As you probably know, Professor Tim Noakes has been on trial in South Africa for a tweet in which he advised a young mother (in response to her question) to wean her baby onto high-fat, real foods. Some idiot dietician was horrified that Noakes would suggest a high-fat diet for a baby (because as we all know, mother’s milk is fat-free!) and threatened to bring him up on charges – which she did. So Noakes was dragged before The Health Professions Council of South Africa on charges of unprofessional conduct. (We can safely assume “professional conduct” therefore means “giving out the lousy, low-fat advice officially sanctioned by governments around the world.”)
The Health Professions Council of SA (HPCSA) released a press release today saying it has found Prof Tim Noakes guilty of unprofessional conduct.
That’s not possible, of course, since the case against him has not concluded. The HPCSA’s Professional Conduct Committee (PCC) that is hearing the charge against Noakes, hasn’t even heard closing argument from lawyers on both sides yet. And it only intends issuing a ruling after that, on April 21, 2017. PCC chair Pretoria advocate Joan Adams has issued a tightly worded, clearly irate statement saying the HPCSA’s press release is “devoid of all truth”.
Well, I think it’s perfectly fitting for the HPCSA to issue a press release that’s devoid of all truth. After all, so are the changes against Noakes.
Noakes has been fortunate to have some impressive experts testify on his behalf, including Nina Teicholz and Zoe Harcombe. You can read about their testimony and other aspects of the kangaroo-court proceed—er, I mean government hearings here.
I’m still hoping and praying for a Cubs miracle. During my 15 years in Chicago, I lived within walking distance of Wrigley Field. I walked to a lot of games and staggered home from a few. Man, I loved watching the Cubs … but I don’t recall the players being overweight. I likewise haven’t noticed an obesity problem while watching the World Series. But according to a recent study, most baseball players are too heavy:
Major League Baseball players have become overwhelmingly overweight and obese during the last quarter century, say health researchers. They found that the athletes’ weight held steady for over 100 years, with the majority of them weighing in at what is considered “normal,” — i.e., with a body mass index (BMI) between 18.5 and 24.9. However, around 1991 the average player’s BMI began to rise, and over the last 25 years nearly 80 percent of players fall into the overweight or obese category with a BMI above 25.
Sure, some power hitters are thick around the middle. But 80 percent of professional baseball players are overweight or obese, seriously? Have these researchers bothered watching any games?
I’m thinking that rise in BMI has a lot more to do with weight-training than with baseball players becoming too fat. Most of these guys are sporting some serious guns under those sleeves.
The USDA’s food-consumption data is nonsense
Back in this post, I wrote about a study of just how reliable those food questionnaires used in observational studies are – or more precisely, are not. Now the same researchers have produced another study pointing that the USDA’s per-capita food-consumption data is highly suspect. Here’s what lead author Edward Archer told me in a recent email:
In the study, we examined the USDA loss-adjusted food availability per-capita caloric consumption data. We found that if the US population actually consumed what the USDA was telling us we consumed, we would have lost ~12-36kg from 1971-1980 and gained ~42-98kg from 1988-2010. The actual changes from 1971-2010 were gains of 10kg and 9 kg in men and women, respectively.
Do you know anyone that lost over 80lbs and then gained well over 200lbs during that time-frame? Nevertheless, the USDA continues to publish these data as fact.
Well, I suppose somewhere in the world we can find a few people who gained 200 pounds from 1988 to 2010 … but they were probably infants in 1988. You can read the abstract of the study here.
NuVal is ByeVille
Back in 2010, I wrote about NuVal, a system for telling grocery-store shoppers which goods are good for them and which foods aren’t. It was the usual low-fat and anti-meat nonsense – such complete nonsense that on a scale of 100, a turkey breast received a “health” score of just 31, while a glass of chocolate soy milk received a score of 68, despite being loaded with sugar.
