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The Cancer Letter      CBS News aired a report Feb. 12 on the Deception at Duke.


     >> Click Here to see an excerpt of the 60 Minutes' interview with Paul Goldberg of The
           Cancer Letter.



 

The Cancer Letter is an award-winning weekly newsletter providing the latest on cancer research funding, legislation, policy issues, drug development, and people in the news. Individual subscriptions are $405 per year (46 issues), or $37 a month. Group and Institutional subscriptions are also available. Delivery via online access. 

The Clinical Cancer Letter is a monthly newsletter for the practicing oncologist, oncology nurse, and cancer patient advocate to keep up with developments in cancer treatment and clinical trials in the U.S. and worldwide. Individual subscriptions $129 a year (12 issues). Delivery via online access. 




Available NowHow We Do Harm, by Otis Brawley with The Cancer Letter's Paul Goldberg, exposes the underbelly of healthcare today—the overtreatment of the rich, the under treatment of the poor, the financial conflicts of interest that determine the care that physicians’ provide, insurance companies that don’t demand the best (or even the least expensive) care, and pharmaceutical companies concerned with selling drugs, regardless of whether they improve health or do harm. Brawley is chief medical officer of the American Cancer Society.


Recent articles

  The Cancer Letter - May 11, 2012
May 11, 2012
  • NCI's Plan to Limit Growth of Core Grants Prompts Smaller Cancer Centers to Cry Foul
  • Senate Investigates Opioid Manufacturers, Requests Study of Impact of DEA Policies 
  • VP Joe Biden Will Not Host Komen's Global Race for the Cure in D.C.
  The Cancer Letter - May 4, 2012
May 4, 2012
  • NCI Pulls Back Curtain on "Zone of Uncertainty" — Funding Patterns Released with Little Comment
  • Studies Seek to Identify High-Risk Groups to Justify Mammography Screening at 40
  • IOM Recommends FDA Consolidate Each Drug's Lifetime History
  • Lippman Named UCSD Cancer Center Director
  Issue No. 17 - April 27, 2012
Apr 30, 2012

  Senate Legislation Tackles Drug Shortages, Proposes Faster Approval For "Breakthroughs"
Apr 30, 2012
Legislation put together by a Senate committee stops short of allowing 
FDA to impose penalties on the manufacturers of generic drugs if they fail to 
warn federal regulators about upcoming shortages.
The version of the bill that funds the regulatory agency’s activities through 
user fees was marked up by the Senate Committee on Health Education Labor 
and Pensions April 25.
The Prescription Drug User Fee Act needs to be reauthorized by Sept. 30 
if FDA is to continue receiving funds from the industry.
For the first time since user fees were enacted two decades ago, the 
legislation will require generic drug manufacturers to contribute about $300 
million a year toward the agency’s operations. 
  News Analysis: Generic Drug Industry's Efforts to Eliminate Shortages Raises Antitrust Law Questions
Apr 30, 2012
The generic pharmaceutical industry announced a proposal last week 
intended to remedy the short supplies of certain critical drugs. 
The program, called the Accelerated Recovery Initiative and put together 
by the Generic Pharmaceutical Association, is entirely voluntary. Proposed as 
an alternative to government regulation, it choreographs interactions between 
manufacturers, wholesalers, distributors, group purchasing organizations, and FDA.
  Richard Pazdur Waxes On Calumet City And Krebiozen
Apr 30, 2012
Does anyone remember Krebiozen? FDA’s oncology chief RICHARD 
PAZDUR does. On an FDA blog that allows agency staff to react to events 
and, on occasion, demonstrate their non-regulatory personae, Pazdur 
recalls growing up in Calumet City, Ill., an industrial enclave on the 
outskirts of Chicago.
Pazdur’s memories include the story of his mother’s friend Dorothy, 
who died of breast cancer before she could obtain Krebiozen, a drug 
developed from the blood of horses that had been injected with bacteria. 
  The Cancer Letter Special Issue, April 20, 2012
Apr 20, 2012
This issue of The Cancer Letter has been made Free and Available to the Public
  Issue no. 15 - April 13, 2012
Apr 16, 2012

