Accreditation places Pfizer at Forefront of Highest Ethical and Safety Standards in Clinical Research

NEW YORK–(BUSINESS WIRE)–Apr 8, 2009 – Pfizer Inc announced today that it has become the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) for ensuring the protection of human subjects taking part in early-stage clinical trials.

The AAHRPP accreditation was awarded to Pfizer’s clinical research units (CRUs) in New Haven, CT, Brussels, Belgium and Singapore, where the company conducts most of its Phase I clinical research. To earn the accreditation, Pfizer participated in a rigorous, 15-month examination of the clinical research practices at these units.

AAHRPP is an independent, non-profit accrediting body that promotes ethically sound research of the highest quality. Organizations seeking accreditation must provide tangible evidence — through policies, procedures, and practices — of their commitment to ensure human rights protection in clinical research.

“Pfizer is committed to upholding the highest ethical standards in all of our clinical research activities,” said Martin Mackay, PhD, president of Pfizer Global Research & Development. “AAHRPP accreditation is tangible evidence of our continuing commitment to maintain the highest global standards for research by protecting the human rights of the individuals who take part in our early-stage clinical trials.”

CRUs and Phase I Research

Pfizer allowed AAHRPP to audit its three CRUs and demonstrated that these facilities met the high quality and ethical standards set by AAHRPP including requirements for research set by the International Conference on Harmonization (ICH), as well as research regulations in the United States, European Union and Singapore. The process included site visits, interviews and an application for accreditation that exceeded 1,000 pages.

Pfizer’s CRUs are staffed by doctors and other health professionals who maintain close ties with nearby hospitals to advance scientific knowledge and share best practices.

Phase I trials are the first studies of an investigational drug in humans. In these trials, small doses of an investigational medicine are administered under close medical supervision to healthy volunteer subjects. This allows researchers to measure responses to the investigational medicine, determine how it is absorbed by the body and how long it remains in the bloodstream, and assess the safety and tolerability of different doses.

“Safety and scientific excellence are the constant themes of our work,” said Rachel Harrigan, MD, Pfizer’s senior vice president of Development Operations. “This accreditation acknowledges the commitment of Pfizer’s physicians and other staff to the well-being of our volunteers and to our efforts to conduct the highest quality clinical trials at all stages.”

Pfizer voluntarily sought accreditation to demonstrate its commitment to integrity in research and because it wanted to be among more than 150 of the world’s best universities, hospitals, institutional review boards (IRBs) contract research organizations (CROs), and other organizations that are AAHRPP-accredited.

Pfizer worked closely with IRBs and ethics committees in New Haven, Brussels and Singapore, all of which invested considerable effort to evolve their standard procedures and methods of review for Pfizer studies in order to meet AAHRP standards.

“We are very pleased that Pfizer took a leadership position by demonstrating its commitment to human research protections by seeking and successfully achieving AAHRPP Accreditation,” said Felix Khin-Maung-Gyi, PharmD, chief executive officer of Chesapeake Research Review, an AAHRPP-accredited independent IRB based in Maryland. “I hope all others in the research enterprise, including fellow independent IRBs, sponsors, research institutions and sites, and CROs will follow Pfizer’s lead.

“While many companies strive for excellence in this area, there is no substitute for AAHRPP accreditation to cement the American public’s trust in our partnership for conducting clinical trials,” Dr. Khin-Maung-Gyi added. “It is our shared responsibility to those who both participate in and rely upon results from these trials to devote the necessary and appropriate resources for high quality, ethical research.”

Integrity in Research

The AAHRPP accreditation is another step in Pfizer’s ongoing efforts to earn public trust for integrity in research. Others include:

· Requiring that all Pfizer sponsored trials – regardless of where they are conducted — are carried out under the same international standards, including the International Conference on Harmonization (ICH) 1996 Guidelines for Good Clinical Practice and the global principles set forth in the Declaration of Helsinki.

· Beginning in November 2008, requiring that all Pfizer U.S. multi-center clinical trials are reviewed only by central IRBs that are AAHRPP-accredited.

· Registering clinical trials on the public database www.clinicaltrials.gov. As of 2008, the company registers all clinical trials conducted on a Pfizer product (Phase I and beyond), as well as non-interventional studies with prospective data collection. To date, the company has registered more than 1,000 trials.

· Posting the results of its clinical trials at www.clinicalstudyresults.org. As of 2005, summary results of all patient studies conducted on a Pfizer product (Phase I and beyond) are posted, and starting in 2008, the results of all clinical studies, whether in patients or normal volunteers, are posted, as well as the results of prospective observational studies.

· Providing a regularly updated public website, describing compounds in its drug development pipeline and detailing their progress

· Building infrastructure of the developing world countries, where an increasing number of clinical trials are taking place. This work is conducted in partnership with local authorities and research institutions.

· Conducting training programs in good clinical practice (GCP) standards around the world in countries such as India, a top location for clinical research.

Pfizer is committed to conducting clinical trials globally according to the highest ethical and scientific standards.

Drug development is a worldwide effort and clinical trials are conducted in many countries, providing experience with different patient populations and reflecting the prevalence and incidence of the diseases for which Pfizer is developing medicines. Pfizer posts key company policies related to human subject protection at http://pfizer.com/sciencepolicy.

About AAHRPP

AAHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors, and the public, AAHRPP encourages effective, efficient, and innovative systems of protection for human research participants. AAHRPP, through accredited research programs worldwide, will ensure that all human research participants are respected and are protected from unnecessary harm.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Phase 3 Clinical Trials Recently Started for the First JAK Inhibitor for Rheumatoid Arthritis and Tanezumab for Pain

Company Achieves March 2008 Goal of Advancing 10 to 12 New Treatments to Phase 3 in One Year

NEW YORK–(BUSINESS WIRE)–Apr 8, 2009 – PfizerInc today provided an update to its pipeline, highlighting the progression of clinical programs in high-priority therapeutic areas, and announced the start of Phase 3 clinical trials for two new molecular entities. In total, the company initiated seven Phase 3 programs within the past six months.

Earlier this year, Pfizer started Phase 3 studies in a first-in-class JAK inhibitor (CP-690,550), the first orally-administered, disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis in 10 years, based on promising Phase 2 efficacy and safety data. Rheumatoid arthritis impacts 1.3 million Americans and can be severe, debilitating, deforming and even shorten life. Pfizer is also conducting Phase 3 trials with tanezumab, a fully-humanized monoclonal antibody targeting nerve growth factor. Tanezumab significantly reduced pain in patients with osteoarthritis of the knee in clinical studies to date.

