Sanofi announces FDA approval of Sklice for treating head lice

I’m not big on tooting my own horn. But I can’t pass up the opportunity to publicize something that has been this important a part of my professional life coming to fruition.

This morning, Sanofi announced that the FDA has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. The product will be commercialized by Sanofi Pasteur U.S., the vaccines division of Sanofi-Aventis Group. Last October, Sanofi-Pasteur acquired Topaz Pharmaceuticals, Inc., my former employer and the company that conducted Sklice’s R&D program, including all of its clinical trials.

I had the great privilege of working on this project for nearly two years. In addition to getting to work on a product that provides a novel method of treating a public health condition affecting millions of U.S. children each year, I got to work with terrific people who are some of the best around at what they do. I learned a lot from them and enjoyed working with them. Some of the people there spent nearly five years working to bring about this day – admittedly far less than the average time it takes to get a new drug through the entire R&D and FDA approval processes, but still a very long period of time. While larger pharmaceutical companies do this frequently, it’s quite a feat for a company that had 10 employees.

I’m very happy for them that they got to see this dream come to fruition.

You can read the entire press release here.

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FDA pharma social media ‘guidelines’ leave pharma wanting

While most of us (myself included) were preoccupied with our holiday celebrations, the FDA quietly released a Social Media guidance.

Sort of, anyway.

Ad Age‘s Rich Thomaselli reported last Friday that the FDA announced new Social Media marketing guidelines for pharmaceutical companies. But the document, titled “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” only covers the discussion of off-label information.

For that reason alone, it falls far short of what the pharmaceutical industry not only was looking for, but needs.

“What everybody was expecting was actual guidelines around social media,” Jim Dayton, senior director of emerging media for Overland Park, Kan.-based InTouch Solutions, a pharma-centric digital-marketing agency, told Ad Age.

“I still think it’s monumental,” he added. “The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn’t happen here.”

The document provides pharma companies with instructions for responding to consumers who use Social Media to ask about potential off-label uses for prescription drugs. A thorough, complete Social Media guidance – the kind the FDA held a public hearing more than two years ago to develop – would have been far more encompassing. Perhaps it’s no wonder then that the FDA released these guidelines during the Holidays (when they’re less likely to get noticed) and did so without even a press release.

“We understand the level of interest and wanted to get out what we had available to provide guidance,” FDA spokeswoman Karen Mahoney told Ad Age. She also added that this was just “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009.”

But when will those guidances come? And why does it have to be done piecemeal? This is all the FDA could get done in 2+ years?

 

What is to come in 2012?

It’s hard to believe, but another year is almost over. Christmas is only a few days a way, and a week after that, we’ll flip the calendar to 2012.

What will happen in the year to come in communication? In healthcare? In public relations? What new technology (or technologies) will emerge? Which existing technologies will be relegated to the dustbin of history, like coin-operated pay phones? What great advances will happen in healthcare and healthcare delivery? Which organization will build a strong foundation for years to come with strong, carefully planned and executed public relations efforts? Which organizations will be tarnished by bungling their public relations, particularly in a crisis situation?

We can ask those questions at this time every year. But here are some unique ones to think about as 2011 comes to a close:

1. Will Google+ seriously challenge Facebook? I was not impressed with it when I first got on, and I still use it only rarely. But it does appear to slowly be catching on. Will it become real competition for Facebook in 2012?

2. Will organizations reevaluate and improve their crisis communication plans? We saw the tattoo scandal at Ohio State and the horrible sexual molestation scandal at Penn State – they were just two examples this year of poor crisis PR. It’s an area to which many organizations do not devote sufficient resources or planning, and they can and have paid a huge price for that. Hopefully this year’s prominent crisis PR disasters taught them a lesson.

3. Will more pharmaceutical companies get serious about social media, even with no FDA guidance on the horizon? One of my favorite reads in the area of pharmaceutical marketing – Rich Meyer’s World of DTC Marketing blog – praised Sanofi’s “Why Insulin?” Social Media campaign as an example of how pharma companies can creatively and effectively use Social Media while not running afoul of the FDA. With no specific FDA guidance likely to come anytime soon, pharma companies can and should learn from Sanofi’s example. Will they? The cutbacks to marketing that many pharma companies made this year won’t help any.

4. Which Presidential candidate will do the best job crafting and selling his/her story? Next year will be a presidential election year (the Iowa Caucus is on Jan. 3!). Which candidate will put forth the best story? Which candidate will be the most effective at selling that story? And how much of an impact will the stories told by PACs and outside groups – who were greatly enabled by last year’s Citizens United ruling by the Supreme Court – have on the election? While I do find the partisan bickering in Washington to be tiresome, I do find campaigns themselves to be fascinating, and the upcoming election will definitely be fascinating, no matter which side you want to win.

That’s all for me in 2011. It’s been an interesting year for me in many ways – finishing my masters degree, helping build a start-up pharmaceutical company into a tangible product that could attract a merger with a major pharmaceutical company and now looking for the next opportunity.  I leave you with what, in my opinion, is an underrated holiday song from an underrated movie. Happy Holidays, and all the best for 2012.

The best businesses allow customer criticism

One of the blogs I have feeding into my RSS Reader in Outlook is Phil Baumann’s “Health is Social” blog. In his latest post, he makes the argument that the best hospitals enable customers to provide negative feedback.

I would venture to say that this same argument can be made for businesses in most or even all industries, not just hospitals.

Nobody likes negative feedback. Nobody likes being told that they’re bad or doing something wrong. But such feedback can be very valuable as well. You can learn about your mistakes and flaws and (hopefully!) fix them before they become more costly. And businesses can learn about how to adapt their product or service offering to better serve its customers.

