There are so many things wrong with this I barely know where to start

OK, not a social media thing but I saw this in Tuesday's Washington Post and I'm flabbergasted:

When a drug to prevent babies from being born too early won federal approval in February, many doctors, pregnant women and others cheered the step as a major advance against a heartbreaking tragedy.

Then they saw the price tag.

The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. That’s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nation’s bloated annual health-care tab would swell by more than $4 billion.

What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost — about $10 or $20 a shot.

Oh, it gets worse. I've probably pushed the bounds of fair use here so I'll just let you go to their website to read the whole thing.  But please read it, because it's as profound an indictment of our system as anything I've ever seen.  SO, let me see if I have all of the factoids from this story straight:

• There's a drug that the FDA just "approved" to help prevent premature births.  That's the good news.
• A full course of the drug costs $30,000.  And most moms in at-risk pregnancies don't have that.
• A full course of "the compound" (i.e., the same drug) has been available for about $200 to $400.
• Along with FDA approval, the company also got a patent and sole rights to manufacture "the compound."
• Which means it's now no longer available for $200 to $400.
• The company that now owns the patent says it's charging that amount to recoup the costs for FDA-mandated clinical trials. 
• The leading advocacy groups and medical specialists were apparently surprised by the new price.  Seriously.
• The "main study" to prove the drug's effectiveness was apparently an NIH (i.e. taxpayer) funded study, but the taxpayers receive no return on this investment.

Again, from the article (sorry):

A form of progesterone known as 17P was used for years to reduce the risk of preterm birth, but it fell out of favor after the manufacturing company stopped making it. In 2003, the NIH study showed that 17P could cut the risk of preterm delivery if given in the first 16 to 24 weeks of pregnancy. That led to a resurgence in the use of 17P. Because no companies marketed the drug, women obtained it cheaply from “compounding” pharmacies, which produced individual batches for them.

Doctors and regulators had long worried about the purity and consistency of the drug and were pleased when KV won FDA’s imprimatur for a well-studied version, which the company is selling as Makena.

So this company basically did some research to verify the safety and efficacy of a drug that people were already using but either did or didn't already have FDA approval.  And here is where it REALLY gets weird:

In an interview with The Washington Post on Friday, an FDA official said that, if requested, the agency could approve a lower-priced generic version of the drug for another use that doctors could prescribe “off label.”

In addition, the official said the agency would not prevent compounding pharmacies from continuing to provide 17P unless patient safety is thought to be at risk.

“We have our hands full pursuing our enforcement priorities,” said the official, who spoke on the condition of anonymity because of the sensitive nature of the issue. “And it’s not illegal for a physician to write a prescription for a compounded drug or for a patient to take a compounded drug. We certainly are concerned about access of patients to medication.”

So an unnamed FDA official is telling the Washington Post that they could approve a generic drug that would be prescribed off-label?  And they won't enforce the company's right to market the drug as the sole provider - a right that FDA itself granted - because they're too busy?

If by the FDA's own admission it's ok to prescribe drugs off-label, then why do we have an FDA in the first place?

So, to sum up:  our systems of drug approval, intellectual property and taxpayer-funded research have taken a relatively well-known and commonly-used drug that cost about $300 and made it $30,000 for the next 7 years.   It costs that much because now we really know it's safe and effective - after all, this company and the taxpayers have invested millions to make sure.

Of course the company gets a financial return on its investment but the taxpayers don't.   But then again, the company loses too - because the company that invested its own money and time in creating this drug will now have to compete with a gray market that the FDA tacitly condones.   And that's because the FDA has anonymously suggested to the Washington Post that patients and providers ignore the very reason we created the FDA in the first place - making sure drugs aren't marketed or prescribed "off label."

SO....

Compounding pharmacies can look forward to lawsuits from the company that actually got FDA approval.
The company that got approval can look forward to ridiculously bad publicity - even though it played by the rules.
Moms with at-risk pregnancies now get to choose between: a) that worry in the back of their mind that the medicine they're getting isn't really FDA approved or b) a $30,000 price tag
Someone at the FDA gets to explain to his or her boss why they just undermined the mission of the FDA in the Washington Post.

