healthy4u

21st century EMR experiments: messing around with people's lives in a broke city, while not having a clue what you're doing

<div style="text-align: left;">I was astounded to read the <a href="http://histalk2.com/2010/10/18/histalk-interviews-leland-babitch-cmio-detroit-medical-center">following passage</a> in an interview of the current chief medical information officer at <a href="http://www.dmc.org/" target="_blank">Detroit Medical Center</a> ("DMC") Detroit, MI: </div> <blockquote>DMC tried CPOE in 2003 and said it would regroup and try it again. What lessons were learned from that first attempt? In 2003 we did try at one hospital — a more community-based hospital — on two units. We did it on our rehab unit, the psych unit. I think the first lesson we learned there was that it was really just designed as, or worked out as, an IT project. I mean, it was really IT-led and there wasn’t clinical involvement from the get-go. There wasn’t really a leadership pattern that had physician and nursing components to it. There wasn’t a design phase that included a lot of clinicians. There wasn’t leadership buy-in from the hospital. We took the product from the vendor and implemented what they gave us. It was really doomed to fail from the start. [Doomed, that is, due to inexcusable health IT illiteracy for the year 2003 - ed.]</blockquote> This is striking for a number of reasons, least of which is the tone in which the failure is presented, a tone that suggests this failure and its "lessons" were banal in character and something that "just happens." It's as if by 2003 there was no other way to have done due diligence and learned these lessons, other than by actual experimentation on hospital floors with live patients and busy clinicians. If this story had appeared about a health IT project in, say, 1983 or 1993, it would have been less remarkable. By 2003, however, the literature on how do do health IT "right" (and on how not to do it, including all the faults mentioned about DMC's efforts), was quite voluminous. The medical informatics literature from AMIA and IMIA, textbooks such as <a href="http://www.amazon.com/Managing-Technological-Change-Organizational-Informatics/dp/0387985484">Lorenzi and Riley's</a> "Organizational Aspects of Health Informatics: Managing Technological Change" (<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC226105/?page=1">ed. 1 - 1995</a>), sites such as my own on <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">HIT failures</a> (freely available and one of the first hits one received via google on searches on "Healthcare IT failure" and similar concepts even then), and other resources could have prevented the CPOE failure - if someone at DMC or their consultants had had the meta-knowledge to know of their existence or the managerial savvy to ask, and the initiative to actually read the materials and heed the advice of experts. Instead, this sounds like a classic example of hospital mismanagement, via not knowing what you don't know, and not caring. What is described is a failure due to HIT naivete and managerial dyscompetence (or incompetence) around technology management that should not have existed in hospitals in an American city in 2003. One should wonder what other mishaps occured in other domains of medical technology under this type of "leadership." Clinical personnel and patients are the potential victims - not laboratory rats. The story is certainly remarkable in terms of risk presented by this experiment on live patients, and again for its banal tone regarding that crucial issue. It is well known that poorly done CPOE is associated with medication errors, not a happy event on a psychiatry unit or PM&R/rehab unit (where elderly frail patients often abound). The story is also remarkable due to the waste of money it represents in a city <a href="http://www.npr.org/templates/story/story.php?storyId=4955488">not exactly rolling in money</a>, looking somewhat like Dresden after the WW2 firebombing and with wide sections of former residential land designated for demolition and "return to nature." Instead of spending money on "let's try to figure out CPOE today, all by ourselves!" health IT experiments, perhaps the money could have been used for better care of Detroit's poor. The "lessons learned" in 2003 could and should have been learned for free and without risk to patients - in a public library. I ask: <ul><li>Did patients get injured in this debacle? If they did, are the records sealed? We may never know.</li></ul><ul><li>Has DMC truly learned the lessons of 2003 fully, or do similar problems continue?</li></ul><ul><li>Were the executives responsible for this failure held accountable in any meaningful fashion? </li></ul> Finally - and this is my major point - how many organizations in 2010 and beyond are similarly stuck in the stone age regarding how to "do health IT well"? I believe the answer is "far too many." -- SS

21st century EMR experiments: messing around with people's lives in a broke city, while not having a clue what you're doing

I was astounded to read the following passage in an interview of the current chief medical information officer at Detroit Medical Center (...

