I am Off to London to Meet Some EU ePharma Pioneers at the DigiPharm 2010 Conference!

I leave tonight to attend and speak at the 2nd annual DigiPharm Europe 2010 conference in London. I am looking forward to meeting a few people I learned about after I launched The Pharmaguy Social Media Pioneer Award nomination process. These include Alex Butler, Digital Strategy and Social Media Manager at Janssen-Cilag; Kai Gait, Digital Commerce Marketing Manager at GlaxoSmithKline; Gary Monk, Product Manager - Concerta XL, Janssen Cilag;

My presentation is scheduled for Thursday, September 30: "New Rules for New Media: A Funny Think Happened While Waiting for FDA Guidance" (see below). I will also be moderating an "unconference" discussion entitled "UTurn." I am interested in learning more about that when I get there.

If you are at the conference, please say hello!

I am not a real road warrior and may not have all my tools with me to allow me to blog a lot while I am attending the conference. But I will try an update this blog at least once or twice during the week and for sure send out tweets from the conference. Follow me on Twitter: @Pharmaguy.

Avandia and Janet Woodcock, the Next FDA Commissioner

By now you all know about FDA's decision to put restrictions on how physicians prescribe Avandia in the US (see "FDA will significantly restrict the use of the diabetes drug Avandia"). European regulators, however, chose to completely ban the sale of Avandia.

Why the difference in approach between two regulatory agencies whose decisions were announced simultaneously in what has been described as "an unusual degree of coordination" (see WSJ article "FDA Restrictions on Avandia Will Lead to 'Minimal' Sales")?

The WSJ tells us the answer: "By keeping the drug on the market with restrictions, FDA Commissioner Margaret Hamburg gave a nod to a powerful internal faction led by drug chief Janet Woodcock, who maintained for years that the evidence against Avandia wasn't conclusive," noted the Wall Street Journal. "Dr. Woodcock noted the divisions Thursday, saying FDA scientists couldn't agree on how to weigh the evidence of Avandia's risk, resulting in 'different conclusions.'"

IMHO, it looks like Janet Woodcock is keeping on the good side of the drug industry, which is now donating large sums of money to the GOP in the hopes of defeating Obama in the 2012 presidential elections. If that happens, it is unlikely that Margaret Hamburg will remain on as FDA Commissioner and the one person remaining who has the backing of the drug industry is Janet Woodcock.

I learned about pharma's support of Woodcock during and after the 2008 elections, when I hosted a survey that tried to determine who among the likely candidates at the time would be nominated by Obama as the next FDA Commissioner (see "Meet the Person Likely to be the Next FDA Commissioner").
[It's interesting to note that several of the candidates for FDA Commissioner in 2008 have been involved in the controversy over Avandia and were mentioned in the Wall Street Journal article; namely, Janet Woodcock, Dr. Steven Nissen, former FDA Commissioner David Kessler, and current FDA Deputy Commissioner Joshua Sharfstein.]
While Hamburg was hardly mentioned as a contender for commissioner in 2008, Janet Woodcock was and she received 11% of the votes from US respondents overall in my survey. However, Woodcock received 56% of the vote of respondents who said they were employed by pharmaceutical companies (see chart below, click for enlarged view).

David Kessler -- not known as a friend of the drug industry -- also received a majority of pharma respondents' votes, which is something I am at a loss to explain.

Of course, this survey of over 450 people should not be considered "scientific." Similarly, according to Woodcock, the meta data results upon which Avandia's cardiovascular risk was pegged are also not scientifically "robust or consistent." "We still feel there's considerable uncertainty about the magnitude and existence" of the risk," said Woodcock.

It's clear that if Janet Woodcock were FDA Commissioner, the fate of Avandia would have been very different. But there's still hope! The fact that Avandia remains on the market means that the reports of its demise may be a bit premature. First, GSK, which markets Avandia, can still supply the FDA with data from its RECORD study that proves the cardiovascular risk of Avandia is not substantial. Second, FDA's actions can be reversed if there is a new regime at FDA after the 2012 elections. The person most likely to head such a new regime is Janet Woodcock.

Did J&J Troll Social Media Sites to Ensure Its Motrin "Recall" was a Secret?

A Blog is a very useful archive of information that over time may reveal connections between seemingly unrelated events. Take the Johnson and Johnson (JNJ) "phantom recall" of Motrin that I and many other bloggers have written about (see, for example, "Parallels Between BP and J and J" and "J and J ‘Phantom Recall’ Shows Motrin Troubles Go Back to 2008"). By now everyone in the US should know about this -- the story has been on the major news networks (see "Are Secret Drug Recalls Common?") and Ed Silverman has reviewed it admirably on Pharmalot (see "Johnson & Johnson Tap Dances Around Congress").

