FDA
lborkowski | February 24, 2011We're hearing a lot of rhetoric about the need to slash government spending, so it's a good time to remind everyone that there's no such thing as a free lunch - and if you think you're getting a free lunch, it might be loaded with pathogens.
Maryn McKenna, writing at Superbug about a New England Journal of Medicine study, has an illustrative example: the Great Tomato Scare of 2008. Between May and August of 2008, 1,499 people (and probably many more) fell ill from the Saintpaul strain of Salmonella, and two people died. The Food and Drug Administration initially thought tomatoes were to…
sb admin | January 7, 2011As part of his Gene Week celebration over at Forbes, Matthew Herper has a provocative post titled "Why you can't have your $1000 genome". In this post I'll explain why, while Herper's pessimism is absolutely justified for genomes produced in a medical setting, I'm confident that I'll be obtaining my own near-$1000 genome in the not-too-distant future.
Matt's underlying argument is that while sequencing costs will continue to drop, obtaining a complete genome sequence that is sufficiently accurate for medical interpretation will require additional expenses (increased sequence coverage to…
dgmacarthur | January 7, 2011As part of his Gene Week celebration over at Forbes, Matthew Herper has a provocative post titled "Why you can't have your $1000 genome". In this post I'll explain why, while Herper's pessimism is absolutely justified for genomes produced in a medical setting, I'm confident that I'll be obtaining my own near-$1000 genome in the not-too-distant future.
Matt's underlying argument is that while sequencing costs will continue to drop, obtaining a complete genome sequence that is sufficiently accurate for medical interpretation will require additional expenses (increased sequence coverage to…
sb admin | December 15, 2010Late last week I stumbled across a press release with an attention-grabbing headline ("The Causes of Common Diseases are Not Genetic Concludes a New Analysis") linking to a lengthy blog post at the Bioscience Resource Project, a website devoted to food and agriculture. The post, written by two plant geneticists, plays a tune that will be familiar to anyone who has encountered the rhetoric of GeneWatch UK: basically, modern genomics is pure hype perpetuated by scientists seeking grant money and corporations seeking to absolve themselves of responsibility for environmental disasters.
The…
sb admin | December 3, 2010A reminder to anyone who reads my other blog Genomes Unzipped that we have a reader survey underway there now, which includes some questions about genetic testing experiences and attitudes towards genetics. We're closing the survey to responses this weekend, so if you're an Unzipped reader but haven't had a chance to fill in the survey, please do so now.
sb admin | November 24, 2010Update 30/11/10: 23andMe has extended their 80% discount until Christmas, without a need for a discount code.
Personal genomics company 23andMe has made some fairly major announcements this week: a brand new chip, a new product strategy (including a monthly subscription fee), and yet another discount push. What do these changes mean for existing and new customers?
The new chip
23andMe's new v3 chip is a substantial improvement over the v2 chip that most current customers were run on (the v2 was introduced back in September 2008). Firstly, the v3 chip includes nearly double the number of…
lborkowski | November 10, 2010Here at George Washington University this morning, Department of Health and Human Services officials unveiled a new strategy aimed at preventing new smoking habits and helping current smokers quit. One major component is the Food and Drug Administration's proposed rule requiring that all cigarette packages and advertising include one of nine health warnings (which will be larger and more noticeable than the current text on cigarette packs) and color graphic images that depict the negative health consequences of smoking.
The Tobacco Control Act that passed last year specified the nine text…
sb admin | October 12, 2010
Back in June I launched a new blog, Genomes Unzipped, together with a group of colleagues and friends with expertise in various areas of genetics. At the time I made a rather cryptic comment about "planning much bigger things for the site over the next few months".
Today I announced what I meant by that: from today, all of the 12 members of Genomes Unzipped - including my wife and I - will be releasing their own results from a variety of genetic tests, online, for anyone to access. Initially those results consist of data from one company (23andMe) for all 12 members; deCODEme for one member…
lborkowski | August 24, 2010The Iowa-based company Wright County Egg is recalling 380 million eggs, which were sold to distributors and wholesalers in 22 states and Mexico, due to concerns about salmonella contamination. The eggs have been sold under several different brand names, so if you've got eggs in your fridge you can check FDA's page for info. Salmonella-infected eggs traceable to this producer may have caused as many as 1,200 cases of intestinal illness in at least 10 states over the past several weeks. A second producer, Hillandale Farms, has also issued a recall 170 million eggs that have been shipped to 14…
dgmacarthur | August 20, 2010The recent Government Accountability Office report into the direct-to-consumer genetic testing industry certainly made a splash: it took centre stage at a Congressional hearing on the industry, and garnered media headlines about "bogus" results being generated by testing companies.
