ACP Internist

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!

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.

Labels: guest post, marketing, MD Whistleblower, Michael Kirsch, smoking cessation

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."

Labels: health care cost, health care reform, health insurance, health policy, QD

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.

Labels: electronic medical records, guest post, health information technology, HIPAA, meaningful use, Neil Mehta, patient communication, 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?

For 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.

Labels: cancer, drug companies, evidence-based medicine, genomics, guest post, JustOncology, research, Richard Just, risks and benefits

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."

Labels: CT, health care cost, health policy, MRIs, new technology, QD, screenings

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.

Labels: cancer, Elaine Schattner, guest post, Medical Lessons

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.

Labels: coding, Everything Health, fraud and abuse, guest post, medicare, Toni Brayer

Contact ACP Internist

Send comments to ACP Internist staff at acpinternist@acponline.org.

Blog log

Members of the American College of Physicians contribute posts from their own sites to ACP Internist and ACP Hospitalist. Contributors include:

Albert Fuchs, MD
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.

David Katz, MD
David L. Katz, MD, MPH, FACP, 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.

DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is 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.

Everything Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.

FutureDocs
Vineet Arora, MD, FACP, 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.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.

I'm dok
ACP Member Mike Aref, MD, PhD, ACP Member, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.

KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.

MD Whistleblower
Michael Kirsch, MD, FACP, 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.

Medical Lessons
Elaine Schattner, MD, ACP Member, 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.

Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a small community hospital in Connecticut. His blog is a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Reflections of a Grady Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being a doctor in a community hospital in Atlanta.

Technology in (Medical) Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management.

White Coat Underground
Peter A. Lipson, MD, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. The blog, which has been around in various forms since 2007, offers musings on the intersection of science, medicine, and culture.

ACP Internist and ACP Hospitalist also contribute to and draw upon content from Get Better Health, a network created by Val Jones, MD, to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the clinician's point of view on health care reform, science, research and patient care.

Other blogs of note:

American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

Clinical Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

PLoS Blog
The Public Library of Science's open access materials include a blog.

White Coat Rants
One of the most popular anonymous blogs written by an emergency room physician.

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