Tuesday, January 31, 2012

Touch me or touch me not?

A tug-of-war is going on in medicine right now between the past and the future. The present is confused and very unsure of itself.

Though I could be writing about health care in the U.S. and the looming Supreme Court battle over the new health care law, I'm actually raising a much more intimate issue: Whether your doctor touches (examines) you or not.

Many pundits have weighed in on whether the physical exam has utility in an age when we have machines that can look inside the body and evaluate its physiology as never before.

Others have suggested that regardless of an exam's diagnostic capabilities, performing a physical has intrinsic value: connecting with patients. It's what they (you) expect. Touch is inherently therapeutic and offers solace.

Medical schools still teach the ancient art of the physical exam:
Inspection. Looking at the patient.
Palpation. Touching the patient.
Percussion. Tapping the patient's torso (chest + abdomen) to locate organs and detect extra fluid if present.
Auscultation. Listening with our stethoscopes.

These artful skills originated as far back as Hippocrates (though it wasn't until 1821 that Laennec invented the stethoscope).

Listen to the talk from Dr. Abraham Verghese (Stanford doctor and author of the novel Cutting for Stone) about the rise of the iPatient and his call to return to fundamentals--not only as good medicine but as effective and therapeutic medicine.

Contrast Dr. Verghese's approach with the experience of Dr. Bryan Vartabedian, a gastroenterologist, blogger, and social media authority from Texas.

Dr. V has a history of herniated lumbar disks. He visited an orthopedic surgeon for a consultation, and this is what he wrote about his visit: "... through the course of my visit he never touched me. We spent an extraordinary amount of time examining my MRI. Together in front of a large monitor we looked at every angle of my spine with me asking questions. I could see firsthand what had been keeping me up at night. I could understand why certain positions make me comfortable. What we drew from those images could never be determined with human hands. In my experience as a patient, I consider it one of my most thorough exams."

The contrast between the two experiences and the reactions to them could not be more profound. It leaves me wondering what the most important elements of doctoring are to pass along to my trainees. Losing the physical exam seems blasphemous. Yet sometimes I'll admit it feels more like hocus pocus than a meaningful endeavor.

What are your views? Is it necessary for a doctor to touch you on each visit? Is a yearly physical crucial? Would a consultation with a doctor be valuable if all you did was talk?

This post by John H. Schumann, FACP, originally appeared at GlassHospital. Dr. Schumann is a general internist. His blog, GlassHospital, seeks to bring transparency to medical practice and to improve the patient experience.

High ratings for personal physicians

It's time for some good news! A study that looked at online patient ratings about their physicians from 2004 through 2010 showed that the average physician rating was 9.3 out of 10. That is amazingly high and shows that patients (at least the ones who posted on Dr.Score) are very content with the care they receive from their doctor. Even though some patients will post a nasty comment about the doctor, the overall patient satisfaction is high. 70% of doctors earned a perfect 10.

The survey asked patients to rate physicians on attitude, the thoroughness of the visit, how well the doctor communicated and how long they sat in the waiting room. It is not a surprise that the longer patients waited, the lower was the rating. 42% of doctors were primary care physicians and the remainder were specialists outside of primary care.

Patient satisfaction is finally getting attention in medicine. More than 60% of health care organizations are using patient satisfaction scores to determine physician incentive payments and large medical groups measure satisfaction and give the doctor feedback on a regular basis. Medicare will also link patient satisfaction with hospital payments and hospitals who do not rate high will lose revenue.

We read a lot about the problems in health care in the United States but those issues are usually concerned with cost and access. In fact a November Gallup poll found that 82% of adults say the quality of health care they receive is "good " or "excellent." A 2010 study by the Clinician and Group Consumer Assessment of Healthcare Providers and Systems found that 94% of nearly 42,000 patients rated their physicians a seven or higher on a 10-point scale. (That group needs a new name.)

Another study I read shows that 90% of physicians feel stressed nearly every day. It is good news that that stress is not being felt by the patients and that we are delivering the patient-centered care that we pledged when we took our oath.

This post originally appeared at Everything Health. Toni Brayer, FACP, is an ACP Internist editorial board member who blogs at EverythingHealth, designed to address the rapid changes in science, medicine, health and healing in the 21st Century.

QD: News Every Day--Appropriate use criteria updated for when to revascularize

Updated appropriate use criteria guide were released Jan. 30 to guide physicians and patients when to use an invasive procedure to improve blood flow to the heart and how to choose the best procedure for each patient. Clinical scenarios affirm the role of revascularization for patients with acute coronary syndromes and significant symptoms.

Prominent among the changes are a re-evaluation of the indications for the treatment of multivessel coronary artery disease by percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) as a result of data from the SYNTAX trial, which came out after the original criteria were published.

The new criteria appear online at the Journal of the American College of Cardiology.

Among the many changes:
--PCI is changed from inappropriate to uncertain for low burden left main disease, and from uncertain to appropriate for low burden three-vessel disease. This is meant to generate careful selection of high-risk surgery patients for PCI.
--Coronary artery bypass is appropriate for patient scenarios with coronary artery disease involving two vessels to include the proximal left anterior descendent coronary artery and all variations of three-vessel and left main coronary artery disease.
--PCI is appropriate in patients with coronary artery disease in all three heart arteries only if the severity of coronary artery disease burden is low.
--It is uncertain whether PCI is appropriate in patients with three- vessel coronary artery disease and an intermediate to high disease burden.
--PCI is also deemed uncertain in patients with blockages in the left main coronary artery, alone or with blockages in other arteries and low coronary artery disease burden.
--PCI is considered inappropriate in patients with blockages in the left main coronary artery with intermediate to high disease burden

The updated appropriate use criteria, drafted in conjunction with 10 major cardiovascular and thoracic medical societies, replace a previous set published in 2009. New clinical data led to the update. For example, publication of the SYNTAX trial called for the reexamination of clinical scenarios for multi-vessel coronary artery disease.

The 2009 appropriate use criteria outlines nearly 200 clinical scenarios that reflect common heart problems seen by cardiologists. The appropriate use criteria scenarios were developed to mimic patient presentations encountered in everyday practice and to address the rational use of coronary revascularization. The ratings take into account such factors as symptoms, medication, results of stress testing, severity of disease burden, and number of coronary blockages.
Monday, January 30, 2012

Weight loss strategies are a matter for heavier discussion

Yesterday's New York Times offered two distinct perspectives on weight loss. One, a detailed feature on gastric surgery by Anemona Hartocollis, details the plight of a young obese woman who opts for Lap-band surgery. In this procedure, surgeons wrap a constricting band of silicone around the stomach so that patients will feel full upon eating less food than they might otherwise. Allergan, the company that manufactures the device, admits to these complications on its website.

The other, a discussion of resolutions and will-power by John Tierney, considers strategies for sticking to diets, exercise regimens and other good intentions for the new year.

Within this piece lies a distracting story of an obese (375 pound) hedge fund manager whose gastric band failed to keep his appetite in check. When he landed a project in Las Vegas and feared regaining weight, he aimed high to lose 100 pounds, outfitted his hotel suite with a gym, and hired a personal trainer to stay nearby and keep him on track in terms of meals and exercise. This costly "outsourcing" of will-power is, obviously, not an option for most people.

Tierney does offer some reasonable suggestions, like setting realistic goals, weighing yourself daily, Tweeting your weight, logging into a weight-loss website, not freaking out if you blow your diet one day, etc.

Both articles (here and here) are well-worth reading.

But here's the thing, how do doctors fit into this picture? In the last few years that I was practicing hematology, I saw a few patients who had B12 deficiency after gastric bypass surgery. These patients turned out to have multiple problems after their stomachs were cut so they'd eat less food. For some it was helpful; I saw individuals who lost over 150 pounds. Still, the surgery was huge and risky. I can't fathom having recommended it to a patient whom I cared for, unless perhaps I'd personally witnessed her struggling to lose weight for over, say, eight to 10 years.

