Tag Archives: fda

FDA Released Draft Guidance on 3D Printing

Boatloads of people and a brain computer interface — #3Dprinting & #Robohand folk at #MakeHealth

The FDA recently released draft guidance for those using 3D printing (also known as “additive manufacturing”) to create or modify medical devices.

Technical Considerations for Additive Manufactured Devices
Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only.
Document issued on May 10, 2016.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

This is a pretty interesting happening, and particularly interesting in the context of the maker movement, #DIYability, #InventHealth, #MakerNurse, and #MakeHealth. These are all concepts or movements driving the improvement of health and healthcare through engagement with the general public. This is where a lot of patients and the general public use creativity, insight, experience, and often various technologies such as 3D printing in order to craft custom solutions to interesting health challenges.

Here, at the University of Michigan, most of the press we’ve gotten around 3D and 4D printing has related to saving babies (in multiple ways) and making surgeries safer.

So, will the FDA guidance impact on people trying to make stuff at home, at work, in the hospital? Possibly. Actually, according to the strict interpretation of the current definitions, it sounds pretty likely. (Please, note, I am not a lawyer!) Here is one section on that aspect.

“Point-of-care device manufacturing may raise additional technical considerations. The recommendations in this guidance should supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.”

So, this is talking about point-of-care, which would include pretty much all the maker communities I was mentioning above, but it’s really really vague. I’m not the only person who thinks so.

“Although the draft guidance is a start, there are still many unresolved regulatory issues that need to be addressed, especially as the technology continues to evolve and more innovative products are brought to market. One still-pressing, unanswered regulatory issue associated with 3D printing is how the FDA intends to approach non-traditional device manufacturers. As background, under the existing FDA regulatory framework, a manufacturer is defined broadly to include “any person who designs, manufactures, fabricates, assembles, or processes a finished device.” As 3D printers become increasingly accessible, a person (or entity) with a 3D printer does not need the financial capital, infrastructure, or resources historically associated with traditional manufacturing operations. While the draft guidance acknowledges point-of-care manufacturing, it does not provide much discussion on non-traditional entities, such as healthcare providers and suppliers becoming “manufacturers” of medical devices. … We also do not know how the FDA intends to resolve the legal and regulatory issues associated with point-of-care manufacturing.”
Matt Jackson, Kevin Madagan. FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown http://www.meddeviceonline.com/doc/fda-s-d-printing-draft-guidance-leaves-much-unresolved-even-more-unknown-0001

The next thing they mention, in the same paragraph, is biofabrication (which technically is less about making devices and more about 3d printing with biological “ink,” living cells, biomaterials, and such).

“In addition, this guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM. Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways. Therefore, all AM questions pertaining to products containing biologics, cells or tissues should be directed to the Center for Biologics Evaluation and Research (CBER).”

I’m actually relieved that they are leaving biofabrication alone for now, but it is not going to go away forever (nor should it). For people working at the intersectional spaces of 3D printing, where it combines with biologics, electronics, programmables, smart materials, and other materials with interactive potential, there is a possibility that content from this guidance may interact in unexpected ways with the other side of the work they are trying to do.

Here’s the good news.

“This draft guidance is a leap-frog guidance; leap frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leap-frog guidance represents the Agency’s initial thinking, and our recommendations may change as more information becomes available.”

AND

“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”

So, don’t worry TOO MUCH just yet, but do please read this, consider how it might impact on work happening in your community, and consider replying to the draft guidance or filing comments. You may submit comments on the Technical Considerations for Additive Manufactured Devices Draft Guidance until August 8, 2016.

Additional reading

3D Printing of Medical Devices http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm

FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices http://www.raps.org/Regulatory-Focus/News/2016/05/09/24901/FDA-Issues-Long-Awaited-3D-Printing-Guidance-for-Medical-Devices/

The FDA Releases Draft Guidance for Industry & Food & Drug Administration Staff Regarding 3D Printing https://3dprint.com/133570/fda-draft-guidance-3d-printing/

FDA releases long-awaited draft guidance for 3D printed medical devices http://www.3ders.org/articles/20160510-fda-releases-long-awaited-draft-guidance-for-3d-printed-medical-devices.html

Personalized Medicine, Biosensors, Mobile Medical Apps, and More

At the Quantified Self Meetup, someone was praising the Rock Health slides. Of course, I had to go explore and see what was so great. These are my favorites.

