Sunday, August 12, 2007

WHEELS FALL OFF BIODEFENSE LAB: Spud proclaims George Mason place of important science where researchers no longer welcome at the National Institutes of Health have a home

Readers of DD blog know US biodefense provides great ground cover for a variety of interesting characters looking for taxpayer dough to fund their research.

In the posting, Alibek dissected like frog, this blog took a back-through-time look at Ken Alibek, a scientist often portrayed in the mainstream news media as one of the nation's leading biodefense warriors, and his strange patent applications, fruitless biodefense firms, OTC health pills and "outside-the-box" thinking at George Mason University's biodefense lab.

However, Alibek is no longer at George Mason. The two parted ways last year in an acrimonious dust-up over academic responsibilities and the direction of graduate teaching in biodefense. Whining internal letters and protests from a George Mason graduate student and Ken Alibek purporting to show the injustice of it were spammed around to a number of websites, including this one, last month. (Since they were self-serving, your friendly neighborhood GlobalSecurity.Org Senior Fellow declined to publish them.)

George Mason's biodefense program is not large. Ken Alibek was its "star," if that's the right word to use, and was its publicity magnet. A recent snapshot of GMU's Life Sciences website shows his spirit still haunting the place on-line. (See pic at foot of article.)

However, in mid-July, George Mason emitted a press release about great new work said to be going on at the biodefense center.

It smacked of desperation.

"Researchers at George Mason University's National Center for Biodefense and Infectious Diseases and its Center for Applied Proteomics and Molecular Medicine are merging their expertise in host-pathogen biology, proteomics and nanotechnology to discover tissue and bloodborne [protein] markers that could be used for the early detection of exposure to infectious diseases," it read.

"Funded by the U.S. Department of Energy, these efforts may help save the lives of civilians and military forces exposed to biological weapons or other emerging infectious diseases, such as influenza and SARS ... "

"A major goal of the program, which initially focuses on anthrax and tularemia, is to discover protein biomarkers that could be used to identify the onset of an infectious disease before a patient exhibits symptoms," explained Charles Bailey, the head of George Mason's biodefense lab.

At the heart of this research are scientists Lance Liotta and Emanuel Petricoin who were said to be developing "cutting edge proteomic technologies and nanotechnology-based devices" in conjunction with high resolution mass spectroscopy to identify biochemical indicators of infection in advance of symptoms.

This research, it was said, "impacts Mason's long-range plans to be a major player in biodefense and infectious diseases research," according to Charles Bailey.

And it illustrated "the powerhouse research that is going on now at Mason," added Petricoin.

Those who follow biodefense issues now know that when Charles Bailey of George Mason claims something to be important, the bullshit detector is ringing loudly.

In 2003, Ken Alibek and another scientist claimed their work had suggested that smallpox vaccination could be adopted to provide protection against the AIDS virus. The claims were immediately dismissed on the basis of lack of evidence and although something on the research had been sent to the Journal of the American Medical Association, it had been rejected for publication.

"This is evidence of the caliber of bioscience research out-of-the-box thinking that is going on at George Mason” said Charles Bailey in a GMU press at the time.

To put George Mason's recent biodefense claims in a proper light it is necessary to delve into the history of Lance Liotta and Emanuel Petricoin, two scientists at the heart of a 2004 Congressional inquiry into conflicts of interest and ethics concerns at the National Institutes of Health.

This was a complicated business involving their former research in potential diagnostic markers for ovarian cancer, a much higher-stakes realm and one of very great interest to the American public, much more so than that of biodefense. It is a story about falling down, from going to big science that many care about in a well-respected universally known institution, to small science in a much, much lesser venue.

In a news story from the Los Angeles Times by David Willman in December of 2004, the nut of it was described in a photo caption for one of the scientists: "Petricoin collaborated with one company in his government role at the same time he was serving as a paid consultant to a competing firm."

The Times had been running a series of articles on conflicts of interest at the National Institutes of Health. These eventually led to a Congressional investigation and rule changes concerning outside consulting at the agency.

"In February 2002, the search for a cure for ovarian cancer appeared to take a significant step forward," wrote David Willman.

"Using an advanced computer program and a single drop of blood from patients, researchers from the National Institutes of Health and a private firm, Correlogic Systems Inc., reported that they had accurately diagnosed 50 out of 50 women with ovarian cancer.

