American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News
for the Week of 3-11-08

Highlights

  • GI groups release colorectal cancer screening guidelines
  • MRI reveals contaminant in heparin from China
  • WHI participants who took hormone therapy may have increased cancer risk

Drug marketing

  • Expensive placebos have greater efficacy
  • Drug prices still on the rise, AARP finds
  • Despite costs, patients asking for and getting advertised drugs

FDA actions

ACP Journal Club

CMS update

  • Demonstration program found improper payments
  • Advanced beneficiary notice form revised

Cartoon caption contest

ACP Internist

  • March issue now available online and in your mailbox
  • ACP Internist wants to hear your stories of difficult diagnoses

From the College


Highlights

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GI groups release colorectal cancer screening guidelines

New joint consensus guidelines for colorectal cancer screening added stool DNA (sDNA) and CT colonography (CTC) or virtual colonoscopy to the list of recommended screening exams, and for the first time stated a preference for screening tests that can not only detect cancer early but also detect precancerous polyps.

The expert panel, made up of the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology, strongly advised that colon cancer prevention should be screening's primary goal. Despite statistics showing that in the U.S., colorectal cancer (CRC) is the third most common cancer diagnosed in men and women and the second leading cause of death from cancer, the majority of U.S. adults do not undergo screening, said the panel in the statement published in the March 5 online edition of CA: A Cancer Journal for Clinicians.

The panel divided recommended tests into two categories applying to asymptomatic adults aged 50 years and older:

Tests that detect adenomatous polyps and cancer:

  • flexible sigmoidoscopy every 5 years,
  • colonoscopy every 10 years,
  • double-contrast barium enema every 5 years, or
  • CT colonography or virtual colonoscopy every 5 years

Tests that primarily detect cancer include:

  • annual guaiac-based fecal occult blood test with high test sensitivity for cancer,
  • annual fecal immunochemical test with high test sensitivity for cancer, or
  • sDNA with high sensitivity for cancer

While the first group of tests is preferable to detect precancerous growths, these tests are not always covered by insurance, said the March 5 New York Times. Virtual colonoscopy, for example, typically is not covered and can cost up to $1,500.

Even virtual colonoscopy, however, cannot always detect flat colorectal neoplasms, according to another study in the March 5 Journal of the American Medical Association. The study determined that flat polyps have a greater association with carcinoma compared with polypoid neoplasms, regardless of size.

Flat lesions have a height of less than half their diameter, and depressed lesions have a base that is lower than the normal mucosa. Colonoscopy and CTC may fail to find lesions "because the subtle findings can be difficult to distinguish from those of normal mucosa," JAMA reported.

Researchers at the Veterans Affairs Palo Alto Health Care System examined 1,819 patients who underwent elective colonoscopy performed by four endoscopists from July 2003 to June 2004. They found flat lesions in 9.3% of patients, and the flat lesions were more than five times as likely to harbor in situ or submucosal carcinoma than polypoid lesions after adjusting for polyp size, the lead author wrote in an accompanying editorial.

The full guidelines are online.

The JAMA abstract is online.

The editorial and the full text are online (subscription required).

The New York Times is online.

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MRI reveals contaminant in heparin from China

As much as 20% of the active ingredient in recalled heparin products from China was a heparin-like compound that got mixed with the actual drug, according to several news reports.

Magnetic resonance imaging revealed the product contaminant-- which routine tests had failed to do-- but officials don’t know what it is or how it got mixed with heparin. The FDA has gotten reports of at least 785 serious injuries and 19 deaths that appear connected with the product, but hasn’t conclusively proven the contaminant is the cause, the March 6 New York Times reported. Injuries have included difficulty breathing, anaphylactic shock, hypotension and rapid pulse.

Baxter Corp., which typically supplies half of the nation’s heparin, began recalling lots of heparin products in November on reports of serious allergic reactions in patients; the company has now recalled all products and stopped production. APP Pharmaceuticals has stepped up production to fill the demand for heparin.

