May 24, 2013 – Vol. 39, No. 21

Translucent Walls, Modern Classics Create Corporate Feel In Office Suite Occupied By Wife of MD Anderson President DePinho

As the first lady and a senior scientist at MD Anderson Cancer Center, Lynda Chin built an executive suite intended to make corporate executives feel at home while hammering out co-development plans or negotiating agreements for licensing anticancer compounds.

Internal documents obtained by The Cancer Letter show that the suite may have cost the state institution at least $1.5 million, and the overall costs could be closer to $2 million.

MD Anderson officials dispute these numbers.

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Feb. 1, 2013 – Vol. 39 No. 5

NCI Ends Brash Foray Into the News Business— Emails Tell the Story of the NCI Cancer Bulletin

In December 2003, after an explosion of feverish work, NCI stood on the threshold of launching a weekly newsletter that would cover the entire field of cancer research.

Other NIH institutes put out house publications, but none cover their entire areas of research. The NCI newsletter promised to serve as the gateway for information about its publisher—and to provide coverage of NIH, Congress, FDA, CDC, the pharmaceutical industry, advocacy groups, and cancer centers. In short, it would serve as the definitive publication of record.

A trail of emails and memoranda obtained by The Cancer Letter reveals that over preceding months, the institute’s employees and contractors had been learning about news judgment, writing and editing.
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July 16, 2010 – Vol. 36, No. 27

Prominent Duke Scientist Claimed Prizes He Didn’t Win, Including Rhodes Scholarship

A high-profile cancer genomics researcher at Duke University claimed in multiple grant applications that he had been a Rhodes scholar, when, in fact, the Rhodes Trust states flatly that he was not.

Documents obtained by The Cancer Letter show that in biographies submitted to NIH, Duke oncologist and genomics researcher Anil Potti claimed variously to have won the prestigious scholarship in 1995 or 1996, depending on the version of the biography.

Potti also made the Rhodes claim in an application that resulted in a $729,000 grant from the American Cancer Society.
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March 28, 2008 – Vol. 34 No. 12

Tobacco Company Liggett Gave $3.6 Million To Henschke For CT Screening Research

Lung cancer researcher Claudia Henschke accepted $3.6 million from the parent company of cigarette maker Liggett Group Ltd., The Cancer Letter has found.

The maker of Grand Prix, Pyramid, Liggett Select, Quest and Eve cigarettes provided the money in four installments between 2000 and 2003, and Henschke placed the funds in a non-profit group where she serves as president, tax documents show.

In her scientific articles, Henschke doesn’t disclose receiving money from Liggett. Instead, she declares support from the Foundation for Lung Cancer Early Detection, Prevention & Treatment, the non-profit that received the tobacco company money and which uses it to fund the work of the International Early Lung Cancer Action Program.

Though a press release was issued at the time the Liggett gift was announced, journal editors and cancer researchers haven’t been aware of the source of Henschke’s funding.
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Jan. 18, 2008 – Vol. 34 No. 2

I-ELCAP Leaders Named As Inventors On 27 Patents; Journals Probe Disclosures

The leaders of a research consortium that advocates computed tomography scanning to detect early-stage lung cancer have built an estate of 27 patent applications worldwide covering technologies and methods of screening.

According to publicly available databases, the leaders of the International Early Lung Cancer Action Project are listed as inventors on patent applications and one issued U.S. patent that cover innovations in lung cancer screening, from clinical trial methodology, to software for interpretation of scans, to technology of biopsy needles.

The first of these patent applications was submitted on April 11, 2000. In the U.S., group leaders are listed as inventors on one patent and 10 published applications. At least one of the inventions has been licensed by General Electric, a maker of CT scanners, and, in another instance, patent rights were reportedly exchanged for stock of a start-up company that markets lung biopsy devices.

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Feb. 16, 2007 – Vol. 33 No. 6

Danish Researchers Post Long-Awaited Aranesp Results—Ever So Discreetly

cA study eagerly awaited by physicians, investors, regulators, and payers around the world showed a signi�?cantly inferior therapeutic outcome from adding Aranesp to radiation treatment of patients with head and neck cancer.

