Mark S. Senak's Blog, page 44

Government Shut Down and FDA – Redux

On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown.  Once again, as in the Spring of 2011, we are faced with the question of what will happen if it occurs – particularly for FDA.

This must be prefaced by saying I have no inside information nor have I spoken with anyone at FDA about what would happen in the event of a shut down of the government should such an event occur on October 1.  Nor do I think FDA would be interested in having that discussion.  However, given that FDA regulates approximately one-fourth of the U.S. economy, one has to figure that there are consequences to our every day lives.

However, there was plenty said in the Spring of 2011 and there are some historical notes from the 6 day shut down that occurred in 1995.  Here is a little bit of what was said then and a few notes from the past of how a shut down affected healthcare in general and FDA in particular.

According to About.com, for Medicare and Social Security – about 400,000 people were delayed from being enrolled into Medicare and 112,000 social security claims were not processed while 800,000 calls when unanswered;
According to an ABC News blog, a shut down will mean that NIH will not be able to accept new patients into clinical trials nor will new trials be able to begin.  Per another posting, this means 640 trials will not be accepting new patients.
Most of the impact of a shut down on FDA’s day to day operations would seem to be concentrated on the agency’s ability to conduct food and drug inspections – both here and abroad – on food and drugs manufactured here and those to be imported into the U.S.
Without knowing what staff would remain for emergencies while the rest are furloughed, one has to wonder whether or not alerts would be sent out that warn the public about emerging issues, sometimes serious safety issues, associated with a foodborne illness or food or drug product adulteration or drug adverse event reports.
If the shut down would last long enough – days or even weeks, holding meetings – and even preparation for meetings – could be affected, including 9 separate Advisory Committee meetings scheduled for October.
Warning and NOV letters would not be coming out, though none have been posted on the OPDP site for nearly two months.
Finally, any company with a PDUFA date for a product approval that comes and goes during a shut down should probably not count on that approval happening on time.

Undoubtedly there are many more consequences, but these are a few that are immediately drawn into question.  And many are hopeful that a solution will be forthcoming because the drastic consequences of a shut down are too undesirable.  But remember – that is what they said about the sequester.

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Weekly Roundup – 9-21-13

Autumn officially arrived, but it seemed as if we have had a preview for the past several days.  Once September began, the light began to take on a completely different effect, particularly at the end of the day.  The mums are all out for sale at the grocer’s and the nurseries and the pet boarding facility is reminding us it is time to make our Christmas travel plans.   And even though summer is done, it seems that the Fall is getting off to a slow start, perhaps in anticipation of the effects of another impending government shutdown.

Here is a little bit of what did happen.

FDA and NIH Create Tobacco Centers of Regulatory Science – Both agencies announced this week what was billed as a first-of-the-kind Tobacco Centers of Regulatory Science (TCORS).  The purpose of the center, which uses designated funds from FDA and which is coordinated by NIH, is to bring together investigators from around the country to develop and evaluate tobacco product regulations.  It is also to help young investigators with training. Their fields of expertise include epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications and marketing.
FDA Prohibits Manufacture of FDA-Regulated Drugs from Ranbaxy Mohali, India Plant -FDA announced that it was exercising its authority under a provision from a January 2012 consent decree by extending the terms of the decree to a Ranbaxy facility if an inspection determines that the facility is outside of CGMP standards.  Under the terms, the company is not allowed to manufacture FDA-regulated drugs at the facility or to introduce them into commerce in the U.S.  The agency said that it was not anticipated that the action would be the cause of any supply disruptions or shortages of drugs in the U.S. as a result.
New System for Identifying Medical Devices – A final rule was announced by the agency today that would allow for a unique device identification (UDI) system to be implemented, having the potential to improve the way adverse events related to medical device use is collected, reported and acted upon.  In addition, the new system should serve as a safeguard against counterfeiting.
OPDP Watch – A few weeks ago, Eye on FDA carried a notice in the Weekly Roundup that the entire month of August had gone by without the issuance of any regulatory action letters by the Office of Prescription Drug Promotion (OPDP). The date of a last issuance of a letter was July 31. As we enter the final stretch of September, it may be that we have a second month in a row where no letters have been issued.  There is a lag time between the time a letter is issued and it is posted – and we still have a little over a week left, but interesting to watch.

