Jack at Apple Store (via iPhone)

Jack at Apple Store (via iPhone), originally uploaded by KidneyNotes.

Hilarious Journal Articles #87: "You've Gotta Know When to Fold 'Em: Goal Disengagement and Systemic Inflammation in Adolescence"

Apparently quitting reduces C-reactive protein.

The notion that persistence is essential for success and happiness is deeply embedded in popular and scientific writings. However, when people are faced with situations in which they cannot realize a key life goal, the most adaptive response for mental and physical health may be to disengage from that goal. This project followed 90 adolescents over the course of 1 year. Capacities for managing unattainable goals were assessed at baseline, and concentrations of the inflammatory molecule C-reactive protein (CRP) were quantified at that time, as well as 6 and 12 months later. To the extent that subjects had difficulties disengaging from unattainable goals, they displayed increasing concentrations of CRP over the follow-up. This association was independent of potential confounds, including adiposity, smoking, and depression. Because excessive inflammation contributes to a variety of adverse medical outcomes, these findings suggest that in some contexts, persistence may actually undermine well-being and good health.

Maria from Intueri

This week met Maria, who writes Intueri, the best-written medical weblog. (So of course, she blogged it.)

Since my last entry, I

am still alive. Just to be clear.

met Joshua Schwimmer, a nephrologist (kidney doctor) who writes at Kidney Notes, Healthline, and The Efficient MD, in addition to his clinical research publications. He managed to spare some time away from writing to meet me for dinner (after we stood in line in the behemoth Apple Store, where Joshua deftly picked up two potential patients at the cash register. Yeah, Apple apparently sells iPatients now.) I also met his adorable French bulldog, Jack, who is well-trained (Joshua is a budding behaviorist) and was definitely the center of attention for the entire evening. In fact, the following is the snapshot moment I have in my mind from meeting him: He and Jack racing back and forth across the smooth tiles in the lobby of his building, expressions of joy on both of their faces.

Joshua is smart. And enthusiastic about many things. And offered lush praise about my writing. (What can I say? The man’s got good taste.)

Photowalk in NYC with David Sifry

Planning to go on a photowalk over the Brooklyn Bridge with David Sifry this Saturday.

My Talk on "Health 2.0" for the 5th Annual Healthcare M&A and Corporate Development Conference

This is the talk I gave at the 5th Annual Healthcare Mergers and Acquisitions (M&A) and Corporate Development Conference on September 24, 2007. I was part of a panel titled "Healthcare 2.0: Technology & Healthcare Services of the Future," and we were asked to talk about disruptive changes in healthcare.

--

Good afternoon.

I'm a bit out of my element here, because I'm a practicing kidney and blood pressure specialist in New York City, but I do have a lot of friends and patients on Wall Street.

I'm going to talk briefly about the disruptive potential of online communities of physicians and patients.

These online communities are an big part of what people have called "Health 2.0." Of course, this is just a buzzword, like "Web 2.0," but it's a buzzword that means something.

Early this month the Economist had an article about Health 2.0, which they defined as "user generated healthcare." In Health 2.0 communities, the content and value is not generated by outside experts, but by the users themselves, by healthcare providers and patients, who interact to share information and insights.

These online communities may be very different from one another -- and I'll give you some examples of them in a minute -- but they all have a couple of things in common: they're all public, collaborative, and simple to use. And this combination can be very powerful and disruptive.

For example, there's a website called Wikipedia which is perhaps the best example of a community that's a major source of health information for a lot of people. If you haven't seen it, Wikipedia is a free online version of an encyclopedia that anyone in the world with an internet connection can read and edit. I'll say that again -- anyone in the world can read it and edit it.

This idea seemed crazy at first and still seems kind of crazy, but it actually seems to work. Wikipedia is now 15 times as large as the entire Encyclopedia Britannica. And partly because of Wikipedia, very few people read the Encyclopedia Britannica anymore.

