Showing posts with label GSK. Show all posts
Showing posts with label GSK. Show all posts

Monday, July 16, 2012

"The Crowd is My Only Drug," Says GSK Olympics Anti-Doping DTC Ad Campaign

GlaxoSmithKline (GSK) will raise awareness of its role in anti-doping measures at the London 2012 Olympic Games as part of its first consumer-facing corporate campaign in the UK (see here).

Advertisements will appear across a range of media, including television, and outdoor advertising space, commencing July 23. One TV ad is currently available on Youtube:



Obviously, when the athlete star of this video is quoted as saying "The Crowd is My Only Drug," he means illegal drugs that some athletes may use to boost performance, not the drugs sold be GSK for legitimate use. But I wonder if social media "crowds" -- as in "Wisdom of the Crowd" -- can replace some Rx drugs for some people? I'm thinking about GSK drugs such as diet pill Alli and diabetes drug Avandia, both of which have been problems for GSK (see here and here).

Thursday, July 5, 2012

Pharma Monopoly Rules! GSK Execs Get Out of Jail Free Card and Pass Go to Lead Other Companies

As reported in Bloomberg BusinessWeek, "Two senior executives at GlaxoSmithKline Plc (GSK) singled out by the U.S. Justice Department for pushing the Advair asthma drug for unapproved uses have moved on to some of Europe’s top pharmaceutical companies. Jean-Pierre Garnier, chief executive officer from 2000 to 2008, is chairman of Swiss drugmaker Actelion Ltd. (ATLN), while Chris Viehbacher, Glaxo’s former president of U.S. pharmaceuticals, is CEO of Sanofi, Europe’s third-biggest drug company. The department cited the men, along with Stanley Hull, a former senior vice president for U.S. pharmaceuticals, in a lawsuit July 2" (see "Former GSK Execs Who Implemented Off-Label Practices Now CEOs").
“The real opportunity for us with Advair is that we can now convince physicians that there is no such thing as mild or severe asthma: you have asthma,” Viehbacher said at a presentation to investors in London in 2004, according to the filing. He quit Glaxo in September 2008 to join Sanofi (SAN) after losing out to Witty in the race to replace Garnier as CEO.

In January 2006, Garnier told investors that the FDA’s warning on Advair’s safety shouldn’t affect Glaxo’s stock price because it is “not meaningful and it is not going to have a big effect. I think products such as Advair are phenomenal for the treatment of asthma, and they should be used for mild to moderate and severe asthmatics. Physicians are not going to listen to the FDA.” Garnier retired as Glaxo CEO in May 2008 and was named chairman of Actelion last year.
Pharma corporations are "persons" who are too big to fail. Unlike "real persons," however, these corporations are never changed with felony crimes, only misdemeanors, which means they can continue to sell drugs.

Meanwhile, most often -- as illustrated in this case -- the guilty real persons within these companies not only have "Get Out of Jail Free" cards, they also are REWARDED by moving up the corporate ladder! WTF?

Tuesday, July 3, 2012

The DOJ v Pharma Settlement Planetary System

The Department of Justice (DOJ) just released a commemorative poster highlighting the six most-recent multi-million dollar settlements that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs. The poster represents just the latest version of the "DOJ v Pharma Settlement Planetary System," which still has room for additional members (see unidentified objects in the poster).


Here's a description of the planets and how they were "discovered" as reported by ProPublica (here):
  • The smallest "planet" in DOJ's System is AstraZeneca, which was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation. NOTE: The size of the AZ settlement "planet" is so small in comparison to the others in the System that many experts do not consider it a true "planet" at all. (The AZ planet was "discovered" in April 2010).
  • Next is Merck, which agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales. (The Merck planet was "discovered" in November 2011).
  • The fourth largest planet is the DOJ System is Eli Lilly, which was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.” (The Lilly planet was "discovered" in January 2009).
  • Next largest in size is Abbott, which was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose. (The Abbott planet was "discovered" in May 2012).
  • Pfizer, which up until recently was the largest planet in the DOJ System, was fined $2.3 billion in September 2009, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.
  • GlaxoSmithKline is currently the largest planet in the DOJ v Pharma Settlement Planetary System. GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data (see "GSK Guilty of Off-Label Marketing from 1999 to 2010: Will Pay $3 Billion Settlement"). This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA. (The GSK planet was "discovered" in July 2012).