Because most people, if inspired or starved, can lose weight. This may sound cruel, but what if the doctors recommending the procedure don't have sufficient confidence in their patients?

The Lap-band is sold as a safer alternative, but upon reading the story (an anecdote, but telling), you have to wonder what are patients' expectations of the procedure, and how well do they understand the likely risks and benefits. Who are the doctors who tell them about the procedures, and what are their ties with industry (besides the obvious link of surgeons who do the surgery and recommend it).

Like patients with cancer, patients with obesity may feel desperate. But unlike cancer, obesity is almost always a function of choices we make, and for which I think we have to hold people responsible.

Doctors, maybe, should expect more of their patients. "Yes, you can lose 30 pounds over the next two years," one might say. And they might talk about strategies, Tierney-style or otherwise, based on the patient's preferences and personality. "Come into my office once each month for a weigh-in," might be very effective in persuading patients to shed pounds. A technician could do the monthly measurement in the office or medical home, and the doctor or nurse might follow-up with an encouraging email. Imagine that!

So why don't more general practitioners, including pediatricians, offer this sort of weight-loss approach? Is it too simple a strategy that doctors don't find it interesting? Or not sufficiently profitable for the office or medical center?

No answers, just thoughts upon reading, for today.

This post originally appeared at Medical Lessons, written by Elaine Schattner, ACP Member, a nonpracticing hematologist and oncologist who teaches at Weill Cornell Medical College, where she is a Clinical Associate Professor of Medicine. She shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology and as a patient who's had breast cancer.

A modern-day fairy tale for medical education

Recently, I was asked to speak about innovations in inpatient medical education for leaders in general internal medicine. Knowing that I would be last in a distinguished lineup of speakers and that my charge was to discuss novel ways to teach in the inpatient setting, I thought it would be important to review how it's been done for a long time--so long that it is embodied in one of my favorite fairy tales.

Glass slippers by Glamhag via Flickr and a Creative Commons licenseYou see, Cinderella dreamed of one day becoming the best clinical educator in the academic kingdom. Unfortunately, her evil stepmom "Mrs. Dean" scoffed at Cinderella and said, "Teaching does not pay. Look at your hard working and loyal stepbrothers. Bill has been our primary breadwinner due to his high volume of patient care and Grant, while it's feast or famine with him, just got a big payout for his clinical research. Teaching? That's no way to make a living. Go work for them until you figure you what you want to do."

So Cinderella toiled away, until one day, she met the Godmother of a grateful patient, "Mrs. Fairy," who donated a small sum money to improve inpatient teaching. With this, Cinderella was able to transform herself into one of the leading teachers of the new curriculum. (She was also able to get a raise to update her wardrobe!)

She quickly became a hit among all the medical students and residents who were truly charmed. Then one day, at the stroke of midnight, Cinderella's protected time ran out, and all of her work went up in smoke as she was forced back to her life of hardship seeing patients and doing research.

The students and residents were distraught at the thought of losing their most prized teacher and searched the academic complex for her. They were so moved they wanted to award her the precious "Glass Slipper" teaching award, which not only is bestowed with honor, but also a promotion to become a tenured educator in the academic kingdom. And she lived happily ever after.

While you may think that this is the stuff of fairy tales (especially happily ever after), we all have Cinderellas at our institutions. And those Cinderellas want to teach, but they struggle not only with funding, but also the realities of today's inpatient environment. So, what are these Cinderellas to do? Well, there are few of the ways to ensure that clinical teaching is rewarded, and possible resolutions for medical educators.

Focus on a gap that needs to be filled. Protected time is most likely be awarded to someone who is filling a need; think the new curriculum that is mandated by LCME/ACGME or other alphabet soup organizational body. What is the specific need that you can fill with teaching? Often this may require thinking about a topic that may not exactly match your initial interest, but it is more likely to lead to funding for your teaching.

Learn new teaching methods. Teaching methods for today's wards are not well developed in the land of an organized chaos. By incorporating a new platform for teaching (think case blogs, video reflection, standardized patients, or a host of other ideas), you can breathe new life into an old topic. For example, using simulation to teach end of life discussion, or using blogs to teach about professionalism, can result in a novel curricular program that not only engage next generation learners, but also gains attention of leaders in medical education.

Document the effectiveness of the teaching. It is only through methodological evaluation that one can document that teaching translates into practice. By showing that teaching can be linked to improvements in knowledge, attitudes, or practice, it is more likely that someone (maybe a fairy) will finance this teaching as critical to the mission of the hospital. Think about procedural training that shows reduction in central lines.

Work with a mentor. Just like big research, mentorship is still important, although not always emphasized. To be honest, mentors can serve to mobilize resources or promote your work with senior leaders.

However, regardless of these strategies, funding for teaching requires institutional leadership to recognize that the academic mission of teaching hospitals is still to teach. Of course, this mission is sometimes lost in the chaos of teaching hospitals surviving budget crisis in an increasingly competitive environment. Now is a great time to remind the fiscally minded Mr. Scrooge in your C-suite that the greatest gift they can give is enabling a teacher to teach the future doctors of our nation.

Vineet Arora, MD, is a Fellow of the American College of Physicians. She is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist, supervising internal medicine residents and students caring for general medicine patients, and serves as a career advisor and mentor for several medical students and residents, and directs the NIH-sponsored Training Early Achievers for Careers in Health (TEACH) Research program, which prepares and inspires talented diverse Chicago high school students to enter medical research careers. This post originally appeared on her blog, FutureDocs.

QD: News Every Day--Diabetic amputation rates falling

Diabetic lower extremity amputations declined significantly in the U.S. diabetic population from 1996 to 2008, a study found, although amputations continued to be substantially higher in diabetics than in nondiabetics and disproportionately affected people aged more than 75 years old, blacks and men.

Researchers calculated amputation hospitalization rates by diabetes status among those ages greater than 40 years on the basis of National Hospital Discharge Survey data and National Health Interview Survey data on diabetes prevalence from 1988 to 2008. Results appeared in Diabetes Care.

Although the number of U.S. residents with diagnosed diabetes increased dramatically from 5.4 million in 1988 to 17.1 million in 2008, the estimated number of diabetes-related amputation discharge codes increased only from 52,868 in 1988 to a peak of 83,153 in 1996, and then decreased to 70,139 in 2008, the authors wrote.

Age-adjusted amputation rates for the diabetic population increased in the early 1990s and then declined by 8.6% annually between 1996 and 2008 (P less than 0.01). With change over the entire study period accounted for, the average annual percentage change in age-adjusted amputation rates was 24.9% (P less than 0.05) in the diabetic population and 0.7% (P greater than 0.05) in the nondiabetic population.

The absolute change in rates between 1988 and 2008 was also greater in the diabetic population than in the nondiabetic population (5.4 vs. 0.03 per 1,000 persons). Despite the much greater decrease in amputation rates in the diabetic population, in 2008 the age-adjusted amputation rate in the diabetic population was still nearly eight times the rate in the nondiabetic population (3.9 vs. 0.5 per 1,000 persons).

But, the authors noted, diabetes and its related amputations continues to disproportionately affects people aged greater than 75 years, blacks, and men.

"[O]ur finding that the reduction in rates was substantially higher in the diabetic population than in the nondiabetic population suggests that the rate reduction in the diabetic population may be partly attributable to improved diabetes care management, differential risk factor improvement, or the differential impact of such improvements," the authors concluded.
Friday, January 27, 2012

Cigarette warning labels may go up in smoke

We live in a free society. One of our most treasured freedoms is our right to free speech. This means that we are free to advertise goods and services to potential customers, although commercial speech does not enjoy the same constitutional protection as does noncommercial speech. Some advertised products are good for us and others aren't. In many cases, the worth and value of the product are in dispute. Nevertheless, if a product is legal, the manufacturer is entitled to advertise and to lure customers.

