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I Saw It on a Billboard (Feb-10)

What is the impact of medical advertising that is directly targeted at patients? What information do consumers of medical products and therapies need in order to make informed decisions about their health?

Consider the following:

Ms. J, a healthy 50-year old woman, drives by a billboard that advertises low-dose spiral computed tomography (CT) scanning to screen for lung cancer. Although she has no family history of cancer and has never smoked, several of Ms. J’s friends have been diagnosed with cancer recently. She worries that she herself may have an undetected malignancy.

Responding to this advertising, Ms. J decides to pay out-of-pocket for a CT scan at the imaging center advertised on the billboard. The radiologist at this imaging center profits from the number of scans interpreted. As a result of the CT scan, an abnormality is found, and Ms. J undergoes a biopsy of her lung. A complication occurs from this procedure, but Ms. J recovers, and the biopsy comes back negative. She is relieved to learn that she does not have lung cancer.

After reading this scenario and thinking about direct-to consumer medical advertising, which of the following statements best represents your views?

  • STATEMENT A: Direct-to-consumer advertising improves patient education and patient-physician communication. Such advertising informs and empowers patients, so that their health care better reflects their needs and values. In particular, certain health services require complex medical equipment with high capital costs. Physicians who invest in such equipment do so because they believe in its promise, and they deserve payment to recoup their investment.
  • STATEMENT B: Direct-to-consumer advertising often results in misunderstanding, increased costs, and disruption of the patient-physician relationship. Such advertising can skew information to portray products in a positive light and can prey upon patients’ fears. Physicians closely allied with a treatment cannot offer objective assessment to patients about the efficacy or risks of the treatment. Further, most patients are ignorant of the financial incentives to physicians for various procedures.
  • STATEMENT C: I have not formed a viewpoint on direct-to-consumer medical advertising.

 

How do your answers compare? 

CBDSM's Reshma Jagsi, MD, DPhil, has written a powerful challenge to the medical profession and medical industries in a recent issue of the Journal of Clinical Oncology. Dr. Jagsi argues that the increasing proliferation of direct-to-patient advertising has raised questions of how physicians can function as unbiased intermediaries between patients and industry.

In the article, she presents six case studies, one of which has been excerpted and adapted for this Decision of the Month. Dr. Jagsi uses these case studies to address serious issues related to both advertising and conflict of interest. Some examples:

  • What implications does the frequently used advertising directive "Ask your doctor about X" have for the doctor-patient relationship?
  • How ethical is it to disguise medical advertising—for instance, to hire celebrities to discuss treatments during interviews?
  • Should a physician who prescribes a particular medical device be allowed to receive payment from the speakers' bureau of a company that produces that medical device?
  • Should a physician who holds an ownership interest in an expensive treatment machine be required to explain alternate treatments to patients?
  • When does a website about a medical treatment cross over from being informational to being promotional?

Dr. Jagsi argues that physicians have a strong ethical responsibility to their patients to call attention to potential conflicts of interest and to help interpret medical information in the best interests of their patients.

For more details about this study:

Jagsi R. Conflicts of interest and the physician-patient relationship in the era of direct-to-patient advertising. Journal of Clinical Oncology 2007;25:902-905.

 

Would you participate if you knew this? (Mar-04)

When you decide to participate in a research study, what do you think the reserachers should inform you about?

Imagine that you have been diagnosed with depression. You see an ad in the local newspaper that a research group is studying a new drug for the treatment of depression and is recruiting people like yourself to participate. The study will investigate how effective the drug is at treating depression and will also look at whether the drug has any negative side effects.

Suppose the new drug is made by a small biotechnology company. The researcher owns a substantial portion of the stocks of the company. The value of the company's stocks can rapidly go up or down by large amounts depending on whether the drug is seen to be safe and effective for treating depression.

How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?

Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?

Which option best reflects what you would do, given the researcher's stock investment in the drug company?How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?

  • Extremely important.
  • Very important
  • Somewhat important
  • Not very important
  • Not at all important

Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?

  • Yes
  • No

Which option best reflects what you would do, given the researcher's stock investment in the drug company?