About FDA’s Guidance for Mobile Medical Apps

FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health: http://www.slideshare.net/RockHealth/fda-101-a-guide-to-the-fda-for-digital-health-entrepreneurs

I especially took note of slide 10, where they describe things I would think of as an app, but which do not qualify as such for FDA regulation. This is an important distinction I hadn’t previously considered. Slide 12 takes it further by describing the categories of regulation as based on risk to patients, with good clear examples. Slie 21 on “pro tips” would have really benefitted companies like 23andMe (even though that isn’t actually a mobile medical app, the pro tips still apply, and in spades).

Biosensing Wearable Tech

The Future of Biosensing Wearables by @Rock_Health http://www.slideshare.net/RockHealth/the-future-of-biosensing-wearables-by-rockhealth

This one definitely gets into topics relevant to the quantified self movement and self-tracking. Slide six emphasizes the shift from the low hanging fruit (fitness, pulse, sleep) to the long tail — more targeted solutions for specific challenges (hydration, glucose, salinity, skin conductance, posture, oxygenation, heart rhythm, respiration, eyetracking, brain activity, etc.). That’s really quite interesting, and it gives examples of companies working in each space.

Slides 19-24 get into several of the areas our own local meetup defined as challenges to success for companies working in this space and for the future success of the entire area — it has to work, easily, and dependably. Slides 27-30 extrapolate these challenges into the transition into healthcare environments.

Personalized Medicine

The Future of Personalized Health Care: Predictive Analytics by @Rock_Health http://www.slideshare.net/RockHealth/the-future-of-personalized-health-care-predictive-analytics-press Video https://www.youtube.com/watch?v=UJak41hIDWc

SLIDES

VIDEO

It’s probably safe to say that most individuals working in the quantified self / self-tracking space eventually end up struggling with the issue of how to use their data to anticipate avoidable problems. This idea can be translated into the jargon phrase of “predictive analytics.” Slide 11 does a nice job of lining this up with how traditional healthcare is practiced, which is very useful. Slide 12 places this in the context of big data resources, databases, and tools, listing several of the main players. This context is essential for making personal data relevant beyond the drawn out process of n=1 studies. Slide 14 identifies the BIG problem of how companies working in this space largely focus on hospitals and health care providers, and seem to have entirely missed the idea that patients are deeply and actively engaged in this space. And, frankly, there are more of us than them (even if our pockets aren’t as deep). I love the phrase on slide 18, “Symptom calculators are the “recommendation engines” of health care.” Most of the rest of the deck identifies challenges and opportunities, which I hope any entrepreneurial types would examine closely. Do notice that there is a video with this one. You can hear the entire webinar as well as reviewing the slides.

Concerns & Clarification on the FDA Guidelines for Social Media (#FDAsm)

FDASM: FDA on Social Media

Last Tuesday afternoon, there was a Twitter chat on the new FDA guidance on social media that was hosted by the medical librarians group (#MedLibs), but which engaged an audience that also included healthcare professionals, lawyers, and communication specialists. It was a very interesting chat that touched on concerns, assumptions, misunderstandings, clarifications, and resources. You will find many of these excerpted from the full conversation and highlighted below. First, though, here is a high level summary.

Concerns included the potentail for a “chilling effect” that might impact on education, innovation, professional and patient public communications, research and clinical trial recruitment; responsibility (who is responsible for what/when/where/how with respect to health social media communications); effectiveness of social media controls for their intended purposes and the costs/benefit assessments; the role of identity, honesty, and transparency in health social media communication; and whether the guidelines will promote inclusion or foster exclusion of relevant voices in useful conversations.

Clarifications sought: plain language summaries of the guidelines; description of the potential and expected impacts on various communities of practice, including health education and patients; the relationship and responsibilities of employers and employees in their social media identity management and communications; and the issue off-label use conversations outside of pharma entities.

