Thursday, April 5, 2012

Animals, Antibiotics, and Superbugs: Will the FDA Do the Right Thing?

It seems inevitable that the use of antibiotics to control bacteria will lead to the evolution of species that have developed a resistance to antibiotics. These forms of bacteria have come to be known as "superbugs." Humans develop immunity to harmful species by allowing themselves to be exposed to doses small enough to generate antibodies, but not large enough to cause harm. Much the same dynamic occurs with bacteria that encounter low levels of an antibiotic; forms eventually evolve that develop immunity. The appropriate use of antibiotics is then: only when necessary, and in strong enough doses to ensure the death of the offending species. Unfortunately, that is not always the manner in which they are used.

There is a tendency to over prescribe antibiotics, even for conditions for which they have no relevance. Patients often discontinue usage early when they feel their symptoms have disappeared. Unused pills are often dumped into our water systems. Even when taken according to directions, if our bodies don’t fully metabolize the antibiotic, it will eventually be excreted into our water systems. Consequently, there are many ways in which bacteria can encounter low levels of antibiotics.

The rise of these superbugs is a growing problem. We recently discussed the situation that has developed in India in India: Politics, Greed, and the Attack of the Superbugs. Poor control of antibiotic use there has resulted in the development of a particularly dangerous form of a gene that can be transferred to a variety of bacteria making them resistant to even the most potent of our antibiotics. Such developments could have catastrophic consequences.

The situation is already dire in the US where it is said that

"In the United States alone, fighting drug-resistant infections costs up to 8 million additional patient hospital days and up to $34 billion every year."

Given this background on an issue that has been of concern for decades, one would think that an appropriate strategy would be in place. An article in the Atlantic by Robert S. Lawrence reminds us that issues of life and death may be of little consequence when matched against matters of profit and loss.

"The vast majority of antibiotics in this country -- about 80 percent -- are sold for use in food animal production, not to treat humans. The vast majority of animals that receive these drugs are not sick, and the doses they receive would be too low to successfully treat bacterial infections if they were. Rather, low doses of antibiotics are fed to healthy animals throughout their lives to speed their growth and to reduce infections in the overcrowded and unsanitary conditions commonly found at the industrial operations that produce these animals."

In Foie Gras Illegal? Why Not Industrial Beef? we discussed the absurd pressure to ban foie gras because ducks and geese spent a few weeks getting overfed, while our beef was produced using procedures that caused more suffering and insured the death of the animals. Why do cattle require antibiotics? There are two reasons. First, they are fed in lots where they are left to wallow in their excrement rather than roam a nice clean field. Second, cattle evolved eating grass and developed organs to digest that food source, but in the feed lots they are fed corn, which they cannot digest without human intervention.

Cows have rumens where eaten grass is allowed to break down under bacterial action before being sent to the stomach for digestion. The acidity in the rumen of a grass-fed cow is neutral. The corn diet given cows makes the rumen acidic. This can cause a condition called "bloat" where gases build up in the rumen and can cause suffocation if not treated. The acidity of the material in the rumen also causes acidosis. Besides causing permanent discomfort to the animals, the constant acidity eventually breaks down the wall of the rumen and allows bacteria into the blood stream. The result is an infected liver.

The logic of industrial beef production is to fatten the animal as fast as possible and feed it whatever is necessary to keep it alive as long as possible. It is a race because the diet will surely kill the cattle, eventually destroying their livers.

The danger involved in using antibiotics in this practice was recognized long ago by the FDA.

"In 1977, the FDA determined that using penicillins and tetracyclines to make animals grow faster was no longer "shown to be safe," as research had linked such uses to the development of antibiotic resistance."

The FDA has a process by which drug use can be restricted. It involves hearings in which the issue can be argued before a ban is imposed. The FDA initiated that process in 1977, but the hearings were never held.

"Under pressure from Congress, the agency backed down, leaving the approvals in place. Although the FDA did not rescind the notices, in theory leaving the matter open for future consideration, the agency took no further action to restrict either drug class for the next 34 years."

One of the problems with the FDA is that it is easily coerced by political forces. When Democrats are in charge the FDA is told that its mission is to protect citizens from dangerous products. When Republicans are in charge, the message tends to be interpreted as "help companies get their product to market as cheaply and as quickly as possible." Legislators from both parties are susceptible to the financial inducements of lobbyists from the most adept of industrial organizations. Greed always seems to trump safety.

Finally, in 2010, the FDA issued some "regulatory strategies" whose provisions are entirely voluntary—meaning corporations should feel free to ignore them.

"Notably, the FDA wrote that using antibiotics for growth promotion "is not in the interest of protecting and promoting the public health." The agency nevertheless described using antibiotics to prevent infections as "necessary and judicious." That is, the FDA endorsed feeding low doses of antibiotics to food animals throughout their lives to prevent infections, if not to promote growth. This practice has time and again been shown to select for antibiotic resistance."

Those who protest against agricultural overuse of antibiotics and the delaying tactics by the FDA finally had their day in court—literally.

"The voluntary approach did not fly with the court. Under the law, it said, the FDA cannot find that an approved use of a drug is no longer safe and then refuse to withdraw its approval. Because the agency made such a determination in 1977, the court said, it must withdraw its approval now, unless drug companies can prove at an administrative hearing that the drugs are actually safe."

While this might appear to be a victory, Lawrence points out that the deep pockets of the drug companies can provide the means for delaying the ultimate resolution indefinitely.

It seems that for this issue to be resolved some difficult choices must be made. The drug companies and the agricultural interests are making a profit under the current system, and they are providing a service that is appreciated by the general public. Few would deny that meat is more abundant, cheaper, and, at least for beef, tastier than ever. It would be unreasonable to ask them to decide on their own to limit their profits to minimize a potential health hazard. The citizenry appreciates the abundant meat and cannot be expected to do the necessary research to decide if it is worth the risk to their health. One cannot expect them to arrive at an appropriate decision.

This seems a classic example of the need for a diligent and competent government agency to sort through the issues and make the argument why a given course of action is necessary. Our problem is that, rightly or wrongly, we have lost faith in the diligence and competence of our government, and in so doing, have guaranteed that its agencies will be neither diligent nor competent.

Those who continually argue for smaller government choose to underfund agencies with a critical mission and denigrate those who would choose a career in public service, thus creating the ineptness. This lack of effective performance they have created is then used to argue for even greater cuts in support. Meanwhile necessary tasks are going unattended.

Those who believe in an effective role for government in the lives of the citizens must be careful about overreach in authority and apply the heavy hand of the government wisely. They must continue to support their agencies while demanding excellence from them without resorting to politically motivated meddling.

There is much to criticize about how the FDA goes about its business, but one must recognize that until our political parties come to some sort of truce over how the government should conduct its business, it is being left dangling in the wind waiting for the next political breeze to tell it in which direction it should move. If excellence is not demanded, it will not be received.

No comments:

Post a Comment

Lets Talk Books And Politics - Blogged