Council for Tobacco Research
the Cancer Letter Volume 11 Number 17 [Examines Surgical Oncology and Presidential Budget Cuts]
Fields
- Type
- NEWSLETTER
- Master ID
- Hk00713115-3122
- Request
- 131
- Depository Date
- 15 May 1996
- Named Person
- Johns Hopkins Univ
- Us General Accounting Off
- Us Congress
- Acs
- Natl Coalition For Cancer Research
- Univ, C.A. Los Angeles
- Bristol Myers
- Ama
- Arenth, L., Johns Hopkins Hospital
- Baylin, S., Johns Hopkins Oncology Center
- Braren, V., Natl Cancer Advisory Board
- Calhoon, E., Natl Cancer Advisory Board
- Cardin, J., Basic Cancer Research Foundation
- Carson, R.
- Cox, J., Medical College, O.F. Wi
- Devita, V., Nci
- Durant, J., Fox Chase Cancer Center
- Fisher, B.
- Hammer, A.
- Henney, J., Nci
- Heyssel, R., Johns Hopkins Hospital
- Hickey, R., Natl Cancer Advisory Board
- Jako, G., Natl Cancer Advisory Board
- Kelly, T., Univ, M.A.
- Lawrence, W., Medical College, O.F. Va
- Longmire, W., V.A. Center Los Angeles, C.A.
- Magee, P., Fels Research Inst
- Mcintyre, R., Norris Cotton Cancer Center
- Mertelsmann, R., Sloan Kettering Memorial Cancer Center
- Muggia, F., N.Y. Univ
- Murphy, G., Nci
- Old, L., Sloan Kettering Memorial Cancer Center
- Oldham, R., J., O.F. Biological Response Modifiers
- Order, S.
- Owens, A., Johns Hopkins Oncology Center
- Patterson, B., Dana Farber Cancer Inst
- Pericola, J., Bristol Laboratories
- Reagan, U.S. Govt
- Relman, A., Nejm
- Rockwell, N.
- Rosenberg, S., Nci
- Ross, R., Johns Hopkins Medical School
- Santos, G., Johns Hopkins Oncology Center
- Schimpff, S., Univ, M.A.
- Schneider, I., Nci
- Shingleton, W., Duke Univ Comprehensive Cancer Center
- Stockman, D., Off, O.F. Management And Budget
- Vogelstein, B.
- Whitmore, W., Sloan Kettering Memorial Cancer Center
- Yates, J., Nci
- Us General Accounting Off
- Author
- Boyd, J.D., Cancer Letters
- Box
- 156
- UCSF Legacy ID
- vra20a00
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HAMMER SAYS "EXCITING TIMES" SHOULD CONVINCE
~ PRESIDENT TO INCREASE BUDGET, OK ACT RENEWAL
Armand Hammer, after hearing once again details on some
remarkable pragreSs in cancer research, repeated his vow to take the
case :o Pcesident Re,agan for increased cancer funeaing and for renewal
of the National Cancer Act. "Ttiese are exciting ti mes in cancer
researehbut theyelsoarc anxious times," Hammersaid Mondayat
meetingof the President's Cancer Pune1, which he chairs, at Johns
(Continued to page 2)
/n Rrirf
IONGMIRE REAPPOINTED TO PANEI: NEW ORGAN
SYSTEM GROUP FOR BRAIN-CNS TUMORS ASKED
111LLBAM LONGMQtE,distinguished physician at Les Angeles
Veterans Administration Hospital and retired head of surgery at
UCLA, hes been reappointed by President Reagan to a sccorxi three year
term on the President's Cancer Panel. Panel Chairman Armand
HammerannouncRd the appoint ment this week at the meeting in
Baltimqre, ... PAR"17CiPANTSin last week's meeting on brain tumors
agreed on recommending to NCI that a new working group on
malignaneies of the brein and central nervous system be established
within the Organ Systems Program. The recommendation will go
to the Div. of Cancer Prevention b Control's Board of Scientific
Counselorsat theBoard'smePtingin. May_;r wni b-- ._tial fi:rtncr;
organ site tobe added to the program since the National Pancreatic
Cancer Project was established 10 years ago under the old Organ Site
Program.... GERALD MURPHY, director of the Organ Systems
Coordinetireg Center, has appointed with N CI's concurrence the six
members of the OSCC Advisory Boerd.7he Board will meet onnually to
evaluate the OSCC and the progress reported by chairmen of the
p"rams and to make recom mendations for termination of ongoing
pqpams or implementation of new ottes,'Itds Board members are James
Cox, Medical College of Wisconsin; Walter Lawrence, Medical
College of Virginia; Peter Magee, Fels Research Institute; Bradford
Pattem,on,Dana-Fantaer Cancer Institute; Will.iam Shingl¢ton, Duke
Comprehensive, Canccr Center; and Willet Whit more,
Memorial Sloatt-Kettering Cancer Center..., oDDN'i'REu1$iCT your
planning on the basis of the present budget," NCI Directer Vincent I
DeYita told center exeeutives at their recent meeting with NCI staff.
Ne was referring to the cuts in the core grants budget which has I
forced NCIto hold the second cycle of renewals to increases of 5 per
cent aver current lev+els. N CI hopesto find enoul:h money to fund them
at least at 85 per cent of recom mended budgets. NCI wouid need a
little more than $3 million to fund them all at 95 per cent of I
reoommended levels, the amounts received by those In the first cycle.
