Limits to Personalized Cancer Medicine

As money is prepared to be poured into personalized cancer medicine, the NEJM has published an opinion that the promises of personally-targeted therapy are little better than the promises of ISO accreditation.

Limits to Personalized Cancer Medicine. Ian F. Tannock, M.D., Ph.D., and John A. Hickman, D.Sc. N Engl J Med 2016; 375:1289-1294 September 29, 2016 DOI: 10.1056/NEJMsb1607705.

limits-to-personalized-cancer-medicine-10-1056nejmsb1607705

Current studies show no or little improvement in duration or quality of life.  In fact, sequencing tumour DNA seldom gives information that is useful for treatment.  And tumours are always mutating to find new pathways drugs aren’t blocking.

The authors “suggest that the clinical benefit of personalized medicine as it is currently practiced will be limited.”

They conclude, “We do not suggest abandoning personalized medicine but rather evaluating it in a small number of well-designed collaborative programs, with research programs that recognize and combat the limitations we have described.”

Maybe this will happen but we are still waiting for well-designed collaborative programs to evaluate accreditation.

 

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ISO silent over Volkswagen certifications

A little bit of history:

“Julian Huxley, Aldous Huxley’s older brother is THE GUY who paved the way for the standardization of our everyday lives. He originated the United Nations Education, Scientific, and Cultural Organization or UNESCO. Under the direction of Julian Huxley, UNESCO gave us the International Organization for Standardization. Also Known As the ISO. (Yes, it should be IOS, but iso is Greek for “same” and these folks do want for us to all be the same.)

ISO 2575 Road vehicles – Symbols for controls, indicators and tell-tales only covers the color and artwork for 350+ symbols in our cars. ISO 26000, or ISO SR is the International Standard for Social Responsibility. ISO SR is not yet mandatory as it was first published in 63 A. F. or 2010.

Since ISO 26000 is still voluntary and VW has no way of being certified as being ISO 26000 compliant, the question arises concerning VW’s or even GM’s meeting International Standards for Social Responsibility. Or any other ISO standards like ISO 9001 or the ISO 14001.

Roger Gareth Frost thinks the joke might be on us, “The operation conformed to procedures and was a success. Unfortunately, the patient died.”

http://asia.nikkei.com/Viewpoints/Viewpoints/ISO-silent-over-Volkswagen-certifications

Mr. Frosts statement makes me wonder if there is an ISO standard for press releases after police shootings.

This link takes us to Nikkei Asian Review which presents us with Gareth Frost’s article: ISO silent over Volkswagen certifications.  This is rare insider insight into how the accreditation cartel works:

Roger Gareth Frost

ISO silent over Volkswagen certifications

One aspect of the Volkswagen emissions scandal that has so far escaped attention is the part played, or not played, by the company’s certifications to the ISO 9001 standard for quality management and ISO 14001 standard for environmental management.

     Neither VW nor ISO (the International Organization for Standardization) have replied to the following question: “Volkswagen has worldwide certification to ISO 9001 and ISO 14001. Doesn’t the scandal over VW’s emissions manipulation indicate a failure of certification to the standards, in terms of meeting customers’ quality requirements, customer satisfaction and environmental management?”

      They were not alone. Also silent were TUV Nord, the German certification body that issued VW’s certifications, and a spokesman for both the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). The latter two groups promote standards and certification as tools for achieving public policy goals.

     On Nov. 2, ISO jointly hosted a conference in Geneva, Switzerland, on “Using and referencing International Standards to support public policy.” ISO said that the conference “looked at the many ways that standards can benefit policy makers, through providing confidence in technical specifications and safety requirements, as well as helping to implement policy commitments.”    

     For many people, the VW crisis would advise caution against a blind faith in standards. However, ISO and the other protagonists remain silent or dodge the issue. This silence is a matter of serious concern because VW’s certifications are intended to give customers and regulatory authorities confidence that quality requirements and environmental responsibilities are being met.

