Error message

The page you requested does not exist. For your convenience, a search was performed using the query news events press coverage 2014 04 08.

Page not found

You are here

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.

The Society of General Internal Medicine (SGIM), Council has selected Jeffrey Kullgren to receive the Milton W. Hamolsky - Junior Faculty Award for his abstract entitled “Financial Incentives for Completion of Fecal Occult Blood Tests among Veterans: A 2-Stage Pragmatic Cluster Randomized, Controlled Trial”. This abstract was rated as one of the top three abstracts presented by junior faculty at the Society’s April 2014 meeting.

Kathryn Moseley served as one of the judges at "The Big Ethical Question Slam 5" hosted by a2ethics.org. In addition, Naomi Laventhal, Michele Gornick, Christian Vercler, Lauren Smith, and Lauren Wancata served as judges at the "Michigan Highschool Ethics Bowl 2."

Thanks to all the CBSSM folks who contributed their time!

For more information about these events and other great ethics-related activites, go to a2ethics.org.

A short video about the Highschool Ethics Bowl can be found here.

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.

 

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.

The August 2016 issue of AMA Journal of Ethics features commentaries by Christian Vercler, Lauren Smith, and Andrew Shuman.

"Is Consent to Autopsy Necessary? Cartesian Dualism in Medicine and Its Limitations"
Commentary by Megan Lane and Christian J. Vercler

"I Might Have Some Bad News: Disclosing Preliminary Pathology Results"
Commentary by Michael H. Roh and Andrew G. Shuman

"Requests for VIP Treatment in Pathology: Implications for Social Justice and Systems-Based Practice"
Commentary by Virginia Sheffield and Lauren B. Smith

http://journalofethics.ama-assn.org/site/current.html

Research Topics: 

How much will chemotherapy really help you? (Dec-08)

After breast cancer surgery, additional treatments such as chemotherapy can reduce the risk of cancer coming back. But do women understand how much (or little) benefit chemotherapy provides? Imagine that you're a woman who has recently been diagnosed with breast cancer and then had the cancerous breast tumor surgically removed. While you're at an appointment about 3 weeks after your surgery, your doctor says the following to you:

"Sometimes cancer cells remain after surgery and start to grow again. To try to prevent your cancer from growing again, you should consider having some additional treatment.

"One of our test results shows that you have a type of cancer that is estrogen receptive (ER) positive. This means that your cancer needs the hormone estrogen in order to grow.

"Because you have an ER-positive tumor, you should have hormonal therapy to block estrogen and make it harder for any remaining cancer cells to grow. Hormonal therapy is usually in pill form. It does not cause hair loss or fatigue and generally has very few short-term side effects. You'll start to take hormonal therapy after all other treatments are finished and continue to take it for at least 5 years.

"Although it's clear that you should have hormonal therapy, you'll still need to make a choice about chemotherapy treatments. You could decide to have additional chemotherapy treatments for several months before starting the hormonal therapy. Sometimes, adding chemotherapy can make a big difference in decreasing the risk of dying from cancer. Other times, there's almost no benefit from adding chemotherapy.

"If you decide to have chemotherapy, you'll have 2 to 4 months of fatigue, nausea, hair loss, and other side effects. You'll also face a small risk (less than 1% or less than 1 in 100) of getting a serious infection, a bleeding problem, heart failure, or leukemia. Only you can decide if the benefit of adding chemotherapy to hormonal therapy is worth the risks and side effects."

Next, your doctor shows you a graph that may help you to decide about chemotherapy.

Your doctor says, "The graph below may help you decide if the risk reduction you would get from adding chemotherapy is worth the side effects and risks that the chemotherapy would cause.

  • The green part shows the chance that you'll be alive in 10 years.
  • The red part shows the chance that you'll die because of cancer.
  • The blue part shows the chance that you'll die from other causes.
  • The yellow part shows how much your chance of being alive in 10 years would increase if you add a therapy.
"Remember, given your situation, I think you should definitely take hormonal therapy. What you need to decide is whether to take both chemotherapy and hormonal therapy."
 