P_.'
.
'
y
~
,
Vol. 11 No. 17
April 26, 1985
I
I@Copv,.gM 1985 T ne Cance' 4eua +nc
I Subscr,pl,on $1 E,9 yed' No"I, Ameaca
$175 vear elsewneie
Geography Still An
tssue For Centers:
Durant Asks Is It
"Holy Water" Or Money?
... PageQ
Biological Modifiers
Journal Objects To NEJ
Policy, Says It Will
OK Clinical Data Release
... Pap 6
NCAB Committee
Stif! Debating
How To Encourage
Surgical Oncology
- . . . Page 7
NCI Advisory Group,
Other Cancer Meetings
...Page7

HAMMER SAYS HE'LL ARGUE FOR BUDGET
INCREASE, RENEWAL OF CANCER ACT
(Continued from page 1)
Hapkins Univ.'Iite plan bythe White HouseOffiee of
Management h Budget to "forward fund" enough NIH
grants with 1985 fiscal year money to hold the
number of competing grants to 5,000 hss been
determined by the General Account ing Of f ice to be
unlawful, Ham mer noted. Congrees had intended for
6,500 competing grants to be funded and appropriated
sufficient money to do that.
"An equally disturbing problem," Hammer
codttinued, "is reauthorization of the National
Cancer Act "If the special authorities the Act gave
the NC1 director are taken away, it would have a
serious, negative impact on cancer research, he
said. He commended the American Cancer Society and
the new National Coalition for'' - er Research, as
well as other organizatL..Is and individual
scientists for the efforts they have made in
exerting pressures on the Administration and
Congress. 'The National Coalition can be especially
helpful, as well as individual scientists," Ham mer
said. "New diseoveries are co m ing f ro m every side.
They are astounding "
Ham mer said he is hopeful "we can persuade
President Reagan that there should be no d.its in the
cancer budget. If anything, the budget should be
increased."
Citing the evidence of progress presented by
Hopkins and Univ. of Maryland investigators at the
meeting Monchy; the work of Steven Rosenberg at NCI
in treating cancer paiient> wiilr uricricuiuir2;
Roland Mertelsmann clinical studies with IL-2 at
Memorial Sloan-Kettering, UCLA's recent decision
to undertake Ilr2 clinical studies; and a com nient by
MSK's Iloyd Old that there have been "more advances
in cancer i m munology in the lsst few m on khs t han in
the last 25 years," Ha m m er said this "astonishing
progress. .. will be brought to the attention of
the President. I think therr that Mr. (David)
Stockman (OMBdirector)shotild be directed to give
his attention to other fields and stay away from
cancer research."
Albert Owens, director of the Johns Hopkins
Oncology Center, said the center had been
establishedhecause of stimulation of the National
Cancer Act. Owens said ma jor problems the center
faces include training of physician scientists,
initial support for young faculty members, initial
support itor novel research, application of research
results to practice, and the potential impact of the
prospective payment (DRG) system.
"We would like for you to carry the message
back that we absolutely support renewal of the
National Cancer Act;" Owens told the Panel. "Not to
renew would be a most retrogressive and regretful
step."
Owens said he was "most distressed" by the
multiple year funding plan of OD'1B. The Hopkins
center would lose 14 grants if thait plan is carried
out. "We need generous and stable funding for
biomedical research. The NCI bypass budget is
reasonable and soundly based. I understand the
argument about reducing the national deficit, but
the argument for increased support for biomedical
research is not entirely self serving. The
Constitution gives Congress the power to'provide
for the oom mon defense and general welfare: 3We went
to be sure that 'general welfare' gets proper
attention "
NCI Director Vincent DeVita asked Owens if he
could predict a time would come when cancer center
core grantsare no longer necessary. He also asked
what role construction grants played in developing
the center.
Tt~e core grant, Owens answered, is beco m; ng a
progressively smaller part of the center's budget,
down from one third at the start to about 12 per
cent now. However, "if we lost the core grant, we
would lose something vital. It funds young invest i-
gators,and provides the operational capability for
sltared resources, an increasingly importan t ele m en t
in pooling our resources. Also, it provides 10-15
per cent of the salaries for the, major program
leaders working in the center "
As for construction grants, "the need for
matching funds proved a very effect ive way to ope n
conversations with a rwmber of people. Havin g t ha t
6 rstt app:avad startcd the p:c.css clli n6."
NCI IJa,puty Director Jane Henney, referring to the
problem cited by Owens of training physician
investigators, referred to "oversaturation of
physicians, even in oncology subspecialtiesd"
"'Ihere may be a surfeit of physicians in genera 1,
but I don't think we've been overwhelmed by
numbers in oncology," Owens said. "We need
more of those individuals. it's not just a matter o:
supporting them in training. They're concerned abou t
what institutions and programs will be there for
them when they complete training. They need to
see the challenge "
Panel member William Longmirc
eom mented that although there may be an over
supply of surgeons, "not enough of them are
interested in cancer research "
Stephen Baylin,associate professor of oncology
at Hopkins, said "it is inconceivable that we're
talking about whether the National Cancer Ac t
would be renewed. It is indispensable. The Cancr-
Program is thebest money the federal governmer, t
spendS"
Bert Vogelstein, assoeiate professor of on co lcpy.
