MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'clinical research'. Sat, 03 Sep 2011 02:07:43 +0100 http://www.medworm.com/index.php?rid=5125920&cid=t_92639_136_f&fid=35300&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fmetastatic-liver-cancer%2F%7E3%2FCPR6Bu2CaKM%2F The clinical trial to treat primary and secondary liver cancer with the drug ALN-VSP from Alnylam Pharmaceuticals is ready to start phase 2 using its highest dose. ALN-VSP is a drug that limits the ability of cancer cells to make proteins used to form their blood vessels. This will lead to less blood flow to [...] (Source: Metastatic liver cancer) Metastatic liver cancer blogs http://www.medworm.com/rss/comments.php?id=5125920 Wed, 03 Aug 2011 13:11:26 +0100 5125920 http://www.medworm.com/index.php?rid=5028517&cid=t_92639_111_f&fid=39123&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fnursingcomments%2Ftdtc%2F%7E3%2FTIy93UnlV6M%2F I was doing some research on clinical trials and it is much more complex than I dreamed!  First of all, any new treatment must go through numerous stages of testing before its benefits and risks can completely be known.  New treatments are discovered in the laboratory and it can take many years of research before they are given to patients.  Why?  Because it is essential to identify that the new treatment is actually better than what is already available.  These research studies are also called clinical trials.  If a treatment has definite potential in the final stages of development, then research is carried out in patients with the particular type of illness that the treatment aims to help.  Furthermore, I always believed that clinical trials were only regarding drugs, and that is... Nursing Comments blogs http://www.medworm.com/rss/comments.php?id=5028517 Thu, 14 Jul 2011 15:37:10 +0100 5028517 http://www.medworm.com/index.php?rid=5028071&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F07%2Fguest-blog-health-care-in-dangerous.html Health Care Renewal presents another guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has long observed the health care scene.Health Care Renewal has often covered the disconnect between the stated goals of companies and the realities of their day to day operations. This raised the following question: Has medicine moved from being dysfunctional to being dangerous?There is certainly no lack of material to support this question as in the last two weeks we can find examples of pharma/biotech/device companies all engaged in questionable behavior. Medtronic and Manipulation of Study DataIn the print media, The Wall Street Journal, a pro-business newspaper regularly highlights storie... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5028071 Fri, 08 Jul 2011 20:02:00 +0100 5028071 http://www.medworm.com/index.php?rid=4968905&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkCs8X6zlPB8%2F Earlier this week, Medco Health Solutions, the big pharmacy benefits manager, struck an unusual deal with Sanofi to help the drugmaker navigate the path from laboratory to formulary placement. Specifically, Medco will provide input on clinical trial design, help develop comparative effectiveness data and review usage of existing medications to improve patient adherence. The move reflects a growing awareness among drugmakers that designing and testing a compound for FDA approval is no longer the only key hurdle to winning sales and market share. We spoke with Robert Epstein, Medco’s clinical research and development officer, about the deal… Pharmalot: You’re saying this is the first deal of this sort. But the problems you hope to address aren’t new, right? Epstein: It’s been very ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968905 Fri, 24 Jun 2011 17:25:12 +0100 4968905 http://www.medworm.com/index.php?rid=4997537&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FFLVaN6eQC5w%2F At LITFL we are constantly trying to find interesting and enigmatic individuals with a passion for emergency medicine to share their experiences. We have a particular passion of International Emergency Medicine and are proud to introduce Dr Bishan Rajapakse. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4997537 Wed, 22 Jun 2011 09:03:33 +0100 4997537 http://www.medworm.com/index.php?rid=4670200&cid=t_92639_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fimho-google-dropping-google-health-just-rumor There is a rumor out there that Google is planning on dropping Google Health, its personal health record platform. I’m going to go out on a limb here, and say it is highly unlikely the rumor is true, in my honest opinion (IMHO). And here's why.  read more (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=4670200 Fri, 01 Apr 2011 20:30:28 +0100 4670200 http://www.medworm.com/index.php?rid=4482721&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F02%2Funiversity-of-minnesota-where-nothing.html As noted on the Periodic Table blog, the administration of the University of Minnesota continues to believe all is well with its clinical research activities.  A recent internal review said there was nothing more to investigate about the unfortunate death of a psychiatric patient years before. So should we all be relieved? It will take an extensive review of the case to ultimately suggest we should not at all be relieved.  The case raised important concerns about the validity of clinical research, and whether it violates the trust of its patient-subjects.  These concerns had not been addressed before the university's most recent review, and thus seem even more pointed after its recent non-investigation.Background: the Untimely Death of Dan Marki... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4482721 Tue, 15 Feb 2011 18:01:00 +0100 4482721 http://www.medworm.com/index.php?rid=4477767&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FNLPyLS0cFnE%2F The UCEM has today received leaked information that Wakefield is set to open his own research institute to collect evidence that supports his assumptions. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4477767 Tue, 15 Feb 2011 02:30:18 +0100 4477767 http://www.medworm.com/index.php?rid=4394392&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fst-jude-medical-settles-again.html Here we go again to kick off the week, legal settlements, cardiac devices, alleged kickbacks, manipulated research, as reported by Bloomberg:Another Legal Settlement by St Jude MedicalSt. Jude Medical Inc. agreed to pay $16 million to settle a U.S. government probe of claims the company paid kickbacks to doctors who implanted its heart devices in patients.The accord resolves a five-year investigation of St. Jude’s marketing practices for defibrillators and pacemakers. This was not even the first recent settlement by this particular company:In June, St. Jude agreed to pay the federal government $3.7 million to resolve a separate whistleblower case over claims that it made illegal payments to hospitals in Kentucky and Ohio that used the company’s heart devices. Our relevant post about th... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4394392 Mon, 24 Jan 2011 22:35:00 +0100 4394392 http://www.medworm.com/index.php?rid=4389188&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FIeMF75Jj4gw%2F The Ten Commandments of Clinical Research according to Stoller and Mireles-Cabodevila. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4389188 Sun, 23 Jan 2011 00:00:25 +0100 4389188 http://www.medworm.com/index.php?rid=4318337&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FbYYKshUIGYU%2F Almost immediately after finishing ‘Time to publish then filter?’ – a post that highlighted a recent editorial in the BMJ outlining the need for an effective system of post-publication peer review — I came across this in the Annals of Emergency Medicine: Millard WB. The Wisdom of Crowds, the Madness of Crowds: Rethinking Peer Review [...] (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4318337 Thu, 06 Jan 2011 12:00:17 +0100 4318337 http://www.medworm.com/index.php?rid=4294583&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fscience-in-medical-informatics-is-dead.html The science in Medical Informatics is dead.I'm not going to even use academic fabric softener in my assertion, e.g., "may be", "appears to be", or "is it?" (as a question) dead.It's dead.When HIT experts recommend changing the study goalposts when existing studies don't give results they'd like to see, rather than first and foremost critically and rigorously examining why we're seeing unexpected results, science is dead. http://www.healthcareitnews.com/news/study-highlights-lurking-question-measuring-ehr-effectivenessStudy highlights 'lurking question' of measuring EHR effectivenessDecember 22, 2010 | Molly Merrill, Associate EditorWASHINGTON – Hospitals' use of electronic health records has had just a limited effect on improving the quality of medical care nationwide, according to ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4294583 Sun, 26 Dec 2010 17:22:00 +0100 4294583 http://www.medworm.com/index.php?rid=4197075&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FgPdkXrKWmIg%2F SMART EM is part of a network of communication tools designed to offer unbiased translation and summaries of medical evidence mainly pertaining to emergency medicine. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4197075 Wed, 24 Nov 2010 10:07:44 +0100 4197075 http://www.medworm.com/index.php?rid=4190161&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FqGH6TAC-eno%2F Dealing with this exponentially growing information resource can be challenging, especially as we are increasingly want to share our knowledge, and invite comment from our peers....enter Today I Learnt That (TILT) is the brainchild of Jon Brassey of TRIP Database and TRIP Answers fame. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4190161 Tue, 23 Nov 2010 06:41:52 +0100 4190161 http://www.medworm.com/index.php?rid=4190162&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FyUfiO-wWAuU%2F Community Acquired Pneumonia EBM Review (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4190162 Mon, 22 Nov 2010 02:00:00 +0100 4190162 http://www.medworm.com/index.php?rid=4190163&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FYWCGzBtegIM%2F Spontaneous Pneumothorax in the Emergency Department an EBM Review (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4190163 Sun, 21 Nov 2010 02:00:42 +0100 4190163 http://www.medworm.com/index.php?rid=4179326&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FgROxfIp6PKo%2F Evidence based review of acute severe asthma including clinical recognition and management (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4179326 Thu, 18 Nov 2010 02:00:08 +0100 4179326 http://www.medworm.com/index.php?rid=4175698&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FWDCNx39-hnc%2F EBM review of Oesophagogastric Varices assessment and management in the emergency department (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4175698 Wed, 17 Nov 2010 02:00:14 +0100 4175698 http://www.medworm.com/index.php?rid=4164527&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2F45wJy3zDE5Q%2F Upper GI Haemorrhage EBM Review. Commonest causes: peptic ulcer (35-50%); oesophagitis (20-30%); duodenitis/gastritis/erosions (10-20%); varices (5-12%); Mallory-Weiss tear (2-5%); tumour (2-5%); angiodysplasia (2-3%); aorto-enteric fistula (<1%). (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4164527 Mon, 15 Nov 2010 02:00:49 +0100 4164527 http://www.medworm.com/index.php?rid=4164529&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FsMX6_NHNJvo%2F Acute Liver Failure in the Emergency Department an EBM Review (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4164529 Sun, 14 Nov 2010 02:00:18 +0100 4164529 http://www.medworm.com/index.php?rid=4155236&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2F4XPYG3zxKIE%2F Review of EBM for the assessment and management of Diabetic Ketoacidosis in the emergency department (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4155236 Thu, 11 Nov 2010 02:00:41 +0100 4155236 http://www.medworm.com/index.php?rid=4151802&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2F_s6MkWxUzc4%2F EBM review of the assessment and management of meningitis and Meningococcaemia (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4151802 Tue, 09 Nov 2010 02:00:18 +0100 4151802 http://www.medworm.com/index.php?rid=4142755&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FIzw9vme6a3Q%2F Evidence based review of venous thromboembolism, DVT and pulmonary embolism (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4142755 Mon, 08 Nov 2010 02:00:50 +0100 4142755 http://www.medworm.com/index.php?rid=4139245&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2F4PX06cQo3d4%2F Aortic Dissection in review: 3 cases per 100 000 people per year; up to 25% missed diagnosis ante-mortem. ‘Typical’ case is 60-80 years old, M>F 3:1, with hypertension. Overall in-hospital mortality 27%. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4139245 Sat, 06 Nov 2010 02:00:12 +0100 4139245 http://www.medworm.com/index.php?rid=4133719&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2Fr4rSIn5CGpo%2F Acute heart failure syndrome (AHFS) spectrum can be divided into 5 groups as regards therapeutic management (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4133719 Thu, 04 Nov 2010 02:00:32 +0100 4133719 http://www.medworm.com/index.php?rid=4133721&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FiHTLu6zqsHk%2F Migraine without aura (‘common’ migraine). 66-75% of migraineurs; must have had at least five attacks. Attacks lasting 4-72 hours untreated. At least 2 of headache characteristics: unilateral, pulsating or throbbing, moderate to severe, aggravated by movement. At least 1 associated symptom during headache: nausea and/or vomiting, photophobia and phonophobia. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4133721 Wed, 03 Nov 2010 09:00:49 +0100 4133721 http://www.medworm.com/index.php?rid=4125013&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FVw7FbQmplsc%2F EBM review of Chest Pain Adjunctive Therapies including adjunctive anticoagulant therapy, adjunctive anti-thrombotic therapy and other therapeutic agents (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4125013 Tue, 02 Nov 2010 00:43:24 +0100 4125013 http://www.medworm.com/index.php?rid=4125014&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2F8OQ_fLkq61Q%2F including early Management of STEMI or NSTEACS, reperfusion strategies, percutaneous coronary intervention (PCI) and thrombolysis (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4125014 Tue, 02 Nov 2010 00:41:19 +0100 4125014 http://www.medworm.com/index.php?rid=4125015&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2Fgj2Lssai_Kw%2F Chest Pain and risk stratification - EBM Review. Coronary heart disease single largest cause of death (16% or 27,000) in 2007 in Australia, but down from 22% in 1998. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4125015 Tue, 02 Nov 2010 00:40:25 +0100 4125015 http://www.medworm.com/index.php?rid=4121862&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FpsB0ayXygsc%2F Status Epilepticus: Synonyms: overt, geneneralised tonic-clinic, major motor SE. Defined as a seizure lasting over 5 mins, or two or more seizures without recovery in between. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4121862 Sun, 31 Oct 2010 02:00:27 +0100 4121862 http://www.medworm.com/index.php?rid=4118942&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2F3jRtI6VX55k%2F Pedagogical disambiguation: Emergency Medicine Lecture Notes and Evidence Based emergency medicine principles from Professor A.F.T Brown and Life in the Fast Lane team. Latest Guidelines International Liaison Committee on Resuscitation (ILCOR). 2010 International Consensus on CPR and ECC Science with Treatment Recommendations (CoSTR). Circulation 2010; 122 (Suppl 2):S250-S581. (12 papers) European Resuscitation Council Guidelines for Resuscitation [...] (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4118942 Fri, 29 Oct 2010 14:23:58 +0100 4118942 http://www.medworm.com/index.php?rid=4118943&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FMzvfm9IcvgU%2F Prof Anthony F T Brown knuckles down and gets to grips with the evidence surrounding assessment and management in acute medicine for the annual FRACP lecture series. Prof Brown aims to contextualize the most pertinent evidence based information pertaining to acute medical emergencies in summative statements. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=4118943 Fri, 29 Oct 2010 13:00:42 +0100 4118943 http://www.medworm.com/index.php?rid=4027161&cid=t_92639_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fbias-in-clinical-research-is-inevitable%2F2010.10.03 DrRich has said many times that clinical science is among the least exact of the sciences, and therefore, the results of clinical research are particularly susceptible to “spinning” by various interested parties, in order to yield the kind of results they would prefer to see. Until recent times in American medicine, the parties who have been most interested in spinning clinical research have been the people who run drug companies and medical device companies (who need clinical research which supports the use of their products), and the medical specialists (who are more likely to be paid for performing medical procedures that are supported by clinical research). In writing about such data-spinning abuses, DrRich has particularly targeted his own Cardiology Guild, but only because he kno... Better Health blogs http://www.medworm.com/rss/comments.php?id=4027161 Sun, 03 Oct 2010 12:00:16 +0100 4027161 http://www.medworm.com/index.php?rid=3965418&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FoPskSFLzMHg%2F Molecular biologists working with a team of anthropologists have discovered a new gene that is set to revise the theories of social structure in humans. The team initially embarked on an ambitious project to discover when humans and our early ancestors formed hierarchies whereby the members in key organisational positions began to become underproductive social malignancies with the sole aim of self perpetuation at the expense of functional individuals. (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=3965418 Tue, 14 Sep 2010 07:51:03 +0100 3965418 http://www.medworm.com/index.php?rid=3965422&cid=t_92639_88_f&fid=38129&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Flifeinthefastlane%2FWZHV%2F%7E3%2FtMZN8RSkHpU%2F Can contemporary medical economics combat the growing threat of microbes? Have we created sufficient evolutionary pressures that the microbe diseases of yesteryear and the neglected pathogens of today become a threat for us tomorrow? Whilst I don't yet have the answers I intend to test my hypotheses and opinions expressed below as part of a review, which I also intend on making into a science communication presentation, (I will share if it’s of sufficient quality). (Source: Life in the Fast Lane) Life in the Fast Lane blogs http://www.medworm.com/rss/comments.php?id=3965422 Sun, 12 Sep 2010 07:39:09 +0100 3965422 http://www.medworm.com/index.php?rid=3933265&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaKrQUrCNzEU%2F Good morning, everyone. How are you today? Slowing down just a bit, perhaps? Here in the states, of course, a three-day weekend is fast approaching. And so we will pull in the sidewalks early. We hope you have the opportunity to do the same. Meanwhile, here are a few nuggets to help you close out the week. Whatever you do over the next few days, may it be enjoyable. Cheers… Celldex Says Pfizer Ends Cancer Vaccine Deal (Reuters) Allergan Steps Up Overseas Clinical Trials (CBS News) Novartis Experimental Malaria Drug May Be First In 30 Years (Bloomberg News) Abbott Cancels Sale Of Solvay Vaccines Unit (The Wall Street Journal) Accenture And ICRI Partner On Indian Clinical Research Training (Outsourcing Pharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3933265 Fri, 03 Sep 2010 12:02:08 +0100 3933265 http://www.medworm.com/index.php?rid=3921075&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0FVhG6k4V6A%2F Drugmakers regularly complain that it is getting more difficult and more expensive to recruit people into clinical trials, hence the rush overseas (background here and here). So how should a drugmaker or clinical research organization entice prospective participants? A new survey finds some companies succeed by simply appealing to the need people have to receive an otherwise unavailable treatment, or to a feeling of altruism. But let’s get down to the numbers: as the chart indicates, the most effective pitch is offering a treatment that represents an improvement, following by the convenience of the trial site, the prospect of receiving a free med, tinkering with the number and frequency of site visits and a short trial duration, according to the survey from CuttingEdge Information, w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921075 Tue, 31 Aug 2010 12:49:14 +0100 3921075 http://www.medworm.com/index.php?rid=3914930&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F08%2Ftrouble-coming-every-day-as-discussed.html With apologies to the late Frank Zappa... even though we are going through the dog days of summer, the parade of health care troubles in the news is never ending, so I thought I would recap some of the more interesting issues discussed by some of my fellow health care skeptic bloggers.We have discussed the ongoing decline of primary care. On DB's Medical Rants, Dr Robert Centor takes on the topic: "The system has, without consciously meaning to, held primary care in contempt." The result is a "quiet rebellion: of primary doctors.We have discussed whether the currently fashionable idea of "accountable care organizations" (ACOs) might turn out to be a cover for health care oligopolies. See what Paul Levy, CEO of the Beth Israel/ Deaconess Medical Center said about them in his blog, Runn... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3914930 Mon, 30 Aug 2010 22:58:00 +0100 3914930 http://www.medworm.com/index.php?rid=3764128&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Favandia-spin-cycle-continues-even-after.html We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug.  While Avandia has received considerable media coverage, we focused on two questions: 1 - what are the benefits and harms of rosiglitazone as a treatment of type 2 diabetes, and therefore for which patients under what circumstances should this drug be used? 2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?  (See recent post here.)  In particular, the Avandia case has illustrated how those with vested interests in the success of a health care product have done their best to obscure information that might threaten its success, even when doing so obsc... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3764128 Sun, 18 Jul 2010 19:00:00 +0100 3764128 http://www.medworm.com/index.php?rid=3723305&cid=t_92639_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Falcoholics-anonymous%2F2010.07.03 To further emphasize my admiration for superb sci/med/health writing, I wish to add another writer to my growing blog category of “Journalists, Awesome.” Via my drug abuse research colleague, DrugMonkey, my attention was drawn to a new Wired magazine article by Brendan I. Koerner entitled, Secret of AA: After 75 Years, We Don’t Know How It Works. I strongly recommend this long-form article for anyone in the field of substance abuse and dependence research, psychology and general clinical research, students of excellent science writing, alcoholics and their family members, and anyone who thinks that good science writing no longer exists. I don’t want to influence your views any further, other than to say that since I poured my first whiskey and water for my grandmoth... Better Health blogs http://www.medworm.com/rss/comments.php?id=3723305 Sat, 03 Jul 2010 18:00:01 +0100 3723305 http://www.medworm.com/index.php?rid=3687099&cid=t_92639_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Finside-the-nih-grant-review-process%2F2010.06.22 The National Institutes of Health (NIH) is the world’s biggest sponsor of research in the life sciences. Today’s biologists, clinical researchers, and many others rely on the NIH for their funding. To help people better understand how the peer review process happens within the NIH, the agency’s Center for Scientific Review created the following video that includes samples of research being openly discussed by a number of scientists: Click here to view another video of tips for NIH grant applicants. *This blog post was originally published at Medgadget* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3687099 Tue, 22 Jun 2010 22:00:59 +0100 3687099 http://www.medworm.com/index.php?rid=3676898&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIbrAMGa6g6I%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something that’s become a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Cegedim Dendrite promoted Angela Miccoli to Americas president, overseeing the US, Canada and Latin America. Most recently, she was senior vp for global business development and led customer relationship management sales... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3676898 Fri, 18 Jun 2010 12:10:12 +0100 3676898 http://www.medworm.com/index.php?rid=3666227&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRGDjRXl_eDU%2F Between 2004 and 2007, the number of clinical trial investigators who are regulated by the FDA fell 5.2 percent in the US and 6.1 percent in Europe, while increasing 16 percent in Eastern Europe, 12 percent in Asia and 10 percent in Latin America, according to a new survey from the Association of Clinical Research Organizations. Why are investigators in the US and Western Europe dropping out? We know that pharma can runs trials more cheaply overseas. But what do investigators say? Well, 70 percent of respondents believe current regulations make trials difficult to manage. They cited such issues as medical liability (42 percent in the US vs. 20 percent in Western Europe), conflict of interest rules and mandates that docs disclose financial relationships with pharma. File this under backlash... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3666227 Tue, 15 Jun 2010 17:50:05 +0100 3666227 http://www.medworm.com/index.php?rid=3662930&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlG3_0WmNlLQ%2F Rise and shine. Another day is on the way. To top it off, the sun is shining here on the Pharmalot corporate campus, where we are hustling the short people off to the schoolhouse. Wish us luck. Meanwhile, there is much to do. So why not start with the mandatory cup of stimulation and the news of the world. Have a great day, everyone… Glaxo Wins FDA OK For Prostate Combo Drug (Reuters) Cheap Generic May Save Lives After Bleeding From Accidents (Bloomberg News) ACRO Wants More US & European Trial Investigators (Outsourcing Pharma) Waiting For The Human Genome To Yield Drugs (The New York Times) Georgia Creates Bioscience Center (Atlanta Journal-Constitution) Cleveland Clinics Inks Research Deal With Lipitor Creator (Crain’s Cleveland Business) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3662930 Tue, 15 Jun 2010 11:54:48 +0100 3662930 http://www.medworm.com/index.php?rid=3607500&cid=t_92639_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhave-we-killed-clinical-research%2F2010.05.27 “…I have always depended on the kindness of strangers.”  — Blanche DuBois in Tennessee Williams’ play A Streetcar Named Desire Years ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack. Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial — the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in s... Better Health blogs http://www.medworm.com/rss/comments.php?id=3607500 Thu, 27 May 2010 16:00:00 +0100 3607500 http://www.medworm.com/index.php?rid=3573718&cid=t_92639_105_f&fid=38964&url=http%3A%2F%2Fdrwes.blogspot.com%2F2010%2F05%2Fhow-weve-killed-clinical-research.html "I have always relied on the company of strangers."- Blanche DuBois in Tennessee William's play, A Streetcar Named DesireYears ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack. Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial: the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in some small way, their fellow man.It never daw... Dr. Wes blogs http://www.medworm.com/rss/comments.php?id=3573718 Tue, 18 May 2010 10:14:00 +0100 3573718 http://www.medworm.com/index.php?rid=3508448&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fnf6jcSWzpi8%2F Rise and shine. Another day lies ahead. And no doubt, it will be a busy one. As always, there is much to do - meetings and deadlines beckon. While we attempt to hustle one of the short people off to the local schoolhouse, here are a few items to jumpstart your day. We hope it is a good one. And once again, do stay in touch… AstraZeneca Wins Wider EU Crestor Labeling (Reuters) Novo Nordisk Raises Forecasts (Bloomberg News) Irish Reference Pricing Could Cause Shortages (PharmaTimes) Abbott Court Loss Prompts Review Of Patent Standards (Daily Herald) ACRO To Fund CRO Academic Research (OutsourcingPharma) J&J Unit Denied Appeal Of Patent Decision (MarketWatch) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508448 Tue, 27 Apr 2010 11:31:24 +0100 3508448 http://www.medworm.com/index.php?rid=3508450&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNC-K4zMZYN8%2F A review and analysis of previously published studies finds that patients, researchers and journal readers believe financial relationships between medicine and industry should be disclosed, partly because over concerns that financial ties may influence research and clinical care, according to a report in the latest issue of the Archives of Internal Medicine. Despite a demand for disclosure, little is known about how financial info affects decision-making, according to the report, which reviewed 20 original studies assessing the attitudes of patients, researchers and journal readers toward financial disclosures. And it’s not clear that financial disclosure will have much effect on the willingness to participate in research. Of these studies, 11 assessed financial ties and perceptions... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508450 Mon, 26 Apr 2010 21:00:36 +0100 3508450 http://www.medworm.com/index.php?rid=3311635&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F02%2Fbring-back-dsi-avandia-case-as-spy.html Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithKline), a glucose lowering drug for type 2 diabetes, presented excess cardiovascular risks, and how evidence about these risks was handled.  SummaryThe Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone then available.  Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug which remained unpublished.  The... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3311635 Thu, 25 Feb 2010 19:47:00 +0100 3311635 http://www.medworm.com/index.php?rid=3290784&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F02%2Fdeja-vu-all-over-again-sheffield.html It's deja vu all over again.  A case reported (so far only) in the UK Times Higher Education Supplement of a biomedical researcher apparently threatened because she tried to present data that did favor a particular commercial health care product. Here is the summary:An academic has risked the wrath of her university by submitting results to a forthcoming conference without permission.The University of Sheffield has claimed that the submission has been made in breach of a contract it has with a pharmaceutical company, which funds work in the scholar's field.Guirong Jiang, a research radiologist who has worked at Sheffield for 13 years, is due to face a disciplinary hearing over her actions this week.Her findings - submitted to a symposium of the European Calcified Tissue Society (ECTS)... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3290784 Fri, 19 Feb 2010 16:59:00 +0100 3290784 http://www.medworm.com/index.php?rid=3185295&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F01%2Fphysician-pleads-guilty-to-fraud-for.html As reported by the Springfield, MA, Republican:A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsifying medical research and must pay $420,000 in restitution to pharmaceutical companies, federal court records show.Dr. Scott S. Reuben, of Longmeadow, was charged on Thursday with health care fraud. He signed a plea agreement with prosecutors a week earlier.Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances. In one notable instance,In 2005, Reuben received a $74,000 research grant from pharmaceutical giant Pfizer, agreeing to test Celebrex as a component of the multimodal therapy. He claimed to have treated 200 patients,... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3185295 Mon, 18 Jan 2010 21:40:00 +0100 3185295 http://www.medworm.com/index.php?rid=3176118&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBYKZy7XOMwU%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something we hope to make a regular feature. Send us a photo (something nice, please) and we will spotlight a different person each week. This time around, we note that Concert Pharmaceuticals hired Steven Weissman as associate director, process chemistry. Before joining Concert, he worked at Merck Research Laboratories as a senior investigator. Vical hired Rich... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3176118 Fri, 15 Jan 2010 13:09:48 +0100 3176118 http://www.medworm.com/index.php?rid=3096808&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F12%2Fbritish-medical-journal-interviews-dr.html About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest.  Our most recent summary of the case was here.  The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.The case was just re-capped in some detail on the occaision of an interview of Dr Blumsohn published in the British Medical J... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3096808 Wed, 16 Dec 2009 20:54:00 +0100 3096808 http://www.medworm.com/index.php?rid=3082380&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F12%2Fperson-no-7-also-known-as-83rd-richest.html This one nearly snuck by.  A Settlement and Some IndictmentsIn May, 2009, we posted that international Swiss-based medical device manufacturer Synthes settled charges that it was paying surgeons who conducted clinical trials for the company with company stock, and in June, 2009, we posted that Synthes was indicted based on allegations that it had subjected patients to an experimental use of its Norian XR bone cement product on the spinal cord, a use not approved by the US Food and Drug Administration, and that its executives had lied to the FDA about these actions.  It was noteworthy that the indictment named but did not charge the then CEO of the company as "Person No. 7" who allegedly decided not to conduct clinical trials of Norian XR, but rather to have surgeons use it in a c... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3082380 Fri, 11 Dec 2009 18:48:00 +0100 3082380 http://www.medworm.com/index.php?rid=3056882&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJB_ObJOoTjc%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? Jazz Pharmaceuticals hired Kathryn Falberg as senior vp and cfo; NovaDigm Therapeutics named R. Gordon Douglas as chairman; Pfizer named Adele Gulfo as US president of its primary care business; Amarin hired Joe Zakrzewski as executive chairman; Cardinal Health added Carrie Cox to its board of directors; Catalent Pharma Solutions hired Paul Burns as vp of global sales; Kfor... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056882 Fri, 04 Dec 2009 13:24:18 +0100 3056882 http://www.medworm.com/index.php?rid=3044707&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F11%2Fhow-industry-views-research-it-sponsors.html We have posted frequently about threats to the integrity of the clinical evidence-based, and to the practice of evidence-based medicine.  In particular, we have discussed how research may be manipulated in favor of vested interests, or suppressed when the results do not favor such interests.Last week, the British Medical Journal electronically published a set of guidelines for how industry sponsored clinical research ought to be published, sponsored by the International Society for Medical Publication Professionals.  The authors came from pharmaceutical companies (Johnson & Johnson, AstraZeneca, Pfizer and Cephalon), medical device companies (LifeScan), and medical publishing and medical education and communication companies (John Wiley... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3044707 Mon, 30 Nov 2009 21:33:00 +0100 3044707 http://www.medworm.com/index.php?rid=2999484&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F11%2Feditorial-that-wasnt-evidence-for.html Woe to those of us who have been advocates for evidence-based medicine.  A short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values. Evidence-based medicine is based on some key assumptions.  One is that a systematic review will reveal all the results of research studies that are relevant to the issue at hand.  A second is that while the research studies may be flawed and imperfect, they are reported honestly.Unfortunately, as we have repeatedly discusse... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2999484 Mon, 16 Nov 2009 21:55:00 +0100 2999484 http://www.medworm.com/index.php?rid=2939250&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F10%2Ffailing-to-report-adverse-effects-of.html We have frequently advocated the evidence-based medicine (EBM) approach to improve the care of individual patients, and to improve health care quality at a reasonable cost for populations. Evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. One can find ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2939250 Wed, 28 Oct 2009 20:55:00 +0100 2939250 http://www.medworm.com/index.php?rid=2930930&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F10%2Fwho-should-sponsor-comparative.html We have tried to argue why comparative effectiveness research is a good idea. To cut and paste what I wrote in a previous post,Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2930930 Mon, 26 Oct 2009 18:34:00 +0100 2930930 http://www.medworm.com/index.php?rid=2923309&cid=t_92639_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F10%2F23%2Fgetting-help-for-depression-online%2F As promised, this is one in a series of posts I’ll write about online interventions that help treat specific mental health concerns. In this post, I’ll talk about some of the depression programs available online. The Australian National University’s Centre for Mental Health Research is one of the unsung heroes in the development and research of programs to treat depression online, for both adults and teens. What they have done over the past decade is not exactly rocket science, and yet, surprisingly, most people have never heard of one of their free online programs. They’ve taken cognitive behavioral theories and techniques and translated them into online tutorials and programs. Then they did something a lot of organizations (and virtually all companies) fail to do ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2923309 Fri, 23 Oct 2009 16:56:20 +0100 2923309 http://www.medworm.com/index.php?rid=2899003&cid=t_92639_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F10%2F15%2Ftreating-depression-and-folate-deficiency-with-medical-foods%2F Midweek Mental Greening First and foremost, I should offer a disclaimer for this post: The scientific media briefing I watched this morning, “Feeding the Brain to Help Manage Depression: The Role of Medical Foods,” was presented by Rakesh Jain, M.D., M.P.H., the Director of Psychiatric Drug Research at R/D Clinical Research Center in Lake Jackson, TX and Teodoro Bottiglieri, Ph.D. of the Baylor Institute of Metabolic Disease, and sponsored by Pamlab, a pharmaceutical company specializing in prescription medical foods. Neither PsychCentral.com nor myself is affiliated with Pamlab or Deplin, the new medical food discussed during the briefing. Now that that’s out of the way, on to the more interesting stuff. “Can we feed the brain to regulate mood disorders?” If you had no exper... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2899003 Thu, 15 Oct 2009 18:25:21 +0100 2899003 http://www.medworm.com/index.php?rid=2832110&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F09%2Freappearance-of-ghost-of-seasons-past.html About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. The early posts were here, here, here, and here. In this post, we summarized the case thus:Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.Despite numerous req... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2832110 Fri, 25 Sep 2009 15:01:00 +0100 2832110 http://www.medworm.com/index.php?rid=2803856&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F09%2Fseeking-justice-for-my-son.html At Healthcare Renewal we often write of the dangers of financial conflict of interest towards medical research and practice.Here is a plea from a father of an 18 year old patient whose death became a cause célèbre against conflict of interest, only to then be swallowed up in the sea of silence known as the "anechoic effect." The plea is in our local newspaper, but deserves much wider attention:Philadelphia Inquirer Posted on Thu, Sep. 17, 2009 Seeking justice for my sonHe died in a gene-therapy trial. Penn and the FDA should release the records.By Paul GelsingerTen years ago today, my 18-year-old son, Jesse Gelsinger, died at the University of Pennsylvania in a gene-therapy trial. Who is responsible? Could his life have been saved? Are other patients at ris... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2803856 Thu, 17 Sep 2009 17:27:00 +0100 2803856 http://www.medworm.com/index.php?rid=2688650&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F08%2Fsixth-international-congress-on-peer.html I just found out that the program of this year's Sixth International Congress on Peer Review and Biomedical Publication, to be held on September 10-12, 2009, in Vancouver, BC, Canada is likely to be of great interest to Health Care Renewal readers. The conference is held every four years on topics relevant to medical journal editors and reviewers, but previous conferences emphasized topics as impact factors, blinded review, open publishing, etc. This year, however, there will sessions on:Authorship and Contributorship - including 3 of 4 presentations on ghost-writingData Sharing and Conflicts of Interest - including 4 of 5 presentations on conflicts of interest in researchPublication Bias - including 3 of 3 presentations which appear to discuss research manipulation and suppression Rhetori... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2688650 Mon, 10 Aug 2009 21:22:00 +0100 2688650 http://www.medworm.com/index.php?rid=2634381&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F07%2Fpseudo-evidence-based-medicine.html As I posted yesterday, the increasingly noisy debate about health care reform in the US has not dealt much with the issues we often discuss on Health Care Renewal. These include problems in how health care organizations are lead which threaten physicians' and other health care professionals' core values using tactics including perverse incentives, deception, and intimidation.Last night, however, President Obama held a news conference mostly devoted to health care issues, in which he stressed the importance of changing not just how health insurance works, but how health care decisions are made. As Newsweek's "The Gaggle" blog reported,Can I guarantee that there are going to be no changes in the health care delivery system? No. The whole point of this is to try to encourage changes that work... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2634381 Thu, 23 Jul 2009 14:27:00 +0100 2634381 http://www.medworm.com/index.php?rid=2441279&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F05%2Fmore-documents-about-selling-of.html We posted earlier this year about how documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). A new crop of documents has just been released, providing yet more insights, as reported by the St Petersburg (Florida) Times:Behind the scenes at the global pharmaceutical company AstraZeneca, the team in charge of the blockbuster antipsychotic Seroquel had one mission: make the multibillion-dollar seller even bigger.To that end, internal company documents released Wednesday show how the British drugmaker hid unfavorable study results, promoted unapproved uses and even considered pitching the drug as less likely to lead to suicidal thinking than comp... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2441279 Fri, 29 May 2009 20:46:00 +0100 2441279 http://www.medworm.com/index.php?rid=2441287&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F05%2Fbreach-of-trust.html This new variation on a now old theme first appeared in the New York Times:A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday. An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.'It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,' Colonel Coots said in a telephone interview on Tuesday. 'So this really was all falsified information.'The former Army surgeo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2441287 Fri, 22 May 2009 18:55:00 +0100 2441287 http://www.medworm.com/index.php?rid=2398639&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F05%2Fattacking-crusaders-against-conflicts.html An editorial appeared in the latest edition of Nature Medicine that suggested "crusaders" are making much too much fuss over insignificant "competing financial interests." [Anonymous. A really serious conflict. Nature Medicine 2009; 15: 463-4]The Editorial's ArgumentsInstead of regarding all conflicts of interest as part of a "monolithic scourge," it suggested we should only attack them in two specific situations.Bad Conflicts of InterestThe first is when it leads to falsification of research data:If there is one reason we need to worry about CFIs [competing financial interests], it is because they could lead to misconduct whenever a researcher has a financial incentive to fabricate data. So, if a clinical trial goes ahead on the basis of fraudulent preclinical work or if a drug is approve... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2398639 Fri, 08 May 2009 18:15:00 +0100 2398639 http://www.medworm.com/index.php?rid=2386951&cid=t_92639_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F04%2Finstitute-of-medicine-report-on-conflicts-of-interest%2F The Institute of Medicine has released a broad-reaching report recommending a number of changes to be implemented in an effort to stop conflicts of interest between doctors, researchers and drug makers. The summary of the recommendations are: 1. Drug companies must disclose any payments they make to doctors, hospitals, and many other institutions. [...] 2. Doctors should no longer accept any free meals, gifts or other items from companies. [...] 3. Doctors must not participate in speakers bureaus for drug companies. 4. Doctors must not do clinical research if they have a financial interest in the outcome of the research. [...] 5. Revamp the system of continuing medical education (CME) so that there is no more industry influence in the content. Dr. Carlat ends with the conclusion, &#8220... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2386951 Mon, 04 May 2009 10:22:21 +0100 2386951 http://www.medworm.com/index.php?rid=2284453&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fblogscan-over-selling-of-seroquel.html The anonymous blogger on the Clinical Psychology and Psychiatry blog has been hard at work on the story of how research on Seroquel (quetiapine, by AstraZeneca) was manipulated and oversold. His latest effort is here. Once again, a major theme is how a "key opinion leader," that is, a prominent medical academic lavishly paid as a consultant or speaker, became overly enthusiastic about his employer's product. Unforunately, academic medicine is now rife with well-paid key opinion leaders. I suspect many may have cause in the future to feel sheepish about their former enthusiasms. Meanwhile, beware marketers in academics' clothing. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2284453 Fri, 20 Mar 2009 18:42:00 +0100 2284453 http://www.medworm.com/index.php?rid=2256082&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fus-president-advocates-for-research.html US President Barack Obama announced a new emphasis on the integrity of science used to help make public policy decisions. As summarized by the NY Times,President Obama’s directive on Monday to 'guarantee scientific integrity' in federal policy making could have a far-reaching impact....The document orders Mr. Obama’s top science adviser to help draft guidelines that will apply to every federal agency. Agencies will be expected to pick science advisers based on expertise, not political ideology, the memorandum said, and will offer whistle-blower protections to employees who expose the misuse or suppression of scientific information.The idea, the president said in remarks before an audience of lawmakers, scientists, patients advocates and patients in the East Room, is to ensure that 'we ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2256082 Tue, 10 Mar 2009 17:23:00 +0100 2256082 http://www.medworm.com/index.php?rid=2256083&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fblogscan-example-of-spinning-clinical.html On the Clinical Psychology and Psychiatry blog, the anonymous blogger did a great job analyzing an article supported by pharmaceutical companies, and authored by in part pharmaceutical company employees, with the assistance of a medical education and communications company (MECC). The article ignored data about outcomes which were unfavorable to the companies' product, and dubbed a drug "well tolerated" even though a number of uncomfortable symptoms occurred two to four times as often on the drug as on placebo. This is a reminder of how often these days clinical research studies are spun in favor of the vested interests of their commercial sponsors. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2256083 Tue, 10 Mar 2009 15:48:00 +0100 2256083 http://www.medworm.com/index.php?rid=2222463&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F02%2Fburied-data-smoke-and-mirrors-job-and.html Documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). As reported by Bloomberg,AstraZeneca Plc 'buried' unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine.The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in 'cherry picking' of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2222463 Fri, 27 Feb 2009 21:54:00 +0100 2222463 http://www.medworm.com/index.php?rid=2152809&cid=t_92639_113_f&fid=34634&url=http%3A%2F%2Fwww.emrandhipaa.com%2Femr-and-hipaa%2F2009%2F02%2F02%2Fcchit-certification-thoughts%2F I just came upon a blog post on the TempDev blog that talks about the expansion of CCHIT certification into a number of new specialty categories. It’s really interesting to look at the list of new categories: Behavioral Health Clinical Research Dermatology Oncology Advanced Interoperability Advanced Quality (in reference to Quality Measures) Advanced Clinical Decision Support Long Term Care OB/GYN As noted by Ben, these are in addition to the HIE and PHR categories added for 2009. Well, I never back away from a discussion about CCHIT. I just wonder why the Senate hasn’t called me up to a hearing to talk about CCHIT certification. Of course, my friend Al Borges would do much better than I, but I digress. After reading through Ben’s post about the expansion of CCHIT I had... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=2152809 Tue, 03 Feb 2009 07:35:07 +0100 2152809 http://www.medworm.com/index.php?rid=1996248&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F11%2Fwhat-me-worry-academic-leaders.html A few weeks ago, the Boston Globe published an investigative report on differences in reimbursements insurers and managed care organizations provide to different hospitals and hospital systems. One major bullet point was that the Partners HealthCare system, whose flagship hospitals include the Massachusetts General Hospital and the Brigham and Womens Hospital, received higher reimbursement rates than other well-known hospital and health care systems. A second was by some measures of quality, the major Partners teaching hospitals did not do better than other Boston hospitals.In the resulting debate in the blogsphere (for example, see these posts and accompanying comments, on the Running a Hospital blog, and on the Movin' Meat blog,) some argued perhaps Partners really did deserve the extra ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1996248 Fri, 28 Nov 2008 16:38:00 +0100 1996248 http://www.medworm.com/index.php?rid=1975000&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F11%2Fwas-gsk-merely-incompetent-about.html At my post "GSK, Avandia and Medical Informatics: More on Why Pharma Fails" I outlined repeated rejection of Medical Informatics expertise by GSK, based on what I believed essentially to be the narrowminded and tunnel-visioned thinking of information technologists and others in pharma. I wrote:It is my belief that a view [at GSK] of medical informatics professionals as "writers of algorithms to solve business problems" reflects a fundamentally narrow and mechanistic view of the field, or perhaps a mislabeling of the position as being one of Medical Informatics. The lack of a requirement for formal Medical Informatics education and training suggests the latter.The U.S. Institute of Medicine (IOM) of the National Academy of Sciences seems to agree with that assessment, as I pointed out in an... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1975000 Wed, 19 Nov 2008 20:24:00 +0100 1975000 http://www.medworm.com/index.php?rid=1915073&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F433454093%2F And welcome back to the working week. Nice to see you again and we hope your weekend was pleasant. We tended to the short people and finished a good book. Now, though, the routine is upon us. So as we grab our sacred cup of stimulation, here are a few developments of interest. Have a good day everyone… Merck Diarrhea Vaccine Cut Cases In Non-Immunized (Bloomberg News) Clinical Research Jobs Forecast To Boom In India (Financial Express) Pfizer Mines For Biotech Gold In Australia (The Age) Pfizer & Merck HIV Meds Match Bristol Treatment (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1915073 Mon, 27 Oct 2008 10:52:22 +0100 1915073 http://www.medworm.com/index.php?rid=1886335&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F10%2Fmisuses-of-ebm.html In an excellent article(1) just published in JAMA on progress in evidence-based medicine, Montori and Guyatt devote a section to the misuses of EBM, worth quoting in its entirety herewith emphasis added.An analogy can be made between EBM and nuclear fission: it can be very powerful when used appropriately and dangerous when used inappropriately. The term evidence-based precedes many recommendations, guidelines, and algorithms that are not transparently linked to the underlying evidence base and do not represent the results of a systematic and critical appraisal of that evidence. It sometimes appears as if using the term obviates the need to describe the quality of underlying evidence, the magnitude of effects, or the applicability of any of the results in the context, values, and preferenc... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1886335 Fri, 17 Oct 2008 15:40:00 +0100 1886335 http://www.medworm.com/index.php?rid=1873028&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F10%2Fnemeroff-case-vs-anechoic-effect.html The saga of Dr Charles Nemeroff was most recently discussed on Health Care Renewal here and here. We had first posted about his failure to disclose relevant conflicts of interest relating an article he wrote for a journal he also edited here. Other posts about Nemeroff's questionable behavior are here, here. Nemeroff has also starred in numerous posts on the Clinical Psychology and Psychiatry Blog, amongst others.Now the tale of how Nemeroff raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while he ran a US government funded project meant to evaluate some of the products of his commercial sponsors, has splashed across major newspapers. There has been a lot of good discussion about the case in the blogsphere. (We await, of co... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1873028 Mon, 13 Oct 2008 19:50:00 +0100 1873028 http://www.medworm.com/index.php?rid=2511020&cid=t_92639_109_f&fid=37784&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fpsychblog%2F%7E3%2F2-2ykFkoVPc%2Fgreys-anatomy-as-health-promotion-really-662.html This study shows the enormous potential for entertainment television to serve as a health educator.” This obviously raises many questions as far as health promotion goes.  Firstly, that the medium of television, and more importantly entertainment programmes can be very powerful in getting positive messages and health awareness out to the viewers. However, this power has to be used carfully – if viewers believe that the information they are ‘absorbing’ from medical entertainment programmes are accurate (as almost 60% of viewers do) we need to ensure that there’s no false or misleading information in these programmes.  A real double-edged sword. Tags: A2, adverts, health, health promotion, prevention, Research (Source: PsychBLOG.co.uk) PsychBLOG.co.uk blogs http://www.medworm.com/rss/comments.php?id=2511020 Fri, 10 Oct 2008 00:00:50 +0100 2511020 http://www.medworm.com/index.php?rid=1865440&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F10%2Fdid-pfizer-marketers-suppress-and.html Here we go again. Multiple media sources reported on allegations that Pfizer Inc, the world's largest pharmaceutical company, attempted to manipulate and suppress clinical research results unfavorable to one of its products. Per the Wall Street Journal,Pfizer Inc. marketers urged the suppression of medical studies that reached unfavorable conclusions about the effectiveness of the company's big-selling drug Neurontin [gabapentin], according to internal Pfizer documents submitted in a lawsuit against the company.In 2004, Pfizer's Warner-Lambert unit pleaded guilty to felony charges that it promoted Neurontin for uses not approved by the Food and Drug Administration, including bipolar disorder and chronic nerve pain. The FDA originally approved the drug as an antiseizure treatment for epilep... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1865440 Thu, 09 Oct 2008 23:30:00 +0100 1865440 http://www.medworm.com/index.php?rid=1825537&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F09%2Fbrown-university-student-journalists.html This article provided confirmation that Senator Charles Grassley (R-Iowa) and the US Senate Finance Committee is, in fact, investigating Dr Keller and Brown University in connection with the controversy. It also included other original reporting, including an acknowledgement from GlaxoSmithKline Director of US Media Relationships Sarah Alspach that the company had provided the committee with full information about the compensation it gave Dr Keller.The second provided a quite clear explanation of the allegations about the manipulation of Study 329. This article also included results of an interview with Dr Jon Jureidini, the author of an article that dissected study 329, and suggested that it had been manipulated to enhance the apparent benefits of paroxetine, and diminish its apparent ris... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1825537 Wed, 24 Sep 2008 19:33:00 +0100 1825537 http://www.medworm.com/index.php?rid=1759835&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F09%2Fblogscan-more-on-jama-commentaries-on.html We recently blogged about Dr Marcia Angell's commentary about how the increasing influence of those with vested interests in selling products or services has "broken" the clinical research system. In the same issue of JAMA were two other commentaries. For further discussion of Dr Arnold Relman's call to end industry influence on continuing medical education, see this post by Dr Daniel Carlat in the Carlat Psychiatry Blog. For further discussion of all three JAMA commentaries, see this post by Merrill Goozner on the GoozNews blog. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1759835 Wed, 03 Sep 2008 20:29:00 +0100 1759835 http://www.medworm.com/index.php?rid=1754637&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F09%2Fdr-marcia-angell-on-reforming-broken.html This week's Journal of the American Medical Association (3 September, the paper version of which seems to arrive early at my house) is notable for having three commentaries on relationships among physicians, academic medicine, and industry. One, by David Rothman and Susan Chimonas, seemed rather optimistic, while two, by Dr Arnold Relman and by Dr Marcia Angell, were quite dark.The latter [Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008; 300: 1069-1071. Link here when available] should be required reading for anyone who worries about the issues we raise on Health Care Renewal. Dr Angell provided an excellent summary of how commercial "sponsors" have come to dominate clinical research, and thus ensure that the resulting studies favor their vested interests. My onl... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1754637 Tue, 02 Sep 2008 16:59:00 +0100 1754637 http://www.medworm.com/index.php?rid=1720300&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F08%2Fadvantage-who-was-actually-in-charge-of.html Roy Poses addresses many of the controversial issues raised by the Annals of Internal Medicine article "The ADVANTAGE seeding trial: a review of internal documents" in "Bad Seed: the ADVANTAGE Trial of Vioxx."I wish to raise a few additional questions:The Wall Street Journal and others pointed out that Edward Scolnick, MD, President of Merck Research Labs and largely seen as the #2 official in the company, worried that the ADVANTAGE study risked disclosing data to the Food and Drug Administration that could cause problems for Vioxx. "Small marketing studies which are intellectually redundant are extremely dangerous," Scolnick said.I believe Dr. Scolnick was, as I've written before at this HCRENEWAL post, the quintessential clinician/scientist of excellence. He apparently held the following... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1720300 Wed, 20 Aug 2008 16:18:00 +0100 1720300 http://www.medworm.com/index.php?rid=1717124&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F08%2Farticle-in-annals-of-internal-medicine.html This article appears to be the first to provide evidence that pharmaceutical companies may deliberately disguise marketing efforts as clinical research. This is a real achievement, since obviously the companies involved make every effort to hide what they are doing, and it only through discovery during litigation did the facts come out.The authors conclude thatAt least 3 elements of seeding trials are harmful to science and society. First, full informed consent is not possible without disclosing the full purpose of the trial. Physicians and patients participating in ADVANTAGE were informed of the scientific objectives of the study, but the research protocol and informed consent templates indicate that they were not told about the key role of Merck's marketing division in the trial or the t... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1717124 Tue, 19 Aug 2008 19:12:00 +0100 1717124 http://www.medworm.com/index.php?rid=1708996&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F08%2Fmore-questions-about-conflicts-of.html Two years ago, we posted about questions whether the "Surviving Sepsis" campaign was driven by marketing as well as science. Then, we discussed a commentary in the New England Journal of Medicine which asserted that the campaign was part of an effort by Eli Lilly & Co to market Xigris (recombinant human activated protein C, or rhAPC, also known as drotrecogin alfa [activated]) for the treatment of sepsis.(1)The Wall Street Journal just published an article questioning another aspect of that campaign. In 2001 a clinical trial in the New England Journal of Medicine by Rivers et al reported favorable results for early goal-directed therapy in the treatment of sepsis.(2) This therapy incorporated continuous monitoring of oxygen in the blood using a special central venous catheter capable ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1708996 Sat, 16 Aug 2008 21:04:00 +0100 1708996 http://www.medworm.com/index.php?rid=1686190&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F08%2Fcourting-tobacco-money.html We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1686190 Wed, 06 Aug 2008 20:42:00 +0100 1686190 http://www.medworm.com/index.php?rid=1671467&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F07%2Fcancer-data-collection-outsourced-and.html I have a favorite quote about the impossibly complex bureaucratic structure of the American health care system from Oxymorons by JD Kleinke,(1) (which I used in my "Cautionary Tale" article in the European Journal of Internal Medicine[2]):Tens of thousands of well-meaning people work throughout the health care system, none of whom ever see a patient or deliver any actual medical care. They preside over an infinity of rules, regulations, forms, processes, contract outsourcing, financial brokering, benefit plan tinkering, analytical processes, incompatible data systems, and dead forests of paperwork. Health care administration in America is a tower of Babel that reaches to the moon.... It seems impossible to keep track of all the administrative, managerial and bureaucratic organizations that... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1671467 Thu, 31 Jul 2008 15:14:00 +0100 1671467 http://www.medworm.com/index.php?rid=1652285&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F07%2Fattacking-side-effects-with-logical_24.html ConclusionWhat Galenberg's review did not do is meaningfully address the facts presented in the book, and Bass' main interpretation of them. Side Effects argued that clinical research evidence specifically about the safety of SSRIs for children and adolescents, not adults was suppressed and manipulated. In fact, there is now considerable evidence that SSRIs may have risks for children and adolescents that were not appreciated until recently, and may not be very efficacious for younger patients. For example, the systematic review by Whittington et al included published and unpublished data from randomized controlled trials of SSRIs in children and adolescents.(3) Its abstact concluded "published data suggest a favourable risk-benefit profile for some SSRIs; however addition of unpublished d... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1652285 Thu, 24 Jul 2008 14:59:00 +0100 1652285 http://www.medworm.com/index.php?rid=1537884&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F06%2Fclinical-trials-torture-economy.html Two recent commentaries in major medical journals on the same topic failed to get the recognition they deserved. Both were about exploitation of the poor in clinical research, usually in Phase I drug trials conducted by contract research organizations (CROs), supervised by for-profit institutional review boards (IRBs), and both paid by pharmaceutical, biotechnology or device companies.The first article was by Carl Elliott and Roberto Abadie. [ Elliott C, Abadie R. Exploiting a research underclass in phase I clinical trials. N Engl J Med 2008; 358: 2316-7. Link here.] Per Elliott and Abadie, the context is:Over the past decade, clinical trials have moved from universities to private testing sites, the pressure to recruit subjects quickly has intensified, and ethical oversight has been outso... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1537884 Mon, 23 Jun 2008 19:26:00 +0100 1537884 http://www.medworm.com/index.php?rid=1420404&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F05%2Fanother-conflicted-defense-of-conflicts.html It seems to be the season for defenses of financial relationships among medical academics and health care corporations to appear in the media. The latest example appeared last week in the Boston Globe as an op-ed [Shaywitz DA, Auseillo DA. Scientific research with an asterisk. April 29, 2008.]Like other articles in this genre, the authors incorporated a number of logical fallacies into their arguments.In particular, they attacked a series of straw-men. Consider, to start,The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them.The straw-man above is in italics. The argument is much more broad than mos... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1420404 Mon, 05 May 2008 18:33:00 +0100 1420404 http://www.medworm.com/index.php?rid=1409693&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F04%2Fselective-reporting-of-study-329.html A new study in a rather obscure journal has revealed more about the now infamous study 329. [Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008; 20: 73-81. Link here.]For the background, let me take the easy way out, and quote Ed Silverman from PharmaLot:Back in 2001, an infamous study was published in the Journal of the American Academy of Child and Adolescent Psychiatry that declared Glaxo’s [GlaxoSmithKline, GSK] Paxil antidepressant - called Seroxat in the UK - [paroxetine] was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the drug, which became a huge seller.Of course, the study was later held in disrep... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1409693 Wed, 30 Apr 2008 15:34:00 +0100 1409693 http://www.medworm.com/index.php?rid=1382320&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F04%2Fanother-example-of-manipulation-of.html We have posted frequently about manipulation of clinical research by those with vested interests in having the research turn out a certain way. (Try clicking on the label "manipulating clinical research" below.) A recent JAMA article, companion to the article on ghost writing and guest authorship which we have already discussed, provided another vivid example of the manipulation of clinical research. [Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA 2008; 299: 1813-1817. Link here.]Basically, the article was a case-study of how mortality results of trials of rofecoxib (Vioxx, by Merck, now off the market) were reported. The article focused on two clinical ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1382320 Fri, 18 Apr 2008 15:44:00 +0100 1382320 http://www.medworm.com/index.php?rid=1376680&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F04%2Fghosts-come-home-to-roost.html This article should be required reading not just for anyone interested in ghost writing, but for anyone concerned about what has gone wrong with health care. The main points of the paper were: Merck used a systematic strategy to facilitate the publication of guest authored and ghost written medical literature. Articles related to rofecoxib were frequently authored by Merck employees but attributed first authorship to external, academically affiliated investigators who did not always disclose financial support from Merck, although financial support of the study was nearly always provided. Similarly, review articles related to rofecoxib were frequently prepared by unacknowledged authors employed by medical publishing companies and attributed authorship to investigators who often did not disc... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1376680 Wed, 16 Apr 2008 18:56:00 +0100 1376680 http://www.medworm.com/index.php?rid=1234813&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235528472%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs being announced each month. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? rfXcel hires Tom Pizzuto as vp of client services; BiPar Sciences hires Hoyoung Huh as ceo and president; AVI BioPharma hires Leslie Hudson as ceo; Ipsos hired Fred LaManna as senior vp; Codexis hired Nicholas Green as president; Cytel Clinical Research Services hired Irving Dark as vp; Memory Pharma names Vaughn Kailian as interim president and c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1234813 Fri, 15 Feb 2008 12:28:48 +0100 1234813 http://www.medworm.com/index.php?rid=1229204&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F02%2Fblogscan-more-on-manipulation-of-paxil.html On the Clinical Psychology and Psychiatry blog, this post dissected allegations that GlaxoSmithKline manipulated data about suicidal ideation as an adverse effect of the drug Paxil (paroxetine , Seroxat in the UK ). (See our related post here.) The post concentrated on how key opinion leaders allayed fears about these advere effects based on summaries of data that had been processed by the company, data the company may have manipulated. Meanwhile, on the Scientific Misconduct Blog, Dr Aubrey Blumsohn noted how the current CEO of GSK chastised journalists for reporting on scientific data (unfavorable to the company) before scientists had looked at it, which makes more sense if the scientists to whom he was alluding were the sorts who are inclined to accept company processed data as is. (So... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1229204 Wed, 13 Feb 2008 19:09:00 +0100 1229204 http://www.medworm.com/index.php?rid=1156749&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F01%2Fwhy-should-patients-continue-to-take.html We have posted before (as have many others, see below) about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how the trial was designed and implemented seemed meant to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected. That decision was then reversed. Later, it turned out that this decision was at the behest of a supposedly "independent" panel, but one which included a majority of members who had previous financial ties to Merck and/or Schering-Plough.Under intense media pressure, the results of this study were just released. As summarized by theHeart.org, th... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1156749 Wed, 16 Jan 2008 21:31:00 +0100 1156749 http://www.medworm.com/index.php?rid=1146250&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F01%2Fwho-decided-to-change-outcome-variable.html We have posted before (as have many others, see below) about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how the trial was designed and implemented seemed meant to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected. That decision was then reversed.Today, Matthew Herper, writing in Forbes, described how the decision to change the outcome variable was made. First, the decision was made apparently entirely without any involvement by the ostensible principle investigator of the study.Forbes has learned that the lead investigator charged with conducting the stu... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1146250 Fri, 11 Jan 2008 19:30:00 +0100 1146250 http://www.medworm.com/index.php?rid=1126149&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F01%2Fblogscan-anomalies-of-arise-rd-trial.html On the Clinical Psychology and Psychiatry blog, this post summarizes some numerous curious anomalies of the ARISE-RD study of rispiridone, [Risperdal, by Janssen, a subsidiary of Johnson and Johnson] which were recently summarized by a letter to the journal Neuropsychopharmacology by Health Care Renewal blogger Bernard Carroll [Carroll B. Effects of risperidone augmentation in patients with treatment-resistant depression: results of open-label treatment followed by double-blind continuation. Neuropsychopharmacology 2007, advance online publication]. This is yet another example of how the design, implementation, analysis and dissemination of clinical research studies may be manipulated by research sponsors who have vested interests in having the studies reflect favorably on the sponsors' pr... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1126149 Wed, 02 Jan 2008 18:55:00 +0100 1126149 http://www.medworm.com/index.php?rid=1100077&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F12%2Fmanipulation-of-enhance-reversed.html We, and many others have written about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how aspects of it seemed meant to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected. After considerable public discussion, and the threat of a US congressional investigation, things have changed, as Ron Winslow reported in the Wall Street Journal,The lead researcher of a long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1100077 Mon, 17 Dec 2007 21:36:00 +0100 1100077 http://www.medworm.com/index.php?rid=1057287&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F11%2Fhealth-wonk-review-health-care-renewal.html We present this edition of Health Wonk Review in this spirit, and with an organizational framework derived from the discussion above. We feature submissions by many HWR regulars, but also note posts in many of the newer blogs that too are concerned with the dark side of health care.Health Care Reform and Policy in GeneralOn the Health Care Policy and Marketplace Review, Bob Laszewski noted the lack of differences among the health care reform proposals of the current US candidates for the presidency, suggesting "that you not cast your caucus or primary vote for a candidate based upon their health care reform plan because from 'thirty thousand feet' there isn't all that much difference" among them. GovernanceOn Health Care Renewal, we have posted frequently on payments made by medical device... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1057287 Wed, 28 Nov 2007 15:17:00 +0100 1057287 http://www.medworm.com/index.php?rid=1051215&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F11%2Fis-it-clinical-research-or-is-it.html The story of the delay in reporting results of the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck) was reported by Matthew Herper in Forbes, Alex Berenson in the New York Times, and theHeart.org and MedScape. Then several prominent skeptical bloggers, including Howard Brody on the Hooked: Ethics Medicine, and Pharma blog, Dr Aubrey Blumsohn on the Scientific Misconduct Blog, and Dr Scott Aberegg on the Medical Evidence Blog analyzed the situation. Therefore, I need not post a lot of detail.Basically, although ezetimibe has been shown to reduce LDL ("bad") cholesterol, it has never been shown that using the drug to do so produces any clinical benefit, e.g., prevents heart attacks or strokes, prolongs life, etc. The ENHANCE trial was designed to... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1051215 Mon, 26 Nov 2007 15:38:00 +0100 1051215 http://www.medworm.com/index.php?rid=1043980&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F11%2Fblogscan-another-case-of-attempted.html A little late for Halloween is this post on the WSJ Health Blog describing a vivid anecdote of an unsuccesful attempt by a medical education and communication company (MECC) to generate a ghost-written abstract for a medical scientific meeting. (Our most recent post on ghost-writing and related pheonomena was here, summarizing an article by Moffatt and Elliott that characterized ghost-writing as harmful to people and undermining science.) (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1043980 Wed, 21 Nov 2007 19:57:00 +0100 1043980 http://www.medworm.com/index.php?rid=1041883&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F188311442%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. Here are some of the latest moves… Watson Pharmaceuticals hired Mark Durand as senior vp and cfo; Polymedix appointed Bozena Korczak vp of drug development; Interbrand Wood Healthcare chose Jane Parker as ceo; APCO Worldwide hires Linda Distlerath, a former Merck heatlh policy vp, as sr vp; Wyeth tapped Andy Davidson, vp for internal audit, as principal corporate officer; Helix BioPharma says Don Segal remains ceo, but John Docherty becomes prez; CellCyte Genetics taps Tony Colasin as director of bus... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1041883 Wed, 21 Nov 2007 14:53:35 +0100 1041883 http://www.medworm.com/index.php?rid=1012326&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F11%2Fclinical-trial-results-lost-in-mist.html This study question was based on the finding that patients who had their PTOs closed after a stroke had fewer migraines. Initially, the trial had two principal investigators, Dr Peter Wilmshurst, "cardiology principal investigator," a noted British cardiologist, and Dr Andrew Dowson, "lead headache specialist," who is "not in fact a neurologist," and who has "'undertakings,' or restrictions [on his practice] relating to past research misconduct." The trial was sponsored by NMT Medical, the manufacturer of STARflex.The trial failed to show any advantage due to PTO closure. One theory raised to explain this was that patients often still had shunt flow across heart chambers after the procedure. Dr Wilmshurst was sent all patients' echocardiograms for independent review. Wilmshurst did find a ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1012326 Wed, 07 Nov 2007 15:01:00 +0100 1012326 http://www.medworm.com/index.php?rid=944517&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F10%2Fretrieving-cases-from-memory-hole.html At the Scientific Misconduct Blog, Dr Aubrey Blumsohn has instituted his new "Memory Hole" feature. To quote Dr Blumsohn, a memory hole is "a mechanism for removing embarrassing documents, previous crimes and inconvenient bungles. Old documents are revised, and the original copies are consigned to the memory hole where 'not even the ash remains.' It is a mechanism for "smoothing over" the actions of leadership. It is a mechanism of censorship. It is about collective amnesia."In this feature, which so far has run daily over three days in a "this day in history" format, Blumsohn summarizes important cases of "corruption and poor leadership in science and academia in general, editorial misconduct, the forgotten lessons we should not forget...." Some of these cases are still on-going, but many... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=944517 Thu, 11 Oct 2007 15:33:00 +0100 944517 http://www.medworm.com/index.php?rid=927837&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F10%2Fblogscan-limits-of-clinical-trial.html On the Clinical Psychology and Psychiatry Blog, this post points out why we should not be too optimistic that clinical trials registries will on their own solve all the problems due to manipulated clinical research. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=927837 Thu, 04 Oct 2007 16:03:00 +0100 927837 http://www.medworm.com/index.php?rid=906027&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F09%2Fhaunted-health-care-scope-of-ghost.html An important new article in PLoS Medicine expanded thinking about the involvement of pharmaceutical companies (and possibly other health care corporations) in the shaping of clinical research. [Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by industry? PLoS Med 4(9): e286 doi:10.1371/journal.pmed.0040286]Sismondo defined ghost management of medical research and publishing:when pharmaceutical companies and their agents control or shape multiple steps in the research, analysis, writing, and publication of articles. Such articles are 'ghostly' because signs of their actual production are largely invisible—academic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility. T... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=906027 Wed, 26 Sep 2007 18:08:00 +0100 906027 http://www.medworm.com/index.php?rid=835413&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F08%2Fconflicted-view-on-pitfalls-of.html Many of have raised concerns that physicians too often favor the latest, most expensive, most high-technology, and sometimes most invasive treatments, contributing to the high costs and often bad outcomes of health care. One solution would be better research comparing the various possible treatments for particular problems. Yet some worry that this approach, too, has its problems.The Wall Street Journal just printed a commentary warning about the dangers of government-sponsored studies comparing treatment effectiveness, written by Dr Scott Gottlieb, described as "a physician and resident fellow at the American Enterprise Institute, ... a former senior official at the Food and Drug Administration and the Centers for Medicare and Medicaid Services."Dr Gottlieb raised some good points about p... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=835413 Fri, 31 Aug 2007 15:12:00 +0100 835413 http://www.medworm.com/index.php?rid=777576&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F08%2Fhow-legal-case-against-purdue-for.html We recently posted about how Purdue Pharma and its top executives pleaded guilty to "misbranding" the potent narcotic drug Oxycontin. It turns out the pleas bargain was almost derailed. Yesterday, the Washington Post reported,The night before the government secured a guilty plea from the manufacturer of the addictive painkiller OxyContin, a senior Justice Department official called the U.S. attorney handling the case and, at the behest of an executive for the drugmaker, urged him to slow down, the prosecutor told the Senate Judiciary Committee yesterday.John L. Brownlee, the U.S. attorney in Roanoke, testified that he was at home the evening of Oct. 24 when he received the call on his cellphone from Michael J. Elston, then chief of staff to the deputy attorney general and one of the Justic... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=777576 Fri, 03 Aug 2007 21:16:00 +0100 777576 http://www.medworm.com/index.php?rid=755594&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fblogscan-when-scientists-disagree-with.html On the Hooked: Ethics, Medicine, and Pharma Blog, Howard Brody discusses how Wyeth's chief of research and development responds to any disagreements by his scientists, "It's not a democracy. You want democracy? Go to Russia." Leaving aside the global political issues, he went on to say that the big question is "whether rigid scientific mindsets will be a barrier to further productivity gains at drug companies less interested in top-to-bottom transformation than Wyeth." Brody's key question: "How far can you shoehorn science into a business-productivity model, before science has been turned on its head completely into marketing and PR?" (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=755594 Tue, 24 Jul 2007 21:28:00 +0100 755594 http://www.medworm.com/index.php?rid=728654&cid=t_92639_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F132676849%2F The commercialization of clinical trials is becoming a hot topic. Last week, we read the tale of PPD, the big clinical research organization, which took a big stake in cash-starved Accentia BioPharma and hopes to earn 14 percent on royalties if a sinus drug its testing for the company gets approved by the FDA. Beyond the excitement of a good deal for whichever corporation is involved, at issue is the patient. The PPD deal with Accentia was criticized, by some, as a conflict of interest, while others either defended the arrangement or downplayed any problems. So we asked you to vote whether the deal is, indeed, a conflict. Here are the results…. Yes - 52 voters, or 78 percent, agreed the deal is a conflict; No - 15 voters, or 22 percent, disagreed. Total Voters: 67 Granted, this isn&#... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=728654 Wed, 11 Jul 2007 15:43:21 +0100 728654 http://www.medworm.com/index.php?rid=714691&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fblogscan-data-from-key-adhd-study.html On the Scientific Misconduct Blog, Dr Aubrey Blumsohn posted about the intriguing Gillberg affair. After a key article on attention deficit hyperactivity disorder (ADHD) was challenged, researchers destroyed the study's data rather than letting it be subject to an outside review (although they claimed that letting outsiders review the data would violate confidentiality assurances given subjects.) The principal investigator eventually was convicted of criminal charges in Sweden. Yet these shaky underpinnings of the popular ADHD diagnosis are not well known, and the journal in whom the key article reporting the study appeared has not been willing to publicly retract or qualify it. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=714691 Wed, 04 Jul 2007 20:31:00 +0100 714691 http://www.medworm.com/index.php?rid=713099&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fblogscan-pfizer-to-demand-clinical.html On PharmaLot is a post on the new proposal by Pfizer Inc to demand that any site that performs clinical trials sponsored by the company not perform trials sponsored by any other company. This appears to take the commercialization of clinical research to a new level. The company did not address the ethics of this stance, or how it might impact trial participants. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=713099 Tue, 03 Jul 2007 21:39:00 +0100 713099 http://www.medworm.com/index.php?rid=707619&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fyet-another-species-of-health-care.html The St. Petersburg (Florida) Times has an interesting story about the relationships between contract research organizations (CROs) and biotechnology and pharmaceutical companies.Like many startup businesses, Accentia BioPharmaceuticals of Tampa was long on dreams but short on cash.It held the license to an experimental sinus drug that looked like a potential blockbuster. But the company needed serious bucks to get the product to market.Accentia found an investor in PPD Inc., a company that specializes in running the studies that must be conducted before regulators can approve a drug.A year after recruiting PPD as an investor, Accentia went looking for someone to run the all-important trials proving the safety and effectiveness of its sinus drug.Guess who got the job.Now PPD is not only the... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=707619 Sun, 01 Jul 2007 21:28:00 +0100 707619 http://www.medworm.com/index.php?rid=687698&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Fdid-conflicts-of-interest-affect-review.html This article has received no attention in the press, as far as I can tell. Note that the main benefit of warfarin after DVT is supposed to be prevention of extension and new clots, not postponement of death. However, Cundiff is certainly correct that the use of warfarin entails the risk of major, sometimes disabling or fatal bleeding, so that mortality should be assessed in any trials of this drug.Note further that the article did not disclose the identity of the reviewers with alleged conflicts of interest, nor the nature of their alleged conflicts. Nonetheless, add this to other cautionary tales about how financial entanglements can influence the design, execution, and in this case, dissemination and discussion of clinical research. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=687698 Thu, 21 Jun 2007 15:21:00 +0100 687698 http://www.medworm.com/index.php?rid=682499&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Fwall-street-journal-gives-avandia-whirl.html We previously have posted quite a bit about what now can be called the Avandia case, which started recently with the publication in the New England Journal of Medicine by Nissen and Wolski of a meta-analysis focused on cardiac adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) (see post here) More recently, we noted how this case has generated its own spin cycle, spinning off multiple obfuscations which distract from what I at least, in my humble opinion, ought to be the main points for patients and physicians.Now the Wall Street Journal has published a major editorial which gives it another whirl. Like some previous efforts, it raises methodological questions about the Nissen and Wolski meta-analysis,Meta-analysis can be a useful contribution to medical knowledge, but it is in... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=682499 Tue, 19 Jun 2007 21:15:00 +0100 682499 http://www.medworm.com/index.php?rid=674872&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Fblogscan-historic-parallels-to.html On the Scientific Misconduct Blog, Dr Aubrey Blumsohn links to some recent blog posts questioning the current conduct of one of the key figures in the case of alleged manipulation and suppression of research about paroxetine, (Paxil, or Seroxat in the UK, made by GlaxoSmithKline.) And Dr Blumsohn reports the results of some historic research on allegations of questionable conduct by that same researcher, and the lackadaisical monitoring of that conduct by the university where he still works. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=674872 Thu, 14 Jun 2007 21:04:00 +0100 674872 http://www.medworm.com/index.php?rid=674874&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Fblogscan-pfizer-trumpets-good-news.html On both Pharmalot and the Wall Street Journal Health Blog are posts about how Pfizer Inc., the world's largest drug company, trumpeted the 14% superiority of its cholesterol lowering drug Lipitor (atorvastatin) over generic simvastatin based on an observational study, then recently very quietly filed a statement with the US Securities and Exchange Commission (SEC) of all places noting that the original findings were incorrect, and that Lipitor did not show a statistically significant advantage over simvastatin. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=674874 Thu, 14 Jun 2007 20:45:00 +0100 674874 http://www.medworm.com/index.php?rid=658713&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F06%2Fwhich-physicians-pharmaceutical.html The New York Times published an article by Gardiner Harris and Janet Roberts about what sort of physicians participate in clinical trials sponsored by pharmaceutical companies in Minnesota. Using a data-base, unique to that state, of pharmaceutical company payments to physicians, they looked for physicians who were paid to participate in trials and had also been subject to medical board sanctions or criminal convictions. Surprise, surprise, they found some:The Times's examination of Minnesota's trove of records on drug company payments to doctors found that from 1997 to 2005, at least 103 doctors who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment over that period was $1,250; the largest was $479,000.The sa... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=658713 Mon, 04 Jun 2007 13:06:00 +0100 658713 http://www.medworm.com/index.php?rid=628955&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F05%2Fdream-turns-to-nightmare-avandia-and.html The just released meta-analysis published in the New England Journal of Medicine that suggests that rosiglitazone (Avandia, by GlaxoSmithKline) is associated with increased cardiovascular risks [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] has received a tremendous amount of media attention. So let me just summarize the story in a chronological way to emphasize some particular issues, based on Anna Wilde Mathews reporting today in the Wall Street Journal.Dr. Nissen began following Avandia closely and was struck last year by the results of two major trials of the drug, published in the New England Journal of Medicine and the Lancet. The two studies showed the drug was effective i... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=628955 Tue, 22 May 2007 19:56:00 +0100 628955 http://www.medworm.com/index.php?rid=611607&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F05%2Fguilty-pleas-for-purdue-pharmas.html One of the most striking cases of deceptive pharmaceutical marketing has just reached sort of a resolution. Purdue Pharma and its top executives have just plead guilty to "misbranding" the potent narcotic drug Oxycontin. As reported, for example, in the New York Times,The company that makes the narcotic painkiller OxyContin and three current and former executives pleaded guilty today in federal court here to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused.To resolve criminal and civil charges related to the drug’s “misbranding,” the parent of Purdue Pharma, the company that markets OxyContin, agreed to pay some $600 million in fines and other payments, one of the largest amounts ever paid by a drug... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=611607 Thu, 10 May 2007 18:59:00 +0100 611607 http://www.medworm.com/index.php?rid=594296&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F05%2Fblogscan-curious-change-in-finding-from.html On the Clinical Psychology and Psychiatry blog is a post about a curious change in the findings from a trial of the atypical anti-psychotic resperidone in depression. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=594296 Mon, 07 May 2007 18:23:00 +0100 594296 http://www.medworm.com/index.php?rid=528788&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F04%2Fannals-of-internal-medicine-shows.html The Annals of Internal Medicine just published a clinical trial that compared a new type of anti-diabetic drug, exenatide, (Byetta, from Eli Lilly & Co, and Amylin) an incretin mimetic, to placebo for patients already being treated for Type 2 diabetes. [Zinman B, Hoofwerf BJ, Garcia SD et al. The effect of adding exenatide to a thiazolidinedione in supoptimally controled type 2 diabetes: a randomized trial. Ann Intern Med 2007; 146: 477-485.] But by publishing it with an editorial that was appropriately critical of the study design and methods, and appropriately attuned to how commercial research sponsors, such as pharmaceutical companies, biotechnology companies, and device manufacturers, may manipulate how research is designed, carried out, analyzed, and reported to serve their vested in... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=528788 Sat, 07 Apr 2007 19:35:00 +0100 528788 http://www.medworm.com/index.php?rid=477986&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F03%2Factonel-procter-and-gamble-and-things.html We had posted a while back and again here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.This story, like those of other cases of research sup... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=477986 Fri, 16 Mar 2007 18:23:00 +0100 477986 http://www.medworm.com/index.php?rid=469309&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F02%2Fplight-of-whistleblower-illustrated.html Two years ago, we discussed the troubling case of Paul Kornak and the Stratton Veterans Affairs Medical Center (SVAMC) in Albany, New York. Kornak was apparently hired despite having lost medical licenses in several states due to forged credentials, and a felony fraud conviction in Pennsylvania. Although Kornak apparently never completed medical training, the Stratton VAMC allowed him to perform physical examinations and identify himself as "doctor." The FDA found that Kornak had falsified patients' medical records in several drug studies, allowing patients to enroll in studies even though they should have been excluded. Kornak plead guilty to fraud and negligent homicide for the death of one patient in a chemotherapy study.Our post in 2005 was based on a New York Times article that sugges... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=469309 Wed, 21 Feb 2007 15:58:00 +0100 469309 http://www.medworm.com/index.php?rid=469313&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F02%2Fnew-black-box-warnings-and.html It has not been a happy few days for the pharmaceutical industry.We previously posted (also here) about the ill-fated clinical trial, study 3014, of the antibiotic telithromycin (Ketek) made by Sanofi-Aventis, run by Pharmaceutical Product Development Inc. (PPD). Problems with the trial included fabrication of data at one clinical site, and allegations of manipulation of data at another. The physician in charge of the first site was convicted of mail fraud, and the physician in charge of the second had his license suspended. Although the results of this trial were never published, it still crept into the clinical literature: it was cited in a review article in the New England Journal of Medicine. Nonetheless, the US Food and Drug Administration (FDA) approved Ketek for use in even relative... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=469313 Wed, 14 Feb 2007 22:53:00 +0100 469313 http://www.medworm.com/index.php?rid=469302&cid=t_92639_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F02%2Fthreat-of-pseudoevidence-based-medicine.html Clinical Governance, a respected but not widely-circulated journal from the UK, just published an article (subscription required) entitled "pseudoevidence-based medicine: what it is, and what to do about it," written by Health Care Renewal occasional blogger Dr Wally R Smith. [Smith WR. Pseudoevidence-based meidicne: what it is, and what to do about it. Clinical Governance 2007; 12: 42-52.] The article was featured on the publisher's latest monthly highlights page.I read (and commented on) an earlier draft of this article, and was struck by its use of the term pseudoevidence-based medicine to describe some of the less healthy trends we have discussed on Health Care Renewal. Some key quotes:Another, perhaps not new threat to the practice of EBM [evidence-based medicine] has been discovered ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=469302 Mon, 12 Feb 2007 15:31:00 +0100 469302