In the News for the Week of 9-19-06
- Agency seeks more data on bevacizumab as breast cancer treatment
- Update on E. coli and botulism outbreaks
- Medicare moves to income-based premiums
Health care access
- Annals of Internal Medicine:
- More AIDS patients die of other causes
- Men call themselves straight but have sex with other men
- Imaging techniques evaluated for detecting artery disease
- VA study questions Gulf War syndrome
- ACP physicians meet with Congress about Medicare cuts
The FDA has requested additional efficacy and safety data before approving colon cancer drug bevacizumab as a treatment for breast cancer, manufacturer Genentech announced last week. The company had hoped to begin marketing the drug in early 2007 but the FDA approval could add another year to the process.
Bevacizumab (brand name: Avastin) has been approved to treat colorectal cancer since May 2006, but Genentech is studying use with several additional tumor types, including lung, prostate and kidney cancers. When used in combination with paclitaxel, bevacizumab has been shown to slow the progression of breast tumors significantly compared with using paclitaxel alone.
Physicians can prescribe bevacizumab off label to treat breast cancer without FDA approval but unapproved use is not always covered by insurance, noted the Sept. 12 New York Times. The drug, which costs about $100,000 a year to treat breast cancer, has sparked controversy over the high cost of oncology drugs.
The FDA contended that the data supporting Genentech's request for approval to treat breast cancer, which was based on studies conducted by the National Cancer Institute, was not as rigorous as data typically collected through industry-sponsored clinical trials, said the New York Times. The agency asked the company to provide more extensive data, including assessment of the drug's effectiveness by independent radiologists.
Genentech officials said the company expects to resubmit an application by mid-2007 and an FDA review would likely take an additional six months.
The New York Times is online.
The FDA is advising consumers not to eat any fresh spinach after 109 reported cases of the outbreak strain of E. coli O157:H7. Among the ill persons, 55 were hospitalized, 16 developed hemolytic-uremic syndrome and an adult in Wisconsin died. According to the Sept. 18 New York Times, state health officials in Ohio are also investigating the death of a 23-month-old girl who was sickened by E. coli to determine whether the case was related to the outbreak.
Dates of illness onset ranged from Aug. 2 to Sept. 9, 2006. Cases have been reported in California, Connecticut, Idaho, Indiana, Kentucky, Maine, Michigan, Minnesota, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Utah, Virginia, Wisconsin and Wyoming.
The outbreak has been traced to Natural Selection Foods LLC, a California company, which produces and packages spinach for other companies in addition to selling under its own name. The New York Times reported that the FDA and the California Department of Health Services were working toward tracing the infected greens to individual farms. The inquiry will review irrigation methods, harvest conditions and other practices at farms possibly involved. The spinach could have been contaminated in the field or during processing.
The CDC on Sept. 16 also issued a health advisory regarding bottled carrot juice. The juice caused a cluster of three botulism cases in Georgia. The three patients had onset of symptoms on Sept. 8, a day after consuming a meal that included commercially produced carrot juice. Botulinum toxin type A was identified in the serum and stool of all three patients by mouse bioassay.
The label on the implicated bottle reads “Bolthouse Farms, Bakersfield, California, 100% carrot juice.” It is unknown whether the contaminated juice was subjected to time or temperature abuse that might have facilitated the growth of Clostridium botulinum spores, which can survive pasteurization. The CDC has not been notified of any cases of suspected botulism since this cluster was reported. They asked health officials and physicians to inquire about consumption of carrot juice in the food history of suspect botulism cases.
The New York Times article is also online.
Medicare premiums for most seniors will increase 5.6% in 2007, but premiums for wealthier beneficiaries will go up even more, marking the first time the government has imposed higher costs on wealthier beneficiaries.
The standard monthly premium for Medicare Part B will rise from $88.50 to $93.50, said a Sept. 12 CMS news release. This is the smallest increase in the Part B premium since 2001, said CMS. Very rapid growth in spending for hospital outpatient services contributed to the new prices, said the release. However, officials noted that the increase is less than the double-digit rise predicted earlier.
For individuals with an annual income of more than $80,000, premiums will range from $106 to $162.10 per month. Medicare officials said the change will save $7.7 billion over the next five years and more than $20 billion in the next decade. Officials told the Sept. 13 Washington Post that they expect 9,000 higher-income people to drop out of the program next year and 30,000 to leave by 2010 as a result of the income-based premium increases.
The program would have required a higher premium increase if not for planned physician payment cuts, Medicare officials said. If Congress had eliminated the payment cut and simply frozen physicians’ Medicare fees in 2007, it would have required a further increase of roughly $1.50 in the monthly premium. ACP has been actively urging Congress to replace the cuts with physician reimbursement updates.
The CMS release is online.
The Washington Post is online.
Health care access
Almost 9 out of 10 Americans who shopped for individual health insurance in the past three years did not get coverage, reports a study released Sept. 14 by the Commonwealth Fund. The study of working-age adults found that coverage was not affordable for 58% of applicants, and 21% were turned down, uprated or sold a policy with exclusions because of medical history.
Most of the increase in the number of uninsured Americans—which the report put at 46.6 million—was due to a decline in workplace coverage. Forty-three percent of adults with individual coverage spent 5% or more of their income on health insurance premiums, compared with 14% of those with employer-sponsored coverage.
