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In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (<a href="https://www.ecri.org/About/Pages/default.aspx">https://www.ecri.org/About/Pages/default.aspx</a>) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports. Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at <a href="https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf">https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf</a>. Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>). From the new report: CONCERN #1: Data integrity failures with health information technology systems <div>At page 7:</div><div> <div style="font-family: serif; margin-left: 40px;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.</div> <div style="font-family: serif; margin-left: 40px;">For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:</div><div dir="ltr" style="font-family: serif; font-size: 16.6667px;"> <div style="font-family: serif; margin-left: 40px;"> </div><div style="font-family: serif; margin-left: 40px;">x  Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff  x  Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended x  Providing sufficient user training and support x  Establishing a mechanism for users to report problems as they are discovered </div></div></div>In the Bizarro world in which we find ourselves in 2014, however: <ul><li>FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).  </li></ul>(Got that?) While: <ul><li>Regulation of E-cigarettes is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (<a href="http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html">http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html</a>).</li></ul>The E-cigarette focus is For The Children, no doubt. <ul><li>Except for children such as these, one might conclude:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>.</li></ul> <ul> </ul> <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/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Bizarro World (<a href="http://en.wikipedia.org/wiki/Bizarro_World">http://en.wikipedia.org/wiki/Bizarro_World</a>).</td></tr></tbody></table> Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems. CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8): <blockquote>... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.</blockquote><ul></ul> CONCERN #3: Test Results Reporting Errors (page 10): <blockquote class="tr_bq">... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice. As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”</blockquote> I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results. -- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania ( https://www.ecri.org/About/Pages/default.aspx ) has had health IT as among the "Top Ten Healthcare...

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Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" (<a href="http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html">http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html</a>) I noted that the American Association of Physicians and Surgeons (AAPS) had received a reply from CMS to a FOIA request that: <blockquote class="tr_bq">"We [CMS] do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives." </blockquote> Put another way, the country is embarking on a $1 trillion healthcare experiment, and blindly. I mentioned I'd post the letter when received from AAPS.  That just occurred. The letter is below (click to enlarge): <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/AVvXsEhXyGzY3biU0IcibR_jpNBb18X__sIeFWVd7E3T1MoAa300RBg2N_3-t_UMmx2bhlwk3KnobEgycCWCVmwWTy13uQVLGi3VBPFpgdzCHBu_0Qq5-fDamfZIWx-WeLaeYztcEayTGeCU7JIC/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXyGzY3biU0IcibR_jpNBb18X__sIeFWVd7E3T1MoAa300RBg2N_3-t_UMmx2bhlwk3KnobEgycCWCVmwWTy13uQVLGi3VBPFpgdzCHBu_0Qq5-fDamfZIWx-WeLaeYztcEayTGeCU7JIC/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge. </td></tr></tbody></table> I've added it as an addendum to the original post, but thought it worthwhile to call out the letter in a post of its own to those who might not revisit the original. An additional thought: While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they do have (or should have made it their business to have) information that EHRs cause harm and take lives (e.g., via FDA at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a> , ECRI at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> and others). -- SS

Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post " CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save ...

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Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>) as follows: <blockquote class="tr_bq">Bad Health IT ("BHIT") is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, 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. </blockquote> Health IT is unregulated, and Bad Health IT results in patient injuries and deaths.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown. At my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems: To recap that post: Out of one side of their mouth FDA wrote this: <blockquote class="tr_bq">... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software. Products with health management health IT functions are of sufficiently low risk and thus, [even] if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</blockquote> While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this: <div style="margin-left: 40px;">...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.   </div>FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>). Note that everyone who needs medical care (which is. essentially, everyone) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are those who willingly buy and consume them. With E-cigarettes, however:  <blockquote class="tr_bq">CBS/AP  April 24, 2014  FDA: Ban sales of electronic cigarettes to minors  <a href="http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/">http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/</a> WASHINGTON -- The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration. </blockquote> Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.) <blockquote class="tr_bq"> While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry. The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards. Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.</blockquote><div dir="LTR" id="article-entry"> (Perhaps the E-cigarette industry hasn't figured out who to pay off yet?) <blockquote class="tr_bq">... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News. "At the present time, when we can't regulate cigarettes, it's like they wild, wild West" she said. "Companies can do anything they want. They can market in ways that they want. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."</blockquote> The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some 'Words that Work?'  (<a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a>) <blockquote>Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. So we see this as really a crucial first step."</blockquote> The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine. <blockquote class="tr_bq">Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.</blockquote> It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See FDA Internal Memo on HIT risk at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>). <blockquote class="tr_bq">... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.</blockquote></div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">E-cigarettes, however, are a major concern that are being reviewed in earnest?</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">Unbelievable.</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">-- SS DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.</div>

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site ( http://cci.drexel.edu/faculty/ssilverstein/cases/ ) as follows: Bad Healt...