“We are executing on our commitment to bring new and effective therapies to patients around the world in areas where there is a significant unmet medical need,” said Ian Read, president, Worldwide Pharmaceutical Operations.

The company has initiated 12 Phase 3 clinical programs since March 2008, achieving its goal of advancing between 10 and 12 new molecular entities and new indications into late-stage development by March 2009. Pfizer reaffirmed the additional R&D objectives shared with investors in March 2008: 15-20 Phase 3 starts in 2008-2009, growing the Phase 3 pipeline to at least 24 and as many as 28 new molecular entities or new indications by December 2009 and 15-20 regulatory submissions from 2010 to 2012.

The Pfizer pipeline now reflects a therapeutic-area focus, with 100 programs in Phase 1 through Registration. In total, 21 programs advanced in the pipeline since September 2008, 12 of them in the identified high-priority disease areas of diabetes, oncology, inflammation/immunology, Alzheimer’s disease, psychoses and pain.

“We are continuing to better align our pipeline candidates with the identified needs of patients and healthcare providers worldwide,” said Mr. Read. “Importantly, our new business unit structure will enable us to advance our development programs with urgency and efficiency in support of achieving our regulatory submission goal and providing high value therapies.”

Pfizer recently formed several smaller, customer-focused business units to better anticipate and respond to customers’ and patients’ changing needs and to ensure the alignment of research and development activities with these needs. Each unit has responsibility for late-stage product development and commercialization. This approach allows for rapid decision-making and a more efficient use of resources to maximize the value of the company’s pipeline and, as a result, will enhance Pfizer’s ability to invest in long-term opportunities.

Pfizer added two late-stage candidates to the pipeline as part of its continuing effort to pursue the best external science through business development opportunities and partnerships. Within the Primary Care Business Unit, Pfizer in conjunction with Medivation is developing Dimebon, currently in Phase 3 for the treatment of Alzheimer’s disease (AD). Dimebon’s mechanism is thought to be distinct from currently available AD medications. It has successfully completed Phase 2 studies for Huntington’s disease, a hereditary, degenerative brain disorder for which there are limited treatment options.

Pfizer’s Specialty Care Business Unit entered into a strategic alliance with Auxilium Pharmaceuticals to develop XIAFLEX™, a new medicine being studied for Dupuytren’s contracture in Phase 3 and Peyronie’s Disease in Phase 2.

“Last year, we refined our approach to research by refocusing our pipeline to allow us to better select targets and molecules for development and move high-priority projects forward with improved cycle times,” said Martin Mackay, PhD, president of Pfizer Global Research & Development. “We will continue to drive our strategies and make the operational improvements necessary to maximize our investments, accelerate development, and advance medical science.”

Pfizer continues to prioritize its portfolio in order to direct resources to projects in areas of unmet medical need and market opportunity. This approach has resulted in the discontinuation of certain development programs that did not meet its criteria regarding therapeutic area focus or measures of potential clinical utility and customer value. As a result, 26 programs were discontinued in the last six months, 15 as a result of strategic decisions made last year and 11 due to clinical attrition.

The Company will seek to monetize some of the compounds that have been discontinued through business development transactions, such as out-licensing or partnering.

Pfizer’s pipeline is posted at www.pfizer.com/pipeline. Accompanying information includes compound name, target disease, phase of development and, for late-stage programs, mechanism of action.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

DISCLOSURE NOTICE: The information contained in this release is as of April 2, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about various products in development and potential additional indications for certain in-line products, including their potential benefits, and about Pfizer’s Phase 3 pipeline and planned regulatory submissions, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications and supplemental drug applications that have been or may be filed for any such products in development and additional indications, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products and such additional indications; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.

BloombergNews.com, by Shannon Pettypiece, April 8 (Bloomberg) — Pfizer Inc. is breaking its research operations into two units, a biotechnology division to be led by a senior executive from Wyeth and a pharmaceutical group that will be run by a Pfizer scientist.

The reorganization, designed to smooth the integration of Wyeth, will take effect when Pfizer’s planned $63 billion acquisition closes later this year, Pfizer said today in a statement. Pfizer will retain eight Wyeth executives, including Mikael Dolsten, now president of Wyeth research. Dolsten will lead the combined company’s biotechnology arm.

Chief Executive Officer Jeffrey Kindler has been restructuring research operations at New York-based Pfizer for two years. He agreed to buy rival Wyeth, based in Madison, New Jersey, to add vaccines, biotechnology medicines and over-the- counter products. Pfizer, the world’s biggest drugmaker, needs to increase new-drug development as it braces to lose $10 billion in annual sales in 2011, when patent protection ends for its cholesterol pill Lipitor, analysts said.

“We wanted to learn from the past acquisitions and make sure this one was firing on all cylinders right from the go,” said Martin Mackay, Pfizer’s head of research, in a telephone interview. “We needed to get a structure in place ahead of time to allow a smooth transition. I think I’ve experienced every organizational model going and this is a new one.”

Mackay will be in charge of traditional, small-molecule pharmaceuticals after the acquisition closes.

Poussot Future

Pfizer declined 20 cents, or 1.5 percent, to $13.51 at 4 p.m. in New York Stock Exchange composite trading. Wyeth fell 31 cents to $42.45.

Wyeth Chief Executive Officer Bernard Poussot will continue to work through the close of the deal, Pfizer said in the statement. A Pfizer spokesman, Ray Kerins, said he couldn’t comment on what Poussot would do after the closing.

“He’s continuing on as Wyeth CEO, working with Pfizer on the integration,” said Doug Petkus, a spokesman for Wyeth, in a telephone interview. “No decisions have been announced regarding his future.”

Wyeth’s head of vaccine research, Emilio Emini, will continue to lead vaccine research at Pfizer after the acquisition, according to the statement. Before joining Wyeth in 2005, Emini was chief of vaccine development at the nonprofit International AIDS Vaccine Initiative. Previously, at Merck & Co., based in Whitehouse Station, New Jersey, he helped lead five AIDS vaccine candidates into human trials.

Pfizer will continue to pursue outside partnerships, licensing opportunities and acquisitions to bolster its own research, Mackay said.

