I'm a big fan of modern medicine.
But I recognize it's limitations and weaknesses, too.
One of those is these: It largely ignores the role of nutrition, and in particular it ignores the role that nutritional supplements can play in preventing and treating various conditions.
Why is that?
One of the reasons is that doctors aren't given a great deal of training in nutrition. Another reason is that drug companies aren't interested in the subject.
Why is that?
Because they make their money off drugs–synthetic substances that they can patent and then charge lots of money for.
I don't begrudge them that. I'm glad that they're developing new drugs, and given the costs of doing that, they need to be able to make their money back and make a profit.
But there is one aspect to this that can be rather insidious.
You see, the human body contains a lot of different natural substances that it needs to run right. Sometimes it needs particular natural substances to repair itself.
But you can't patent these substances, and they are often easily derivable from natural sources that don't require a patentable process to extract them.
That means drug companies can't make money off them. Or, rather, they don't think that they can make the kind of money they'd want in order to invest in producing them.
So what do they do?
Often times they'll sink a lot of research dollars in coming up with a synthetic substance that mimics the function of a natural one or that stimulates production of a natural one in the body–or something along these lines–and this synthetic substance they can patent and make a lot of money off.
If they can sell it to doctors, who (just coincidentally) don't know much about nutrition or nutritional supplementation.
What's bad about that?
Well, for one, it costs patients (directly or via their insurance companies) a lot more money to pay for the synthetic substance when they could just take the original natural one.
For another, the synthetic substance may not work exactly like the natural one. It may, for example, have side effects that the natural one doesn't. (Because, y'know, it's not naturally found in our bodies. Though, N.B., that I'm not arguing that just because something is natural it's automatically harmless or harmless in a particular dose or automatically effective or effective at a particular dose.)
So I don't like this aspect of the situation.
What brought all this to mind?
IT WAS THIS STORY ABOUT A NEW INSOMNIA DRUG.
As a life-long suffer of insomnia (when people ask me "Where did you get your theological background?" I tell them "School of Late Night Studies"), I'm always interested in possible insomnia treatments, so I read the story. And guess what it says?
Maryland-based Vanda Pharmaceuticals Inc. reported on two studies of its drug tasimelteon, also known as VEC-162, that showed it helped patients sleep longer and more deeply than a placebo.
Okay, great. A drug company has come up with a drug that stimulates melatonin production and, as a result, people taking the drug sleep better than if they take a placebo.
Fine.
But . . . uhhh . . . excuse me. . . . why don't people just take some melatonin?
I mean, melatonin is a natural substance that is widely available. It's in every nutritional supplements store out there.
Why spend lots of money (directly or via your insurance company, which ultimately has to be paid for out of the customers' pockets) to take a drug that stimulates melatonin production when you could just take melatonin itself?
I can imagine reasons.
For example, some natural substances are ones that we can't nutritionally absorb by eating them. Some, for example, need to be taken sublingually so that they go into the bloodstream directly, bypassing the digestive system. And, in fact, there are sublingual melatonin tablets out there. Whether melatonin needs to be taken that way, I don't know, but it's available either way.
So . . . why?
The story notes toward the end:
Okay, so we are offered two reasons: First, over-the-counter supplements aren't regulated the way drugs are.
That's not a sufficient argument. Lots of things, including food, isn't regulated the way drugs are, and it's a good thing, too. Imagine what would happen to your ability to eat if every single meal you consume had to be prepared under strict, patented processes that had been rigorously scientifically tested for safety. Even the cost of the healthiest food in the world would skyrocket.
Lack of comparable regulations thus isn't a reason on its own. If one wants to argue that something should be avoided if it hasn't been regulated the way drugs are then one needs to show (a) that it needs to be in the same class as drugs and (b) that the regulations on drugs are calibrated correctly.
The second reason was that OTC melatonin products "have not been consistently shown to help treat jet lag and other sleep disorders."
That is a fascinating statement for sooo many reasons.