Tuesday, November 29, 2011

Are Pharma Sales Reps Service Employees?

The Supreme Court agreed to decide whether drug companies have to pay their sales representatives for working overtime hours, "a question that could have considerable financial impact on the industry," according to the Wall Street Journal (see "Supreme Court to Decide if Pharma Reps Are Exempt from Receiving Overtime Pay"). The question (see here) before the court in case "CHRISTOPHER V. SMITHKLINE BEECHAM CORP" is:
The outside sales exemption of the Fair Labor Standards Act exempts from the overtime requirements of the Act "any employee employed ... in the capacity of outside salesman (as such terms are defined and delimited from time to time by regulations of the Secretary ...)." 29 U.S.C. § 213(a)(1). The Secretary of Labor has implemented various regulations that "define and delimit" the outside sales exemption and, filing as amici in this and other related matters, has interpreted these regulations to find the exemption inapplicable to pharmaceutical sales representatives. A split exists between the Second and Ninth Circuits concerning whether this interpretation is owed deference and whether the outside sales exemption of the Fair Labor Standards Act applies to pharmaceutical sales representatives.
The questions presented are: 
  1. Whether deference is owed to the Secretary's interpretation of the Fair Labor Standards Act's outside sales exemption and related regulations; and  
  2.  
  3. Whether the Fair Labor Standards Act's outside sales exemption applies to pharmaceutical sales representatives.
If the Supreme Court rules that pharma sales reps are NOT exempt as per Q#2, some sales reps worry that they will become "service" employees. "This will be a similar model to UPS / Fed Ex etc. Log in.............track activity..........gps............clock out at 5:00 pm." (see this CafePharma thread in the GSK discussion board).

This is interesting considering that the pharmaceutical industry is now moving away from the sales force being the primary channel of promotion focused on a narrow stakeholder audience to that of "a multi-faceted influence model where it has to really maximize its return on investment,” according to Mark Sales, Head of Global Brand and Stakeholder Management at Kantar Health (see "The Changing Pharma Commercial Model in 2010 and Beyond"; a PMN article sponsored by Kantar Health). The new sales model drivers are all about becoming more customer-centric and service model-focused. So, a NO ruling by the Supreme Court in this case would be a good thing for the pharmaceutical industry, aside from the billions in additional expenses?

Reps also worry that their companies would cut back on the number of sales reps and overtime hours to forestall the added expenses going forward. "The problem is that if overtime has to be paid out it will lead to more cuts," said an anonymous CafePharma poster. "Lets face it, the impact of reps has been going down for quite a while."

What do pharma sales reps do in "overtime" (after 5 PM) anyway? It may be "role-playing": "Would the role playing to India at 9:00pm count as overtime?," asks another anonymous CafePharma poster. "Get ready for bye bye role plays after 5pm," said another.

Some reps do not think this is an issue at all: "Since most reps really only work a couple hours a day, this really looks like a non-issue." To which this response was made:
"Actually it's a huge issue! Other big pharma companies have had to pay and pay big! This could cost GSK hundreds of millions. As to your comment about a couple of hours, please stop with that nonsense. I avg about 9 hrs per day. It's not back breaking work (that's why I went to college) but it is work. Inventory at the storage facility, lifting boxes, conference calls, emails, coordinating lunches/dinners, knowing and understanding the complex molecules and how they interact invivo/invitro, analytics, ability to utilize Microfoft word/excel, intrapersonal skillls, the list goes on an on...oh but you say reps only work 2 hours. When are reps supposed to answer email, voicemail, build a business plan? On their office day? Ohhhh that's right, there is no office day. So when does all this work get done? According to you we only work 2 hrs a day. C'mon dude! Look, I'm not saying the law suit is a good thing, but the pharma companies had their cake and got fat eating it."

