There is More Regulation of Your Dog's Medicine than Your Dietary Supplements

Did you know that in the U.S. drugs for animals are regulated by the Food and Drug Administration (FDA), which means that they must be shown to be safe and effective, and are manufactured under tightly controlled conditions?

Did you know that dietary supplements for people generally receive little-to-no scrutiny by FDA?

Last week's Science had a nice story of one physician's David-and-Goliath fight against tainted supplements. It all began when Dr. Pieter Cohen noticed that patients taking the same weight loss supplement started getting sick. This started him on a quest of testing various supplements for extra substances (chemicals, hormones, etc) and his work is getting the FDA's attention.

To understand the regulatory issue, you need some background. The dietary supplement industry is practically a libertarian's dream:

THE MODERN SUPPLEMENT ERA began in 1994, when Congress passed the Dietary Supplement and Health Education Act, or DSHEA (pronounced duh-shay-uh). In the decades before, the supplements industry was overwhelmingly focused on vitamins and minerals. Much of the regulation centered on recommended daily allowances of products like vitamin C, iron, or calcium.

DSHEA established the first broad framework for regulating supplements. It also gave supplements a legal definition: as substances intended to “supplement the diet,” containing “dietary ingredients” such as herbs, botanicals, or vitamins.

At the same time, the law sharply curtailed FDA's power. Companies were not required to notify FDA provided the dietary ingredient had a history of use before the law was passed. For the first time, DSHEA allowed them to make claims on the label suggesting supplements affected the structure or function of the body—for example, by boosting the immune system or protecting prostate health. And DSHEA codified a loose arrangement: Under the law, as FDA notes on its website, “unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to ‘approve’ dietary supplements … before they reach the consumer.” The agency can act only after a supplement is on the market and evidence shows it's unsafe.

The article is accompanied by a graphic that says that "prescription and illegal drugs are routinely found in supplements." It has two examples of supplements that are supposed to help with sexual enhancement. Any guesses what was found in them? Answer: Viagra. The article gave me a little more sympathy for athletes who claim that they didn't know their supplements contained a banned substance. They really may not have known!

FDA has a Q&A page about supplements. It's worth reading through the whole thing, but check out this gem:

Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?

No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information.

The next time you are in the pharmacy, have a look at all of the products with the disclaimer that their claims have not been evaluated by the FDA.

I'm going out on a limb here, but my sense is that straight-up vitamins and similar products are not the main problem (though they may indeed be a waste of money [1]). Rather, in my opinion products that are claimed to actually help some kind of performance (strength, sexual, weight loss, etc) are more likely to have some kind of drug or hormone to help produce the desired effect, or the illusion thereof. Most people who take a multivitamin or similar product are not going to notice any substantial difference in their health, nor will they care. But when it comes to, say, weight loss supplements, consumers will expect to see some progress. The balance of incentives and disincentives to play fast and loose with the truth and your safety are quite tilted toward the manufacturer.

The irony of course is that many consumers of dietary supplements are operating under the illusion that they are avoiding 'unnatural' substances, or that the law wouldn't let manufacturers put claims on the bottle that are not true. In reality, most consumers don't really know what they are consuming, and don't realize how little evidence manufacturers need behind their products.

You have been warned.


Notes:
1. Most people get all the nutrients they need from their diet. However, I fully accept that some dietary supplements may be helpful for some people.

---

Continue reading...

Book of Mormon DNA Apologetic Arguments Have a Shelf-life

There have been a couple of scientific advances on Native American origins this summer. First, DNA was finally isolated from the 9,000 year-old Kennewick man (KM) and it is clear that he is closely related to several current Native American tribes. Some had argued based on skull morphology that KM was more closely related to Australians and that his ancestry was outside of the East Asian/Siberian mainstream. However, the genetic evidence now puts him firmly within the Native American mainstream.

The second finding, reported by two separate groups a couple of weeks ago, is that some Amazonian tribes have a small DNA contribution from a common ancestor of indigenous Australians and Melanesians. This Boston Globe article is one of the better ones I have seen (and it has a nice accompanying graphic). It is very easy to get confused by the differing interpretations of the data. From what I have read, it boils down to this: Does the Australian DNA come from migrants who came into the New World around the same time as the East Asians/Siberians (>15,000 years ago), or later through the Aleutian Islands around 9,000 years ago? Some news articles use the terms ancient and recent without being clear about the associated dates, which can lead people to imagine evidence of trans-Pacific voyages. That is NOT what is proposed here.