  The Cost of Healthcare How to Become a Urology Millionaire...Alas, One Little Problem—Overtreatment
Apr 16, 2012
If marketing materials are to be believed, the advantages of being able 
to perform intensity-modulated radiotherapy can be worth as much as $6 million 
in gross revenue per year to a urology practice. Setting up a pathology lab on 
the premises can be worth another $1 million.
Generally, the practice of “self-referral,” or referring patients to healthcare 
entities in which the doctor prescribing a procedure has an interest, is verboten by 
the “Stark laws” that govern Medicare and Medicaid. 
However, these laws leave open a loophole—for situations where such services 
are provided by a member of the referring physician’s practice and when the services 
are provided in the building that houses the practice.
In urology practices, the loophole covers pathology, radiation therapy and
diagnostic radiology.

>> Read More
  Oncologists Don't Demand Increased Survival When Ordering Expensive Drugs, Survey Finds
Apr 16, 2012
A survey showed that U.S. and Canadian oncologists prescribe 
treatments with little consideration of their cost. 
The study, led by Peter Ubel, a physician and behavioral scientist 
who teaches at Duke University Fuqua School of Business, found that 
these doctors don’t demand an increased benefit, which researchers 
measured in months of survival, from an expensive drug than they do 
from a less expensive one. 
The study was published in the April issue of the journal Health 
Affairs.
  Issue 14 - April 6, 2012
Apr 9, 2012
  As For-Profits Provide Phase I Studies Faster, NCI Seeks to Look Deeper, Learn More
Apr 9, 2012
       NCI has started restructuring its early-phase drug development program
to make better use of assays, imaging and genomic information.
       The change is occurring at a time when big pharma companies are increasingly
turning to for-profit organizations to conduct their phase I research, which these
groups are able to do faster than NCI and its grantees.
       The objective of the institute’s restructured early phase program would be
to provide more in-depth studies and to focus, at least initially, on compounds
developed by smaller biotech firms.
       The change would start with the institute-funded Early Phase Therapeutics
Network, which currently operates 14 sites, has a budget of just under $8.9 million
a year, and accrues 898 to 1,290 patients a year.

>> Click Here to Read More
  Q & A with The Cancer Letter: Phase I Program Will Stress Correlative Studies For Small Biotech Firms, Says NCI's Doroshow
Apr 9, 2012
In a conversation with The Cancer Letter, James Doroshow, NCI deputy 
director for clinical and translational research, explained the rationale for 
changing the way the institute conducts early-phase clinical research.
The interview was conducted by editor Paul Goldberg.
PG: Given how much has changed in the phase I environment, what is the 
NCI role in this new world?
JD: We are trying very hard to provide value-added investigational services 
to enhance the phase I program. It’s still true that for many agents, especially 
those that are brought forward from small biotech companies, resources to do 
the correlative science that is absolutely essential in today’s environment are 
not available. And many of these agents are very interesting with respect to 
uniqueness of target or other mechanism of action. 
  Issue No. 13 - March 30, 2012
Apr 2, 2012

>> Click here to get a free look inside this issue
  ODAC Votes for Marqibo Accelerated Approval; Two Sarcoma Drugs Pose Classic Question: How Much PFS Does it Take to Get a Nod?
Apr 2, 2012
      The FDA Oncologic Drugs Advisory Committee recommended
accelerated approval for Marqibo (vincristine sulfate liposomal
injection) for recurrent or relapsed acute lymphoblastic leukemia. 
      The recommendation—reached in a 7-4 vote with two
abstentions—is evidence of the committee’s continuing willingness
to recommend accelerated approval based on intriguing signals
from single-arm phase II studies in difficult-to-treat populations. 
      ODAC accepted the story of Marqibo’s potential to get
responses that could allow patients to move on to transplantation. 

>> Read More
  Additional Level of Grant Review Proposed As NIH Prepares For Cost Cutting in 2013
Apr 2, 2012
       During the next fiscal year, NIH plans instill an additional level of review
to new grant proposals from any principal investigator who already receives
$1.5 million or more of NIH money in total annual costs, NIH Director Francis
Collins told a Congressional subcommittee. 
       Approximately 6 percent of NIH-funded investigators fit into this category,
Collins said. The additional review will be conducted by each institute’s
advisory council.
       Collins made this announcement as he and NCI Director Harold Varmus
made their annual trip to Capitol Hill March 28, to present their case for
biomedical research funding in the 2013 federal budget. 

