237.00 06/08/01
D.C. MALE 15 Deceased 19 $ 1,249,649.42 04/04/99
K.H. MALE 56 Deceased 57 $ 1,439,696.61 01/11/02

The numbers do not include out of pocket, travel and lodging costs, or other incidentals such as OTC drugs etc.

One of the goals of treatment is to extend life; with each passing day treatments improve and the discovery of a cure becomes more possible. When mesothelioma is diagnosed at a late stage there are few treatment options, but patients who discover their diagnosis early are candidates for the best available care. Unfortunately, the longer these patients survive, the more costs they and their families will incur - at the very time that the patient's permanent disability renders him unable to earn a living.

As written, the bill would cap compensation for mesothelioma victims at $1.1 million, regardless of the claimant's age, lost earnings capacity, life expectancy, number of dependants, medical and financial hardships, and other factors, such as pain and suffering.

The recovery cap elevates administrative convenience over substantive justice. It fails to adequately address the extreme physical, medical, emotional and financial hardship suffered by mesothelioma patients and their families. We ask that the legislation address the exceptional suffering of mesothelioma patients. Although there is no universal standard for measuring "suffering," we submit that on a scale of 0 to 100, mesothelioma patients typically are at the highest range of this scale.

Conclusions

The conclusion is inescapable: medical bills for younger mesothelioma patients who pursue life-saving treatment can easily exceed the $1.1 million cap on awards prescribed by SB 852. The bill works against younger patients and long survivors, and as treatments improve, their numbers will increase.

If a trust fund is the best remedy, we urge our government to adopt the same model that it used to compensate victims of the 9/11 terrorist attacks, and permit claimants to present evidence of their losses before an impartial arbiter who is not bound by arbitrary caps. We note that the average compensation awarded by the U.S. Government in 9/11 death cases was $2 million, and the compensation awarded to injured claimants was between $250,000 and $8.6 million.

The undersigned are encouraged by the effort to globally compensate victims of asbestos exposure and provide long overdue research funding for this neglected, orphan asbestos-related cancer. However, we remain seriously concerned about whether the legislation, as drafted, will fairly compensate mesothelioma patients and provide the best hope through research. At a minimum, the Fund should allow seriously injured "hardship" claimants to present evidence of their economic and medical losses and award damages accordingly.

Respectfully,

Dr. Harvey Pass, Co-chairman
Karmanos Cancer Institute, Michigan Dr. Robert Cameron, Co-chairman
UCLA Medical Center, California Dr. Bret Williams, MM survivor
Hillsborough, North Carolina Klaus Brauch, MM survivor
Huntington Beach, California Dr. Mike Harbut
Center for Occupational & Environmental

Medicine, Royal Oak, Michigan

Dr. Nicholas Vogelzang
Nevada Cancer Institute, Nevada Dr. Steven Albelda
University of Pennsylvania Dr. Eric Vallieres
Swedish Cancer Institute, Washington Dr. Dan Miller
Emory University, Georgia Dr. Claire Verschraegen
University of New Mexico, New Mexico

Dr. Victor Roggli

Duke University, North Carolina

Dr. Raphael Bueno
Harvard/Brigham & Women's Hospital, Boston, Massachusetts Dr. Jill Ohar
Wake Forest University Medical
Winston-Salem, North Carolina Dr. Brad Black
Libby, Montana Dr. Michele Carbone, Ph.D
University of Chicago Medical, Illinois Dr.Lu Bo
Vanderbilt Medical Center, Tennessee Dr. David Jablons
UCSF/Mt. Zion, California Dr. Alan Whitehouse
Spokane, Washington Dr. Lary Robinson
H. Lee Moffit/Tampa, Florida Dr. Joseph R. Testa, Ph.D
Fox Chase Cancer Center, Pennsylvania Dr. Gavin J. Gordon, Ph.D.
Harvard Medical School, Massachusetts Dr. Douglas Pohl
Cleveland Clinic, Florida Dr. Jim Dahlgren
UCLA, California Dr. Eugene J. Mark
Massachusetts General Hospital, Massachusetts Dr. David Egilman
Brown University, Rhode Island Dr. Hector Battifora
Arcadia, California Dr. Jacques F. Legier
Riverside Regional Medical Center
Newport News, Virginia Dr. John C. Maddox
Riverside Regional Medical Center
Newport News, Virginia Dr. Samuel P. Hammar
Bremerton, Washington Dr. Hedy Kindler
University of Chicago, Illinois Dr. Steven Hahn
University of Pennsylvania Dr. Carlos Bedrossian
Chicago, Illinois Dr. Daniel Sterman
Philadelphia, Pennsylvania Dr. Fred Garfinkel
Tulsa, Oklahoma

Dr. Ronald Dodson
University of Texas
Tyler, Texas

Dr. Arthur L. Frank
Drexel University School of Public Health
Philadelphia, Pennsylvania Dr. Arnold Brody, Ph.D.
Tulane University Medical School
New Orleans, Louisiana Dr. Samuel G. Armato III, Ph.D. University of Chicago, Illinois

As of press time, over 11,873 U.S. citizens, the majority of which are asbestos cancer patients or survivors, have petitioned their government for the creation of a comprehensive mesothelioma research and treatment program. See www.marf.org