  • I would not participate in this study.
  • I'm not sure
  • I would still consider participating in this study

First, a little background:

The scenario you read and the questions you just answered were similar to ones that were asked to participants who have actually been diagnosed with depression. Also, individuals with coronary heart disease and breast cancer were given scenarios in which the researcher was said to be studying drugs that treated these health conditions. In the actual study, participants read seven scenarios, each having to do with a researcher's or university's personal financial investment in the drug being investigated. For instance, other scenarios included the university medical centre owning stocks of the drug company, the researcher receiving a lump sum of money per person enrolled in the study, and the drug company paying for the study.

Why were those questions important to ask?

Much of clinical research depends on patient volunteers to serve as research subjects. Patients must rely on the trustworthiness of the researchers who recruit them to help them decide whether to enroll in the study. This is especially true since benefit from participation can be uncertain. If an investigator or institution does not disclose that they have personal financial connections to the drug being studied, this could potentially undermine the trust of the participants. At the time that this study was submitted, there were no federal requirements on investigators or their institutions to disclose such financial conflicts of interest to potential research participants. This may continue to be the case in the future.

What can we say based on this study?

This study found two important trends: (1) Most potential research participants desired to be informed (and believed this should be required) regarding financial conflicts of interest in research, and yet (2) most still wanted to participate in such research. A clear majority still wanted to participate even in the most controversial scenario, which was the one you read on the previous screen. From these findings, then, it seems that the current practice of non-disclosure of financial conflicts of interest do not conform to the values and wishes of potential patient volunteers. It is not clear, however, whether disclosure, management, or elimination of financial conflicts of interest is the best solution. This study should not be taken to mean that only disclosure is required.

For more information see:

SYH Kim, RW Millard, P Nisbet, C Cox, ED Caine. Potential Research Participant's Views Regarding Researcher and Institutional Financial Conflicts of Interest. Journal of Medical Ethics, 30. 73-79. 2004.

A New Drug for the New Year (Jan-04)

Out with the old drugs and in with the new! How is your doctor prescribing for you?

Imagine that you are a physician and your patient is a 55-year-old white male with high blood pressure. He has no other medical problems, is on no medications, and has completed a 1-year program of diet and exercise to control his condition, but his blood pressure remains elevated at 170/105 (140/90 is the definition of high blood pressure).

As his physician, you have to decide on a medication to prescribe him in order to lower his blood pressure. You have the following options to choose from:

Diuretics: Diuretics are medications that lower blood pressure by getting rid of excess fluid in your body, making it easier for your heart to pump. They were first introduced in the 1950s.

Beta-blockers: Beta-blockers are medications that lower blood pressure by helping the heart to relax and pump more effectively, and by also reducing heart rate. They were first introduced in the 1960s.

ACE inhibitors: Angiotensin converting enzyme (ACE) inhibitors are medications that lower blood pressure by widening blood vessels and increasing blood flow. They were first introduced in 1981.

Calcium channel blockers: Calcium channel blockers are medications that lower blood pressure by relaxing blood vessels, reducing the heart's workload, and increasing the amount of blood and oxygen that reach the heart. They were also first introduced in 1981.
 
What type of medication would you prescribe this patient?
 
  • A diuretic
  • A beta-blocker
  • An ACE inhibitor
  • A calcium channel blocker

How do you compare to the physicians surveyed?

Of the physicians surveyed, 18% chose the same medication as you did. 38% chose an ACE inhibitor, 29% chose a beta-blocker, and 11% chose a calcium channel blocker. Most physicians chose an ACE inhibitor, a newer type of medication, rather than beta-blockers or diuretics, which are older types of medication.

Why is this important? When asked how they made their decision, the majority of physicians believed that diuretics were less effective and that beta-blockers were less likely to be tolerated by a patient's body than the other medications. However, a number of important studies have shown that beta-blockers and diuretics are as effective at lowering blood pressure as newer medications like ACE inhibitors and calcium channel blockers. Studies have also shown that beta-blockers and diuretics are equally or even better tolerated than the newer types of medications. Yet, the use of beta-blockers and diuretics has declined steadily in the past 15 years in favor of the newer and more expensive types of medications.