Friday, August 19, 2011

Social Media "Flash Mobs": Pharma's Worst Facebook Nightmare!

Last week I  presented two case studies of how pharmaceutical companies are dealing with Facebook's new commenting policy that requires most pharma pages to allow commenting (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?"). These cases illustrated two different approaches to shutting down pharma FB pages in anticipation of the commenting policy change.

The trend seems to be to shut down pharma product or disease awareness FB pages while maintaining the corporate pages. Two examples of this trend are the Pfizer (here) and GSK (UK; here) FB pages, which are open and allow comments (with post-moderation; ie, deleting offending comments AFTER posting).

So, how's that working for Pfizer and GSK?

GSK is experiencing the kind of attack that beset one of Sanofi's Facebook pages awhile ago (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). That is, an organized attack by disgruntled patients. In fact, a blog post (here) gives specific instructions for how to participate in this Facebook "flash mob" action:
  1. Sign up to the GlaxoSmithKline Facebook page.
    [Do this by clicking the 'Like' button.]

  2. Open comments under the "Glaxo "Builds Bonnie Babies" advertising hoarding opposite Kings Cross Station, London in 1921, UK" thread.

  3. Ask them a question about one of their products.

  4. Sit back and watch consumer queries get deleted.

GSK is now busy dealing with all the comments coming in.

Here's a typical exchange:
"Joanne" posts this: "Hi , A friend of mine is taking paroxetine and she is thinking of having a baby. Is paroxetine a teratogen?" 
To which GSK responds: "Hi Joanne – We are not allowed to discuss product information or offer advice to individuals about medicines. Please ask your friend to speak to her healthcare provider if she has any concerns about her medication." 
To which Joanne responded: "i too would like to know why the only answers here appear to be consult your healthcare provider, surely we should be asking GSK the makers of these drugs as surely GSK would know more than any GP? after all surely it is GSK who do all the trials ect and not the gps?" 
To which GSK responded: "Unfortunately, we have had to remove from this thread a series of comments that mentioned prescription medicines or contained defamatory messages. Due to the regulations that govern our industry, we are not able to discuss our medicines or offer advice to individuals about medicines on this Facebook page."
Whew!

Pfizer took a pro-active approach and opened a thread on its new policy with this post:
"Now that you can respond to our posts, please know that we may sometimes need to remove a comment. Click on the 'Not Seeing Your Comment?' link on the left to learn why. Thank you for visiting us!'
Pfizer was immediately embroiled in a comment war with "Dana" and removed one of her posts and added this comment: "Hi Dana – It looks like your earlier post was blocked, as it led to a discussion about products. As a regulated industry, there are a number of rules that concern how we talk about our medicines. In light of that, we have elected not to have any conversations regarding prescription products on our Facebook page. That being said, why don’t you reach out to us at www.pfizer.com/contact, and we can address your question."

Of course, Dana expected this, having previously posted "Take your time. I bet you're just thinking of a really good answer to my question." After Pfizer explained why they deleted her question, Dana said "'Reach out to us'. What a cute marketing phrase. What genius thought of that. So you won't tell us, the American people, why our hospitals don't have the supplies they need. Also cute."

And so it goes.

All this raises a number of questions:
  • Will these types of comments and exchanges continue to plaque pharma FB pages?

  • Will pharma need to employ additional internal or external resources to manage FB comments? Is it boom time for vendors offering this service?

  • Considering that corporate pages are targets for "muppets" -- a term @Alex__Butler uses to describe people who attack pharma pages -- will pharma EVER re-open product and disease specific pages that are even more juicy targets for social media "flash mobs?"

Only time will tell.

Monday, May 2, 2011

GSK, National Headache Foundation and "Migraine Diary." Is There an App for That?

Last week I came across this tweet posted by @GSKUS:
RT @NHF: Need help remembering your #migraines details? Find an online migraine diary from @GSKUS at http://bit.ly/hBS98Q
For my Twitter-challenged readers, I should point out that "RT" signifies that @GSKUS "retweeeted" a tweet originally made by @NHF, which is the Twitter account of the National Headache Foundation.

