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 'conflicts'. Sat, 03 Sep 2011 02:12:22 +0100 http://www.medworm.com/index.php?rid=5159836&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAhQvJIfu6qE%2F Concerns about conflicts of interests are all the rage these days. The FDA is debating whether to loosen rules over complaints that an insufficient number of experts are available for its advisory committees. And the National Institutes of Health just issued new rules covering academics who receive federal funding for their research and also have ties to industry (see here and here). As it turns out, the US Department of Health & Human Services, which oversees both agencies, has its own problems with conflicts. A new report by the HHS Office of Inspector General found most conflict-of-interest waivers issued two years ago were not documented as recommended in federal ethics regulations and only a minority of waivers were signed and dated by HHS employees receiving them. These waivers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159836 Thu, 25 Aug 2011 15:12:11 +0100 5159836 http://www.medworm.com/index.php?rid=5107457&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F08%2Fretreat-back-to-regulatory-capture-us.html After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs.Weakening FDA Conflict of Interest RulesAs reported by Reuters,U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts.Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.This was not purely an initiative of legislators, but was egged on by a top FDA administratorThe agency often must delay panel meetings while i... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5107457 Mon, 08 Aug 2011 17:13:00 +0100 5107457 http://www.medworm.com/index.php?rid=5097093&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FB_rma9edmls%2F Last week, FDA commish Margaret Hamburg told a congressional committee that the agency may loosen conflict of interest rules that were enacted in 2008, because finding qualified experts to serve on advisory committees has become increasingly difficult (back story here). Her remarks parroted a point made three months ago by Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, who has been pushing to relax the rules, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000 ( you can read more here). Last year, the agency tweaked its procedures for granting waivers (see this). The effort by FDA officials to roll back the rules, which were passed after an arduous campaign to promote greater ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097093 Thu, 04 Aug 2011 14:37:45 +0100 5097093 http://www.medworm.com/index.php?rid=5077624&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F07%2Fexecutives-get-rich-despite-ethical-and.html We recently posted about some shocking allegations suggesting that the for-profit corporations that now dominate hospice care may prey on vulnerable patients to increase their revenues, and may specifically recruit patients who are not terminally ill for hospice, and then neglect to attend to their treatable medical problems.  The post was based on a Bloomberg investigative report.The Bloomberg report focused on two large for-profit hospice providers, Vitas, a subsidiary of Chemed, and VistaCare, a subsidiary of Gentiva. We have repeatedly seen a pattern in numerous other health care organizations, non-profit as well as for-profit: despite questionable corporate behavior that appears to violate the values of health care professionals, executives receive rich compen... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5077624 Thu, 28 Jul 2011 18:51:00 +0100 5077624 http://www.medworm.com/index.php?rid=5029207&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmeIeLnrcOiY%2F Earlier this month, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital were sanctioned for violating conflict of interest rules. The trio received grant money from various drugmakers while studying their meds, but failed to report some of the outside income to the institutions while also receiving grants from the National Institutes of Health (see this). The move followed a long-running controversy over the interplay between academia and pharma, which was prompted by a high-profile US Senate Finance Committee probe over concerns that such undisclosed relationships may unduly influence medical research and practice. For their sins, the trio issued a mea culpa. The most prominent among them is Joseph Biederman, a psychiatrist with a national profile ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029207 Fri, 15 Jul 2011 13:36:22 +0100 5029207 http://www.medworm.com/index.php?rid=4992989&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl9r_qs2CrEo%2F Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments. In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these polici... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992989 Sat, 02 Jul 2011 14:04:29 +0100 4992989 http://www.medworm.com/index.php?rid=4968427&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F06%2Fembedded-networks-of-influence-in.html At the 12th International Anti-Corruption Conference (IACC), sponsored by Transparency International, one of the plenary sessions was devoted to the topic of "embedded networks of influence."  The session description included this description of the topic as:the major stumbling block in the fight against corruption, namely, the power of 'embedded networks' in advancing personal or group interests through state institutions. The extent of their power can create what is known as “state capture” meaning democratic governance failure. It will take a close look at the influential role of private sector, especially of the multinational private sector.A recent investigative report in the Chronicle of Higher Education illustrated a striking case of how one key individual has affected... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4968427 Fri, 24 Jun 2011 19:11:00 +0100 4968427 http://www.medworm.com/index.php?rid=4960329&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fdzqbvzs1qj4%2F Two years ago, a study found that nearly 53 percent of academic researchers have some form of relationship with the pharmaceutical industry, especially consulting, and faculty with industry research support were more productive than faculty without support. For instance, faculty with industry relationships published significantly more and published at a greater rate in the past three years. In an update of the findings, which first appeared in Health Affairs (read the abstract), the researchers explored conflict of interest policies at universities that have been under increasing pressure to scrutinize and disclose financial ties between faculty and drugmakers. The attention is an outgrowth over concerns that medical practice may be unduly influenced by industry (see here). What did the l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960329 Wed, 22 Jun 2011 15:13:27 +0100 4960329 http://www.medworm.com/index.php?rid=4960330&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeV33sONHAAI%2F Now you see recusal, now you don’t. For the past couple of years, National Institute of Mental Health director Tom Insel has found himself at the center of a furious controversy over conflicts of interest involving academic researchers who simultaneously receive NIH funding and do work for drugmakers. At one point, he was ensnared in a probe by the US Senate Finance Committee. What prompted this attention was a long-standing relationship with Charles Nemeroff, a former Emory University psychiatry department chair who accepted sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The revelation sparked a probe by the US Department of Health and Human Services Office of Inspector General. Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960330 Wed, 22 Jun 2011 13:32:59 +0100 4960330 http://www.medworm.com/index.php?rid=4953359&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVV5N71KRqKg%2F The FDA hearing officer who is presiding over the upcoming Avastin review has rejected a request from her agency colleagues to require all outside scientific experts who speak at the meeting to disclose financial ties to Roche’s Genentech unit or rival manufacturers. The June 17 request had been made by FDA lawyers in the name of greater transparency. The two-day event, which begins June 28, stems from an unprecedented decision last year by the FDA to yank the breast cancer indication for the best-selling Avastin cancer med. That came after results of four clinical studies showed the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks (see here). In response, Roche appealed the d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953359 Tue, 21 Jun 2011 18:10:01 +0100 4953359 http://www.medworm.com/index.php?rid=4952851&cid=t_169282_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F06%2F17%2F83-reasons-to-question-autism-speaks-for-hiring-big-pharma-scientist%2F The big secret finally is out. Autism Speaks made a radical announcement May 9th, 2011 that said Robert Ring, PhD, a scientist from Pfizer, was placed “into to the newly-created position of vice president of translational research.” Ring’s appointment was made simultaneously with the discovery that 83 cases of vaccine-induced autism were paid compensation secretly by the U.S. government’s Vaccine Injury Compensation Program (VICP). Why is former Pfizer employee Ring’s appointment radical? Two years ago Pfizer announced the pharmaceutical industry’s first “Autism Spectrum Disorders Unit.” Robert Ring led that group since 2009. I’ll provide more information on this later, but I also want you to consider another very important point. After the U.S. government’s secret ... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4952851 Fri, 17 Jun 2011 11:43:55 +0100 4952851 http://www.medworm.com/index.php?rid=4934027&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F06%2Fucb-settles-pleads-guilty.html Tromp, tromp, tromp.... the legal settlements keep marching along.  This latest story was reported by Reuters and Bloomberg.  The basics were, per Reuters:The American unit of Belgian pharmaceutical company UCB SA (UCB.BR) pleaded guilty on Thursday and will pay $34.4 million to settle criminal and civil charges that it illegally promoted a drug for migraines.The company pleaded guilty to one count of promoting the epilepsy treatment drug, Keppra, in the United States in 2004 for migraine treatment without the necessary approval from the Food and Drug Administration, the U.S. Department of Justice said.One atypical element here is that the company actually pleaded guilty to a crime.Another slightly off-key note came from the description of the activities constituting the ill... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4934027 Wed, 15 Jun 2011 21:41:00 +0100 4934027 http://www.medworm.com/index.php?rid=4911819&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpiJzMoYrTX4%2F And yet another country wants to get tough on the interactions between docs and drugmakers. This time, India’s Department of Pharmaceuticals is proposing an updated Uniform Code of Marketing Practice for drugmakers that would tighten rules on doling out samples and encounters between docs and reps. The revised code, which is voluntary, would also improve procedures for reporting complaints. Among the dictums: the code requires employees who draft promotional materials to be familiar with the rules; promotional material such as mailings and journal ads must not be designed to disguise their real nature, and sales reps “must not employ any inducement or subterfuge to gain an interview. They must not pay, under any guise, for access to a healthcare professional.” In general,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911819 Wed, 08 Jun 2011 12:01:56 +0100 4911819 http://www.medworm.com/index.php?rid=4893343&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F06%2Fstealth-marketing-of-medical-devices.html We have frequently discussed the use of organized, deceptive stealth marketing campaigns to influence physicians to prescribe pharmaceuticals. Now more information is coming to light about similar campaigns to influence physicians to use particular medical devicesAs reported in the New York Times, based on documents supplied apparently by a corporate whistleblower, here are some tactics used by a small German device manufacturer, Biotronik:Seeding TrialsThese are ostensibly clinical trials, but designed more to market than to discover meaningful data. We have discussed them in the context of drug marketing.The message from cardiologists was loud and clear, according to a top executive at a heart device company. The doctors wanted implant makers to produce more clinical trials of devic... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4893343 Thu, 02 Jun 2011 21:32:00 +0100 4893343 http://www.medworm.com/index.php?rid=4883907&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUaHLMBOJt7k%2F For the past few years, one of the more contentious controversies has been the close financial ties between drugmakers and some doctors. But why have some docs embraced the pharmaceutical industry? Were their attitudes formed early in their careers? If so, would there be virtue in educating medical students and residents about the downside to industry interactions? That is the conclusion reached in a report issued last week in PLoS Medicine, which analyzed 32 studies that looked at industry interactions with medical students and whether these influenced student views (this amounted to reviewing data concerning some 9,850 students at 76 med schools or hospitals). They found that most had some interaction with drugmakers, but contact increased in the clinical years, with up to 90 percent of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4883907 Tue, 31 May 2011 12:03:59 +0100 4883907 http://www.medworm.com/index.php?rid=4872030&cid=t_169282_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=4862923&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FS4p18a2bMJQ%2F Health Department workers in West Australia have received $745,000 worth of gifts, business class flights and hotel accommodations from drug and device makers, many of which sell meds and equipment to area hospitals, The West Australian reports. According to documents revealed in Parliament, between last July and April 6, there 259 instances in which perks - including champagne, iPads, flights and hotel packages to Paris, Vienna, Montreal and Los Angeles - were accepted. More than half of the gifts or trips were accepted by staff from the South Metropolitan Area Health Service, which is headed by Nicole Feely, a former chief of staff to former Prime Minister John Howard, the paper writes. And the goodies included return business-class flights to New Orleans and six nights accommodation wo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862923 Wed, 25 May 2011 12:03:00 +0100 4862923 http://www.medworm.com/index.php?rid=4862926&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fq283udIKjWI%2F In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years. “During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.” The guidance would require any drugmaker to submit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862926 Tue, 24 May 2011 15:43:46 +0100 4862926 http://www.medworm.com/index.php?rid=4848114&cid=t_169282_136_f&fid=35302&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FWhitePebble%2F%7E3%2F6i9jrj4yQFc%2F Bill Maher: If you rejoice in revenge, torture and war …you’re not a Christian. This should be self-evident, but evidently some folks need a refresher on the basic tenets of the religion they profess to follow. via Todays signs that the Apocalypse may be upon us – What Would Jack Do. Filed under: Current Affairs, Link Tagged: Bill Maher, christianity, Religion and Spirituality, Wars and Conflicts (Source: white pebble) white pebble blogs http://www.medworm.com/rss/comments.php?id=4848114 Fri, 20 May 2011 13:54:19 +0100 4848114 http://www.medworm.com/index.php?rid=4848151&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHW9228lhNLE%2F Last month, the Massachusetts House of Representatives voted overwhelmingly to repeal a 2008 law that bans drug and device makers from giving gifts to docs. The law, which you can see here and here, was seen as a way to limit undue industry influence over medical practice. But the ban has upset doctors, and pitted various consumer and patient groups against the state’s restauranteurs and drug and device makers ever since. Those in favor of repeal argue the ban stifled business seeking to expand in Massachusetts and robbed the state of revenue from two medical conventions that held their events elsewhere (back story). “I think we acted in haste,” state legislator James Miceli, who voted in favor of the ban originally but recently voted to overturn the law, recently told WB... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848151 Fri, 20 May 2011 11:46:06 +0100 4848151 http://www.medworm.com/index.php?rid=4841980&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1PSVJ9RSQKk%2F Stanford University has disciplined five faculty members at its medical school for violating school policy by giving paid promotional speeches for drugmakers, according to ProPublica, which a few months ago wrote that Stanford was one of several teaching hospitals that failed to enforce their own conflict-of-interest rules. At the time, more than a dozen faculty members were identified as paid speakers (back story). Paul Costello, a Stanford spokesman, declined to name the disciplined faculty members or discuss their penalties. But in a written statement, he told ProPublica that the “actions are significant” and have or could impact the doctors’ compensation or positions. In a note to faculty last December, medical school dean Paul Pizzo wrote that a preliminary investig... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841980 Thu, 19 May 2011 21:25:04 +0100 4841980 http://www.medworm.com/index.php?rid=4841984&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmsrQpBjd9A8%2F Four years ago, the FDA issued new rules concerning conflicts of interest for its advisory committees. The idea, of course, was to avoid the possibility that a panel member may have a financial connection of some sort to a company or type of drug to be reviewed (read here). Ever since, some critics charge the rules are too draconian and, worse, the effort amounted to overkill, because finding qualified panelists becomes harder. Last week, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, made the same point. The conflict of interest guidelines made it “tough to find knowledgeable people” to serve on advisory committees, she told the Reuters Health Summit. “It’s a concern for all our staff…There is no doubt it is difficult findi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841984 Thu, 19 May 2011 11:58:03 +0100 4841984 http://www.medworm.com/index.php?rid=4841390&cid=t_169282_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_169282_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=4803573&cid=t_169282_180_f&fid=38619&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FALifeCoachsBlog%2F%7E3%2FZZSsKyS8W0Y%2F Other than with clients, very rarely these days do I get an A-ha! moment when it comes to Life Coaching and/or self development. I presume this is simply the product of being exposed to so much self development material on a daily basis that it’s tricky to unearth anything that genuinely surprises me. The other morning was an exception though, and I almost fell out of the shower with surprise. I Continue reading... (Source: Life Coach Blog: The Discomfort Zone :) Life Coach Blog: The Discomfort Zone : blogs http://www.medworm.com/rss/comments.php?id=4803573 Sun, 08 May 2011 19:37:55 +0100 4803573 http://www.medworm.com/index.php?rid=4795056&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgtIUt5aYG24%2F How closely tied are professional medical societies to drug and device makers? Just how much money do some receive? And how obvious is the spending at annual meetings? The answers - some have very close ties, get lots of money and the outlay can be enough to burst a blood vessel. Take the Heart Rhythm Society, which is holding its annual to-do in San Francisco this week. For instance, Sanofi-Aventis shelled out a total of $351,00, which was divided this way: $110,000 on programs & guides; another $110,000 on educational support; $96,000 for exhibit space; $25,000 for ‘turndown service,’ and $10,000 for bag inserts and cards. Similarly, Johnson & Johnson spent $386,750. Here’s how: $275,000 for exhibit space and lounge;s $36,000 on educational support; $25,000 for ban... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795056 Fri, 06 May 2011 13:44:32 +0100 4795056 http://www.medworm.com/index.php?rid=4780272&cid=t_169282_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=4759040&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9a0xO_8AxcM%2F For the second time in less than a year, the Massachusetts House of Representatives has attempted to repeal a 2008 law that bans drug and device makers from giving gifts to docs. An effort last summer failed (read here). This time, however, a repeal is gaining traction. A bipartisan majority voted 128-to-22 yesterday to overturn the ban. The law, which you can read here and here, was seen as a way to limit undue industry influence over medical practice. But the ban has upset doctors, and pitted various consumer and patient groups against restauranteurs and the pharmaceutical and device industries ever since. Those in favor of repeal argue the ban stifled business seeking to expand in Massachusetts and robbed the state of revenue from two medical conventions that held their events elsewhere... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759040 Wed, 27 Apr 2011 13:13:56 +0100 4759040 http://www.medworm.com/index.php?rid=4753629&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Frucing-about-conflicts-of-interest.html Since 2007, we have been writing about the secretive RUC (RBRVS Update Committee), the private AMA committee that somehow has managed to get effective control over how Medicare pays physicians. The RUC has been accused of setting up incentives that strongly favor invasive, high technology procedures while disfavoring primary care and other "cognitive medicine." Despite the central role of (perverse) incentives in raising health care costs while limiting access and degrading quality, there was surprisingly little discussion about the pivotal role played by the RUC until the formation of the "Replace the RUC" movement (see post here).  Recently, the leaders of Replace the RUC scored a journalistic coup by putting the current list of RUC members publicly on-line.  As we have di... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4753629 Tue, 26 Apr 2011 21:26:00 +0100 4753629 http://www.medworm.com/index.php?rid=4753971&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU0H-Kz5ZdoU%2F For many people, the Provenge controversy has come and gone. The prostate cancer vaccine was approved a year ago by the FDA and, more recently, the Centers for Medicare & Medicaid Services signaled that coverage would be provided (see here). Meanwhile, Provenge sales are rising, manufacturing is increasing and Wall Street tracks shares in Dendreon, which makes the vaccine, very closely. But one aspect apparently remains unresolved, at least for some. Four years ago, the unexpected FDA delay in approving Provenge occurred amid alleged conflicts of interest involving two members of an agency advisory committee. They quietly wrote FDA officials to veto a panel recommendation in favor of approval. The episode prompted a lawsuit and patient protests, but full details were never disclosed (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753971 Tue, 26 Apr 2011 14:06:15 +0100 4753971 http://www.medworm.com/index.php?rid=4733993&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fkhadafys-academic-mercenaries-health.html We just discussed Henry Kissinger as an early example of the intellectual mercenary, and recent striking examples of academic mercenaries,particularly the Harvard University-derived Monitor Group's academically disguised public relations work for Libyan tyrant Moammar Khadafy.We concluded that academic mercenaries help foster the corporate culture in which health care is now immersed.  However, it also appears they may have direct influence on health care.  Monitor Group LeadershipConsider for example the main figure in the Monitor Group - Khadafy scandal.  According to a Boston Globe article, Michael Porter developed the Monitor-Khadafy connection: Monitor’s work in Libya began when Michael Porter, a Harvard Business School professor who is a... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4733993 Tue, 19 Apr 2011 19:54:00 +0100 4733993 http://www.medworm.com/index.php?rid=4733995&cid=t_169282_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=4723806&cid=t_169282_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fonline-health-information-can-be-more-trustworthy-than-printed-texts%2F2011.04.17 Recently Ed Silverman of Pharmalot considers the case of a ghost-written medical text’s mysterious disappearance. The 1999 book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” (reviewed in a psychiatry journal here) came under scrutiny last fall when it became evident that the physician “authors” didn’t just receive money from a relevant drug maker, SmithKline Beecham; they received an outline and text for the book from pharmaceutical company-hired writers. poster for the X-Files Now the book’s listing is gone from the website of STI (Scientific Therapeutic Information), the company that provided the authorship “help.” I tried to get a copy of the handbook on Amazon.com, where it’s currently out-of-stock. The book ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4723806 Sun, 17 Apr 2011 16:00:58 +0100 4723806 http://www.medworm.com/index.php?rid=4714693&cid=t_169282_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=4693505&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1ht08wD4WlQ%2F The run-up to what will be a closely watched FDA meeting this coming June to review the Avastin cancer med is prompting some interesting behind-the-scenes sparring between the agency and Roche. To wit, in a recent letter to different FDA officials, Covington & Burling attorney Michael Labson, who represents Roche’s Genentech unit, accused the FDA Oncologic Drugs Advisory Committee of bias. Why? In his view - and obviously, the view of the drugmaker - there are concerns about “objectivity and fairness.” To underscore this contention, Labson writes in his March 10 missive that nearly all members of the committee last July voted to withdraw FDA approval for the metastatic breast cancer indication for Avastin (back story). And since then, various committee members were q... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693505 Fri, 08 Apr 2011 13:26:24 +0100 4693505 http://www.medworm.com/index.php?rid=4684758&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDD9bzsNsVtU%2F Is there a link between antidepressants and breast and ovarian cancer? A new meta-analysis of 61 trials identified a connection in nearly 33 percent of the epidemiological and pre-clinical studies conducted between 1965 and 2010 found an association between cancer and antidepressants. And the link was stronger among women using selective serotonin reuptake inhibitors, or SSRIs. Moreover, the study found researchers with industry ties were significantly less likely than researchers without those affiliations to conclude antidepressants increase the risk of breast or ovarian cancer. The authors of the meta-analysis, which was published this week in PLoS Medicine, suggest the findings raise public health and policy issues, “because there is increasing evidence that financial ties among... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684758 Thu, 07 Apr 2011 14:29:41 +0100 4684758 http://www.medworm.com/index.php?rid=4653602&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdtWgguerbvk%2F Yet another study has found a conflict of interest among doctors. This time, conflicts were reported by 56 percent of 498 docs who helped write 17 guidelines for the American Heart Association and American College of Cardiology between 2003 through 2008, according to the study published today in the Archives of Internal Medicine (see the abstract). And this finding matters because these panels typically wield considerable influence. “Panels are the select groups of experts who are assigned to evaluate science independently and issue their advice to other doctors on what to do in clinical practice,” the researchers write. Guidelines “play an important role in synthesizing information for clinicians, as well as increasing uniform practice to certain standards and avoiding t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653602 Tue, 29 Mar 2011 20:15:11 +0100 4653602 http://www.medworm.com/index.php?rid=4636396&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Finstitute-of-medicines-release-reports.html Two days ago, the prestigious US Institute of Medicine released two reports on important health care issues, clinical practice guidelines and systematic reviews.  Systematic reviews of the relevant clinical research have been advocated by evidence-based medicine proponents as the appropriate basis for clinical and policy decisions.  Clinical practice guidelines have been advocated by many health researchers, policy makers, and clinicians as the best way to encapsulate the evidence to inform clinical and policy decision making.  Both reports suggested series of standards for how systematic reviews and clinical practice guidelines should be developed.  These topics are of general importance to clinicians, health services researchers, and health policy makers.  T... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4636396 Fri, 25 Mar 2011 16:05:00 +0100 4636396 http://www.medworm.com/index.php?rid=4626770&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fdespite-poor-financial-results.html It is the season for share-holders' meetings of big US publicly held corporations, and as the proxy statements prepared for these meetings, prepare for more eye-popping, jaw-dropping examples of executive compensation.  Pfizer's 2010 CEO CompensationThe AP (via the Wall Street Journal) just noted the compensation given to Jeffrey Kindler, the outgoing (in 2010) CEO of Pfizer, Inc, the world's largest pharmaceutical company:Former Pfizer Inc. Chairman and CEO Jeffrey B. Kindler may have left the world's largest drugmaker abruptly last December, but he didn't leave empty-handed thanks to a compensation package valued almost $22 million.Kindler received a 60 percent increase last year over his 2009 compensation, according to an Associated Press analysis of a Pfizer regulatory filing Tues... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4626770 Wed, 23 Mar 2011 21:14:00 +0100 4626770 http://www.medworm.com/index.php?rid=4615424&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FY1gMg4H-zKQ%2F The European Medicines Agency has placed new restrictions on the business activities of its former director, Thomas Lonngren. after he resigned in late December and then issued a letter just a few days later indicating he had accepted an industry consulting position. The move prompted criticism, in part, because the EMA initially failed to investigate (back story). Today, the agency has issued a statement approving Lonngren’s consulting arrangements and found that there was no misuse of confidential or privileged info gained while he headed the EMA, there was no activity that risk improper influence on EMA decision and, more generally, none of his activities posted a conflict of interest. Nonetheless, the EMA “regretted the late notification by Mr. Lönngren of details of his ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4615424 Mon, 21 Mar 2011 18:35:06 +0100 4615424 http://www.medworm.com/index.php?rid=4610776&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fconflicts-of-interest-government.html There seems to be a small surge of stories about conflicts of interest regarding health care affecting government leaders who can affect health care.  The Institute of Medicine defined conflict of interest in medicine as "circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest."  So we will summarize these stories by first showing what each leader's secondary interests are, and then show how they may influence carrying out his leadership responsibilities.  (We used "his" because all examples are of male leaders.)Florida: Governor Scott and SolanticRick Scott, the new Florida Governor, apparently still has strong ties to a for-profit chain of urgent care centers, as reported by the ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4610776 Fri, 18 Mar 2011 19:15:00 +0100 4610776 http://www.medworm.com/index.php?rid=4600495&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fdespite-recalls-legal-settlements.html For our latest story about the tremendous disconnect between the pay and performance of leaders of health care organizations, we turn to Reuters.  