>> Read More
  Issue No. 12 - March 23, 2012
Mar 26, 2012

  Called "Unscrupulous" in Abramson Lawsuit, Thompson Calls Abramson a Rich Man Scorned
Mar 26, 2012
      Attorneys for Craig Thompson characterized a legal action against him
as the work of a rich man who apparently feels slighted.
      “In short, this proceeding is brought by a wealthy donor to the University
of Pennsylvania, upset that Dr. Thompson, one of the country’s leading cancer
scientists, is no longer associated with Penn or the donor,” Thompson’s lawyers
said in a document filed March 16 in the U.S. District Court for the Southern
District of New York.
      The donor in question is, of course, Leonard Abramson, a Philadelphian
who once ran U.S. Healthcare and who founded a research institute at Penn,
providing $110 million to the endeavor.

>> Read More
  IOM Omics Committee Offers Blueprint to Prevent Other Duke-Style Disasters
Mar 26, 2012
       A panel convened by the Institute of Medicine called on FDA to publish a
guidance or regulation on submitting omics-based tests for regulatory review.
       The panel that formed in the wake of the Duke University genomics scandal
reaffirmed the existing FDA policy that requires that all tests used to guide
management of patients obtain an Investigational Device Exemption clearance
from FDA.
       The panel took a broad view of the issues involved, looking beyond the
troubling events in Durham, N.C., and focused on providing recommendations for
the development pathway of omics-based tests from discovery to clinical trials.

>> Read More
  Issue No. 11 - March 16, 2012
Mar 16, 2012
  The Philadelphia Story: How Surprise Filing by Abramson Spurred Penn to Follow Suit
Mar 16, 2012
Public run-ins, private vitriol and cease-and-desist letters are on the list
of harbingers of lawsuits.
However, none of the above-mentioned expressions of dissatisfaction are 
known to have preceded the exploding dispute between Craig Thompson and his 
former place of employment—the Leonard and Madlyn Abramson Family Cancer 
Research Institute and the University of Pennsylvania.
Even though Thompson had been an unsuccessful candidate for dean of the 
medical school, his departure was amicable. After taking the top job at Memorial 
Sloan-Kettering Cancer Center in October 2011, Thompson was seen returning to 
Penn to attend university-related social events. 
Things were cordial until—suddenly—they weren’t.

>> Read More
  Guest Editorial: Cancer From Fukushima? Is Sushi-Eating Over?
Mar 16, 2012
By Robert Gale
The ongoing accident at the Fukushima Daiichi nuclear power facility 
in Japan, now one year old, has re-ignited the debate regarding cancer 
risks to the public from released radionuclides, like iodine-131 and cesium-137.
The Japanese are on the front line for potential adverse effects, but 
people as far away as the U.S. and Europe remain concerned. Many people—
including, remarkably, some scientists, physicians and cancer experts—have 
canceled and continue to cancel travel to Japan.
Does this make sense? 
  Issue No. 10 - March 9, 2012
Mar 9, 2012
  News Analysis: Filing Will Ignite Complex Litigation Costing Millions, With Uncertain Rewards
Mar 9, 2012
The Abramson Institute and University of Pennsylvania are suing a
former faculty research star, who went on to become president at Memorial
Sloan-Kettering Cancer Center, one of the most conspicuous and prestigious
jobs in cancer research.
The dispute appears to be entirely about money, since the complaint does
not ask for an injunction, which is usually the sought-after tool in conflicts
over intellectual property.
  In Legal Brawl, UPenn, Abramson Institute Say Former Director "Absconded" With Inventions
Mar 9, 2012
This is the fourth installment in a series of articles that examines the
fundamental challenges to the cancer centers as they chart their future
beyond 2012.

