Doctors Recommend Different Treatments for Patients Than for Themselves

A patient who can't decide between two available treatments asks his doctor: "What should I do?" Another patient, torn between the same two treatments, asks: "Doctor, what would you do if you were me?"

Will those two patients get the same answer? That question, posed by researchers from Duke University and the University of Michigan in a national survey of physicians, found doctors often recommend different treatments for patients than they would choose for themselves.

The study, from professor Peter Ubel and post-doctoral associate Andrea Angott of Duke University's Fuqua School of Business and professor Brian Zikmund-Fisher of the University of Michigan, appears in the April 11 edition of the Archives of Internal Medicine. Funding for the study was provided by the American Cancer Society, the National Science Foundation and the National Institutes of Health.

In the study, the researchers conducted a randomized experiment asking some physicians to make a recommendation to a patient seeking advice, while other physicians were asked what they themselves would choose as a patient facing the same health care decision.

Doctors frequently advised patients to pursue treatments with higher rates of side effects and lower mortality rates, while choosing treatments with lower rates of side effects and higher mortality rates for themselves.

"Our research found that people felt living with a colostomy or being paralyzed was better than dying. From that perspective, the ‘right' decision is to take the risk of side effects and reduce the chances of dying," Ubel said.

However, emotions brought on by potential significant side effects often push people away from the "right" decision. Doctors -- free from the side effects of treatment -- can make more objective treatment recommendations to their patients.

"When making recommendations to patients, physicians can push aside any emotions that would lead them astray," Ubel said. "But those emotions may loom large when a doctor is deciding for him or herself. In other words, the act of giving advice to others may reset the balance between emotion and reason."

Ubel noted, "Many physicians are biased by their own backgrounds, valuing things that patients don't necessarily value, or they can even be influenced by financial and professional conflicts of interest that can skew judgment."

As a result, you might not always get the objective advice you seek, Ubel said. "Instead, the advice you get could depend on whether your doctor is thinking about what you should do, or instead thinking about what he or she would do in your situation."

A detailed report on the research is available at http://archinte.ama-assn.org/.

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Xanodyne agrees to withdraw propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (EKG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Xanodyne is based in Newport, Ky.

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FDA significantly restricts access to the diabetes drug Avandia

The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Also today, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings.

In addition, the agency halted the GSK’s clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs.

The FDA may take additional actions after the independent re-analysis of RECORD is completed.

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FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin

The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

Qualaquin is not FDA-approved to treat or prevent night time leg cramps.

A review of reports submitted to the FDA’s Adverse Event Reporting System (AERS) between April 2005 and Oct. 1, 2008, found 38 U.S. cases of serious side effects associated with the use of quinine, the active drug in Qualaquin.

Quinine use resulted in serious and life-threatening reactions in 24 cases, including low level of platelets in the blood (thrombocytopenia), and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura, a blood disorder that results in clots in small blood vessels around the body that can be accompanied by kidney impairment.

In some patients, these side effects resulted in permanent kidney impairment and hospitalization. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome.

The risk management plan, called a Risk Evaluation and Mitigation Strategy (REMS), requires that patients be given a Medication Guide explaining what Qualaquin is and is not approved for, as well as the potential side effects of the drug. The company is also required to issue a Dear Health Care Provider Letter warning of the potential risk of serious and life-threatening blood-related (hematologic) reactions.

“Health care professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of night time leg cramps,” said Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “FDA has received reports that some patients have developed serious side effects when taking quinine for night time leg cramps.”

Qualaquin was approved by the FDA in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if untreated. According to the U.S. Centers for Disease Control and Prevention, about 1,500 cases of malaria are diagnosed in the United States each year, primarily resulting from travel abroad.

Qualaquin is marketed by Philadelphia-based AR Scientific.

Health care professionals and patients may report serious adverse events (side effects) to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.

* Online
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500. Mail to address on the pre-addressed form.
* Fax: 800-FDA-0178
* Phone: 800-332-1088

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