Saturday, December 12, 2009

From Twitter 12-11-2009

Tweets copied by

buzz this

Friday, December 11, 2009

From Twitter 12-10-2009

  • 07:57:38: Who else will be joining the Healthcare Coalition call on #FDASM this morning?
  • 08:00:00: GOTO MEETING/CALL starts in 2 minutes: See Invitation from John Kamp: #fdasm
  • 08:01:12: @pfanderson : Really? Do you have every single video? Do you have permission from anyone yet?
  • 08:15:24: Discussing #FDASM on Healthcare Coalition Call, see slide:
  • 08:25:41: Discussing an e-bay like system ("trusted sellers") for healthcare information; could this work (WITH or IN ADD 2 FDA-approved seal)? #fdasm
  • 08:34:27: @bradatpharma @horationelson : Still curious if ROI for SM ala @skypen & @xpetit - see slides 60-70:
  • 08:42:33: GR8 @DIABETESMINE post "The FDA and Social Media", opinions on what the FDA needs to address: #fdasm
  • 08:45:38: An FDA Insider: "Those who planned the FDA public hearing were not on the same page as those who sent paid search warning letters" #fdasm
  • 08:47:37: An FDA Insider: "Frankly we were embarrassed abt the warning letters & part of the reason 4 pub hearings was 2 get things back on rt track."
  • 08:57:47: New Study: "Mobile Phone Technology May Address Unmet Needs of Parents of Children With Diabetes":
  • 08:59:38: @mayorkl On the Healthcare Coalition call, someone said they spoke directly to the FDA and that is what they were told. I can get u name.
  • 09:04:51: Some people are EXTREMELY politically connected/aware of all the back-room wheeling-and-dealing regarding #FDASM. Frightening.
  • 09:14:31: Gr8 idea by HealthCentral re AE in SM: a Craig'sList-type "reply" system 4 pharma 2 inquire abt AEs #fdasm
  • 09:18:28: Reminder: if anyone is having a twitter convo re #FDASM and needs >140 characters, get a room! A chat room, that is :)
  • 09:19:43: Let me see what I can do 2 help. RT @pfanderson: Yes, we have all the #FDASM videos, but no permissions. Not sure how to contact...
  • 09:25:56: ATTENTION @accelmed @jonmrich @maureenmiller: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:26:11: ATTENTION @pnalen @CompassHC @TLGraham: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:26:56: ATTENTION @fardj @avandy @cmschroed: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:27:16: ATTENTION @drumbeat @wendyblackburn @markbard: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:27:41: ATTENTION @rohitbhargava @pharmaguy @ljpeck33: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:28:07: ATTENTION @donnawray @healthyjack @jbell99: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:28:27: ATTENTION @melissakdavies @mickelberg: Ur #FDASM Pub Hearing Video is ready 4 FREE YouTube posting. Need permission. Pls Reply & RT.
  • 09:28:43: @pfanderson - OK, let's see what happens :) #fdasm
  • 09:32:56: @planetrussell - crazy! re: Chihuahua crisis. I recently got one - most incredible dog in the world! Peeps, u must adopt!
  • 09:36:19: Pls RT this message: "@pfanderson has EVERY SINGLE #FDASM video ready 4 posting on YouTube, jst need speakers 2 say YES. Help us find them!"
  • 09:36:57: Awesome -- thank you for the permission @avandy (cc: @pfanderson) #fdasm
  • 09:38:40: HAHA! He gets real excited! RT @planetrussell: @skypen Does your Chihuahua like watching the movie version of himself?
  • 09:40:11: @planetrussell "Hotel 4 Dogs", "Beverly Hills Chihuahua", even "Bolt" -- he loves all that stuff! Animal Planet rescue kinda freaks him out
  • 09:41:37: @cmschroed 1. Say YES. 2. Re-Tweet 3. Help track down other speakers who might not be on twitter. THANKS! (cc: @pfanderson) #fdasm
  • 09:42:30: Rick, you rock! RT @rdublife: @pfanderson I spoke at #fdasm please dm me for email info so we can work out permissions
  • 10:14:55: New SOCIAL MEDIA REPORT from Marketing Profs. Sample chart: video use by industry Biotech #2? more info
  • 11:31:47: Is link correct? RT @GrayscaleFDA: Extraodinary food for thought control for FDASM. have a look here:
  • 11:34:52: THANK YOU @mickelberg @jonmrich @fardj @cmschroed @skypen @avandy @MelissaDavies @rdublife 4 permission 2 post ur #FDASM on YouTube, others?
  • 12:30:56: Any1 know more abt this 8/19 story? Pfizer & Private Access Announce Plans 2 Dvlp Online Community 2 Accelerate Clin Rsrch
  • 12:41:23: FASCINATING, must-read: "Health Insurers Caught Paying Facebook Gamers Virtual Currency To Oppose Reform Bill": #fdasm
  • 12:48:39: "Virtual Astroturfing", a whole new level of deception? Grassroots campaign leverages Gambit "Virtual Currency" platform.
  • 12:52:17: MOL Global acquires FRIENDSTER. Does anyone care? Asia does, where Friendster is leading Website w/over 75 MIL REG USERS!
  • 12:54:52: Check it out -- new Google LABS project "LIVING STORIES", collaboration w/NYT & Wash Post:
  • 13:05:12: Tried the new "GOOGLE GOGGLES" visual search on my #Android ... GR8 idea, but was 0 for 3 on my pics :(
  • 15:13:54: Agency people have failed to educate legal & regulatory depts at pharma on social media: (@jbselz @PRforPharma) #fdasm
  • 15:19:30: @alexdcrx @jbselz @prforpharma 1 gr8 resource 4 explaining Social Media, Commoncraft's "In Plain English" series: #fdasm
  • 15:26:34: My newest follower is "Farf's Wife". I don't know Farf, and certainly don't want him to get the wrong idea! #strangefollowers
  • 15:34:39: @alicia189 - can you repost link - perhaps use a shortener - didn't work. Thanks!
  • 18:36:43: @jbell99 -- it needs to be cut-up and uploaded ... @pfanderson is doing this for us ! So not sure exactly when, but will let u know
  • 18:50:17: @theartostu you too! Look forward to seeing u next week. Don't forget to check out Night.
  • 22:11:00: Or a collar sticking up? @WendyBlackburn: @skypen Fabio- re: video, you have permission, as long as there's nothing hanging out of my nose

