Pfizer recently announced its plans to use eDiary technology in the first ever Participatory Patient-Centered (PPC) clinical trial. The pilot seeks to replicate the results of a previous study for the treatment of overactive bladder.
Successful replication will validate the PPC approach of using mobile technology to enable patients to participate in a trial regardless of age or location.
Increased patient enrollment and retention is not the only benefit of this approach. Real-time data capture directly from the patient allows investigators to react quickly to extraordinary symptoms that could adversely affect the patient's safety. Remote data reporting by the patient also has the potential for significant savings by cutting down on costly site management and reducing the time investigators must invest in a trial from end to end.
Here is an example where today's digital capabilities go beyond enabling simplification and convenience in this industry and actually work to transform the model for clinical trial performance. The metrics by which trial sponsors and CROs measure their performance - cycle times, enrollment targets, adherence to protocol, and so on - can be directly and positively impacted by empowering patients to take a more active role in the trial management process. Data capture is instant and can be kept in check with friendly patient reminders - or text message proompts, in the case of Pfizer's trial. Sponsors might actually begin to measure trial performance based on outcomes-based indicators, rather than on intermediate targets.
Overall, the speed and quality with which clinical trials are run is the biggest win with the use of eDiary technology - not just the ability to reach a larger audience.
In related recent news, social network site PatientsLikeMe has demonstrated a successful "social study" for ALS in which patients were enrolled, data was collected, and preliminary results were presented in just nine short months. Read more about the potential impacts of social media on clinical trials here.
Monday, June 27, 2011
Friday, January 28, 2011
Grading Pharma's Use of YouTube (A First Look)
When you think of YouTube, the first things that might come to your mind are satirical home-grown clips created with the purpose of entertaining the masses - or with no purpose at all, as the case might often be. When a few key pharmaceutical executives think of YouTube, different things come to mind: an integrated communication strategy; a broadcast medium for noteworthy corporate productions; a news channel reporting advances in development; a soapbox for corporate responsibility; or a method of communicating helpful information to patients on disease, drug safety, or treatment compliance.
While the pharma industry experiments with social media, several pharma companies are maintaining dedicated YouTube channels, among them Pfizer (PfizerNews, PfizerEurope), Johnson & Johnson (JNJHealth), GlaxoSmithKline (GSKVision), and Boehringer (BoehringerIngelheim).
Let's examine Pfizer: the PfizerNews channel reveals around 20+ videos, just over 100 subscribers, and nearly 83,000 channel views. The PfizerEurope channel similarly has a handful of videos with 67 subscribers (as of today). Both channels were created in 2009. These numbers seem impressive for a pharmaceutical giant; its videos are clearly reaching a large audience. But what value is the company getting out of it? Better yet, what value are its patients getting out of it?
Taking a look at another giant with a more successfully managed YouTube presence, you'll find that Johnson & Johnson's JNJHealth channel boasts well over 3,000 subscribers in less than three years' time. Upon entering you will be made aware of J&J's transparent strategy for social media ("videos to promote a better understanding of health") and can watch a video discussing the opportunity to use "social media for social good," stressing the value of relationship building through social media.
J&J's social media vision is not just fluff. A few of its channel playlists focus mainly on J&J's philanthropic activities, but one of the channel's playlists stood out to me as ingenious. It provides helpful information for caregivers of patients living with difficult diseases, such as cancer, multiple systems atrophy, and alzheimer's. This is useful social media for patients and their loved ones.
If I were to compare both companies' channels, Pfizer would receive a grade of D while J&J would be awarded a B+. Who gets the A?
Janssen, the mental health pharmaceutical company, with its LivingWithADHD channel, gets the A. (Note: Janssen is a subsidiary of Johnson & Johnson). In just 7 short months, the channel has roped in 124 subscribers and boasts over 43,000 channel views. This channel is unique because although it was created and is maintained by a pharma company, its focus and purpose lies in a particular segment of the population living with ADHD, not on the company itself. It embraces the movement in the industry towards customer segmentation. The channel's main "A Day in the Life" video has been viewed nearly 140,000 times and is linked to the company's Living with ADHD website: http://www.livingwithadhd.co.uk/. Also contributing to Janssen's grade of A is its fearless transparency. It allows any users to post comments on its videos, unlike many other pharma channels - even comments such as "drug company propoganda posing as informational video."