At first glance this has nothing to do with the Book of Mormon. The Asian ancestry of Native Americans is nothing new, and the timing of the migrations inferred from the above studies occurred long before the Book of Mormon chronology. Defenders might even point out that the added complexity that has been discovered shows that we must remain open-minded about Native American genetics because surprises do happen. However, there may be subtle implications for the future of Book of Mormon apologetics, which rely heavily on the population genetics principles of founder effect, genetic bottlenecks, and genetic drift.

To make things easy, I'll break my point up into several bite-sized propositions:

1. Although the exact genetic signatures that the Jaredites/Lehites would have carried are unknown, each advance in characterizing the ancient origins of Native American genetics helps to establish the background from which Jaredite/Lehite markers would stand out. We may not know exactly what we are looking for, but we have an increasing ability to recognize markers that are unusual.

2. Mitochondrial DNA and Y chromosome types are particularly sensitive to genetic drift, etc.--a point made in the two papers describing the Australian connection. Originally most ancient genetic research focused on mtDNA and Y chromosomes because they were easier to deal with. However, the technological advances in recovering and sequencing autosomes (i.e. most of the genome) have greatly improved in the last decade.

3. Autosomal markers are more resistant to disappearing from populations. It's one thing for mtDNA or Y chromosomes (which are inherited by daughters and sons, respectively, as a block) to go missing; it's another for all traces of autosomes (which mix by recombination each generation) to disappear. As an example, scientists initially ruled out interbreeding between modern humans and Neanderthals based on mtDNA differences. However, once the Neanderthal genome was sequenced, it became clear that modern humans of ancient European decent got about 4% of their DNA from Neanderthals (which went extinct ~30-40,000 years ago).

4. The increased ability to recover and sequence DNA from ancient remains means it is probably only a matter of time before a variety of genomes dating from Book of Mormon times--and in the favored locations--are recovered. It is one thing to explain why modern Native Americans do not show any genetic relationship to the Middle East; it is another to explain why two thousand year-old Mesoamerican remains do not show any genetic relationship.

I am not suggesting that genetic studies are going to definitively disprove the Book of Mormon as an ancient American record. What I am suggesting is that, as the science around Native American origins progresses and the realm of plausibility contracts, the current arguments that Book of Mormon defenders advance with respect to Native American DNA will begin to wear thin. That is, unless a pre-Columbian Middle-Eastern genetic signal is discovered. But if that happens, we won't need the current arguments any more. So either way, we are marching toward their expiration date.

---

Continue reading...

BYU Tears Down Another Piece of My Past (WIDB)

It seems like every time I visit my undergraduate alma mater another construction project has destroyed a building of significance to me. Most recently, the Widtsoe building (WIDB) was torn down in May/June after the new Life Sciences building was dedicated. As a microbiology major, I spent a lot of time in the WIDB (and waiting for the elevator). And since most of that time was in my junior and senior year, I also associate it with the vast career unknown that lay before me at the time.

Here's a fun memory: As part of a micro lab class we had to culture the aerobic and anaerobic bacteria in our own poop! When the time was right, I took the little cup I was given to a bathroom in the southwest corner of the sixth(?) floor and...ready, aim, fire. This was all kind of awkward, but really, would you rather culture your own poop or someone else's? I then nonchalantly (I like to think) walked over into the lab and swabbed my specimen onto agar plates. (Meanwhile, over in the Tanner building, students were learning how to make money.)

I recognize the need for the university to update facilities, but it would be nice if they could leave a few buildings more or less the same so that I can show my children and grandchildren the actual locations of my memories. 'I once cultured my own poop in a building that used to be right there' just doesn't have the same punch.

Here is a time-lapse video of the demolition of the WIDB.

---

Continue reading...

The Story of John Taylor's Watch Seems Too Good to Let Go

I just returned from my summer vacation, part of which included a visit to Carthage Jail. When the sister missionary leading our tour told us that John Taylor's watch had stopped a bullet, I figured it was just one missionary repeating the traditional story. Later, in the bedroom where Joseph and Hyrum were killed, and John Taylor nearly-killed, we listened to an audio production that also told the traditional watch story. I realized that the issue of accuracy went beyond the missionary.