Clarifications which appeared during the chat (but which are note from the FDA, and therefore not the authoritative word with respect to these issues): who is covered by the guidance; community and individual efforts to create plain language distillations of the guidance; context; and a reminder that freedom of speech does not equal freedom of consequences for that speech.

For Medical Librarians: role for medical librarians in supporting and demonstrating best practices in Twitter chats; role for medical librarians in supporting education around the FDA’s guidance for their institutions as well as for patients and the public; and a caution about medical librarians being potentially excluded from social media as part institutional image controls as well as potentially as an impact of the guidance.

Takeaways: how to format an FDA-style tweet; avoid creating branded accounts for free conversation; encourage individuals to create personal accounts that are not branded and are distinct from the brand; consider correction of health misinformation as an opportunity; avoid perception of “practicing medicine” on social media, but discussions are alright; consider commenting on the FDA draft guidelines before September 17.

In addition, the conversation included discussion of best practices for identifying tweets as representing personal opinion, as well as a rich collection of resources.

CONCERNS

CLARIFICATION NEEDED

CLARIFICATION RECEIVED

FOR MEDICAL LIBRARIANS

TAKEAWAYS

FURTHER QUESTIONS

RESOURCES

FDA On Social Media: Time to Pay Attention, Take Two

FDASM Campus Forum Feb 16SL: Virtual Ability: Introduction to the FDASM
FDASM Transcripts Wordle23andMe, reduced

Remember five or so years ago when we put together a campus event about the FDA call for input on social media guidance? I blogged about it a lot. I’m sure many of you are already aware of the new FDA Social Media draft guidelines that were, at long last, released last month.

Recently I heard an interview with David Harlow about the new draft guidelines. I was very surprised when I heard him say that the FDA sent a warning letter to a company for clicking “like” on a patient’s Facebook post. That seemed a bit over the top to me, although I confess I haven’t yet found the original warning letter. I had been inclined to just trust that after thinking about this so long, the FDA would come out with something helpful, but it sounds like that isn’t what happened. Responses from the drug companies seem to be along the lines of just avoiding the whole problem, if the FDA is going to be so challenging and confrontational. Responses from folk working actively in HCSM are that the FDA is not getting the point or purpose of social media engagement, and that the guidelines are sufficiently restrictive as to make it impossible to adhere to the specifications.

I know that I need to know more about this, and I believe that readers of this blog do also. The period for public comment is over in September, so there is very little time to respond. My fault — I should have paid closer attention to this sooner.

BACKGROUND

For context, I’d like to first remind people of the comments we filed with the FDA during the original call for comments. Where it sounds like things have broken down is with respect to our third point (#3): “the potential to be perceived as interfering with free speech of the public or creating an undue and insupportable burden for industry and the healthcare communities,” and to the concerns about use of social media within an educational framework.


FDA-2009-N-0441 Docket Comments, University of Michigan Public Forum: http://www.slideshare.net/umhealthscienceslibraries/fda2009n0441-docket-comments-university-of-michigan-public-forum

Here are my slides from five years ago, just to provide context for the background of the conversation.


FDA Social Media Guidelines – Introduction http://www.slideshare.net/umhealthscienceslibraries/fda-social-media-guidelines-introduction

Now, here are some links about where things stand today, plus the presentation by David Harlow, which I encourage you to watch.

DAVID HARLOW


FDA Social Media Changes that May Affect Healthcare https://www.youtube.com/watch?v=aEutmz0kFsM

#FDAsm – FDA Releases Draft Social Media Guidance Five Years After Public Hearing http://www.healthblawg.com/2014/06/fdasm-fda-releases-draft-social-media-guidance-five-years-after-public-hearing.html

FDA Social Media Guidance – Hangout on Air http://www.healthblawg.com/2014/07/fda-social-media-guidance-hangout-on-air.html

PUBLIC HEARINGS

2009: Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm

July 10, 2014: Social Media Guidance Webinar – July 10, 2014: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm403810.htm

FDA ANNOUNCEMENT

FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internet-communications-about-medical-products-designed-with-patients-in-mind/

Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/html/2014-14221.htm

NOTE: This is where to file comments >>
[Docket No. FDA-2014-D-0447] Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability https://www.federalregister.gov/articles/2014/06/18/2014-14221/draft-guidance-for-industry-on-internetsocial-media-platforms-correcting-independent-third-party

DRAFT GUIDELINES

Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf

Guidance for Industry : Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf

Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Jan 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf

#FDA vs #23andMe, Take Two — Hashtags of the Week (HOTW): (Week of December 9, 2013)

Last week we tracked opinions and responses with regards to the FDA warning letter sent to the direct-to-consumer personal genomics service, 23andMe. This week 23andMe officially announced that they are reducing the services they offer in response to the FDA’s warning letter.

