In the News for the Week of 4-12-05
Clinical news in the headlines
- CDC: Order flu vaccine early for high-risk groups
- College comments on proposed Medicare e-prescribing rule
Pfizer Inc. last week suspended all U.S. sales and marketing of its arthritis drug valdecoxib (Bextra after the FDA asked the company to withdraw the drug from the market. The FDA also asked Pfizer to add a warning to the label of celecoxib (Celebrex) about potential cardiovascular risks.
And the FDA urged all other makers of COX-2 inhibitors, part of the non-steroidal anti-inflammatory class of drugs (NSAIDs), to include warnings about increased potential for cardiovascular events and gastrointestinal bleeding, according to an April 7 FDA news release. Makers of over-the-counter NSAIDs were also asked to add more specific information about risks to their labels.
Pfizer agreed to the halt, pending further discussions with the FDA, according to the April 7 Modern Physician.
The FDA determined that the overall risks were greater than the benefits of valdecoxib due to inadequate data on long-term cardiovascular safety and increased risks of adverse events in short-term coronary artery bypass surgery trials, according to an accompanying FDA question-and-answer sheet. That Q&A sheet also noted that valdecoxib has been associated with potentially fatal skin reactions and that the drug has not proven superior to other NSAIDs. Pfizer agreed to suspend sales pending further discussions with the FDA.
In the case of celecoxib, the agency concluded that the benefits outweighed the potential risks, but that patients should be adequately informed of risks via the warning label and discussions with their physicians, according to the FDA Q&A sheet. In addition, physicians should try to use the lowest effective doses for the shortest possible time.
The FDA's action follows last fall's worldwide withdrawal of rofecoxib (Vioxx) by Merck. The FDA said it still plans to review proposals by Merck to resume marketing of rofecoxib.
The FDA news release is online.
The accompanying questions and answers are online.
Modern Physician is online.
The FDA recently approved a new pill for osteoporosis that can be taken once a month, the first such drug approved for a chronic disease.
Ibandronate sodium (Boniva), a bisphosphonate that helps build bone density, is already available in daily doses, according to the March 28 WebMD. Other biphosphonates such as risedronate (Actonel) and alendronate (Fosamax) are available only in daily and weekly doses.
The FDA approved the 150 mg monthly pill based on clinical trials involving about 1,600 postmenopausal women with osteoporosis, said WebMD. The trials demonstrated that the pill was as effective as daily medication after a year of treatment.
Side effects of the monthly pill include stomach disorders and ulcers, and the pill should not be taken by patients with high calcium levels or sensitivity to biphosphonates, said WebMD. The article added that nearly 50 million mostly postmenopausal women are affected by or at risk for osteoporosis.
WebMD is online.
Clinical news in the headlines
Two recent reviews that focused on corticosteroid therapy concluded that a relatively longer course of low-dose corticosteroid therapy improved survival of patients with severe sepsis and septic shock.
One review found that high-dose corticosteroid therapy does not improve survival and may cause harm through secondary infections. Both reviews concluded that a five- to 11-day course of low-dose corticosteroids improved ICU discharge, hospital discharge and survival at 28 days in patients with vasopressor-dependent septic shock. The reviews are abstracted in the March-April ACP Journal Club.
The two reviews highlight differences in trials conducted before 1989--which tended to use higher daily doses over longer periods and higher steroid doses--vs. more recent trials that looked at longer courses of lower-dose therapy, an ACP Journal Club reviewer said. Control group mortality rates were higher in the more recent trials, which focused on vasopressor-dependent septic shock. The divergent results between early vs. later trials, said the reviewer, appear to be connected to differences in daily dose and therapy duration.
The studies do not resolve the issue of whether to use adrenal testing in selecting patients for corticosteroid therapy, the reviewer noted. However, the findings do not justify withholding corticosteroid therapy while waiting for the results of adrenal function tests. A commonly accepted alternative is to test and treat all patients with vasopressor-dependent septic shock and to wean those patients off steroids whose results rule out adrenal insufficiency.
Cognitive therapy worked as well as antidepressants and was more effective in preventing relapses, according to the results of a recent study.
In the trial, 240 patients treated at the University of Pennsylvania in Philadelphia and Vanderbilt University in Nashville received either antidepressants (up to 50 mg daily of paroxetine), cognitive therapy or placebo over a 16-week period. After eight weeks, response rates were 50% for the medication group and 43% for the therapy group, compared with 25% for placebo.
