Tuesday, March 31, 2015

Incidental Findings

Medicine is oftentimes filled with surprises. Consider the issue of incidental findings. Suppose a patient had has bad back pain. They had lifted something and as their physician you just want a simple plain X-ray to see if it is really L4-L5 as you suspect. You get a call from the Radiologist, not the usual response, in fact you hardly know them. But they tell you that there are multiple thoracic lesions, possibly a lymphoma. Now what?

That is an incidental finding. Yow were not looking for zebras but you found a herd.

Now consider dermatological mobile apps. I saw one today that may or may not apply, but it was a mobile dermatological app. Looking at acne, a common ailment especially with younger people.

The article notes:

Users who want to consult with a dermatologist can select a condition they want to get treated for in the app, which is currently only available for the iPhone. After they choose their condition, the app will provide users with an explanation of what to expect from the service. From there, they can choose a doctor. If users want to get the opinion of the first available doctor, they are guaranteed a 24 hour response, but they also have the option to choose a specific doctor. All doctors have a full profile that shows users where the doctor practices medicine, where they went to school...Then, they can upload pictures of their condition and after 24 hours, they will receive a response from the doctor with a treatment plan and a prescription, if needed.

Now assume a patient uploads a picture of their acne. Next to an acne lesion is a suspicious pigmented lesion. The patient did not ask about it, this after all is an iPhone picture, but you are concerned. The patient may have a melanoma. Incidental finding, lots of zebras.

Now what do you do? Contact the patient immediately? Who does the biopsy, where, how fast? You are now faced with a plethora of issues and possibly legal issues as well. What is your responsibility?

The problems may be significant. The problem with many mobile apps is that there may always be incidental findings. If one were in a physicians office perhaps a dermoscope would be available, a biopsy made, a record of the visit detailed, a discussion had. But arms length apps may present significant problems and massive legal issues.

New Dimensions in Peer Review

I noticed that Peer Review is now a paid process if you want it expedited. The Scientist reports:

Private peer review is now a multimillion dollar industry, with many journals now offering a service through which authors can fast-track their manuscripts through the process—for a price. Last week (March 24), Scientific Reports announced that, for a cost of $750, it had begun offering such expedited service, through the peer-review service Rubriq, which pays its editors $100 each per review. (Rubriq also offers pre-review services for researchers looking for feedback before submitting to a journal.)

It is not clear that such a process is good or bad. The purpose of Peer Review was to filter out bad papers, bad because they may have been incorrect, duplicated, unreadable, or just outright wrong. However as one having done it for years, Peer Review was a process of sending out proposed publications to individuals who would without prejudice examine and critique a work so that it became better if published.

Over the years the Editorship became more club like and if the right senior author appeared on a paper then it was published. This often led to publications not properly reviewed by the senior author and then retractions having been made. Internal reviews were often left to the external reviewer and then external reviewer assumed the internal reviewer did the work. The result is an explosion of retractions.

How will paying someone help. Not at all clear. It appears that the readers have become the reviewers, namely the marketplace.

Monday, March 30, 2015

Quality and Value

Words sometimes mean something. But at other times the mean a lot of different things and oftentimes they mean nothing at all. Take Quality and Value. I am always drawn back to the Quality idea that drove the prime character in Zen and the Art of Motorcycle Maintenance to insanity. He spent a lifetime trying to define it. Perhaps like pornography it is in the eyes of the beholder. But what is quality to me may not be quality to you.

The value in Health Care is all too often measured in QALYs, the subjective measure of the use of some treatment or lack thereof. In fact the ACA was written to prohibit its use. Alas, with the current administration even their own laws don't count!

Now in Healio we have an interesting piece worth tracking. They state:

In esponse to concerns over Medicare’s current fee-for-service payment system, the Obama administration announced in January that by 2018 Medicare instead will aim to associate half of all payments to the quality and value of health care provided...Some of the changes that private insurers and the government are hoping to advance are the use of bundle payments, population-based payments and Accountable Care Organizations....under the Affordable Care Act, Medicare will be cut significantly....“Relative to the rates that private insurers pay, the rates for Medicare and Medicaid are going to trend down over time. In fact, by the middle of the century, they are going to be about half of what private insurance pays hospitals,” he said. “We should be concerned that quality may suffer unless we do something about this.”...Research has shown that when Medicare payments to hospitals are cut, it leads to higher patient mortality and other negative outcomes,...

Yes, cut Medicare and people die. But ironically the Democrats blame the Republicans for that yet it is the ACA which mandates it.