As I noted at the time of its release, the report is an obscenely one-sided affair: it's transparently framed as an attack piece rather than a balanced analysis of the state of the industry. That's a real shame, because the information collected by the GAO could so easily have been used to provide valuable insight…
dgmacarthur | August 9, 2010In my previous post I quoted from Mary Carmichael's excellent interview with two officials from the FDA, Alberto Gutierrez and Elizabeth Mansfield (part of her fantastic week-long DNA dilemma series, which you should read in full if you haven't already). There are numerous nuggets of gold tucked away in this interview that warrant further analysis, and I wanted to highlight a few in more detail. For a more complete dissection I'd recommend Keith Grimaldi's post commenting on the whole interview.
I wanted to focus on two crucial tidbits unearthed by Carmichael: the attitude of the FDA towards…
dgmacarthur | August 5, 2010Two days ago I reported a rumour that the FDA might have convinced genotyping chip provider Illumina to stop providing its products to direct-to-consumer genetic testing companies - a move that would effectively prevent these companies from being able to operate.
The rumour seemed plausible at the time, based on two pieces of evidence. Firstly, a letter sent to Illumina by the FDA in June warned the company that the use of its chips by personal genomics companies appeared to violate FDA regulations:
Although Illumina, Inc. has received FDA clearance or approval for several of its devices,…
dgmacarthur | August 4, 2010Following up on the rumours I posted about yesterday regarding a potential bid by the FDA to choke of direct-to-consumer genetic testing companies' supply of genotyping chips, I received the following statement by email from 23andMe's PR firm:
23andMe is engaged in an ongoing process with the FDA.
23andMe understands that Illumina is also engaged in such a process.
23andMe has no reason to believe there will be an interruption in the supply of Illumina chips at this time.
I understand we'll have some more clarity on this issue from the FDA tomorrow.
egrossman | July 26, 2010By Elizabeth Grossman
In mid-June most of the seafood shacks along the bayou roads between New Orleans and Grand Isle were closed. A seafood market that I stopped by on the western edge of New Orleans was virtually devoid of customers despite bins brimming with bright blue crab and tawny shrimp. Business was so slim that two women who should have been tending to customers were playing Yahtzee. "We've never done this on a workday before," they told me. Another woman unloading sacks of shrimp frowned at my notepad and said, "I blame the media. We've got plenty of shrimp and it's safe." She…
dgmacarthur | July 22, 2010(Cross-posted to Genomes Unzipped.)
Today's US Congress Committee on Energy and Commerce hearing into the direct-to-consumer genetic testing industry was a vicious affair. Representatives from testing companies 23andMe, Navigenics and Pathway faced a barrage of questions about the accuracy and utility of their tests, made all the worse by the fact that many of the Committee's members seemed unable to distinguish between the more responsible companies in the field and the scammers and bottom-feeders. (I watched by web-cast, which I can't yet track down a copy of online; you can read the…
dgmacarthur | July 21, 2010I 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.…
lborkowski | July 6, 2010The ScienceBlogs Book Club continues the discussion on Mark Pendergrast's Inside the Outbreaks: The Elite Medical Detectives of the Epidemic Intelligence Service. In my post this week, I look at how Congress influences federal agencies' work on public health - an issue that crops up throughout the book. Here's an excerpt:
Congress's creation of federal agencies is clearly a huge achievement, and they've also periodically given new powers to already existing agencies. For instance, Mark Pendergrast tells the story of the Dalkon Shield, an IUD that turned out to cause infections while failing…
sb admin | July 6, 2010Liz Borkowski writes: I wrote last week about how federal agencies can solve the problems that create conditions for disease outbreaks - or fail to solve them, as is too often the case. This week, I wanted to focus on the role Congress plays in public health agencies' effectiveness, because that's another angle that crops up repeatedly in Inside the Outbreaks.
Congress's creation of federal agencies is clearly a huge achievement, and they've also periodically given new powers to already existing agencies. For instance, Mark Pendergrast tells the story of the Dalkon Shield, an IUD that turned…
lborkowski | July 6, 2010Liz Borkowski writes: I wrote last week about how federal agencies can solve the problems that create conditions for disease outbreaks - or fail to solve them, as is too often the case. This week, I wanted to focus on the role Congress plays in public health agencies' effectiveness, because that's another angle that crops up repeatedly in Inside the Outbreaks.
Congress's creation of federal agencies is clearly a huge achievement, and they've also periodically given new powers to already existing agencies. For instance, Mark Pendergrast tells the story of the Dalkon Shield, an IUD that turned…
sb admin | July 2, 2010Steve Schoenbaum writes: In his blog this week, Mark Pendergrast challenges someone/anyone to take on explaining the differences between case-control studies vs. cohort studies. As an EIS officer, back in late May/early June 1968, I did a case-control study as part of the investigation of a common source outbreak of hepatitis in Ogemaw County, Michigan, so I will try to pick up the challenge. I believe it was only the second time case-control methods were used in a CDC epidemic investigation. In using this method I learned about the power of comparison, not just that numerators need…