Ending on a personal note, you may have noticed that I haven’t been around of late.  I have been out on bereavement leave, but am happy to be back now.

That’s it for me this week.  I hope you all have a wonderful, relaxing and safe weekend.

Photo credit:  Anne Becker

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Weekly Roundup 9-6-13

Always so sad to part with my seersuckers, the linens and the white bucks rounding them up and putting them in the barn for their long slumber until Memorial Day of 2014.  Where did the time go?  To console me, however, came the news that a friend near Seattle had a cow give birth to a new fancy Jersey heifer who was given the name Markie, after your’s truly.  You can bet that Markie, pictured above, is going to be seen often here in The Weekly Roundup.

Despite the fact that it was “back to school” week, it was still kind of slow-going.  In fact, there is very little activity to report on.  Everyone is easing back into the regular work schedule rather than rushing which would include everyone in our little corner of the world.  Here are a few noteworthy things:

Brief Update to Yesterday’s Posting - Naturally after I posted yesterday about pharma use of Pinterest, I located a few more pharma sponsored boards – 4 actually, bringing my grand total up to 43 from 39.  One of the most interesting uses involved posting pictures that depicted the history of the company.  Very interesting and creative.
FDA’s CFSAN Outlines Upcoming Priorities – The Center for Food Safety and Applied Nutrition outlined their six policy goals for the coming 2013-2014 year – (1) reducing foodborne illness rates and cosmetic injury rates each year; (2) establish regulations/policies/guidances and inspection and compliance strategies based on the best science, prevention and public health risk; (3) increase compliance with newly creative preventive control standards; (4) improve public health indicators through better nutrition and dietary choices; (5) develop and deploy the fastest most effective methods for identifying, containing and eliminating food and cosmetic hazards; (6) achieve optimal use of staff and resources.  The details and agenda for each of these goals can be found here.
More About Something That Hasn’t Happened – The Office of Prescription Drug Promotion (OPDP) has not posted a regulatory action letter since one dated July 31.  August may have been a violation-free month (as was January).  There have been a total of 13 letters issued so far this year.  By this time last year, the office had sent 20 letters out and in 2011 they had sent out 22 letters by this time.
3rd Medical Communications and Information Summit – CBI, an Advanstar company, will be holding its 3rd meeting of this name in San Francisco on September 19 and 20.  I will be giving a talk on the regulatory enforcement by FDA regarding digital communications.  Come by and let’s have a chat!  You can check out the agenda and brochure here.

That’s it for me and Markie this week.  I hope you all eased back into your routine painlessly this week and that you enjoy the weekend.

(Photo credit of Markie to Anne Hainsworth)

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Pharma Interest in Pinterest

Welcome back everyone!  I hope you all had a great end to the summer season.  While we still have a few technical weeks to go, the back to school, back to work calendar says the fun is over.

As regular readers know, I have been working with a colleague to track pharma social media activity by noting all of the activity of which I am aware in Twitter, YouTube, Facebook, Google+ and Pinterest.  Each entry is categorized so that it can be tracked as to the platform as well as its purpose – i.e. product specific, disease awareness, corporate, etc. We also track country of origin as well as the activity level, number of followers, etc. All of this is compiled into a Pharma Social Media Database with the help of an intrepid colleague.

There is a good deal of activity in social media by pharma, at least on the face of it, which many people still think is not the case.  I am tracking over 230 Twitter feeds, 121 Facebook pages, 172 YouTube channels, and over 80 Google+ pages (more on that in an upcoming posting).  As always, it is important to note that this is the activity of which I am aware and there is likely activity beyond what I know – so this is only a partial look at pharma social media activity, though I believe we have captured a very large chunk of it.

In addition to the above platforms, also included in the tracking efforts is pharma activity related to Pinterest – the social media platform that allows you to take images and pin them to various categories of boards for others to see and share.  Here are a few highlights of the Pharma Pintrest Profile:

Number of Pharma Pinterest Pages. While there are 39 Pharma Pinterest pages, not all of them are active.  In fact over one-third (16) are dormant pages where there has been no activity for at least the past year;
Geography. Of the remaining active 23 or so that are active, slightly less than half of them are from the U.S. while the balance are out of Europe;
Purpose. The overwhelming majority of pages are corporate or general pages with only about 4 being product-specific and 2 aimed at recruitment;
Regularity of Activity. Only 3 provide daily updates, but 9 (25%) provide either weekly or daily updates;
Volume. The highest number of pins was over 4000 and the highest number of followers is 460.

