Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

There have been several cases where Fraud in clinical trial has questioned the  Integrity of Data and ethics , when conducting clinical trial in India, which have been used by crusaders against outsourcing. But the new evidence suggest that the clinical trial fraud is more prevalent even in US. The most recent being MannKind Corporation Accused of Covering Up Adverse Clinical Trial Results

India’s poor history on adhering to patents, strong legal system, and the image of corruption means, any fraud in conducting clinical trial in India will invite serious punishment from FDA and western world. Yes we can cry that we will be singled out , or we can take necessary steps to avoid incidents such as above

MNC pharma MannKind is accused of Data Fraud Coverup  in securing FDA approval for Afrezza the inhaled insulin drug. A senior manager uncovered unlawful clinical trial conduct pertaining to the company’s Afrezza inhalant insulin device.  John Arditi, who was MannKind’s senior director of worldwide regulatory affairs, filed a wrongful termination lawsuit against his former employer, in New Jersey Superior Court, claiming he was unfairly fired by MannKind after internal audits he conducted in November 2009 uncovered “potential fraud and scientific misconduct” involving Afrezza clinical trial data

Arditi discovered discrepancies in data at both a Russian and Bulgarian trial site, according to his lawsuit.  For several months, Adverse event results were either not being recorded properly, or were fabricated to favor the approval of Afrezza.  Arditi’s lawsuit asserts that he informed superiors at MannKind, on November 9, 2009, of his adverse findings and encouraged the company to approach the U.S. Food and Drug Administration (FDA) but MannKind did not contact the agency because negative information would delay approval of the New Drug Application (NDA) for Afrezza.

The new revelation on MannKind Afrezza Clinical Trial that emerged last week , comes just days after the report published by The Council for Clinical Research Subject Safety & Data Integrity (CCRSSDI)  on widespread fraud in the Clinical Trial drugs by pharma and CROs in Unites States.

Two time Emmy winning reporter Kathy McDevitt led an investigative team from The Council for Clinical Research Subject Safety & Data Integrity (CCRSSDI), to record Subjects committing fraud. Her investigation led to on-air confessions by two such subjects on the nature and the extent of the fraud in the industry

Ms. McDevitt and CCRSSDI have jointly released a documentary tilted “Pervasive Fraud in the Clinical Trial World” . It is available on the CCRSSDI website. Copies of the DVD may also be requested by the video.

Among the findings in the documentary:

• Multiple simultaneous trial enrollments by Subjects
• Inability of research sites to check for dual clinical trial enrollments
• No single record of all the studies a subject has taken
• Inability to verify amount of actual drug usage by a Subject in a Study
• Potential for flawed results in Studies

Watch the Documentary on YouTube

“I was shocked by how lax the identification process is for potential Study Subjects”, said Kathy McDevitt. “I always had assumed that a thorough identification and verification was required to enroll qualified patients in studies for drugs that you and I take”

Kerri Weingard, the Director of CCRSSDI, further adds “We here at the Council have consistently raised this issue. Many members of this Council run their own Study Sites and we have seen the level of fraud increase year after year. Unfortunately, no steps are being taken by the industry as a whole to combat this problem. If this problem is left unchecked, the whole industry will suffer and public confidence in our Drug Testing process will be fundamentally undermined”

CCRSSDI has led the charge on this issue. Its charter clearly defines that the primary goal of CCRSSDI is to ensure that every study by every site and every sponsor utilizes and identification and verification process to ensure that there is no fraud occurring and that subjects are not dual-enrolled or have been expelled from previous studies.

Download the explosive documentary “Pervasive Fraud in the Clinical Trial World”, at http://www.CouncilForClinicalResearch.com

For further information please contact Kerri Weingard, Director, Council for Clinical Research Subject Safety & Data Integrity at KWeingard(at)CouncilForClinicalResearch(dot)com or 646-225-6624

Council for Clinical Research Subject Safety & Data Integrity is composed of established members of the medical profession. Its goal is to ensure that our testing process for Clinical Research Trials remains error free and that Subject Safety is always assured. meetings are open to all. For further information please email  at info@CouncilForClinicalResearch.com.
ONE of Australia’s most senior cancer specialists has accused pharmaceutical companies of manipulating some clinical trials of medicines for commercial reasons, including deliberately delaying the release of negative findings and being reluctant to fund research into the toxicity of their drugs.  More details

Professor Stephen Clarke, who has conducted clinical trials involving humans for 15 years, agreed to speak publicly for the first time because he said it was essential for governments to fund trials of great public importance rather than leaving critical research solely to drug companies.