Why do physicians believe these things when the studies say otherwise?

The answer to this question is not fully known. One possibility is that physicians may be prescribing newer medications because these are the medications actively promoted by pharmaceutical companies. By providing free samples of the newer medications for physicians to give to patients, these companies may be influencing which medications physicians actually decide to prescribe. To test this possibility, after physicians had decided between diuretics, beta-blockers, ACE inhibitors, and calcium channel blockers, they were asked if they ever provide their patients with free medication samples from these companies to treat their high blood pressure. It was found that physicians who used free samples were more likely to believe that ACE inhibitors are more effective. This isn't proof that physicians are influenced by pharmaceutical companies when prescribing medication for high blood pressure, but it does urge us to seriously consider if physicians may need to be re-educated about the effectiveness and tolerability of beta-blockers and diuretics.

For more information see:

Ubel, PA, Jepson, C, Asch, DA. Misperceptions about beta-blockers and diuretics. Journal of General Internal Medicine, 18, 977-983. 2003.

 

Thu, April 04, 2013

Babies cry and spit up … and too often those common symptoms are labeled as disease, according to a new study conducted by U-M researchers. Frequent use of the GERD label can lead to overuse of medication. The study was published online today in the journal Pediatrics.

Stories have already been published by Reuters,  Yahoo News!MedPage TodayNPRMSN Healthy Living,  CBS News, and the Chicago Tribune, among others. Laura Scherer, PHD, Brian Zikmund-Fisher, PhD, Angela Fagerlin, PhD and Beth Tarini, MD are authors on this study.

CBSSM Postdoctoral Research Fellow, Kayte Spector-Bagdady presented the keynote address  at the 2015 International Association of Clinical Research Nurses (IACRN) 7th Annual Conference. Her talk was entitled, “Why We've Always Needed Ethics: Grants, Research, and the Law."

Researchpalooza

Wed, August 27, 2014, 11:00am to 2:00pm
Location: 
Circle Drive in front of Med Sci I

 

This will be the first year that CBSSM will be participating in Researchpalooza. Please come and enjoy the fun!

 

Wednesday, August 27, 2014
11:00 a.m. - 2:00 p.m.
Circle Drive in front of Med Sci I

 

All UMHS employees from the Hospitals and Health Centers and Medical School are invited to celebrate this annual event.

Stop by the University Hospital Courtyard and Medical School Circle Drive for:

  • Ice Cream sundaes and sugar-free alternatives
  • Karaoke and musical entertainment
  • Festival Games
  • Department and vendor tables with information and giveaways

 

For more info: http://medicine.umich.edu/medschool/research/office-research/research-news-events/researchpalooza

As part of the UM health-related Massive Open Online Course (MOOC), participants also will have an opportunity to design a health insurance program using a special simulation experience developed by Susan Goold. Her CHAT (Choosing Healthplans All Together) program helps users create health plans that take into consideration the realities of scarce health care resources.

Link to full article

Bioethics Grand Rounds: Musical Event "When Death Comes Callin"

Wed, October 26, 2016, 12:00pm
Location: 
UH Ford Amphitheater & Lobby

When Death Comes Callin': Songs and Reflections About Death

Charlotte DeVries, Jeanne Mackey, Merilynne Rush, and friends offer a program of songs and brief readings reflecting various perspectives on death - humorous, sad, thoughtful, and quirky.

Lunch is provided on a first-come, first-served basis.

Funded by the NIH

The overarching goal of our research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed analgesic decision-making, and drug storage/disposal behaviors among parents of youth who are prescribed these agents for home use. With this proposal, we aim to demonstrate that our Scenario-Tailored Opioid Messaging Program (STOMP?) will: 1) Improve parents' opioid risk understanding and their analgesic decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP? plus provision of a method to get rid of left-over medications will effectively nudge parents to safely dispose of left-over opioid analgesics. For more info: http://grantome.com/grant/NIH/R01-DA044245-01A1

PI: Terri Lewis-Voepel

CBSSM Co-Is: Brian Zikmund-Fisher & Alan Tait

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