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Thursday, 29 January 2015

Princess Health and CMS: Millions of patients across the nation are benefiting from the - um - potential - of Health IT?. Princessiccia

I presume this is, in part, a response to the Jan. 21 letter from AMA and the other medical societies as I wrote about two days ago at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html:

CMS intends to modify requirements for Meaningful Use
http://blog.cms.gov/2015/01/29/cms-intends-to-modify-requirements-for-meaningful-use/

January 29
By Patrick Conway, MD

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce our intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in 2015. These intended changes would help to reduce the reporting burden on providers, while supporting the long term goals of the program.

Read the document at the link above.

Note in particular this cheerful statement:

Since the first year of the EHR Incentive Programs in 2011, the United States has seen unprecedented growth in the adoption and meaningful use of EHRs. To date, more than 400,000 eligible providers have joined the ranks of hospitals and professionals that have adopted or are meaningfully using EHRs. This means that millions of patients across the nation are benefiting from the potential of better coordinated care among professionals, more accurate prescribing, and improved communication.

How does one, I ask, benefit from "potential of better care"?

How about the more factual "millions of patients are being put at risk and actually being harmed by the non-potential, but in fact actual, flaws in the technology?"

Until our leadership stops the mental cheerleading like this (or is it a form of subliminal messaging?), which blinds the uninformed to the reality ... the situation with healthcare IT will not improve, in my opinion.

And this after a formal letter of complaint about health IT disruptions to care, dangers, etc. from these organizations:

American Medical Association
AMDA � The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology�Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery

-- SS

Addendum 1/30/15:

Also see my April 26, 2014 post "Followup to CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" at http://hcrenewal.blogspot.com/2014/04/followup-to-cms-does-not-have-any.html with its attached March 2014 lettert from CMS. This document was obtained by the American Association of Physicians and Surgeons (AAPS) via FOIA on the "potential" benefits patients are realizing from the hundreds of billions of dollars spent on this technology to date:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives." [But millions of patients are already benefiting from the potential!] Click to enlarge.

-- SS

Wednesday, 28 January 2015

Princess Health and None Dare Call It Health Care Corruption . Princessiccia

anechoic effect bribery cancer Columbia University crime fraud health care corruption

Gusty 09:15 Add Comment

... even when allegedly a prominent academic physician's traded referrals of cancer patients to a law firm, resulting in referral fees to a prominent politician who worked for the firm, for government research grants to the physician's foundation and another foundation on whose board he sat, and a job for his son at yet another non-profit organization.
***

Health care corruption, remains a largely taboo topic, especially when it occurs in developed countries like the US. Searching PubMed or major medical and health care journals at best will reveal a few articles on health care corruption, nearly all about corruption in less developed countries far away from where the authors live. When the media may publish stories about issues related to health care corruption, they are almost never labelled as such.

For example, last year we discussed two widely reported cases of alleged political corruption. One included allegations that a company producing a supposedly anti-inflammatory dietary supplement bribed Robert McDonnell, the former Governor of Virginia. Mr McDonnell was later convicted and sentenced to two years in jail for public corruption (look here). Another included allegations that Rick Perry, the former Governor of Texas abused his power by cutting funding of the state anti-corruption unit, which was investigating whether the Texas Cancer Research and Prevention Institute was awarding grants based on political influence rather than clinical and methodological merit. The reporting of both cases underplayed the health care aspects, and never mentioned health care corruption, or words to that effect.

Yet Transparency International's report on global health care corruption suggested health care corruption occurs in all countries. A recent TI survey showed that 43% of US citizens believe the country has a health care corruption problem (look here). Perhaps some US citizens have been reading between the lines, or have personal experiences with health care corruption. However, as long as we cannot talk about this problem openly, there is no chance it will be solved.

In January, 2015, a case of apparent political corruption made headlines. It turns out to also be a case of apparent health care corruption.

New York Assembly Speaker Sheldon Silver Charged with Fraud, Extortion, and Receiving Bribes

In late January, 2015, from early reporting by the Capital New York,

The federal corruption case against Assembly Speaker Sheldon Silver rests in part on his alleged scheme with a doctor who referred asbestos cases to the Weitz & Luxenberg law firm where Silver is of counsel.

