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Vol. 18 No. 1 Editor: Martha L. Golar, Esq. February 2013

In December, JALBCA presented itsannual symposium on “Evolution of MedicalCare and Research: What Is Happening toMedicine and How Will It Affect Us?” Theprogram was co-sponsored with MemorialSloan Kettering Cancer Center’s Resourcesfor Life After Cancer. This year, our panelconsisted of Dr. Larry Norton (MSKCC),Deputy Physician-in-Chief for Breast Cancer;Professor Kathleen M. Boozang, a health lawprofessor at Seton Hall University School ofLaw; William B. Rosenblatt, MD (Lenox HillPlastic Surgery Center); and Bruce C.Vladeck, Ph.D. (Nexera, Inc.), a nationallyrecognized expert on health care policy. The

Honorable Judith S. Kaye was the moderator,and co-presidents, Edward S. Kornreich andJudge Jennifer G. Schecter, served on the pan-el as questioners.

IntroductionPrior to the commencement of the panel

discussion, Dr. Norton delivered his statementon the current status of research in breast can-

cer. He covered three topics: (1) the explosionof information in molecular biology, (2) mam-mography screening, and (3) control of theclinical trial agenda.

With respect to molecular biology, Dr.Norton noted that technological advanceshave enabled scientists to create a “CancerGene Atlas”, bringing research to “ the end of[its] childhood”. Investigators have learnedthat breast cancer is a whole spectrum of dis-eases, and genes provide all the information.The area is complex, and we do not yet knowthe connection between primary and metastat-ic disease – why some people respond to ther-apy and why some do not. Computer modelsare being used to decipher the puzzle, andphysicists are joining researchers in learningthe biology and finding treatment. The biolo-gy of metastatic disease differs from the biol-ogy of the primary tumor. While Dr. Nortonbelieves the problem is solvable, the unknownis how the economic model will deal with thefact that breast cancer may be hundreds of dis-eases, not one.

The subject of mammography screening is“a bad joke that won’t go away”, explained Dr.Norton. He noted there are unequivocal bene-fits of screening and data shows there is a sur-vival advantage to getting a mammography.Randomized trials demonstrate that use ofmammographies find smaller lesions, result inhigher cure rates and fewer deaths, and con-serve breast tissue. Talk of mammographiesnot being necessary has caused fewer womento seek screening, more surgery, more chemoand more deaths.

Dr. Norton rued the fact that the clinicaltrial agenda is invisible to the general public.He has experienced promising clinical trialsbeing discontinued mid-stream for commer-cial reasons by pharmaceutical companies.The researchers are under contract and cannot

continue the trial. There is no legal recoursefor the investigators. Thus, the public will notbenefit from the potential of any of thesedrugs. Moreover, there is no economic modelby which the drugs, which were the subject ofdiscontinued clinical trials, will be developedby alternative means. The Federal governmentno longer funds research. It is “out of the pic-ture” to a remarkable degree.

Panel DiscussionThe first question posed was an inquiry as

to how the practice of medicine has changedin the last decade and where it will be in thefuture. Dr. Rosenblatt answered that physi-cians are trying to leave managed care becauseof difficulties dealing with insurance compa-nies. Insurers are no longer paying “usual andcustomary” charges and, instead, try to pay apercentage of the amount reimbursed underMedicare. This has caused many doctors tocease their private practices and seek employ-ment with hospitals. Dr. Rosenblatt noted thatthere will be 30 million more patients underthe Affordable Care Act (ACA) and askedwho will take care of them.

Dr. Norton painted a darker picture,describing how doctors eventually stop mak-ing certain treatment recommendations thatthey know, from past experience with insurers,will not be honored. The insurance companiesmake it impossible to spend sufficient timewith patients. He also indicated that more per-sonnel are needed to maintain a standard ofcare, including some staff whose sole task is tocommunicate with insurance companies, dol-lars which could be better used to treatpatients.

Dr. Vladeck, however, stated that physi-cians are the only group in the U.S. that hasnot suffered a loss of income in the last decade– the largest occupation in the “1%” are physi-

JALBCA HOLDS ITS ANNUAL SYMPOSIUM

Dr. Larry Norton

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cians – though he acknowledged that physi-cians groups of single digit size will beincreasingly difficult to maintain becausecosts have grown so substantially. The mostimportant piece of this cost is IT, electronicmedical records which will generate data forbetter patient care.

Professor Boozang’s perspective was thathealth care reform largely addresses reform-ing the health care system by access; butthere still will be 23 million uninsured. Infact, care for undocumented aliens will not bereimbursed. She added that many physicianswill be ambivalent about practicing medi-cine, and more physician assistants will beneeded. The delivery system needs to bechanged and physicians will need to be data-responsive. She also applauded electronicmedical records and opined that mining the

data could provide data as to treatment out-comes.

