For Whom Does the Center for the Protection of Patient Rights Advocate?

We have occasionally discussed the cases of  some patient advocacy organizations which seem to be influenced by substantial financial support from the health care industry.  For example, look <a href="http://hcrenewal.blogspot.com/search/label/patient%20advocacy%20groups">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/NAMI">here</a>.  Related are "astroturf" organizations, which promote policies that may be favored by their industrial sponsors (e.g., <a href="http://hcrenewal.blogspot.com/2007/11/cultivating-astroturf.html">here</a>.) <br /><br /><strong>Background on the Center for Protection of Patient Rights</strong><br /><br />The topic of this post is the Center for Protection of Patient Rights, which may have started out as something like an astroturf organization, but seems to have become something even more interesting.  The Center, which, by the way, seems not to have a web-site, was the subject of an <a href="http://www.latimes.com/news/nationworld/nation/la-na-secret-money-20120528,0,7342535,full.story">investigative report</a> in the Los Angeles Times in May, 2012.  Here is the article's description of how the Center began,<br /><br /><blockquote class="tr_bq">The Center to Protect Patient Rights was created in April 2009, just as the debate over the healthcare bill was heating up. The group's mission was to 'protect the rights of patients to choose and use medical care providers,' according to its corporate paperwork, filed in Maryland.<br /><br />While never surfacing publicly, the center sent more than $10 million in its first year to groups such as Americans for Prosperity, which took a lead in protesting the measure.<br /><br />'I think they saw what we were doing and liked it,' said Tim Phillips, president of Americans for Prosperity, which got $4.1 million. He said he did not know the source of the center's funding and declined to comment on whether it still supports his group.</blockquote><br />So this group supported an advocacy position about health care reform, so perhaps it could be considered an astroturf organization, were we to know it was funded by the health care industry.  Many astroturf organizations do reveal support from particular corporations.  However, at the time the Los Angeles Times published the report, the source of the Center's funding was unknown.  <br /><br /><strong>Secretive Leadership</strong><br /><br />Furthermore, while astroturf organizations may be eager to get more public notice, presumably so they can further their advocacy, the Center seemed oddly secretive.  Its executive director and president is one Sean Nobel.  However, as the LA Times article noted, <br /><br /><blockquote class="tr_bq"><em>Noble did not respond to repeated phone calls and emails. Courtney Koshar, a Phoenix anesthesiologist and the organization's only other director, did not respond to requests for comment. And a Phoenix doctor who once sat on its board said he couldn't remember who asked him to join.</em><br /><br />'I honestly played very little role,' said Dr. Eric Novack, who headed an organization called the US Health Freedom Coalition that received nearly its entire budget — $1.7 million — from the center to help pass a state ballot measure that aimed to block President Obama's healthcare overhaul.</blockquote><br /><strong>Support for Political Organizations, not Health Care Advocacy</strong><br /><br />Even more curiously, despite its name, the most of the Center's spending was not for advocacy about health care reform, but went to organizations that  seemed to have little or nothing directly to do with health.  As the Times reported, <br /><br /><blockquote class="tr_bq">During the 2010 midterm election, the center sent more than $55 million to 26 GOP [Grand Old Party, that is, Republican Party] -allied groups, tax filings show, funding opaque outfits such as American Future Fund, 60 Plus and Americans for Job Security that were <em>behind a coordinated campaign against Democratic congressional candidates.</em></blockquote>It seemed that these grants were used for nothing that directly related to health.  For example,<br /><br /><blockquote class="tr_bq">The <em>largest share of the center's money went to American Future Fund</em>, a Des Moines-based group started by onetime GOP congressional aide Nick Ryan. The fund, which <em>ran campaigns against two dozen Democrats in the 2010 election cycle, spent $23 million that period, tax filings show, with nearly $13 million coming from the center.</em><br /><br /><em>Its biggest target was an up-and-coming Iowa Democrat</em>, Rep. Bruce Braley. In August 2010, American Future Fund launched an ad falsely claiming that Braley supported building a mosque at the former World Trade Center site in New York — the beginning of a $2-million fusillade that included radio ads, robo-calls and nine mailers. </blockquote><br />A list of the recipients of the Center's 2010 grants was also publised in the LA Times <a href="http://spreadsheets.latimes.com/cppr-funding/">here</a>.<br /><br /><strong>Where Did the Center Get its Support?</strong><br /><br />Just before this week's US election, the plot thickened.  The LA Times <a href="http://articles.latimes.com/2012/nov/05/local/la-me-secret-donors-20121106">reported </a>that because of the Center's obviously political activities in California, an effort was made to determine its source of funding, but that came up short.<br /><br /><blockquote class="tr_bq">After a frantic court battle, state election officials succeeded Monday in <em>forcing an Arizona group to disclose the identities of contributors that provided $11 million to a California campaign fund.</em><br /><br />But the revelations added little clarity for voters. <em>The mystery donors turned out to be other nonprofits, whose individual contributors remained secret.</em><br /><br /><em>The money started with the Virginia-based Americans for Job Security and was transferred to a group called the Center to Protect Patient Rights. Over the course of a few days in October it was sent to the Arizona group, Americans for Responsible Leadership, and then transferred again to California.</em><br /><br />Finding the source of the money 'becomes daunting,' said Derek Cressman of Common Cause, an activist organization that filed the original complaint about the donation. 'How many layers can you drill through?'</blockquote><br />Note that in 2010, the Center for Protection of Patient Rights gave money to the Americans for Job Security, but in 2012, the latter organization gave money to the former - curiouser and curiouser.  <br /><br /><strong>Allegations of Illegalities, Including Money Laundering</strong><br /><br />It turns out the Americans for Job Security has been in trouble before for activities that seemed contrary to state election law:<br /><br /><blockquote class="tr_bq">Americans for Job Security, one of the nonprofits involved in the $11-million donation, was investigated by Alaskan officials for its role in a 2008 mining referendum.<br /><br />Authorities concluded that the organization's <em>'sole purpose is to allow individuals and corporations to financially support various causes without having to disclose that financial support.</em>'<br /><br />That investigation showed how a wealthy landowner sent $2 million to the group, which then funneled most of it back to Alaska to try to fend off construction of a mine near the landowner's property.<br /><br /><em>Americans for Job Security agreed to a settlement, paying a $20,000 fine and pledging 'not to engage in similar activity'</em> again in Alaska.</blockquote><br />In addition, the Mercury News<a href="http://www.mercurynews.com/elections/ci_21932215/fppc-releases-names-donors-who-made-secret-11"> reported</a> allegations that the fund transfers by the Committee for the Protection of Patient Rights were illegal.<br /><blockquote class="tr_bq">two conservative groups, <em>Americans for Job Security and the Center to Protect Patient Rights, are part of a tangled web of so-called dark donors who operate largely out of public view, shielded by their status as nonprofit advocacy groups that are supposedly not involved primarily in politics.</em><br /><br />While the groups have been identified, however, individual donors who have bankrolled them remain a mystery.<br /><br />But 'this isn't going to stop here,' said Ann Ravel, chairwoman of the Fair Political Practices Commission, the state's political watchdog. <em><strong>'They admitted to money laundering</strong></em>. We agreed to do this without an audit because we wanted to get information to the public before the election. But we in no way agreed this would preclude further action.'<br /><br />The FPPC determined that the Arizona group, Americans for Responsible Leadership, had violated California campaign law.<br /><br /><em>Money laundering -- sending money through multiple sources to conceal the original donor -- is a misdemeanor. But a conspiracy to commit money laundering is a felony</em>. It was not clear Monday whether the FPPC or the state Attorney General's Office will pursue criminal charges.</blockquote><br /><strong>Summary</strong><br /><br />So the answer to the question posed in the title of this post is unknown.  At this point, there is nothing public that indicates for whom the Center for Protection of Patient Rights advocates.  However, it is hard to conceive that its advocacy is for patients.  <br /><br />So rather than merely being an astroturf organization (a health care policy advocacy group funded by industry money), the benignly named Center for the Protection of Patient Rights appears to be a dark money group whose goals may have allegedly included money laundering to facilitate vast monetary influence on political campaigns by people and organizations whose identities remain secret.<br /><br />We have often discussed the role of deception in health care, including <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing</a>, <a href="http://hcrenewal.blogspot.com/search/label/stealth%20health%20policy%20advocacy">stealth public policy advocacy</a>, and <a href="http://hcrenewal.blogspot.com/search/label/stealth%20lobbying">stealth lobbying</a>.  Now we see health care being used as a vehicle for political deception, stealth political campaigns being disguised as stealth public relations campaigns.  The convolutions of the deceptions induce dizziness.  <br /><br />Of course, this is the opposite of the sorts of transparency health care professionals and academics ought to support, and patients and the public ought to demand.  How will we ever improve health care when health care organizations are used to hide layer upon layer of deception?<br /><br />Real improvements in health care require health care leadership dedicated to transparency, honesty, and accountability. 

