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Getting the Patient’s POV

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By JESSIE GRUMAN

One major challenge for the new Patient Centered Outcomes Research Institute (PCORI) is to make good on its stated mission to improve health care by producing evidence “that comes from research guided by patients, caregivers and the broader health care community.”

In order to “guide” that research, patients will offer their time and their experience to serve on various panels alongside scientists and other stakeholders, many of whom have competing agendas. This means that representing the patient perspective in research governance, priority-setting, design, execution and dissemination is not a good task for the shy or the ill-prepared.  Not only do you have to have reflected on your own experience as a patient, but you have to have a good sense of how much you can generalize from that experience. This is, after all, not about you. It is about us – all of us patients.

Sometimes this means gathering information from others who have a similar diagnosis and who have been treated with similar approaches. What was getting chemotherapy for breast cancer like for you?

Sometimes it means learning about how people with different kinds of heart conditions or kinds of cancer experience their diagnoses and treatments or health care in general. What happened when you were discharged from the hospital?

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Invalidated Results Watch

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By MARYA ZILBERBERG, MD

My friend Ivan Oransky runs a highly successful blog called Retraction Watch; if you have not yet discovered it, you should! In it he and his colleague Adam Marcus document (with shocking regularity) retractions of scientific papers. While most of the studies are from the bench setting, some are in the clinical arena. One of the questions they have raised is what should happen with citations of these retracted studies by other researchers? How do we deal with this proliferation of oftentimes fraudulent and occasionally simply mistaken data?

A more subtle but no less difficult conundrum arises when papers cited are recognized to be of poor quality, yet they are used to develop defense for one’s theses. The latest case in point comes from the paper I discussed at length yesterday, describing the success of the Keystone VAP prevention initiative. And even though I am very critical of the data, I do not mean to single out these particular researchers. In fact, because I am intimately familiar with the literature in this area, I can judge what is being cited. I have seen similar transgressions from other authors, and I am sure that they are ubiquitous. But let me be specific.

In the Methods section on page 306, the investigators lay out the rationale for their approach (bundles) by stating that the “ventilator care bundle has been an effective strategy to reduce VAP…” As supporting evidence they cite references #16-19. Well, it just so happens that these are the references that yours truly had included in her systematic review of the VAP bundle studies, and the conclusions of that review are largely summarized here. I hope that you will forgive me for citing myself again:Continue reading…

Is There Something Wrong With the Scientific Method?

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By DAVE deBRONKART Dave-deBronkart

A recurring them on this blog is the need for empowered, engaged patients to understand what they read about science. It’s true when researching treatments for one’s condition, it’s true when considering government policy proposals, it’s true when reading advice based on statistics. If you take any journal article at face value, you may get severely misled; you need to think critically.

Sometimes there’s corruption (e.g. the fraudulent vaccine/autism data reported this month, or “Dr. Reuben regrets this happened“), sometimes articles are retracted due to errors (see the new Retraction Watch blog), sometimes scientists simply can’t reproduce a result that looked good in the early trials.

But an article a month ago in the New Yorker sent a chill down my spine tonight. (I wish I could remember which Twitter friend cited it.) It’ll chill you, too, if you believe the scientific method leads to certainty. This sums it up:

Many results that are rigorously proved and accepted start shrinking in later studies.

This is disturbing. The whole idea of science is that once you’ve established a truth, it stays put: you don’t combine hydrogen and oxygen in a particular way and sometimes you get water, and other times chocolate cake.

Reliable findings are how we’re able to shoot a rocket and have it land on the moon, or step on the gas and make a car move (predictably), or flick a switch and turn on the lights. Things that were true yesterday don’t just become untrue. Right??

Bad news: sometimes the most rigorous published findings erode over time. That’s what the New Yorker article is about.

I won’t try to teach here everything in the article; if you want to understand research and certainty, read it. (It’s longish, but great writing.) I’ll just paste in some quotes. All emphasis is added, and my comments are in [brackets].

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The Needle In the Haystack

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By J. LEONARD LICHTENFELD, MD  J. Leonard Lichtenfeld

Well, it didn’t take long to get into the New Year, did it?

There I was this earlier this week, starting my New Year right by getting exercise on my elliptical when I heard the announcement that Johnson & Johnson was partnering with researchers at Massachusetts General Hospital’s cancer center and other major cancer centers to evaluate the potential of a new technology which can isolate single cancer cells circulating in the blood of patients with known cancers.