One of the developers of NuVal, by the way, was Dr. David Katz – who got in hot water after reviewing his own novel under a fake name, comparing his own writing to the works of Charles Dickens and John Milton. After being busted, Katz explained that the fake review was no big deal because he was expressing his honest opinion. Hey, we all love an honest egomaniac.
Tops Markets is getting rid of a controversial nutrition ratings system it has used to help customers make food purchasing decisions. The system rates brownie mix and ice cream as healthier than some canned fruits and vegetables.
And let’s not forget sugary soy milk being healthier than turkey.
The NuVal Nutrional Scoring System debuted at Tops in 2011. The system scores foods on a scale from 1 to 100–the more nutritious the food, the higher the number. The NuVal score is based on an algorithm developed by a team of scientists from schools such as Yale and Harvard.
The process behind the scoring has never been disclosed but the company has said it calculates a food’s good elements–such as protein, calcium and vitamins–against its bad elements–such as sugar, sodium and cholesterol. NuVal has said it does not share details about how it comes up with its scores because that information is proprietary.
Meaning we just made this @#$% up.
Two other grocery chains have dropped NuVal recently, including California-based Raley’s and Massachusetts-based Big Y, which told the Yale Daily News the system was “out of date.”
No kidding. I think we’re probably seeing the Wisdom of Crowds effect kicking in. Consumers are probably telling grocery-store managers what they think of the ratings, and the store managers are responding.
If this trend continues, perhaps Dr. Katz will retire from handing out lousy nutrition advice and turn his attention to writing more novels. I think he should compare himself to James Joyce next time … under an assumed name, of course.
My daughter Sara is a big fan of the comedy troupe Studio C. I’m a fan too, mostly because they do all clean comedy and I don’t have to worry about my kids picking up any interesting new words or ideas while watching. Sara occasionally puts a dozen or so of their YouTube videos into a playlist, then we all enjoy a family Studio C night.
Anyway, I think some of you will relate to this skit.
Last week, some local hospital sponsored a health fair where I work. Employees who wanted the free cholesterol test were told to fast overnight. At an early afternoon meeting later that day, one of my co-workers struggled to explain something, then apologized with “Sorry, I can’t think straight. I haven’t eaten since last night, and I haven’t had time to grab lunch yet.”
Heh-heh … I hadn’t eaten since dinner the previous night either, and wasn’t planning to eat until 7:00 p.m. or so. I wasn’t hungry, or tired, or mentally foggy. That’s because I’m used to it. Most Mondays and Thursdays, I don’t eat until dinner. Those are my 24-hour intermittent fasts.
If you haven’t tried intermittent fasting, I’d recommend it. I’d also recommend you educate yourself first by picking up a copy of The Complete Guide to Fasting by Dr. Jason Fung and Jimmy Moore. (Why the heck this thing isn’t called Fasting Clarity is beyond me. I’ll ask Jimmy when he visits us for Thanksgiving week.)
Dr. Fung wrote about the benefits of fasting at the end of his excellent book The Obesity Code. This book is the extended version of those chapters, with an introduction by Jimmy, fasting success stories supplied by some of Dr. Fung’s patients, and commentary by health experts such as Mark Sisson, Abel James, Dr. Thomas Seyfried and Robb Wolf.
In his half of the introduction, Dr. Fung explains that he looked into fasting largely out of frustration. He was treating type 2 diabetics the traditional way, and neither he nor his patients were happy with the results:
Instinctively, most patients knew what we were doing was wrong. They would say to me, “Doctor, you have always told me that weight loss is critical in the treatment of type 2 diabetes, yet you have prescribed me insulin, which has made me gain so much weight. How is that good for me?” I never had a good answer for this. Now I knew why. They were absolutely right; it wasn’t good for them.
As patients took insulin, they gained weight, and when they did, their type 2 diabetes got worse, demanding more insulin. And the cycle repeated: they took more insulin, they gained more weight, and as they gained more weight, they needed more insulin. It was a classic vicious cycle.