And what's written on Wikipedia definitely matters. Wikipedia is one of the top ten websites worldwide. Wikipedia is often one of the first places people go if they're diagnosed with a new disease, or if they want to research a person or a corporation. The definitions on Wikipedia are often near the top of any Google search.

But again, it's amazing that Wikipedia works at all, because anyone with an internet connection can change any of the definitions. And that's potentially very scary.

But the system works because it's self policing -- errors are picked up and changed by the users. But of course that still leaves some potential for significant inaccuracies and abuse.

[The author Charles Stross points out that if you extrapolate from current trends in computing, sooner or later everyone in this room will have an entry on Wikipedia. Try to imagine what they might be like.]

I'm going to talk about some other Health 2.0 communities that have the potential to be as disruptive as Wikipedia.

For example, there's an online community for physicians called Sermo. Sermo was founded on the idea of information arbitrage, that there's valuable information locked in the heads of physicians, if you could only figure out a way to get to it.

The way Sermo works is this: physicians ask and answer anonymous questions, but some of the questions are also asked by firms. When physicians answer some of these questions, they get paid, but they don't know which questions will pay them. So the incentive is to answer as many questions as possible. Sermo is basically an experiment in classical conditioning, it mines physicians for information by turning them into compulsive gamblers and taking advantage of their desire to collaborate. And it works very well.

It's only about a year old but Sermo is the largest online network of physicians that's ever existed. Sermo is also partnering with the AMA and the FDA, who are interested in information from Sermo about the safety of medical products. Sermo may actually be a better way to encourage physicians to report problems with drugs and devices than the FDA's own website.

There are also many online communities for patients, including sites with names like Organized Wisdom, Revolution Health, and Patients Like Me. These sites offer a number of services. They function as support groups for people whose physicians may not know enough about their disease or who don't have the time to explain it. They also allow patients to share their collective insights with one another. And they allow them to rate different sources of health information on the web. Some people like to use the phrase that "people are the new algorithm."

And some of these sites also allow patients to rate their doctors, health systems, and health products. And this is potentially disruptive, but not necessarily in a bad way. If people can search on Google for a review of your organization as easily as they can search for a review of a toaster, that can be a powerful incentive to change for the better. But as with Wikipedia, there's obviously a potential for inaccuracy and abuse.

And finally, there's also thriving community of medical blogs, which are online interactive journals written by patients, physicians, and other health care professionals. Many healthcare blogs contain hidden gems of information. And there's a sustained level of discussion on blogs that's hard to find anywhere else.

For example, there's a blog called "Kevin, MD" which collects all the most interesting stories in the media in one place. There's a blog called "Running a Hospital" by the CEO of Beth Israel Deaconess in Boston. And the Wall Street Journal even now has it's own excellent Health Care Blog, which I recommend to anyone interested in the business of healthcare. And the interactive nature of blogs is essential, because sometimes the comments can be more interesting than the original posts themselves.

To summarize: technologies like Wikipedia, blogs, and online communities have the potential to dramatically change and improve communication in the healthcare industry.

Thank you.

"Wrong Object"

wrongobject, originally uploaded by brucesflickr.

More attempts to capture unusual glowing cloud formation

More attempts to capture unusual glowing cloud formation, originally uploaded by KidneyNotes.

Leaving Nashville

Leaving Nashville, originally uploaded by KidneyNotes.

Healthcare M&A Conference

Healthcare M&A Conference, originally uploaded by KidneyNotes.

5th Annual Healthcare M&A and Corporate Development Conference

On September 24th, I'll be appearing on a panel at the 5th Annual Healthcare M&A and Corporate Development Conference. The panel topic is "Healthcare 2.0: Technology & Healthcare Services of the Future." I'll be speaking on online communities of physicians and patients.

If you'll be at the conference, please feel free to look me up.

If there's time, I'll be posting pictures from the conference on Kidney Notes and posting observations on Twitter.

The Health 2.0 Conference Video

Currently Reading: Against the Day by Thomas Pynchon

Not reading, exactly -- more like listening to the 56 hour audiobook from Audible.com, which is worth it for the range of accents alone, and which makes referring to the Pynchonwiki easy while listening, but man, this is 1000 pages and it's his most accessible book -- I'll see you in a week.