For Whom Does the Center for the Protection of Patient Rights Advocate?

We have occasionally discussed the cases of  some patient advocacy organizations which seem to be influenced by substantial financial suppor...

Đọc thêm »

Bad Health IT -Yet Another Health IT 'Glitch' - Potential Image Loss in GE Centricity PACS; ECRI Again Reports Health IT a Top Ten Hospital Risk

From my definition of bad health IT (BHIT) <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">at this link</a>:<br /><br /><blockquote class="tr_bq"><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;"><b>Bad Health IT</b> ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, <b>loses data or provides incorrect data</b>, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, <b>creates the need for <span class="SpellE">hypervigilance</span> (i.e., towards avoiding IT-related mishaps) that increases stress</b>, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.<span style="mso-spacerun: yes;">   </span></span></blockquote><br />Considering the problem of lost data (lost x-rays) that affects not one, but two versions ("versions 3.x and 4.x and higher") of a common GE PACS (radiology image management) system, as in the attached memo to hospital radiology and IT executives, one might ask:<br /><br /><ul><li>How long has this been going on before this 'glitch' was discovered? </li></ul><ul><li>What validation and safety testing does GE use before releasing its health IT to production? </li></ul><ul><li>Why was it discovered in several successive versions of PACS systems being used on live patients, instead of in laboratory testing? </li></ul><ul></ul><ul></ul><ul><li>How many delayed diagnoses, injuries and/or deaths might have occurred as a result of this "disappearing image" bug? </li></ul><ul><li>What is the likelihood this "workaround" will be uniformly adopted in short order?  </li></ul><ul><li>What levels of hypervigilance, stress and increased likelihood of error will this temporary "workaround" engender? </li></ul><ul><li>When will it be fixed in all implementations worldwide?</li></ul><ul></ul><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwnvhRrJFx_UdhErl1oGbzG8rJ2QsoWKw8UjUxAJKCtYc1UxFazjHvvW8MdGj776Qp_5lCROBxdnWTqtG-V7tKNWTBJD11Fu28z7lScOk2sOmR2IQqRY5cZkEIELuqFEKDPFTXT1W_28ng/s1600/ge1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwnvhRrJFx_UdhErl1oGbzG8rJ2QsoWKw8UjUxAJKCtYc1UxFazjHvvW8MdGj776Qp_5lCROBxdnWTqtG-V7tKNWTBJD11Fu28z7lScOk2sOmR2IQqRY5cZkEIELuqFEKDPFTXT1W_28ng/s400/ge1.jpg" width="310" /></a></div><div style="text-align: center;"> Beware disappearing x-rays.  Make sure every system user performs this workaround, too <b>(click to enlarge)</b>.<br /><br /></div><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgzYZYXgWlFsHXA9aKzHCO7jeeZ6JA-5hBlRE92SpHqGo_rKZS5vMMlAG_Gn7Frx46JsR3oMjRSwMpKWBydYMExyDytO5CRA37w2cZy0BBUWvV_NO3gRbgOX_9EKOcw4_7K_Fo7rv_G4UzO/s1600/ge2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="202" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgzYZYXgWlFsHXA9aKzHCO7jeeZ6JA-5hBlRE92SpHqGo_rKZS5vMMlAG_Gn7Frx46JsR3oMjRSwMpKWBydYMExyDytO5CRA37w2cZy0BBUWvV_NO3gRbgOX_9EKOcw4_7K_Fo7rv_G4UzO/s320/ge2.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="font-size: small;">Page 2 <b>(click to enlarge)</b></span></td></tr></tbody></table><br />It's not as if missing x-rays are a trivial matter.  One routine x-ray lost to followup resulted in the needless and rather horrible death of an infant, and a $1.5 million settlement, as at the June 2011 link "<a href="http://www.chicagotribune.com/health/ct-met-technology-errors-20110627,0,5447654.story">Babies' deaths spotlight safety risks linked to computerized systems</a>" (case #2).<br /><br />Patient safety <b>is</b> being compromised.<br /><br />Lack of regulation of health IT, and lack of reporting and accountability, needless to say, are major contributors to the prevalence of BHIT.<br /><br />I also note for several years running, including in the latest report of 2013, the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI Institute</a> (an independent tester of healthcare technology) reports health IT-related problems as among the top ten technology problems in hospitals (<a href="https://www.ecri.org/Press/Pages/2012_Top_Ten_Hazards.aspx" target="_blank">link</a><a href="https://www.ecri.org/Press/Pages/2012_Top_Ten_Hazards.aspx" target="_blank"> to report</a>):<br /><br /><blockquote class="tr_bq">...Five of the top 10 hazards explained in ECRI Institute’s [2013] report are: <br /><br />    1.  Alarm hazards<br />    2.  Medication administration errors using infusion pumps<br />    3.  Unnecessary radiation exposures and radiation burns during diagnostic radiology<br />         procedures<br />    4.  Patient/data mismatches in EHRs and other health IT (HIT) systems<br />    5.  Interoperability failures with medical devices and health IT systems<br /><br />Three of the ten topics on the 2013 list are directly associated with the still-maturing<i><b> <span style="color: red;">[i.e., experimental - ed.]</span> </b></i><span style="background-color: red;"></span>health IT field where the interplay between complexity and effectiveness and potential harm is most evident; several of the other topics are peripherally related to HIT issues.<br /><br />“The inherent complexity of HIT-related medical technologies, their potential to introduce new failure modes, and the possibility that such failures will affect many patients before being noticed—combined with federal incentives to meet Meaningful Use requirements—leads us to encourage healthcare facilities to pay particular attention to health IT when prioritizing their safety initiatives for 2013,” says James P. Keller, Jr., vice president, health technology evaluation and safety, ECRI Institute.<br /><br />The hazards included in the 2013 list, published in the November 2012 issue of ECRI Institute’s Health Devices journal, met one or all of the following criteria: <b>it has resulted in injury or death; it has occurred frequently; it can affect a large number of individuals; it is difficult to recognize; it’s had high-profile, widespread news coverage.</b> </blockquote><br />-- SS <br /><br />

Bad Health IT -Yet Another Health IT 'Glitch' - Potential Image Loss in GE Centricity PACS; ECRI Again Reports Health IT a Top Ten Hospital Risk

From my definition of bad health IT (BHIT) at this link : Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, ...