We doctors had been treating type 2 diabetes exactly wrong. With the proper treatment, it is a curable disease. Type 2 diabetes, like obesity, is a disease of too much insulin. The treatment is to lower insulin, not raise it. We were making things worse. We were fighting the fire with gasoline. I needed to help my obesity and type 2 diabetes patients lower their insulin levels, but what was the best approach?
Certainly, there are no medications that do this. There are surgical options that help, such as bariatric surgery (commonly called “stomach stapling”), but they are highly invasive and have many irreversible side effects. The only feasible treatment left was dietary: reducing insulin levels by changing eating habits.
The change in eating habits included adding various fasting protocols to a better overall diet. As Dr. Fung emphasizes in the book, intermittent fasting does not give us license to live on a junk diet on non-fasting days.
Jimmy’s half of the introduction describes his own experiences with fasting, ranging from his first attempts at intermittent fasting, all the way through his n=1 experiments with 21-days fasts. He learned a few hard lessons along the way, such as don’t drink diet sodas while fasting, and don’t try to fast when you’re in a period of high stress.
The chapters in Part One describe what fasting is and why it’s good for your health. Part of understanding what fasting is understanding what it isn’t: it’s not starvation, and it’s not living on a permanent low-calorie diet.
Starving and fasting should never be confused with each other, and the terms should never be used interchangeably. Fasting and starving live on opposite sides of the world. It is the difference between recreational running and running because a lion is chasing you. Starvation is forced upon you by outside forces. Fasting, on the other hand, may be done for any period of time, from a few hours to months on end. You may begin a fast at any time of your choosing, and you may end a fast at will, too. You can start or stop a fast for any reason, or for no reason at all.
As later chapters explain more fully, low-calorie diets and fasting produce markedly different hormonal responses. That’s why most low-calorie diets fail. We’re eating less, but still eating. The body still believes it’s supposed to store calories, but there are fewer of them. So the body may respond by slowing the metabolism. Fasting, on the other hand, produces hormones that tell the body it’s time to tap the reserves.
A decreased insulin level is one of the most consistent hormonal effects of fasting. All foods raise insulin to some degree. Refined carbohydrates tend to raise insulin the most and fatty foods the least, but insulin still goes up in both cases. Therefore, the most effective method of reducing insulin is to avoid all foods altogether. During the initial stages of fasting, insulin and blood glucose levels fall but remain in the normal range, maintained by the breakdown of glycogen as well as gluconeogenesis. After glycogen is used up, the body begins to switch over to burning fat for energy. Longer-duration fasts reduce insulin more dramatically. Regularly lowering insulin levels leads to improved insulin sensitivity—your body becomes more responsive to insulin.
And later in the book …
Most people expect that a period of fasting will leave them feeling tired and drained of energy. However, the vast majority of people experience the exact opposite: they feel energized and revitalized during fasting. Partly this is because the body is still being fueled—it’s just getting energy from burning fat rather than burning food. But it’s also because adrenaline is used to release stored glycogen and to facilitate fat-burning, even if blood sugar is high. The increased adrenaline levels invigorate us and stimulate the metabolism. In fact, studies show that after a four-day fast, resting energy expenditure increased by 12 percent. Rather than slowing the metabolism, fasting revs it up.