Friday, March 27, 2015

Numbers Do Not Add Up

Sometimes people should read what they write. I do, at times, and that is why I am wont to change what I said...it may not add up. But if you are in the NY Times it seems to me that you get away with almost anything. Just look at the number of corrections to the on line stories.

Today in the Times I read a piece which I think spoke of scientists, and most likely engineers too, as well as physicians and surgeons, can get insight by looking at something differently. Wow, that is big news! As if what we have been done for two and a half millennium has been something different. But this statement really rang a bell:

In a recent experiment at the University of Virginia, researchers used a perceptual-learning module to train medical students about gallbladder removal. In the past, doctors removed gallbladders by making a long cut in the abdomen and performing open surgery. But since the 1980s many doctors have been doing the surgery by making tiny incisions and threading a slender tube called a laparoscope into the abdominal cavity. The scope is equipped with a tiny camera, and the surgeon must navigate through the cavity based on the images the scope transmits. All sorts of injuries can occur if the doctor misreads those images, and it usually takes hundreds of observed surgeries to master the skill. Half the students practiced on a computer module that showed short videos from real surgeries and had to decide quickly which stage of the surgery was pictured. The other half — the control group — studied the same videos as they pleased, rewinding if they wanted. The practice session lasted about 30 minutes. On a final exam testing their knowledge of the procedure, the perceptual-learning group trounced their equally experienced peers, scoring four times higher. Their instincts were much sharper.

Now slowly reread the last sentence. These are erstwhile surgeons removing a simple gallbladder via a scope procedure. Those that had this so-called perceptual technique score 4 time higher than the others. Now assume they all scored 100%. That means the regular docs got 25%! You want a surgeon who scored 25%, are you kidding me. Worse, there is zero chance the top group got all 100% most likely 80% average. That means the characters in the regular learning mode got 20%. But wait! We have no idea how badly the top group did, only that the others got only 25% of what they got!

Can we really believe this, does it make logical sense, does the "pattern" make sense? Not really. Perhaps they should go back and check the numbers, or make certain than none of them ever practice surgery...at least on my gallbladder!

Fiber Telecommunications and The Mid East

Telegeography has an interesting map on the many fibers going down the Red Sea through the Gulf of Aden and then to Asia. We all too often fail to recognize that this now Hot Spot is also a key strategic point for global telecommunications. A couple of years ago I was working on a proposed fiber across the Arctic above Russia and had indicated to various US Government types its strategic importance, the Russians not withstanding. The current situation in the Gulf region further intensifies this issue. In a brief moment these lines could be severed and global finance and commerce could suffer. It will be interesting to watch this effort. The irony is that Russia could have established itself as a Global conduit for such efforts but alas it has soured the well over the last year.

Thursday, March 26, 2015

Climate Change and the Academy

There are small groups forming on many campus locations whose goal is to eliminate any investments in what they see as "dirty energy" companies, and to support a program of "sustainability". At one extreme it is the banning of bottled water, never really drink the stuff, to reverting to a zero carbon footprint existence. Now I can appreciate that as I sit amongst my 4,000+ seedlings sprouting up around my office ready for their outside potting once the winter ends, it is the longest in 30 years here in New Jersey.

Now Harvard has had a bit of a time on this issue and their President has decided to answer the call to have a Campus wide discussion. As the Crimson announces:

University President Drew G. Faust will convene a panel about climate change on April 13, following several requests on behalf of a faculty group calling for an open forum about Harvard’s investment in fossil fuel companies.The panel will be moderated by talk show host and journalist Charlie Rose, who has interviewed Faust on television in the past. The roster of panelists is scheduled to include Harvard science and public policy professors as well as experts from outside the University.

The Harvard President has done a superb job on all she has handled and this is one way to address the campus debate. On additional consideration the choice of Rose is frankly quite wise. He has an amazing manner to evoke what a guest, presenter, position taker, really has to say, more so than any others in today's market. Unlike many other PBS types who spend time telling listeners what they think, Rose get to people and get them to tell what they think, which is useful.

This is an interesting approach and worth following.

In contrast MIT has a Sustainability Program. It allegedly purports to:

The Sustainability Initiative at MIT Sloan is built on the promise of a new future. We believe that environmental, societal, economic, business, and personal wellbeing are parts of an interconnected whole. The strains we face in each of these domains demand that we think differently and invent new ways of living and working. We are committed to creating a new vision for progress and prosperity and a world that will flourish and thrive for generations.  We empower students, faculty, researchers, and business leaders to join together in this endeavor.