For instance: "Consistently"? Is that an admission that some studies have shown them to help these conditions, though not all? Just how many studies? What the ratio? How were they done?
And . . . just how many studies have been done on the new melatonin-encouraging drug? One?
Something like a third of all studies turn out to be wrong. Is the stution that we have a bunch, though not all, studies saying melatonin helps sleep disorders but only one saying that the new drug does?
And if the drug company is interested in arguing to Reuters that their drug is preferable to natural melatonin (note that the story says "they pointed out" these arguments), why did they only test it against a placebo instead of melatonin itself?
Interesting questions!
Jimmy, as a fellow sufferer, I found that the only thing that consistently works is clearing my mind from the thoughts of the day. I took melatonin for awhile, but I got scared that I might need it to fall asleep so I stopped. I found that it worked about 50% of the time. Also, let me take a moment as a PSA and recommend against alcohol.
Hot bath and a cold room usually work for me, barring my brain just refusing to shut down for the night.
(Raises and lowers the body’s temp, which is what happens when you sleep, so it kinda tricks your body into thinking “I meant to do that”– at least, that’s how it was explained to me)
Interestingly enough, I find that staying awake after Compline (Night Prayer) can be quite difficult, whereas otherwise I have no trouble staying awake well into the night to the not-so-wee hours of the morning. So if I need to get more work done on a particular night, I sometimes put off Night Prayer so I can stay awake.
why don’t people just take some melatonin? I mean, melatonin is a natural substance that is widely available. It’s in every nutritional supplements store out there.
In addition to the answers you found in that news article, the company who is developing the new drug answers, “What you get in a health food store isn’t necessarily pure and the dose isn’t necessarily what they say on the bottle.” And reportedly, “Melatonin itself does not make a practical drug for treating circadian rhythm-associated insomnias because of its pharmacokinetic properties.” And of course, no supplement is legally approved in the U.S. for sale for the treatment of sleep and mood disorders.
if it hasn’t been regulated the way drugs are then one needs to show (a) that it needs to be in the same class as drugs and (b) that the regulations on drugs are calibrated correctly
Or, one needs to show (a) that the product doesn’t need to be a drug, and (b) that regulations on supplements are calibrated correctly. As to (a), supplements cannot be legally sold for the treatment of sleep and mood disorders. As to (b), “What you get in a health food store isn’t necessarily pure and the dose isn’t necessarily what they say on the bottle.” Some people are happy gambling at the health food store and self-medicating as such. Others aren’t.
just how many studies have been done on the new melatonin-encouraging drug? One?
In November 2006, results were announced from the Phase III trial of tasimelteon in transient insomnia. In June 2008, results were announced from the Phase III trial of tasimelteon in chronic primary insomnia. The trial was a randomized, double-blind, and placebo-controlled study with 324 patients. Tasimelteon is also ready for Phase II trials for the treatment of depression. The company will have to conduct additional Phase III trials for tasimelteon in chronic sleep disorders prior to their filing of an NDA for tasimelteon. For example, a limitation of the studies to date was an inability to evaluate daytime effects, and a multiday study in patients with chronic circadian rhythm sleep disorder — a different population than that targeted in the Lancet studies — would be needed to fully assess daytime effects. Also, important pharmacokinetic caveats still need to be investigated.
To expand on what Milton said above, melatonin (and other herbal supplements, like St. John’s Wort or ginkgo biloba) are not classified as drugs by the FDA. A new drug goes through years of extensive tests before FDA approval. For a new herbal supplement the company only needs to give the FDA 75 days notice, and since it’s a supplement, they don’t need to do efficacy testing. Thus, you can’t be sure you’re getting the correct dose from a herbal supplement because nobody knows what the correct dose is!
For more in-depth info, go here: http://www.quackwatch.org/02ConsumerProtection/dshea.html
Here’s a summary of the pertinent legislation: http://vm.cfsan.fda.gov/~dms/dietsupp.html
For me, saying a few decades of the Rosary gets me right to sleep.