Despite paying more in premiums, these consumers actually received less coverage, with more than a third of those with individual coverage having deductibles of $1,000 or more, said the Sept. 14 Los Angeles Times. Of those high-deductible customers, 44% limited their use of medical care by not filling a prescription, not seeing a specialist when needed, skipping a recommended test, treatment or follow-up, or not going to a physician or clinic when they had a medical problem.
The report, "Squeezed: Why rising exposure to health care costs threatens the health and financial well-being of American families," was based on findings from the Commonwealth Fund’s latest biennial health insurance survey, a telephone survey of more than 4,000 consumers.
A summary of the report is online.
The Los Angeles Times is online.
There is federal money available for treatment of undocumented aliens, but physicians must sign up to be paid.
As part of the Medicare Modernization Act of 2003, Congress allocated $250 million per year to the Emergency Medical Treatment and Labor Act. This money is used to reimburse physicians, hospitals and ambulance providers for inpatient or outpatient services provided to undocumented aliens, aliens paroled into the U.S. for the purpose of receiving medical services, and Mexican citizens permitted temporary entry with a laser visa.
During fiscal years 2005-2008, two-thirds of the fund will be divided among all 50 states and the District of Columbia, based on their relative percentages of undocumented aliens. The remaining one-third will be divided among the six states with the largest number of undocumented alien apprehensions.
In order to receive reimbursement, medical providers must be enrolled in the program, known as Section 1011. Enrollment and additional information is available from TrailBlazer Health Enterprises, the national contractor for the program.
More information is online.
The following articles appear in the Sept. 19 issue of Annals of Internal Medicine. This issue includes an article about people with AIDS dying of non-HIV-related causes, among others. The Full text is available to College members and subscribers online.
More people with AIDS die of “common” causes in 2004 than in 1999. Researchers in this study found that of 68,669 New York City residents with AIDS who died between 1999 and 2004, 26.3% did not die of HIV-related causes. That's a 33% increase from 19.8% in 1999. The principal causes of death were cardiovascular disease, substance abuse, and cancer.
In a new survey, men call themselves straight but have sex with men. A survey of 4,193 men living in New York City found that nearly 10% of all the male participants who identified themselves as straight reported having sex with at least one man during the previous year. Compared to men who identified themselves as gay, these men were more likely to belong to a minority racial or ethnic group, be foreign-born, and have a low educational level. This study is one of the largest U.S. population-based surveys to report on the contrast between a man’s sexual identity and his actual sexual behaviors.
Three imaging techniques evaluated for detecting artery disease. In this study, researchers obtained images of the coronary arteries of 108 patients with suspected coronary artery disease using multislice computed tomography (CT), magnetic resonance imaging (MRI), and conventional coronary angiography. The researchers found that the multislice CT was superior to MRI for ruling out CAD.
Although veterans of the Persian Gulf War report more symptoms of illness than do soldiers who didn't serve in the 1990-1991 war, there is no such thing as Gulf War syndrome, according to a new report released by the Institute of Medicine (IOM) Sept. 12.
The fourth in a series commissioned by Congress, the study found no cluster of symptoms that constitute a syndrome unique to Gulf War veterans. In 1998, the VA entered into a contract with the IOM to investigate associations between illness and exposure to toxic agents, environmental hazards and preventive medicines associated with Gulf War service.
Nearly 30% of all those who served in the brief war have reported problems, including fatigue, memory loss, muscle and joint pain, rashes and difficulty sleeping. The variety of symptoms has complicated efforts to pinpoint their cause, the report said. The report did find evidence of an elevated risk of the rare nerve disease amyotrophic lateral sclerosis (ALS) among Gulf War veterans. The veterans also have an increased risk of anxiety disorders, depression and substance abuse.
The VA will rely on this study to determine whether Gulf War veterans are eligible for special disability benefits if they are found to suffer from illnesses that can be linked to their service. Veterans can now claim those benefits only by making an undiagnosed illness claim, the Associated Press reported on Sept. 12.
The Associated Press article is online.
A summary of the report is online.
Physician leaders from ACP met with members of Congress on Sept. 12 to describe the negative impact Medicare cuts would have on their practices. In a joint effort with physicians from the American Academy of Family Physicians (AAFP) and the American Osteopathic Association (AOA) they met to discuss the magnified effect these cuts would have on primary care physicians in particular.
Medicare payments to physicians are scheduled to be cut by 5.1% on Jan. 1, 2007. The reduction is the result of the sustainable growth rate (SGR) formula that is used to calculate the physician fee schedule. Since 2001 the aggregate payment rate has decreased 20% below the government’s conservative measure of inflation for medical practice costs.
“Medicare beneficiaries rely upon their primary care physicians not only for quality health care, but also for access to other parts of the Medicare program,” said C. Anderson Hedberg, MACP, immediate-past president of ACP. “We look forward to working with Congress to maintain access to physician services for the millions of beneficiaries participating in the Medicare program.”
More information about the meetings and other ACP activities to let Congress know about the potentially devastating effects of the SGR cuts is online.
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Copyright 2006 by the American College of Physicians.
A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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