While an advertisement may not be false, it may not be the complete truth either. We expect that these pitches will be buffed and sanitized to present the product in a favorable light. That's why they're called advertisements, and not testimony.

It would be absurd for a company to include negative material about its products in its promotional materials, barring a legal requirement to do so. While issuing product warnings and legal disclaimers may be a laudable public interest maneuver, it's not a way to run a company.

Imagine the following scenarios:
Join Our Tanning Salon. Get skin cancer!
Join Our Gym. Have a stroke on our treadmills!
Dine at our Family Restaurant. We don't wash hands!
Computer Protective Services Our PCs have viruses!
Expert Car Repair. We're Crooks!

The tobacco companies, the mother of all villains, had been required by the Food and Drug Administration (FDA) to include graphic and dire death and illness warnings prominently on their packages. One of the warnings depicts a corpse with the traditional autopsy incision visible.

I don't dispute the accuracy of the health claims. Indeed, I've often issued them personally as a doctor in my office. But is it fair, reasonable and necessary to compel cigarette companies to scare folks from purchasing their legal products? It would be more rational and intellectually honest for the FDA and the federal government to declare tobacco to be illegal. How can they permit a product so dangerous to be freely sold to the public? The reasons that restrain them from doing so are self-evident. Readers are free to offer their own views on the government's paradoxical (in)action.

A federal judge recently issued a preliminary injunction against the FDA's edict arguing that the cigarette companies were likely to prevail in a First Amendment challenge. The judge recognized that graphic and macabre material likely exceeded a reasonable government requirement to inform smokers of health risks on cigarette packaging. Their purpose was quite transparently to shock, not inform. Not surprising, my beloved liberal New York Times has editorialized that the judge's injunction was wrong. This judge, in my view, was spot on. I predict that his ruling will be upheld on appeal.

As an aside, are there folks out there who are not aware that smoking cigarettes is not a salubrious activity?

Our medical office needs new promotional material. Since I'm a taxpayer, perhaps the FDA can assist me. Here's my draft:
Michael Kirsch, MD
Specialist in Screening Colonoscopy
WARNING! He Has Perforated Many Colons. You Might End Up Here!
Old Graveyard in East Douglas, MA by wickenden via Flickr and a Creative Commons license

This post by Michael Kirsch, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

QD: News Every Day--Does Massachusetts predict federal health care reform's impact?

Massachusetts residents reported that 94.2% of the state's adult nonelderly residents have health insurance, a significant increase over the 86.6 percent estimate of 2006, the year that Massachusetts's health reform bill went into effect.

Massachusetts health insurance penetration rates are far above an estimated 77.7% coverage rate for nonelderly adults nationwide, based on the National Health Interview Survey. Many look to Massachusetts as the bellwether for national health care reform, because that state's legislation was largely adopted into the federal Affordable Care Act.

The survey also showed first-time reductions in emergency department visits and hospital inpatient stays as well as improvements in self-reported health status. At the same time, there was a significant increase in premium costs paid by workers, reflecting Massachusetts' decision to delay efforts to lower health care costs in the 2006 legislation.

Results from the survey appeared online at Health Affairs and will appear in the journal's February 2012 issue. Results are based on a randomly sampled telephone survey of 3,000 nonelderly adults in the state. The response rate was 39%, and cell phones as well as landlines. The authors compared the 2010 data with previous annual surveys from 2006 through 2009.

Other key findings:
--68% reported coverage through an employer, a significant increase from 64.4% in 2006. The study finds no evidence that employers are dropping coverage under health reform.
--Although access to care was generally better in 2010 than 2006, the number of respondents who had reported a general doctor visit declined by 3.5 percentage points between 2009 and 2010, perhaps reflecting increases in the use of specialists and preventive care under reform.
--In 2010, 6.1% of respondents said that their level of out-of-pocket health spending was at least 10% of their family income, a decline from 9.8% in 2006. Premiums increased between 2006 and 2010 from $1,011 to $1,200 for single coverage and $3,128 to $3,444 for family coverage.
--Overall, the authors found that in Massachusetts coverage and access to care remain strong, and the effectiveness of health care delivery continues to improve. The affordability of health care remains a challenge as the Bay State, like the rest of the nation, continues to struggle with rising care costs.

"Just as Massachusetts's 2006 health reform legislation provided the template for the Affordable Care Act ... the state's experience under that legislation provides an example of the potential gains under federal health reform," concluded the authors. "It is likely that the path to near-universal coverage nationally will be slower and bumpier than it was for Massachusetts in 2006. Yet the findings for Massachusetts are a reminder that major gains in coverage and associated benefits are possible."
Thursday, January 26, 2012

Meaningful use core measure #13, the patient-generated clinical visit summary

One of the Meaningful Core Measures is to provide a clinical summary of the office visit to each patient. This a well-intended measure as we know that patients will often retain only a part of all the information that they received at the office visit. The summary needs to contain very important information about the visit and decisions made during the visit including patient instructions.

Patients when they leave the office often go out with a sheaf of papers and find it difficult to know which ones they really need to read.

I have been actually giving the patient the "task" of creating their own summary of the office visit. Once we have gone through the history and exam and labs, I will engage them in a discussion on next steps. Then I ask them to summarize the plans and action steps and write them down on a piece of paper. They write down what they agree to do instead of what I would tell them to do. They take this paper with them as a summary of the visit in addition to the EHR generated printed after visit summary.

This activity can take a couple minutes but is incredibly powerful. There is something about a patient's own handwritten plan that cannot be replicated by a physician generated print out.

This is a summary created by a hypothetical patient who was diagnosed with high blood pressure.

How different is it when a patient-physician discussion results in the patient writing down himself that he will cut back on the alcohol vs. a physician telling him to cut back and then handing him a printed patient instruction?

This process has another advantage. It gives the physician an idea about the patient's literacy level. This has to be addressed in a sensitive manner but is incredibly useful information that each physician should know but often does not. This may also not be appropriate for patients with writing disability (Parkinson's or rheumatoid). In these cases you can ask a patient to tell you what to write down.

If you want you can take scan the handrwitten document with an app on your iPhone or android and upload into the electronic health record (make sure your HIPAA police are OK with this. One option is not to have any patient identifiers on the image like the one above).

Neil Mehta MBBS, MS, FACP, practices internal medicine at a large tertiary care hospital in Ohio. He is also the Director of Education Technology (Academic Computing) for his medical school and in charge of his hospital system's home grown Learning and Content Management System. He is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management. This post originally appeared at Technology in (Medical) Education.

Trials and errors in oncology, part II

So, the purpose of the Cancer Genome Atlas is to identify all mutations in the most common cancers. A massive project. Several maps have been completed including melanoma, pancreatic, ovarian, and lung cancers. Activation of these mutated genes results in the 6 characteristics of cancer previously listed. Therefore, it would stand to reason that aiming novel agents at these targets would inhibit growth and spread, possibly cure, cancer. But which targets to aim at?

Sentier au bord du Cher by via Flickr and a Creative Commons licenseFor example, pancreatic cancers contain between 50 to 60 mutations. To make order out of chaos, the most frequently identified mutated genes are inferred to be causative or "driver" mutations while the rest are "bystanders." Also, by recognizing that driver mutations tend to be found in certain "core" pathways but not others, this further reduces possible targets to a more manageable number. Between 13 to 15 pathways, an average of 13, are affected in a typical cancer type.

Getting back to the issue of causation, this month's issue of Wired contains an intriguing article by Jonah Lehrer headlined by the following statement: "Deadeend experiments, useless drugs, unnecessary surgery. Why science is failing us." The title, "TRIALS AND ERRORS", persuaded me to read on.