23andMe, reduced

So what has been the reaction on Twitter? Let’s take a look at some of the most popular articles and examples of opinions.


First posted to THL blog: http://thlibrary.wordpress.com/2013/12/09/fda-vs-23andme-take-two-via-23andme-vs-the-fda-hashtags-of-the-week-hotw-week-of-december-9-2013/

Collecting Thoughts on the FDA vs. 23andMe

Lantern Slides: Heritance of Clefting

I’ve been reading many of the news articles and blogposts about the 23andMe / FDA controversy, and marking interesting points, agreements and disagreements, various perspectives. These are some of my favorite bits from the pieces that have come out so far. I have a distinct personal bias regarding this extremely complicated topic, but also have good friends on “the other side,” as well as having a professional commitment to attempt to be unbiased. In this collection of quotes and highlights, I try to not let my own bias interfere too much, and to fairly represent opinions both pro-FDA and pro-23andMe. Please note that, on both sides, there are extremists, who I found typically didn’t clearly express the complexity of the issues, thus most of the quotes excerpted below are from more moderate authors.


Pic of the Day - PGen
Thoughts on the FDA

“The Food and Drug Administration’s recent directive to the company 23andMe to stop marketing its genetic tests directly to consumers is a shortsighted, heavy-handed, double-standard act of paternalism.”

Marchant, Gary. The FDA Could Set Personal Genetics Rights Back Decades. Slate Nov. 26 2013 12:39 PM. http://www.slate.com/articles/technology/future_tense/2013/11/_23andme_fda_letter_premarket_approval_requirement_could_kill_at_home_genetic.html

“I am deeply frustrated by the simplistic narrative of OMG FDA BIG GUBBERMINT SILENCING DARING ENTREPRENEUR. It’s not that simple.”

Wilbanks, John. FDA’s Culture Is Mendelian Dominant Over 23andme’s Business Model. DEL-FI November 30, 2013. http://del-fi.org/post/68560843111/fdas-culture-is-mendelian-dominant-over-23andmes

“The outrage over the FDA’s treatment of 23andMe is the wrong response. We should be holding 23andMe accountable for the claims they make in marketing their product. Even a product with such great potential should have to support its claims with valid evidence.”

Curtiss, Chase. Here’s what health entrepreneurs can learn from 23andMe. The Verge Beat November 29, 2013 5:11 PM. http://venturebeat.com/2013/11/29/heres-what-health-entrepreneurs-can-learn-from-23andme/

“This incident highlights the tension between the paternalistic medical establishment that arose to deal with the dangers of 19th-century quack medicine, and a “techno-populist” element of American society pioneering personal health assessment and decision-making by leveraging new information technologies.”

Khan, Razib. The FDA’s Battle With 23andMe Won’t Mean Anything in the Long Run. Slate Nov. 25 2013 2:46 PM. http://www.slate.com/blogs/future_tense/2013/11/25/fda_letter_to_23andme_won_t_mean_anything_in_the_long_run.html

“If the F.D.A. indeed insists on making 23andMe prove beyond doubt the validity of every single correlation, no genetic-testing service will be able to economically deliver medically relevant genetic information directly to consumers. It will destroy the industry and leave medical genetics in the hands of a medical establishment that has already failed to give people an easy way to obtain and use the elemental information in their own spit.”

Dobbs, David. The F.D.A. vs. Personal Genetic Testing. New Yorker November 27, 2013. http://www.newyorker.com/online/blogs/elements/2013/11/the-fda-vs-personal-genetic-testing.html

“Years ago, the FDA used the same argument against selling blood glucose meters to patients with diabetes. I believe that the FDA is wrong in saying that data in the hands of patients will do damage.”