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More on Hospital Market Dominance, Enabled by Secret Pricing

This week two more articles appeared describing how large hospital systems use market dominance to charge more.  Naturally, both were in news publications, not scholarly health services research journals. San Francisco Kaiser Health News (<a href="http://www.contracostatimes.com/top-stories/ci_16357914?nclick_check=1">via the Contra Costa [CA] Times</a>) discussed hospital market dominance in the San Francisco area.  The article documented how particular systems can command higher prices. Consider the example of John Muir Health vs San Ramon Medical Center: <blockquote>Often, a hospital's dominance in an area helps determine how much it can charge, experts say. Consider John Muir Health, a two-hospital nonprofit system in the East Bay. With campuses in Concord and Walnut Creek, John Muir has the biggest footprint in the local hospital market, accounting for 54 percent of all the acute care inpatient stays in 2009, more than any other hospital group, according to state data. The hospital with the weakest market penetration is San Ramon Medical Center, a Tenet-owned, for-profit hospital, with 10 percent of the acute care inpatients. The least the insurer Aetna paid John Muir for an outpatient colonoscopy was $3,185, according to Aetna's website, which tracks two years of payments. Aetna paid $1,483 to San Ramon Regional Medical Center for the same service. The least Aetna paid John Muir for an uncomplicated birth was $7,722, while its lowest price for a birth at San Ramon was $5,278. Yet on broad quality measures, John Muir's hospitals generally score no better than San Ramon's, according to the California Hospitals and Reporting Taskforce, a nonprofit that produces hospital report cards published at Calhospitalcompare.org. San Ramon ranks equal to John Muir's Walnut Creek campus in most major measures, including mortality rates in the intensive care units, overall patient satisfaction and maternity care. John Muir's Concord campus ranks below San Ramon on several measures, including mortality rate and patient experience, though John Muir was rated better in avoiding complications for patients on ventilators. </blockquote> Then there is Sutter Health: <blockquote>[Stanford University associate vice president for Benefits Les] Schlaegel says so many employees like to see doctors at the Palo Alto Medical Foundation, a doctors' organization affiliated with Sutter with a clinic near the Stanford campus, that the university feels obliged to keep offering insurance networks that include Sutter. 'Sutter basically has a stranglehold on Northern California,' says Schlaegel. 'They are strategically situated, both for hospitals and medical groups. They know purchasers need them. When you are strategically located, you can say 'this is our price and you can pay it.'' </blockquote> Secret Pricing The ability of dominant hospitals to charge higher prices is facilitated by secrecy in which hospital pricing is cloaked <blockquote>The hospitals haven't made it easy for consumers to comparison shop. State law requires hospitals to reveal their charges for specific services. But those charges don't reflect the lower negotiated rates insurers actually pay - rates hospitals usually insist be kept secret. The California Hospital Association has opposed legislation to ban such 'gag clauses'; the most recent of these bills died in the state Assembly in August. Hospitals have also resisted a four-year campaign by the Pacific Business Group on Health, an employer coalition, and CalPERS to create a 'hospital value initiative' that would allow hospital comparison based on cost and quality of care. </blockquote> Summary <blockquote>In many cases, hospitals are able to keep raising prices beyond inflation because their sizes or reputations give them clout in negotiating rates with insurers, researchers say. Yet high prices don't always equate with superior care. Quality measures for some of the Bay Area's most prestigious hospitals, including Stanford and John Muir, show that in some instances, less expensive competitors perform as well or better in their basic responsibilities, such as avoiding infections and high death rates for patients in intensive care. 'Some hospitals are able to charge higher prices than the market normally would bear, even without providing higher quality,' says Dr. R. Adams Dudley, a professor of medicine and health policy at the University of California, San Francisco. 'That means they're getting those higher prices without really offering more to patients or the rest of society.'