Doktor Sleepless

ds6w, originally uploaded by warrenellis.

Hilarious Journal Articles #86: Elvis to Eminem: quantifying the price of fame through early mortality of rock and pop stars

From the Journal of Epidemiology and Community Health:

Background: Rock and pop stars are frequently characterised as indulging in high-risk behaviours, with high-profile deaths amongst such musicians creating an impression of premature mortality. However, studies to date have not quantified differences between mortality experienced by such stars and general populations.

Objective: This study measures survival rates of famous musicians (n = 1064) from their point of fame and compares them to matched general populations in North America and Europe.

Design: We describe and utilise a novel actuarial survival methodology which allows quantification of excess post-fame mortality in pop stars.

Participants: Individuals from North America and Europe performing on any album in the All-Time Top 1000 albums from the music genres rock, punk, rap, R&B, electronica and new age.

Results: From 3 to 25 years post fame, both North American and European pop stars experience significantly higher mortality (more than 1.7 times) than demographically matched populations in the USA and UK, respectively. After 25 years of fame, relative mortality in European (but not North American) pop stars begins to return to population levels. Five-year post-fame survival rates suggest differential mortality between stars and general populations was greater in those reaching fame before 1980.

Conclusion: Pop stars can suffer high levels of stress in environments where alcohol and drugs are widely available, leading to health-damaging risk behaviour. However, their behaviour can also influence would-be stars and devoted fans. Collaborations between health and music industries should focus on improving both pop star health and their image as role models to wider populations.

The Hilarious Journal Article collection is here. (Thanks, Huck.)

FDA Hearing on Erythropoeisis-Stimulating Agents (ESAs)

Via the American Society of Nephrology:

On September 11, 2007, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research held a joint session with the Cardiovascular & Renal Drugs Advisory Committee (CRDAC) and the Drug Safety & Risk Management Advisory Committee (DSaRM) to examine the risks and benefits of erythropoesis-stimulating agents (ESAs) when used in the treatment of anemia due to chronic renal failure. The drugs, sold under the brand names Aranesp and Epogen, boost red blood cell production and raise hemoglobin levels in kidney disease and dialysis patients. The hearing was prompted by the “Normal Hematocrit” study and the CHOIR study. The task was to evaluate the appropriate hemoglobin target for patients using ESAs and the identification and management of ESA “hypo-responders.”

You can view further information about the hearing, such as the overall agenda and a list of committee members here, under September 11, 2007.

Drs. Lynda Szczech and Jonathan Himmelfarb represented the ASN and presented testimony during the Open Public Hearing. The ASN Public Policy Board submitted a statement to the FDA prior to the hearing and received an invitation from the FDA to speak at the Open Public Hearing. Dr. Himmelfarb is the chair of ASN's Public Policy Board. Dr. Szczech is a member of the Public Policy Board and chair of ASN's Dialysis Advisory Group. You can read more about their testimony below.*

Meeting Summary:

FDA Invited Speakers (You can view these slides here)

Dwaine Rieves, MD, Acting Director of Medical Imaging and Hematology Products and the FDA introduced the invited speakers.

The first presentation was given by Ajay Singh, MD, Clinical Director of the Renal Division at Brigham & Women's Hospital, who gave an update on Anemia and Chronic Kidney Disease based on results of the CHOIR study.

The second presentation addressed Epoetin Outcomes Research and was given by Dennis Cotter and Yi Zhang from the Medical Technology and Practice Patterns Institute in Bethesda , Maryland and Miguel Herman, Associate Professor of Epidemiology at Harvard University 's School of Public Health.

Sponsor Presentations (You can view their slides here)

Paul Eisenberg, MD, MPH, from Global Regulatory Affairs & Safety at Amgen, Inc. provided the introduction. This was followed by a presentation on the Clinical Perspective provided by Allen Nissenson, MD, Professor of Medicine at UCLA. Preston Klassen, MD, MHS, Global Development, Amgen, Inc. then spoke about the benefits and risks. Paul Eisenberg, MD, then addressed Risk Management.