Tweets copied by

buzz this

Thursday, December 10, 2009

Coalition of health insurance groups use social networking games

Written by Jaimy Lee
December 10 2009
Source: PR Week

Media reports are questioning a coalition of health insurance trade groups that is offering Facebook users "virtual currency" if they send letters protesting healthcare legislation to members of Congress.

"Virtual currency" can be used to purchase virtual products in social networking games like Mafia Wars.

The Get Health Reform Right coalition includes America's Health Insurance Plans, the BlueCross BlueShield Association, the Healthcare Leadership Council, and the National Retail Association.

buzz this

Pfizer And Private Access Announce Plans To Develop Online Community To Accelerate Clinical Research

Privacy-enhanced search technology addresses privacy concerns to increase patient participation

Source:Pfizer Media Room
Published on August 19, 2009

NEW YORK--(BUSINESS WIRE)--Recognizing that patient participation in clinical trials is the key to progress in medical research, Pfizer Inc announced today that it has entered into a collaboration with Private Access, the innovator in privacy-enhanced search technology, to create a new online community aimed at increasing clinical trial awareness and participation. The site will be the first to focus on patient privacy rights to connect patients, physicians and researchers with tailored information, tools and technology that will lead to more informed decisions about patient care, including clinical trial participation industry-wide.

Pfizer’s collaboration with Private Access will help address patients’ and physicians’ top concerns regarding research and clinical trials. The companies will work toward reducing the time needed to develop new and improved treatments by making it possible for researchers and investigators -- based on express private access rights granted by the patient -- to conduct more focused searches for clinical trial candidates.

Private Access’ patented technology allows patients to control to whom, and for what purposes, they grant access to see all or selected portions of their personal health information. By granting “private access” only to researchers focused on the conditions that interest them, patients can be more quickly and precisely matched to appropriate clinical trials while simultaneously protecting their confidential personal health information.

Nearly 85 percent of patients in a recent survey stated they were unaware that clinical trials were a possible treatment option, and 31 percent of physicians surveyed did not refer patients to trials due to, among other things, lack of information. According to a study commissioned by the Institute of Medicine (IOM), the number one reason patients who were aware of trials were not willing to participate was fear that their health information would not remain confidential.