Bartlett, Ann. Genetic Testing and the FDA. Health Central Wednesday, November 27, 2013. http://www.healthcentral.com/diabetes/c/9993/164554/genetic-testing-fda?ap=2008

“FDA acted properly in view of 23andMe’s cavalier attitude toward its regulatory obligations and its failure to meet past commitments. However, it would be a setback for science if 23andMe were not allowed to proceed. For its research model to deliver, it needs more people, far more people in its database. A campaign to sign up a million customers is a good start, and not losing momentum is essential. Perhaps 23andMe and FDA can find an accommodation — such as a consent order — that allows 23andMe to move forward while catching up on its overdue obligations, under threat of financial penalties or even perhaps the licensing of its database.”

Munos, Bernard. 23andMe: A Fumbling Gene In Its Corporate DNA? Forbes 11/29/2013 @ 10:19AM. http://www.forbes.com/sites/bernardmunos/2013/11/29/23andme-a-fumbling-gene-in-its-corporate-dna/

“It reads like the letter of a jilted lover,” Misha Angrist, a former genetic counsellor who writes about personal genomics and teaches at Duke University, said. “ ‘We went on fourteen dates! We exchanged all these e-mails! We held hands in the park! Now you’re telling me, “F*** you,” and kicking me to the curb.’ ”

Dobbs, David. The F.D.A. vs. Personal Genetic Testing. New Yorker November 27, 2013. http://www.newyorker.com/online/blogs/elements/2013/11/the-fda-vs-personal-genetic-testing.html

“Though the FDA talks up progress, there is a risk that it may slow it down. The agency is weighing regulations on test kits sold directly to consumers, laboratory tests and software that analyses raw genetic data. It is clear that 23andMe is not the only testing firm in its sights.”

And the FDA: A regulator brings a genetics company to a halt. Economist Nov 30th 2013. http://www.economist.com/news/business/21590941-regulator-brings-genetics-company-halt-and-fda

“Is the FDA and the rest of the medical establishment too conservative about innovation and health data that consumers can get directly? Well… is the Pope Catholic?”

MacManus, Richard. Thoughts On 23andMe & The FDA. November 27, 2013. http://ricm.ac/2013/11/27/thoughts-on-23andme-the-fda/

“I asked Dr. Hamburg if she were to have any power that FDA currently lacks, what would it be? The central thesis of her reply was: “I also think we need to find a way – maybe it’s just completely unrealistic – where we can have more flexibility in the system so that every time there’s a crisis or a recognition of a need to do more…we don’t have to go through the process of seeking new legislation.””

Kroll, David. Why The FDA Can’t Be Flexible With 23andMe, By Law. Forbes 11/28/2013 @ 8:45AM. http://www.forbes.com/sites/davidkroll/2013/11/28/why-the-fda-cant-be-flexible-with-23andme-by-law/


PGEN, Take 2
Thoughts about 23andMe

“Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.”

Herper, Matthew. 23andStupid: Is 23andMe Self-Destructing? Forbes 11/25/2013 @ 3:51PM. http://www.forbes.com/sites/matthewherper/2013/11/25/23andstupid-is-23andme-self-destructing/

“On the Twitterz, I wrote that 23andMe’s attorneys should be disbarred for letting things reach this point. Interestingly, it appears that General Counsel left the company several weeks ago (and no replacement has been found). I’m not always a big fan of the FDA (they still haven’t really figured out how to approve new antibiotics), but the reality is that the FDA is like those humongous tractors used to move space rockets: they’re slow, but crush everything in their path. You can’t bullshit these guys–they just keep coming.”

Mike. Some Thoughts on the FDA Action Against 23andMe.com. Mike the Mad Biologist November 26, 2013. http://mikethemadbiologist.com/2013/11/26/some-thoughts-on-the-fda-action-against-23andme-com/

“The consequences of mistakes by 23andMe can be deadly serious. If it reports a “false positive” for a major disease, that can alter someone’s whole life (though I’m rather sure that any medical professional would obtain results from another service to confirm positive results).”

