In the News for the Week of 10-11-05
Nobel Prize winners
- ACP Member honored for breakthrough research on ulcers
- CDC issues advisory on tularemia bacterium
- Guillain-Barre syndrome reported following meningitis vaccine
- Name of hypertension drug leads to prescribing confusion
Clinical news in the headlines
- Study finds “normal” glucose levels may predict diabetes
- Fewer cancer deaths but racial disparities remain
- Highlights of ACP Journal Club
Health information technology
- HHS awards three contracts to advance national HIT adoption
- ACP comments on CMS’ payment policy revisions
- College seeks support to retool, rescind payment formula
- Regents' Chair testifies before Senate committee on DTC ads
- ACP heart disease patient education video to air on local TV stations
Nobel Prize winners
Barry J. Marshall, ACP Member, was one of two Australian scientists awarded the 2005 Nobel Prize in Physiology or Medicine last week for his work linking the bacterium H. pylori to gastritis and peptic ulcer disease.
Dr. Marshall, 54, a gastroenterologist at the University of Western Australia in Nedlands, will share the award with J. Robin Warren, MD, 68, a retired pathologist, according to the Oct. 4 New York Times. The two scientists triggered a revolution in medicine when they presented research showing that Helicobacter pylori causes ulcers.
Before that discovery in 1982, it was thought that stress and lifestyle issues caused peptic ulcer disease, according to an Oct. 3 Nobelprize.org press release. It is now accepted that H. pylori causes more than 90% of duodenal ulcers and up to 80% of gastric ulcers.
It took years before many in the medical community accepted the findings presented by Drs. Marshall and Warren, the New York Times noted. To prove their theory, Dr. Marshall, then 32, swallowed a pure culture of H. pylori to trigger gastritis and then underwent successful treatment.
Before the doctors' discovery, ulcers were considered a chronic disease requiring surgery, the New York Times said. After the role of H. pylori became known, doctors began treating gastritis and ulcers with antibiotics and drugs inhibiting the production of stomach acid. The Australians’ discovery also prompted theories that infectious agents may be at the root of many chronic diseases, such as the possibility that microbes produce atherosclerosis.
Researchers are now investigating whether genetic differences or differences in H. pylori strains influence why only some people with H. pylori develop gastritis and ulcers, the New York Times said. Drs. Marshall and Warren will divide the $1.3 million Nobel Prize to be awarded in Sweden on Dec. 10.
A Nobelprize.org press release is online.
The New York Times is online.
The CDC has issued an advisory that low levels of Francisella tularensis, the bacterium that causes tularemia, were detected in the Washington's Capitol Mall area from Sept. 24-25. Findings were made using detectors that identify airborne bacteria and pathogens.
CDC officials said in a Sept. 30 advisory that there have been no reports of related human or animal illnesses, but concerns were raised because the Capital Mall is a busy tourist destination. Physicians were asked to test and report any suspected cases to appropriate health authorities.
Tularemia, also known as rabbit fever, typically presents with pneumonic, oculoglandular and oropharyngeal symptoms, the advisory said. The usual incubation period is between three to five days and the disease can be effectively treated with antimicrobials.
Physicians were advised that patients experiencing an onset of acute febrile illness between Sept. 26 and Oct. 5 should be checked for the following:
- conjunctivitis with preauricular lymphadenopathy
- stomatitis, pharyngitis or tonsillitis and cervical lymphadenopathy
- cough, shortness of breath or pleuritic chest pain
The CDC is not recommending mass or targeted prophylaxis because the usual incubation period passed without an increase in suspicious illness and air sampling has been negative, the advisory said. The infection is not contagious and can be easily treated in adults with streptomycin or gentamicin.
The CDC advisory is online.
The FDA has issued an alert about several reports of Guillain-Barre syndrome following administration of a meningitis vaccine.
Five cases of Guillain-Barre syndrome were reported following administration of Sanofi Pasteur’s Menactra in patients age 17 or 18, said a Sept. 30 FDA news release. The teens, who recovered, developed weakness or abnormal sensations in their arms or legs within four weeks after vaccination. Guillain-Barre syndrome is a neurological disorder that can occur after certain infections and typically causes weakness in the legs and arms that can require hospitalization.
FDA officials stressed that it is not yet known whether the vaccine caused these cases but alerted physicians because of the serious nature of the disease. The Menactra vaccine prevents meningococcal infection—a major cause of bacterial meningitis, which affects about one in 100,000 people annually and can be fatal, the FDA release said.