The trustees of the University of Pennsylvania and a research institute
founded by a major donor filed two separate lawsuits in which they claim that
former Penn cancer center director Craig Thompson had failed to turn over
intellectual property worth hundreds of millions—or perhaps billions—of
dollars.
Thompson has since moved from Philadelphia to become president of
Memorial Sloan-Kettering Cancer Center. He denies any wrongdoing.
Using harsh language and claiming astronomical damages, the two
lawsuits filed in the U.S. District Court for the Southern District of New
York amount to a very public brawl in the top-most tier of cancer research.
The Leonard and Madlyn Abramson Family Cancer Research Institute,
one of the plaintiffs, is affiliated with the University of Pennsylvania but is a
separate non-profit. Thompson served as both the Penn cancer center director
and the research institute scientific director until November 2010.
  Issue No. 9 - March 2, 2012
Mar 5, 2012
  Importation is Remedy of Last Resort in Effort to Obtain Generic Injectables
Mar 5, 2012
In all the activity surrounding drug shortages, FDA is treating 
importation as a remedy of last resort.
Importation is starting to emerge as a potential strategy for 
alleviating drug shortages in the U.S. 
When viewed from the perspective of international trade, the 
drug shortages suddenly become less mysterious—and conversation 
quickly turns to U.S. drug pricing structures and regulatory barriers.
“One obvious solution to this would be to bring in foreign 
manufacturers,” suggested Bruce Chabner, chairman of the National 
Cancer Advisory Board, speaking at a panel discussion at the NCI 
Director’s Consumer Liaison Group Feb. 29.
  News Analysis: The Political Economy of Importations to Alleviate Cancer Drug Shortages
Mar 5, 2012
By Rena Conti

Oncology drug shortages are of critical national policy concern since 
cancer is the second leading cause of death in the U.S. 
Fortunately, only a limited number of drug shortages have caused 
serious safety concerns related to both their availability and the potential 
mis-dosing of alternatives. 
On Feb. 21, FDA announced a three-fold approach to increase the 
supply of cancer drugs in short supply. One aspect of the new policy is the 
importation of Lipodox to replace supply of the cancer drug Doxil (doxorubicin 
hydrochloride liposome). 
  HHS Agency Says it has No Jurisdiction and No Cause to Act on Allegations
Mar 5, 2012
The HHS Office for Human Research Protections determined that the 
federal government had no jurisdiction over the International Early Lung Cancer Action Program.
The letter announcing the decision was placed on the office’s website in January.
  Issue No. 8 - Feb. 24, 2012
Feb 28, 2012
  FDA Relies on Early Importation, Fast Approval, and Early Reporting to Combat Shortages
Feb 28, 2012
FDA announced a series of measures to combat shortages of generic 
drugs in oncology. 
At a briefing Feb. 21, the agency said it has:
• Allowed the temporary importation of an Indian-made drug to relieve 
shortages of Doxil (doxorubicin hydrochloride liposome injection). Despite 
being on the market, the imported drug, Lipodox, will remain unapproved 
in the U.S.
• Averted a shortage of methotrexate after the drug’s manufacturer, Ben 
Venue Laboratories, suspended operations at its production facility. FDA 
expedited the review of an alternative manufacturer’s application for 
preservative-free methotrexate.
• Published a draft guidance requesting an increase in voluntary 
notifications of shortages by the industry. Sole producers of drugs deemed 
“life-supporting, life-sustaining, or intended for use in the prevention of a 
debilitating disease or condition” are already required to notify the agency 
about impending shortages. The draft guidance applies to situations where 
multiple makers exist.

>> Read More
  Guest Editorial: FDA Must Address Economic Incentives to Resolve Drug Shortages Permanently
Feb 28, 2012
By Rena Conti

