BrandweekNRX

Novartis Yanks Zelnorm and $85 million in Ads; Web Site Already Down

Novartis announced today that it was pulling Zelnorm from the market. The company noticed worrying incidents of heart attack and stroke, it says.

The anti-irritable bowel syndrome drug is best known for its ads featuring people's bare stomachs with pleas for help drawn on them. Novartis has wasted no time--even Zelnorm.com is currently showing "Error 404--Not Found." The company spent $85 million on consumer advertising for the brand last year, up from $62 million the year before.

The move punches a hole in Novartis's sales, Reuters reports: Revenues in 2006 were "$561 million, of which $488 million was in the United States, and [the brand] boasted growth rates of around 30 percent annually."

Novartis's press release on the subject is a masterpiece of diplomacy. It starts by noting that the FDA requested Zelnorm be yanked after reviewing the data. "A small (but not statistically significant) imbalance in cases of angina pectoris was recorded and included in the US label when Zelnorm was approved in 2002," Novartis says the FDA said.

"Not statistically insignificant"? In plain English: "Significant," am I right?* What does this mean?

Here are the actual numbers: "events occurred in 13 out of 11,614 patients treated with Zelnorm/Zelmac (0.11%), compared to one case in 7,031 placebo-treated patients (0.01%). All patients affected had pre-existing cardiovascular disease and/or CV risk factors."

OK, so that is a small number of people, but it is still an increase of incidents by a factor of 10. Multiply that across the entire patient base and that's a lot of lawsuits.

Note that "the affected patients had risk factors." Were they triple bypass patients or where they people who're merely carrying a couple of extra pounds? The release doesn't say.

"Give me something different," indeed!

*Typos by me, not Novartis. Apologies to Novartis for the error. But my point stands--a tenfold risk increase on a patient base in the hundreds of thousands or millions is either significant or it isn't.

Sanofi in for Rough Ride on Acomplia

This came a little quicker than I expected, but as virtually everyone at Sanofi now knows, the company's as-yet-unapproved weight loss pill, Acomplia, got a savaging from the WSJ yesterday. Three days ago I predicted that because Acomplia is also associated with depression and anxiety among some users, "I can't see the press giving Sanofi a free pass on this issue if those side effects are in any way significant."

Lo and behold, the WSJ prints a takedown piece on its front page. In addition to the side effects, the drug won't have an anti-smoking indication in the U.S., it remains delayed at the FDA, and it's had trouble getting major indications in France and Germany.

The next moment of interest will be the Sanofites' response. Will they take this lying down, preferring not to antagonize the FDA by talking loudly about their unapproved brand? Or will they rush to the barricades to defend something that hasn't made it out of the starting gate yet? Watch this space.

Claim: Merck Will Lose $130 Million a Year on Gardasil by Stopping Its Controversial Lobbying

How much money will Merck lose following its announcement that it will stop lobbying states to make its Gardasil anti-HPV vaccine mandatory? Pharmalyst, a blogger who does interesting back-of-the-envelope calculations on pharma marketing economics—says it's about $130 million a year.

Sounds bad? Here’s the context:

“The financial hit to Merck is about $130 million per year (till Glaxo & others come up with competing products). These calculations also show that this is a lucrative market and despite Gardasil not being mandatory, Merck is likely to generate about $950 million from sixth grade female students each year.”

So, Merck isn’t giving up that much even though only 19 states and DC (by Pharmalyst’s reckoning) have some sort of Gardasil mandate. Pharmalyst also has a nifty set of charts so you can check his or her numbers. Stopping the lobbying campaign may yet turn out to be even more of a bargain, Pharmalysts says, because “they stand to lose a couple of millions less once you factor in their lobbying cost savings.”

This news comes on the heels of the CDC’s recent decision that Gardasil will be on the Vaccines for Children Program. Not that I want to rehash this debate, but it’s nice to know that the CDC took my position and not my opponents’.