The Cancer L,et:ter
F'age 2 r Aprnl 26, 1985

said "Most of the exciting discoveries in cancer
research are in the United States, the bulk of them
supported by NCL'Jhat should be a great souree of
pride for us all, We need first a, place to'do
research and second, the support to Qo it... There
must be :nuch greater stabilitvin that support."
Stanley Order, professor of oncolop, described
tis studies in using radiolabejed anttbodies in the
treatment of hepatomas. The process apparentl y has
cured some patients in the most advanced stages.
One "with the largest tu mor I have ever seen,"
Order said, weighing 7,200 grams, has had t ne tu m or
shrink to 1,700 grams. Others have had upresectable
tumors reduel'd to reseetable size. No toxicity has
been observed frum the treatment.
Order mentioned his majoreoneern about cancer
funding. "Each of us in the medical profession has
certain commitments. One I have stuck with is
radiolabeled antibodies. The other ic in training
youngscientists:" He referred to the late Rachel
Carson's book "Silent Spring" which warned about
potential effects of environmental poisoning. "We
face in oncology research another silent spring,
which would be the result of cutting off support for
research training"
George Santos, professor of oncology at Hopkins
and a leader in development of bone marrow
transhlents in the treatment of some cancers and
aplastic anerhia,describea current results. With
matched donors, "we should be able to get 70 per
cent survival" in aplastic anemia.
With allogeneic bone marrow transplant for acute
lymphocyticleukemia given during first or second
remission, 50 per cent long term survival is being
at:iueveti. in aiuvnic myclogenous leukemia, use of
cyclosporine to combat graft vs. host disease
resulting from bone marrow transplant has improved
the prospect for long term survival.
In acute nonlymphocytic leukem ia, patients under
age 201tave 65 percent disease free subvival after
BM T. For those over 20, 30 per cent disease free
suavival is being seen "but that should move up to
50 per cent."
"Without the National Cancer Act, this would not
be happening," Santos said. "N inet y per cent of m y
research is funded by NCL" He agreed with Order on
training of new investigators. "We need people to
take our place "
Richard Ross,deanof the Johns Hopkins Medical
School, said that at first "the idea of taking
peecs out of departments" in sta rt ing the oncology
center Wd not meet with'hmiversal enthusiasm. Now,
10 years later, there is no quest ton of :t!. success.
It xes a wise decision."
The center represents "scp:ore,tUon Nrthout
isolation. ..!t ia not tsolutcd fror:. the re,r7
ttrra-- of t0jatranulcffort. T1Wt`s wlr-n- u. wunF:
people are." Ross said he was pleased by Ha m mer's
reference to Steven Rosenberg, a Hopkins alumnus.
"We're very proud of him. He's had a magnifieent
career in surgery and research."
Ross continued, "If the whole institution
operated as well as the oncology center, we would be
a better place. The research is first class." He
noted that two thirdsof the center's btldget comes
from thepeerreviewsystem, with 49of 61 faculty
members having ROl or other pri mary suppor t through
an independent review mechanism. "I'rn especially
dPlighted to see an e mphasis on basic research and
clinical research working together. Nowhere is the
link between basic research and patient research
stronger than in the oncology center." However,
"that is a threatened activity because of patient
costs and reimbursement policies."
Robert Heyssel, president of Johns Hopkins
Hospital, told the Panel, "We need your help and
some assurances that we b`on't fall back." Refer-
ring to inconsistencies and unfair rei rtiburse ment
posed bythe prospective payment system, Heyssel
mentioned the DRG for anemia. "There is iron
deficiency anemia and aplastic anemia."
Stephen Schimpff, director of the Univ. of
Maryland Cancer Center in Balti more, descri bed t he
development of the center from 1981, tvhetz NCI's
BaltimorP Canoer Rewsrch Progra m was etjded and the
center was established, to the present.'Che staff in
1981 had had no prior extra mural grant experience
and the center had no money in peer reviewed grants.
Today the center has $1.3 million in grants.
Schmimpff said the two centers in Baltimore are
"eomplementarv" in evtoveeetic:q snri AlnS!w-y-pMh;
they"overlap with breadth" in leukemia research;
and "overlap with depth" in pharmacology.
Thomas Kelly,professor of molecular biology a
geneticsat the Univ. of Maryland Cancer Center,
said,"This really is a very exciting time in basic
cancer research and basic science in genera l. That
isnot an accident. It is the result of support from
the federal government. Recent reduct ions and those
contemplated will take a toll. It is essential to
provide adequate support for new i n vest iga t ors, not
only to train them, but it is essential that we
provide support for their projects after training.
Our fellows and facultyhave s&nrat deal of anxiety
about the stability of support."
Julius Pericola, president of Bristol l.abora-
tories, described his company's involvement in
ouvcr research and development of antieaneer drugr.
At the time Bristol-bt yers made the decision for a
mapr effort ut cancer, the conventional wisdom in
tlre pturrmaceutical industry was that the market
potcntUnl was not enough to justify research and
tkvclo{,ment costs, Pericola said."We believed to
ttr oont.nrry, and thst proved to be sound judg ment.
The Cancer Letter
Vol. t t No. 17 / Page 3

Bristol-Myers is now the country's leading maker
and marketer of anticancefr drugs"
Bristc1-Mye.rs' progra m of in aking unrestricted
grants to selected institutions (now totaling 17)
was started at Owens' instigation, Pericola said.