Once the companies are merged, Pfizer will have a research budget of about $12 billion, which it plans to reduce, though not below last year’s budget of $7.9 billion, Mackay said in a telephone interview.

The acquisition will probably close in the second half of the year and Pfizer Chief Financial Officer Frank D’Amelio is leading the integration, Pfizer said this month.

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BBCNews.co.uk, April 7, 2009, by Michelle Roberts — Colon cancer is the third most common cancer in the UK. Destroying abnormal stem cells could be a way to kill off bowel cancer in its very earliest stages, say UK experts. Immature cells line the gut and normally replace and repair the tissue but malfunctions can lead to cancer.

Scientists believe detecting and obliterating these rogue cancer stem cells as soon as they appear could be a potent new anti-cancer strategy.

A UK National Stem Cell Network conference heard the same method might also work for other cancers. Professor Malcolm Alison, of Barts and The London School of Medicine, has been looking at how bowel cancers grow and spread in the body.

He said there was mounting evidence to show that faulty self-renewing stem cells are to blame.

And like the root of a weed, unless they are removed they will continue to propagate.

Scientists are still uncertain exactly which cells in the gut become cancer stem cells.

But they know definitively that they exist – and that they play a central role in the formation of cancer.

Once these are found, it would be possible to identify and treat these cells before life-threatening tumours develop, said Professor Alison.

Less invasive

Early detection would make treatment easier, less invasive and more effective.

Professor Alison said: “Drugs could be targeted to specifically work on cancer stem cells and so provide a more direct approach for treating bowel cancer.

“For instance, it may be possible to kill these abnormal stem cells by triggering them to self-destruct.

“I can see trials within the next three years in patients to knock out these cells.”

A more targeted approach to treatment could avoid some of the unpleasant side-effects encountered with chemotherapy, which attacks healthy as well as cancerous cells.

Adeyinka Ebo, of Cancer Research UK, said: “Finding out more about the cells where cancer begins is crucial in helping scientists to detect cancer early, when treatment is simpler and more effective.

“If researchers can identify which cells in the gut will become cancer stem cells it would provide a vital step forward towards beating this type of cancer.”

Bowel cancer is the third most common cancer in the UK. More than 100 people every day are diagnosed with the disease.

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How Gut Bugs Could Trigger Cancer

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“This research puts into perspective the complexity of the effect
normal gut bacteria can have on the health of the individual”

Professor Mark Huycke

BBCNews.co.uk — Scientists have uncovered a chain reaction which could link a type of bacterium living in our intestines to the development of colon cancer.

Enterococcus faecalis is harmless in the vast majority of people, but US scientists have found that it can produce harmful chemicals.

The Journal of Medical Microbiology study found these can damage DNA, and prompt gene activity linked to cancer.

A UK expert said it was plausible that bacteria could cause colon cancer.

However, he stressed that E.faecalis was very unlikely to be the only bacterium which had such an effect.

Our guts provide a home to dozens of different types of bacteria, many of which actually provide a useful service, helping break down indigestible sugars in food by fermentation, or even “training” the body’s immune system.

However, in recent years, scientists have suggested that in certain, susceptible individuals, these bacteria can actually do harm.

E.faecalis, sometimes also known as Group D Streptococcus, is one of those under suspicion, and the research by the Department of Veterans Affairs Medical Center in Oklahoma City strengthens the link.

The researchers investigated how colon cells in the laboratory reacted to the presence of the bacterium, when it is in a “fermentation” state.

In this state, it produces a kind of oxygen molecule called “superoxide”, and it is this which can damage DNA in surrounding cells.

Gene activity

Professor Mark Huycke, who led the research, found that the apparent effects were not limited to this.

“We found that superoxide led to strong signalling in immune cells called macrophages – it also altered the way some cells in the gut grew and divided and even increased the productivity of genes which are associated with cancer.”

In total, the expression of 42 genes linked to vital processes in human cells was altered by the presence of E. faecalis in this state.

“This research puts into perspective the complexity of the effects normal gut bacteria can have on the health of the individual.”

Dr Barry Campbell, a gut microbiology researcher from the University of Liverpool, agreed that E.faecalis was a candidate for cancerous changes.

However, he said that other bowel bacteria could also be behind the cell changes which eventually lead to tumours.

He said: “There is not going to be only one culprit. Our own team is interested in a particular type of E.coli with this in mind.

“There are also many other factors which are involved, such as genetics and environment.”

Professor Ian Rowland, a specialist in gut bacteria from Reading University, said: “This shows how it could happen, although whether this actually does happen in a human is another matter.

“There is a lot of circumstantial evidence that gut bacteria are important in colorectal cancer, although we don’t fully understand why.

“In the case of Enterococcus faecalis, we know that most people have this in their gut, but most people don’t get colon cancer, so there must be other factors involved.”

“In the foreseeable future, artificial limbs may be able to perform as well as or better than natural ones.”

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(Image credit: Win McNamee/Getty)

The Real Arms Race

GoogleNews.com, TheAtlantic.com, April 7, 2009, by William Haseltine — Regenerative medicine, which seeks to replace organs, tissues, and cells damaged by disease, injured by trauma, or worn by time (see my earlier posting on this subject, “Stem Cells and Beyond,” March 9), holds much promise. But at present it is not possible to regenerate entire limbs lost to accident or war. Until the field of regenerative medicine advances further, artificial limbs offer the most hope for those who have lost an extremity. And thanks to remarkable progress in microelectronics, computer science, micro-engineering, and neurosurgery, we are nearing a time when artificial arms may move as spontaneously and naturally as the original.

A recent issue of the Journal of the American Medical Association* describes one notable advance by a team of neurosurgeons, engineers and rehabilitation specialists working in Chicago and Canada, funded by both the Defense Advanced Research Projects Agency and the National Institutes of Health. Their goal is to create an artificial arm that naturally responds to signals from the brain.

The first step of the process is to surgically relocate nerves that signal absent muscles. For example, the ends of severed nerves that would connect to the biceps or forearm are stitched to separate muscles of the chest. After the body heals, a signal from the brain that normally contracts a muscle in the arm now tightens one in the chest. An array of sensors placed over the chest to detect the slightest muscle tension relays signals to a computer, which in turn sends signals to a set of tiny motors that move the new limb.