Pharmalyst first came to my attention when he produced a set of stats supporting my reporting on Pfizer’s Exubera—and how its expenses seem to be eclipsing its revenue. See those numbers here.

As Expected: Merck Drops Gaboxadol, Its Not-Very-Good Sleep Drug

Friedman Billings Ramsey in a note to analysts today (see download below) says Merck has dropped its fledgling sleep compound, the difficult-to-type gaboxadol. "The companies cited a high incidence of psychiatric side effects and noted a lack of efficacy in a recent study," the note says.

Let me adopt my best Stephen Colbert voice: I called it! regular readers of BrandweekNRX will note that back on March 8 I tagged this compound as a loser. Read that post here.

Interestingly, FBR is not changing its outlook on Sepracor's Lunesta as a result. The category is still crowded and Sanofi's Ambien still slays newcomer brands. Thus the only remaining question is, will Lilly persist in its seemingly suicidal mission to get into this business?

Download fbr_sepracor.pdf

Human-Style Drugs for Dogs: Big Pharma's New Frontier

In this week's Brandweek I wrote a somewhat tongue-in-cheek review of the current FDA approvals for canine drugs, many of which seem indicated for disorders that humans suffer from but that dogs generally don't—such as anxiety disorder.

The piece seems especially apt as there appears to be a growing cottage industry of "experts" whose job it is to diagnose various forms of anxiety in humans, as if anxiety was an illness.

Let me put it this way: We live in a world at perpetual war with itself, where technology is changing faster each day, and where the only certainty is, well, uncertainty. Anxiety is the correct human response to this, not an illness.

Why some humans have reached the conclusion that their dogs are aware of this, I don't know. Feel free to email me with an answer. jedwards@brandweek.com.

Pfizer's Friede, Supporter of Relaxation of Off-Label Rules, Is Leaving

Arnold “Arnie” Friede, senior corporate counsel at Pfizer, has resigned, according to an email he sent friends and colleagues on Tuesday. Friede most recently made headlines when he told the ANA’s AdLaw conference that he believed drug companies should have greater leeway to tout off-label studies of drugs in medical journals, and that he agreed with the Washington Legal Foundation’s view on this topic. There is no indication that Friede’s departure and the conference are connected.

“I have been invited to remain at Pfizer Legal until August 2008,” Friede wrote in his email. “In the meantime, however, I am starting my search now.  I am open to a variety of new opportunities, including in-house, private practice, and other exciting possibilities that might emerge.”

He goes on to say, “If you have some time now, and would like to talk, I would really appreciate hearing from you.  I can’t tell you how much it means for me to be able to call on you for help.”

Friede will speak at the DTC National conference April 10-12 in DC, on the topic of “Regulation and Enforcement, including actions by FDA, the Office of the Inspector General in the Department of Health and Human Services, and the Department of Justice; Legislation and Public Policy; and, Litigation, including Consumer Fraud Class Action Litigation, as well as key developments in First Amendment law that will have a going-forward impact on DTC advertising.”

Psychiatric Bloggers Bash Decision Resources Inc. and Its 'Gold Standards'

I recently mentioned that Decision Resources Inc. had said Sanofi's Acomplia will replace GSK's Xenical as the 'gold standard' of weight loss drugs. Today I notice that two psychology/psychiatry blogs, ClinPsyc and Furious Seasons, are casting doubt on DRI's use of the term 'gold standard.'

Said Philip Dawdy at FS: "I had no idea (GSK's) Lamictal was a 'gold standard' in treating bipolar depression. And, as rotten a drug as I believe (AZ's) Seroquel to be in anything other than short-term use, of course it outperforms Lamictal in short-term treatment situations: Lamictal takes about 8 weeks of up-tapering to achieve a therapeutic dose, whereas Seroquel can get there inside of a week."

