OCEANSIDE, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB:ISCO),http://www.internationalstemcell.com, announced today that it had launched the first phase of its previously announced joint marketing campaign with John Mauldin, the founder and Chairman of Millennium Wave Investments, to market Lifeline Skin Care’s (LSC) new topical skin care products to more than one million of Mauldin’s subscribers. This launch follows ISCO’s earlier successful release to its own investor base and to the general public through its website,http://www.lifelineskincare.com.

“Having seen a strong demand from our investors and followers, we have been working diligently to increase both our marketing and production capabilities. John Mauldin’s participation will support the continuation of our rapid progress”

Mauldin, a best-selling writer, author of a monthly investment newsletter, and recognized marketing expert, provides LSC with the skills and a platform to enable LSC to continue expanding its sales while keeping marketing cost per customer lower than would be possible with a traditional media campaign.

Lifeline Skin Care’s exclusive patent pending skin rejuvenation serums contain extracts from ISCO’s proprietary “parthenogenetic” stem cells created from unfertilized eggs. The stem cell extract was discovered during ISCO’s therapeutic research that revealed the extract’s potential applications in skin cell rejuvenation. Independent third party testing indicates that both the day and the night serums now being offered have significant positive effects on the look and feel of the skin.

“Having seen a strong demand from our investors and followers, we have been working diligently to increase both our marketing and production capabilities. John Mauldin’s participation will support the continuation of our rapid progress,” says Dr. Ruslan Semechkin, CEO of Lifeline Skin Care.

John Mauldin adds, “I’m pleased to be involved with LSC and to help these truly revolutionary skin care products reach a broader audience. This new collaboration gives me the ability to offer these unique LSC products to my loyal client base.”

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 has developed and is now marketing a line of skin care 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

Tobacco companies may be bypassing marketing bans by secretly posting promotional videos online, according to a study conducted by researchers from the University of Otago, New Zealand, and published in the journal Tobacco Control.

"Tobacco companies stand to benefit greatly from the marketing potential of Web 2.0, without themselves being at significant risk of being implicated in violating any laws or advertising codes," the researchers wrote.

The researchers analyzed the first 20 pages of YouTube search results featuring five different tobacco brands, consisting of 163 video clips.

"It is disturbing to note that some of the pro-tobacco videos appeared to be of a professional standard, many followed similar themes within a brand and large numbers contained images or music that may be copyrighted to tobacco companies but have not been removed," they said.

Copyright holders regularly ask YouTube to remove materials used without permission, and the company nearly always complies with such requests. Read more...

ClariMind Memory & Concentration Supplement

International Stem Cell Corporation (OTCBB:ISCO),http://www.internationalstemcell.com, announced today that it had entered into an agreement with Aspire Capital Fund, LLC, to provide, at the Company's sole option, up to $25 million of equity capital over the next three years. As part of this transaction, Aspire purchased, upon execution of the agreement, 333,333 shares of ISCO Common Stock at a price of $1.50 per share, a 7% premium over Friday's closing price of $1.40 per share.

Pricing of future sales under the agreement will be determined each time the Company elects to sell shares to Aspire by a formula that is based on the actual sale prices of the Company's stock over the 12 days preceding each sale to Aspire. Thus, the Company will control the timing and amount of any sales of its Common Stock to Aspire, and will always know at the time it gives a notice of sale what the cost of that round of financing will be.

Aspire has no right to require any sales by the Company, but is obligated to make purchases as the Company directs in accordance with the purchase agreement, and the Company has the right to terminate the agreement at any time. The agreement does not restrict other financings by the Company. A more detailed description of the transaction agreements with Aspire is set forth in the Company's current report on Form 8-K, filed today with the U.S. Securities and Exchange Commission.

Ray Wood, Chief Financial Officer of ISCO, commented on the agreement, "This transaction is designed to provide both a source of working capital and maximum flexibility for the Company in determining the pricing and timing of any future financing it elects to use under this agreement. It provides us with access to capital that we believe will be adequate to fund our research activities for an extended period of time, but does not preclude us from pursuing additional financing during the term of the agreement. Because of the pricing flexibility this facility gives us, we believe that this agreement will provide both the lowest cost of capital currently available, plus maximum flexibility in meeting our future financing needs. If we don't need working capital or don't need as much as expected, we may elect not to use the facility. If we do need capital, it is available and we can choose when to obtain it."

