http://rss.lecom.edu en-us Copyright 2008 LECOM jczarnecki@lecom.edu jczarnecki@lecom.edu mirabyte Feed Writer Thu, 27 Mar 2008 19:01:46 -0600 On October 1, 2009, the United States Pharmacopeia (USP), a non-profit organization that provides authoritative, unbiased standards for manufacturers and regulatory agencies, revised the heparin monograph as well as changed reference standards for the manufacturing of heparin. Late 2007 and early 2008 marked the emergence of several deaths and hundreds of adverse reactions to contaminated heparin sold in the United States.2 Lack of government oversight allowed the distribution of impure heparin which subsequently caused the deaths and adverse reactions. http://cdir.lecom.us/dins_10-05-2009.html Mon, 5 Oct 2009 08:00:00 -0600 A strongly worded editorial appearing in the open access journal Public Library of Science - Medicine (PLoS Med) suggested the retraction of medical journal articles written by unacknowledged authors. The PLoS editorial is attached and available on the Center for Drug Information and Research (CDIR) Web site at http://cdir.lecom.edu. In Drugs in the News posted August 5, 2009 (http://cdir.lecom.us/dins_08-05-2009.html) ghostwriting was defined as a pharmaceutical industry practice of contracting with medical communications companies to write medical journal articles and solicit and pay physicians or pharmacists to be authors. The extent of ghostwriting in the medical literature is unknown. http://cdir.lecom.us/dins_09-23-2009.html Wed, 23 Sep 2009 10:00:00 -0600 http://cdir.lecom.us/dins_08-11-2009.html Tue, 11 Aug 2009 12:00:00 -0600 http://cdir.lecom.us/dins_08-05-2009.html Wed, 5 Aug 2009 14:00:00 -0600 The Center for Drug Information and Research (CDIR) has long held the view that it is no longer possible to conduct and an independent review of the therapeutic value of a new drug by relying exclusively on the peer reviewed medical literature because of the high probability of publication bias. Recent research indicates that only about 50% of the randomized clinical trials (RCTs) submitted to the FDA as part of new drug approval process are ever published. Those that are not published are generally negative.2 This results in a body of published literature that gives an overly optimistic impression of the therapeutic value of new drugs placing in question the validity of systematic reviews, meta analyses, and clinical practice guidelines. http://cdir.lecom.us/dins_07-08-2009.html Wed, 8 Jul 2009 16:00:00 -0600 Three epidemiological studies (observational studies) conducted in Sweden, Germany and Scotland, all suggesting a possible link between the use of insulin glargine (Lantus) and an increased risk of cancer compared to human insulin, have been published in Diabetologia. http://cdir.lecom.us/dins_07-01-2009.html Wed, 1 Jul 2009 18:00:00 -0600 In January 2005 the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK's equivalent of the US FDA, announced that all propoxyphene containing products would be withdrawn from the market by December 31, 2007. The basis for this regulatory action was lack of analgesic efficacy and the unacceptable safety of the drug. The risk and minimal, if any, benefit of propoxyphene have long been documented in the medical literature. http://cdir.lecom.us/dins_06-19-2009.html Fri, 19 Jun 2009 20:00:00 -0600 The Food and Drug Administration (FDA) issued a Warning Letter to Matrixx Initiatives, Inc. (http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/ucm166909.htm) on June 15, 2009 concerning the safety of the company's homeopathic drugs Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs and reports of anosmia (loss of sense of smell). These reports indicated that users experienced a long lasting or permanent loss of smell. The immediate safety concern is the inability to detect gas leaks, fire, or spoiled food. http://cdir.lecom.us/dins_06-17-2009.html Wed, 17 Jun 2009 22:00:00 -0600 Here is an editorial on free drug samples from the open access journal Public Library of Science, Medicine (PLoS Med). The is that the purpose of free samples is marketing and the editorial underscores that they may do more harm than good. http://cdir.lecom.us/dins_05-13-2009.html Thu, 14 May 2009 00:00:00 -0600 Assuming that the "Feedback from Capitol Hill" quotes are accurate the message to pharmacy is forceful and blunt. Nurses or others with less education than pharmacists, armed with electronic algorithms (e.g. clinical practice guidelines) can be substituted for pharmacists at a much lower cost with no measurable difference in