A number of researchers who spoke to The Age agreed, saying commercial decisions meant the public did not always get the full picture about a drug’s usefulness and safety.

Other more high profile clinical trial related issues in recent past are PPD Inc responsibility in Ketek Trial for Aventis

The FDA found the fraud 2002 in a trial supervised by PPD, the doctor was indicted 2003, convicted 2004 and Ketek was approved 2004 by the FDA using the faulty data. It wasn’t until early 2006 that liver problems in patients using Ketek came to light and subsequently, the continued reliance on the fraudulent data. Congressional hearings were called for in 2006 which were held 2007 and again 2008 when Fred Eshelman, founder of PPD testified

The FDA and drug maker Aventis were directly faulted. Eshelman washed his hands. . This clip is one of three showing Fred Eshelman’s verbal responses to questions.

Some of the other high profile cases are

News that Schering-Plough, one of the largest drug companies in the world, has been outright bribing physicians to prescribe drugs and operate sham clinical trials http://www.naturalnews.com/001298.html

University of California findings in the October issue of the Annals of Internal Medicine, that 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.

The Utah Attorney General has filed a lawsuit charging GlaxoSmithKline illegally marketed its controversial Avandia diabetes pill as a new “wonder drug” that would reduce cardiovascular risks for diabetes, but instead increased the possibility of heart attacks. Consequently, the AG alleges Glaxo hoodwinked the state Medicaid program out of $7.8 million, which is the amount Utah spent to purchase Avandia between Jan. 1, 2001 and June 30, 2010

The more recent events in India were

Glenmark Pharmaceuticals and Omnicare have closed a clinical trial site in India operated by the contract research organisation (CRO) amid accusations that an investigator acted fraudulently.

Clinical Trial Fraud – How to Identify and Steps to Handle If Found, events like these makes adherence to GCP and training of CRA, and all stake holders in clinical trial more and more important

Had an interesting chat with the CEO of the US based IT service provider for clinical research industry in June. Apparently the company a SalesForce.com partner introduces new CTMS application in India. Just came to know that they are going commercial this month. The applications is aimed at clinical trial management, Study site management and Patient Recruitment in the clinical research industry . Aimed at CROs, Hospitals, University Research centers and clinical trial Study Sites.

The application is based on Force platform by SalesForce and already have few Indian Organization using it for several months. The product will be offered in SaaS/Hosted/Cloud versions, which will render affordable TCO and higher ROI with less or no Capital investmental.

Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents

“Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials,” the authors write. “Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.”

“In conclusion, automated safety surveillance of medical devices is feasible using automated monitoring tools applied to detailed clinical registries and can efficiently help identify emerging potential postmarket safety risks. Automated medical product surveillance can complement existing public health strategies, providing an additional mechanism to assess the comparative safety of approved medical products and improve the quality of health care delivered,” the authors write.

Original article on

http://www.scientificcomputing.com/news-DA-Computer-automated-System-for-Identifying-Medical-Devices-with-Safety-Risks-111110.aspx

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that the first new topical skin care products of its subsidiary, Lifeline Skin Care, are now available to the general public within the United States at http://www.lifelineskincare.com. Lifeline Skin Care's first two products consist of a Defensive Day Moisture Serum and Recovery Night Moisture Serum. Previously, these breakthrough serums, containing extracts from "parthenogenetic" stem cells, were available only to individuals and organizations formerly identified and selected for their interest in innovative approaches to skin care.

According to Lifeline Skin Care CEO, Dr. Ruslan Semechkin, "Because the quality products Lifeline Skin Care offers are experiencing strong demand and the human stem cell extracts require innovative manufacturing processes, we chose to develop our sales channels gradually and incrementally. We are very pleased with the customer feedback from our first limited launch and are delighted to now be able to expand production and make the products available to the general public within the US."