</blockquote>New York City Meanwhile, a long feature story <a href="http://nymag.com/news/features/68991/">in New York magazine </a>about the demise of St Vincent's hospital (see our post <a href="http://hcrenewal.blogspot.com/2010/08/st-vincents-goes-bankrupt-executives.html">here</a>) also discussed the market power of its competitors as one factor in its decline: <blockquote>The city’s largest and most powerful hospitals, which are crucial to an insurer’s customers, exert their leverage to secure deals that are believed to pay well above the average margin; smaller hospitals, which are often located in low-income neighborhoods, have little choice but to accept the dismal rates dictated by insurers if they want to remain in the insurers’ plans. 'When the big players take their cut, there are only scraps left for everyone else,' says the CEO of an outer-borough hospital. “'United HealthCare couldn’t care less about having my hospital in their network. They tell me to take it or leave it. </blockquote>Secret Prices Like in California, market dominance is enabled by secret pricing: <blockquote>the rates negotiated between hospitals and insurance providers are withheld from public scrutiny—even state health and insurance regulators are denied the information</blockquote>Free Markets? Secret prices determined by market power hardly sound like characteristics of a free market. Yet in New York, at least, they seem partially to be the result of the free market ideology of previous political leaders: <blockquote>Then George Pataki took office in 1995, determined to allow hospitals to test their mettle in the free market by negotiating their own terms with insurers. It turned out to be an exercise in shock-therapy capitalism. Inexperienced at the bargaining table, hospitals engaged in intramural rivalry with each other, cutting unfavorable deals with insurers in order to hold on to patients in the short term. With their already thin margins pared down further by deregulation, many hospitals soon built up paralyzing debt loads. Even the largest and seemingly least vulnerable facilities decided that their best hope for survival was to get bigger. A flurry of mergers and buyouts ensued, and by the end of the nineties, the hospital system began to assume its current bewildering patchwork of partnerships and affiliations. Columbia Presbyterian and New York Hospital, both attached to elite medical schools, joined forces. NYU and Mount Sinai forged a deal (it later came undone). On the eastern edge of the city, North Shore hospitals merged with nearby Long Island Jewish, staking out an enormous swath of the hospital market on Long Island, Queens, and Staten Island. Beth Israel and St. Luke’s–Roosevelt, debt-ridden and left on the sidelines by the major academic hospitals, decided to try making a go of it together. It was unclear if bigger was actually better—for patients or the bottom line—but size seemed to offer hospitals a buffer against collapse. By 2005, less than a decade into its dalliance with free enterprise, the city’s hospital system had taken on something of a post-Soviet tinge, with winners ruling the roost like oligarchs and losers reduced to a state of grim dependency. A pecking order emerged, with elite academic centers at the top, well-regarded independent hospitals like Lenox Hill in the middle, and community hospitals on the bottom. </blockquote>Summary We have previously written (for example, <a href="http://hcrenewal.blogspot.com/2010/08/more-examples-of-us-hospital-market.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/price-is-what.html">here</a>) about how increasing market dominance by large, sometimes strategically located, and sometimes politically well-connected (e.g., see <a href="http://hcrenewal.blogspot.com/2009/01/scorpions-in-bottle-shook-hands-secret.html">here</a>) hospital systems run by conflicted leaders. This seems like another unintended consequence of the "free markets solve all problems" ideology, possibly fueled by conflicts of interest that has done so badly in our financial arena (see <a href="http://hcrenewal.blogspot.com/2010/10/what-conflicted-web-we-weave-academic.html">here</a>). What some of these free market enthusiasts seem to forget, their forgetfulness perhaps fueled by payments received from the large corporations that have profited from this movement, are that true free markets are hard to maintain. This is particularly so in health care, in which knowledge is asymetric, outcomes are uncertain, and sick and anxious patients have trouble making cool, rational choices (as per Arrow, see <a href="http://hcrenewal.blogspot.com/2010/08/how-fallacy-of-perfect-health-care.html">this post</a>.) But if the free market enthusiasts really believe in free markets, why have they not been out campaigning to prevent the "unfree" characteristics, like secret pricing, of current health care markets?  Of course, ending secret pricing might compromise the ability of their financial sponsors to keep earning their millions