Khan, Razib. The FDA’s Battle With 23andMe Won’t Mean Anything in the Long Run. Slate Nov. 25 2013 2:46 PM. http://www.slate.com/blogs/future_tense/2013/11/25/fda_letter_to_23andme_won_t_mean_anything_in_the_long_run.html

“But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.”

Seife, Charles. 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks. Scientific American November 27, 2013. http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda

“Some experts claim that the risk of ailments like Type 2 diabetes can only be partially calculated based on genetic information. A credible diagnosis would require understanding a lot more about the person’s lifestyle and health history. Promoting a do-it-yourself culture when talking about serious health concerns like cancer and heart disease might have major downsides. However, the opinion in favor of 23andMe is that a dangerous double standard is at work. Today a doctor can sell many types of genetic tests to a patient, at a much higher cost. Only a few have received FDA approval. So why penalize the direct-to-consumer model?”

Kaushik, Preetam. FDA vs. 23andMe: The DNA of a disagreement. All Voices Nov 29, 2013 at 8:35 PM PST. http://www.allvoices.com/contributed-news/16062954-fda-vs-23andme-the-dna-of-a-disagreement

“However, according to one expert, the accuracy of the test is not the biggest issue. The company’s testing methods have been found to meet federal standards for lab testing, called Clinical Laboratory Improvement Amendments (CLIA), said Amy Sturm, a genetic counselor at The Ohio State University Wexner Medical Center. A greater problem is that the results provide “a very incomplete view” of a person’s risk for a given disease, Sturm said.”

Rettner, Rachel. 23andMe: What’s Really Wrong with Personal Genetic Tests. November 26, 2013 01:55pm ET. http://www.livescience.com/41534-23andme-direct-to-consumer-genetic-test-shortcomings.html

“Unfortunately, due to all the complex interactions between the markers, this full unravelling is impossible. The number of interactions is probably so high that every patient will have his or her own unique complex cause of disease. And what has never happened cannot be identified or predicted by big data. Advances in genome science will improve what tests offer, but these improvements will be small. While the hope is based on big data, the reality is that most diseases are simply not genetic enough. Other risk factors such as diet, body weight, smoking, exercise and stress are too important. And big data cannot change the biology of diseases – it will not make them more genetic.”

Janssens, Cecile. It is game over for 23andMe, and rightly so. Pando Daily November 27, 2013. http://pando.com/2013/11/27/it-is-game-over-for-23andme-and-rightly-so/

“It’s not all 23andMe’s fault. In my book research, I’ve read a lot about personal genomics. And the more I read up on genetics, epigenetics, etc., the more I see that the scientific community still has very little clue about what actually causes disease.”

MacManus, Richard. Thoughts On 23andMe & The FDA. November 27, 2013. http://ricm.ac/2013/11/27/thoughts-on-23andme-the-fda/

“THAT is the future. The DTC SNP chip era is ending. 23andMe’s two main competitors, Navigenics and deCODEme, already left the market. 23andMe’s SNP chips are slipping rapidly into the past. And 23andMe knows it.”

Greely, Hank. The FDA Drops an Anvil on 23andMe – Now What? Stanford Law School Blog November 25, 2013 http://blogs.law.stanford.edu/lawandbiosciences/2013/11/25/the-fda-drops-an-anvil-on-23andme-%E2%80%93-now-what/

“As to what will happen now is actually very simple. 23&Me will have to either file as a diagnostic and go through medical approval (which will cost millions of dollars) or start to only offer their service through a medical practitioner, more than likely through a clinical geneticist that can walk a patient through the intricacies of genetics and disease. The problem though is that according to the US News, there are only 358 clinical geneticists currently practicing in the United States. Measure the knowledge dissemination of a clinical geneticist, who usually only sees patients through referral, to the marketing power of a Google backed company like 23&Me, that was gearing up for a television marketing campaign: the outcome is a nail in the proverbial coffin for recreational genomics. As for 23&Me, its problems will only worsen as it will struggle to validate itself through the FDA since genomics is still in its infancy, thus: RIP the only viable, scalable consumer genetics company in the world.”

