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Tuesday, February 7, 2012

Freebies leave one internist wanting something more--the truth

Once upon a time we used to let drug reps feed us, bring us tchotchkes, and generally use our time. The staff liked the free food, and our patients liked the free drug samples. But we didn't like how it made us feel. The pharmaceutical companies have stopped giving out pens and such, and we have stopped allowing them to bring us lunches. There are a few samples which are still useful, especially respiratory drugs that aren't available as generics. To this, we give in, and we do allow reps to stop by the office with samples, occasionally taking a bit of our time.

Studies show that these interactions affect prescribing patterns. I'm not happy about it, but it's hard to get some drugs for my patients. The reps know me well enough to know that I don't like to be detailed and that I'm pretty easily annoyed. They're tenacious beasts though. A new one stopped by today.

She was trying to get me to prescribe a drug called Glumetza (Santarus, Inc.). It's a diabetes drug. In fact, it's a really good diabetes drug. Not only is it a good diabetes drug, but it's laughably cheap, although not under that name.

Glumetza is metformin, a drug also branded as Glucophage, in an extended release form. Metformin costs about $4 per month. The extended release version costs about $10 to $15 per month. Glumetza costs about $250 per month. This must be some sort of uber-metformin, right? At that price it better lower your sugar and wipe your ass for you.

And that's basically what it claims to do. One of the problems with metformin is that it can cause some stomach upset, especially diarrhea. In nearly all patients, this wears off in a few days, and when it doesn't, changing to the extended release form ($10 to $15 per month, remember?) usually does the trick. What does Glumetza claim? "Unlike immediate-release metformin, GLUMETZA uses a special advanced polymer technology that delivers the medicine slowly and steadily over several hours.5 This delay in the release of the medicine may result in fewer stomach-related side effects, such as nausea, in the 1st week of taking the medication.4"

I don't doubt that the company has a proprietary drug delivery system. But what about the other claims?

The footnotes point to:
1. The Glumetza package insert
2. An inaccurate citation, but allows me to track down a journal article about extended-release metformin, not Glumetza specifically
3. A patent summary
4. A study that compared Glumetza, extended-release metformin, and immediate release metformin. What did it find? We'll get to that.
5. A footnote leading nowhere.

Footnote 4′s study found that: "Even with a 1,000-mg q.d. starting dose, the overall incidence of gastrointestinal adverse events during the 1st week of dosing was low and comparable among treatment groups (Table 3). There was a higher incidence of nausea in the immediate-release metformin group than in the extended-release metformin groups (P=0.05). In addition, there were more adverse events of nausea and diarrhea causing treatment discontinuation in the immediate-release metformin group than in the extended-release metformin groups. The overall incidence of adverse events considered possibly or probably related to the study drug was similar for all treatment groups; the only such events reported for greater than 5% of patients in any treatment group were gastrointestinal events."

In other words, all forms of metformin were well-tolerated. Even so, there was a measurable difference between the immediate release form and the extended release forms. There was no convincing evidence that Glumetza was better than the cheaper, generic extended release metformin. The discussion tries to be convincing, but the data don't back any other conclusion: Glumetza is different than generic metformin--it costs more money.

The lesson here isn't that medicine is bad. Metformin is a terrific drug, and cheap. But the marketing of predictable and high-priced knock-off drugs does nothing to contribute to our health. And plenty of physicians and patients fall for the not-so-cheap marketing.

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.

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posted by Peter A. Lipson, MD at 11:00 AM  

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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.

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.

CasesBlog
Ves Dimov, MD, ACP Member, is an allergist/immunologist and Assistant Professor of Medicine and Pediatrics at the University of Chicago, where he evaluates and treats both pediatric and adult patients.

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.

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

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.

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.

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.

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).

Musing of an Internist
Justin Penn, MD, ACP Associate Member, attended medical school at the University of Washington School of Medicine and trained in internal medicine at the University of Rochester, where he is serving as Chief Resident.

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.

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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