Astronomical PayDespite having a very bad 2010, Johnson and Johnson continued to reward its CEO royally:After a year in which Johnson & Johnson's product quality control was deemed such a shambles that the U.S. government will oversee some plants, the board had praise for Chief Executive William Weldon and awarded him almost $29 million in overall compensation.The once golden reputation of the diversified healthcare giant was severely tarnished by seemingly endless recalls of widely used consumer products as well as recalls of medical devices and products from other units in 2010.U.S. consumer product sales fell by more than 19 percent ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4600495 Wed, 16 Mar 2011 21:00:00 +0100 4600495 http://www.medworm.com/index.php?rid=4592326&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F03%2Fsome-dare-call-it-corruption.html We have discussed many cases of health care organizations' leaders reaping rewards disproportionate to any concept of their performance, and especially to any concept of the effect of their conduct on patients' or the public's health.  Most of these cases have been pretty anechoic, but for some reason, the case of the huge golden parachute given to the outgoing CEO of Massachusetts Blue Cross Blue Shield despite a tenure  marked by financial losses and no particularly brilliant advances in patients' care or outcomes, (see this post) continues to generate responses.  One editorial suggested that should the non-profit health insurance company continue to pay so lavishly, it should lose its tax exemption.  Another noted that the company should start put... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4592326 Mon, 14 Mar 2011 21:50:00 +0100 4592326 http://www.medworm.com/index.php?rid=4575244&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyX0B1GekJDo%2F Earlier this week, we wrote how the European Association for the Study of the Liver had difficulty maintaining an embargo on abstracts to be reviewed at its upcoming annual conference, even though the material is freely available on the Internet (see here). Then Embargo Watch notes that the public relations firm for the EASL is Cohn & Wolfe, which also represents various drugmakers, such as Allergan, Genzyme, Sanofi-Aventis, Boehringer-Ingelheim and Merck (see this). This raises a question: how can a public relations firm equitably run the media operations for a professional society conference and simultaneously represent drugmakers who may have a great deal at stake at these conferences? You know, abstracts from one or more clients could be on display at the gathering. How can the EA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4575244 Fri, 11 Mar 2011 16:36:35 +0100 4575244 http://www.medworm.com/index.php?rid=4570758&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fy1VW3WAJzGI%2F Last year, the World Health Organization was criticized for refusing to disclose the identities of panel members who helped make decisions about the H1N1 pandemic and their declared conflicts of interest, such as paid work for drugmakers. It was not until the pandemic was declared officially over last summer that the WHO released their names and pertinent info (see this). The issue threatened to stain the WHO because of concerns that its Emergency Committee members were unduly influenced by the pharmaceutical industry. Now, though, the WHO Review Committee on the Functioning of the International Health Regulations, another group of outside advisors, has released a draft report saying there is no proof industry swayed WHO decision making on the pandemic. “The WHO performed well in man... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570758 Thu, 10 Mar 2011 16:43:03 +0100 4570758 http://www.medworm.com/index.php?rid=4536027&cid=t_169282_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=4532567&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsAQS7vachLg%2F Japan’s Osaka District Court late last week ordered AstraZeneca to pay 60.5 million yen - or about $733,000 - to nine of 11 plaintiffs for failing to include proper warnings about serious side effects on the labeling for its Iressa lung cancer med when it was approved in the country in July 2002. However, the three-judge panel ruled the Japanese government was not liable for any damages. At issue was interstitial lung disease, or ILD, which was cited in 810 deaths through March 2010, according to Medwatcher Japan, a non-profit watchdog, and attorneys who represent the plaintiffs. They argued AstraZeneca downplayed safety issues by failing to prominently note on the labeling the potential for ILD at the time of approval and then advertised Iressa as “anti-cancer drug with little... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532567 Tue, 01 Mar 2011 13:53:37 +0100 4532567 http://www.medworm.com/index.php?rid=4532572&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJhdgNC8Xh6E%2F The European Medicines Agency is being criticized for not objecting to a pharma industry consulting gig taken by its former executive director, Thomas Lonngren, who left at the end of the December. However, he only told the EMA board of his intention to pursue consulting in a December 28 letter - and his new consulting job was to begin on January 1. Instead of asking questions, the EMA chair, Pat O’Mahony, responded that the agency had no objections to Lonngren’s new position, according to consumer advocacy groups, which wrote a letter to the EMA to complain about its decision (here are the letters between Lonngren and O’Mahony, although the Lonngren letter is misdated). The groups charge in their own letter that the EMA board did not request details from Lönngren about his cons... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532572 Mon, 28 Feb 2011 15:43:18 +0100 4532572 http://www.medworm.com/index.php?rid=4495202&cid=t_169282_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhy-negative-medical-studies-are-good%2F2011.02.18 This is a guest column by Ivan Oransky, M.D., who is executive editor of Reuters Health and blogs at Embargo Watch and Retraction Watch. One of the things that makes evaluating medical evidence difficult is knowing whether what’s being published actually reflects reality. Are the studies we read a good representation of scientific truth, or are they full of cherry-picked data that help sell drugs or skew policy decisions? That question may sound like that of a paranoiac, but rest assured, it’s not. Researchers have worried about a “positive publication bias” for decades. The idea is that studies showing an effect of a particular drug or procedure are more likely to be published. In 2008, for example, a group of researchers published a New England Journal of Medicin... Better Health blogs http://www.medworm.com/rss/comments.php?id=4495202 Fri, 18 Feb 2011 22:20:24 +0100 4495202 http://www.medworm.com/index.php?rid=4482721&cid=t_169282_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=4450252&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F02%2Fafter-publicity-about-losses-from.html Over the last few weeks a series of stories appeared about how corruption siphons off money from worthy global health initiatives.  Corruption Depletes Global Fund to Fight AIDS, Tuberculosis and MalariaThe story that first got attention was from AP:A $21.7 billion development fund backed by celebrities and hailed as an alternative to the bureaucracy of the United Nations sees as much as two-thirds of some grants eaten up by corruption, The Associated Press has learned.Much of the money is accounted for with forged documents or improper bookkeeping, indicating it was pocketed, investigators for the Global Fund to Fight AIDS, Tuberculosis and Malaria say. Donated prescription drugs wind up being sold on the black market.The fund's newly reinforced inspector general's office, which unco... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4450252 Tue, 08 Feb 2011 21:05:00 +0100 4450252 http://www.medworm.com/index.php?rid=4405728&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fbig-door-keeps-on-turning-bi.html Recently we noted some complex examples of the health care "revolving door," cases of health care corporate leaders who came from government heading back into government.  The first was reported by Politico:California Rep. Mary Bono Mack has hired PhRMA’s former chief spokesman as a senior adviser, adding another Republican lawmaker to the list of those who have recruited staff members with K Street ties.Ken Johnson will serve as a senior policy and communications adviser to Bono Mack, chairwoman of a House Energy and Commerce subcommittee. Johnson has deep ties to the committee, having worked for former Republican Rep. Billy Tauzin when he headed the Energy and Commerce Committee.When PhRMA hired Tauzin months after the Louisiana congressman helped pass the industry-supported ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4405728 Thu, 27 Jan 2011 19:47:00 +0100 4405728 http://www.medworm.com/index.php?rid=4377789&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaVe4cHW2HSM%2F In a move that some may consider long overdue, more than a dozen of the most prestigious medical journals will consider requiring doctors who submit studies to disclose any payments received from hedge funds and other large investors. The proposal is expected to be discussed at the next annual meeting of The International Committee of Medical Journal Editors, which is scheduled for June, according to a spokeswoman for the New England Journal of Medicine. The possibility follows ongoing concerns about conflicts of interest between researchers and the pharmaceutical industry and the extent to which undisclosed financial relationships may unduly influence medical research and, from there, medical practice. But the issue is also encompassing financial ties to large investors, given the growing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377789 Thu, 20 Jan 2011 15:21:05 +0100 4377789 http://www.medworm.com/index.php?rid=4361308&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGTi6GBLv1fs%2F Hello, everyone, and nice to see you again. We hope your extended weekend - on this side of the pond, that is - was pleasant. Now, of course, the routine resumes with all those meetings and deadlines. So please join us for a cup of stimulation as we dust the snow off the Pharmalot corporate campus, ready the short people for the school house and prowl around for interesting items. Hope your day goes well and do stay in touch… FDA Staff Questions Lilly Alzheimer’s Drug (Reuters) Teva Will Lay Off 200 California Workers (Orange County Register) Pfizer Sued Over Dilantin Side Effects (Madison-St. Clair Record) Ariad Stock Pops After Sarcoma Drug Meets Study Goal (Bloomberg News) Servier Chief Called To Mediator Court Hearing (The Telegraph) EU Will Ask Sanofi To Write Docs About M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361308 Tue, 18 Jan 2011 12:52:21 +0100 4361308 http://www.medworm.com/index.php?rid=4343096&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fwho-undermined-these-wonderful.html The rise and fall of yet another esteemed health care institution provides another cautionary tale about health care dysfunction.  The Tragic Fall of the Picower FoundationTwo years ago, a highly-regarded charitable foundation had to close its doors, apparently one of the biggest victims of the Bernard Madoff Ponzi scheme.  Here is the Boston Globe version of the story:The unfolding scandal surrounding the alleged Ponzi scheme run by Bernard L. Madoff yesterday claimed as a victim one of the largest foundations in the country, which has funded groundbreaking brain research at the Massachusetts Institute of Technology and diabetes research at Harvard Medical School.The Picower Foundation of Palm Beach sent an e-mail to 'colleagues and friends' late yesterday saying that it was a v... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4343096 Thu, 13 Jan 2011 22:11:00 +0100 4343096 http://www.medworm.com/index.php?rid=4343331&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMzN0NGIvnh4%2F In 2008, the US Senate Finance Committee charged that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, the former chair of its psychiatry department, who owned a substantive amount of stock in Corcept Therapeutics, which was studying the development of mifepristone, or RU-486, for treating psychiatric depression. Beyond his stock holdings, Schatzberg was also listed as a co-patent holder for the drug, which is best known for inducing abortion, and he received a grant from the National Institutes of Health to oversee the research. The allegation was part of a lengthy probe into the wider issue of taxpayer-funded research and undisclosed and unmonitored conflicts involving universities, academic researchers and the pharmaceutical industr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343331 Thu, 13 Jan 2011 14:26:00 +0100 4343331 http://www.medworm.com/index.php?rid=4330970&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fblogscan-attention-to-medtronics.html On the HealthBeat blog, Maggie Mahar takes up the case of huge royalty and consulting payments to spine surgeons by medical device company Medtronic.  We had discussed the case recently here, followed by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog (see link in this post).  Ms Mahar was notably optimistic because of the continued attention to this case by the main stream media.  She argued that the increased emphasis on aspects of health care dysfunction shown by the media means "health care reform is moving ahead on the ground."  I hope she is right, but I would feel more hopeful if ill-informed, mission-hostile, self-interested, conflicted, and corrupt health care leadership was less anechoic, if health care dysfunction actually got some atte... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4330970 Mon, 10 Jan 2011 20:02:00 +0100 4330970 http://www.medworm.com/index.php?rid=4318291&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fwhy-would-directors-of-health-care.html We recently posted about 36 well-paid top executives in the University of California system, including leaders of medical schools, academic medical centers, and public health, who threatened a lawsuit if their pensions were not increased according to what they claim was a promise made to them in 1999.Riddle me this: why would a group of directors of for-profit corporations that provide health care goods and services. plus a director of a leading biotechnology trade group, and the director of a leading mutual fund family band together to support this demand, thus to push for bigger pensions for these top managers of the University of California system?Here is a list of the directors, and their corporations:-  Mark R Laret, director of Varian Medical Systems and Nuance Communicatio... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4318291 Thu, 06 Jan 2011 22:35:00 +0100 4318291 http://www.medworm.com/index.php?rid=4302851&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fblogscan-on-device-companys-obfuscation.html On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody analyzed further the case of the huge royalties paid to spine surgeons by Medtronic (see our most recent post here).  He wondered why surgeons would get such sizable payments for "intellectual property" related to devices that they neither seemed to use or to research?  I would note that the lack of clarity about the reason for Medtronic's payments to these surgeons is just part of a larger lack of clarity about most of the payments made to physicians and medical and health care academics for "consulting" or serving on advisory boards.  If such professional-industrial collaboration is so important for "innovation," one wonders why the people engaged in it are almost never willing to disclose the topics of these... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4302851 Sat, 01 Jan 2011 21:19:00 +0100 4302851 http://www.medworm.com/index.php?rid=4302106&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fformer-nih-director-spins-trhough.html ConclusionsSo the revolving door just keeps spinning, its revolutions suggesting how closely tied together big government and big corporations have become in what is now the health care business.  