Pablo, Juan. What is next for Direct to Consumer Genetics. 1EQ Nov. 27, 2013. http://1eq.me/blog/?p=182

“We’re ignoring the bigger issue! The real reason 23andMe can’t test for my mutation is the company who formerly held a patent on BRCA1 and BRCA2 still has a proprietary database of our genetic mutations, and they aren’t sharing it with anyone! We need to fix THIS. We need for the government to help us figure out how data can be shared rather than be treated as a trade secret.”

Andrea. FDA B*tchslap of 23andMe: A BRCA Previvor’s Perspective. Brave Bosom November 26, 2013. http://www.bravebosom.com/fda-btchslap-of-23andme-a-brca-previvors-perspective/

“23andMe is simply doing what the Internet does best: forcing old dogs to learn new tricks. That’s what the fight between Uber and taxicab commissions is about. Same for AirBnB and hotel regulators. The only profession slower to change how they do things than doctors is bureaucrats. So the FDA’s reaction is understandable — but misguided.”

Szoka, Berin. FDA Just Banned 23andMe’s DNA Testing Kits, and Users Are Fighting Back. Huffington Post 11/26/2013 7:46 pm. http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html


23andMe Celiac Disease Risk Markers
Thoughts about Regulation of Personal Genetic/Genomic Services

“We need DTC screening. It helped me. It’ll help many others. But until the FDA learns how to deal with Bayes’s rule and its discomforts – and until DTC companies figure out a business model that isn’t based on massive loss leadership – we’re going to keep coming back to this clash of culture and business models. Both sides need to make some changes if we’re going to avoid doing this over, and over, and over.”

Wilbanks, John. FDA’s Culture Is Mendelian Dominant Over 23andme’s Business Model. DEL-FI November 30, 2013. http://del-fi.org/post/68560843111/fdas-culture-is-mendelian-dominant-over-23andmes

“23andMe embodies a generation preoccupied with itself. Our right to know has superseded our ability to understand. Empowerment has evolved as data, information, knowledge and wisdom are almost seen as one in the same. Whether 23andMe’s reporting is actionable is to miss the point. When you’ve got your data, what more do you need, really? Epigenetics…what epigenetics?”

Vartabedian, Bryan. 23andMe – Why Our Big Government is Right. 33 Charts November 28, 2013. http://33charts.com/2013/11/23andme-government-is-right.html

“As a citizen, I expect corporate transparency for any new health product. As a patient, I think the risks of taking the test outweigh the benefits for my health. As a doctor, I have my concerns for people with distress or misinformation from results of an unproven genomic test. As a human being, I worry about misuse and unintended social consequences of our genetic heritage.”

Matthew Katz on 23andMe: “Return to Sender, Genome Unknown: Seven Reasons I Will Return My Personal Genome Kit.” e-patients.net December 3, 2013. http://e-patients.net/archives/2013/12/matthew-katz-on-23andme-return-to-sender-genome-unknown-seven-reasons-i-will-return-my-personal-genome-kit.html#!

“Our society has increasing information and public access to information. While it is difficult for me to think that this isn’t a good thing overall, we have to thoughtfully consider the possible unintended negative consequences. This case is part of a larger pattern of sacrificing quality-control filters for the sake of open access. This increasingly puts the burden on the public to make sense of sometimes complex and technical information. Everyone, now, can be their own geneticist.”

Novella, Steven. The FDA and Personalized Genetic Testing. Science Based Medicine November 27, 2013. http://www.sciencebasedmedicine.org/the_fda_and_personalized_genetic_testing/

“Community forums and news sites across the web exploded with debate, with most people rallying to 23andMe’s defense. The company’s ample support-base claims that the Food and Drug Administration is over-regulating, and is stifling innovation. However, the majority of geneticists and medical professionals I’ve spoke with have sided with the Food and Drug Administration, arguing that many patients require genetic counseling after receiving DNA test results that point to a high risk of cancer and other life-threatening conditions.”

Farr, Christina. Here’s why the FDA is targeting 23andMe. MedCityNews November 26, 2013 10:00 am http://medcitynews.com/2013/11/heres-fda-targeting-23andme/

“When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask about 23andMe, the more the medical profession is catching up. Slowly but surely, they’re brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them.”