The Sponsors summarized that:

(1) Hb target is clinically important (label recommendation 10-12 g/dL)

(2) Relationship between dose and outcomes is highly confounded

(3) Additional investigation of hypo responsiveness and outcome required

FDA Presentations

Ann Marie Trentacosti, MD, Study Endpoints and Labeling, gave an overview of Patient Reported Outcomes (PRO) Claims and the limitations of these studies related to their design. Ellis F. Unger, MD provided the “FDA Perspectives on Erythropoiesis-Stimulating Agents (ESAs) Anemia of Chronic Renal Failure: Hemoglobin Target and Dose Optimization” to include analyses suggesting a relationship between the rate at which hemoglobin rises and risk and a reanalysis of the Normalization of Hematocrit Trial with extended follow-up favoring the low hematocrit group (p=0.01) ( Click here for PDF).

Open Public Hearing

Presenters at the Open Public Hearing included the following:

Roberta Wager, RN, MSN, President of the American Association of Kidney Patients stressed that ESA doses should be decided by a physician and a patient on an individual basis and that the FDA should strive for a “Goldilocks” solution — not to much, not too little, but one that should improve the Quality of Life for kidney disease patients.

*Dr. Himmelfarb, ASN Public Policy Chair, discussed the problems patients encounter when they have become sensitized from blood transfusions given to manage their anemia and as a consequence may lose access to kidney transplantation as a therapeutic modality.

*Dr. Szczech, ASN Dialysis Advisory Group Chair and member of the Public Policy Board, provided the results of new post-hoc analyses of the CHOIR data examining interactions between the dose of administered epoetin alpha, targeted hemoglobin, achieved hemoglobin and patient outcomes. She will be presenting these important results more fully during the late breaking clinical trial session at Renal Week.

Drs. Robert Wolfe and Friedrich Port from the University of Michigan presented new research from Arbor Research Collaborative for Health. The research found that mortality is lower in dialysis facilities having more patients with hematocrit levels greater than or equal to 33%. They cautioned that it is also possible that some facilities have sicker patient populations.

Dr. Robert Provenzano, DaVita, and past president of the Renal Physicians Association, spoke about the risks of cycling. Data from DaVita clinics suggests that holding EPO when the hemoglobin is at 12 or 13 g/dL increases the risk of both low and high hemoglobin levels later. He recommended that EPO should be used to keep the hemoglobin above 11 and to decrease it if above 12.

Michael Lazarus, MD, Fresenius Medical Care, presented data showing that even thoughp hysicians are unable to stop shifting hemoglobin levels, overall the mean level stays around 11g/dL.

David Van Wyck, MD, co-chair of the KDOQI anemia work group recommended that the target range should be 11-12 g/dL, not to exceed 13 g/dL. This recommendation follows the examination of evidence from 27 Randomized Clinical Trials (RCTs).

Alan Kliger, MD, President of the Renal Physicians Association also represented the American Society of Pediatric Nephrology. He spoke to the fact that the doctor-patient relationship should be preserved and that warning should target specific patient populations (pediatrics, CKD, ESRD, cancer). He also testified that Quality of Life should be included in the committee's considerations.

Lori Hartwell, founder of the Renal Support Network, was the final witness. Ms. Hartwell has suffered from chronic kidney disease for 39 years, has had 3 kidney transplants and 12 years of dialysis therapy . As a nurse and a kidney disease patient, Ms. Hartwell has seen the benefits of ESAs and discussed concerns from the patient community about potential lowering of hemoglobin target levels.

Committee Discussion and Voting

The first question posed to the committee was whether the ESAs label should “&be changed to state that the target hemoglobin should not exceed ~11 g/dL for patients on hemodialysis&” The committee voted 14 to 5 against this question. Many Committee members were uncomfortable with the language “shall not exceed” and felt that the 11 g/dL upper target was inappropriate. Several members preferred other options, such as a 10-12 g/dL range or a target of 11 or 11.5 g/dL (omitting the words “not exceed”).