"The results created a sensation ... But nearly three years later, the diagnostic breakthrough is not close to reaching patients.

"The project stalled while the government's two lead researchers -- Dr. Lance A. Liotta of the National Cancer Institute and Emanuel F. 'Chip' Petricoin III of the Food and Drug Administration -- signed on as paid consultants with a rival of Correlogic named Biospect Inc.

"Both companies were seeking ways to diagnose diseases, including ovarian cancer, by developing systems that could recognize patterns of proteins in the blood."

Hype came from a 2002 report by Petricoin and published in the respected medical journal, Lancet, under the title: "Use of proteomic patterns in serum to identify ovarian cancer." Proteomic patterns is just a fancy term for markers consisting of proteins and breakdown products or fragments of them.

"[Liotta and Petricoin] and their team used mass spectrometry and pattern-recognition software to probe serum samples for ovarian cancer biomarkers," reported The Scientist in September of 2005. "Their findings suggested that [protein] patterns – series of peaks in mass spectra representing unidentified peptides or low molecular-weight protein fragments – could be used to diagnose early ovarian cancer with surprising accuracy ... This was the hope in late 2003 when biotech startup Correlogic licensed Quest Diagnostics and LabCorp to market OvaCheck, a blood test for ovarian cancer based on the initially promising findings. But doubts about the validity of Petricoin's results and the robustness of serum proteomics as a tool for biomarker discovery quickly emerged ..."

Subsequently, OvaCheck -- an exploratory system which attempted to diagnose ovarian cancer -- died.

Hype and enthusiasm surrounded this science until around mid-2004 when Congress began investigating NIH researchers, including Liotta and Petricoin, for conflicts of interest in consulting agreements. A negative critical mass resulted from inability to reproduce the science and the investigation embroiling the scientists.

According to the National Cancer Institute's Cancer Bulletin, in meeting, "[Congressional legislators] voiced concern about consulting agreements with Biospect, Inc., that were held until recently by Drs. Liotta and Petricoin."

"Drs. Liotta and Petricoin, through the Food and Drug Administration/National Cancer Institute Clinical Proteomics Program, were the principal investigators on a cooperative research and development agreement with Correlogic Systems, Inc [which was developing OvaCheck.]"

"This agreement focused on the research and early development of proteomics patterns recognition as a potential approach for early detection of cancer," continued the Cancer Bulletin. "Both Drs. Liotta and Petricoin's agreements were approved by their respective ethics officers. Biospect was portrayed in the hearing as a direct competitor of Correlogic Systems."

Liotta and Petricoin did not reply to questions from the Los Angeles Times for the article on the matter. Their lawyer said to the newspaper in December 2004 that "both men had performed their government duties diligently and properly."

The Congressional investigation into Liotta, Petricoin and others, however, moved National Institutes of Health director Elias Zerhouni to make "additional revisions to ethics rules related to consulting agreements between agency employees and pharmaceutical and biotechnology companies to help avoid potential conflicts of interest," according to an American Health Line report from June 2004.

Drastic changes were needed, said Zerhouni.

For the LA Times, "Zerhouni declined to defend [Lance Liotta's] dealings with Biospect. Referring to the circumstances surrounding the collaboration with Correlogic, he told the [Congressional hearing in June 2004] that he had reached a 'tipping point' in dealing with NIH conflicts of interest."

"Cancer researcher Lance Liotta said he retired [from NIH/NCI] in May 2005 with pension and benefits, accepting 'a great opportunity' in research at George Mason University," reported the Associated Press in September of last year. ("NIH: Scientists escape ethics punishment," Rita Beamish, September 12, 2006.)

Demoted from looking for early diagnosis of ovarian cancer at the illustrious NIH by history, Liotta and Petricoin wound up exiled to the colorful but thoroughly brokedown biodefense research effort at George Mason University.

From ovarian cancer to something very few care about outside the bioterror lobby, rabbit fever, a disease agent once clandestinely cultured and spilled in an accident at an offensive biowar factory in the Soviet Union run by Ken Alibek.

GMU-generated list of publications by Emanuel Petricoin. Science on diagnosing ovarian cancer mysteriously gone missing.

Los Angeles Times on Liotta and Petricoin.

GMU press release.

Ghost of Ken Alibek seen lurking at GMU in this recent web snapshot.


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