23andMe, Vitamins and why I approve FDA decisions….

The Food & Drug Administration (FDA) have been under fire these couple of weeks. First, its decision to ask the genetic testing company 23andMe to stop using “genetic risks” in their incentive for selling their products was a reasonable move.

I do not deny that we are in an era of life sciences that we never have been before. We are in an era of “omics” is the big and hot topic in Biology. Genomic, proteomic, metabolomic, lipomic, glycomics….We never have been able to generate as much data as today and still we just start to make sense of these data, thanks to a huge data-mining and lots of “bioinformatics” that builds up these nice algorithms and programs that help us “bench” scientists to make sense of all these data and joining the dots.

Yes, it is big time for biomedical sciences and I am very enthusiastic to see how my discipline have experienced quantum leaps in less than 20 years. For instance, induced pluripotent stem cells (iPSCs) (that allowed Yamanaka to get its Nobel Prize last year) was just revealed less than 7 years, as well as the seminal work of Yu and Thompson on how to generate human iPSCs. There is a whole field in Neurosciences that have been created to use these iPSCs to better understand certain neurological diseases and hopefully find some cures to alleviate them. I am in the tipping edge of my field (BBB research) and very few of us can grasps how this technique can change a lot our understanding of the BBB in the context of neurological diseases.

However, it is important to remind us that there is a huge gap between what basic sciences find and how rapidly and immediately it can translate into human health and diseases. To illustrate my example, you have to think about how much effort and money have been injected for developing new treatments, from the time a chemical library drug screening finds an interesting “hit” on a high-throughput screening and the time this drug candidate gets the FDA seal of approval. Numbers: 10-15 years, 3-5 billions USD spent to have this compound on the market and still a risk of being withdrawn if there is any serious cases of side effects.

The FDA is maybe one of the most feared regulation agency in biomedical sciences, as it can make you miserable to demonstrate with 1000 ways that your new compound is safe and efficient. It is a major pain in the neck for many scientists and clinicians to comply to all these technical and bureaucratic hurdles but it also plays an important outcome on the public health: to ensure that we know that such new drug is relatively safe (again there is no risk-free in health sciences, more a benefit/risk ratio) and that it display a proven therapeutical advantage (Far West snake oil sellers anyone?).

This brings the case of the 23andMe and vitamins.

The decision to cut grass short on 23andMe by the FDA is making sense as genomics is still a bubbling and experimenting disciplines. When I was an undergraduate, Affymetrix microarray was the big fad and was enough to get your name on a high-impact peer-reviewed journals. Nowadays, you rather have to show an RNAseq to be taken seriously. This is part of evolving and improving science. Peer-reviewing is the basis of making basic science and validating findings. Such peer-review can only work when you have an open-access and clearly defined experimental conditions, so any scientists in the field can judge if your statement is valid or not. Now, the case of 23andMe would have been harmless if they stuck to non-health aspects of your DNA and I would be more than happy to pay $99, spit in a tube and have my DNA sequenced to be able to better build my biological lineage. But it becomes more ambiguous when you refers to “genetic risks” testing when there is not an established consensus on which methods is considered reliable and how the scientific literature supports it. Even worse when you have a “black box” with an input-output with no knowledge on how things works inside. Unless 23andMe opens access to its black box to have a fair and peer-reviewed conclusion on their claims, their statements on health related issues cannot be taken for granted and have to clearly inform their customers that their statements are not verified and cannot be used for a diagnostic purposes. Any drugs on the market have to have the FDA stamp on it to validate its efficacy, but that does not means that anyone can claim that their drug have therapeutical effects.
Thats brings to the second aspect, about the vitamins. Vitamins are important and have to be complemented to our body through nutrition. In modern days, we should have access to all of these vitamins through an equilibrated diet, unless you are on a poor-diet choice or have a condition in which you need a diet supplementation. Again, I believe that these vitamin supplementation should be the results on rigorous medical investigations and followed by a physician and dietitian. There maybe no harm to have an acute vitamin overdose, but having your body overdosed on a daily basis may not be the best. One example? Vitamin C.
Vitamin C is refereed as ascorbic acid (derived from the word scorbut or scurvy) and plays an important role as a coenzyme for the synthesis of collagen, an important protein present in your muscles, gum and skin (thus explaining the clinical features of scurvy found in many sailors for centuries). Now, ascorbic acid can also act as a very good anti-oxidants, capable to scavenge free radicals. But a high dose, ascorbic acid can also play a role as pro-oxidant, capable to generate free radicals. You can now imagine that having a repeated excessive dose of vitamin may impact your health and induce certain diseases conditions that you were expecting to avoid.
Again, the statements claimed by many products are not verified by FDA, in other words they did not underwent a stringent review of their claims by scientifically accurate methods. No one can guarantee you what your supplement contains, at least they should be safe for your health (as FDA regulates food safety) but may not have the expected effect. The only one I can surely assess is their overpriced values.

To conclude, it is okay to take vitamins if you have shown deficiency that your normal diet cannot alleviate and that has been controlled by your physician. It is fine to use 23andMe for entertainment purpose, but take their “risks factors” as reliable as a month weather forecast. You may guess what kind of weather you would expect, but it remains simply a probability.