Whatever the motivations of Doctors Zerhouni, von Eschenbach, and Geberding were, the message to every person in a leadership position in health care in the US government has to still be: you too can earn big corporate compensation soon after you leave here.  Who knows how much that siren song will lead current government leaders to avoid antagonizing the leaders of big health care corporations during their government "service."  That is, of course, not what we want them to be thinking about if government agencies ae to serve the people, not the CEOs of big corporati... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4302106 Thu, 30 Dec 2010 21:15:00 +0100 4302106 http://www.medworm.com/index.php?rid=4300524&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fformer-nih-director-spins-trhough.html ConclusionsSo the revolving door just keeps spinning, its revolutions suggesting how closely tied together big government and big corporations have become in what is now the health care business.  Whatever the motivations of Doctors Zerhouni, von Eschenbach, and Geberding were, the message to every person in a leadership position in health care in the US government has to still be: you too can earn big corporate compensation soon after you leave here.  Who knows how much that siren song will lead current government leaders to avoid antagonizing the leaders of big health care corporations during their government "service."  That is, of course, not what we want them to be thinking about if government agencies ae to serve the people, not the CEOs of big corporati... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4300524 Thu, 30 Dec 2010 21:15:00 +0100 4300524 http://www.medworm.com/index.php?rid=4298600&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fspine-surgeons-reticent-about.html Starting in 2007, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves. In 2008, our post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.  In 2009, an article in the New England Journal of Medicine showed that alm... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4298600 Wed, 29 Dec 2010 21:28:00 +0100 4298600 http://www.medworm.com/index.php?rid=4294579&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fhow-marketing-mixes-into-medical-school.html Misery loves company, so here is an interesting case reported by the Canadian Press, via CTV News, about how students in a pain management course at the University of Toronto complained that marketing seemed to have been mixed into their curriculum:The complaint centered around students being provided a book on managing chronic pain that was funded and copyrighted by the maker of the prescription pain killer OxyContin. The book had been brought in by a non-faculty lecturer with financial ties to the drug company. It turned out that:From 2002 to 2006, the pain course was funded by donations, included $117,000 in unrestricted educational grants from four drug companies -- Merck-Frosst, Purdue Pharma, Pharmacia Canada and Pfizer -- although they had no input into course content. Since 20... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4294579 Tue, 28 Dec 2010 21:32:00 +0100 4294579 http://www.medworm.com/index.php?rid=4294580&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fhackensack-university-medical-center.html Last year was an embarassing one for Hackensack University Medical Center (HUMC), a large academic medical center affiliated with the University of Medicine and Dentistry of New Jersey.  In April, former state senator Joseph Coniglio was convicted of fraud (against the public) and extortion for a scheme that involved him being paid $5000 a month for undefined consulting work for HUMC while he promoted the hospital's interests in the state legislature (see post here).  A subsequent investigative report revealed widespread self-dealing on the part of the HUMC board (see post here).  Soon after, the HUMC CEO, John Ferguson, announced his retirement, per the Newark Star-Ledger.Scandal Leads to Apparent ReformsSo when I read an article from last week on NorthJersey.com entit... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4294580 Mon, 27 Dec 2010 22:47:00 +0100 4294580 http://www.medworm.com/index.php?rid=4294584&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fblogscan-charels-ferguson-inside-job.html On the Naked Capitalism blog, there is a video clip of an interview with Charles Ferguson, who directed Inside Job (see this post).  It is highly recommended, if as disturbing as the movie.  Look for the parallels with health care, and think about how the health care crisis is interlinked with the global financial crisis.  See the movie if you haven't already. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4294584 Fri, 24 Dec 2010 20:11:00 +0100 4294584 http://www.medworm.com/index.php?rid=4287386&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fblogscan-charels-ferguson-inside-job.html On the Naked Capitalism blog, there is a video clip of an interview with Charles Ferguson, who directed Inside Job (see this post).  It is highly recommended, if as disturbing as the movie.  Look for the parallels with health care, and think about how the health care crisis is interlinked with the global financial crisis.  See the movie if you haven't already. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4287386 Fri, 24 Dec 2010 20:11:00 +0100 4287386 http://www.medworm.com/index.php?rid=4287387&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fthese-pharma-paid-key-opinion-leaders.html At "The Lancet Emphasizes the Threats to the Academic Medical Mission" Roy Poses summarized the major categories of ills affecting healthcare today.The list reads like a list of the Ten Plagues of Egypt visited upon the Pharaohs (actually thirteen categories are listed, but plagues they are indeed to patients and conscientious medical practitioners).This list, with keyword-hyperlinked examples, can serve as an index to the threats to healthcare's core values covered at the Healthcare Renewal blog:1. Abandonment of traditional prohibitions of the commercial practice of medicine2. Making money takes precedence over education3. The medical school re-imagined as a biotechnology company4. Faculty become employees of industry5. Academics become "key opinion leaders" paid to market drugs and devi... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4287387 Fri, 24 Dec 2010 14:48:00 +0100 4287387 http://www.medworm.com/index.php?rid=4277799&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fblogscan-medtronics-multi-million.html Starting in 2007, we discussed the huge payments made by four medical device companies to orthopedic surgeons and medical organizations related to the use of hip and knee prostheses.  (See post here with links backward.)  Payments, in the millions of dollars per year range, went to surgeons including noted academics, and leaders of the main orthopedic physicians' society.  Payments went to medical schools, teaching hospitals, and professional societies.  Many of these financial relationships were not disclosed, and the disclosures that were made rarely indicated the amounts involved.Now the Wall Street Journal reports millions being paid to spine surgeons by Medtronic in connection with devices used in spinal fusion.  See Dr Howard Brody's discu... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4277799 Tue, 21 Dec 2010 21:10:00 +0100 4277799 http://www.medworm.com/index.php?rid=4275294&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fdrug-companies-are-now-no-1-when-it.html A new report from Public Citizen, as summarized by National Public Radio:Drug companies are now No. 1 when it comes to defrauding the government, leaving defense contractors in the dust.A report from the consumer group Public Citizen says financial penalties against drug companies under the federal False Claims Act far outstripped defense contractors between 2007 and 2010.The problem has been getting worse recently:Documented pharma fraud has been accelerating lately, Public Citizen says. It looked at fines and settlements paid by drug companies over two decades. Since 1991 those penalties totaled $19.8 billion. But three-quarters of those occurred over the past five years.Regarding the biggest offenders:Just four giant drug companies – GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4275294 Mon, 20 Dec 2010 22:20:00 +0100 4275294 http://www.medworm.com/index.php?rid=4272603&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpB1YDacfltc%2F Over the past few years, the growing debate over pharmaceutical industry influence on medical academia has prompted numerous schools to issue policies for monitoring conflicts of interest. Yet some are failing to adequately police their own faculty when it comes to paid speaking engagements on behalf of drugmakers, according to an analysis by ProPublica. The issue remains hot because critics say such talks can bump up against independental educational discourse if drugmakers control the topic of the lecture, train the speakers and require them to use slides presented by the company. Drugmakers say the requirement is designed to ensure speakers comply with FDA regulations and only discuss approved uses for drugs, the news service writes. Yet, adhering to such can put speakers in violation ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272603 Mon, 20 Dec 2010 14:02:21 +0100 4272603 http://www.medworm.com/index.php?rid=4265743&cid=t_169282_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F12%2F18%2Ftake-off-the-billion-dollar-blindfold%2F Would you buy an unlabeled bottle of vitamins from a health food store? Would you give those vitamins to your child? Would you trust a stylist who didn’t ask about your own wishes for your appearance? Would you have confidence in a salesperson’s ability to give you sound advice about a purchase if you knew they received huge perks from the company they are promoting? Most of us would not walk blindfolded into a salon and allow the stylist to cut or color our hair without our input. We would not consider giving our child a mystery pill from an obscure bottle of vitamins or a prescription with an unintelligible label. Yet many parents continue to accept vaccines and their long-lasting, dangerous effects without question, permitting doctors and nurses to inject their son or daughter with ... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4265743 Sat, 18 Dec 2010 07:01:34 +0100 4265743 http://www.medworm.com/index.php?rid=4265628&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fwhy-i-shouldnt-read-non-systematic.html I usually resist looking at non-systematic review articles in medical journals, but because the title interested me, and things seem to be getting slow this holiday season, prompted by an update email from the American Journal of Medicine, I looked at Ram CVS. Beta-blockers in hypertension. Am J Cardiol 2010: 106: 1819-1825. (Link here.)The Ram Article in Praise of Vasodilating Beta-BlockersThe article focused on the results of meta-analyses:Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.The article discussed several meta-analyses in which beta-blockers, [a specific class of blood pressure lowering drugs] but most... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4265628 Thu, 16 Dec 2010 21:22:00 +0100 4265628 http://www.medworm.com/index.php?rid=4249005&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fon-interconnectedness-of-leadership-of.html We just posted about some misbehavior by Abbott Laboratories: a physician Abbott paid as a "key opinion leader" to help market its cardiac stents was accused of inserting stents in many patients who had no need for them; Abbott settled for over $400 million a lawsuit alleging the company defrauded Medicare and Medicaid; and it settled an unrelated suit for over $40 million alleging the company paid kickbacks to physicians for prescribing its drugs.  I thus thought it would be interesting to see how well paid are the corporate leaders who presided over these activities, and who are the board members who were supposed to be providing stewardship of this company.According to the company's 2010 proxy statement, the five highest-paid executives were:Miles D White, Chairman of the... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4249005 Fri, 10 Dec 2010 21:24:00 +0100 4249005 http://www.medworm.com/index.php?rid=4237848&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fboards-who-ought-to-be-accountable-for.html I recently posted about the multiple conflicts of interest affecting a university health sciences leader.  While he was supposed to be running a medical school and an academic medical center, he was also responsible for the stewardship, as a board member, of three health major health care corporations, and a food and beverage corporation (whose products have bearing on nutrition and public health.)  .This one case suggested how pervasive are conflicts of interest affecting the people at the top of health care leadership in the US, and also how such conflicts may be associated with problems for all the organizations involved.  The story originally came to my attention because students were demonstrating against the lavish compensation given the health sciences leade... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4237848 Tue, 07 Dec 2010 17:44:00 +0100 4237848 http://www.medworm.com/index.php?rid=4233133&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fduke-divinity-students-protest-pay-of.html This may be a first.  A small group of Duke University divinity students publicly protested the compensation given to some top university leaders, specifically including the Chancellor for Health Affairs.  According to the Raleigh-Durham News-Observer:Theo Luebke strolled the plaza outside Duke's Bryan Center on Thursday afternoon with a bucketful of apples and a tale of woe.'Come on! Everyone's in this together! Get your apples!' he exhorted students passing by during the lunchtime rush. 'With all the cuts we have around here and all the bonuses we have to give to the big guys, we need to raise all the money we can.'Luebke isn't really the Depression-era fruit peddler his costume suggested. Luebke and a couple of other Duke divinity students hawked apples, ostensibly to raise mo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4233133 Mon, 06 Dec 2010 22:58:00 +0100 4233133 http://www.medworm.com/index.php?rid=4197002&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F11%2Fof-drug-talks-deception-and-denial.html A month ago, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records.  Since then, a series of local or regional news organizations have reported on physicians in... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4197002 Tue, 23 Nov 2010 19:31:00 +0100 4197002 http://www.medworm.com/index.php?rid=4179286&cid=t_169282_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=4167923&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F11%2Fliving-high-life-on-money-to-treat-poor.html Here is another story that has developed over the last week about questionable goings on at a not-for-profit health care organization.  The organization in question this time was the not-for-profit, but state government supported Medicaid managed care organization/ health insurer for the Louisville, Kentucky region.  The details came from a Louisville (Kentucky) Courier-Journal article about a state auditor's report on the Passport Health Plan:The organization providing Medicaid services in Jefferson and surrounding counties has spent lavishly on such things as travel, meals, salaries, bonuses and lobbying in recent years, the state auditor’s office said in a report released Tuesday.The scathing report, which Gov. Steve Beshear described as 'disheartening,' said two Passpo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4167923 Mon, 15 Nov 2010 21:49:00 +0100 4167923 http://www.medworm.com/index.php?rid=4151701&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F11%2Fwhat-conflicted-web-we-weave-more-about.html The issue of conflicted academic economists providing public policy recommendations just got bigger.  As discussed by Felix Salmon in his blog for Reuters, and by Nancy Folbre in the Economix blog for the New York Times,  a new study by Epstein and Carrick-Hagenbarth showed that some very prominent economists who frequently make pronouncements about financial policy often failed to disclose some major conflicts of interest.  In summary, they identified "two groups of economists that were prominent in the field of financial economics and which had taken a public stance on financial regulation."  