Whenever a pharma company retweets a message from a third party, it raises some flags. For example, suppose NHF was a patient advocacy organization that promoted off-label use of medications and suppose those medications were marketed by GSK? Further, what if GSK helps support NHF with funding? What if NHF received the majority of its funds from GSK? What if NHF was actually created by GSK and not independent at all?

I am asking these questions because I have previously cited the close relationship between GSK and a supposedly independent Restless Leg Syndrome patient advocacy organization (see Pharma Dollars (Pounds, Euros) are Grassroots Seeds).

These days there are quite a few tools I can use to answer my questions. But, first, let's look at the link in the tweet.

When you click on the http://bit.ly/hBS98Q link in the GSKUS tweet, you discover that the real link is http://www.lowerthepain.com/pdf/Migraine_Diary.pdf. The "Lower The Pain" website (www.lowerthepain.com) is a GSK site that prominently promotes a migraine survey. "Editorial and other support for the survey provided by National Headache Foundation with funding, development, and other support provided by GlaxoSmithKline," says GSK on the site. See this Fact Sheet on the NHF site for more about the survey.


But I also see an invitation to get "tips & tools you need that may enhance your conversation with your doctor today." Right NEXT to that is a picture of an iPhone, which GSK is careful to point out is a registered trademark of Apple Inc.

When I click on "Tools to Help" I am brought to the following screen:


This further HINTS that there is an app for that (ie, "MIGRAINE DIARY").

So, is there an iPhone version of the Migraine Diary?

Yes, there IS an iPhone "Migraine Diary," BUT it does NOT appear to be a GSK app or an NHF app. Here's the app by that name that I found on iTunes:


This is a nice little app, but it does NOT resemble the GSK's PDF version of "Migraine Diary."

The iPhone app was developed by Net Workz LLC, a Software Engineering Firm located in the UK, which is the only connection I can see between it and GSK. In fact, the creator of the app is Aaron Douglas. His about page states that "Net Workz LLC is a small company I started that I use for anything I do geeky-related. I don’t have much content here but I plan on expanding this site soon. My full time job employs me as a software engineer. This place is for my personal projects that need to be legit, like iPhone Apps."

Maybe GSK and Douglas are negotiating a deal right now to allow "Migraine Diary" to "go legit."

The only comment Douglas has received about his app is this:
"I like this app. It's not the fanciest, but I wanted something easy to fill out when I'm in pain! The only problem I have is that sometimes when I add a journal entry, it only shows up when I turn it off then on again, but it is there. I wish it had more graphs to see more than one month, to see a patten. An option for an "all day" headache instead of having to put in a time would be good!"
OK, so what about the relationship between GSK and NHF? There's obviously the survey mentioned above. There's a guest post to GSK's blog by Merle L. Diamond, MD entitled "Teaming up to Close the Gap in Doctor-Patient Migraine Communication" (see here). "Dr. Merle L. Diamond was compensated by GlaxoSmithKline for her participation in this campaign," GSK disclosed. Dr. Diamond is a member of the NHF board of directors.

Dr. Diamond is daughter to Seymour Diamond M.D., Executive Chairman of NHF, who originally founded the National Migraine Foundation, which was renamed the National Headache Foundation in 1987.

Seymour Diamond is the also the founder of Diamond Headache Clinic and Merle Diamond is it's president.

I'm not going to track this much further, but it would be interesting to know how many other physicians involved with NHF and the Diamond Headache Clinic are on GSK's payroll. Now that GSK has been required to list all payments to physicians, it should be easy to find out.

OK, I will track this a bit further. I just downloaded NHF's 2009 IRS Form 990, which has some interesting tidbits an accountant may be able to dechiper.

I notice, for example, that NHF made a "gift" of $1,112,748 to the Seymour Diamond Fellowship Fund [of] the Diamond Headache Clinic Research and Education Foundation. Are the Diamonds using the NHF as their personal piggy bank?

