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Michael Moore Sicko Movie to Debut -- Three Weeks Too Late to Be Relevant

You've all heard that Michael Moore will debut his new documentary, Sicko, in Cannes tomorrow.

Undoubtedly it will give the industry some PR headaches. It's not hard to find damaging facts about healthcare in the U.S. We're the richest country on the planet, but somehow 40 million people have no health coverage whatsoever.

Here's the unconventional wisdom: Big Pharma should crack open a bottle of champagne and celebrate Moore's inability to make a film in less than three years. The Senate gutted the drug bill two weeks ago. It's a done deal. Congress is not going to pick that bill back up just because of Michael's movie.

Had Moore gotten his fat ass out of the editing suite six months ago, maybe the movie would have been screened in front of enough Americans by now to create a bit more pressure to keep key requirements in that Senate bill, such as allowing Americans to purchase drugs on the free international market, and not restricting them to the Soviet-style trade protectionism that Big Pharma currently enjoys.

So Moore's movie currently only functions as a vehicle for Moore to make money and maybe win another Oscar, rather than what it could have been--something that could have driven a vital debate about how exactly this country is going to pay for healthcare costs that are crippling our ability to compete and crippling the uninsured in a more literal fashion.

Peter Rost, the Frankenstein's Monster of Pfizer

Anyone who has ever read Mary Shelley's Frankenstein in the original knows the story:  A scientist creates a monster. The horrified boffin allows his creation to escape, and  it spends the rest of the book terrorizing his friends and family.

Isn't this pretty much the case with Peter Rost, the former Pfizer marketing vp  whom Pfizer fired after he made too much noise about dubious practices that had occured on the company's Genotropin franchise? Pfizer failed to secure its monster, and now Rost is roaming the foothills of Pfizer-town, creating havoc for CEO Jeff Kindler, who was involved in the decision to kick Rost out of the company back in 2005.

Rost this week has devoted his blog to an astonishing series of posts which allegedly describe how Pfizer execs in India took kickbacks in connection with the sale of a Pfizer building for far less than it was worth; how Pfizer hires private detectives to spy on rival executives and pay bribes, and how Pfizer India kept a "gift" list for certain Indian government officials.

This is the fourth set of whistleblower allegations to come from Rost. (First was Genotropin, second was AZ's Arimidex scandal, third was Pfizer's treatment of maraviroc and fourth -- this.)

I care about things from a marketing and brand image point of view, of course. I'm happy to cover good news and bad coming out of Pfizer. But in terms of the company's image, it just makes me think that about November 2005, when Pfizer had the opportunity to pay Rost to shut up and go away. Instead, he was fired. Wouldn't it have been a lot easier to settle with him? Sure, Pfizer has probably so far saved money by fighting Rost rather than settling (the company would have had to pay that Genotropin settlement anyway), as Rost's individual suit has so far borne no fruit in court.

But you've got to think that Pfizerstein's Monster would never have gotten off the operating table if they'd written him a modest check.

Utah Sues Lilly Over Alleged Off-Label Promotion

Is it just me, or does it suddenly feel like it's all off-label, all the time in drug marketing these days? Utah just joined a bunch of other states suing Lilly over its marketing of Zyprexa, according to the AP.

"Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa. As a result, Lilly has been illegally enriched at the expense of the state," the lawsuit said. The state is seeking civil damages and penalties, including $5,000 to $10,000 for each prescription that was "not medically necessary."

Ed at Pharmalot writes that the other states who have surrounded Lilly with pitchforks and burning torches include Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania and West Virginia.

Phil Dawdy at Furious Seasons alleges this has already cost Lilly $1.2 billion in settlements.

If you want more specific info on what Lilly is accused of doing, start here over at ClinPsy.

RX Marketers Take a Page From the OTC Playbook

In a story I wrote for Brandweek published Monday, I dig around in the curious world of companies who try to make Rx drugs taste nice -- or at least not disgusting.

The OTC world has known for years that making meds palatable helps their brands. (This is why I mourn the demise of Novartis' Cherry flavored Theraflu with guaifenisin, dextro, acetominophen and one other  chemical I can't remember. A Novartis rep recently confirmed to me that flavor and the formulation are both dead.)

But there seems to be some sort of acceptance for Rx meds to be disgusting. Certainly, they shouldn't be as attractive as candy. But  if compliance really is the problem that Big Pharma keeps whining that it is, then maybe this is an area they should look more closely at.