While it does not represent a great deal of activity, for many Pinterest is a platform that many may be surprised as any pharma activity at all, much less two job recruitment efforts.  And while the volume of activity may not be significant, what is perhaps significant is how far pharma has been willing to explore emerging social media platforms even without the long-awaited guidance from FDA.  (BTW, I did not find an FDA presence on Pintrest.)

Next time we take a look at this material, let’s look at Pharma and Google+.  In the meantime, welcome back.

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Pharma Interest in Pintrest

Welcome back everyone!  I hope you all had a great end to the summer season.  While we still have a few technical weeks to go, the back to school, back to work calendar says the fun is over.

As regular readers know, I have been working with a colleague to track pharma social media activity by noting all of the activity of which I am aware in Twitter, YouTube, Facebook, Google+ and Pintrest.  Each entry is categorized so that it can be tracked as to the platform as well as its purpose – i.e. product specific, disease awareness, corporate, etc. We also track country of origin as well as the activity level, number of followers, etc. All of this is compiled into a Pharma Social Media Database with the help of an intrepid colleague.

There is a good deal of activity in social media by pharma, at least on the face of it, which many people still think is not the case.  I am tracking over 230 Twitter feeds, 121 Facebook pages, 172 YouTube channels, and over 80 Google+ pages (more on that in an upcoming posting).  As always, it is important to note that this is the activity of which I am aware and there is likely activity beyond what I know – so this is only a partial look at pharma social media activity, though I believe we have captured a very large chunk of it.

In addition to the above platforms, also included in the tracking efforts is pharma activity related to Pintrest – the social media platform that allows you to take images and pin them to various categories of boards for others to see and share.  Here are a few highlights of the Pharma Pintrest Profile:

Number of Pharma Pinterest Pages. While there are 39 Pharma Pinterest pages, not all of them are active.  In fact over one-third (16) are dormant pages where there has been no activity for at least the past year;
Geography. Of the remaining active 23 or so that are active, slightly less than half of them are from the U.S. while the balance are out of Europe;
Purpose. The overwhelming majority of pages are corporate or general pages with only about 4 being product-specific and 2 aimed at recruitment;
Regularity of Activity. Only 3 provide daily updates, but 9 (25%) provide either weekly or daily updates;
Volume. The highest number of pins was over 4000 and the highest number of followers is 460.

While it does not represent a great deal of activity, for many Pinterest is a platform that many may be surprised as any pharma activity at all, much less two job recruitment efforts.  And while the volume of activity may not be significant, what is perhaps significant is how far pharma has been willing to explore emerging social media platforms even without the long-awaited guidance from FDA.  (BTW, I did not find an FDA presence on Pintrest.)

Next time we take a look at this material, let’s look at Pharma and Google+.  In the meantime, welcome back.

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OPDP Letters for Promotion of Investigational Compounds, Part 2

In my last posting, I provided an overview from my database of Warning and Untitled (NOV) letters data base that spans the years 2004 – present regarding FDA actions around communications perceived by the agency to be promoting an investigational compound prior to approval.  In that posting, we looked at the number of letters, the type, the communications vehicles involved, among other things.  Today, we are going to look at the language.

There were 8 letters in all where one can discern how characterizing a compound that is still being investigated with conclusions as to safety or efficacy can catch the eye of regulators:

November 2008 – An investigational oncology related compound discussed on a Web site.  The language used said that the drug “is a biological product designed to…” “is the only drug that can remove…”.  In addition, it stated that the drug “contains a recombinant enzyme which rapidly cleaves…” and “was able to achieve a clinically important reduction” – “consistently reduced … concentrations” and said that the drug “is well-tolerated” “a unique drug that allows clinicians to control patient exposure…” (Partial list from the letter)
January 2011. A cosmetic treatment under consideration for approval discussed in media interviews by a clinical investigator.  Statements cited by the agency included one that the drug “will likely come out later this year.  Early data shows that it may last longer and kick in faster….” and “I can’t wait to use” the drug.  ”Effects last a month longer”  than the competitive drug on the market; and “It’s time we have something that lasts a little bit longer…” For this letter – there was also consideration of the fact that there were no head to head trials comparing the investigational compound to any other drug out on the market.
April 2011. Brochure for an investigational oncology compound distributed a conference.  Brochure title included the words “new therapies” and described the mode of action saying that it “is particularly active against a number of short-lived proteins…” noting also that as positive data from clinical trials has become known demand for access under compassionate use had increased.  Stated that the investigational drug “is a valuable option for the treatment of patients… FDA said that the totality of these claims suggest that the drug is safe and effective for patients.
June 2011. An investigational oncology compound Web site.  Here the site made statements such as that the product “has demonstrated both safety and clinical efficacy….” and that it had a “safety profile that is distinctly different” and that the it was demonstrated in the trials that it “can be safety given to humans” and “has generally been well tolerated.  Even when accompanied by specific language stating that “[t]his investigational drug product has not been approved by the US Food and Drug Administration for safety and effectiveness” the agency felt was insufficient to overcome the impression that was given by the language used on the Web site.
August 2011. An oncology related investigational product set of Web pages.  Used language such as saying the product “is non-toxic because it works with the body’s immune system” and “is the first combination immunotherapy” and that it “is able to directly affect both the tumor cells themselves and activate a robust anti-tumor immune response” and “has been shown to be safe and well tolerated”.  It also showed some before and after pictures which demonstrated dramatic improvement.   There was additional language, but along the same lines as that already stated.
October 2012. While the primary communications vehicle here is a Web site, the site included press releases and embedded videos regarding an investigational drug in oncology which contained the language that concerned FDA.  The release stated that the product was “well-tolerated with easy manageable side effects….” which “compared favorably to radiation therapy and chemotherapy” and citing remarkable response of one patient in the trial.  In another press release, the mechanism of action was described and in yet another, similar language to the first that stated that the product was “well tolerated, with just two cases of serious reversible toxicities”.  The letter then addresses some language on the Web page that provides specific information on how the compound works and lastly cites a video on the Web site that was entitled “Tomorrow’s Cancer Treatment Today” and talks further about the mechanism of action.  This provides an example of how the agency looks at the totality involved in the communication.
November 2012. This involved discussion of an investigational treatment for diarrhea contained in a podcast on a website.  Here there were some statements on the mechanism and what it does and does not do and statements that the product “is ideally suited to treat” the diarrhea and that the product “targets the primary cause”.  Further cited was language that stated that the “mechanism of action and safety profile provide a strong rationale for treatment…” and in the podcast there were further statements about what the treatment did – such as the statement that the “product has so many different indications becasue the mechanism of action is a basic normalizing…. so it works for the most severe, acute, infectious…”
April 2013. Another investigational oncology drug discussed on a website.  Statements that the compound “achieves the required therapeutic concentration necessary…” and “demonstrated no significant or lasting side effects in the clinical setting, and had a very favorable adverse event profile”.



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Weekly Roundup – 8-16-13

Oh sweet summer!  The tomatoes hang heavy on the vines, hopefully out of reach of greedy little critters.  The peaches and plums are deliciously ripe.  It is almost time to put in a second batch of basil to keep growing through the autumn months.  And sweetest of all, there simply is no traffic and many parking spaces while people are away on their vacations.

For those looking for Part 2 of the posting about FDA regulatory actions related to pre-approval promotion, it will come next week.

And here is a little bit else:

Approval of New GSK HIV Drug - Last week in the Weekly Roundup we noted the approval of a new HIV test, this week we note the approval of a new HIV treatment.  The agency announced approval this week of GSK’s Tivicay – an integrase strand transfer inhibitor that works by interfering with one of the enzymes that HIV requires in order to multiply.  According to the release, it is to be taken daily in combination with other antiretroviral drugs.
Another Recall Involving Compounding – The concerns related to drug compounding have been much in the headlines in the past year or so, leading me to organize a tab on the Eye on FDA blog site dedicated to tracking the developments related to reform around compounding laws.   The agency announced on August 11 a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding due to reports of a potential connection to bacterial bloodstream infections.  It is also noteworthy for FDA watchers who wonder if weekend press releases are issued by FDA – this one came out on a Sunday.
Questions About Medical Foods? Medical foods is one of those areas where I have always been a little fuzzy – like a dandelion at the end of summer.  FDA is here to provide a puff of wind to alleviate the fuzziness with the update of a draft guidance serving up a healthy portion of Q&A about medical foods.  So if you are like me, you will want to click on this link to get to the newly updated Draft Guidance of Medical Foods.