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Innumeracy at the Centers for Medicare & Medicaid Services (CMS)

<div class="MsoNormal">A physician participant in an American Medical Informatics Association listserv I subscribe to had some time ago commented that the CMS, in their requirement that physicians meet certain percentages on measures regarding adherence to the "Meaningful Use" incentive program for EHRs, were calculating those percentages incorrectly.</div><div class="MsoNormal"> </div><div class="MsoNormal">He followed up with an actual response from CMS, and has given me permission to repost.  I am redacting his name:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">... I have posted previously that the CMS calculator found at <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=mnsZV_x_TUmIjS3hVz8N2LbSo8knNNEIzqgX1E2MFvWksVZnCP86blNjPEz3cFW5L-p0fS64-Xw.&URL=http%3a%2f%2fwww.cms.gov%2fRegulations-and-Guidance%2fLegislation%2fEHRIncentivePrograms%2fStage_2.html" target="_blank">http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Stage_2.html</a> appears to calculate improperly.  Last night I received a response from CMS regarding my concern:</div><div class="MsoNormal"> </div><div class="MsoNormal" style="margin-left: .5in;">“Dear Mr. (sic) [name redacted],</div><div class="MsoNormal" style="margin-left: .5in;"> </div><div class="MsoNormal" style="margin-left: .5in;">Thank you for your recent inquiry. Below is the information you requested about the attestation calculator.</div><div class="MsoNormal" style="margin-left: .5in;"> </div><div class="MsoNormal" style="margin-left: .5in;">As adopted by CMS, measures generally require that providers achieve "more than" a specific percentage. The language in these measures is clear; "more than 50 percent" would equate to 51 percent or more. This has consistently been the policy from the beginning of the program.</div><div class="MsoNormal" style="margin-left: .5in;"> </div><div class="MsoNormal" style="margin-left: .5in;">The attestation calculator now rounds fractions of a percent to the closest whole number. This correctly identifies when the required performance level is reached.</div><div class="MsoNormal" style="margin-left: .5in;"> </div><div class="MsoNormal" style="margin-left: .5in;">The tracking number for this inquiry is 2014-XXXXX. . . . “</div><div class="MsoNormal"> </div><div class="MsoNormal"> </div><div class="MsoNormal">My examples included a numerator of 549 with a denominator of 10,000 for a metric that required “greater than 5%”.  These are screen shots of the submission:</div></blockquote> <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz4oQ46S84r4Sngb24v9Pa9ZGQwMsdKclLNIrq5OxygKMLJGGKhi8FHYQyCVhakiWWGKCj_wYEPDAVkgBA_La0WQxm0UiKpVx9XWgp61BWs_Ot8HivmbQJu11s0bx0yLQlxc0ty6HrHVbX/s1600/calc.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="335" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz4oQ46S84r4Sngb24v9Pa9ZGQwMsdKclLNIrq5OxygKMLJGGKhi8FHYQyCVhakiWWGKCj_wYEPDAVkgBA_La0WQxm0UiKpVx9XWgp61BWs_Ot8HivmbQJu11s0bx0yLQlxc0ty6HrHVbX/s1600/calc.jpg" width="400" /></a></div> <blockquote class="tr_bq"><div class="MsoNormal"></div><div class="MsoNormal" style="margin-left: .5in;"></div><div class="MsoNormal"> </div><div class="MsoNormal">Note that the calculator appears to use 3 significant figures, but in fact rejects the calculation by rounding to only 1 significant figure.  </div><div class="MsoNormal"> </div><div class="MsoNormal">Years ago at a CMS conference I remember the speaker remarking that physicians and hospitals only had to enter the numbers “and we could agree on the arithmetic.”  I learned in fourth grade how to round numbers, and how to count significant digits.  I do not agree with their arithmetic, nor do I accept their determination that “more than 50 percent" would equate to 51 percent or more”.  Granted, one hopes that those attempting to attest will not have numbers that skim so closely to the metric limit, but it could happen.</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">I note in the reply from CMS this statement:</div><blockquote class="tr_bq"><div class="MsoNormal"> </div>"The language in these measures is clear; 'more than 50 percent' would equate to 51 percent or more."