But hey, lawyers and PR guys are probably gonna get paid, so it all works out.

Thanks Bora

Bora Zivkovic was kind enough to post an email interview with me.  Here and here.

What I'm Reading This Week

Or more specifically, what I'm trying to read because work has gotten busy again.  Hey, I haven't done a "link post" in a while so cut me some slack.

• Where Do Bad Moods Come From? by Jonah Lehrer at Wired Science Blogs' The Frontal Cortex
• In Defense of the Selfish Parent by Catherine Connors at Her Bad Mother
• Grid-based Energy Storage: Widely Misunderstood Challenges and Opportunities by John Petersen at Alt Energy Stocks
• Why the Quest for Social Media ROI Will Never Die! And Why It Shouldn't by Kami Huyse at Communication Overtones
• Pre-Tax Purchase of OTC Drugs: A Prescription for Compromise by William Pewen at Health Affairs Blog
• Where All That Wine Is Going by Alder Yarrow at Vinography

I hope to have the time very soon for more podcasts with smart people.  Stay tuned.

Media Overhype and the Profound Wisdom of the Warlock Assassin

Over the past week I've watched with everyone else the nightmare that's happening in Japan.  I've seen the surreal videos, the ongoing drama of the situation at Fukushima, and the incessant commentary on it.

The team at Global Voices Online asked me to provide a summary of what science bloggers were saying about the whole mess, and I have two posts there now - one that provides explanations of earthquakes and tsunamis, and one that looks at what's being said about the partial nuclear meltdown.

I'm really struck by two things, however.  First, the panic the US media has instilled in everyone through their horror-movie graphics and end-of-days tone.   Earlier this week I heard Eliot Spitzer teasing upcoming segments on CNN by saying things like "is the situation as bad as the pictures tell us, or is it even worse?" and then peppering people on his show with questions like "so what is the worst-case scenario for us here."  Never mind that the worst-case scenario isn't close to being the most likely scenario, but hey, if it bleeds it leads.

The next morning CNN reports that people in the United States are stocking up on iodine pills, despite the fact that they're not even remotely necessary here and these pills have some side effects.   And I do note the irony that the media reports on the frenzy it helped create.

The second thing that strikes me is how amazingly polarized the discussion about energy is becoming, and how that is affecting our willingness and ability to plan. Rita King wrote a great piece at the Scientific American Guest Blog and summed it up thusly:

Opinions around nuclear energy tend to be binary, with industry proponents acting as if nothing could possibly go wrong while critics, terrified of nuclear apocalypse, remain convinced that old nuclear plants are time bombs.

She's right.   A very significant portion (though not all) of the environmental movement is now NO NUKES- NO WAY.  Make it 100 percent safe before you do it.  But the truth is there's no such thing as a 100 percent safe anything - particularly when it comes to energy.  Coal mines will cave in from time to time.  Oil rigs will explode.  Hurricanes will hit refineries.  Even windmills have their issues (though not nearly on the same scope).  And we sometimes forget that we have enormous energy needs and the only way we can meet those needs right now is through those high-yield, high-emission fossil fuels.

What's worse to me, though, is the PR position of the energy industry - perhaps in reaction to the environmentalists, but I think more likely in reaction to the regulatory environment - the idea that so many things that could go wrong are simply not possible.  The messaging apparently became part of the culture at BP and other companies.  It's why you submit a disaster response plan for the Gulf of Mexico that's simply cut and pasted from your disaster response plan for Alaska.  It's not like anything's going to happen anyway, so who cares?

We have moved forward on energy siting and building decisions with an incomplete notion of contingencies.  And of course, this isn't isolated only to the energy sector - essentially any company or government or NGO that has anything that serves as a potential risk is vulnerable.

Shockingly, so much of this can be resolved by following the advice of Charlie Sheen, the self-described warlock assassin with tiger blood coursing through his veins - PLAN BETTER.  Seriously, suck it up and acknowledge that crazy stuff can and eventually will happen and you should be ready for it.  Embracing this notion will make companies more, not less credible with their neighbors, customers and the media. The evidence that we don't do enough of this is staring us in the face in the Gulf of Mexico, in coal mines in West Virginia, and in Fukushima.