     One of the objectives of ISO 9001 is to make enterprises more efficient in turning out products that enhance customer satisfaction, by ensuring that these products meet customers’ quality requirements — both stated and implicit. It is unlikely that software designed to cheat emissions tests, as VW has admitted to installing, was a requirement of the 11 million customers who bought the affected vehicles. Clearly, VW’s ISO 9001 systems and certification did not deliver on customer satisfaction.

     ISO 14001 is aimed at enabling organizations to reduce negative impacts on the environment as a result of their activities. It is designed to be a tool for meeting regulatory requirements. Despite VW’s ISO 14001 systems and certification, the company deceived its customers about the environmental impact of the cars they had bought and manipulated the results of regulators’ pollution tests.

     ISO itself does not handle certification. This is performed by certification bodies independent of the organization. However, many of the national standards bodies that make up ISO’s membership do carry out ISO 9001 and ISO 14001 certification, and this activity can represent a sizable portion of their income.

     In practice, ISO has an ambiguous attitude toward certification. On one hand, it states that certification to its standards is not compulsory and not a requirement of the standards. On the other hand, it indirectly promotes certification through The ISO Survey of Certifications, published annually, which provides data on the number of certificates of conformity issued worldwide to ISO 9001, ISO 14001 and other ISO management standards. In ISO’s comments on the survey data, it highlights what it sees as significant increases and downplays less flattering figures.

     It might be argued that such is the stuff of public relations. However, ISO now presents certification to its standards in completely overblown marketing terms.   

Announcing the latest edition of the ISO survey, the organization in September claimed the world is “still under the spell of management systems.” It added, “As the world evolves, it continues to trust ISO management systems standards to keep its organizations performing well.”

     However, ISO’s marketing, communication and information department had “no time” to answer the question on its flagship standards and certification in light of the VW scandal.

Unnoticed irony

ISO’s silence may prove to reveal disastrously poor judgement. This is because more than 1 million ISO 9001 certificates and over 324,000 ISO 14001 certificates had been issued worldwide at the end of 2014 to businesses of all types and sizes, as well as to public-sector organizations. So the question of confidence in standards and certification goes well beyond VW and its customers.   

      Despite the scandal, VW’s website continues to publicize the ISO 14001 certification of its technical department, awarded “for the environmentally compatible development of Volkswagen brand vehicles.”

     TUV Nord, VW’s supplier of certification, is accredited — approved as competent — by DAkkS, the German national accreditation body and a member of the IAF. Shareholders in DAkkS include the German government. On TUV Nord’s website, it continues to display an April press release publicizing its re-certification of VW to ISO 9001, as well as recalling its ISO 14001 certification of the company. Regarding the ISO 9001 certification, TUV Nord says, “The quality management system also fulfills requirements of German and international road traffic legislation ….”

     Apparently, neither VW nor TUV Nord is sensitive to the irony of the above statements in the wake of the scandal.

     A spokesman for the IAF and the ILAC was contacted for comment because the two organizations, along with the Independent International Organisation for Certification, have launched a new website, Public Sector Assurance, promoting standards, certification and accreditation as assets to help government officials and regulators attain policy goals. The IAF is an association of the national accreditation bodies, such as DAkkS, that approve certification bodies as competent according to ISO standards for conformity assessment. ISO, the IAF and the ILAC work closely together on developing ISO standards for conformity assessment activities, such as the accreditation of certification bodies and testing laboratories.

     The spokesman responded with a long-winded general explanation of certification and accreditation, but like ISO, VW and TUV Nord, he did not answer the specific question about the apparent failure of certification.

     The response included the statement, “Accredited certification to ISO 9001 should provide confidence in the organization’s ability to ‘consistently provide product that meets customer and applicable statutory and regulatory requirements.'” Presumably, the important qualifier in this statement is “should.”

     The IAF/ILAC spokesman also stated that, while “accredited certification to ISO 14001 provides confidence in the organization’s ability to meet its own environmental policy, it does not ensure that the organization is currently achieving optimal environmental performance. It is important to note that the ISO 14001 accredited certification process does not include a full regulatory compliance audit and cannot ensure that violations of legal requirements will never occur, although full legal compliance should always be the organization’s goal. Similarly, not all legal noncompliance would also be a noncompliance to a given standard and must also be considered in the context of the scope of certification.”