Recent survey results from Ogilvy find that 74% of pharma execs anticipate an increase in spend on digital activities in the coming year. I'm left wondering what percentage of "digital spend" will be directed towards YouTube. As the role of the patient changes to be much more proactive and self-informed, pharma companies need to come up with more interactive ways of reaching patients not only to promote drugs, but to help with the overall management of disease. At the same time, they need to anticipate abuse from commenters who are critical of "Big Pharma" and seek to manage this commentary rather than disallow it.
While the pharma industry experiments with social media, several pharma companies are maintaining dedicated YouTube channels, among them Pfizer (PfizerNews, PfizerEurope), Johnson & Johnson (JNJHealth), GlaxoSmithKline (GSKVision), and Boehringer (BoehringerIngelheim).
Let's examine Pfizer: the PfizerNews channel reveals around 20+ videos, just over 100 subscribers, and nearly 83,000 channel views. The PfizerEurope channel similarly has a handful of videos with 67 subscribers (as of today). Both channels were created in 2009. These numbers seem impressive for a pharmaceutical giant; its videos are clearly reaching a large audience. But what value is the company getting out of it? Better yet, what value are its patients getting out of it?
Taking a look at another giant with a more successfully managed YouTube presence, you'll find that Johnson & Johnson's JNJHealth channel boasts well over 3,000 subscribers in less than three years' time. Upon entering you will be made aware of J&J's transparent strategy for social media ("videos to promote a better understanding of health") and can watch a video discussing the opportunity to use "social media for social good," stressing the value of relationship building through social media.
J&J's social media vision is not just fluff. A few of its channel playlists focus mainly on J&J's philanthropic activities, but one of the channel's playlists stood out to me as ingenious. It provides helpful information for caregivers of patients living with difficult diseases, such as cancer, multiple systems atrophy, and alzheimer's. This is useful social media for patients and their loved ones.
If I were to compare both companies' channels, Pfizer would receive a grade of D while J&J would be awarded a B+. Who gets the A?
Janssen, the mental health pharmaceutical company, with its LivingWithADHD channel, gets the A. (Note: Janssen is a subsidiary of Johnson & Johnson). In just 7 short months, the channel has roped in 124 subscribers and boasts over 43,000 channel views. This channel is unique because although it was created and is maintained by a pharma company, its focus and purpose lies in a particular segment of the population living with ADHD, not on the company itself. It embraces the movement in the industry towards customer segmentation. The channel's main "A Day in the Life" video has been viewed nearly 140,000 times and is linked to the company's Living with ADHD website: http://www.livingwithadhd.co.uk/. Also contributing to Janssen's grade of A is its fearless transparency. It allows any users to post comments on its videos, unlike many other pharma channels - even comments such as "drug company propoganda posing as informational video."
Recent survey results from Ogilvy find that 74% of pharma execs anticipate an increase in spend on digital activities in the coming year. I'm left wondering what percentage of "digital spend" will be directed towards YouTube. As the role of the patient changes to be much more proactive and self-informed, pharma companies need to come up with more interactive ways of reaching patients not only to promote drugs, but to help with the overall management of disease. At the same time, they need to anticipate abuse from commenters who are critical of "Big Pharma" and seek to manage this commentary rather than disallow it.
Sunday, November 28, 2010
Managing Diabetes on an iPhone
Merck's introduction of a mobile app for patients with Type 2 diabetes (Vree) is an innovative way to manage the disease. A more recent announcement last week reminded me of Merck's introduction of the mobile app - a report that half the country could have diabetes by 2020, with costs totaling $3.35 trillion over the next decade if trends continue.
Our country is clearly in need of an increase in methods for diabetes prevention (it has been coined an epidemic since the 90s), but we also need new ideas for empowering patients who are already living with the disease to manage it well. Mobile apps such as the one created by Merck are a useful tool I expect to see much more of in our digital age.
Also in September, Denmark's Novo Nordisk introduced a mobile insulin dosing guide for physicians to look up dosing guidelines and blood glucose goals for diabetic patients (NovoDose).