A criminal complaint from U.S. Attorney Preet Bharara alleges that Silver obtained referrals of asbestos
cases from a doctor affiliated with a university in Manhattan, referred to as 'Doctor-1,' by using his position as speaker to quietly direct $500,000 in state funds to the doctor's research and give 'additional benefits' to the doctor and the doctor's family.

The Doctor-1 described in the criminal complaint appears to be Dr. Robert Taub of Columbia University, based on details outlined in the criminal complaint, and confirmed by a secretary at his office and separately by a knowledgeable source. Taub specializes in mesothelioma research, for which it is hard to find research funding.

Regarding the advantages gained by Mr Silver,

Silver allegedly received millions of dollars in referral fees from Weitz & Luxenberg, and was credited with referring more than 100 clients, many of whom were referred for asbestos cases, according to the complaint.

The firm paid Silver $3.2 million for referrals related to asbestos cases between 2003 and 2014, according to the complaint. Prosecutors claim that several of those asbestos clients said they had been referred to Doctor-1 for treatment, and said the doctor had also recommended they retain Weitz & Luxenberg as their counsel.

Regarding the benefits to Dr Taub,

The complaints say the scheme began when the doctor allegedly asked Silver if his firm would help fund mesothelioma research and Silver declined. But prosecutors claim the doctor became aware that Silver wanted him to refer asbestos patients to Silver and the law firm for counsel, in exchange for funding for his medical research.

Doctor-1 started referring patients to Silver, and Silver began directing state funding to the doctor's research, the complaint alleges.

In December 2003, Doctor-1 requested a $250,000 grant from Silver to establish a Mesothelioma center at a university, according to the complaint. The complaint also says that the request was granted, and Silver approved payment from a pool of discretionary funds paid for by health care-related assessments that was under Silver's sole control until the year 2007.

Silver later directed another grant from the same pool of funds, also worth $250,000, to the Mesothelioma Center.

In 2008, the speaker directed a further $25,000 discretionary member item grant to a not-for-profit where the doctor was a board member, according to the complaint.

In 2012, the complaint alleges that Doctor-1 asked Silver for help in finding a family member a job with a nonprofit organization that 'received millions of dollars in member items and capital funding from Silver.'

A New York Times article verified that "Doctor-1" was Dr Robert N Taub, a previously highly reputed academic.

In the criminal complaint against Sheldon Silver, he is identified simply as �Doctor-1.�

But Dr. Robert N. Taub, who headed a Columbia University center dedicated to curing a rare form of cancer caused by asbestos, is no ordinary doctor.

Also,

In 2002, Dr. Taub created one of the nation�s few mesothelioma research hubs, the Columbia University Mesothelioma Center. He was also active in an organization that raised money for research, sitting on the scientific advisory board of one of the few nonprofits created to help victims, the Mesothelioma Applied Research Foundation. The foundation, which awards research grants, relies heavily on gifts from law firms.

Finally, the NY Times story identified Dr Taub's family member who got a job through Mr Silver's intervention,

According to the complaint and people briefed on the investigation, Dr. Taub also asked Mr. Silver in 2012 to help his son, Jonathan, find a job. The speaker arranged for an interview at OHEL Children�s Home and Family Services, a social services organization based in Brooklyn that had received millions of dollars in state funds from Mr. Silver.

After the allegations were made public, the NY Times also reported that Dr Taub "is leaving his position as head of a Columbia University cancer center, and the center is being disbanded," and the New York Post reported that Mr Silver is stepping down from his position as Speaker of the NY Assembly.

Political Corruption Highlighted, Health Care Corruption Ignored

Corruption as defined by Transparency International is abuse of entrusted power for private gain. Thus TI does not limit the term to cases involving politicians or government. Clearly, the allegations above were for corruption in this sense, and that corruption involved health care.

Furthermore, the alleged facts in the case implied,
- Dr Taub abused his patients' trust in him by directing them to Mr Silver's firm, whether or not that was the best choice for these patients
- Dr Taub abused the trust he inspired as a medical researcher by trading referral of his patients for government research grants
- Dr Taub personally profited from these arrangements by obtaining a job for his family member, and a grant for another (non medical research) foundation on whose board he sat.
- By directing grants to Dr Taub's research foundation, and the foundation on whose board Dr Taub sat, Mr Silver allocated scarce research funding for private gain, rather than for clinical, public health, or scientific reasons.

