FDA Limits the Use of Cephalosporins in Animals

When the FDA announced this week that it was moving to limit the use of the antibiotic cephalosporin in farm animals, it sounded like it might actually be a meaningful step toward slowing the rate of development of bacterial resistance to antibiotics. But while it may do that for cephalosporin, it is not much more than a token gesture when it comes to preventing antibiotic resistance in general.

First, the new rule only eliminates the “off-label” (unapproved) use of cephalosporins – uses that shouldn’t have been happening anyway, such as using higher than recommended doses, using cephalosporin drugs intended for humans in animals, and using cephalosporin drugs indiscriminately to prevent disease. Veterinarians are still free to prescribe cephalosporins for animals when they think the drug is needed to treat disease.

More importantly, the new rule applies only to cephalosporins, which represent less than 1% of the antibiotics used in the agricultural industry. That’s why the FDA’s new ruling is just a token gesture. The meat-producing industry uses over 29 million pounds of antibiotics per year, most of which is penicillins and tetracyclines, not cephalosporins. These two antibiotics are routinely put in animal feed and water because they prevent disease outbreaks in animals grown under (sometimes) unsanitary conditions. The result is fatter animals and fatter profits. The FDA has wanted to restrict the indiscriminate use of antibiotics in the meat industry for decades, but always runs up against the meat industry lobby.

The meat-producing industry seems to be responding to the new ruling on cephalosporins with a great big yawn. Perhaps it knows that the impact of the ruling will be minor?

To be fair, the new FDA ruling could be seen as a first step in the right direction. It would be nice to see the FDA take the next big step and limit the indiscriminate use of all antibiotics in animal feed, and not just the 1% that no one cares about. I’m betting it won’t happen until the problem of bacterial resistance to antibiotics gets much worse.

Fewer Children are Receiving Vaccinations

According to a report in USA Today and elsewhere, more parents are choosing not to have their children receive their regular childhood vaccinations, even though these vaccinations are considered mandatory for attendance in school in most states. Rules for allowing exemptions differ from state to state, but generally speaking all states permit parents to opt out for specified reasons, including medical, religious, and even “philosophical” concerns. As a result, vaccination rates have declined in many Midwestern and Western states. In eight states now, over 5% of all schoolchildren have not gotten all of the vaccinations allegedly required for school attendance. The state with the most opt-outs is Alaska.

Parents’ reasons for requesting exemptions vary. Some parents are still convinced that there is a connection between vaccinations and autism, despite all the evidence to the contrary. Other parents complain about the large number of vaccinations recommended these days – up to two dozen shots by the time a child is 6 years old – saying that while some vaccinations may be important, perhaps not all of them are. And there’s a widespread distrust the motives of pharmaceutical companies, who promote the vaccines and profit from manufacturing and selling them.

Health officials are concerned that outbreaks of diseases once thought to be a thing of the past may begin to re-occur once the percentage of unvaccinated children exceeds a certain threshold. But no one can say for certain what that threshold might be. In the meantime, there are occasional outbreaks that hint at a future problem, but nothing cataclysmic yet.

My guess is that we will tolerate the current trend toward tolerance of parents who refuse to vaccinate their children until a serious outbreak occurs (if ever). After that, the states will tighten up their vaccination requirements. And perhaps that’s the way it should be, in a democracy. What do YOU think?

NTSB to the States: “Ban Texting While Driving”

The National Transportation Safety Board (NTSB) has issued a strong recommendation to the states that they should ban texting while driving. The recommendation comes after a well-publicized accident last year in which a teen driver slammed into truck, causing two school buses to lose control as well. Two persons were killed (including the teen driver) and 38 school children were injured. The teen was texting at the time of the accident.

The NTSB does not have the power to require that the states ban texting; that is up to each individual state. So far, 35 states have done so, though the conditions under which a person can be cited and the penalties for an infraction vary widely.