The news in itself is an impressive step forward in this type of research.  Being able to isolate a single cancer cell in a sample of blood is in a sense one of the holy grails of cancer research.  Scientists have been working diligently on developing these techniques for a number of years, and to now have a technology that may in fact move that dream closer to a clinical reality where it actually improves the treatment of patients with cancer is exciting.

However, there is always a caution that comes along with these types of announcements.

First, and perhaps the most obvious, is the fact that this is an announcement of a research deal.  Nothing more, nothing less.  It is not a new breakthrough. It is not something that has been proven effective in improving cancer detection and treatment.  Not that it is anything less than stunning to develop and demonstrate that this technology works-but as with all research it is a giant step to go successfully from the laboratory phase of development to the clinical phase of making a real difference in patients’ lives.

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The Difficult Science, Part II

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By KENT BOTTLES, MD Kent Bottles

“Despite their great explanatory powers these laws [such as gravity] do not describe reality. Instead, fundamental laws describe highly idealized objects in models.”

— Nancy Cartwright, “Do the Laws of Physics State the Facts?”

In Part I the limitations of science in helping us make wise choices and decisions about our health were examined.

Because of an inherent difficulty in establishing causation, absolute certainty is unattainable even in science. Medical knowledge follows Karl Popper’s theory of science because the right answer, whether about what causes ulcers or if you should take hormone replacement therapy, keeps changing with the publication of new studies. And most depressingly of all, a respected expert on evidence-based medicine concludes, “The majority of published studies are likely to be wrong.”

Part I ended with some suggestions that seemed to imply that savvy patients should enroll in a graduate level statistics class and understand the subtleties of observational studies, meta analysis, and randomized controlled clinical trials. Being an informed health care consumer is evidently difficult indeed.

Part II explores how we all have to change if we are to live wisely in a time of rapid transformation of the American healthcare system that everyone agrees needs to decrease per-capita cost and increase quality.

PATIENTS

When I talk to physicians about pay for performance programs, I am always asked why should doctors be responsible for patient behavior that they cannot control. Even if we were able to have health care access for all and eliminate every error in medicine, we would only account for 10% of whether an individual stays healthy. Environment and genetics account for about 35%, but the remaining 55% of whether one stays well depends on behavior (exercise, smoking, diet) and social support systems (families, communities, places of worship).

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The Difficult Science

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By KENT BOTTLES, MD Picture 1

“The mind leans over backward to transform a mad world into a sensible one, and the process is so natural and easy we hardly notice that it is taking place.” Jeremy Campbell

On the same day in November, headlines from the Wall Street Journal and the New York Times reported on the same story about a federal panel’s recommendations on consumer intake of vitamin D.

“Triple That Vitamin D Intake, Panel Prescribes” read the WSJ story;

“Extra Vitamin D and Calcium Aren’t Necessary, Report Says” stated the New York Times. (http://ow.ly/3tJMe) Since I had recently started taking vitamin D daily, I was interested in what the experts in Washington, DC were recommending.

How should you decide what advice to follow about the relationship between your diet, lifestyle, medications, health, and wellness?

Is this just another example of how the media does a terrible job? Many of us resonate with the view of media watchdog Steven Brill who said, “When it comes to arrogance, power, and lack of accountability, journalists are probably the only people on the planet who make lawyers look good.” (http://ow.ly/3tKdM)

The media does play a role here and needs to improve, but it turns out that it is really complicated to figure out what the “truth” is about diet, exercise, medicines, and your individual well being. Everybody (journalists, government panel members, scientists, patients, physicians, and nurse practitioners) needs to change.

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Don’t Tell, Don’t Ask

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By LISA SUENNENPicture 49

A few weeks ago I wrote a post about the unbelievable cost associated with Alzheimer’s disease and how large a population it is likely to affect.  According to an op-ed piece written by Sandra Day O’Connor, among others, it is estimated that by 2050 approximately 13.5 million Americans will be stricken with Alzheimer’s, up from five million today, and that the cumulative price tag for treating Alzheimer’s, in current dollars, will be $20 trillion.  In contrast, remember that the cost of our ENTIRE healthcare system today is around $2.4 trillion.

This week there was a follow-up piece in the NY Times entitled, “Tests Detect Alzheimer’s Risks, but Should Patients Be Told?” The article described how new diagnostic tests have become available that make it possible to detect early Alzheimer’s and, more interestingly, to predict more accurately one’s likelihood of getting Alzheimer’s in the future.  The focus of the article was the moral and ethical dilemma presented by the availability of this knowledge.

