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 'institutional'. Sat, 03 Sep 2011 02:25:57 +0100 http://www.medworm.com/index.php?rid=5050579&cid=t_225269_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fincreasing-government-oversight-of-irbs-could-help-prevent-seeding-trials%2F2011.07.21 I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go. Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements. Now, it has come to light that Parke Davis’ marketing department sponsored... Better Health blogs http://www.medworm.com/rss/comments.php?id=5050579 Thu, 21 Jul 2011 14:00:20 +0100 5050579 http://www.medworm.com/index.php?rid=4872030&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F05%2Fmedical-societies-paid-to-do-corporate.html BackgroundLast year we posted about how two medical societies which received funding from a drug manufacturer tried to persuade the US Food and Drug Administration (FDA) to deny approval of a generic competitor to one of that company's products.  The medical societies were the Society of Hospital Medicine (SHM) and the North American Thrombosis Forum (NATF).  The company was Sanofi-Aventis and the product involved was its anti-coagulant derivative of heparin, Lovenox.  At the time, we noted that the SHM CEO denied the need to specifically disclose funding from Sanofi-Aventis in the letter to the FDA, since he asserted the letter was about "providing the best, most effective care to the hospitalized patient." If so, I wondered why the SHM ha... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4872030 Fri, 27 May 2011 18:37:00 +0100 4872030 http://www.medworm.com/index.php?rid=4841390&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F05%2Fmore-medical-societies-supported-by.html There were several new reports about the extent that medical societies are supported by industry.  Last week we asked whether the extent of the industrial support provided the Heart Rhythm Society made that organization appear to be more of a marketing firm than a professional society.  Society for Cardiac Angiography and Interventions (SCAI)ProPublica reported last week:The Society for Cardiac Angiography and Interventions (SCAI) received 57 percent of its revenues in 2009 from medical device and pharmaceutical makers, according to financial information on the group's website.Industry contributions to the society's budget covered $4.7 million of the $8.2 million it received that year.The group's biggest funders are the companies with the biggest share of the stent market: C... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4841390 Wed, 18 May 2011 21:43:00 +0100 4841390 http://www.medworm.com/index.php?rid=4813212&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F05%2Fhas-heart-rhythm-society-become-more.html ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir.  (The full ProPublica version is here.)  It's worth doing a little reading between the lines to see its further implications.The Basic StoryThe story focused first on the annual meeting of the Heart Rhythm Society (HRS), a sub-specialized medical society for cardiologists who specialize in electrical or rhythm disorders.  The meeting seemingly has become a giant marketing opportunity, supported by $5 million in industry money, in which practically every flat surface became a medium for advertising.  (The ProPublica article included multiple pictures of branded items from carpets in the exhibit halls to the backs of the seats in shuttle buses... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4813212 Wed, 11 May 2011 20:02:00 +0100 4813212 http://www.medworm.com/index.php?rid=4780272&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F05%2Fwho-is-really-bullying-academic-leaders.html Universities, which are supposed to discover and disseminate knowledge, ought to be the foremost defenders of free speech and a free press.  However, in the past decades, university executives have become notorious for trying to control speech that offends their political sensibilities (for numerous examples, see the FIRE - Foundation for Individual Rights in Education web-site.)  It seems that academic leaders get even more upset when their or their faculties' conflicts of interest are criticized, as demonstrated by updates about two important cases we have discussed.Columbia UniversityWe recently posted about reactions at the university to revelations in the movie "Inside Job" that the Dean of the Business School and one of its prominent professors failed to disclose ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4780272 Tue, 03 May 2011 19:46:00 +0100 4780272 http://www.medworm.com/index.php?rid=4733995&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fhenry-kissinger-icelands-promoter.html In which we discuss how medical academic mercenaries (like the key opinion leaders paid to promote drugs and devices cloaked in their academic and professional credentials) now appear to be just part of a larger problem.Henry KissingerAlmost 17 years ago, an article by David Halberstam in Vanity Fair(1) should have warned us of the rise of the academic and intellectual mercenary.  