The computer must then learn how to interpret the signals, which it does by connecting the output signals from the computer to a television model of an arm. Patients direct the virtual arm to perform specific tasks such as raising and lowering the forearm, flexing the wrist, opening and closing the hand, and pinching the thumb and forefinger. The patient learns by watching how the virtual arm responds to the intent as signaled by the brain. The computer learns as data from the multiple sensors is sorted into reproducible patterns that will provide input to the individual motors of the mechanical arm.

The researchers compared the abilities of the amputees and people with normal limbs to direct actions of the virtual arm. For the control group, the sensors were placed over muscles normally used to move the hand and arm. Both groups learned simple arm motions, such as raising and lowering the arm, equally well. Those with normal limb function learned fine hand movements more rapidly than the amputees, although some of the amputees learned such movements almost as fast.

Patients were then fitted with mechanical arms, most of which had been developed by DEKA Integrated Solutions Corporation and were capable of ten separate movements. (An arm developed by the Johns Hopkins Applied Physics Laboratory and collaborators was also used.) All the patients were able to perform basic operations using mechanical arms on the very first day of testing. Over the next two weeks, all gained proficiency. Usually each motion was performed separately, although occasionally two separate motions would occur simultaneously, particularly as people reached for objects to pick up. The speed of movements was nearly normal. Eventually, some patients became expert at complex tasks such as picking up checkers pieces rolling across a table, stirring a spoon in a cup, and moving small blocks (see www.jama.com for a demonstration).

This is a remarkable advance. The movement of the mechanical arm, directed by the transplanted nerve, is as intuitive as the motion of a natural arm. People learn to control the positions of the elbow, wrist, and hand in a sequential, ordered, and useful way.

Of course, there are several caveats. The work was done with a group of only five patients. And although during the training period all patients learned to move the arm, some never learned fine movement control. The biggest drawback is that the mechanical arm must be controlled visually. The arm cannot send sensory input to the brain. Designing limbs that transmit sensory signals from the arm to the brain is the next frontier. In the foreseeable future, it’s very likely that mechanical arms will be able to perform as well as or better than the original.

· “Targeted Muscle Reinnervation for Real-time Myoelectric Control of Multifunction Artificial Arms” Kuniken et. Al. Journal of the American Medical Association. Volume 301, pages 619-628, February 2009.

· William Haseltine is a scientist, businessman and philanthropist. For much of the ’70s, ’80s and ’90s he was a professor at Harvard Medical School, where he researched cancer and HIV/AIDS. He is also the founder of several companies, including Human Genome Sciences, where he served as Chairman and CEO. He is President of the William A. Haseltine Foundation for medical Sciences and the Arts.

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Stem cells and beyond

TheAtlantic.com, by William Haseltine — On March 9th, President Obama lifted the Bush administration’s ban on federal funding for embryo-derived stem cell research. This executive order marks an important step forward in the search for new lifesaving medicines. But by itself, it is not enough. As policy makers debate health care reforms, they should renew their support for regenerative medicine, a broader field of which embryonic stem cell research is only one important part.

Last week, I witnessed some of the most promising research in this field when I paid a visit to the Wake Forest University Institute for Regenerative Medicine. My host was Dr. Anthony Atala, the Institute’s director. Ten years ago, when Dr. Atala was a pediatric surgeon and urologist at Harvard, he and I cofounded the Society for Regenerative Medicine in the hopes of catalyzing the rapid development of a new specialty. The goal of regenerative medicine is to create new organs to replace those lost to disease, trauma, or age. Ambitious as this ideal may be, it is now being pursued at dozens of new university departments and research centers around the world.

Scientists and doctors at Wake Forest have already successfully implanted the first laboratory-made human organs–bladders and urethras. Coming soon: synthetic corneas, heart valves, skin, cartilage, tracheas, and vaginas. More ambitious plans are underway to replace lost digits, muscles, and nerves, and to build entirely new complex organs such as livers, kidneys, and human hearts.

How are new organs built? Take the bladder, a simple balloon-like organ that is made of two layers of tissue: an outer layer of muscle and an inner layer of epithelial cells connected by an elastic matrix. The process begins with a tiny snippet of the patient’s own bladder–a sample of what remains behind after injury or surgery. Muscle and epithelial stem cells are then located, separated, and used to grow large sheets of pure muscle and epithelial cells. It takes six to seven weeks to grow enough new tissue to make a new bladder.

When the tissue is ready, scientists wrap it around a bladder-sized support made from fine fibers of a collagen-like material. The outside of this support is covered with a layer of muscle, while the inner cavity is lined with the sheet of epithelial cells. The new organ is then inflated and deflated repeatedly while being bathed in a body-temperature nutrient fluid. Just before implantation, doctors drape the bladder with a blood-vessel-rich section of membrane, taken from either the intestinal or abdominal wall, to ensure adequate blood supply.

Over time, the artificial support dissolves and is replaced with the natural matrix. Within six months to a year, the tissue of the new bladder is virtually indistinguishable from the original. Urethras can be made in a similar manner. New urethras and bladders have now been implanted in more than two hundred patients, and success rates for this surgery exceed 80 percent.

Although these developments are exciting, the most spectacular advances still lie ahead. There is real hope that stem cells will soon be available to regenerate tissue for any part of the body. Throughout the past eight years, funding restrictions have forced researchers to develop workarounds. By inserting two or three specific genes into normal skin cells, scientists have managed to turn mature cells into the equivalent of embryo-derived stem cells. Meanwhile, Dr. Atala and his staff have isolated a new kind of stem cell from readily available amniotic fluid and used it to create muscle, bone, fat, blood vessel, nerve, and liver cells in their laboratories.

While stem cells derived from adult cells and amniotic fluid hold their own promise, there is still much to be learned about how early-stage stem cells operate in their most natural embryonic state. For that reason, the ban on federal funding has had a chilling effect on all stem cell research in the United States. Other countries without such funding bans have moved ahead aggressively in this area while our own laboratories, staffed with our most brilliant doctors and scientists, have been slowed by funding limitations.

President Obama’s executive order presents an excellent opportunity to renew America’s commitment to this whole promising field. Even in these tight times, universities, states and counties should continue to invest in biomedical research. Over the past six years, Wake Forest University has invested close to $100 million in the Institute of Regenerative Medicine. The state of Florida, meanwhile, has made a large-scale investment in biomedical research (see my previous post, “Renewing Florida”), and other states would do well to follow this example.