News on the iPad - Zite is the early winner

I'm not much of a tech gadget guy, but as a self-confessed news junkie, Zite at first blush seems to be the iPad app I've been looking for.  I've been trying to mold my iPad into a super-news device, and Zite is a big piece.

Basically it's a smart RSS reader that attempts to customize the news you receive based on your preferences and feedback.  The format is crisp and easy on the eye, similar (though not identical) to Flipboard.  I'm surprised at how good the news sources are and I'm stunned that they are offering the app for free.    As they keep learning more about my "preferences" it will be interesting to see what kind of marketing profile I generate, and what they'll actually do with that information, but from a usability and performance standpoint I'm quite impressed.

I'm still looking for a top-notch "breaking news" tool.  That's considerably harder to pull off, though I'm sure it will involve some combination of Global Voices Online people (like Amira Al Hussaini, who just got a great writeup in NYT from Jen Preston), the major journalism-industry sources of breaking news (i.e., the wires, BBC, Al Jazeera, CNN, etc.) and Twitter.  The challenge comes in curating this tool - once news "breaks," you have to identify the most credible sources of information and ping them often for updates.   You also have to be flexible enough to accommodate multiple stories and then manage multiple streams of content with an effective visual interface.  I'm also looking for something that can add radio streams in the background.

By the way, I would pay for these apps and for subscriptions to content.  So there's a business model to be won here.

Twitter Influence Update - U Can't Touch This

Part of my ongoing series that examines the number of twitter followers as a gauge of "influence."  As of today...

White House Official Twitter Account: 1,993,684 followers

MC Hammer Official Twitter Account: 2,052,022 followers

Curing "The Gay" - Now Available on iTunes

Old pal John Aravosis reports that Exodus International now has its very own iPhone app - one that tells kids they can relieve their burdens of homosexuality through prayer:

Pardon my French, but WTF? Why does Apple require you to click some "yes I'm old enough" button when downloading gay apps on the iPhone, but when downloading "ex-gay" apps - i.e., apps built by hateful anti-gay bigots who falsely tell young impressionable children that they can pray away the gay - Apple has no restrictions at all on that app. In spite of the fact that federal statistics show 1 in 3 gay kids tries to commit suicide. In spite of the fact that the very first thing in the FAQ of the app is focused at kids.

Apple would be wise to be very, very cautious here. I'm sure the argument they'll make is on first amendment and restraint of trade grounds - people of faith have as much right to their marketplace as anyone else, and they can't be denying apps simply because their content is controversial.  But they clearly are, and want to be, the dominant (if not the only) online marketplace for mobile applications.  They undeniably exercise their market power to influence other market forces to their advantage - look at the fight over flash versus HTML5.    And they review and approve any application that will be available for download - and quite often deny or restrict apps based on their content.  This makes them first amendment traffic cops by default.

So they're in a similar situation to what Facebook was in back in 2007 - banning pictures of breastfeeding while allowing pro-anorexia groups to grow and thrive on their massive-but-closed network.

And let's be clear about one thing - there is absolutely no valid scientific evidence whatsoever that so-called "reparative therapy" or "conversion therapy" or whatever Exodus International wants to call it will turn people from gay to straight.  None. Nada. Zilch. Zip.  Zero.   There is evidence, however, that this kind of "therapy" is harmful.  

From a PR perspective, I think Apple just dropped a turd in the collective lap of its gay and lesbian employees, not to mention loyal customers like John.  I understand the free-speech argument, but I don't envy Apple's position now as the arbiter of what's appropriate and what's not.  Because as John points out, their position is already precarious.

Of course, they could open up the iTunes store, creating even more choice for consumers, allowing for more innovation and creativity... oh, right.

Neil deGrasse Tyson's mortal sin in online PR

Dr. Tyson (h/t: Wikipedia)

I recently listened to a Point of Inquiry Podcast - Chris Mooney interviewed Neil deGrasse Tyson.  Dr. Tyson is an astrophysicist, director of the Hayden Planetarium, host of the NOVA ScienceNOW tv show, and probably the best science communicator in the United States right now.

