Here’s what I’ve been up to the past several weeks, which – as it turns out – were my final ones at Consumer Reports.
Kratom: The CDC and FDA have linked a multi-state salmonella outbreak to several kratom-containing products. A couple of companies have recalled the offending items from store shelves. But one company initially refused to do so, even after the FDA asked / insisted. So the agency was forced to issue a – gasp – mandatory recall. According to the press release, this was the first-ever mandatory recall in the agency’s history. I found that pretty shocking. I’m actually still not convinced it’s true, though I suppose it does stand to reason: if the FDA asks you to voluntarily remove a product from the marketplace, and you know that if you decline that request they will just do it themselves anyway, then you say ‘yes of course.’ So what were these guys thinking?
Another thing that stood out to me: each company involved in a kratom recall has several sub-companies, all with different names. It made me wonder about where, exactly, the kratom is coming from. Like, who is bringing it in, packaging it, and selling it? There’s a good list of papers here that unpacks some of this.
DTC Genetic Testing: The FDA has just approved the first over-the-counter genetic risk test for breast cancer – a BRCA screen that detects three specific gene variants, found almost exclusively in women of Ashkenazi Jewish descent. Much has been made of the fact that these variants are exceedingly rare – so rare that many experts say the new screen is effectively useless. What hasn’t gotten as much mention is that this is not the only at-home genetic test available for this disease. Other at-home-testing companies offer BRCA screens that are equally affordable and far more comprehensive. For example, a company called Color has a test that screens the entire BRCA gene for just $99.
So why does the 23andMe test get the special “first FDA approved” designation, and all the press that goes with it? Because those other tests require a prescription. So you can buy Color’s BRCA screen online, but only with a note from your doctor. If you don’t have a doctor, or if your own doctor won’t write you a prescription, the company can refer you to one of their affiliated physicians. That may or may not be as dubious as it sound, depending on how impartially the affiliated doctor’s evaluation and advice is.
But it’s definitely not great that the FDA approved (aka 23andMe) tests are of such questionable utility. As one source put it, “the FDA has effectively put its stamp of approval on the worst products instead of the best ones.” The agency has also cleared the path for more such tests to enter the marketplace.
Lyme Disease: Tick season is here. In the North Eastern U.S. that means it’s time to talk about (and argue over) Lyme disease. The only thing everyone seems to agree on is that it’s the most common insect-borne disease in the U.S., by far, and that it can be very serious and debilitating. Everything else—from how can you catch it, to what counts as a diagnosis, to which treatments work best—has been subject to vigorous and acrimonious debate. For a thorough parsing of all that, see this 2013 New Yorker article. For a very quick and incomplete summary:
While most people recover quickly from Lyme Disease with a short course of antibiotic therapy, about 20 percent of treated patients do not. Doctors are deeply divided over how to think about this condition, which some doctors refer to as Chronic Lyme Disease (let’s call it CLD) and others call Post-treatment Lyme Disease Syndrome (PLDS).
PLDS refers to symptoms that persist in people who have been diagnosed with and treated for Lyme Disease. The doctors who use this term, including those at the CDC and IDSA (which Consumer Reports defers to on this issue), say that these persistent symptoms are not in themselves Lyme Disease, because the people who experience them don’t test positive for Borrelia burgdorferi, the bacteria that causes Lyme. They have other possible explanations (like maybe it’s an autoimmune reaction to the treatment?). Chronic Lyme refers to roughly the same thing – symptoms that persist long after a person has received the standard antibiotic treatment for Lyme. But the folks who use this term generally believe that the condition does in fact result from a failure to cure the initial infection. They argue that the absence of bacteria proves nothing (in part because Lyme diagnostics are shaky to begin with). Some of them also argue that the condition is far more common than 20 percent, and—this is where it gets super tricky—that even people who have never tested positive for B. burgdorferi may well be suffering from Chronic Lyme.
And of course, disagreements over diagnoses beget disagreements over treatment. Does long-term antibiotic therapy (i.e. more than a month) work against this chronic condition, whatever it may be? Again, doctors are divided, and patients are stuck in the middle. Partly because insurance doesn’t cover more than a month or so of antibiotics for a Lyme diagnosis (but also because the schism has left an opening for all sorts of quackery), folks are turning to a wide range of alternative therapies and Lyme Disease specialty clinics. Some of those treatments may well be helping people suffering with the long-term effects of Lyme infection. But without hard science—and given the lack of diagnostic certainty—it’s very tough to say which patients are truly in that camp and which may be suffering from other ailments altogether (Thomas N. Mather of the excellent Tick Encounter Resource Center once told me that people frequently mistake many other insects for ticks, and that not everyone who thinks they’ve been bitten by a tick has actually been bitten by a tick). It’s also difficult to say what relief is due to treatment and what role placebo effect may be playing.
The IDSA is working to update its official guidelines for the diagnosis and treatment of Lyme. It will be interesting to see if they come round at all on the Chronic Lyme question. But the bottom line here (as in so many other places) is that much more research is needed, and quick – because regardless of what you call it, real people are suffering badly.
E-cigs: And E-cigs. The steady trickle of studies showing that e-cigs may cause more public health problems than they solve has continued unabated. I only wrote about those two, but there were several others.
I admit I’ve grown frustrated with covering the issue in this piecemeal way. For every study showing that e-cigs produce a net harm, there is one suggesting they will result in a net benefit. Science is incremental and individual studies are never definitive, and rarely terribly instructive. And in this particular case, I think common sense goes a long way: We don’t need data to tell us that we should discourage teenagers from using any kind of cigs, including e-cigs. By the same token, if we know that e-cigs are less toxic than regular cigs (in the short term at least), and that some adults are using them to try and kick the regular habit, we should do our best to help those folks use them safely and effectively to that end – even as we’re still figuring out whether they can work as a cessation tool.
I think the more interesting questions reach beyond that basic consumer guidance, and touch on how we regulate these products. There have been several developments on that front, that I’ve done only a mediocre job of keeping up on, but that I will be circling back to in the coming weeks.
Up Next: I’ve had an amazing two years at Consumer Reports. I’m going to miss so much about my gig there, including and most especially the people I got to work with. I’ll be taking everything I learned over to the NYT. I don’t officially start until May, but I’ll be spending the next few weeks gearing up for my new role. I may use this space to work out some preliminary ideas. Feel free to hit me up with tips, suggestions, thoughts about what I should be covering.