At the same time, the federal government should not only continue but expand its support. Federal funding has already proven key in the success of biomedical science. Grants from the National Institutes of Health, the Department of Defense and other federal agencies provide most of the $40 million annual research budget of the Wake Forest Institute. The new health care reforms should allot even more funds to this lifesaving work.

Training and continued support for staff will also be key as more researchers join the field. Progress at the Wake Forest Institute would not be possible without teams of dedicated professionals who are both scientists and surgeons. Like Dr. Atala, these dual-trained professionals are inspired by the clinical problems they have encountered and can move discoveries quickly from the laboratory to the clinic.

In our search for economic efficiency, we cannot afford to sacrifice the future of medical science. With thoughtful reform, the goals of scientists like Dr. Atala may be fulfilled–otherwise, the bright future of regenerative medicine may never be realized.

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UNIV-FLORIDA, GAINESVILLE, Fla, April 8, 2009 . — To truly kill colon cancer and eliminate the risk of recurrence, it is important to kill the “root” of the disease, according to a University of Florida College of Medicine surgeon.

“It’s like a dandelion, if you don’t kill the root it just keeps coming back,” said Dr. Emina Huang, a UF colorectal surgeon, who added that colon and rectal cancers have high recurrence and spread rates, especially if the disease is not found until advanced stages.

Her findings, available online now and to be featured on the cover of the April 15 print version of Cancer Research, identify a biomarker for colon cancer stem cells that she believes will help researchers further evaluate the cancers’ origins and progression. The discovery sheds light on the cancer stem cell theory, an idea that has arisen because cancer cells and stem cells share many qualities, including the ability of cancer stem cells to demonstrate self-renewal.

The research determined a protein called aldehyde dehydrogenase 1, or ALDH1, can be used to identify, isolate and track these ultra-resilient cells throughout the development of malignant colon or rectum disease. Previously used markers cannot as precisely track colon cancer stem cells.

“Without a better handle on what cells might be contributing to cancer metastases and recurrence, we won’t have any targets to go after,” said Huang, an associate professor in the UF department of surgery and a member of the Program in Stem Cell Biology and Regenerative Medicine at the UF College of Medicine. “This gives us a potential target.”

According to the American Cancer Society, about 150,000 Americans are diagnosed each year with colorectal cancer, and more than 50,000 die from the disease. In addition to the potential advances in therapeutic strategies, Huang said having a more direct target to explore will benefit progress in the areas of diagnostics and prevention.

In collaboration with Dr. Bruce Boman, a professor of medical oncology at Thomas Jefferson University in Philadelphia, Huang chose to evaluate ALDH1 because of its known association with breast, brain and other cancers. In addition to being a strong marker for malignant colon stem cells, the researchers believe ALDH1 may be a marker for benign colonic stem cells. Whether these two types of colonic stem cells are one of a kind still needs to be determined.

Researchers implanted human colon tissue cells into mice and analyzed the resulting growth. Although normal cell tissue was evaluated, it never replicated in the mice — only the tissue that was malignant grew. Comparing ALDH1 patterns with that of the previously used markers, the researchers found ALDH1’s presence was much more targeted, suggesting a way to more definitively identify colon cancer stem cells in the original tissues.

They also noted that ALDH1 indicated an increasing number of colonic stem cells throughout the progression of colon tissue’s transformation from normal cells to premalignant cells to cancerous cells. These findings support the theory that an increase in ALDH1 expression marks the tumor growth in colon cancer stem cells.

Dr. Sanford Markowitz, the Markowitz-Ingalls professor of cancer genetics in the department of medicine at Case Western Reserve University in Cleveland, said this research marks an important new advance in demonstrating that ALDH1 is the most specific marker yet described for identifying stem cells in both the normal colon and in colon cancers.

“The work advances our understanding of how the health of the normal colon is maintained, and also offers a chance for helping to identify new targets that may lead to new approaches for treating colon cancers, by focusing on the stem cells that maintain these tumors,” said Markowitz, who also is an investigator with the Howard Hughes Medical Institute.

Although the theory that cancers are seeded by cancer stem cells is still becoming scientifically accepted, Huang said she thinks that in every cancer there is a small fraction of cells capable of reproducing the cancer. If these unique cells are not killed or removed during treatment, the cancer will not be entirely destroyed.

While changes in patient care are most likely years away, she says the findings give researchers an immediate target to focus on as they try to develop new medical interventions and optimize treatment regimens to completely kill the disease.

Potentially, tumors could be examined to determine if there is an overwhelming expression of the biomarker, or tests taken to determine if the biomarker may be circulating in the bloodstream — scenarios that could possibly indicate a worse outcome, thus signaling the need for more aggressive treatment.

“The next step is to look at some of the predisposing conditions and see if the pattern is suggestive of anything we can do in the prevention mode,” said Huang, who noted that people with inflammatory bowel disease, for example, have a higher risk of cancer.

Primarily conducted at the University of Michigan in Ann Arbor, the team’s research was funded in part by the National Cancer Institute, the Will and Jeanne Caldwell Fund for Cancer Research and private grants.

Public release date: 6-Apr-2009
American Association for the Advancement of Science

AAAS/Science to Launch New Journal:
Science Translational Medicine

Elias Zerhouni, M.D., former director of the National Institutes of Health, named chief scientific advisor

The journal Science, published by the nonprofit American Association for the Advancement of Science (AAAS), today announced plans to launch a new journal devoted to research in translational medicine, which uses insights from basic biology to improve medical care. The journal, Science Translational Medicine, will launch in fall, 2009. (See www.sciencetranslationalmedicine.org.)

Elias Zerhouni, M.D., Senior Fellow at the Bill & Melinda Gates Foundation’s Global Health Program and former Director of the U.S. National Institutes of Health, has accepted the position of Chief Scientific Advisor for Science Translational Medicine.

Together with the journal’s Advisory Board of clinician scientists and other experts, and Editor Katrina L. Kelner, Dr. Zerhouni will set the strategic direction of the journal and work with staff to attract and publish research that represents both excellent science and significant advances for human health.

“We need to find novel and more effective ways to better understand and develop, for patients, the extraordinary advances we have made in the past few years. This is why translational medicine has to become a more rigorous and, in my view, a redefined new discipline of biomedical science, with a vibrant and focused community dedicated to basic and applied investigations of the highest scientific quality, and without artificial barriers between its constituent disciplines,” Dr. Zerhouni said.