quality. Medication Therapy Management (MTM) programs are just another commodity to sell for a profit according to those on The Hill. http://cdir.lecom.us/dins_04-20-2009.html Tue, 21 Apr 2009 02:00:00 -0600 In May of 2007, the Rocephin© package insert was updated to reflect a new interaction between ceftriaxone and concurrently administered IV calcium products. Roche provided the FDA with five post marking reports of neonatal deaths related to the interaction. Since, four additional post-marketing reports of the interaction have occurred in patients up to 1 year of age. http://cdir.lecom.us/dins_04-17-2009.html Sat, 18 Apr 2009 02:00:00 -0600 Prescrire International is the English language version of Prescrire a French drug newsletter that has been published for the past 30 years. Prescrire is highly regarded for its independence. http://cdir.lecom.us/dins_04-16-2009.html Fri, 17 Apr 2009 02:00:00 -0600 The Food and Drug Administration (FDA) has just posted FDA 101: Clinical Trials and Institutional Review Boards (IRBs). The full article appears below. This may be in response to a congressional investigation by the Government Accountability Office (GAO). A fake medical study for a fake product was created to see if for-profit IRBs adequately supervise and protect human subjects in clinical trials. http://cdir.lecom.us/dins_04-15-2009.html Thu, 16 Apr 2009 02:00:00 -0600 Prescrire is a highly respected independent source of drug information written in French that has been published for the past 30 years. The English language version, Prescrire International, is available to students at the soon to be opened Drug Information Center at the Bayfront campus. Prescrire has also announced an English language Web site available at http://english.prescrire.org. It is worth a bookmark in your favorites list. http://cdir.lecom.us/dins_04-12-2009.html Mon, 13 Apr 2009 02:00:00 -0600 In response to cardiovascular (CV) safety concerns with rosiglitazone (Avandia) and other drug used to treat type-2 diabetes the Food and Drug Administration (FDA) convened a public advisory committee meeting in early July 2008 to review the role of CV risk assessment in the pre-approval and post approval phases for new drugs and biologics being developed for the treatment of type-2 diabetes. http://cdir.lecom.us/dins_04-07-2009.html Wed, 8 Apr 2009 02:00:00 -0600 The "Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein" was published in the November 20, 2008 New England Journal of Medicine. This trial is also known by the acronym JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). http://cdir.lecom.us/dins_04-06-2009.html Tue, 7 Apr 2009 02:00:00 -0600 A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked. http://cdir.lecom.us/dins_03-11-2009.html Thu, 12 Mar 2009 02:00:00 -0600 Last week, a federal court in Boston unsealed a whistleblower-initiated lawsuit backed by 17 states and the District of Columbia that accused WebMD and Medscape of being part of an illegal conspiracy to promote the off-label use of two of Amgen's flagship products -- Aranesp for anemia and Enbrel for rheumatoid arthritis. http://cdir.lecom.us/dins_03-07-2009.html Sun, 8 Mar 2009 02:00:00 -0600 In a previous Drugs in the News the association between the American Society of Health-system Pharmacists' (ASHP) American Hospital Formulary Service Drug Information (AHFS-DI) and the Foundation for Evidence Based Medicine (FEBM) to review off-label cancer drug uses was noted. This association creates an apparent conflict of interest and gives the ASHP plausible deniability that ASHP does not accept industry money to list off-label cancer uses in AHFS-DI. http://cdir.lecom.us/dins_02-26-2009.html Fri, 27 Feb 2009 02:00:00 -0600 In 1990, the Institute of Medicine proposed guideline development to reduce inappropriate health care variation by assisting patient and practitioner decisions.1 Unfortunately, too many current guidelines have become marketing and opinion-based pieces, delivering directive rather than assistive statements. http://cdir.lecom.us/dins_02-25-2009.html Thu, 26 Feb 2009 02:00:00 -0600 This is an editorial from this morning's New York Times that discusses the problem and a government proposed solution, in part, to the rapidly escalating costs for chemotherapy and potential conflicts of interest with recognized drug compendia such as the American Hospital Formulary Service - Drug Information (AHPS - DI) as the source of information for reimbursing for the off-label use of cancer drugs. http://cdir.lecom.us/dins_02-10-2009.html Wed, 11 Feb 2009 02:00:00 -0600