Stopping 23andMe will only delay the revolution medicine needs

We need to collect billions of data points for analysis by computers, and the only company in major contention to do this soon is 23andMe.

Genetic testing is a powerful tool. Two years ago, with the help of my colleagues, it was this tool that helped us identify a new disease. The disease, called Ogden Syndrome, caused the death of a four-month old child named Max. But the rules and regulations for genetic testing in the US, laid down in the CLIA (Clinical Laboratory Improvement Amendments), meant I could not share the results of the family’s genetic tests with them.

Since that time, I have advocated performing all genetic testing involving humans such that results can be returned to research participants. This I believe should extend beyond research, and some private companies, like 23andMe, are helping to do just that.

For as little as $99, people around the world can send a sample of their saliva to 23andMe to get their DNA sequenced. Their Personal Genome Service (PGS) analyses parts of a person’s genome. This data is then compared with related scientific data and 23andMe’s own database of hundreds of thousands of individuals to spot genetic markers, which the company claims “reports on 240 health condition and traits”.

Today, however, as I had feared, the US Food and Drug Administration (FDA) has ordered 23andMe to stop marketing their service. In a warning letter, FDA said: “23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorisation for the device.” By calling PGS “a device”, the FDA fears that people may self-medicate based on results they receive from 23andMe.

Somehow the US and UK governments find it acceptable to store massive amounts of data about their own citizens and that of the rest of the world. They are happy spending billions on such mass surveillance. But if the same people want to spend their own money to advance genomic medicine and possibly improve their own health in the process, they want to stop them.

There are many diseases that appear to occur in the presence of genetic mutations, with large effect in certain populations. A case in point is that of deltaF508 mutation in the CFTR gene, which is known to predispose people to cystic fibrosis, which causes scarring inside organs.

The expression of cystic fibrosis in each of these people is highly variable, but the presence of the mutations can certainly raise suspicion for this illness in individuals with any such symptoms. This is particularly the case when there is an already known instance of cystic fibrosis in the immediate family.

This is why carrier screening in families with diagnosed cases of such diseases is advocated. And yet, such screening is not commonly performed, even though it could decrease prevalence of affected infants.

Genetic data (or genotype) on its own is of little use. It is the correlation of how those genes manifest in people, which is their phenotype, that makes genotypes useful.

I dream of a world in which we have phenotype and genotype data on millions of individuals, so that we can really begin to better understand genotype-phenotype relationships.

Instead, we still live in the medical world described in the Pulitzer prize-winning novel Arrowsmith pubished in 1925, where doctors pretend to know far more than they actually do. The sad fact is that there is no way the FDA can evaluate and regulate each and every genetic variant in the billions of letters which make up the human genome that get variably expressed in trillions of cells in every human body.

We need to collect billions of data points for analysis by computers. The only company in major contention to do this soon is 23andMe. With FDA’s latest attempt to stop 23andMe, all it is really doing is delaying, or worse stopping, the revolution that today’s medicine desperately needs.

Gholson Lyon does not work for, consult to, own shares in or receive funding from any company or organisation that would benefit from this article, and has no relevant affiliations.

This article was originally published at The Conversation. Read the original article.

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A 23andMe testing kit. (Photo: widdowquinn/Flickr)
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After his latest reshuffle, who’s who on Donald Trump’s campaign team?

Following a number of personnel shake-ups, here is a guide to who’s in and who’s out of the Republican candidate’s campaign team.

Donald Trump’s campaign chairman, Paul Manafort, stepped down last week. A man as controversial as Trump himself, he has departed following the announcement last Wednesday of a new campaign manager and CEO for Team Trump. Manafort had only been in the post for two months, following another campaign team reshuffle by Trump back in June.

In order to keep up with the cast changes within Team Trump, here’s the low-down of who is who in the Republican candidate’s camp, and who-was-who before they, for one reason or another, fell out of favour.

IN

Kellyanne Conway, campaign manager

Kellyane Conway is a Republican campaign manager with a history of clients who do a line in outlandish statements. Former Missouri Congressman Todd Akin, whose campaign Conway managed in 2012, is infamous for his comments on “legitimate rape”.

Despite losing that campaign, Conway’s experiences with outspoken male candidates should stand her in good stead to run Trump’s bid. She is already credited with somewhat tempering his rhetoric, through the use of pre-written speeches, teleprompters and his recent apology, although he has since walked that back.

Conway is described as an expert in delivering messages to female voters and has had her own polling outfit, The Polling Firm/WomanTrend for over 20 years and supported Ted Cruz’s campaign before he was vanquished by Trump in May. Her strategy will include praising Trump on TV and trying to craft an image of him as a dependable candidate without diminishing his outlier appeal.