“We should never forget that the public supports our research not just for its own sake but for its promise to bring new and more effective approaches to health across the world. I am pleased by the decision of AAAS to launch this journal at this time and honored to serve as its inaugural chief scientific advisor.”

What is Translational Medicine?

Often described as an effort to carry scientific knowledge “from bench to bedside,” translational medicine builds on basic research advances – studies of biological processes using cell cultures, for example, or animal models – and uses them to develop new therapies or medical procedures.

Translational medicine is becoming ever-more interdisciplinary. For example, researchers need new computational approaches to deal with the large amounts of data pouring in from genomics and other fields, and as new advances in physics and materials science offer new approaches to study or diagnose medical conditions.

Science Translational Medicine is being launched to help researchers more efficiently access and apply new findings from many different fields, explained Bruce Alberts, Science’s Editor-in-Chief. Specifically, the journal will serve researchers and management in academia, government, and the biotechnology and pharmaceutical industries, physician scientists, regulators, policy-makers, investors, business developers, and funding agencies.

“The new journal should help scientists and engineers work toward bigger-picture goals for improving patient care, by allowing them to better assimilate information that currently is coming at them from multiple sources,” Alberts said. “Too often, information with the potential to improve human quality-of-life is available only through silo-like channels. For example, cardiologists who only attend specialized meetings and read the basic cardiology literature, but not the physics or computer science literature, might miss an important breakthrough that could advance their own research. Science Translational Medicine will help keep researchers informed about advances across all disciplines.”

“Science Translational Medicine will encourage the flow of information from the lab to the clinic – but also from the clinic back to the lab. We believe that continuous feedback and communication among the diverse players in this system are essential for success,” said Editor Katrina Kelner.

Specific Examples of Translational Research

· Harry Dietz and his colleagues at Johns Hopkins University found that losartan, a drug already approved in the United States for use against high blood pressure, can prevent the aortic aneurisms found in mice engineered to have Marfan syndrome, a genetic disease that affects the body’s connective tissue. Losartan has now been tested as a therapy in a group of children with this syndrome and found to inhibit the development of these potentially deadly abnormalities in the aorta.

· Using sophisticated image processing algorithms, Anant Madabhushi and colleagues at Rutgers University can analyze the texture in high-resolution MRI medical images to detect and locate early stage prostate tumors. This application of computational tools to medical imaging yields a more sensitive and reliable technique for clinical application than existing approaches.

· After several decades of unsuccessful efforts to find a vaccine for meningitis B using conventional methods, a research team led by Rino Rappuoli of IRIS, Chiron S.p.A. in Siena, Italy identified a vaccine candidate using a translational approach called reverse vaccinology, which involved analyzing the meningococcal genome sequence. Novartis is now testing this candidate in clinical trials.

· To delay the onset of blindness, many patients with glaucoma must administer eye drops multiple times during the day, a demanding routine that can prevent effective control of the disease. Erin Lavik at Yale University has developed microspheres containing the glaucoma drug timolol maleate, which can be injected into one spot in the eye, where the microspheres secrete controlled amounts of timolol for over a month. This improvement in the way that glaucoma patients receive their medication could lead to more consistent levels of the drug and better outcomes for the patient.

· Gold nanoparticles or “nanoshells” developed by James Tunnel’s group at the University of Texas in Austin can be localized to cancer cells, allowing detection by fluorescence spectroscopy even when the tumors are quite small. These same particles can then be activated with strong light to potentially destroy the tumor. This approach combines optical imaging, spectroscopy and nanotechnology for early cancer diagnosis.

Inside the Journal

Science Translational Medicine will publish original, peer-reviewed, science-based research, including small clinical trials and other studies of human biology, as well research on animal models of human disease. “Perspective” articles and Reviews will discuss new findings from both a basic science and a clinical point of view. The journal also will feature and synthesize informed commentary on policy, funding, regulatory issues, and more.

The scope of content in Science Translational Medicine will encompass advances related to cancer; cardiovascular disease; metabolism, diabetes and obesity; neuroscience, neurology, and psychiatry; immunology and vaccines; infectious diseases; policy; behavior; bioengineering; physics; chemical genomics and drug discovery; imaging; applied physical sciences; medical nanotechnology; drug delivery; biomarkers; gene therapy and regenerative medicine; toxicology and pharmacokinetics; data mining; cell culture; animal and human studies; medical informatics; other interdisciplinary approaches to medicine.

Science Translational Medicine will be published weekly online, every Wednesday, and a compilation of selected articles will be offered in a print edition, published monthly.

“Science Translational Medicine will join Science’s other sister journal, Science Signaling, in providing a unique forum for researchers from many different disciplines to connect and collaborate in new ways that benefit human health,” said Alan I. Leshner, Chief Executive Officer of AAAS and Executive Publisher of the journal Science.

Science Translational Medicine’s Leadership

In addition to Chief Scientific Advisor Elias Zerhouni and Science Editor-in-Chief Bruce Alberts, Science Translational Medicine’s leadership includes Editor Katrina Kelner and Science Executive Editor Monica Bradford.

Science Translational Medicine’s Advisory Board

Kenneth R. Chien, M.D., Ph.D.
Director, Cardiovascular Research Center, Massachusetts General Hospital
Harvard Stem Cell Institute, Harvard Medical School

Harry C. Dietz, M.D.
Professor, Institute of Genetic Medicine, Johns Hopkins Hospital
Investigator, Howard Hughes Medical Institute, Johns Hopkins University, School of Medicine

Jeffrey I. Gordon, M.D.
Director, Center for Genome Sciences, Washington University in St. Louis, School of Medicine

Philip Greenland, M.D.
Senior Associate Dean, Clinical and Translational Research, Feinberg School of Medicine
Director, Northwestern University, Clinical and Translational Sciences Institute
Former Editor, Archives of Internal Medicine

Joseph B. Martin, M.D.
Professor, Neurobiology and Co-Chair, Governance, NeuroDiscovery Center, Harvard Medical School
Former Dean, Harvard Medical School

Elizabeth G. Nabel, M.D.
Chief and Principal Investigator, Nabel Lab, Cardiovascular Branch, Vascular Biology Section
Director, National Heart, Lung, and Blood Institute, National Institutes of Health

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‘Plenty of PCs have been compromised’ in different industries, critical or not, says Roger Thompson

Computerworld.com, April 8, 2009, by Gregg Keizer — The hackers who reportedly planted malware on key parts of the U.S. electrical grid, perhaps with the intent to cripple the country’s power infrastructure, most likely gained access like any other cybercriminal — by exploiting a bug in software such as Windows or Office, a security researcher said today.