</blockquote> I emphasize:    THE - LANGUAGE - IN - THESE - MEASURES - IS - CLEAR. Here are  actual instructions for, say, CPOE measurement on medication ordering (<a href="http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/Stage2_EPCore_1_CPOE_MedicationOrders.pdf">http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/Stage2_EPCore_1_CPOE_MedicationOrders.pdf</a>): <blockquote class="tr_bq">Attestation Requirements DENOMINATOR/NUMERATOR/THRESHOLD/EXCLUSION Measure 1: Medication DENOMINATOR: Number of medication orders created by the EP during the EHR reporting period. NUMERATOR: The number of orders in the denominator recorded using CPOE. THRESHOLD: The resulting percentage must be more than 60 percent in order for an EP to meet this measure. EXCLUSION: Any EP who writes fewer than 100 medication orders during the HER (sic) reporting period. </blockquote> Now, I had a perfect "800" in math on my SAT test in 1974, so (while probably excluding me from some employment in today's culture of stupid due to having "too much experience"), I do believe I am perfectly well qualified to determine that "more than 60 percent" would mean, anything more than 60.0, such as, say, 60.1%. Let's consider possible explanations. Possibility (1) Perhaps CMS is performing their calculations with an old Pentium-1 computer whose CPU has the FDIV bug causing math errors (<a href="http://en.wikipedia.org/wiki/Pentium_FDIV_bug">http://en.wikipedia.org/wiki/Pentium_FDIV_bug</a>)? On second thought: I don't think that is a good explanation. Possibility (2) Perhaps I have become demented from too much exposure to the numeracy-challenged since 1974? An experiment is in order: In 1969, we landed men on the Moon.  It took a lot of math to perform that feat, and miscalculation would have led to disaster, for example on the 25,000-MPH re-entry into Earth's atmosphere at precisely the correct angle required to avoid burn up, or skipping off the atmosphere like a stone off a pond, back out into space to be lost forever. I learned computing about that time on a Digital Equipment Corporation PDP-8/S, a computer from that era (<a href="http://cci.drexel.edu/faculty/ssilverstein/medinformatic1/gw-pdp8s.htm">http://cci.drexel.edu/faculty/ssilverstein/medinformatic1/gw-pdp8s.htm</a>). I wrote and ran a small program on a PDP-8 emulator WinEight (available free at <a href="http://www.sparetimegizmos.com/Software/WinEight.htm">http://www.sparetimegizmos.com/Software/WinEight.htm</a>) that perfectly emulates the old PDP-8.  Here is the program in the programming language FOCAL, 1969 version: <blockquote class="tr_bq">CONGRATULATIONS!! YOU HAVE SUCCESSFULLY LOADED 'FOCAL,1969' ON A PDP-8 COMPUTER. SHALL I RETAIN LOG, EXP, ATN ?:YES PROCEED. *1.1 SET P=(601/1000)*100 *1.2 IF (P-60) 1.3, 1.4, 1.5 *1.3 TYPE "P IS LESS THAN 60%";G 1.6 *1.4 TYPE "P EQUALS 60%";G 1.6 *1.5 TYPE "P IS MORE THAN 60%" *1.6 TYPE !;QUIT</blockquote> The program sets variable "P" to 601/1000, then multiplies by 100 to derive a percent.  It then compares the result stored in "P" to 60, and branches to the correct statement regarding the relation of P to 60%.  Let's run the program: <blockquote class="tr_bq">* *GO P IS MORE THAN 60% *</blockquote> Good news. I guess I am not demented after all. Possibility (3) Someone (or a group of people) at CMS doesn't or don't realize that in large datasets, percentages are often not integer whole numbers. Possibility #3 can be illustrated best by a cartoon: <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/AVvXsEiCRwf49Ok93IT5g9puPUujkyj3ul4BmKe8A8RqrIo0xa-IaaqSuPQaQrL1HN0B62MUgOK7Lcam4QlpMYcJK7erGTMTlgEUngVZ2fkD5omr5yNOIa8vwH_dDUQNEFcdUckR1lsJtHNkEyXH/s1600/dunce.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiCRwf49Ok93IT5g9puPUujkyj3ul4BmKe8A8RqrIo0xa-IaaqSuPQaQrL1HN0B62MUgOK7Lcam4QlpMYcJK7erGTMTlgEUngVZ2fkD5omr5yNOIa8vwH_dDUQNEFcdUckR1lsJtHNkEyXH/s1600/dunce.jpg" width="133" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge.  1+3 = 13, right?</td></tr></tbody></table> Or perhaps this: <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/AVvXsEiUDXpKjjMtOtSTY_6Jibyh2Cf2AQJvS5BhjbKbKf43JslhQ3Ly9hKSQNypPSiY2v7EsycBsKEoCNGL3uf8ankUN8BXdRawaP6xZDCyqbNCramZgQkeYYs72OwJQ806XeQiW_JZkQBofhv8/s1600/Butterfinger-math.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="152" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUDXpKjjMtOtSTY_6Jibyh2Cf2AQJvS5BhjbKbKf43JslhQ3Ly9hKSQNypPSiY2v7EsycBsKEoCNGL3uf8ankUN8BXdRawaP6xZDCyqbNCramZgQkeYYs72OwJQ806XeQiW_JZkQBofhv8/s1600/Butterfinger-math.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Math for Underachievers.  Click to enlarge.</td></tr></tbody></table> I leave it to the reader to determine which of the three possibilities is the explanation for the assertion by CMS that "The language in these measures is clear; 'more than 50 percent' would equate to 51 percent or more." Note: this post was meant as satire and humor and irony, but innumeracy in our healthcare regulators is anything but funny. -- SS