The first difference I can see between the drug and just taking melatonin is that the drug is stimulating the body to produce more melatonin.
While it may not seem like that huge a difference, there can be quite a difference in long-term impact. If you only used a wheelchair to move around instead of walking, your legs would atrophy, and you’d reach a point where using the wheelchair was no longer optional. It’s possible that overdoing the supplement would atrophy the body’s ability to generate its own melatonin.
On the other hand, the body has some way of triggering the production of melatonin, and the drug could have the same impact, just one step back. Instead of reducing the body’s ability to produce melatonin, it could reduce the body’s ability to produce the triggering signal, and thus you’d end up with the same problem.
Personally, I think that dietary supplementals need to be improved to deliver consistent doses (something that doesn’t require government oversight). That would remove one of the biggest arguments I’ve seen against them.
Now, none of that addresses the underlying problem…why isn’t the body working the way it’s designed to? Both the drug and supplemental merely treat the symptom (insomnia).
Sorry, but I’m one of those individuals who fall asleep the moment their head hits the pillow, so this doesn’t impact me much. My wife deals with insomnia occasionally (no, I don’t snore that badly).
Begrudging or not begrudging the pharmaceutical industries their (reasonable or unreasonable) profits, it’s good to recognize that they have a big motivation to say “hey, look over there!” if there’s something that they can’t patent and own that might solve the problem over here. Certainly they have a responsibility to their stockholders, but it’s one that runs directly counter to their responsibility to the public sometimes.
And, while herbal and dietary supplements aren’t subject to FDA approval, it’s also good to remember that the FDA process is itself vulnerable to influence by the highly organized, motivated and funded lobbying arms of the large pharmaceutical industries. Those lobbies are one reason that we’re unlikely to see any kind of certification program for non-synthetic/naturally occuring or otherwise unpatentable substances, however beneficial such a program might be fromm a public health standpoint, IMH(but slightly cynical)O.
If you do pursue dietary and herbal remedies, one way to do so while still exercising some amount of caution is to both research the subject yourself and to develop a relationship with someone who is more knowledgable. Many times Co-Ops and natural food stores are staffed with at least a couple of people who have fairly extensive (sometimes anecdotal, sometimes research based) knowledge of the products that they sell. This requires using some people-evaluating skills of your own, finding a person and a store that you’re comfortable with and that you trust. It isn’t as convenient (or impersonal) as just picking something with a label off the shelf, but there are real benefits in terms of wellness that can come from cultivating these kinds of relationships, beyond the money taht you can save.
OTOH & as an anecdotal caveat regarding melatonin itself: I tried it myself for a while a few years ago, & did so without following any of the advice that i gave above. (I’d like to think that I’m smarter now ) & it did help, about 50% of he time, but it also seemed to have some side effects in terms of overall energy level. I stopped using it after a specialist in brain chemistry that i met through work (long story) said that a glass of warm milk would likely b ejsut as effective.
Ahh..my overall energy level probablyu corresponds to Milton’s quoted “pharmacokinetic properties” eh?
The literature on chronobiology is huge and the literature on neurochronobiology isn’t shabby, either.
I have done tangential work in this area-specifically phase shifts in neural oscillators and the work is really cool, although still relatively primitive. Some of the cooler writers on the subject, at least I think, are (the late) Arthur Winfree, whose book, “The Geometry of Biological Time,” is a classic and Leon Glass and Michael Mackey, who wrote, “from Clocks to Chaos”.
Unfortunately, the resetting of the body’s internal clock isn’t as simple as “flood the system with melatonin.” There are systems that are interconnected that depend on phase entrainment to couple together. One can, in theory (although I don’t know how), cause some of the systems to decouple.
There are many systems that are controlled by hormone-like systems (such as sleep, reproduction, etc.) and there is a complex balance that occurs between the various “clocks” of these processes. Some of the processes are relatively robust and not easily disturbed, but some can be thrown off fairly easily.
