Friday, March 9, 2007

Idiots in the Driver’s Seat at FDA

Anyone who even gives cursory attention to health issues in this country and the world, knows that the unprecedented use of antibiotics for everything from pneumonia to a case of the sniffles puts us at risk. The wonder of these wonder-drugs has run its course. We are on the threshold of massive viral resistance to the antibiotics we now depend upon.

Antibiotic Anyone who even gives cursory attention to health issues in this country and the world, knows that the unprecedented use of antibiotics for everything from pneumonia to a case of the sniffles puts us at risk. The wonder of these wonder-drugs has run its course. We are on the threshold of massive viral resistance to the antibiotics we now depend upon.
There are over 18,000 annual AIDS deaths in the United States, according to the Centers for Disease Control and Prevention. AIDS is a national health issue, front and center in public awareness. Each year, breast cancer claims in excess of 40,000 lives. Highway deaths take an additional 40,000+ and everyone has lost or knows someone who has lost a friend, child or parent to an automobile accident.
Hospitalinfections National programs and experimentations abound to slow the growth of the national tragedy that is, essentially, preventable deaths. Yet hospital infections—diseases patients didn’t have at admittance, but caught in the hospital—killed in excess of 100,000 people last year, more than AIDS, breast cancer and highway deaths combined.
Many significant infection-causing bacteria in the world are becoming resistant to the most commonly prescribed antimicrobial treatments.  Resistance occurs when bacteria adapt in ways that allow them to survive the very antibiotics they were designed to kill. In some cases bacteria become so resistant that no available antibiotics are effective against them. Overusing antibiotics, primarily in the last 50 years on the part of prescribing physicians, is part of the problem.
Another is ingestion of antibiotics from eating chicken, beef and other meat from excessively treated feed-lot animals.
Beeffeedlot Industrial agriculture—the virtual force-feeding of corn to animals unable to process corn in their grass-oriented digestive systems--is only possible with massive infusions of antibiotics. Essentially poisoning cattle with corn, feedlots are barely able to keep these animals on their feet for the approximate 45 fattening days prior to slaughter.
These antibiotics are transferable to you and to me through eating the meat—a choice we would not make, but are made on our behalf by the meat and poultry industries. With the active participation of a co-conspirator—the United States Food and Drug Administration, the FDA.
Rick Weiss writes in the Sunday, March 4th Washington Post,
The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA's advisory board last fall voted to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.
Fda So, we have a drug so potentially dangerous that it is among medicine’s last defenses against potentially fatal human disease, a drug that has never been allowed into the food chain, a drug rejected by the American Medical Association and the FDS advisory board.
Yet Stephen Sundlof, head of the FDA's Veterinary Medicine Center, told the panel members that under agency rules they should ignore those issues and consider only the language in Guidance #152.
And what in hell is Guidance #152?
Essentially, it’s 36 pages of industry-speak, written by and tailored for the pharmaceutical industry. Interestingly, its first paragraph, even before the Introduction, states
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statute and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing the guidance. If you cannot identify the appropriate staff, call the appropriate number listed on the title page of this guidance.
Fdastephensundlof So, Guidance #152 does not operate to bind FDA. Unless Stephen Sundlof says  it does.
"We have to take a fairly legal interpretation," Sundlof said in an interview. "If we have no evidence of a problem, or sparse evidence, we would not be able to make the prohibition prior to approval."
No evidence of a problem, like
  • Objections by the FDA’s own advisory board
  • Complaint by the AMA
  • Complaint by another dozen health groups
  • The fact that cefquinome, belongs to a class of highly potent antibiotics among medicine's last defenses against several serious human infections
  • The fact that no drug of cefquinome’s class has ever been approved
Stephen Sundlof is merely the head of the FDA's Veterinary Medicine Center, but apparently he is in the driver’s seat on this matter. FDA does not explain or apologize for the fact that Sundlof is railroading this decision through, notwithstanding reasoned and concentrated argument against his position.
You may want to contact Jeffrey M. Gilbert at the Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. His phone number is 301-827-0233 and e-mail: jgilbert@cvm.fda.gov.
Ask him if he knows a guy named Stephen Sundlof. Then ask him why, if the Guidance does not create or confer any rights and does not operate to bind FDA or the public, it’s being interpreted as a fairly legal interpretation.
One can only presume that Sundlof has a cushy and highly paid job awaiting him at InterVet Inc., the pharma on whose behalf this decision is being rammed down the FDA's throat.
Against the interests of America's collective medical well-being.
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