Also, NHF paid $814,955 to Vedanta Associates Inc., an independent contractor, for "research on various projects and programs." Seems like a lot of money for "research." What I've been able to find out about Vedanta Associates is it "provides marketing research and medical communications solutions to the pharmaceutical and heathcare industry."

Friday, April 15, 2011

(Little) Used Drug for Sale. GSK Says, Bye Bye Alli!

"Four years after launching the nonprescription diet pill Alli with much fanfare and a heavy marketing budget, U.K. drug maker GlaxoSmithKline PLC (GSK) on Thursday said that it plans to sell off the drug," according to this story in today's WSJ.

Back in November, 2010, I noted that the EU would release data in December that could put Alli diet pill sales in the toilet (see here). GSK "acknowledged in February that demand for the drug was falling in the U.S. and Europe."

Duh!

GSK sold £150 million of Alli in 2007, £75 million in 2009, and £203 million in 2009 as GSK launched Alli throughout Europe. GSK didn't break out Alli sales in 2010, but I bet it's back down to £100 million level. Not exactly in the toilet yet.

I can't wait to see who buys this lemon.

RELATED NEWS:

Public Citizen Asks FDA To Remove Two Diet Drugs From The Market.
ABC World News reported, "You've probably seen the ads for that diet pill Alli [orlistat] that promises safe weight loss without starving yourself. Forty million people have tried it or its prescription alternative Xenical, but complaints of nasty and dangerous side effects are increasing and for the second time in five years health advocates urged the government to ban it."

The AP reports that "Public Citizen filed a petition with the FDA on Thursday calling on the agency to remove" both drugs "from the market." The group "says it identified 47 cases of acute pancreatitis and 73 kidney stones among patients taking the drugs. The reports were culled from the FDA's public database of negative drug reactions."

New Research Links Orlistat To Increased Risk Of Acute Kidney Injury. 
HeartWire reported that "a review of patients taking the diet drug orlistat (Xenical/Alli, Roche) in Ontario, Canada over a seven-year period points to a 2% increase in acute kidney injuries within one year of patients starting the drug." The data "were reported by Dr. Matthew Weir (University of Western Ontario, London) and colleagues in a research letter published April 12, 2011 in the Archives of Internal Medicine."

Sunday, January 23, 2011

GSK's U.S. Sales Reps "Europeanized": No Longer Rewarded for Ability to Push Prescriptions

According to the Financial Times, "GlaxoSmithKline will this month scrap payments to its US-based commercial staff based on individual sales targets, as it attempts to draw a line under past aggressive marketing practices that have incurred substantial fines" (see here).

GSK’s sales "reps" will no longer receive commissions "based on their ability to push prescriptions. They will instead be paid based on their scientific knowledge, feedback from customers and the performance of their business unit."

An anonymous poster to CafePharma described what the "new" sales model will look like:
You will be judged on 3 categories. Product Knowledge, Customer Value, and Business Acumen. Each one of these will be split into 2 parts. Preparation and implementation. Basically, 6 categories to be subjectively assigned expertise levels by your manager. Hope you have a good relationship... This is how you will get your "cut" of your region's take of bonus dollars.

Oh yeah... you are also no longer referred to as pharmaceutical sales reps... from now on you are called "Customer Facing Staff". No joke...

GSK recently revealed a $3.5bn charge to settle product liability lawsuits and regulatory fines linked to past sales practices (see story here), which may have prompted this change as well as changes in funding physician continuing medical education (CME): GSK will now restrict funding CME courses to a small number of non-profit institutions.

This seems to be a radical shift in the evolution of the pharma sales model that has been followed by companies like Kantar Health. I've written on this subject in several Pharma Marketing News articles over the past year or so. See this recent article: "The Changing Pharma Commercial Model in 2010 and Beyond" (use discount code '95MDK' to download it free).

I also note that in order for a pharma company to reward its sales reps based on prescription volume of physicians they have detailed (the "old" model), the company has to have access to the prescription writing data of individual physicians. It's not a coincidence perhaps that the Supreme Court will soon determine if states have the right to prevent access to that data by pharma companies (see "Supreme Court to Decide Fate of State Laws that Prohibit Use of Rx Records by Pharma"). GSK may be sensing that the decision will go against them and they can take the "high" voluntary road now instead of taking the "low" legally-forced road tomorrow.