Beyond the question of regulated drugs vs. non-regulated dietary nutrients, is the question of basic science. Most of the basic science that is done in circadian rhythms is funded by NSF and the like. There may be not only an economic bias against dietary nutrients, but also a sociological one. Nutritional supplements just don’t have either the lab control or the “coolness” factor of laboratory produced compounds to entice many scientists in well-funded labs to research them.
I would love to see more research in nutritional supplementation, but under current budget restrictions and the prevailing sociology of science, I don’t see it happening, not to mention the lobbying by pharmaceutical companies.
The Chicken
melatonin is a natural substance that is widely available. It’s in every nutritional supplements store out there.
Just to note… While melatonin is a naturally-occurring substance, the melatonin sold in health food stores is almost always synthetically produced (i.e. man-made) and not natural except in the sense that the man-made product would be chemically identical to the natural variety. Buying true natural melatonin (if anyone sells it) is not recommended for a variety of reasons, including animal-sourced contaminant concerns (think mad cow).
By comparison, the new drug is also man-made but not naturally occurring (as far as I know).
And of course, the act of popping a melatonin pill or drug is itself generally not considered natural.
why did they only test it against a placebo instead of melatonin itself?
Comparison only against placebo is standard practice in preparing for FDA new drug approval. Effectiveness comparisons with melatonin are not needed for FDA new drug approval. And as melatonin supplements cannot legally be sold for the treatment of sleep and mood disorders, the effectiveness of melatonin supplements for such treatment is also legally moot. I could also mention the added cost, potential confusion or risk to the results the FDA is looking for, as well as potential ethical concerns of doing additional unnecessary tests with an unapproved drug.
However, studies of ramelteon (which reportedly has the same mechanism of action as the new drug tasimelteon) in animals have shown efficacy over melatonin. For example, in cats, ramelteon was shown to be more effective than exogenous melatonin in promoting and maintaining sleep. And in monkeys, ramelteon demonstrated significantly shortened sleep onset latency and increased total duration of sleep compared to melatonin.
Aside from guessing at the similarities between animals and humans, one might also guess using some technical factors that may weigh in favor of the new drug, or at least ramelteon. One is that the half-life of circulating ramelteon is considerably longer than that of melatonin, which may make ramelteon preferable to melatonin in supporting sleep maintenance. Ramelteon also reportedly may act more specifically on the sleep-onset process than melatonin. And in addition to exhibiting selective affinity for MT1 receptors, ramelteon has been shown to have a 3- to 6-fold higher affinity for human MT1 and MT2 receptors (expressed in Chinese hamster ovary cells) in comparison to melatonin. None of these factors proves that the new drug is more effective than melatonin in humans, and to my knowledge, even though ramelteon has been on the market since 2005, there has yet been no (human) clinical comparison study with melatonin. However, in an evidence-based review in 2008 comparing ramelteon against some other standard hypnotic agents, clinical efficacy data indicated ramelteon had moderate efficacy in reduction of sleep latency in adults of all ages with chronic insomnia, with estimated effect sizes (in comparison with placebo) roughly comparable to other standard hypnotic agents.
The first difference I can see between the drug and just taking melatonin is that the drug is stimulating the body to produce more melatonin.
Like ramelteon, the new drug tasimelteon is a melatonin receptor agonist. It selectively affects/alters the activity of the melatonin receptors. In addition, to the extent it’s like ramelteon, the metabolism and oxidation chemistry of the new drug is entirely different from that of melatonin. Precisely if or how the new drug may shift melatonin levels, I don’t know.
It could reduce the body’s ability to produce the triggering signal, and thus you’d end up with the same problem.
It could, maybe. Again going by what (little) we know about ramelteon, although the extent and duration of melatonin receptor desensitization following ramelteon therapy are unknown or not fully known, these effects are described as “probably limited” (in the short term at least), as clinical studies have shown no next-day hangover, withdrawal symptoms, or rebound insomnia with ramelteon. But the long term effects of these new drugs are not known.