'lt:e blineher in Owens' argument was his statement
that "Bristol-Myers support will provide a window on
the unexpected," according to Pericola.
"1We hoped that other companies would follow sLdt,
and some have;" Pericola said. "We are proud of our
program. We believe in it, and v+e intend to stick to
it. But it has e limit. I still feel (as he said he
had when Owens made the suggestion) that it is a
dropin the bucket.,i NCI's basic research budget
is substantially reduced, will private enterprise
pick up the difference? In my opinion, the answer is
no. Bristol-Myers couldn't edd, enough.Otu role is
nezmwly defined. Our major cornmitment has to be to
applied research, which depends on basic research.
1b assume that privatP enterprise can niake up for
substantial cuts in basic research is unrealistic "
Comments from members of the audience
included:
Jerome Cardin, representing an organization
called the Basic Cancer Research Foundation-"We
believe basic research is our best hope, and the
Johns Hopkins Oncology Cent'er is one of the best.
Government should provide irdqreased support for
basic research. (Recent actions by the government)
have sent a confusing message. On one hand, the
Administration is encouraging private support; on
the other hand, it is withdrawing funds already
aFpropriated by Congress. I hope you can convince
the President that he can't encourage private
support by withdrawing federal commitments."
David Ettinger, on the DItG issue-"Clinical
cancer research equates with the best cancer treat-
ment. It is sometimes costly. (HHS Secretary)
Margaret Heckler'sstatement that DRGs will have
no impact on clinical research has no basis in
fact."
Linda Arenth, director of nursing at Hopkin9-" W e
are concerned about prospective payment. Variations
in cancer treatment are not fully reflected in DR G
rates.'Itiey must recognize severity of illness and
variations in treatment."
Norman Rockwell, private citizen--"I'm
overwhelmed by the progress which appears to have
been made in the last 35 years. But from the point
of view of the dying patient, it is too little, too
late." Ne described the facility at Hopkinq for
dying patients and family members. "The only
intelligent course for this country is to carry out
research with all possible resources."
Bart Fisher, chairman of the Aplastie Anemia
Foundation .4dvisory Com missic+rr"Fifty one billion
dollars appropriated for defense has not t+een
obligated:' He recom mended a freeze on the defense
budget which he contended would nat cut actual
defense spending due to the unobligated funds left
over from prior years. Failing that,'"the medical
com munity will have to lobby our fellow ci tizens for
more taxes to pay for biomedical research:'
GEOG~RAPHY REMAINS AN ISSUE FOR CANCER
CENTERS; NCI "HOLY WATER" OR MONEY?
=ince the early days following enactment of the
National Cancer Act of 1971, NCI has had to contend
with pressures frc:n a varietyof sources, not the
least of which is Congress, to make available to all
regions of the country the best and latest in the
dagnosis and treat ment of cancer.'IT>st was stmngly
implied in the section of the Act which authorizes
NClsupport for'new centers for basic and clinical
research into, training in, and demortistration of,
advanced diagnostic, prevention and treatment
methods for cancer."
The goal in those days was to encourage develop-
ment of either comprehensive cancer centers or
clinical centers with advanced capabilities so
geographically distributed that no patient would
have to drive more than half a day to reach one.
That goal evolved into the various community
prc~grams initiated andsupported by NCI, including
regional cooperative groups, the Cooperative Group
Outreach Program and Com munity Clinical Oncology
Progra m.
The issue of geographic distribution of NCi
aupported cancer centers remains alive, however, and
the pressures are still there.
Jerome Yates, who heads the Centers & Com-
munity Oncology Program in the Div. of Cancer
Prevention & Control, presented a discussion paper
on the issue at the recent meeting of cancer center
executives at NCI:
"NCI cancer centers are often portrayed as
oiganizetions where excellence in the diagnosis and
maregement of cancer as well as concentrated cancer
training and research occurs. Research, pat ient ca re
and training are present to a varying extent in all
of the NCI cancer centers. Basic science research is
coordinated in some centers without clinical
components and some clinical research is conducted
inlocations without laboratory reseerch or onsite
training activities. The NCI centers progra m has
developed and maintained excellence through the
peer review system.
"NCI has not stipulated that every center have
programs in training, basic research, clinical
research, cancer control research, or outreach
activities. Indeed, NCI formally recognizes and
funds flourishing laboratory and cancer control
centers without clir.ical care components. These
specialiaed centersand omsortial centers are foci
The Cancer Letter
Page 4 / April 26, 11 985

of resemdi without direct cancer pat ient management
responsibilities. They are largely located in
envirormentsproviding a critical mass of research
expertise-most often at universities or in free
standing institutes.
"One major intent of the National Cancer Act of
1971 was to provide patients wit h access to opt i m al
patient care through replication of, NCI centers in
the U.& Multiple models for geographic distribution
have been dt:veloped over the past 15 years. All have
addressed patient access to centers. However, the
lack of clinical research capability and laboratory
and training programs persists in some areas of the
country, and this is unlikely to change. The
shiftingof oncologists traiiied in clinical research
from largeurbe.n center. to moderately sized cities
without medical schools has gradually increased the
level of interest and ability of medium sized
corn munities to participate in clinical research.