Innumeracy at the Centers for Medicare & Medicaid Services (CMS)

A physician participant in an American Medical Informatics Association listserv I subscribe to had some time ago commented that the CMS, in ...

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American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed</a> the American Board of Internal Medicine's exceedingly weak conflict of interest policy.  This came to light after the board's previous president was revealed to have simultaneously served for years on the board of directors of a privately held for-profit hospital purchasing organization. The susceptibility of ABIM leadership to conflicts of interest is particularly important because the board, in its role as the de facto sole source of credentialing for all US internists and internal medicine sub-specialists, sets what these physicians need to know to pass the certifying examinations. Conflicts of interest raise doubts about whether the examinations may be used to further commercial agendas and similar vested interests. Furthermore, the ABIM has been willfully expanding its scope into "maintenance of certification," that is, into requiring physicians to engage in ABIM educational and evaluation activities to maintain their previously obtained certification.  They have been criticized in particular (e.g., <a href="http://www.medscape.com/viewarticle/822914">here</a> and <a href="http://drwes.blogspot.com/2014/03/is-maintenance-of-certification-our.html">here</a>) for pursuing maintenance of certification in the absence of clear evidence that it improves physician performance or patients' outcomes.  Conflicts of interest affecting MOC raise further doubts that this "innovation" may also be about furthering commercial interests. ABIM Begins Conflict of Interest Disclosure Now it appears that the ABIM is beginning to disclose more about its leadership's conflicts of interest.  One of our scouts notified me that the ABIM web-site now provides disclosures for the members of its <a href="http://www.abim.org/about/governance/board-of-directors.aspx">board of directors and officer,</a> <a href="http://www.abim.org/about/governance/abim-council.aspx">council,</a> and <a href="http://www.abim.org/about/executives.aspx">executives</a>. There seem to be limits to these disclosures.  As far as I can tell,They do not reflect a change in the preexisting ABIM <a href="http://www.abim.org/conflict-of-interest-policies.aspx">conflict of interest policy</a>, which still calls for conflicts to be disclosed, but only to ABIM leadership, while they are otherwise kept confidential.  Nor were these disclosures accompanied by any further explanation that I can find.  The disclosures include multiple categories, consulting relationships, peer educational activities, promotional activities, grants, intellectual property, stock/option, gift/ donations, expert witness, leadership in professional organizations, and other, which are not otherwise defined.  It was not clear, however, whether the disclosures covered services on corporate advisory boards or boards of directors, or service as executives or founders of companies.  The time course of the disclosed relationships were not clear.  Finally, ttere are no disclosures about members of <a href="http://www.abim.org/about/examInfo/committee.aspx">exam writing committees of sub-specialty board members</a> Nonetheless, the disclosures do give an idea of the scope of conflicts of interest affecting ABIM leadership.  Because the disclosures have not otherwise been publicized, I thought it would be worthwhile to summarize them here. Prevalence of Conflicts Of the 12 officers and directors, 8 disclosed relationships with for-profit health care corporations Of the 15 council members (one of whom is also a director), 9 revealed conflicts. Of the 12 executives, 5 revealed conflicts. Thus, a majority of ABIM physician leadership, and nearly a majority of  ABIM executives disclosed conflicts of interest. Nature of Conflicts The conflicts were predominantly consulting relationships, grants, holdings of patents, or of stocks or options.  The conflicts of the officers, directors and council members primarily involved pharmaceutical, biotechnology and device companies.  Several officers, directors and council members had two kinds of relationships with the same company, for example, consulting relationships and grant funding. It was striking that 15 companies had multiple relationships with officers, directors and council members.  All were large pharmaceutical, biotechnology, and device companies.  They were AbbVie (1 consulting relationship 2 grants) Amgen (1 consulting, 1 grant, 2 stock holdings) AstraZeneca (3 consulting, 1 grant) Bristol-Myers-Squibb (2 consutling, 2 grants, 1 stocks) Celgene (2 consulting, 1 grant) Gilead (1 consulting, 2 grants, 1 stocks) Johnson and Johnson (1 consulting, 2 grants [one through Janssen], 2 stocks) Eli Lilly (1 consulting, 1 grant) Medtronic (2 consulting, 1 grant) Merck (2 consulting, 2 stocks) Novartis (2 grants, 1 stocks) Pfizer (1 consulting, 1 grant, 2 stocks) Roche (1 consulting, 2 stocks) Teva (1 consulting, 1 stocks) Millennium (1 consulting, 1 grant) The officers, directors, and council members additionally had relationships with a vast number of companies, including in attempted alphabetical order: Abbott Laboratories, Agios, Allos, AllScripts, Arrowhead, Biocontrol Medical, Cephalon, Cephied, CorAssist, Cornovus, CVRx, Covidien, Dr Redy's Labs, Emergent Biosolutions, Express Scripts, Genentech, Gen-Probe, Hologic, Human Genome Sciences, Incyte,  ION(?), miRNA Therapeutics, Peluton Therapeutics, Pharmacyclics, Regeneron, Repros Therapeutics, Research to Practice (owned by AmerisourceBergen) Prime Healthcare, Rigel, Seattle Genetics, Sunesis, TG Therapeutics, UnitedHealthcare, Value Capture, Viamet, Ventrigen, Vertex, XCenda,  and ZS Pharma. Thus, the conflicts of interest were extensive, and involved major health care corporations. Summary The American Board of Internal Medicine is to be congratulated for taking steps towards more transparency and honesty about conflicts of interest affecting its leadership.  However, the steps were baby steps.  Lacking still are definitions and time courses of the relationships disclosed, assurances of the completeness of disclosure of all relevant relationships, assurances that disclosure is now the policy going forward, and disclosures for members of committees and sub-specialty boards who are also very influential in constructing examinations and maintenance of certification activities.  These ought to be addressed. The disclosures reveal that the conflicts of ABIM leadership were extensive.  While disclosure is good, disclosure does not assure physicians and the public that certification and now maintenance of certification are not influenced by marketing needs and other commercial interests.  In my humble opinion, the ABIM now ought to phase out, as quickly as possible conflicts of interest affecting those who make its policy, write its exams, and conduct its other activities that can influence physician behavior, decisions made for patients, and health policy.  Also, in my humble opinion, the ABIM ought to suspend its efforts to promote maintenance of certification until it has greatly reduced the conflicts of interest that may affect this effort.

American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently discussed the American Board of Internal Medicine's exceedingly weak conflict of interest policy. This came to light after...