The FDA’s actions earlier this week are an important first step in 
ensuring the supply of medically necessary drugs.
To attain the long term policy goals of adding domestic manufacturing 
capacity to produce medically necessary drugs at competitive prices—
accessible by all purchasers in the U.S. market—will require the pursuit 
of complementary policies mindful of intended and unintended consequences. 
  South Carolina Clinic, Anil Potti Part Ways
Feb 28, 2012
Anil Potti doesn’t work at the Coastal Cancer Center anymore.
The Myrtle Beach practice, which employed the disgraced cancer 
researcher who had claimed to be a Rhodes Scholar, said his last day 
at work was Feb. 21, just short of one year from when he began in March 2011.
  Issue No. 7 - Feb. 17, 2012
Feb 17, 2012
  ODAC Votes to Nix Amgen's Drug Xgeva For New Prostate Cancer Indication
Feb 17, 2012
The FDA Oncologic Drugs Advisory Committee voted 12-1 against 
approval of the Amgen Inc. drug Xgeva (denosumab) for the treatment 
of men with castrate-resistant prostate cancer who are at high risk of 
developing bone metastases.
ODAC’s recommendation at the Feb. 8 meeting is consistent with 
the views it expressed about the proposed indication at a meeting last 
September (The Cancer Letter, Sept. 23, 2011). 
The committee’s recommendation on this Supplemental Biologics
License Application also appears to constitute clinical advice on the validity 
of the indication of “castrate-resistant non-metastatic prostate cancer.” 
  President Obama Proposes Flat Funding for NIH; And Realignment of Institutes' Budgets
Feb 17, 2012
President Barack Obama presented his budget request to Congress for
 the 2013 fiscal year Feb. 13. 
The proposal freezes the funding level for NIH—with no change from 
the 2012 appropriations of $30.86 billion.
It does however suggest realigning funding within NIH. If approved, 
the Office of the Director would take a $28 million cut, down to $1.429 billion; 
and the National Institute of General Medical Sciences would take a $48 million 
cut, down to $2.379 billion.
  See The Cancer Letter on 60 Minutes: Deception at Duke
Feb 14, 2012
      CBS News aired a report Feb. 12 on the Deception at Duke.

     >> Click Here to see an excerpt of the 60 Minutes' interview with Paul Goldberg of The
           Cancer Letter.
  Planned Parenthood May Be Doing Harm By Selling Screening To Women Under 40
Feb 10, 2012
The Susan G. Komen for the Cure Foundation and Planned Parenthood may have 
had their differences over reproductive politics, but they march in lockstep when they 
overstate the promise of breast cancer screening to young women, a group of experts 
said to The Cancer Letter.
Much of the controversy over screening mammography is focused on women 
between the ages of 40 and 49. No responsible health authorities suggest starting to 
screen earlier, before the age of 40. 
Yet, nearly all the women Planned Parenthood serves are in their twenties and 
thirties—and the health claims these women see on the organization’s website go far 
beyond the evidence-based recommendations of the U.S. Preventive Services Task Force.
  Issue No. 6
Feb 10, 2012
  Issue No. 5 - Feb. 3, 2012
Feb 3, 2012

  Issue No. 4 - Jan. 27, 2012
Feb 2, 2012
The Cancer Letter, Jan. 27, 2012
  From One Competitive Market to Another: UC San Diego Stakes a Claim in Las Vegas
Feb 2, 2012
Cancer centers have been known to buy physician practices to boost referrals. But
few have gone as far as the University of California, San Diego, which reached out 330 miles
across the desert, to buy the clinical practice of the failed Nevada Cancer Institute.
The move has prompted many oncology insiders to ask a simple question: Why?
In an interview earlier this week, UCSD Health System officials said they had one good
reason to make the $18 million deal that closed Jan. 23. They needed to grow.

  FDA Didn't Punish Duke for Failure to Seek Proper Regulatory Clearance for Three Trials
Feb 2, 2012
FDA officials explicitly informed Duke University investigators that regulatory
clearance would be required for their controversial single-institution trials that used
genomic signatures to assign patients to therapy.
Internal documents released by the agency provide a fascinating glimpse of
the role federal regulators played in the scandal that has become a case study in
how not to conduct cancer studies in which therapy is selected based on biomarkers.
The documents are important, because they make it possible to analyze internal
workings of the FDA in an area of unsettled legal and regulatory procedures.

  News Analysis: Trials Went On Despite FDA Statements
Feb 2, 2012
By Keith Baggerly, MD Anderson Cancer Center
In 2007 and 2008, Duke initiated three clinical trials in which genomic
“signatures” of sensitivity were used to determine patient allocation to
treatment arms.
Duke has acknowledged that the three now-terminated clinical trials
were conducted without FDA approvals in the form of investigational device
exemptions (IDEs), despite the fact that FDA views such signatures as
medical devices for which approvals must be obtained before they are used
in “significant risk” situations.