U.S. Food and Drug Administration
FDA Consumer magazine
July-August 2001
Table of Contents
The recent fast-track approval of the anti-cancer drug Gleevec was a historic occasion. Also known as imatinib mesylate or STI-571, Gleevec received approval in less than three months to treat a rare, life-threatening form of cancer called chronic myeloid leukemia.
The FDA approved Gleevec under its orphan drug program, which provides financial incentives for drugs developed to treat rare diseases. The action marked the quickest-ever FDA approval for a cancer therapy. Gleevec's promising performance in trials prompted FDA staffers to work weekends and to skip vacations to expedite the approval process.
Gleevec, called Glivec outside the United States, is the first of a new type of gene therapy that targets and turns off a molecule responsible for some cancer cell growth. The anti-cancer pill is a part of a class of drugs called signal transduction inhibitors.
In clinical trials, Gleevec quickly and substantially reduced the level of cancerous cells in the bone marrow and blood of cancer patients. However, the long-term effects of Gleevec are not known, and more research is needed to determine whether the drug provides improved survival or other clinical benefits.
Efficient reviews and high product standards set by the FDA have made the United States the country of choice for the world's leading drug manufacturers who want to introduce new medicines. For more on the FDA's approval of Gleevec, see the article in this issue.
This issue's cover story, titled "Food Allergies: When Food Becomes the Enemy," examines the growing prevalence of food allergies. A simple purchase at the grocery store can represent a health risk to someone with a food allergy. One key to prevention is knowing how to read food labels, an area regulated by the FDA.
We also examine irritable bowel syndrome (IBS), the most common gastrointestinal disorder diagnosed by physicians. People with IBS frequently have abdominal pain, bloating, gas, and diarrhea or constipation. One person with IBS says his intestines feel "as though they're being wrung out like a dishrag." The FDA and drug manufacturer GlaxoSmithKline are considering whether to restore access to the drug Lotronex for certain people with IBS. The drug was removed from the market last year after adverse event reports indicated that it may pose an unreasonable risk to some people.
If you've read or heard about hepatitis C recently, you probably think that the virus is a "silent killer" that quietly--and relentlessly--attacks the liver over several decades, with death as the inevitable result. Researchers now say this isn't always the case. We give you the latest from the lab.
During the last 100 years, substantial achievements have been made in the control of many diseases thanks to the widespread use of effective vaccines. In the United States, smallpox has been eradicated, polio caused by wild-type virus has been eliminated, and cases of measles have been reduced to record low numbers. In this issue, we bring you the latest on vaccine development, complete with a handy reference chart prepared by vaccine experts.
Raymond Formanek Jr.
Interim Editor
Table of Contents
| How to Subscribe |
Back Issues | Editorial Questions
FDA/Office of Public Affairs
Web page created by clb 2001-JUN-18.