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 humanstem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryosand, 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 has developed and is now marketing a line of skin care 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.

ABOUT ASPIRE CAPITAL FUND, LLC

Aspire Capital Fund, LLC is an institutional investor based in Chicago,Illinois, with a fundamental investment approach. Aspire Capital invests in a wide range of companies and industries emphasizing life sciences, energy and technology.

FORWARD-LOOKING STATEMENTS

Statements pertaining to financing plans and capital needs, anticipatedtechnological developments and therapeutic applications, the potential benefits of 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," "should," "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, uncertainty in the results of clinical trials or 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 these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman, 760-940-6383
kaldrich@intlstemcell.com
or
Ray Wood, CFO, 760-640-6383
rwood@intlstemcell.com

(HealthDay News) -- Cryptococcus gattii -- an airborne fungus that can cause life-threatening illness -- is an emerging infection in the Pacific Northwest, U.S. health officials said Thursday.

While C. gattii infections are rare -- only 60 cases have been reported since 2004 -- they can be severe and even fatal, researchers at the U.S. Centers for Disease Control and Prevention report in the July 23 issue of the Morbidity and Mortality Weekly Report.

"C. gattii is still rare so we don't want people to panic or to misunderstand the risk of infection, but it is serious," said co-author Julie Harris, of CDC's National Center for Zoonotic, Vector-Borne, and Enteric Diseases.

Harris explained that people get the infection by breathing in the spores of the fungus, which live in the environment and are usually found in the bark of certain trees and the surrounding ground. Read more...

Detox, herbs detox, detox symptoms

Earlier this year, we reported the kind of story that almost seems too far-fetched to be true. According to a study by University of California at San Francisco (UCSF) researchers that was published in the American Journal of Public Health, unneeded, expensive mammograms are regularly pushed on elderly women who are incapacitated and dying from Alzheimer's disease or other forms of dementia, especially if the patients still have assets of $100,000 or more.

Think the cancer screening industry couldn't get any greedier than that example? Think again. Another study, just out in the October 13 issue of the Journal of the American Medical Association (JAMA) concludes a sizeable proportion of terminally ill cancer patients are being subjected to common, expensive (and often painful) cancer screening tests. And these tests provide virtually no benefit whatsoever to those dying of cancer -- although they do hike up medical bills and profits for health care providers. Read more...

Home detox, best detox, detox treatment

Researchers are zeroing in on specific nutrients and natural therapies that not only can prevent and heal disease but promote longevity. For example, as NaturalNews previously reported, a research team from Nu Skin Enterprises, Inc., and LifeGen Technologies found that Cordyceps sinensis (Cs-4), a traditional Chinese mushroom, is a powerful anti-aging food that could lengthen lifespan (http://www.dreddyclinic.com/forum/viewtopic.php?f=13&t=24075). And University at Buffalo endocrinologists recently documented for the first time that resveratrol, a phytochemical found in red grapes, grape juice and red wine, has anti-inflammatory and antioxidant properties in humans and may promote human longevity, too (http://www.dreddyclinic.com/forum/viewtopic.php?f=21&t=20422). Read more...

Detoxify , detoxifying, holistic detox

(HealthDay News) -- Peer pressure and fear of malpractice lawsuits seem to be behind the decisions by some doctors to order unnecessary cardiac catheterizations, new research suggests.

When asked in a national survey why they might order this potentially hazardous procedure that measures blood flow to the human heart, even when it might not be called for clinically, the top two reasons that cardiologists around the country gave were the fact that other doctors do it routinely and that patients might sue if the test wasn't done.

"We didn't say unnecessary," noted study author Frances Lee Lucas, an epidemiologist with the Maine Medical Center in Portland, whose report was published in the April 13 online edition of Circulation: Cardiovascular Quality and Outcomes. "We said how often for non-clinical reasons. We didn't want to say unnecessary because we knew nobody would ever say they ordered an unnecessary test."

The study of 598 cardiologists didn't attempt to determine the number of catheterizations performed that weren't really needed -- an important issue in an era of rising worry about medical costs. That would be a very difficult study to do, and it would have to include errors in both directions, people who need one and don't get it as well as people who get one and don't need it, Lucas said. Read more...

