The American Medical Association’s new president, Andrew W. Gurman, MD, known for his affability and quick wit, is not one to seek out controversy.
In an interview before being sworn in this week as the AMA’s annual meeting in Chicago, IL, Gurman said he has no agenda for his tenure at the top of the organization.
Considering the mass hatred of EHRs by physicians (and nurses), the issue of EHR-related harms, compromised patient data security, physician scorecards, and other noxious issues, maybe he should have an agenda. E.g., see my Jan. 28, 2015 post "Meaningful use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html.
... Though physicians’ anger over the frustration of using existing electronic health records was a major topic of conversation at the [annual AMA] meeting, Gurman said he had little to add other than no one could make him use one.
“I don’t have an EHR,” he said. Due to the fact that he runs his own practice he found it easier and cheaper just to forgo the enhanced payments he would get under the federal “meaningful use” regulations for converting to electronic records. “I just take the penalties,” he said.
Not every physician can afford the time sink most EHRs represent, and the increasing penalties for non-users, unfortunately.
Perhaps on the AMA agenda should be a return to sense regarding physician and nurse documentation, with significant reduction in their clerical burden for starters.
A former nursing executive at Sonoma West Medical Center in Sebastopol, Calif., has filed a lawsuit against the hospital, alleging she was fired after raising concerns the EMR was a threat to patient safety, reports The Press Democrat.
Autumn AndRa, RN, was serving as CNO of the hospital when she approached CEO Ray Hino and said the EMR, called Harmoni, was unsafe, according to the report.
Ms. AndRa was reportedly terminated from her CNO position April 14 and was offered a position in the intensive care unit, which her attorney Daniel Bartley told The Press Democrat would have been a demotion. Ms. AndRa left the hospital due to alleged harassment, according to Mr. Bartley.
If these allegations are true, a clinician, the Chief Nursing Officer, was shown the door in an act of recklessness for her complaining about bad health IT.
Some definitions:
Bad health IT:
Bad Health IT 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, lacks evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.
Reckless indifference:
Deliberate indifference is the conscious or reckless disregard of the consequences of one's acts or omissions. It entails something more than negligence, but is satisfied by something less than acts or omissions for the very purpose of causing harm or with knowledge that harm will result.
A wrongful termination lawsuit was apparently filed:
... The lawsuit alleges the EMR system mixes patients' records, so information in one patient's chart moves to another patient's chart. It also alleges the EMR has issues tracking and updating patient medications and does not display patient code status information, which informs providers of patients' desired medical interventions, according to the report.
These types of gross defects, if true, represent an on its face menace to patient safety.
Further, these issues (and the harm that may result) are well known. In fact ONC's contractor RIT just released a comprehensive review article on health IT problems (see "Report of the Evidence on Health IT Safety and Interventions", May 2016, at https://www.healthit.gov/sites/default/files/task_8_1_final_508.pdf).
Mr. Hino told The Press Democrat the EMR did not pose any danger to patients, and no patients have been harmed because of software defects.
Like most others uttering that line, as I've documented, Mr. Hino apparently lacks expertise (e.g., in clinical, IT or Medical Informatics domains) to render such a judgment about patient danger if the EHR did or does exhibit such problems. His bio is at https://www.linkedin.com/in/raymondhino.
As to whether patients were harmed, that is irrelevant if the EHR has such defects. Sooner or later, they will be. The issue is risk, not body counts (yet).
There's also this. The EHR in question is not the product of the major EHR vendors but the work of apparent insider. See http://about.harmonimd.com/usa/ referencing just two implementations, one at Somona West Medical Center, California, the subject of this post, and one at the Kilimanjaro Christian Medical Centre, Tanzania, Africa:
... The lawsuit also names Dan Smith, the developer of the EMR software in question, as a defendant. According to the lawsuit, Mr. Smith "has engaged in retaliation against [Ms. AndRa] and other employees who have voiced concerns that Mr. Smith's electronic medical records system, his self-dealing, and his management of medical and financial decisions are not in the best interests of SWMC and pose life-threatening risks to patient care," reports The Press Democrat.
Not only did Mr. Smith develop the software in question, but he is a significant financial backer and influencer at SWMC. According to a 2015 report from The Press Democrat, Mr. Smith and his wife have contributed nearly $9 million to the hospital in donations and forgivable loans, and he plays a role in "ever major decision" regarding the hospital. Mr. Smith is on SWMC's board of directors.
I really don't think injured or dead patients (or juries) will find those relationships an excuse for bad health IT, what seems like a clinical trial of new IT by a private company and owner without informed consent (including divulging to patients and users a possible COI), and the discharge of someone complaining about it.