     Translating these statements into plain English gives something like this: Even though a company has implemented ISO 9001 and ISO 14001 and had its management systems certified by a body accredited by an IAF member, this does not necessarily mean that customers can count on their quality requirements being fulfilled by the company’s products. And regulators cannot necessarily count on the company meeting environmental and other relevant rules.

     What is more, according to IAF/ILAC, despite noncompliance with regulations, the company may still be awarded a certificate because legal noncompliance does not necessarily mean noncompliance to a standard.

The joke’s on us?

This situation seems analogous to the medical joke: “The operation conformed to procedures and was a success. Unfortunately, the patient died.” However, it is doubtful that many of the 11 million purchasers of VW cars with manipulated emissions devices would find the joke amusing.

     In the circumstances, these customers might consider complaining to ISO and the IAF. On ISO’s website, it states: “ISO is interested to hear from you if you feel that any ISO standard, including ISO 9001 or ISO 14001, is being misused.” Likewise, the IAF declares on its own website: “The IAF Board treats any complaints with the utmost concern and will deal with them expeditiously and in confidence. All complaints involving IAF members or certification/registration bodies accredited by IAF members are regarded as extremely serious.”

     Hopefully, ISO will find the time to answer and the IAF will stop hiding behind generalities. Otherwise, the confidence of customers and regulators in standards, certification and accreditation could be seriously dented by the VW crisis.

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IYI

We wouldn’t say those that developed ISO management accreditation were intellectuals. Nor would we apply the word to those that assess other human beings to these standards. However, Nassim Nicholas Taleb‘s essay, The Intellectual Yet Idiot, provides some insight into the minds of those who do live by inspecting others.

“The IYI pathologizes others for doing things he doesn’t understand without ever realizing it is his understanding that may be limited.”

Image result for intellectual yet idiot

and I can do the ISO accreditation magic!

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Antibacterial soaps banned because they do nothing – why not ban ISO 17025?

Soap and water works: FDA says antibacterial soaps do nothin

Bacteria are good at making babies.

So next time you see an advert claiming the product removes 99.9 per cent of bacteria, talk to a microbiologist who will say that’s a 3-log reduction, we look for 5-7 log reductions.

Maggie Fox of NBC News reports the U.S. Food and Drug Administration says antibacterial soaps do little or nothing to make soap work any better and said the industry has failed to prove they’re safe. Companies will have a year to take the ingredients out of the products, the FDA said. They include triclosan and triclocarban. Soap manufacturers will have an extra year to negotiate over other, less commonly used ingredients such as benzalkonium chloride.

“Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” the FDA said in a statement. “Some manufacturers have already started removing these ingredients from their products.” Triclosan used in 93 percent of liquid products labeled “antibacterial” or “antimicrobial” – at least 2,000 different products, according to the FDA. “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water”.

In 2013 FDA gave soap makers a year to show that adding antibacterial chemicals did anything at all to help them kill germs. It made the rule final Friday.

antibacterial.soap

So why has laboratory accreditation not been banned?  We have no scientific evidence that it is any better than just being a professional scientist.

It does nothing but kill 99.9% of common sense.

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A billion, billion monkeys typing

Fred Reed presents his calculation:

“- a monkey typing randomly on a keyboard would eventually write all the books in the British Museum. This sounds plausible and, in a purely mathematical sense, is true. What are the odds?

Consider a fair-sized book of 200,000 words that, by newspaper average, would contain about a million letters. To make it easy on the monkey, we will ignore upper case and punctuation and let him work with an alphabet of 26 letters. What are his prospects of getting the book in a given string of a million letters?