The company has distributed more than 2.5 million doses of Menactra, according to the FDA. The release noted that a preliminary scan of health care databases by the CDC did not turn up any cases of Guillain-Barre syndrome among the 110,000 people who received Menactra.
The FDA news release is online.
The FDA recently advised physicians that it has received reports of prescribing errors involving a hypertension drug and several similarly named products.
Reports have involved mix ups between AstraZeneca’s Toprol-XL (metoprolol succinate) extended release tablets—used to treat hypertension, angina pectoris and heart failure—and Ortho-McNeil Neurologics’ Topamax (topiramate), used to treat epilepsy and migraine prophylaxis, according to a Sept. 30 FDA advisory.
Toprol-XL has also been confused with Novartis Pharmaceuticals’ Tegretol or Tegretol-XR (carbamazepine), prescribed for complex partial seizures, generalized tonic-clonic seizures and trigeminal neuralgia. In a Sept. 22 letter to physicians, AstraZeneca said the mistakes were the result of verbal and written prescriptions incorrectly interpreted or filled.
Some cases in which one drug was confused with another have led to adverse events, the FDA alert said. According to AstraZeneca, those events included recurrence of seizures or hypertension, return of hallucinations and attempted suicide.
The FDA alert is online.
Clinical news in the headlines
A new study suggests that high-normal fasting plasma glucose levels in young adults may be a useful indicator for identifying patients at risk for type 2 diabetes while there is still time to take effective preventive measures.
The 12-year study involved more than 13,000 men between ages 26 and 45 with baseline fasting plasma glucose levels of less than 100 mg per deciliter. Researchers found that men with fasting plasma glucose levels of 87 mg/dL or more had a progressively increased risk of type 2 diabetes compared with men whose levels were less than 81 mg/dL. The study appears in the Oct. 6 New England Journal of Medicine (NEJM).
Researchers concluded that higher fasting plasma glucose levels, even if in the normal range, may be an independent risk factor for type 2 diabetes. Fasting plasma glucose levels in the high-normal range from 91-99 mg/dL, they said, should alert physicians to counsel an otherwise healthy patient about lifestyle and weight, and to assess their lipid profile.
The findings highlight the often murky line between abnormal and normal, according to an accompanying editorial. In 1979, the recommended fasting plasma glucose level was below 140 mg/dL, a threshold that has been gradually lowered to the recent goal of below 100 mg/dL set by the American Diabetes Association. This study suggests that the recommended upper range may get even lower.
While the study involved only men, the results likely apply to women as well, the editorial said. A high-normal fasting plasma glucose level is insufficient in itself as a predictor of diabetes, according to the authors, but it can be a valuable tool in determining risk when considered in combination with body mass index and triglyceride levels.
The NEJM abstract is online.
According to the latest annual report on cancer, death rates from the disease in the United States have declined overall but liver cancer is on the rise and significant racial disparities persist in cancer incidence.
An annual 1.1% decline in overall cancer death rates for men and women from 1993-2002 was reported for most of the 15 most common cancers, including lung, colon, prostate and breast, according to the "Annual Report to the Nation on the Status of Cancer, 1975-2002," published in the Oct. 4 Journal of the National Cancer Institute (JNCI). Researchers attributed the declines to more effective prevention and screening, improved treatments and medical management.
A 1.6% annual increase in liver cancer among men between 1995 and 2002 was a notable exception to the overall positive trend, said researchers form the NCI, the CDC, American Cancer Society and North American Association of Central Cancer Registries. The data suggest that this once relatively rare cancer may be becoming more common, they said.
Racial disparities were particularly apparent among black men compared with other groups, the report said. The overall cancer incidence rate was 25% higher in black men than in white men, for example, and more than 50% higher for certain cancers such as myeloma and cancers of the prostate, lung, stomach, liver, esophagus and larynx. The overall cancer death rate was also 43% higher in black men than in white men.
While noting that adherence to clinical guidelines has improved overall outcomes, the authors said some important recommendations are not being fully followed, according to the Oct. 5 Washington Post. Those include a significant number of early stage breast cancer patients skipping follow-up radiation following surgery; patients age 65 or older not receiving chemotherapy after surgery for advanced colorectal cancer; and female Medicare beneficiaries having ovarian cancers removed by general surgeons instead of gynecologist-oncologists.
The JNCI article is online.
The Washington Post is online.