Siccessful NCI com m unit yclinical research prog-
tams sur, ~~ as the ~operative Group Outreach Pnogra m
and the Community Clinical Oncology Program
demonstrate new abilities of community
elinieal investigators. They also serve as regional
leaders for consultation in diagnosis ehd management
of cancer in a selection of geographic areas
presently devoid of cancer centers.
"We are considering an in depth analysis of the
eommunity clinical trials efforts as data become
avaaable from our community program evalua-
tior..'Iherelationshipof these com m unity clinical
research efforts to their research bases (clinical
trials groups and cancer cettters) and the regional
networks formed by some, for example, the Northern
Cali.fomia Oncology Group, North Central Cancer
Tieaimeni Group, Piedmont Oncology t3 oup, and tne
Illinois Cancer Council represent different models
which have been able to extend their interests
beyond treat ment research to regional cancer control
research.
"''l7ie cancer center cdnsortial concept was
developed to encourage this type of interaction, but
most com munity physiciahs involved in clinical
research will still interact primarily with the
national clinical trials groups ."
71hepaper offered these questions to consider:
1. What are the advantages and disadvantages for
destpwating com munity cancer centers without readily
accessible NCI (prototype) cancer cimters in their
regions?
2. What are the appropriate criteria for their
designation, their location, and their research
participation?
3. What should the relationship of the com-
munity cancer centers be with other regional cancer
interests, clinical trials groups, and the formally
designated NCI cancer centers in regions where this
may occur?
4. Should cancer control act ivities be a require-
ment to the primary activit y of such a center? lf
so, to what extent should financial and mrganiza-
tional stability be assured? Is such assurance
realistic in our present environment2.
5.Ce.nt:rsservingconcentrated minorAty popu-
lations pro%:de benefits for their communities by
increasing awareness and facilitating aceess to
state of the art care for cancer-might an NCI
designation foster iRproved patient manogement?
6. What is the role of all types of cancer
eenters in the N Cl goals for decreased mortali t y and
morbidity for the Year 2000?
Yates offered these options to consider:
1. Geoggraphic distribution of centers should be
allowed to develop spontaneously within the e~d st ing
center and consortial guidelines (the draft of
guidelines for the new consortia). cancer center
grant were'disctssed by the center executives who
suggestedsbme changes and will be presented to the
DCPC Boai d of Scientific Counselors in 1Nay-71te
Cancer l.etter, April 19).
2. Free standing clinical cancer centers with
peer reviewed approved participation in clinical
research should be considered.
3.Onlyc^ommuniitycancer centers with clinical
research links to existing cancer centers in or
close to their regions should be considered.
4. Requite 2 or 3 above but also demonstrate that
multidisciplinary cancer management planning
is the norm.
5. Need for different types of centers to provide
access topetients from underserved areas (minority
or geographic) to state of the art screening,
prevention, diagnosis and treatment.
Yatesopened the discussion with the qiuestion,
"Where should we go in supporting com munity
centers where no prospect exists for basic
research?" He said he plans to bring together
persons representing community centers, rooperative
groups, traditional cancer centers, DCPC and the
Div. of Cancer 7reetment to discuss the issue.
However, "'I'he bottom line is where will t he m oney
come from? We've invested a fair amount of
money in community programs. We ought to
use informntion coming out of them in logical
planning to determine if we should issue new RFAs
for CCOP or its successor."
"Are you about to get into an accreditation
process?" asked John Durant,Fox Chase Cancer
Center.'7s It a matter of money, or is it holy
water, holy waterbeing accreditation? Why do you
have to tie money to holy water?"
"You eould say that the core grant acts as an
The Cancer Letter
Vol. 11 No. 17 / Page 5

aect+editationsystem," Yates replied. He added that
erticism from Congress has included charges that
rural physicians who participate in clinical
researchsometinpes "feel theyare being treated as
second class citizens."
"What business are we in?" asked Ross M cIntyre,
Norris Cotton Cancer Center. "Is it coping with the
most difficult tiiological problem man has ever
addressed? Or are we in the business of satisfying
political expediency?"
The resounding answer, from Yates and others in
the room, was "Both!"
Franco Muggia, New York L'niv., asked if "there is
any thought of tieing in com munity activities with
the consortium centers?"
"'ftt's a good point," Yates answered. "Maybe
through that sort of thing (other mechanisms to
improve geographic distribution) will not be
necessary."
BIOLOGICAL MODIFIERS JOURNAL SAYS
IT WILL OK RELEASE OF CLINICAL DATA
At least one professional journal in the cancer
research field objects to the policy of the "New
England Journal of Medicine" relating to release of
information prior to publication.
In an editorial in the "Journal of Biological
Response Modifiers,"Editor Robert Oldham called
NEJ's policy "indefensible" when clinical studies
are involved and set forth his journal's policy of
makingavailable to inquiry im mediately data from
any study accepted for publication.
nli4wmkPditorialacknowled¢ed that scientists
have proprietary rights to the products of their
studies which they may consider "as their personal
intellectual property." However, "while such
feelings are natural and probably occur in all of
us, it is importar,t to examine the effect of such
ieelings anct their resulting actions on others. For
research a:tivities in the laboratory, where the
resultsdorot have immediate clinical application,
the question of timingand privacy are probably not
of major importance. . .