More on Hospital Market Dominance, Enabled by Secret Pricing

This week two more articles appeared describing how large hospital systems use market dominance to charge more. Naturally, both were in new...

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Last Week's Scandals

The march of settlements and other unfavorable legal results for health care organizations continued last week, in alphabetical order CVS Settles for $77.6 Million for Violating the Controlled Substances Act As <a href="http://www.bloomberg.com/news/2010-10-14/cvs-to-pay-77-6-million-in-methamphetamine-accord-over-sales-to-criminals.html">reported</a> by Bloomberg, <blockquote>CVS Caremark Corp. agreed to pay $77.6 million to settle claims that some of its stores in California and Nevada allowed criminals to buy cold medications that were used to make methamphetamine. The pharmacy chain will pay a $75 million fine, the largest civil penalty ever paid under the Controlled Substances Act, and forfeit $2.6 million in profits from the illegal sales, the U.S. Attorney’s Office in Los Angeles said today in a statement. Between September 2007 and November 2008, CVS failed to ensure that stores in Southern California complied with laws limiting sales of over-the-counter drugs made with pseudoephedrine, which allowed methamphetamine traffickers to buy large amounts of the drugs, according to the statement. CVS changed its sales practices only after it became aware of the investigation, prosecutors said. </blockquote> What was unusual about this case is that the company's CEO actually seemed to acknowledge that it did something wrong, and vowed change: <blockquote>'While this lapse occurred in 2007 and 2008 and has been addressed, it was an unacceptable breach of the company’s policies and was totally inconsistent with our values,' CVS Chief Executive Officer Thomas Ryan said in a statement. 'We have strengthened our internal controls and compliance measures and made substantial investments to improve our handling and monitoring of PSE.' </blockquote>Amazing, a CEO acknowledging that his corporation's values include complying with the law... [sarcasm off] Note that we most recently posted about a settlement by CVS, one by CVS Caremark for improperly charging a public entity, in September, 2010, <a href="http://hcrenewal.blogspot.com/2010/09/at-end-of-summer-everybody-well-nearly.html">here</a>. Johnson & Johnson Found Liable for $257.7 Million for Fraud As <a href="http://www.businessweek.com/news/2010-10-15/j-j-told-to-pay-257-7-million-over-risperdal-marketing-tactics.html">reported </a>by Bloomberg, <blockquote>Johnson & Johnson lost a $257.7 million jury verdict in Louisiana for making misleading claims about the safety of the company’s Risperdal antipsychotic drug. J&J officials defrauded the state’s Medicaid system by wrongfully touting Risperdal as superior to competing antipsychotic drugs and minimizing its links to diabetes, said jurors in state court in Opelousas, Louisiana.</blockquote> Specifically, <blockquote>The jury found 35,542 violations of the state’s Medical Assistance Programs Integrity Law and imposed a penalty of $7,250 for each. The total $257.7 million verdict is the fifth- largest in the U.S. so far in 2010, according to data compiled by Bloomberg. 'You can’t come into Louisiana and disseminate false and misleading information,' Patrick Morrow, who represented the state, said after the verdict in a phone interview. 'I’m sure this matter will be in the appellate courts for years to come. This is the first step.' The state’s case centered on drug safety claims that J&J and Ortho-McNeil Janssen made in November 2003 correspondence to 700,000 doctors. In those letters, J&J touted Risperdal as safer than competing antipsychotics such as Indianapolis-based Eli Lilly & Co.’s Zyprexa and London-based AstraZeneca Plc’s Seroquel. Risperdal global sales peaked at $4.5 billion in 2007, declining after the company lost patent protection. The U.S. Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to rival medicines. Lawyers for the state asked jurors to hold J&J liable for the 7,604 letters it sent to Louisiana doctors and regulators making those claims along with more than 27,542 sales calls in the state made by the drugmaker’s representatives in 2003 and 2004.</blockquote> Note that we last discussed problems at Johnson and Johnson, those being manufacturing issues leading to contaminated drugs, in September, 2010, <a href="http://hcrenewal.blogspot.com/2010/09/should-president-of-university-of.html">here</a>. Medtronic Settles for $268 Million for Personal Injuries As <a href="http://www.startribune.com/business/104968279.html">reported</a> by the Minneapolis Star Tribune, <blockquote>Medtronic Inc. has agreed to pay $268 million to settle thousands of lawsuits that patients filed after a 2007 recall of a faulty heart defibrillator wire that caused at least 13 deaths. The settlement announced Thursday covers some 8,100 personal injury lawsuits in both federal and state courts over Medtronic's popular Sprint Fidelis lead, which was implanted in some 235,000 people when the company recalled the device after a small number fractured. The malfunction could cause the defibrillator to stop working or to inappropriately shock patients -- a frightening and uncomfortable experience, but usually not life-threatening. The cases had been lingering in a kind of legal limbo that began with a 2008 U.S. Supreme Court decision involving another Medtronic case that prevented many patients with faulty medical devices from filing suit against the makers of those products. Rather than wait for a definitive resolution to various legal appeals, the Fridley-based medical technology giant agreed to end the three-year legal battle with a settlement. </blockquote> Note that we last discussed Medtronic's payments to physicians, in June, 2010, <a href="http://hcrenewal.blogspot.com/2010/06/deferred-prosecution-agreements-end-so.html">here</a>. Summary Ho-hum, another week, another set of settlements, convictions, and/or verdicts unfavorable to large, important health care organizations. Although all the actions above would result in seemingly large payments by the companies involved, all of the payments were trivial in size compared to the companies' revenues. Note that in none of the cases above did any individual pay any penalty. In only one of the cases did a corporate leader acknowledge that bad things were done, but should be done no more. As we have noted infinitum, penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  Note that each of the companies discussed above have had their previous ethical lapses discussed in previous Health Care Renewal posts. The continuing march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements</a>, and sometimes <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> convictions involving major health care organizations should be regarded merely as providing a floor to estimates of the extent of bad behavior by large health care organizations. Bad behavior may not be reported, or lead to legal action, and legal action may not lead to settlements or convictions. However, it is amazing how many organizations that were once regarded as exemplary have had to settle, or plead guilty, or been convicted. When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.

