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UPMC Fouls Another One Off

It's almost World Series time in the US, so here's a baseball story, <a href="http://pittsburgh.bizjournals.com/pittsburgh/stories/2009/09/07/daily21.html">courtesy the Pittsburgh Business Times</a>, <blockquote> University of Pittsburgh Medical Center lobbyist Leslie McCombs used Pittsburgh Pirates baseball tickets purchased by UPMC’s insurance arm to entertain film executives and others to promote the creation of a state film tax credit, according to the State Ethics Commission. The commission fined McCombs $5,025 for failing to promptly register as a lobbyist for Lions Gate Entertainment Corp. and omitting a daytime phone number in registering as a lobbyist for UPMC, according to a commission ruling reached on July 22. The confidential decision was disclosed Sept. 9 by The Associated Press. McCombs, who works for UPMC as a consultant, received permission from UPMC President and CEO Jeffrey Romoff to lobby on behalf of Lions Gate, which she described in a February 2007 e-mail to him as the, 'largest independent producer and distributor of motion pictures and television in the country.' Romoff cleared her work with Lions Gate after consulting with UPMC legal counsel and assured by McCombs in the e-mail that, 'UPMC signs will be prominently featured throughout the (‘Kill Pit’ television) series.' Filming for the eight-part miniseries, which was renamed 'The Kill Point,' began in March 2007 in Pittsburgh. Gov. Ed Rendell signed the Film Production Tax Credit bill into law in July 2007, which provided for a 25 percent film tax credit to offset production expenses. </blockquote> Also, <blockquote> From 2005 to 2006, McCombs was director of public relations for UPMC Health Plan, a for-profit subsidiary of the nonprofit hospital network. She was then named senior consultant with UPMC’s government relations department. The State Ethics Commission lists 18 baseball games where McCombs treated Lions Gate and government officials using UPMC tickets. In addition, she attended a June 15, 2007, matchup against the Chicago White Sox with Rendell and his wife, Marjorie, and Romoff and his wife, Stefania, according to the commission. It’s not clear from the commission report whose interests McCombs was representing at that game, but Rendell later reimbursed $960 for the tickets to the five games that he attended, which was returned to the health plan. In 2007, UPMC Health Plan bought $61,440 worth of Pittsburgh Pirates tickets, which were available to employees of the insurer 'in the performance of their duties,' the report states. The sum included a $20,000 seat license. </blockquote> So did you get all that? The director of public relations for the UPMC Health Plan, the managed care subsidiary of UPMC, a large academic medical center, lobbied the state governor for the enactment of a tax credit for television and movie production, partially so that the UPMC logo would appear in a television series, and entertained the governor using a few of the more than $60,000 worth of baseball tickets the medical center purchased for employee use. Amidst the complication, the public relations director violated state lobbying rules. None of these shenanigans had anything directly to do with health care, or medical education and research. The only conceivable advantage accruing to the institution would be the appearance of the UPMC logo in a television series. But most likely everyone had good times at the ball game. This story again suggests that managers of health care organization are more focused on playing marketing and political games than on health care, and generally are more focused on benefiting themselves than upholding their organizations' mission. The amounts of money involved in this case may be small, but do not underestimate the collective effects on health care access, cost and quality of managers who have their eyes on the wrong balls. UPMC has provided grist for the Health Care Renewal mill before, see earlier posts <a href="http://hcrenewal.blogspot.com/2008/11/questions-of-benefits-vs-risks-for-upmc.html">here</a>, <a href="http://hcrenewal.blogspot.com/2009/01/can-hospital-have-trade-secrets.html">here</a>, <a href="http://hcrenewal.blogspot.com/2009/02/healthcare-it-blamed-in-patient-death.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/04/upmc-pioneers-in-health-it-or-pioneers.html">here</a>.

UPMC Fouls Another One Off

It's almost World Series time in the US, so here's a baseball story, courtesy the Pittsburgh Business Times , University of Pittsbur...