Mr. Smith and hospital officials declined to comment on the lawsuit, citing pending litigation, according to the report.
My expertise is available should the parties so desire.
The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R.219.102(f)). (Lim, 1990)[2]
As defined by HHS regulations:
"Intervention"- physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes [45 C.F.R.46.102(f)][2]
"Interaction"- communication or interpersonal contact between investigator and subject [45 C.F.R.46.102(f)])[2]
"Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 C.F.R.46.102(f)] )][2]
"Identifiable information"- specific information that can be used to identify an individual[2]
Human subject rights
In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:
Voluntary, informed consent
Respect for persons: treated as autonomous agents
The right to end participation in research at any time[3]
There is a disconnection between the FDA’s drug approval process and the reports we see in medical journals. Pharmaceutical corporations exploit this gap through adulterated, self-serving analyses, and the FDA sits on its hands. I suggest we need a new mechanism to fix the problem – by independent analyses of clinical trials data.
When they analyze and publish their clinical trials in medical journals, pharmaceutical corporations have free rein to shape the analyses. The FDA conducts independent analyses of the data submitted by the corporations, and it may deny or delay approval. But the FDA does not challenge the reports that flood our medical journals, both before and after FDA approval. It is no secret that these publications are routinely biased for marketing effect, but the FDA averts its gaze. That failure of the FDA – a posture known as enforcement discretion – has been well documented. The question is why? At the same time, exposing the biases has been difficult for outsiders because the data are considered proprietary secrets.
A Case Study
Now, a detailed example of deliberate corporate bias has finally been documented, through materials released in litigation. This exposé was reported by Drs. Jon Jureidini, Jay Amsterdam, and Leemon McHenry. Their findings were recently published, and their article is freely available on-line. This example concerned a clinical trial of an antidepressant drug in children and adolescents. The drug, citalopram, was already approved for use in adults, and its off-label use in children would spread if there was published supportive evidence. An Investigational New Drug (IND) protocol and plan of analysis were filed by Forest Laboratories with the FDA in 1999. The trial was completed in 2002, and the results were publishedin American Journal of Psychiatry in 2004 – but the FDA did not accept the results as sufficient to approve this drug for use in children or adolescent patients. By that time the patent on citalopram had expired and Forest Laboratories introduced a virtual twin drug, escitalopram (single active enantiomer). That more expensive version of citalopram was heavily promoted, and it was approved in 2009 for use in children, but even then the FDA specifically noted that safety and efficacy were not established in children under age 12. Since then, new analyses suggest that most antidepressant drugs have little evidence of efficacy even in older children.
Tricks of the Trade
In service of a positive report, the statistical analyses performed by Forest Laboratories deviated from the IND plan of analysis, and negative results were edited out. The biases now documented by Dr. Jureidini and his colleagues for that 2004 sponsored reportin American Journal of Psychiatry included:
·Inflating the main measure of the drug's effect by reporting an incorrect and clearly exaggerated effect size. On being challenged, the authors later explained their misinformed computation without actually acknowledging the error.
·Failure to report secondary measures of response because they were negative. Those measures had been stipulated in the IND protocol to serve as cross-checks on the main result. These negative findings were airbrushed out of the publication by corporate marketing.
·Unplanned, new secondary measures of response were inserted ex post facto because they were positive (that is a real no-no).
·Violations of the IND protocol were not reported and were then fudged (patients who had properly been excluded per protocol were put back in for analysis, which made a nonsignificant primary outcome analysis turn positive).
·Adverse events were analyzed and summarized in a misleading way.
·The finding that the drug had no effect on depression in children under age 12 was not reported, even though an age-effect interaction analysis had been specifically projected in the IND protocol. This strategic omission left the impression that off label use of citalopram in younger children could be clinically reasonable.
·The corporation knew that another, unpublished, trial in children, conducted by their European partner Lundbeck was negative, and that it raised concerns about suicide risk, but that information was withheld. The authors later were challengedin the journal about this concealment. Their responsewas utterly disingenuous.
·The published article failed to acknowledge that it was authored by a non-medical ghostwriter, who took direction from marketing executives – the 2004 publication was a marketing product purporting to be an objective scientific report.
·Academic authors were recruited only after the manuscript was written, reviewed, and approved in-house – these nominal academic authors were signed on to front for the corporate narrative.
·The perfunctory role of the academic (ahem) authors is clear from the fact that they failed to recognize the wildly inflated effect size claimed for the drug – something that was instantly obvious to several groups of competent readers.