Đọc thêm »

"Phony Consulting and Royalty Agreements," "Chocolate" Bribes, a Sales Representative Doubling as a Stripper, Oh My - Three Settlements for Othrofix

On this US election day, we seem to be in a mini-squall of cases involving unethical, deceptive, and now very colorful marketing practices used to push drugs and devices.  <br /><br />We recently discussed a settlement of allegations of deceptive marketing practices and kickbacks by pharmaceutical company Boehringer-Ingelheim (<a href="http://hcrenewal.blogspot.com/2012/10/just-another-day-at-office-boehringer.html">here</a>), a US congressional report alleging deceptive influence by Medtronic marketers over ostensibly scholarly publications (<a href="http://hcrenewal.blogspot.com/2012/10/marketers-systemic-influence-over.html">here</a>), a study of documents released after litigation that appear to show how Pfizer had a systemic marketing campaign that used controlled trials as deceptive marketing vehicles (<a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">here</a>), <br /><br />Now three separate settlements by device/ biotechnology company Orthofix have come to light.<br /><br /><strong>Settlement 1 - "Phony Consulting and Royalty Agreements," and Prostitution as Kickbacks, and a Sales Representative as Stripper</strong><br /><br />A Bloomberg <a href="http://www.bloomberg.com/news/2012-11-02/orthofix-will-pay-u-s-30-million-to-settle-kickbacks.html">article</a> outlined Orthofix's two latest settlements.  The newest seems the most audacious, or bodacious,<br /><br /><blockquote class="tr_bq">Orthofix International NV, (OFIX) a maker of spinal implants, <em>agreed to pay the U.S. $30 million to settle claims that a subsidiary paid illegal kickbacks and provided prostitutes to doctors in return for orders. </em><br /><br />The subsidiary, Blackstone Medical Inc., <em>paid kickbacks to spinal surgeons in the form of phony consulting and royalty agreements, and travel and entertainment</em> to entice them to use its products, the U.S. Justice Department said in a statement today. </blockquote><br />This case adds to the mounting pile of evidence that many of the financial relationships among physicians and health care academics and drug, device, biotechnology and other health care corporations are not merely conflicts of interest incidental to innovation.  In particular, Bloomberg reported,<br /><br /><blockquote class="tr_bq">[Whistle blower Susan] Hutcheson <em>alleged that officials of Blackstone, purchased by Orthofix in 2006, violated kickback and false-claim laws by setting up a system to compensate doctors under sham consulting agreements and phony research grants</em>, according to court filings. The sales executive said the company also offered <em>lavish travel opportunities</em> to doctors who implanted its products, the filing said. <br /><br /><em>Some doctors were paid as much as $8,000 a month under the fictitious consulting agreements,</em> Hutcheson said in her suit, filed in federal court in Massachusetts. Orthofix’s U.S. unit is based in Lewisville, Texas. <em>Some also received phony research grants for as much as $18,000, the suit added. </em></blockquote><br />Then there was this colorful detail,<br /><br /><blockquote class="tr_bq">Blackstone salespeople also were <em>urged to take surgeons out for expensive dinners, escort them to strip clubs and pay for liaisons with prostitutes to get their business</em>, Hutcheson said in the suit. <br /><br /><em>One female sales manager in Dallas agreed to disrobe and join strippers on stage at the request of two surgeons to whom she was pitching the company’s products</em>, Hutcheson said in her suit. The sales manager was demoted, not fired, over the incident, Hutcheson said in the suit. </blockquote><br />We often hear from drug, device, and biotechnology companies that their sales efforts are all about providing needed information to physicians, information they could not otherwise obtain.  In this case, the information appeared to be rather anatomical, but also rather personal.<br /><br />The AP <a href="http://www.businessweek.com/ap/2012-11-02/orthofix-paying-30m-to-settle-kickbacks-case">coverage </a>of this store (here, via Businessweek) also noted that the settlement involved a corporate integrity agreement.  Neither story mentioned any admissions made by the company.  As far as I could tell, no corporate executives suffered any consequences as part of this settlement.<br /><br /><strong>Settlement 2 - Fraud, Obstructing the US Government, and Less Colorful Kickbacks to Promote Bone Growth Stimulators</strong><br /><br />The article did nor provide any helpful photographs, but it did note that Orthofix recently made a second settlement.<br /><br /><blockquote class="tr_bq">The settlement’s approval comes after <em>Orthofix officials agreed to pay $42 million to resolve a separate whistle-blower suit and a criminal probe of allegations</em> it paid kickbacks to doctors who used its bone-growth stimulators.<br /><br /><br /><em>One of its units will plead guilty in federal court in Boston federal court to a single felony count of obstructing a U.S. government audit and pay a $7.8 million fine, according to a June 7 regulatory filing. Orthofix also will pay $34.2 million to resolve whistle-blower claims that the company defrauded the federal Medicare program over bone-growth stimulators</em>, which patients wear after surgery to speed healing.</blockquote><br />Amazingly, unlike the first settlement, and unlike most settlements we have discussed,<br /><br /><blockquote class="tr_bq"><em>Five Orthofix employees have pleaded guilty to criminal charges in connection with probes</em> of the kickback allegations. <em>Thomas Guerrieri, an Orthofix vice president, pleaded guilty in April to violating the federal anti-kickback statute by setting up fake consulting agreements for doctors who used the company’s products</em>.</blockquote><br />Note that we discussed a surgeon who pleaded guilty to accepting kickbacks from multiple device companies, including the Blackstone subsidiary of Orthofix, <a href="http://hcrenewal.blogspot.com/2008/01/neurosurgeon-admits-kickbacks-from.html">here</a> in 2008. <br /><br /><strong>Settlement 3 - "Chocolate" Bribes to Mexican Government Officials</strong><br /><br />Finally, the AP story noted in passing "the recent resolution of a federal Foreign Corrupt Practices action" against the company.  I could not find any news coverage of that, but in July there did appear a <a href="http://www.sec.gov/news/press/2012/2012-133.htm">SEC press release</a>.<br /><br /><blockquote class="tr_bq">The Securities and Exchange Commission today <em>charged Texas-based medical device company Orthofix International N.V. with violating the Foreign Corrupt Practices Act (FCPA) when a subsidiary paid routine bribes referred to as 'chocolates' to Mexican officials in order to obtain lucrative sales contracts with government hospitals.</em><br /><br />The SEC alleges that Orthofix’s Mexican subsidiary Promeca S.A. de C.V. <em>bribed officials at Mexico’s government-owned health care and social services institution Instituto Mexicano del Seguro Social (IMSS). The 'chocolates' came in the form of cash, laptop computers, televisions, and appliances that were provided directly to Mexican government officials or indirectly through front companies</em> that the officials owned. The bribery scheme lasted for several years and yielded nearly $5 million in illegal profits for the Orthofix subsidiary.<br /><br /><br /><em>Orthofix agreed to pay $5.2 million to settle the SEC's charges</em>.</blockquote>Also,<br /><br /><blockquote class="tr_bq">Orthofix also disclosed today in an 8-K filing that it has<em> reached an agreement with the U.S. Department of Justice to pay a $2.22 million penalty in a related action</em>.</blockquote><br /><strong>Summary</strong>   <br /><br />So the box score here includes settlements of legal actions alleging bribery and kickbacks, a corporate integrity agreement, a guilty plea by a company subsidiary to obstructing the US government, and multiple guilty pleas by company executives.  The bribes and kickbacks were provided in various colorful forms.   <br /><br />The variety of unethical behaviors unearthed suggests a company with a seriously deranged corporate culture.  Whether the various actions taken against it, including the very unusual punishments meted out to some of its apparently mid-level executives will change its behavior, or serve as a lesson to other companies and their leaders is not clear.  Whether they are sufficient to suggest anyone should trust this company, its leaders, or its products seems questionable.    <br /><br />This story adds to our various compilations of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> and tales of <a href="http://hcrenewal.blogspot.com/search/label/crime">crime</a>, including <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribery</a>, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a> and <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a> involving major health care organizations which suggest serious, deep afflictions within the culture of our commercialized health care system.  Yet almost nowhere, except here on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>are there calls for serious reforms to restore trust in our health care organizations and their leaders.<br /><br />As we have said endlessly, up to now, such legal settlements seemingly have had no effect on the bad behavior of big health care organizations, while they continually erode trust in these organizations and their leadership, and trust in physicians to put patients ahead of personal gain. <br /><br />Furthermore, these cases seem to be part of a larger social problem. It seems that nowadays the leadership of large, powerful organizations feels free to promote their own interests using psychologically sophisticated but deceptive marketing and public relations strategies no matter what their effect on the public welfare.<br /><br />Again as we have said all too many times before, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.<br /><br />Maybe after all the election hoopla dies down here in the US, we can finally have a serious conversation about health care reform that will make our health care system more trustworthy. 