The chance of getting the first letter correctly is 1/26 times the chance of getting the second letter, 1/26, and so on, making the chance of getting the entire book 1/261,000,000. Since 26 equals 10log 26, (log 26 being about 1.41) the chance of getting the entire book is 1 in 10 log 26 x 1000,000 or about 101,400,000. Innocent  looking numbers like this are remarkably intractable. For example, a billion billion monkeys (more monkeys than Iwant) typing a billion billion characters a second for a billion billion times the estimated age of the universe (1018 seconds ) would  have essentially zero chance of getting the book.

To give our monkey a fighting chance, let’s ask whether he would get even the title of a book, for example On the Origin of Species by Means of Natural Selection, or the Preservation of Favoured Races in the Struggle for Life, which Microsoft Word tells me contains 119 characters. The monkey’s chance of getting the title in a give string of 119 is one in 10119 x x 1.41 or 10168 Thus our billion billion monkey at a billion billion characters a second for the life of the universe is essentially zero.

Is the chance of accidentally forming a living Crittter a similar problem? We don’t know, especially since evolutionists cannot tell us what the First Critter was. But it is their responsibility to tell us, first, what of what complexity formed and, second, why the odds are not astronomically against it. The point to take away is that the invocation of long  periods of time can mean  little when speaking of the probability of complex yet unspecified events.”

It’s easy to accept such urban myths without doing the calculations, even when they’re straightforward.

Image result for monkeys typing

See the lengths of improbability even scientists will go to in order to preserve their foundational dogma from anything better?

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Lean cost $1,511 for each dollar saved

Repackaging aspects of Toyota management to sell to gullible managers and politicians as LEAN may be even more wasteful than ISO accreditation.  John Seddon commented,

How politicians deal with evidence

The failure to value evidence is not limited to UK politicians. Canadian politicians were sold the dreaded ‘Lean’ and had it rained down on their healthcare system. When the evidence of failure became abundant – apparently it cost $1,511 for every $1 ‘saved’, and I put that in inverted commas as I know these are usually false claims – what did the minister do?

 Denied it!

At least in Canada they tried to measure the savings/waste.  Would that happen in the UK?

Click through and read the report:

New report ‘final straw’ for Lean, Sask. NDP says

The study found Lean cost Saskatchewan $1,511 for each dollar saved

NDP Leader Cam Broten

NDP Leader Cam Broten says a new report is the last straw for Lean. (CBC)

118 

A new report published in a medical journal said for every dollar saved by Lean, Saskatchewan spent $1,511.

The study by the School of Public Health at the University of Saskatchewan was published in the International Journal for Quality Health Care. It found that Lean in hospitals did not improve patient outcomes and it brought down morale among nurses.

“The study should be the absolute final straw for the disastrous and costly John Black Lean program,” NDP Leader Cam Broten said.

Modelled after Toyota’s production system, Lean is focused on rooting out waste. The Saskatchewan Ministry of Health committed to a multi-million dollar investment bringing the Lean methodology across the province’s healthcare system starting in 2008. It was government-wide by 2010.

The process has been filled with controversy and a few months before expected, the Lean contract with American consultant John Black and Associates ended in March 2015.

The new study followed the implementation and roll out. It showed that Lean doesn’t help patient satisfaction, health outcomes, and hurts worker satisfaction.

“For the government, for the Sask Party and Mr. Wall, to be shovelling out the millions still on this project is offensive to every person who needs proper health care in this province, and every person who works within our health care system” Broten said.

No proof of savings or improved patient outcomes, report says

The report said there was no data to show cost savings, and the province of Saskatchewan appeared to be the only jurisdiction with actual financial cost information. The study found that if the numbers reported were accurate, it means that $1,511 was spent on Lean for every one dollar saved by the province.

The report also evaluated both health and process outcomes.

“When measuring direct outcomes for 90,000 patients on their experience with doctors and nurses no effect of Lean was observed. Only three outcomes showed statistically significant positive outcomes,” the report said.

Those positive effects were a slight increase in staff washing or disinfecting their hands, an increase in staff checking ID bands, and a slight increase in patients being given safety brochures.

The report also looked at 1,500 randomly surveyed nurses.

“Outcomes reported a statistically significant negative effect of Lean on nurse engagement, usefulness, patient care, time for patient care, workplace issues, availability of supplies, workload stress, and patient safety,” the report stated.