Szoka, Berin. FDA Just Banned 23andMe’s DNA Testing Kits, and Users Are Fighting Back. Huffington Post 11/26/2013 7:46 pm. http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html

“If you scare somebody into believing they’re high risk, they could take actions that hurt their health,” says Gutierrez. Not only is the data on some genetic links inconclusive, he adds, it’s well-chronicled that patients can push their doctors into authorizing unnecessary procedures. “Doctors do a lot of double mastectomies because of fear.”

Brady, Diane. Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe. Business Week November 27, 2013. http://www.businessweek.com/articles/2013-11-27/do-genetic-tests-need-doctors-fda-defends-its-challenge-to-23andme#r=hp-lst

“Should this third party be a doctor, as some (mostly doctors) are arguing? There are certainly doctors out there who have a great grasp of human genetics. But there aren’t a lot of them. And even the doctors who do know the world of human genetics inside and out aren’t in a position to help people navigate every nook and cranny of their genome. This is a job for software, not for people.”

Eisen, Michael. FDA vs. 23andMe: How do we want genetic testing to be regulated? November 26, 2013. http://www.michaeleisen.org/blog/?p=1480

“This is a broad cautionary tale,” says Quackenbush. “We need to be careful about how we define phenotypes, such as whether a patient is likely to respond to a drug or have an adverse event, because if we don’t do it well, we’re not going to have good tools for advancing personalized medicine.”

Hayden, Erika Check. Personalized cancer treatments suffer setback. NATURE 27 November 2013. http://www.nature.com/news/personalized-cancer-treatments-suffer-setback-1.14238


OTHER COLLECTIONS

Alexander, Lindsey. Six smart takes on the 23andMe FDA standoff. MedCityNews November 27, 2013 11:58 am. http://medcitynews.com/2013/11/smart-takes-23andme-fda-standoff/

Dobbs, David. I Got Your 23andMe – FDA Food Fight Links Right Here. Neuron Culture November 30, 2013. http://daviddobbs.net/smoothpebbles/i-got-your-23andme-v-fda-links-right-here/

Exploding & Exploring #PGSethics (via #23andMe vs the #FDA) — Hashtags of the Week (HOTW): (Week of December 2, 2013)


RiskBites: 23andMe, FDA and DNA health profiling: http://www.youtube.com/watch?v=VZXDtTNqDuQ

As you’ve probably already heard, on November 22nd the FDA sent a Warning Letter to the personal genomics company 23andMe. As someone who has participated in clinical studies about personal genomics and blogs (occasionally) about this area, my social media streams have been EXPLODING!

Just through Twitter (for which it is easier to grab numbers), in the past 3 days there have been over two thousand more posts mentioning 23andMe, and over 500 new mentions in my own Twitter interactions stream. I cannot keep up, I can’t read them all, much less reply. Friday night the conversation was burning the wires, and I finally had to stop to sleep. I promised I’d get back to folk in the morning. In the morning, I had 250 new interactions. While I tried to read those, I made it through about 50, and in that time another 163 had arrived. During the conversations, a number of us decided we had so many folk in the conversation we needed a new hashtag to corral the content. We decided to use #PGSethics for “Personal Genomics Services, Ethics.” Obviously, this is the topic of the moment, but this blog post is going to require being extremely selective to merely hint at the boundaries of the conversations occurring even as I write this. Also, because the very nature of the topic is enormous, with complex issues, much of the conversation is shifting back and forth between Twitter and blogs. Analyzing all this will make a fabulous doctoral dissertation for someone!

Here are the main hashtags I am using to track this, BUT with a huge caveat. Most of the conversation is not happening through hashtags right now, and I seem to be being cc’d on much of several conversations. And since many of the most pungent comments don’t even include the word “23andMe” the only way to really find what people are saying is by sheer brute force digging. Still, this is a start.

#23andMe: https://twitter.com/search?q=%2323andme&src=typd
#FDA: https://twitter.com/search?q=%23FDA&src=typd
#PGSethics: https://twitter.com/search?q=%23PGSethics&src=hash


First posted at: THL Blog http://wp.me/p1v84h-1yJ