In the News for the Week of 6-22-04
The business of medicine
- FluMist manufacturer cuts vaccine's price in half
- Medicare will cover some PET scans to aid Alzheimer's diagnosis
- Supreme Court strikes down state laws on suing HMOs
Clinical news in the headlines
- Glaxo data show paroxetine ineffective in adolescents
- Statin response may have genetic link
- Losing weight via liposuction brings no health benefits
Highlights of ACP Journal Club
- A clinical model predicted 30-day and one-year mortality in patients hospitalized for heart failure
- Study: Almost 82 million people lacked coverage during part of 2002-2003
- College supports bill to regulate tobacco sales, marketing
- College ends formal community-based teaching program
- Make your voice heard with an ACP resolution
The business of medicine
In a move to jumpstart lackluster sales of the live intranasal flu vaccine FluMist, its manufacturer last week announced that the price of the vaccine for the upcoming flu season would be almost half what it cost in 2003-04. The company also said it would focus its marketing efforts this year on physicians, not consumers.
The per dose price of FluMist for physicians and pharmacists in 2004-05 will be $23.50, down from $46 last year. At the same time, MedImmune Inc., which manufactures FluMist, is launching a marketing campaign to educate physicians on the vaccine, according to the June 16 Washington Post.
Approved for healthy patients ages 5 through 49, FluMist was introduced during last year's flu season, along with a $25 million direct-to-consumer advertising campaign aimed at selling 4 million doses of the live vaccine. However, the company sold less than 500,000 doses, even though the entire supply of last season's injectable flu vaccine was depleted.
Price was a major factor, although the Washington Post noted that many patients and physicians worried that the live vaccine could pose problems for patients with weakened immune systems, or their close contacts. The fact that the vaccine is approved only for healthy patients who are less likely to be vaccinated was another factor in slow sales. And some physicians didn't carry the vaccine, which must be kept frozen and has special storage requirements.
MedImmune is working to produce another version of the vaccine that won't need to be frozen, the Washington Post reported. This year, MedImmune plans to produce between 1 million and 2 million doses.
The Washington Post is online.
The CMS last week announced that it will expand coverage of positron emission tomography (PET) scanning for some Medicare patients with suspected Alzheimer's disease. The proposal to expand coverage, which is now open for 30 days for public comment, may take effect in 90 days.
The agency plans to cover the cost of PET scans for those patients for whom an Alzheimer's diagnosis is still uncertain, despite a thorough clinical workup by physicians. Medicare also announced that it will cover the cost of PET scans for patients with suspected Alzheimer's disease who are enrolled in clinical trials.
Medicare has not paid for PET scans in the past because the effectiveness of PET scanning has been unclear, according to a June 15 CMS press release. After reviewing evidence, a National Institute on Aging (NIA) expert panel recommended covering PET scans to help physicians diagnose Alzheimer's in patients who have inconclusive clinical evaluations. Those experts, however, also expressed concern that expanded coverage could trigger overuse of the procedure, leading to misdiagnoses, unnecessary radiation exposure and higher medical costs.
The scans, which cost up to $1,500 each, can detect plaque in the brain that may indicate Alzheimer's disease, according to the June 17 Philadelphia Inquirer. Medicare's decision to expand PET scan coverage may lead private insurers to follow suit.
The NIA panel also recommended that the CMS initiate a community-based clinical trial to test whether PET scans lead to more rapid diagnoses of Alzheimer's to help patients and families manage the progressive disease.
The CMS press release is online.
The memorandum of the proposed coverage is on the CMS Web site.
The Philadelphia Inquirer is online.
In a decision that may revive momentum for national patients' rights legislation, the Supreme Court this week struck down a Texas law allowing patients to sue their HMOs through state courts.
In a 9 to 0 vote, the justices ruled that a 1974 federal statute prohibits individual states from allowing patients to sue managed care companies in state courts for negligence or malpractice arising from health plans' decisions to deny coverage for treatments. According to the June 22 Washington Post, the ruling disallows existing patients' rights laws in Texas and nine other states: Arizona, California, Georgia, Maine, New Jersey, North Carolina, Oklahoma, Washington and West Virginia.
The court claimed that the federal statute--the Employee Retirement Income Security Act (ERISA)--was intended to establish one set of regulations for employee benefit plans to simplify the regulatory process. Allowing patients to sue HMOs in state courts would undermine that statute, the justices ruled.
Supporters of state patients' rights laws claimed that suing health plans over treatment-denial determinations did not violate ERISA because those determinations involved judgments on medical--not insurance--issues.