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A Tangled Web of Perversity by a Healthcare Company Owner - Subpoenaing Emails of Law Student Critics at NYU Law School, Where He is a Trustee

At Healthcare Renewal, we are largely calling for removal from healthcare of perverse managers and perverse management practices.  One of those practices is the attempted silencing of critics. I have first hand experience with a perverse but unsuccessful attempt myself, where the apparently (and IMO, and as protected by the 1st Amendent) megalomaniacal management of a once-reasonable hospital (I did my residency there 1985-7) sought to abridge my 1st Amendment rights regarding care of my late mother.  See my August 11, 2013 post "Who Would Have Thought, Comrades, That The Most Severe Form of Attempted Internet Censorship Could Originate in a Community Hospital, Abington Memorial, That Alleges Itself A Non-Profit Public Servant?" at <a href="http://hcrenewal.blogspot.com/2013/08/who-would-have-thought-comrades-that.html">http://hcrenewal.blogspot.com/2013/08/who-would-have-thought-comrades-that.html</a>. This recent story, however, is simply stunning in the audacity of its principal regarding "shutting up" critics, this time two law students at a law school of which he is a Trustee: <blockquote class="tr_bq">Law School Trustee's Company Chills Critical Speech With Subpoena For Students' Personal Emails <div class="storydate">Mon, Apr 21st 2014 1:14pm</div><div class="storydate"><a href="http://www.techdirt.com/articles/20140418/18013426963/law-school-trustees-company-chills-critical-speech-with-subpoena-students-personal-emails.shtml">http://www.techdirt.com/articles/20140418/18013426963/law-school-trustees-company-chills-critical-speech-with-subpoena-students-personal-emails.shtml</a> </div> <style type="text/css">P { margin-bottom: 0.08in; }A:link </style>A New York University trustee has found a way to chill speech critical of him and the [healthcare] companies he owns: <a href="http://www.dnainfo.com/new-york/20140417/greenwich-village/judge-orders-law-students-give-up-emails-after-criticizing-nyu-trustee" target="_blank">subpoena the personal emails of two particularly outspoken opponents</a>. <blockquote>A New York University Law trustee's company wants two students to hand over their personal emails after they circulated a letter criticizing him, according to a subpoena. The law students, second-year Luke Herrine and first-year Leo Gertner, were targeted after they helped circulate a letter denouncing NYU Law School trustee Daniel Straus, who owns Care One Management, a home health aide and nursing home company embroiled in a labor dispute.</blockquote></blockquote><blockquote>The two students <a href="https://docs.google.com/forms/d/1X8Zb-03UyyAZi4CNz8LWRN4KHRhHraOO30WO310_Wfo/viewform" target="_blank">started a petition asking for the removal of Straus</a> from the Board of Trustees, pointing out that a law school should probably be associated with someone who respects the law, something Straus' companies seem to have trouble doing. His two companies, CareOne (<a href="http://care-one.com/">http://care-one.com/</a>) and HealthBridge Management (<a href="http://www.healthbridgemanagement.com/">http://www.healthbridgemanagement.com/</a>), have been cited at least 38 times by the National Labor Relations Board for violating federal labor laws. In addition, HealthBridge was held in contempt of court for refusing to allow 600 workers to return to their jobs at their pre-strike pay levels. </blockquote> "A law school should probably be associated with someone who respects the law" seems an oxymoron, not to mention protected speech under the First Amendment of the U.S. Constitution: <a href="http://en.wikipedia.org/wiki/First_Amendment_to_the_United_States_Constitution">http://en.wikipedia.org/wiki/First_Amendment_to_the_United_States_Constitution</a>. <blockquote class="tr_bq">CareOne's current legal battle with a local labor union, Service Employees International Union (SEIU), something that has dragged on for years at this point, <a href="http://www.nyunews.com/2014/04/18/served/" target="_blank">has seemingly turned into a convenient way for Straus to get back at his critics</a>. Of course, CareOne claims otherwise. <blockquote>CareOne spokesperson Deborah Maxson said the deadline for the requested information is April 25. “Straus is not a party to the lawsuit and is not managing the litigation,” Maxson said. </blockquote></blockquote><blockquote>Straus may not be a party to this lawsuit, but these are his companies, and there can be very little doubt that Straus would prefer the ongoing criticism of his business efforts be halted. If CareOne wants to use the excuse that Straus isn't a "party" to this lawsuit, then it needs to extend that same courtesy to the two students, who also aren't a "party" to the ongoing legal fight. </blockquote> But they're defenseless students, and in healthcare matters, dissing a high-ranking healthcare management  person seems to be a crime that such persons cannot seem to tolerate.  (I won't get into the psychopathological issues that may come into play). <blockquote class="tr_bq">Then there's the content sought by the subpoenas. This, too, mentions Straus directly, even as CareOne claims this has nothing to do with him. According to a letter sent by the Board of Trustees to NYU administration, this is what CareOne is hoping to obtain: <blockquote>“The subpoenas requested information regarding any contact the students may have had with SEIU and any activity they may have engaged in, such as protests or meetings, relating to Mr. Straus or CareOne...” </blockquote></blockquote><blockquote>If Straus isn't "party" to this lawsuit, why does CareOne need information relating to Straus? Beyond that, the information requested bears all the hallmarks of trying to use the power of the court to silence free speech. Protests and meetings, both activities covered by the First Amendment, are mentioned specifically by the subpoena. </blockquote> Perhaps some members of the generation after the "Greatest generation" have such low self-esteem that they have to bully mere students into submission. <blockquote class="tr_bq">For what it's worth, NYU has stepped up and has provided the students with the pro bono help of one of the school's lawyers. It also issued a very carefully-worded defense of the students, no doubt mindful of Straus' $1.25 million annual endowment. <blockquote>“The Law School is not a party to the litigation between Care One and SEIU, and will remain uninvolved in it," the school wrote in a statement to DNAinfo New York sent Thursday. "We vigorously support the right of our students to express their views and to organize and participate in lawful demonstrations and other protest activity, at the same time that we acknowledge that parties to litigation are permitted, subject to applicable rules and judicial oversight, to gather evidence in support of their case."</blockquote></blockquote><blockquote>Further statements reiterated NYU's support for its students' rights but also noted it considered Straus to be an "upright and honorable person." That said, it seems that there is a clear -- and somewhat massive -- conflict of interest for Straus to remain on the board of trustees at NYU Law at the same time he's using the legal process to demand the email contents from two of its students. </blockquote> Conflicts of interest are nothing new to healthcare. <blockquote class="tr_bq"> As is noted by <a href="https://docs.google.com/forms/d/1Q-QfTZh1iJiN7sZNF21N42ceFFKz8GU7oJZc7ta6W0o/viewform" target="_blank">the students' new petition demanding the withdrawal of the subpoenas</a>, this sort of activity, undertaken by a "victim" of criticism, will discourage others from approaching anything remotely controversial. <blockquote>Forcing students to turn over emails and other private communications in litigation that does not concern them can chill free speech on campus and make students think twice about raising their voice about controversial issues. This is antithetical to NYU's mission of open academic inquiry and commitment to the public interest. </blockquote></blockquote><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">That's assuming the mission of NYU and other universities still remains "open academic inquiry."  Many have begun to doubt that, and with good reason; e.g., see <a href="http://www.bloombergview.com/articles/2014-04-22/free-speech-zones-and-other-college-lies">http://www.bloombergview.com/articles/2014-04-22/free-speech-zones-and-other-college-lies</a> as just one example. </div><div style="margin-bottom: 0in;"> </div><blockquote class="tr_bq"><div style="margin-bottom: 0in;">Rather than address these concerns, Straus is allowing (or directing) his company to shut down his critics by seeking personal communications from non-party NYU students. Straus also has additional leverage with the university should this fail to keep future criticism at bay. Of course, there's always a chance NYU will side with the students and decide that Straus' companies don't really reflect the culture it's trying to instill in its students. But until this all plays out, we're just witnessing the sort of tactics deployed by entities who would rather <a href="http://www.techdirt.com/articles/20140129/15052326039/university-yanks-professors-email-access-after-he-criticizes-school-chancellor-compares-his-statements-to-school-shootings.shtml" target="_blank">shut people up</a> than address their concerns. </div></blockquote><div style="margin-bottom: 0in;"> </div>I note the following statement on the web page of Care One Management: <blockquote class="tr_bq">"With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey. With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities."</blockquote> <div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div class="big dark">With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.</div>With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities. - See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div id="content"><div class="col1 museo"> <div class="big dark">With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.</div>With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.</div></div>- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div id="content"><div class="col1 museo"> <div class="big dark">With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.</div>With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.</div></div>- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf P { margin-bottom: 0.08in; }A:link { } </div>In healthcare, I remind, the "shut people up" mentality results in patient injury and death.  It seems to me that this Trustee is not just setting a bad example for the legal profession, but it also throws the management of his healthcare organizations into question. -- SS

