By Marc Kaufman
For the first time, the Food and Drug Administration has succeeded in forcing off the market an antibiotic used to treat animals because of concerns that it will make similar antibiotics less effective in treating people. After a five-year battle, Bayer Corp. said yesterday that it would immediately stop selling its poultry antibiotic, Baytril, a close relative to its widely used human antibiotic, Cipro. The company could have appealed the FDA ban on the drug to a federal court but instead decided to comply.
"We disagree with the FDA's conclusion about our drug," said Bayer spokesman Robert Walker. "But we understand they made a scientific decision, and courts tend to defer back to the agency. . . . It seemed like the chances that we would be successful in court were small."
The resolution of the Baytril case opens the door to FDA action against other animal antibiotics. The agency has already told the makers of at least three types of penicillin used on farm animals that their products might raise similar concerns, and regulatory action might be needed.
Yesterday, public health advocates hailed Bayer's decision and the FDA actions that precipitated it.
"We applaud Commissioner [Lester M.] Crawford for defending the public's health and Bayer for finally recognizing the need to comply with the FDA's ruling," said Karen Florini, senior lawyer at Environmental Defense and chairwoman of the Keep Antibiotics Working coalition. "Cipro is a critical antibiotic for treating human illness. It simply makes no sense to allow its effectiveness to be squandered by continued use of near-identical drugs in poultry flocks."
All antibiotics grow less effective over time as bacteria evolve to become resistant to the drugs' effects. Experts say wider use of an antibiotic -- by either animals or people -- leads to a speedier development of resistance.
In its battle to continue marketing Baytril for use in poultry flocks, Bayer was joined by the Animal Health Institute, which represents drug makers, and four poultry trade associations. The company and the groups argued that no proof existed that Baytril was making drugs such as Cipro less effective, and that the drug's benefits were not properly considered.
"It's disappointing to us that the case played out this way," said Ron Phillips, spokesman for the Institute. "While we disagreed with the FDA's methodologies and conclusions, consumers should be comforted by the fact that the agency does have sufficient authority to act when it thinks there's a threat to public health."
Antibiotics are used on American farms to treat sick animals and promote faster growth. Makers of animal drugs do not have to report how much animal antibiotic they sell, and no firm statistics exist. The Union of Concerned Scientists has estimated that 24.6 million pounds of antibiotics are used on American farms yearly, about 75 percent of the nation's antibiotic consumption. The animal drug industry says most of the antibiotics on farms are used to treat disease, but UCS scientists, who oppose the widespread use of antibiotics for livestock, say most is to promote growth.
The FDA and critics of widespread antibiotic use on farms have argued that the use of Baytril to treat chickens and turkeys was especially worrisome because the drug is a fluoroquinolone, in the same family of antibiotics as Cipro (ciprofloxacin hydrochloride). The agency also said during a long administrative hearing that poultry farmers have alternatives that are as effective as Baytril but pose less of a threat to the human antibiotic supply.
In 2003, the World Health Organization urged that the use of antibiotics as animal growth promoters be stopped worldwide to preserve the effectiveness of important human drugs.
When the FDA first ordered Bayer to stop producing Baytril in 2000, it also told Abbott Labs to take its similar fluoroquinolone for poultry off the market. Abbott voluntarily withdrew the product, but Bayer appealed. An administrative law judge upheld the FDA position in March 2004, and Crawford affirmed the decision in July.
Last week, Bayer, the AHI and poultry associations made an eleventh-hour request to delay the ban, but Crawford rejected that petition on Friday.
Baytril, which was approved for sale in 1996, quickly became a popular treatment for respiratory diseases in chickens and turkeys. Because farm birds cannot be treated individually, entire flocks are regularly given the drug in their feed to treat those that are sick and to protect others. The FDA concluded that this kind of broad use led to increased antibiotic resistance.
The ban affects only the use of Baytril in poultry; the drug can still be given to pets and other farm animals that can be treated individually.
The withdrawal of Baytril is encouraging, Florini said, but she called on the FDA to go further.