My hesitation about intermittent fasting (before I read more on the subject and tried it for myself) centered around the belief that I’d lose muscle mass. In a chapter titled Busting The Myths of Fasting, the book explains why that belief is wrong. Unlike low-calorie dieting, fasting actually encourages muscle growth by spurring production of growth hormone – which makes perfect sense if you think about it from a paleo perspective. If an unsuccessful hunt left paleo man weak and slow, he’d be even less likely to bring down prey on the next attempt. As the book explains:
The most potent natural stimulus to growth hormone secretion is fasting. In one study, over a five-day fasting period, growth hormone secretion more than doubled. During fasting, in addition to the usual early-morning spike of growth hormone (pulsatile), there is also regular secretion throughout the day (non-pulsatile). Both pulsatile and non-pulsatile release of growth hormone is increased during fasting. Interestingly, very low-calorie diets are not able to provoke the same growth hormone response. A study of a religious forty-day fast found that baseline growth hormone levels increased from 0.73 ng/mL to peak at 9.86 ng/mL. That is a 1250 percent increase in growth hormone, all done without drugs. And a 1992 study showed a fivefold increase in growth hormone in response to a two-day fast.
Of course, as many of us have learned from experience, fasting is much easier if your daily diet is a good one. That means real food with real fats. The book takes some well-deserved shots at the U.S. Dietary Guidelines, which turned us into a nation of carbivores who are hungry six times per day. But Dr. Fung (I’m assuming this came from him) doesn’t push a strict low-carb diet either:
Relying on macronutrient-based guidelines or calorie limits makes eating far more complicated than it should be. We do not eat a specific percentage of fats, protein, and carbohydrates. We eat foods. Certain foods are more fattening than others. Therefore, the best advice focuses on eating or not eating specific foods, not specific nutrients.
There is nothing inherently unhealthy about carbohydrate-containing foods. The problem arises when we start changing these foods from their natural state and then consuming them in large amounts. The same also applies to processed fats. Processing transforms relatively innocuous vegetable oils into fats that contain trans fats, toxins whose dangers have now been well recognized.
Chapter four summarizes the many advantages of fasting: it’s convenient, it’s free and it’s flexible – you can add fasting to your lifestyle whether you’re a vegan or a confirmed carnivore. Fasting also allows many people to free themselves of fearing every little treat:
Now, I am not saying that you should eat dessert every single day. However, fasting restores the ability to occasionally enjoy that dessert by balancing out the feast. It is, after all, the cycle of life. Feasts follow fasts. Fasts follow feasts. This is how we have always lived. Birthdays, weddings, holidays, and other special occasions have always, throughout human history, been celebrated with feasts. But those feasts should be followed by fasts.
Even if you do live on a low-carb diet, fasting provides additional benefits:
The very low carb diet does remarkably well, providing you 71 percent of the benefits of fasting, without actual fasting. But sometimes low-carb just isn’t enough. I’ve had many patients who limited their carbohydrates but still had elevated blood sugars. How do you get more power? Fasting. Insulin is the main driver of obesity and diabetes. A very low carb diet can reduce insulin by more than 50 percent, but you can go another 50 percent by fasting. That’s power.
The next several chapters go into more detail about using fasting for specific benefits: to treat type 2 diabetes, to slow the aging process, to boost heart health.
Part Two is the how-to section of the book. I know, I know: how much how-to information do we need to learn how not eat for awhile? Well, there’s more to it than you might think. There’s good advice in here on how to avoid common effects like headaches (salty broths help), who shouldn’t fast (kids, pregnant or nursing women, underweight and malnourished people), and various fasting protocols.
There’s no single protocol that’s best for everyone. Some people may find they do best with a four-hour eating window, some may prefer alternate-day fasting, some may prefer the 5:2 plan popularized by Dr. Michael Mosley in the U.K, and some may want go to for extended fasts lasting several days or longer. The book explains each protocol and describes the advantages.
My protocol, in case you’re curious, is to mix Mosley’s 5:2 with 24-hour fasts. In other words, twice per week I don’t eat for 24 hours, then eat one meal of around 600 calories for dinner. I haven’t noticed a shift in weight, but I view the fasting as a health regimen. After seeing Chareva’s father hobbling around our house because of his stroke, I’m more determined than ever to keep the biological machinery from breaking down.
Part Three is the resources section. There are suggested schedules for various fasting protocols, recipes for broths and teas that make fasting more pleasant, and lots of real-food recipes for meals on non-fasting days.
