The U.K.’s Department of Health, prompted by a Freedom of Information request made by the watchdog group Ethics and Genetics, revealed the fact that personal data obtained during creation of the 100,000 genomes database may not be secure. The database is meant to provide researchers information on enough diseases and genomes to accelerate drug discovery and ultimately reduce costs for the National Health Service. In contrast to government claims that patient information will be anonymous, material released as a result of the FOI request indicates that companies and firms can invoke an appeal process to demand “patient-identifiable data” such as age and postcode, setting off fears that drug and insurance companies will be able to determine the identities of people susceptible to particular diseases. The Department of Health explained that approval to release information can be granted “where consent cannot be obtained” and that “there are circumstances where it is very difficult to contact patients to seek their consent, or where it is vital that the data is identifiable.” A government-commissioned review to recommend how to reconcile people’s desire for confidentiality with the benefit of sharing information with third parties is expected later this year. “The privacy and confidentiality of National Health Service patients will be paramount at every stage of fulfilling the government’s commitment to sequence 100,000 whole genomes,” says Professor Dame Sally Davies, chief medical officer for the U.K.
Retractions in the biomedical literature continue to rise, with a record 348 retraction notices distributed in 2012, up from 254 in 2011, an increase of 37 percent. An analysis by investigator John Krueger, reported in the U.S. Office of Research Integrity’s newsletter, shows that even when adjusted for the tremendous increase in number of papers published annually, the number of retractions has skyrocketed. One theory for the sharp rise seen since 2005 is that as publications are increasingly available electronically, it’s easier to detect inconsistencies in digital images and plagiarism. The incidence of retraction is still twentyfold less than the incidence of unreported research misconduct, according to the report.
The prescription drug benefit manager, Express Scripts, sued Ernst & Young alleging that former E&Y partner Don Gravlin snuck into its headquarters and stole confidential information over a number of months during the time Express Scripts was completing its $29 billion acquisition of Medco Health Solutions in early 2012. The complaint accuses Ernst & Young of violating trade secret and state computer tampering laws, and misappropriation of confidential and proprietary data. Express Scripts claims the equivalent of 20,000 pages of data, including pricing, integration strategy, and business strategy details, were emailed to a private Google account and that an Ernst & Young partner knew that Gravlin had taken data but did not notify them. The company is one of the largest managers of prescription drug benefits for Americans, and in addition to damages, is seeking a court order to bar the disclosure of confidential data.
Two patients died in clinical trials of a drug designed to treat relapsed or hard-to-treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and small lymphocytic leukemia. As a result, Roche and AbbVie, the Abbott spin-off and trial partner, cancelled five mid-stage trials designed to determine the amount of drug that is most effective while still being safe. “ABT-199 is a highly potent agent and can result in the tumors reducing really quickly,” said Tracy Sorrentino, an AbbVie spokeswoman. “We are working to refine the dose.” The deaths were caused by tumor lysis syndrome, a consequence of tumor breakdown following aggressive cytotoxic treatment, that results in the rapid destruction of malignant cells and the acute and overwhelming release from the dying cells of ions, nucleic acids, proteins and their metabolites into the tissue space that surrounds all cells. The body is unable to clear this debris, and if not caught and treated early enough, the syndrome can lead to acute renal failure and death. The drug in the trial, a BCL-2 inhibitor, targets a family of proteins involved in natural cell death that can be either pro-death or pro-survival. Cancer cells evade natural cell death through activation of the prosurvival pathway, and directly inhibiting this pathway with specific BCL-2 inhibitors is still a promising therapy for difficult to treat cancers. AbbVie says patients originally given the medicine in the trial are able to continue their treatment, and an ascending dose study in women with systemic lupus erythematosus is ongoing.
After reports of device fractures and loosening inside the leg, the U.S. Food and Drug Administraton issued a Class I recall on February 15 of a component part to DePuy Orthopedics’ artificial knee system. The component that may cause serious adverse health consequences or death is part of the medical device company’s knee preservation system that allows surgeons to reconstruct severe soft tissue and bony defects around the knee following knee replacement surgery. The defect lies in a sleeve that surrounds the knee and is supposed to improve the fit and fill of the long bone component that connects to the metal knee. The sleeve may be insufficient for the stress and force loads transferred to the junction between the artificial long bone and the artificial knee during normal gait in some patients, according to the FDA. The FDA has received reports of 6 fracture and 4 loosening incidents in which the device malfunctioned. The recall covers products manufactured and distributed from 2008 to mid-2012.
Under pressure to curtail German health care costs, the German Institute for Quality and Efficiency in Health Care, IQWiG, decided that neither Pfizer’s lung cancer drug Xalkori nor Bristol-Myers Squibb/Astra Zeneca’s diabetes drug Komboglyze was worth the high price over currently available treatments. Xalkori, a chemotherapeutic for the treatment of non-small cell lung cancer, has too many side effects with not enough benefit, according to IQWiG, to justify the treatment cost of $9600 a month for possibly up to 2 years, depending on how long the patients live. IQWiG also determined that Komboglyze, a combination pill of two diabetes drugs approved in the U.S. for treating Type 2 diabetes, showed no evidence of additional benefit and also stated that one of the drugs used in the trial as a comparator was not suitable since it is no longer available in Germany. Both Pfizer and AstraXeneca issues response statements and will work with the German agency to eventually gain approval.
February 22, 2013
http://www.burrillreport.com/article-personal_information_may_be_released_from_u_k_sequencing_effort.html




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