"We certainly hope that Crawford's rock-solid analysis of this issue is an indication he will take the bull by the horns in dealing with the much bigger quantities of medical antibiotics that are used as feed additives," she said. "These are too valuable to be used to just make animals on big industrial farms grow faster."
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Friday, September 9
Ending Battle With FDA, Bayer Withdraws Poultry Antibiotic
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 09 Sep 2005 04:45 PM EDT
Inhaled insulin gets green light from FDA panel
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 09 Sep 2005 04:44 PM EDT
09/09/2005 - Diabetics moved a step closer to having an alternative to injections for their insulin therapy yesterday, after a US Food and Drug Administration (FDA) advisory committee gave its backing to an inhaled formulation of the drug developed by Pfizer, Sanofi-Aventis and Nektar Therapeutics.
Link to Article In-PharmaTechnologist.com
Drug Discovery Online Newsletter - Collaboration Key To Overcoming Obstacles To Drug Development
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 09 Sep 2005 04:42 PM EDT
================================================================
Drug Discovery Online Newsletter - http://www.drugdiscoveryonline.com Friday, September 09, 2005 ================================================================ ------------------------------------- TOP NEWS STORIES ------------------------------------- 1) Collaboration Key To Overcoming Obstacles To Drug Development 2) Genstruct Reaches First Performance Milestone In Multi-year Relationship With Pfizer 3) Xenogen Launches First Commercial Three-Dimensional Biophotonic Imaging System 4) America's Pharmaceutical Companies Increase Relief Efforts 5) Wolters Kluwer Health Adds Chemical Structure Searching To Its Array of Pharmaceutical Intelligence Tools 6) Liquent Announces Support For Microsoft's Digital Pharma Initiative 7) Cytori Therapeutics Completes Development Of The Celution(TM) System 8) World Premier Of Compact Automated Cell Culture System --------------------------------------- 1) Collaboration Key To Overcoming Obstacles To Drug Development Industry, academic medicine, and government researchers are calling for new and increased collaborations among pharmaceutical companies, academic researchers, and regulatory agencies to strengthen the processes that move scientific breakthroughs to novel diagnostics and therapeutics that benefit the public... http://www.drugdiscoveryonline.com/nl/225576/760156 2) Genstruct Reaches First Performance Milestone In Multi-year Relationship With Pfizer Genstruct Inc., a knowledge-driven discovery company using systems biology to increase the effectiveness of drug discovery and development, recently announced that it has achieved its first performance milestone in its multi-year relationship with Pfizer to help understand and treat complex diseases... http://www.drugdiscoveryonline.com/nl/225577/760156 3) Xenogen Launches First Commercial Three-Dimensional Biophotonic Imaging System Xenogen Corporation announced recently the launch of its IVIS® 3D Imaging System, the first commercial three-dimensional biophotonic imaging system, on display at the Fourth Annual Meeting of the Society for Molecular Imaging (SMI) in Cologne, Germany... http://www.drugdiscoveryonline.com/nl/225578/760156 4) America's Pharmaceutical Companies Increase Relief Efforts America's pharmaceutical research companies continue to send comprehensive disaster aid packages to public and private relief organizations to help lessen the suffering of survivors and to stem a looming public health crisis in the Gulf Coast region following Hurricane Katrina... http://www.drugdiscoveryonline.com/nl/225579/760156 5) Wolters Kluwer Health Adds Chemical Structure Searching To Its Array of Pharmaceutical Intelligence Tools Wolters Kluwer Health, a leading global provider of drug and medical information services and content to the pharmaceutical and biotechnology industries, recently announced a partnership with CambridgeSoft of Cambridge, Mass., to market chemical structure search tools for drug discovery scientists and pharmaceutical chemists... http://www.drugdiscoveryonline.com/nl/225580/760156 6) Liquent Announces Support For Microsoft's Digital Pharma Initiative Thomson Scientific recently announced Liquent's support of Microsoft's Digital Pharma initiative, a vision and solutions framework that addresses the industry imperatives of speed-to-insight and value-for-cost, by helping improve productivity, integrate disparate