Terry McCann of Dana Point, California won the Gold Medal at the 1960 Olympics in Rome. He is a member of four different wrestling Halls of Fame and before he was diagnosed with pleural mesothelioma in 2005 was an avid surfer.
(http://blackmagic.com/ses/surf/HallofFame/McCann/McCannwrest.html)

Section 131(b)(3) of SB 852 allows the administrator to pay more (without stating how much more) to a younger patient (i.e., younger than age 51) with minor children, but only so long as she can balance the books by deducting money from an award to an older patient (i.e. older than age 65). At the end of the day, any surplus awards must remain "cost-neutral." Numerous questions arise. Who decided that when a mother reaches 51 years of age the quality of her medical, physical, emotional and financial hardship no longer warranted due process? Who decided that when a father reached 65 years of age he would be fair game to have his award reduced? Is the Administrator empowered to assess the needs of a mesothelioma patient 65 years of age or older and unilaterally decrease the award? Or do the bill drafters expect the "older" patient to voluntarily request a lower award? SB 852 provides no guidance on the evidentiary thresholds a "younger" patient must meet to secure a higher award.

We are deeply concerned that many married patients with young children may opt to forego aggressive and expensive treatments simply because the costs of doing so will deplete the size of his survivor's inheritance. In this sense, the caps may actually discourage the pursuit of life-extending treatments.

SB 852 forces living mesothelioma patients who have filed civil claimants, regardless of the date of their trial, to stay their litigation for at least 9 months. If after 9 months the new federal bureaucracy is not able to pay the claim, and the patient has not yet died, then the latter may refile his lawsuit, starting all over again, but her settlement would be capped at 150% of $1.1 million, with a set off for earlier settlements. If the patient dies, the decedent's estate would have to wait two years before they could return to court. During the 9-month stay on litigation, mesothelioma patients cannot preserve their testimony. Since the median survival for mesothelioma patients who are not candidates for aggressive treatment is 9 months, the overwhelming majority of mesothelioma claimants with civil lawsuits pending at the time the bill becomes law will likely die during the stay.

SB 852 directs the NIH to budget $12 million per year towards the mesothelioma research program (NMRTP). We remain concerned that the program may merely become another federal "unfunded mandate." The Labor Health Human Services (LHHS) in the House has already passed its appropriations bill with no provision for funding the NMRTP. Senator Specter, who is chairman of Senate LHHS, to date has not included funding for NMRTP in the draft appropriations bill for the NIH. See "Sen. Specter Breaks Promise to Mesothelioma Patient and Research Community," June 29, 2005. http://biz.yahoo.com/prnews/050629/law087.html?.v=33

The Mesothelioma Applied Research Foundation, www.marf.org, estimates there are 5,800 mesothelioma patients struggling to survive now in the U.S. According to MARF, between 2,500 and 4,000 Americans are diagnosed every year with mesothelioma and the cancer's incidence is not anticipated to peak for another 10 to 15 years. The average survival for patients who are not eligible for surgery is less than 12 months. Mesothelioma accounts for about 1% of all cancer deaths in the U.S.

Surgery for pleural mesothelioma presents two options. In the pleurectomy / decortication (P/D) procedure, the surgeon attempts to preserve the lung while removing the lining of the chest cavity (the pleura) and all visible tumors. The more radical extra pleural pneumonectomy (EPP) involves removal of the entire affected lung with the pleural lining; any involved areas of pericardium and diaphragm are also removed and are reconstructed from artificial material. Either of these surgeries requires at least 4 to 6 hours. The incision extends from the back, underneath the shoulder blade, and around the front nearly to the center of the chest.

To illustrate this point further, we present more detailed information about patient "KAB." This 51-year-old man was diagnosed with right-sided epithelial pleural mesothelioma at an early stage. He was therefore a good candidate for aggressive treatment, including radical surgery. KAB resided in California, but he sought treatment at a specialized center in Boston. His costs to date, not including travel, lodging, rehabilitation, and over-the-counter medication and supplements, add up to $1,243,237. Now, more than four years out from surgery, he continues to accumulate medical expenses. His periodic diagnostic testing includes regular PET scans, not covered by most insurance. And if his tumor recurs, Patient KAB will again be forced to pursue aggressive, expensive treatment options.

Capping awards at a specific number for specific disease categories is bureaucratically efficient, but it's not fair. The government acknowledged this truth when it set up the September 11th Victim Compensation Fund. As with asbestos, the Government's objective was to provide speedy compensation in place of highly contentious, costly and high-risk third party litigation. In a relatively short period of time, the government set up criteria for individually weighing the damages of each 9/11 victim. They looked at such factors as age, marital status, future earnings capacity, the number of dependent children, life insurance, and other factors (such as medical bills for living claimants), and attempted to tailor the award to the specific facts. In about three years, the Government paid out $7 billion to over 5,000 living and deceased claimants, which included rescue workers, office workers and plane passengers. The average payout for a death claim was about $2 million, ranging from $250,000 to over $7 million. Injured claimants received awards ranging from $250,000 to $8.6 million for a woman badly injured by falling debris, who presumably would require a life-time of medical care. Our Federal Government lauded the program as a great success.

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