In the News for the Week of 5-1-07
- Physician-industry relationships the norm, survey reports
- Wal-Mart to open more in-store clinics
- Care for disabled needs improvement, IOM says
- Annals of Internal Medicine:
- Necrosis factor drug doesn’t help two inflammatory diseases
- Antidepressants not effective for bipolar depression, study finds
HIV treatment update
- Unapproved drug maker to stop distribution
- First generic versions of Ambien approved for insomnia
- Recall issued on CPAP devices
Most physicians who responded to a recent survey on industry ties reported having some kind of relationship with pharmaceutical, medical-device or other medically related companies.
The survey polled 3,167 physicians in six specialties (internal medicine, anesthesiology, cardiology, family practice, general surgery and pediatrics) during 2003-04. Most respondents (94%) reported having some type of relationship with industry, mostly involving food or drug samples. More than one-third received reimbursements for meetings or CME, while 28% were paid for consulting, lecturing or conducting clinical trials. The results appear in the April 26 New England Journal of Medicine.
The survey, conducted by researchers at the Institute for Health Policy, Massachusetts General Hospital–Partners Health Care System and Harvard Medical School, also found that family practitioners met more often with industry reps than other specialists, while cardiologists were most likely to receive payments. Physicians in solo or small practices reported having more contact with industry reps than physicians in hospitals and clinics.
Family practitioners reported the highest number of meetings with industry representatives, with an average of 16 per month, followed by internists with an average of 10 per month. Women were less likely than men to receive payments related to consulting, lecturing or clinical trials.
Researchers suggested several possible reasons for the variations among specialties:
- Industry focuses its marketing efforts on cardiologists and other specialists (such as those who help develop clinical guidelines or train residents) who are perceived as influencing other physicians' prescribing patterns;
- Physicians in small practices have more control over what they prescribe than doctors in hospitals and clinics, which often use formularies;
- Hospitals and clinics are more likely than smaller practices to have policies limiting industry relationships; and
- Hospitals and clinics are more likely to provide educational programs and products, making physicians there less dependent upon drug reps as sources of information.
The New England Journal of Medicine article is online.
Wal-Mart Stores announced plans last week to open as many as 400 new in-store health clinics in the next two to three years. Within the next seven years, the retailer hopes to have 2,000 clinics in stores, according to company officials.
The new clinics represent a major expansion of a pilot project begun in September 2005. Currently, 76 clinics are operating in Wal-Mart stores in 12 states. Wal-Mart leases the space within stores to clinic operators. Company officials said the new walk-in clinics will be managed by local hospitals or other organizations, according to the April 26 Washington Post.
The providers will decide what services to offer and will usually focus on preventive and routine care, including services like allergy and sinus infection treatment, cholesterol screenings and school physicals. The clinics will be staffed by certified nurse practitioners or physicians.
Wal-Mart officials said that the clinics are intended to provide customers with affordable, local access to health care. Surveys of existing in-store clinics have reported that more than half of clinic patients said they are uninsured and more than 15% would otherwise have gone to an emergency room for care, according to Wal-Mart officials.
The Washington Post is online.
The Wal-Mart press release is online.
The U.S. health care system is insufficiently prepared to handle the projected rapid growth in the number of disabled Americans over the next 30 years, according to a new report from the Institute of Medicine. More than 40 million Americans currently have some sort of disability.
In addition to the aging baby boomer population, declines in physical activity and increases in obesity and diabetes will contribute to the predicted growth of the disabled population, the report found. In the April 24 Washington Post, IOM officials said that far too little progress has been made over the past two decades in public policy and practice advances to reduce disability.
The report did note some recent progress, including the growth of electronic technologies that allow people to interact with their environments and advances in public health and medicine which have contributed to reduced incidences of certain injuries, developmental disorders and other disabling health conditions.
In the report, the IOM outlined a number of suggested changes, including:
- Increasing funding for research on disability,
- Strengthening the Americans with Disabilities Act to ensure health care facilities are accessible to the disabled,
- Eliminating the two-year Medicare waiting period for Social Security Disability recipients,
- Modifying Medicare’s in-home-use requirement for durable medical equipment,
- Promoting the medical home and chronic care models of care, including changes in Medicaid and the State Children's Health Insurance Program, and
- Developing evidence reviews to be used in designing clinical practice and consumer guidelines.