“Any computer connected to the Internet is potentially vulnerable,” said Roger Thompson, chief research officer at AVG Technologies USA Inc. “Getting to the actual infrastructure devices directly — that’s always possible, but a whole lot less likely. In any industry, critical or not, there are always plenty of PCs that have been compromised.”

According to a report earlier today in The Wall Street Journal, unnamed national security sources said that hackers from China, Russia and elsewhere have penetrated the U.S. power grid, extensively mapped it, and installed malicious tools that could be used to further attack not only the electrical infrastructure, but others as well, including water and sewage systems.

The discoveries were made by U.S. intelligence agencies, not the utilities’ security teams, the Journal said.

“I’m a bit bothered by all the anonymous sources [in the Journal story]: one unnamed source here and another unnamed source there,” said Thompson. “But I think there’s a high likelihood that it has a strong basis in fact. Any infrastructure device that’s connected to the Net is potentially hackable.”

It’s more likely, he added, that the power-grid hackers exploited the same kinds of vulnerabilities — but not the exact same bugs — that have plagued consumers and businesses that run Microsoft Corp.’s Windows and its Office application suite.

“I have no doubt that there’s been this kind of attack, or attempt to attack, for quite some time,” said Thompson, “perhaps using the same kind of Office zero days that have been coming out.” In security parlance, a “zero-day” exploit is one that leverages an unpatched vulnerability.

Vulnerabilities in Microsoft Office — typically file-format flaws that let attackers hijack PCs by duping users into opening a malformed Word, Excel or PowerPoint document — are often used in targeted attacks that focus on just one company or organization, or even on only a few top-level executives in that company. The hackers try to get control of a senior official’s machine because that’s where the most important and salable information is located.

Microsoft has released two security advisories in the past six weeks for unpatched Office vulnerabilities that are already being exploited in similar targeted attacks. Neither the Excel bug, which was revealed in late February, nor the more recent PowerPoint vulnerability has been patched by Microsoft.

“[The general antivirus industry] never ever get to see the best zero days,” Thompson continued. Although the community is well-known for sharing samples, there are always cases in which a victimized organization — a government agency, for example — refuses to share the attack code with others for analysis. “You’ll ask for a sample, and he’ll say, ‘Well … no, I’m not allowed’,” said Thompson.

Although information about Conficker, the 2008 worm that infected millions of PCs in 2009, was shared in the security community, Thompson cited it as the kind of malware that poses a threat to any Windows machine, no matter whether it’s in a home or running on the network of a major power company. “Conficker, for example, was primarily a business problem, not a consumer problem, because it spread so easily across network shares,” he said.

But there is a silver lining to the Journal report, Thompson argued. “I doubt that the problem is that serious,” he said. “Because the worst hack is the one you don’t discover. But even if it’s exaggerated, it behooves us all to be careful and thoughtful about our critical devices.”

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Deep computer-spying network touched 103 countries

Analysts find spyware installed on servers belonging to foreign ministries, embassies and private companies

By Jeremy Kirk

Computerworld.com, March 29, 2009 (IDG News Service) A 10-month cyberespionage investigation has found that 1,295 computers in 103 countries and belonging to international institutions have been spied on, with some circumstantial evidence suggesting that China may be to blame.

A 53-page report, released on Sunday, provides some of the most compelling evidence of the efforts of politically motivated hackers while raising questions about their ties with government-sanctioned cyberspying operations.

It describes a network that researchers have called GhostNet, which primarily uses a malicious software program called gh0st RAT (Remote Access Tool) to steal sensitive documents, control webcams and control infected computers.

“GhostNet represents a network of compromised computers resident in high-value political, economic and media locations spread across numerous countries worldwide,” said the report, written by analysts at the Information Warfare Monitor, a research project of think tank The SecDev Group, and the Munk Centre for International Studies at the University of Toronto. “At the time of writing, these organizations are almost certainly oblivious to the compromised situation in which they find themselves.”

The analysts did say, however, that they have no confirmation if the information obtained has been valuable to the hackers or whether it has been commercially sold or passed on as intelligence.

The operation probably started around 2004, when security researchers noticed that many of these institutions were being sent bogus e-mail messages with executable files attached to them, according to Mikko Hypponen, director of antivirus research at F-Secure Corp. Hypponen, who has been tracking the attacks for years, said that GhostNet’s tactics have evolved considerably from those early days. “For the past three-and-a-half years or so, it’s been fairly advanced and fairly technical,” he said.

“It’s really good to see a spotlight on this whole thing right now, because it’s been going on for so long and nobody’s been paying attention,” he added.

Although evidence shows that servers in China were collecting some of the sensitive data, the analysts were cautious about linking the spying to the Chinese government. Rather, China has a fifth of the world’s Internet users, which may include hackers who have goals aligning with official Chinese political positions.

“Attributing all Chinese malware to deliberate or targeted intelligence gathering operations by the Chinese state is wrong and misleading,” the report said.

However, China has made a concerted effort since the 1990s to use cyberspace for military advantage “The Chinese focus on cybercapabilities as part of its strategy of national asymmetric warfare, which involves deliberately developing capabilities that circumvent U.S. superiority in command-and-control warfare,” it said.

A second report, written by University of Cambridge researchers and published in conjunction with the University of Toronto paper, was less circumspect, saying that the attacks against the computer systems of the office of the Dalai Lama were launched by “agents of the Chinese government.” The Cambridge team titled its report “The Snooping Dragon.”

The analysts’ research started after they were granted access to computers belonging to Tibet’s government in exile, Tibetan nongovernmental organizations (NGO) and the private office of the Dalai Lama, which was concerned about the leak of confidential information, according to the report.

They found computers infected with malicious software that allowed remote hackers to steal information. The computers became infected after users opened malicious attachments or clicked on links leading to harmful Web sites.