 Somehow the above is reminiscent of my old days at MIT in the 60s with one small protest group after another. Now however they seem to set up Centers, appoint faculty, provide space and resources and put it on the students tab. Again, we see an ever growing cost of getting an education.

CRISPR Cas 9 Again

The system used by bacteria to defend against a virus attacking is the CRISPR Cas 9 system. An interesting use of a protein, enzyme, and a DNA segment that can open DNA at desired locations and cut and insert new segments of DNA. We have been discussing this for well over a year now and have discussed its potential and its risks.

Now along come researchers who instead of doing this in somatic cells do it in germline cells, thus changing the potentially maturing entity. Thus each cell has this changed gene or genes.

In a recent Nature article the authors state:

There are grave concerns regarding the ethical and safety implications of this research. There is also fear of the negative impact it could have on important work involving the use of genome-editing techniques in somatic (non-reproductive) cells....In our view, genome editing in human embryos using current technologies could have unpredictable effects on future generations. This makes it dangerous and ethically unacceptable. Such research could be exploited for non-therapeutic modifications. We are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development, namely making genetic changes that cannot be inherited. At this early stage, scientists should agree not to modify the DNA of human reproductive cells. Should a truly compelling case ever arise for the therapeutic benefit of germ­line modification, we encourage an open discussion around the appropriate course of action.

Now this point is well made. Germline cell changes introduce all sorts of issues. Not only is there the issue of what this new gene will do, we hardly have begun to understand gene interactions, but the issues of epigentic factors such as methylation dramatically change the risks.

Frankly I miss Michael Circhton, in this case he would have clearly shown us the mistakes we could be making with an unruly unleashing of this technology. Jurassic Park would be a walk in the park as compared to what these could unleash. Imagine correcting those few genes in Apes and the other close to man mammals and see what we could get!

The again you do have the advocates in Technology Review, that somewhat unidentifiable magazine sent to MIT alumni and others, that states:

When I visited the lab last June, ... proposed that I speak to a young postdoctoral scientist named ..., a Harvard recruit from Beijing who’d been a key player in developing a new, powerful technology for editing DNA, called CRISPR-Cas9. With ..., ...had founded a small company to engineer the genomes of pigs and cattle, sliding in beneficial genes and editing away bad ones. As I listened to ..., I waited for a chance to ask my real questions: Can any of this be done to human beings? Can we improve the human gene pool? The position of much of mainstream science has been that such meddling would be unsafe, irresponsible, and even impossible. But ... didn’t hesitate. Yes, of course, she said. In fact, the Harvard laboratory had a project to determine how it could be achieved. She flipped open her laptop to a PowerPoint slide titled “Germline Editing Meeting.” Here it was: a technical proposal to alter human heredity. “Germ line” is biologists’ jargon for the egg and sperm, which combine to form an embryo. By editing the DNA of these cells or the embryo itself, it could be possible to correct disease genes and to pass those genetic fixes on to future generations. Such a technology could be used to rid families of scourges like cystic fibrosis. It might also be possible to install genes that offer lifelong protection against infection, Alzheimer’s, and, ... told me, maybe the effects of aging. These would be history-making medical advances that could be as important to this century as vaccines were to the last.

 The problem is as the writers in Nature and in Science, led by David Baltimore, have noted, the germ line modifications could be unwieldy.

Just because we have a new technology is no reason to let is loose. The problem with this technology is that it not only can be weaponized but that it can be done in a basement lab. This not building a nuclear weapon. This is potentially setting the world afire.

The again there is the issue of Government regulation. In an interesting piece in Xconomy the author remarks:

But researchers’ and investors’ fear that a patchwork of regulation would cripple biotechnology in the United States did not disappear right away. Biologist Thomas Maniatis of Harvard left his home lab to work on the techniques in tighter-security conditions at Cold Spring Harbor Laboratory in New York. Others went abroad. Biogen, founded in 1978, put its first major lab in Geneva, Switzerland. This was a time of intense concern about environmental dangers from the chemical industry in particular and science in general. It took some years for biologists to gain respect among local state, and federal officials for their sense of responsibility in the recombinant DNA maelstrom of the mid-1970s. But politicians did accept that biotechnology was a significant new industry that other countries, like Japan, might seize if America dropped the ball.

A valid point, but in the 70s we worried about errant scientists. Now we are terrified about terrorist post docs! One wonders what would be worse; the Government Regulators or the Terrorist?

Wednesday, March 25, 2015

And Why is Tuition Increasing?