But when I was searching Pharma Marketing Blog for another story (ie, J&J's new scandal about the safety of the Ortho Evra birth control patch: "Did J and J Hide birth control patch risks?"), I came across a post about J&J Agents Trolling for Adverse Events on the Internet. In that post I recounted a story of a person who applied to be an agent for JNJ "where if chosen, [she] agreed to notify J and J if [she] became aware of any negative talk about their products" on the Internet.

At the time I wrote that post, I was mainly interested in how drug companies may be using social media to proactively learn about adverse events associated with their products in general. The fact that JNJ was doing this suggested to me at the time that the company was doing the right thing to ensure that it kept informed about any adverse events reported by patients.

The person ("Christine B.") who was contacted by BzzAgent about being a JNJ Internet/social media trolling agent posted her story to the Arthritis Foundation Forum, where she is a member (see the post here).

I immediately connected the dots: arthritis ... pain ... Motrin! Bingo!

The timing is right -- the post was made on Tuesday, September 22, 2009. JNJ's agents began secretly buying up Motrin in stores in the Spring of 2009. It's logical that "Christine B." and other people/patients who may frequent pain-related online forums was contacted soon afterward to see if the story had "leaked out" to the patient community.

JNJ contends that it did not intend to deceive the FDA or the public. However, if it was employing agents to ensure that its "phantom recall" was under the radar of patients who take pain pills, then JNJ may indeed intend to deceive the public, if not the FDA.

Of course, this is not a smoking gun, but perhaps the House Oversight and Government Reform committee should look into this and see if it can find evidence. The first place to look should be emails between BzzAgent and JNJ.

BTW, I suggest BzzAgent rebrand itself. "Agent" is beginning to take on some negative connotations!

LillyPad Launches Specious Rocket Attack Against Drug Price Control Straw Man

Eli Lilly, the drug company that increased the price of its antidepressant Cymbalta by 13.6% in 2009, is using its new corporate blog (LillyPad) as a launching site for defending high drug prices (see "Why Price Controls Are Not The Right Answer"). This latest post was in response to a Washington Post article that articulated fears that drug companies would increase drug prices to cover the costs of offering Medicare beneficiaries a 50% drug discount when they find themselves caught within the infamous "doughnut hole" (see "Will Drug Companies Increase Drug Prices to Cover Medicare 'Doughnut Hole' Discounts?").

Lilly's response -- written by Amy O’Connor, Notre Dame alumna, who "manages the intersections between the political environment and Lilly’s business portfolio" -- interests me on several levels.

First, I now understand why Lilly chose the name "LillyPad" for its blog. My Twitter friend Andrew Spong criticized the name as a "an eye-roller, not an eye-catcher" (see here). Spong thought it might have something to do with TypePad, a "third-on-the-podium blogging platform." Whatever the reason, said Spong, "it eludes me."

Well, Andrew, it eludes no more. Lilly's blog is a launching pad destined to promote and sustain the policies of the drug industry -- as if the activities of the drug industry's trade association -- PhRMA -- were inadequate in this regard.

But the main reason I was interested in writing about Lilly's response was because it skirted the main issue raised by the Post article. While the latter was focused specifically on the drug industry's partial coverage of the cost of medicine for Medicare recipients in the doughnut hole, Lilly's post does not mention Medicare at all (except when it references the Post article in the opening paragraph)! In addition, Lilly mis-characterizes the theme of the Post article as highlighting "concerns that biopharmaceutical manufacturers will raise prices on prescription medications." The remainder of Lilly's post is an argument against government price controls in general.

In other words, Lilly has raised a straw man to knock down rather than address the specific issues raised by the Post article.

Lilly also engages in what I would argue are scare tactics, which are definitely aimed at the American consumer (but probably not Medicare recipients). "Did you know that price controls erode incentives to innovate?" asks Amy. "The question is… should we let the fear of the unknown undermine the future of our health care when so much is at stake? Shouldn’t we continue to invest in innovation so we can continue to see real improvements in health care?"

I am not sure what Amy means by "fear of the unknown," except that she uses it to raise the issue of fear itself. It's a nice way to associate fear with government control of prices.

Amy also selectively quotes data such as "From 2006-07, prescription drug prices increased only 1.7 percent." She neglected to mention more up-to-date and relevant data such as "Drug companies sharply raised prices last year [2009], ahead of increased rebates they must pay to Medicaid and other expenses tied to the federal health overhaul passed last month..." (see Drug Prices Rose 9.1% Last Year, Ahead of Federal Health Overhaul). She also did not mention that in 2009 Lilly itself increased the price of antidepressant Cymbalta by 13.6%, according to data from Credit Suisse (op cit).

Finally, Amy cites cancer and AIDS drugs as specific examples of drug company innovations made possible by higher drug prices. Drug companies always the cite bogeyman diseases like cancer to bolster their case. I don't particularly buy the argument because a lot of other factors are responsible for advances made in the treatment of certain cancers -- better screening, for example. As Amy herself says, drugs represent only a small fraction of the costs of healthcare. Ipso facto, drugs also represent a small fraction of healthcare innovation.