Most of the world’s heparin supply originates in China, as do many other pharmaceutical ingredients distributed worldwide. Quality concerns are mounting after recent scares with contaminated cold medicine and pet food that contained ingredients shipped from China. There is also growing concern that the FDA doesn’t have the resources to adequately inspect products, devices and manufacturing facilities in or originating from foreign countries, the New York Times reported.

FDA information on recalls and production is online.

The New York Times is online.

The Washington Post is online.

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WHI participants who took hormone therapy may have increased cancer risk

A follow-up study of participants in the Women's Health Initiative (WHI) indicates that women who stopped taking hormone therapy after the trial was halted may have an increased risk of breast and other types of cancer.

Women who took estrogen plus progestin during the WHI trial of 16,608 postmenopausal women, which was stopped in 2002 because of concerns over increased risk of breast cancer and lack of evidence of benefit, had a higher global risk index than women in the placebo group, according to the study in the March 5 Journal of the American Medical Association. The two groups had similar risks for cardiovascular disease and fractures.

The follow-up study included 15,730 WHI participants who were followed after they stopped hormone therapy in July 2002 until March 2005. Researchers determined that women in the hormone therapy group had higher annualized event rates for all types of cancer (1.56% per year [n = 281] for the therapy group vs. 1.26% per year [n = 218] in the placebo group). The researchers noted that while the risk of invasive breast cancer, in particular, was higher in the therapy group, the risk was still lower than at the end of the WHI trial.

The increased risk for cardiovascular disease found during the WHI trial lowered after women stopped taking hormone therapy, according to the study. Risks for hip, vertebral and other osteoporotic fractures were similar in both groups during the follow up. While not statistically significant, the rate of death from all causes was 15% higher in the hormone therapy group than in the placebo group during follow up and the global risk index (including outcomes for heart disease, breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture and deaths due to other causes) was 12% higher in the therapy group, about the same level as when the trial was halted.

Trends observed during the follow-up phase suggest that the participants should continue to be watched for other delayed effects of hormone therapy, said the authors. They recommended close surveillance of women for up to 8.5 years after stopping hormone therapy due to the higher risk of malignancies.

The JAMA abstract is online.

Drug marketing

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Expensive placebos have greater efficacy

When patients are told that a medication is expensive, they are more likely to believe that it works, a new study found.

Researchers at the Massachusetts Institute of Technology recruited 82 healthy people to test a pill which was described as an opioid analgesic recently approved by the FDA. Half of the patients were informed that the drug had a price of $2.50 per pill and the other half were told that the medication was discounted to 10 cents per pill. Actually, all participants were given identical placebo pills.

The study subjects were then given a series of electric shocks and asked to rate how well the pills blocked pain. Of the patients in the $2.50 per pill group, 85% said that the pill reduced their pain, compared with 61% of those who were told the pill was discounted. The study was published in a research letter in the March 5 Journal of the American Medical Association.

The study results are consistent with previous research on the effect of commercial variables on quality expectations and that of expectations on therapeutic efficacy, the study authors said. The findings could explain why patients switching from branded to generic drugs sometimes report that the medications are less effective, as well as highlighting a means for clinicians to combat that effect, by de-emphasizing the low cost or generic nature of prescriptions.

The results need to be replicated in larger studies to more fully explore how clinicians can communicate quality cues to patients to maximize treatment benefits and satisfaction, the study authors concluded.

The Journal of the American Medical Association is online.

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Drug prices still on the rise, AARP finds

Wholesale prices of the drugs most commonly used by Medicare patients continued to increase significantly last year, according to a new report from the AARP.

The Watchdog report included the 220 brand-name drugs which are most frequently prescribed through Medicare Part D. It found that the prices of the drugs rose by an average of 7.4% during 2007, more than twice the rate of general inflation. Overall, the prices of all but four of the included drugs increased in the past year.

AARP representatives also noted a particular spike in the drug prices since 2006, which they attributed to diminished public concern about prescription prices since the government began covering more of the cost through the Medicare Part D program. They suggested that the findings should encourage legislators to find solutions to the increasing costs of medication.