Another potential concern, according to limited data, is that the concentration of one of ramelteon’s metabolites measured after the therapeutic dose was only one third of the no-effect level for induction of hepatic tumors in male mice, and micronuclei formations were observed in Chinese hamster lung cells after metabolic activation. Would the same apply to the new drug tasimelteon?
I think that dietary supplementals need to be improved to deliver consistent doses
In many cases, the supplements are not standardized. But in others, they have gone to some effort, it seems. Consumer Labs sampled some melatonin supplements this year and also did so back in 2002. As I recall, in the 2008 study, of the 10 products they sampled and analyzed, all contained (at least) the advertised dose and none had lead levels of concern, according to however the tests were performed. In 2002, of 18 products they sampled and analyzed, one did not have the amount of melatonin advertised and another contained a notable amount of lead.
I am a big fan of Big Pharma, but I take melatonin supplements to fall asleep. I thought they wouldn’t work, but the first time I took it I fell asleep quickly.
It doesn’t work all of the time – for example, if I am overly stressed. I find it a gentle way that helps more often than not.
I find it interesting that they take a swipe at melatonin in claiming it does not always work; but at the same time advocate a drug that helps the body produce melatonin under a claim that it does help.
Are they claiming that it is the production of melatonin (not the melatonin itself) that helps people sleep??
Perhaps they are not being completely honest with us.
One of the (seemingly) potential hazards of even taking melatonin supplements is that their presence in the body may induce the body to shut off its natural ability to produce melatonin, thereby creating supplemental dependency for sleep and exacerbating the whole problem.
The body is extraordinary “smart” after all: when it sees a natural substance artificially introduced to it it tends to shut down its own capacity to produce the substance to avoid unhealthily high levels of the substance in the body.
Everything you ever wanted to know about melatonin.
Click through the arrows at the bottom.
The Chicken
This is off topic. But I just recently started listening to you on the radio. I was able to find this blog.
But, WOW.
It’s insane how many different topics you know Jimmy. One day you’re talking about historical issues, another you were talking about Greek and Hebrew language, then recently I heard you talking about 4 dimensional cubes. It’s so great listening to you.
I would like to be an apologist too. But hearing you kind of intimidates me. Because I don’t have a clue how I could get a knowledge base as vast as yours.
Do you have any tips? Should I go back to school? Sometimes my studying fields like buckshot. Alittle over here with infant baptism, alittle over there with the Spanish Inquisition. Topics with Evangelicals and then topics with atheists. I just don’t feel my knowledge is that deep. Like a veneer.
How do you do it?!?!?
God bless and thank you, Jimmy
Hey Timmy
I remembered that Jimmy has already answered someone about it.
Thanks for the link Matheus!!
The reason that it’s significant that over-the-counter nutritional supplements aren’t regulated is that there’s no guarantee that the pill you buy will actually have any melatonin in it, so you could be throwing your money away.
My husband and I have our own cynicism with Western Medicine. I agree that more research and education on nutrition and nutrition supplements is needed. After 10 years of various health problems, including insomnia, crushing fatigue, headaches, emotional disturbances, precipitous weight loss, heart palpitations, digestive disturbances, and other stuff, my husband got sick of the medical establishment brushing him off. The final straw was when a doctor said he was too obsessive about his diet and wanted to put him on Prozac. (He was “obsessive” about diet because everything he ate made him feel sick and overwhelmingly tired, and he had lost 50 lbs in about 3 months and looked like a walking skeleton). Anyway, after months of research on the internet and many conversations with “alternative medicine” and nutrition types, he finally discovered that he is allergic to corn. After eliminating corn from his diet and from his personal care products (a tall order, believe me), he is feeling mostly normal again and is able to maintain a more normal weight. As for the insomnia… he tried melatonin and it didn’t work for him. What worked best was Benadryl… sometimes four times the recommended dose, but he was eventually able to wean himself off. What actually ended his insomnia was one day at Mass, he was looking at the Host at the Elevation, and he felt something “loosen” in his head. He hasn’t had a problem with insomnia since, and has a deep devotion to the Eucharist.