Response rates for the active treatment groups were about the same after 16 weeks, but patients in the therapy group had a lower remission rate two years after treatment: 40% vs. 46% for the group taking medication.
The results, which appear in the April issue of Archives of General Psychiatry, challenge current guidelines set by the American Psychiatric Association recommending antidepressants as first-line treatment, according to an April 4 University of Pennsylvania news release. According to the authors, the results indicate that therapy can be as effective as drugs even in severely depressed patients.
The authors also noted differences in outcomes between the two sites: Vanderbilt patients did better on antidepressants while patients at University of Pennsylvania fared better in cognitive therapy. The authors attributed the difference to a higher number of patients at Vanderbilt with anxiety symptoms, which paroxetine treats, and to more experienced therapists at the University of Pennsylvania.
Cognitive therapy may have more lasting effects than medication because it helps teach patients the skills needed to deal with depression, whereas the effects of drugs may diminish over time, according to the University of Pennsylvania news release. However, the authors noted, the success of cognitive therapy is highly dependent upon the expertise of the therapist.
The Archives of General Psychiatry abstract is online.
The University of Pennsylvania news release is online.
The CDC recently advised physicians to use a two-step process in ordering vaccine for the 2005-06 influenza season to ensure that high-risk groups are immunized in the event of another shortage.
Customers who use inactivated vaccine should place their initial order based on anticipated demand among priority groups, the CDC reported in the April 1 Morbidity and Mortality Weekly Report (MMWR). A second order could include the estimated number of doses needed to vaccinate non-priority groups, which would be shipped if supplies are sufficient.
Seeking to avoid a repeat of the 2004-05 shortage, which was due to the failure of Chiron Corp. to deliver its vaccine, the CDC also urged manufacturers to take a phased approach to distribution. Companies should send partial shipments early in the season to accommodate high-risk groups, such as seniors and those with chronic diseases, according to the MMWR, and ship the remaining orders later if supplies are adequate.
Two vaccine manufacturers—Sanofi Pasteur and MedImmune—are expected to provide a total of at least 61 million doses of vaccine next season, about the same amount as last season, the MMWR said, enough to meet historical demand from priority groups. Chiron Corp., which had its license suspension lifted by the British government, may supply additional doses next season, pending FDA approval of its vaccine, the CDC said. Other manufacturers are also in talks with the FDA regarding possible vaccine licensure.
Sanofi Pasteur has begun taking orders for Fluzone vaccine via its Web site or by phone (800-822-2463), according to a March 2005 letter to providers. Customers should make two requests: a total vaccine request and a priority group request, the company said. Only one request will be shipped based on the CDC's announcement of whether there will be enough vaccine to treat non-priority groups.
The MMWR is online.
Sanofi Pasteur's pre-booking letter is online.
ACP has submitted comments to the CMS on the agency's proposed rule on e-prescribing and the prescription drug program. While the College said it supports the CMS' suggested implementation of specific foundation standards for e-prescribing, it also issued several recommendations.
Those recommendations were included in an April 1 letter send to CMS administrator, Mark McClellan, FACP. Among the recommendations the College made were the following:
The CMS should ensure that planned formulary representation and medication-history standards it adopts can successfully interact with the foundation e-prescribing standards. ACP said that evidence for successful interaction is now lacking and that pilot programs are needed to ensure the standards' usefulness.
ACP recommends that the CMS expedite the development, pilot testing and implementation of a common e-prescribing dictionary and structure that will adequately capture prescriber intent when bridging disparate drug databases.
The College urged the CMS to broadly interpret the language included in 2004 Medicare reform legislation that would preempt state law regarding e-prescribing. There are wide disparities among states regarding electronic prescription transmissions, the letter stated, which cause unnecessary costs and complexity and prohibit the implementation and development of a functional national e-prescribing system.
ACP also said it strongly supports the use of a national provider identifier (NPI) for all pharmacists and physicians who participate in the prescription program under Medicare Part D. While the proposed rule does not address the use of a unique patient identifier, ACP said that CMS should consider including such language to safeguard patient safety benefit and ensure more accurate e-prescribing.
The letter is online.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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