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Supporting students in open source software development

<a href="http://code.google.com/soc/">Google Summer of Code</a>, our program to introduce students to open source software development, is now in full swing for 2009. Over the past four years, we've paired nearly 2,500 "graduates" with more than 2,500 mentors from industry to academia, with some spectacular results: millions of lines of source code produced and over $15M in funding provided to open source development. This year student participants have more than <a href="http://socghop.appspot.com/program/accepted_orgs/google/gsoc2009">150 open source software and technology–related projects</a> to choose from when submitting their applications, from operating systems to content management systems. During the <a href="http://code.google.com/soc/2008/">2008 program</a>, we had more than 975 students successfully complete their projects. Each participant received a $4,500 stipend and an ultra-awesome t-shirt to go along with their newly honed programming skills. We're particularly excited by the social ties our students form through the course of the program, as well. We've connected people in more than 98 countries, and hope to bring people from even more places into the Google Summer of Code community this year. We'll be accepting student applications through April 3, 2009 at 12:00 pm PST. If you're interested in learning more, check out our <a href="http://code.google.com/opensource/gsoc/2009/faqs.html">Frequently Asked Questions</a> or subscribe to our <a href="http://groups.google.com/group/google-summer-of-code-discuss">discussion list</a>. You can also check out the <a href="http://google-opensource.blogspot.com/search/label/gsoc">Google Open Source Blog</a> for regular updates on the program. When you're ready to get started, visit the Google Summer of Code 2009 site to submit your application. Best of luck to all of our applicants! For an overview of the program, check out this video. <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/vBRRR0BQyz0&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/vBRRR0BQyz0&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344"></embed></object> Posted by Leslie Hawthorn, Program Manager, Open Source Team

Supporting students in open source software development

Google Summer of Code , our program to introduce students to open source software development, is now in full swing for 2009. Over the past ...

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JAMA Editors Try Attacking the Messenger