The Washington Post is online.
The College has long advocated for strong federal patients' rights legislation. Information about College efforts is online.
Clinical headlines in the news
Clinical trial data released last week by GlaxoSmithKline on paroxetine (Paxil) showed that the drug was ineffective in treating depression in children and adolescents and could increase young patients' risk of suicidal behavior.
The drug company posted the data on its Web site after being sued by New York's attorney general. The suit alleged that Glaxo was suppressing negative findings from pediatric trials on the drug, according to Reuters on June 16.
The data showed no benefits in treating depression in younger patients. They also showed that, although no patients participating in the trials committed suicide, the rate of adverse events possibly linked to suicidal behavior was 2.4% in the group taking paroxetine, compared to 1.1% for those taking placebo, Reuters said.
While paroxetine is not approved for minors, many physicians have prescribed the drug for younger patients off-label.
Reuters is online.
In related news, the AMA last week passed a resolution that urges the federal government to require drug companies to register drug tests with the federal government to establish a database that would register all pharmaceutical clinical trials when those studies begin.
According to the June 16 New York Times, the resolution asks HHS to maintain that database to ensure that inconclusive or negative study findings are not suppressed.
The AMA resolution comes at the same time as editors of 12 leading medical journals, including Annals of Internal Medicine, The Journal of the American Medical Association, and The New England Journal of Medicine, are considering a similar proposal. That proposal would require drug companies and researchers to register all clinical trials at the outset as a condition for publishing study findings.
The New York Times story is available online.
A study has found that common genetic variations may cause people to respond differently to statin therapy. The findings suggest that genetic screening, which has been extensively studied for different cancers, may one day guide how physicians tailor lipid-lowering therapy.
The findings, published in the June 16 Journal of the American Medical Association (JAMA), showed that people with a genetic variant in the HMG-CoA reductase gene were less responsive to cholesterol-lowering therapy than people without the variation. Study participants with the genetic variant had a 22% smaller reduction in total cholesterol and a 19% smaller reduction in LDL cholesterol after being treated with pravastatin for 24 weeks. A total of 1,536 men and women participated in the study.
While noting that the study looked only at pravastatin, researchers said the results were compelling enough to suggest the possibility of using "personalized medicine" and genetic screening to target therapies. Future studies, they said, should focus on whether people with the HMG-CoA genetic variation may benefit from alternative non-statin lipid-lowering therapies or from adjustments in statin dosages.
Full text of the JAMA article is online.
For more on gene testing, see "Problems, promise for molecular medicine" in the January/February 2004 ACP Observer.
According to a new study, obese patients who shed pounds by undergoing liposuction do not receive the same reductions in heart disease and diabetes risks as people who lose weight through diet and exercise.
The study involved 15 obese women who underwent large-volume liposuction to remove about 20 pounds of abdominal fat. Researchers measured the effect of the procedure on insulin sensitivity in patients' liver, skeletal muscle and adipose tissue.
They also examined the procedure's effect on risk factors for coronary heart disease, including waist circumference, blood pressure, plasma lipid concentrations and serum markers of inflammation. The results were published in the June 17 New England Journal of Medicine (NEJM).
After 10 to 12 weeks, researchers found no improvement in the women's blood pressure, cholesterol levels, triglycerides, glucose or insulin. According to the June 17 New York Times, the findings contradict earlier studies that suggested liposuction might be as effective as weight loss in reducing lipids and other risk factors.
Researchers claimed that the lack of health benefits may be due to the fact that liposuction removes only subcutaneous fat, not deeper fat deposits in the organs and abdomen. They also said that liposuction fails to shrink as many fat cells as does dieting, and they suggested that although liposuction has cosmetic benefits, it should not be considered an effective clinical therapy for obesity.
The New York Times reported that liposuction is the most common aesthetic surgical procedure in the United States, with nearly 400,000 procedures performed annually.
The NEJM abstract is online.
The New York Times is online.
Highlights of ACP Journal Club
A prediction model based on clinical data gathered when heart failure patients were admitted to a hospital was effective in predicting mortality rates at one month and one year. Data were gathered from a retrospective analysis.
The study, abstracted in the May-June ACP Journal Club, looked at patients admitted to 48 different hospitals with a primary diagnosis of heart failure. Statistics showed that mortality rates at one month and one year corresponded to risk scores based on age, decreased systolic blood pressure, increased respiratory rate, hyponatremia and increased urea nitrogen levels, as well as to comorbid conditions such as dementia and cancer.