Last Week's Scandals

The march of settlements and other unfavorable legal results for health care organizations continued last week, in alphabetical order CVS Se...

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More Contaminated Heparin, But Who Leads the Company Who Supplied It?

We have posted multiple times over the last two years about the deadly contaminated heparin from China. (See the case summary and link at the end of this post.) One of the key players in this case was a company called Scientific Protein Laboratories (SPL). The company that sold the heparin in the US under its logo, Baxter International, had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from Scientific Protein Laboratories, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. Even More Contaminated Heparin? Now it looks like SPL may have sold contaminated heparin elsewhere, after the above story of the contaminated heparin sold by Baxter became public, as <a href="http://online.wsj.com/article/SB10001424052748704763904575550490003088252.html">reported</a> by Alicia Mundy in the Wall Street Journal: <blockquote>A major U.S. heparin wholesaler received a complaint from a corporate customer about a contaminated batch of blood thinner in October 2008, but didn't investigate for almost a year, according to a recent Food and Drug Administration notice to the company. Scientific Protein Laboratories LLC got the customer complaint months after the FDA announced nationwide recalls of many heparin products.</blockquote> In more detail, <blockquote>In a report last month, reviewed by The Wall Street Journal, the FDA told SPL that it 'did not adequately investigate a complaint that affected product quality.' The report said SPL didn't begin a probe of the contamination complaint until September 2009, and failed to investigate 'other lots of heparin that may have been associated with the complaint.' The FDA said Wednesday it cited SPL for 'violations of current good manufacturing practice' and is still investigating. 'FDA believes the issue does not present a significant public-health risk,' it said. An FDA spokeswoman said the batch in question never reached patients. After SPL looked into the October 2008 complaint, it found that the contaminated raw material was used in two processed batches of heparin , the FDA report said. SPL ended its review of one batch in June 2010. It didn't investigate the second, the FDA said.</blockquote> It looked like this instance of contaminated heparin did not pose a public health hazard because the company to whom it was shipped, possibly alerted by the case above, tested and rejected the SPL heparin <blockquote>SPL said Wednesday the heparin lots in question 'passed all the then-required, state-of-the-art testing' to detect contamination, however trace amounts of contaminant, oversulfated chrondroitin sulfate, were found by a customer using their own specialized testing. The company also said no adverse events were reported involving the batch in question. [Ed - apparently because the buyer realized the problem and never used the batch in its products that were provided to the public.]</blockquote> So even after the whole problem of oversulfated chrondroitin sulfate contaminated heparin had become a public scandal, the company that passed along the heparin that became subject of that scandal had "state-of-the-art testing" that could not adequately detect that specific contaminant, although the company to whom it sold the heparin apparently was able to test for it. Providing pure, unadulterated products is the most elementary responsibility of drug companies. The US Food and Drug Administration was set up mainly to ensure the purity of drugs (and only later, to ensure their effectiveness and then safety). Yet some US companies have proven unable to assure the purity of their products. (For another prominent case, go <a href="http://hcrenewal.blogspot.com/2010/09/should-president-of-university-of.html">here</a>.)  Now we have an instance in which a company still seemed unable to check their products for impurities even after they knew dangerous impurities could be present and had been present in other batches of the products they sold, and even after other companies had figured out how to perform such checks. As we have said before, seemingly infinitum, if we want a health care system that provides good quality, affordable, accessible care, we need health care leaders who put the wellbeing of patients ahead of their own pocketbooks, and to hold them accountable for doing so. Holding Leaders Accountable, If Only One Could Find Them By the way, this case further illustrates how far from that ideal we are, because it is not even obvious who the leaders of SPL who ought to be held so accountable actually are.  The <a href="http://www.spl-pharma.com/index.htm">SPL web-site</a> says nothing about corporate governance or leadership.  After some Google searching, it turns out that the reason for this is that SPL was<a href="http://ir.americancapital.com/phoenix.zhtml?c=109982&p=irol-newsArticle&ID=1320964&highlight="> bought out</a> by private equity firm American Capital Strategies Ltd in 2006, two years before the contaminated heparin scandal became manifest.  Although American Capital Strategies Ltd is publicly traded, its <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMTE5MzEyNS0xMC0xODEwMjMvZG9jL0FtZXJpY2FuQ2FwaXRhbExURF9ERUYxNEFfMjAxMDA4MDYucGRmJnR5cGU9MiZmbj1BbWVyaWNhbkNhcGl0YWxMVERfREVGMTRBXzIwMTAwODA2LnBkZg==">2010 proxy statement</a> and most recent publicly available <a href="http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MzQ2ODEwfENoaWxkSUQ9MzM0ODYzfFR5cGU9MQ==&t=1">annual report</a> (of 2008) say almost nothing about SPL.  Private equity firms are known for acquiring troubled companies and trying to turn quick profits from them, often from stringent cost-cutting and selling off assets.  They are not particularly known for their devotion to better patient care.  None of the top executives and directors of American Capital Strategies Ltd seem to have health care backgrounds or experience or any other reason to sympathize with the core values of health care professionals. Further Google searching did suggest that the CEO of SPL is one <a href="http://www.linkedin.com/pub/david-strunce/12/366/707">David G Strunce</a>, but revealed little biographical information about him.  How he and other executives of that company might better be held accountable is not obvious. So what will it take to get the leaders of pharmaceutical companies to take their responsibility to provide pure, unadulterated drugs more seriously? How will society be able to better hold those leaders accountable?  How can we get leaders of health care to put the health of the people ahead of their own financial returns?  The case of the adulterated heparin suggests these questions will not be easily answered. Case Summary In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product. (For a more detailed summary of the case, look <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.)