In the "You can't Make This Up" category we now have a Dean, yes most likely one of hundreds, at Cornell, advising a putative ISIS group to train on campus. All of this caught on video.

In the UK Daily Mail they state:

A dean at Cornell University has been filmed apparently endorsing the idea of an ISIS 'training camp' at the college. ..., assistant dean for students at the Ivy League college in Ithaca, New York, said such an initiative would be 'just like bringing in a sports coach'. Video has emerged of Mr ... speaking to an undercover reporter who was posing as a Moroccan student.  

This rather rotund looking individual, whose Medicare I am may now be paying into, supports the training of what? If he were in a real business he would be applying for a job elsewhere...

This is a classic example of what is wrong with our Education systems. Positions like this should not exist at all, people like this should find out what life is really like!

On the otherhand the President of Cornell states:

 Project Veritas, the organization behind this shoddy piece of "journalism" has been repeatedly vilified for dishonest, deceitful activity. It is shameful that any individual would pose as a student facing racial discrimination at another university, ask leading questions on hidden camera about Cornell's tolerance for differing viewpoints and backgrounds, and then conveniently splice together the resulting footage to smear our assistant dean and our University. After speaking with Assistant Dean ..., I am convinced that he was not aware of what he was being asked. 

 Thus what are we left to believe, what is on the video or what the President says. Perhaps if the University filed a defamation suit against the perpertrators and won in Court we could have some faith in the process. A rejection with what appears to be a limited examination is a bit of a weak stand to be in.

The problem is that the words seem to speak for themselves. Also anyone near American Universities is tempted to believe this, especially since we see all too much of this type of action.

Perhaps in lieu of a rapid defense one should have take a deep breath and set out to examine this in detail. It appears that this has not been the case.

Sunday, March 22, 2015

The Feds Evaluate Higher Ed

In the Crimson is an interesting piece on the proposed Administrations proposal to rank our higher education establishments.

They state:

The U.S. Department of Education is considering revising its controversial draft college rating system to create two systems instead of the one system initially proposed, according to a report by the Chronicle of Higher Education. The dual rating system would have two parts, tailored to different audiences, that would use different metrics of evaluation, according to the Chronicle. The first, using raw outcome data, would be directed towards a consumer audience, while the second, using data adjusted for individual institutions, would be aimed to help policymakers and researchers measure accountability. First proposed by President ... in 2013, the college rating system intends to evaluate institutions of higher education along a number of proposed criteria, such as graduation rates, average net price, student loan debt, and post-college earnings, according to the draft report. The drafted version would classify colleges and universities as high-, middle-, or low-performing based on these and other metrics, but would not rate institutions numerically.

Well now consider this. Some group of GED GS9s grading Harvard, Princeton, MIT.  The chicken comes home to roost! What a nightmare this will be. Our last vestige of competence, now being invaded by politicians. The final step in destroying any future competence in this country.

Higher education is already rated by the market place. By other nations. Perhaps we need to take the advice of our Government employees to make things more like Washington. Shudder the thought! We get a mass crowd of uneducated GS9s wandering around with massive forms and reviews and reports. It will make the Health Care EHR Meaningful Use fiasco along with ICD 10 look like Kindergarten.

This is truly a monumental mess!

Friday, March 20, 2015

EHRs, Meaningful Use and the Death of Medicine As We Know It

The HHS is issuing a new set of regulations on the EHR use for Medicare and Medicaid. The rule is massive over 300 pages. It mandates will surely place a tremendous load on any physician driving up costs and reducing any level of care.

They state: 

This Stage 3 proposed rule would specify the meaningful use criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under Medicare for Stage 3 of the EHR Incentive Programs. It would continue t o encourage electronic submission of clinical quality measure ( CQM ) data for all providers where feasible in 2017, propose to require the electronic submission of CQMs where feasible in 2018, and establish requirements to transition the program to a single stage for meaningful use. Finally, this Stage 3 proposed rule would also change the EHR reporting period so that all providers would report under a full calendar year timeline with a limited exception under the Medicaid EHR Incentive Program for provider s demonstrating meaningful use for the first time . These changes together support our broader efforts to increase simplicity …

 Yet one just read thrus say the first 50 or so pages and ask; when is any physician going to get through this. The demands are truly counterproductive and pure Government overhead.....


CRISPR Cas 9 is a new technique to cut and splice genes. We had written about it about a year ago regarding its use in cancer treatment and also regarding the patent so quickly issues. Now David Baltimore, a highly respected scientist, and colleagues have in Science suggested a prudent set of steps as to its use in humans. It is reminiscent of the concerns some 49 years ago regarding recombinant DNA.