“Many patients who could benefit from participation in clinical trials don’t enroll in them because they are not aware that potentially relevant research is under way or they cannot find a specific trial to meet their needs; others worry that they will lose control of their health information,” said Freda Lewis-Hall, M.D., Pfizer’s chief medical officer. “With unprecedented collaboration among key groups, Pfizer and Private Access believe we can build the preeminent online clinical trial community to be used industry-wide to share knowledge while giving patients the confidence and control to share their health information.”

The costs to find and enroll patients into clinical trials more than doubled between 2000 and 2005, and continue to climb. With study protocols becoming more complex, the number of clinical research studies increasing to more than 35,000 and patient participation in clinical trials declining, effective patient recruitment is a critical factor in successfully bringing new treatments to patients.

“A privacy-enhanced search engine for personal health information enables patients to simultaneously address their privacy concerns and improve access to care,” said Robert Shelton, founder and CEO of Private Access. “It is great that the Internet can be used today to find publicly available information for free in seconds or to locate potential employees for a small fee in minutes, yet it still takes months or years and often thousands of dollars per patient to locate individuals for clinical trials that might save or improve lives.

“By introducing technology that honors each patient’s privacy needs, we can leverage the efficiency of Internet-based search for clinical trial patients – speeding up the recruitment process and the discovery of new treatments,” Mr. Shelton continued.

Pfizer and Private Access will work together to bring a wide range of partners to the online community, including additional clinical trial sponsors, patient advocacy groups, technology providers, and other key public and private stakeholders. The portal will also encourage social networking on the clinical trial experience. The new platform and online community will be rolled out in phases, starting in late 2009.

"Patients are the most important stakeholders in medical research. By merging respect for their privacy with access to relevant and actionable medical information, we are giving patients more control over their destinies," said Greg Simon, senior vice president for worldwide policy at Pfizer. "This collaboration has the potential to accelerate medical progress by putting patients' needs front and center."

About Private Access, Inc.

Private Access, Inc. is making it safe for sensitive personal information such as medical records to be accessible over the Internet. We accomplish this with technology that allows each person to grant private access to all or selected parts of their confidential personal information to doctors, family members, researchers and others based on their particular needs and interests. Our people and technology platform, as well as the applications we build, are all dedicated to empowering individuals to improve the care they receive, accelerate the discovery of new treatments for diseases and chronic illnesses that affect them or others they care about, and reduce health care costs for their families and the nation. Founded in late 2006 upon issuance of its core patent, Private Access is headquartered in Irvine, California.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with health care providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

buzz this

Mobile Phone Technology May Address Unmet Needs of Parents of Children With Diabetes

Mobile Phone Technology May Address Unmet Needs of Parents of Children With Diabetes, Sending Blood Sugar Readings Via Text, to Help Manage Child's Illness

According to new study conducted by the Center for Connected Health, parents most concerned about access to their child's healthcare provider

Source: Pr Newswire

BOSTON, Dec. 8 /PRNewswire-USNewswire/ -- In a recent study conducted by the Center for Connected Health, a division of Partners HealthCare, new data revealed that parents of children with diabetes were receptive to using novel health technology - such as a mobile phone that could collect and transmit the child's blood sugar readings to a doctor - to help manage their child's diabetes. This study was published in the November issue of the Journal of Diabetes Science and Technology (Volume 3, Issue 6, November 2009).

Over two-thirds (69.3%) of the parents of children with Type 1 diabetes (n=125) and Type 2 diabetes (n=77) completing an online survey had a 'very positive' response to the proposed mobile phone glucometer (blood sugar or glucose monitor) prototype. More than half of parents expressed interest in signing up for the service.

Parental concerns and the willingness to adopt mobile-phone-based technology to help monitor and communicate their children's diabetes are likely tied to the unmet need of parents, including provider access, limited available information and support, and the complex management of children with diabetes. Nearly 30% of parents (27.7%) reported they would 'definitely sign up' for the prototype mobile phone glucometer service, and another 27.7% reported they would 'probably sign up.'

"Parents are often the primary caregivers for children with diabetes, and they must learn to adjust their child's treatment based on signs and symptoms, which can vary from day to day. This can be extremely challenging during a child's transition to adolescence," said Alice Watson, MD, MPH, Corporate Manager, Center for Connected Health.

"This study demonstrates that parents of children with diabetes are interested in using mobile phone technology to help manage their child's illness, which further illustrates the belief that technology offers a solution," added Venessa Pena, first author.