Anyway, that's my take on the rocket launched today from Lilly's pad.

P.S. Of course, I submitted a comment to Amy's post. While that awaits moderation, let me reproduce here for the record:

I think you are not addressing the actual issue raised by the Post article, which has to do with specific concerns about how the drug industry MIGHT finance its costs associated with Medicare doughnut hole coverage. You raise a "straw man" by focusing on government price controls in general rather than addressing the specific issue.

"I wrote up my critique on Pharma Marketing Blog (http://bit.ly/agUGuA) and hope you will respond."

Are Secret Drug Recalls Common?

When Johnson and Johnson's McNeil Pharmaceuticals discovered that Motrin tablets on drugstore shelves might be faulty, the company hired contractors to purchase all the affected Motrin they could find in stores.

In an exclusive interview with ABC News, Lynn Walther, who works for a Portland, Ore., inventory company, said that he was "hired by a contractor to walk into convenience stores and quietly buy specific lots of Motrin IB caplet eight-count vials. Though he said his purchases often were met with puzzled looks from store owners, Walther said he had been told not to give the stores an explanation" (see the video below and "Contractor Questions Order to Remove Motrin From Shelves").

Walther was following the instructions he'd been given. "You should simply act like a regular customer while making these purchases," the document said. "There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."

This "secret recall" program was authorized by Colleen A. Goggins, Worldwide Chairman, Consumer Group, Johnson & Johnson. Goggins testified before Congress that there was no effort at concealment. Since then, Goggins has fallen on the sword for J&J and tendered her resignation as of March 2011 (see here). I imagine that she is not likely to appear before Congress again for fear of facing perjury charges.

J&J defends itself by claiming it's actions were NOT secret at all -- it did the "recall" with the full knowledge of the FDA, a claim the FDA seems to deny. Listen to the ABC interview for the details.

One wonders how common it is for drug companies to engage in secret recalls like this?

Online Behavioral Tracking Becomes More Sophisticated, Annoying -- Soon Illegal?

A few months ago, I searched for and bought a futon on Overstock.com. For weeks afterward I kept seeing ads for Overstock.com futons pop up on almost every web site I visited. This, I realized, was the result of tracking "cookies" -- small programs -- that I "allowed" overstock.com to place on my computer. Too bad the technology (or programming) wasn't advanced enough to know that I already purchased my futon, had it delivered, and assembled it.

These days, however, tools that track users' whereabouts on the Web are more intrusive, more sophisticated and are "facing increased regulatory and public scrutiny and prompting a flurry of legal challenges," according to a Wall Street Journal article (see here).

"Since July, at least six suits have been filed in U.S. District Court for the Central District of California against websites and companies that create advertising technology, accusing them of installing online-tracking tools that are so surreptitious that they essentially hack into users' machines without their knowledge. All of the suits seek class-action status and accuse companies of violating the federal Computer Fraud and Abuse Act and other laws against deceptive practices."

One particular new technology involves Flash cookies -- cookies programmed using Adobe's Flash. Researchers have found that some Flash cookies were being used to re-create regular browser cookies that users had deleted. "Adobe and the Network Advertising Initiative, an industry group, condemn the practice of using Flash cookies to re-spawn deleted cookies," said the WSJ.

All this prompts me to ask if tracking cookies are being used by pharmaceutical marketers? Please take a few minutes to respond to my Use of Online Behavioral Tracking by Pharma Marketers Survey, which asks the following questions:
  • Have you ever used behavioral targeting in an online advertising campaign?
  • Should the pharmaceutical industry adopt similar self-regulatory principles that were established by media and marketing trade associations to protect consumer privacy when employing behavioral targeting.
  • Should pharma marketers use behavioral targeting at all?
  • If they do use it, when is it appropriate?
After you complete the survey, you will be able to see an up-to-date summary of results. AND be able to download the Pharma Marketing News article "Use of Behavioral Targeting by Pharma Marketers."

"Congress and regulators also are looking more closely at online tracking," notes the WSJ article. "Two bills have been introduced in the House of Representatives that would restrict the practice. The Federal Trade Commission is expected to issue new privacy guidelines by the end of the year and is considering a do-not-track registry, similar to the do-not-call list for telemarketing, that would allow consumers to opt out of behavioral targeting."

J&J's Goggins Takes Bullet for CEO Weldon

The New York Times reports that Colleen A. Goggins, who testified this spring before a Congressional committee investigating the recalls, will retire in March. Recall that I likened Googins testimony to that of a deer caught in the headlights (see "Parallels Between BP and J&J") and that J&J's CEO Weldon should take his medicine like a man and appear before Congress (see here). Ninety-three percent (93%) of my readers taking a poll agreed.

