Many people have provided excellent summaries of the events that happened at #FDASM, or as the FDA called it, "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001)." In the words of Jonathan Richman, "Catchy, right?"
Just a few that I enjoyed,
http://healthed.typepad.com/healthed-blog/ (what we didn't learn)
http://www.spectrumscience.com/blog/2009/11/17/the-fda-has-no-idea-what-to-do-about-social-media-%E2%80%93-day-2-of-the-fda-public-hearing/
http://creationinteractive.com/articles/lessons-fda-social-media-hearing/ (international implications)
http://blog.roskadigital.com/2009_11_01_archive.html
Ultimately, there were a few take-away points (opinions) that were made by several speakers:
1. Social Media is important. We knew that, but it appears as though the speakers were unsure that the FDA did.
2. Average Joe does not trust our industry. By preventing our use of social media, the FDA may be preventing transparency that the consumers and the agency want.
3. Companies want to provide fair balance, but believe that under current guidelines it is not possible to do effectively. Fair balance information is incomprehensible to those without medical backgrounds. The verbiage on it should change and be permitted to be "one click away" in order to track and understand when the vocabulary is effective and useful.
4. Adverse Event reporting should be made easier and more available to the consumer. The current Medwatch (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm) submission form is too long, and discourages compliance.
There were, of course, the nay-sayers, namely Dianna Zuckerman, President of the National Research Center for Women & Families and Steve Findley, a Senior Health Policy Analyst for Consumersunions.org.
Diana Zuckerman accused sites such as Wikipedia and Drugs.com as having "user-edited content” and “inaccurate or incomplete information.” Drugs.com responded in their blog and pointed out, with evidence, her inaccuracies, http://blog.drugs.com/2009/11/drugs-com-refutes-erroneous-claims/. Zuckerman later made some convincing points on AE on the second day, however they were overshadowed in most listener's ears by her lack of understanding of the media being talked about. Her most knowledgeable comment was probably, "(Reporting) links should be hard to miss, instead of hard to find."
Steve Findley felt that all restrictions on fair balance should be on web pages as it is in print media, stating that the space on the web is not restrictive. He is absolutely right. The space is not restrictive. I can easily place fair balance information on a drug 2020 pixels to the right of the advertising information. Most will not scroll their bottom scroll bar to the side to find it. But it is there, in the "unlimited" space on the same page. Of course, it is not obvious, or comprehensible.
Now that the Nay-Sayers are out of the way, let's talk about the ones we were watching for.
Yahoo's presentation sounded more like an advertisement, and they made no mention of their health pages. I was disappointed. Google provided an excellent solution on the search result advertisements that previously received warning letters from the FDA. (Though no mention of Side-wikis)
They also presented valuable statistics on the value of the information and click through rates since the warning letters.
The red line represents the date of the warning letters.
You can see the difference in the number of follow through to quality health information sites from before to after the letters. More users are now following the links to the purveying "snake oil" of our times. "This is potentially dangerous," was the general consensus from other presenters. Google also gave us the information that in the last three months of the year 2007 there were about 4.6 billion (That's the estimated age, in years, of the earth) searches on healthcare terms. These 4,600,000,000 searches were made by 111 million people and that the number is only going up.
PatientsLikeMe.com presenter, James Allen Heywood, had some very valid points, that he felt are being over-looked. He brought out the point about "how you say" vs. "what you say" in regards to consumer comprehension of potential side effects.
Heywood also mentioned that we have our amendment rights, namely- free speech. He used this argument not for the rights of pharmaceutical companies but he believes the consumer has the right to say what they feel about the product. If the government goes through and removes posts because they are "off-label" then Heywood feels they are interfering with that right. In addition, Heywood felt that heavily pushing side effect information on the consumer could influence the patient and doctor relationship in a negative way. Confused consumers could stop taking a medication for fear of side effects, without discussing the change with their primary care physician.
Compass Healthcare Communications' Peter Nalen and Maureen Miller brought up a a point about fair balance. They held the FDA accountable for tweeting about products that had been approved. They felt the FDA did not include the fair balance information about the drug in the tweet.
MISI Company's Kathleen Fourte and Alejandra Diaz made an interesting point. Not clicking through on a link to fair balance information would be like changing the channel before the end of a pharmaceutical commercial got to the fair balance information they are required to include. Sure, it is present, but consumers can listen to it, or change the channel.
ORC Guideline, Inc. 's Morris Whitcup made an amusing claim- that the internet is arguably the best invention since the Gutenberg Bible. He also showed survey results that said consumers feel there is too much risk information put forth by pharmaceutical companies and that 40% of consumers tune out that information on television.
HealthCentral's Christopher M. Schroeder said "At no point should a consumer have any confusion about the information that he/she is considering."
Sermo's Daniel Palestrant presented the information that the heaviest users of Sermo.com are the older, and busiest of physicians. They collected information that also indicated that those participating on Sermo are in the group that prescribes the most. Most of the doctors responding also said they were in favor of reporting Adverse Events online. They now have 111,000 physicians as part of their social networking group.
As a complete re-cap, I would like to give you this youtube.com link from WOMMA lawyer Tony DiResta. It is a re-cap of what occurred, in video.
At the end, Tom Abrams stated that "what we have heard is 'it's a different medium'" and that is a good sign. Abrams also asked, when Johnson and Johnson (JNJBTW) stated they were committed to providing accurate and timely information to the consumer, "how can we help you do that." This shows a deep interest (as if the hearing itself wasn't) in doing what is necessary and protecting the consumer.
In conclusion, I believe the FDA will be issuing some guidelines towards the end of 2010. What they will be, I do not know, but I know they have a great deal of work ahead of them. I also know, as a child of government workers, they will be working hours beyond what they are paid to do so. A special thank you should probably be given to Jean-Ah Kang, Special Assistant to the Director, DDMAC and CDER.
These are the FDA panelists at the hearing-
• Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
• Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
• Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
• Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
• Kristin Davis - Deputy Director, DDMAC - CDER
• David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
• Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
• Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
• Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
• Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
• Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
• Robert Temple - Director, OMP - CDER
• Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH
(Images in this post were taken from Google's FDA presentation)
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