However, the coverage of the charges against Mr Silver, and particularly those relating to Dr Taub, was solely in terms of political corruption. While the media reported the facts related to health care, there was no mention of health care corruption.

Even the pithy op-ed on the case by Prof Zephyr Teachout, now widely known for her expertise in corruption, and for increasing awareness of the importance of corruption in modern US society, did not mention health care corruption. Her op-ed did note the earlier case of former Virginia Governor McDonnell,

As with the recent conviction of the former Virginia governor Bob McDonnell for receiving improper gifts and loans, a fixation on plain graft misses the more pernicious poison that has entered our system.

However, Professor Teachout did not note that these gifts and loans resulted from Governor McDonnell using his influence to market a supposed anti-inflammatory nutritional supplement.

Summary

Professor Teachout has decried how the definition of corruption has narrowed.

A fixation on plain graft misses the more pernicious poison that has entered our system.

However, our system is poisoned not only by political, but by health care corruption.

However, when health care corruption is clearly the issue, the news media will not use that term. Only when the corruption is occurring far away, usually in a supposedly benighted less developed country, will the news media or the scholarly medical, health care, and health policy literature discuss it as such. So the anechoic nature of health care corruption has not changed since my post of August, 2014.

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.

ADDENDUM (29 January, 2015) - This post was reposted on Naked Capitalism.

Princess Health and "Meaningful Use" not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing. Princessiccia

AMIA healthcare IT dissatisfaction healthcare IT safety Kaizen Event Karen De Salvo management mysticism MAUDE meaningful use

Gusty 06:02 Add Comment

The "Meaningful Use" program for EHRs is a mismanaged boondoggle causing critical issues of patient safety, EHR usability, etc. to be sidestepped.

This is on top of the unregulated U.S. boondoggle which should probably be called "the National Programme for IT in the HHS" - in recognition of the now-defunct multi-billion-pound debacle known as the National Programme for IT in the NHS (NPfIT), see my Sept. 2011 post "NPfIT Programme goes PfffT" at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.

The complaints are not just coming from me now.

As of January 21, 2015 in a letter to HHS at: http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf, they are now coming from the:

In the letter to Karen B. DeSalvo, National Coordinator for Health Information Technology at HHS, these organizations observe:

Dear Dr. DeSalvo:

The undersigned organizations are writing to elevate our concern about the current trajectory of the certification of electronic health records (EHRs). Among physicians there are documented challenges and growing frustration with the way EHRs are performing. Many physicians find these systems cumbersome, do not meet their workflow needs, decrease efficiency, and have limited, if any, interoperability.

Of course, my attitude is that we need basic operability before the wickedly difficult to accomplish and far less useful (to patients) interoperability.

... Most importantly, certified EHR technology (CEHRT) can present safety concerns for patients. We believe there is an urgent need to change the current certification program to better align end-to-end testing to focus on EHR usability, interoperability, and safety.

Let me state what they're saying more clearly:

"This technology in its present state is putting patients at risk, harming them, and even killing them, is making practice of medicine more difficult, is putting clinicians at liability risk, and the 'certification' program is a joke."

... We understand from discussions with the Office of the National Coordinator for Health Information Technology (ONC) that there is an interest in improving the current certification program. For the reasons outlined in detail below, we strongly recommend the following changes to EHR certification:

1. Decouple EHR certification from the Meaningful Use program;
2. Re-consider alternative software testing methods;
3. Establish greater transparency and uniformity on UCD testing and process results;
4. Incorporate exception handling into EHR certification;
5. Develop C-CDA guidance and tests to support exchange;
6. Seek further stakeholder feedback; and
7. Increase education on EHR implementation.

Patient Safety
Ensuring patient safety is a joint responsibility between the physician and technology vendor and requires appropriate safety measures at each stage of development and implementation.

I would argue that it's the technologists who have butted into clinical affairs with aid from their government friends, thus the brunt of the ill effects of bad health IT should fall on them. However, when technology-related medical misadventures occur, it's the physicians who get sued.

... While training is a key factor, the safe use of any tool originates from its inherent design and the iterative testing processes used to identify issues and safety concerns. Ultimately, physicians must have confidence in the devices used in their practices to manage patient care. Developers must also have the resources and necessary time to focus on developing safe, functional, and useable systems.

