Category Archives: Genetic medicine

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.

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

Dr. Mehdi Khalid Vice President, Healthcare and Life Sciences Industry Business Unit Asia Paci?c and Japan at Oracle about key aspects of healthcare IT market in India & Oracle’s presence in this space.

DownloadHealth India 2010

Launched by British Prime Minister David Cameron on 28 July 2010 in Bangalore, India, Dishaa is an initiative that will expand, enrich and energise relations between India and the UK.

Dishaa means direction in India’s national language Hindi. And that what the it is aiming for direction for for future leaders from India and UK

Dishaa has announced the new challenge for the millenia will be

Heart surgery at $1,000 (USD) – what has to change in how society operates and innovates to make this a reality?

Dr Devi Shetty of  Narayana Hrudayalaya a large hospital group specializing in Cardiac Surgery from Bangalore, India says  it is on the way to become a reality

And he is going ahead with the plan to open India’s first low-cost hospital for caridac surgery will be up and running in Mysore  by early next year, to offer Cardiac Surgery at $1500 USD against the current cost of  $5000 USD in India

These state-of-the art hospitals will be built at a cost of  just $ 35 Million USD, about one-fifth the cost of constructing a 300-bed super-speciality hospital in India.  By 2012 Dr. Shetty plan to open 50 more such hospitals in India. the next are coming up in Siliguri (West Bengal) and Bhubaneswar (Orissa) with help from  The Union health ministry of India

Details on Dishaa page

http://www.commonpurpose.org/info/media-releases/101021_$1,000-(usd)-for-heart-surgery

Ah. well they should be protected, with the number of physicians unhappy with the Healthcare IT systems rising. We ll thank goodness patients will also get third party coverage if the software errs.

Chubb Group of Insurance Companies has established the “Healthcare Information Technology” liability insurance to protect Healthcare IT companies.

Over 1,000 companies supply information technology products and services to the healthcare and medical research industries in the US and Canada would be happy to hear that

An integrated liability solution from Chubb can help protect healthcare information technology companies from:

• general and products liability when software or hardware that is defective or contains inaccurate or incomplete information causes or contributes to patient injuries;
• errors and omission liability when a product defect or service deficiency results in economic injury to a customer;
• third-party liability to patients, healthcare providers and others associated with database security breaches; and
• costs incurred to comply with state, federal

Chubb is targeting Healthcare Information Technology Companies providing any of the following services

• Electronic health record system providers
• Clinical decision support system providers
• Telehealth and health information exchanges
• Practice management system providers
• Payor system providers
• Drug discovery firms
• Clinical informatics firms
• Healthcare systems consulting firms

Dr. Mehdi Khalid Vice President, Healthcare and Life Sciences Industry Business Unit Asia Paci?c and Japan at Oracle about key aspects of healthcare IT market in India & Oracle’s presence in this space.

DownloadHealth India 2010