healthy4u: In the Pipeline

Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer. However, I have been commenting on various posts on other blogs.  One resultant thread stands out as yet another example of a likely industry shill or sockpuppet defending the state of health IT, oddly at a blog on pharma (same blog as was the topic of tmy post "<a href="http://hcrenewal.blogspot.com/2012/04/more-youre-too-negtive-and-you-dont.html" target="_blank">More 'You're Too Negative, And You Don't Provide The Solution To The Problems You Critique', This Time re: Pharma</a>"). Industry-sponsored sockpuppetry is a form of stealth marketing or lobbying, through discreditation of detractors, although in a perverse form. The following exchanges meet the sockpuppetry criteria once pointed out by business professional and HC Renewal reader Steve Lucas in 2010 in a post about an industry sockpuppet caught red-handed through IP forensics <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">here</a>: <blockquote class="tr_bq">... In reading this thread of comments I have to believe [anonymous commenter moniker] "IT Guy" is a salesperson. My only question is: Were you assigned this blog or did you choose it? We had this problem a number of years ago where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings. In my very first sales class we learned to focus on irrelevant points, constantly shift the discussion, and generally try to distract criticism. I would say that HCR is creating heat for IT Guy’s employer and the industry in general. I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned. </blockquote> In the hopes that continued exposure of this nonsense can educate and thus help immunize against its effects, I present this: At "In the Pipeline", a blog on medicinal chemistry (the science of drug making) and other pharma topics, a rebuttal to a claim that over 500,000 people (not 50K) might have died due to VIOXX was posted entitled "<a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php" target="_blank">500,000 Excess Deaths From Vioxx? Where?</a>" That 500K possibility appeared on a UK site 'THE WEEK With the FirstPost' at "<a href="http://www.theweek.co.uk/us/46535/when-half-million-americans-died-and-nobody-noticed" target="_blank">When half a million Americans died and nobody noticed</a>."  The author of the FirstPost piece started out by raising the point made by publisher Ron Unz that life in China might be more valued than that in the U.S., where major pharma problems and scandals generally meet what this blog calls "<a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect" target="_blank">the anechoic effect</a>."  (In China, Unz noted, perpetrators of scandalous drug practices actually get arrested and suffer career repercussions.) FirstPost notes: <blockquote class="tr_bq">ARE American lives cheaper than those of the Chinese? It's a question raised by Ron Unz, publisher of <a href="http://www.theamericanconservative.com/blog/chinese-melamine-and-american-vioxx-a-comparison/%20" target="_blank">The American Conservative</a>, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals – melamine in baby formula - and how the US handled the Vioxx aspirin-substitute disaster ... (Unz) "The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China."  </blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> Not to argue to merits of the order of magnitude-expanded VIOXX claim, which I disagree with, but having concern for the general state of ethics in biomedicine in the U.S., I posted the following comment at the comment thread of the rebuttal post at "In the Pipeline" <a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#973935" target="_blank">at this link</a>: </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="commentsbody"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#973935">6. </a>MIMD on May 30, 2012 11:38 AM writes...</div> While I agree the VIOXX numbers here are likely erroneous, the point of the cheapening of the value of American life is depressingly accurate. For instance, look how readily companies lay people off, ruining them, and perhaps forcing them out of the workforce forever. Also, currently being pushed by HHS is a medical device for rapid national implementation known to cause injury and death. The government is partially financing it to the tune of tens of billions of dollars, probably with Chinese money no less.  [Either that, or with freshly-printed money adding to the trillions of $ in our deficit - ed.] There are financial penalties for medical refuseniks (non-adopters). However, FDA, the Institute of Medicine and others readily admit in publication thay have no idea of the magnitude of the harm because of lack of data collection, impediments to information diffusion and even legal censorship of the harms data. In effect, we don't even know if the benefits exceed the harms, and FDA and IOM admit it. FDA in fact refers to the known injuries and deaths from this device as "likely the tip of the iceberg." Perhaps to some it's no longer a big deal if people are injured and/or die in data gathering for this medical enterprise. E.g., see "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA Internal Memo on H-IT Risks</a>", and the Inst. of Medicine report in the same issues <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a>. </blockquote><blockquote class="tr_bq">It's all for the greater social good, they might say.