Detox fast, detox center , detox programs

By Bernadine Healy M.D.
Posted 3/4/07

Vitamin studies always seem to stir controversy, but certainly not visions of death. On that score, last week's report on antioxidant vitamins, published in the Journal of the American Medical Association, was a doozy. The researchers concluded that people taking the antioxidants vitamins A, its precursor beta carotene, and vitamin E, for whatever reason, at whatever dose, and for however long, may be putting their lives in jeopardy. But before you toss out your vitamin pills, let's examine this alarmist study a little bit closer.

Researchers from Copenhagen University Hospital set out to determine whether the antioxidant supplements lengthen one's life. That's difficult to answer, since most people taking vitamins are healthy. So the researchers identified antioxidant clinical trials large and small, as long as they reported at least one death. Any death counted, whether from heart disease or cancer, kidney failure or hip fractures, murders or suicides. Out of 747 antioxidant trials reviewed, 68 met the bill. Then, in what is called a meta-analysis, the 68 trials were combined into what is effectively one study. Read more...

Diet detox , detox patch , kidney detox

LIVER diseases have become a silent killer in Europe, and are now responsible for more than one in six deaths in the European Union.

More than 10 million people in the region suffer from viral hepatitis alone but many of them will not even be aware of it, according to medical experts.

The European association for the study of the liver want the European Union to launch a public awareness campaign especially about viral hepatitis.

Professor Jean-Michel Pawlotsky told members of the European Parliament yesterday that viral hepatitis is one of the most common and lift-threatening communicable diseases in Europe, and yet it seems to have been forgotten by governments.

"It has become a silent killer because of the large and increasing number of individuals who carry hepatitis B or C, but have not been tested and are so unaware of their condition.

"Without treatment, viral hepatitis can lead to cirrhosis, liver cancer and death," he said.

The condition should be recognised as an urgent health priority with awareness campaigns, primary prevention measures, earlier diagnosis and better management of the disease, said Prof Pawlotsky. Read more...

Blood sugar levels, Healthy blood

To celebrate the ends of years, decades and other milestones, science publications often churn out "Whither science?" predictions. Just last week, The New York Times Science Times section celebrated its, um, 32nd birthday with a special issue on "What's next in science". What I found fascinating was the issue's overall tone of caution rather than the traditional boosterish enthusiasm.

Gina Kolata recalled a job interview 25 years ago with U.S. News and World Report, an editor of which asked her, "What will be important medical news next year?" Kolata replied that "next year gene therapy will be shown to work." Gene therapy, of course, has been a big bust. Kolata goes on to say that the best answer to "Whither science?" is to expect the unexpected. (Fortunately for her, Kolata didn't get the job with what a mean friend of mine liked to call "U.S. Snooze and World Distort," the print version of which just died after years of terminal illness.)

[More]

Vicki Phelan, Managing Director, Pharmaceutical and Life Sciences Practice
with Stan Lepeak, Managing Director, Global Research

Trends in the life sciences and pharma research and development  outsourcing (RDO)

The complete report is available at http://goo.gl/MgVBu

Oracle Siebel CRM is the base application behind Oracle’s Siebel CTMS.

Prepackaged OBIEE Applications does not have a module for Clinical Analytics and so there is a need to develop a complete custom OBI application in order to accomplish the requirements. This was untill Oracle has introduced Oracle Clinical Development Analytics (CDA) which is based on OBIEE+

Oracle CDA includes prebuilt data models, prebuilt Extract-Transform-Load programs sourcing from Oracle Clinical / Remote Data Capture and Oracle’s Siebel Clinical Trial Management System

Business Intelligence can be deployed in several Core functions

• Protocol Design and Study Start-Up
• Patient and Investigator Recruitment
• Clinical Trial Management
• Clinical Data Management
• Data Analysis
• Clinical Supplies
• Regulatory and Safety

Nonclinical Use of  Business Intelligence in Clinical Trial
There are a number of ways in which business intelligence as a technology platform can be used to support the pharmaceutical value chain. There is ample evidence to show how business intelligence has been used successfully in a number of areas including:

• Sales and Marketing
• Manufacturing
• Finance
• Human Resources
• Information Services
• Executive and Portfolio Management

Clinical Use  of  Business Intelligence in Clinical Trial
Within clinical research, the strongest use of technology is in pre-clinical research, clinical, statistical programming and supporting other groups such as:

• Data management (patient profiles)
• Medical writing
• Finance
• Project management
• Patient registries and post-marketing surveillance

Without CDA an OBIEE architect needs to understand CRM data model and also the actual business process flow of a CTMS application.It is observed that usually there is a customization to an extent of 25% on the CRM application.