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"Seeking Justice for My Son"

At Healthcare Renewal we often write of the dangers of financial conflict of interest towards medical research and practice. Here is a plea from a father of an 18 year old patient whose death became a cause célèbre against conflict of interest, only to then be swallowed up in the sea of silence known as the "<a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect</a>." The plea is in our local newspaper, but deserves much wider attention: <blockquote>Philadelphia Inquirer <div class="sig"><div class="article_timestamp"> Posted on Thu, Sep. 17, 2009 </div> </div> <a href="http://www.philly.com/inquirer/opinion/59589542.html">Seeking justice for my son</a> He died in a gene-therapy trial. Penn and the FDA should release the records. By Paul Gelsinger Ten years ago today, my 18-year-old son, Jesse Gelsinger, died at the University of Pennsylvania in a gene-therapy trial. Who is responsible? Could his life have been saved? Are other patients at risk? These questions have yet to be fully answered. Jesse lived with a rare metabolic disease. The point of the research trial was to see if an adenovirus (a cousin of the cold virus) could safely deliver corrective genes to Jesse's liver. Instead, the adenovirus killed Jesse. Jesse became the poster child for what not to do in human-subjects research. Neither he nor I was warned that, as the Washington Post later reported, monkeys had died in a prior trial. And the Wall Street Journal reported that the researcher who developed the adenovirus, James Wilson, had a seven-figure financial interest in the trial's outcome, as did Penn. I stood by Penn, Wilson, and the two principal investigators, Mark Batshaw and Steven Raper, until I understood the extent of Wilson's financial ties and the extent to which Jesse was misled about the risks and efficacy of the therapy. I eventually sued and ultimately settled. The amount of the settlement was sealed; the documents were not. The federal government also sued, claiming that the researchers blew through clinical stop signs in conducting the trial, ignoring evidence that Jesse was not well enough to receive the adenovirus and failing to sufficiently alert the Food and Drug Administration about severe incidents involving prior patients. The researchers disagreed, saying they had the discretion to proceed despite Jesse's test results, and that they had alerted the FDA. The government also reached a settlement, which restricted the researchers' activities for a period of years. Before the government settled, I urged federal officials to make the documents they collected public. They refused, saying this is simply not done. I believe a better understanding of what happened to Jesse could improve practices. So I gave the documents collected for my lawsuit to a law professor, Robin Wilson, who teaches at Washington and Lee University in Lexington, Va. They appear in her new book, Health Law and Bioethics: Cases in Context. While they are incomplete, the documents show a chilling pattern. They show that a lot of good people inside Penn raised alarms about Wilson's financial ties from the get-go, but that Penn approved the deal anyway. The documents also show misleading disclosures to Jesse about the risks posed to him. For example, although animals died in prior trials, we were told that "animals have not shown toxic effects ... at the dosage of virus that is needed to transport the gene in this study." I thought the lawsuits brought by me and the government would change research practices and the rules governing research. When I settled, real reform seemed likely. The Senate had held hearings, the FDA was investigating whether mistakes were made in the trial, and influential medical bodies such as the Association of American Medical Colleges had begun to examine disclosure practices and financial ties. But, sadly, we have not yet learned enough from Jesse's death. The shroud of secrecy that envelops legal settlements has helped hinder reform. No one has publicly accounted for the mistakes that led to Jesse's death. We don't know whether the FDA was misled or dropped the ball. We don't know whether the researchers' claims of efficacy had any basis in fact or were just wishful thinking. We don't know why Penn approved the deal despite warnings. And we don't know whether the researchers' decision to administer the virus to Jesse was reasonable or reckless. Ten years ago today, my son died in a science experiment. A complete record of what the researchers and FDA regulators knew is the best precaution against future tragedies like Jesse's death. I am asking that the University of Pennsylvania and the FDA finally do the right thing and release their records. If they did nothing wrong, let us see the proof. If they made a mistake, let us all learn from it and do better in the future. We owe it to Jesse to make his life and death mean something. [Emphases mine - ed] </blockquote> Other than stating that I strongly agree that these records should be released for others to learn from, I do not think additional commentary is necessary. -- SS

"Seeking Justice for My Son"

At Healthcare Renewal we often write of the dangers of financial conflict of interest towards medical research and practice. Here is a plea ...

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New AdWords bidding tutorial