The authors noted that risk-assessment methods are common for patients with coronary artery disease but not for those with heart failure. Identifying high-risk patients could help direct them to appropriate specialized care units and help families deal with end-of-life issues earlier. At the same time, identifying low-risk patients could help reduce costs by leading to earlier discharge to outpatient care.
The retrospective analysis suggests that predictive models can work for heart failure patients, but a prospective validation study is needed, ACP Journal Club reviewers noted. They pointed out that the study had some deficiencies, including limited information about data abstraction methods and the fact that not all patients were assessed for ventricular function.
The ACP Journal Club abstract is online.
A study released last week found that rising health care costs care and a soft economy left nearly 82 million people uninsured at some point during the past two years.
That figure, published in a report by the nonprofit group Families USA, is almost twice the number of uninsured reported last fall by the U.S. Census Bureau. The Census Bureau found that 43.6 million Americans were uninsured for the entire year during 2002.
The Families USA report, however, looked at a longer period of time and at the number of Americans who lacked coverage for part of a year. Many of those who lacked coverage, the report said, were uninsured for more than nine months.
The report found that blacks and Hispanics were disproportionately among the ranks of the uninsured, according to the June 16 Washington Post. Almost 60% of Latinos and 43% of blacks were uninsured, while the figure among whites was 23.5%. Minorities were more likely, the report found, to have jobs with no health benefits.
Uninsured figures are most acute among people younger than 25, according to the Washington Post. The report found that Texas had close to 44% of its population without coverage during some portion of 2002-03, followed by New Mexico with more than 42% and California with more than 37%.
The Washington Post is online.
The Families USA report can be downloaded online.
ACP resources on access to care are online.
ACP has endorsed a federal bill that would regulate tobacco sales and marketing and restrict minors' access to tobacco products.
In letters sent June 10, the College voiced support for the Family Smoking Prevention and Tobacco Control Act (H.R. 4433/S. 2461). The bill would give the FDA oversight of tobacco products, require manufacturers to place more realistic health warnings on product packages and mandate the disclosure of ingredients used in tobacco products.
The bill also seeks to reduce tobacco use among minors by restricting advertising that appeals to children, limiting where tobacco products are sold and cracking down on illegal sales of tobacco products to minors.
Tobacco products lead to 440,000 deaths in United States every year and cost the federal and state governments more than $45 billion to care for tobacco-related illnesses, the letters said. The letters, which called the legislation "long overdue," were sent to several senators and to members of the House Committee on Energy and Commerce.
The College's letter is online.
As of July 1, ACP will end its Community-Based Teaching (CBT) program, which was designed to prepare community practitioners to teach medical students and residents in their practices.
Formally launched in 1993, the College's CBT program, through its task force, sponsored a quarterly newsletter, maintained a clearinghouse of free teaching resources, produced a videotape on developing office-based teaching skills and recognized physician achievements in community teaching.
The College decided to end the program because the program's original goals of engaging community physicians in teaching efforts had either been met, implemented by other organizations or incorporated into local student and resident rotations. Through the College's Internal Medicine Revitalization Program, ACP will continue to work to eliminate the gaps between training and practice and to advocate for the basic principles delineated by the CBT Program.
More information is online.
In addition, the ACP's "Teaching in Your Office: A Guide to Instructing Medical Students and Residents" can still be ordered online.
ACP members have until June 30 to submit new resolutions to their chapter leaders for consideration at the September 2004 Board of Governors meeting.
Any ACP member may initiate a resolution by submitting it to their Governor and/or chapter council. Proposals become resolutions of the chapter after being approved by the chapter council. Chapter resolutions will be presented to the Board of Governors at its fall meeting.
New resolutions are voted on by the Board of Governors and, if approved, presented to the Board of Regents as policy or action recommendations. Once the Board of Regents has considered recommendations approved by the Governors, resolutions are either adopted and implemented, or forwarded to College committees and/or staff for more study.
More information about the ACP resolutions process is online.
Contact information for ACP Governors is also online.
To search the College's archive of past resolutions, visit ACP's online resolutions database. (Free registration is required.)
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Copyright 2004 by the American College of Physicians.
A 30-year-old woman is evaluated for difficult-to-treat migraine. She has had severe headaches, usually on the first day of menses, since menarche. The pain is hemicranial, pulsatile, and associated with severe nausea and vomiting but no aura. She frequently awakens with the attack already in progress. A series of drug regimens have become ineffective in controlling pain. Following physical and neurological exams, what is the most appropriate next step in treatment?
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