The story starts with Big Pharma's nightmare: a failed clinical trial. The drug, torcetrapib, appeared to be a slam dunk in that it lowered bad cholesterol (LDL) and increased the good (HDL) by inhibiting a protein that converts HDL to LDL. Inferred from these facts was that plaque formation would be reduced, which in turn would result in decreased morbidity and mortality from heart attacks and strokes.

In fact, the opposite occurred, and the Phase III trial was terminated. Pfizer had invested more than $1 billion dollars to develop torcetrapib, plus an additional $90 million to expand the manufacturing facility. The value of the company dropped by $21 billion in one week. Since 40% of drugs fail Phase II clinical trials, and 25,000 volunteers were participating in this trial alone, both the financial and human costs are staggering. $100 billion is invested in biomedical research annually.

How could torcetrapib fail? After all, the entire pathway of cholesterol metabolism had been mapped out and the drug's exact site of action was known. Sound familiar? As the author states, "It is a tale of mistaken causation." By lowering LDL and increasing HDL, it was assumed that improved cardiovascular health would result.

"This assumption-that understanding a system's constituent parts means we also understand the causes within the system-is not limited to the pharmaceutical industry or even to biology. It defines modern science. In general, we believe that the so-called problem of causation can be cured by more information, by our ceaseless accumulation of facts. Scientists refer to this process as reductionism ... Once we find the cause, of course, we can begin working on a cure."

Over the years we have learned that our attitude toward cause and effect is perceptual and that causal explanations are oversimplifications. We have learned to deal with the issue of causation through statistical correlation. The central concept is statistical significance, which "defines a significant result as any data point that would be produced by chance less than 5% of the time."

But significant correlation does not necessarily equal cause. "While correlations help us track the relationship between independent measurements, such as the link between smoking and cancer, they are much less effective at making sense of systems in which the variables cannot be isolated." The human body is extremely complex with inter-relationships between multiple pathways. Mapping one pathway and identifying all mutations does not reveal interactions between multiple pathways that are connected. This is why torcetrapib failed.

We are designing new clinical trials. We are mapping all the pathways of various cancers. By inference and statistical correlation, we think we have unearthed the driver mutations and core pathways that cause cancers, whose hallmarks have been identified. Are we setting ourselves up for another torcetrapib?

This post by Richard Just, MD, ACP Member, originally appeared at JustOncology.com, a joint publication of Richard Just, MD, aka @chemosabe1 on Twitter and Gregg Masters, MPH, aka @2healthguru on Twitter. Dr. Just has 36 years in clinical practice of hematology and medical oncology.

QD: News Every Day--Top 10 technologies a hospital might test this year

A top 10 list of important technologies and technology-related issues that hospital and health system leaders should pay close attention to this year questions each the need for each one based on economics, patient safety, reimbursement and regulatory pressures, as assessed by staff at the ECRI Institute.

1) Electronic health records: Hospitals will need not only IT infrastructure, but also the ability to integrate patient care device data into the electronic health record.
2) Minimally invasive bariatric surgery: Hospitals will need to develop interdisciplinary teams, invest in equipment, care setting and staffing models
3) 3D digital breast tomosynthesis: It requires more capital outlay and operational costs without a clear clinical benefit, and it doesn't replace full-field digital mammography.
4) New CT radiation reduction technologies: dose monitoring and measuring are critical to achieving lower radiation doses, and this aspect of the treatment is as important as the technology itself
5) Transcatheter heart valve implantation: hybrid cath lab models may be the ultimate destination for many of these procedures due to its lower cost and patient volumes. But this may happen only after procedures mature and proficiencies improve.
6) Robotic-assisted surgery: There's steady growth in the number and types of surgeries being done, despite a lack of definitive evidence for the superiority of it compared to traditional laparoscopic surgery.
7) New cardiac stent developments: A 60% use for off-label indications, high complication rates from treating bifurcated lesions with current stents, and higher-than-desired reocclusion and reintervention rates all signal the need for a more personalized approach to stents.
8) Ultrahigh-field-strength MRI systems: 3T systems offer better image resolution than their 1.5T counterparts, but cost about $1 million more than standard systems. Looming next: 7T systems.
9) Personalized therapeutic vaccines for cancer: The many new and high-cost pharmaceuticals and biotechnologies can cost $100,000 and more per patients, and they are all add-ons to existing therapy regimens.
10) Proton beam radiation therapy: Building these centers is a monstrous cost, as is running them. But no randomized controlled trials have proven to be more effective than photon beam treatments. And even newer (but just as expensive) regimens are also in development, carbon ions.

"Themes emerging on our 2012 list reflect ongoing impacts of healthcare reform initiatives and new technology developments that emphasize patient-centered care, including safety improvement, interconnectedness of technology, personalized medicine catering to individual care needs and preferences, and ever-increasing cost pressures," ECRI staff wrote in their white paper. "While the imperative to integrate health information technology with healthcare technology marches on, emerging devices, drugs, and procedures are tailored more than ever to individual patients' medical characteristics."
Wednesday, January 25, 2012

ACS issues annual report on cancer stats

This week the ACS released its annual report on Cancer Facts and Figures in the U.S. The journal Cancer analyzes and considers the data in a helpful article. Some of the key and mainly positive findings have been covered elsewhere:

Between 1990 and 2008, death rates from cancer in the U.S. declined rather steadily, overall, by 22.9% in men and 15.3% in women. More recently, between 2004 and 2008, the incidence of cancer has declined slightly in men (0.6% per year) but it's been stable in women. During this most recent period for which complete data are available, the overall death rates continued to drop by 1.8% in men and by 1.6% per year in women.

This is generally good news. Still, the total number of people in the U.S. who will receive a new cancer diagnosis in 2012 is estimated at 1,638,910. Some 577,190 people will die of a malignancy, which approximates to 1,500 cancer deaths per day in the U.S. Cancer is second only to heart disease as the cause of death in North America. Most cancers, some 77%, arise in people aged 55 or older; conversely, approximately 23% arise in people under 55 years of age. The NIH estimates that in 2007, direct health expenditures for cancer in the U.S. totaled $103.8 billion.

Some notes on survivorship
The latest estimate is that 12 million people are alive in the U.S. after a cancer diagnosis. This number includes people who are undergoing treatment and many who are in remission. Another encouraging detail: from 1975-77, the overall 5-year survival was just 49%. Now, between 2001 and 2007, overall 5-year survival stands at 67%. In other words, in 1975, just over half of cancer patients died within 5 years of their diagnosis; by 2007, two thirds of cancer patients were alive at 5 years.

The report includes a critical section on a few kinds of cancers for which the rates are increasing. These include cancer in the oropharynx (mouth and throat) associated with human papillomavirus (HPV); esophageal cancer (adenocarcinoma type), melanoma and tumors of the pancreas, liver, bile duct, thyroid, and some kinds of kidney cancer. The Cancer journal has a separate article on these.

The full and detailed document, at 68 printed pages, deserves close review in many particulars. Next week I'll go over the new data for breast cancer.

This post originally appeared at Medical Lessons, written by Elaine Schattner, ACP Member, a nonpracticing hematologist and oncologist who teaches at Weill Cornell Medical College, where she is a Clinical Associate Professor of Medicine. She shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology and as a patient who's had breast cancer.

Kwasiorkor codes in California Medicare population triggers investigation

Is it plausible that one small hospital in rural Northern California treated 1,030 cases of Kwashiorkor within a two year period?

Before you answer that, let me explain what Kwashiorkor is. It is a severe form of protein malnutrition ... starving to death actually. It is the type of starvation you see in African children. It is so severe that the patient needs special nutritional support, including special re-feeding with vitamins, and it occurs mainly in children ages 1-4. Adults can starve to death, but they do not develop classic Kwashiorkor.