The ability to receive and harvest that feedback is the greatest benefit of Social Media. Previously, the only way businesses could get steady feedback from customers was from watching whether their sales increased or decreased, by which point the problem was costing the business money. And even then you might not ever know what the problem really was.

The pharmaceutical industry has been perhaps the most hesitant to embrace Social Media, partly because of the lack of guidance, and also partly due to its fear of patients sharing adverse events that, even if they had nothing to do with the drug itself, could still convict the company in the court of public opinion (see my earlier blog post on this subject). But even that feedback can be beneficial. If nothing else, it could provide more insight as to who their customers are, where they are and what they do, allowing the company to refine its marketing strategies and tactics. This knowledge could even identify a new therapeutic area might want to investigate.

It never feels good to get criticized. But it is often the best thing that can happen to us. When the news is good, we are more tempted to ignore the areas still needing improvement. But negative feedback allows us – and businesses – to confront our shortcomings and fix them.

Are the obstacles to hospitals using Social Media really “myths?”

The Mayo Clinic and Ragan recently held their third annual Health Care Social Media summit. And among the presenters was popular writer and Social Media expert Shel Holtz, who debunked the myths that he says keep hospitals from utilizing Social Media.

I highly respect Mr. Holtz’s opinion, but I believe it is a stretch to call them myths. They are certainly obstacles hospitals can and should overcome. But they are legitimate obstacles.

Holtz specifically mentions the possible negative effect on workplace productivity, the risks of exposing the hospital’s networks to viruses and malware, HIPAA concerns and consuming the hospital’s bandwith. You can definitely overcome those obstacles by investing in sound IT infrastructure and putting clear guidelines in place and strictly enforcing them. Yes, hospitals can and do exaggerate the dangers of these potential pitfalls. But to call them myths is a similar exaggeration. Just ask any hospital that has been slapped with a fine and/or a lawsuit for revealing a patient’s identity on Social Media, however unintentionally.

Another reason hospitals, particularly religious ministry hospitals, block Social Media are ethical concerns. This was the case at one hospital I worked for, which is run by the Sisters of Mercy, a Roman Catholic religious order. Such institutions are not only providing healthcare, they are also doing so in the context of their religion’s principles and values. While we may not agree with another religion’s beliefs, how can we expect a hospital supported by a religion to not adhere to that religion’s beliefs?

Are there other reasons you can think of for why more hospitals aren’t using Social Media? Would you consider those reasons to be myths?

Hospitals, healthcare providers should be smartphone-friendly

Last night, on the weekly Health Communication Social Media tweetchat, one of the discussion topics was the impact of the increased proliferation of smartphones in regards to health communication. If it is an opportunity, how can hospitals and providers tap into it? If it is a potential problem, what can they do about it?

I take the former view. With 54% of all mobile phone sales in the U.S. now being for smartphones, hospitals and healthcare providers need to become smartphone-friendly.

They don’t necessarily need to go out and develop their own apps for smartphones, though that’s something they should consider if they find it is the best way to reach their patients. But hospitals and larger medical practices should, as a start, build smartphone-optimized versions of their websites.

I’ve been a smartphone user for a few years now. If I’m away from my computer, it makes it relatively easy to look up information online. But websites that are not smartphone-optimized take a long time to load and are difficult to view on smartphone screens. You may also not be able to use all the features of the website on your smartphone.

I can read the New York Times in a smartphone-friendly format. Why shouldn’t I be able to get information on hospitals or healthcare providers the same way?

I understand that, especially in these difficult economic times, this may be beyond the budget of smaller practices. And even if they could financially afford it, it may not make business sense if its customers/patients don’t use smartphones heavily. After all, any business purchase decision has to provide some kind of a return.

But the larger practices, hospitals and healthcare systems that serve large numbers of people should do this. For them, it does not require that large of an investment. And it would help them better reach a public that will only increase its usage of smartphones.

What do you think?

Clinical trial sponsors, investigators must now account for social media in study designs

The Pink Sheet is a newsletter on the pharmaceutical industry read by many drug manufacturers. One recent issue had a report discussing the impact of Social Media, such as Facebook, on the design and execution of clinical trials.

You can read the whole story here: Social Networks in Clinical Trial Design

Clinical trials, in particular the all-important Phase 3 Pivotal trials, cost many millions of dollars to execute. They are designed meticulously, especially when it comes to blinding and randomization controls. Study subjects can’t know whether they took the study drug, the placebo (or, if applicable, the comparative drug) until after the trial is completed. If they did, they might not react naturally or adhere to the study protocol, and the trial results could be compromised.

Derrick Gingery reports:

Craig Lipset, Pfizer senior director in clinical research, said patients are using chat rooms and forums directed at specific diseases, in some cases talking about the clinical trials in which they are participating and their experiences with the study drugs. The online talk could threaten a trial’s blinding and randomization, especially as patients are more able to interact with other trial participants, he noted.

At the same time, as Lipset says later in the story, asking clinical trial subjects to refrain from using Social Media is not realistic. Recruiting subjects for clinical trials and getting them to follow existing protocols is hard enough as it is. So trial sponsors and investigators need to account for these tools in designing clinical trials.

Lipset’s employer, Pfizer, took a step in this direction this past June by conducting a virtual clinical trial for the long-acting formulation of Detrol LA. Other drug sponsors, investigators and CROs (contract research organizations) will likewise need to design clinical trials with Social Media in mind.

At the same time, researchers and pharmaceutical companies can also use Social Media to their advantage. While comments on a Facebook page or an internet message board are not statistically reliable or a substitute for the FDA’s adverse events reporting guidelines, they can provide hints of problems  before they become catastrophic public relations disasters. On a more positive note, sponsors can, as Gingery reports, tap into social media to recruit subjects for clinical trials.

 

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