Right now, those design and testing processes compare to those in other mission-critical sectors employing IT quite poorly.

Considering fundamental stunningly-poor software quality that I've observed personally, such as lack of appropriate confirmation dialogs and notification messages supporting teamwork, lack of date constraint checking (see my report to FDA MAUDE at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552 and many others at http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and other fundamentals, I would say grade schoolers could probably have done a better job of safety testing than the vendors and IT amateur-implementers of the major systems I observed did.

... Unfortunately, we believe the Meaningful Use (MU) certification requirements are contributing to EHR system problems, and we are worried about the downstream effects on patient safety.

In other words, computers and the government thirst for data do not have more rights than patients. In the current state of affairs, as I have observed prior, computers do seem to have more rights than patients and the clinicians who must increasingly use them.

... Physician informaticists and vendors have reported to us that MU certification has become the priority in health information technology (health IT) design at the expense of meeting physician customers� needs, patient safety, and product innovation. We are also concerned with the lack of oversight ONC places on authorized testing and certification bodies (ATCB) for ensuring testing procedures and standards are adequate to secure and protect electronic patient information contained in EHRs.

Not just security, but patient safety also. See for example my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'" at http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html.

Read the entire letter at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.

Sadly, while on the right track regarding the problems of bad health IT, the societies take a Milquetoast approach to correction:

... In May 2014, stakeholders representing accredited certification bodies and testing laboratories (ACB & ATL), EHR vendors, physicians, and health care organizations provided feedback to ONC on the complexities of the current certification system. Two main takeaways from these comments were for ONC to host a multi-stakeholder Kaizen event and to prioritize security, quality measures, and interoperability in the EHR certification criteria. We strongly support both of these ideas...

A multi-stakeholder "Kaizen event'? (http://en.wikipedia.org/wiki/Kaizen)

That's one recommendation I find disappointing. The industry plays hard politics, and organized medicine wants to play touchy-feely "good change" management mysticism with that industry and their government apparatchiks. That's how organized medicine wants patients and the integrity of the medical profession to be protected from the dysfunctional health IT ecosystem (see http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem)?

When I originally created my old website called "Medical informatics and leadership of clinical computing" back in 1998, Kaizen events were not exactly what I had in mind.

Finally, the American Medical Informatics Association (http://www.amia.org) was apparently not informed of this letter, nor did it participate in its drafting. While this is regrettable, as the organization is the best reservoir of true Healthcare Informatics expertise, I opined to that group that this may have been due to the organization's tepid response to bad health IT and to industry control of the narrative, and the problems these issues have caused for physicians and other clinicians. The lack of AMIA leadership regarding bad health IT is an issue I've been pointing out since the late 1990s. AMIA has been largely a non-critical HIT promoter. That stance has contributed to the need for this multiple-medical specialty society letter in the first place.

Parenthetically, and for a touch of humor about an otherwise drab topic: Here's an example of how management mysticism plays out in pharma.

It's meant to be satirical, but captures reality all too well, in fact scarily so at times:

Management mysticism and muddled thinking. See https://www.youtube.com/watch?v=kwVjftMMCIE

In pharma, as well as in hospital IT in my days as CMIO, gibberish like this was real. I imagine it's no different in many hospital management suites these days.

-- SS

1/28/2015 Addendum:

Per a colleague:

FierceHealthIT (1/28) reports, �It�s time for the American Medical Association and more than 30 other organizations urging change in the electronic health record certification process to be part of the solution, former Deputy National Coordinator for Health IT Jacob Reider said in a blog post.� Reider said, �So far, I don�t see much [any?] engagement from the AMA or the others who signed the letter. It�s relatively easy to write a letter saying someone else is responsible for solving problems. Time to step up to the plate and participate in the solutions, folks!"

Regarding the victims of compelled use of bad health IT, this erstwhile health IT leader opines "It's relatively easy to write a letter saying someone else is responsible for solving problems?"

That is simply perverse.

I ask: why are we in the midst of a now-compelled national rollout with Medicare penalties for non-adopters when a former government official once responsible for the technology remarks that it's apparently not the makers' problem and that it's "time to step up to the plate and participate in the solutions, folks [a.k.a. end users]!"