What is most interesting to me about these tools is that they are representative of a larger role movement in the pharma industry from drug manufacturing to patient health management - a much more holistic, patient-centered approach that expands the expectations society has on pharma companies. Leading companies will not only have to continuously improve insights into patient populations for more targeted treatments, but will also be held accountable for increased compliance with those treatments and for coming up with novel ways to better manage patient health outside of medication. Put another way, IBM predicts a movement from "treating the patient" to the "health of a person."
Our country is clearly in need of an increase in methods for diabetes prevention (it has been coined an epidemic since the 90s), but we also need new ideas for empowering patients who are already living with the disease to manage it well. Mobile apps such as the one created by Merck are a useful tool I expect to see much more of in our digital age.
Also in September, Denmark's Novo Nordisk introduced a mobile insulin dosing guide for physicians to look up dosing guidelines and blood glucose goals for diabetic patients (NovoDose).
What is most interesting to me about these tools is that they are representative of a larger role movement in the pharma industry from drug manufacturing to patient health management - a much more holistic, patient-centered approach that expands the expectations society has on pharma companies. Leading companies will not only have to continuously improve insights into patient populations for more targeted treatments, but will also be held accountable for increased compliance with those treatments and for coming up with novel ways to better manage patient health outside of medication. Put another way, IBM predicts a movement from "treating the patient" to the "health of a person."
Monday, November 1, 2010
Social Media Guidance and the Art of Patience
The FDA recently gave Novartis a slap on the hand for "misusing" the Facebook Share widget on its website for the drug Tasigna. The violation? Failing to communicate risks associated with the drug.
The Facebook Share widget gives Facebook users the opportunity to share content by generating a link on their profiles to the information alongside a thumbnail image and brief description of the content. In the case of Tasigna, the drug's brief description made no mention of the drug's risks.
Should Novartis be blamed for this oversight? Maybe so - the FDA does make the communication of risk information associated with a company's drugs a requirement in all other facets of media - but this could have been avoided had the FDA provided the industry with clear, no-nonsense instructions on what rules apply to social media.
Some in the industry are asking for increased guidance in an attempt to use their social media channels responsibly according to regulators. Back in March, AstraZeneca issued a proposal to the FDA outlining key principles and a draft regulatory framework for the use of social media. The company remarked that "without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making." This proposal came as a response to the FDA's November 2009 hearing on social media, after which it was understood that the regulatory body would release new guidelines the following year.
Others, however, are proposing a different tactic: First Amendment rights. Pfizer and the Washington Legal Foundation filed a brief with a U.S. District Court in March to uphold First Amendment rights by limiting the FDA's authority on barring free speech of drug manufacturers on social media sites. Acting as an injunction against FDA enforcement action, this move is sure to delay further short-term progress in the form of FDA guidelines this year.
I can't say which tactic is smarter at this point - what I can say is that I don't believe guidelines should be issued as quickly as possible. Given enough time, the FDA will be able to formulate fair guidance over social media based on historical analysis and increased insights into the chain of online information. If this process is rushed, the industry will continue to chastised over individual cases that were not covered clearly under issued guidance.
In the meantime, learning from others' mistakes by closely monitoring warnings from the FDA directed at peers is a worthwhile short-term strategy.
References:
(1) Krigman, Eliza. FDA Tightens Reign on Social Media Practices. 9 Aug 2010.
(2) Fierce Biotech. AstraZeneca Outlines Principles for Product-Related Online Communications. 2 Mar 2010.
(3) WLF Press Release. 31 Mar 2010.
The Facebook Share widget gives Facebook users the opportunity to share content by generating a link on their profiles to the information alongside a thumbnail image and brief description of the content. In the case of Tasigna, the drug's brief description made no mention of the drug's risks.
Should Novartis be blamed for this oversight? Maybe so - the FDA does make the communication of risk information associated with a company's drugs a requirement in all other facets of media - but this could have been avoided had the FDA provided the industry with clear, no-nonsense instructions on what rules apply to social media.