"Phony Consulting and Royalty Agreements," "Chocolate" Bribes, a Sales Representative Doubling as a Stripper, Oh My - Three Settlements for Othrofix

On this US election day, we seem to be in a mini-squall of cases involving unethical, deceptive, and now very colorful marketing practices u...

Đọc thêm »

DOES AMERICAN PSYCHIATRY MATTER?

<br />DOES AMERICAN PSYCHIATRY MATTER?<br /><br />The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he has done more than anyone to document the follies and the ethical challenges of contemporary American psychiatry. His site is required reading for all who care about behavioral health issues. <br /><br />In his <a href="http://1boringoldman.com/index.php/2012/11/02/cest-la-vie/">latest posting</a> he compared the domain of American psychiatry to Yugoslavia. Cast Melvin Sabshin as Marshal Tito. Sabshin was the medical director of the American Psychiatric Association in the late 1970s, the period leading up to DSM-III. Tito and Sabshin each strong-armed a confederation of sorts but failed to deal with the conflicts beneath the surface. Both leaders were faced with the prospect of their domains disintegrating – Tito’s at the hands of Moscow and Sabshin’s at the hands of insurance companies. Both persuaded wary stakeholders to sign on to a compromise, for want of anything better and fearing a worse outcome.<br /><br />The domain of psychiatry hasn’t yet reached the stage of ethnic cleansing and genocide that we saw in Yugoslavia after Tito’s death, but it is well on the way. One only has to look at the vicious response of the American Psychiatric Association leaders to Allen Frances and other critics of DSM-5. The APA president in 2009, Alan Schatzberg from Stanford, went out of his way to <a href="http://www.psychi%20imes.com/dsm-5/content/article/10168/1425806atrict">smear</a> Dr. Frances and Robert Spitzer, the architects of DSM-IV and DSM-III because he had no credible scientific response to their criticisms of the directions DSM-5 is taking. He was joined in this low act by David Kupfer and Darrel Regier, who are directing the DSM-5 effort. Where is the comity, Comrades? Where are the shared values? Why is the APA holed up in a bunker?<br /><br />Then we have the unsavory sight of the APA lawyers <a href="http://hcrenewal.blogspot.com/2012/01/self-inflicted-damage.html">threatening</a> a blogfrauchen in the U.K. with a SLAPP lawsuit for alleged infringement on the APA’s intellectual property – as though the APA owns psychiatric classification! Talk about chutzpah. So now the confederation Sabshin cobbled together is breaking up and the stakeholders are starting to go their separate ways – psychologists, counselors, social workers, patient advocacy groups, even many psychiatrists. Christopher Lane in <a href="http://www.psychologytoday.com/blog/side-effects/200912/american-psychiatry-is-facing-civil-war-over-its-diagnostic-manual">Psychology Today</a> has said American psychiatry is facing “Civil War” over its diagnostic manual. Even an international psychiatric journal like British Journal of Psychiatry is <a href="http://bjp.rcpsych.org/content/201/4/334.full">distancing itself</a> from DSM-5 and there is talk of abandoning DSM-5 for the next ICD classification.<br /><br />Why is American psychiatry self destructing? Because the grand bargain forged in 1980 with DSM-III was a sham from the get-go and the promised benefits of diagnostic reliability have not materialized. They knew all along that reliability was a poor substitute for validity, but they settled for half a loaf. That compromise led us into the <a href="http://hcrenewal.blogspot.com/2009/04/in-defense-of-psychiatric-diagnoses-and.html">epistemologic quagmire</a> of today, where there is no solid ground for clinical decisions or clinical research progress or drug development. A stunning absence from the DSMs to date is any statement about treatment. That compromise also led us to diagnostic inflation, which Pharma embraced. Pharma quickly filled the vacuum with <a href="http://www.ncbi.nlm.nih.gov/pubmed/15169734">experimercials</a> that <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">pretended</a> to be real clinical science, and in the process diverted precious clinical research infrastructure away from genuinely important questions. Just look at the clinical trials er, experimercials, mill operating out of Massachusetts General Hospital at Harvard University.<br /><br />What lies ahead? Stakeholders are going to vote with their feet. DSM-5 is likely to be a footnote in the history of psychiatric classification. The APA will become even less relevant than it is today, much like the American Medical Association, which now commands the loyalty of maybe <a href="http://mediamatters.org/research/2009/06/15/nbcs-guthrie-falsely-suggests-ama-represents-th/151182">30% of U.S. physicians</a>. Mel Sabshin will turn in his grave, the APA will lose revenue, ICD-11 will become the dominant classification of psychiatric disorders, and the quagmire will continue until a new synthesis arises from the ashes. If Yugoslavia is any kind of model, don’t hold your breath.<br /><br />

DOES AMERICAN PSYCHIATRY MATTER?