A Tangled Web of Perversity by a Healthcare Company Owner - Subpoenaing Emails of Law Student Critics at NYU Law School, Where He is a Trustee

At Healthcare Renewal, we are largely calling for removal from healthcare of perverse managers and perverse management practices. One of th...

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Knee Deep in the Hoopla - "A Triumph of Medical Technology" Sans Evidence of Superiority from Published Randomized Double Blind Controlled Trials

With the publication of several new articles in the prestigious New England Journal of Medicine, the buzz about Sovaldi (sofosbuvir - Gilead), a new oral treatment of hepatitis C, has become feverish.  The drug had been hailed as near miraculous, and the only debate has been about its near stratospheric cost (look <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">here</a>).  This week, of all weeks, however we should be extremely skeptical about expensive drugs promoted as the cures of our most feared ills.  This week a series of articles appeared in the British Medical Journal showing that there was no evidence to support the clinical value of the  antiviral drugs stockpiled for governments as proof against dreaded influenza epidemics (look <a href="http://www.bmj.com/content/348/bmj.g2695">here</a> to start).   The Latest Buzz As we <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">posted earlier</a>, the discussions contrast the ostensibly near miraculous aspects of the drug's performance with its extremely high price.  For example, a few days ago the Los Angeles Times <a href="http://www.latimes.com/science/la-sci-hepatitis-c-cure-20140412,0,3083638.story">reported</a>, <blockquote class="tr_bq">In a series of clinical trial results, a new generation of antiviral medications was able to clear the liver-ravaging virus from virtually all patients' bloodstreams in as little as eight weeks. Even in patients with the most stubborn infections, the new drugs were capable of suppressing the virus completely at rates well over 90%. The treatments, however, come with a steep price tag.</blockquote> So, <blockquote class="tr_bq">The new medications are 'a triumph of modern medical technology,' said Dr. Jeffrey Tice, a UC San Francisco physician who was not involved in any of the clinical trials.</blockquote> Accompanying the research reports in the New England Journal was a commentary by Dr Raymond T Chung and Dr Thomas F Baumert.  Its title proclaimed Sovaldi and similar drugs also to be part of "The Arc of Medical Triumph."(1)  Buried in the commentary's <a href="http://www.nejm.org/action/showSupplements?doi=10.1056%2FNEJMp1400986">supplementary material</a> was a<a href="http://www.nejm.org/doi/suppl/10.1056/NEJMp1400986/suppl_file/nejmp1400986_disclosures.pdf"> link</a> to disclosure forms that showed that: <blockquote class="tr_bq">Dr Chung reports grant support from Gilead Sciences [the manufacturer of Sovaldi], Mass Biologics, Vertex and Merck, and personal fees from Abbvie, Enanta and Idenix.</blockquote> Note that Abbvie and Merck are also at work on antiviral treatments for hepatitis C. and <blockquote class="tr_bq">Dr Baumert reports several patents ... and pending patents [apparently that could be conflicts of interest] </blockquote> It is clear that there have been major scientific advances in the characterization of the hepatitis C virus, and development of multiple new antiviral agents which promise to treat that infection.  Furthermore, clearly there is reason for hope for treatment of hepatitis C that prevents its long-term complications and averts premature death. (Of course, that hope could be a bit stronger in the hearts of those who have financial relationships with the corporations that stand to profit from sales of these drugs.) But it is not obvious that there is sufficient clear evidence from clinical research, particularly from double-blind randomized controlled trials (RCTs), that shows the newest treatments will provide triumphal benefits to patients that outweigh their possible harms. One Published Unblinded RCT Compared Sovaldi to Peg-Interferon In our <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">previous post</a>, written after the immense price of the new drug in the US became apparent, we questioned whether the evidence from controlled trials then available would justify the hype, and the high price. We looked at what appeared to be the then single best available study. The <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1214853">most prominent randomized controlled trial of Sovaldi for patients who had not had previous therapy for hepatitis C</a> that had been published by March, 2014, appeared in the New England Journal of Medicine in May, 2013.(2)   While it provided some reason for hope, it did not provide clear evidence that Sovaldi was a miracle drug. The study showed that Sovaldi plus ribavirin produced the same rate of sustained virologic response (SVR), 67%, as did the previously accepted standard treatment, peg-interferon plus ribavirin, again 67%.  (SVR means that the hepatitis C virus has become undetectable in the patient's blood, and is believed, but not proven to represent a cure.) While Sovaldi had lower rates of unpleasant side effects than did peg-interferon, these rates were not negligible. For example, the rate of nausea after peg-interferon was reported to be 29%, but after Sovaldi it was still 18%.  Given that the trial was unblinded, and that some of these side effects have a subjective element, these figures could have been biased due to patient expectations that the new drug would have fewer side effects. Furthermore, Sovaldi appeared to produce higher rates of severe adverse effects (3%) than peg-interferon (1%).  However, the article did not mention any deaths in either treatment group.  When I later reviewed the  <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214853/suppl_file/nejmoa1214853_appendix.pdf">supplemental data</a> available on the web from the May, 2013 article, I found that buried within this information were the facts that two people died during treatment with Sovaldi, and one after treatment with peg-interferon.  So, the rate of  severe adverse effects or death after Sovaldi treatment was more than double (9/256 ) than that after peg-interferon (4/243).  It is very curious and concerning that the authors chose not to mention deaths of study subjects in the paper that reported their trial results.    Finally, the trial, like just about all previous trials of treatment of hepatitis C, did not follow patients long-term, and hence could not show whether treatment actually resulted in better clinical outcomes, for example, longer survival, decreased rates of severe liver disease, etc.  We thus concluded that there really was no clear evidence that Sovaldi was really a miracle drug, which could cure more people, in fact, nearly everyone, compared to standard therapy, yet with fewer side effects and more safety. Any Evidence from Other Controlled Trials? We looked through the newly published articles, the articles they cited, and the official US label for sofosbuvir to see if there is any other evidence from controlled trials to support the triumphant claims about sofosbuvir.  To simplify this casual, not systematic review, we only looked at articles about patients who had not been previously treated for hepatitis C. The <a href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm">drug label</a> mentioned a controlled trial that compared sofosbuvir to placebo.  The POSITRON study (study 107) was a trail that compared Sovaldi and ribavirin to placebo in patients who are "interferon intolerant, ineligible or unwilling."  