The NY Times reported: Mr. Weldon, who did not testify at the first hearing because he was recovering from back surgery, said he would appear for the next round. “I will definitely testify,” Mr. Weldon said. “I wanted to testify at the last one.”

Sure you did Bill. But you let poor Colleen take the bullet for you. I don't imagine that you are giving Colleen a gold watch for her retirement -- although you are probably giving her a golden parachute or maybe one of these?

Here's how it works.

Googins goes before Congress and is not quite truthful: Congress has invited Goggins back to testify because "when you appeared before the committee on May 27, 2010, you testified that you were not aware of the behavior of the contractors who conducted the phantom recall. However, after that hearing the committee obtained a Johnson & Johnson//McNeil document that instructed the contractors how to behave while conducting the phantom recall."

Goggins subsequently announces "her decision" to "retire."

Weldon then announces he will "definitely testify."

During his testimony Weldon will claim no knowledge of the phantom recall and imply that it was something "previous" management was responsible for and since then things have changed.

In other words, Goggins is expected to figuratively use the corporate Hari Kari sword and assume responsibility.

"Ms. Goggins," says the NY Times, "could not be reached for comment."

Eli Lilly's LillyPad Blog: To Whom Does It Speak?

Eli Lilly just joined the ranks -- more like single file -- of drug companies that have corporate blogs. Lilly calls their blog "LillyPad," a name that my Twitter pal Andrew Spong says is "an eye-roller, not an eye-catcher" (see LillyPad flops into the pharma blogosphere). Rich Meyer, another Twitter pal of mine, asks "Lilly launches BLOG but who are they trying to talk to?"

They're talking to ME, Rich!

So far there have been two blog posts made by Lilly that got me juiced up enough for me to submit a comment. One post was about the dismay state of math and science education in the US (see The Importance of Science and Math Education) and another was about counterfeit medicines found on the Internet (see Efforts to Stop Counterfeit Medications).

Lilly, like me, wisely moderates comments that people submit to LillyPad. So there was a short delay before my comments appeared on the blog.

In my comment about math education, I related a personal story about a teacher who told my son that "both" ways of plotting ordered pairs of numbers were correct. You'll have to read my post to get the details of why this upset me so much. A former teacher replied to my comment and confirmed that "Degree requirements for teaching math at the elementary school level are minimal."

Rich would rather see posts to LillyPad made by "John" -- Lilly's CEO -- and by brand leaders rather than corporate PR people who are currently submitting the posts.

Frankly, CEOs and brand leaders bore me -- they are the real hacks who can never carry on a real conversation. The former always has to paint a rosy corporate finance image for investors and the latter would just spout package insert gibberish.

The notion that pharma companies should only speak to one audience to speak to -- ie, their customers (patients and physicians) -- is limiting. Big pharma companies like Lilly have thousands of employees and a blog is a good way for the company to keep them informed about all the good things their company is doing. Most employees know what the company is doing around health issues, but employees have other interests that motivate them. Perhaps there are employees who want to get more involved in math and science education initiatives and may get motivated by Lilly's post on the topic -- maybe even push Lilly to do more.

Of course, Lilly also lobbies in state and US legislatures. A blog is also a good way to bolster those activities.

LillyPad is off to a good start, having fostered 2 or 3 conversations. Of course, I started two-thirds of these conversations and my attention span is notoriously short: I haven't been following other pharma corporate blogs and I don't expect to be visiting LillyPad that often either. I will, however, add its RSS feed to the News Direct from Drug Industry Forum, which aggregates newsfeeds from many pharma industry sources. That way, whenever a new post is made to LillyPad, I will be notified by email.

Pharma, Facebook, and Inappropriate Ads

The following tweet from Boehringer Ingelheim (BI) was posted to the "News Direct from Drug Industry" forum on Pharma Marketing Network:
Boehringer: Thank you. RT @Pharmafocus: Digital Pharma: Boehringer gets social with Facebook http://ht.ly/2DWD8
This is a typical corporate Facebook page that includes general information about the company -- including information about the company's Jubilee (125th) celebration. It has a Wall with comments, but you cannot post comments to it -- it seems only invited guests can do that.

CORRECTION: Anyone can post comments as long as they first click on "Like This" on the page. Still, most pharma companies don't allow comments. Even when they do -- as in BI's case here -- they have the ability to delete comments they don't link. That's fine.

Let's get over the fact that pharma companies don't want to include comments from visitors -- at least not the negative comments or comments they don't like. I understand all the reasons for this. But what I don't understand is why a pharmaceutical company would stand for having a site where they appear to have no control over the ads that appear on the page. Take a look, for example, at the top ad on BI's Facebook page (see screen shot below; click on image for a larger view):

The image of a woman (I assume) "eating a banana" is not something I would like to see on my official FB page if I were a pharmaceutical company.