The Payoff
These changes created the appearance of a positive result, and the publication drew wide attention. According to Thomson Reuters Web of Science, it has been cited over 160 times, placing it in the top 5% of cited articles in clinical medicine from 2004. This early publication gave plausible justification for off-label use of citalopram/escitalopram in children, even with FDA approval having been denied, and even though the trial was actually negative. The FDA has reported that between 2005 and 2010 well over 750,000 patients up to age 17 received escitalopram, including almost 160,000 under age 12. Thus, the sleight of hand about failure to show even fudged efficacy in younger children is especially deplorable. Internal memoranda reproduced in the exposé by Dr. Jureidini and his colleagues give a clear picture of the corporate manipulation of the scientific publication process. Now we know – in black and white – just how bad the bias can be. This kind of data manipulation, with ad hoc cherry picking and moving of goalposts, is unacceptable, but it is entrenched. Indeed, it is business as usual – and the FDA looks away.
A Specific Proposal
Our primary defense against such perversions of scientific reporting is fidelity to the registered IND protocol and plan of statistical analysis. The solution is not hard to see: We need independent analyses of clinical trials because we cannot trust the corporate analyses. In effect, we need something like the Underwriters Laboratory to verify the statistical analyses of clinical trials. Nobody takes the manufacturing corporation’s word for it concerning the safety and performance of X-ray machines or cardiac defibrillators. Why treat the statistical analysis of drug trials any differently? It’s highly technical work.
Who should assume that responsibility? Why not the FDA? After all, they alone see all the data. My specific proposal is for Congress to mandate that the FDA analyze all clinical trials data strictly according to the registered protocols and analysis plans. That requirement should apply to new drugs or to approved drugs being tested for new indications. It should apply also to publications reporting new trials of approved drugs. Corporations and investigators should be prohibited from publishing their own in-house statistical analyses unless verified by FDA oversight.
Why Bother?
There are three good reasons for prohibiting in-house corporate analyses of clinical trials data. First, as the present example illustrates, the inherent conflict of interest is simply too great to be ignored. Second, when corporate statisticians who answer to marketing executives get “creative” in the ways exposed here, then the conditions for valid statistical analyses no longer apply – the statisticians are then on a fishing expedition and they are no longer testing the defined study question with fidelity to the methods specified in the IND protocol. In that case, any nominally significant statistical findings are just exploratory, not actionable – not good enough to justify off-label use of the drug, especially when properly evaluated alternatives are available.
Third, there can be no justification for treating the production of influential publications in medical journals any differently than we treat the production of potent drugs. Our FDA continuously inspects production facilities for evidence of physical adulteration, even as far away as China. They now need to monitor the adulteration of clinical trials reports in medical journals. The harms of adulterated analyses can be just as serious as the harms of adulterated products.
Push Back from Pharma?
We can expect the pharmaceutical industry to mount a First Amendment challenge to this proposal. It will fail, because the public health is too important. Just as there is no First Amendment right to shout fire in a crowded theater, so also corporations have no First Amendment right to say a drug is safe and effective when they know it isn’t. That is a betrayal of patients.
The corporations will also claim piously that their publications undergo peer review. Sadly, that is no barrier to this pervasive corporate bias because the peer reviewers for medical journals don’t see all the real data – they see only the data the corporation wants them to see. Only the FDA sees all the data. We can no longer cling to the myth of informed and unbiased peer review of clinical trials reports. The corporations rely on that myth as a fig leaf to support their First Amendment claims and to defend their practice of in-house statistical analyses. Moreover, medical journals also are subject to bias and conflict of interest. We could note that the Associate Editor of American Journal of Psychiatry in 2004 was also a major U.S. key opinion leader for Forest Laboratories. According to one of the released depositions, he was instrumental in securing acceptance of the report by the journal.
Business as Usual?
The present example is not an isolated case. Dr. Jureidini and his co-authors described several similar, recent examples. One of those was the reanalysis by Jureidini and others of an infamous trial of paroxetine for pediatric depression. And still, fresh exposés keep appearing. The latest is from Lisa Cosgrove at the University of Massachusetts in Boston and her colleagues, involving “ghost management of the information delivery process” for another new antidepressant drug, vortioxetine – available on-line here. (What is it with the antidepressants, anyway?) On this Health Care Renewal blog, Roy Poses has called attention to these issues. As recently as June 8, 2016 he discussedthe Transparency International report on corruption in the pharmaceutical sector.