Medicare pays hospitals a flat rate based on diagnosis codes for patients. Patients with more severe coded illnesses get paid at a much higher rate. Shasta Regional Medical Center, located in Redding, Shasta County, California is under the microscope for billing Medicare (our tax dollars at work) for 1,030 cases of Kwashiorkor to the tune of $11,463 for each diagnosis. This medical center is a 246-bed facility in a town of about 90,000 people. The entire county is less than 200,000 population. The median home price in 2010 was $245,000 and the average household income is $62,222. Hardly the demographics for Kwashiorkor.

Prime Healthcare Services owns 14 California hospitals, including the one in Redding. After they took over the hospital in 2008, the diagnosis of Kwashiorkor exploded. One of the patients that they billed Medicare for was interviewed and she said she was never malnourished and was never told she had Kwashiorkor. She had diabetes and kidney failure and, according to her daughter, was actually overweight. There was no notation in her chart about edema swelling or nutritional consult. She received no vitamins.

A former medical coder at another Prime Healthcare Hospital told California Watch that she was pressured to write up patients for Kwashiorkor if they had low albumin levels and were diagnosed for ordinary malnutrition. Low albumin is very common in hospitalized patients and it can accompany a number of medical illnesses. Coding these as Kwashiorkor is fraud, plain and simple.

Most hospitals across the Country are doing their best to take care of patients and function with the byzantine regulations of Medicare and hundreds of insurance companies. The majority of hospitals lose money on Medicare patients. Flagrant abuse in billing, such as is suspected at Shasta Regional Medical Center, gets no sympathy from me. I hope the CEO ends up in stripes and that all of the Prime Healthcare Hospitals are closely investigated.

This post originally appeared at Everything Health. Toni Brayer, FACP, is an ACP Internist editorial board member who blogs at EverythingHealth, designed to address the rapid changes in science, medicine, health and healing in the 21st Century.

QD: News Every Day--Get cancer, keep smoking, what does it take to quit?

Patients continue to smoke after their diagnosis, including nearly one in seven lung cancer patients, a study found.

Because CT scanning is becoming more prevalent for lung cancer screening, and earlier detection could lead to less mortality, the issue of smoking cessation will become even more important in the future, the authors suggested in their research.

The research was a cohort of more than 10,000 patients in the multi-regional Cancer Care Outcomes Research and Surveillance cohort, of which lung cancer comprises 2,456 people and colorectal cancer 3,063. Results appeared in Cancer.

At diagnosis, 38.7% of patients with lung cancer and 13.7% of patients with colorectal cancer were smoking. Five months after the diagnosis, 14.2% of patients with lung cancer and 9% of patients with colorectal cancer were still smoking. This means that slightly less than two-thirds (63%) of lung cancer patients and slightly more than one-third (34.3%) of patients with colorectal cancer who had been smoking around the time of diagnosis had quit five months later, researchers noted.

Factors that were associated with lung cancer patients continuing to smoke included being unmarried, using public insurance over private insurance, not undergoing surgery, having more lung cancer symptoms, having a history of cardiovascular disease or lung disease, reporting worse pain in the past month, having a lower body-mass index, having more depression, and having a greater highest reported number of cigarettes smoked per day (all P less than .05).

Significant factors associated with continued smoking among patients with colorectal cancer were white race/ethnicity, older age, not undergoing surgery, not receiving chemotherapy, reporting higher levels of depression, and having a greater highest reported number of cigarettes per day (all P less than .05)

Authors also noted that two factors were associated significantly with continued smoking in both groups: not undergoing surgery and the highest number of cigarettes ever smoked per day. Because of the negative effects of smoking on wound healing, many surgeons insist on abstinence from cigarettes before surgery, which may reduce treatment complications and boost efficacy. Smoking more cigarettes per day could be proxy for addiction, and underscores the need for pharmacologic support to stop smoking.

"Because of the widespread public knowledge that smoking causes lung cancer, it is plausible that patients with lung cancer associate their diagnosis with smoking and quit accordingly, whereas patients with colorectal cancer may not associate their diagnosis with smoking and, thus, may be less likely to change their smoking behavior as a result of their diagnosis," the authors wrote. "Another possibility is that oncology providers are more likely to talk to patients with lung cancer about quitting."
Tuesday, January 24, 2012

Is the fight over cigarette pack warnings the right one?

Cigarettes help keep me employed. They contribute to about one in five deaths in the U.S., and their effects on health are broader than most people realize. Lung cancer is bad, but not as common as struggling to breath with emphysema-ravaged lungs, trying to walk on legs rotting from loss of their blood supply, or waiting for a heart transplant.

The good news (and I'm happy to lose the business) is that cigarette smoking has diminished significantly over the last few decades, although not equally in all populations. It would be hard to deny that the 1964 Surgeon General's report on smoking helped begin this decline.

But smoking rates in the U.S. have leveled off at about 20% (once again, dependent on the segment of the population you look at). No one can rationally deny that ill-effects of smoking, so why is anyone still doing it?

Everyone knows the answer, but few acknowledge the implications. Nicotine addiction is powerful, therefore prevention efforts focus on both prevention of starting smoking and on helping people quit. Smoking usually starts in the young, and the more smokers adolescents are surrounded by, the more likely they are to smoke. We traditionally think of adolescents as being a group particularly difficult to influence, but if they are influenced to smoke, the can be influenced not to. For example, states with stricter smoking laws help prevent cigarette use. Once they start, getting them to stop is an uphill battle.

Exposure to advertising is a risk factor for starting smoking. Theoretically, regulating advertising should help modify smoking habits, and evidence supports this.

The current battle over cigarette package warnings should be seen in this context. If more graphic ads help prevent people from starting to smoke, great, let's do it. That's an important part of the battle. But since peers and family have such a strong correlation with cigarette smoking, we need to take the fight to the smallest levels of society, especially targeting communities with higher smoking rates.

A recent study of blood pressure screening in African-American barber shops had encouraging results. We need wide-spread community-level interventions. We have to take into account that many smokers have a lower level of education than non-smokers. Ads have to be aimed at proper education levels, but ads that speak down to people probably won't be taken well.

The ad industry is pretty damned smart. If they can get poor kids to spend their hard-earned cash on an expensive and deadly habit, they can probably help prevent it.

But once people start to smoke, we have a problem. Most of my patients who smoke want to quit, but it's not a matter of willpower. More insurance companies are starting to pay for smoking cessation programs, although most don't pay for the drugs that are usually required to help people fight the tenacious neurochemistry that keeps them smoking in the first place. A typical prescription for Chantix costs about as much as one month of a pack-per-day habit, but has to be paid up front, unlike 30 packs of cigarettes.

I'm all for graphic cigarette ads. I'm all for draconian smoking regulations that prevent people from smoking in public and at work. But we need a comprehensive national smoking policy, one that any physician can guide people to, one that targets prevention and cessation in every community, one that makes it harder to start and easier to quit.

Peter A. Lipson, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. After graduating from Rush Medical College in Chicago, he completed his internal medicine residency at Northwestern Memorial Hospital. This post first appeared at his blog, White Coat Underground. The blog, which has been around in various forms since 2007, offers "musings on the intersection of science, medicine, and culture." His writing focuses on the difference between science-based medicine and "everything else," but also speaks to the day-to-day practice of medicine, fatherhood, and whatever else migrates from his head to his keyboard.

Trials and errors in oncology research

The explosion of information in molecular oncology has identified a seemingly infinite number of targets for novel therapeutic agents. This has spawned the concept of personalized oncology, which has "gone viral."

However, a disconnect between the very large number of possible targets and the very small number of treatments is now apparent. In addition, most (85%) of drugs thought to be beneficial in Phase II clinical trials cannot be validated when other labs and institutions attempt to reproduce these results. And it is still taking up to 10 years and costing over $1 billion to bring a single new agent from the bench to the bedside. A postulated major roadblock is that clinical trial design has not adapted to these new developments.