Some of these economists also had prominent advisory roles for government economic agencies, including the US Federal Reserve, the US Council of Economic Advisers, the ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4151701 Tue, 09 Nov 2010 17:37:00 +0100 4151701 http://www.medworm.com/index.php?rid=4133610&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F11%2Fthere-you-go-again-richard-epstein-says.html Richard Epstein, a professor at the New York University and University of Chicago law schools, isjust authored a report on the perils of conflict of interest rules.  In his blog, "The Libertarian," he summarized his beliefs that strict conflict of interest (COI) rules and restrictions on pharmaceutical marketing "spell lower rates of innovation and slower dissemination of new products."  Prof Epstein is extremely prominent.  The Manhattan Institute, of which he is a fellow, claimed, "Professor Epstein's influence is profound: he is one of the three most cited law professors in the United States and the most cited professor writing largely in private law." Thus, it is disturbing that it appears that his objections are based on a series of&nb... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4133610 Thu, 04 Nov 2010 21:55:00 +0100 4133610 http://www.medworm.com/index.php?rid=4125283&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fz4r5rINz09I%2F Much attention has been paid to conflicts of interest relating to the pharmaceutical industry, but where do medical journals fit in this equation? A new study notes that journals also have vested interests that warrant disclosure. Specifically, industry-supported clinical trials can boost a journal’s so-called impact factor by generating greater distribution of reprints that increase citation rates and, of course, revenue. The trials are often supported by drugmakers, which purchase reprints. What is an impact factor? The researchers defined it this way: a measure of a journal’s importance based on how often its articles are cited. This is not just about prestige, of course, but the potential for greater circulation (there is a formula contained in the study, which was publishe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4125283 Mon, 01 Nov 2010 12:41:53 +0100 4125283 http://www.medworm.com/index.php?rid=4119077&cid=t_169282_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F10%2F29%2Fwhite-house-policy-adding-to-stigma-of-suicide%2F A Department of Defense task force dedicated to preventing suicide in the military recently released a report with some disturbing facts. The report acknowledges that the physical and psychological demands on our volunteer fighting forces are huge. Between 2005 and 2009 alone, more than 1,100 soldiers committed suicide. That is one soldier dying by suicide every 36 hours. The report notes that the rate of suicide deaths in the Army has more than doubled. The task force mentions numerous research reports that have documented the psychological and emotional injuries — “the hidden wounds of war” — that have devastated many military members and their families. Personnel who are deploying — as well as those left behind — are under stress because of an imbalan... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4119077 Fri, 29 Oct 2010 17:07:46 +0100 4119077 http://www.medworm.com/index.php?rid=4106062&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPTSfGsg6psw%2F In his latest effort to probe conflicts of interest in the drug and device industry, US Senator Chuck Grassley has written FDA commish Margaret Hamburg to ask how the agency determines whether the financial interests of clinical investigators may adversely affect patients in clinical trials and the “integrity and reliability” of the studies submitted for product approval. As Grassley notes in his October 22 letter, the FDA requires manufacturers that submit applications and clinical studies for product approvals to file disclosure statements about the financial interests of investigators who are not full-time or part-time employees, but are or were involved in conducting studies submitted to the FDA. Specifically, disclosures should include info about financial arrangements bet... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106062 Mon, 25 Oct 2010 13:03:45 +0100 4106062 http://www.medworm.com/index.php?rid=4097858&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F10%2Fnot-best-and-brightest-drug-marketers.html A combined investigative reporting effort by Pro Publica, partnering with the Boston Globe, Consumers Reports, the Chicago Tribune, National Public Radio, the Public Broadcasting System on seven major pharmaceutical companies' payments to doctors who make speeches on the companies' behalf has gotten a lot of press.  It inspired several separate reviews by news organizations in Colorado, Illinois, Minnesota, Ohio,Washington, etc on local doctors who were paid to talk.  Many of my fellow health care skeptic bloggers, including the Carlat Psychiatry Blog, Hooked: Ethics,Medicine and Pharma blog, the Health Beat blog, have been all over this story.Yet I think it is reasonable to underline three important points.Not the BrightestPharmaceutical and other health care... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4097858 Fri, 22 Oct 2010 19:49:00 +0100 4097858 http://www.medworm.com/index.php?rid=4098458&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWhw08OSezIA%2F In the latest chapter in the Stephen Ondra saga, US Senator Chuck Grassley has written both the US Department of Veterans Affairs and Medtronic in search of still more information about the prominent spinal surgeon and his dealings with device maker both before and after he accepted his current government position as the VA’s senior policy advisor for health affairs. The backdrop is an inquiry begun late last month, when Grassley - the ranking Republican the Senate Finance Committee who has undertaken numerous conflict-of-interest probes into drug and device makers - noted that Ondra was paid about $4 million in royalties by Medtronic in the two years before joining the VA in 2009. And the senator cited emails in which Medtronic officials are attempting to secure a position for Ondra... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098458 Fri, 22 Oct 2010 19:30:26 +0100 4098458 http://www.medworm.com/index.php?rid=4086229&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F10%2Ftoxic-and-dangerous-watchdog-vs.html An odd story that appeared earlier this month linked several people we have discussed on Health Care Renewal.On one hand, we posted about how Dr David Polly, a spine surgeon at the University of Minnesota, testified before the US Congress in support of research on treatments of bone injuries afflicting US soldiers.  He did not then reveal that he had been paid more than one million dollars for consulting by Medtronic, the manufacturer of a bone growth product used to treat such injuries, also the source of payments of his expenses for the trip to Washington.  At the time, we suggested this case was a reminder to be skeptical about academics who are really stealth health policy advocates for industry.On the other hand, in a post about renewed payments... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4086229 Wed, 20 Oct 2010 21:23:00 +0100 4086229 http://www.medworm.com/index.php?rid=4082087&cid=t_169282_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fdollars-for-doctors-investigative-public-service-journalism%2F2010.10.19 An historic piece of journalism was published today. Six news organizations partnered on the “Dollars for Docs” project — ProPublica, NPR, PBS’s Nightly Business Report, the Chicago Tribune, Boston Globe and Consumer Reports. They examined $258 million in payments by seven drug companies in 2009 and 2010 to about 18,000 healthcare practitioners nationwide for speaking, consulting, and other tasks. This webpage can be your gateway to the project, with links to a database searchable by doctor’s name or by state, and links to the journalism partners’ efforts: Boston Globe “Prescription for Prestige” The Harvard brand, unrivaled in education, is also prized by the pharmaceutical industry as a powerful tool in promoting drugs. Its allure is evid... Better Health blogs http://www.medworm.com/rss/comments.php?id=4082087 Tue, 19 Oct 2010 20:00:21 +0100 4082087 http://www.medworm.com/index.php?rid=4074445&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjXyjAatMwKk%2F Good morning, everyone. Another day is on the way, but this one brings us to the weekend. And not a moment too soon, yes? Have any special plans? Watching a ball game? Picking apples? A nap on the couch? For our part, we hope to spend time with Mrs. Pharmalot and all of the Pharmalittles, and catch up with a favorite relative, too. Whatever you do, enjoy. Meanwhile, here are a few items to help you glide through the day. Have a great weekend and see you soon… CVS Fined For Allowing Meth Ingredient Sales (Associated Press) EMA Tightens Guidelines For Impartiality On Commitees (PharmaTimes) Sanofi Says MS Drug Cuts Relapses By 31 Percent (Reuters) Reckitt Fined By UK Regulators Over Heartburn Drug Supplies (Bloomberg News) FDA May Limit Anemia Drugs For Kidney Use (Associated Press) (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4074445 Fri, 15 Oct 2010 11:41:40 +0100 4074445 http://www.medworm.com/index.php?rid=4060594&cid=t_169282_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F10%2F12%2Fchief-justice-john-roberts-jr-has-history-of-selling-shares-in-drug-companies%2F Today, Tuesday 12th October 2010, a case involving a child who has been vaccine damaged is being heard at the Supreme Court USA. This high profile case has the potential to change the law surrounding cases that involve vaccine injuries. However, already there is controversy surrounding this case. The reason is because Chief Justice John Roberts Jr. recently sold his shares in the company Pfizer, worth $15,000 or more, enabling him to participate. If this was the first time Roberts had done this, I guess that he could be excused to some degree, but this guy seems to make a habit of selling shares to suit. According to a report on Kentucky.com (http://www.kentucky.com/2010/…), this was not the first time that Chief Justice John Roberts Jr has decided to sell stocks to enable him to tak... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4060594 Tue, 12 Oct 2010 19:53:14 +0100 4060594 http://www.medworm.com/index.php?rid=4036597&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F10%2Fwhat-conflicted-web-we-weave-academic.html We have been writing about conflicts of interest in health care now for a long time.  We started with a focus on academic physicians'  and leaders' financial ties to pharmaceutical/ biotechnology/ device companies, then went on to the intense conflicts generated by academic medical and other health care non-profit leader who also sit on boards of directors of for profit health care corporations, and to conflicts affecting various kinds of respected not-for-profit health care organizations, like medical societies and patient advocacy groups.Meanwhile, we uncovered the curious dominance of the boards of some health care organizations by leaders in the finance world, including some of the leaders of the failed companies that brought us the "great recess... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4036597 Wed, 06 Oct 2010 20:11:00 +0100 4036597 http://www.medworm.com/index.php?rid=4022875&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F10%2Fnovartis-settles-but-wait-theres-more.html Back in January, 2010, we posted about Novartis' settlement of charges that it promoted its anti-seizure drug, Trileptal, (Oxcarbazepine) for off-label uses, agreeing to plead guilty to one charge of violating the US Food, Drug and Cosmetic Act.  This week, the full story of the settlement just came out, and yes, but wait, there's more.  Per the New York Times article by Duff Wilson, the story is not only about Trileptal:The Swiss drug giant Novartis is paying $422.5 million to settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs, federal officials said on Thursday.The other drugs were:Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4022875 Fri, 01 Oct 2010 19:40:00 +0100 4022875 http://www.medworm.com/index.php?rid=4018216&cid=t_169282_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F09%2F30%2Fhoward-sterns-endless-psychotherapy%2F Howard Stern, the ubiquitous satellite radio talk-show host, is big proponent of psychotherapy. He has noted how he’s been in psychotherapy three times a week for the past few decades, much like Woody Allen. But what kind of psychotherapy is Howard Stern in? And why does it seem endless? This type of intensive, long-term psychotherapy is almost always psychoanalysis — a specific type of psychotherapy that focuses on how a person’s unconscious conflicts impact a person’s everyday functioning. People who undergo psychoanalysis almost always meet with their analyst 2 to 3 times a week, every week, for years on end. Howard Stern has said he sees his analyst 3 times a week, but sometimes feels like he would like to cut down to twice a week. Psychoanalysis is considered a... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4018216 Thu, 30 Sep 2010 17:33:38 +0100 4018216 http://www.medworm.com/index.php?rid=3987234&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaWze7AH3p9A%2F For the past three years, Paul Thacker was an investigator on the US Senate Finance Committee, working for Iowa Republican Chuck Grassley, who is the ranking minority member. During his tenure, Thacker was central to probes into the pharmaceutical industry, specifically, investigations into the disclosure of clinical trial data for GlaxoSmithKline’s Avandia diabetes pill and undisclosed financial conflicts of interest among academic researchers. Earlier this month, the former US Army specialist left to join a non-profit watchdog, the Project on Government Oversight. We caught him as we walked out the door to ask about his efforts and whether he thought the probes created any change. Pharmalot: Why leave now? Thacker: I’ve been on the committee for three years and two years is cons... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987234 Mon, 20 Sep 2010 13:37:49 +0100 3987234 http://www.medworm.com/index.php?rid=3983382&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F09%2Fshould-president-of-university-of.html We first started to discuss the intense conflicts of interest generated when leaders of academic medicine are also members of boards of directors of for-profit health care corporations in 2006.The issue really made the big time in 2010 when the New York Times published a front page article in its Sunday Business section about whether university presidents who also were corporate directors were part of an "academic-industrial complex."University of Michigan President Mary Sue Coleman as a Director of Johnson and JohnsonOne such director we discussed this year is Mary Sue Coleman, President of the University of Michigan, and hence leader of a prestigious medical school and academic medical center, who is also Director of the large health care conglomerate, Johnson and Johnson. This... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3983382 Sun, 19 Sep 2010 22:33:00 +0100 3983382 http://www.medworm.com/index.php?rid=3980796&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F09%2Fforest-pharmaceuticals-pleads-guilty-to.html The parade of legal settlements marches on.  The latest story is about Forest Laboratories and its marketing of Celexa (citalopram ) and Levothyroid (l-thyroxin).  Here is the most complete version, courtesy of Natasha Singer reporting for the New York Times. First, the lead sentence:A unit of Forest Laboratories, the maker of the antidepressant Celexa, agreed on Wednesday to pay more than $313 million to settle criminal and civil complaints, including a claim that it had illegally promoted the drug for use in children. Here are the charges:Among the criminal charges was one that the subsidiary, Forest Pharmaceuticals, marketed Celexa, which was approved only for adult depression, to treat children and adolescents. The government also claimed that, in conjunction with the company... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3980796 Fri, 17 Sep 2010 19:27:00 +0100 3980796 http://www.medworm.com/index.php?rid=3981016&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnhV0EShxyos%2F After an especially nasty boardroom spat spilled into public view this month, Elan has reached a deal with a pair of dissident board members, who wanted to conduct their own corporate governance audit and threatened a lawsuit that the beleaguered biotech had to race to court to block (back story here). At issue were several transactions that raised questions about undisclosed financial conflicts of interest among Kelly Martin, the embattled Elan ceo, and still other board members. The revelations were not a secret - they were publicized by a dissident shareholder who went so far as to create a web site this year for agitators called Save Elan (read more here). In response to these developments, Martin earlier this month issued an extraordinary, 18-page letter touting his accomplishments an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981016 Fri, 17 Sep 2010 12:43:15 +0100 3981016 http://www.medworm.com/index.php?rid=3976711&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT-dukPIsxP4%2F Several years after issuing conflict-of-interest guidelines for its physicians, the Yale Medical Group, which is an appendage of the Yale University School of Medicine, has adopted a new, comprehensive policy that addresses financial ties to drug and device makers; gifts, meals and other goodies from industry; ghostwriting; samples; consulting and continuing medical education. “We wanted to upgrade the guidelines to a full-blown policy so that faculty and others understand that these are no longer electives, because the landscape has changed,” David Leffell, Yale Medical Group’s ceo, tells us. To clarify, the Yale Medical Group is staffed by roughly 800 academic physicians from the Yale School of Medicine; it is not a separate practice or foundation. The move reflects ong... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976711 Thu, 16 Sep 2010 12:45:51 +0100 3976711 http://www.medworm.com/index.php?rid=3973112&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRb9UzJInrkA%2F Among the many contentious debates embroiling the pharmaceutical industry in recent years is the argument that freebies given to doctors - gifts, meals, dinners and trips - unduly influence the physican mindset. But why do some docs believe accepting such goodies is okay? A new study offers a clue - some docs believe these treats are a reward for the sacrifices made to study medicine. Two Carnegie Mellon University researchers asked 301 pediatric and family medicine residents about the appropriateness of accepting freebies. But they were divided into three groups. Before completing the survey, one group was asked about sacrifices made in getting their education. Another group was asked the same questions but also whether the sacrifices - poor working conditions and school debt - justified ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973112 Wed, 15 Sep 2010 14:01:59 +0100 3973112 http://www.medworm.com/index.php?rid=3965698&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGxM5hMWP1ak%2F Only 46 percent of surgeons who received at least $1 million from orthopedic device makers disclosed their relationships in their published scientific articles, according to a study by the Institute on Medicine as a Profession, a think tank based at the Columbia University College of Physicians & Surgeons. IMAP examined the 2007 physician payment info from five device makers - Biomet, Smith & Nephew, Stryker, Zimmer and Johnson & Johnson’s DePuy - that made 1,654 payments totaling $248 million consulting, honoraria or other activities, according to an analysis of publicly available data. Such info is increasingly posted by drug and device makers due to large settlements with federal prosecutors (look here), negative publicity over conflicts of interest and a new feder... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965698 Mon, 13 Sep 2010 20:10:32 +0100 3965698 http://www.medworm.com/index.php?rid=3943028&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fgy2YlHI1sNw%2F The ongoing probe of undisclosed conflicts of interest by the US Senate Finance Committee uncovered numerous instances involving academics, who simultaneously had ties to drugmakers while also conducting research that was funded by the National Institutes of Health. And a common thread among many of those who were probed was their work concerning psychiatric drugs, such as antidepressants and antipychotics (look here). So it probably should not come as a surprise that some of these people continue to pop up in various settings where they can hob-knob if they so choose. For those wishing to keep track of such things, Alan Schatzberg, who last week retired as chair of the psychiatry department at Stanford University (see the goodbye note here), is scheduled to appear during the Grand Rounds ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3943028 Tue, 07 Sep 2010 13:01:05 +0100 3943028 http://www.medworm.com/index.php?rid=3925084&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHa5z-LE_Be8%2F After a decade of running one of the world’s most prestigious medical journals, Catherine DeAngelis is leaving her job as editor-in-chief of the Journal of the American Medical Association next year to join Johns Hopkins University School of Medicine, Baltimore, where she will develop a Center for Professionalism in Medicine and the Related Professions, including nursing, public health, business and law. “This program, based in ethical professional conduct, will be a culmination of education, training and experience. It is the logical next step for me based back in my academic home,” DeAngelis says in a statement, which notes she was vice dean for Academic Affairs and Faculty at Hopkins School of Medicine before going to JAMA and is a professor of pediatrics there. During her te... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925084 Wed, 01 Sep 2010 22:45:53 +0100 3925084 http://www.medworm.com/index.php?rid=3914997&cid=t_169282_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fspinal-fusion-device-from-revolutionary-advance-to-public-health-alert%2F2010.08.30 There are many stories journalists could report on about conflicts of interest and questions about evidence in the treatment of low back pain, perhaps especially with spinal fusion. We talked about many of these with journalists from the American Society of News Editors in a workshop at the Foundation for Informed Medical Decision Making in Boston in May. John Fauber of the Milwaukee Journal-Sentinel hammers one of these issues, looking at how Medtronic’s Infuse product “went from revolutionary advance to public health alert.” Here’s his story on MedPageToday: “Spinal Fusion Device: A Bone of Contention for FDA.”  His entire series entitled “Side Effects: Money, Medicine and Patients” is indexed on the Milwaukee Journal-Sentinel website. Th... Better Health blogs http://www.medworm.com/rss/comments.php?id=3914997 Mon, 30 Aug 2010 18:00:22 +0100 3914997 http://www.medworm.com/index.php?rid=3907780&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fr3X_-REYm-Q%2F We spend a fair amount of time on this site tracking the controversy over continuing medical education and the extent to which industry may unduly influence the physician mindset. For the second year running, though, a drugmaker - it happens to be Pfizer - is underwriting an extensive seminar on cancer issues for journalists that is organized by the National Press Foundation. Here are the basics: the NPF is awarding 15 fellowships to journalists who will attend a four-day session in October on cancer issues that will be presented by several experts (you can read more here). The idea, says Bob Meyers, the NPF prez and a former editor and reporter for The Washington Post, is to give journalists a chance to learn needed info about complex subjects, especially at a time when media resources ar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3907780 Thu, 26 Aug 2010 13:12:01 +0100 3907780 http://www.medworm.com/index.php?rid=3895834&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F08%2Fmaking-community-health-agency-into.html As we predicted, it seems that the US Internal Revenue Service's (IRS) increased reporting requirements for not-for-profit organizations are leading to more examples of the coziness now prevalent among the top leaders of such organizations.  The latest entry in this new parade comes from a story in the Bradenton (Florida) Herald about a not-for-profit community health agency whose mission is to provide health care to the poor and disenfranchised:Providing medical services to the indigent and uninsured in Manatee and Sarasota counties has financially benefitted some of Manatee County Rural Health Services Inc.’s officers, board members and their families, records show.The nonprofit agency has paid nearly $2 million in recent years to businesses owned by board members, officers, emplo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3895834 Mon, 23 Aug 2010 20:30:00 +0100 3895834 http://www.medworm.com/index.php?rid=3889047&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F08%2Fwhere-theres-smoke-university-president.html A long time ago, in 2006, we first blogged about a "new species of conflict of interest" which we thought might prove to be even more important than those afflicting health care that were then starting to be discussed.  This involved health care organizational leaders who were simultaneously members of the boards of directors of for-profit health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]   Thus, for example, the conflict posed by the pre... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3889047 Fri, 20 Aug 2010 21:30:00 +0100 3889047 http://www.medworm.com/index.php?rid=3946470&cid=t_169282_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F08%2F18%2Frockefeller-vaccine-secret-revealed%2F Discussions Presented at the Third International Poliomyelitis Conference: Developments in Tissue Culture., (pp. 221). Philadelphia: J.B. Lippincott Company. [18] Brown, R., et. al. The Mass Production and Distribution of HeLa Cells at Tuskegee Institute, 1953–55. J Hist Med Allied Sci.1983; 38: 415-431. [19] Nelson-Rees, W.A. Responsibility for truth in research. Philos Trans R Soc Lond B Biol Sci. 2001 June 29; 356(1410): 849–851. [20] Paul, J. (1974). A Biographical Memoir: Thomas Francis, Jr. – 1900-1969 (pp. 79). Washington D.C.: National Academy of Sciences. Retrieved August 17th, 2010 from http://books.nap.edu/html/biomems/tfrancis.pdf Henry Kumm [21] Snowden, F.M. (2006). The Conquest of Malaria: Italy, 1900-1962, (pp. 200). Frederick W. Hilles Publication Fund of Yale Un... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=3946470 Wed, 18 Aug 2010 14:04:52 +0100 3946470 http://www.medworm.com/index.php?rid=3858379&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRTxXs44cPn8%2F Last week, the University of Minnesota finally released its long-awaited conflicts of interest policy. Nearly three years in the making, the rules attempt to address what has become a common problem among universities - undisclosed financial conflicts among top faculty and administrators who have ties to industry, notably drug and device makers. But some present and former faculty argue the rules come up short. They say the new policy lacks sanctions; there is no ban on consulting fees; there is no requirement for public disclosure of ties or holdings that may represent a conflict, and industry-funded continuing medical education is permitted, despite proposals to eliminate such financing. “Read the fine print,” says Bill Gleason, an associate professor in the medical school, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3858379 Wed, 11 Aug 2010 14:06:40 +0100 3858379 http://www.medworm.com/index.php?rid=3858382&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F80EA963DpmU%2F Now that the World Health Organization has officially declared that the swine flu pandemic is over (see this), the agency has finally released the names of the scientific advisors who helped with pandemic decisions and their declared conflicts of interest, such as paid work for drugmakers. The move comes four months after the WHO denied the pharmaceutical industry had undue influence over its decisions about the extent of the pandemic and two months after the Council of Europe issued a report harshly criticizing the agency’s lack of transparency around the handling of the swine flu pandemic (back story here and here). For its part, the WHO called the accusations “conspiracy theories,” but refused to release the conflict of interest forms filed by the 16 members of its eme... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3858382 Wed, 11 Aug 2010 11:45:32 +0100 3858382 http://www.medworm.com/index.php?rid=3848841&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F08%2F2-legal-settlements-1-corporate.html Omnicare's Trail of Legal SettlementsLast year, we discussed a $98 million settlement made by Omnicare, US based corporation that manages pharmacy-benefits, of allegations that it received kickbacks from generic drug manufacturers for buying and recommending their drugs.  Omnicare had previously submitted to a corporate integrity agreement in 2006, and paid $102 million to settle allegations it defrauded Medicaid.  At the time, we noted that this was yet another of the many cases in which the organization alleged to be involved in wrong-doing paid a fine, but no one who authorized, directed, or implemented the bad behavior was subject to any negative consequences.So last week, Cincinnati.com ran a story on the retirement of the CEO who presided over Omnicare during the time of th... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3848841 Mon, 09 Aug 2010 21:47:00 +0100 3848841 http://www.medworm.com/index.php?rid=3827345&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTP0trINh5Nk%2F Joining a small, but growing list of academic institutions, the University of Minnesota has adopted new rules governing conflicts of interest for its med school employees, The Minneapolis Star-Tribune writes. The ethics policy overhaul is part of a university-wide effort, but the new rules are tougher for faculty and staff at the Academic Health Center, which includes the schools of Medicine, Dentistry, Nursing and colleges of Pharmacy and Veterinary Medicine. “The feeling was that the bar needed to be higher for people who come in clinical contact with patients and others,” Frank Cerra, the U’s senior vp for health sciences, tells the paper. “I think it’s a good policy. The move comes a year after the med school was the target of a congressional inquiry into ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827345 Thu, 05 Aug 2010 15:11:20 +0100 3827345 http://www.medworm.com/index.php?rid=3823160&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtzsBy8SMXoI%2F Early last year, a stink arose at Tufts University when top university officials refused to allow other administrators to be panelists at a conference on conflicts of interest in medicine and research because Paul Thacker, an aide to US Senator Chuck Grassley, was due to give the keynote speech. Why? They were uncomfortable that Grassley was investigating ties between a Tufts professor and drugmakers (back story here and here). In the same time period, however, one subject of the ongoing Grassley probe did speak at Tufts. According to disclosure forms filed with his employer, Charles Nemeroff, who is now psychiatry chair at the University of Miami Miller School of Medicine, gave a lecture at Tufts sometime between June 1, 2009 and May 31, 2010. He was paid between $1,000 and $5,500, but th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3823160 Wed, 04 Aug 2010 14:09:54 +0100 3823160 http://www.medworm.com/index.php?rid=3802342&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fhospital-ceo-as-debt-collector.html Last year we noted that the US Internal Revenue Service (IRS) required more detailed reporting starting in 2009 by US not-for-profit organizations. Many US health insurance companies/ managed care organizations, most hospitals, nearly all medical associations, nearly all disease advocacy organizations, all health care charities, and nearly all medical schools are not-for-profit organizations. We suggested then that this reporting might lead to more transparency about the leadership and governance of these organizations.  