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.

New Rules for New Media: A Funny Think Happened While Waiting for FDA Guidance

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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:

"Amy,

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."