(Cross-posted from the <a href="http://adwords.blogspot.com/2009/09/new-adwords-bidding-tutorial.html">Inside AdWords Blog</a>) Last month we launched a new feature of <a href="http://adwords.google.com/support/aw/bin/answer.py?hl=en&answer=6084">AdWords</a> called <a href="http://adwords.blogspot.com/2009/08/bid-like-pro-with-bid-simulator.html">Bid Simulator</a>. Bid Simulator takes some of the guess work out of <a href="http://adwords.google.com/support/aw/bin/answer.py?hl=en&answer=10188">cost per click</a> (CPC) bidding by estimating the number of clicks or impressions you could have received if you had used a different maximum CPC bid. Today, I thought I would take the opportunity to help you make the most of this new feature by explaining how to use the data from Bid Simulator to maximize the profit from your marketing investment. In general, when you increase your maximum CPC bid for keywords on search you are able to generate more clicks to your site. This may be because your new bid qualifies you to appear higher up in the Sponsored Links on the search results page, or because your higher bid qualifies your ad to appear in new, more expensive auctions. The goal for you as an advertiser is to decide whether or not these additional clicks come at a cost that is still profitable for you. To make this decision, you need to compare your expected value per click to your incremental cost per click. Your value per click is how much a click for a particular keyword is worth to you, on average. Your incremental cost per click is how much extra you are paying, on average, for the extra clicks you are getting from your higher bid. When your value per click is higher than your incremental cost per click it makes sense to increase your bid. On the other hand, if your value per click is lower than your incremental cost per click, you probably want to decrease your bid. To learn more, you can watch the tutorial video below. In the video, I'll show you how to calculate these values, how to interpret them and how to use the data to maximize the profit from your marketing investment. My team and I are always looking for ways to help make the AdWords auction easier to understand so if you have other topics that you'd like us to address, please leave a comment on the video and we may be able to make it a topic for a future video. <object height="340" width="560"><param name="movie" value="http://www.youtube.com/v/jRx7AMb6rZ0&hl=en&fs=1&rel=0"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/jRx7AMb6rZ0&hl=en&fs=1&rel=0" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="560" height="340"></embed></object> Watch it on YouTube: http://www.youtube.com/watch?v=jRx7AMb6rZ0 Posted by Hal Varian, Chief Economist

New AdWords bidding tutorial

(Cross-posted from the Inside AdWords Blog ) Last month we launched a new feature of AdWords called Bid Simulator . Bid Simulator takes som...

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Teaching computers to read: Google acquires reCAPTCHA

<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhstfrAxF-YaMH8KlXsnO9K470PndlHTsOvMhyphenhyphenF5d3dzDlQR5pRL3f_Oif9htPcBY-PRqp084iuGy-UMV2mWJp76JdSdWekCEgYGTJvqpQbRM7ngCj0q_DLYUYAI3uVubJBZh3pSe_9Dj9F/s1600-h/dcvf9tks_13fp86ngd5_b.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5382086094433677970" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhstfrAxF-YaMH8KlXsnO9K470PndlHTsOvMhyphenhyphenF5d3dzDlQR5pRL3f_Oif9htPcBY-PRqp084iuGy-UMV2mWJp76JdSdWekCEgYGTJvqpQbRM7ngCj0q_DLYUYAI3uVubJBZh3pSe_9Dj9F/s400/dcvf9tks_13fp86ngd5_b.jpg" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 63px;" /></a>The image above is a <a href="http://en.wikipedia.org/wiki/CAPTCHA">CAPTCHA</a> — you can read it, but computers have a harder time interpreting the letters. We tried to make it hard for computers to recognize because we wanted to give humans the scoop first, but we're happy to announce to everybody now that Google has acquired <a href="http://recaptcha.net/">reCAPTCHA</a>, a company that provides CAPTCHAs to help protect more than 100,000 websites from spam and fraud. Since computers have trouble reading squiggly words like these, CAPTCHAs are designed to allow humans in but prevent malicious programs from scalping tickets or obtain millions of email accounts for spamming. But there’s a twist — the words in many of the CAPTCHAs provided by reCAPTCHA come from scanned archival newspapers and old books. Computers find it hard to recognize these words because the ink and paper have degraded over time, but by typing them in as a CAPTCHA, <a href="http://video.google.com/videoplay?docid=-8246463980976635143#">crowds teach computers</a> to read the scanned text. In this way, reCAPTCHA’s unique technology improves the process that converts scanned images into plain text, known as Optical Character Recognition (OCR). This technology also powers large scale text scanning projects like <a href="http://books.google.com/">Google Books</a> and <a href="http://news.google.com/archivesearch">Google News Archive Search</a>. Having the text version of documents is important because plain text can be searched, easily rendered on mobile devices and displayed to visually impaired users. So we'll be applying the technology within Google not only to increase fraud and spam protection for Google products but also to improve our books and newspaper scanning process. That's why we're excited to welcome the reCAPTCHA team to Google, and we're committed to delivering the same high level of performance that websites using reCAPTCHA have come to expect. Improving the availability and accessibility of all the information on the Internet is really important to us, so we're looking forward to advancing this technology with the reCAPTCHA team. Posted by Luis von Ahn, co-founder of reCAPTCHA, and Will Cathcart, Google Product Manager

Teaching computers to read: Google acquires reCAPTCHA

The image above is a CAPTCHA — you can read it, but computers have a harder time interpreting the letters. We tried to make it hard for com...