Like The Obesity Code and Jimmy’s Clarity series, The Complete Guide to Fasting is an easy-to-read, consumer-friendly book that passes my Aunt Martha test. The science nerds will also be happy to see that each chapter ends with a list of references to studies.
When the book was released, Amazon ran out of stock within days. There’s a good reason for that: it’s an excellent resource, and word got around quickly. You may have to wait for a copy, but I believe you’ll be glad you added The Complete Guide to Fasting to your library.
I’ll be brief. Saturday was a perfect day for working outside: 65 degrees and partly sunny. So Chareva and I made more progress on finishing Sara’s cabin. The side walls cover the corner gaps for the front and back walls, so I was extra careful cutting the planks. I intentionally made each cut a little too long, then shaved the plank once or twice to get a tight fit in the corners. That mostly worked. In the few places where it didn’t work, we’ll make good use of some wood filler.
Afterwards, we locked down a couple more chapters of the book, which is coming along nicely.
Sunday was Chareva’s birthday. When I asked several days ago what she wanted for her birthday, she thought for a minute, then replied, “You know what I’d really like? I’d like us to start finishing the inside of Sara’s cabin this weekend.”
I immediately recognized how considerate she was being. Instead of shopping for an hour and spending, say, 100 bucks for a present, I could now spend several times that amount on building materials, then put in two long days of manual labor to start, with several more to follow. You’ve got to love a wife who doesn’t take advantage of her husband’s generosity. So I enthusiastically agreed to the plan.
She then informed me that building materials are supposed to “acclimate to the environment” for a few days before being installed. When I asked for a translation, she said it means we should buy the building materials no later than Wednesday and put them in the cabin.
Well, okay then. It’s Sara’s cabin, so it was up to her to decide what we’d use to finish the inside. Some kind of paneling? Vertical planks? Horizontal planks?
Chareva was rooting for horizontal planks because she likes how they look. I was rooting for horizontal planks because I have no flippin’ idea how to cut and fit paneling around windows and doors. After much hemming and hawing and walking around Lowe’s looking at different options, Sara decided she liked horizontal planks. Whew. I did some quick math and estimated that 100 pine planks would do the trick, with enough to spare for the inevitable mistakes. We also picked up several rolls of insulation, an extra hammer and a shootload of panel nails.
The primary task was to cover the inside of the cabin with the planks. Here’s what the inside looked like before we started.
But before tackling that job, we needed to build a set of stairs. In its previous location, the front of the cabin was near the ground. Now it’s on a hill, and without stairs, that would be quite a step up.
We began the interior decorating with the back wall. The planks aren’t as long as the wall, so we had to choose where to join them. Sara was quite opinionated about where the joins should go. She wanted them staggered. Here she is explaining the correct pattern.
We’re not exactly what you’d call experienced carpenters, so I wondered how many panel nails we’d bend and have to yank out, then try again. I’m happy the say the answer is: only a few. Sara hammered away all day and did a fine job. So did Chareva. I did some hammering as well, but my primary job was to cut the planks with a miter saw.
The insulation is 18 inches wide. That’s because in houses, the 2x4s are 18 inches apart. In the cabin, the distance between 2x4s varied from 16 inches to 24 inches. So we ended up turning the insulation sideways and cutting it to fit, then stuffing it behind the planks.
By the end of our workday on Saturday, we had the back wall done. Here’s Sara pounding in the last nail.
Even though Chareva was happy to make the construction project her birthday present, I suggested we head out Saturday night for a nice dinner. October happens to be Wild Game Month at Rodizio Grill in downtown Nashville, one of those awesome Brazilian steakhouses where they keep bringing meat to your table until you tell them to stop. In addition to the usual variety of meats, we got to sample wild boar and rattlesnake sausage. That’s the sausage below.
Here’s the birthday girl with her husband outside the restaurant.