Eric Topol, who helped to expose the Vioxx scandal, made similar points recently in a BMJ commentary: “The bad science in clinical trials has been well documented and includes selective publication of positive results, data dredging, P hacking, HARKing, and changing the outcomes that were prespecified at the beginning of the study….Furthermore, the disparity between what appears in peer reviewed journals and what has been filed with regulatory agencies is long standing and unacceptable.”
It’s No Time for Old Solutions
As the eye-popping numbers of children treated with escitalopram show, even off-label use of an undistinguished drug in a niche population can be highly profitable. That is why I am proposing that the statistical analysis of clinical trials data can no longer be entrusted to pharmaceutical corporations, on account of their massive inherent conflict of interest. Open access to patient level data, as well as pre-registration of protocols and of data analysis plans, have been actively promoted for some years now to clean up the corporate bias in clinical trials. These are positive developments, but they will not close the disconnection highlighted just above by Dr. Topol. The once idealistic world of clinical trials has changed irreversibly in the past 30 years. As one observer has noted, “… in the course of time the coordinated actions of industry, government, and the biomedical research community have degraded the basic rules of empirical science…” We would do well to acknowledge this fact, and to recognize with Abramson and Starfield that “The first step is to give up the illusion that the primary purpose of modern medical research is to improve Americans’ health most effectively and efficiently. In our opinion, the primary purpose of commercially funded clinical research is to maximize financial return on investment, not health.”
When corporations are involved, there is no point in prolonging the myth of noble and dispassionate clinical scientists searching for truth in clinical trials. It’s over. We would do better to stop pretending that corporate articles in medical journals are anything but marketing messages disguised with the fig leafs of coöpted academic authors and of so-called peer review. The case study reported out by Drs. John Jureidini, Jay Amsterdam, and Leemon McHenry shows us the real face of business as usual in commercial clinical trials. That being the case, it makes no sense to expect corporations and academic key opinion leaders suddenly to reform their biased and conflicted behavior. Only a structural change from the outside like I propose here has any chance of succeeding. The statistical analysis of clinical trials is too important to be entrusted to the sponsoring corporations.
It is time for Congress to grasp this nettle. The time for enforcement discretion is past, and we need Congress either to direct the FDA to act or to create a new mechanism of oversight. To do nothing would be unthinkable.
Bernard J. Carroll
Professor and Chairman Emeritus,
Department of Psychiatry,
Duke University Medical Center.
E-mail: bcarroll40@comcast.net
The writer is a former chairman of the Psychopharmacologic Drugs Advisory Committee, Food and Drug Administration, U.S Public Health Service.
Acknowledgment: Several colleagues commented and made suggestions on drafts of this post – in particular John M. Nardo, MD, Donald F. Klein, M.D., and Patrick Skerrett from STAT News.
Update 06-23-2016: This post was cross-posted on Naked Capitalism, where some interesting comments can be found.
A thousand apologies - since the Society for Medical Decision Making meeting in London, we have been traveling in the UK, and I have been unable to find the time to post on the blog. But in exchange we have caught up with good old friends, met lovely people, and seen fabulous sights and beautiful country. I plan to return very soon, and then after much catching up, will then resume normal activity.
But a reminder - a comment on our latest post suggested that Health Care Renewal does good work, but requires more effort.
Yet, all our blog posts are written by volunteers who have day jobs or are retired. At the moment, we have no real budget, no paid staff, no investigators, no researchers, no paid legal counsel, much less communications and public relations specialists. If more effort is required, it may have to come from YOU, dear readers. If you think that casting light on the issues we discuss is important, and taking action to improve health care dysfunction is more important, YOU also need to do something.
Of course, we would greatly appreciate contributions to FIRM - the Foundation for Integrity and Responsibility in Medicine, the tiny non-profit organization which we formed to provide support to the blog and similar dissemination, education and advocacy efforts to address health care dysfunction. FIRM is a US 501(c)3 non-profit and so contributions are deductible in the US to the extent provided by law. You can send contributions to FIRM at 16 Cutler St, Suite 104, Warren, RI, 02885, USA. Or email me (info at firmfound dot org) with questions.
If FIRM had real money, maybe we could develop a staff and do a lot more to shine light on the dark side. However, what is really required is effort by more than one organization and a few volunteer bloggers. Consider doing something yourself. Write a guest blog post for us, start your own blog, write a letter to the editor, an op-ed, or a journal article. Write your legislator. Meet with your legislator's staff. Organize a group of like minded people and do something organized. If you are a health professional, try to do your work in a way that will address health care dysfunction.