DOES AMERICAN PSYCHIATRY MATTER? The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he ha...

Đọc thêm »

Just Another Day at the Office: Boehringer Ingelheim Settles Allegations of Deceptive Off-Label Marketing, Kickbacks

Legal settlements by pharmaceutical companies for less than $100 million now seem to barely rate as news in the US. The best report, albeit short, of a by Boehringer Ingelheim for a mere $95 million, seems to be<a href="http://articles.courant.com/2012-10-26/business/hc-boehringer-ingelheim-fraud-20121026_1_hypertension-drug-civil-settlement-risk-of-heart-attacks"> in the Hartford (CT) Courant</a>. The summary was: <br /><blockquote>Boehringer Ingelheim, a German company with U.S. headquarters in Ridgefield, has agreed to pay $95 million to settle allegations that it promoted four drugs for uses unsupported by research, and that it paid kickbacks to doctors to prescribe the drugs, the U.S. Department of Justice has announced. </blockquote>It included most of the usual elements.<br /><br /><b>Off Label Marketing</b><u> </u><br /><blockquote>Two of the drugs in the case are for treating chronic bronchitis and emphysema, and were suggested for children with asthma and coughs from the flu. The drugs had not been tested on children. </blockquote><blockquote>'I was concerned that <i>doctors were basing their treatment decisions on false information</i>,' [former Boehringer Ingelheim pharmaceutical representative and whistle blower Ron] Heiden said in the released statement. '<i>Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior</i>.' </blockquote>I note parenthetically that some industry apologists belittle the possible harms of truthful off-label marketing (e.g., look <a href="http://hcrenewal.blogspot.com/2008/08/what-influences-advocates-of-providing.html">here</a>).  However, at least in this case, the marketing was alleged to be based on falsehoods. <br /><br />Furthermore, some industry apologists may also decry the regulation of off-label marketing as a violation of the US Constitutional guarantees of freedom from government infringement on individual free speech<a href="http://hcrenewal.blogspot.com/2008/08/what-influences-advocates-of-providing.html"></a>.  Note, however, that Boehringer Ingelheim in this case got exclusive rights to market these drugs for many years from the government.  In exchange for these rights, the law restricted their right to market the drugs to approved indications.   <br /><br /><b>Promotion Beyond the Evidence </b><br /><blockquote>The company told doctors Aggrenox was better than Plavis to reduce the risk of heart attacks, but there was no evidence to support that claim, the Justice Department said. The drug had FDA approval to prevent secondary strokes. </blockquote>Again, the truthfulness of the premises underlying the marketing apparently was questionable, to use charitable phrasing.   <br /><br /><b>Kickbacks to Physicians</b><br /><br />This information came from the AP version of the story, here <a href="http://www.washingtonpost.com/business/pharmaceutical-company-to-pay-95m-to-settle-allegations-of-improper-promotion/2012/10/25/ef595032-1ee1-11e2-8817-41b9a7aaabc7_story.html">via the Washington Post</a>: <br /><blockquote>the settlement resolved allegations that Boehringer Ingelheim paid kickbacks to health care professionals to induce them to prescribe all four of the drugs. These <i>kickbacks included payments for participating in advisory boards, speakers’ training programs, speaker programs and consultant programs. </i></blockquote> Note further that apologists for industry also belittle the importance of the effects of conflicts of interest on health care (e.g., look <a href="http://hcrenewal.blogspot.com/2009/07/stossel-and-acre-wheres-beef.html">here</a>).  In this case, activities that are often referred to as species of conflicts of interest, e.g., advisory board membership, speakers board membership, consulting, apparently were meant as vehicles for payments to induce prescribing.  That is, apparently what some might have called conflicts of interests were allegedly kickbacks, or bribes.  As we have discussed before, it is one thing to be paid for legitimate clinical, educational, or scientific activity when such payments might influence professional, educational, or scientific judgments or activities about other matters.  It is entirely another thing to be paid a kickback to favor a drug company's marketing campaign instead of making decisions that put patients first.<br /><br /><b>A Corporate Integrity Agreement</b><br /><br />[From the Hartford Courant] <br /><br /><blockquote class="tr_bq">Also as part of the settlement, Boehringer agreed to enter into an expansive Corporate Integrity Agreement to avoid such marketing in the future.</blockquote><br /> We have noted before that such agreements do not seem to deter future bad behavior, (e.g., look <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreement">here</a>).<br /><br /><b>No Admission of Wrongdoing by the Company</b><br /><br />[from the AP]<br /><br /><blockquote class="tr_bq">'The pharmaceutical industry as a whole has undergone significant changes over the past decade and continues to be under intense scrutiny,' said Greg Behar, president and chief executive officer of Boehringer Ingelheim. 'Likewise, our internal processes and compliance practices have evolved significantly over the years.' The company said it has been cooperating with the government investigation.</blockquote>Again, if there is no acknowledgement by the company that it did wrong, do we expect it not to do wrong in the future?<br /><br /><b>Summary</b><br /><br />Here was yet another legal settlement that documents the pervasiveness of the influence of marketing and public relations over physicians' professional responsibilities.  This is just one of several recent posts (e.g., <a href="http://hcrenewal.blogspot.com/2012/10/marketers-systemic-influence-over.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">here</a>) about the malevolent influence of <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> marketing or public relations on the evidence that health care professionals should be using to make the best possible decisions for individual patients.<br /><br />Such <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> seemingly have had no effect on the bad behavior of big health care organizations, while they continually erode trust in these organizations and their leadership, and trust in physicians to put patients ahead of personal gain. <br /><br />Furthermore, these cases seem to be part of a larger social problem.  It seems that nowadays the leadership of large, powerful organizations feels free to promote their own interests using psychologically sophisticated but deceptive marketing and public relations strategies no matter what their effect on the public welfare. <br /><br />As we have said all too many times before, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.<br /><br /><br />

Just Another Day at the Office: Boehringer Ingelheim Settles Allegations of Deceptive Off-Label Marketing, Kickbacks

Legal settlements by pharmaceutical companies for less than $100 million now seem to barely rate as news in the US. The best report, albeit...