Well partners, I am going to mosey off to the weekend now.  You do the same and have a good one.

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OPDP Letters for Promotion of Investigational Compounds, Part 1

As many know, I have put together a data base for my use that tracks the letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) since 2004 – tracking company, date, indication, product name, type of communications vehicle and type of violation, among other things – which allows me to sort on various fields or combination thereof.  One of the fields tracked is whether or not the communications vehicle involved in a violation was digital or not, which allowed me to produce the white paper in April on that topic.

Recently I had cause to go back and look for any warning or untitled letter sent because of a violation cited by FDA for promotion of an investigational product.  If you have ever wondered what would trigger a letter in this regard, it is a good idea to look back and see what has.  Here is a little overview of letters since 2004:

Number. There were a total of 8 letters relating to promotion of an investigational compound, involving 9 different communications vehicles
Indication. Interestingly 5 were in Oncology, 1 involved a cosmetic treatment, 1 treatment for ADHD and 1 treating diarrhea;
Type of Letter. Only 1 involved a warning letter – the rest were untitled (NOV) letters;
Digital or Non-Digital. Another point of interest – nearly all involved digital communications vehicles – 6 were Web pages, 1 was a brochure and 1 involved statements made by spoken word during media interviews (that one involved a clinical investigator)’;
Violations. Finally, none of the letters involved any other violation except the promotion of an investigational compound.

What comprises promotion of an investigational new drug?  ”A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.  This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.  Rather, its intent is to restrict promotional claims of safety of effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”

In my next posting on this topic, I will try to summarize the language and circumstance that the agency cited that prompted the letter.

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Weekly Roundup 8-9-13

The Congress is gone, the humidity is back.  All things considered, that is the way we prefer it.  It is that time of year where the grass appears to have had it and we find ourselves dreaming of and longing for that first crisp autumn day.  And alas, sadly, the days are already noticeably shorter.

And speaking of shorter, since Congress is gone – no new legislation to report – no testimonies happening so the Roundup is also a little short.  As we drift through these dog days of summer, here are a few things that I thought would be of interest:

First Rapid Diagnostic Test for HIV-1 Antigen and HIV-1/2 Antibodies – I was thinking back to the time when I was working in the early days of the HIV epidemic – before it was called HIV even – and what it was like.  There was no test.  One only found out one was infected when one acquired an infection – likely life-threatening – that was a signal that your immune system was gone. Contrast to this week when FDA approved the first HIV test for both antigen and antibodies in a single effort.  According to the release the test does not distinguish between antibodies to HIV-1 and HIV-2 and will not be intended to screen blood donors, but can be apparently be used in outreach settings to provide rapid results.
Sunshine on the Sunshine Act – For some time now, virtually all of the stakeholders in healthcare have been anticipating, but not necessarily always understanding, aspects and implications of the Physician Payment Sunshine Act passed into law and in the process of implementation. The day is coming where understanding and knowledge about the Act should no longer be put off.  The Policy and Medicine blog has for a long time covered various aspects of the Act and written at length and in depth about it.  However, this week a posting to the Policy and Medicine site on the Sunshine Act Deadlines, Resources and Responsibilites provided a incredibly thorough overview of subject matter. It is extremely impressive and if you are in need to know, you should check it out.
FDA-TRACK Updated – For those of you interested in following the stats that the agency posts in FDA-Track marking its progress in multiple areas across the agency, it would appear that new data was posted in several areas, including the Advisory Committees Dashboard, the Freedom of Information Act Dashboard and the Health Care Reform Dashboard among others.

That’s it for me this week folks.  Have a wonderful weekend.

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Practicing Medicine and Practicing Social Media

While attending the 2nd ExL Digital Pharma Conference in Berlin in 2010, I listened to a dynamic presentation by a young physician from Hungary who talked about the ways that social media could – and would – make an impact on the practice of medicine.  His talk was the hit of the conference and he really excited everyone in the room about the potential for social media and medicine.  Afterwards, I caught him for a quick video interview and wrote a posting about it here on Eye on FDA – “The Places That Medicine Can Go – Fascinating Presentation by Dr. Berci Mesko“.