The study conducted by the Danish Head and Neck Cancer Group was highlighted three years ago by Aranesp’s sponsor, Amgen Inc., as one of a series of rigorous trials designed to assess the impact of erythropoietin on “hard endpoints,” including survival and disease progression.

The EPO agents were approved based on their ability to decrease the need for blood transfusions, and the question of their impact on disease remains unsettled.

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May 19, 2006 – Vol. 32 No. 19

Alliteration And Prayer Were His Tools For Making Progress Possible For People

NCI Director Andrew von Eschenbach brought a ministerial style of speech to the federal government’s cancer research program.

Von Eschenbach employed sermon-like cadences to describe his vision of a world where no one suffers and dies from cancer. He praised God for the blessings bestowed on the U.S. and its scientific research enterprise. On occasion, he suggested that experts advising him bow their heads in prayer.

Whether he addressed a lay audience or a committee of cancer experts, von Eschenbach kept things simple, resorting to metaphors and alliteration. His speeches were intended to reassure believers and persuade doubters that an explosion of knowledge—an “exponential” rate of progress—would make it possible to fulfill his goal to “eliminate suffering and death due to cancer by 2015.”

Von Eschenbach’s speeches reflected his beliefs, his understanding of biology, and his approach to managing NCI. Consider his catch phrase, “the three Ds,” which stands for “discovery, development and delivery.” This was more than a clever rhetorical device. The three Ds guided von Eschenbach’s reorganization of the NCI leadership structure.

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Aug. 2005 – Vol. 31 No. 31

An “Insurgency” Targets Randomized Trials, Demands Access To Investigational Drugs

Perhaps it would have been prudent of the Food and Drug Administration oncologist Richard Pazdur to deflect the Congressman’s question.

Yet, there it was: an opportunity to lean toward the thin, black microphone on the witness table and reduce a messy situation to a maxim.

What was the problem with Erbitux, the monoclonal antibody so scandalously mishandled by ImClone Systems Inc.?

“It’s called good drug, bad development plan,” Pazdur said at the June 13, 2002, hearing of the subcommittee on oversight and investigations of the House Committee on Energy and Commerce.

Surely, it seemed that this would be a hard point to misconstrue: Erbitux was “good,” because it had been shown to shrink tumors. The company’s development plan was “bad,” because it failed to show convincingly how often tumor shrinkage occurred and why. There was no way for Pazdur to foresee that these words would identify him as a target of opportunity in a half-century-long battle over the criteria for approval of cancer drugs.

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Jan 4, 2002 – Vol. 28 No. 1

FDA Says ImClone Data Insufficient To Evaluate Colorectal Cancer Drug C225

FDA last week declined to review the application by ImClone Systems Inc. for C225, a treatment for colorectal cancer patients who develop progressive disease following treatment with CPT-11.

The agency’s “refusal to file” letter for C225 said the data presented by the company were insufficient to evaluate the Biologics License Application for the therapy.

ImClone (Nasdaq: IMCL) planned to present its application for accelerated approval of C225 to the Oncologic Drugs

Advisory Committee in February. The drug’s trade name is Erbitux and the generic name is cetuximab.

Last fall, Bristol-Myers Squibb Co. bought a 20- percent stake in the New York-based biotechnology firm for $1 billion, and co-licensed C225 in a transaction that could add up to another $1 billion if C225 is approved. ImClone’s regulatory approval strategy was in place before the transaction with Bristol, and under the deal, ImClone is responsible for the filings.

The FDA letter was dated Friday, Dec. 28, and was announced after the stock market closed. In a telephone conference for the press and the financial community before the reopening of the market on the morning of Dec. 31, ImClone officials assured Wall Street that the agent had met clinical endpoints, and that the FDA concerns involved documentation that could be reproduced.

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Sept. 25, 1998 – Vol. 24 No. 36

The Antineoplaston Anomaly: How A Drug Was Used For Decades In Thousands Of Patients, With No Safety, Efficacy Data

Clinical trials of “antineoplastons” therapy are unlike any other in modern medicine.

