Guest The average cost of bringing a drug from development to FDA approval is over $2.5 billion. But if researchers can use wearable devices to grab insights early on in a drug trial, they can cut failure rates and reduce costs.
It’s hard to write a great corporate blog if you’re in the pharmaceutical industry. There is so much you can’t say… So much of what’s going on in the industry is, well, not very interesting to outsiders…. And – let’s be honest – the inside gossip in your company isn’t going to gain much traction either.
So how can you still provide material that is of true value to your audience? Here are three examples of excellence!
Roche uses a blog to help with its recruitment, regularly running profiles of some of its employees from around the world. They get to talk about their jobs, their personal background, and their experiences working at Roche.
Not only do potential employees get an idea of the wide range of jobs that are available, the employees talk about the aspects of working there that really matter to them – and most importantly, the company is given a human face (many, actually!).
Hospital readmission rates and other quality metrics are becoming increasingly important in an age of hospital quality transparency. It's not surprising then, that social media marketing will continue to be a growing piece of hospital marketing budgets.
When we looked at the social media landscape of healthcare CIOs, it could only be described as a ghost town. We found a grand total of six healthcare representatives among the 50 Most Social CIOs on Twitter. This was unfortunate, since the healthcare...
For companies in the pharma sector, LinkedIn represents a vastly under-used opportunity to conduct business and generate that elusive return-on-investment online . How does pharma get a return on investment on social media? It's the question that...
While social media is moving quickly through the “hype” line it can serve as an important source of information from people who are researching health information online. In the latest research update we found that people are in fact relying on social media for information, but there is a lot of “trust but verify”. The key finding is that although patients still trust their doctors they want a better relationship with physicians and they want more face to face time.
The research, just concluded, was for a startup here in the Boston area and I have permission to share top findings. The research consisted of qualitative (5 cities, 64 people) and quantitative (n=1,254). Please not thatquant research subjects were compensated with a Starbucks card.
Objective: Determine the extent to which online health seekers are using social media to make healthcaredecisions.
Participants: Online health seekers (gone online for health information within last 90 days and at least 4-6 times in the last year.
(1) There is mistrust in the messenger when it comes to pharma health information-Although most said they have gone to a pharma product website most sites did not meet all their informational needs and the audience felt that they were trying to be “sold”. They want to be able to see a list of competitive medications without having to research them online so that they can compare benefit/cost/side effects.
(2) People 30 or younger tended to rely on social media more for health information and connect with others to ask specific information about drug side effects, costs and dosage recommendations. People 40+ used social media forhelp and support.
(3) Social media is becoming more important in filling the missing pieces for health information, more specifically others experiences especially around negative side effects. It can both influence whether a patient fills an Rx and is compliant, but it varies by health condition.
(4) Patients want and need a “trusted source” to ask key health questions. As some indicated “I just don’t know who to ask when I want a question answered. I don’t have the time to spend all day searching for answers”.
(5) Very few people actually trust the information they find on social media. For example, if someone reads about a side effect mentioned on Twitter they are most likely to “want to know more” and “how this could affect me?”.
(6) If a health website has a relationship with pharma patients are more likely to be skeptical of health information on that site. “They’re not going to tell me the truth if they rely on a drug company for their profits”. A health site needs to be more transparent when it comes to their relationship with pharma companies.
(7) An online community is very much desired for caregivers/patients with chronic conditions and most said they would read the information posted by others, even if on pharma website.
(8) The more serious the health condition, the more time spent online researching health information. Patients want to know “how is this going to affect the quality of MY life”.
(9) Peer to peer social media, health information is most desired, not communication from a pharma company. However, patients were receptive to pharma posting information about updating health information, clinical trials or “in the news”. It’s about informing them first so they don’t have to spend the time researching themselves.
In summary, social media use by patients in evolving as people evolve their use of social media. There is still a high level of mistrust of “big pharma” but there is also more trust of smaller biotech companies that are delivering new classes of drugs.
"To tweet or not to tweet?" is often the question for pharmaceutical and medical device companies when it comes to advertising their products in the burgeoning social media environment.
The very specific rules the U.S. Food and Drug Administration has regarding marketing for drugs and devices makes it difficult to market products on platforms like Twitter, Facebook and blogs. Counsel representing these companies should be familiar with several interpretive guidance documents the FDA released last year that help explain the agency's thinking as it grapples with emerging and future social media platforms. The issuance of guidance on social media was required by the 2012 "Food and Drug Administration Safety and Innovation Act" (FDASIA), Section 1121. This required the FDA to, by August 2014, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA]." The FDA complied and issued three sets of guidance related to social media in 2014, with two more still pending. Though these guidance documents are not regulations, they represent the FDA's current thinking and best practice is to follow and comply with them.
One of the guidance documents addresses social media platforms with limited character spacing. The most common example of such a platform is Twitter, which is limited to 140 characters for a single tweet. The FDA guidance says that if an "accurate and balanced" presentation of both risks and benefits is not possible within the constraints of the specific platform, the company should reconsider using that platform. In other words, if a company cannot present both the benefits and the warnings and risks about a product in the space provided, it should not advertise it there.
The FDA rules on labeling govern how a company is allowed to market its product. The agency requires company advertising to meet several requirements: be truthful and non-misleading (FD&C Act 502(a), 201(n)); include certain information, such as the indicated use and risks (21 CFR 201.100(d), 201.105(d), 801.109(d)); be prominently placed on the label; and any advertisement that makes representations about drugs must include certain risk information (502(n), 21 CFR 202.1). Advertising on social media must be presented in a fair and balanced way.