A spokesperson for the Pharmaceutical Research and Manufacturers of America disputed the report’s findings in the March 5 Washington Post. He noted that the AARP statistics do not represent the cost that consumers pay for medications and he said that prescription drug prices have increased more slowly in the past several years than have total health care costs.

The AARP press release is online.

The Washington Post is online.

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Despite costs, patients asking for and getting advertised drugs

Most Americans consider their doctor to be their primary source of information about prescription medications, but that does not stop a significant percentage of them from asking for the drugs they’ve seen advertised, according to a new survey.

The survey of 1,695 American adults was a joint project of USA Today, the Kaiser Family Foundation and the Harvard School of Public Health. Participants were asked about their perceptions of pharmaceutical companies and their use of prescription medications.

About a third of respondents said they had talked to a doctor about a prescription drug they saw advertised. Of those patients, 44% said the doctor gave them a prescription for the drug, and 54% said the doctor recommended another prescription drug. In total, 82% of those who asked about an advertised drug got a prescription for either that drug or another. The report also found that patients are having trouble paying for prescription drugs; 41% of respondents said that it is somewhat of a problem for their family to pay for their prescription drugs, and 16% said that it is a serious problem.

Issues of cost also appeared to affect general attitudes toward pharmaceutical manufacturers. The majority of survey respondents were positive about how pharmaceutical developments have affected public health, the attention paid by drug companies to safety and testing, and the value of advertising. However, 79% said that the cost of prescription drugs is unreasonable, and the same percentage attributed the high costs to corporate profits.

More than 70% of patients said that they rely on their doctor heavily to provide information about prescription drugs, compared with 51% for the pharmacist, 43% for drug packaging, 22% for government agencies, and 15% for family and friends.

The Watchdog report is online.

FDA actions

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Tamiflu label now warns of possible fatal events

The maker of oseltamivir phosphate (Tamiflu) has strengthened its warning of possible neuropsychiatric events on the drug’s label to note that events are sometimes fatal.

The label update follows recommendations made by an FDA committee last November. Post-marketing reports, mostly in children in Japan, showed some patients with influenza who were taking Tamiflu had delirium and abnormal behavior that led to injury and death. The maker of zanamavir (Relenza) also added a similar warning about delirium and unusual behavior to its label, a March 4 Reuters article reported.

The neuropsychiatric events, which often had a rapid onset and resolution, “appear to be uncommon,” both labels say. Influenza itself can cause behavior changes, and it’s not clear if the drugs directly caused the reported symptoms or events, but health professionals should still closely monitor patients on the drug for abnormal behavior, the labels say.

The FDA safety alert and prescribing information for Tamiflu are online.

The Reuters article is online.

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Newly-approved antidepressant requires no titration

The FDA last week approved desvenlafaxine (Pristiq), a new serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adults with major depressive disorder.

Unlike other antidepressants, including the chemically similar venlafaxine (Effexor) the new drug doesn’t require titration, so patients can start it at the recommended therapeutic dose of 50 milligrams per day. Often, it takes weeks to ramp up to the optimal dose of an antidepressant to determine if a patient can tolerate it. Desvenlafaxine also isn’t metabolized by the liver, so it is unlikely to interact with other medications which are broken down that way, the drug’s maker said. Critics questioned whether desvenlafaxine is truly unique, given its similarity to venlafaxine, and wondered if insurers would cover it, the March 1 New York Times reported. Manufacturer Wyeth Pharmaceuticals said it plans to start shipping the drug in the second quarter of 2008.

The most common side effects of desvenlafaxine in clinical trials were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders. The drug is contraindicated in patients with a hypersensitivity to venlafaxine, and shouldn’t be used in patients taking an MAOI, or who stopped an MAOI in the last 14 days.

The FDA approval is online.

The March 1 New York Times is online.

Wyeth’s press release is online.

ACP Journal Club

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Prednisolone vs. acyclovir for treatment of Bell's palsy

A recent study found that prednisolone, but not acyclovir, promoted complete recovery of facial-nerve function in patients with Bell's palsy.

