Apr 21 2015

Recent Death from Diet Supplement

Eloise Aimee Parry, 21, died on April 12 after taking 8 diet pills she bought online. The pills contained 2,4-dinitrophenol (DNP), which is essentially an illegal weight loss aid. The case illustrates the failure of current regulations to protect the public from potentially dangerous drugs. There are many factors that contribute to this failure.

First, some background on DNP

DNP is a powerful uncoupler of oxidative phosphorylation – it allows protons to leak across the mitochondrial membrane, bypassing ATP synthesis. Mitochondria are the energy factories of cells; they make energy using oxygen in a process called oxidative phosphorylation, essentially adding a phosphate atom to ADP to make ATP. ATP are the batteries of cells, they store energy in their phosphate bonds and then can release that energy to drive the reactions necessary for cell functions.

DNP uncouples oxidative phosphorylation from the generation of ATP. Therefore, in order to make enough ATP the mitochondria need to dramatically increase their metabolic rate. The body starts burning fuel and generating mostly waste heat, rather than usable ATP. This is how DNP works to burn fat and lose weight.

The problem is that the chemical is very dangerous. It is easy to overdose, resulting in runaway hyperthermia, which can be fatal, as it was in the case of Parry. She walked into the emergency department after ingesting the pills and not feeling well. There is no antidote or way to reverse the effects of DNP, so her doctors were helpless to prevent her racing metabolism and hyperthermia from killing her.

DNP was used in the US from 1933-1938 as a diet pill, but was removed from the market because it was too dangerous. It has continued use as an industrial chemical, but is not intended for human consumption. This has not stopped the black market of DNP for bodybuilders and those looking for a quick fix to lose weight.

Today you can buy DNP online, where it is marketed as a “dietary supplement.” (To be clear, this is probably not the product used by Parry, which was not specified in the reporting. It is also not clear if this product contains actual DNP. They list “DNPX” as an ingredient, without saying what it is, but do market it as a “thermogenic amplifier.”)  A UK study found that overdoses of DNP have increased sharply in the last few years. There were 22 in 2013, including 5 fatalities, with a mean age of 23.5 years.

Regulatory failures

There are several regulatory failures here, in my opinion. The first is the failure to sufficiently regulate products sold online, often imported  from foreign countries. Agencies tend to be underfunded and understaffed, and so they simply cannot keep up with the game of whack-a-mole represented by the burgeoning online supplement market. For this reason they also often rely upon foreign governments to regulate products being exported, often with disastrous results.

However, I think the biggest regulatory failure here is the very concept of “supplements” as defined in regulation. In the US supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act defines a supplement mainly by the claims made for it. A supplement cannot contain a substance that is already a registered drug, and cannot make disease claims, but can make “structure function” claims (which often imply disease claims).

This has created a profound misconception in the public as to what a “supplement” is. The general attitude is that supplements are natural and therefore safe, and are akin to vitamins. The reality is that many products sold as supplements are pharmacological agents, such as herbal drugs. These products are drugs in reality, but are not regulated as drugs, and the public does not think of them as drugs.

This has created a false sense of safety in the public with products labeled supplements, and in my opinion this contributes to people like Parry thinking they can take 8 diet pills because they are “supplements” and not “drugs.”

I have discussed before the overall inadequate regulation of the supplement industry, which is rife with contaminants, mislabeling, substitutions, and pills that don’t even contain the listed active ingredient.

Conclusion

It seems clear to me that the public interest would be best served if DSHEA were repealed and replaced with a far simpler and more rational regulatory scheme. All drugs should be regulated like drugs, meaning they need to be approved prior to going on the market, with approval requiring adequate evidence for safety and effectiveness (this includes “homeopathic drugs”, by the way).

This move will have several effects. First, it will remove from the market countless supplement products which are worthless, misleading, and/or dangerous. Americans would save billions of dollars currently being wasted on what is essentially snake oil.

This would also dramatically reduce the size of the supplement industry, making it easier for the FDA and FTC to manage. Now DSHEA essentially requires post-marketing regulation, which means that the FDA and FTC have to track and research thousands of products and can’t possibly manage them all. The result is effectively indistinguishable from no regulation at all.

Of course, the supplement industry will cry foul. They will moan about the loss of freedom, but what they really are interested in is their freedom to sell snake oil without regulation. For now the industry is protected by their guardians in the senate, and the consumer pays the price.

Part of that price are young otherwise healthy people dying from overdoses of dangerous drugs that were sold to them with the comforting label of “supplement.”

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