The Web sites or malicious attachments would then try to exploit software vulnerabilities in order to take control of the machines. In one example, a malicious e-mail was sent to a Tibet-affiliated organization with a return address of “campaign@freetibet.org” and an infected Microsoft Word attachment.

As the analysts probed the network, they found that the servers collecting the data were not secured. They gained access to control panels used to monitor the hacked computers on four servers.

Those control panels revealed lists of infected computers, which went far beyond the Tibetan government and NGOs. Three of the four control servers were located in China, including Hainan, Guangdong and Sichuan. One was in the U.S., the report said. Five of the six command servers were in China, with the remaining one in Hong Kong.

The University of Toronto report classified close to 30% of the infected computers as being “high-value” targets. Those machines belong to the ministries of foreign affairs of Bangladesh, Barbados, Bhutan, Brunei, Indonesia, Iran, Latvia and the Philippines. Also infected were computers belonging to the embassies of Cyprus, Germany, India, Indonesia, Malta, Pakistan, Portugal, Romania, South Korea, Taiwan and Thailand.

International groups infected included the ASEAN (Association of Southeast Asian Nations) secretariat, SAARC (South Asian Association for Regional Cooperation) and the Asian Development Bank; some news organizations such as the U.K. affiliate of the Associated Press; and an unclassified NATO computer.

GhostNet’s existence highlights a need for urgent attention to information security, the analysts wrote. “We can safely hypothesize that it [GhostNet] is neither the first nor the only one of its kind,” they said.

The Cambridge researchers predicted that these highly targeted attacks bundled with sophisticated malware — they call them “social malware” — will become more prevalent in the future. “Social malware is unlikely to remain a tool of governments,” they wrote. “What Chinese spooks did in 2008, Russian crooks will do in 2010.”

Although F-Secure has seen a few thousand of these attacks so far, they are already a problem for corporate users in the defense sector, Hypponen said.

“We’re only seeing this right now on a minuscule scale,” he said. “If you could take techniques like this and do it on a massive scale, of course that would change the game.”

Robert McMillan of the IDG News Service in San Francisco contributed to this report

The intrusions were not just limited to the electrical power grid, but affected systems like water and sewage.

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The Empire State Building and midtown New York City are shown during the 2003 blackout. (AP Photo)

BloombergNews.com, April 8, 2009 — The U.S. has uncovered evidence that cyberspies, most likely from China and Russia, have penetrated the U.S. power grid and left behind software that could be activated to disrupt American infrastructure, FOX News confirmed Wednesday.

The “intrusions,” first reported by The Wall Street Journal, have occurred over a period of time, one U.S. official said — not all at once.

The breaches are “something we’re concerned about,” a U.S. official told FOX News.

The concern is that any software could be activated at a later date to disrupt critical systems.

The intrusions were not just limited to the electrical power grid, but affected systems like water and sewage.

White House spokesman Nick Shapiro said in a written statement that President Obama takes the issue of cyber security “very seriously,” but that the administration is not aware of any such “disruptions” to the power grid.

“Cyber attacks are made all the time, however, industry continuously looks for and mitigates against such attacks and we are not aware of any disruptions to the power grid caused by deliberate cyber activity here in the United States,” he said.

The motivation for the breaches is not well understood, and while the electronic trail appears to lead to China and Russia, it is not clear whether these actions were state-sponsored.

The Washington embassies of China and Russia deny involvement.

According to The Wall Street Journal, the espionage appeared pervasive across the country and did not target any particular region or company.

The intrusions were in many cases detected by U.S. intelligence agencies, not the companies, officials told the Journal.

“If we go to war with them, they will try to turn them on,” one official told the Journal.

Hackers look to map power grid and install malware for possible attacks

ComputerWorld.com, by Grant Gross, April 8, 2009 (IDG News Service) Cyperspies from China, Russia and elsewhere have gained access to the U.S. electrical grid and installed malware tools that could be used to shut down service, according to a story published today by The Wall Street Journal.

Thus far, the attackers haven’t used their access to damage the electrical grid, but the cyberespionage appears to be “pervasive,” the Journal reported, citing anonymous national security officials. Federal officials are worried that the cyberspies could use their access to try to shut down the grid or take control of power plants during a time of crisis or war, the story said.

Many of the intrusions, which for now appear to be aimed mostly at mapping the domestic power grid, were discovered not by electric utilities but by U.S. intelligence agencies, the story added.

The cyberspies have left behind software tools that could be used to destroy components of the grid, one intelligence official told the Journal. “If we go to war with them, they will try to turn them on,” that official was quoted as saying.

U.S. lawmakers and some security analysts have raised concerns for several years about the security of the power grid and other industrial control systems.

In 2007, for example, a simulated attack done by the Idaho National Laboratory for the U.S. Department of Homeland Security showed that a known software vulnerability in a Supervisory Control and Data Acquisition, or SCADA, system could be used to destroy power grid equipment.

There also have been previous disclosures of actual hacking incidents involving electrical grids, both in the U.S. and abroad. Early last year, the CIA said that cybercriminals had been able to launch online attacks that disrupted power equipment in several regions outside of the U.S.

And at a congressional hearing in March, Joseph Weiss, managing partner of Applied Control Solutions, claimed that networks controlling industrial control systems in the U.S. have been breached more than 125 times in the past decade, with one incident resulting in deaths.

A coordinated attack on critical infrastructure systems “could be devastating to the U.S. economy and security,” Weiss said at the hearing. “We’re talking months to recover. We’re not talking days.”

Other security experts have raised concerns that the electrical grid could become more vulnerable as it is transitioned into a two-way smart grid, potentially using the Internet for transmission. The federal government included $4.5 billion for smart-grid deployment as part of the economic stimulus package approved earlier this year.

IOActive Inc., a Seattle-based security consultancy, has spent the past year testing smart-grid devices for security vulnerabilities. The company said last month that it had discovered a number of flaws that could enable hackers to access networks and cut power.

Brian Ahern, president and CEO of Industrial Defender Inc., a vendor of security tools for control systems, also voiced concerns about the power grid in an interview before the Journal story was published.

“One of the challenges that we have today in this country is that you’ve got all this critical infrastructure that has been deployed over the last 20 years, and no one was even thinking about security,” Ahern said. “When you think about our existing infrastructure today — power plants, transmission distribution systems — they all have their own security problems. That’s what we’re all working diligently on right now: making sure that our existing infrastructure is secure.”