May 21, 2013 2:29 pm
For patients suffering from C. difficile colitis—a stubbornly persistant severe bowel inflammation that often evades conventional treatment—a stool transplant from a family member, friend or even doctor can often fix the problem. Over the past several years, an increasing number of patients have found relief through fecal transplants, which involves an injection of sterile communities of gut microbes from another person—not actual feces. Patients undergoing such procedures have seen seemingly miraculous results. Some trials show that up to 94 percent of patients’ C. difficile infections clear up following a transplant.
But now, as Scientific American writes, “the sh*t has hit the fan.” The Food and Drug Administration has caught a whiff of the controversial new treatment and has declared fecal transplants as a biologic therapy, meaning any doctor who wants to use it will have to file an investigational new drug application. For patients, this means more paperwork, a longer wait for treatment and a potential application rejection from the FDA.
This isn’t exactly welcome news for doctors, either. Judy Stone, an infectious disease specialist, further delves into the issue in SciAm:
Yes, there are many questions involving FMT that do warrant further study. For example, what is the best diluent for the stool? Saline or water or milk or other? What is the most efficacious route of administration—colonoscopy vs enema vs nasoduodenal tube?
However, she writes, fecal transplants do display better efficacy in patients than many other treatments—some already approved by the FDA, others not—which also tend to cost more and may cause serious side effects.
I think it is reasonable for the FDA to provide guidance and to try to collect data in some standardized format so that we can learn more about best approaches. My understanding is that individual physicians will have to develop and submit their own plan for treatment—which is both burdensome and will not result in any generalizable conclusions. While the FDA says that in emergencies, physicians can seek urgent approval, rather than wait for a 30 day turnaround time on their IND submission, in practical terms, this isn’t going to happen.
On MedPageToday, infectious disease expert William Schaffner at Vanderbilt University, predicted that the new regulation would significantly increase cost to researchers (though he could not put a number on that figure). Michael Edmond, a physician at Virginia Commonwealth University, complains on his blog Controversies in Hospital Infection Prevention:
Over the past several days I have spent a lot of time talking to patients, trying to explain why I’ve had to cancel their upcoming fecal transplant.
So now I must apply for an IND number, which requires that I send the FDA my protocol. On the 30th day after receipt of my documents the FDA will let me know whether I can proceed. When I talked to the FDA officer yesterday she informed me that the FDA is only interested in fecal transplants with regards to safety. They want to ensure that donors are appropriately screened. Thus, I need to send them my protocol for donor testing and then I will get a ruling. I asked the officer what the FDA was looking for and was told that they can’t say but will either approve or not approve my protocol. Now wouldn’t it have made more sense for the FDA to review the literature and consult experts about what optimal testing of donors and safeguards should be for the procedure and simply require practitioners to follow their guideline instead of the guess-what-I’m-thinking-and-wait-30-days game?
Other doctors are put out, but more understanding of the FDA’s decision. MedPageToday writes:
Herbert DuPont, MD, of the University of Texas Medical Center in Houston, who is gearing up for a major fecal transplantation program there, said he already had his protocol approved by the center’s Institutional Review Board (IRB).
“Am I disappointed? Yes,” DuPont told MedPage Today. “Do I have problems with the outcome? Absolutely not.”
DuPont, who also attended the hearing, said he understood the FDA’s concerns about needing to set standards for safety and efficacy with procedures such as fecal transplant.
Dr. Stone suggests instead that the FDA clinicians to pursue the treatment in certain patients who qualify, and exclude them from the lengthy approval process. Otherwise, just like so-called worm therapy, or deliberate infection with parasitic worms to treat diseases ranging from asthma to Crohn’s disease to multiple sclerosis, patients may try to perform the procedure at home and a blackmarket may even emerge for fecal transplants. So, while law-abiding patients suffer in the hospital from C. difficile infections, others will try to perform their own DIY fecal transplants at home, which will likely cause additional health and safety issues when things in the bathroom go awry.
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May 21, 2013 12:44 pm
As a patient, dealing with the anxiety of waiting to get poked with a needle may be no fun at all. But it’s actually a positive behavior. In trials with mice, stress boosted the immune system, a team of Stanford University researchers found, making it vaccines more effective. Ferris Jabr reports for Scientific American:
Mice that were stressed out prior to their inoculations had an easier time overcoming a subsequent infection than mice that the researchers left in peace before their shots.
Something similar seems to happen to people. In a study of knee surgery patients, for example, Dhabhar and his teammates found that anticipating surgery increases the number of immune cells circulating in the bloodstream in the days preceding the operation.
While stress is generally thought of in terms of its negative effects, researchers are beginning to distinguish between two different types of stress. Chronic stress, suffered over a long period of time, can cause harm, whereas acute stress, like visiting the doctor or racing to meet a deadline, may actually make us stronger and healthier.