GSK and Schering-Plough Busted by FDA on Rival Products for Essentially Similar Bad Acts

The FDA has sent letters to S-P and GSK over their detail aids for Nasonex and Flonase respectively. Hilariously, the FDA accuses both companies of doing essentially the same thing: using misleading information about studies to create the impression that their brands are more effective than the evidence warrants.

Here's the text of GSK's detail piece:

• “Choose greater EFFICACY for your patients with SEASONAL ALLERGIC RHINITIS…” (original emphasis) above a chart titled, “SUPERIOR REDUCTION in Patient-Rated TOTAL NASAL SYMPTOM SCORES (TNSS) vs NASONEX1” (original emphasis) which in turn presents data that Flonase patients experienced a superior reduction of 25% (P=0.03) in TNSS versus Nasonex patients.

• “Patients given FLONASE experienced GREATER RELIEF of NASAL SYMPTOMS in a head-to-head clinical study of seasonal allergic rhinitis (SAR) sponsored by Schering Corporation, the maker of Nasonex®” (original emphasis).

The FDA didn't like that:

"These claims and presentations are misleading because they suggest that Flonase is superior to Nasonex for the treatment of seasonal allergic rhinitis symptoms, when this has not been demonstrated by substantial evidence or substantial clinical experience. The reference cited1 to support this claim does not provide substantial evidence for the following reasons. First, the study design raises multiplicity issues. It was designed as a placebo-controlled trial comparing Nasonex to placebo; the active comparison was not clearly planned. It is therefore difficult to determine exactly what significance level should be attached to that comparison. Second, the study was not replicated."

Here's what the FDA had to say about S-P's Nasonex:

• Page one of the Nasonex detail aid contains the headline claim, “Nasal allergy sufferers report Congestion at night can be a BIG problem” (original emphasis). ... "…the only nasal-inhaled steroid that's also FDA approved to help PREVENT congestion” (original emphasis).

What's the problem? As the FDA writes:

"Nasonex, however, is not specifically indicated for congestion."

Ouch.

Note how GSK's error -- claiming efficacy over another brand when there's a lack of head to head studies -- is essentially the same as AZ's error in the Arimidex/Bucket of Money fiasco.

More of Pharma's Enemies Join the Blogosphere

The Prescription Access Litigation Project, an advocacy group that sues drug marketers over things like  average wholesale pricing manipulations, has started a blog. It's called Ask Pharmie, a reference to PAL's cartoon pill character. As you can probably guess, it gives a rough ride to Big Pharma.

The move underscores the need of pharma marketers to get to grips with blogs. Most brand managers will admit they have no idea how to tackle the sphere, even though it is becoming increasingly influential. (A recent Congressional demand for an OIG inquiry was made largely on the back of blog coverage.) J&J has made some tentative inquiries but nothing concrete has emerged from the New Brunswick Giant.

Seperately, is it just me or does Pharmie bear a weird resemblance to Towelie, the drug-taking handcloth from South Park? Are they by any chance related?

Senate to Big Pharma on DTC: 'Never Mind!'

After years of threats, warnings, complaints, and handwringing, the Senate finally dropped the proposed 2 year ban on DTC for new products in the Kennedy-Enzi drug safety bill now heading toward President Bush's desk.

Adopts Stephen Colbert voice: "I called it!" Looks like the awesome power of PhRMA's lobbyists prevailed once again.

The most comical statement made to explain all of this was by Sen. Tom Harkin (D-Iowa). From the Star-Ledger:

[Harkin] "said the compromise provisions in the bill will require the FDA to preview every ad to insure it has adequate safety information and that all side effects are stated in clear and concise language. He said the FDA will be able to fine drugmakers if their ads are false and misleading."

Er, isn't this what the law already requires?

"This is a shot across the bow. If the companies don't rein it in and be responsible, tougher measures will be coming," Harkin told the Ledger.

Ooooh! I'm scared!

Please, Harkin, your position is ridiculous. We've had 10 years of DTC. Either it's fine the way it is or it needs to be reined in. If it needed reining in, then this was the chance to do it. And you balked. No one believes that Congress will ever again take serious action to change DTC rules.

Everyone involved in the DTC business can now go back to work -- it's business as usual, folks.