Overall, parents expressed most concern with access to their child's provider, with 84.9% of parents wanting shorter waiting times and 78.7% easier phone access to their physician. 77.8% stated they would like to be able to contact their provider via email to discuss their child's diabetes.

"These study results provide strong evidence for the link between current problems in our medical system and the willingness for parents to adopt new technologies that can overcome these problems," said Joseph C. Kvedar, MD, director, Center for Connected Health. "Increased enthusiasm for the use of communications technology in patient care management is helping to overcome traditional barriers to technology adoption, making the use of these technologies in clinical practice more feasible."

Diabetes is one of the most common chronic diseases in children and adolescents; about 151,000 people below the age of 20 years old have diabetes (Centers for Disease Control). Each year, more than 13,000 children and adolescents are diagnosed with type 1 diabetes. The obesity epidemic and a low level of physical activity among young people is contributing to an increasing number of children with type 2 diabetes, a disease usually diagnosed in adults over 40 years old. According to the American Diabetes Association, one in every 400 to 600 children and adolescents has Type 1 diabetes, and 2 million adolescents (1 in 6 overweight adolescents) aged 12-19 have pre-diabetes.

About the Center for Connected Health

The Center for Connected Health, a division of Partners HealthCare, is creating effective, new solutions and innovative interventions to deliver quality patient care outside of the traditional medical setting. Our programs use a combination of remote-monitoring technology, sensors, and online communications and intelligence to improve patient adherence, engagement and clinical outcomes. The Center also offers expert online second opinions, enhanced medical education and training, and engages in innovative research to discover new pathways to better care, including the use of virtual worlds and online coaching. Visit

Boston-based Partners HealthCare is an integrated health system founded in 1994 by Brigham and Women's Hospital and Massachusetts General Hospital. In addition to its two academic medical centers, the Partners system also includes community and specialty hospitals, community health centers, a physician network, home health and long-term care services, and other health-related entities. Partners is one of the nation's leading biomedical research organizations and a principal teaching affiliate of Harvard Medical School. Partners is a non-profit organization. Visit
buzz this

