Updates of 28 October 2007 are italicized
Well here we have real irresponsibility, and it’s just one of many examples of the USA health infrastructure falling to sub-standard oversight. In typical fashion, this has received almost no press coverage, and caters to the interests of the pharmaceutical industry and the mega-food manufacturers, ignoring the advice of the American Medical Association and 12 other public health groups. This is especially relevant today, with the recent explosion of antibiotic resistant bactaria, such as MRSA, which is a direct result of this process:
The Washington Post
The government is on track to approve a new antibiotic to treat a pneumonialike 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, cefquinome, belongs to a class of potent antibiotics that are among medicine’s last defense 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 12 other health groups warned the Food and Drug Administration that giving cefquinome to animals probably would speed the emergence of microbes resistant to that important class of antibiotic, as has happened with other drugs. [emphasis added by EF] Those supermicrobes could then spread to people.
Echoing those concerns, the FDA’s advisory board last fall voted to reject the request by Intervet of Millsboro, Del., to market the drug for cattle.
Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented “guidance document” that codifies how to weigh threats to human health posed by proposed new animal drugs.
The wording of “Guidance for Industry 152” was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs such as cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.
What’s especially disheartening about the present proposal, is that we really should have learned better by now, as exactly the same thing happened with a class of antibiotics that was developed for poultry back in the early 1990’s, when the FDA overrode the CDC’s advice on two drugs. About two years after these drugs were released, Doctors began seeing patients with germs resistant to that class of antibiotics. So apparently, the interest of pharmaceutical manufacturers are on some kind of permanent over-ride when in conflict with public health priorities.
One of the mechanicisms that is operating here is horizontal genetic transfer (link to wikipedia article) which has been shown to be key to bacteria evolving (very quickly) antibiotic resistance. The type of gene transfer that most laypeople are familiar with is vertical transfer, that is genes transferred from a cell to it’s descendant. However, bacteria, especially when placed in a stresssful environment, begin to disperse their DNA, and other bacteria, of perhaps a different species, pick-up this DNA and may incorporate it into it’s genome. The discovery of horizontal gene transfer has been one of the under-reported science stories, causing some thing of a paradigm shift in certain fields as seen here and here. A lack of understanding of this mechanism, and its relevance to this decision, among policy makers is probably one of the reasons the FDA is considering approval of, Cefquinome, a fourth-generation cephalosporin, for use in animals when it potential has barely been realized in humans.
Lest we think antibiotic resistance isn’t a problem, from the CDC’s own website:
Why should I be concerned about antibiotic resistance?
Antibiotic resistance has been called one of the world’s most pressing public health problems. Over the last decade, almost every type of bacteria has become stronger and less responsive to antibiotic treatment when it is really needed. These antibiotic-resistant bacteria can quickly spread to family members, schoolmates, and co-workers – threatening the community with a new strain of infectious disease that is more difficult to cure and more expensive to treat. For this reason, antibiotic resistance is among CDC’s top concerns.
Antibiotic resistance can cause significant danger and suffering for children and adults who have common infections, once easily treatable with antibiotics. Microbes can develop resistance to specific medicines. A common misconception is that a person’s body becomes resistant to specific drugs. However, it is microbes, not people, that become resistant to the drugs.
If a microbe is resistant to many drugs, treating the infections it causes can become difficult or even impossible. Someone with an infection that is resistant to a certain medicine can pass that resistant infection to another person. In this way, a hard-to-treat illness can be spread from person to person. In some cases, the illness can lead to serious disability or even death.
So, my question is: will this issue get any follow up coverage in the Press? Also, what I would love to see is some good investigative reporting on how the “Guidance for Industry 152” document was authored. Any chance that will happen?