However, back in those go-go years of the new gilded age, most of us were not listening.  Halberstam focused on Henry Kissinger, once a protege of New York Governor and then US Vice President Nelson Rockefeller, who became the infamous President Nixon's National Security Advisor, then Secretary of State:Kissinger’s capacity to be all things to all campaigns—an overt Rockefeller man, a semi-over... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4733995 Mon, 18 Apr 2011 19:27:00 +0100 4733995 http://www.medworm.com/index.php?rid=4714693&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fthird-rail-that-no-one-wishes-to.html DiscussionWhile the data from this case-study were limited, they do suggest that major private foundations that support global health, and by extension, health care, services, and policy research may have institutional conflicts of interest, and their leaders may have personal conflicts of interest. It is possible that these conflicts have steered global health policy to favor vested interests, particularly towards approaches that depend on drugs and devices, perhaps instead of more effective ones using less technology.Furthermore, it is possible that that these conflicts of interest have helped create the anechoic effect.  Conflicts of interest could have pushed the foundations in directions that favored specific vested interests, and away from... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4714693 Thu, 14 Apr 2011 20:11:00 +0100 4714693 http://www.medworm.com/index.php?rid=4536027&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fonce-more-with-feeling-another-defense.html Despite increasing recognition of the adverse effects of health care professionals' and health care institutions' conflicts of interest on health care, such financial relationships continue to have their prominent defenders.  The latest example was an article in Medscape General Surgery by Frank J Veith MD, entitled "Physicians and Industry: Fix the Relationships, but Keep Them Going."  Dr Veith is a prominent vascular surgeon who "received numerous awards and honors as a leader, outstanding teacher, and innovator in vascular surgery," according to New York UniversityWe have noted before how defenders of conflicted professionals and professional societies often employ logical fallacies to support their arguments.  Some recent examples were discussed here,... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4536027 Tue, 01 Mar 2011 19:10:00 +0100 4536027 http://www.medworm.com/index.php?rid=4482721&cid=t_225269_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=4455485&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJX184xjbHIA%2F In December 2009, the Anesthesia & Analgesia journal published a study by Joachim Boldt, a prominent German anesthesiologist, but a few readers raised questions about the data and, after some digging around by the editor, the article was retracted last October. Now, though, a state medical association in Germany, where the research was supposedly conducted, investigated a long list of studies attributed to Boldt and released some startling findings. To wit, Boldt failed to take a required step: there was no evidence that he obtained Institutional Review Board approval to conduct research for 92 articles - count ‘em, 92. As you might imagine, this suggests dozens more retractions may be in the offing and further reviews have been under way, according to this letter from the edito... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455485 Wed, 09 Feb 2011 13:17:42 +0100 4455485 http://www.medworm.com/index.php?rid=4429225&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0bIqSuEDX98%2F It seems to remain true that some people just can’t count. Take the folks at West Coast IVF Clinic in Beverly Hills. A corporate entitly that is connected to the operation, which endeavors to help couples conquer infertility, received a warning letter from the FDA for violating rules pertaining to Institutional Review Boards. And these were rather basic rules. To wit, federal law requires that IRBs have at least five members and one must be primarily concerned with so-called non-scientific matters (in other words, someone with a different background and mission). Also, no IRB member is allowed to participate in reviewing any project in which this person may have a conflict of interest. But an FDA inspection of the Napoli LLC, which is housed in the same Wilshire Boulevard location as... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429225 Wed, 02 Feb 2011 15:02:40 +0100 4429225 http://www.medworm.com/index.php?rid=4406031&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSXdVGulP3Q4%2F Remember that sting operation in which the US Government Accountability Office conducted nearly two years ago of some Institutional Review Boards? The undercover operation involved creating a fictitious company, which then applied to three for-profit IRBs to approve a trial of a non-existent surgical adhesive gel. The episode made a splash, because one IRB - Coast IRB - actually approved the study, a gaffe that was discussed in detail at a Congressional hearing where the sting was revealed. Well, the FDA has issued an alert that some fictitious applications were submitted to several IRBs and the agency says it “appears” that the name and address of the clinical investigator listed on a required FDA form are the same as that used in the GAO sting. “The current and previous... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406031 Thu, 27 Jan 2011 18:31:47 +0100 4406031 http://www.medworm.com/index.php?rid=4179286&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F11%2Fwho-you-gonna-call-how-should-young.html To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a conflict of interest:Consider a health care researcher called by a commercial health care corporation's marketing department. The department representative proposes paying the researcher as a consultant to write a scholarly article on a specific policy topic of interest to the company. The implication is that the article should be favorable to the interests of the corporation in this arena. The corporation would be delighted to give the researcher editorial and staff assistance in writing the article and getting it published.Who you gonna call?The researcher is concerned that getting this consultancy might be a conflict of interest. What organization ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4179286 Thu, 18 Nov 2010 20:17:00 +0100 4179286 http://www.medworm.com/index.php?rid=3965704&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0BKEg-uDqt0%2F Hello, everyone. Nice to see you again. We hope you enjoyed the weekend, which amounted to an extended break, in our case. In any event, the routine has now returned and, of course, we are brewing the mandatory cup of stimulation to help us along. Please join us with a cup of your own, or a water bottle, perhaps, we scan the news of the world. Have a great day and stay in touch… IRB Delays Frustrate Investigators (OutsourcingPharma) India Becomes A Hub For Counterfeit Meds (The Washington Post) Genzyme Sells Genetics Unit For $925M To LabCorp (Associated Press) An Eli Lilly Scout Discusses Social Media (140conf) AstraZeneca And UCL Sign Stem Cell Deal (The Guardian) Hopes Fade For Roche And Ipsen Diabetes Drug (Reuters) Mcgarrybowen Wins Creative Duties On Pfizer Advil Account (AdWee... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965704 Mon, 13 Sep 2010 11:56:12 +0100 3965704 http://www.medworm.com/index.php?rid=3764128&cid=t_225269_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=3726580&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fsanofi-funded-society-of-hospital.html Here is another case to raise questions about the true goal of some medical societies.  As reported by Alicia Mundy in the Wall Street Journal in late June, A medical researcher and two medical groups with financial ties to Sanofi-Aventis SA have asked federal regulators to hold off on approving generic forms of a Sanofi blood-thinner....Citing potential patient safety issues, the head of the Society of Hospital Medicine and a medical researcher at Duke University last month sent letters to the Food and Drug Administration contending that Lovenox is too complex for any generic maker to copy fully.Earlier this year, another Sanofi-sponsored medical group, the North American Thrombosis Forum, sent two letters in favor of Sanofi's position opposing generic Lovenox. None of the letters me... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3726580 Mon, 05 Jul 2010 20:22:00 +0100 3726580 http://www.medworm.com/index.php?rid=3625773&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fs5ATp06PrMM%2F As part of its get-tough posture on patient safety and industry conduct, the FDA has issued a new guidance for disqualifying clinical trial investigators. The 10-page document, which the agency notes does not establish a “legally enforceable” set of responsbiliites, nonetheless, spells out the possible consequences for messing with a clinical trial. Basically, this reads like the primer it’s intended to be on agency thinking. Take a look to learn about disqualification proceedings, consent agreements and even the possibility of criminal prosecutions. Who should read this? Lots of folks - drugmakers, doctors and, of course, institutional review boards, which will likely have their hands full understanding regulations (see this). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3625773 Thu, 03 Jun 2010 13:23:14 +0100 3625773 http://www.medworm.com/index.php?rid=3529781&cid=t_225269_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2F-E9F5R-sVuw%2F By Glenna Crooks. Full disclosure – I’ve practiced yoga fairly consistently for decades. It’s been good for me. In grad school it helped me stay focused – and calmer – through killer statistics classes. Later, it was a way to unwind at the end of a workday. Still later, it saved me from surgery to correct fairly severe scoliosis. It’s not cured the deformity but I’m virtually pain free most of the time – no small feat for one who spends 18-24 hours on flights and 8 hours standing to facilitate meetings. More disclosure – I am certified to teach, though I don’t. The same erratic travel schedule that prevents attending classes on a regular basis precludes committing to teaching them. I trained to be able to practice on the road. It was a good investment of my time and fun... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=3529781 Tue, 04 May 2010 13:45:13 +0100 3529781 http://www.medworm.com/index.php?rid=3504875&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F04%2Fblogscan-cmss-new-ethics-code-analyzed.html The Council of Medical Specialty Societies got some good press for its new code of ethics regarding medical associations' interaction with industry.  Two of the best skeptical bloggers about health care dissected the code, suggesting it will not be as tough as it was cracked up to be.  See these posts by Dr Daniel Carlat on the Carlat Psychiatry Blog and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3504875 Sun, 25 Apr 2010 19:52:00 +0100 3504875 http://www.medworm.com/index.php?rid=3390722&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F03%2Feffort-to-make-health-insurance.html We previously discussed a legal settlement of charges that UnitedHealth's Ingenix subsidiary manipulated its database of payments to physicians so as to reduce its and other insurers' payments to "out-of-network" physicians.  One aspect of the settlement was a new initiative to better determine such payments.  Now that effort has been caught up in the web of conflicts of interests that has ensnared health care.  As reported by the Syracuse (NY) Post-Standard, [New York state Attorney General Andrew] Cuomo obtained $100 million in settlements from 13 insurers, including Excellus, that used the defective reimbursement data supplied by Ingenix, a subsidiary of United Health, the nation’s second biggest insurer. Cuomo’s investigation showed... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3390722 Mon, 22 Mar 2010 15:50:00 +0100 3390722 http://www.medworm.com/index.php?rid=3327295&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzEJPPjqF0fE%2F After the ruckus over the FDA advisory meeting for the Provenge prostate cancer vaccine in 2007, there was little expectation that yet another panel would be convened, especially after favorable data was released last year. But Favus Institutional Research issued a report yesterday saying it spoke with some docs, who claimed to be invited to such a meeting, according to TheStreet.com. The news sent Dendreon stock down about 5 percent and set off a scramble to ascertain the truth. An FDA spokeswoman later said a panel isn’t planned, and a Dendreon spokeswoman said there was no indication from the agency a meeting was scheduled. Deutsche Bank analyst Mark Schoenebaum noted companies must be informed of a planned panel 55 business days before a PDUFA date. The Provenge PDUFA date is May... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3327295 Wed, 03 Mar 2010 13:18:25 +0100 3327295 http://www.medworm.com/index.php?rid=3290784&cid=t_225269_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=3172203&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F79WEYfGWBKA%2F Another day, another deadline. But this is a busy world, after all. And what better way to prepare than to keep up with events. So, as you gird for the challenges ahead, here are a few items to help you along. As for us, we will reach for our usual cup of stimulation. Have a good day, everyone… FDA Issues New Guidance To IRBs On Multi-Site Trials (OutsourcingPharma) US Pharmacopeia Recalls New Edition Of USP-NF (statement) Glaxo Forms Global Media Team (PR Week) Blood Pressure Drugs May Cut Dementia Risk (Bloomberg News) Glaxo Sees Little Generic Threat To Advair (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172203 Thu, 14 Jan 2010 12:01:24 +0100 3172203 http://www.medworm.com/index.php?rid=2610914&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F07%2Fagain-logical-fallacies-in-defense-of.html In conclusion, the first published rebuttal of Rothman and colleagues' suggestions for ensuring the independence of professional medical associations from outside vested interests was not based on evidence, but on logical fallacies rather than clear reasoning, and failed to disclose its authors' relevant financial relationships. We will see if anyone can make a better attempt.References1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link here.)2. Bove AA. President's page: relations with industry: thoughts on claims of a broken system. J Am Coll Cardiol 2009; 54: 177-179. (Link here.)3. Somers VK, White DP, Amin R et al. Sleep apnea and cardiovascular disease: an American Heart Association/... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2610914 Thu, 16 Jul 2009 17:12:00 +0100 2610914 http://www.medworm.com/index.php?rid=2584331&cid=t_225269_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2009%2F07%2Fviva-la-revolucion-dtc-genomics.html Ok,I am not late to the party here on this one. I have been talking about this for quite some time with posts which include"We have No use for YOUR laws""Who Needs Institutional Review Boards""Steal Your Baby's Genome"I could go on and on here, but this is a natural move here.......23andSergey have decided to move the company into a space which is less likely to get them into hot water with the federal government and in fact may win them a few points with the Federales....Why? Everyone knows the end game here. A huge database of millions of phenotypes paired with millions of genotypes and millions of metabolomes and millions of demographics........With that you create the greatest query machine for human health, generate hypotheses from this and cure mankind of illness. That being said, wh... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=2584331 Wed, 08 Jul 2009 12:01:00 +0100 2584331 http://www.medworm.com/index.php?rid=2570377&cid=t_225269_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FQSNrgT7mcy8%2F Yesterday, the SEC repealed a long-standing rule which allowed brokers to vote shares on behalf of their investors, unless they obtained written directions from each individual investors.  While investors have long been able to direct the voting of their shares, many do not take the time to.  In these cases, the brokers vote those shares, after all they are the agents of the investors and are hired to act on their behalf. The direct effect of the rule will be to reduce the voting weight of retail investors, as represented by their brokers.  In voting against the rule, SEC Commissioner Kathy Casey raised the point that the rule would skew voting toward large institutional investors and away from little retail investors. What did the large institutions investors have to say?  As reported... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2570377 Thu, 02 Jul 2009 17:52:31 +0100 2570377 http://www.medworm.com/index.php?rid=2510428&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F06%2Fpracticing-clinical-trials-medicine.html Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times:Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hos... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2510428 Tue, 23 Jun 2009 18:50:00 +0100 2510428 http://www.medworm.com/index.php?rid=2510437&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F06%2Fpharmacy-benefit-managers-as.html We posted a number of times about questionable practices Eli Lilly used to market its atypical anti-psychotic drug Zyprexa (olanzapine). A post from 2007, with links backward, is here, and our most recent post is here. The company remains entangled in litigation over its marketing of this drug. That litigation has lead to the release of numerous internal documents that provide quite a view of Lilly's marketing practices. Bloomberg continued its reporting on these documents, with its latest effort here via the Boston Globe, describing yet another surprising way this drug was sold:A unit of CVS Caremark Corp. used its access to doctors to market Eli Lilly & Co.'s Zyprexa antipsychotic while it was under contract to bargain with the drug maker on behalf of health insurers, internal Lilly ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2510437 Wed, 17 Jun 2009 01:00:00 +0100 2510437 http://www.medworm.com/index.php?rid=2469483&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F06%2Fletter-from-ruc-and-my-reply.html The vast amounts spent in the US on health care have not translated into access for many patients, consistently excellent quality of care, and signiticantly improved outcomes. While we spend all this money, the primary care and generalist practitioners on the front lines are increasingly embattled and disgruntled, and their numbers are rapidly thinning. One problem may be the pattern of fees paid to physicians. Fees paid to physicians not only influence costs directly, but provide incentives for physician decision making about what tests and treatments patients receive. We have posted several times, most recently in February, 2009, here, about how the US Medicare system sets fees paid to physicians.Since health care reform is now a hot topic in the US, there has been increasing discussion ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2469483 Wed, 10 Jun 2009 18:35:00 +0100 2469483 http://www.medworm.com/index.php?rid=2306976&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fsham-studies-and-commercial-irbs-that.html We have occasionally posted about the activities of for-profit contract research organizations (CROs). These are commercial entities that conduct human research, including clinical trials for pharmaceutical, biotechnology and device companies. More clinical research is being done by such CROs rather than by academic investigators. CROs seem to operate under the radar of most physicians, academics, and policy makers, but sometimes stories surface that raise questions about them.For example, we discussed the trials by SFBC International (now PharmaNet Development Group) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post here and links backward); and the trial by Parexel Int... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2306976 Tue, 31 Mar 2009 19:07:00 +0100 2306976 http://www.medworm.com/index.php?rid=2169792&cid=t_225269_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F02%2F09%2Fproblems-with-psychology-research-irbs%2F The Association for Psychological Science latest issue of Perspectives on Psychological Science has a few interesting articles about the research and publishing side of psychology. One of the articles that caught my eye was about Institutional Review Boards. There is a certain arbitrary nature when it comes to a university’s research review board. These committees, called Institutional Review Boards (or IRBs), are charged with protecting subjects from unethical or unscrupulous researchers’ practices. IRBs exist in a world unto their own. They are run under the auspices of the university and while ostensibly they’ve been setup primarily for patient protection, they’ve arguably morphed into something else in more recent times. Ceci & Bruck (2009) discuss thei... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2169792 Mon, 09 Feb 2009 09:51:05 +0100 2169792 http://www.medworm.com/index.php?rid=1847902&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F10%2Fanother-industry-supported-physician.html The President of the American College of Cardiology (ACC), W Douglas Weaver MD, has written a second editorial on relationships between the ACC and industry, continuing medical education, and conflicts of interest. In his first editorial [ Weaver WD. President's page: disclosures, transparency, and firewalls protect integrity. J Am Coll Cardiol 2008; 52(11): 964-965. Subscription required.] his major points were:Major activities of the ACC require industry funding - "the Annual Scientific Session would not be possible in its current form if it were not for industry grants and fees from the Exposition.""Firewalls" provided by the society prevent influence by industry on educational or scientific programs -Let me assure you that we have very strong firewalls around industry support.As part o... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1847902 Thu, 02 Oct 2008 15:36:00 +0100 1847902 http://www.medworm.com/index.php?rid=1834805&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F403964808%2F Members of institutional review boards (IRBs) that review protocols involving children may not have adequate understanding of pediatric research regulations, according to a pilot study by The Hastings Center, a nonpartisan, nonprofit bioethics research institute. The center evaluated 71 eligible IRB members, and 41 responded to five multiple choice questions. Most respondents considered themselves “well prepared” or “very well prepared” to perform common IRB tasks. However, the median knowledge score was one correct answer. Some other interesting revelations: 13, or 32 percent, replied that they did not have prior training in review of pediatric protocols. And 20, or 49 percent, responded that they did not have professional experience in child health or development.... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834805 Fri, 26 Sep 2008 17:32:40 +0100 1834805 http://www.medworm.com/index.php?rid=1655415&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F07%2Fmanaging-conflicts-of-interest-at.html This article acknowledged Dr. Schatzberg’s NIH grant support at Stanford. Corcept Therapeutics was not acknowledged as a source of funding. The first concern is that, if Dr. Schatzberg’s relationship to the Stanford studies is as Stanford claimed, then he has no business publishing a NIH-supported review article that portrays his drug’s prospects in a favorable light. Hello! Is there a conflict of interest here? Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be. His many favorable, even exaggerated, articles, reviews and commentaries since he founded Corcept should have come under this proscription. So much for Stanford’s “mana... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1655415 Sat, 26 Jul 2008 00:26:00 +0100 1655415 http://www.medworm.com/index.php?rid=1437096&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F288653659%2F The idea is to distinguish between adverse events and unanticipated problems in clinical trials, and to clarify when problems must be reported to institutional review boards, FDAnews reports. And after releasing the final guidance, the agency will “probably institute regulatory changes to make it clearer,” Jean Toth-Allen, a biophysicist with the FDA’s Good Clinical Practices Program, told the annual conference of the Association of Clinical Research Professionals, according to FDAnews. (Here is the draft guidance from last year). As you may know, a sponsor must report serious and unexpected adverse events to the FDA. While clinical investigators aren’t required to report adverse events that don’t fall into this category to the IRB, they must record all adverse events on ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1437096 Mon, 12 May 2008 12:29:10 +0100 1437096 