Purchases that could previously be made only by phone, can now be made directly through the company's website,http://www.lifelineskincare.com. "Enabling electronic order processing though our website provides the benefit of both lowering our transaction costs and increasing our scalability, while simultaneously simplifying the ordering process for our customers," said ISCO VP, Dr. Simon Craw.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments, product introduction plans and related support, the potential benefits of planned products, anticipated sales growth for recently introduced products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Key Words: Stem cells, parthenogenesis, biotechnology, skin care, anti-aging

International Stem Cell Corporation

Kenneth C. Aldrich, Chairman

1-760-940-6383

kaldrich@intlstemcell.com

or

Lifeline Skin Care, Inc.

Ruslan Semechkin, PhD, President & CEO Vice President, ISCO

ras@intlstemcell.com

The initial launch of the serums is to a pre-existing list of interested parties. We expect that the products will be available to the general public via our online store http://www.lifelineskincare.com in the near future.

A key innovation in creating the Lifeline Skin Care™ serums was the encapsulation of the parthenogenetic stem cell extractsinto nanospheres, which not only protect the proteins, but substantially enhance the effectiveness of the serums. World renowned skin cream formulation experts assisted ISCO's scientists to create the finished products and ensure that the final serums deliver the most up-to-date advances in skin rejuvenation technology that also helps to prevent and repair damage caused by the environment.

According to Gregory S. Keller, MD, FACS (2007 Specialist of the Year in Facial Cosmetic Surgery in Strathmore's "Who's Who"): "These new day and night serums represent a huge step forward in anti-aging skin care products. Combining liposome-encapsulated proteins derived from ISCO's powerful new class human stem cells with a unique blend of anti-oxidants, vitamins and natural extracts, allowed Lifeline Skin Care to create highly effective stem cell-based serums that provide strong anti-aging benefits."

The new skin rejuvenation serums are based on the breakthrough discovery that certain proteins derived from ISCO's proprietary pluripotent human parthenogenetic stem cells are beneficial to the culture of human skin cells in the laboratory. ISCO, the world leader in human parthenogenetic stem cell technology, is studying this new class of stem cells, and has demonstrated their therapeutic potential in many fields of regenerative medicine. Human parthenogenetic stem cells are created from unfertilized human eggs and do not involve any harm to a viable human embryo, thus avoiding serious ethical questions that surround other areas of stem cell research. hpSC possess unique immune-matching attributes making them an excellent platform for the development of cellular therapies for large populations of individuals. As of today, ISCO has successfully derived ten hpSC lines. One of these lines carries the most common immune type found within the US population and can be immune-matched to an estimated 75 million people worldwide.

"The commercial launch of the new skin care products represents an important step in the execution of ISCO's strategy. The revenue generated from sales will help support the development of our therapeutic programs utilizing our unique and powerful class of human pluripotent stem cells," said Dr. Ruslan Semechkin, CEO of Lifeline Skin Care.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments, product introduction plans, the potential benefits of planned products, collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Key Words: Stem cells, parthenogenesis, biotechnology, skin care, anti-aging

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
1-760-940-6383
kaldrich@intlstemcell.com
or
Lifeline Skin Care, Inc.
Ruslan Semechkin, PhD, President & CEO
Vice President, ISCO
ras@intlstemcell.com

(HealthDay News) -- Exercising during adolescence may help guard against a deadly form of brain tumor in adulthood, new research suggests.

The study also found that avoiding obesity during the teen years was associated with a lower risk of developing the cancerous brain tumors called gliomas, while being tall increased the chances of such malignancies.

The study appears in the Nov. 1 issue of Cancer Research.

Gliomas are the most common type of brain and central nervous system cancers, accounting for 80 percent of cases, according to background information in the study. Gliomas cause 13,000 deaths in the United States each year.

Though little is known about why people develop the tumors or who is at risk, previous research has hinted that "early life exposures" may increase the risk of developing the cancer in adulthood, said study author Steven C. Moore, a research fellow in the Nutritional Epidemiology Branch of the U.S. National Cancer Institute. Studies have shown that people who are left-handed, for example, are at higher risk of the disease. Read more...

