A loophole - created by lobbying from the pharmaceutical industry - could lead to the release of a drug to treat cattle that experts believe will result in the creation of supermicrobes.
Drug company profits can't be put ahead of human lives A loophole - created by lobbying from the pharmaceutical industry - could lead to the release of a drug to treat cattle that experts believe will result in the creation of supermicrobes.
By the Editorial Board of the Union-Bulletin
New pharmaceuticals can easily be worth millions if they fill the right niche. That holds true whether the drugs target disease in animals or humans.
Drug companies often rush them to market so they can cash in. But these drugs can have dangerous side effects.
And this is why it is critical that the federal government, through the Food and Drug Administration, test and monitor the new drugs for safety.
Unfortunately, the system isn't foolproof - humans are involved. Greed can too easily cause the health and welfare of the public to be minimized, if not ignored.
This appears to be what's happening as InterVet Inc. pushes to get a new antibiotic to treat a pneumonia-like disease in cattle on the market.
The drug, cefquinome, is a highly potent antibiotic that medical experts classify as the last line of defense against a number of serious human infections. The Washington Post reports that no drug from that class has ever been approved for use in animals.
The reason for that is simple. As antibiotics are used on animals - or people - the microbes become resistant to those drugs over time. The fear is that if this powerful antibiotic is used on animals it will speed the emergence of supermicrobes that will spread to humans.
The American Medical Association and a variety of other groups concerned about human health have urged the FDA not to approve the use of cefquinome for cattle. The FDA's advisory board agreed and rejected InterVet's request.
But it now looks like a loophole - created by lobbying from the pharmaceutical industry - is going to result in the approval of cefquinome. FDA officials say their hands are tied by a guidance document - Guidance for Industry 152 - that codifies how to weigh threats to human health posed by proposed new drugs for animals.
The wording of the Guidance for Industry 152, as The Post reported, is more deferential to pharmaceutical companies than is recommended by the World Health Organization. In short, drug companies have a better lobby than the WHO.
``The industry says that `Until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,''' said Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin. ``But do we really want to drive more resistant genes into the human population?
It's easy to open the barn door, but it's hard to close the door once it's open.''
In this case, the barn in question contains a very serious disease that would be devastating if unleashed. Let's not forget that the type of drug at issue here is the last line of defense to a life-threatening disease in humans.
Profits should never be put ahead of lives.
Action needs to be taken now to alter the FDA guidelines before microbes are altered and human lives are lost.Walla Walla Union-Bulletin (WA)