Howwever, do not expect it to be easy. There are many people personally enriching themselves through the current system. They will do all they can to preserve the status quo. They may command vast marketing, public relations, lobbying, and legal resources (all ultimately paid using other peoples' - often your - money) to maintain the status quo.
Saying something to combat the anechoic effect is hard. Doing something is harder. But if we don't do something, it will all get worse.
Transparency International (TI) defines corruption as
Abuse of entrusted power for private gain
In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.
the scale of corruption is vast in both rich and poor countries.
Also,
Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.
The report did not get much attention. Since then, health care corruption has been nearly a taboo topic in the US. When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries. On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.
Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here). But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries. Health Care Renewal was practically the only source of coverage in the US of the survey's results.
Transparency International's New Report on Corruption in the Pharmaceutical Sector
Now Transparency International (TI) has tried, and Health Care Reenewal will try again. In June, 2016 Transparency International published a new report entittled
Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.
In my humble opinion, the report is particularly significant in that it classifies as corrupt various kinds of activities that occur within the pharmaceutical sector (and also in other parts of health care) which are often discussed publicly as anything from standard operating procedure through unfortunate errors to unethical behavior. These include many activities which we have frequently discussed on Health Care Renewal. For example,
We have frequently discussed how pharmaceutical companies, and biotechnology, medical device, and other health care companies and organizations, may manipulate clinical research to enhance the likelihood that is results will favor their products and marketing goals, even if the results are biased, inaccurate, could mislead physicians and patients, and ultimately harm patients. The TI report included:
As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients.
We have frequently discussed how health care organizations (as above) may outright suppress clinical research when the results fail to support their interests. The TI report included:
Transparency and access to information through mandatory clinical trial registration, sanctions for not registering results or providing clinical trial information, and the publication of both positive and negative results are commonly discussed as helpful tools to curb corruption. With the European Medicines Agency (EMA) as a notable positive exception, public agencies and authorities do not require R&D-based pharmaceutical companies to make their raw data publicly available, making it impossible to verify whether the reported results are accurate. Based on laws and regulations clinical trial data is considered to be proprietary information, which allows pharmaceutical companies to conceal important data from the public domain.
Manipulation of the Dissemination of Clinical Research
We have frequently discussed how health care organizations may manipulate the dissemination of clinical research, through various forms of publications, presentations, courses, media summaries, etc, to favor their products and marketing goals, even if the results are misleading and could harm patients. For example, a while back we discussed the problem of "ghost-written" articles appearing in scholarly journals. The TI report included:
The practice of ghostwriting is also a risk with clinical trials. Ghostwriting involves the writing of clinical trial publications by industry and then having a highly esteemed researcher pass these findings off as their own without disclosing their actual involvement with the authorship of the article. It is a common practice, particularly in industry led trials. Ghostwriting is done to increase the prestige and reputation of the findings, while simultaneously researchers are able to improve their reputation, which can lead to promotions. Clearly this practice can result in inaccurate results being published.
Deceptive Marketing
We have frequently discussed how marketing of pharmaceuticals (and nearly everything else in health care) may be deceptive, favoring companies' products and services, but again misleading health care professionals and patients, and ultimately risking patient harm. In the extreme, pharmaceutical companies (and other health care organizations) may resort to bribes or kickbacks. The TI report included:
There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company’s medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences.
Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors’ prescribing habits and encouraging off-label, unlicensed use to increase sales.
Again, while the report summarizes information that is likely familiar to most Health Care Renewal readers, what is striking is that it describes manipulation of clinical research, suppression of clinical research, manipulation of dissemination of clinical research, and deceptive marketing as corruption. That is a sentiment rarely heard in the US, and one that appears nearly taboo.
Demonstrating the strength of the taboo, this striking report has gotten almost no attention in the media or scholarly medical and health care literature in the developed English-speaking countries. Let me note the important exceptions, however.
I learned of the report from a brief news item from the BMJ, the prestigious UK journal that seems most at the forefront of championing the integrity of medical and health care research.(1) The only substantial news article I could find on the report was also from the UK, in the Independent. Its sub-title is worth repeating:
Transparency International says corruption is making a few rich and wrecking the health of some of the world's poorest people
Also, there were brief articles in Reuters, and in (web-only) FiercePharma. That is about it so far.
The report itself suggests why it has been so anechoic, just like nearly every other attempt to expose health care corruption to public discussion. Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure. In the TI Report itself,
However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.
Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks. It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.
I might as well repeat myself once again. As I wrote in 2015,
If we are not willing to even talk about health care corruption, how will we ever challenge it?