Maitland and Schilsky addressed this topic in a comprehensive article, " Clinical Trials in the Era of Personalized Oncology, CA, A Cancer Journal for Clinicians; vol 61 no 6, Nov/Dec 2011: pp 365-381. Table 1, pg 366 summarizes "Oncology Care and Clinical Trials in the Eras of Population Oncology, Transition and Personalized Oncology."

In the areas of screening, diagnosis, staging, treatment determination, and assessment intervals, we are headed for molecular-based and individual-based decision making, but we're still in the transition phase. As far as early phase clinical trials are concerned, the population oncology era was oriented to maximum tolerated dose; the transition phase is oriented to "optimum biologic dose" and the personalized oncology era to determine the range of tolerable and active doses.

Mid-phase clinical trials use histology and prior treatment-based eligibility in typically single-arm, non-comparator trials in the population oncology era; the addition of some marker-based screening and some randomized controlled trials in the Transition Phase and some trials, histology, and prior treatment-based eligibility with rapid, serial assessments in the personalized oncology era, many with eligibility restricted to tumor marker subsets. Obviously, the trend is to stratify patients according to their biomarkers and to serially assess for response or lack of it at more frequent intervals to accelerate the conduct of trials.

Another issue is the complexity of the diseases we're dealing with. Weinberg and Hanahan proposed 6 "rules" that define the behavior of cancers, the so-called hallmarks of cancer:
--Self-sufficiency in growth signals. cancer cells acquire an autonomous drive to proliferate, so-called pathological mitosis, by virtue of the activation of oncogenes
--Insensitivity to growth-inhibitory (antigrowth) signals. Cancer cells inactivate tumor suppressor genes that normally inhibit growth.
--Evasion of programmed cell death (apoptosis). Cancer cells suppress and inactivate genes and pathways that normally enable cells to die.
--Limitless replicative potential. cancer cells activate specific gene pathways that render them immortal even after generations of growth.
--Sustained angiogenesis. Cancer cells acquire the capacity to draw out their own supply of blood and blood vessels-tumor angiogenesis.
--Tissue invasion and metastasis. Cancer cells acquire the capacity to migrate to other organs, invade other tissues, and colonize these organs, resulting in their spread throughout the body.

A cancer genome atlas is currently in process of development for the major cancers to map all these mutations and pathways to hopefully identify targets important in the causation of these cancers.

This post by Richard Just, MD, ACP Member, originally appeared at JustOncology.com, a joint publication of Richard Just, MD, aka @chemosabe1 on Twitter and Gregg Masters, MPH, aka @2healthguru on Twitter. Dr. Just has 36 years in clinical practice of hematology and medical oncology.
Monday, January 23, 2012

Lack of health insurance leaves one man's fate to chance

You're in your 30s. You work hard. You strive to master your craft. You support your extended family. You are liked by both your co-workers and boss.

Roulette by ChodHound via Flickr and a Creative Commons licenseProblem: You unexpectedly become unhealthy; you find out your kidneys are failing.

Solution: Regular kidney dialysis can keep you alive, by filtering toxins out of your blood.

Problem: Dialysis is time consuming (>3 hours/session, 3 sessions/week) and leaves you feeling tired and weak.

Solution: Your brother, who is a tissue match, offers you the gift of a lifetime, one of his kidneys.

Problem: Because you don't have health insurance (you are covered under the Medicaid program for your 'emergency' dialysis only) you are deemed ineligible for the transplant surgery.

Fact: The estimated cost of dialysis is $75,000 per year. The cost of the transplant surgery and care is $100,000, with an additional $10,000/year in anti-rejection medication costs.

Fact: Research shows that transplant pays for itself vs. the cost of dialysis at four years. Beyond that point, transplant is a tremendous cost saver overall. Patients feel better and live longer with transplant, too.

Solution: Surgeons at a medical center agree to waive their fees to perform the transplant.

Problem: The hospital still won't allow the transplant to go forward.

Solution: Your kind boss offers to pitch in for health insurance.

Problem: You are denied because your kidney disease is a 'pre-existing' condition.

Solution: Raise $200,000 to pay the hospital up front for the cost of the operation and any potential complications.

Any readers out there willing to step up?

You can read the full story of this patient's plight. Pay attention to the comments below the article to see the extremes of opinion.

The patient in question is an undocumented immigrant. His children were born here and are citizens. He meaningfully contributes to the community.

But because of his status, he's out of luck in the sweepstakes world of health care.

I welcome your opinions on how this situation should be handled.

This post by John H. Schumann, FACP, originally appeared at GlassHospital. Dr. Schumann is a general internist. His blog, GlassHospital, seeks to bring transparency to medical practice and to improve the patient experience.

Statins and prostate cancer

The Wall Street Journal is reporting on a study published in the journal Cancer, and described by Reuters that links statins to reducing the risk of prostate cancer. According to the report: "The researchers found that men who died of prostate cancer were half as likely to have taken a statin at any time, and for any duration, than men in the "control" group. Those with fatal cancers were 63 percent less likely to have ever taken a statin, according to findings published in Cancer."

I would love for statins to reduce the risk of prostate cancer. Readers of this blog know I am relatively pro-statin, in the right patient population. However, this study is too limited to make an actual connection, and I would not recommend taking statins solely for prostate cancer prevention.

What did the researchers do? They looked at the medical records of 380 men who died of prostate cancer and matched them with the records of another 380 men who did not have prostate cancer. They use statistical techniques to adjust for difference such as age, weight and other medications.

What's the problem with the study? First, if the study findings are correct, such a study that uses medical records and then looks back in time cannot prove causation. It only proves association. This means that the study doesn't prove that taking a statin will ward off prostate cancer. Rather, the results mean that men who had died of prostate cancer were less likely to take a statin. This is a big difference.

There are multiple examples where a confirmed association did not result into a confirmed causation (Vitamin E/C and folic acid for preventing heart attacks). In addition, there are many reasons that the association is in fact not correct. Perhaps men who had been diagnosed with prostate cancer chose not to take statins, even if their doctors recommended it, because they were more concerned about the prostate cancer? Perhaps men who did not have prostate cancer were extremely health conscious and were more aggressive about both doing things to prevent cancer (exercise, diet, etc.) as well as being more aggressive about taking statin medications for high cholesterol?

Why this might be true? The only way to truly determine causation is to perform a randomized clinical trial (RCT). Only a RCT can both eliminate some of the confounding variables (i.e. were the men without prostate cancer more aggressive about their overall health) and demonstrate the primary ingredient for causation, that exposure always precedes the outcome. If factor "A" is believed to cause a disease, then it is clear that factor "A" must necessarily always precede the occurrence of the disease.

However, there are two findings from this study that support causation. First, there is a dose-response relationship. Only the newer, more potent statins showed benefit. Taking a lower potency statin was not protective.

The second is biologic plausibility. According to the Reuters report, "Dr. Stephen Freedland, who studies prostate cancer at the Duke University Medical Center in Durham, but wasn't involved in the new study was quoted as stating that statins may protect against fatal prostate cancer through their known cholesterol-lowering effects, mentioning that cholesterol is a "key nutrient" for cancer cells, so lower cholesterol levels in the body could prevent more aggressive forms of cancer from developing."

Bottom Line: This study is exciting and will hopefully lead to randomized trials which can prove whether or not taking a statin will prevent prostate cancer. For now, there is very limited evidence to suggest this would actually work, and men should not start taking a statin just to lower their risk of prostate cancer.

Matthew Mintz, MD, is a Fellow of the American College of Physicians. He is board certified in internal medicine and has been practicing for more than a decade. He is also an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients. This post originally appeared at Dr. Mintz' Blog. Conflict-of-interest disclosures are available here.

QD: News Every Day--Office staff drive positive reviews; bedside manner drives negative ones

More than 60% of online reviews of primary care physicians are positive, and the overall experience of the office visit influences positive reviews while bedside manner drives negative reviews, researchers found.