Bertaln Mesko, M.D., PhD. is a “medical futurist” and has a Medical Futurist website to prove it.  , He is a medical doctor, a lecturer and a visionary and founder and managing director of the robust site Webicina – which curates social media resources in medicine for both health care professionals and patients (I am on the Webicina International Advisory Board) and founder of The Social MEDia Course.  He blogs at Scienceroll.com. In other words, he does a real lot….

This includes writing a new book called Social Media in Clinical Practice. It is a very practical guide for a medical practitioner who wants to learn about how to use social media platforms in various ways to support communications with patients and other medical professionals.  It takes you through the how and the why.

Because social media and medicine has evolved so much since our 2010 meeting, I sent Dr. Mesko a few questions about the topic – questions that I thought might be posed from medical professionals who might be curious, but have not yet embraced social media in their practice.  Here is what he had to say:

While social media use among those in medical practice is growing, there are a lot of concerns on the part of practitioners that range from potential lapses of privacy to concerns about the return on investment.  How would you characterize the “risk-benefit” ratio of social media use by physicians?

I think there aren’t many essential differences between real-life and online communication.  I teach my students they should behave online just like they do in the offline world.  Therefore, social media can only make processes faster and more interactive, although if your offline communication as a doctor is bad, it’s going to be the same on any social media platforms as well.

There are risks, obviously, but if you know the limitations and potential problems related to the active use of social media, you know what you can do and what you should never do online.  That was the basic concept behind writing this handbook so then medical professionals worldwide would get a clear picture about the online channels and ways of communication.

Teaching tricks and rules about the Internet should get a huge emphasis in medical school, but it doesn’t get that kind of attention.  This is why I thought there is a niche for such a handbook which includes step-by-step instructions and tutorials focusing on all the major social media channels.

What do you see as the most important benefits to physicians and to patients respecting social media and medicine?

Communication between doctors and patients; or even among doctors; and patients could be more efficient, faster, more interactive and archivable.  As we tend to use such social media channels more and more in different areas of our lives from banking to shopping to making friends, it is quite inevitable that at some point it takes its place in practicing medicine and delivering healthcare.  In order to take its place in medical communication, we have to make sure all the stakeholders of medicine know how to use it properly and securely.  From my perspective, medical professionals should become guides for their patients online and as plenty of patients are quite web-savvy being up-to-date in their own conditions or therapies, it’s time for medical professionals to step up and educate themselves.  For this, they need to be even better at using digital channels than their own patients.  This is the area where I try to help them make their first steps.

There are many physicians who have embraced social media and are using it regularly in their practice, while there are still many others are not even using email.  Are we becoming a system of “haves” and “have nots” in medical practice and what are the consequences of that?

It was quite an expected phenomenon and it happens all the time when anything new is introduced as a new member of the range of technologies doctors should be able to use.  It took time to embrace e-mails – now it takes time to embrace social media.  But I must observe these processes from a neutral point of view.  I tell my medical students that my aim with the course is not to transform them into bloggers and Twitter stars, but to show them solutions so when they meet e-patients or will be challenged with digital-related problems, they will know where to find a solution.

While the practice of medicine is always human-based, some patients do want to use social media channels to keep in touch instead of many phone calls or unnecessary personal visits.  If new channels provide us with better methods in medical communication, why not use them?

How do you see the development of medical apps – both for patients and physicians – impacting the use of social media and the practice of medicine?

Medical apps are now on a different level and have the potential to play a crucial role in practicing medicine.  Patients will soon be able to measure almost any health parameters about their conditions at home from blodo sugar level to even genomic data; but physicians will have to be able to deal with the additional data patients will bring to the visits.

Although the number of health apps is skyrocketing, we should not forget the basics of evidence-based medicine and stick to this approach when implementing medical smartphone apps into medicine and healthcare.  There are more and more studies dedicated to this issue, but their number is still not enough.  The potential is clear, but as long as we cannot put evidence behind using these, this is just potential and nothing more.

Social Media in Clinical Practice is available from the publisher and on Amazon.

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