Baltimore et al recommend:

In the near term, we recommend that steps be taken to:

1) Strongly discourage, even in those countries with lax jurisdictions where it might be permitted, any attempts at germline genome modification for clinical application in humans, while societal, environmental, and ethical implications of such activity are discussed among scientific and governmental organizations. (In countries with a highly developed bioscience capacity, germline genome modification in humans is currently illegal or tightly regulated.) This will enable pathways to responsible uses of this technology, if any, to be identified. 

2) Create forums in which experts from the scientific and bioethics communities can provide information and education about this new era of human biology, the issues accompanying the risks and rewards of using such powerful technology for a wide variety of applications including the potential to treat or cure human genetic disease, and the attendant ethical, social, and legal implications of genome modification. 

3) Encourage and support transparent research to evaluate the efficacy and specificity of CRISPR-Cas9 genome engineering technology in human and nonhuman model systems relevant to its potential applications for germline gene therapy. Such research is essential to inform deliberations about what clinical applications, if any, might in the future be deemed permissible. 

4) Convene a globally representative group of developers and users of genome engineering technology and experts in genetics, law, and bioethics, as well as members of the scientific community, the public, and relevant government agencies and interest groups—to further consider these important issues, and where appropriate, recommend policies.

 Baltimore et al have a point. Not only can this be significant on a person by person basis but it also has the potential to be weaponiozed. The technology is out there, thousands are now proficient in it, the cost is low and the means for distribution is high.

Clearly a sensible effort in collaboration with others is essential. The problem is that with much of science, the genie is out of the box.

Tuesday, March 17, 2015

Happy Saint Patrick's Day

Oh then, tell me Sean O’Farrell, why you hurry so
hush—a buach-aill hush and listen and his cheeks were all a glow.
I bear orders from the captain get you ready quick and soon
for the pikes must be together at the risin of the moon.

Oh then, tell me Sean O’Farrell, where the gath’rin is to be?
In the old spot by the river well known to you and me
One word more for signal token, whistle up the marchin’ tune,
With your pike upon your shoulder, by the risin’ of the moon”.

Out from many a mud wall cabin eyes were watching through that night
Many a manly heart was throbbing for the blessed warning light
Murmurs passed along the valleys, like the banshee’s lonely croon
And a thousand blades were flashing at the risin’ of the moon.

There beside the singing river, that dark mass of men were seen
Far above the shining weapons hung their own beloved green
“Death to every foe and traitor! Forward! strike the marching tune
And hurrah, my boys, for freedom, ‘tis the risin’ of the moon”.

Well they fought for poor old Ireland, and full bitter was their fate
(O, what glorious pride and sorrow fills the name of Ninety-Eight!)
Yet, thank God, e’en still ard beating hearts in manhood’s burning noon,
Who would follow in their footsteps at the risin’ of the moon!

Sunday, March 15, 2015

Finding Asteroids

NASA has announced an asteroid hunting program for the masses. As they state:

Astronomers find asteroids by taking images of the same place in the sky and looking for star-like objects that move between frames, an approach that has been used since before Pluto was discovered in 1930. With more telescopes scanning the sky, the ever-increasing volume of data makes it impossible for astronomers to verify each detection by hand. This new algorithm gives astronomers the ability to use computers to autonomously and rapidly check the images and determine which objects are suitable for follow up, which leads to finding more asteroids than previously possible.

Apparently using this program every one of us can set up our small Mount Polamar scopes and watch for small segments of the universe and its pending asteroids.

They continue:

Through NASA's asteroid initiative, the agency seeks to enhance its ongoing work in the identification and characterization of near-Earth objects for further scientific investigation. This work includes locating potentially hazardous asteroids and identifying those viable for redirection to a stable lunar orbit for future exploration by astronauts using NASA’s Space Launch System rocket and Orion spacecraft. The Asteroid Grand Challenge, one part of the asteroid initiative, expands the agency's efforts beyond traditional boundaries and encourages partnerships and collaboration with a variety of organizations.

 Now I would be very cautious in downloading any program sent to me by the Government. Who knows what agency has deposited what little things to watch inside our computers.

But NASA needs our help. So spend you nights looking skywards.

Learning to Program

Is learning to program computers an essential skill for each student? Now let me lay out my experience. In 1963 I got the opportunity to work on an IBM 7090 tape based computer using FAP, Fortran Assembly Programming language, an assembly language that was a base to Fortran. I stumbled over its use in some technical areas and got piles of paper which I eventually had to plot by hand.