Although this model may be new in the U.S., it's not so new in Europe where pharma companies never had access to individual physician prescribing behavior. In Europe -- as I understand it -- pharma companies can only see how prescriptions change among a block of physicians in a certain geographical area more or less equivalent to a zip code in the U.S. Thus, basing sales rep commissions upon "district" performance in the U.S. is similar to how it's done in the EU. From the anonymous post made to CafePharma cited above, it looks like U.S. reps are not going to be happy to be "Europeanized."

Monday, November 29, 2010

Drug Discovery is as Much an Art as a Science, Says GSK CEO Witty

GSK's "More Than Medicine" blog posts today announced that GSK CEO Andrew Witty "recently wrote a forward-looking essay focusing on the future of the pharmaceutical industry for 2011 and beyond."

In that essay -- published in the Economist (here) -- one paragraph stands out: "Art, not just science" is the heading, under which Witty says: "First, we need to recapture the ability to empower creative talent in the discovery phase of r&d by creating an environment in the labs that reflects the fact that discovering a drug is as much an art as it is a process."

Maybe Witty envisions "Jackson Pollock" wannabe lab researchers throwing chemicals against a wall & seeing what sticks?

Thursday, July 15, 2010

GSK Kills the FDA Beast! Avandia Lives Another Day. Stay Tuned for DTC.

It seems that the 14 million pages of documents that GSK submitted to the FDA in defense of Avandia has had the intended effect: overwhelming FDA's advisory panel with "science," questionable as it may be.

I'm reminded of the scene in the original King Kong movie that fascinated me as a kid: the scene in which King Kong rips open the jaws of the T Rex and kills it. That's exactly what GSK has done to the FDA -- ripped open its regulatory jaws and rendered it powerless to take Avandia off the market even though it is known that the drug is responsible for the deaths of 400 times more people per year than is Toyota's cars (see "If Drugs Were Like Automobiles").

I have no doubt that the FDA will follow the recommendations of the advisory committee, the majority (17) of whose members voted to keep Avandia on the market albeit with stronger warnings or tighter restrictions on prescribing. Although 10 members voted to take the drug off the market, I don't see that view being taken seriously by the FDA. After all, Avandia's patent will expire within a year and it has received such bad press lately that it is hard to imagine physicians prescribing it. FDA's strategy may be to slap restrictions on Avandia and hope it dies a death of a thousand cuts. That way, the agency can appear to be responsible and science-driven rather than being gung ho anti-industry.

All this leads me to consider how GSK will address the problem of a likely drop off in prescribing by physicians. This is already happening. GSK hopes to solve that problem with a clinical trial that demonstrates that Avandia is as safe (or just as unsafe) as its competitors. It is reported, however, that GSK is having problems recruiting patients for this new study.

Just as BP is hedging its bets on stopping the Gulf oil leak by placing a new cap on the well rather than relying on the success of the relief well option, GSK will roll out a direct-to-consumer (DTC) ad campaign to hedge its bet on the comparison study.

A DTC campiagn can be launched almost immediately and may already be ready to roll. Such a campaign may resemble the Celebrex campaign that Pfizer launched after competitor drug Vioxx was removed from the market and put Celebrex's safety in doubt (see "Celebrex Ad: Let's Dive Deeper").

Keep in mind that DTC campaigns are aimed NOT just at consumers, but also at physicians who are even more likely to watch the evening news on TV than you or I. GSK may also simultaneously launch an equivalent direct-to-physician ad campaign.

The new Avandia advertising campaign will draw upon positive data that GSK cherry picks from its 14 million pages of documents just as the Senate Committee cherry picked negative data.

It was destined that the great Ape would die and so will Avandia. It won't be the FDA gunships that kill Avandia, however. It will be the "beauty" of the marketplace!

Police Lieutenant: Well, Denham, the airplanes got him.

Carl Denham: Oh no, it wasn't the airplanes. It was beauty killed the beast.