So to repeat an ending to one of my previous posts on health care corruption.... if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption. Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage. Yet such action cannot begin until we acknowledge and freely discuss the problem. The first step against health care corruption is to be able to say or write the words, health care corruption.
Reference
1. Torjesen I. Group calls for more to be done to tackle corruption in the pharmaceutical industry. BMJ 2016;353:i3099. Link here.
Your smartphone allows you to get almost instantaneous answers to the most obscure questions. It also allows you to waste hours scrolling through Facebook or looking for the latest deals on Amazon. More powerful computing systems can predict the weather better than any meteorologist or beat human champions in complex board games like chess.
But for several years, economists have asked why all that technical wizardry seems to be having so little impact on the economy. The issue surfaced again recently, when the government reported disappointingly slow growth and continuing stagnation in productivity. The rate of productivity growth from 2011 to 2015 was the slowest since the five-year period ending in 1982.
Healthcare becomes the gravamen of the article:
One place to look at this disconnect is in the doctor’s office. Dr. Peter Sutherland, a family physician in Tennessee, made the shift to computerized patient records from paper in the last few years. There are benefits to using electronic health records, Dr. Sutherland says, but grappling with the software and new reporting requirements has slowed him down. He sees fewer patients, and his income has slipped.
Unfortunately, the advisors who helped him with the article may have provided incomplete information:
... “The government funding has made a huge difference,” said Dr. Ashish Jha, a professor at the Harvard School of Public Health. “But we’re seeing little evidence so far that all this technology has had much effect on quality and costs.”
Why would anyone expect (good) effects on "quality and costs" of healthcare when the technology is so unfit for purpose in design and implementation that it has alienated most of its users?
... "I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."
I do not think "political appeal" is a good justification for a multi-billion dollar cybernetic experiment in medicine, where the risks of the technology are considerable and where basic healthcare needs are not being well met among the poor and underprivileged.
Former ONC Chair David Brailer is quoted:
“People confuse information automation with creating the kind of work environment where productivity and creativity can flourish,” said Dr. David J. Brailer, who was the national health technology coordinator in the George W. Bush administration. “And so little has gone into changing work so far.”
Brailer was little better than Jha, and moves the goalposts with a type of circular logic. He appears to be saying that technology that will revolutionize medicine can't work until we change how things are done in medicine so the technology can revolutionize medicine.
The article then quotes one Tennessee physician, a Dr. Sutherland, who is "happy" to accept bad health IT, a resultant pay cut, and increased work:
... Today, Dr. Sutherland’s personal income and the medical group’s revenue are about 8 percent below where they were four years ago. But in 2015, both his earnings and the revenue of Healthstar, which employs 350 people in 10 clinics, increased slightly, by nearly 3 percent from 2014.
... Dr. Sutherland bemoans the countless data fields he must fill in to comply with government-mandated reporting rules, and he concedes that some of his colleagues hate using digital records. Yet Dr. Sutherland is no hater. Despite the extra work the new technology has created and even though it has not yet had the expected financial payoff, he thinks it has helped him provide better information to patients.
He values being able to tap the screen to look up potentially harmful drug interactions and to teach patients during visits. He can, for example, quickly create charts to show diabetes patients how they are progressing with treatment plans, managing blood glucose levels and weight loss.
He is working harder, Dr. Sutherland says, but he believes he is a better doctor. Blunt measures of productivity, he added, aren’t everything. “My patients are better served,” he said. “And I’m happier.”
While being able to provide fancy charts and check drug-drug interactions (for which a massive and expensive EHR is certainly not needed; a PDA will suffice) is fine.
However, anyone who gladly accepts a pay cut, and inconvenience, and harder work due to bad health IT, and is a happy camper with that state of affairs, either suffers from the Stockholm syndrome or has a lot of discretionary income and free time to spare that many clinicians do not.
From: S Silverstein To:Steve Lohr Date: Tue, Jun 7, 2016 at 10:02 AM Subject: Re: Why the Economic Payoff From Technology Is So Elusive
Dear Mr. Lohr,
In medicine, the answer to this question is straightforward. I don't know if Ashish Jha brought this to your attention, or if he himself is aware of it.
This letter from nearly 40 different medical societies to HHS about bad health IT is specific about how bad the current health IT is:
You should be aware of the letter's contents. I've also attached it to this email.
In academic Medical Informatics, such matters are often ignored, as they run contrary to the narrative that IT will "revolutionize medicine"; I know, as I was Yale faculty in Medical Informatics myself.
The assumption in academic circles and in the Administration (unfortunately) is that "all health IT is good health IT."