From an evolutionary perspective, the fact that short-term stress revs up the immune system makes sense. Consider a gazelle fleeing a lioness. Once the gazelle’s eyes and ears alert its brain to the threat, certain brain regions immediately activate the famous fight-or-flight response, sending electrical signals along the nervous system to the muscles and many other organs, including the endocrine glands—the body’s hormone factories. Levels of cortisol, epinephrine, adrenaline and noradrenaline rapidly increase; the heart beats faster; and enzymes race to convert glucose and fatty acids into energy for cells. All these swift biological changes give the gazelle the best chance of escape.
The brain also responds to stress by priming the immune system to prepare for a potential injury. This may explain why people and mice more readily respond to vaccines when they’re stressed out. So cry all you’d like in the waiting room – you may be doing your body a favor in the long run.
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May 20, 2013 1:27 pm
In the animal kingdom, larger males—think chimpanzees, lions, bulls—often try to acquire or defend more resources, like territory, food, and females, than their weaker underlings. Researchers decided to apply the competitive animal model to human political decision making about redistribution of wealth and income to see if there was any correlation.
The Atlantic describes the study:
Researchers at Aarhus University in Denmark and UC Santa Barbara collected from several hundred men and women in Argentina, the U.S., and Denmark. They categorized the subjects by socioeconomic class, their upper-body strength, or “fighting ability” (as measured by the “circumference of the flexed bicep of the dominant arm”), and their responses to a questionnaire gauging their support for economic redistribution.
They hypothesized that men with more upper body strength would be less open to wealth distribution, following the same tendency of stronger males of many animal species. After all, upper-body strength has counted as a major component of dominance throughout human evolutionary history. When economics, strength and gender were taking into account, that hypothesis turned out to be true. Popular Science reports:
Socioeconomic status also showed a correlation with economic views. As expected, rich men were generally opposed to redistribution, and poor men generally in favor of it. Men with stronger upper bodies tended to have stronger views–rich, strong men were very much opposed to redistribution, while less strong but still rich men were less opposed. On the side of those that support redistribution, the trend was reversed: poorer but strong men were strongly in favor of redistribution, while weaker poor men were not as committed.
Political party had nothing to do with the results, the researchers found, and no correlation turned up between women’s opinion on the subjet and their physical strength and/or wealth.
The authors conclude: “Because personal upper-body strength is irrelevant to payoffs from economic policies in modern mass democracies, the continuing role of strength suggests that modern political decision making is shaped by an evolved psychology designed for small-scale groups.”
For many men, apparently, animal antics still hold strong.
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May 20, 2013 11:01 am
“Dying of a broken heart” is more than just a turn of phrase. The despair of losing a loved one—the stress and the anxiety and the pumping adrenaline—can actually kill you. Writing for The Conversation, cardiologist Alexander Lyon tells the tale of the broken-hearted, those whose hearts simply shut down during times of stress.
Known to doctors as Takotsubo cardiomyopathy, broken heart syndrome is a special type of heart attack. In a normal heart attack, a blocked artery chokes the flow of blood to the heart, cutting off the supply of oxygen and killing heart tissues. In a Takotsubo heart attack, there is no such blockage. For the broken-hearted, nine out of ten of whom are “middle-aged or elderly women,” says Lyon:
They have chest pains, a shortness of breath and ECG monitors show the same extreme changes which we see with a heart attack.
But when an angiogram is performed, none of their coronary arteries are blocked. Instead, the lower half of their ventricle, the main pumping chamber of their heart, shows a very peculiar and distinctive abnormality – it fails to contract, and appears partially or completely paralysed.
…In the most extreme cases the heart can stop – a cardiac arrest.
We’re still not really sure what causes broken heart syndrome, writes Lyon, but research suggests that adrenaline—the hormone behind the body’s “fight or flight” response—may be to blame.
At low and medium levels adrenaline is a stimulating hormone, triggering the heart to beat harder and faster, which we need during exercise or stress. However at the highest levels it has the opposite effect and can reduce the power the heart has to beat and triggering temporary heart muscle paralysis.
Unlike normal heart attacks, where the tissues are usually damaged for good, people can often walk away from a Takotsubo heart attack unscathed. But though the physical damage may be undone, a broken heart never truly mends.
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May 20, 2013 10:42 am
The public pool may as well be renamed the public poo. The Centers for Disease Control and Prevention recently announced that the majority of public swimming holes have feces in them—brought to the pool on people’s unwashed skin or deposited by those who lack self-control. And along with fecal matter come illness-inducing bacteria.
Last year, the CDC tested the water from 161 public pools around Atlanta, where the CDC’s main offices are located. In 95 of them, or 58 percent, they found the bacteria Pseudomonas aeruginosa, a bacteria that causes rashes or ear infections. In 59 percent of pools they found E. coli, another sign that feces had been in the water. The CDC puts it delicately:
Fecal material can be introduced when it washes off of swimmers’ bodies or through a formed or diarrheal fecal incident in the water. The risk for pathogen transmission increases if swimmers introduce diarrheal feces.
Though the CDC only tested pools in Atlanta, they’re pretty sure that the results apply to the whole country. As the CDC tells the Associated Press, outbreaks of diarrhea are common across the country. Along with taking a pre-swim shower, the health agency wants to remind you that it’s probably a good idea to not drink the water.
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