He's also an agnostic - not an atheist.  And while he says the public "God debate" is really not something he chooses to engage in much, he seems willing to disobey a rule so well-established in social media PR these days you might even call it one of PR's Ten Commandments - "thou shalt not edit thine own Wikipedia page."

About 36 minutes or so into the podcast, Dr. Tyson talks with Mooney about how he feels mislabeled as an atheist, and then makes an admission that makes an online PR flack like me raise an eyebrow:

It was funny – I don’t know who created my wiki page – but in there, a few years ago it said “Neil deGrasse Tyson is an atheist who is an astrophysicist” and I said “what… that’s not really..” so I said, so I put in there, “Neil deGrasse Tyson is agnostic” and then three days later or so it was back to “atheist.” So there’s an urge to claim me in that community. So then I had to – So I had to put it - word it in a way that would survive an edit so I said, “widely claimed by atheists, Tyson is actually an agnostic” so that managed to stick. I haven’t checked it lately but that’s how I left it off.

(Note: the edits to which Dr. Tyson refers don't appear on his Wikipedia page today.) Let me be clear about something:  I don't think what Dr. Tyson did is "wrong" - he took steps to correct the record as he sees it, and protect his own reputation. After all, this is essentially what I do for clients. When people write things about you, you have a right and an obligation to ask that those people get the "facts" right.   And in a forum as public and influential as Wikipedia, Dr. Tyson is quite right to be paying attention.

But let's be clear about something else - this sort of edit runs counter to Wikipedia's guidelines about conflict of interest and "neutral point of view"edits.  Dr. Tyson may view his action as simply correcting a minor point, but there is a clear public relations interest in a popular science communicator avoiding the unpopular, often misunderstood label of "atheist." It has been argued that Dr. Tyson's use of the word "agnostic" rather than "atheist" represents a distinction without a difference. And there's also a public relations interest in avoiding getting sucked into a debate over religious nomenclature.

Put it this way - If I, a public relations professional, were working for Dr. Tyson or the Hayden Planetarium or NOVA, and made exactly the same edits at exactly the same time, I'd be absolutely slaughtered for it. Companies and PR firms have been called out publicly for making far less substantive edits to their own or their client's Wikipedia pages.

The problem here isn't with anything Dr. Tyson did - the problem is with Wikipedia's guidelines.  Wikipedia's relatively inflexible guidelines have created a situation where "neutral" third parties can purposely or inadvertently post inaccurate or misleading information about a person or company - and that person or company is essentially "forbidden" (or at the least strongly discouraged) from responding quickly on the same forum. No, Wikipedia should not be a place for people to post their CV's or companies to plant marketing materials and press releases. However, just as Dr. Tyson has a right to weigh in on what's being said about him without fear of being labeled as a whitewasher, companies and PR flacks have a right to do so as well.

I do think we should disclose when we're making edits or additions.  Frankly, I have no problem with some special kind of citation that an edit to a page was made by the subject of that page or one of its agents. We should be using legitimate sources and follow the same rules as everyone else on this platform.

Wikipedia's popularity (and search engine optimization) has unquestionably positioned it as an unbiased and authoritative resource.  It's increasingly cited in other publications.  But even the "outs" you can find in Wikipedia's guidelines - things like "if a rule prevents you from improving Wikipedia, then break the rule" or "use common sense" - haven't made it acceptable for the subjects of pages to correct the record.  We're left with contacting the Wikipedians and hoping that they'll get back to us before they deal with any of the 738 gazillion other pages on the site, and even then there's no guarantee that the matter will be dealt with appropriately.

This is crap.  And it should change.

The Science-to-English Dictionary Doesn't Include the Words "Fuck Off"

Some interesting discussions in the field of science communications in the past few weeks.  First, Chris Mooney interviews Neil deGrasse Tyson and writes about it at the Intersection.  He also included this somewhat noteworthy exchange between Tyson and Richard Dawkins:



While quite funny (and a bit salty at the end there), it illustrates a growing tension among scientists - whether they should take the time and effort to persuade those less science literate than themselves, or whether they should essentially "speak truth to power" in debates where sides are growingly intractable - climate change, evolution, vaccines, and so on.