Radical prostatectomy was more effective than watchful waiting in a 10-year study of men with early stage prostate cancer—but physicians are advised that the results may be out of step with modern practice.
In the study, almost 700 men in Sweden, Finland and Iceland who were newly diagnosed with prostate cancer were randomized to receive either watchful waiting or radical prostatectomy. In the 10-year follow-up period, there was a 21% relative risk reduction for death from any cause (absolute risk reduction 6%) in favor of the group that received radical prostatectomy. The study is abstracted in the November-December ACP Journal Club and has been released early.
The results are largely based on improved survival in patients less than age 65, said Journal Club reviewer Alastair J. Munro, professor of surgical oncology at the University of Dundee in Scotland. He noted that radical prostatectomy was no better than watchful waiting in men older than 65.
The age of the study limits its applicability to modern practice, Dr. Munro said. Ad hoc screening and stage migration have changed clinical practice since the study was designed almost 20 years ago.
The study was biased in favor of prostatectomy, he added, because patients in the watchful waiting group who developed local progression were not offered any treatment until 2003. The study did not include radiotherapy, either external beam or brachytherapy, both of which are effective in early prostate cancer. In addition, researchers must consider quality of life issues and patient preferences because 90% of patients may be at risk for harm without benefit.
Dr. Munro concluded that physicians should be cautious about applying the results to current practice as the options for care have improved.
Peer ratings for this article: 7/7 stars by all specialty groups.
ACP Journal Club is online.
Health information technology
The HHS last week awarded three multimillion-dollar contracts to public-private partnerships charged with laying the foundation of a national electronic health record (EHR) system over the next decade.
As part of their contracts, the groups will report to the American Health Information Community, a new federal advisory committee. That committee will then make recommendations to the HHS on computerizing health records and ensuring that information is interoperable and can be shared across networks.
The following three contracts were awarded:
American National Standards Institute (ANSI), a nonprofit, received $3.3 million to convene a health information technology standards panel, which will bring together standards development organizations to develop widely accepted health information technology standards supporting interoperability among EHRs. ACP had previously sent a letter to HHS recommending that ANSI receive the standards contract and has agreed to formally participate in the program.
The Certification Commission for Health Information Technology (CCHIT), a private nonprofit, received $2.7 million to develop criteria for certifying EHRs and associated infrastructure. CCHIT will submit recommendations for ambulatory EHR certification criteria—such as standards for sharing health information and clinical features for improving outcomes—in December 2005. John Tooker, FACP, the College's EVP/CEO, serves as a commissioner of CCHIT.
The Health Information Security and Privacy Collaboration (HISPC), a new partnership made up of security experts and the National Governors’ Association, will work with states to address business policies and state laws that affect privacy and security and that may conflict with creating an interoperable health information network. RTI International, a private nonprofit corporation, will oversee the $11.7 million contract.
An HHS news release is online.
The College has sent the CMS its comments regarding the agency’s proposed rule on 2006 payment policy revisions in the Medicare program.
In a Sept. 30 letter to CMS Administrator Mark McClellan, FACP, the College said it supports many of the CMS’ proposals, including the agency’s proposed use of the “bottom-up” method to determine direct practice expense costs, which would identify and factor direct practice expenses including clinical labor and supplies. That methodology, the letter said, assumes the same cost for any given service, regardless of specialty-specific factors.
The letter also, however, repeated ACP's position that the sustainable growth formula should be replaced with a system linked to changes in the actual costs of medical practice, and that CMS should do its part to fix the formula by removing physician-administered drugs from the SGR (see next ObserverWeekly item). The letter also addressed other proposed changes:
Submission of supplemental survey data. The College supports using current, reliable physician practice costs data. It recommends that the CMS recruit stakeholders to establish a process to update practice expense costs from all specialties. ACP also supports the CMS' proposal to transition in the resulting practice expense relative value units over a four-year period.
Medical nutrition therapy. The College supports the agency’s proposal to add such therapy to the list of Medicare-covered telehealth services. However, the College wants clarification that Medicare will pay a physician practice for this therapy when it is provided through "interactive telecommunications systems" by qualified personnel. The College said the CMS should revise its definition of these systems to include two-way radio and one-way telecommunication equipment.
Miscellaneous practice expense issues. The College asked the CMS to elaborate why practice expense RVUs for G codes related to plan oversight and home health certification and recertification were decreased.
The letter is online.
