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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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Chrome Experiments are here

When Google Chrome launched last September, it included a powerful JavaScript engine, V8, which was built to make the next generation of web applications perform faster in the browser. In the past few months, we've reached out to more than a dozen developers and designers to experiment with V8 and to find new and fun uses for JavaScript. We worked with <a href="http://www.reas.com/">REAS</a>, <a href="http://www.mrdoob.com/">Mr. Doob</a>, <a href="http://onecm.com/">Ryan Alexander</a>, <a href="http://www.jtnimoy.net/">Josh Nimoy</a>, <a href="http://www.weareinstrument.com/#/team/mark-mahoney">Mark Mahoney</a>, and <a href="http://postspectacular.com/">Toxi</a>, among others. The results of their experimentation have been great, with each project turning the browser window into an interactive application, a game, or even a piece of art. Whether you're a casual web surfer or an advanced JavaScript developer, we think you'll appreciate what they've achieved. Here's a preview of what they have built: <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/aZo-Uv7TZs8&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/aZo-Uv7TZs8&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344"></embed></object> Take a look for yourself at <a href="http://www.chromeexperiments.com/">Chrome Experiments</a>. Although you don't need Google Chrome to view the site, some of the experiments may run slower, or incorrectly, in older browsers. To download Google Chrome, click <a href="http://www.google.com/chrome?brand=CHMP">here</a>. Naturally, we're looking for more experiments. We will update the site regularly and promote the best projects as Featured Experiments. So, if you have an idea for a web browser experiment, please build it, make it sparkle, and submit it. We'll be highlighting more experiments and holding sessions on Google Chrome at <a href="http://code.google.com/io">Google I/O</a> on May 27 - 28 in San Francisco. Posted by Aaron Koblin, Google Creative Lab

Chrome Experiments are here

When Google Chrome launched last September, it included a powerful JavaScript engine, V8, which was built to make the next generation of web...

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A few not so random thoughts on Healthcare IT

A few thoughts for a Wednesday morning: <ul><li>I had recently written on some (probably) minor issues about <a href="http://hcrenewal.blogspot.com/2009/02/cchit-dissolved-involuntarily-in-april.html">CCHIT</a>, the Certification Commission for Healthcare Information Technology. However, I have more substantive concerns. I would like to know how CCHIT functions differently from a fictional "Drug Certification Commission." Imagine such a Commission founded by <a href="http://www.phrma.org/">PhRMA</a> and other pharmaceutical industry advocates, partly staffed at high levels by pharmaceutical executives, and "certifying" drugs for consumer purchase simply on the basis of their being manufactured under cGMP guidelines (current good manufacturing processes). Imagine this Commission declaring drugs "certified" without clinical trials, impartial regulatory oversight, postmarketing surveillance and in the face of equivocal studies and outright unfavorable studies showing increased risk of adverse events. How is CCHIT conceptually and substantively different from this fictional drug certification commission? </li></ul><ul><li>I would also like to know how the irrational exuberance over Health IT, vastly accelerated for reasons unclear to me by the "Economic Stimulus Bill", differs from the Madoff scandal. The "Bernard Madoff" version of HIT reality promotes the point of view that even in the face of flimsy and/or <a href="http://hcrenewal.blogspot.com/2009/03/reader-on-why-we-have-busywork.html">contradictory evidence</a>, billions of dollars in investment in today's HIT is guaranteed to reap massive rewards, no matter what. Worse than Madoff's scam, those clinicians who don't invest will be penalized. In effect, the government has now taken over Madoff's Acme Anvil EMR Securities, Inc. and is forcing everyone to invest - or else. </li></ul> -- SS

A few not so random thoughts on Healthcare IT

A few thoughts for a Wednesday morning: I had recently written on some (probably) minor issues about CCHIT , the Certification Commission fo...

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