The 2009 990 forms seem to be trickling into public view, sometimes leading to some striking disclosures about how US not-for-profit health care organizations are lead.The California Watch blog just reported about the interesting part-time job of a hospital CEO:The fo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3802342 Thu, 29 Jul 2010 22:17:00 +0100 3802342 http://www.medworm.com/index.php?rid=3798515&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fare-ill-informed-leaders-cause-of-drug.html Fundamental Corporate FailuresIn the last few years, there seems to have been an epidemic of once revered companies suddenly unable to perform the most basic functions necessary for their businesses.  Finance firms ran out of money and ended up bailed out or bankrupt.  An automobile firm produced cars that seemed to accelerate out of control.  Another automobile company, once the world's biggest, went bankrupt and had to be bailed out by the government. An oil company took months to cap a blown out well. In the health care world, drug companies which could no longer manufacture pure and unadulterated drugs.  Baxter International sold deadly contaminated heparin (post here). Johnson and Johnson sold contaminated or wrongly dos... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3798515 Wed, 28 Jul 2010 21:26:00 +0100 3798515 http://www.medworm.com/index.php?rid=3790658&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fstifling-whistle-blowers-old-and-new.html Discussions with my colleagues suggest that the problem is not limited to one pharmaceutical company ....We and many others have frequently discussed the conflicts of interest that may be generated by physicians or health care academics having financial relationships with industry. The Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, Conflict of Interest in Medical Research, Education, and Practice, is:Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Second... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3790658 Mon, 26 Jul 2010 20:55:00 +0100 3790658 http://www.medworm.com/index.php?rid=3790923&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9PSZP9s4wQg%2F Remember David Capuzzi? He was a member of the recent FDA advisory committee on Avandia who, as it turns out, has also been a speaker for GlaxoSmithKline, which sells the controversial diabetes pill. The FDA, apparently, was not aware of this relationship until it was disclosed last week (see here). Capuzzi, who is a professor of medicine and biochemistry at Thomas Jefferson University in Philadelphia was paid a total of $14,750 over the past several years, mostly for talking about Lovaza, including at least one engagement earlier this year. But there was once instance in which he spoke about Avandia, according to a Glaxo spokesman. When asked about this last week, the FDA issued a statement saying the agency “takes these allegations very seriously and is investigating the matter.”... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3790923 Mon, 26 Jul 2010 12:08:13 +0100 3790923 http://www.medworm.com/index.php?rid=3790924&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtLMA5wp2JEs%2F Israel’s Comptroller has launched an investigation into the financial ties between drugmakers and various health-care organizations, including hospitals and their research foundations, as well as any related organizations, and expects to release his report in May, Ha’aretz reports. The move comes as the Israel Medical Association voluntarily disclosed the amount of money received last year from drugmakers, which was done in hopes of thwarting legislation to require doctors to report payment from the the pharmaceutical industry. The IMA also agreed to support a bill that would require disclosure of payments to medical organizations and research physicians, the newspaper continues (see here). According to the IMA’s voluntary disclosure, the organization received about $184,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3790924 Mon, 26 Jul 2010 12:07:57 +0100 3790924 http://www.medworm.com/index.php?rid=3767310&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjqjElo7HkFY%2F When the FDA held a media briefing prior to the controversial advisory panel last week for the Avandia diabetes drug, an agency official was asked whether any conflict of interest waivers were issued for the panel members. Under pressure, you may recall, the agency revised its those rules and now attempts to vet financial holdings or relationships to drugmakers that are provided by panel members (see this). In response, Jill Warner, acting associate commissioner for Special Medical Programs, said none were issued. However, there was an undisclosed, ongoing relationship involving one panel member. David Capuzzi, an endicrinologist who has been a professor at Thomas Jefferson University in Philadelphia, last year earned $3,750 as a speaker for GlaxoSmithKline, which sells Avandia (see the li... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767310 Tue, 20 Jul 2010 01:11:38 +0100 3767310 http://www.medworm.com/index.php?rid=3764128&cid=t_169282_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=3761391&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fnew-york-times-reports-university.html Three months ago, we discussed the controversy at the University of Michigan about  the university president's position on the board of directors of the big pharmaceutical, medical device and medical supply company Johnson and Johnson as a potential conflict of interest that could have influenced her decision to make the campus smoke-free.  (Johnson and Johnson makes drugs to aid in smoking cessation.)  I argued that by the Institute of Medicine definition, President Coleman did have a conflict of interest, and while it was not possible to tell whether it influenced the smoke-free decision, the issue with conflicts is that they constantly raise the possibility of undue influence on decisions.Now this issue has made it to the big time.  New York Times reporter Duff Wilso... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3761391 Fri, 16 Jul 2010 20:32:00 +0100 3761391 http://www.medworm.com/index.php?rid=3754070&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdY5mqnO9a9Y%2F Last year, the University of Wisconsin and the UW Medical Foundation began drafting a new conflict of interest policy in response to admonitions by the US Senate Finance Committee, which has been investigating undisclosed financial ties between academic researchers and drug and device makers. In response, some doctors railed against the idea. How do we know? Their not-so-discrete remarks were made in e-mails obtained by The Milwaukee Journal-Sentinel. Although some docs supported the move, others argued vociferously against it in e-mails to UW officials, and threatened to quit or take legal action when the UW Foundation drafted rules to restrict their financial relationships with drugmakers, the paper writes. Others also complained about exceptions proposed for docs who consult with devic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3754070 Thu, 15 Jul 2010 09:23:50 +0100 3754070 http://www.medworm.com/index.php?rid=3737293&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcDZXteAWacE%2F For the past several weeks, National Institute of Mental Health director Tom Insel has found himself at the center of a furious controversy over conflicts of interest involving academic researchers who simultaneously receive NIH funding and do work for drugmakers. An ongoing probe, meanwhile, by the Senate Finance Committee has made a poster boy of Charles Nemeroff, an old Insel colleague who recently landed a job as the psychiatry chair at the University of Miami med school. Insel was caught up in this affair, because he spoke with the med school dean Pascal Goldschmidt, who asked for a reference before hiring Nemeroff, who was working at Emory University when the Senate committee learned of the large consulting fees he received from GlaxoSmithKline. The query from Goldschmidt was made ju... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3737293 Thu, 08 Jul 2010 14:14:41 +0100 3737293 http://www.medworm.com/index.php?rid=3726580&cid=t_169282_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=3714129&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F06%2Fsmoke-detector-medical-center-leader.html Last year we posted about the seemingly incongruous choice of a wealthy biotechnology executive with little academic or practice experience to run the prestigious University of California - San Francisco, a health oriented university housing a respected medical school.  We wondered whether her corporate background would make it difficult to uphold the university's academic and patient care missions.In line with our concerns, Duff Wilson, writing in the New York Times, reported:When Dr. Susan Desmond-Hellmann was named chancellor of the University of California, San Francisco, last summer, she took over a medical institution focused on world health generally and tobacco control in particular. But she forgot one thing in adjusting to her new role: personal stock holdings listed las... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3714129 Wed, 30 Jun 2010 20:49:00 +0100 3714129 http://www.medworm.com/index.php?rid=3714130&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F06%2Finsel-admits-his-statements-may-be.html Dr Bernard Carroll has posted several times, most recently here, about shenanigans by "key opinion leaders" in psychiatry whose apparently academic writing and speeches have conveyed messages in line with the marketing agendas of drug and device companies, while they downplayed or concealed their financial ties to these companies.  Lately, Dr Carroll noted how the current director of the US National Institute for Mental Health (NIMH), Dr Thomas Insel, has defended Dr Charles Nemeroff, whose recent move to the University of Miami let him shed sanctions imposed by Emory University for his failure to disclose conflicts of interest while he was there. Dr Carroll wrote, "For the past three months, Insel has been trying to put some distance between himself and Nemeroff, but the pu... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3714130 Wed, 30 Jun 2010 20:20:00 +0100 3714130 http://www.medworm.com/index.php?rid=3714444&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJSU5gTPTZaE%2F Earlier this week, the Archives of Internal Medicine published a few articles and editorials about statins, although one, in particular, generated some heat - a review of the controversial Jupiter study from 2008. The study, which focused on AstraZeneca’s Crestor cholesterol pill, measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease. The results prompted debate over the extent to which CRP should be used as a guideline for treating cholsterol and the wisdom in prescribing Crestor and other statins to people with low cholesterol. This week’s revisitation (see here) stirred anew the controversy, but also focused on allegations of poor methodology, bias and conflicts of interest (see here). However, as was noted yesterday, two ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3714444 Wed, 30 Jun 2010 13:42:30 +0100 3714444 http://www.medworm.com/index.php?rid=3710795&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYYomDF92Fdo%2F For those tracking the ongoing investigation by the Senate Finance Committee investigation into conflicts of interest among academic researchers and industry funding, Charles Nemeroff was one of the targets. The former Emory University professor, who now works at the University of Miami, came to the committee’s attention because he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The Senate investigation, spearheaded by Chuck Grassley, the Iowa Republican, prompted Emory to suspend Nemeroff’s work on an NIH grant and asked him to step down as chair of psychiatry while it studied his conduct. And the Department of Health and Human Services Office of Inspector General began ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710795 Tue, 29 Jun 2010 14:00:58 +0100 3710795 http://www.medworm.com/index.php?rid=3695810&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6eIRDd_IgcA%2F In August, the Georgia Psychiatric Physicians Association will hold a three-day continuing medical education meeting at the Ponte Vedra Inn & Club in Florida, where the discussions will focus on issues surrounding bipolar disorder and obsessive compulsive disorder, among other things. One of the featured speakers will be Charles Nemeroff, the recently hired psychiatry chair at the University of Miami medical school, who also has become a sort of poster child for the controversy over undisclosed financial conflicts among academic researchers who accept federal grants while also doing work for drugmakers (see here, here and here). In Nemeroff’s case, his infractions occurred while he worked at as a professor at Emory University in Atlanta. Interestingly, his bio for the upcoming e... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3695810 Thu, 24 Jun 2010 13:20:16 +0100 3695810 http://www.medworm.com/index.php?rid=3671636&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F06%2Fdeferred-prosecution-agreements-end-so.html Starting in 2007, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. These revelations were the results of deferred prosecution agreements made in 2007 between four of the companies and the US Department of Justice after the latter charged Biomet, DePuy, Zimmer, and Smith and Nephew with giving surgeons kickbacks, disguised as consulting fees, to promote their products.  Stryker entered into a voluntary compliance agreement (see post here).  We also noted that some of th... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3671636 Thu, 17 Jun 2010 21:31:00 +0100 3671636 http://www.medworm.com/index.php?rid=3665927&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F06%2Fmore-hospitals-hiring-ceos-children.html As we predicted (here), the new reporting requirements imposed on US not-for-profit organizations are beginning to yield interesting results about the coziness of the leadership of some health care organizations.  Western PennsylvaniaFor example, we start with an article in the Pittsburgh Tribune-Review about hospitals in western Pennsylvania.Board members at Western Pennsylvania hospitals have provided legal, real estate, insurance and advertising services to their organizations, according to IRS reports examined by the Tribune-Review.The reports, which cover the fiscal year ending June 30, 2009, are the first under new reporting requirements imposed on nonprofit hospitals by the IRS. Still more requirements will kick in next year.Details of the filings by the two largest area health... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3665927 Tue, 15 Jun 2010 21:49:00 +0100 3665927 http://www.medworm.com/index.php?rid=3662925&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQAzZBxIUqkY%2F Last month, the National Institues of Health proposed new rules that would require academic researchers who receive agency funding to more thoroughly report financial conflicts of interest and also require universities to do a better job of gathering this info and forwarding it to the NIH (background). One of those leading this effort has been Tom Insel, who heads the National Institute of Mental Health. Lately, though, Insel has been caught up in a bit of a conflicts quagmire himself after a report that, at the same time he was sorting out the proposal, he was allegedly helping one academic - Charles Nemeroff, who has been the target of a US Senate Finance Committee probe - land a new job at another university. The disclosure prompted the committee to widen its ongoing probe into Nemeroff... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3662925 Tue, 15 Jun 2010 12:29:22 +0100 3662925 http://www.medworm.com/index.php?rid=3659155&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8fG5oNlG4M0%2F Under scrutiny for relationships with drugmakers, the American Psychiatric Association has issued its long-awaited code of conduct, although specifics are lacking. For now, the APA says financial relationships between developers of continuing medical education programs and research activity and outside organizations must be “clearly stated;” APA educational programs must follow ACCME standards (see this) and advertising in APA publications, meetings, or websites does not include endorsements of any particular medicine or drugmaker. More than some other specialties, psychiatry has been singled out as part of a US Senate Finance Committee probe into financial conflicts of interest among academic psychiatrists who accept federal funding while simultaneously maintaining relationshi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3659155 Mon, 14 Jun 2010 13:28:28 +0100 3659155 http://www.medworm.com/index.php?rid=3648800&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fjrz55Ui52oM%2F As the National Institutes of Health grappled last year with an ongoing Senate probe into financial conflicts of interest involving academic researchers who accept federal grants and industry funding, Tom Insel downplayed the need for a “COI shop” devoted to handling the problem. Insel, you may recall, heads the National Institutes of Mental Health, and helped lead the NIH regulatory review process that recently proposed new rules for monitoring conflicts of interest (see this). His view was expressed in a May 6, 2009, e-mail to colleagues who asked about hiring someone to help with COI issues that have been “swamping me,” as one wrote in a different e-mail the same day (you can read them here). Insel wasn’t persuaded. “I think there are more urgent need... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648800 Thu, 10 Jun 2010 11:56:10 +0100 3648800 http://www.medworm.com/index.php?rid=3648619&cid=t_169282_109_f&fid=38951&url=http%3A%2F%2Fcarlatpsychiatry.blogspot.com%2F2010%2F06%2Fuh-oh-thomas-insel-gets-pulled-into.html One truism of professional life is that some favors, no matter how alluring, should be politely turned down. The trick is predicting which bestowers of favors spell D-A-N-G-E-R, and which do not. Unfortunately, it looks like Dr. Tom Insel, the director of the National Institute of Mental Health, made the mistake of accepting multiple favors from Charles Nemeroff, and he is now paying the price.Several media outlets have covered this developing saga, or scandal, or Greek tragedy (following the analogy of the Trojan horse, the most famous examples of bad judgment in gift-accepting). The best and most thorough coverage is in this article in The Chronicle of Higher Education, which broke the story. Also, see today's coverage in the Washington Post, and ongoing coverage in Health Care Renewal.H... The Carlat Psychiatry Blog blogs http://www.medworm.com/rss/comments.php?id=3648619 Wed, 09 Jun 2010 14:42:00 +0100 3648619 http://www.medworm.com/index.php?rid=3641321&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrYivhU7sae4%2F The Charles Nemeroff affair encompasses more people all the time. Now, the University of Miami Medical School has become ensnared in the ongoing probe launched by US Senator Chuck Grassley, who investigated Nemeroff as part of an inquiry into undisclosed financial conflicts of intereest among academic researchers who receive federal grants. You may recall Nemeroff, who was recently hired by the University of Miami, had departed Emory University after the Senate probe disclosed he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (see this). Before his departure, Emory imposed a two-year ban on grants for on Nemeroff. This week, however, the U of Miami med school head, Pascal Gol... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3641321 Tue, 08 Jun 2010 15:44:41 +0100 3641321 http://www.medworm.com/index.php?rid=3636020&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fey5jUPYG6Hs%2F For the past two years, the National Institutes of Health has been pressured by Congress to do a better job of monitoring conflicts of interest in which academic researchers accept funding from the agency and drugmakers. At issue is the concern that key research and subsequent studies will unduly influence treatment, and so the NIH recenty proposed tougher rules (see this). Earlier this year, the US Senate Finance Committee extended its scrutiny to Tom Insel, the director of the National Institutes of Mental Health (see photo), given that many conflicts involved academic psychiatrists and drugmakers that market antidepressants and antipsychotics (see this). Now, The Chronicle of Higher Education peels back an interesting, long-running relationship between Insel and one of the more notoriou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3636020 Mon, 07 Jun 2010 13:21:25 +0100 3636020 http://www.medworm.com/index.php?rid=3621681&cid=t_169282_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhealth-journalism-gems-you-shouldnt-miss%2F2010.06.02 A couple of health journalism gems you shouldn’t miss just because they were published over the holiday weekend: Natasha Singer of the New York Times had an important piece, “When Patients Meet Online, Are There Side Effects?,” about privacy concerns when social networking sites like CureTogether.com and PatientsLikeMe.com offer online communities for patients and collect members’ health data for research purposes. John Fauber of the Milwaukee Journal-Sentinel published another in his “Side Effects” series on conflicts of interest in healthcare. This one was about doctors vouching for the drug Multaq for treating atrial fibrillation without ever having seen all of the data. The Minneapolis Star Tribune began a “Too Much Medicine” series. Heal... Better Health blogs http://www.medworm.com/rss/comments.php?id=3621681 Wed, 02 Jun 2010 14:00:47 +0100 3621681 http://www.medworm.com/index.php?rid=3621951&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff7mnT2ghmmk%2F In its latest report to Congress, the US Securities and Exchange Commission’s Office of Inspector General never mentions Dendreon by name, but sources tell us the agency probe into allegations of market manipulation and a “bear raid” into an unnamed “manufacturer” do, indeed, concern the maker of the celebrated Provenge prostate cancer vaccine that was recently approved by the FDA (background). The investigation was opened last summer and the SEC’s OIG last report to Congress noted that a complaint was filed “alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug.” The newest OIG report says the probe into the trading ap... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621951 Wed, 02 Jun 2010 13:30:25 +0100 3621951 http://www.medworm.com/index.php?rid=3599770&cid=t_169282_167_f&fid=38576&url=http%3A%2F%2Fwww.drbriffa.com%2Fblog%2F2010%2F05%2F26%2Fpsychiatrist-blows-the-lid-on-the-psychiatric-profession%2F While I am fan of certain aspects of orthodox medicine, I think overall it’s less effective and more hazardous than we generally imagine. As I wrote recently here, there is some thought that less medicine can result in improved outcomes. There is certainly some evidence that less can be more, where conventional medical care is [...] (Source: Dr John Biffa's Blog) Dr John Biffa's Blog blogs http://www.medworm.com/rss/comments.php?id=3599770 Wed, 26 May 2010 16:25:39 +0100 3599770 http://www.medworm.com/index.php?rid=3599492&cid=t_169282_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F05%2F25%2Fdoc-am-i-normal-yes%2F In conclusion, if you are experiencing any of these things, hang in there, it is a normal part of the human experience. If these things become more severe or difficult to cope with, or you want to learn how to master your individual experience with them, then counseling can be a great help. PS: I am back! - Will Meek, PhD (Source: World of Psychology) World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3599492 Tue, 25 May 2010 23:14:31 +0100 3599492 http://www.medworm.com/index.php?rid=3595892&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQSAnsm62eTY%2F A special committee of state Attorneys General is getting ready to launch a new program that would educate physicians about the impact of industry promotion and marketing, and also establish procedures at academic medical centers and teaching hospitals to train “prescribers-in-training” about evidence-based medicine in hopes of creating an environment free of conflicts of interest. To make this happen, there are requests for proposals for grants to create such programs and the deadline is June 3. The grants are the result of the 2004 settlement between Warner-Lambert, which is owned by Pfizer, and 50 states to settle charges of off-label marketing of Neurontin. The deal included a $21 million provision to create the Consumer and Prescriber Education Grant Program, whiich will ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3595892 Tue, 25 May 2010 13:16:21 +0100 3595892 http://www.medworm.com/index.php?rid=3595540&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fstewards-of-elite-university-or.html We have postulated that one of the key reasons US health care has become so dysfunctional is that the leaders of some of the most august health care institutions have strayed from, if not totally abandoned their organizations' fundamental missions.  There are many possible reasons for this phenomenon, but one is that the ultimate stewards of not-for-profit health care organizations, their boards of directors or trustees, have become uninterested in the mission, or impotent to uphold it.  So, we have tried to figure out what has happened to these boards that has lead to this sorry state.Dartmouth College: the Packing of the Board of TrusteesOne example we have come frequently discussed (beginning here) is that of Dartmouth College, despite its name, really a university, and o... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3595540 Mon, 24 May 2010 19:27:00 +0100 3595540 http://www.medworm.com/index.php?rid=3588840&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fat-upmc-dealings-with-board-members.html Last year we noted that the US Internal Revenue Service (IRS) required more detailed reporting starting in 2009 by US not-for-profit organizations.  Many US health insurance companies/ managed care organizations, most hospitals, nearly all medical associations, nearly all disease advocacy organizations, all health care charities, and nearly all medical schools are not-for-profit organizations.  We suggested then that this reporting might lead to more transparency about the leadership and governance of these organizations.  Some of these new 990 forms are now being publicly disclosed, with some interesting findings.  The Pittsburgh Tribune-Review just reported some interesting findings about financial ties between the University of Pittsburg... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3588840 Fri, 21 May 2010 21:12:00 +0100 3588840 http://www.medworm.com/index.php?rid=3585835&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Focplmedia.od.nih.gov%2Fnihradio%2FNIHtelebrifing-2010.05.20.mp3 In a bid to restore public trust, the National Institues of Health has proposed new rules that would require academic researchers who receive agency funding to more thoroughly report any financial conflicts of interest, and also require institutions - such as universities - to do a better job of gathering this information and then forwarding it to the NIH. This includes posting info on a web site. The move follows an ongoing probe by the US Senator Chuck Grassley of the Senate Finance Committee, who uncovered several examples in which academic researchers accepted funding from both the NIH and various drugmakers, but failed to fully or properly disclose the extent of their financial ties. At the same time, several universities failed to monitor their faculty for conflicts. At the heart of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3585835 Thu, 20 May 2010 17:05:55 +0100 3585835 http://www.medworm.com/index.php?rid=3577623&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjN_3H3gL_f0%2F In a bid to open a window into the way it does business, the FDA has released a Transparency Report containing 21 draft proposals for public disclosure policies. This is all part of the three-phase Transparency Initiative that was launched last year. The proposals cover such areas as adverse event reports; the docket management process; enforcement priorities and actions; import procedures; inspections; product applications; recalls and warning letters. At the end of the day, the FDA hopes this process will better explain agency decisions, provide more data to doctors and patients, “illuminate” enforcement efforts and support innovation for rare diseases. How so? If the FDA explains an abandoned application for an orphan drug could represent a significant therapeutic advance, t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577623 Wed, 19 May 2010 14:24:47 +0100 3577623 http://www.medworm.com/index.php?rid=3552193&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fleaders-of-discredited-financial-rating.html This is the latest in our informal series on the cross-linkages between the thinking and leadership that lead to the global financial collapse/ great recession and that current in health care.  Last month, a US Senate sub-committee held hearings on the role of the rating agencies, actually for-profit corporations that evaluated securities, including derivatives, in the collapse.  The Fundamentally Conflicted Rating AgenciesTo briefly provide some background, these agencies were hired by the firms that created these securities to evaluate them.  Because the securities were complex, they were hard for investors to evaluate.  Investors had become used to using the rating agencies' evaluations as benchmarks for the quality and riskiness of complex securities.  Many did... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3552193 Mon, 10 May 2010 20:45:00 +0100 3552193 http://www.medworm.com/index.php?rid=3534107&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8xdsIfTLwRo%2F Transparency is the new religion in the health care world and two trade groups - AdvaMed and Eucomed, which represent medical device makers on both sides of the Atlantic Ocean - released a statement today in which they have agreed to urge their members to adhere their respective ethics codes for guiding interactions with doctors and other health care professionals [UPDATE: We wrote earlier that the two groups are adopting the same code]. The effort to adhere to an ethics code has been a work in progress. Both groups had previously adopted guidelines. Eucomed, for instance, approved rules two years ago and issued a framework earlier this year before releasing a final version today. And AdvaMed issued its own code last summer. The codes cover the usual gamut of issues - continuing medical ed... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534107 Tue, 04 May 2010 16:59:41 +0100 3534107 http://www.medworm.com/index.php?rid=3508450&cid=t_169282_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=3505134&cid=t_169282_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJYBY4SIvTJ4%2F Last December, the Health and Human Services Office of Inspector General released a report showing that the Centers for Disease Control and Prevention was having a hard time gathering sufficient financial disclosure info from so-called Special Government Employees, or SGEs, who serve on CDC advisory committees. The HHS OIG reviewed info provided to 17 committees that met in 2007 and also found that many SGEs served on committees, even though potential conflicts weren’t disclosed. And so Chuck Grassley, the ranking Republican on the Senate Finance Committee who has spent the last few years probing conflicts of interest among government agencies, academic researchers and the pharmaceutical industry, has written a letter to the CDC noting that 41 percent of SGEs didn’t receive eth... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3505134 Mon, 26 Apr 2010 16:20:12 +0100 3505134 http://www.medworm.com/index.php?rid=3504875&cid=t_169282_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=3499024&cid=t_169282_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F04%2Fsmoke-screen-how-conflict-of-interest.html As a physician, not being a big fan of cigarette smoking, I would have found little to criticize had anyone showed me the Smoke-Free Initiative at the University of Michigan, as promoted by the University President, Mary Sue Coleman.  A Conflict of Interest: University President and Johnson & Johnson Board MemberIt turns out, though, that this initative has provoked debate on that campus, not so much about its possible benefits and harms, but about whether the Ms Coleman's promotion of it had to do with a conflict of interest.  The debate broke out with an op-ed in the Michigan Daily:It’s clear, then, that University President Mary Sue Coleman is the architect of the Smoke-Free Initiative, which will take effect in July of 2011. The initiative will prohibit smoking on all o... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3499024 Thu, 22 Apr 2010 21:26:00 +0100 3499024