The Washington Post is online.
The IOM report is online.
The following article appears in the May 1, 2007 issue of Annals of Internal Medicine. The full text is available to College members and subscribers online.
Anti-tumor necrosis factor drug doesn’t help inflammatory diseases. Two studies in this issue of Annals of Internal Medicine find that infliximab, a widely used anti-tumor necrosis drug, has no benefit in patients receiving standard corticosteroid treatment for giant-cell arteritis (GCA) or polymyalgia rheumatica (PMR). The diseases, common overlapping inflammatory rheumatic diseases of unknown origin, are usually treated with steroids, which can have serious side effects if used for long periods at high doses.
In one study, 44 patients being treated with steroids for newly diagnosed GCA were assigned to receive either infliximab or placebo. All patients followed a schedule to gradually reduce the steroid dose. The study, planned to last 54 weeks, was stopped at 22 weeks because it became clear that infliximab did not prevent relapse of symptoms or reduce the amount of steroids needed to decrease the symptoms.
In another study, 51 patients being treated with corticosteroids for newly diagnosed PMR were assigned to receive either infliximab or placebo. At the end of the 22-week study, infliximab had not prevented relapse of symptoms or reduced the dose of steroids.
GCA and PMR remain “therapeutic challenges,” said an accompanying editorial. For now, steroids remain the standard treatment.
Adding antidepressants to mood stabilizers does not improve symptoms of depression in patients with bipolar disorder, according to a study in the April 26 New England Journal of Medicine.
In the study, patients with bipolar disorder were randomly assigned to receive either mood stabilizer plus antidepressant (179 patients) or mood stabilizer and placebo (187 patients) over 26 weeks. The rates of treatment-emergent mania or hypomania were similar for both groups, suggesting that the addition of antidepressants (bupropion or paroxetine) does not increase the risk of cycling from depression to mania.
The findings are surprising since it had been widely thought that antidepressants effective in treating unipolar major depression would be effective for bipolar depression as well, said an accompanying editorial. However, two factors may have skewed results: Enrollment was relatively low, and the study does not address whether antidepressants cause mania in the absence of a mood stabilizer.
The study is part of the larger Systematic Treatment Enhancement Program for Bipolar Disorder, which is funded by the National Institute of Mental Health. The program includes 4,360 patients, 2,689 of whom have experienced major depression. Many of those patients with a history of mania or a manic response to antidepressants may have excluded themselves from the smaller study, noted the editorial, out of fear that antidepressant treatment would induce mania.
The study may lead to less use of antidepressant therapy, but treatment should remain individualized for bipolar patients, continued the editorial. Physicians should continue to be vigilant about checking for a history of mania before starting antidepressants for depression and should base treatment decisions on a patient's past response to treatment and clinical history.
The New England Journal of Medicine abstract is online.
HIV treatment update
The use of antiretroviral therapy may increase HIV-infected patients’ risk of myocardial infarction, according to a new study. Researchers found that protease inhibitors, in particular, can raise cardiovascular risk.
In the prospective observational trial of 23,437 HIV-positive patients in 21 countries, 345 subjects had a myocardial infarction over the median follow-up period of 4.5 years. After adjusting for cardiovascular risk factors (excluding lipids), researchers found that patients taking protease inhibitors had a 16% increased risk of MI per year. Patients on nonnucleoside reverse-transcriptase inhibitors had a 5% increased risk per year.
Controlling for lipid levels, hypertension and diabetes mellitus reduced the relative risk for protease inhibitors to 10% and that for nonnucleoside reverse-transcriptase inhibitors to 0. The study was published in the April 26 New England Journal of Medicine.
Although the study concluded that protease inhibitors increase the risk of MI, it is important to note that the magnitude of increased risk is not high, especially as compared with other risk factors such as increasing age, male sex, and smoking, noted an accompanying editorial. The study’s findings do not indicate an epidemic on the horizon, just a risk factor that needs to be managed, said the editorial writer, who also suggested that perhaps more effort should be spent assisting patients with smoking cessation and the prevention of diabetes.
A government advisory panel voted unanimously last week to approve a new drug to treat HIV-infected patients. The drug, maraviroc, would be the first to block a pathway that HIV uses to infect cells, instead of targeting the virus directly.
