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Monday, August 31, 2015

Drug-company funded research in the New England Journal of Medicine feels like a conflict of interest

I thought I'd read the New England Journal of Medicine (NEJM) and learn something deeply meaningful. I usually love the NEJM (Wikipedia says it is “among the most prestigious peer-reviewed medical journals and the oldest continuously published one”) because I feel like it has such a strong history of academic excellence that whatever they print will have value. This is probably not true.

In 2009, Marcia Angell MD, a senior lecturer at Harvard University and the former Editor in Chief of the NEJM wrote an article entitled “Drug Companies and Doctors, a Tale of Corruption” in the New York Review about the way drug companies skew research to encourage increasing and inappropriate use of medications. It was based on what she had seen published in the NEJM and others. This might have been a hint that there was something amiss in the contents of my favorite professional publication.

In 2012, the Washington Post published an article about a diabetes drug, Avandia (rosiglitazone), which has proved to increase the risk of heart attacks and heart failure. The NEJM decided to publish articles which reported results of studies funded by GlaxoSmithKline, the company which produced the drug. These articles concealed information that showed that the drug was harmful. Editorial decisions were made which, at least in hindsight, were bad. The Washington Post article discussed the many ways in which a drug company which funds research for a medication can manipulate the presentation of the data and get that version published in a prestigious journal which doctors like me tend to believe.

The NEJM has several sections, but the Original Articles is the one I like best. This is the section where new research is reported. There is also the Perspective section, which has gotten more prominent in recent years, and consists of articles by people who are in the thick of something, maybe mass casualty situations, maybe health policy, big picture articles. There are also editorials, usually about the original articles, and there are letters and image challenges and case presentations and educational updates about specific topics.

Recently, the NEJM's Original Articles were primarily about new drugs, and were mostly funded by the drug companies that will or do make money off of those drugs. Oh yeah, and 1 about a new diagnostic test, funded by the company that will make money off of that diagnostic test. There was 1 article not funded by industry which looked at the causes of pneumonia in patients who were admitted to the hospital with it, reporting that the majority were caused by viruses.

The first article was funded by Pfizer and reported a new chemotherapy drug for breast cancer that, combined with another chemotherapy drug which costs over $10,000 per month, results in longer survival. The new drug's is not yet marketed and so a price has not yet been decided.

The second was funded by a Boston company, Vertex, for their new product that can reduce the lung problems that go along with cystic fibrosis, a genetic disease that causes pneumonia and problems with breathing. If the cost of other drugs for cystic fibrosis is a guide, its cost will be sky-high.

The third article is funded by Merck Sharp and Dohme, and studies their drug sitagliptan (Januvia), one of the many drugs that reduce blood sugar in patients with type 2 (generally adult onset) diabetes. The study was primarily to see if their drug caused heart problems, because people thought that it might. They studied more than 14,000 patients for about 2 years and found that their drug did not cause heart problems at least over the course of those two years. It also didn't work very well to reduce blood sugar, but not much was made of this in the conclusions. The drug, which helps reduce blood sugars by just a smidgen, costs $3,000 a year or thereabouts, far more than generic medications which work better.

The fourth article evaluated a test that could be done to more accurately determine if a person has lung cancer at the time of a bronchoscopy. Since the test can simply be ordered at the time of the bronchoscopy it will probably be ordered nearly all of the time this test is done, and, I'm just guessing, may just about double the cost of the procedure. The first noted funding source for this study was Allegro Diagnostics, which will be marketing the product.

Then came the pneumonia article (yay, information I can sink my teeth into.) If viruses cause most cases of severe pneumonia, there may actually be some argument for not putting everyone we see with pneumonia on antibiotics.

The final article which was funded by GlaxoSmithKline looked at the ability of an antibody to clear amyloid from the liver in a very rare condition called systemic amyloidosis, which mainly causes death and disability through deposits of a protein in various tissues, of which the liver is one. If this is released it will be very very, very expensive and will probably serve only to palliate a very rare disease.

Not to put down miracle drugs, because they are pretty cool, but perhaps the Original Articles section should be renamed Articles Funded by Drug Companies Supporting the use of Very Expensive Medications.

Drugs and Doctors

Doctors are increasingly prescribing more and more expensive drugs for just about any complaint. Even the Onion has noticed (read this brief article and chuckle.) This is in no small part because we believe that drugs are the answer, because the research tells us so. The research that tells us so is funded by the companies that make the medications, because they have the money to fund expensive studies. There is much less money in research on cool stuff like what causes severe pneumonia. According to the Washington Post article, the NEJM had published 60 articles about new drugs that were funded by drug companies in the year prior to the report in 2012. Since it publishes 54 times a year, that's just a touch over 1 article per issue. This week's issue had 4 such articles plus the one about the lung cancer test. It seems like they may be escalating.