</blockquote>  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The following anonymous reply ensued:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="commentsbody"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974103">10. </a>Watson on May 30, 2012 1:47 PM writes...</div> @6 You keep using that word - "device" - I do not think it means what you think it means</blockquote>  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I replied:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974232">11. </a>MIMD on May 30, 2012 3:48 PM writes...</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> #10 'medical device' is the term chosen by FDA and SMPA (EU). But that's a distraction from the points I raise in the linked post about the experiment.</div></blockquote> To which this confused misdirection came forth from the ether: <blockquote class="tr_bq"><div class="commentsbody"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974290">12. </a>Watson on May 30, 2012 4:46 PM writes...</div><div class="commentsbody"> </div>The linked article is discussing the poor state of "medical device records" because of a lack of uniform specifications with respect to Health Information Technology, i.e. how these technologies code data and the challenges of making the data obtained uniform across a wide variety of implementations and vendors. [Erroneous, incomplete misdirection - ed.] It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event.  [What in the world? - ed.] This problem with replication exists because there are different health record systems where this data needs to be input, and perhaps the same patient uses different physicians who have different systems, but all of which are required to report adverse events. [I have little idea what this even means - ed.] </blockquote><blockquote class="tr_bq">In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction. [The "real" distraction from the ethical issues of the HIT experiment is terminology about medical devices?  Misdirection again from the ethical issue, and of a perverse nature - ed.] Yes, some of the "devices" (a blood pressure monitor for example) may have underlying issues, which the FDA regulations for "medical device records" are designed to identify. The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used.  [Now we're in la-la land of misinformation and distraction- ed.] The power that the FDA does have is to inspect that the manufacturer of a device keeps appropriate medical device records (e.g. a lot of syringes, or a batch of formulated drug) and addresses any complaints about the device to the satisfaction of the FDA.</blockquote> My replies: <blockquote class="tr_bq"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976431">17. </a>MIMD on May 31, 2012 8:51 PM writes... #12 It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event Yes, fix just that little problem and then the problems with clinical IT are solved! (Actually,I'm not even sure what you're referring to, but the evidence is that fixing it as you suggest is the cure.)  [Sarcasm - ed.] The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used. You are also right about FDA. They were completely toothless even <a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" rel="nofollow">in this situation</a>.  [Sarcasm again - ed.] <a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976453">18. </a>MIMD on May 31, 2012 9:10 PM writes... #12 In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction. Those who conducted the Tuskegee experiments probably felt the same way. It's all about definitions, not ethics, and not data - which FDA as well as IOM or the National Academies, our highest scientific body, among others, admits, as in the linked posts in #6, is quantitatively and structurally lacking on risks and harms. I don't really mean to laugh at you, not knowing how little you really know about the Medical Informatics domain, but you bring to mind this Scott Adams adage on logical fallacy: FAILURE TO RECOGNIZE WHAT’S IMPORTANT Example: My house is on fire! Quick, call the post office and tell them to hold my mail! And with that, I move on, letting others enjoy the risible comments from surely to follow! :-)</blockquote> <div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I could not have been more correct. In typical industry shill/sockpuppet fashion comes this, with clear evidence of a not-so-clever liar which I've bolded:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976731">19. </a>Watson on June 1, 2012 12:35 AM writes... @18 I read the articles you originally linked to, and my comments were based upon trying to interpret your meaning from those selections. I worked in the industry and had to deal with GMP, and had to make sure to follow all of the guidelines with respect to medical device manufacturing and electronic records. I understand the terminology very well. Luckily, I never had to deal with "health IT", but I did have to pore over enough pages of Federal Register legalese to know that what is sufficient is not necessarily what is best.  [Right.  