The debates over the Obama Administration’s health care reform law, and, more recently, the federal budget deficit and national debt have focused attention on the growth in costs of the Medicare program. Three approaches to reducing Medicare expenditures command the most attention. Under the first, changes to the Medicare delivery system – such as accountable care organizations (ACOs) and medical homes – are believed to have the potential to reduce the growth in costs in the program over time. Under the second, tinkering with the reimbursement formulae in the Medicare program – pejoratively, government “price fixing” – will reduce the price that Medicare pays for an item or service, thereby reducing the growth in costs. A third approach – converting Medicare to a premium support or defined contribution model – has been passed by the House of Representatives, but has failed in the United States Senate.
This article addresses the effect of these various approaches on Medicare payment for outpatient prescription drugs and biotechnology products. It begins by analyzing the Administration’s ACO regulation and the effect that this regulation may have on reimbursement for outpatient prescription drugs and biotechnology products. It then addresses legislative proposals to alter the Medicare reimbursement formulae for these products. It concludes by speculating on how the Medicare reform legislation passed by the House of Representatives might affect reimbursement for outpatient prescription drugs and biotechnology products. Full details at the Journal of Commercial Biotechnology
Cancer is a complex disease with a network of multiple metabolic pathways that are interlinked to promote growth and resist immune surveillance. Such a network is efficiently maintained through acquisition of multiple mutations in the human genome that result in the escape from normal cellular growth regulation and formation of lumps of fast growing cells known as tumors. The varied pathways through which cancer cells grow and inhibit their own cell death have made it difficult to develop effective drugs either to prevent the emergence of tumors or to check their rapid growth. Current anticancer drugs are either small molecules or monoclonal antibodies that target and inhibit a key important step in cancer progression pathway, thereby significantly inhibiting their proliferation. No effective drug or vaccine exists to prevent cancer initiation and drug resistance and toxicity are major problems in cancer chemotherapy. This article describes recent attempts to develop bacterial proteins that are used as weapons by certain pathogenic bacteria with long term residence in human bodies to prevent invasion of their habitat by invaders such as cancers, viruses or parasites. In one instance, such a protein, termed azurin, has been shown not only to have entry specificity in cancer cells and prevent cancer cell growth by interfering in multiple pathways by which cancer cells grow, but also to prevent induction of pre-cancerous lesion formation triggered by a potent carcinogen. A 28 amino acid peptide derived from azurin, p28, also shows similar anticancer and cancer preventive activity. In phase I human clinical trials, chemically-synthesized p28 has shown very little toxicity but significant beneficial effects, including partial and sometimes complete regression of metastatic refractory solid tumors in 15 advanced stage (stage IV) cancer patients where no conventional drugs were working. A second such protein, termed ATP-01, very different from azurin and obtained from a different bacterium, has shown similar anticancer and anti-HIV/AIDS activity and a 30 amino acid peptide derived from it has anticancer activity similar to p28. It would be of great interest to test these two proteins, should they prove to be non-toxic and non-immunogenic in humans, and the peptides derived from them, for their efficacy in cancer therapy and prevention. Such efficacies can be tested, singly or in combination, in vulnerable people such as people with predisposition to cancer (women with BRCA1/2 mutations, for example) or in HIV/AIDS patients with Kaposi’s sarcoma or other forms of cancer. Full details at the Journal of Commercial Biotechnology