Unfortunately, it is not. From my own site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/ :
Definitions authored by myself and Australian informatics expert Dr. Jon Patrick:
Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.
Bad Health IT ("BHIT") is defined as 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, is lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.
It comes as no surprise not to find productivity gains, but instead hundreds of thousands of angry physicians (and nurses), when health IT is mostly bad IT.
The health IT industry itself needs serious remediation before its products will be a boon to medicine.
Background: Untrustworthy Clinical Practice Guidelines
Since the 1990s, clinicians have been exhorted to follow clinical practice guidelines (CPGs) to improve their decision-making and patients' outcomes. When Dr Wally Smith and I started teaching a short course (often at the Society for Medical Decision Making meetings) about changing physician behavior, we naively set out to improve decisions by increasing adherence to such guidelines. We first thought that physicians' apparent shortcomings in guideline adherence were due to their lack of knowledge of the guidelines and the underlying evidence, and to their human cognitive limitations.
That approach, however, failed to yield ways to improve adherence. After a while, it occurred to us that there might be other reasons physicians did not follow guidelines, including their lack of trust of the guidelines or the evidence supposedly incorporated within them. We learned that integrity of the clinical evidence base has been severely degraded due to the manipulation of clinical studies by those with vested interests, and the outright suppression of trials for which manipulation does not produce the desired results.
Furthermore, as we became less naive, we learned that the integrity of the guideline development process was also suspect, again due to the influence of those with vested interest. No wonder physicians were suspicious of guidelines, and resisted adhering to them.
In 2011, the prestigious Institute of Medicine released a report on the development of better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust. Link here.) We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect. The IOM report cited conflicts of interest (COIs) affecting the guideline development process as a major reason such guidelines might be untrustworthy, and suggested a variety of ways to reduce COIs affecting guidelines.
These included in particular: - Guideline committee members should disclose their conflicts of interest in detail, and these should appear in the guidelines (Standard 2.1, 2.2) - The number of conflicted committee members should be minimized, and in no case should be a majority of the committee (2.3, 2.4) - Funders should have no role in guideline development (2.4)
This week, an original article(1) and editorial(2) in PLoS Medicine discussed how guidelines published since the report was produced addressed conflicts of interest.
Article Summary
Below I summarized the article, but presented results somewhat differently than did the authors.
Design
Campsall et al did a cross-sectional study of clinical practice guidelines that appeared in the US Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse in 2012 from national or international organizations, excluding guidelines produced by organizations restricted to allied health professionals, guidelines produced by corporations, or guidelines that had no specific recommendations. They obtained information from the guidelines, the organizations' websites, and surveys sent to the organizations.
Study Population
The study population was 290 guidelines produced by 95 organizations. The response rate for the surveys was 68%. The organizations were primarily professional societies (67%) or disease advocacy groups (21%).
My comment is that therefore this study assessed guidelines mainly produced by non-profit organizations which ostensibly uphold health care professionals' values and/or primarily support patients' interests.
Industry Funding
63% of organizations reported receiving funds from biomedical companies. (It was not clear whether the remainder denied receiving such funding, or provided no information about funding.)
My comment is that the majority of such ostensibly "do-gooder" organizations are nonetheless at least somewhat supported by commercial firms that market health care products, presumably mainly drugs or devices.
Conflict of Interest Policies
Please note that the authors provided results to emphasize the positive, for example, they provided the proportion of organizations which provided specific types of information about COIs or had particular policies to reduce COIs. In most cases, I simply did subtractions to emphasize the negative. Furthermore, the authors further emphasized the positive by choice of denominator, as noted below.
20% of organizations did not provide any information about conflict of interest policies, and 7% asserted the existence of such policies, but did not disclose them. A majority, 55%, did not have disclosed policies that specifically dealt with with conflicts of interest affecting guidelines.
My comment is thus that a majority of these do-gooder organizations did not apparently even begin to address, at least in terms of clear, transparent written policy, the recommendations of the IOM report on trustworthy guidelines.
Measures to Improve Guidelines Trustworthiness by Decreasing Influence of Conflicts of Interest
The authors provided the number of organizations with disclosed policies that addressed particular issues of concern to the IOM in their report on trustworthy guidelines, but made the proportions of such organizations seem larger by using as a denominator the number of organizations that disclosed their entire policies, rather than the total number of organizations which produced the guidelines.