data sources, and enable better collaboration across the pharmaceutical value chain... http://www.drugdiscoveryonline.com/nl/225581/760156 7) Cytori Therapeutics Completes Development Of The Celution(TM) System Cytori Therapeutics, Inc. recently announced it has completed the development of its Celution(TM) System for the isolation and concentration of adipose stem cells and will submit CE Mark application seeking approval for the system in Europe... http://www.drugdiscoveryonline.com/nl/225582/760156 8) World Premier Of Compact Automated Cell Culture System The Automation Partnership is launching its new CompacT SelecT automated laboratory cell culture system on Stand 720 at Drug Discovery Technology. This specialised system is designed for the reproducible generation of assay-ready plates every day and when used continuously could increase productivity by over 20 per cent... http://www.drugdiscoveryonline.com/nl/225583/760156 ------------------------------------- FEATURED PRODUCTS ------------------------------------- 1) Dual-Chamber Technology 2) CombiFlash System Sq16X 3) Palltronic® High Flow Flowstar Filter Integrity Test Instrument 4) Supercritical Fluid Chromatography Systems 5) Walk-in Environmental Rooms --------------------------------------- 1) Dual-Chamber Technology The Vetter Lyo-Ject® dual chamber ready-to-use syringe is designed for sensitive drugs which will not degrade in a lyophilized state... http://www.drugdiscoveryonline.com/nl/225584/760156 2) CombiFlash System Sq16X This automated, 16 sample system sets the standard for productivity and versatility in automated organic purification... http://www.drugdiscoveryonline.com/nl/225585/760156 3) Palltronic® High Flow Flowstar Filter Integrity Test Instrument The Palltronic® High Flow Flowstar is a unitized, compact and splash-proof filter integrity test instrument designed for use in the most demanding production environments... http://www.drugdiscoveryonline.com/nl/225586/760156 4) Supercritical Fluid Chromatography Systems Thar offers a wide selection of chromatography systems, from analytical SFC, SFC-MS, Semi-prep SFC, and Prep SFC capitalizing on the advantages of supercritical fluids... http://www.drugdiscoveryonline.com/nl/225587/760156 5) Walk-in Environmental Rooms Since 1908, Hotpack has been an innovator in the development and manufacture of highly accurate controlled environmental rooms for biological research, stability and shelf life testing, cold storage, and other applications... http://www.drugdiscoveryonline.com/nl/225588/760156 ------------------------------------- FEATURED DOWNLOAD ------------------------------------- Brochure: Kodak Image Station 4000 Digital Imaging Systems Featuring a cooled CCD camera with 4-million pixel resolution, true 16-bit imaging, and more than 5x the sensitivity of our other systems, the new KODAK Image Station 4000 Digital Imaging Systems outperform the competition every time. Choose from two configurations, plus an optional x-ray imaging module... http://www.drugdiscoveryonline.com/nl/225589/760156 ------------------------------------- CONSULTING SERVICES ------------------------------------- ProSavvy brings clients with projects together with consultants who have the right expertise. We also provide consultants the ability to access project opportunities. Visit http://www.drugdiscoveryonline.com/nl/225590/760156 and post your project today! ------------------------------------- TRAINING RESOURCES ------------------------------------- Thinking About Continuing Your Education? Let us help you find the right school for you. Whether you would like to get an Associate's Degree, Bachelor's Degree or Master's Degree we can help you pinpoint which schools to choose from. http://www.drugdiscoveryonline.com/nl/225591/760156 ------------------------------------- TRADE PUBLICATIONS ------------------------------------- Browse from the extensive list of complimentary trade publications. Visit http://www.drugdiscoveryonline.com/nl/225592/760156 for more information. ------------------------------------- SUBSCRIBER SERVICES ------------------------------------- ========================================================== If you need to update your Drug Discovery Online subscription profile please visit: http://www.drugdiscoveryonline.com/pref/760156 This newsletter is being sent to hywang@ENGIN.UMICH.EDU . 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'Clock' genes mediate leptin effects on bone formation
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 09 Sep 2005 04:37 PM EDT
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