"Clinical research activities should be viewed
differently. As is illustrated by the recent
caitroversysurroimdingthe publication of research
results from the National Surgical Ad juvan t Breast
Program, it is clear that this issue has major
implications for patients. In the press analysis of
this controversy, it was reported that Dr. Bernard
Fisher (NSABP chairman) was unwilling to share the
results of a clinical study involving the use of
radical vs. le:;s radical surgery in patients with
breast cancer. This study was to be publ:shed in the
"New England Journal of Medicine." Their policy of
not releasing information prior to pubiication was
the basis for Dr. Fisher's unwillingness to share
ti:ese data in advance of publication. Such a
pra_.^:.~ has been defended by the Journal's editor,
Dr, :.:ziold Relman,on the grounds that his journal
pun-shes rapidly anr) contains 'newsworthy'
sc:e',tific articles.
-?s the editor of this journal and as a clinician
sc:entist, this position seems indefensible.
'Pi.-er r°ss and newsworthiness may mean one thing to
a joa:.-nal editor or to a clinical investigator, but
it tas auite another meaning to the patient. For the
patient, timeliness is today and newsworthiness
relates to facts which might be important to the
treatment of the disease. It can be easily
envisioned that several hundred to sever i1 thousand
woa:en may have been affected in this controversy.
The study.. addressed an i m portant issue for each
woman developing breast cancer.. Aver the span of
a few weeks, hundreds of patientsacross the United
States and around the world will have to make the
decision to have or not have a more or less radical
surgical excision of their breast cancers. This
personal decision must be made on a'real time'
basis and if data have already accrued which might
influence this decision, it should be available to
those patients im mediately.
"It is indefensible to withhold such data from
patients who are making this decision because of
joiumal policy, newsworthiness, privacy of data or
any of these kinds of issues. In particular, this
study, being supported by public funds (govern ment
grants) is at risk for criticism when the informa-
tion from it is not freely available at any point in
time during the conduct of the study. Statisticians
have many arguments as to when data must be
analyzed, and there has been much written on the
dangers of a preliminary analysis of an ongoing
triaL However, onee the data have been analyzed and
submitted for publication, the timing of statistical
analysis, the acceptance of the article and the
timingof thepublication become moot issues.The
date have been analyzed and the study, for the
purpose of that publication, is complete. Informa-
tion from surhstudiesshould be freely available to
patients when these studies might immediately
influence patient decisions and clinical care. While
no system exists for the rapid or instantaneous
dissemination of such clinical information to
patients or to their physicians and while it is
unclear that the initiation of such a system of
rapid communication (in preference to standard
publication of medical journals) would be useful or
cost effective, it is ciear that data which are
available and accepted for publication should not be
restricted when investigators are spevifically asked
questions on results of their studies.
"It is our policy to make available to any
inquiry clinical data from any study accepted for
The Canceer Let-ter
Page 6/ April 26. 1985

publication'an the 'Journal of Biological Response
Modifiers.' The time frame from acceptance to
publication may be only one to two months or
may be as long as three or four months. in either
case, it would be unreasonable to withhold data
from clinical studies which mi,,ht be relevant to
'real time' deeision making by patients and their
physician. I would urge other editors of medical
journals to take a similar stance on this issue."
NCAEt COMMITTEE STILL DEBATING ISSUE,
HOW TO ENCOURAGE SURGICAL ONCOLOGY
The National Cancer AdvisoryBoard's Committee
on Innovations in Surgical Oncology continues to
debate the seemingly never ending issue of how
surgical oncology can be encouraged and developed.
The com mittee, chaired by Ed Calhoan, is scheduled
to meet again during the May session of the NCAB.
"We have made a giant stepforward in competing
for ytxmgsurgeons through NCI's surgical oncology
training programs," committee member Robert
Hickey said at the last meeting.
"One of the paramount functions of this committee
might be to talk with our colleagues, persons
interested in surgical oncology, and ask them their
views of NCI programs," committee member
Victor Braren com mented. "1 still think N Cl has a
tolerant view of surgical oncology. N Cl would like
to have mare surgeons involved in the CAmcer Program
but doesa't know, how to get them. There are too
manyshrdy sections with no surgeons, with no one
looking at grants from a surgeon's viewpoint."
Iris Sdneider, NCldirector of staff operations,
objected to the word "tolerant" and suggested
instead, "puzzlement," which Braren agreed was
appropriate.
"Surgeons do not think NCI ig-interested in
auge=; Braren continued. "There needs to be a
basic change in approach by NCL" eeds to be a
"We have to change the entire atmosphere,"
committee member Geza Jako said. "Since this
committee was formed, Dlr. (Bruce) Chabner (director
of the Div. of Cancer Treatment) and the NCl
atmosphere have changed."
"I know surgeons," said Calhoon, one himself.
"There are five in my family. At AMA, they're
difficult to deal with. Who gets the press?
SLcgeons. They'll have to be spoon fed on grants-
manship. Thit is something NCI will have todo "
"Jatathan Rhoeds (first chairman of the NCAB) was
a practicing surgeon; NCI assistant director Elliot
Stonehill said. "1There has always been more than
tolerance for surgeons on the NCAB.'1'he lack of
interest has been on the part of surgeons, not N CI.
We have to stimulate them to develop good research
ideas. It is not an issue of tolerance. The issue is
lack of raw material."