Early this month, yet another story surfaced about allegations of undisclosed conflicts of interest affecting the author of a highly publicized clinical trial. This story has now taken such an odd twist that it seems worth discussing in some detail. Let me first try to present some relevant facts, derived from published articles, mainly peer-reviewed, which do not seem to be in dispute, in chronological order. 2005 - In a multi-author review article on mood disorders in the medically ill, Dr Robert G Robinson, of the University of Iowa, disclosed that he served on the speakers bureau of Forest Laboratories.(1) In an article in Stroke: Clinical Updates, he made a similar disclosure.(2) 28 May, 2008 - Dr Robinson was the first author of an article published in JAMA that described a randomized controlled trial comparing placebo, problem-solving (cognitive talking) therapy, and escitalopram (Lexapro, Forest Laboratories) in the prevention of depression in patients who have had strokes.(3) Patients who received placebo had a higher rate of depression (11 major, 2 minor cases, 22.4%) than patients who received escitalopram (3, 2, 8.5%) or who received problem-solving therapy (5,2, 11.9%). At the end of the article, Dr Robinson disclosed, "over the past 5 years, Dr Robinson reports serving as a consultant to the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company," but made no disclosure about any financial relationship with Forest. In a news article published the day before, Dr Robinson was quoted as saying, "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression," but did not advocate the use of problem solving therapy.(4) 15 October, 2008 - In a letter to JAMA, Lacasse and Leo asked whether Robinson et al had done an analysis directly comparing problem-solving therapy and escitalopram, and noted that the reported incidence data for stroke in the two treatment groups suggest that the difference in treatment results "does not appear to be either clinically or statistically significant."(5) Robinson et al responded that there was no statistically significant differences between the groups.(6) 5 March, 2009 - In a rapid response section in the British Medical Journal, Leo and Lacasse raised their concerns about the interpretation of the results of the 2008 trial, and also stated that "during a subsequent internet search we were surprised to learn that four years previously the lead author had been listed on the speaker's bureau for Forest. The omission, however innocent or mistaken, is disturbing; neither the JAMA article nor subsequent media accounts noted that the lead author had served on the speaker's bureau for the manufacturer of Lexapro."(7) Their citation was to our reference 2. 11 March, 2009 - In a letter to JAMA, Robinson and Arndt reported that the financial disclosure for their 2008 article was incomplete, "resulting from erroneous recollection of the appropriate dates for speaking presentations sponsored by pharmaceutical companies...."(8) Dr Robinson disclosed receiving honoraria for two presentations in 2004, and serving on the Forest Laboratories speakers bureau "in 2004 and perhaps 2005." No editorial comment accompanied this letter. So far, this seems to be a familiar story about an author who seemed to be excessively enthusiastic about a product of the company with whom he had had a financial relationship, but reluctant to disclose this relationship. But wait, 20 March, 2009 - A rather extraordinary editorial was published electronically in JAMA on 20 March, 2009.(9) Let me review its main points, section by section. After acknowledging the attention conflicts of interest now receive, and briefly describing the 2008 study and the subsequent letter by Lacasse and Leo, the editorial stated that JAMA editors had received a communication from Leo on or after 16 October, 2008 which "indicated he had evidence that Robinson had not reported in his article that he had served on the speakers bureaus for pharmaceutical companies." The editorial then devoted several paragraphs explaining the "due diligence" JAMA editors used to investigate this "allegation." They noted the "sensitive nature of these investigations," which required them to conduct them "confidentially," and again insisted "these investigations into undisclosed conflicts of interest are time-intensive and require careful attention." Thus, from the time Leo sent his "allegations," (apparently 16 October, 2008), it took until 31 January, 2009 to get a letter from Robinson et al acknowledging his undisclosed conflicts, and until 11 March, 2009 to publish it, a total of five months. However, the concerns with confidentiality, and the repeated emphasis on the need for unusually painstaking investigation seemed disconnected to the particular case. It is clear that it may take quite a bit of time and effort to investigate some allegations of undisclosed conflicts of interest, especially when the allegations are vague, but the alleged conflicts are severe. However, in this case, it should have taken trivial effort to find Dr Robinson's previous, published disclosures. (It took me about 5 minutes of internet searching to find the two 2005 articles.) Once (easily) discovered, the disclosures in the 2005 articles starkly contrast with the disclosures, or lack thereof in the 2008 article. Furthermore, since these disclosures were already in the public domain, there should have been no concerns with confidentiality. Nonetheless, the editors then asserted: <blockquote> While the confidential investigation of unreported conflicts of interest is under way, we consider involvement of third parties— such as Leo had done by his posting on the BMJ site and by contacting the media—to be a serious ethical breach of confidentiality that not only potentially damages our ability to complete a fair and thorough investigation (of the specific issue that Leo had brought to our attention), but also potentially damages JAMA’s reputation by the insinuation that we would fail to do so. </blockquote> This makes no sense. There was no need for confidentiality, because the allegations were not based on whistle-blowing or confidential information. They were based on published articles, articles which clearly disclosed Dr Robinson's financial ties to Forest Laboratories. Anyone who bothered to do a simple Google search could have found that Dr Robinson's disclosure in his 2008 JAMA article did not agree with his disclosure in several 2005 articles. Lacasse and Leo used no confidential information whatsoever in making their allegations. Actually, they were not making "allegations," but simply pointing out that