By 1966 I had picked up Fortran and Cobol, why Cobol I will never know, and slowly saw other languages. Then over the years Basic, ADA, Pascal, C, C+, etc, then Python, Java, and the list continues. I remember using my Atari 800 with a Basic Interpreter and was overjoyed to play around with it.

Now did I really benefit from this? Kind of, but my thought process was not in any way enhanced by it. I found programming like Chess, addictive and time consuming, you can get hooked. You want to get better at it.

So must all students learn to program?

The first question is; what is programming? Is it Basic, simple equations. Is it Python, with a bit more complex abilities to manipulate strings. I used it to make a DNA to protein encoder. Yet I find I can do a great deal with Excel, yes manipulating it to get answers. And it makes nice graphs.

Now there are entities like Codeacademy and Code to Learn who think we should all be taught this skill. Now I never had shop, yet I did electrical work on houses for my father. And yes I can still do it now, just in case the demand for EEs drops by the wayside. But demand for programmes is different, it can be done in China and India, whereas my electrician skills cannot be outsourced. I have to enter the customers location and apply my skills. Not that way with programming.

As Code to Learn states:

We view coding as a new form of literacy, another way for people to express themselves and share ideas. Just as learning to write is valuable for everyone (not just professional writers), we believe that learning to code can be valuable for everyone (not just professional programmers). We promote approaches to coding that engage young people in thinking creatively, reasoning systematically, and working collaboratively—essential skills for everyone in today’s society. The ultimate goal is not just learning to code, but coding to learn.

 Learning Spanish may be more helpful, it teaches grammar as well. Learning to code may be a distraction unless there is a clear objective. I learned to code to accomplish a task; calculate an equation or plot a trajectory or analyze data. Yet each was a specific task. Coding works in my opinion if task driven, accomplishing something.

Code Academy states:

Hear how Tommy went from knowing nothing about code to building one of Time's '50 Best Websites' after learning with Codecademy.

 But one could argue that "Tommy" may have better spent his time elsewhere, learning better social skills, interacting in a social environment, reading about political science. Why do a web site. What is the reward? What is the benefit? Most importantly why everyone?

This in many ways sounds like the rebirth of the New Math post Sputnik. Coding is a skill, useful for some, addictive for some, but highly fungible. It does not assure any future skill. Software techniques change in a real time manner and today's Python will be tomorrows ADA. Also India and China, Vietnam and Thailand are much cheaper.

QALYs are Back

Despite the ACA not allowing the use of QALY as measures in the delivery of Health Care the academics are flooding the airwaves. In a recent Health Affairs paper by some Dartmouth folks they state:

Compared to Western Europe, for three of the four costliest US cancers—breast, colorectal, and prostate—there were approximately 67,000, 265,000, and 60,000 averted US deaths, respectively, and for lung cancer there were roughly 1,120,000 excess deaths in the study period. The ratio of incremental cost to quality-adjusted life-years saved equaled $402,000 for breast cancer, $110,000 for colorectal cancer, and $1,979,000 for prostate cancer—amounts that exceed most accepted thresholds for cost-effective medical care. The United States lost quality-adjusted life-years despite additional spending for lung cancer: −$19,000 per quality-adjusted life-year saved. Our results suggest that cancer care in the United States may provide less value than corresponding cancer care in Western Europe for many leading cancers. 

I suspect that this is a  move to again eliminate PSA testing and allowing those with prostate cancer just to wait until it mets.

In a recent OncLive piece Dr Benson at Columbia is quoted as follows:

Active surveillance is increasingly employed in men diagnosed with low-risk prostate cancer despite a lack of high-level clinical trial evidence supporting this approach, and physicians should engage in careful patient selection before recommending the strategy, according to Mitchell C. Benson, MD. That note of caution was among the key points that Benson stressed during a presentation on localized prostate cancer that he delivered at the 8th Annual Interdisciplinary Prostate Cancer Congress in New York City.

