Did Washington Post's Rob Stein exaggerate negative stories about personal genomics?

I mentioned last week on Genetic Future that a reporter with the Washington Post, Rob Stein, had emailed the National Society of Genetic Counsellors to search specifically for people with negative experiences of personal genomics for an upcoming article on the industry. At the time I called for personal genomics customers with positive experiences to email Stein, to ensure that he had a balanced view of the industry's impact.

Stein's article came out a couple of days ago, presumably timed for maximum impact in advance of the FDA's meeting on lab-developed tests over the last two days. Overall it's less unbalanced than I'd feared - the piece concludes with a fair discussion of the pros and cons of increased regulation, including quotes from me and Dan Vorhaus (fellow Genomes Unzipped blogger).

However, Stein did manage to find some negative stories from personal genomics customers, all of which center around the mistake made by LabCorp back in June that resulted in incorrect data being received by 87 23andMe customers - and unfortunately those stories are what lead off his piece:

One woman panicked when the genetic test she had ordered over the Internet concluded that her son was carrying a life-threatening disorder and, even more disturbing, that he was not -- genetically -- her son. Another, who always thought she was white, was flabbergasted to find her genes were mostly of African origin. A third woman's result was still more stunning: She was a man, it said.
"I thought, 'Oh my God. Am I really a man?' " said Denise Weinrich, 48, of St. Peters, Mo. "I thought, 'What's the matter with me? I'm not who I thought I was. How am I going to tell my children?' DNA doesn't lie."

Firstly, it's remarkable that despite two separate emails to the NSGC, Stein only managed to uncover three negative stories from personal genomics customers, all of which refer to a single (rapidly corrected) laboratory error. That's testament to the fact that - despite the fear-mongering of critics - the majority of personal genomics customers are not tormented by the experience.

Secondly, even these anecdotes appear to have been very selectively presented by Stein. Cece Moore, who writes the blog Your Genetic Genealogist, has personal insight into two of the stories relayed by Stein, and suggests in a post that both of these are exaggerated. Firstly:

"flabbergasted" - This is a misstatement. I know this because the person to whom Stein is referring is my niece. He never spoke to my niece directly and I never said, nor implied, that my niece was "flabbergasted." Actually, I expressed the exact opposite to Stein. First of all, I told him that when she initially called me about her test, she very matter-of-factly stated, "My genes are most similar to a Nigerian" with, surprisingly, little reaction.

Secondly, I told Stein that I immediately informed my niece that it was a mistake, so there was never any real question of whether she was actually African genetically. How he got "flabbergasted" from that, I do not know.

Secondly, Moore quotes an email from the third person mentioned in Stein's piece, Denise Weinrich:

"This is so sad....95% of what I said was how thankful I am for the testing...Told the story of my adopted children and the 30+ Guat(emalan) kids who also tested with 23andMe. How I would never want DNA testing regulated because it would be hard to do for cash strapped adoptive parents, etc.

No wonder people complain about the interviews they give to reporters." [emphasis added by Moore]

Moore also notes that the wording of the first experience is also shaped for dramatic effect; the woman in question was informed that her son was a carrier of a single haemochromatosis variant, which doesn't actually mean that he would suffer from the disease.

As I wrote back in June, the mistake made by LabCorp was deeply unfortunate, but the negative impacts of it on customers were swiftly minimised by 23andMe, and as far as I can tell there's no evidence of any long-term harm occurring as a result of the incident. It's extremely telling that this is the best example of negative experiences that a Washington Post reporter can uncover, and deeply unfortunate that these incidents will be the only part of the article that most readers walk away with.

Speaking of fear-mongering, there's another quote in Stein's piece that warrants attention:

"It's come to the point where really there's a need for some oversight," said Alberto Gutierrez, who heads the FDA's Office of In Vitro Diagnostics. Results from questionable tests can be unnecessarily alarming, Gutierrez said, adding that some women have undergone surgery, for example, based on tests that purport to gauge the risk for ovarian cancer.

We know of reports of people who have found a test, found a doctor that is willing to order the test since they are so afraid of the disease, and even removed ovaries based on questionable results," Gutierrez said.

It's a serious, disturbing claim - and one that requires evidence, which is not provided. If Gutierrez intends to keep using this anecdote to justify increased regulation of the genetic testing industry, he needs more than just a vague "we know of reports". Gutierrez should provide details of the testing company involved, and explain exactly why he regards the results of the test as "questionable". If indeed someone has had ovaries removed due to spurious genetic testing results the surgeon should be immediately investigated for malpractice (if that hasn't happened already). If Gutierrez can't provide these details he should quit courting media attention with an unverifiable anecdote.

Mind you, Alberto Gutierrez is a man who also decided to announce that the FDA regarded DTC genetic tests as illegal via a quote in the Washington Post (also via Rob Stein) - so I suppose we should not be entirely surprised at such flippant use of media scare-mongering. It's hard to create fear when you can't actually quote convincing empirical evidence that information from genetic testing is harmful - and you can't quote such empirical evidence because it doesn't actually exist. As such, the FDA is forced to resort to "we know of reports" to muster the requisite sense of horror.

As I mentioned above, Stein quoted me briefly towards the end of his piece, noting that increased regulation is not cost-free. For context, here's the rest of the email that I sent to him two weeks ago:

While regulations are sometimes necessary to protect consumers, people also need to remember that they come at a cost: increased prices, decreased competition and reduced innovation. That means we need to weigh up the potential benefits of any proposed regulation against the stifling effect it will have on progress in the field, especially for a field as crucial to the future of medicine as the genetic testing industry.

Right now the direct-to-consumer genetic testing industry is an engine of innovation in a range of key areas - for instance, companies like 23andMe have developed ways of presenting complex genetic risk data to consumers that are far better than anything you'll get from your doctor. While there's a place for very careful regulation that punishes companies who make false claims about genetic testing, excessively heavy-handed regulation from the FDA will end up reducing the number of new companies entering the field, thus inhibiting competition, as well as increasing the cost of creating new products. Suppressing innovation in this way could easily have seriously negative effects on the long-term development of technologies for personalised medicine.

There are alternatives to stringent FDA regulation - for instance, forcing genetic testing companies to disclose the markers they test and the scientific evidence backing up their claims would go a long way towards cleaning up the field. Incorporating this kind of information into the NIH's proposed genetic test registry, and making registration mandatory for testing companies, would be one way of doing this. That way consumers get access to the information they need to avoid the dodgy operators, but the overall cost to the industry is much lower.

We all agree that there is room for better regulation of the direct-to-consumer genetic testing industry - something that makes it hard for outright scammers to operate, or for companies to make false claims or use unreliable tests. However, everyone should be aware that if the FDA moves beyond its remit here, and imposes unnecessarily stringent regulatory hurdles on genetic testing companies, it won't just be the companies that suffer: excessive regulation will cost consumers, and it will directly inhibit innovation in the crucial and emerging field of genomic medicine. It's not just 23andMe's fate that's at stake here, but all of the start-up companies - some of which haven't even been formed yet - that will create the products and devices that bring medicine into the genomic era.

This needs to be done right. If we allow bureaucrats from the FDA to bury the genetic testing industry beneath piles of arbitrary demands (sorry, "enforcement discretion"), this will hurt all of us. I'll have a post up soon on Genomes Unzipped expanding on this topic.

For now, we all need to sit back and absorb the key lessons from the last two days of presentations at the FDA's meeting. A good place to start is Dan Vorhaus' summary of day one, and the excellent presentations made by Anne Wojcicki and Ashley Gould from 23andMe and Katherine Borges from the International Society of Genetic Genealogists.