More Contaminated Heparin, But Who Leads the Company Who Supplied It?

We have posted multiple times over the last two years about the deadly contaminated heparin from China. (See the case summary and link at th...

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Dr Coca-Cola, Meet Dr Butterfinger

First, it was the American Academy of Family Practice accepting money from Coca-Cola to support educational programs to foster a "healthy lifestyle," (see our post <a href="http://hcrenewal.blogspot.com/2009/11/paging-and-paying-dr-coca-cola.html">here</a>, and the <a href="http://brodyhooked.blogspot.com/2010/07/more-on-aafp-coca-cola-controversy.html">post</a> by Dr Howard Brody here that also linked to his article in Annals of Family Medicine.) Now, it is the American Academy of Pediatrics accepting money from Nestle, specifically, the NestleNutrition Institute, to support "obesity prevention and care."  The AAP news release (<a href="http://www.aap.org/obesity/HALF.html">here</a>) said:  <blockquote>HEALTHY ACTIVE LIVING FOR FAMILIES (HALF): RIGHT FROM THE START is a program of the American Academy of Pediatrics (AAP). It is sponsored through the generous support of the Nestlé Nutrition Institute (NNI). The goal of the HALF project is to develop and test a series of positive, family-focused messages specific to obesity prevention and care for the following developmental stages: infancy, toddlerhood, and early childhood/preschoolers, which can be used at pediatric well-child visits. These messages and materials will be unique from those already in existence because they will be crafted using the medical home framework, a developmental approach to children’s care, and parent-tested. </blockquote> Nestle, of course, is the manufacturer of all sorts of delicious, gooey chocolate candies.  (Full disclosure: I have been known to eat Nestle chocolate products.) So far, this notable collaboration has drawn some criticism in the blogsphere, e.g., <a href="http://bfmed.wordpress.com/2010/10/07/nestle-aap-partnership-half-baked">in the Breastfeeding Medicine blog</a>, by DrAlison Stuebe: <blockquote>The AAP should not be taking money for an anti-obesity project from an institute whose parent company sells candy and ice cream — and hawks flawed advice designed to undermine breastfeeding mothers. If the AAP is really 'dedicated to the health of all children,' they should send that check back to Nestle and start over. American families deserve nothing less.</blockquote> Also, consumer advocates have come out against this dubious alliance, as mentioned <a href="http://www.walletpop.com/blog/2010/10/12/critics-nestle-american-academy-of-pediatrics-alliance-a-confl">in the WalletPop blog</a>. So far, I have seen nothing in the main-stream media about this.  Clearly, this raises the same sorts of issues that the alliance between the AAFP and Coca-Cola raised.  In summary, pediatricians are trusted by parents to give advice not just about drugs, vaccines, and surgery, but about diet, exercise, life-style, etc.  Having the most respected pediatric professional society hawking a diet and life-style program paid for by a chocolate manufacturer risks biasing the advice that its members give, and threatening the trust parents and children have in their pediatricians.  The AAP has been previously criticized for providing guidelines advocating extremely aggressive drug treatment for childhood hyperlipidemia amid questions about whether support from the pharmaceutical industry, including "$433,000 from Merck, $835,250 from Abbott Laboratories’ Ross Product Division and $216,000 from the Bristol-Myers Squibb company Mead Johnson Nutritionals," biased these guidelines. (Amounts were from 2007, <a href="http://www.nytimes.com/2008/07/13/weekinreview/13parker.html">per the New York Times</a>)  Once a medical society becomes accustomed to living off corporate largess, it may not be a big leap to add funding from Nestle to that from drug companies.  I respectfully submit that professional organizations which wish to be seen as upholding physicians' professionalism should not be taking money from corporations that may see physicians' advice and prescriptions as means to market their products.  Professional organizations that do take such money risk being viewed more as arms of corporate marketing than as upholders of physicians' ideals.  (And the medical home they advocate may be seen as a <a href="http://www.nestle.com/MediaCenter/MediaLibrary/VideoResources/Detail.htm?Ctx=Vcd3kcka%2BO0UuPEAROaFwPRyBhnLIshn7iP75hLIpod7KH0jUY0%2FVc%2BcZvrM36JZN6CDTQldJe7UeVXnVzJWSg%3D%3D&Itm=B4304A8C-9D05-450C-A3C8-DF29C88011B3">house made of chocolate</a>.)