 The piece further states:

Benson said genetic analysis of the “true biologic behavior” of prostate cancer would eventually help clarify which patients should appropriately be recommended for active surveillance. Gene signature tests that assess risk can be used to help support decisions, he added. As it stands now, Benson said clinicians could improve patient selection by augmenting the standard evaluation through more extensive biopsies. He said a single transrectal ultrasonography should not be used to select patients for active surveillance. “Saturation biopsy improves risk stratification,” he said, adding that he performs an immediate confirmatory biopsy at presentation. Benson and colleagues conducted a study of confirmatory biopsies in 60 patients with low-grade prostate cancer and found that 31.7% (19 patients) would not be candidates for active surveillance based on the results

In MedPage the authors note about the Dartmouth study:

"We are experiencing declines in mortality from cancer in the U.S.," Soneji says. "But those declines are coming at the same pace as in Europe, which is spending a lot less money. Screening, prevention, and treatment have extended life, but that's coming at a much higher cost [in the U.S.] than in Europe." Soneji's paper is at odds with findings in the 2013 Economic Report of the President, which says that the U.S. has realized greater gains in breast and prostate cancer survival compared with Europe, and generated $600 billion in value. That study, Soneji says, does not account for stage of cancer at diagnosis, making conclusions vulnerable to "well-known biases with diagnosis and screening that inflate survival time." That's because in more recent years, cancers are being diagnosed earlier, without corresponding changes in actual dates of death. In other words, he says, it just means people are finding out they have cancer earlier.

One must be very cautious regarding the QALY approach. We have written extensively about this in the past and demonstrated its dangers. Further, we must also pay attention to clinical data, especially from the likes of Benson and others since it deals with facts, not just figures.

More on MOOCs

As I do from time to time I examine new MOOCs as they come out. A recent one was of great interest but I was sorely disappointed. Here are the reasons:

1. The Video was Chaos. The Instructor had the habit of walking from left to right and then back again, while writing on a blackboard. The video tracked him and his one was seeing a constant flash of the marks on the board while watching the movement and attempting to understand what he said.

2. There is no text and there are no notes. A student asked why and in a slightly surly manner a TA responded that they felt you learned better by taking notes. Perhaps but also perhaps someone would tell the video person that the note should be visible and not just to follow the Brownian motion of the Instructor. I believe that having some form of content on line would help. Especially for international students. But there seems to be a bit of arrogance that is less than helpful.

3. Chaotic Content: This has to deal with DNA analysis using various tool kits available to the bench biologist. Now the result is akin to using a CSHL Lab book, following the protocol, and hopefully filling in the gaps.

4. Quizzical Class: The Instructor would ask a question of the MIT students and apparently there were few if any that even tried to answer. This feedback should have an affect on the Instructor. It did not.

5. Why? Here is where the engineer separates from the scientist. We engineers ask why, bench people ask what and how. Why does a certain protocol work, and why one is better than another. Such a discussion is missing.

6. Lander and his exposition is still a sine qua non. Lander is like listening to a symphony, like listening to Shakespeare, and this was like listening to some reality TV program. Why? The Instructor is quite well known, he has even written the book that the on campus folks use. Why the disconnect? Good question. Perhaps there should be some feedback.

Remember, if all else fails, listen to the customer.

Beware The Ides of March

Soothsayer Caesar!

CAESAR Ha! who calls?

CASCA Bid every noise be still: peace yet again!

CAESAR Who is it in the press that calls on me? I hear a tongue, shriller than all the music, Cry 'Caesar!' Speak; Caesar is turn'd to hear.

Soothsayer Beware the ides of March.

CAESAR What man is that?

BRUTUS A soothsayer bids you beware the ides of March.

NOTE: Image from Wikipedia. "Bust of Gaius Iulius Caesar in Naples" by Andreas Wahra - Photo by Andreas Wahra, first uploaded to de.wikipedia GiulioCesare.jpg. Modifications by Wolpertinger und Phrood.. Licensed under Public Domain via Wikimedia Commons - https://commons.wikimedia.org/wiki/File:Bust_of_Gaius_Iulius_Caesar_in_Naples.jpg#/media/File:Bust_of_Gaius_Iulius_Caesar_in_Naples.jpg

TED and Shark Tank

I had the opportunity to attend an MIT Sloan Conference this past week and in the process they had students "pitch" their businesses to the audience. I sat through three of them and they were 5 minutes apiece. Now in each case they had the Shark Tank approach. Telling us of how big the market was and how unique they were. However I generally ask three questions:

1. How do you make money, namely cash flow.

2. Who is the team I am betting on.

3. What will kill the business.

In all three cases I had no clue as to how these questions would be answered. However they would show well on a Shark Tank episode.