While John Taylor was recovering from his bullet wounds, received during the martyrdom of Joseph and Hyrum Smith, his family noticed a small hole cut in his pocket and damage to the face of the watch. He and his family came to believe that his watch had stopped a bullet, which not only saved him from another (perhaps fatal) wound but also prevented him from falling out of the window. The story has become a prominent part of the story of the martyrdom, and serves as a faith-promoting miracle in church history. It can be found in church publications as recent as the 2011 John Taylor manual. The problem is that it probably isn't true.

Historian Glen M. Leonard was the director of the Church History Museum for twenty six years. In his book, Nauvoo: A Place of Peace, a People of Promise (published by Deseret Book in 2002), Leonard wrote that after John Taylor was shot in the leg,

He collapsed on the wide sill, denting the back of his vest pocket watch. The force shattered the glass cover of the timepiece against his ribs and pushed the internal gear pins against the enamel face, popping out a small segment later mistakenly identified as a bullet hole.

The reason for the alternative story, simply put, is that the damage to the watch is not consistent with a bullet hitting it. Consider that Hyrum's watch was much more damaged by a bullet that had passed part-way through his body. Other leading historians, such as Richard Bushman in Rough Stone Rolling, have followed Leonard's lead [1].

This information has been known for over a decade, and was featured in a 2010 BYU Education Week presentation that was reported in a Deseret News article, so why hasn't it penetrated the presentation at Carthage Jail (to say nothing of the average saint, or even the 2011 manual)? It's possible that I'm being too nit-picky, but how would you feel if you spent your mission repeating the story every day, only to find out later that it was known to be mistaken since you were at least 3 years old?

I am happy to report a couple of signs of progress. First, the new Institute manual, Foundations of the Restoration, omits the watch entirely in its treatment of the martyrdom.

As the conflict at the doorway increased, John Taylor tried to escape the room through a window. As he attempted to leap out of the window, he was shot in the thigh from the doorway and was also shot by someone outside. He fell to the floor, and while attempting to get under the bed next to the window, he was severely wounded by three more shots.

Second, and more importantly, an article published last April in the history section of the Church's website, John Taylor's Miracle, is devoted to the damage of Taylor's pocket watch. Although it bends over backwards to retain the miraculous in his survival, it does a nice job of gently putting the traditional story to rest--or at least legitimizing the alternative.

So now you don't have to cite some historian nobody cares about [2] when challenged on the revision of the pocket watch story. Instead you can cite the Church's own website. Maybe someone should tell the missionaries at Carthage [3].

Notes:

1. The LDS history blog Juvenile Instructor has a nice summary of the issue, with great references that I am too lazy to reproduce here.

2. You know what I mean.

3. I didn't raise the issue when I was there because I was afraid I would sound like a jerk, and it wasn't until I returned home that I found the Church article. However, given the number of people who tour the jail, I find it hard to believe that nobody has ever called them on it.

---

Continue reading...

EVEs Are Bone of Our Bones and Flesh of Our Flesh

When we think of the human genome, we generally have in mind the collection of genes that make us human. What most people don't realize is that a significant portion of their genome (at least 8%) actually comes from viruses, and these parts are called endogenous viral elements (EVEs). EVEs, and other genetic elements like them [1] (which all together make up around half (!) of the human genome), can help establish genetic relationships because they are like molecular fossils. In fact, the term 'paleovirology' has been coined to describe their study. A paper from 2010, aside from being interesting in its own right, has a great illustration that helps to convey this concept [2].

The left side is not very important for our purposes, but basically it shows various types of viruses and the pathways that can land their genetic material into a host genome. The box in the middle-bottom represents double-stranded DNA where the viral sequence has integrated into a host genome.

The right side of the figure represents what happens after that. When the virus integrates into a host genome, it doesn't instantly become part of the genome of the whole population. At first, only one individual in the population has the virus in its genome in a particular spot. However, when that individual has offspring it can pass on the viral element as if it was just another gene. Simply by chance (or perhaps due to selection) the new genetic variant containing the EVE can become more common in the population. (That exact scenario is currently happening in koalas.) Not every individual has it, just like not every human has color blindness, type A blood, blue eyes, or blond hair. Eventually, though, the variant may go extinct, or it may become fixed, which means that every member of the population has it. From that point on, all descendants will have the viral element in the same spot of the genome (unless it is secondarily deleted, which generally leaves a genetic scar).