The overall SVR in the treated group was 78%.  The label did not mention adverse effects rates in this trial, and as far as I can tell, it was not published.  Again, while the SVR was good, it was NOT over 90%.  As far as I could tell, the results of this study have not otherwise been published.  The new studies in the New England Journal, and the studies cited by one of them were NOT double-blind randomized controlled trials of sofosbuvir versus some other treatment, or versus placebo for that matter. For example, the study by Afdhal et al in the New England Journal considered sofosbuvir in combination with another new drug from Gilead, ledipasvir.  However, this was an open label (unblinded) study that compared patients given different durations of treatment with both sofosbuvir and ledipasvir with or without ribavirin.  It did NOT directly compare sofosbuvir (or ledipasvir) to any other treatment, or to placebo.(3) Another study by Sulkowski et al in the NEJM focused on previously treated patients. Cited by Afdhal et al were studies by Osinusi et al (an unblinded study that compared different doses of ribavirin given to patients also who all received sofosbuvir)(4); Lawitz et al (an unblinded study that compared different durations of treatment for both sofosbuvir and ledipavir with or without ribavirin)(5); and Gane et al (a study that compared various drugs again all added to sofosbuvir)(6).  Again, NO study compared sofosbuvir to any other treatment, or to placebo. Thus so far I have been unable to find any additional studies that compared Sovaldi (sofosbuvir) to any other potential treatments for hepatitis C.  Without a comparison to another treatment, it is not possible to tell whether the high rates of patients whose blood tests show no detectable hepatitis C virus in the short-term after treatment were due to the excellence of the treatment, or due to selection of patients with particularly good prognoses.   Recall that there is evidence that some patients with hepatitis C spontaneously clear their blood of hepatitis C, and become spontaneously cured (see our <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">previous discussion</a>, and particularly the study by Seeff et al[7]).  There is evidence that the studies above may have been designed to only include patients with the best prognoses.  They generally were designed with very complicated, restrictive and subjective inclusion and exclusion criteria that could have eliminated all but the healthiest patients.  For example, according to the <a href="http://www.nejm.org/doi/suppl/10.1056/NEJMoa1402454/suppl_file/nejmoa1402454_protocol.pdf">study protocol</a> found in the <a href="http://www.nejm.org/action/showSupplements?doi=10.1056%2FNEJMoa1402454">supplementary material</a> for the study by Afdhal et al, patients with "clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol" would have been excluded, as would have "subjects currently under evaluation for a potentially clinically-significant illness (other than HCV)...." So, while many articles about sofosbuvir (Sovaldi) have appeared recently, in my humble opinion they do not provide strong clear evidence that this drug is extremely effective and remarkably safe, i.e., that the drug is a "triumph" that will cure nearly everyone without risk or harm to them, and therefore warrants a princely price. Summary While the buzz about Sovaldi intensifies, there still seems to be little clear evidence to justify extravagant claims made for it, or the extravagant price demanded for it.  Yet there seems to be a bandwagon building to somehow pay whatever it takes to provide the "triumph" of medical science to every patient who needs it.  At the current price, that should make the CEO of Gilead even richer (increases in the stock price after the $84,000/ course drug price was announced already turned him into a billionaire on paper, look <a href="http://www.bloomberg.com/news/2014-03-03/gilead-ceo-becomes-billionaire-on-84-000-hepatitis-drug.html">here</a>.)  As noted above, it is not clear what benefits such a costly policy would bring to patients, and at what risks. We have discussed how our current policy of letting corporations sponsor and run the clinical research meant to assess their own products has lead to widespread <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of research</a> to make their products look better, and sometimes <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a> that cannot be manipulated into making their products look good.  This should make health care professionals, policy makers, and the public extremely skeptical of every over-hyped new "innovation."  So far, there seems to be no public skepticism about this latest, and seemingly most expensive pharmaceutical "triumph." The US health care system, and to some extent the health care systems in most developed countries are experiencing ever higher prices.  Much of these prices' effects seem to drive up remuneration of health care executives and managers, but whether they buy better care or outcomes for most people is not so clear.  The ever rising prices seem to be buoyed by endless enthusiasm for new tests, treatments, programs, and unbridled faith in the benefits of all new technology.  It is not clear how much of that is due to evidence, how much is based on ideology and unquestioning faith in technological progress, and how much is driven by marketing and public relations, which not always may be entirely honest and free from deception. Evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender could lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. If only such skepticism were easier to find. References 1.  Chung RT, Baumert TF.  Curing chronic hepatitis C - the arc of medical triumph.  N Engl J Med 2014:  Link<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1400986"> here</a>. 2.   Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1214853">here</a>. 3.  Afdhal N et al.  Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.  N Engl J Med 2014: Link<a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1402454"> here</a>. 4.  Orinusi A Meissner EG, Lee YJ et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.  JAMA 2013; 310: 804.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=1733720">here</a>. 5.  Lawitz E, Poordad FF, Hyland RH et al.  Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised phase 2 trial.  Lancet 2013; 383: 515.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962121-2/abstract">here</a>. 6.  Gane EJ, Stedman CA, Hyland RH et al.  Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection.  Gastroenterology 2013.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/24262278">here</a>. 7.  Seeff LB, Hollilnger B, Alter HJ et al.  Long-term mortality and morbidity of transfusion- associated non-A, non-B, and type C hepatitis: a National Heart Lung and Blood Institute Collaborative Study.  Hepatology 2001; 33: 455-463.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/11172349">here</a>. ADDENDUM (21 April, 2014) - Also see the post on "breakthrough cures?" by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2014/04/breakthrough-cures-reasons-for.html">on the Hooked: Ethics, Medicine and Pharma blog</a>.

Knee Deep in the Hoopla - "A Triumph of Medical Technology" Sans Evidence of Superiority from Published Randomized Double Blind Controlled Trials

With the publication of several new articles in the prestigious New England Journal of Medicine, the buzz about Sovaldi (sofosbuvir - Gilead...

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