Since there is no known treatment for Alzheimer’s and none on the short term horizon, physicians with knowledge of a patient’s Alzheimer’s risk are put in an interesting spot.  If they tell their patients the bad news, it may have a profound negative effect on their psyche and lead to debilitating depression; if they don’t tell, they are withholding information that might enable a person to prepare their life more effectively to deal with the oncoming challenges.  As the article so well articulates:

“Modern medicine has produced new diagnostic tools, from scanners to genetic tests, that can find diseases or predict disease risk decades before people would notice any symptoms.  At the same time, many of those diseases have no effective treatments. Does it help to know you are likely to get a disease if there is nothing you can do? “

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Biotech Grant Funding: Are a Few Crumbs Better Than No Crumbs At All?

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By GLENN LAFFEL, MDPicture 13

After assuming control of the House in the mid-term elections, Republicans vowed to eviscerate the Affordable Care Act, the health reform law signed by the Big O last March. Thank heavens therefore, that the Boehners were too busy congratulating themselves to even notice those federal helicopters dumping $1 billion in cash on some needy biotech companies just as the election results were being tallied.

Yep, it happened. Federal disbursements in the form of grants and tax credits were made last week, as required by a provision in the reform law known as the Qualifying Therapeutic Discovery Project Program. According to the terms of this Program, biotech and life sciences companies with less than 250 employees could apply for federal funds to cover research costs they had incurred in the last 2 years, so long as the research focused on the prevention, diagnosis and treatment of chronic diseases.

The Program amounted to a nod by the Feds to biotech and life sciences, 2 industries that had been battered to near oblivion by the Great Recession of 2008-2010. Biotech and life sciences fared worse than most industries because the core of their business, research and development, consumes enormous capital early-on and there are long delays before these projects hit pay-dirt–if they ever do. Early-stage companies in these industries are therefore high risk investments, the sort VCs steer clear from when the going gets tough.

Unfortunately for the targeted industries, the Program turned out to be a small nod, indeed. It attracted 5,600 applications, far more than expected, and by rule all 4,600 that met congressional requirements had to be funded. With the pool capped at a bil, qualifying projects attracted far fewer dollars than requested.

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How Health Services Researchers Can Harness Data : Discussion at Health Innovation Week, SF

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By TED EYTAN, MD Ted Eytan

Last week’s Health Innovation Week in San Francisco started for me with a day entitled “From Data to Information, to Knowledge to Application: How Health Services Research Can Harness Data to Help Support a More Rapid Learning Cycle,” at @KPGarfield in Oakland, California.  I was asked to present an example from clinical practice on “Novel Means of Data Generation.”

Kind of a lot to get my head around as since I am not a health services researcher.

I knew that I would be co presenting with Gilles Frydman ( @gfry ) and as I have always learned, even if you don’t know what to do, take a good history, so I went.

The second in my slide is maybe a small reflection of my anxiety over Twitter, thanks to the audience for letting me express it.

Speaking of social media, I really liked the stated approach for the day, “share whatever you like, just don’t attribute it to people.” For me that sets a great tone, so kudos to the organizers for discussing this proactively rather than waiting for someone to ask. With that in mind, I will attribute things to myself only, since they’re my things to attribute…

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Shining a Light on Conflict of Interest in Biomedical Research

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By NAOMI FREUNDLICH
Naomi Freundlich

Last week Francis Collins, the director of the National Institutes of Health proposed important new rule changes for federally-funded investigators that are designed to increase transparency and remove many of the conflicts of interest that abound in biomedical research.

The proposed NIH rules, which are open for comment and expected to go into effect before the end of the year, represent the first time financial reporting requirements have been overhauled since 1995. The rules require investigators to disclose to their institutions all payments they receive from industry above $5,000, as well as any equity position they hold in a company. Research funding, speaking fees, paid authorship and travel expenses all must be part of this accounting. The previous limit was $10,000. The new regulations, which are aimed at reducing or removing industry bias from academic research, also require the academic medical centers to come up with a plan to manage investigator’s conflicts of interest—for example, university officials might insist that an investigator sell stock he owns in a company that helps pay for his research. Institutions will also be required to post all relevant payments (along with names of individual investigators) on a public website.

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