Some in the industry are asking for increased guidance in an attempt to use their social media channels responsibly according to regulators. Back in March, AstraZeneca issued a proposal to the FDA outlining key principles and a draft regulatory framework for the use of social media. The company remarked that "without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making." This proposal came as a response to the FDA's November 2009 hearing on social media, after which it was understood that the regulatory body would release new guidelines the following year.
Others, however, are proposing a different tactic: First Amendment rights. Pfizer and the Washington Legal Foundation filed a brief with a U.S. District Court in March to uphold First Amendment rights by limiting the FDA's authority on barring free speech of drug manufacturers on social media sites. Acting as an injunction against FDA enforcement action, this move is sure to delay further short-term progress in the form of FDA guidelines this year.
I can't say which tactic is smarter at this point - what I can say is that I don't believe guidelines should be issued as quickly as possible. Given enough time, the FDA will be able to formulate fair guidance over social media based on historical analysis and increased insights into the chain of online information. If this process is rushed, the industry will continue to chastised over individual cases that were not covered clearly under issued guidance.
In the meantime, learning from others' mistakes by closely monitoring warnings from the FDA directed at peers is a worthwhile short-term strategy.
References:
(1) Krigman, Eliza. FDA Tightens Reign on Social Media Practices. 9 Aug 2010.
(2) Fierce Biotech. AstraZeneca Outlines Principles for Product-Related Online Communications. 2 Mar 2010.
(3) WLF Press Release. 31 Mar 2010.
Thursday, October 21, 2010
Perspective on Social Media in Pharma
There has been no shortage of headlines in recent years about the impact social media will have on the pharma landscape. While traditionally a change-averse industry, pharma companies are finally embracing social media... with half-open arms. The benefits of expanding your digital presence - reaching a broader range of customers, establishing a feedback loop, enhancing credibility - are just the tip of the iceberg when we examine the monumental business opportunity for pharma presented by social media.
There are two compelling reasons that stick out in my mind for pharma companies to embrace social media as an enduring strategy:
(1) To Build the Brand
Pharma can use some help here. Negative press leads to distrust, and I'm not particularly aware of any pharma or biotech that is immune from this. Pharma frequently comes under attack with highly publicized issues that affect consumer trust. Pharma has a responsibility to various industry stakeholders, not to mention its shareholders. Building your brand online will build trust with stakeholders who are both active and passive "listeners" of online content - including patients, who are perhaps more likely to enroll in your clinical trials. Key takeaway: transparency with stakeholders, both in formal communications and in social media outlets (where regulatory constraints do not exist).
(2) To Improve Patient Safety
The amount of information on the web about this opportunity is tremendous - here I will mention a couple of broad opportunities that I find most interesting.
First, improve on the reach and speed of information to patients. Traditional methods of educating patients on treatment and risks have clearly been ineffective - the New England Healthcare Institute estimated last year that anywhere from one-third to one-half of patients do not take their medications as their doctors intend them to. This is partly due to economic factors, but a lack of basic knowledge about treatment is also a factor. You might hypothesize that those patients who turn a deaf ear during doctor visits could be, on average, more likely to seek out information from sources on the web (ex: Internet-savvy young adults). Likewise, growing numbers of patients are feeling more empowered to take matters into their own hands, performing online research and answering their own questions before making a call to their doctor.
Patients who correctly adhere to medical guidance are more likely to reap the intended benefits of the medication and are less likely to become hospitalized - contributing to decreased cost of healthcare. Don't allow Google to send one of your consumers to an informal forum convincing them that it's okay to double their dosage because Patient27 said they experienced positive benefits from doing so. Take control of the information on your products by creating a credible forum and feedback loop closely monitored by your safety organization.
Speaking of feedback loops, a second opportunity for improved patient safety through social media is an increase in the volume and speed of information from patients to your safety organization. Product safety profiles, particularly of those new to the market, are continuously evolving. The potential in social media to improve safety profiles by acting as a new source for adverse events might not be as great as was once projected (studies have shown the number of adverse events found online that meet the required criteria are not coming in high numbers), but pharma companies should start becoming adept at collecting safety-related information from non-traditional sources. If not a formal source of AEs/cases, it is at the very least an indicator of potential signals or real-world usage patterns that provide information not easily discovered during the clinical trials process.