Memory concentration, loss of memory, short term memory loss

The cordyceps mushroom is back in the spotlight again, except this time for its anti-aging properties. Researchers from Nu Skin Enterprises, Inc., and LifeGen Technologies have found that Cordyceps sinensis (Cs-4), a traditional Chinese mushroom, is a powerful anti-aging food with the ability to improve energy metabolism, decrease fatigue, bolster endurance levels and lengthen lifespan.

Back in March, we covered breakthrough research on the power of cordyceps to treat cancer (http://www.dreddyclinic.com/forum/viewtopic.php?f=19&t=22848,http://www.dreddyclinic.com/forum/viewtopic.php?f=13&t=22276), but the new research has found even more beneficial uses for this emerging superfood. By encouraging human genes to express in ways that promote longevity, cordyceps has incredible potential in helping to reverse the negative effects of aging.

"We're making great breakthroughs in gene expression science that have application in the fields of health and longevity," explained Joe Chang, Ph.D., chief scientific officer and executive vice president of development at Nu Skin. "These studies ... help validate the critical role gene expression modulation plays in the aging process. We believe that the future of anti-aging is in developing consumer solutions that support youthful gene expression." Read more...

Youtharia for Anti-Aging & Longevity

This LA Times article will let you see where Integrative Medicine may be taken over by major medical centers. There are some important observations made by this Times Staff Writer that can help you differentiate for your clients what you offer them from what these centers are doing.

The concerns voiced about appearing unscientific etc. by a cancer patient here is important to appreciate. Please understand that in my view, no one is fully offering adequate Vitamin C based programs to their patients. The books written can provide your patient with scientific information that will help most begin to deal with their problem of ill health, which virtually always needs to be a multifactorial approach. They can start with Irwin Stone's Vitamin C The Healing Factor, which anyone can obtain free of charge from following the links on Wikipedia after you search on Vitamin C, to newer books like Dr Levy and Dr Hickey have written or the audiotape by Dr Riordan. Read more...

More information's about detox diets

In response to a question posed by one of my oldest and most perceptive friends, I posted what follows to my Facebook profile.

Her question was posed after watching this video http://vimeo.com/15979195

"Rocky, am I really ignorant and paranoid?

It seems like this technology holds they key to either really, really good stuff for us as a species, or it has the potential for really really bad stuff.

I trust the science and the scientists. I don't trust the Money that controls what's done with the science.

Einstein was a really nice guy. He had no idea his science would be used for war. I don't think any of the Manhattan Project scientists went into it knowing what they were unleashing on the world."

~ Carla Conrad

My answer: A most perspicacious observation, and right on the mark. Occam’s Razor, 21st century style, meaning that you have hit upon the simplest explanation for the potential outcome; like every technological innovation in the past, nanoscale technologies have both the potential for tremendous good and/or tremendous bad. And don’t let my seemingly cavalier use of "tremendous" lull you into a false sense of security; I mean "tremendous" as in "things that have the potential to change everything we think we know about ourselves, while enabling each of us with the power to effect and experience our surroundings in ways heretofore only imagined."

I have been actively and intensely following nanoscale technologies since the early ‘90’s. At the end of the day, my most prescient observation would be that these technologies will have an impact on our global society many times greater than ALL past technological revolutions. Let me put it another way: nanoscale technologies - and the products thereof - will enable far greater change than our discovery, development and use of fire, bronze, iron, steel, electrical power, cars, planes and space travel put together.

Any person, institution or government entity that says "Oh yeah, nanotechnology, we got that handled" is lying their ass off. Equally, any person, institution or government entity that says "Oh yeah, nanotechnology, it’s gonna kill us all in one or more horrible ways" is also lying their ass off. Anyone that fervent usually has a hidden agenda, and one which serves a higher master. You’ll notice I said "usually" – many of my colleagues in the nanospace are humanitarians in the best sense and are talking about and planning for ways in which the good things can be emphasized and the bad minimized or eliminated.

My philosophy is summed up thus:

Nanotechnology will certainly play a pivotal role in our future; now, with the introduction of lighter/stronger materials in the auto, space, and military industries, and later, with the introduction of molecular manufacturing (making items per your specifications, in your own home, for pennies on the dollar of current prices – think "replicator" and you will not be too far off).