an author had published statements which were inconsistent. Since Lacasse and Leo were simply pointing discrepancies among published articles, how could they have breached "confidentiality," ethically or not? Second, there was no need for a complex or prolonged investigation. The discrepancies were apparent as soon as one viewed the published articles side by side. The third point was a non sequitur, and a classic example of blaming the messenger for the message. JAMA had published an article. Other journals published other articles. Publishing these articles put them in the public domain. If comparison of these articles in the public domain were to reflect badly on on of their publishers, it would not be the fault of making the comparison. Regardless of the illogical nature of their concerns with non-existent confidentiality, assertions that it takes a long, complex investigation to demonstrate the obvious, and their aspersions on the messenger for the message, the JAMA editors then revealed that: <blockquote> A telephone conversation intended to inform Leo that his actions were inappropriate transformed into an argumentative discussion, as Leo continued to refuse to acknowledge any problems with his actions, even after he was informed that the investigation was completed and was advised to read the upcoming March 11 issue of JAMA (where the letter of explanation and apology from Robinson and the formal correction were in press). </blockquote> Furthermore, the editors proposed punishing Leo, first by effectively banning him from publishing in the pages of JAMA, <blockquote> Leo also was informed that, if his actions represented his apparent lack of confidence in and regard for JAMA, he certainly should not plan to submit future manuscripts or letters for publication. </blockquote> Then, by complaining to his supervisor <blockquote> However, since Leo apparently did not appreciate the serious implications of his actions, despite our attempts to explain, we felt an obligation to notify the dean of his institution about our concerns of how Leo’s actions were potentially damaging to JAMA’s reputation. We sought the dean’s assistance in resolving this issue involving a member of the faculty of his institution, to assure there would be no need to publicly identify that faculty member. No dean wants his or her institution implicated in a publication reflecting improper behavior by a faculty member. </blockquote> Finally, they seemed bitterly offended that the British Medical Journal would publish anything that disagreed with anything printed in JAMA: <blockquote> In addition, we were dismayed that BMJ would post the article by Leo with the allegations against Robinson and the negative insinuations about JAMA, without at least contacting JAMA to verify the veracity of the report. </blockquote> Again, rather than raising unsubstantiated allegations, Leo and Lacasse's letter to the BMJ simply showed the discrepancy between the disclosures in Robinson and colleagues' 2008 JAMA article and those in one of his 2005 articles. Both articles are publicly available. What useful information about the letter above and beyond that provided by viewing the discrepant articles could the JAMA editors have provided? While the JAMA editors castigated Leo for unethical behavior, and sought to punish him for it, they said nothing negative about Robinson. Yet it was Dr Robinson who was supposed to disclose his conflicts to JAMA, but who managed to forget conflicts that he had disclosed before. Why would would it be more unethical to point out publicly available evidence about failure to disclose conflicts of interest than to conceal these conflicts in the first place? This story is saddening. JAMA has published many important and useful articles on conflicts of interest, and other matters relevant to Health Care Renewal. We have probably favorably cited more editorials by JAMA on these topics than those in any other journal. Yet now the journal's leadership seems to have somehow lost their way. Instead of trying to constructively respond to criticism, they now seem intent on punishing the critics. I hope they find their compass soon, before an important medical institution really is irreparably damaged. Note: another detailed analysis of this case is <a href="http://brodyhooked.blogspot.com/2009/03/jama-editors-need-to-come-down-off.html">here</a> in the Hooked: Ethics, Medicine and Pharma blog. <a href="http://online.wsj.com/public/resources/documents/leo_statement_for_WSJ.htm">Here</a> is Professor Leo's response to the JAMA ediorial. ADDENDUM (24 March, 2009) - see also<a href="http://scienceblogs.com/insolence/2009/03/catherine_deangelis_and_jama.php"> the extensive analysis </a>of this case on the Respectful Insolence blog, and the comments <a href="http://scienceblogs.com/effectmeasure/2009/03/jamas_editors_make_sewage_out.php">here</a> on the Effect Measure blog, <a href="http://www.gooznews.com/archives/001359.html">here</a> on Gooznews, and <a href="http://www.kevinmd.com/blog/2009/03/jama-versus-jonathan-leo-debacle.html">here</a> on KevinMD. References 1. Evans DL, Charney DS, Lewis L et al. Mood disorders in the medically ill: scientific review and recommendations. Biol Psychiatry 2005; 58: 175-189. [Link <a href="http://userwww.service.emory.edu/~jdbremn/papers/evans_mooddisorders.pdf">here</a>.] 2. Robinson RG, Zorowitz RD. Pseudobulbar affect and stroke. Stroke: Clinical Updates 2005; XV (Jan-Feb). [Link <a href="http://www.stroke.org/site/DocServer/SCU_-_Jan-Feb_2005.pdf?docID=5161">here</a>.] 3. Robinson RG, Jorge RE, Moser DJ et al. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA 2008; 299: 2391-2400. [Link <a href="http://jama.ama-assn.org/cgi/reprint/299/20/2391">here</a>.] 4. Elias M. Study: antidpressants help stroke victims. USA Today, May 27, 2008. 5. Lacasse J, Leo J. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1757-1758. 6. Robinson RG, Jorge RE, Arndt S. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1758-1759. 7. Leo J, Lacasse J. Clinical trials of therapy versus medication: even in a tie, medication wins. Brit Med J, 2009: 338: b464. [Link <a href="http://www.bmj.com/cgi/eletters/338/feb05_1/b463">here</a>.] 8. Robinson RG, Arnd S. Incomplete financial disclosure in a study of escitalopram and problem-solving therapy for prevention of poststroke depression. JAMA 2009; 301: 1023-1024. [Link <a href="http://jama.ama-assn.org/cgi/content/full/301/10/1023-a">here</a>.] 9. DeAngelis CD, Fontanarosa PB. Conflicts over conflicts of interest. JAMA 2009; 301: [Link <a href="http://jama.ama-assn.org/misc/jed90012pap_E1_E3.pdf">here</a>.]