In interpreting this graph, imagine that there are two groups of 100 women each. All of these women have the same type of cancer as your hypothetical cancer.
  • The first group all decides to take hormonal therapy only.
  • The second group all decides to take both chemotherapy and hormonal therapy

How many fewer women will die from cancer in the second group, as compared with the first group?

Your doctor continues, "Now, here is another graph that shows the same information in a different way. As before,

  • The green part shows the chance that you'll be alive in 10 years.
  • The red part shows the chance that you'll die because of cancer.
  • The blue part shows the chance that you'll die from other causes.
  • The yellow part shows how much your chance of being alive in 10 years would increase if you add a therapy.
Now we asked you to consider the following question:
How many fewer women will die from cancer in the second group, as compared with the first group?
Do you want to change your answer?
 

About the study

Many participants who saw this graph in a study conducted by CBDSM researchers had similar problems. However, when study participants saw GRAPH B (with the two pictographs), many more were able to correctly calculate the difference.

The CBDSM study compared tools intended to help cancer patients make informed decisions about additional therapies (also called "adjuvant" therapies). The 4 horizontal stacked bars were taken from an online tool called "Adjuvant!" that is often used by physicians to explain risk to cancer patients. The researchers compared comprehension of risk statistics from horizontal bars and from a pictograph format.

They found that study participants who viewed a 2-option pictograph version (GRAPH B in this Decision of the Month) were more accurate in reporting the risk reduction achievable from adding chemotherapy to hormonal therapy for the hypothetical cancer scenario. With GRAPH B, 77% of participants could identify that 2 fewer women out of 100 would die from cancer with both chemotherapy and hormonal therapy. With the 4 horizontal bars (GRAPH A), only 51% of participants could make this calculation. Participants who saw GRAPH B were also much faster at answering this question than participants who saw GRAPH A.
In addition, participants in this study strongly preferred the format of the pictograph you saw (GRAPH B) to the bar graphs you saw (GRAPH A).
The researchers comment:
"While decision support tools such as Adjuvant! use graphical displays to communicate the mortality risks that patients face with different adjuvant therapy options, our research shows that women had difficulty interpreting the 4-option horizontal bar graph format currently used by Adjuvant!. Two simple changes, displaying only risk information related to treatment options that included hormonal therapy...and using pictographs instead of horizontal bars, resulted in significant improvements in both comprehension accuracy and speed of use in our demographically diverse sample....The results...support the concept that simpler information displays can make it easier for decision makers to implement optimal decision strategies. Specifically, focusing patients' attention on those treatment options currently under consideration while removing information related to options which have been already eliminated from consideration (for medically appropriate reasons) may be particularly beneficial. In the context of adjuvant therapy decisions, such an approach would imply that clinicians should discuss the decision in two stages: A first stage in which hormonal therapy is considered and a second stage in which the incremental benefit of chemotherapy is evaluated...Adjuvant! and other online risk calculators enable oncologists and patients to receive individually tailored estimates of mortality and recurrence risks, information that is essential to informed decision making about adjuvant therapy questions. Yet, the full potential of these modeling applications cannot be realized if users misinterpret the statistics provided."
 
Read the article:
Zikmund-Fisher BJ, Fagerlin A, Ubel PA. Cancer 2008;113(12):3382-3390.

 

Should this patient get a liver transplant? (Nov-08)

There aren't enough donor organs to go around for patients who need aliver transplant. This sometimes forces doctors to make tough choices.If you were the doctor, how would you decide in the following scenario?  There aren't enough donor organs to go around for patients who need a liver transplant. This sometimes forces doctors to make tough choices. If you were the doctor, how would you decide in the following scenario?Suppose there is a person who develops acute liver failure (ALF). While waiting for a liver transplant, this person gets sicker and sicker. When an organ is finally available, the chance that this person will survive WITH a transplant is only 42% at five years after the transplant. Since the average survival for most patients who receive a liver transplant is 75% at five years, the doctor wonders if it would be better to save the liver for someone else. Two possible ethical principles may guide the doctor in making this decision. 