Dr. Norton replied that it has been shownthat the best standards of practice come fromclinical trials, not such data. Unfortunately, themoney needed for this is not forthcomingsince government is out of the business offunding research and the pharmaceutical com-panies are aligned with the insurance compa-nies. Dr. Rosenblatt concurred, referring toinformation technology with the acronym“DRIP” – data rich, information poor.

The discussion then moved to the questionof how the ACA may change medical care forcancer survivors and how it will affect accessto care. It was noted that there are changes inthe rules governing insurance companies – the“doughnut hole” will be eliminated (the cover-age gap is to close completely by 2020); insur-

ance plans are prohibited from setting life-timelimits on coverage; annual limits will bebanned beginning in 2014; co-pays are elimi-nated for preventive cancer screenings; dis-crimination is prohibited based on pre-existingconditions, age, and gender; insurance plansare prohibited from dropping people from cov-erage who are sick; etc., all of which shouldincrease access. However, in the New Yorkarea, there is a significant number of undocu-mented residents who are not eligible foraccess and, accordingly, this community willcontinue to find access a problem. Dr. Vladeckmentioned that, presently, the uninsured havetheir cancers detected at later stages and have ahigher mortality rate. Generally, for unin-sured/undocumented patients, if a breast can-cer survivor is currently unable to obtain healthinsurance s/he may access a policy through ahigh risk pool that has been establishedthrough the end of 2013. Beginning January 1,2014, those who do not receive health insur-ance through their employers will be able toobtain insurance through an AffordableInsurance Exchange, in which members ofCongress will also be participating.

The panelists then were questioned aboutthe risks presented by electronic medicalrecords. Dr. Vladeck discussed how the enthu-siasm for electronic medical records exempli-fies the problem in this country, i.e., policypeople are desperate for magical solutions tohealth care problems – managed care andinformation technology being two examplesof this pattern. We can’t afford what we noware paying. There is a need, he explained, for asocially acceptable mechanism for allocatinghealth care. The population is aging and the

JALBCA panelists and Symposium Chairs

JALBCA Panelists

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NEWS BRIEFS ___________________________________________________________________________________________________________________________________

DOJ Recovers Almost $5 Billion UnderFalse Claims Act in 2012

The U.S. Justice Department recovereda record amount of $4.9 billion in settle-ments and judgments in civil cases involv-ing fraud against the government in the fis-cal year ending September 30, 2012. Thiswas secured under the False ClaimsAct, thegovernment’s primary civil remedy toredress false claims for federal money orproperty, such as Medicare benefits, federalsubsidies and loans and payments undercontracts for goods and services, includingmilitary contracts. The majority of therecoveries in FY2012 came from healthcare fraud initiatives. During the last fiscalyear, a record 647 qui tam suits were filed,and a record $3.3 billion in suits filed bywhistleblowers was recovered.

The DOJ attributes its success, in part,to the Administration’s priority to fightinghealth care fraud. In 2009, AttorneyGeneral Holder and Health and HumanServices (HHS) Secretary KathleenSebelius announced the creation of aninteragency task force, the Health CareFraud Prevention and Enforcement ActionTeam (HEAT), to increase coordination andoptimize criminal and civil enforcement.For more information about the govern-ment’s efforts in this area, go toStopMedicareFraud.gov, a web page jointlyestablished by the Department of Justiceand HHS.

Update on Tamoxifen – ATLAS StudyA new study suggests that tamoxifen

should play a larger role in the treatment ofbreast cancer. As published in The Lancet inDecember 2012, the interpretation of the find-ings is that “(f)or women with ER-positivedisease, continuing tamoxifen to 10 yearsrather than stopping at 5 years produces a fur-ther reduction in recurrence andmortality, par-ticularly after year 10. These results, takentogether with results from previous trials of 5years of tamoxifen treatment versus none,suggest that 10 years of tamoxifen treatmentcan approximately halve breast cancer mortal-ity during the second decade after diagnosis.”The impact of this finding is expected to bethe greatest on pre-menopausal women,although post-menopausal women also taketamoxifen if they cannot tolerate the alterna-tive drugs, aromatase inhibitors (e.g., anastro-zole or letrozole).

Findings from the worldwide AdjuvantTamoxifen-Longer Against Shorter (ATLAS)trial were reported by Prof. Richard Peto,senior author of the study and Professor ofMedical Statistics and Epidemiology at theUniversity of Oxford. The trial consisted ofalmost 13,000 women with early breast can-cer who had completed 5 years of treatmentwith tamoxifen. They were randomly allocat-ed to continue tamoxifen to 10 years or stopat 5 years (open control). In the groupassigned to take tamoxifen for 10 years,21.4% had a recurrence of breast cancer in the

ensuing 10 years, i.e., the period 5 to 14 yearsafter their diagnoses. The recurrence rate forthose who took only five years of tamoxifenwas 25.1%. About 12.2% of those in the 10-year treatment group died from breast cancer,compared with 15% for those in the controlgroup.

