The following stories appear in full on today's Vidyya Medical News Service Web site.
The Food and Drug Administration has alerted health care providers and patients to a potential safety concern involving an unapproved experimental product for HIV (human immunodeficiency virus, the AIDS virus)/AIDS. The sponsor of the product, Gary R. Davis, M.D., alleges that a batch of product has been stolen from a "storage facility" in Raleigh, N. C.
For more information: FDA News: Issues Safety Alert On Unapproved Goat Serum Treatment For HIV/AIDS
Bovine-derived materials have traditionally been used in the manufacture of many biological products, including vaccines. Bovine spongiform encephalopathy (BSE), so-called "mad-cow disease," was first recognized in the United Kingdom (UK) in the 1980s. The Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration (FDA) has been concerned about eliminating any potential for contamination of biological products with the BSE agent This concern was heightened by the appearance of the human transmissible spongiform encephalopathy known as variant Creutzfeldt-Jakob Disease (vCJD, also referred to as new-variant (CJD) in the UK in 1996; vCJD has been attributed, among other possibilities, to eating beef products from cattle infected with the agent of BSE. There is some fear, though slight, that vaccine products could be contaminated with the prion that causes BSE.
For more information: Recommendations For The Use Of Vaccines Manufactured With Bovine-Derived Materials
The FDA has requested that manufacturers of vaccines using bovine-derived materials obtained from countries on the USDA list replace these materials with materials from countries not on the USDA list, consistent with the recommendations of the FDA's joint Advisory Committees. The manufacturers have agreed to fully implement these changes. Indeed, several manufacturers have already initiated a number of these changes. The full list of questionable vaccines appears in today's Vidyya. Vidyya will watch for updates of the vaccine list and post an updated list as necessary. It is hoped that soon, there will be no vaccines on the list.
For more information: Current List Of Vaccines Using Bovine-Derived Materials From Countries On The USDA's BSE List
Scientists from the National Institute of Mental Health (NIMH) have used functional brain imaging to show how visual working memory may be affected by a class of drugs that is used with modest effectiveness to improve cognitive functioning in some patients with Alzheimer's Disease (AD). This class of drugs, cholinesterase inhibitors, includes the only FDA-approved treatments for AD.
For more information: Imaging Study Shows How Cholinesterase Inhibitor Improves Working Memory
A drug for obesity has been shown to be effective at helping people lose weight - and keep it off. However, questions remain about the long term safety of the drug, sibutramine.
For more information: Sibutramine Helps Patients Keep The Weight Off
Today's Vidyya articles are:
As always, we hope you enjoy the issue.