Porter v. Tap Pharmaceutical, et al

Filing 581

Judge Richard G. Stearns: ORDER entered on A. David Mazzone Research Awards Program First Annual Research Progress and Accounting Report #3. (Zierk, Marsha)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

IN RE LUPRON® MARKETING AND
SALES PRACTICES LITIGATION

M.D.L. No. 1430
Civil Action No. 01-10861

MEMORANDUM AND ORDER ON A. DAVID MAZZONE
RESEARCH AWARDS PROGRAM FIRST ANNUAL PROGRESS and
ACCOUNTING REPORT # 3
October 22, 2012
STEARNS, D.J.
On October 5, 2012, Dr. Philip Kantoff of the Dana-Farber/Harvard Cancer
Center (DF/HCC), the principal investigator for the A. David Mazzone Research
Awards Program,1 and co-principal investigator, Dr. Jonathan Simon, President of the
Prostate Cancer Foundation (PCF), submitted the First Annual Research Progress and
Accounting Report #3 for the court’s review. The 499-page Report details the progress

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The Research Awards Program is named in the memory of the Honorable A.
David Mazzone, a much-admired United States District Court Judge who for nineteen
years oversaw the federally-mandated clean up of the Boston Harbor and who died
prematurely of prostate cancer. The Program is funded from a pool of unclaimed
consumer class funds created as part of the settlement of a national class action lawsuit
involving overpricing of the prostate cancer drug Lupron®. See In re Lupron® Mktg.
and Sales Practices Litig., 729 F. Supp. 2d 492 (D. Mass. 2010). The Program is
administered jointly by the DF/HCC and the PCF under supervision of the court.

of the Research Program and its associated financial expenditures during the fiscal year
August 1, 2011, through July 31, 2012. As required by the mandate of the Court of
Appeals,2 the financial statements are certified by Leslie Y. Cohen, the Manager of
Accounting for DF/HCC. Expenditures relative to each grant have been independently
reviewed and verified by the appropriate officials at each grantee’s host institution.
As established by the court, the goals of the Program are as follows.
To direct leftover Settlement Pool funds from the Lupron® litigation to
research initiatives of merit in prostate cancer and other Lupron®-treatable
diseases.
To distribute Settlement Pool funds to researchers in prostate cancer and
other Lupron®-treatable diseases at the national and local level, and to
spur collaborative research into the treatment and cure of prostate cancer
and Lupron®-treatable diseases.
To distribute Settlement Pool funds through existing organizational
channels that have an established record of successful grant distributions
(that is, those that have advanced the state of knowledge in the Program’s
stated areas of research).
To increase the power and breadth of research in prostate cancer and
other Lupron®-related diseases, by (i) the strategic administration of new
and existing funding mechanisms; (ii) expanding current avenues of
investigation; (iii) recruiting new talent into the field; and (iv) ensuring
that research is relevant to the primary goals of advancing diagnostic,
treatment and quality of life options for patients with prostate cancer and
other Lupron®-treatable diseases.

See In re Lupron® Mktg. and Sales Practices Litig., 677 F.3d 21
(1st Cir. 2012).
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Grant applications are solicited annually by DF/HCC and the PCF from faculty,
research clinicians, and students at university-affiliated hospitals and research
institutions on a national and international level. Administrative oversight of the
Program is vested in a Scientific Advisory Board (SAB) consisting of the principal
investigators, and Dr. David Tindall, Director of Urologic Research at the Mayo
Clinic, Dr. Howard Soule, Chief Science Officer of the PCF, Dr. Ken Pienta, Director
of the University of Michigan SPORE, Dr. Peter Kendall, Director of the University
of California-San Francisco SPORE, Dr. Peter Carroll, Director of the University of
Washington SPORE, Dr. Peter Scardino, Director of the Memorial Sloan Kettering
Cancer Center SPORE, Dr. William Nelson, Director of the Johns Hopkins University
SPORE, and two court-appointed members, Dr. Jonathan Tilly of the Vincent Center
for Research and Reproductive Biology at Massachusetts General Hospital and Circuit
Executive Gary Wente, the court’s Patient Advocate.3 The members of the SAB serve
on a volunteer, non-compensated basis and are personally ineligible to compete for
grant awards.
The Mazzone Awards Program provides funding for High Impact research
grants directed to the treatment and cure of prostate cancer and other Lupron®-treatable
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Marsha Zierk, Chief Law Clark to Judge Stearns, serves as the court’s liaison
to the SAB. The undersigned Judge participates as appropriate as an ex-officio nonvoting member of the SAB.
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diseases such as precocious puberty, as well as to issues of community outreach,
student education and career development, and treatment-disparity studies. The PCF
also supplements the funding of the Mazzone Program through annually awarded
Challenge Grants of its own.
In the inaugural grant awards cycle, the SAB voted, after peer review, to grant
five High Impact Awards in the amount of $500,000 each; nine Project Development
Awards each in the amount of $100,000; five Disparities Research Awards in the
amount of $100,000 each; four Community Outreach Awards in the amount of
$100,000 each; six Career Development Awards in the amount of $100,000 each; eight
Student Training Awards each in the amount of $20,000; three Lupron®-treatable
disease awards in the amount of $100,000 each; and five Challenge Grants, each in the
amount of $1,000,000. Grant awards are made on a two-year basis subject to the
SAB’s interim review. Awards are staggered over the five-year anticipated life of the
Program.4
Successful grantees are required to submit quarterly invoices detailing actual
expenditures. Full progress and financial reports are required at the anniversary of each
grant. The second year funding installment is contingent upon satisfactory compliance
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A final accounting and achievements report will be submitted to the court on
September 30, 2017, the seventh anniversary of the Program’s official start date on
October 1, 2010.
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with the Program’s reporting requirements. No settlement award money may be used
to pay overhead expenses at the institutions hosting the grantee research.
Administrative and overhead expenses are assessed only once upon the receipt of the
funds by the DF/HCC and the PCF administrators at a rate that may not exceed a courtmandated ten percent of the total of the settlement pool funds allocated.
And the end of the first awards cycle, the Program had made thirteen grant
awards (selected from among 120 applications) supporting a total of thirty-nine
investigators in twenty-one teaching and research institutions in the United States and
abroad.5 The specific nature of each of these grant awards is detailed in the Progress
Report.
The reports submitted by all thirteen of the initial grantees demonstrate solid
progress towards achieving the goals set out in the grantee’s initial proposals.6

