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Body fat than to lean body mass.96, 98 Encouraging advances in the antiviral treatment of HIV infection and developments in the prophylaxis of and therapy for opportunistic infections have recently changed the outlook for the long-term health of HIV-infected people. Death rates have been halved, and the frequency of serious complications, including malnutrition, has fallen markedly.94, 133 Future Therapy The primary focus of future therapies for wasting in HIV-infected patients is to increase lean body mass as well as appetite. Active systemic infections are associated with profound anorexia, which is believed to be mediated by cytokines that stimulate inflammation through their actions in and outside the brain.132 Cytokine inhibitors, such as thalidomide, have been under investigation as potential treatments to increase lean body mass and reduce malnutrition. Even though cannabinoids do not appear to restore lean body mass, they might be useful as adjunctive therapy. For example, cannabinoids could be used as appetite stimulants, in patients with diminished appetite who are undergoing resistance exercises or anabolic therapy to increase lean body mass. They could also be beneficial for a variety of effects, such as increased appetite, while reducing the nausea and vomiting caused by protease inhibitors and the pain and anxiety associated with AIDS. Considering current knowledge about malnutrition in HIV infection, cannabinoids, by themselves, will probably not constitute primary therapy for this condition but might be useful in combination with other therapies, such as anabolic agents. Specifically, the proposed mechanism of action of increasing food intake would most likely be ineffective in promoting an increase in skeletal muscle mass and functional capacity--the goal in the treatment of cachexia in AIDS patients. Malnutrition in Cancer Patients Malnutrition compromises the quality of life of many cancer patients and contributes to the progression of their disease. About 30% of Americans will develop cancer in their lifetimes, and two-thirds of those who get cancer will die as a result of it.5 Depending on the type of cancer, 50?80% of patients will develop cachexia and up to 50% of them will die, in part, as a result of cachexia.11, 40 The cachexia appears to result from the tumor itself, and cytokines proteins secreted by the host during an immune response to tumor ; are probably important factors in this development. Cachexia does not occur in all cancer patients, but generally occurs in the late stages of advanced cancer of the pancreas, lung, and prostate. The only cannabinoid evaluated for treating cachexia in cancer patients is dronabinol, which has been shown to improve appetite and promote weight gain.54 Present treatments for cancer cachexia are similar to that for cachexia in AIDS patients. These treatments are usually indicated in late stages of advanced disease and include megestrol acetate and enteral and parenteral nutrition. Megestrol acetate stimulates appetite and promotes weight gain in cancer patients, although the gain is mostly in fat mass reviewed by Bruera 199814 ; . Both megestrol acetate and dronabinol have dose-related side effects that can be troublesome for patients: megestrol acetate can cause hyperglycemia and hypertension, and dronabinol can cause dizziness and lethargy. Cannabinoids have also been shown to modulate the immune system see chapter 2, "Cannabinoids and the Immune System" ; , and this could be contraindicated in some cancer patients both the chemotherapy and the cancer can be immunosuppressive ; . Future treatments will probably depend on the development of methods that block cytokine actions and the use of selective -adrenergic receptor agonists to increase muscle mass.14, 73 Treatments for cancer cachexia will also most likely need to identify individual patients' needs. Some patients might need only a cytokine inhibitor, whereas others could benefit from combined approaches, such as an appetite stimulant and -adrenergic receptor agonists. In this respect, such cannabinoids as THC might prove useful as part of a combination therapy as an appetite stimulant, antiemetic, analgesic, and anxiolytic, especially for patients in late stages of the disease. Anorexia Nervosa. 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These drugs mimic natural compounds vitally needed for cell division, acting specifically at the Synthesis phase of the cell cycle. Methotrexate imitates the compound folate, one of the B vitamins needed for a certain enzyme to function properly. Azathiaprine imitates a purine while cytarabine imitates a specific nucleoside, both fundamental building blocks of the DNA ladder. Basically, the biochemical machinery of the cell continues to operate, using these false-compounds, until the gears are jammed and division is halted.

Most antidepressants are ineffective and may actually be unsafe for children and adolescents, according to a study published in the April 24 edition of the British medical journal Lancet. With the widespread use of drugs like Prozac and Paxil to treat depression, government agencies and scientists have been studying whether children and adolescents who use certain antidepressants are more likely to have suicidal thoughts or behaviors. In the United States, the Food and Drug Administration is reviewing the issue but has yet to reach any conclusions. The Lancet study The British study is a "meta-analysis" -- the first comprehensive scientific review of both published studies and unpublished data that pharmaceutical companies have said they own and have the right to withhold. The British government allowed the scientists access to the unpublished, largely negative, data. The report concluded that young patients, aged 5-18, should not take four popular antidepressants -- Paxil, Zoloft, Effexo5 and Celexa -- because there was a clear risk of suicidal behavior among those taking the drugs and no benefit. The fifth drug studied -- Prozac -- was found to be effective for depressed children and did not have an elevated risk of suicide. The authors of the study said the unpublished research had a major impact on the report's findings. "In each of the published articles, the authors concluded the drug was either effective, safe or both, " said Tim Kendall, one of the authors of the study. "When you look at the combined evidence, it is ineffective, unsafe or both." The drug companies contend that their products are safe and deny they are risking the lives of younger patients in order to sell more prescriptions. "The use in children of our drug in particular, is a very, very, very small percentage of the overall total prescriptions of this product, " Mariann Caprino, spokeswoman for Pfizer Inc., which makes Zoloft, told The Washington Post. "To suggest that we are motivated by profiting off of children is ludicrous!

Page 32 reimbursement mechanisms. This would undermine the policy of allowing LTC pharmacies to bill out-of-network at the usual and customary rate to ensure that pharmacies are adequately paid to provide specialized services to LTC residents. Therefore, we propose amendments to the proposed regulations that include a new subsection 4: Section 423.782 a ; 4 ; Elimination of financial responsibility for the differential between the out-of-network pharmacy's usual and customary price and the PDP sponsor or MA organization's plan allowance as described in Sections 423.124 b ; 1 ; and b ; 2 ; . recognize that CMS intends to treat low-income beneficiaries differently than full benefit dual eligible beneficiaries, in that low-income beneficiaries will remain responsible for a reduced co-pay. While we recognize that difference, we believe that the low-income subsidy for even these beneficiaries should include payment of any cost differentials for prescription drugs. For that reason, we also propose the following amendment: Section 423.782 b ; : 4 ; Elimination of financial responsibility for the differential between the out-of-network pharmacy's usual and customary price and the PDP sponsor or MA organization's plan allowance as described in Section 423.124 b ; 2 ; . addition, and to make explicit that PD sponsors and MA plans must flow through those payments made to them by CMS pursuant to the low income subsidy program, we propose the following new subsection 7 ; to section 423.120 a ; , which clarifies that the PD sponsor or MA organization must provide any low-income subsidy funding through to the pharmacies. Section 423.120 a ; : 7 ; sponsor or MA organization is required to pay the pharmacy the full plan allowance, as well as amounts referenced in Section 423.782. In addition, if CMS chooses to retain the policy that enrollees are responsible for this differential payment, we encourage CMS to retain its position that it count as a beneficiary incurred cost under Section 423.100. Recommendations: The final rule should reflect that plans will be responsible for paying outof-network pharmacies the usual and customary price. CMS should clarify in its final rule that full benefit dual eligibles and other low-income beneficiaries residing in long term care facilities have no cost.

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Richard D. Paoletti, RPh, MBA Manager, Pharmacy Services Crozer-Chester Medical Center Upland, Pennsylvania.

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