Dr Coca-Cola, Meet Dr Butterfinger

First, it was the American Academy of Family Practice accepting money from Coca-Cola to support educational programs to foster a "healt...

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Synthes and its Subsidiary Plead Guilty, Boss Remains Billionaire.

In December, 2009, we <a href="http://hcrenewal.blogspot.com/2009/12/person-no-7-also-known-as-83rd-richest.html">updated</a> the story of Swiss-based medical device company Synthes and the marketing by its Norian division of a bone cement.  At that time, US authorities charged the company with use of an unapproved product in about 200 patients, three of whom suffered untimely deaths.  At that point, four US based Synthes executives had pleaded guilty to charges related to this affair.  Last week, another shoe dropped.  As <a href="http://www.google.com/hostednews/ap/article/ALeqM5gIXyxNWxFR-4GgLo4_YeIXy2A0ngD9IL4UN02?docId=D9IL4UN02">reported</a> by the Associated Press, <blockquote>A medical devices company will admit criminality and pay the maximum $23 million fine for illegally testing bone cement on about 200 spinal patients, three of whom died in surgery, U.S. prosecutors said Monday. Norian Corp. trained surgeons to conduct unapproved clinical tests of its bone cement from 2002 to 2004, subverting U.S. Food and Drug Administration safeguards, prosecutors said. The trials were stopped after the third patient death, they said. The cement, which is used to fill in bone defects, is approved for use in the arm but not the load-bearing spine, authorities said. The surgeries often involved older patients with compression fractures, they said.</blockquote> The results are: <blockquote>Norian will plead guilty to conspiracy to impede FDA functions, a felony, and 110 misdemeanor counts of interstate shipping of misbranded Norian XR. Synthes will plead guilty to the same misdemeanor shipping count. As part of the agreement, Norian will be sold to an outside buyer, the parent company said.</blockquote> Imposing divestiture of the offending subsidiary was unusual, <a href="http://www.philly.com/inquirer/business/20101005_Manufacturer_pleads_guilty_to_improper_use_of_bone_cement.html">according to the Philadelphia Inquirer</a>: <blockquote>Forcing a divestiture of a business unit in a plea agreement was precedent-setting for the U.S. Attorney General's Office in the Philadelphia area, spokeswoman Patricia Hartman said Monday. Officials with the Office of the Inspector General in DHHS said the divestiture should send a message to other health-care companies that Synthes' behavior had grave consequences. 'Criminal conduct can result in a company getting rid of part of their business,' Greg Demske, a top official with the Inspector General, said Monday. 'This is an egregious case, and it made us firm in our belief that we should draw a line here,' he said. If it remained a subsidiary of Synthes, Norian would be excluded from participating in Medicare and other government-funded health care programs, which would be potentially devastating to its business. According to a divestiture agreement released Monday by the U.S. Attorney in Philadelphia, Synthes has to sell Norian by May 24. The assets of Norian would not be allowed to be transferred to another part of the Synthes 'corporate family' as part of the divestiture, Demske said. Synthes will update the government monthly on its plans to divest Norian, and if it fails to sell the company by the May deadline, it can be fined $10,000 a day.</blockquote> So does this case signal a new toughness by US authorities in cases of bad behavior by health care corporations? <a href="http://online.wsj.com/article/SB10001424052748704631504575532400696935326.html">According to the Wall Street Journal</a>, Synthes officials were not exactly quaking in their boots because of these penalties, as their spokesperson said Synthes "does not expect this settlement to have any significant financial impact." Synthes would only be liable for fines of "about $24.3 million in total." That pales in comparison to the "company['s] posted total sales of $3.4 billion last year." As for the divestiture of Norian, the WSJ reported, "a spokesman said Monday that the Norian unit is mostly active in product development and isn't actively selling products. That business has fewer than 100 employees,...." In fact, company leadership did not seem to realize that they did anything wrong, despite the company and four executives pleading guilty to crimes, actions involving the death of three patients, <blockquote>'Synthes remains committed to operating in accordance with the highest legal and ethical standards, and bringing closure to this matter will permit the company to focus on its mission to improve patient care,' the company said. </blockquote>Furthermore, while this is one of the few cases in which some company executives actually may have to pay penalties (after pleading guilty to at least misdemeanors), the big fish appeared to get away. As we discussed last year, an unindicted "person no. 7" was alleged to have set up the scheme to "test" the bone cement in a clinical series. Person No. 7 was at that time identified as the company CEO. That CEO, according to the Philadelphia Inquirer last year, was one Mr Hansjorg Wyss, noted to have a fortune estimated at $5.7 billion, making him the richest man in Philadelphia, and the 83rd richest man in the world, according to Forbes magazine.  (See <a href="http://hcrenewal.blogspot.com/2009/12/person-no-7-also-known-as-83rd-richest.html">this post</a>.)   The settlement of this case would apparently have no impact on his immense wealth. So although this case has some unusual wrinkles, and may yet yield some negative consequences for some of the people involved in the direction and implementation of the wrong-doing, it would appear to leave unscathed the person who has personally profited the most from the company, and its actions, including its less savory actions.  There is progress here, but only a little. Once again, it appears that in the eyes of the law, top corporate leaders are different from you and me.  They appear immune from the penalties that lesser individuals may suffer.  They have impunity to continue to amass wealth even wealth that results from actions that were deemed illegal.   Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Synthes and its Subsidiary Plead Guilty, Boss Remains Billionaire.