Milton said:
“Comparison only against placebo is standard practice in preparing for FDA new drug approval. Effectiveness comparisons with melatonin are not needed for FDA new drug approval.”
Only if there is a lack of information pertaining to or a reason to doubt the effectiveness of something other than a placebo. So no, it’s not simply standard practice to test solely against the placebo.
And in this case they were already aware of the effectiveness of melatonin, so it can’t be the latter. And, we have quite of bit of information about melatonin…. so it’s not the former. Heck, if it wasn’t because of the known effectiveness and the current information we already have on it the researches wouldn’t have been placing their aim on an indirect approach to coax the body into producing more.
Also,
When studies have been done to gage the effectiveness of red wine with respects to cardiovascular health, improved response to various treatments for cancer patients.
They didn’t simply test it against water, or something assumed to be inert. They also ran those tests in tandem with white wine.
Only later finding out that red wine was significantly more beneficial in acheiving the desired outcomes. While the success of white wine was waived off as statistically insignificant.
Milton said:
“I could also mention the added cost, potential confusion or risk to the results the FDA is looking for, as well as potential ethical concerns of doing additional unnecessary tests with an unapproved drug.”
This is arguing in circles. It’s unapproved because of a lack of sufficient testing done on it. What’s the ethical dilemma in testing it to begin with? If that’s the case then with that standard their would be an ethical dilemma in testing all unapproved drugs… which would get us nowhere, because they don’t start off as approved drugs.
But still, the end result in their study is the production of melatonin. So I think you’re arguing a point that isn’t worth arguing. Jimmy’s not suggesting testing it against something entirely unrelated. But this should be clear.
“Like ramelteon, the new drug tasimelteon is a melatonin receptor agonist. It selectively affects/alters the activity of the melatonin receptors. In addition, to the extent it’s like ramelteon, the metabolism and oxidation chemistry of the new drug is entirely different from that of melatonin. Precisely if or how the new drug may shift melatonin levels, I don’t know”
I don’t see how this is related to the point Jimmy was making… the section you quoted. Sounds like you’re trying to impress with knowledge.. however unrelated to the quoted segment.
“For example, in cats, ramelteon was shown to be more effective than exogenous melatonin in promoting and maintaining sleep.”
Wait, cats? Cats? Why would cats need an insomnia cure? And how did they test that? Checked to see that the cats slept for 24 hours a day instead of just 23 and 1/2 or so?
And why does “ramelteon” sound like some kind of sci-fi name?
AS a physician, let me suggest that the volume of basic medical information (anatomy, pathology, pharmacology, etc) is so overwhelming that issues like nutrition get reduced to a lecture or two. With the obesity and poor nutrition in this country, I think there are two best hopes. One is that nutrition becomes a fundamental subject like math and reading. Second is that paramedical specialists fill the void. Physicians are probably not the best resource for this.
Jimmy,
Thanks for bringing up this point. I’ve contemplated this dilemma since I’ve been teaching NFP. The medical establishment is abysmal at helping resolve fertility issues, instead women are placed on the pill for decades and told to do expensive In Vitro when they want “their own” child. Dealing with infertility myself, I started to study nutrition and found a wealth of useful information through Marilyn Shannon.
As Marilyn taught me, melatonin is also important in fertility so I studied it and learned that it is produced in the body during periods of darkness. Consequently, I recommend wearing a sleep mask and hanging blackout curtains in the bedroom to encourage melatonin production all night. Dimming the lights before bedtime can also help.
Along this nutrition path, I’ve met more than a few Christians who are selling nutritional supplements or nutritional expertese to help people who are ignored otherwise. People who would be left by the medical establishment to suffer needlessly. Please keep them all in your prayers.