A 2009 CBS/New York Times poll found that 97% of Americans support a ban on texting while driving. However, about half of the respondents felt that the punishment for texting while driving should be “less severe” than the punishment for drunk driving. Perhaps this is because almost half of all texting adults have texted at least once while driving, according to a 2010 poll by the Pew Research Center. It sounds like a small cry for help, doesn’t it? – “Please save me from my own bad behavior, but don’t punish me too severely!”

It would be interesting to know how much texting while driving actually declines after a state institutes a ban. My guess is that like speeding, it may depend on the perceived level of enforcement and the severity of the penalty.

The Morning-After Pill – Politics vs. Science

Once again, politics appears to have trumped science.

An expert scientific panel of the FDA recommended recently that the morning-after pill, called Plan B, be made available to all women without a prescription. The FDA argues that younger women would benefit from easy access to Plan B, and that the pill is both safe and effective. But the current Health and Human Services secretary, Ms. Kathleen Sebelius, used her legal authority to overrule the FDA, saying that the drug has never been tested and proven to be safe in girls as young as 11 and that girls that age may not understand how to use the pills.

Huh? Countless drugs that have not been tested specifically in children and that can have severe side effects if misused are available over-the-counter. Besides, there’s no evidence that adolescent girls are unable to read and understand the instructions on a drug’s label. If that were true, many drugs currently available over the counter should be pulled from the shelves.

The Plan B pill has always been embroiled in politics – the politics of contraception and birth control. The Bush administration initially resisted approval of over-the-counter sales of Plan B, but then justified over-the-counter sales in 2006 by limiting sales to women 18 and older. The age was reduced to 17 in 2009 when a judge ruled that the age limitation of 18 was ruled by politics, not science.

The Health and Human Services secretary is a political appointee. President Obama later publicly backed Ms. Sebelius’s position. Is it possible that Ms. Sebelius’s decision was influenced by a desire not to anger social conservatives during an election year? You decide.

Starve Your Fat Cells, Not Yourself.

The two basic ways to lose weight are to reduce your caloric intake and/or increase your caloric output (through exercise). But at some time in the future, there may be an easier way. Several news agencies (including ABC) report that researchers have found a way to starve fat cells pharmacologically with an experimental drug. The drug, called Adipocide, destroys the small blood vessels within fat, depriving fat cells of nutrients and oxygen (starving them, really) and thereby causing them to shrink and/or die.

So far, Adipotide has only been tested in mice and in monkeys. The company that has the patent on Adipocide plans to apply to the FDA for permission to test the drug in humans sometime soon. But given how long it takes to test a new drug for safety and efficacy, it will be years before Adipocide or any drug like it reaches the market.

Nevertheless, it seems like poetic justice – losing weight by starving your fat cells (the very cells that are causing your weight problems), without the feeling that you are starving yourself by dieting all the time! If it becomes possible, it would change the dieting landscape forever. Let’s wait and see.

Stretching and Exercise-Induced Muscle Soreness

Previously I reported that a U.S Track and Field Association study had indicated that stretching before exercise does not decrease the risk of running-related injuries (see "Pre-run Stretching Doesn't Prevent Injuries"). Now a review of 12 stretching-related studies reveals that stretching before exercise does not reduce perceived muscle soreness, either, in the days following exercise.

None of the studies of the effects of stretching on exercise-induced injury or soreness are considered scientifically ideal, however. Ideally, such studies would be randomized (subjects assigned randomly to either the stretch or no-stretch group) AND double-blind (neither the investigators nor the subjects would know which group each subject was in until the study was over). Unfortunately, subjects in exercise studies always know whether they are stretching or not, and therefore a double-blind study design is impossible! It’s conceivable that subject bias about the value of stretching affected the subjects’ judgment of their own post-exercise level of soreness. Until we have a truly objective measure of “soreness”, there’s no other way to conduct such studies. It’s the best we can do for now.

But from what we can tell so far, there’s no compelling evidence that stretching before exercise is either good or bad for you. Do it (or don’t do it) as you wish.

Reference: Henschke, N. and C.C. Lin. Stretching Before and After Exercise Does Not Reduce Delayed-onset Muscle Soreness. Br. J. Sports Med. 45:1249-1250, Dec. 2011.