JAMA Editors Try Attacking the Messenger

Early this month, yet another story surfaced about allegations of undisclosed conflicts of interest affecting the author of a highly publici...

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Let's Deregulate Pharmaceutical Information Technology

... after all, a full Electronic Medical Record/Order Entry/Decision Support system is far more complex, with potential for far more immediate patient impact, then pharma's research IT systems. Yet the former is unregulated. <a href="http://www.phrma.org/">PhRMA</a>, you should start lobbying to create your own private Certification Commission For Pharmaceutical IT (CCPIT) now. You can start certifying all your IT by going through a checklist of features, and avoid those pesky FDA inspections just as hospital do! Seriously, my views are identical to that of Hoffman and Podgurski. They expressed their views in the article "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems"</a>, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1, and now have summarized and amplified them in the short piece "<a href="http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=3284#">Why Electronic Health Record Systems Require Safety Regulation</a>", Bioethics Forum, Sharona Hoffman and Andy Podgurski, March 20, 2009. Emphases mine: <div style="margin-left: 40px;">...In light of these risks to patient care, federal regulations must establish rigorous quality control mechanisms. Currently, initial approval of EHR systems is conducted by a certification program operated by the Certification Commission for Health Information Technology, a private, industry-based organization. Our review of the certification criteria revealed that they are inadequate to ensure the safety and efficacy of EHR systems . For example, testing is conducted in just one eight-hour period , and the criteria do not explicitly address important issues such as safety and usability. </div> We believe that EHR systems should be scrutinized through a careful premarket approval process, including field testing at several facilities for at least six months. We also recommend local system oversight committees, based on the IRB model , that would oversee field testing and conduct postmarketing monitoring throughout the life of the product. Adverse event reporting would be mandated under this system to ensure that problems are detected and addressed swiftly and that the government intervenes when necessary to safeguard patient welfare. Federal regulations should also require that all EHR systems meet specific quality standards. Audit trails and capture-replay capabilities should be required to facilitate discovery of both system and user errors, much as black boxes allow the reconstruction of conditions that led to aviation incidents . ... Because EHR systems will manage patient care to a significant degree, they must be subject to government oversight akin to the highest level of scrutiny required, in principle, by the Food and Drug Administration for complex medical devices ... Federal regulations should establish appropriate oversight and quality control through EHR system standards, approval processes, and ongoing monitoring requirements. It is only with careful oversight that providers can be assured of investing in high quality EHR products. And it is only with appropriate safeguards that the benefits of this very promising technology will be maximized–that health outcomes will improve and risks as well as costs will decline. I do not think these suggestions are unrealistic. After spending considerable time in pharma, to be consistent I say either we discontinue FDA regulation of pharma clinical IT, or we continue to regulate pharma's IT and add the even more complex provider healthcare IT to the pool of regulated medical devices.-- SS