Most of us are familiar with Internet "trolls," those sometimes angry and often misinformed commenters to online articles or blog posts. What happens, however, when someone posts something online about your client's medical device or drug that is false? What if, say, this person posts that the drug is dangerous and caused Side Effect X and killed his elderly mother who had diabetes? What if the company knows the drug does not cause Side Effect X, or the drug was specifically labeled warning people with diabetes to not take it? It is these types of situations where a company may feel the need to say something—so others do not take the drug incorrectly and to protect its brand.
The FDA has issued guidance on this type of situation. The agency understands a company cannot be the sheriff of the Internet and correct, much less know about, each instance of someone saying something wrong about a company's product. Its guidance states a company is not responsible for user-generated content on social media platforms it does not operate or control. This means that if misinformation is generated in a tweet or Facebook post, the company has the option, but not the obligation, to post something and correct the misinformed poster. However, if the post is on the company's page, or in a forum the company hosts, then it is responsible for setting the record straight.
Whether the company is obligated to respond to misinformation or voluntarily chooses to respond, the FDA guidance sets forth the following specific things the company must do when responding.
1. Be relevant and responsive to the misinformation
2. Tailor the message to the misinformation
3. Be non-promotional in nature, tone and presentation
4. Be accurate
5. Be consistent with the FDA-required labeling
6. Be supported by sufficient evidence
7. Post in conjunction with the misinformation in the same area or forum
8. Disclose the person providing corrective information affiliated with the company that makes the product
Legal Implications of Social Media Rules
The FDA guidance leaves open the issue of liability faced by drug and device companies, even if complying with the rules. Specifically, "failure to warn" claims are possible for a company advertising on social media. Even if it complies with the FDA guidance, a company can still face liability over its labeling. If, for example, a company decides to tweet and tries to highlight the use of the drug with its risk, what if it only includes the most significant risk and not others? Will that expose the company to a failure to warn claim?
In addition to product liability, social media advertising raises the issue of competitors having the ability to bring suit under the Lanham Act (15 U.S.C. §1525). This law allows a private right of action so a party may sue a competitor for any false or misleading description or representation of fact which
" … in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person's goods, services or commercial activities." Pharmaceutical companies can face Lanham Act liability for many types of claims, including minimizing risks, broadening indications, overstating efficacy and making comparative claims in the absence of supporting head-to-head clinical data.
It’s a story that has been told many times in these pages: A patient is told that they are afflicted by an inoperable brain lesion, only to find hope and—often—a cure by traveling to Barrow Neurological Institute.
The story of Tony Thompson, a 29-year-old artist from upstate New York is no different in that regard.
However, how he found his way here highlights an emerging trend across medicine—people using social media communities in their effort to find specialty medical care.
Bleed after bleed
Thompson first experienced the symptoms of what would eventually be diagnosed as a cavernous angioma—a benign tumor composed of dilated capillaries—in September of 2011. The tumor was located in his brainstem, and when it began to bleed into the surrounding tissue, his symptoms quickly worsened.
“I was just shocked that these symptoms progressed to something like this, to the point where I couldn’t even stand up, and to find out that there was actually blood in my brainstem,” says Thompson. “I am very healthy and active, so to have this random thing making me lose control of my body was terrifying.”
He would eventually spend 57 days in the hospital recovering from the initial bleed. During that time, his search for answers began.
Wanted: A second opinion
While Thompson was in rehabilitation, friends of his family were hard at work finding neurosurgeons specializing in the treatment of lesions of the brain stem. They soon realized that they would be dealing with a very short list, and that Robert Spetzler, MD, of Barrow was at the top.
However, as Thompson relates, his research into the work of Dr. Spetzler had a distinctly social flavor.
“My research was mainly through Facebook. I was able to get in touch with people—some who had already been treated at Barrow by Dr. Spetzler and his team—who had great stories of recovery. Some of them couldn’t find anybody willing to perform their surgery for years before they found Dr. Spetzler.”
After his cavernous angioma bled for a third time, Thompson decided to travel to Barrow and join their ranks. He is now back at home, continuing rehabilitation and hoping for the best.
"I still have a long way to go, but my symptoms have slowly gotten better after surgery," Thompson said.
Ahead of the digital curve
Thompson’s story and others like it have gotten the attention of leadership at Barrow. As a result, plans are in place to totally redesign the Barrow website in 2015. A significant investment is also being made on improvements to Barrow’s online second opinion program.
“We’re really seeing it emerge as a huge trend in healthcare. People want more information about their diseases and their doctors, and they want it all at their fingertips,” says Barrow Director of Informatics Judd Shaft.
For his part, Thompson is a big believer in the power of the web and social media to help people find the care they need.
“It kind of shocked me how many people in these online support groups had been told that their conditions were inoperable,” he says. “Many of those same people end up getting treated by Dr. Spetzler at Barrow. He is easily the most-referenced surgeon in those groups.”
He also noted that for many in the groups, their participation doesn’t end with recovery.
“We keep checking up with each other to this day,” he says. “We’ve made new friends—we call each other brain buddies.”
Dr. Stephanie Pope conducted this study as an effort to demonstrate the clinical implications of social media and form an understanding of the legal and ethical consequences of social media within practice. Institutions across the country lack protocols relating to the media forms and professional guidelines need to be established.
Hospital ratings on social media correlate with traditionally accepted measures of hospital quality, such as 30-day readmission rates, according to a recent study conducted at Massachusetts General Hospital (MGH).
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