She recently told MSNBC, “I think you should judge people by their actions, not just their words on a campaign trail”. Given that Trump’s campaign pledges, particularly those on immigration, veer towards the completely unworkable, one wonders what else besides words he actually has to offer.

Perhaps Conway, with her experience of attempting to repackage gaffes will be the one to tell us. Conway also told TIME magazine that there is “no question” that Trump is a better candidate than Hillary Clinton. Given Trump’s frightening comments on abortion, to name just one issue, it’s difficult to see how this would prove true.

Stephen Bannon, campaign CEO

While Conway may bring a more thoughtful, considered touch to Trump’s hitherto frenetic campaigning, Stephen Bannon promises to bring just the opposite.

Bannon is executive chairman of right-wing media outlet Breitbart, also the online home of British alt-right provocateur Milo Yiannopoulos. Once described by Bloomberg as “the most dangerous political operative in America”, the ex-Goldman Sachs banker can only be expected to want to up Trump’s rhetoric as the election approaches to maintain his radical edge.

Trump has explicitly stated that: “I don’t wanna change. I mean, you have to be you. If you start pivoting, you’re not being honest with people”.

As Bannon leads a news site with sometimes as outlandish and insensitive views as Trump himself, one can safely assume that Bannon will have no problem letting Trump “be himself”.

The Trump Brood, advisers

While his employed advisers come and go, the people that have been unwaveringly loyal to Trump, and play key advisory roles, are his four adult children: Donald Jr, 38, Ivanka, 34, Erik 22 and Tiffany, 22. With personalities as colourful as their father’s, the Trump children have been close to the campaign since its inception.

Donald Jr personally delivered the bad news to Lewandowski, the younger Trumps describing him as a “control freak”. Although it’s common for the offspring of politicians to take part in their parent’s campaigns (see Chelsea Clinton), in Trump’s case the influence of his children goes undiluted by swathes of professionals. This, despite his actual employed campaign directors being experienced establishment figures, adds credence to the image of Trump’s brand as family-based and folksy, furthering also his criticism of Hillary Clinton as being “crookedly” in the sway of bankers and elites.

Lewandowski’s ultimate downfall has been attributed to his attempts to spread negative stories in the media about Jared Kushner, Trump’s son-in-law and husband of Ivanka. Ivanka and Kushner were long-time critics of Lewandowski for his indulgence and encouragement of Trump’s most divisive instincts, and apparently they were integral to his firing.

Whether any good came from this is hard to discern, as Trump still managed to insult the Muslim community all over again with his comments last month about the late solider Humayun Khan, also insulting veterans and “gold star” families in the process.

OUT

Paul Manafort, former national campaign chair

Although Trump called his departing campaign manager “a true professional”, Manafort has recently been beset by personal controversy and criticised for failing to deliver results. Manafort has taken the blame for the poor polling results that have followed Trump’s awful last few weeks, with Trump’s recent (lacklustre and unspecific) apology representing a complete change of tack.

Despite his many years of experience in politics, Manafort fell out of favour with Trump partly because of his spending on media, such as a $4 radio appearance in Ohio, Pennsylvania, Florida and North Carolina. Trump was judging these investments worthwhile.

Manafort’s personal cachet was also diminished by his dodgy links to ex-clients including Ukrainian former prime minister, the pro-Russian Victor Yanukovych. As Trump has already racked up a number of Russia-related gaffes, continued association was Manafort would have likely proven electorally unwise.

Corey Lewandowski, former campaign manager

Campaign manager until Trump’s team shake-up in June this year, Lewandowski was not the picture of a calm and collected operative. With a list of antics behind him such as bringing a gun to work and then suing when it was taken away from him and lacking the experience of ever having directed a national race, Lewandowski was a divisive figure from the start of Trump’s bid for the nomination.

Although Lewandowski most often accompanied Trump on the nomination campaign trail, it was Manafort, even then, who was in charge of most of the campaign’s logistics, making use of his 40 plus years of experience to do so.

Trump was clearly taken with Lewandowski’s aggressive campaign techniques, as he stood by him even when Lewandowski was charged with battery against former Breitbart reporter Michelle Fields. Although the charges were later dropped, these kind of stories do not bode well for Conway’s hopes for a more women-friendly Trump.

***

Perhaps this latest round of hiring and firing will do him some good, but with only three weeks to go until absentee voting begins in some states, the new team doesn’t have much time.