Đọc thêm »

Marketers' Systemic Influence over Ostensibly Scholarly, Peer-Reviewed Publications: the Medtronic Infuse BMP-2 Example

On the heels of our <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">discussion</a> of how one pharmaceutical company employed a "publications strategy" to commission and control randomized controlled trials to serve marketing purposes, a US Senate committee has released a report about how a device/ biotechnology company "influenced the content of articles in peer-reviewed scientific publications to present... [its product] in the best possible light."<br /><br />The report was <a href="http://online.wsj.com/article/SB10001424052970204530504578076993827301944.html">summarized</a> by the Wall Street Journal, <br /><br /><blockquote class="tr_bq">A report by the Senate Finance Committee based on thousands of documents it subpoenaed from Medtronic Inc<i> raises new questions about the integrity of the medical research underpinning one of the medical-device maker's products</i>.<br /><br /><i>Medtronic was 'heavily involved in drafting, editing and shaping the content of medical journal articles' about the product</i>—a bone-growth protein used in spine surgery called Infuse—<i>even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work</i>, the Senate report alleges.<br /><br />In one instance, <i>a Medtronic employee recommended to one of the physicians not publishing a list of side effects</i> associated with Infuse in a 2005 journal article, company emails show. <i>Medtronic marketing officials also urged inserting language into other journal articles touting the use of Infuse as better for patients</i> than using bone harvested from their pelvises because of the pain associated with the latter, other company documents show.<br /><br /><i>Medtronic's influence extended to preparing a physician's 2002 speech to a panel advising the Food and Drug Administration </i>on whether to approve the drug, the report alleges. The physician's disclosure to the panel at the time suggested his testimony was independent, but the company had in fact helped him draft it and paid him as a consultant the previous year, company documents show. Medtronic later hired the physician as an executive.<br /><br />In response to the Senate report, Medtronic issued a statement saying it 'vigorously' disagreed with any suggestion that 'it improperly influenced or authored any of the peer-reviewed published manuscripts.' The company also denied that it 'intended to under-report adverse events' associated with Infuse.</blockquote><b>The Extent of the Problem </b><br /><br />The report itself is available <a href="http://www.finance.senate.gov/imo/media/doc/Medtronic_Report1.pdf">here</a>. It is worth discussing some of its sections about how the company is alleged to have influenced the peer-reviewed, scholarly clinical literature in more detail.<br /><br />First, it asserted that "Medtronic employees, including employees working for its marketing department, collaborated with physician authors, many of whom had significant financial relationships with Medtronic, to draft" 11 specific articles in the literature published between 2002 and 2009.<br /><br /><b>Obfuscating Adverse Effects</b><br /><br />The report provided detail about specific instances in which Medtronic employees appeared to influence publication to further marketing objectives.  The first was apparently to cloud discussion of adverse effects of its product [italics added for emphasis]:<br /><br /><blockquote class="tr_bq">documents indicate that a Medtronic employee involved in editing a draft of the 2005 Journal of Bone and Joint Surgery (JBJS) article by Burkus, et al. about a similar InFuse procedure involving allograft bone (a cage made from donated bone rather than the FDA-approved titanium), <i>recommended that 'significant detail' concerning adverse event  data should not be published.</i><br /><br />On June 16, 2004, Dr. Julie Bearcroft, <i>Director of Technology Management in Medtronic’s Biologics Marketing Department,</i> wrote an e-mail to other Medtronic employees, commenting on a draft of the study, 'I have made some significant changes to this document (some at the request of Dr. Burkus) both in format and content.  In this e-mail, she asked: 'How much information should we provide relative to adverse events? . . . You will see my [note] in the attached document but <i>I don’t think significant detail on this section is warranted</i>.'  The referenced note in the draft article stated: 'I don’t believe we want to report in the same manner as we do in IDE studies. I personally think <i>it is appropriate to simply report the adverse events were equivalent in the two groups without the detail.'</i> According to an internal e-mail, the adverse events were observed in the trial and formatted in a detailed table. But following the advice of Bearcroft, this table of adverse events was not included in the published paper.<br /><br />On July 3, 2004, after Medtronic edited the paper, Dr. Burkus sent a draft to his co-authors writing that 'this manuscript documents the superiority in clinical and radiographic outcomes with the use of rhBMP2 in a study population of only 133 patients.'<br /><br />According to the Carragee et al. Spine Journal article published in 2011, the 2005 JBJS article 'reported no complications, such as end-plate fracture, collapse, and implant migration associated with rhBMP–2 despite the clear radiographic findings in at least the one presented case.  The e-mail exchange indicates that,<i> in addition to Medtronic editing the manuscript without attribution, the company was recommending that the article omit a complete accounting of adverse event data, including serious adverse event data that were already considered a documented concern by FDA in similar application.</i><br />  <br />These types of adverse events were disclosed in Table V of a 2009 follow-up article concerning the original IDE study. Studies published in 2007 revealed that InFuse is associated with 'a clinically important early inflammatory and osteoclastic effect of the rhBMP–2 in soft tissue and bone, respectively.  In other words, Medtronic recommended against including information in the study that was ultimately revealed to have an association between In-Fuse and weakening that could lead to collapse of the bone and implant and required that patients undergo additional surgery.</blockquote><br />Note that in this example, someone explicitly associated with marketing apparently edited a draft of a scholarly article, suggested that detail about adverse effects of the company's product be omitted, and that the published article in fact omitted such detail. <br /><br />The report also included an example in which another Medtronic employee apparently tried to "tone down" the discussion of adverse effects of the product, but did so too late to influence the published version.  <br /><br /><b>Emphasizing the Adverse Effects of an Alternative to Using the Company's Product</b><br /><br />On the other hand, the report also included an example in which it alleged that a company employee suggested adding emphasis to the drawbacks of using a management strategy that did not include use of the company's product.<br /><br /><blockquote class="tr_bq">Documents show that <i>Medtronic edited draft publications to stress the pain patients experienced from undergoing a bone graft procedure instead of receiving InFuse</i>. Medtronic markets InFuse as a less painful alternative to bone graft procedures for patients undergoing spinal fusion surgery.</blockquote><br />In particular, <br /><br /><blockquote class="tr_bq">After receiving a draft of an early InFuse study 52 to review in October 2001, Medtronic’s Neil Beals, whose '<i>primary job responsibility was to manage Biologics marketing programs and initiatives,</i>'  <i>recommended that the physician authors of the study emphasize pain experienced by patients who received the bone graft</i>. The patients were divided into an investigative group that received InFuse and a control group that received a bone graft obtained from the iliac crest of their pelvis.  An October 31, 2001 e-mail shows that Beals suggested to Dr. Burkus that '<i>a bigger deal should be made of elimination of donor site pain with INFUSE . . . so that ‘equivalent’ results aren’t received as a let down</i>.'   Again, after reviewing a later draft of the study, Beals asked Dr. Burkus on March 8, 2002, '<i>would it be appropriate to make a bigger deal out of donor site pain</i> and include more discussion and references?  Subsequently, a sentence was inserted at the end of a later draft, and included in the published version of the article, that read, 'The use of rhBMP–2 is associated with high fusion rates without the need for harvesting bone graft from the iliac crest and <i>exposing the patient to the adverse effects associated with that procedure.