During the initial five years, there was lit-tle difference between the two groups in termsof rate of recurrence or death - the divergenceoccurred in later years. This would suggestthat tamoxifen has a carry-over effect thatlasts long after cancer survivors stop takingthe drug. Note that the side effects of tamox-ifen – such as endometrial cancer, blood clotsand hot flashes - continue to cause people todiscontinue its use prematurely. Cost, howev-er, is not a great barrier to continued use oftamoxifen because the drug costs less than$200 annually.

Questions remain. For example, woulduse for longer than 10 years be even better?Would this finding apply to other endocrinetherapy such as aromatase inhibitors, suchthat longer use of aromatase inhibitors bypost-menopausal women may be beneficial?

The ATLAS study was financed byCancer Research UK, UK Medical ResearchCouncil, AstraZeneca UK, the United StatesArmy and EU-Biomed.

To read The Lancet abstract, seehttp://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61963-1/abstract

need for more healthcare increasing. InEurope, countries negotiate what will be spent.

Professor Boozang disagreed, noting thatEuropean countries differed in their healthcaresystems. She mentioned that comparative clin-ical effectiveness is not built into theACA, butthat this will be increasingly challenging astreatment continues to move in the direction ofpersonalized medicine.

JALBCA’s co-Presidents then asked whymedical practitioners do not increase electron-ic interactions with patients, in lieu of officevisits. Dr. Norton insisted that physicians oftenmust examine the patient’s body – the humanelement cannot be removed from the practice.Medicine is an art. Dr. Rosenblatt agreed andadded that HIPAA makes electronic medicineharder.

The panelists then discussed whether, withincreased health care coverage under theACA, we can expect an increasing shortage of

physicians. Dr. Vladeck noted a physicianshortage already exists in the U.S. and eventu-ally many tasks traditionally performed byphysicians will have to be performed by oth-ers. Also, the economics will squeeze the rela-tive incomes of certain specialists, as it has forcardiologists, and over time he sees that therewill be a migration back to primary care. Dr.Rosenblatt responded, however, that primarycare doctors are not making enough money tocause physicians to return to primary care.

During the question-and-answer period,moderated by Judge Kaye, the panelists madeseveral additional points. Finally, in the wrap-up, panelists were asked if they saw a “ray ofsunshine”. Dr. Vladeck commented that NewYorkers are living longer than ever before and,except for adolescents, are healthier. Further,he noted that death rates for many illnesses aredown dramatically and some speak of canceras a chronic disease. Professor Boozang was

excited that many people will have access tohealth care under the ACA who did not previ-ously have access. Dr. Rosenblatt felt thatmedicine is still one of the best professionsand can be practiced anywhere in the country,though he remarked that he would like to seethe tort system fixed. Dr. Norton emphasizedthe critical importance of public educationsince so much of what transpires in medicalresearch and treatment is not apparent to peo-ple who are not in the profession. He warnedthat academic medical centers trying to doresearch are in trouble and that complex med-ical care is not properly covered.

Co-President Ed Kornreich ended the pro-gram with the comment that health care hasbeen a one-size-fits-all enterprise and this willnot work. In the future, health care will need tobe a price sensitive system where the wealthypay more for health care than is currently thecase.

JALBCAc/o Jennifer FiorentinoExecutive Director1324 Lexington Avenue, PMB 324New York, New York 10128www.jalbca.org

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CALENDAR/CONTACTS______________________________________________________________________________________________________________

ADELPHI NY STATEWIDEBREAST CANCERHotline & Support ProgramAdelphi University School of Social WorkGarden City, NY 11530www.breastcancerhotline@adelphi.edu

CancerCare275 Seventh AvenueNew York, NY 10001www.cancercare.org1.800.813.HOPE (4673)

ELLEN’s RUN200 West End Avenue, Suite 12 GNew York, NY 10023www.ellensrun.org212.840.0916

MEMORIAL SLOAN KETTERINGCANCER CENTERPost-Treatment Resource ProgramEducational Forums215 E. 68th St., Ground Fl.New York, NY 10021www.mskcc.org212.717.3527

Bendheim Integrative Medicine Center1429 First Avenue (at 74th Street)New York, NY

SHARE (Self-Help for Women withBreast or Ovarian Cancer)1501 Broadway, Ste. 704ANew York, NYwww.sharecancersupport.org212.719.0364Speak to a survivor toll-free:1.866.891.2392

TO LIFE!410 Kenwood AvenueDelmar, NY 12054518. 439.5975110 Spring StreetSaratoga Springs, NY 12866518.587.3820www.tolife.org

YOUNG SURVIVAL COALITION61 BroadwayNew York, NYwww.youngsurvival.org646.257.3025

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