(One wonders if Reider believes those who step up to the plate are entitled to fair compensation for their aid to an industry not exactly known for giving its products away, free.)

It seems to me it's not up to (forced) customers to find solutions to vendor product problems, some deadly.

It's the responsibility of the sellers.

Put more bluntly, Reider's statement is risible and insulting.

I've already opined the following to the AMA contact at the bottom of the letter:

... Relatively milquetoast approaches such as multi-stakeholder Kaizens are not what I had in mind ... A more powerful stance would be to advise society members to begin to avoid conversion, report on bad health IT, and even boycott bad health IT until substantive changes are realized in this industry.

That's "stepping up to the plate" to protect patients, in a very powerful way.

-- SS

Tuesday, 27 January 2015

Princess Health and Is Meat Unhealthy? Part VII. Princessiccia

vegetarian

Gusty 22:38 Add Comment

Looking at individual diseases is informative, but it can cause us to become myopic, making broad health-related decisions based on narrow information. It can cause us to miss the forest for the trees. In this case, the "trees" are individual diseases and the "forest" is total mortality: the overall risk of dying from any cause. Does eating meat increase total mortality, shortening our lifespans?

Non-industrial cultures

Traditionally-living cultures such as hunter-gatherers and non-industrial agriculturalists are not the best way to answer this question, because their mean lifespans tend to be short regardless of diet. This is due to ~30 percent infant mortality, which drags down the average, as well as a high risk of death in adulthood from infectious disease, accidents, and homicide/warfare. It can also be difficult to accurately measure the age of such people, although there are reasonably good methods available.

However, there are semi-industrialized cultures that can help us answer this question, because they feature a somewhat traditional diet and lifestyle, combined with modern medicine and the rule of law. The so-called Blue Zones, areas of exceptional health and longevity, fall into this category. These include Sardinia, Italy; Okinawa, Japan; Loma Linda, California; Nicoya Peninsula, Costa Rica; and Icaria, Greece.

Read more �

Friday, 23 January 2015

Princess Health and Food Reward Friday. Princessiccia

Food reward Fridays

Gusty 10:43 Add Comment

This week's lucky "winner"... barbecue ribs!!

Wednesday, 21 January 2015

Princess Health and Logical Fallacies in Defense of Aggresive Screening for and Treatment of Hepatitis C. Princessiccia

anechoic effect evidence-based medicine hepatitis c logical fallacies Sovaldi

Gusty 12:37 Add Comment

And the hepatitis C follies continue...

As we have frequently written, most recently last week, the hepatitis C screening and treatment bandwagon keeps rolling along. There is constant public argument about the prices of treatment regimens, which approach $100,000 per patient in the US. However, nearly all the public chatter, which seems mostly to come from corporate public relations people and marketers, investors and investment advisers, physicians with financial conflicts of interest, and pundits with little background in clinical epidemiology, seems never to question the assumption that the new drugs for hepatitis C are miraculous cures, which, of course, makes it hard to argue that they should not cost royal amounts.

The Lack of Good Evidence for the New Hepatitis C Treatments

However, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous. The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
- The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
- There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
- There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure.
- While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns. These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally. (See posts here, here, and here.)

Yet the lack of evidence, and the discussion up to last week of this lack of evidence, was mostly anechoic. The public argument continued to be based on the assumption that new treatments of hepatitis C are miraculous.

The BMJ Elicits An Interesting Response

Last week the British Medical Journal provided the first opportunity for a large audience to be exposed to skepticism about the hepatitis C bandwagon. As we discussed here, the article by Koretz et al(3) based an affirmation of the four points above on a critical examination of the evidence.

The article, and even our blog post about it, seem less anechoic than the previous articles and blog posts mentioned above. At least a few commentators were inspired to a defense of the currently received wisdom. However, in my humble opinion, the commentators mainly succeeded in demonstrating how received wisdom is often supported by illogic.

Defending the Received Wisdom with Logical Fallacies - Analysis of an Anonymous Comment

Let me start with examples derived from dissecting the arguments of the first anonymous comments we received on our blog post.