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Sixty-one applications were submitted through DF/HCC and fifty-nine through
the PCF. A total of forty research and teaching institutions were represented, involving
161 researchers. DF/HCC funded eleven grants to ten institutions involving twentyeight researchers. The PCF funded two grants to four institutions involving eleven
researchers.
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During the 2011-2012 Program year, all Mazzone Awards recipients were
invited to participate in the 5th Annual Multi-institutional Prostate Cancer Program
Retreat, co-sponsored by Memorial Sloan-Kettering Cancer Center,
Dana-Farber/Harvard Cancer Center, Johns Hopkins Hospital, and the University of
Michigan.
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Highlights among the accomplishments to date include the following.
Freedman and Coetzee performed eQTL-based analyses on 662 tumor
normal pairs and found that 4/12 known prostate cancer risk
polymorphisms were strongly correlated with five transcripts (NUDT11,
MSB, NCOA4, SLC22A3 and HNF1B). (Grecians et al., PANS 2012).
Brown et al. demonstrated that EZH2’s oncogenic function in CRPC is
independent of its role as a transcriptional repressor in Polycomb
repressive complex 2 (PRC-2). Instead, it involves the ability of EZH2 to
act as a co-activator for critical transcription factors including the AR.
This functional switch is dependent on phosphorylation of EZH2, and
requires an intact methyltransferase domain. These findings suggest that
targeting the non-PRC2 function of EZH2 would have significant
therapeutic efficacy to inhibit CRPC growth and avoid the toxicity of
PRC2 inhibition.
Gray et al. developed the first potent selective Bmx kinase inhibitor
(manuscript in preparation).
Based on Program experience and inquiries from potential grantees, the SAB
decided to seek applications in 2013 for a new “High Impact Clinical Trial Award”
designed by Dr. Kantoff to promote the use of novel drugs and therapies in prostate
cancer treatment. The SAB also modified the Community Outreach RFA in response
to the suggestions of applicants to make clear that both hypothesis-driven research
proposals as well as community intervention proposals would be accepted. The
Program funded one Community Outreach project in 2012 and received approval from
the court to provide two additional seed funding grants in the amount of $10,000 each.
As it entered the second grant awards cycle, the RFAs were widely advertised
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through targeted emails to Cancer Center Directors and Administrators of
NCI-designated Cancer Centers through the PCF website and research newsletter, the
DF/HCC and institutional weekly and monthly newsletters, direct correspondence to
the faculty in relevant DF/HCC programs, and to principal investigators of NCI
Prostate Cancer SPOREs. The Program received nearly 150 applications for the
second award cycle (peer review of which was completed in the spring and early
summer of 2012). Awards are in the process of being announced.
Comments
The court is pleased with the ongoing progress of the Mazzone Awards Program
and the commitment demonstrated by DF/HCC and the PCF to ensure that the Program
fosters broad-based and innovative inter-institutional research. The court is also
appreciative of the determination of the principal investigators and the SAB to ensure
the transparency and the financial and scientific integrity of the Program. And finally,
the court takes special note of the many hours devoted on a volunteer basis to the peer
review process by the distinguished members of the medical and scientific community
who share the Program’s goals.
ORDER
After review of the First Annual Research Progress and Accounting Report # 3, the
court directs the Court Registry Investment System, on November 12, 2012, to disburse
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from the Lupron® Settlement Pool Account a check in the amount of $4,000,000.00,
payable to Dana Farber Cancer Institute d/b/a/ Dana-Farber/Harvard Cancer Center,
to be deposited into the Lupron® Settlement Fund Account - DF/HCC’s dedicated
account for the Mazzone Awards Program. The principal investigator of the A. David
Mazzone Research Awards Program, Dr. Kantoff, and the co-principal investigator, Dr.
Simons, are requested to submit to the court the previously scheduled programmatic
Report # 4 by March 30, 2013; and the research progress and accounting report for all
grants (Annual Report # 5) on or before September 30, 2013.
SO ORDERED.
/s/ Hon. Richard G. Stearns
__________________________
United States District Judge

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