NCI ADVISORY GROUP, OTHER CANCER
MEETINGS FOR MAY, JUNE, FUTURE
Society of Head and Neck Surgeons Fifth Anmual joint
Meetrng--May 5-8, Cerromar Bea ch, Pue rto Rico.
Contact Drr, James Helsper, SHNSSecretary, 635 E.
Union St., Pasadena, Calif. 91101.
Cliaical Cytopathclogy for Pathologists-->`t a y 6-17,
Johns Hopkins. Contact John Frost, M.D., 604
Patholagy Bldg, Johns Hopkins Hospital, Baltiadore
21205.
Biometry dt Epidemiology Contract Review
Committee--May 6-7, NIH Bldg 31 Rm 8, open
May 6 8:30-9 a.m.
Fitst hterbational Conference on S7cin Melanema
-May 6-9v Vatice. Contact Conference Secretariet,
lstitutoIQazionale Tumori, Via Venesian 1, 20133,
Mil an, Italy.
NationalTumor Registrars Assn; -May 7-10, Hotel
QQxen Mary, Long Beach, Calif. 1985 annual meeting.
Contact Cynthia Creech, Cancer Program Manager,
Huntington Memorial Hospital,100 CongressSt
Pasadena, Calif. 91105, phone 818-440-5186.
Div. of Cancer Etiology Board of Scientific
Comselotip-May 9-10, NIH Bldg 31 Rm 10, open 1
p.m,-adjummcnt May 9, 9 a.m: adjoumment May, 10.
Div. of C,ancer Prevention a Control Board of
Scientific Comaeloet-May 9-10, NIH Bldg 1 Wilson
Hall . Open May 9 8:30 a.mr3 p.m., May 10
8:30 a.m,-adjournment.
DCPC Board of Scientific Counselors Prevention
Committeb-Map 9, NIH Bldg 1 Wilson Hall, open
5-7 p.m., closed 7 p.m: adournment,
1ldrances in Cancer 1reatmena-May 9, Roswell Park
continuing education in oncology.
Cancer Cbtmotberapy Update:1985-May 9-10,
Alientown, Pa. Contact Richard Attilio, Allentown
Hoseital, 17th a Chew Sta., Allentown 18102.
Society for Clinical Trials Sixth Annhtal
Meeting~-May 12-15,NcwOrleana. Contact Dr. Curt
Futberg, 600 Wpndhurat Ave., Baltimore 21Z10. t~}-one
301-435-4200.
CimOenEe of Local7bmor Control and Its Impact
on9unival'-Mat 12-17, Rome.Third Rome Intcr-
nationalSympas-um, Contact Assoeia:ione Italiana
la Promizione dello Studio deUe Mallattie
Wcologiscbe,Via Ple diMarmo, 18,Rome,Italy.
National Cancer Advisory Board Committee on
0qan9ptedan Plaogtams-May 12, AiIH Bldg 31 Rm 8,7
m., open.
a' Cbncer Advisory Board-May 13-15, NIH
Bldg 31 R m 6, open M ay 13 8 15, 8; 3 0 a,m.-adjourn-
ment, clobed May 14.
NCAB Committee an Caaatrecrion-May 13, 5 p.m.,
elosed.
NCAB Committee on Year 2000 GaaL-May 14, NIH
Bldg 31 Rm 2, 5 p.w., open,
NCAIi Cmdnitta mliorn,ataotrMay 14, NIH Bldg 31
Rm 6, 7:30 p.m., open.
NCAB Cowatittee on Sapeal OrwoZogy-May 14, NIH
Bldg 31 R m 4, 8 p.m., open.
AQHToclnoiogT Aseessnoenr Mceting an Registries for
Booc Mars+r Traneplant atioo--M ay 13-15, Masur
Auditotatm,ddD-i,Bethesda, Md_ Contact Peter Murphy,
Prospect AAsoeiatea,Suite 401, 2115 E. jefftrson
The Cencer Letter
Vol. 11 No.17 /Page7

St., Rockville, Md. 20852 phone 301-468-6555.
Stm~eam Aaa4, for Caneet kesearch--May 13-15,
Brat~slava, Czechoalovakia. Eighth meeting. Contact
Dr. Marta Grofova,Seaetary General, 8th Meeting
BACR, Cancer Research Institute,ulul armady
21,812 32 Bratislava.
Clnealogy Iiuvi gSocisty 106 CAMess-May 15-18,
Houston. Contact Nancy Berkocenta, ONS, 3111
BanJcaville Rd Stirite 200, Pittsburgh 15216, phone
412-344-3899.
International Meeting on Advances in Yxrology--
M5-18, Cats,nia, ltaly. Contact Angclo Castro
krstitute of Microbiology,Uv.iv, of Catania,
-Fa ndrone, 81, 95124 Catanta.
Canca ReseacchMaapowet ltevietq Comtnittee--
May 16-17, Bethesda Holiday Inn, open May 16
8: 3 0-9 a.m.
Nattions,l Assn.of Oncology Social Workers-May
16-18, Houston. Contact Office of Conference
Services, Box 131, M.D. Anderson Hospital, 6723
Bertner Ave., Houston 77030.
Wozehless Cmceti'Iirestmenta-May 17-19, Victoria,
B.C. CG act Blue Mountain Oncology Program,
PO Box 327, Walla Walls, Wash. 99362,
phone 509-525-1290.