On Sunday, we decided we’d best tackle the front walls of the cabin, which include the front door and the windows and therefore require a bit of precision.
I observed the measure-twice, cut-once rule to avoid wasting wood. I also did more hammering on Sunday, and managed to only smack my thumb once. Not bad for a amateur.
By the end of the day, the front walls were done and looking pretty good.
We still have the side walls to cover. I don’t expect those to be much trouble. The interesting part will be figuring out what to with the upper part of the cabin. Here’s why:
I have no idea how we’ll cover those angles. But I’m sure we’ll figure it out. And I’m sure when we’re done, we’ll be enjoying a state of Dog-Tired Satisfied.
But we already knew that, right? You can hardly open a newspaper without being told this-or-that is “linked” to a higher or lower rate of cancer. Some researchers with a sense of humor decided to randomly select ingredients from a cookbook and see how many of them have been associated with cancer in observational studies. Here are the opening paragraphs from the study:
Background: Nutritional epidemiology is a highly prolific field. Debates on associations of nutrients with disease risk are common in the literature and attract attention in public media.
Objective: We aimed to examine the conclusions, statistical significance, and reproducibility in the literature on associations between specific foods and cancer risk.
Design: We selected 50 common ingredients from random recipes in a cookbook. PubMed queries identified recent studies that evaluated the relation of each ingredient to cancer risk.
A “highly prolific field” … yeah, that’s one way to phrase it. Anyway, here’s what the researchers found:
At least one study was identified for 80% (n = 40) of the ingredients selected from random recipes that investigated the relation to cancer risk: veal, salt, pepper spice, flour, egg, bread, pork, butter, tomato, lemon, duck, onion, celery, carrot, parsley, mace, sherry, olive, mushroom, tripe, milk, cheese, coffee, bacon, sugar, lobster, potato, beef, lamb, mustard, nuts, wine, peas, corn, cinnamon, cayenne, orange, tea, rum, and raisin.
We found that 80% of ingredients from randomly selected recipes had been studied in relation to malignancy and the large majority of these studies were interpreted by their authors as offering evidence for increased or decreased risk of cancer.
So darned near everything causes or prevents cancer.
However, the vast majority of these claims were based on weak statistical evidence.
No kidding. But I’ll bet most of them also led to big headlines.
At least okra doesn’t give me the munchies.
This is an old CNN story, but only came to my attention recently when a reader warned me that Chareva’s okra might lead to a raid by cops.
The grower was alarmed when the police helicopter swooped low over his property.
Soon, Bartow County, Georgia, deputies — “strapped to the gills” and with a drug dog in tow — converged on his doorstep. They had the grower dead to rights.
Except the plant that the chopper cops had spotted from the air was … okra.
The helicopter was combing the area in search of cannabis plants when it came across the five-leaflet okra plant, the station reported. Marijuana plants can have anywhere between one and 13 leaflets per leaf, depending on maturity and health, but they generally have seven or nine.
“It did have quite a number of characteristics that were similar to a cannabis plant,” Georgia State Patrol Capt. Kermit Stokes told WSB.
If you haven’t already heard Kermit the Frog in your head, explaining how okra looks a lot like marijuana, something went very, very wrong in your childhood.
“Here I am, at home and retired and you know I do the right thing,” Perry told the station. “Then they come to my house strapped with weapons for no reason. It ain’t right.”
Upon realizing that it had dispatched officers to confiscate a popular gumbo ingredient, the Georgia State Patrol, which operates the task force, issued an apology, both to Perry and publicly.
I’ll bet Mr. Perry was so annoyed with the cops, he gave them each a bag of okra.
Spread the news: Butter may not be the unhealthy food many Americans believe it to be, new research suggests.
“Overall, our results suggest that butter should neither be demonized nor considered ‘back’ as a route to good health,” study senior author Dr. Dariush Mozaffarian, dean of the Tufts University School of Nutrition Science and Policy in Boston, said in a university news release.