Examples of the Straw Man Fallacy

The commentators arguments included,

The article suggests that the INF+RBV therapy is just as good as Harvoni,

Note that whether by "the article" the commentator meant the article by Koretz et al,(3) or the blog post on Health Care Renewal was not clear. In any case, neither made a statement to that effect. Incidentally, I am not aware of any trial that directly compared Harvoni to some combination of interferon and ribavirin.

Both Koretz et al and I did refer to the ONLY trial in which one of the new antiviral drugs (sofosbuvir) was directly compared to peg-interferon and ribavirin.(4) I discussed that trial in detail here ( http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html) It showed no significant difference between the sustained viral responses at 12 weeks produced the two regimens. As far as I can tell, there is NO evidence from any controlled trial that the new drugs are more effective than the old drugs.

So the commentator's argument was based on a misstatement of either Koretz and colleagues' or my argument. In any case, it is therefore an example of a logical fallacy, the straw man fallacy. The commentator was not arguing with something we wrote, but rather a straw man assertion which the commentator constructed.

The commentator also said,

the claim that INF+RBV causes adverse effects in less than 1% of treated is just false,

Again, neither Koretz et al nor I wrote that. So this began another argument based on the straw man logical fallacy.

Koretz et al and I again referred to data from the Lawitz et al controlled trial. That trial did suggest that the new drug produced more, not less severe adverse effects than the old drug.

The Red Herring Fallacy

The commentator wrote,

The statement that most patients will not go on to severe liver damage/liver cancer is unproven.

Presumably, this meant most patients with untreated hepatitis C will not go on to severe liver disease/ cancer. This, however, is a statement about the natural history of a disease. How a statement about disease prognosis could be "proven," however, is not clear. It is not ethically easy, or perhaps possible, to do an experiment to prove the natural history of disease. Our knowledge of prognosis therefore relies on observational studies. While such studies can show association, they cannot prove causation. So it is true that the prognosis of hepatitis C is unproven, but in practical terms it cannot be proven, or unproven. While the commentator implied that longer term studies would show that patients have very bad outcomes, but no one knows that with certainty. Thus, the assertion seems to be an example of a red herring, bringing up an irrelevant point to distract from the issue.

Appeal to Authority

The commentator wrote,

SVR12 is a commonly accepted evidence for complete eradication of the virus

So the argument was that some people, perhaps, as was said at the conclusion of �Raiders of the Lost Ark,� top men believe that SVR means complete cure.

Why anyone believes that SVR12 means cure, and particularly whether this belief is based on evidence and logic was not explained. Just because some people, even top men, believe it does not mean it is true. Thus this assertion is an example of another logical fallacy, an appeal to authority. By the way, there are plenty of people, including Koretz et al, who do not believe this.

ADDENDUM (27 January, 2015) - I have now independently verified that the comments made on our blog by "anonymous" were made by a patient, and were made honestly, not cynically. Furthermore, English is not the patient's first language, so he or she may have used English words such as "unproven" and "commonly accepted" somewhat differently than I understood.

More Logical Fallacies in the BMJ Rapid Responses

Similarly, the article by Koretz et al has generated a few rapid responses which contain their own share of logical fallacies. Some examples follow from comments through January 19, 2015.

Begging the Question and the Burden of Proof Fallacy

In the January 15, 2015 comments by Donna R Cryer

[The article by Koretz et al] severely undervalues the harms, to the individual and society, of active HCV infection. Reduction or avoidance of end stage liver disease or death are not the only appropriate measures of value of screening or the effectiveness of new medications.

Ms Cryer did not state what the values of the harms are, nor what the other appropriate measures might be, and provided no evidence for either assertion. So this boils down to, "you are wrong and I am right." More formally, this could be an example of begging the question, that is, an argument - in this case that screening is warranted - simply based on assumptions without explanation or supporting evidence. On the other hand, this could also be an argument of the burden of proof fallacy. Ms Cryer implies that Koretz et al must prove their conclusions, while she simply needs to assert hers.

Appeal to Fear

Again from Cryer,

To propose that widespread birth cohort screening efforts be undermined is a disservice to every individual living, unknowingly, with the silently devastating disease that is hepatitis C.

Note that this sentence again appears to include begging the question, with the assertion that hepatitis C is "silently devastating," without explanation or supporting evidence, and the burden of proof fallacy, since it implicitly rejected Koretz and colleagues' argument that hepatitis C is not devastating to all patients, which was based on at least some evidence, without supplying any evidence that it is devastating. Furthermore, this has an element of an appeal to fear in its use of the emotionally loaded word, "devastating." Note that Koretz et al instead talked about specific complications of hepatitis C.