Study authors conducted qualitative content analysis of 712 online reviews from ratemds.com and Yelp.com, purposively sampling reviews of 445 internists and family practitioners from Atlanta, Chicago, New York and San Francisco. Results appeared in the Journal of General Internal Medicine.

Reviews were first categorized as positive or negative. The analysis then distinguished between global remarks and specific descriptions. Global remarks were those about the medical encounter or the doctor, while specific remarks included more detail insight into the medical encounter or the doctor. In short, if investigators could answer the question, “Why does the patient perceive this doctor positively or negatively?” then the review was defined as specific.

Most reviews (63%) were positive, recommending the physician. There was a major distinction between global reviews--"Dr. B is a great doctor"-- compared to specific descriptions, in which comments tended to be more positive (69% and 80%, respectively). For office-related issues related staff or wait times, results were more mixed (60% positive, 40% negative).

So what drives a positive review? Not the diplomas on the wall, the authors said; the prestige of the doctor's medical school or fellowship never came up. Instead, trust and confidence in the doctor, ease of appointment making and a good interpersonal relationship lead to patient satisfaction among Internet reviewers.

The authors wrote, "The subset of specific, negative reviews may be particularly useful for providers and health systems. First, negative interpersonal reviews underscore the importance of well-perceived bedside manner for a successful patient-physician interaction. In addition, our findings reaffirm that the care encounter extends beyond the patient-physician dyad; staff, access, and convenience all affect patient’s reviews of physicians. Such reviews could prompt efforts to make the office environment more patient-centered."

Further, they wrote, online reviews shift the balance of power in patient communication. Patients can write anonymous reviews in a public forum, and doctors can't respond without breaching patient confidentiality. This can impact a physician's career. Physicians have been driven to make patients sign promises not to criticize doctors online, and those clinicians who have sued haven't always been pleased with the outcomes.

"Although we cannot predict the exact effect, we do expect these reviews to influence trust and communication in the patient-physician relationship."
Sunday, January 22, 2012

QD: News Every Day--Pomegranate seed oil not useful for menopausal hot flashes

Pomegranate seed oil does not significantly reduce hot flashes in postmenopausal women, researchers concluded.

pomegranate seeds by little blue hen via Flickr and a Creative Commons licensePomegranate seed oil is rich in phytoestrogens, believed to be an alternative to hormone therapy for menopausal symptoms. Phytoestrogens mainly bind to estrogen receptor-beta, but rarely activate the estrogen receptor-alpha expressed in breast and endometrial tissue, a potential contributor to tumors, the researchers noted.

They conducted a prospective, randomized, placebo-controlled, double-blinded trial that included 81 postmenopausal women who received two daily doses of either 30 mg pomegranate seed oil containing 127 Kg of steroidal phytoestrogens per dose or a placebo for 12 weeks. This study was funded by PEKANA (Kisslegg, Germany), which provided the capsules of pomegranate seed oil used in the research.

The primary endpoint of the trial was a reduction in frequency of hot flashes of more than 60% compared to placebo. Women were included if they reported at least five hot flashes per day, 12 months of amenorrhea and a negative mammogram in the past year. Women were excluded if they'd undergone hormone therapy or any other hormonal or phytoestrogen treatment within the last 12 weeks.

At the initial visit and after 12 weeks of treatment, blood samples were taken to assess hormonal status. Each participant kept a daily diary to complete the Menopause Rating Scale II. The diary assessed three subcategories of symptoms: mental (such as irritability, anxiety and exhaustion); urogenital (sexual or bladder problems); and sleeping (heart discomfort, sleeping disorders, hot flashes, and joint and muscular discomfort). Each symptom was ranked from 0 (no complaints) to 4 (severe symptoms).

Results appeared at Menopause: The Journal of The North American Menopause Society.

The treated group receiving pomegranate seed oil (n=43) reported a mean of 11.1 (interquartile range [IQR], 7.5) hot flashes per day at baseline. After 12 weeks of treatment, a mean of 6.8 (IQR, 2.0) hot flashes per day was recorded. The placebo group (n=38) reported a mean of 9.9 (IQR, 7) hot flashes at baseline and of 7.3 (IQR, 2.3) hot flashes per day after 12 weeks.

Hot flashes decreased significantly after 12 weeks of treatment with pomegranate seed oil by 38.7% in the treated group (P less than 0.001) and by 25.6% in the placebo group (P less than 0.01). However, since the primary endpoint was a reduction in frequency of more than 60% compared with placebo, there was no statistically significant difference (P=0.17).

Twelve weeks after stopping treatment (follow-up period at week 24), the difference between the two groups increased. In the treated group, a mean of 7.1 (IQR, 4) hot flashes per day was reported, whereas the placebo group reported a mean of 8.8 (IQR, 5) hot flashes a day (P=0.02).

During the first 12-week observation period, the overall sum score of the Menopause Rating Scale II parameters showed that symptoms markedly declined in the treated group (from 16 to 9) and in the placebo group (from 18 to 14.5; P=0.08). Urogenital and mental symptoms did not significantly change while taking pomegranate seed oil, but sleep symptoms did (P less than 0.03). And, sleeping disorders decreased significantly after 12 weeks of treatment (P less than 0.02). There were no significant hormonal changes found.

The authors noted, "It is important to note that the placebo effect plays a significant role regarding the treatment of menopausal symptoms. Most placebo-controlled studies described a pronounced placebo effect, showing a reduction in frequency of hot flashes in the placebo group ranging from 1% to 59%. In our study, the placebo effect was 25.6%. We hypothesize that this effect might be related to high expectations of women with menopausal symptoms at the beginning of the study."
Friday, January 20, 2012

Can a $99 spiral CT scan detect curable lung cancer?

A hundred bucks doesn't buy much these days. A crisp Ben Franklin can be exchanged for:
--50 Big Macs
--a Broadway show ticket
--a night in a New York City hotel (just joking)
--a college textbook (paperback)
--your life

Your life? Yes, five crumpled Andy Jacksons can save your life, as was reported earlier this year in a front page article in The Plain Dealer, Cleveland's only daily newspaper. University Hospitals is now offering a $99 spiral computed tomography (CT scans) of the chest in individuals who are at increased risk of developing lung cancer. The rationale is that if cancers can be detected early, then the cure rate for surgical removal is very high.

Gary Schwitzer, medical blogger and press watchdog, tries to bring some balance to the distorted media coverage of CT lung cancer reportage.

The test is not covered by insurance, so consumers will have to hand over 10 Al Hamiltons to get in the door.

I'm a deep skeptic of this effort, and predict that with some more time, the promised benefits will prove to have been exaggerated and the drawbacks will become clear. Although one national study suggested that spiral CT scanning was effective, one study shouldn't change the course of medical practice. If you've been reading medical journals for a while, as I have, you realize that today's breakthrough may break apart tomorrow. Let's see what future studies on screening for lung cancer with spiral CT scans conclude. I predict growing medical dissent on this issue.

Although I am uncertain about the early promise of saving lives, I am quite certain that the scans will uncover zillions of "abnormalities." Undoubtedly, folks will be discovered with benign, insignificant lung lesions, which physicians call incidentalomas. This term refers to abnormalities found by radiologic tests that have no medical significance, but inexorably generate a cascade of medical testing. Every physician can attest to this phenomenon.

Most lesions that spiral CT scans discover will be incidentalomas. Of course, unless there exists a prior CT scan that would prove that the lesion was present years ago and is unchanged, then the incidentaloma will be described as suspicious. So, although most of the abnormalities are benign, they will have a malignant effect on patients and their families. Here is what these folks have to look forward to:
--anxiety that cancer is present
--diminishment of quality of life
--referral to a pulmonary specialist for more fun and games
--prospect of periodic CT scans for 2 years to verify the lesion is stable
--consideration of a biopsy of the lesion (Ouch!)
--consideration of surgery to remove the lesion (Mega-ouch!)
--medical complications from biopsy or surgery
--waste of health care dollars

Although The Plain Dealer's piece was gushing, there is another side to the story. Is University Hospital pursuing this for medical or for marketing reasons? Will other area hospitals start hawking their own screening CT scans so as not to be left out? Will a bidding war begin driving prices down? This sounds like it could become a 2 a.m. TV telemarketing pitch.