It's interesting that pharma companies are so reluctant to have negative comments placed on their Facebook pages, but obviously turn a blind eye to inappropriate ads being served up on the same page! Does BI think having a presence on FB is so critical that it can overlook the fact that it's image is being tarnished by suggestive advertising?

Visitors to BI's Facebook page may be well aware that BI has no control over the ads displayed on the site. But, still, it's a bit embarrassing, don't you think?

UPDATE (Sept 18, 2010): Upon revisiting the BI FB page, I no longer see ANY ads in the right-hand column (see screen shot below). There is only a FB "house ad" and a link to "More ads," which will show you the ads by themselves and not in conjunction with BI content. It appears that BI was able to suppress the ads. Not sure how they do that, but it is a trick I'd like to learn more about. 

UPDATE (Sept 22, 2010): John Pugh (Director of Corporate Communication/External Communications, Boehringer Ingelheim) posted this comment on my FB page: Hi John. I just answered you comment on our Facebook page. Here's what I said: "Facebook does allow ads to be turned off in the right rail for any pharma page that requests it. So, after your blog post, we requested it. Best, John"

Is Pharma Really "Listening" to Patients on Social Media?

After criticizing Astrazeneca's @AZHelps Twitter account as being a poor model for use of social media by the pharmaceutical industry (see @AZHelps: Is This a Good Model for Pharma Use of Social Media?), I received several comments that made me think a bit more about how pharma marketers are trying to adopt a new communication paradigm without giving up their old model of communication. That old model is essentially "tone deaf" when it comes to "listening" to consumers.

Don't get me wrong. Pharma marketers "hear" what people are saying on social media sites such as Twitter. They just are not actually listening to what consumers are saying and understanding.

Let's look at @AZHelps as an example of this. It appears that @AZHelps seeks out Tweets that mention problems people are having affording Astrazeneca medications. Apparently, AZ monitors social media using tools such a V-Fluence (see comments to the post cited above). This is not the same as having a real person monitor social media, but it's a necessary tool to get an idea of what people are saying about your product out there. But just like any automated program, it lacks human intelligence -- it hears, but does not listen.

One post the @AZHelps bots pricked up was this one, which was posted by @busterwilson:

"Almost home. Pat drove most the way. Second day of the trip w/extensive migraine! NO Zomig cause Obamacare made insur. Not wiiling 2pay4 it!"

After a couple days delay, @AZHelps responded with:

"@busterwilson Saw your tweet about access to or the cost of ZOMIG® (zolmitriptan) AstraZeneca may be able to help. Call us @ 800-236-9933"

Did @AZHelps actually "listen" to what @busterwilson was really complaining about? No. They heard what they wanted to hear and responded with a "solution" to the problem they thought they heard. But they didn't really listen to @busterwilson's real gripe, which was about "Obamacare."

Let's use an analogy: How is social media like helping your wife deal with a problem?

A: It's been my experience that when my wife complains about something, she is not looking for me to give her a "solution," but for me to listen to her and understand her problem. The same may be true for helping patients who complain about products. Before you offer a solution --- ie call this number -- have a conversation and make sure you get to what the real problem is. In the case I cited here, @busterwilson was spouting off about "Obamacare" and no amount of free ZOMIG is going to put him at ease about that.

@AZHelps did not bother to learn more about @busterwilson and his Zomig problem, let alone about his problem with Obama. Turns out that @busterwilson is "a husband, father, grandfather, media personality, Sheriff's Chaplain, motorcycle rider, and lover of Jesus!" It sounds like he has an agenda much bigger than the price of Zomig.

Of course, @AZHelps is not going to get into a discussion about "Obamacare." AZ is more interested in getting IT'S message out about Zomig and making sure people call that 1-800 number.

@AZHelps: Is This a Good Model for Pharma Use of Social Media?

Recently, @jilliantate (Jullian Tate), Director, digital strategy, for Integrated Media Solutions in Los Angeles, and someone I follow on Twitter, tweeted this:

"Wow. Great article on how @astrazeneca is using Twitter to monitor mentions of products, and respond. #socpharm #fdasm http://bit.ly/crk3K8"

Naturally, I had to have a look and see what all the fuss was about. In the blog post that @jillintate referred to, Bruce Grant was said to have pointed to AstraZeneca as "one company with a solid grasp of the social-media realm. The company has used its Twitter account to monitor any tweets about its products, so that it can respond to consumers directly."