The second question was very similar to the first except it addressed the target hemoglobin for patients NOT on dialysis. The committee again voted 14 to 5 against the question for the same reasons as the first.

The committee omitted the third question, regarding future randomized clinical studies to study hemoglobin targets, due to time constraints.

The fourth question posed to the committee asked whether the “ESA dosages used to achieve the hemoglobin levels in the lower target groups in Normal Hematocrit and CHOIR are sufficient to form the basis for ESA dosage recommendations.” This question garnered a positive vote of 14-3, with 2 abstentions.

The fifth question addressed the identification and dosages for “ESA hypo-responders.” Members noted that the Sponsor presented a recommendation on how to identify these patients.

The final question asked the committee to discuss dosing algorithm hypotheses. Members agreed that additional attention to dosing algorithms would be useful.

The role of the FDA Advisory Committee is strictly to advise the agency and the FDA issues final decisions. However, the recommendations of the committee often have a strong influence on the final decisions. In general, the committee members acknowledged the value of ESAs and hesitated to impose stringent restrictions on their use.

The hearing was covered by several major media outlets including the New York Times , Bloomberg, the Wall Street Journal , the LA Times , CBS News, Inside CMS, the Associated Press, and Reuters, as well as CBS News. Most articles indicated a positive outcome for the kidney disease community.

The ASN Public Policy Board will keep the membership informed of any future developments in the controversies surrounding management of the anemia of chronic kidney disease in subsequent issues of Renal Policy Express.

Currently Reading: Understanding Exposure

Grand Rounds is Up

Grand Rounds is up at The Efficient MD. My interview with Medscape is here (free registration required):

Blogs are also a remarkably efficient tool for recording your thoughts and sharing them. What doctor doesn't have advice and reference material they'd like to share with friends, colleagues, current or potential patients, or their future self at some later date? Blogs are one way of making this easier. And in a few years, why shouldn't inexpensive mobile phones or PDAs have evolved to the point where blogging -- that is, the mobile sharing of information and media with small or large groups -- is second nature to most people?

World Trade Center

World Trade Center, originally uploaded by KidneyNotes.

Twitter and Twitterfeed Explained

I'm using Twitter with Twitterfeed to tie together Kidney Notes, The Efficient MD, Tech Medicine, and Facebook. See the sidebar and this post by Clinical Cases for more details.

Grand Rounds Call for Submissions: Healthcare Innovations and New Technologies

The next medical blogosphere Grand Rounds will be held at The Efficient MD on September 11, 2007.

The theme of Grand Rounds will be "Healthcare Innovations and New Technologies." Submissions broadly related to innovations in healthcare are welcome: new technologies, models of practice, and ways of improving efficiency or the quality of care. Speculations about the future of healthcare are also encouraged. Old posts are welcome. If you haven't written about this topic before, feel free to use this opportunity to write on the future of healthcare. Be creative.

Please send your submissions to [email protected] with the subject "Grand Rounds" by Sunday, September 9 at 6 pm EST.

Some background on the topic of this Grand Rounds: I chose "Healthcare Innovations" because I will be participating in a panel discussion titled "Healthcare 2.0: Technology & Healthcare Services of the Future" at the 5th Annual Healthcare M&A and Corporate Development Conference. (And by all means, if you'll be at the conference, look me up.) Particularly interesting ideas from this Grand Rounds may also be mentioned prominently at the panel discussion.

(As an aside, the conference will be held in Nashville. Coincidentally, the last time I was in Nashville was on a trip away from New York on September 11, 2001 -- the date of this Grand Rounds -- but that's another story.)

Of course, if you don't have a formal submission to Grand Rounds but would like to mention an important link or idea, please feel free to comment.

Alison and Jack

Alison and Jack, originally uploaded by KidneyNotes.

Audible, Wishlist, Random, iPhone

Randomly working my way through an Audible.com wishlist on the iPhone using numbers generated by Random.org. Just finished The Dip.