Original Old Article on OBIEE for CTMS which was the only Business Intelligence solutions for Clinical trial management before Oracle announced CDA is Available at http://www.obieetalk.com

Requirements gathering sessions must be interactive with group of SME’s, Team of members from business, project sponsors to mitigate any risk of
slipping the time lines. It is recommended to plan for regular client reviews and approvals of every build to avoid any gaps in the expectations by the client .

At a high level the reporting requirements may include tracking budget and finance, clinical trials, activities, investigators,Initiations, enrollments, expiration’s, terminations. Cross dimensional hierarchies from Program to Protocol to Site to Subject is commonly desired.

Major dimension tables specific to CTMS includes Program, Protocol,Site,Subject, application, Investigator. Other common dimensions include Accounts, Contacts, Activities, Time, Geography,product, etc.

Here is a screen shot of a sample rpd for CTMS

one of the very few interesting article by Microsoft Engineers on Clinical Research Industry. Certainly interesting as it is written by none other than      Les Jordan-CTO, Life Sciences Industry Unit at Microsoft . Microsoft and IBM had much longer and deepr association with Lifescience/Healthcare/Bioinformatics industry than Oracle.

But I love to see microsoft grow beyond Sharepoint for Clinical Research and the BioIT alliance. Also love to ask microsoft what is the current status of some of those applications mentioned in the blog by Les, Especially the Microsoft Clinical Trial Initiation solution

Original article from microsoft website

Interesting how weeks become months when you’re writing and updating blogs.  This CTMS project certainly hasn’t gone away, but it did go on a bit of a hiatus while my “day job” intervened.  Enough excuses.  Mea Culpa.  On to the fun!

As we discussed in the previous post, the key to a clinical trials management system is thinking of it in terms of a project – after all, the people who run the clinical trial think of it in terms of a project, and it is measured in project management terms, so why not treat it that way from an architectural point of view?

A second and equally important “requirement” is one that we are increasingly seeing as an industry trend: having EDC (Electronic Data Capture) functionality and CTMS (Clinical Trials Management System) functionality in the same system, or at the very least having EDC and CTMS closely integrate and interoperate.

The clinical trials world of today is fairly fractured.  Think of all the different systems – often standalone systems – that are used by Life Science organizations:

• EDC – Electronic Data Capture
• CTMS – Clinical Trials Management Systems
• CLIP – Clinical Investigator Portals
• Project – Clinical Trials Project Management
• Analysis – OK, it’s SAS, but how do you get the data there?  What about real-time analytics?
• IRB & DSMB – Outside organizations with their own management systems, like a Click Commerce Research Compliance Automation solution?

What if you could have a system that gets close to doing all of that – or at least being able to manage all of it – through one interface?  How much would that save in training costs, integration costs, and implementation costs?

Well – that’s the vision.  Here’s how we pull it off:

1. Start with Microsoft Office SharePoint Server 2007 and SQL Server 2008 as the foundation to build upon.
2. As discussed in the last post, we’ll use Microsoft Office Project Server as a way to organize the information and provide us with a trial specific taxonomy, along with roll-up of reporting metrics.
3. To cover the EDC aspects, we’ll utilize Microsoft Office Forms Server 2007 – which is a web facing InfoPath solution – to handle data entry and front-ending the workflow for data checks, etc.

EDC forms in Forms Server can even handle digital signatures (with compliance and security being the subject of a future post) inside the InfoPath forms.  This has implications for those organizations that are involved with SAFE BioPharma (worth checking out).

The beauty of all of this is that it is all Web Service enabled, which means that you have easier integration mechanisms with existing analysis and EDC systems:

• SAS – With integration with .NET, SOAP, and Web Services.
• Medidata – We’ve demonstrated use of their Web Services API module that utilizes CDISC.
• Perceptive Informatics – At the DIA annual meeting a couple years ago, we did a demonstration using DataLabs (now Perceptive) and InfoPath integration, using Web Services and about 5 lines of code!
• EHR/EMR Integration – While it is still on the horizon, I think it is getting closer.  Check it out.