Let's Deregulate Pharmaceutical Information Technology

... after all, a full Electronic Medical Record/Order Entry/Decision Support system is far more complex, with potential for far more immedia...

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BLOGSCAN - The Over-Selling of Seroquel

BLOGSCAN - The Over-Selling of Seroquel

The anonymous blogger on the Clinical Psychology and Psychiatry blog has been hard at work on the story of how research on Seroquel (quetiap...

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Putting a New Schein to the FDA?

When the national discussion seems preoccupied with the bonuses at AIG, the nomination of a new leader of the US Food and Drug Administration did not seem to get the attention it may have deserved. Last week, the president nominated Dr Margaret Hamburg to this position. As <a href="http://www.latimes.com/news/nationworld/nation/la-na-fda-chief12-2009mar12,0,3622976.story">reported by the Los Angeles Times</a>, <blockquote> President Obama has decided to nominate former New York City Health Commissioner Margaret Hamburg to head the Food and Drug Administration, turning to a onetime Clinton administration official to help right the beleaguered regulatory agency, a source briefed on the choice said Wednesday. Hamburg, 53, a physician who has worked extensively on bioterrorism issues, is a senior scientist at the Nuclear Threat Initiative, a Washington-based foundation focused on threats from nuclear, biological and chemical weapons. Though less experienced as a regulator, Hamburg has extensive government experience. She served as health commissioner in New York for six years in the 1990s before becoming assistant secretary for planning and evaluation at the Department of Health and Human Services in 1997. </blockquote> Tucked away at the end of the LA Times story, and not emphasized in other news articles, was a salient fact: <blockquote> She sits on the board of medical supply distributor Henry Schein Inc., but would have to surrender the position if confirmed by the Senate. </blockquote> Many now believe the FDA is in crisis, having failed to protect the people from unduly hazardous drugs and devices, and becoming too cozy with drug and device companies, which it may not regard, instead of the population as a whole, as the agencie's clients. Would Dr Hamburg's current position with Henry Schein Inc, however, jeopardize her ability to restore peoples' trust that the agency will put their interests, rather than those of health care corporations first? <a href="http://www.henryschein.com/">Henry Schein Inc </a>is a large distributor of health care supplies, including drugs and devices. For an example of its very extensive catalog, look <a href="http://www.henryschein.com/us-en/medical/Default.aspx?did=medical">here</a>. Henry Schein makes its profits by selling the products that the FDA regulates, particularly drugs and devices. In her role as director of Henry Schein, Dr Hamburg had a legal responsibility to enhance the finances and profits of the company and its stockholders. As we have <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">discussed</a> many times previously, a corporate director has a legal obligation to advance the profits and financial fortunes of the corporation he or she serves. As Robert AG Monks put it, corporate directors are supposed to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] As compensation for that loyalty, corporate directors are usually exceedingly well-paid for the nominal hours they spend in their meetings.So, according to the company's <a href="http://ccbn.10kwizard.com/xml/download.php?repo=tenk&ipage=5585641&format=PDF">2008 proxy statement</a>, Dr Hamburg owned the equivalent of 63,472 shares of stock (current value, at the price of $37.32, <a href="http://www.google.com/finance?hl=en&q=henry%20schein&um=1&ie=UTF-8&sa=N&tab=we">via Google Finance</a>, $ 2,368,775.04). Her total compensation in 2007 for her position as director was $249,151.) Given that Dr Hamburg has spent over five years living with the obligation for unyielding loyalty to the interests of Henry Schein, and has become what many people would consider rich in the process, how easy will it be for her to turn to becoming a strict regulator of the products her former company used to sell? Time will tell. But this is the <a href="http://hcrenewal.blogspot.com/2009/03/meet-new-boss-same-as-old-boss-health.html">second nomination </a>to a major health care post charged with improving the health of all citizens that has gone to someone currently obligated to protect the interests of corporations that now profiting from today's health care milieu. Let us see if this will lead to the change we need in health care.