AmericanSodetyof Clitoical0ncalogy--M,ay 19-22,
Houston. 21st annual meeting. Contact ASCOE:ecir
tive Director, 435 N. Michigan Ave., Suite 1717,
Chicago 60611, phone 312-644-0828.
Societyof 8argicslClncology-May 19-22, Houston.
Anstal meeting. Contact Charlene Terranova, SSO, 13
Elm St., Manchester Mass. 01944.
Effect of Ti.n on Mahgnant Cell Growt}r-May
19-22, Scranton, Pa. Second international symposium.
Contact Dr. Larry Sherman, Chemistry Dept., Univ.of
Scranton,Scranton 18510, phone 717-961-7705.
American Aaaa.for Cancer Reseaach-May 22-25,
ttOUSOOn, 7tRh acrlial meetIDg. lAntact ApAl.i, T emple
Univ. School of Medicine, West Blvd, Rm 301,
Philadelphia 19140.
American Aaro. for the Advaacecserrt of Scienee-
May 26-31,Los Angel,ts. Contact AAAS Meetings
OE6ce,1101 Vermont Ave.NW, Washington D.C. 20005.
Div. of Cancer Biology R Diagnosis Board of
Scientific Counselors-M ay 29, NIH Bldg 31 R m 9,
open 9-11 a.m.
Cancer RestArca t Repoat-ies Contrsct Review
Committee--May 31, NIH Bldg 31 Rm 9, open
9-9:30 a.m.
President's Cancer Pancl-June 3, Memorial
Sloan-Kettering Cancer Center, New York, 9 a,m,,
open.
Div. of Cancer Treatment Board of Scientific
Couasellors--June 10-11, NIH Bldg 31 Rm 10.
AdvaotoiaH~abgy- une 10-14, London. Contact
Mrs. E. Backer, School O1fic.e, Royal Postgraduate
Medical School, Du Cane R aad, London W 120HS,
England.
Advances in the Care of the Chald with Cancer--June
12-14, HiYton Hotel, Los Angeles. Cont act A m e rie an
Cancer Society, 777 Third Ave., N ew Yoirk 10 017,
phone 212-371-2900.
Breast Preaer.atidn: Worlahop on the Technique of
Coasaratiot Strrgery and Radiotherapy for Early
BoaR Csmxt-June 14-15, Memorial Sloan-Kettering
Cancer Censer,Nehv York. Contact CME Conference
Planning Office, C-180, MSKCC, 1275 York Ave.,
New York 10021, phone 212-794-6754.
Asm,of American Ca:aeet Iastitutes-3une 16-18,
Washington Hilton Hotel, Washington D.C.
dmiealOnoobgyeod Cancet Ntmting-june 16-20,
Stockholm. Contact Mrs. Ira Thilen, Stockholm
Convention Bureau, Jakobs Torg 3, S-111 52
Stockholm, Sweden.
8dembcanaa7lsmbr Growtir-june 17-20, Catholic
Univ., Rome. Contact Scientific Secretariat,
Istituto Patologia Qeneaale University' Catrolic, S.
Cuore, Largo F, Vita, 1-00168, Roma, Italy.
7taricologyUpdate'85-June 17-19 Johns Hopkins
School of Hygicnte lR Public Heaith, Baltimore.
Contact Program Coordinator, Toxicology Updatc '85,
'Ilrtner Rm 22,720 Rutland Ave., Baltimore 21205.
Cistieal Care aad Medical Management of the Cancer
Patient-Jtme 20, Roswell Park continuing education
in oncology.
Hrra3Bary Gyneonknie a Breast Caneer-Juae 23-25,
Redl.ionIrm,Omaha. Contact Hereditary Cancer
Institute, Creighton Univ., Omaha, Neb. 68178.
Fourth Intermtiooal Comfercnce on Environmental
lAutageaa-June 24-28, Stockholm, Sarellite sym-
Qpsia are scheduled ntr genetic tozicology of the
diet in Copenhagen June 19-22; risk assessment in
relation to mutagens and carcinogens in Oslo June
20-22;and monitoring of occupationaletposure to
genotosicanta in Helsinki June 30-July 2. Contact
Congress Office,ICEM-85, Stockholm Convention
Burcau, Ho= 1617, ."i-1iioo, SQoe.'sitoim,
FUTURE MEETIIBGS
X11th International Symposium on Comparative
ResearchonLeakemia and ReLted Diseases-July
7-12, Hambuzg, Germany. Contact Dr. David Yohn,
Secretary General, Suite 302, 410 W, 12th Ave.,
Columbus, Ohio 43210, phone 614-422-5602.
'Popia is GaatroenRerolog ar liver Disease--Oc t,
3-5, Turner Bldg, Johns Hopkins Medical
Institutions, Baltimore. Contact Jeanne Ryan,
Program Coordinatot,Offace of Continuing Education
Johns HpldnsUniv,Sehoolof Medicine,720 RutlanJ
Ave., Baltimorc 21205.
Immttnobiology of Cancer and Allied lmmtme
Dysftmetions--Nav. 4-7, Copenhagen, Includes
presentations on human cancer immunobiology,
markers, emgenously induced immunodefieieneies,
clinical management, AIDS, new approaches to
immunomodulation, and immunobrology of
metastases. Contact M, Rodler & Co., Freyung 6,
Poatfach 155, A-1014 Vienna, Austria.
TheCancer Lefler _Editor Jerry D. Boyd
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