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Sites Continue To Expand Their Capabilities With Digisonics
HeartCare Cardiovascular Specialists in Libertyville, IL has expanded their CVIS capabilities with a new DigiNet Pro system. This system will provide the site with web access enabling users to have full CVIS capability from anywhere at anytime.
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Study Shows Decreased Risk Of Death From Opportunistic Infections With Earlier Antiretroviral Treatment
HIV-positive people with opportunistic infections who receive earlier antiretroviral treatment lower their risk of death compared with people who delay treatment, according to a new study conducted by the Stanford University School of Medicine and published in PLoS One, the San Jose Mercury News reports. The findings could lead to changes in recommendations for antiretroviral treatment protocol, specifically for patients diagnosed with HIV at an advanced stage, the Mercury News reports. The study included 262 HIV-positive participants at 39 health care sites across the U.S., and 20 participants in South Africa. During the yearlong study, the researchers found that among the participants who were treated promptly after developing an opportunistic infection, 14% died or developed another infection. The researchers also found that 24% of participants who deferred treatment for an average of 45 days died or had a decrease in health outcomes. According to the Mercury News, the question of when to start HIV-positive people on antiretroviral treatment remains unclear because of issues such as the high cost of medicines, side effects, and drug interactions or resistance. Andrew Zolopa, head of Stanford University School of Medicine"s division of infectious diseases and lead investigator of the study, said that physicians often treat HIV-positive people for an "acute crisis, then follow up later with treatment for HIV." He continues, "But that answer is wrong. The study shows very clearly that there is no safety downside to doing this -- and the benefit is quite substantial, reducing death by 50%." "Even in San Francisco, one of the first epicenters of HIV in the United States, we still find that many people present late in the course of their illness with an opportunistic infection," Mitch Katz, director of San Francisco"s Department of Health who was not involved in the study, said. He added, "This study shows that it is lifesaving to treat those persons with antiretroviral drugs while they are still in the hospital." Katz said that the results could lead to changes in HIV/AIDS practices worldwide. The International AIDS Society, CDC and the British AIDS Society have developed guidelines recommending that early antiretroviral treatment be considered in patients with opportunistic infections, Zolopa said. In addition, NIH is considering an international study to examine earlier initiation of antiretroviral treatment involving more than 9,000 people from both developed and developing countries (Krieger, San Jose Mercury News, 5/15).
News of the day
Suburban Research Associates On The Forefront Of Clinical Research And Patient Care For Major Depressive Disorder
With appointment waiting periods stretching as long as three-months to see a psychiatrist, Delaware County patients often don"t know where to turn for "best in class" mental health services. This barrier to care is further compounded by the fact that 67 percent of primary care physicians nationwide have trouble accessing mental health services on behalf of their patients.
Endocrinology

FDA Approves Opioid Pain Reliever With Required Risk Reduction Plan

The U.S. Food and Drug Administration approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain - severe flares of pain that break through regular pain medication. Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth"s mucous membranes. Onsolis delivers fentanyl via an absorbable film that sticks to the inside of the cheek. The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use. Because fentanyl is subject to abuse and misuse, Onsolis was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which is a required plan for managing risks associated with a drug or biological product. "Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death," said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA"s Center for Drug Evaluation and Research (CDER). "For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications." The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require that drugs and biological products have a REMS to ensure that the benefits of a drug or biological product outweigh its risks. As part of the REMS, Onsolis will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients" homes. Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products. In February, the FDA announced that it would require a REMS for a different class of opioids that offer long-acting and extended-release medication. The FDA has held a series of meetings with stakeholders, including a large public meeting, and also solicited written public comments to hear more about how to develop this REMS. "The REMS for Onsolis was specifically tailored to that drug and should not be viewed as a model REMS for long-acting and extended-release opioid products," said Douglas Throckmorton, M.D., deputy director of CDER. "Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection." Onsolis is manufactured by Aveva Drug Delivery Systems, Miramar, Fla., and marketed under license from BioDelivery Sciences International Inc. of Raleigh, N.C., by Meda Pharmaceuticals Inc., based in Somerset, N.J. For more information see here. U.S. Food and Drug Administration


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