The Twitter account Grant was undoubtedly referring to is @AZHelps and NOT @Astrazenca (AZ has several Twitter accounts). Practically every tweet made by @AZHelps is similar to these:

"@redban Saw your tweet about access to NEXIUM® (esomeprazole magnesium) AstraZeneca may be able to help. Call us @ 800-236-9933"


"@busterwilson Saw your tweet about access to or the cost of ZOMIG® (zolmitriptan) AstraZeneca may be able to help. Call us @ 800-236-9933"

@AZHelps averages less than one tweet per month! The latest tweet -- to @redban, a husband, father, grandfather, media personality, Sheriff's Chaplain, motorcycle rider, and lover of Jesus! -- was made on July 7, 2010. It was in response to this tweet made by @busterwilson on July 5:

"Almost home. Pat drove most the way. Second day of the trip w/extensive migraine! NO Zomig cause Obamacare made insur. Not wiiling 2pay4 it!"

It seems to me that this is a very inefficient way for AZ to use social media resources. First of all, taking two days to respond to a tweet is an eternity in today's social media world. I hardly remember what I was talking about 2 hours ago, let alone 2 days ago!

It's also interesting that @AZHelps suggests that @busterwilson call 800-236-9933 rather than visiting the AZandMe.com Web site, which is what was recommended to me when I called the number.

I am not sure, however, that AZ can help people like @busterwilson. When I visit AZandMe.com, it informs me right up front "If you are an individual making $30,000 or less or a family of four making $60,000 or less you may qualify for an AZ&Me™ Prescription Savings Program." I doubt that a media personality and Sheriff's Chaplain such as @busterwilson would qualify.

Although the people answering that AZ number were very friendly and competent, I spent about 15 minutes on the phone before I got the information I needed. Wouldn't it be much better for @AZHelps to refer people to the Web site rather than the 1-800 number?

The only advantage I would see in calling the 1-800 number is the opportunity for AZ to have a real person to answer your questions. In this case, my experience with call center people was positive.

Still, I don't find this a very "Wow" use of social media. What do you think?

Will Avandia Failure Lead to More Closely Supervised Clinical Studies and Longer Patent Life for New Drugs?

In a BMJ editorial, editor Fiona Godlee contends that Avandia "should not have been licensed and should now be withdrawn." She cites problems that FDA discovered with the RECORD post-marketing study and finds fault with regulatory agencies' oversight of such studies.

Regulators should "should require a higher quality of evidence," Godlee says, "including proof that new drugs are better than existing drugs before being licensed. And if they do ask the manufacturer to undertake post-marketing trials, they must do a better job of overseeing the way these trials are designed and done."

Godlee also called for other reforms, including "far greater transparency from industry and the regulators, including access to raw data and funding for independent trials..."

Holding out a carrot in front of this stick, Godlee suggested that "the patent for new drugs should be extended, from the current 20 years to perhaps 25 or 30."

Personally, I don't think it's a good idea to extend the patent life by up to 50% for "greater transparency" by the drug industry. But Godlee is also calling for "funding for independent trials" as part of the deal. Is she talking about post-marketing trials like RECORD or the clinical trials upon which first approval for marketing is based? Where does the funding come from? I suppose she means that drug companies should somehow pay for "independent trials." That's going to be a problem even bigger than the problem of funding "independent" physician continuing medical education.

No matter how independent the pre-marketing trials are, the data are limited to a small population, which is often not representative of the population at large that will be exposed to the drug once it's on the market. That means additional studies may still be required after the drug is on the market to evaluate the safety among a larger population.

Perhaps having a drug on the market while additional studies are still underway is NOT as big a problem in Europe as it is in the U.S. where direct-to-consumer (DTC) advertising plays a big role in driving millions of consumers to their doctors to demand new medications. As online marketing begins to play a bigger role in marketing to consumers, this effect can be heightened. A recent study by About.com, for example, revealed that online health ads activate consumers as a result of seeing a healthcare (ie, drug) ad online:
  • 44 percent researched medication in more detail as a result of seeing a healthcare ad online, up from 36 percent in 2009.
  • 35 percent talked to their doctor after seeing an online healthcare ad.
IMHO, a better solution -- in the U.S. anyway -- might be to temporarily prohibit DTC advertising of drugs that require additional studies until those studies prove that the drugs are safe and effective as used in the marketplace. The carrot can still be an extended patent life as Godlee suggests. I have suggested this before -- see "Restrict DTC, but Extend the Patent for New Drugs" -- and the topic may arise again in my upcoming debate with DTC advocate Bob Ehrlich (see "The Great DTC Debate. Round 1: Are Drug Marketers an Endangered Species?").

My Journey From Obesity to Normal. First Stop: Stuck in Overweight!

Because of the long holiday weekend looming here in the U.S., I anticipate that today will be pretty slow. Therefore, it's a good time to record something personal and not offend my readers who may be looking for a "Mack Attack" such as the one I launched yesterday against Allergan, which I labeled an "unethical marketer and the the drug industry poster boy for off-label promotion" (see here). I guess most people started their vacations yesterday, because I didn't get any response to that attack.

