Archive for the ‘FDA’ Category

All We Want for 2012

By Daphne Swancutt


20121 300x218 All We Want for 2012  While the beginning of a new year always prompts a watershed of trend lists and stories, we thought we’d take it a step further and combine our trend watch with a wish list for 2012. No question, there are big—even revolutionary—things happening in healthcare. But, trends without the potential for long-term influence are just fads that fade away.

1.  Mobile Health: With the market for mobile health apps projected to quadruple to $400MM by 2016, we anticipate continued growth in the volume of sports, fitness and wellness tools designed for use on smartphones and tablets. And, no doubt we’ll see more key tech players coming up with new applications that offer further integration with social networks and other apps, plus durable yet fashionable products to track activities and behaviors.
Wish List: An iPhone app/wearable device that combines RunKeeper, Gain Fitness, The Eatery and LARK’s sleep tool to manage personal health from one product. We think Fitbit is coming close and anticipate the release of the My Basis watch for a tool that aptly combines almost all of these functions.

2.  Crowdsourced Dieting: With the introduction of experimental dieting apps like The Eatery and Jawbone’s UP interface, we’re beginning to see that calories are taking the back seat to photos and user feedback for diet monitoring. From apps that allow you to rate how you feel following a meal, to those that allow the users’ friends to weigh-in on a meal choice, it seems like crowdsourcing feedback socially on what you eat is more effective than counting digits, unless you keep that chocolate mousse a secret.
Wish List: A Jawbone UP band that still works after two weeks. #FAIL

3.  Regulatory Implications: We’re glad that the FDA finally weighed in with its recent draft guidelines for pharma doing social. Depending on whom you’re talking with, it’s either too little or it’s just what the industry ordered. We’re somewhere in between. But as the industry looks toward social for further engagement, we see it as only good sense that the FDA step in with clearer guidance—faster.
Wish List: We’re listening, FDA! Move!

4.  Glocial Health: Pharma’s going big investing in emerging markets, and there are significant challenges—communication, regulatory, skilled workforce, and more. We see communication with a spectrum of stakeholders as crucial to pharma’s success, including consumers, HCPs, and government representatives. And, we know these emerging markets are using social networks and are highly mobile.
Wish List: A brand looking to tackle international social marketing from one Facebook hub. Share your ideas; we’re listening!

5.  Health Reform: Even though President Obama uttered a mere forty-four words about healthcare in his recent State of the Union address, we see this as a driving discussion among candidates and legislators as we enter election season. Expect that discussion to play out across social networks, and watch how candidates listen and participate in those exchanges.
Wish List: Meaningful social discussion and common-sense legislation to help us, the people and patients.

What are you looking forward to or anticipating in healthcare this year? Share your thoughts below or email us at healtheditor@imrehealthiq.com to share!

By Daphne Swancutt

HiRes 300x300 AstraZeneca’s #Rxsave Twitter Chat:  Shake, Rattle and Roll—or Much Ado About Nothing?Depending who you’re talking with, last week’s @AstraZenecaUS chat (hashtag #rxsave) on Twitter was either a PR stunt or the shot heard ‘round the world. The one is cynical, the other hyperbolic.

So let’s forget the extremes, and talk about what comes in the middle. First, AstraZeneca did attempt to demonstrate leadership in an industry notorious for being skittish on social media. Twitter can be especially unnerving for pharmaceutical companies, and moderating a wide-open chat would make most of them break out in to a cold sweat. (more…)

Smoke Gets in FDA’s Eyes

By healtheditor

smoke2 300x214 Smoke Gets in FDAs Eyes

So much for the government wanting people to quit smoking. Seems the FDA has some concerns about the new electronic cigarettes on the market. Why? Get this: They contain nicotine and may contain small amounts of carcinogens.

Keep in mind, more than 4,000 different chemicals have been found in tobacco and tobacco smoke, including more than 60 chemicals that are known to cause cancer.

Electronic cigarettes—or e-cigs—resemble real cigarettes, with a red-glowing tip and smoke-like puffs of odorless vapor, and with each drag deliver a dose of nicotine similar to a real cig. E-cigs don’t contain the cancer-causing chemicals and carcinogens found in real cigs, say the manufacturers. (more…)

Just Say Nocebo

By healtheditor

The FDA goes to great lengths to ensure drug makers disclose side effects. This “fair balance” language in ads and marketing materials is intended to ensure patients know the risks involved in taking a medication, and have all the information they need to make an informed decision with the help of their physician. And, to keep drug companies from making bold claims about a drug while minimizing risks.

All of this makes sense.

Except: What if disclosing side effects actually causes a patient to experience them, thus making a patient sicker and ultimately making the drug less effective?

It’s called the “nocebo effect,” the opposite of the “placebo effect.” A nocebo response occurs when the suggestion of a negative effect actually leads to a patient experiencing that side effect. It’s for real and has repeatedly been scientifically proven: (more…)


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