Hambrecht Analyst Tears Into Nektar Over Exubera; Is 'Astonished' at Pfizer's Lack of Advertising

I've said before that I enjoy the commentary of WR Hambrecht + Co's Andrew Forman,  because he doesn't sugarcoat his coverage.

In a recent note on Nektar, the supplier of Pfizer's ill-fated Exubera diabetes product, Forman had this to say:

"With less than 5,000 diabetics using Exubera, which Pfizer's CEO and Nektar's both characterized as 'highly disappointing', about a third of those beloved 'Nektarines' who stuck it out all the way up to the top of Mt. Everest will likely soon be out of a job.  As we approach the one year anniversary of Pfizer's launch at last year's ADA, and with enough Exubera inventory to supply a few hundred thousand diabetics, we are astonished that Pfizer is still holding back on DTC until the second half 2007. But after everything we have observed over the past year, nothing should surprise us any more. Maybe Pfizer can say it has just launched Exubera, but this analyst can't re-launch coverage of Nektar with any credibility. ..."

But we'll try to extrapolate on last night's call and make adjustments accordingly with a focus on lowering Exubera production revenues in 2008E, lowering Pfizer Exubera sales projections, and tempering our outlook through 2010. Our new 2007-2010 Exubera end sales forecasts are lowered from $250M, $485M, $917M and $1516M to $67M, $200M, $713M and $1,045M which now assumes about 30,000 diabetics will be using Exubera as we exit this year, reaching 100,000 diabetics in 2008 and reaching 500,000 diabetics by 2010 which is less than half what Pfizer was forecasting a year ago."

"Combining a more achievable forecast which necessitates Pfizer making its new, better-late-than-never marketing mix that involves DTD (direct to diabetic) pull marketing beginning this fall (yes, a full year later than everything else it should have done) with Nektar's internal cost cutting measures, we arrive at the following new NKTR revenue and EPS estimates through 2010..."

The full note, with all Forman's numbers an predictions, follows after the jump.

Penalties for Off-Label Drug Marketing Are Virtually Negligible

Check out this roundup of off-label marketing cases by the AP. Here's a key section:

"Critics of off-label marketing say drug makers continue to do it for one simple reason: profits. Even when drug makers are forced to pay huge fines, the amounts are small when compared to the money that can be made by promoting drugs for off-label uses.

In 2004, Pfizer paid $430 million in fines to settle allegations it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses. David Franklin, a medical liaison who became a whistleblower against the company, said that even after the settlement - one of the largest ever in a health care fraud case - doctors told him that other pharmaceutical companies were still actively promoting their drugs for off-label uses.

'The $430 million penalty was widely referred to as a slap on the wrist,' Franklin said."

I wish I had written this story. Here's why: The key factor here is that drug company M&A activity has created corporations of such enormous size that even a fine of $430 million is not regarded as significant. Thus, it can be argued, Big Pharma has essentially discovered a way to avoid complying with the FDA rules -- by becoming so big that the rules are trivial by comparison.

For example: Pfizer's annual revenues are in excess of $50 billion. That $430 million Neurontin fine represents exactly 0.86% of those revenues.

While people within the drug business are aware of this, most lawmakers and almost all consumers are certainly not. I remember discussing the Genotropin story with my boss before we published it. She wanted me to find out whether any potential fines paid by Pfizer for Pharmacia's off label marketing of the drug could impact the value of the company and trigger shareholder lawsuits.

It took me a while to explain to her that even if the fine was as big as the Neurontin settlement, Pfizer was so massive that its impact on the share price would be too tiny to register. In the event, the Genotropin fine was even smaller than that ...

Introducing the J&J Probe-Watch-O-Meter

It's difficult to keep track of all the investigations surrounding J&J and its various units these days—because there are so many of them. So I've decided to keep a running list. If you think I've missed any, please drop me a line and let me know, at jedwards@brandweek.com.

1. N.J. U.S. Attorney's office probe re allegations that doctors received kickbacks to recommend knee replacement devices from J&J unit Depuy, as reported in the Star Ledger.

2. OIG probe  re sales and marketing of Risperdal by J&J unit Janssen.

3. Boston U.S. Attorney's Office probe re sales and marketing of Topamax of J&J unit Ortho-McNeil.

4. Boston U.S. Attorney's Office probe re sales and marketing of Natrecor by J&J unit Scios, as reported in the Boston Globe.

5. DOJ/SEC probe re " improper payments in connection with the sale of medical devices in two small-market countries."