In December, 2009, we updated the story of Swiss-based medical device company Synthes and the marketing by its Norian division of a bone ce...

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Another Wheel Already Invented (in 1988) - the WHO Ethical Criteria for Medicinal Drug Promotion

At the 2010 Gezonde Scepsis (Healthy Skepticism) "Selling Sickness" conference, I was made aware of another wheel invented a long time ago, the <a href="http://apps.who.int/medicinedocs/en/d/Jwhozip08e/">1988 WHO Ethical Criteria for Medicinal Drug Promotion</a>, a document about which few now seem to be aware.  Were this code to have been widely followed, it might have prevented some of the problems afflicting the pharmaceutical industry today. Some relevant quotes follow: Drug Promotion <blockquote>6. In this context, 'promotion' refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. 7. Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word 'safe' should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature. 8. Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs. 9. Scientific and educational activities should not be deliberately used for promotional purposes.</blockquote> Note that these provisions would seem to prohibit promotional efforts begun before a drug is legally approved (e.g., <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writing</a> as in <a href="http://hcrenewal.blogspot.com/2005/04/ghosts-busted.html">this case</a>), the use of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">"key opinion leaders"</a> without full disclosure of their role as marketers of drugs, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of clinical research</a> sponsored by pharmaceutical companies whose results did not support these companies' marketing interests, e.g. studies which failed to show efficacy of their products, nearly all kinds of payments to physicians, and nearly all pharmaceutical sponsored <a href="http://hcrenewal.blogspot.com/search/label/continuing%20medical%20education">continuing medical education</a>. Medical Representatives <blockquote>17. Medical representatives should have an appropriate educational background. They should be adequately trained. They should possess sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers are responsible for the basic and continuing training of their representatives. Such training should include instruction regarding appropriate ethical conduct taking into consideration the WHO criteria. In this context, exposure of medical representatives and trainees to feed-back from the medical and allied professions and from independent members of the public, particularly regarding risks, can be salutary. 18. Medical representatives should make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data sheet or other source of information with similar content. 19. Employers should be responsible for the statements and activities of their medical representatives. Medical representatives should not offer inducements to prescribers and dispensers. Prescribers and dispensers should not solicit such inducements. In order to avoid over-promotion, the main part of the remuneration of medical representatives should not be directly related to the volume of sales they generate.</blockquote> Note that these provisions appear to prohibit the current cheer leader/ ex-athlete model of the drug representative, and to prohibit many of the current activities of such representative, including providing gifts, meals, travel to meetings, honoraria, etc  (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/03/what-drug-reps-really-care-about.html">here</a> and <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a>). If only these standards had gotten some traction, think of the trouble that could have been averted.  On the other hand, it is obvious that such traction would have threatened some peoples' lucrative incomes and power, who may have worked hard to make sure it did not happen.

Another Wheel Already Invented (in 1988) - the WHO Ethical Criteria for Medicinal Drug Promotion

At the 2010 Gezonde Scepsis (Healthy Skepticism) "Selling Sickness" conference, I was made aware of another wheel invented a long ...

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