The report concluded that there is no evidence to prove quality improvements to healthcare.

“For now, the question remains whether continuing to heavily invest in Lean is bringing us closer to or taking us further away from a much needed, viable, long-term solution to an increasingly problematic and unsustainable healthcare delivery system,” the report stated.

In December, the provincial auditor Judy Ferguson said she did not have the information to say whether the Lean program worked.

Province responds to report

Health Minister Dustin Duncan said the report is “not an accurate reflection” of the impact of Lean. 

“We require our health regions, including the chief financial officers, to sign off on any savings that are derived from Lean,” Duncan said. 

“Right now, our number is well over $130 million we’ve seen saved in the system because of Lean.”

As for how the report came up with its findings, Duncan said he figured the authors were working off old information. He added that more rigorous analysis is needed to really evaluate the impact Lean had on the health care system.

Duncan said the Health Quality Council has commissioned an academic at the U of S to create the baseline methodology, and that report should be coming out in “short order”.

http://www.cbc.ca/beta/news/canada/saskatoon/new-report-final-straw-for-lean-ndp-says-1.3429291

At least Lean lacks the coercive aspects of ISO accreditation and will more easily go away again.

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Audit and The Emperor’s New Clothes – on view for over 20 years

We previously drew attention to,

D. J. PRATT.   British Standard (BS) 5750 – quality assurance?
Prosthetics and Orthotics International, 1995, 19, 31-36

Abstract

BS5750 is the British Standard on “Quality Systems”. Its equivalent in European standards is EN29000 and in the International Standards Organisation ISO9000. This paper points out that these standards lay down formalised procedures and require documentation but do not ipso facto lead to quality assurance.  The author points to the Japanese post-war industrial success as being an example of Total Quality Management within the framework provided by the philosophy of Dr. W. Edwards Deming (1988 and 1993). This philosophy on the management of “systems” to provide high quality products and services is briefly outlined. The author argues that improvement in prosthetic and orthotic services will not be reached through implementation of BS5750 but rather through radical rethinking and the adoption and application of the Deming philosophy.

We have stressed the difference between clinical audit that has the possibility of improving practice and of ISO compliance audit of laboratories.  However, this is not to offer unquestioning support for the introduction of pseudo-accountancy into medicine or any other non-financial discipline.  After all, the big accountancy firms are allowed to sign off the banksters’ loan and stockmarket frauds and governments turn a blind eye.

It is also twenty years since Dr Fulton recognized medical audit as an Emperor’s New Clothes situation – RA Fulton.  Audit: The Emperor’s New Clothes.  Journal of Evaluation in Clinical Practice, 2, 3, 199-201.

http://sci-hub.bz/10.1111/j.1365-2753.1996.tb00044.x

In point 5 he saw External Quality Assurance as a possible alternative to audit, devoid of its hostility and with an emphasis on improvement.  However, EQA was just one element that was engulfed by the ISO laboratory standards.  Now an improvement has been reduced to an “improvement action record”, evidence for inspection.  EQA samples still show wrong results.  Accreditation’s attempt to control everything continues to fail.

Next year Earnshaw made related points about clinical audit, its expense and difficulty in verification:

Earnshaw JJ. Auditing audit: the cost of the emperor’s new clothes. Br J Hosp Med. 1997 Sep 3-16;58(5):189-92.

Abstract

Clinical audit is undeniably a theoretically worthwhile and useful activity. A considerable sum of money and large amounts of clinical time have been spent establishing audit activity in the UK. It was promised that audit would be a tool for improving clinical services to patients and yet this has been difficult to verify. This article reviews the costs and potential benefits of audit.

While last year’s paper of Wilson et al. was able to put some figures on the ineffectiveness of accreditation, it simply showed there has been little interest in putting the claims to the test over twenty years.  But it keeps the dissent alive.

The staff who succeeded these insightful earlier authors have been much more impressionable in allowing this nonsense to grow.