See below - ed.] Is that risible enough for you? The link that you provided in @17 was a much more concrete example, and if you had referenced it in your original post, would have cleared up much of the confusion that I (and I assume @9) faced in understanding what it was you were trying to convey. It would have been useful if you had explained which device or devices you were talking about. If you had more than conjecture to back up the Chinese money trail, and if you had provided an example of a company that has been damaged by being a refusenik, those would have supported your argument as well. [Continuing haphazardly with the irrelevant as a distraction in an attempt to shift the focus from the ethical issue of nationally implementing HIT in a relative risk-information vacuum, having weakly conceded the main argument's been lost - ed.] Straw man and ad hominem fallacies are pretty transparent around here, and I wish you the best with both. [Another attempt at diversion - ed.] I assure you that I recognize what's important, that I have ethics, and that I care about people having reliable healthcare. [This seems a form of post-argument-lost attempt to seize the moral high ground - ed.]</div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><table border="0" cellpadding="0" cellspacing="0" id="content"><tbody><tr><td valign="top" width="100%"> I then point out the nature of what is likely a bold-faced lie.  Someone who's read the Federal Register in depth would likely know FDA's authority is not a "Constitutional power", as bolded below: <blockquote class="tr_bq"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#977304">20. </a>MIMD on June 1, 2012 6:44 AM writes... @19 The FDA taxonomy of HIT safety issues in the leaked Feb. 2010 "for internal use only" document "H-IT Safety Issues" available at the link in my post #6 is quite clear: - errors of commission - errors of omission or transmission - errors in data analysis - incompatibility between multi-vendor software applications or systems This is further broken down in Appendices B and C, with actual examples. Both this FDA internal report and the public IOM report of 2011 (as well as Joint Commission Sentinel Events Alert on health IT of a few years ago, and others) make it abundantly clear there is a dearth of data on the harms, due to multiple cultural, structural and legal impediments to information diffusion. Yes, it's in the linked IOM report at #6 entitled "Health IT and Patient Safety: Building Safer Systems for Better Care". See for instance the summary pg. S-2 where IOM states about limited[ed] transparency on H-IT risk that "these barriers to generating evidence pose unacceptable risks to safety." Argue with them, not me. Back to my original point: national rollout of this medical device (whatever you call it is irrelevant to my point, but see Jeff Shuren's statement to that effect <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" rel="nofollow">here</a>) under admitted conditions of informational scarcity regarding risks and harms represents a cheapening of the value of patient's lives. Cybernetics Over All. As to your other misdirection, spare me the lecture. It's not ad hominem to call statements like "The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used" for what they are - laughable (and I am being generous). FDA's authority is statutory, not written in the Constitution. Same with their parent, HHS. To get quite specific, on human subjects experimentation, which the H-IT national experiment is, the statutory authority for HHS research subject protections regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 28. [The USC or United States Code is the codification by subject matter of the general and permanent laws of the United States.  HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations on human research subjects protections themselves are codified at 45 CFR (Code of Federal Regulations, aka Federal Register) part 46, subparts A through D. See <a href="http://www.hhs.gov/ohrp/humansubjects/guidance/">http://www.hhs.gov/ohrp/humansubjects/guidance/</a>. - ed.] A real scientist would have known things like this before posting, or have made it their business to know. </blockquote><blockquote class="tr_bq">Tell me: are you in sales? Not to point fingers, but with your dubious evasion of the ethical issue that was the sole purpose of my post, and your other postings using misdirection and logical fallacy to distract, you fit that mindset. You certainly don't sound like a scientist. Any med chemist worth their salt (pun intendend) would have absorbed the linked reports and ethical issues accurately, the first time.</blockquote> I then pointed out I've moved this 'discussion' to the HC Renewal Blog, as it is not relevant per se to pharma, the major concern of In the Pipeline. Industry shill/sockpuppet (as in the perverse example at <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">this link</a>) or just a dull, ill-informed but opinionated person who happens to read blogs for medicinal chemists, where layoffs have been rampant in recent years, takes issue with my attacks on those practices, and defends health IT like a shill? You be the judge. Whether a shill or know-nothing contributed the cited comments, it is my hope this post contributes to an understanding of pro-industry sockpuppetry. -- SS </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td></tr></tbody></table></div><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#zemail"></a>

Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer. However, I have been co...

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More "You're Too Negative, And You Don't Provide The Solution To The Problems You Critique", This Time re: Pharma

I think it worth noting that critical writers about both health IT and pharma attract a similar phenomenon: the anonymous attack accusing them of 'negativity' and not providing 'solutions.' One excellent blog I read, as a former director of a pharmaceutical R&D department that supported, among others, medicinal chemists, is Derek Lowe's "<a href="http://pipeline.corante.com/">In the Pipeline</a>." In the comment thread at his 'In the Pipeline' understatement-of-the-year post "Taking the Ax to the Scientists Is Probably a Mistake" (<a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php">link</a>), I posted numerous links to various Healthcare Renewal posts on pharma's current travails related to that theme, and to other forms of pharma mismanagement. The comment thread is below the post itself at the aforementioned link. I post as "MIMD" and frequently link here and to my Drexel academic site, so I am anything but anonymous. Invariably, a response (anonymous, of course!) of the type we've seen here at Healthcare Renewal (such as <a href="http://hcrenewal.blogspot.com/2010/01/electronic-medical-records-and-going.html?showComment=1264052395182#c3086217865260584599">here</a> and in a more extreme example, <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">here</a>) has appeared. Various logical fallacies are used as a form of argument. Emphases and red comments mine: <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885215"></a><blockquote><a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885215">74. </a>Reply to MIMD [how's that for anonymity - a screen name of "Reply to MIMD"? - ed.] on April 4, 2012 3:44 AM writes... MIMD, you have commented at length on this post blaming various parties for the industry's woes [i.e., you're too negative - ed.], dismissing other points of view [that are almost always unsubstantiated; I provide hyperlinks to posts at this blog and others regarding pharma mismanagement and malfeasance to justify my views - ed.] out of hand [well, no, actually - ed.] and offering nothing in the way of new ideas or solutions. [Except for the myriad aforementioned links and clearer identification of the problems - ed.] And then, this: "If I were still in pharma and had kids in college and a mortgage, and a hope for a pension, I'd literally be keeping my head low. And certainly not writing the types of posts I do here and on the blog I often link to!" [Pharma is as retaliatory of its internal critics and "whistleblowers" as is clinical medicine, except doesn't even bother with sham "peer review"; they just send people out the door. I do not believe pharma management understands or cares about the implications to people who are not wealthy. Discreetness and timing are everything for putative internal medchem change agents in this environment - ed.] I'd just like to get your thoughts on the delicious irony of this post in the middle of your long-winded and boring commentary. [Approaching ad hominem - ed.] As far as I understand, you're advocating that pharma scientists blame anything that breathes for the problems whilst [seems to be from UK or related country - ed.] actively avoiding attempting to find a solution. [Classic strawman argument - ed.] Weirdo [another anonymous poster, possibly the same person as this - ed.] commented on this, and you laughably dismissed it out of hand so I expect no more. [I opined that a naïvely idealistic and/or cruel Marie Antoinette-like suggestion that laid-off medicinal chemists simply just set up their own drug discovery shops to show Big Pharma how it 'should be done', as if doing so were a realistic option financially for mostly middle class people strapped by being laid off mid-career, was a useless suggestion - ed.] But if you do fancy dropping a few more 'pearls of wisdom' our way I'd be fascinated to read them! I think it was Homer Simpson that said "It's everybody's fault but mine". Seems apt, no? [No, in fact - ed.] <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885215">Permalink to Comment</a></blockquote> My reply was: <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885615"></a><blockquote><a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885615">75. </a>MIMD on April 4, 2012 9:49 AM writes... Re: #74 Regarding your comments, I offer a hearty "so what?" In your comment I see no meaningful critiques of any of the volumes of writing I've posted links to, other than the hackneyed, quasi-ad hominem, without-merit statement about "dismissing other points of view out of hand and offering nothing in the way of new ideas or solutions." That's disappointing. I also must point out this classic example of the strawman fallacy: you're advocating that pharma scientists blame anything that breathes for the problems whilst actively avoiding attempting to find a solution I do believe they teach better debating skills in the Commonwealth realms. Finally, when you come out from behind your cloak of anonymity, I'll consider answering in more depth. Who are you? What agenda are you hiding? My bio is on the site I often link to, as well as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="nofollow">here</a>. <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885615">Permalink to Comment</a></blockquote> Derek Lowe's blog is a serious site for medicinal chemists and like-minded scientists currently being discarded by pharma; a perfect place for anonymous pharma sockpuppets to intersperse their materials. Although I doubt it, it will be interesting to see if the anonymous poster reveals exactly who they are and what their agenda is. I add that in an industry plagued with scientific <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghostwriting</a>, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of negative research</a>, misleading <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, an endless parade of "<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>" for various forms of malfeasance, mass <a href="http://hcrenewal.blogspot.com/2008/06/gsk-whacks-its-employees-hard.html">layoffs</a> and other troublesome practices, I find "ghost commenters" who attack the industry's detractors from behind cloaks of anonymity quite suspect. (Unless, of course, and ironically, the writer is afraid of pharma retaliation.) Finally, I can understand how pharma executives might find detailed stories about pharma mismanagement and leadership thought errors profoundly disturbing. They are usually protected from such candid material in their dystopic, highly remunerative cocoons surrounded by ear-pleasing consultants and employee sycophants rightly fearing career termination. -- SS

More "You're Too Negative, And You Don't Provide The Solution To The Problems You Critique", This Time re: Pharma

I think it worth noting that critical writers about both health IT and pharma attract a similar phenomenon: the anonymous attack accusing t...

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