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About two years, I posted an opinion piece on BioJobBlog which argued that pharma’s reluctance to engage in social media because of fears of being swamped with adverse events (AEs) reports was little more than a red herring.

In that piece I opined “what is really at stake, is the systemic changes that would be required to transform a historically, opaque and unresponsive industry into a transparent, accountable and responsive one that would be required if it embraces social media as an integral part of its business model.” Nevertheless, two years later, there is still no FDA guidance on the use of social media in the pharmaceutical industry and while some companies have warmed up to the concept, it has not been wholly embraced by most companies.

However, there is new data that may put the “fear of being swamped by AEs reporting” argument to rest. The Pharmalot Blog reported today that a new study conducted by Visible Technologies, a social media monitoring and software firm, showed that only 0.3 percent of more than 257,000 posts about 224 different products —33 antacid over-the-counter meds, 38 over-the-counter decongestants, 10 prescription statins and 143 prescription drugs used to treat high blood pressure—mentioned an AE. For a more detailed analysis of the study please click here.

According to the Pharmalot post the study was conducted over a recent 30-day period and posts were collected from millions of social media sources including “blogs; forums; message boards; message groups; social networks, notably Facebook and LinkedIn; Twitter; regular news sites; specialized health sites, such a WebMD; and video and photo sites, such as YouTube and Flickr.” The study’s focus on statins, blood pressure medications, over-the-counter decongestants and antacids was intentional because tens of millions of persons use these products and therefore, would be more likely to comment on them at social media sites. The bottom line: the use of social media by pharma companies will not overwhelm their existing AE reporting networks nor will it require that more persons be hired. In fact, as I argued in my previous post, using social media for AE report may actually help companies better managed approved and marketed drugs as part of their FDA-required post marketing drug surveillance programs. 

At this point, I am at a loss as to why pharma has not yet embraced social media and leveraged it to their advantage like other industries. I suspect that most companies will not act until FDA issues the social media guidance it has been promising for the past two years. Sadly, it is anyone’s guess when the agency will finally issue the guidance—it has already been delayed several times over the past two years!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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About a year ago, I suggested that real time social media platforms like Twitter could be invaluable tools for adverse event (AE) reporting and related pharmacovigilance activities. However the mere mentioned of the dreaded AE causes many marketing, legal and regulatory affairs professionals at major pharmaceutical companies to break out into a cold sweat. 

As Mark Senak aptly pointed out in a recent post on his blog EyeonFDA,

“...the reporting of adverse events using social media has long been the bogeyman feared by the legal and regulatory departments of drug manufacturers in the US.”

Further, Mark rightly asserts:

“....the adverse event issue may have proven a red herring.  That is perhaps evidenced by the now large number of Twitter feeds that are active representing pharmaceutical manufacturing companies and even their products; the growing, though not as quickly and not with as much success, presence of YouTube channels; the large number of Facebook pages and even an uptick in the number of corporate sponsored blogs – now at five by my count.  If the adverse event reporting issue really were an issue, this presence would be shrinking, not growing.”

So, what is the “real reason” why drug manufacturers refuse to embrace social media like almost every other industry that I can think of? True, FDA has not yet issued its long awaited guidance on the use of social and digital media in the life science industry. But, the lack of guidance has not prevented pharma and biotech companies from innovating in the past. I suspect that one of the reasons why many companies refuse to adopt social media is the requisite transparency and interactivity that are typically associated with its use. And, perhaps more importantly is the perceived loss of control over product messaging that companies with approved drugs on the market have enjoyed for the past 50 years or more.

Whatever the reasons are, I still contend that social media platforms are ideal tools for AE reporting and pharmacovigilance activities. Hopefully, drug makers will come to realize this with or without FDA guidance on the topic.

Until next time...

Good Luck and Good Tweeting!

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I realize that I have been blogging about adverse events for the past couple of day but, let’s face it; the pharmaceutical industry lives or dies by the number of adverse events (AEs) that are reported for approved and marketed drugs. In any event, I came upon an interesting post in a Pharmaceutical Processing e-blast about the results of a survey  (conducted by Pfizer) which revealed that physicians are more likely to report side effects and adverse events through an electronic health records (EHR) system as compared with traditional paper methods. Nearly 60 percent of the 300 physicians who responded to the survey also agreed that AE reporting through an EHR would improve patient care.

While the results of the survey are not surprising (to me anyway), they suggest that the use of electronic methods for adverse events reporting may be a boon to drug manufacturers that are required (by FDA and other regulatory agencies) to collect information regarding the safety and tolerability of approved and marketed drugs.

In a previous post, I opined that social media would be an ideal platform for AE reporting. The results of the Pfizer survey tend to support this supposition. While EHR aren’t exactly social media, they are electronic and, it appears to me (based on Pfizer survey results), that healthcare providers and consumers may be more likely to report potential AEs using electronic as compared with conventional methods. Put simply, electronic reporting is much simpler, quicker and more facile than the current pen and paper model for AE reporting. And, in today’s rapidly paced and hectic world, time savings can translate into cost savings and improved efficiencies.

Paradoxically, the Pfizer survey results tend to contradict the notion that social media would be a bane to AE reporting for most drug makers. As I mentioned yesterday, many drug makers who have almost universally shunned social media, contend that the use of social media would overburden their AE reporting systems and possibly put them at enormous legal and regulatory risk. However, as I pointed out many times in the past, AEs are an expected reality in the pharmaceutical, biotechnology and medical devices industries. And, while drug makers are deathly afraid of AEs and reluctant to learn of them, the more information this is available about potential safety and tolerability issues, the better off most drug manufacturers may be. For example, if Merck was alerted earlier about the cardiovascular problems that Vioxx patients were experiencing, then possibly fewer patients may have been affected and harmed and perhaps, an improved version of Vioxx, an effective pain medication, might still be availability to patients who benefit from it.

To that end, providing physicians, healthcare workers and consumers with an accessible e-based AE reporting system built around social media would allow drug makers to quickly determine whether or not one of their drugs exhibits tolerability or safety issues that might warrant further investigation.  And, I believe that putting the appropriate social media AE reporting systems in place would allow drug and device manufacturers to monitor the performance of their products in real time and more accurately monitor, collect and analyze safety and tolerability data for certain drugs. This, in turn, would likely lead to the development of improved safer and more effective medications and devices, lower drug development and manufacturing costs and ultimately reduce drug makers’ exposure to legal and regulatory actions.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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