Expect to see revolutionary changes in solar, fuel cell and hydrogen storage technologies within the next few years. And expect to see a great deal of interest in and subsequent higher funding of nanotech-enabled sensor technologies for military, homeland security and civilian applications within the next few years. Put another (albeit obvious) way: expect to see cultural tsunamis of a magnitude that rival anything we have thus far experienced.

No informed person doubts that developments at the nanoscale will be significant. We debate the time frame, the magnitude and the possibilities, but not the likelihood for large-scale change. The least-speculative views suggest that we're in for changes of an order that justifies – if not demands – our undivided attention. Will we be ready? (BTW: not kidding, not even the weensiest amount)

OK, off my high horse and back to your previously programmed station…

Everyone knows about cancer. According to the World Health Organization eight million people died of one of the many forms of cancer 2007 and this number is expected to grow to more than 12 million by 2030. However, unlike many other significant diseases, cancer is not confined to a continent or socioeconomic cohort. Also unlike other entrants on the WHO’s top 10 there is no vaccine or wonder drug. This insidious disease requires surgery, chemotherapy or radiotherapy all of which wreak havoc on the patient during and often long after treatment. But recently novel research looking at using certain bacteria as a therapy is gaining traction that may result in new treatment options that are cheap, easy to produce, noninvasive and if the current research is any indication capable of complete remission in some cases.

[More]

SAN DIEGO-- On day two of TEDMED , running between Oct. 27 and 30, three themes stood out: the difference between children and adults for therapies; the connection between animals, people and disease; and how genetics will shape health care.

Frances Jensen of Harvard University and Children’s Hospital Boston explained the dramatic differences between developing and adult brains. With faster synapses, teens learn faster than adults, for instance. But as a consequence, they also "get addicted faster, longer and stronger than adults do," she said. Because teens have more synaptic material to affect, they suffer greater brain damage from alcohol than in adults. Differences in developing brain mean should have "no more hand-me-down drugs" for youths, added Jensen.

[More]

The psychologist Rollo May once described depression as “the inability to construct a future”. [More]

Despite the enormous efforts of clinicians and researchers, our limited insight into psychiatric disease (the worldwide-leading cause of years of life lost to death or disability) hinders the search for cures and contributes to stigmatization. Clearly, we need new answers in psychiatry. But as philosopher of science Karl Popper might have said, before we can find the answers, we need the power to ask new questions. In other words, we need new technology. [More]

Every day as a practicing psychiatrist, I confront my field’s limitations. Despite the noble efforts of clinicians and researchers, our limited insight into the roots of psychiatric disease hinders the search for cures and contributes to the stigmatization of this enormous problem, the leading cause worldwide of years lost to death or disability. Clearly, we need new answers in psychiatry. But as philosopher of science Karl Popper might have said, before we can find the answers, we need the power to ask new questions. In other words, we need new technology.

Developing appropriate techniques is difficult, however, because the mammalian brain is beyond compare in its complexity. It is an intricate system in which tens of billions of intertwined neurons--with multitudinous distinct characteristics and wiring patterns--exchange precisely timed, millisecond-scale electrical signals and a rich diversity of biochemical messengers. Because of that complexity, neuroscientists lack a deep grasp of what the brain is really doing--of how specific activity patterns within specific brain cells ultimately give rise to thoughts, memories, sensations and feelings. By extension, we also do not know how the brain’s physical failures produce distinct psychiatric disorders such as depression or schizophrenia. The ruling paradigm of psychiatric disorders--casting them in terms of chemical imbalances and altered levels of neurotransmitters--does not do justice to the brain’s high-speed electrical neural circuitry. Psychiatric treatments are thus essentially serendipitous: helpful for many but rarely illuminating.

[More]

A decade ago biologists and nonbiologists alike gushed with optimism about the medical promise of the $3-billion Human Genome Project. In announcing the first rough draft of the human “book of life” at a White House ceremony in the summer of 2000, President Bill Clinton predicted that the genome project would “revolutionize the diagnosis, prevention and treatment of most, if not all, human diseases.”

A year earlier Francis S. Collins, then head of the National Human Genome Research Institute and perhaps the project’s most tireless enthusiast, painted a grand vision of the “personalized medicine” likely to emerge from the project by the year 2010: genetic tests indicating a person’s risk for heart disease, cancer and other common maladies would be available, soon to be followed by preventives and therapies tailored to the individual.

[More]