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Leadership by Those Who "Live Insulated from the Daily Travails of Ordinary" People; the University of Washington Example

<a href="http://www.margaretsoltan.com/?p=17513">On the University Diaries blog</a>, Prof Margaret Soltan picked up on an article on the privileges now given to university leaders, using the example of the President of the University of Washington (which includes a medical school, academic medical center, etc). At a time when the university budget was being cut, President Mark Emmert refused to take a voluntary cut in his greater than $900,000 total annual compensation. This included a $12,000 car allowance and free use of the university mansion. From the original article comes this key quote: <blockquote> How could this happen? It happened for the same reason that Wall Street types, with acquiescence of their boards and public officials, saw no reason to make any personal sacrifice at a time when others are sacrificing greatly. The UW Board of Regents, as most others at public universities, is not made up of scholars and altruists. It consists mainly of governor-appointed businessmen, lawyers, and other high-income types who themselves live insulated from the daily travails of ordinary state taxpayers. </blockquote> As <a href="http://www.projo.com/opinion/columnists/content/CL_harrop16_09-16-09_0FFNJ2L_v15.3f88fbb.html">Froma Harrop put it</a>, the ethos among leaders of the finance sector now seems to be "heads, I win, tails, I'm bailed out." That ethos has now infiltrated the leadership of many kinds of organizations, perhaps because in many cases the Masters of the Universe from the finance sector now lead the boards of these organizations. The result may be leaders of academia more focused on enriching and empowering themselves than on their organizations' high-minded missions.

Leadership by Those Who "Live Insulated from the Daily Travails of Ordinary" People; the University of Washington Example

On the University Diaries blog , Prof Margaret Soltan picked up on an article on the privileges now given to university leaders, using the e...

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Introducing Google for the Public Sector

<div>(Cross-posted with the <a href="http://googlepublicpolicy.blogspot.com/2009/09/introducing-google-for-public-sector.html">Google Public Policy Blog</a>)</div><div> </div>The 2008 elections demonstrated how technology can increase political participation, and now we're beginning to see the power of Web 2.0 come to government. On the heels of last week's <a href="http://googlepublicsector.blogspot.com/2009/09/transparency-technology-you-message.html">Gov 2.0 Summit</a> in Washington, D.C., we're excited to launch <a href="http://www.google.com/publicsector/">Google for the Public Sector</a>, a one-stop shop of tools and tips that local, state and federal government officials can use to help promote transparency and increase citizen participation. The site helps government agencies: <ul><li>Make your website, and the information it offers, easier to find. For example, in less than 50 technical staff hours, Arizona's Government Information Technology Agency <a href="http://www.google.com/publicsector/content/arizona.html">made hundreds of thousands of public records</a> and other webpages "crawlable" to search engines and visible in Google search results.</li><li>Visualize your information and tell your story in Google Earth & Maps to the hundreds of millions of people who use them. The State Department runs an <a href="http://www.state.gov/secretary/trvl/map/?trip_id=13">interactive Google Map</a> of Secretary Clinton's travels, which shows where she has been and includes photos and videos.</li><li>Use the power of online video to engage millions of potential viewers and give constituents a voice. In the U.S. alone, the Senate, House of Representatives, White House, and federal government, among others, all have YouTube channels. </li></ul>According to the <a href="http://www.pewinternet.org/">Pew Internet and American Life Project</a>, nearly four out of five American Internet users go online to find government information. Technology will help play a key role in making this information accessible, useful and transparent. Posted by Ginny Hunt, Public Sector Project Manager

Introducing Google for the Public Sector

(Cross-posted with the Google Public Policy Blog ) The 2008 elections demonstrated how technology can increase political participation, and ...

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Biovail Settles, and a Judge Explains Why Settlements in Which Only the Organization Pays a Penalty Do Not Deter Bad Behavior