The blinded trial included 551 Scottish patients who had unilateral facial-nerve weakness of no identifiable cause who were referred by their primary care physician or the emergency department within 72 hours of symptom onset. The patients were randomized into four groups: one that received prednisolone, 25 mg twice daily, and acyclovir, 400 mg 5 times daily; one that received the prednisolone but placebo acyclovir; one that received acyclovir and placebo prednisolone; and one that received both placebos. Study drugs were taken for ten days.

At both three months and nine months, the patients who had received prednisolone had a significantly higher rate of complete recovery than those who had not taken the drug (83% vs. 64% at three months, 94% vs. 82% at nine months). The patients who received acyclovir did not have any higher rate of recovery than those who did not take the drugs. On the study's other measured outcomes-health-related quality of life, facial appearance and pain-all groups showed a similar degree of improvement after three months. The study is abstracted in the April/May ACP Journal Club.

This study is the first properly designed and sufficiently powered trial to show that steroids, given within three days of onset, improve outcomes in Bell's palsy, said Journal Club reviewer Wieslaw Oczkowski, MD, of McMaster University in Hamilton, Ontario. Based on the trial's results, prednisolone therapy will provide complete recovery, at nine months, for one additional person for every nine patients treated, Dr. Oczkowski said. Given that the study showed that ten days of prednisolone, 25 mg twice daily, is not associated with serious side effects, patients with Bell's palsy should be treated with steroids but not antiviral agents, he concluded.

Peer ratings for this review: Primary Care, Neurology: 7/7 stars. Emergency, Internal medicine: 6/7 stars.

ACP Journal Club is online.

CMS update

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Demonstration program found improper payments

The CMS has identified $371.5 million in improper Medicare payments collected from or paid to providers and suppliers in California, Florida, and New York. The improper payments were identified as part of a demonstration program that examined Medicare fee-for-service payments in 2007.

The Recovery Audit Contractor (RAC) demonstration program was designed to find a cost-effective way to ensure that CMS is making correct payments to its providers and suppliers. In addition to the states with the identified improper payments, the program is also currently operating in Massachusetts and South Carolina.

According to CMS, in 2007 approximately 96% of the improper payments were overpayments collected from health care providers; the other 4% were underpayments to health care providers. Most of the overpayments identified were collected from inpatient hospitals and almost half of the improper payments were the result of incorrect coding. Less than 5% of the collected overpayments came from physicians. The RAC program will expand throughout the country by 2010.

The CMS press release announcing the improper payments is available online. And, further information about the RAC program can also be found online.

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Advanced beneficiary notice form revised

CMS last week began a six-month transition period to phase in revisions to the Advanced Beneficiary Notice form. All providers and suppliers must be using the new form by Sept. 1, 2008.

CMS is introducing one form, the Advanced Beneficiary Notice of Noncoverage (CMS_R-131), to replace both the General Use Advanced Beneficiary Notice (CMS-R-131-G) and the Lab Advanced Beneficiary Notice (CMS-R-131-L). The new title is meant to more clearly communicate the purpose of the form.

The new form includes a mandatory field for cost estimates of the items or services being provided. It also allows beneficiaries a new option of paying for a service out-of-pocket directly, rather than submitting a claim to Medicare. The new form also may be used for voluntary notifications, in place of the Notice of Exclusion from Medicare Benefits.

The Advanced Beneficiary Notice form allows providers to bill Medicare beneficiaries for services that are not covered under Medicare. The form explains that Medicare may deny payment for the service and that the beneficiary is responsible for the payment if it is denied by Medicare.

The revised form and instructions are available online.

Updated manual instructions and a Spanish version of the form will be posted soon, CMS said.

Cartoon caption contest

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Put words in our mouth

ACP InternistWeekly wants readers to create captions for this cartoon--and help choose the winner.

cartoon

E-mail all entries to acpinternist@acponline.org by March 14. ACP staff will choose three finalists and post them in the March 18 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the March 25 issue.

Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

ACP Internist

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March issue now available online and in your mailbox

The March issue of ACP Internist is now online at www.acpinternist.org and arriving in mailboxes. Highlights of the issue include:

    • ACP's Center for Practice Innovation finds ways to untangle all those phone calls at the front desk in the third of a six-part series on solutions for common problems encountered by small practices.

    • Internists are reaching out to homeless patients by taking their medical expertise and resources to the streets. Learn more about how doctors adapt their treatment for the indigent.

    • Assess the next diagnostic dilemma in the Mindful Medicine column. In this issue, a patient's skepticism about his cancer diagnosis prompts his doctor to dig deeper for the correct diagnosis.

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ACP Internist wants to hear your stories of difficult diagnoses

ACP Internist columnists Jerome Groopman, FACP, and Pamela Hartzband, FACP, would like to hear about your stories of difficult or missed diagnoses for possible use in their next 'Mindful Medicine' column.

Dr. Groopman, a hematologist/oncologist and author of the bestselling "How Doctors Think," and Dr. Hartzband, an endocrinologist, are on the Harvard Medical School faculty and serve as staff physicians at Boston's Beth Israel Deaconess Medical Center. Every other issue, they present a case study from an ACP Internist reader describing a difficult or missed diagnosis, and provide commentary on how a mistake was, or might have been, avoided.

E-mail your ideas to Drs. Groopman and Hartzband at acpinternist@acponline.org. The authors will contact physicians whose cases they would like to use in the column.

From the College

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ACP commends new commission on health care disparities

Recognizing that “health care disparities” is one of the College’s strategic priorities, ACP commended the Robert Wood Johnson Foundation for launching the new Commission to Build a Healthier America.

Last month, the Robert Wood Johnson Foundation announced the launch of a two-year commission that will focus on factors outside of the health care system that affect the health of Americans. The commission will identify non-medical, evidence-based strategies to improve the health of all Americans. And, they will investigate how factors, such as education, environment, income and housing, shape and affect personal behavioral choices.

"The American College of Physicians continues to realize the importance of eliminating health care disparities through its Board actions, policy papers, educational sessions, as well as the work of the ACP Foundation," said David C. Dale, FACP, president of ACP. "ACP believes that the Commission to Build a Healthier America will provide a much-needed framework for a broad national effort to research the reasons behind health care disparities and to develop workable solutions."

ACP is addressing health care disparities in its public policy, research and educational initiatives. The College has scheduled a session for its upcoming annual meeting, IM 2008, entitled "Racial and Ethnic Disparities in Health Care: Lessons for Clinical Practice." ACP pledged to make its public policy position papers, research on limited English language proficiency and health illiteracy, educational activities, and other initiatives to eliminate health care disparities available to the Commission to Build a Healthier America.

"ACP hopes to partner with the Robert Wood Johnson Foundation and The Commission to research, design and implement strategies to eliminate disparities based on gender, race, ethnicity or language proficiency—one of our top strategic priorities for the College," concluded Dr. Dale.

More information about ACP’s work on health care disparities and the Commission are available online.

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ACP celebrates Women’s History Month

To celebrate Women's History month, ACP features women members and leadership in profiles, panel discussions and historical review on its Women in Medicine Web site.

  • “A Historical Look into Women in Medicine (1880-1930)” explores the journey of female physicians in internal medicine
  • Four ACP female physician members discuss challenges, what they love about their jobs, and balancing work and family in a panel interview and podcast
  • “My Kind of Medicine” features profiles from ACP’s student newsletter, IMpact, offering unique perspectives of women across the country on why they decided to pursue internal medicine
  • Dr. Risa Lavizzo-Mourney, president and CEO of the Robert Wood Johnson Foundation is featured in an ACP Internist profile
  • “Early Women Leaders of ACP” highlights the first female ACP Governors, Regents and Officers.

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About ACP InternistWeekly

ACP InternistWeekly is a weekly newsletter produced by the staff of ACP Internist. It is automatically sent to all College members who have an e-mail address on file with ACP.

To add your e-mail address to your member record and to begin receiving ACP InternistWeekly, please click here.

Copyright 2008 by the American College of Physicians.

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