WHO YOU GONNA BELIEVE?
Ghostwriting Charges and Stonewalling at the American Psychiatric Association
The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.
The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.
The coup de grâce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.
Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.
Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.
For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.
Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.
Senin, 04 April 2011
Minggu, 03 April 2011
Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments
There has recently been much debate about how to save this country from European-style financial ruin. From "GOP 2012 budget proposal cuts taxes on rich, cuts Medicare in the future", Examiner.com, April 3, 2011:
I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.
Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.
At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:
I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.
Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).
This recent revelation should also be considered:
The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.
The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:
If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.
Or perhaps coffins.
I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:
To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:
Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":
More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism:
Finally, here's another reason to withdraw HITECH for now:
I reiterate from my January 2011 post:
I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment.
It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.
In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.
We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My mother's May 2010 HIT-related injuries only strengthened my convictions in this regard.)
Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."
A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.
-- SS
On Tuesday House Budget Committee Chairman Paul Ryan (R-WI) is expected to release the Republicans’ 2012 budget proposal. Currently Democratic and Republican leaders are trying to negotiate a compromise on the 2011 budget would make some cuts to discretionary spending. Republicans have said they would not be able to propose really significant cuts to lower the deficit until 2012. According to reports, the GOP proposal would dramatically cut taxes on corporations and the rich, while also making significant cuts to Medicare and Medicaid.
I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.
Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.
At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:
In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":
... Spending Reduction Act of 2011
DIVISION A—APPROPRIATIONS PROVISIONS
... TITLE XIII—HEALTH INFORMATION TECHNOLOGY
Title XIII of the ARRA along with title IV of division B is better known as HITECH:SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.
(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.
I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.
Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).
This recent revelation should also be considered:
The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.
The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:
- Analysis of Cerner Problems Defined by ED Directors, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116
- A study of an Enterprise Health information System, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146
If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.
Or perhaps coffins.
I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:
- This country cannot afford HITECH at this time. Put simply, we are broke, and the national deficit is ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford that care.
- HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.
- Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. In fact, the evidence might actually point in the negative direction. See my aforementioned post "An Updated Reading List on Health IT."
- The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.
To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:
- A similar experiment in the much smaller and strongly government-managed healthcare system of the UK didn't exactly have stellar results (link, link). We also have been warned not to make the same multi-billion dollar errors (link).
- The cavalier attitudes by the administration-appointed ONC director Blumenthal towards evidence of health IT-caused adverse effects, including deaths, reported to him by the FDA (see this Feb. 23, 2010 Internal FDA Memorandum on Health IT Safety Issues, PDF).
Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":
ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.These exact cavalier attitudes about "anecdotes" just failed in the Supreme Court. (See my Mar. 27, 2011 post about the Zicam decision in "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style").
More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism:
- The irrational exuberance and idealism about this technology purportedly saving money, a dreamer's dream explicitly refuted, for example, by notable figures at Wharton (link) and Stanford (link). (Also see "Pessimism, Computer Failure, and Information Systems Development in the Public Sector", Shaun Goldfinch, Public Administration Review 67;5:917-929, Sept/Oct. 2007).
- More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" in the agency's 2007 report on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view.
- Yet another irrationally exuberant dream about the use of the massive amounts of uncontrolled clinical data, entered by myriad observers in an infinite variety of situations into these systems, to be used for research. This is the antithesis of sound methods for data collection and management in medical research. It is a dreamer's concept of the "Randomized Controlled Clinical Trial Made Easy." (See my essay "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry." Also see "Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?".)
Finally, here's another reason to withdraw HITECH for now:
- As I'd written in a series of essays at this blog query link, we simply don't know how to make computerized medical information reasonably private and secure. (One might wonder whether the current administration, sponsors of the out-of-the-blue HITECH act, actually wants healthcare information to be private and secure.)
I reiterate from my January 2011 post:
I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment.
It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.
In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.
We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My mother's May 2010 HIT-related injuries only strengthened my convictions in this regard.)
Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."
A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.
-- SS
With this device in your chest, an Elvis suit for the doc?
The April 3, 2011 NY Times has a nice piece about pacemakers and AICDs from a little-known and low market share German device manufacturer, Biotronik. Apparently this company's pacemakers have pretty much cornered the market among cardiologists at University Medical Center in Las Vegas.
(By the way, the Times has gone to a pay-wall, so the above link to it can't be counted on to work for too long after this posting comes out. Try a search engine. There's no permalink as one used to use to make sure the link stayed put.)
In any case, how fitting it all seems in anything-goes Nevada. According to the article the Feds may or may not be going after this egregious example of conflict of interest. Let's hope they are. But at least we can make sure that what plays in Vegas doesn't stay in Vegas.
Apparently some of the cardiologists at UMC are (or were) pulling down up to 5k a month in consulting fees. That may or may not have anything to do with the fact that the small German device-maker went from having, oh, zero 2-3 years ago to 95% of all devices implanted there last year, by total number of patients.
Good work, gentlemen. Let the word go out. Come to America and roll the dice in Las Vegas. It's almost enough to make me want to become a brimstone-spouting right wing pastor. "To gamble, it's of the devil."
But this is a place where the state's new governor is a former chair of the gaming commission.
Of course, the real culprit here is, collectively, those cardiologists and the middle-man distributors who court them. According to the article, the cardiologists who didn't enroll their patients (and presumably take dough) were on what the sales guys called the "loser" list.
Yes, "winning" in health care is about market share and effective sales. No surprise here. We knew that already, of course, from Wendell Potter's Deadly Spin, with which most readers of this blog are no doubt already familiar.
It sure as hell isn't about the patient winning. But last time I checked, professionalism and the Hippocratic Oath have something to say about the patient being the one who's supposed to win.
One understands that these gotta-make-a-buck middle-men, and the device vendor-manufacturers, are interested in the almighty share. Birds gotta fly, fish gotta swim. But the doctors--a sad commentary indeed if, as this articles says, "[they] then did the rest."
In this same vein, loss of meaning, clearly the word "university" in hospitals' names has ceased to have much real meaning. The article says the hospital CEO never bothered to ask the docs whether they had a conflict of interest.
Alas, too often that's equally true across the rest of the country. "University" centers behave just like proprietary players, as anyone reading this blog can't have failed to notice.
Maybe just a wee bit more glaring in Vegas, though, where guys in Elvis suits fall out of the sky and pay-to-play pacemakers fall into patients' chests.
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