Putting a New Schein to the FDA?

When the national discussion seems preoccupied with the bonuses at AIG, the nomination of a new leader of the US Food and Drug Administratio...

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Does Pharma Want its Researchers to Believe They Are Next to God?

In "<a href="http://www.nytimes.com/2009/03/20/us/20psych.html?_r=1">Drug Maker Told Studies Would Aid It, Papers Say</a>" (New York Times, Mar. 19, 2009), the Times discusses the case of psychiatrist Dr. Joseph Biederman. Dr. Biederman outlined plans to test Johnson & Johnson’s drugs including risperidone/Risperidal in presentations to company executives and seemed to guarantee positive outcomes for his studies of the drug, raising questions about his research. Biederman has become a key witness in a series of lawsuits filed by state attorneys general claiming that makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines. His work helped fuel a rapid rise in the use of these medicines in children. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but about $200,000 of this income to university officials. However, if a passage about Dr. Biederman's testimony in court is correct, I believe pharma should consider whether it wants to use someone who believes they are next to God in any capacity whatsoever. There are certain damning statements that, once made by a person, cast a deep shadow over a person's character. I believe this one, if true, may rise to that level: <blockquote>In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered. “What’s after that?” asked a lawyer, Fletch Trammell. “God,” Dr. Biederman responded.“Did you say God?” Mr. Trammell asked.“Yeah,” Dr. Biederman said.</blockquote> One does not usually joke in deposition. I've been Yale faculty, and would never, ever have made anything even approaching such a comment, least of all in a deposition about drug issues affecting kids. Let alone the the palm-greasing he was afforded, could Dr. Biederman's apparently hyperinflated ego have clouded his judgment and scientific objectivity? In drug R&D, that is inherently an extremely dangerous proposition. Where children are concerned, catastrophic might be a more apt term. -- SS

Does Pharma Want its Researchers to Believe They Are Next to God?

In " Drug Maker Told Studies Would Aid It, Papers Say " (New York Times, Mar. 19, 2009), the Times discusses the case of psychiatr...

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March is for hoops

As a big college hoops fan, I'm pretty excited that it's finally March. Sadly, my beloved Stanford Cardinal didn't make it to the tourney, but as a proud Arizona native, I still root for my hometown Arizona State Sun Devils. I always go a little crazy -- you might even say mad -- this time of year. I fill out my bracket, wear a lot of red and gold, and get into arguments with friends of mine from the UofA. I'm a little obsessed. If you're like me, then I have some good news for you. We have several products that can help you follow the tournament. <ul><li>Live scores when you search for your favorite team</li><li>An iGoogle gadget for following the action</li><li>Breaking news on all the tournament excitement on Google News</li><li>Local search to find a spot to watch the game </li></ul>To get you started, we put together <a href="http://www.google.com/landing/collegebasketball09/">some helpful tips</a> about using Google to keep up with the Madness. Best of luck to you and your team! Unless, of course, they're playing ASU. ;-) Posted by Nundu Janakiram, Associate Product Manager

March is for hoops

As a big college hoops fan, I'm pretty excited that it's finally March. Sadly, my beloved Stanford Cardinal didn't make it to th...

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