From Twitter 12-09-2009

  • 00:39:58: "Greg Matthews, Humana: future of health brands and Social Media" (via @roskadigital @jbselz @ericbrody): #fdasm
  • 08:45:33: MUST READ: New CAREGIVER STUDY (PDF) from AARP reveals 29% of US adult population (65.7 million people) are caregivers:
  • 08:53:42: CAREGIVER STUDY: 53% of caregivers used Web 2 find caregiving info-78% of these 2 find condition/treatment info #fdasm
  • 08:58:02: Caregiver Math: 78% (condition/treatment info search) of 53% (use Web) of 29% (US caregivers)= 27 mil adults. Huge. #fdasm
  • 09:11:44: Creator, critic or collector? Forrester's SOCIAL TECHNOGRAPHICS Profile Engine now updated w/2009 data: (via @Ideagoras)
  • 09:14:26: Fantastic! Thank you! RT @pfanderson: #FDASM Videos YouTube PLAYLIST
  • 09:18:06: Agree! @pfanderson: The FDA should have created playlist of INDIVIDUAL videos from #fdasm hearing organized by day/speaker
  • 09:35:50: New post from @jonmrich "Monitoring Adverse Events in Social Media for Pharma’s Biggest Brands": #fdasm
  • 09:45:58: @jonmrich & @MelissaKDavies explore specific pharma brands 2 undrstnd if monitoring 4 AEs in SM is a hopeless task #fdasm
  • 10:03:51: Listening 2 Insights & Perspectives re: #FDASM w/Jonathan Richman (@jonmrich) & Lilly's Mel Halkyard (melhalkyard) ePharma Summit webinar
  • 10:07:22: Anyone using a specific hashtag for the ePharma Summit webinar going on now? #epharmafda ? #epharmawebinar ? Just pick one?
  • 10:08:39: #ePharmaFDA: @jonmrich: the session on Adverse Event reporting received the most attention @ #fdasm publich hearings
  • 10:09:05: #ePharmaFDA: What should manufacturers be responsible for? #fdasm
  • 10:10:07: #ePharmaFDA: @jonmrich: Is company responsible for sites you create and control, or everything online? #fdasm
  • 10:11:23: #ePharma Webinar: @jonmrich: If, for example, you edit an entry on wikipedia once, are you responsible in perpetuity? #fdasm
  • 10:12:32: "#ePharm" Webinar -- will be using Shwen's suggestion for the rest of the call. #epharm #fdasm #hcsm
  • 10:13:06: ePharm Question: is there one specific Q that you hope is answered when FDA releases guidance? #fdasm
  • 10:14:15: #ePharma Webinar: @melhalkyard: We'd like to hear clarity on WHAT we are responsible for exactly -- for ex, not the whole web! #fdasm
  • 10:15:26: #ePharma Webinar: @jonmrich: re: AE reporting & FDA's MedWatch form. No incentive for consumer to fill out this form. #fdasm
  • 10:16:08: #ePharm Webinar: @jonmrich: we need clarification on what exactly is a "reportable adverse event" for ex, is twitter handle enough? #fdasm
  • 10:17:10: #ePharm Webinar: @jonmrich: referencing his great blog post from today re: AEs: check it out: #fdasm
  • 10:19:13: #ePharm Webinar: @melhalkyard: Despite data showing only 1/500 AEs meet all 4 criteria, we might be responsible 4 reporting more #fdasm
  • 10:22:56: #ePharm Webinar (live now!): @jonmrich: Risk turning pharma cos into private investigators if criteria for AE reporting not reasonable Fdasm
  • 10:24:10: #ePharm Webinar (live now!): @melhalkyard: until now, it's abt the message, not the channel. Now, that clearly seems to have shifted #fdasm
  • 10:24:53: #ePharm Webinar (live now!): @melhalkyard is referring to the "intergalactic task force" :) #fdasm
  • 10:25:51: #ePharm Webinar (live now!): @melhalkyard: From what i understand, everyone that asked to present at hearings was given opp #fdasm
  • 10:26:31: #ePharm Webinar (live now!): @melhalkyard: If there's compelling data that people can provide, that would be useful to FDA #fdasm
  • 10:28:07: #ePharm If you have questions for the FDA re: "next steps", don't forget to submit here: #fdasm
  • 10:28:46: #ePharm Webinar Question (live now!): What can companies do today in light of fact there is no guidance? #fdasm
  • 10:30:12: #ePharm Webinar (live now!): @melhalkyard: only when u understand WHAT people are talking abt online, can u consider possibilities #fdasm
  • 10:31:18: #ePharm Webinar Question (live now!): Thoughts abt Social Media for clinical trial recruitment? #fdasm
  • 10:32:12: #ePharm Webinar (live now!): @jonmrich: Novartis has a twitter accnt for clinical trial recruitment: @NovartisTrials #fdasm
  • 10:33:01: #ePharm Webinar Question (live now!): Where there any presentations about e-rep programs at the hearings? #fdasm
  • 10:33:46: #ePharm Webinar Question (live now!): Cool! @jonmrich, thanks for the plug! #fdasm
  • 10:34:27: #ePharm Webinar (live now!): @melhalkyard: Lion's share of conversation at hearings were related to consumers #fdasm
  • 10:35:32: WWW.FDASM.COM -- links to all the info you need regarding FDA & Public Hearings. #fdasm #epharm #hcsm
  • 10:36:27: #ePharm Webinar ending ... link to archived version coming soon, and will be available on Great job @jonmrich & @melhalkyard!
  • 10:38:10: Yes, FDA/CDC savvy when it comes to communicating w/consumers, but have not leveraged the tools for purposes of comm w/#fdasm stakeholders
  • 10:47:42: Future note to all folks hosting webinars: Select, Publish & Publicize a simple & unique HASHTAG for your event. #fdasm #hcsm #epharm
  • 10:52:47: Everyone knows this, right? Monday Google launched "live real-time search", includes twitter. For exmp, fdasm: #fdasm
  • 11:10:21: GREAT Post by @jonmrich re: AE reporting in Social Media now w/7 key takeaways: #fdasm
  • 11:20:18: @ddwebster hmmm. wasn't bob's article originally posted on 11/20? Is this different?
  • 13:22:20: Great! RT @SusannahFox: But stay tuned: @Pew_Internet will have our own #caregiver study out soon (yes, including social media use) #fdaSM
  • 13:23:02: You are welcome! RT @treatheadlice: Thank you @skypen for providing content like this Google study @ #fdasm
  • 13:28:26: SPECIAL THANK YOU 2 @jonmrich @eyeonfda @pharmaguy @whydotpharma @wendyblackburn 4 being "Creators" & giving us new stuff 2 read this week!
  • 13:33:29: @gfry re: Isn't every patient & caregiver an e-patient? I wish we cld suddenly jump into twitter-chat-mode & discuss this in >140 characters
  • 14:46:53: @gfry alright, give me a few minutes.
  • 14:59:28: @gfry Let's try this so others can join too: #fdasm chat
  • 15:01:16: @gfry : let me know when you jump in -- just pick a screen name and u should see me.
  • 15:05:02: @ePatientDave @susannahfox: u r welcome 2 join @gfry & I 2 discuss patients, caregivers, e-patients-why the difference?
  • 15:14:25: @alexdcRx Alex, so you're "AlexdcRx" now? Weren't you @AlexDC before? You have 18,000 followers w/that accnt -- that's mighty impressive!
  • 15:25:39: @alexdcRx : aha! I look forward 2 seeing ur tweets. I'm sure u already follow all these gr8 folks:

Tweets copied by

buzz this

Wednesday, December 09, 2009

From Twitter 12-08-2009

  • 07:48:05: RT @FDASM: FDASM Update: Transcripts from hearings now available on #fdasm (@pharmaguy)
  • 10:53:24: Facebook alert. More changes on the way. Be ready.
  • 14:33:27: Coalition 4 HC Comm. meeting on FDA pub hearings, reflections on ideas proposed, a call 2 keep the #FDASM movement alive
  • 14:47:08: I look forward to it Amy! RT @DiabetesMine: I have my own post coming out on #fdasm real soon!
  • 14:56:53: @eyeonFDA: "FTC New Efforts Regarding Endorsements Testimonials": #fdasm
  • 15:40:15: Coalition for Healthcare Communications to discuss FDA public hearings. See their perspectives here: #fdasm
  • 17:01:24: Thanks for sharing. RT @roskadigital: Pharma gains back control over Google's Sidewiki #fdasm #hcsm #hcmktg
  • 20:03:15: @jonmrich I really said that, didn't I? FDA's response was: "I don't think I've ever heard anyone ask for an intergalactic taskforce". :)
  • 20:18:34: Simply put: HTML cut into 3 columns. Sproutbuilder controls left and right columns, center us widgetbox.
  • 20:19:52: Sproutbuilder is composed of mutiple feeds, mostly pubicly available RSS feeds.

Tweets copied by

buzz this

Tuesday, December 08, 2009

FDA Public Hearings: Closing Remarks by Tom Abrams, director of FDA's DDMAC

Extracted from Day 2 (Nov 13, 2009) transcript of part 15 Public Hearing "PROMOTION OF FDA-REGULATED MEDICAL PRODUCTS USING THE INTERNET AND SOCIAL MEDIA TOOLS"

Tom Abrams:

"Wow, we made it through the two days. I just have a few closing remarks. We had a very full two days of interesting, diverse, and useful comments.

Taking a step back and looking at FDA's objective, we want consumers and healthcare professionals to have accurate, balanced, and timely information about medical products. FDA needs to ensure that promotion of medical products is not misleading and is balanced.

This objective is the reason why we conducted this two day hearing.

The Internet -- we've heard a lot about the Internet and social media tools. What we have heard is it's a different medium. It's one that provides information. It's rich in the information it can provide. At the same time, it's one that presents challenges.

Therefore, FDA wants to give this much thought as we determine the best approach to the Internet and social media tools.

FDA has much work to do in this area and one that we are determined to do. It's important and we will do it.

We want to have the involvement of our stakeholders. This hearing has been an excellent meeting. It has provided us a wealth of information, comments, and data. FDA encourages our stakeholders to submit your comments, information, and data to the open docket. As a reminder, the docket is open until February 28 of 2010.

Next steps -- I know that's the big question. FDA's next steps include the review of all this information. We will do this carefully so we get this right. It's too important of an area not to do it right as we want the best information about medical products for consumers and healthcare professionals.

The FDA panel would like to thank the speakers for their presentations and all the valuable information they shared today and yesterday. We want to thank all the folks in the audience, both here and viewing this by webcast for their attention and participation listening and interest in the meeting.

We would also like to thank Rochelle and Anton of the NTSB staff for their terrific, simply terrific, assistance and guidance with this hearing. They made it much easier for us.
We also would like to thank all the folks in FDA that worked real hard to make this hearing possible. It was not the easiest thing that these folks put together.