Anyway, today I record here the first leg of my my journey from obesity to normal weight. The following chart shows my progress to date:

This chart was created by an iPad app that I am using to record my meals, weight and exercise history. The app is called "FatSecret." It syncs up with the FactSecret.com web site so that whenever I update data using the iPad, my Web account is also updated and vice versa. There's also a community, buddy system, etc. on the Web site, but I haven't used those social networking tools yet. That may change, however.

As you can see from this chart, I seem to be a bit stuck at my current weight of 191 lbs. My current body mass index (BMI) is 29.0. According to the National Heart Lung and Blood Institute's BMI calculator, that puts me out of the obesity range (BMI greater than 30.0), but at the high end of the overweight range (BMI = 25 to 29.9). To get into the normal BMI range of 18.5 to 24.9, I will have to lose another 27 lbs!

Since I am halfway there, I can look at this as a glass half empty or half full. Right now I feel half full, I can tell you that!

My goal, however, is to reach 175 lbs by the New Year. I am using the Numbers app on my iPad to plot my goal each month against my actual weight:

I missed my "goal" this month by 1 lb! Actually, I have been resetting the goal based on past performance. In August I reset the goal for the beginning of September to be 190 lbs. That's an 11 lb drop from the goal I set at the beginning of August (you can see the graph dropped steeply). I now have set my monthly weight loss goal to be about 4 lbs, which I hope is more realistic and attainable.

If you have any ideas how I can keep on schedule -- including some good low calorie recipes/meals, etc. -- let me know.

To those of you who have called me an "ass" or worse, thanks for not prefacing it with "fat"! When I lose that additional 27 lbs, nobody will be able to legitimately call me fat. I may, however, still be an ass!

"Reasonable" $600 MILLION Fine for Misbranding BOTOX: I Guess Allergan's Suit Against FDA Paid Off!

Allergan -- the company that markets Botox legally for wrinkles and illegally for other things -- agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.

Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems "reasonable," which is exactly how  Larry Biegelsen, an analyst at Wells Fargo Securities in New York, described it: “The $600 million settlement amount appears reasonable based on industry standards.”

Why such a "reasonable" settlement for a drug company that, IMHO, is an unethical marketer and the the drug industry poster boy for off-label promotion? Allergan, for example, has refused to abide by PhRMA's DTC Guidelines as well as PhRMA's Guidelines for Interactions with Healthcare Professionals (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway"). Allergan has also been cited by the FDA for other violations such as a misleading Latisse Web site (see "FDA Reads My Blog: Declares Latisse Web Site Misleading").

You must read a bit further down in the media articles about this to learn that Allergan "is required as part of the agreement to drop the lawsuit it filed against the FDA in October challenging a government rule that prohibits marketing drugs for unapproved uses."

There's a lot to ponder when reading that statement.

I ponder, for example, whether Allergan got off much easier because it agreed to drop its suit? Which was probably frivolous to begin with!

BTW, I've written about Allergan's off-label migraine shenanigans previously. See Allergan's "Eye-popping" Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

Allergan is currently seeking FDA approval of Botox for the treatment of migraine. In the above post I reviewed a clinical study that Allergan is doing to support its case. The drug was so ineffectual that the researchers admitted they “have searched for patient characteristics that may predict a favorable treatment response.” Of course, they ultimately were successful in winnowing down the migraine population that is responsive to treatment: ie, those people who suffer from "imploding" or "eye-popping" headaches but NOT "exploding" headaches.

This would all be a joke if Botox was not such a dangerous drug, which includes a black box warning on its label. But I won't get into that -- you can read what other people have to say about the dangers of Botox here.

P.S. As part of the agreement with the Justice Department, Allergan also will be required to publish information about its payments to doctors. I am not anticipating that Allergan's physician payment information will be easy to analyze considering that much more ethical drug companies have failed to be transparent in this regard (see "Transparency Vs. Translucency in Reporting Physician Payments").

Pharma Email Spam: Three Degrees of Separation for Merck, Pfizer, and Genentech

Soon after I posted a blog entry and tweeted about cholesterol-lowering drugs (see here), I "coincidentally" received the following e-mail message (click for an enlarged, readable view):

I do not remember opting in to receive email from Insyst Media -- the company that sent me this email. But, who knows, it may be one of those "third-party partners" of a website where I signed up to learn more about cholesterol.

So, naturally, I clicked on the "GET THE FACTS" button and was delivered to this intriguing Web page (click on image for an enlarged, more readable view):

Again,I don't recall opting in to any list maintained by  SearchNext, which is the company that seems responsible for this page. But being really curious where all this was leading, I obey and click on the button as indicated and end up on this page (click on image for an enlarged, more readable view):

Needless to say, I also never opted in to receive ads from FreshDeals.com --the entity that maintains this page. But I suspected that I was getting close to the sources who paid for all these companies to deliver ads to me. So I click on each ad on this page and discover that the top three links lead to pharmaceutical drug.com sites. One leads to Vytorin (Merck), another to Lipitor (Pfizer), and the third takes me to Zetia (also Merck). The last link goes to a Genentech non-branded site.