http://www.medworm.com/index.php?rid=1432795&cid=t_225269_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F286818662%2F The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, marking the first FDA effort to issue regulations instead of guidances for clinical trials, FDANews reports. Existing FDA regs don’t take into account all the different types of organizations - vendors, co-investigators, site management organizations and contract research organizations - involved in conducting clinical trials, David Lepay, the agency’s senior advisor for clinical science, told the Association of Clinical Research Professionals annual conference, FDANews writes. What are some of the problems? Let’s start with the fact that FDA regs fail to account for electronic data issues, data standardization, electronic health records, electr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1432795 Fri, 09 May 2008 13:15:33 +0100 1432795 http://www.medworm.com/index.php?rid=1408234&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F04%2Faamc-report-on-medical-schools-industry.html The Association of American Medical Colleges (AAMC) just unveiled a report on relationships among academic medical institutions and the pharmaceutical, biotechnology, and device industry. The report was notable in its toughness in certain areas, laxity in others, and for what it did not mention, and what kinds of conflicts of interest it actually encouraged. Where it was tough:It advocated banning "acceptance of any gifts from industry by physicians and other faculty, staff, students, and trainees...."It considered "industry supplied food and meals" as "personal gifts" which should be therefore banned (but see below).It advocated prohibiting "physicians, trainees, and students from directly accepting travel funds from industry." (But see below.)It advocated prohibiting "physicians, trainee... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1408234 Tue, 29 Apr 2008 21:12:00 +0100 1408234 http://www.medworm.com/index.php?rid=1369662&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F04%2Fdid-politics-trump-mcat-in-admissions.html Several stories in the Gainesville (Florida) Sun and the Florida Alligator suggest issues with the leadership of the University of Florida College of Medicine. As first reported in the Sun,In a move that breaks with the norms established by medical school accreditors, the dean of the University of Florida's College of Medicine has opted to admit a student from a politically connected family, even though the student didn't have the backing of the Medical Selection Committee.Kone wouldn't name the student, but sources close to the situation identified him as Benjamin Mendelsohn, the son of Dr. Alan Mendelsohn, a Hollywood ophthalmologist and a Republican fundraiser who was a grassroots organizer for Gov. Charlie Crist during his 2006 campaign.Before Kone took over as dean in May 2007, Gov. C... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1369662 Sun, 13 Apr 2008 23:46:00 +0100 1369662 http://www.medworm.com/index.php?rid=1235969&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F02%2Fblogscan-brody-on-institutional.html On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody offered some interesting thoughts about institutional conflicts of interest, a topic recently in the news because of a JAMA article that showed few medical schools seem to have clear policies about such conflicts. Dr Brody noted the tremendous pressure on medical schools to bring in external funds, which certainly make it hard for the schools' leadership to deal with ICOIs. (On the other hand, I again wonder why medical schools and academic medical centers are always under pressure to bring in external funds, while the rest of the university seems to mainly get by on tuition, alumni contributions, and endowment income?) Thus, he wonders if any attempt to control ICOIs would work unless some body external to the schools could ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1235969 Fri, 15 Feb 2008 21:28:00 +0100 1235969 http://www.medworm.com/index.php?rid=721277&cid=t_225269_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F07%2Fnaming-public-health-school-after.html Sometimes, you just can't make this stuff up. The Des Moines (Iowa) Register reported,The University of Iowa is considering naming its College of Public Health after the Wellmark Foundation, the charitable arm of Iowa's largest health insurance company, Wellmark Blue Cross and Blue Shield, in exchange for a $15 million gift from the foundation.Part of the proposed $15 million gift would supplement $20.7 million in state money being put toward a new $44.7 million building to house the public health college. The rest would provide endowed professorships and scholarships at the college.But the Wellmark deal, if approved, would make the U of I the only public university in the state - and one of few in the country - to give a major academic unit a corporate name.The Board of Regents would make... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=721277 Mon, 09 Jul 2007 15:08:00 +0100 721277