To begin with, the inventor of antineoplastons, their manufacturer, proprietor of the clinic that offers the alternative therapy, and the principal investigator on clinical trials are all the same man: Stanislaw Burzynski, a Polish-trained physician who initially produced antineoplastons by extracting them from human urine.

Working outside peer review, Burzynski is conducting 71concurrent, preliminary phase II trials that covermost cancer indications—an unheard of number for a single investigator, and for a drug which is yet to be proven effective for any indication.

These trials are fundamentally flawed in design and execution, said three experts after reviewing the Burzynski Research Institute’s 1997 annual report to the Food and Drug Administration.

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Nov. 3, 1995 – Vol. 21 No. 42

P-32 Ingestion At NCI Attracts Attention; Similar Cases Seen At Labs In The Past

Following months of press coverage, the story that began when a postdoctoral researcher at NCI received an internal dose of phosphorus-32 is continuing to attract national attention.

In the latest development, the CBS news show 60 Minutes is preparing a report on the circumstances surrounding the contamination of Maryann Wenli Ma, the researcher, who was pregnant at the time she had ingested the isotope.

Setting the stage for a public hashing out of this immensely complicated story, Ma’s lab chief John Weinstein, who is portrayed as a villain in Ma’s complaint to nuclear regulatory authorities, is also expected to appear on the program.

In a complaint to the Nuclear Regulatory Commission, Ma and husband Bill Wenling Zheng allege that Weinstein, chief of the Laboratory of Molecular Pharmacology at the NCI Division of Cancer Treatment, had been relentlessly pressuring the Chinese scientist to terminate the pregnancy. The complaint also alleges that Weinstein had interfered with the assessment of Ma’s exposure and her treatment.

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April 21, 1995 – Vol. 21 No. 16

NCI Intramural Budget: Well-Funded Labs, High Costs, Or Deceiving Appearances?

Item: On average, an NCI laboratory or branch chief controls more than $4 million per year.

Item: Altogether, eleven NCI intramural laboratories and branches control over $100 million a year, about a quarter of the NCI intramural research budget.

Is NCI putting too much money in the hands of a few scientists? Is there a strategy behind these expenditures? And, finally, would extramural investigators conduct the research more efficiently? These are among the central questions being asked by the National Cancer Advisory Board’s Ad Hoc Working Group on the NCI Intramural Program. In the process of the review, the Institute was directed to produce a breakdown of spending by the intramural branches and laboratories.

Until the working group asked to see the numbers, only top NCI officials had access to this information. Tables summarizing intramural spending in fiscal 1993 were obtained by The Cancer Letter under the Freedom of Information Act.

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April 30, 1993 – Vol. 19 No. 18

Controversial Dr. Rajko Medenica Sued By Patient;
Hilton Head Hospital Reviews His Practices

Rajko Medenica, a controversial Hilton Head, SC, physician whose healing talents are lauded by well-connected patients but rarely published in peer reviewed literature, is facing a civil suit stemming from management of a node negative breast cancer patient.

The suit alleges that Medenica inappropriately used the drug mitomycin-C to treat the patient, failing to monitor her kidney functions and causing hemolytic uremic syndrome.

At the same time, Hilton Head Hospital is conducting a peer review of Medenica’s practices and credentials. Recently, Medenica requested a six-month leave of absence from the hospital.

The suit, filed in the Beaufort County Court of Common Pleas last month, as well as the hospital’s peer review have opened questions about the veracity of credentials listed on Medenica’s curriculum vitae and the patient brochures published by his clinic.

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Aug. 7, 1992 – Vol. 28 No. 32

Breast Cancer Coalition To Congress: ‘Find A Way To Fund The War;’ Bypass Level Is Not Enough

It looked as though Fran Visco was demanding money for a disease other than cancer.

She did not exchange nods with other cancer activists, did not shmooze with the lobbyists who accompanied them. Instead, Visco sat down with a groups of ‘women, several of them wearing ribbons emblazoned with “$300 million more,” the slogan of the Breast Cancer Coalition over which Visco presides.

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Dec. 21, 1973 – Vol. 1 No. 1