ACP is seeking help from two influential White House offices in its efforts to replace the sustainable growth rate (SGR) formula with a physician payment methodology tied to the actual costs of medical care.
Until the formula is replaced, ACP would like to see the SGR changed to make physician pay more equitable. In letters to top officials at the Office of Management and Budget and the National Economic Council, the College asked them to support requiring the CMS to retroactively remove physician-administered drugs from the SGR formula calculation. The College made similar requests in 2002 and 2004.
Because the costs of physician-administered drugs have risen rapidly over the past several years, inclusion of such drugs in the SGR is a major reason why overall expenditures on services measured by the SGR have risen faster than the economy, resulting in projected across-the-board cuts in payments to physicians. Removing the drugs would lower cuts to physicians and make it less expensive for Congress to repeal the SGR, as ACP has long recommended.
In the Sept. 30 letters, Robert B. Doherty, the College’s Senior Vice President for Governmental Affairs and Public Policy, said the College is aware that such a move would increase Medicare “baseline” spending attributable to the administration and Part B beneficiary premiums.
He pointed out, however, that costs associated with the new Medicare Part D prescription drug program that takes effect Jan. 1 are expected to be less than previously estimated. These savings would positively affect baseline projections when Parts B and D are considered jointly. Mr. Doherty said the College supports the use of baseline Part D savings to fund the requested change.
The letter also pointed out that unless Congress takes action, many physicians, especially those in small practices who treat the majority of Medicare patients, may not be able to afford to stay in practice or deliver the same level of patient care. If Congress does not change the formula, physicians face a 26% income reduction between 2006 and 2011.
The letter is online.
The Chair of ACP's Board of Regents told a Senate special committee on aging last month that Congress should strengthen FDA guidelines on direct-to-consumer (DTC) pharmaceutical advertising.
In her Sept. 29 testimony, Donna E. Sweet, FACP, said ACP has long opposed such advertising. She asked that FDA regulations be tightened to make drug advertising as “honest and useful as possible” and told legislators that marketing should be directed at clinicians, not consumers who can misinterpret the information.
She also said that Capitol Hill must continue to fund studies to define and measure the impact of DTC advertising. According to Dr. Sweet, ACP members say that more patients are giving them lists of drugs they want to try, many of which are not appropriate.
Physicians must then spend time explaining why other medications might be more beneficial. “When a physician withholds something a patient wants, patients often mistrust the physician," Dr. Sweet told senators. "The result is a subtle but chronic adversarial element in the doctor-patient relationship.”
She also cited FDA study data showing that 75% of physicians asked believe that DTC advertising leads patients to overestimate drugs’ medical value and that 38% say ads cause patients to question physicians' diagnoses.
The testimony is online.
ACP newest patient education video, "Guide to a Healthy Heart for Latinos," is appearing on several local television stations over the next month.
Featuring celebrities Rita Moreno and Esai Morales, the 30-minute educational program is designed to show patients how to take care of their "heart health." Viewers will learn how to manage their blood pressure, cholesterol and weight. They'll also get tips on healthy eating, active living, the importance of smoking cessation and the role of diabetes in heart disease. Throughout the program, viewers are urged to work with their internist to help manage their heart disease risk.
The program will air in the following cities:
New York: WNJU (Telemundo), Ch. 47. Oct. 15, 9:30 a.m. Spanish-language program.
Miami: WTVJ (NBC), Ch. 6. Oct. 16, 12:30 p.m. English-language program.
Los Angeles: KWHY (Telemundo), Ch. 22. Oct. 16, 3:30 p.m. Spanish-language program.
San Antonio: KENS (CBS), Ch. 5. Oct. 22,1:30 p.m. English-language program.
Chicago: WSNS (Telemundo), Ch. 44. Oct. 30, 8:30 a.m. Spanish-language program.
The video program is also available in DVD format at no charge to members. The DVD offers viewers the choice of viewing the program with either an English or Spanish language soundtrack.
To order, please contact ACP Customer Service at 800-523-1546, ext. 2600 (product #700450010) or order on ACP Online. (Shipping and handling fees apply.)
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Copyright 2005 by the American College of Physicians.
A 52-year-old man is evaluated for low back pain of 3 months' duration that is nonradiating, progressive, and worse with ambulation. He reports no preceding injury. Medical history is notable for smoldering multiple myeloma diagnosed 1 year ago; he has been stable since that time. His only medication is as-needed acetaminophen. Following a physical exam and lab results, what is the most appropriate management?
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