Resources to get you started:

• Configuring SharePoint for 21 CFR Part 11 Compliance
• Project Server and Office SharePoint Server 2007 Integration
• Project Server Architecture and Programmability
• InfoPath Forms Server Form Template Authoring
• Microsoft Clinical Trial Initiation solution

Finally – there are other organizations and software vendors that are thinking along these lines.  Check out the following solutions:

• A solution in place in the US Department of Veteran Affairs
• TENALEA – Trans European Network for Clinical Trials Services
• Transenda – An Office & Project based CTMS system
• StreamLogic – A Project Based CTMS system

Next up in this series:

• Using MOSS templates for maintaining Part 11 compliance
• Extranets & Identity Management
• Architecture Diagrams & Screen shots
• Validation and compliance

I had posted last month about the Pegasystem pharmacovigilance solution.

Pega Systems the industry leader in Business Process Management (BPM) software solutions, released a Pharmacovigilance case processing software.

Pega has experience in clinical trial space, specifically in Clinical Trial Management. The solution is designed for rapid deployment to quickly leverage existing adverse event processing rules and requirements and can produce specialized documentation to help ensure compliance in a validated environment.

I have not come across any new updates after that. But apparently Accenture  has acquired Knowledge Rules, Inc., a Philadelphia-based consulting company that focuses exclusively on implementing and integrating business solutions using Pegasystems’ Business Process Management (BPM) software.

Accenture has a very large Pharmacovigilance division serving several large pharmaceutical companies. It would not be very suprising if Accenture roles out the BPM software for their pharmacovigilance services.

I think that is a possibility because Accenture  has announced plans to use the applications for all its Fortune 500 customers.

I would predict that United Health Group could be one of those customers as they are an existing customer of Pega.

Speaking of which Pega sounds like an attractive target Oracle can acquire

Laboratory Corporation of America Holdings…announced…a collaboration between Esoterix Clinical Trials Services, a division of LabCorp, and Clearstone Central Laboratories, a global central laboratory specializing in drug development and pharmaceutical services.…The collaboration provides LabCorp with access to Clearstone’s global network of labs, including China, France, Singapore and Canada, in addition to LabCorp’s existing labs in the United States and Belgium. The companies will collaborate on providing standardized central laboratory testing for clinical trials to their respective clients. The transaction also provides LabCorp access to Clearstone’s clinical trials management system APOLLO CLPM clinical trials management software, enhancing the ability of clients to conveniently send, receive and manage data.

APOLLO CLPM is a secured globally accessible web based, 21 CFR part 11 validated clinical trials management software. Designed and developed by subject matter experts of every applied discipline integral to the system. Built on an Oracle database, the APOLLO CLPM system is a truly singular database that replaces multiple legacy systems and sub-systems, helping to drive improvements in efficiency and quality across the central laboratory business Apollo provides for global standardization of requisitions, reports, kits, barcode labels, as well as scientific information, and improves the accuracy and speed of sample reception and processing

The multinational pharma companies are planning to approach the health ministry with a proposal calling for the utilisation of the 1.7 lakh post offices across the country to distribute over the counter drugs.

The move if implemented would increase the reach of OTC drugs by 20%.

The plan initially submiited 2 years ago requires  the approval of and coordination between department of pharma under the ministry of chemicals and fertiliser, department of post under ministry of communications and the health ministry.

The Organization of Pharmaceutical Producers of India (OPPI), an association of multinational pharma companies, is in the process of reviving the proposal as top officials at the health ministry have shown interest in discussing it and considering its implementation

The Indian over-the-counter (OTC) medicines market, the 11th largest globally, is pegged at $1.9 billion. It is the second fastest growing market globally with a growth rate of around 9% per annum.

Ranjit Shahani, country president, Novartis gives the analogy of the how petrol pumps have metamorphosed into multi-utility centres in last two decades. “One simple legislation can change that for over the counter medicines,”

Would you support this, even in US where people are more educated and FD keeps a watch on drug advertisement , people are often misguided.

India is yet to come up with a strong and comprehensive adverse drug event reporting infrastructre.

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.