Frankly, there's too many from FDA that worked on this to name them individually. You met many of them in the lobby today and yesterday.

However, we would like to recognize two FDA folks who have done an incredible job of coordinating this hearing. They are Jean-Ah Kang and Barbara Chong. Thank you, Dr. Kang and thank you, Dr. Chong for your incredible work and hard work on this. We all appreciate it.

To all the attendees and speakers and staff, have a safe trip home. The meeting and now hearing is now adjourned."
buzz this

Coalition for Healthcare Communication Meeting on the FDA Public Hearings, Reflections on Ideas Proposed, and a Call to Keep the FDASM Movement Alive

Dear Readers,

On Thursday December 10th John Kamp, Executive Director, Coalition for Healthcare Communication, has organized a meeting to discuss the recently-held FDA public hearing on the use of the Internet and Social Media; specifically, to reflect on what was said and discuss next steps. A document that was put together by Mr. Kamp reflects the coalitions perspectives regarding several topics presented at the meeting. Below is an outline of that document. Click here if you wish to download the full document in PDF format.

Most promising ideas
  • Create a system to flag and click to risk data
  • Develop a system to elevate all FDA regulated content
  • Reverse course on the "one click away" warning letters
  • Clearly state that without control, companies have no responsibility
  • Make the AER process much more patient and company friendly
  • Coordinate enforcement against internet health scams
Most Difficult to Implement
  • Reverse the FDA position that "one click is insufficient"
Most Unrealistic or Otherwise Bad Ideas
  • Enshrine existing AER reporting and pay for expansion with user fees
  • Send AERs directly to FDA
  • Create a new FDA advisory committee
Next Steps
  • Think this over and make suggestions at the December 10 meeting
  • Reach out to the wider network
  • Develop a short "consensus comment" from a broad array of industry players, a
  • "consensus of the willing"
  • Start developing the AAAA/Coalition FDA Comment now
Along with this document Mr. Kamp also included the following message message which directs those who were sent the invitation to the Dec. 10 meeting to take the following action items:

# # # Excerpt from Mr. Kamp's Message # # #

"Please come prepared to offer writing support for sections of the comment.

Reach out to the wider network. I suggest we try to involve the pharma companies that participated, PhRMA, AdvaMed, IAB, the media companies, including Google, Health Central, WebMD, Waterfront, Sermo, Patients Like Me, etc. If you have contacts or ideas or other resources for this outreach process, we want to hear about it.

Develop a short "consensus comment" from a broad array of industry players, a "consensus of the willing." If there are enough "willing," this could be very powerful comment to FDA, particularly if we could get a consumer group or patient group to join. If you have suggestions, make a list for us.

Start developing the AAAA/Coalition FDA Comment now. Outline what we might best say, starting with our points for the FDA presentation, adding data and other compelling content. We will have a draft outline by the December 10 meeting and will be asking you to contribute to sections."

# # # End of Excerpt # # #

The reason I am sharing this with all of you is that you ARE my wider network -- and, in my opinion, you ARE the coalition of the willing.

What you choose to do from here is up to you. However, I strongly urge (regardless of whether you choose or care to attend this particular meeting) that we all continue to share information with each other -- as this is the only way we are going to be the kind of coalition that can effect change. Whatever you share with me (unless you explicitly request otherwise) will be posted on and make it visible to as many people as possible. So please, keep sharing, keep discussing, keep debating, and help keep the movement alive.


Fabio Gratton

buzz this

From Twitter 12-07-2009

  • 11:49:04: Happy Monday @heldincontempt @shwen @eyeonfda @ellenhoenig @MarianCutler @jeannemale @swoodruff @whydotpharma @skypen @andrewspong @jonmrich
  • 13:11:33: Say "no" to toxic chemicals found in household products. Join the Million Baby Crawl #MBCrawl
  • 16:21:53: Yes, white elephant=no patients! RT @whydotpharma: Was there a white elephant in the FDA hearing? #hcsmeu #hcsm #fdasm
  • 17:40:24: Brilliant! "MIT team wins Darpa's treasure hunt in less than one day". How? Make everyone a player! #hcsm
  • 21:03:30: The most important document you will download in the next 6 months -- THE SCHEDULE FOR THE 2010 FIFA WORLD CUP (PDF):

Tweets copied by

buzz this

Sunday, December 06, 2009

From Twitter 12-05-2009

Tweets copied by

buzz this