But why does the NEJM publish this stuff? I think this may be a big part of it: we all love magic potions; it's in our basic makeup as people. Even societies nearly untouched by pharmaceutical companies delight in miracle cures. Doctors and chemists love to dabble in potion making and testing, hoping for that amazing discovery that abolishes misery and old age. They have even been successful. Look at penicillin and many others. But when big money backs these endeavors to the exclusion of other good science, we tend to focus on them, and our professional publications will reflect that in what they publish. Unfortunately the economic forces at work favor creating potions that sell, and not necessarily ones which work. Even though I think I understand the rationale, it's pretty disappointing that one of the “oldest and most prestigious peer reviewed journals” is filling its pages with research that is funded by the companies that financially benefit from positive results and therefore is likely to be skewed and misleading.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.

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Talking about death

A few recent experiences have me thinking about death.

The first was hearing a story on the radio about how physicians “manage” their deaths. The gist of it was that physicians are more likely to die at home without aggressive life-extending interventions than the general public. The implication was that more people would have a “better” death, more in accord with their own wishes, if frank discussions about end of life care were more common.

I didn't think too much about the story, which registered only a “no kidding” in my mind when I heard it, until I thought about it in the context of two deaths that touched me this past week.

The first was a medical school classmate of mine who died after a long course with prostate cancer. A message from a mutual friend who shared the news of his passing concluded with this: “at least it all developed as he and [his wife] chose, at home, with peace.” It conjured up a scene of serenity, and I was oddly glad that I was able to imagine him, comfortable and surrounded by his family, gently slipping away.

That scene was nothing like what was described to me as the final days of a friend's elderly father, who died in a hospital with advanced heart failure. He had had a long history of heart disease. Over several months, he was hospitalized half a dozen times for worsening heart failure. He spent his final days, I learned, “in agony,” uncomfortable, thirsty, and short of breath. Sounded absolutely horrible. And here's the thing that really got me: She was surprised that he died.

Really? How could she be surprised? To the cardiologist in me, it was clear that he had been in steep decline for months. The prognosis for an elderly man with progressive heart failure leading to multiple hospitalizations is obviously grim. Maybe this was just the subconscious denial of a loving daughter, who could not imagine losing her father. I am sure that played a role.

But there was more. She told me that she was surprised, in part, because she was so engaged with his doctors over the details of his care that she “lost the forest for the trees” and did not see the bigger, inevitable picture. Also understandable. It is easier for many to fight the day to day battles than to think about the bigger questions of “why” and “where is this going” or “how is this going to end.” I don't blame her.

But I can't help but think that his doctors failed him, and her. Maybe his doctors tried to engage them, and maybe they didn't want to hear what was being said, but over months and multiple hospitalizations, it seems that there was no effective conversation about these bigger questions. No chance, apparently, for her and her father to have it end “as he chose.” Instead, he was miserable and she was shocked.

So sad; so unnecessary.

Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.

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Friday, August 28, 2015

Are we really ready for quality-based doctor payments?

The dramatic change in how we pay doctors is well underway. The “fee-for-service” model, in which you get paid for every “thing” you do, is on the way out. Under this model, for example, I can get paid about $60 for helping someone manage their heart disease and diabetes, thereby preventing severe complications. If I simply clean out their ears, I can bill closer to $80 because it's a “procedure.”

Under the newer “quality-based” model, more of my payment is based on outcomes: what percentage of my diabetics have their sugar under control, etc. This noble idea has a number of inherent problems that have been addressed elsewhere, but one of the biggest is bureaucratic.

Every insurer has its own quality measures and reporting schemes. Some companies have several, depending on the insurance product. For example, Blue Cross collects data 1 way for Medicare patients, another way for HMO patients, and other ways for plans purchased by employers.

We have no idea how to keep track of all of these reporting systems. There seems to be an endless supply of data that they request, some relevant, some not, and some insane.

For example, for some of my BCBS patients I have to log in to their website and enter patient data. Among the data is a question asking if the patient has a history of depression. If I answer “yes” it asks for a depression “score” based on a simple clinical tool. Since my patient isn't currently depressed, I enter a score of 0, and get rejected. You're not allowed to have been depressed in the past, but no longer be depressed. When I've questioned BCBS about it their response is often either nonsensical or they tell me to lie. Really; they told me more than once to just answer that the patient has no history of depression.