Wishful Thinking

In the January 18, 2015, comments by Nowlan Selvapatt

newer regimes will ultimately improve pricing competition and sustained virologic response rates compared to interferon based therapies.

The author did not explain why these improvements will occur. This could be another example of begging the question. On the other hand, it also could be wishful thinking, which at least some people consider a logical fallacy as well as a cognitive bias. Obviously, it would be nice for the newer treatments to achieve better results at lower prices in the future, but the future is not so predictable.

An even more explicit example of wishful thinking, alsoby Selvapatt, was,

The hope would be that ... [screening] would serve to reduce the economic and healthcare pressures associated with end stage liver disease caused by hepatitis C.

That would be the hope, certainly, but should the decision to screen be based on hope, or on evidence and logic.

Appeal to Authority

In the January 19, 2015, comments by Padmanabhan Badrinath

Regarding side effects Koretz et al state 'However, in a trial of sofosbuvir versus peginterferon plus ribavirin, 3% of participants taking sofosbuvir experienced serious adverse events compared with 1% in the peginterferon plus ribavirin arm (difference not significant)'. According to NICE 'Evidence Review Group (ERG) was satisfied that the evidence showed that treatment with sofosbuvir-based regimens was generally well tolerated and led to fewer adverse events than treatment with peginterferon alfa and ribavirin'.

Note that Koretz et al provided data, and again, that from the only clinical trial that compared a new drug (sofosbuvir) to an old drug, peg-interferon. However, Badrinath contrasted that evidence with conclusions from the NICE report that were about apparently any, rather than just severe adverse events, and Badrinath did not provide any justification of or evidence supporting these conclusions. While NICE is admittedly often considered to be pretty authoritative, simply stating its conclusions in the absence of evidence to refute Koretz's presentation of evidence amounts to an appeal to authority.

Summary

So it appears that the BMJ article on hepatitis C rendered the skepticism about the miraculous qualities of the innovative new antiviral drugs for hepatitis C less anechoic. However, the response to these echoes seems to have been enriched with illogic.

So it goes in the brave new world of health care. In the current money driven system, new "innovations" touted as miraculous constantly appear. When a few skeptics question the evidence or logic supporting these claims, these doubts usually start as anechoic. If the doubts are more widely expressed, the first line of defense seems to be often based on logical fallacies. We most recently saw such fallacies deployed defending another drug, sacubitril, touted as miraculous from annoying skeptics.

Health care professionals, health care policy makers, and the public at large should not be swayed by illogic. Our continuing series about how logical fallacies are used to support the status quo and the powers that be in health care suggests, if nothing else, that health care professional education ought to include courses in logic.

References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Inte Med 2014. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3. Koretz RL, Lin KW, Ioannidis JPA, Lenzer J. Is widespread screening for hepatitis C justified? Br Med J 2015; 350: g7809. Link here.
4. Lawitz E, Mangia A, Wyles D et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887. Link here.

Monday, 19 January 2015

Princess Health and Making the Arc of the Moral Universe Bend . Princessiccia

Gusty 12:13 Add Comment

On this day, the US celebrates the legacy of the Rev Martin Luther King Jr.

Martin Luther King Jr once famously addressed the question of how long it would take to achieve some measure of real equality in the US (in the "Our God is Marching on Speech.") He stated,

the arc of the moral universe is long, but it bends towards justice.

In context, he clearly meant that such bending was possible when people devoted hard work and concerted action toward this end. Rev King was hardly one to sit back and passively expect good things to happen. However, as pointed out in the Huffington Post entry by Christ Weigant, this sentence has often been taken out of context to justify passivity, and argue that we need not discomfit ourselves too much to achieve justice.

I have heard it used that way in the health care sphere, to justify collaboration with industry in areas where management's typical thrust to achieve quick revenue may lead to interests very different from those of medical professionals. (We have posted frequently about conflicts of interest, and institutional conflicts of interest in health care, and how justification for such "collaboration" is often based on logical fallacies.)

So on this day, I urge you to think about how hard it may be to make health care more just, but how necessary it is to push on regardless.