</i>'<br /><br />Medtronic also sought to include discussion of long-term pain in the Baskin, et. al. 2003 paper on InFuse in the cervical spine. In a draft of the publication that was being circulated on August 30, 2002, the authors wrote, '[b]y 12 months after surgery, the patients [sic] graft-site pain had resolved . . . and no patients complained about the graft-site appearance.'  Beals inserted comments after this sentence stating, '<i>ALTHOUGH THE PATIENTS DID NOT COMPLAIN ABOUT APPEARANCE DIDN’T SOME STILL EXPERIENCE PAIN AT THE DONOR SITE? SEEMS LIKE RESIDUAL EFFECTS OF DONOR SITE SHOULD BE NOTED</i>.  [sic] [emphasis in original]. In an e-mail to his colleague, Beals wrote, '<i>I would also add in more discussion on donor site pain and need for osteogenetic graft material (plant seed of doubt for just using allograft by itself )</i>.  A review of the final published article reveals that, after Beals made the suggestion to emphasize pain at the bone graft site, a sentence was added in the final version of the article that read,  '. . . even at the 24-month follow-up assessment, <i>some patients continued to experience residual pain at the donor site, and rated the appearance of the site as only fair</i>.'</blockquote><br />Note that in these two examples, another marketing employee edited drafts of two scholarly articles, suggested that more emphasis be put on supposed adverse effects of the procedure that the articles compared to the procedure which used the company's product, and that the two articles included such emphasis.  <br /><br /><b>Deceptive Response to Peer Reviewers' Criticisms of Apparent Bias </b><br /><br />Finally, the report included an instance in which a company employee managed correspondence between an article's ostensible first author and journal editors to try to defend wording which reviewers had criticized for bias in favor of the company's product.<br /><br />In summary,<br /><br /><blockquote class="tr_bq">E-mail exchanges between Dr. Burkus and Medtronic employees regarding a study of InFuse utilizing the posterior lumbar interbody fusion (PLIF) technique and published in The Spine Journal in 2004 demonstrates that<i> Medtronic employees not only edited the draft manuscript to include comments supportive of InFuse,  they also covertly participated in the peer-review process by drafting responses to peer-reviewers on behalf of the physician authors</i> named on the paper.</blockquote><br />In particular, one employee, Rick Treharne, previously identified as "Senior Vice President of Clinical and Regulatory Affairs," wrote a very positive summary statement for the article's discussion section:<br /><br /><blockquote class="tr_bq">In a January 10, 2003, e-mail to Dr. Burkus, Rick Treharne wrote, 'In looking over the data,<i> I was impressed with how well the BMP patients actually did. So much so that I added a few paragraphs at the end</i> that you may not agree with.' </blockquote>However, the reviewers were skeptical,<br /><br /><blockquote class="tr_bq">One reviewer wrote: 'Unless the authors can discuss the results of this study in an unbiased manner, which they have been unable to do in its present form, this data should not be published.'  Another reviewer wrote: 'The manuscript is full of biased statements that are a reflection of the data evaluators—the company that markets the product.'  That reviewer recommended a discussion of potential bias in the text of the paper writing,  'As it stands it is an advertisement for a specific product without significant scientific merit.'</blockquote><br />Then, Medtronic employees then took over the process of responding to this review, to wit,<br /><br /><blockquote class="tr_bq">E-mail correspondence on May 28, 2003, indicates that <i>Medtronic’s Rick Treharne wrote and sent Dr. Burkus a draft letter to Dr. Tom Mayer, Editor-in-Chief of The Spine Journal</i>, to address concerns raised by orthopedic surgeons tasked with peer-reviewing the submitted PLIF paper. <i>A subsequent e-mail by Julie Bearcroft notes that she and Dr. Burkus collaborated further on the response to the peer-reviewers</i> of this study during a Lumbar Spine Study Group event.<br /><br />In response to the peer-reviewers’ concerns about bias in the manuscript, <i>the response letter seemingly misled The Spine Journal by stating that 'To help eliminate any potential bias, only one of the co-authors was a clinical investigator—the other three were independent reviewers </i>of all the data. Since these data are taken from a clinical IDE study sponsored by a company, only the company would have all the data in its database—data that is reviewed by FDA auditors. We don’t believe any discussion of bias is needed for the text.'  <i>By the end of 2003, 'independent reviewers' Dr. Haid and Dr. Burkus would have received $7,793,000 and $722,000 from Medtronic, respectively.</i> This draft letter, written at least in part by Medtronic on behalf of Dr. Burkus, did not disclose the company’s role in directly editing the paper nor did it disclose the magnitude of financial payments made to the supposed 'independent reviewers.'</blockquote><br />Thus, in this case, a marketing employee apparently edited a draft of a scholarly article to exaggerate benefits of the company's product, directly adding text to the article, and when peer-reviewers suggested that the article showed bias towards the company's product, apparently two employees ghost-wrote a response letter that claimed that certain authors were "independent reviewers," obfuscating that they had previously received large payments from the company.<br /><br /><b>Summary</b><br /><br />In 2010, we <a href="http://hcrenewal.blogspot.com/2010/12/blogscan-medtronics-multi-million.html">noted</a> reporting that suggested Medtronic had paid huge amounts, millions of dollars, to spine surgeons for reasons that were not clear.  Later that year, we <a href="http://hcrenewal.blogspot.com/2010/12/spine-surgeons-reticent-about.html">noted</a> further reporting that surgeons who were getting amounts sometimes exceeding one million dollars from Medtronic were not disclosing these payments in scholarly articles about the company's BMP-2 product. <br /><br />Now there appears a US Senate committee report alleging that Medtronic marketing employees systematically influenced the writing, editing, and publication of multiple ostensibly scholarly articles, ostensibly written by doctors, to favor the Medtronic In-Fuse BMP-2 product.  This adds to previous case studies suggesting that pharmaceutical, biotechnology, device and probably other kinds of company marketers may try to systematically <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> the design, implementation, analysis, and dissemination of supposedly scholarly and unbiased clinical research to more effectively market their products and services.   <br /><br />This is discouraging to a former full-time academic physician who now realizes that the difficulties I encountered getting my manuscripts published, given that they written entirely by academic investigators and uninfluenced by marketers, may have been due to the cacophony of competition from marketing influenced texts professionally promoted to journals to serve vested interests.<br /><br />This is more discouraging to a proponent of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> who believes that medical decisions ought to be informed by critical review of clinical research obtained by systematic search in order to weigh the benefits and harms of management options,accounting for patients' values.  When that clinical research was being deliberately influenced and biased by people selling goods and services, it is not clear that even rigorous critical review will distill the truth from the injected bias.  Yet if physicians cannot depend on published research to guide their decision making for individual patients, what can they depend on?<br /><br />I conclude as I did my last post,...   Thus health care professionals, policy makers, researchers, and the interested public need to be even more skeptical about arguments made to promote innovative treatments and other clinical interventions.  However, it is not clear that even rigorous skepticism can defend the integrity of evidence based medicine from marketing disguised as clinical research. <br /><br />Going forward, we must consider erecting an impregnable barrier between clinical research and those whose primary interest is to make money by selling health care goods and services.  If we do not do that, we will forever need to worry that we really have no idea what "works in medicine," and whether any particular test, treatment, or program provides benefits that outweigh its harms.  <br /><br />

