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The FDA Shuts Down Home Genetic Testing Company 23andMe

As the FDA close 23andMe a look at home genetic testing

On Monday the US Government FDA forced the main home testing company 23andMe to stop selling its saliva genetics home testing kit. As this is their only product this means that they effectively shut down their operation.

Looking at Genes
Looking at Genes

The problem seems to be that the company is offering testing for gene mutations that may lead to rises in probability of contracting diseases. This is considered a medical test by the FDA, and so they require trials and results in order to see how well the tests work before they license them. 23AndMe have been unable or unwilling to provide such results, so cannot market their device unless they take away all of the medical arguments.

This is the technical reason, but there are serious ethical issues surrounding home genetic testing. The following are just a few of my own ideas:

Without serious research doubt must remain about the quality of the results. The samples are not second tested, and the quality of testing cannot be of the same level as other medical hight cost exams. There have been problems reported due to the small number of people involved in the test groups, as statistics require masses of data that are not yet available.

Are customers qualified to interpret the results? What does a statistical rise in probability actually mean to a person that has never studied statistics or probability? And the results are delivered without any counseling, so if there is bad news the customer is left to process the information alone.

Here just a few examples might demonstrate the difficulty. If I have a 1% chance of contracting problem A, but I have a gene variant that means that I am 70% more likely to contract it, I might be distraught. The reality is that I now have a 1.7% chance, very little difference, but I might try to change my lifestyle, treat my kids differently, get paranoid, have preemptive surgery, who knows how an individual will react without medical advice?

If on the other hand I am negative for a mutation for something I might adopt an equally problematic stance. I don’t have the gene mutation that leads to skin cancer so I can stop worrying and have another hour on the sun bed. Social factors are really the big ones in many cases.

And what about testing your children? How will parents react knowing that their child might be susceptible to certain problems later in life?

Oh and if I discover that I have something hideous, should I tell my brothers? They might carry it and pass it on to their children. How personal is this type of medicine? It is familial, not individual.

The 23andMe problem is a prime example of money ruling. They have operated for 6 years, without regulation and blatantly challenging the FDA and medical profession that they see as holding up progress. As far as I can see this is about as far away from the responsible innovation that I have spent my recent life trying to promote as I would like to see anyone go. I would add though that it is a systemic problem here in the USA, not a personal divisive choice, and it is very different to the European approach underscored by the precautionary principal (with all its critics).

For further reading you will find several of my articles linked through this post on the same subject from last year.

The National Post has a good article too that includes both sides of the argument.

0 replies on “The FDA Shuts Down Home Genetic Testing Company 23andMe”

Hi Jonny,

It’s a little bit like people self diagnosing from the internet. I know these days when I go to a GP I have already reviewed all of the possibilities. On a number of occasions however I have been wrong. With your home genetic test you could quite easily add one and one and get three and as you say turn into a paranoid wreck.

I love the idea that science now allows us to get a kit for testing genetic’s however I can see that in the wrong hands they may be dangerous.

Yes, I think giving information outside a medical setting is a dangerous game. The problem of reviewing symptoms on the Internet is also something to think about. It often not only leads to self diagnosis but also self treatment, another path that we should be wary about taking.

I used to be so loyal to Google, they had me fooled. I don’t trust it one bit anymore.

Anything which plays with biology or lets people analyse themselves shouldn’t be allowed to be publicly available without a throughout analysis. As you said, we aren’t all doctors, and I am not sure many people would be qualified to interpret the results.

Here in the US everything is framed in terms of freedom. So the argument is reversed. Who are you (or the FDA) to stop me having my own personal information? It is my right to know! So the ethical discussion takes on a completely different tone.
I should explain the Google link or readers might not understand. 23andMe has received funding from Google, probably partly due to the fact that they are family. I quote from Wikipedia: Co-founder Anne Wojcicki “married Google co-founder Sergey Brin in May 2007”.
Just to pour ‘Gas’ on the fire Forbes report that 23andMe are still selling their kits today, despite the FDA ruling.
I spent a couple of days with Wojcicki at a conference, and I am not surprised.

Thanks for pointing out the Google link. I had read the National Post article, so I understood the link.

Okay, you can have your own personal data, I am all for that, but only if it is safe for you to interpret. If you read it wrong and make dramatic adverse changes to your life surely it would have been better to consult a Doctor?

Why would you ignore the government!?

As I say I spent a few days in the company of the CEO at a conference at Harvard. She told us that she did not have FDA approval, and that they would not have given her permission to start her company, so she launched anyway so that she could build up the company and have something to barter with. I am not suggesting that this is the same as ignoring the government, but it gives an idea of the business model.
Many people say that the data is easy to interpret, and the company offers links to academic articles that the user can consult. I have never seen it so am not qualified to comment, but at the moment most of the people that choose to be tested are well educated and relatively affluent. I studied statistics for my masters at uni though and am not convinced that without training an individual can grasp the significance.

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