Following the Money Trail
I'm not interested in tracking down ALL these entities. I did, however, learn that SearchNext is a "pay-per-click advertiser marketplace [that] makes it easy to expand your already successful Google campaigns. Simply send us a dump of your AdWords campaigns and we will target your best converting keywords, geos and demos with our proprietary targeting and user qualification platform to turn users searching for your products into sales."

This "marketplace" conveniently puts 3 degrees of separation between the spam email I received and the pharmaceutical advertiser:

Pharmaco --- Fresh Deals --- SearchNext --- Insyst Media -- ME

I wonder if Merck, Pfizer, and Genentech realize that their Adword campaign is paying for spam e-mail? With 40% of pharma's online advertising budget allocated to search marketing, I can't imagine them NOT knowing!

Until All of Us Have This "Blue Button," the Online Health Revolution Has Not Even Begun!

Today I will listen to the BlogTalkRadio show "E-patients, Cyberchondriacs, and Why We Should Stop Calling Names," which promises to be an "open, honest and stimulating discussion" about the "potential implications of the use of the term e-Patient and why some argue that it should be reconsidered." As background to that discussion, see this blog post by Susannah Fox (@SusannahFox) who leads the Pew Internet & American Life Project's health research. Susannah will be a guest on the BlogTalkRadio show today and will be speaking at the e-Patient Connections 2010 conference next month in Philadelphia, PA.

In her post, Susannah says: "In short, the data -- Pew Internet's and others' -- are quite clear that the online health revolution is over and that use of digital tools in tackling health problems is the natural state of affairs."

I would argue that the online health revolution is no where near "over" just because the data shows that seeking health information online is now part of mainstream America (ie, 61% of American adults looked online for health information in the past year).

Seeking and FINDING credible, actionable, and personal health information online are TWO DIFFERENT things!

One piece of the online health revolution that has not yet occurred is the ability of the majority of Americans to easily access online their personal health information -- things like summaries of doctor visits, medications you are currently taking, or test results. I have been thinking about this recently. With diet and exercising -- something pharma marketers are often required to suggest in ads -- I recently lost 25 lbs. But my doctor told me my cholesterol is still too high. She wanted to prescribe a stronger cholesterol-lowering drug that I would have to take for the rest of my life, whereas one of my goals for losing weight was to stop taking this medication all together. What I wanted to know -- and what my physician didn't tell me -- was how my numbers compared pre and post weight loss. To get that information, I would have to go back to the doctor's office and ask her for the data. Why can't I just push a button in my Internet browser and get the data myself???

Yesterday, the Markle Foundation released a policy paper that said the ability for people to download their health records should be a priority in the nationwide push to upgrade health information technology. A public-private collaborative group of 46 providers, consumers, technology companies, insurers, and privacy advocates envisions a "blue button" as a common offering among secure websites for patients and beneficiaries by medical practices, hospitals, insurers, pharmacies, laboratories, and information services (see "Empowering the ePatient: A Simple "Blue Button" to Access Medical Records Online").

“By clicking the blue button, you could get your own health information electronically—things like summaries of doctor visits, medications you are currently taking, or test results. Being able to have your own electronic copies and share them as you need to with your doctors is a first step in truly enabling people to engage in their health care,” said Carol Diamond, MD, MPH, managing director at Markle.

Soon US Veterans will have such a "blue button" (see Blue Button: Download My Data): President Obama announced the blue button for veterans in an August 3 address. “For the first time ever, veterans will be able to go to the VA website, click a simple blue button and download or print your personal health records so you have them when you need them, and can share them with your doctors outside of the VA,” the President said.

IMHO, when ALL Americans have access to a "blue button" the online health revolution will truly have just BEGUN!

P.S. "Question to Ask Your Doctor": Where's My Blue Button?

After posting this, I saw a tweet from @AstraZenecaUS:

"September is National Cholesterol Education Month. See your doctor and visit http://ow.ly/2qo5v for a list of questions to ask."

This resolves to a page on the Crestor Web site. It just so happens that Crestor is the drug my doctor wants me to take instead of generic pravachol.

There are about 16 questions in AZ's list! Given that the average time a patient has with a physician during an office visit is maybe 10 minutes, that's about 38 seconds to ask each question and get an answer! Is AZ kidding? No wonder we don't remember what the physician told us!

One question that AZ left was "How can I get my personal health record online so that I remember all this and can use it?"

It's also amusing that AZ suggests you print out the pdf version of its list of questions and bring it with you to the doctor's office. How quaint! Shouldn't there be a "Share This With Your Physician" button on the page so that you can send the questions immediately to your physician before you even see her? Now that's when the online health revolution will truly begin here in the US!