I realize it doesn't have to be an either-or thing, and there may be a time and place for each approach, but in general I count myself squarely in Tyson's camp on this.  On the very important debates where the goal is to encourage or change behavior, I've never found the words "fuck off" to be especially effective.  There really is a better way.

To me the answer lies in creating a groundswell of support on the pro-science side of these arguments, and that means establishing a large, deep reservoir of goodwill between scientists and the general public. Doing so aligns the incentives of policymakers (who respond to the public) and scientists more directly.

That's why I was so impressed with Maggie Koerth-Baker's presentation at the SAGE Weston Lecture Series at University of Wisconsin-Madison.   Koerth-Baker is the science editor at Boing Boing, and I thought her advice to scientists about being more persuasive with the general public was outstanding:

I think the best recommendation that I have is to go to presentations and go to public lectures on subjects that you know absolutely nothing about. Step outside your expertise and start thinking like somebody who doesn’t know about this. And when you do you are going to find questions that you’re not asking about your own work. And you are going to find sources of skepticism that you aren’t applying to your own work. And you can kind of turn around and start doing that. One of the things I think you are going to run into if you do this is the issue of how long it takes for basic science to find its way to the commercial sector. This is really, really, really poorly understood. And neither journalists nor scientists do a very good job of giving the public what it needs to understand.

Of course, understanding others by listening to what they have to say is only part of the task.  When you're speaking, Koerth-Baker says you have to do so on the most basic of terms:

Sacrificing storytelling and understandability for extreme accuracy is often just as bad as sacrificing accuracy for the sake of storytelling. To start off with that what I mean is dumbing down is OK. I hear lots and lots of people, even journalists, making fun of USA Today because it is written at a 6th-grade reading level. It should be. We should write more at a 6th-grade reading level. If you are not writing about your science at a 6th-grade reading level you are probably doing something wrong. And not enough people are understanding what you’re talking about.

And finally, her advice to science communicators sounds quite a bit like PR or marketing counsel to me:

Basically everything that I have told you here boils down to two basic lessons. First: KNOW YOUR AUDIENCE. And Second: KNOW YOUR MESSAGE. And finally, be able to match the correct audience and the correct message so that people really understand what you’re saying.

It goes back to what I was saying about climate change and strategic communications a while back.  Scientists really have a choice: lift people up or put people down. One approach will bring people closer to your understanding of the nature of the world around us, while the other will push people away.    With the issues we face, the stakes are far too high to settle for the smug satisfaction of knowing you're right.

Charlie Sheen Is In On The Joke

Coming Soon to Reality TV

And right now he owns the media.

I just resurfaced from a few days offline to learn about "winning" and tiger blood and warlock assassins hired by the Pope.  And how Charlie Sheen is getting so much airtime on every big talk show and got a million followers on Twitter in a day and all that.  And how there are revolutions happening in Arab countries, Wisconsin is about to fire a bunch of teachers, initial jobless claims in the US are finally dipping below 400K per week, but none of that really matters because some actor likes to sleep with two women and say weird stuff about his boss.

Is he suffering from mental illness?  Ask someone who would know.  But this strikes me as a situation that will be settled by lawyers, not doctors.  Because somewhere right now someone is developing a plan for a Charlie Sheen reality tv show. And they're trying to figure out what, if anything, they can do to buy off CBS and get this into production.   And Charlie Sheen knows this and he's stoking his PR and he's trying to get people to use his goofy catchphrases and he's demonstrating to networks and production houses that he commands an audience.  And he's telling people to sit back and enjoy the show.

And predictably we're all buying it.  The speculation on his mental health, his family situation, his cracks about being a fighter jet.  This is what gets you noticed today.

Charlie Sheen wants to live a rockstar lifestyle, he hates his boss, and he's angling for a new gig.  That's all.