The new study was funded by the U.S. National Heart, Lung, and Blood Institute. Mozaffarian’s team reviewed data from nine studies that included more than 636,000 people living in 15 countries.
The findings showed that eating butter was only weakly associated with increased risk of premature death and not associated at all with heart disease. There was a slight association with protection against diabetes, the study found.
I’m sure those findings won’t surprise you. Unfortunately, this probably won’t surprise you either.
One nutritionist said her views on butter remain unchanged, however.
“Despite the findings of this study, I am not about to make a huge shift in the recommendations I make about consumption,” said Dana White. She is a dietitian and professor of sports medicine at Quinnipiac University in Hamden, Conn.
“Butter remains a very high-calorie and high-fat food with little nutrient density to offer, and therefore still needs to be consumed in strict moderation,” White said.
In other words: I’ve been telling people to strictly limit their butter intake for years, and I’m going to keep on doing it, no matter what the evidence says.
Head. Bang. On. Desk.
The FDA plans to poops all over poop transplants.
If you’re a regular reader, you know I think our government’s regulations are often full of poop. So it seems rather appropriate that a branch of the government wants to regulate poop, as reported by BuzzFeed.
Gastroenterologist Colleen Kelly performed her first poop transplant eight years ago, on a young woman with a life-threatening gut infection who had run out of options. The bacterium Clostridium difficile had invaded the woman’s gut, bringing her constant diarrhea and pain, and antibiotics weren’t working.
Kelly’s patient persuaded her to try a fecal transplant, in which poop from a healthy person is put into a sick person’s colon in the hope of resetting the mix of microbes there. The patient’s boyfriend provided fresh stool, and Kelly introduced half a cup of it into her patient via a colonoscopy. To Kelly’s surprise, it worked — by the next day, the woman’s symptoms began to wane.
Kelly, an assistant professor of medicine at Brown University, has since performed some 300 fecal transplants for C. diff infections. These days, she usually buys healthy stool samples from OpenBiome, a nonprofit “stool bank” in Somerville, Massachusetts that launched in 2013. “It’s really unlike any therapy to date,” she told BuzzFeed News.
So this spring, when the FDA announced that it intended to tighten its rules on the procedure, known as fecal microbiota transplantation (FMT), making it harder for doctors to buy stool from banks, Kelly was among the commenters who wrote back, opposing the proposal.
It’s the typical pattern. People working in a profession find something that works. Businesses spring up to provide that something at a reasonable price. Then the feds, seeing something successful happening that they don’t control, step in to regulate.
“If the FDA makes it prohibitively difficult for clinicians to work with stool banks, I believe this will actually make the procedure less safe, and of course, less accessible,” wrote Sarah McGill, a gastroenterologist at the University of North Carolina Medical School who has performed about 30 fecal transplants on C. diff patients in the last two years.
Yes, of course that’s how it will play out. If I’ve said it once, I’ve said at least twice: most of the “protect the public” regulations that come along are backed by businesses who want to leverage the coercive power of government to stifle their competition. Public safety is merely the excuse. The BuzzFeed writer, unlike most media writers, actually understands that.
But one company, at least, welcomes more government regulation of stool. Rebiotix, a startup based in Minnesota that is developing an enema treatment of bacteria extracted from poop, told the FDA to shut down the stool banks and adopt the strictest regulation possible in dictating how samples are procured. The company contends that this is for the patients’ own good, as stool banks may not be fully screening their samples for diseases.
And now for the real reason …
Rebiotix is also worried about its bottom line. If the company’s poop-like drug for C. diff makes it through the rigorous clinical trial process before anybody else, it would win the rights to be an exclusive seller of the product for seven years, gaining a huge lead in a market expected to be worth $1.5 billion by 2024.
Anyone who tells you the FDA is imposing this limit on patient choice to protect the public is full of unregulated poop.