"You won't pay $250, or even $200. No, you won't pay $150. For just five easy payments of $19.99, you get a state-of-the-art spiral CT scan. And, if you order in the next 10 minutes, we will include a set of Japanese steak knives guaranteed for life. These knives alone are a $200 value. But wait, there's more. If you promise to tell a friend about this special TV offer, we will include a cigarette lighter that opens up to form an ashtray. No smoker should be without one. And, if for any reason, you are not completely satisfied with your scan, we will return the full purchase price, minus a shipping and handling charge, no questions asked. Return the knives, but keep the lighter/ashtray as our gift."

My view? I recommend that smokers find a better use for 20 Abe Lincolns than a spiral CT scan. My suggestion? See a Broadway show.

This post by Michael Kirsch, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Reimbursement for obesity counseling: So what?

Medicare recently announced new regulations that authorize reimbursement for obesity management counseling by physicians. That's good, assuming the counseling is good. We are a long way from being able to count on that, however.

With a nod to my many colleagues who are genuinely expert in weight management counseling, and have long addressed it well, and especially to those who taught me to do so, I must acknowledge that the track record for the large majority of our clan is not pretty. Historically, there have been two ways physicians have mucked up weight management counseling: by providing it, and by not providing it.

The problem with not providing it is pretty self-evident. If a patient presents who is clearly severely overweight--perhaps even huffing and puffing just to settle into the exam room--not to address it is both ludicrous and an abdication of clinical responsibility. It would be as if a patient walked into the office with a spear sticking out of their chest, and left in the same condition with no mention of it in between.

But bad counseling can be worse than none at all. When the best a doctor can do is blame the victim--"Don't you know that being so fat is bad for you?"--the net effect can range from an erosion of the patient's self-esteem, to outright estrangement of the patient from the medical system. The former is bad enough--making a patient feel about an inch tall (note that if height goes down while weight remains constant, BMI actually goes up; talk about counter-productive!). The latter, however, can actually be life-threatening, when patients eschew vital preventive services, such as Pap smears or mammograms, or neglect essential care to avoid the associated denigration. This may sound like melodrama, but I have firsthand knowledge of cases in which bad obesity counseling ultimately proved lethal, and other cases in which it was nearly so.

It is in this context that the new Medicare regulations must be assessed. The change is good in that lack of reimbursement has long been cited as one of the impediments to weight management counseling. Extending this line of reasoning, the case can be made that lack of reimbursement means lack of counseling; lack of counseling means lack of experience with, or dedication to, counseling; and lack of experience and dedication in turn mean that such counseling as does occur will tend to be poor. If this were the whole story, then reimbursement might fix everything.

But it's not the whole story. Docs don't tend to get much training in nutrition, and while this has been oft lamented, it is difficult to fix due in part to the intense competition for real estate in the crowded landscape of medical education. There is, it seems, ever more to cram into those four years.

Even if time for robust nutrition education were claimed, it would only be a start. Training in behavior modification also tends to be limited, and would need to be upgraded considerably. Perhaps less daunting than these, additional training would be required for effective promotion of physical activity as well, along with the proper ways to measure and monitor not just weight but body composition.

And because in unity there is strength, approaches to weight control that engage the whole family are best. One person on a diet is weak; a family seeking health together is strong. So good counseling should address all household members, another area in which physician training (with the possible exception of family practitioners) is limited.

Were all such upgrades to occur in medical education, formidable challenges would still remain. The first is obvious: those notorious "15 minute encounters," which are in fact often less, don't allow time for conventional behavior modification counseling even by those who know how to provide it.

The second, obvious to those of us in the medical trenches, is apt to be less so for others. The time-honored adage to describe medical education is "see one, do one, teach one." If trainees don't see their mentors practicing weight management counseling, they will be dissuaded from doing so. Getting beyond the impasse requires concurrent incentives for docs in practice, which the new reimbursement scheme may provide, and improvements in training so that the next generation of practitioners can do this job better.

There are ways to address these issues. One is to enhance medical school and medical residency curricula in these areas. That struggle is underway all around the country. Another is to deliver relevant material in time-honored ways, such as textbooks. Yet another is interactive on-line training specific to weight management in clinical practice, and incentivized with continuing medical education credits. CME credits are required to maintain medical licensure, and thus serve as a potent goad.

But even if all of this were to move forward in tandem, physicians would still be struggling to allocate time to weight management counseling and away from other matters. The solution to this is for physicians to initiate the counseling, and then defer to others better suited to address the details. Dietitians are the obvious choice. In some cases, health coaches could play this role as well. But for this strategy to work, there would need to be reimbursement for that counseling as well.

Another, and perhaps even better option, is for clinicians to be able to direct patients into well-established weight management programs. There is a lot to a comprehensive weight management program, and it's unlikely that even a highly skilled and motivated physician could address all of this on his or her own. Two very compelling recent studies here and here suggest that Weight Watchers does a far better job at this than primary care, so linking the two is attractive. But again, the reimbursement model does not yet correspond.

Another challenging issue is the linkage of reimbursement to outcomes. On the one hand, it is quite appropriate to ensure that we are "getting what we are paying for." And of course, we are paying, since ultimately, Medicare and Medicaid resources derive from taxpayers. We should all want to know that counseling is actually working.

The danger in this is that weight change is the obvious measure of success, but not the right one. A physician might counsel well, and yet a patient with many other challenges in their life might not comply. Should a physician who takes care of especially challenging patients be financially penalized?

Even more compelling is the fact that two patients might be equally diligent about improving diet and activity, but one might lose weight and the other not due to genetic factors and other causes of relative weight loss resistance. Should that good faith effort by physician and patient alike, an effort likely to improve health even if weight does not change, be dubbed a failure? Pay-for-performance might more reasonably focus on behaviors individuals do control directly, such as dietary choices and activity pattern, than on weight, which they do not.

While good quality counseling may help with weight management, we should not get carried away with that idea. The metabolic complications of obesity are bona fide clinical problems, but weight gain over time is quite another matter.

Weight gain is a result of more calories in than out, and that in turn is largely the result of a modern, obesigenic environment and the ways in which a majority of us interact with that environment. It is about daily use of feet and forks. It is about food marketing and food processing; suburban sprawl and drive-throughs; vending machines and video games; long days and labor-saving technology. Medical school does not provide a fix for any of these! The origins of prevailing weight gain and obesity are not clinical--they are not about physiology run amok--they are societal.

Fixing obesity will thus require a societal response. It will require solutions populating the settings where people spend most of their time, and make relevant decisions about the use of feet and forks--home, school, and work; supermarkets and shopping malls; online, in church, and so on. Empowering programming can be devised to populate all such settings--and physicians can guide patients to its use. One national physician organization has endorsed a supermarket-based nutrition guidance system to that end. Many more such linkages between enlightened clinicians and empowered patients will help us get to the prize.

So what, exactly, does reimbursement for obesity counseling give us? It can help make physicians a part of a comprehensive solution. Being a part of the solution is far better than being a part of the problem. So reimbursement for counseling is a good start, assuming we can make sure the counseling is consistently good.

But we clinicians, at our best, can never be more than a modest part of the comprehensive solution epidemic obesity requires. We will see the toxic tide of epidemic obesity turn when, and only when, we fix the problem at its many sources in our society, and make eating well and being active the norm, rather than the exception, when health is found along the path of lesser resistance, rather than the road less traveled.

The promise of that day is great. We have miles to go to get there from here.

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.