Last year, we <a href="http://hcrenewal.blogspot.com/2008/05/biovail-pleads-guilty.html">posted</a> about the guilty plea by the US arm of the Canadian firm Biovail to charges that it paid physicians kickbacks to prescribe a long-acting version of the drug diltiazam. This week, the plea was formalized, <a href="http://www.reuters.com/article/rbssHealthcareNews/idUSN1452312520090914">per Reuters</a>, <blockquote> A U.S. unit of Canadian drugmaker Biovail Corp (BVF.TO) has pleaded guilty to conspiracy and kickback charges, ending a case over its Cardizem hypertension drug, the U.S. Justice Department said on Monday. Prosecutors said Biovail has been sentenced to pay $22.2 million in fines, formalizing an agreement reached last year. It also agreed to pay $2.4 million to settle civil claims. Both involved charges it improperly paid doctors and other prescribers up to $1,000 to recommend Cardizem. </blockquote> When we originally posted about this case, we focused on the unprofessional behavior of the physicians who accepted the payments apparently in turn for prescribing. However, this is also yet another in a string of cases in which charges of unethical behavior by a large health care organization (a drug company this time) are settled by the company paying a fine, but not by any penalties accruing to any people at the company who authorized, ordered, or implemented the unethical actions. We have written about many such cases (see <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">this</a>). Also this week, a US judge addressed another proposed legal settlement of an important parallel case in the world of finance, and how he ruled suggests what needs to be done to truly discourage unethical behavior by health care organizations. The background, <a href="http://www.nytimes.com/2009/09/15/business/15bank.html">summarized by the New York Times</a>, is: <blockquote> Giving voice to the anger and frustration of many ordinary Americans, Judge Jed S. Rakoff issued a scathing ruling on one of the watershed moments of the financial crisis: the star-crossed takeover of Merrill Lynch by the now-struggling Bank of America. Judge Rakoff refused to approve a $33 million deal that would have settled a lawsuit filed by the Securities and Exchange Commission against the Bank of America. The lawsuit alleged that the bank failed to adequately disclose the bonuses that were paid by Merrill before the merger, which was completed in January at regulators’ behest as Merrill foundered. </blockquote> Now consider some of the Judge's main points, and how they might apply to the many settlements of cases of unethical behavior of health care organizations. Per <a href="http://online.wsj.com/article/SB10001424052970203917304574413242609077958.html">an editorial in the Wall Street Journal</a>, <blockquote> Judge Rakoff was having none of it. In a 12-page opinion, he tore into the SEC for ignoring its own guidelines and penalizing shareholders rather than the individuals who supposedly acted improperly. The settlement 'does not comport with the most elementary notions of justice and morality, in that it proposes that the shareholders who were the victims of the Bank's alleged misconduct now pay the penalty for that misconduct.' </blockquote> Note that the settlement of nearly every health care case involved a payment by the organization, but none by the people who authorized, ordered, or implemented the unethical behavior in questions. In those cases involving public for-profit corporations, just like the current one, the shareholders were the ones footing the bill. In most such cases, the shareholders were also ultimately victims in that it was their money that ultimately paid for the bad behavior, just like in this case. So in those cases the shareholders, who were victims of the companies' managers' bad behavior, were penalized while the managers got off Scot free. (In cases involving not-for-profit organizations, in parallel, one could argue that it was the organizations' line employees and other constituencies who were both the payers of the penalties and the victims of the conduct.) Also, <blockquote> As for the SEC's argument that this shareholder punishment will result in better management, the judge called it 'absurd.' The judge also had little sympathy for the SEC's argument that it would be too difficult to pursue executives, since they had been guided by lawyers. 'If that is the case, why are the penalties not then sought from the lawyers? And why, in any event, does that justify imposing penalties on the victims of the lie, shareholders?' he asked. </blockquote> In most settlements of parallel cases in health care, the relevant government agency usually suggested that the settlement will lead to better behavior by the organization. As we have noted before, the take-away lessons for managers was more likely that bad behavior will at worst lead to increased costs of doing business, but no penalties to the people involved. Such lessons would likely reinforce managers' decisions to behave unethically when doing so would benefit the managers themselves in the short run. In parallel cases in health care, the relevant government agency has rarely explained why it did not pursue the managers who authorized or ordered the behavior, or the lawyers that advised them, for that matter. The current case suggests that there was no logical rationale for failing to hold the people responsible accountable, except... <blockquote> [The judge said] broadly the deal 'suggests a rather cynical relationship between the parties: the SEC gets to claim that it is exposing wrongdoing on the part of the Bank of America in a high-profile merger; the Bank's management gets to claim that they have been coerced into an onerous settlement by overzealous regulators. And all of this is done at the expense, not only of the shareholders, but also of the truth.' </blockquote> And it is likely in health care that previous settlements arose out of such a cynical relationship. The government agency got to claim it was exposing wrongdoing. The executives of the offending organization got to claim they were coerced into an onerous settlement by overzealous regulators. The main casualty was the truth. Again, in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.

Biovail Settles, and a Judge Explains Why Settlements in Which Only the Organization Pays a Penalty Do Not Deter Bad Behavior

Last year, we posted about the guilty plea by the US arm of the Canadian firm Biovail to charges that it paid physicians kickbacks to presc...

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