Said ClinPsyc: "Decision Resources has recently claimed that (Lilly's) Zyprexa will remain the “gold standard” for schizophrenia treatment.  Philip Dawdy found such a finding rather odd, as neither he nor many others (including myself) had ever found Zyprexa to be the most supported schizophrenia treatment. Most research indicates that Zyprexa works roughly as well as other medications, with its slight efficacy advantages in some studies (which may be based on biased research) likely offset by its tendency to induce weight gain and diabetes."

As it turns out, DRI does indeed award its gold  standard rather a lot (see here). Could gold standard inflation be setting in? Does anyone remember what happened the last time we all relied on the gold standard?

Could Anna Nicole Smith's Death Boost Peter Rost's Case Against Pfizer?

I can't believe I am typing these words, but ... Given that the coroner today said that human growth hormone was found in Anna Nicole Smith's body, could that assist former Pfizer vp Peter Rost in his jihad against Pfizer?

For those of you late to class: Rost sued Pfizer when the company failed to respond to his complaints that Genotropin, the brand Pfizer acquired in the Pharmacia merger, was being marketed off-label to healthy people for vanity purposes.

A Massachussetts judge kicked Rost's whistleblower suit out of court, and the feds officially declined to show an active interest. But Rost recently appealed the judge's decision on the grounds that in order to show he has a case he would have to  file confidential patient data in court—which, in a classic Catch 22, is against the law.

The feds perked up again when they saw Rost's appeal, and asked for time to file their own brief. Rost suspects that the DOJ suspects that if the ruling stands it will knock out any other pharma whistleblower case that relies on patient data. The feds likely don't want that because it would make it virtually impossible to bring a whistleblower case without violating patient data privacy.

Anyway, to bring this full circle—given that Smith was using HGH, that almost certainly means she was abusing it, says Rost (it's indicated for dwarfism and various GH deficiencies, not weight problems). 

And given that her death has now highlighted the prevalence of HGH abuse (check it out on Google here), could this be the extra fact that tips the appeals court to overturn the decision and allow Rost's suit to proceed?

You can't make this stuff up. Perhaps this is the ending Rost needs for his alleged movie?

FDA to Consider Acomplia in June; Depression a Side Effect

Sanofi's hoped-for anti-obesity blockbuster will go before the FDA advisory committee on June 13, it says here. This application has been delayed before, so the tension will be mounting among the Sanofites all through the summer.

Couple of interesting things to consider:

First, although some reports have said that the drug's name might not be Acomplia but Zimulti, Sanofi is calling it Acomplia in its press releases and on its press page.

Second, this report by Decision Resources notes that Acomplia will become the 'gold standard' in weight loss treatment--despite side effects of depressiona and anxiety among users.

Hold on a second: depression and anxiety have caused havoc for Roche's Tamiflu and Lilly's Strattera (both linked to reports of suicide). I can't see the press giving Sanofi a free pass on this issue if those side effects are in any way significant.

Pfizer's Exubera DTC to Start 'In a Month'; Mag Buys Included?

I'm trying to move on from the whole Exubera fiasco but, like the mafia, it just keep dragging me back in. Check out this thread on the WSJ's health blog. There appear to be at least two posts from Pfizer Pfolks. One, "helpless," says this:

"As the member of the product team –we are not aloud to make the simplest marketing desisions–i can not even chose what magizines to run my advertising message to the doc’s–my hands are tied in the big burac-mess–we move live a snall–because nobody here is aloud to make a desision—except–of course our agency’s—we need to break free of the chains–the bind us—"

And "Superman" responds:

"this drug will be a blockbuster. Once DTC hits next month and once we undo the bogus garbage that our injectable competitors have been spreading, patients will be knocking down doctor’s doors to get Exubera. Also, as we’ll have at least 1 - and maybe 2 - competitors in the next couple years, I predict injectable insulin will be less than 50% of the market 5 years from now."

So, Exubera DTC ads in magazines in a month, huh? We'll be on the lookout...