Marketers' Systemic Influence over Ostensibly Scholarly, Peer-Reviewed Publications: the Medtronic Infuse BMP-2 Example

On the heels of our discussion of how one pharmaceutical company employed a "publications strategy" to commission and control ran...

Đọc thêm »

Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incentive programs, and other factors as <a href="http://ihealthtran.com/wordpress/2012/10/senate-republicans-send-letter-to-sebelius-with-concerns-over-meaningful-use/" target="_blank">here</a>.<br /><br />However, what was largely left out was the issue of safety.<br /><br />I've written this letter to the congresspeople who've written to HHS secretary Sebelius (PDF available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/EHR_congress_letter_oct24_2012_final.doc" target="_blank">at this link</a>):<br /><br /><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">October 24, 2012</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sens. Coburn, Burr, Roberts and Thune</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Reps. Ellmers, Camp, Herger, Upton and Pitts</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">United States</span><span style="font-family: Arial; font-size: 10.0pt;"> Congress</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Washington</span><span style="font-family: Arial; font-size: 10.0pt;">, DC</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Re:<span style="mso-spacerun: yes;">  </span>HITECH and healthcare information technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Dear Senators and Representatives,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I applaud your recent inquiries to HHS regarding critical issues related to healthcare information technology (EHRs, physician order entry, decision supporting systems, etc.)  Issues such as the possible role of these systems in upcoding and Medicare overbilling, test overutilization, abuse of incentives, etc. must be addressed.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">However, you did not address an issue probably more important to the public, indeed to us all as patients – that of health information technology <i style="mso-bidi-font-style: normal;">safety.</i></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must be made aware that health IT exists in two forms:  <b style="mso-bidi-font-weight: normal;">good health IT </b>and<b style="mso-bidi-font-weight: normal;"> bad health IT</b>.  <span style="mso-bidi-font-weight: bold;">Bad health IT reduces safety, creates close calls, injures, kills, raises costs, and sacrifices information privacy and confidentiality, among other ill effects</span>.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must also be made aware that unfortunately due to systemic impediments to free flow of information about health IT systems and lack of FDA or other independent industry regulation, bad health IT is rarely removed from the marketplace or fixed.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">FDA and its director of the Center for Devices and Radiological Health (CDRH), Jeffrey Shuren MD JD, testified to HHS in Feb. 2010 that “under the Federal, Food, Drug, and Cosmetic Act, health information technology software is a medical device”, but that FDA has “largely refrained from enforcing our regulatory requirements with respect to HIT devices.”  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To clarify about the two types of health IT:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Good Health IT</span></b><span style="font-family: Arial; font-size: 10.0pt;"> provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Bad Health IT </span></b><span style="font-family: Arial; font-size: 10.0pt;">is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Agency for Healthcare Research and Quality (AHRQ) recently reported that the highest prevalence of medical technology safety issues was related to EHR systems.<span style="mso-spacerun: yes;">  </span>Even worse, there is a lack of reporting transparency. Harms are known of, but the magnitude admittedly unknown due to systematic impediments to reporting transparency, collection and analysis, as noted by FDA in a 2010 internal memo and IOM itself in its 2012 report on health IT safety.  This is unprecedented in modern medicine, violates patient’s rights, and under no circumstances should be considered acceptable.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I personally know of adverse patient outcomes including death related to bad health IT that are unreported (even in a state that mandates reporting of medical incidents and serious events), as do numerous colleagues.<span style="mso-spacerun: yes;">  </span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Institute of Medicine has just released a Discussion Paper written by experts in health information technology entitled “<b>Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used"  </b>(<a href="http://www.iom.edu/Global/Perspectives/2012/%7E/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf" target="_blank">http://www.iom.edu/Global/Perspectives/2012/~/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf</a>). The recommendations in this paper need to be put into place, and Congressional awareness of the issues and official inquiry as to when this will happen is essential.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">This paper’s recommendations will not happen without the oversight of Congress.  As stated in the paper itself, “Some medical and IT leaders have invested their reputations, and their organization’s time and money, in the software [implementation] program; complaints that expose large problems may not be appreciated or carried forward.” </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Some claim safeguards are already in place in the form of HHS certification of health IT.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Unfortunately, the HHS health IT certification guidelines do not have sufficient depth nor the correct focus to distinguish between bad health IT and good health IT.  Certification for MU does not look at real-world testing for safety, reliability and usability, for instance, under real loads, in actual clinical settings, and is not very thorough.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">On the other hand,  NASA, the pharmaceutical industry (via FDA's regulation of pharmaceutical research and manufacturing IT) and others dependent on mission-critical software have rigorous validation procedures to check for such factors, e.g., NASA’s "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf" target="_blank">Certification Processes for Safety-Critical andMission-Critical Aerospace Software</a>" that includes rigorous testing to distinguish bad IT from good IT, and remediate or abandon the former.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">p. 6-7:  In order to meet most regulatory guidelines, developers <span style="mso-bidi-font-weight: bold;">must build a safety case</span> as a means of documenting the safety justification of a system. The safety case is a <span style="mso-bidi-font-weight: bold;">record of all safety activities</span> associated with a system throughout its life. Items contained in a safety case include the following:<br /><br />• Description of the system/software<br />• Evidence of <span style="mso-bidi-font-weight: bold;">competence of personnel</span>involved in development of safety-critical software and any safety activity<br />• Specification of <span style="mso-bidi-font-weight: bold;">safety requirements</span><br />• Results of <span style="mso-bidi-font-weight: bold;">hazard and risk analysis</span><br />• Details of <span style="mso-bidi-font-weight: bold;">risk reduction</span>techniques employed<br />• Results of design analysis showing that the <span style="mso-bidi-font-weight: bold;">system design</span> <span style="mso-bidi-font-weight: bold;">meets all required safety targets</span><br />• <span style="mso-bidi-font-weight: bold;">Verification and validation strategy</span><br />• Results of <span style="mso-bidi-font-weight: bold;">all verification and validation activities</span><br />• Records of<span style="mso-bidi-font-weight: bold;"> safety reviews</span><br />• Records of <span style="mso-bidi-font-weight: bold;">any incidents which occur throughout the life of the system</span><br />• Records of all changes to the system and<span style="mso-bidi-font-weight: bold;"> justification of its continued safety</span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These processes need to be put in place regarding healthcare IT as well, but will take much time and regulatory push on the industry to occur.  In the absence of truly rigorous testing, though, transparency is essential.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The aforementioned IOM Discussion Paper outlines the creation of a nationwide post-marketing surveillance process and transparency on health IT usability problems, safety issues, billing fraud promotion, etc. is essential.  It recommends:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">“Flight simulator”-like, thorough laboratory evaluation of test scenarios;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Point-of-use reporting by doctors and nurses on their experiences;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Third party–administered doctor and nurse surveys about their experiences with EHR systems;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Direct clinician-to-public reporting; and</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">A formalized system of hazards reporting from EHR systems.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These measures are essential if the technology is to achieve the benefits of which it is theoretically capable, but not presently achieving despite the hundreds of billions of dollars being spent.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">In conclusion, I ask you to add to your inquiries the subject of health information technology safety.  That includes the need for HHS to develop a robust, transparent national reporting system for safety problems created by the technology, and a system to ensure that bad health IT is either fixed in a timely manner or removed from the marketplace.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sincerely,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">-----------------------------------------------------------------</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot M. Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Drexel</span><span style="font-family: Arial; font-size: 10.0pt;"> University</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">College</span><span style="font-family: Arial; font-size: 10.0pt;"> of Information Science</span><span style="font-family: Arial; font-size: 10.0pt;"> and Technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">3141 Chestnut St.</span><span style="font-family: Arial; font-size: 10.0pt;">, Philadelphia, PA 19104-2875</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Email:<span style="mso-spacerun: yes;">  </span>sms88 AT drexel DOT edu </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Bio:<span style="mso-spacerun: yes;">  </span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> </span></div></blockquote><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;"></span></div><br /><br />I hope this letter has some beneficial effect.<br /><br />-- SS

Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incent...

Đọc thêm »