Using the principle of URGENCY, the doctor would give the first available organ to the sickest patient on the transplant waiting list, the ALF patient, because she/he is otherwise likely to die within a few days.

Using the principle of UTILITARIANISM, the doctor would try to maximize the quality and quantity of life of all the people on the transplant list. Let's say there are 25 other patients currently on the waiting list, and transplanting the ALF patient increases their risk of death by 2% each, for a cumulative harm of 50%. Since this harm of 50% is more than the benefit to the ALF patient (42%), the liver should be saved for someone else on the list.

A third possibility is for the doctor to weigh both URGENCY and UTILITARIANISM in making a decision about a transplant.

If you were the ALF patient's doctor, what would you base your decision about a transplant on?
 
  • URGENCY (sickest patient on the list gets preference)
  • UTILITARIANISM (maximize benefit for the entire waiting list)
  • A combination of URGENCY and UTILITARIANISM

How do your answers compare?

There's no absolutely right or wrong answer in this case—the choice depends on which of several competing ethical principles or which combination of principles you follow. In choosing a combination of URGENCY and UTILITARIANISM, you've decided to try to balance the needs of the sickest patient with the needs of all the people on the transplant waiting list.

CBDSM researcher Michael Volk, MD, is the lead author on a recent article that tackles difficult decisions like this one. Volk and his colleagues examined a method to incorporate competing ethical principles in a decision analysis of liver transplantation for a patient with ALF. Currently, liver transplantation in the United States is determined by the principle of “sickest first," with patients at highest risk for death on the waiting list receiving first priority. In other words, the principle of URGENCY is paramount. However, most experts agree that, given the limited supply of organs, there should be a cutoff for posttransplant survival below which transplantation is no longer justified.

Where does society draw this line? And what framework can we use for ethical guidance?

Decision analysis of resource allocation would utilize the principle of UTILITARIANISM, to maximize the broad social benefit. But surveys of the general public have shown that most people prefer to temper utilitarianism with other considerations, such as equal opportunity, racial equity, and personal responsibility. Another factor that might be considered is the principle of fair chances. This is the idea that patients who have not had a chance at a liver transplant should receive priority over those who have already had once chance at a transplant.

Volk constructed a mathematical model (Markov model) to test the use of competing ethical principles. First he compared the benefit of transplantation for a patient with ALF to the harm caused to other patients on the waiting list, to determine the lowest acceptable five-year survival rate for the transplanted ALF patient. He found that giving a liver to the ALF patient resulted in harms to the others on the waiting list that cumulatively outweighed the benefit of transplantation for the ALF patient. That is, using UTILITARIANISM as the sole guiding ethical principle gave a clear threshold for the transplant decision: if the ALF patient did not have a five-year survival rate of at least 48%, she/he should not receive a transplant under this principle.

But UTILITARIANISM is not always the sole guiding ethical principle. When Volk adjusted the model to incorporate UTILITARIANISM, URGENCY, and other ethical principles such as fair chances, he got different thresholds. Depending on the combination of ethical principles used, Volk and his colleagues have shown that the threshold for an acceptable posttransplant survival at five years for the ALF patient would range from 25% to 56%.

The authors of this study conclude:

"Our model is an improvement over clinical judgment for several reasons. First, the complexity of the various competing risks makes clinical decision making challenging without some form of quantitative synthesis such as decision analysis. Second, a systematic approach helps ensure that all patients are treated equally. Most important, this study provides moral guidance for physicians who must simultaneously act as patient advocates and as stewards of scarce societal resources."

Volk ML, Lok ASF, Ubel PA, Vijan S, Beyond utilitarianism: A method for analyzing competing ethical principles in a decision analysis of liver transplantation, Med Decis Making 2008;28, 763-772.

Online: http://mdm.sagepub.com/cgi/content/abstract/28/5/763

More information:

Beyond utilitarianism: A method for analyzing competing ethical principles in a decision analysis of liver transplantation.
Volk M, Lok AS, Ubel PA, Vijan S. Medical Decision Making 2008;28(5):763-772.

 

Pages