And that's just for one group of BCBS patients. Others may not require this sort of reporting but another log-on adventure entirely.

It is nearly impossible for me to figure out which of these so-called incentive programs cost me money or make me money or are simply a wash. I cannot for the life of me figure out exactly how many different programs there are and how to satisfy their requirements.

If reimbursing doctors for quality of care is truly the goal (rather than the cynical interpretation of it being a way to avoid paying docs via Byzantine reporting requirements) then we need one system. If we had a single-payer system this would be fairly simple, but since we don't, there should be a data repository that all the insurers fund and are required to use. This way, doctors wouldn't have to take time out of the exam room to try to fulfill each set of requirements, or worse, give up entirely.

It is hard to overstate the amount of time taken gathering and reporting this data. Take, for example, colon cancer screening. Because it may have occurred a couple of years ago (and is still up to date) it may not appear in the insurance company's billing records and therefore is listed as “incomplete”. Then we have to review “x” number of charts, looking for records, dates, etc. And if the patient has changed insurers or doctors a few times, there may be no data at all to work with.

At this point, quality-based reimbursement is a Kafkaesque joke. Doctors will lose money, patients will lose time with their doctors, and quality will suffer as doctors spend more time trying to figure out how to report data than how to treat disease.

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Maximum frustration of opiate demands

Ask any primary care physician or hospitalist (and many subspecialists) and I wager that patient opiate demands represent their most frustrating recurrent issue. We are clearly caught between those who demand that we relieve pain and those who point fingers at us for excessive opiate prescribing.

Many people like how opiates make them feel. Many people become addicted easily to opiates. It seems that they use knowledge of the pain imperative to ask us for more opiates.

We clearly have a conundrum. We can receive criticism when we do not address the patient's pain to the patient's satisfaction, and we can receive sanctions when we prescribe opiates too freely.

We also have another serious problem. Once a patient becomes an opiate addict (often when a patient starts with a legitimate need for pain relief), then when we do not prescribe more opiates they may turn to illegal opiates such as heroin.

Heroin use jumps in US as painkiller addicts switch drugs

The CDC reported that over 8,000 people died from a heroin-involved overdose in 2013, nearly twice the number of deaths seen just two years earlier.

Federal officials cited a number of factors causing the rise in heroin use.

As authorities have cracked down on prescription drug abuse in recent years, users who have become addicted to the pills have switched to heroin. The drug is often cheaper and more easily available.

The amount of heroin being brought into the U.S. has also increased, driving down the cost of the street drug.

So what are we to do? This is a most serious public health issue that we must face patient by patient. And we hate the problem. We like patients, but fulfilling their opiate demands is not really a good idea.

Any good suggestions?

db is the nickname for Robert M. Centor, MD, FACP. db stands both for Dr. Bob and da boss. He is an academic general internist at the University of Alabama School of Medicine, and is the Regional Associate Dean for the Huntsville Regional Medical Campus of UASOM. He still makes inpatient rounds over 100 days each year. This post originally Maximum frustration of opiate demands">appeared at his blog, db's Medical Rants.

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Blog log

Members of the American College of Physicians contribute posts from their own sites to ACP Internistand 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.

And Thus, It Begins
Amanda Xi, ACP Medical Student Member, is a first-year medical student at the OUWB School of Medicine, charter class of 2015, in Rochester, Mich., from which she which chronicles her journey through medical training from day 1 of medical school.

Auscultation
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.

Controversies in Hospital Infection Prevention
Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).

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

Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health 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
Mike Aref, MD, PhD, FACP, 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.

Informatics Professor
William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.

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.

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, FACP, 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.

Mired in MedEd
Alexander M. Djuricich, MD, FACP, is the Associate Dean for Continuing Medical Education (CME), and a Program Director in Medicine-Pediatrics at the Indiana University School of Medicine in Indianapolis, where he blogs about medical education.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice internist, returns with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind).

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.

The Blog of Paul Sufka
Paul Sufka, MD, ACP Member, is a board certified rheumatologist in St. Paul, Minn. He was a chief resident in internal medicine with the University of Minnesota and then completed his fellowship training in rheumatology in June 2011 at the University of Minnesota Department of Rheumatology. His interests include the use of technology in medicine.

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.

Peter A. Lipson, MD
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.

Why is American Health Care So Expensive?
Janice Boughton, MD, FACP, practiced internal medicine for 20 years before adopting a career in hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling.

World's Best Site
Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington.

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.

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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