Maraviroc is part of a new class of drugs called CCR5 receptor agonists, and would be the first novel oral HIV medicine to hit the market in more than a decade. Pfizer Inc. manufactures the drug and plans to sell it under the brand name Celsentri, if it is approved by the FDA. The Wall Street Journal reported that the agency will complete its evaluation by the end of June, and that the drug was granted priority review status, which reduces the time the agency takes to consider a new medicine.
The panel of FDA advisers did recommend additional research into the drug’s interaction with other drugs and its effects on women and minorities, according to the April 26 Washington Post. Studies reviewed by the panel showed that, when combined with traditional treatments, maraviroc drops HIV levels below the detectable range better than traditional treatment alone.
The FDA had previously expressed concern that the new class of drugs could increase the risk of infection, lymphoma or liver damage, the Washington Post said. The panel found a modest increase in liver problems and no increase in lymphomas or infections in patients on maraviroc. The new drug, and others in its class, could also accelerate a shift from one variant of HIV to another, and patients taking maraviroc would have to be monitored for this complication.
Pfizer reported on its Web site that there were no significant increases in hepatotoxicity, malignancy or mortality in maraviroc’s treatment arms, while there were slight increases in upper respiratory and herpes simplex virus infections as well as ischemic events, consistent with the rate observed in treatment-experienced HIV and AIDS patients.
The Washington Post is online.
Pfizer's release is online.
PharmaFab Inc., and a subsidiary, PFab LP, will halt the illegal manufacture and distribution of prescription and over-the-counter drug products not produced according to the required current good manufacturing practice guidelines. Many of these products also lack FDA approval.
PharmaFab makes more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.
The unapproved drugs manufactured by PharmaFab include, but are not limited to:
- De-Congestine Sustained Release Capsules,
- GFN 1200/DM 60/PSE 60 Extended-Release Tablets,
- Rhinacon A Tablets,
- Sudal 12 Chewable Tablets,
- Histex PD 12 Suspension,
- Atuss HX CIII,
- Ergotrate Tablets, and
- Hyoscyamine Sulfate Time-Release Capsules.
PharmaFab did not comply with good manufacturing practices by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures, the FDA stated in a release. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products.
A consent decree requires PharmaFab to:
- destroy certain illegal drugs,
- stop distributing all drugs until they obtain required FDA approval and fully comply with good manufacturing practices,
- retain an auditor to conduct inspections of their facilities for a period of five years and provide reports to the FDA analyzing compliance with good manufacturing and labeling requirements before resuming distribution, and
- allow the FDA to require recall or shutdown in the event of future violations.
The FDA release is online.
The FDA approved the first generic versions of zolpidem tartrate (Ambien) immediate-release tablets, a sedative-hypnotic drug indicated for the short-term treatment of insomnia.
Zolpidem tartrate tablets in formulations of five and 10 mg are manufactured by 13 drug makers with FDA approval, the agency stated in a press release. According to the online magazine Drug Topics, in 2006, Ambien was the 13th highest-selling brand-name drug. The patent for zolpidem tartrate expired on April 21.
In March, the FDA requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving--driving while not fully awake with no memory of the event. Generic versions of these drugs will also include this labeling.
The FDA release is online.
FDA news about sleep-driving is online.
The FDA issued a recall for about 300,000 continuous positive air pressure (CPAP) devices used for the treatment of obstructive sleep apnea. There is a remote potential for a short circuit in the power supply connector in ResMed S8 devices manufactured between July 2004 and May 15, 2006.
Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should stop using the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients using supplemental oxygen should immediately contact their home health care provider for a replacement.
ResMed voluntarily recalled the product after learning that in 0.2% of instances a component supplied by a third party caused the devices to fail. In seven cases worldwide, device failures have led to thermal damage to the device, with a remote potential to start fires. No significant property damage or patient injury has been reported.
Affected products can be identified by the serial numbers on the bottom of each device. A list is online.
Patients will be contacted as soon as possible to arrange for a replacement device and are encouraged to visit ResMed’s Web site for more information. Patients in the U.S. and Canada may also contact the ResMed S8 Replacement Call Center at (888) 899-8991.
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