Perhaps the greatest future sources of feedback are patient social networks: niche online networks connecting patients with others who can relate to their condition. Patient social networks have spread all over the web and have contributed to the phenomenon of patient health issues "going public." For an example, visit www.patientslikeme.com. This network consists of a variety of "communities" organized around disease, allowing patient users to share health data, find patients like them, and learn from others' experiences.
George Botsakos, Associate Partner in IBM's Life Sciences practice, speaks clearly about the vision and challenges behind social media in drug safety: “Imagine a world where social media is effectively used to drive increased reporting of adverse events and allow independent, comprehensive, and reliable management of an individual's health. Well that may be a long time coming as the industry remains in waiting mode. Even companies that recognize the potential value of this insight are paralyzed by the negative implications associated with 'listening' to unregulated information. Until companies receive clear guidance in these areas, the risk of applying social media to patient safety will always be perceived to outweigh the rewards.”
There are two compelling reasons that stick out in my mind for pharma companies to embrace social media as an enduring strategy:
(1) To Build the Brand
Pharma can use some help here. Negative press leads to distrust, and I'm not particularly aware of any pharma or biotech that is immune from this. Pharma frequently comes under attack with highly publicized issues that affect consumer trust. Pharma has a responsibility to various industry stakeholders, not to mention its shareholders. Building your brand online will build trust with stakeholders who are both active and passive "listeners" of online content - including patients, who are perhaps more likely to enroll in your clinical trials. Key takeaway: transparency with stakeholders, both in formal communications and in social media outlets (where regulatory constraints do not exist).
(2) To Improve Patient Safety
The amount of information on the web about this opportunity is tremendous - here I will mention a couple of broad opportunities that I find most interesting.
First, improve on the reach and speed of information to patients. Traditional methods of educating patients on treatment and risks have clearly been ineffective - the New England Healthcare Institute estimated last year that anywhere from one-third to one-half of patients do not take their medications as their doctors intend them to. This is partly due to economic factors, but a lack of basic knowledge about treatment is also a factor. You might hypothesize that those patients who turn a deaf ear during doctor visits could be, on average, more likely to seek out information from sources on the web (ex: Internet-savvy young adults). Likewise, growing numbers of patients are feeling more empowered to take matters into their own hands, performing online research and answering their own questions before making a call to their doctor.
Patients who correctly adhere to medical guidance are more likely to reap the intended benefits of the medication and are less likely to become hospitalized - contributing to decreased cost of healthcare. Don't allow Google to send one of your consumers to an informal forum convincing them that it's okay to double their dosage because Patient27 said they experienced positive benefits from doing so. Take control of the information on your products by creating a credible forum and feedback loop closely monitored by your safety organization.
Speaking of feedback loops, a second opportunity for improved patient safety through social media is an increase in the volume and speed of information from patients to your safety organization. Product safety profiles, particularly of those new to the market, are continuously evolving. The potential in social media to improve safety profiles by acting as a new source for adverse events might not be as great as was once projected (studies have shown the number of adverse events found online that meet the required criteria are not coming in high numbers), but pharma companies should start becoming adept at collecting safety-related information from non-traditional sources. If not a formal source of AEs/cases, it is at the very least an indicator of potential signals or real-world usage patterns that provide information not easily discovered during the clinical trials process.
Perhaps the greatest future sources of feedback are patient social networks: niche online networks connecting patients with others who can relate to their condition. Patient social networks have spread all over the web and have contributed to the phenomenon of patient health issues "going public." For an example, visit www.patientslikeme.com. This network consists of a variety of "communities" organized around disease, allowing patient users to share health data, find patients like them, and learn from others' experiences.
George Botsakos, Associate Partner in IBM's Life Sciences practice, speaks clearly about the vision and challenges behind social media in drug safety: “Imagine a world where social media is effectively used to drive increased reporting of adverse events and allow independent, comprehensive, and reliable management of an individual's health. Well that may be a long time coming as the industry remains in waiting mode. Even companies that recognize the potential value of this insight are paralyzed by the negative implications associated with 'listening' to unregulated information. Until companies receive clear guidance in these areas, the risk of applying social media to patient safety will always be perceived to outweigh the rewards.”
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