So looking again at the right side, we can see a rabbit-like species that eventually gave rise to three daughter species. The population giving rise to species C branched off before the EVE invaded the genome, so it is clean (in that specific genetic location). When the EVE first invaded the host genome, it was passed along to descendants until it became fixed--present in all members of the species. So when species A and B branched off, both were marked by the EVE. If you knew nothing about how species A, B, and C were related to each other beforehand, the presence of the EVE in identical spots in the genome would tip you off. After all, the genome is a large place and the likelihood that two EVEs would independently end up in the exact same location are pretty small. This also works for populations within a species as well.

With improvements in technology over the last 10-15 years, scientists have been sequencing the genomes of all kinds of animals to see what is in them. It turns out that EVEs are all over the place. Scientists looking for the presence of one type of human EVE in other primates got results like what is shown below. In case it isn't obvious, the entry of each virus group is mapped onto the primate family tree, and it communicates much of the same information as the figure above, with humans and chimpanzees most closely related because they share the most EVEs [source].

Probably most of the EVEs are just genomic junk hanging around. Sometimes they can cause problems by disrupting a needed gene or its regulation (see: cancer). However, occasionally they can be helpful. For example, in mammalian evolution retroviruses have repeatedly, and independently, donated a gene that is used in placenta formation.

Their critical role in fetal development, their ability to reveal common ancestry, and the fact that they are an integral part of us--all of this makes EVE a fitting name.


Notes:
1. Things like transposons, LINEs, and SINEs (especially Alu elements).
2. Katzourakis A, Gifford RJ (2010) Endogenous Viral Elements in Animal Genomes. PLoS Genet 6(11): e1001191.

---

Continue reading...

Before Richard Dawkins, There Was Orson Pratt

At By Common Consent, writer WVS shared an excerpt of Wilford Woodruff's journal, which captured a speculative explanation that Orson Pratt gave for the origin of God. After referring to the trial-and-error process that chemists often go through, Pratt said:

An eternity was filled as it were with particules of intelligences who had their agency, two of these particles in the process of time might have joined their interest together exchanged ideas & found by persueing this course that they gained double strength to what one particle of intelligence would have & afterwards were joined by other particles & continued untill they organized a combination or body though through a long process...

Pratt's process is that of an individual advancing in organization. But if you look at it from a slightly different angle and apply his process to populations, then you're not very far from 'the replicators' in Richard Dawkins' The Selfish Gene. (The 'replicators' chapter defies a concise summary quote, so you'll just need to click through and read it.)

This all reminds me of something that Terryl Givens recently wrote [1]:

Mormons ironically find an unlikely (and surely unwilling) ally in the arch-atheist Richard Dawkins. In his controversial critique of religion, he wrote that: “Any creative intelligence of sufficient complexity to design anything comes into existence only at the end product of an extended process of gradual evolution.” Elaborating this point, he said that

you have to have a gradual slow incremental process [to explain an eye or a brain] and by the very same token, God would have to have the same kind of explanation. … God indeed can’t have just happened. If there are Gods in the universe, they must be the end product of slow incremental processes. If there are beings in the universe that we would treat as Gods, … that we would worship … as gods, then they must have come about by an incremental process, gradually.

It's fun when the 'new atheism' sounds like the old Mormonism!

Notes:
1. Givens, Terryl L. (2014). Wrestling the Angel: The Foundations of Mormon Thought: Cosmos, God, Humanity (p. 216).

---

Continue reading...

The Ways of Correlation are Mysterious: When Jesus Was Born

Lately I've been browsing through some of the newer manuals published by the Church. I've found some things that I like, and some things I dislike. And then there are other things that are just...interesting. Let's take the birth of Jesus, for example. In the old New Testament (Ha!) manual for Institute (1979), we find the following subheading in chapter 3: "Jesus Was Born in Bethlehem, April 6, 1 B.C." The manual then states:

After summarizing the opinions of various scholars in the matter of Christ’s birthday, Elder James E. Talmage compares their conclusions with modern revelation and then affirms: “We believe that Jesus Christ was born in Bethlehem of Judea, April 6, B.C. 1.” (Jesus the Christ, p. 104.) Of this President Harold B. Lee declared:

“This is the annual conference of the Church. April 6, 1973, is a particularly significant date because it commemorates not only the anniversary of the organization of The Church of Jesus Christ of Latter-day Saints in this dispensation, but also the anniversary of the birth of the Savior, our Lord and Master, Jesus Christ. [Quoted D&C 20:1]” (CR, Apr. 1973, p. 4.)