Therefore, they found that of the 60 (out of 95 total) organizations that fully disclosed their conflict of interest policies: 98% required committee members to disclose conflicts of interest; 90% required review of conflicts of interest before guideline publication; 68% required that a majority of guideline committee members be free of conflicts of interest; 92% reported publishing committee members' conflicts of interest within guidelines; 78% did not allow direct industry funding of guideline development 82% did not allow industry participation in selection of committee members 67% did not allow industry to review guidelines prior to publication.
That all sound good, but consider what happens when one uses the total sample of organizations in the denominators.
Therefore, the article also found that of all 95 organizations that produced the guidelines of interest:
38% did not require CPG committee members to disclose conflicts of interest 43% did not require review of committee members' conflicts of interest prior to guidelines development 57% did not require that a majority of guideline committee members be free of conflicts 44% did not report publishing committee members' conflicts of interest within guidelines 48% did not report preventing direct industry funding of guidelines 51% did not report preventing industry participation in selection of committee members 61% did not report preventing industry review of guidelines prior to publication.
My comment is that thus the results suggested that substantial numbers of organizations that produced CPGs did not demonstrate that they were committed to measures that would improve guidelines trustworthiness by reducing the influence of conflicts of interest.
Disclosure of Conflicts of Interest Within Guidelines
Again, it was necessary to recalculate some proportions using the full population of guidelines reviewed as the denominator.
Of the 290 guidelines reviewed: 65% "included disclosure statements regarding direct funding and support" 37% specifically disclosed the absence or presence of direct funding from biomedical companies However, 49% did not disclose committee members' financial relationships 99% did not disclose relevant financial relationships of the organization (that is, institutional conflicts of interest) that produced the guidelines as a whole
My comment is that substantial numbers of published guidelines were not clearly produced so as to increase their trustworthiness by reducing the influence of conflicts of interest on them.
Did the Guidelines Follow the Organizations' Stated Policies?
The authors commendably provided information about whether the guidelines produced by organizations that disclosed conflict of interest policies followed those polices. They found:
16% of organizations "that reported that committee member conflicts of interested were published in guidelines" produced guidelines that did not include committee members' COI disclosure
61% of organizations that "reported the majority of committee members must be free of conflicts of interest" produced guidelines by committees with majorities of conflicted members
6% of organizations that "reported that industry partners were not permitted to directly fund clinical practice guideline development" produced guidelines which disclosed such funding.
My comment is that thus even of the organizations that stated they had policies in place to improve the trustworthiness of the guidelines they produced by reducing the influence of conflicts of interest, they allowed guidelines to be produced that did not follow those policies.
Authors' Conclusion
Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appear to be common. These relationships are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers. We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies.
Editorialists' Conclusion
The editorial by Bastian(2) was sharper in tone. It included an observation that reinforced my confession of naivete above:
With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It seemed so self-evident, it got barely a mention even in national policy on guideline development
She also noted that the Campsall study did not address all the ways conflicts of interest can influence guideline development:
Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients’ organizations.
She noted that the failure of guidelines to report their developers' conflicts of interest is a continuing problem. The rate of failure to report found by Campsall et al was
about the same rate that Taylor and Giles found in 2004 and Norris and colleagues found in 2010.
Finally, she emphasized that we are still a long way from having guidelines that health care professionals and patients can trust:
Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it’s a case of caveat lector: let the reader beware.
My Summary
So should physicians trust clinical practice guidelines? At least this article suggests they ought to be very very skeptical of them. The IOM report meant to improve the trustworthiness of practice guidelines seems to be honored mainly in the breach. The likelihood that any given guideline was produced so as to reduce the influence of conflicts of interest on it is low. Even organizations that ostensibly put professional values and patients first in their efforts to develop guidelines seem to often be financially beholden to companies that want to sell drugs and devices. Physicians and patients ought to be concerned that most new clinical practice guidelines may be as much about marketing commercial products as improving medical practice or patients' outcomes.
The current US presidential race has made it evident that we have a lot of disgruntled citizens, many of whom believe our system is rigged to favor the "establishment." I suggest that the more we know about clinical practice guidelines, the more it appears that the health care system is rigged to favor certain parts of the "establishment," the big corporations that market drugs and devices, and their paid part-time hands within medical societies and patient advocacy groups who have turned these ostensibly idealistic, do gooder organizations into part-time marketing machines.
The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system. True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.
Musical Interlude
To dispel the darkness a bit, Paul Simon, "Still Crazy After All These Years," 1992 acoustic version:
References
1. Campsall P et al. Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study. PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002029 Link here.
2. Bastien H. Nondisclosure of financial interest in clinical practice guideline development: an intractable problem? PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002030 Link here.