Now for TED. Today in the NY Times is a fantastic piece comparing TED to a revival meeting. Now I have never attended a TED event, and frankly would never really desire to go, too West Coast "love in" in what I have seen. But the writer noted:

I grew up among Christian evangelicals and I recognize the cadences of missionary zeal when I hear them. TED, with its airy promises, sounds a lot like a secular religion. And while it’s not exactly fair to say that the conference series and web video function like an organized church, understanding the parallel structures is useful for conversations about faith — and how susceptible we humans remain. The TED style, with its promise of progress, is as manipulative as the orthodoxies it is intended to upset. A great TED talk is reminiscent of a tent revival sermon. There’s the gathering of the curious and the hungry. Then a persistent human problem is introduced, one that, as the speaker gently explains, has deeper roots and wider implications than most listeners are prepared to admit. Once everyone has been confronted with this evidence of entropy, contemplated life’s fragility and the elusiveness of inner peace, a decision is called for: Will you remain complacent, or change? Jesus said to the crowds, “Whoever has ears, let him hear.” A skilled tent revivalist can twist those words to suggest that simply showing up to listen makes you part of the solution.

Indeed they are. They are the antithesis of a technical presentation at some professional society, all dry and focused. They shout out new world views that the speaker has just recently been the sole discovered of. They are like so many 1960-1970 West Coast feel good sessions on new life realities, gurus who have discovered meanings of life.

In my limited exposure, I am told by some that I should watch some topic, I have found them to be truly evangelical. The speaker has found a truth and has converted it to a Shark Tank like exposition and is now enlightening us. 

Is this of value? I am far from one to opine on this, never having attended. But those who have seem to have an EST like response. Frankly I would rather share a glass of good red wine on the Left Bank in September in Paris and speak of great ideas, at least the wine and food are great, as is the view. TV seems to have penetrated everything, and reality TV, at least some ersatz reality, is the most pervasive.

Saturday, March 14, 2015

Wishful Thinking

Medical Trials have gone through decades of improved sophistication and are also extremely expensive to conduct. I would argue that the main reason is patient compliance. Trials often spend time on recruiting and then monitoring patients.

Patients are the most difficult part. They lie. "I do not smoke", "I really did not eat that much", "I take the medications as you told me", "I am dieting every day", "I check my blood sugar", and "I don't drink that much" Son consider this article describing Apple's view of patient self reported data.

In MedCity News they report:

Apple executives envision ResearchKit serving as an aggregator of medical and health data from hundreds of millions of iPhone users worldwide, helping researchers identify and track subjects for their work. That’s a great idea, and would be an even greater idea if Apple follows the open-source model and builds or allows a third party to create an Android version. The company described ResearchKit as a framework to help medical researchers design apps for clinical studies, speeding up data collection on an exponential scale.

The problem is that we do not know whether the information is correct or not. Patients lie to their Physicians, patients lie to themselves. So what are they going to tell their iPhones? Is there some truth meter here?

The article continues:

Medicine is also going toward personalization as genomics grows in popularity and falls in price. Hopefully, someone will develop apps on the ResearchKit platform that helps make sense of the massive amounts of genomic data that sequencing is just starting to generate. According to Williams, ResearchKit will provide academicians and practitioners alike with nearly continuous data flows, not just occasional “snapshots” of information, so they will be able to track patient symptoms more accurately. “But perhaps the most significant challenge is the communication flow,” Williams said. “When you participate in a study, you often don’t hear back until the very end of the study, if at all.”

It is not at all clear how an iPhone and genomics play out, are we placing a sequencer on the iPhone? Doubt it. But as to the  continuous flow of information, if it relies on the patient then it is highly suspect. The purpose of many clinical trials is to take the patient out of the loop specifically because of this fact. Reliance is upon objective measures. Also patient compliance even in a Trial is a challenge.

Thus claims that these technologies are a panacea are at best specious.

Pi Day

Every once in a while it is worth some useless comment. Today, 3-14-15 is Pi day, yes the pi related to the circle. Like 2 pi r, etc.

The Guardian has a great historical piece:

The symbol π was popularised in 1737 by the Swiss mathematician Leonhard Euler (1707–83), but it wasn’t until as late as 1934 that the symbol was adopted universally. By now, π is instantly recognised by school pupils worldwide, but few know that its history can be traced back to a small village in the heart of Anglesey. William Jones was born in 1674 on a small holding close to the village of Capel Coch in the parish of Llanfihangel Tre’r Beirdd, north of the county town of Llangefni in the middle of the island.

 So we can thank these fellows for choosing pi rather than some other symbol for the ratio of the circumference and radius of a circle.

We I guess can thank them for pi day!

Oh yes,

pi = 3.1415......

That is whay today is pi day, unless you are in Europe and they switch day and month so today is 14-3-15......so much for pi day.