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Stick it in

We recently drew attention to the UKAS customer satisfaction survey.  What a fantastic organization!…think those who bothered to return the questionnaires.  Do their own customers rate them so highly?  Did they rate them lower before they were accredited?

Doug Powell shares a low opinion of opinion polls:

“FSA’s idea of risk communication is to commission a meaningless surveypeople lie, especially about food and drink – which found that despite 71% of people stating that they are concerned about food poisoning, over a third (36%) of Brits would eat a burger that isn’t fully cooked through. More than one in 10 said that they actually prefer burgers cooked this way.  When cooking them at home 81% of those admit to undercooking them. So we at the FSA are encouraging all those who are getting their barbecues out this weekend to ensure they cook their burgers all the way through – until steaming hot throughout, there’s no pink meat in the middle and the juices run clear.

“Those scientifically meaningless terms – steaming hot, no pink – have featured prominently in FSA food safety talk for years, with steaming hot replacing piping hot.

“Lead FSA policy thingy said something that is not worth repeating because it ignores the risks associated with needle-tenderized steaks.”

Stick it in

 

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A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices

Prasad et al. have published an analysis of 146 medical practices that had to change when they were shown to have no benefits.  A large proportion of treatments remain of unknown effectiveness or may be harmful.

gr2

 

For this reason the authors favour a high barrier of validation before new practices enter widespread use.

“Recently, a project of BMJ, entitled Clinical Evidence,81 completed a review of 3000 medical practices. The project found that slightly more than a third of medical practices are effective or likely to be effective; 15% are harmful, unlikely to be beneficial, or a tradeoff between benefits and harms; and 50% are of unknown effectiveness. Our investigation complements these data and suggests that a high percentage of all practices may ultimately be found to have no net benefits. 

“To our knowledge, this is the largest and most comprehensive study of medical reversal. Previously, we have considered the causes and consequences of reversal.4-6,82 When medical practices are instituted in error, most often on the basis of premature, inadequate, biased, and conflicted evidence,4 the costs to society and the medical system are immense.5 As such, we favor policies that minimize reversal. Nearly all such measures involve raising the bar for the approval of new therapies6,83,84 and asking for evidence before the widespread adoption of novel techniques. In all but the rarest cases,82 large, robust, pragmatic randomized trials measuring hard end points (with sham controls for studies of subjective end points) should be required before approval or acceptance. Our position is in contrast to efforts to lower standards for device and drug approval,85 which further erodes the value of the regulatory process.” (emphasis added.)

The paper is further indirect endorsement of this blog’s argument that laboratory accreditation is unproven and should never have been accepted until third-parties could offer convincing evidence of its value.

Without genuinely critical research, who is going to know that accreditation is a sham?

Suitably powered proof should have come before acceptance.  Professional leaders should be ashamed of their naïveté in doing the reverse.

Image result for professional naivete

They were so convincing…I never thought something so expensive could be of such little value…

 

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The Dark Side of Tight Financial Control: Causes and Remedies of Dysfunctional Employee Behaviors

Goebel, S. & E. Weißenberger, B. Schmalenbach Bus Rev (2016) 17: 69. doi:10.1007/s41464-016-0005-8

Abstract

Following recent corporate accounting scandals and governance failures, there has been a renewed interest in dysfunctional employee behaviors as potential drawbacks of financial goal-setting. Our study therefore assesses the impact of tight financial results controls as a cause for common behavioral displacements like information manipulation or gaming behavior in combination with countervailing effects of informal controls and management accountants’ business orientation as potential remedies. Based on a cross-sectional survey among 295 large- and medium-sized companies, our results show that even though a strong emphasis on financial results controls is associated with dysfunctional behaviors, higher levels of informal means of control and a more intense business orientation of management accountants are associated with a decrease of behavioral displacements. Our paper contributes to literature in a twofold way. First, it adds to the extant management accounting and control literature by providing comprehensive insights into the interplay between tight financial controls, informal controls, and management accountants’ role-taking behaviors. Second, by using a large-scale survey design, our results reflect a broad array of organizations and control situations.

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