To help drive the point home, the manual has a graphic showing the months of the years 1 B.C. and 1 A.D. (there is no year zero), with an arrow pointing to April accompanied by the words (in two lines), "April 6, 1 B.C." and "Birthday of the Lord."

That is pretty straightforward, and it is complemented by commentary in the Institute manual for the Doctrine and Covenants. The statement by President Lee was cited by Elder Bednar in his April 2014 General Conference talk in which he said that April 6 is known by revelation to be "the actual and accurate date of the Savior's birth."

The new manual (2015) is a little different:

Concerning the year in which Jesus Christ was born, “the Church has made no official declaration on the matter” (J. Reuben Clark Jr., Our Lord of the Gospels [1954], vi). The calendar currently used throughout most of the world was created many centuries after Jesus Christ lived, and experts disagree about how to use existing historical information to calculate the year of His birth. Elder Bruce R. McConkie wrote: “This is not a settled issue. Perhaps also it does not matter too much as long as we have an accepted framework of time within which to relate the actual events of [Christ’s] life” (The Mortal Messiah: From Bethlehem to Calvary, 4 vols. [1979–81], 1:350).

For some reason the manual went from a declarative statement of belief based on revelation, to a complete punt on the year and no mention of April 6 at all. And it's not like the J. Reuben Clark quote didn't exist when the first manual was printed, so why the change?

We can only speculate, but it might in part be because in 2010, BYU religion professor Jeffrey Chadwick published an article in BYU Studies [1] that pretty much demolished 1 B.C. as a viable option, and kicked out the supports from underneath the April 6 date as well [2]. Yes, Presidents Lee, Kimball, and Hinckley made comments in support of April 6, but so far as can be determined, they were relying on a tradition started by Elder James E. Talmage in Jesus the Christ [3]. Of course it's possible that Elder Talmage was just really lucky on the April 6 part and later Church presidents felt inspired that he was right, even if his reasons were wrong [4]. Whatever the case, it seems that the authors and editors steered clear of April 6, which allowed them to avoid taking a position that would contradict a fresh conference statement by a living Apostle on the one hand [5], or lend additional support to the date on the other.

I should clarify that I support the change that the manual made, although I wish they had given the history of the topic more discussion. And who knows? Maybe April 6 will make a comeback in another manual (though I doubt 1 B.C. will). When exactly Jesus was born has zero significance to any core element of the gospel. But it is the insignificance of the issue that allows us to think about how we relate to the manuals, and issues of revelation, tradition, authority, doctrine...and of course correlation.


Notes:
1. Don't ignore the endnotes, especially 9, 10, 11, 12, and 18. A summary of the article was published in the Deseret News. FAIR also has a nice treatment of the issue.
2. Elder Talmage's use of D&C 20:1 applies with equal force to both the year and the date. In his argument, both stand or fall together.
3. In fact if you look at the first passage you will find that President Lee quoted D&C 20:1--clearly following Elder Talmage's argument.
4. Scientists, too, sometimes accidentally hit on the right answer.
5. Elder Bednar spoke in April 2014, and the manual appears to have been approved the following November. If I have misinterpreted the approval date, then Elder Bednar's talk would have come after the manual approval.

---

Continue reading...

On Being Faithful to the Future

I've been a little more active in my reading lately, but am unable to comment in detail on some of the pregnant passages I have found. So from time to time I will simply post quotations as food for thought. First up:

Often Christians focus on the need to be faithful to the past, to make sure that present belief matches that of previous generations. I support the sentiment in general, but we must be just as burdened to be faithful to the future, to ensure that we are doing all we can to deliver a viable faith to future generations.

--Peter Enns, The Evolution of Adam, What the Bible Does and Doesn't Say about Human Origins, (pp. 147-148).

---

Continue reading...