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Prescription Drug Adspend Continues Its Love Affair With Dinosaur Media

For the last couple of years, whenever I've talked to DTC brand managers about where their ad budgets are going they tell me 'on the web.' The logic: Sophisticated marketers who want to closely track their patients also want to meet them on the web, where they can be engaged in more in-depth discussions about their health.

And for the last couple of years, I've occasionally produced a story that says, 'that may be so, but the category as a whole is still increasing its spend on dinosaur media, like network TV.'

This year, something changed. For my preview of the  upfront TV buying season in Brandweek this week, sources told me that yes, in fact, they're upping their spend generally on those old standbys—network TV and print.

There are a bunch of reasons for this, including the difficulty of advertising such highly regulated products in non-traditional media, measurability, and the relative youth and lack of sophistication of an industry that is only 10 years old.

But perhaps this year there's another reason: The looming DTC reform bill in the Senate. Could it be that brand managers have been told to spend it all while they still can?

It's Already a Bad Day at Pfizer, as PR Problems Arise on Lipitor, Maraviroc and Viagra

I thought I had a nice little scoop about Dr Robert Jarvik, Pfizer's celebrity Lipitor spokesmodel, being subpoeaned for what he knows -- or doesn't -- about whether Lipitor was promoted off-label. The plaintiffs in the case (mainly labor union healthcare plans) want to depose both Jarvik and the Lipitor sales and marketing staff. Stay away from those shredders, guys!

However, my story has been eclipsed by the latest from Peter Rost, who has obtained what he believes is a set of PowerPoint slides promoting Maraviroc, Pfizer's not-yet-approved HIV drug. Rost and his anonymous whistleblower source allege that the Pfizer sales force detailed the slide show to docs as early as November 2006--a clear violation of FDA rules if it turns out to be true. Again, it's all anonymous, so the usual caveats apply.

Finally, Alex Berenson at the NYT has a nice piece on Pfizer's new Viagra TV spot airing in Canada. Apparently, the entire commercial is in gibberish except for the word Viagra. A line from the script: “Minky Viagra noni noni boo-boo plats!” And this is going to help stave of DTC reform how, exactly?

Americans Are 150% Crazier Than They Used to Be, According to Psych Med Sales Numbers

Check this scary statistic: "Spending on prescription drugs to treat depression, anxiety, pain, schizophrenia and other conditions climbed from $7.9 billion in 1997 to $20 billion in 2004 – over a 150 percent increase, according to the latest News and Numbers from the Agency for Healthcare Research and Quality."

Let's assume the numbers are true. Does this mean that people in the US became crazier and more pained during those years? Or did the level of mental illness remain constant while percentage of those being treated went up?

Or was it simply that a whole bunch of people are now taking crazy meds who, perhaps, shouldn't be?

FDA Official Sews More Confusion Over Painkiller Warnings

Interesting story here about whether the FDA has been consistent in its treatment of Cox-2, NSAIDs and other painkillers. The feds recently ruled that all NSAID painkillers should carry harsher warnings, even OTCs. But naproxen (Aleve) should not have a black box warning, says Curt Furberg, who’s on the FDA’s drug safety committee, because the evidence shows its safer. On the other hand, diclofenac (Voltaren) carries the same warning as Aleve, even though Furberg says it’s as dangerous as Vioxx and Bextra—which have been taken off the market. (Thanks to Internet Drug News for digging out this one.)

My 2 cents: The dosage of Voltaren cited in this story is quite a high one—75 mg twice daily. Does every patient need that much? I think not. The bottom line is that all these drugs should be on the market, and they should all carry appropriate warnings. I've argued the same point here. Patients need options, even if those options are risky.

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I respect Sydney Wolfe's position on this matter—anecdotal evidence that some patients respond well to a risky drug is not science proving that a drug should be on the market. But, what Wolfe doesn't say is that good science doesn't prove that there will be a safe drug for every patient. As long as patients start at the safe end of the scale, and only step up to the more risky treatments when options run out, then doctors should have the right to tell their patients about drugs even when they are risky. And drug companies should have the right to sell them.

The weak link in this chain, however, are the DTC brand managers. To be credible on this issue they need to market powerful, new and risky drugs in responsible and informative ways. So far, only Pfizer, in its new Celebrex campaign, has had the cojones to be upfront about risks and benefits.

Skokie, Illinois -- Pharma Corruption Central!

The DOJ has described for the first time in real detail how the feds believe Pharmacia’s Genotropin/formulary kickback scheme worked, according to a memo in Massachussetts federal court (see download below). The scheme—planned at a meeting in Skokie—increased Pharmacia’s sales of painkillers at the cost of lowered standards of care for the sick kids who needed Genotropin, in the view of Pharmacia executives described in the memo.

Pfizer—or rather, “Pharmacia & Upjohn,” the now-defunct company that Pfizer acquired a couple of years ago—formally pled guilty on Wednesday in the Genotropin marketing kickback case.

The plea makes concrete what Brandweek reported a few weeks ago.

However, on Tuesday the DOJ filed its sentencing memorandum, which contained the most detailed description yet of how Pharmacia conspired with an unnamed “Company Q” in a kickback scheme that would increase sales of Pharmacia drugs by short-changing kids with genetic conditions that needed Genotropin, Pharmacia's (and now Pfizer’s) human growth hormone brand.

Among the tantalizing details:

• The word “Celebrex” has been mentioned for the first time in the government’s documents on the case. On page 3 of the memo, the government describes the business background: “During the relevant time frame, namely the year 2000, Pharmacia developed, manufactured, distributed and sold pharmaceutical products nationwide and in the District of Massachusetts. Among those pharmaceutical products were Celebrex, Detrol, Genotropin and Xalatan.”

Brandweek reported in 2006 that Pharmacia’s relationship with PBM Express Scripts and its formulary position for Celebrex were the subject of grand jury hearings in Boston (scroll down for details). The allegation, by ex-Pfizer vp Peter Rost and ex-Pharmacia marketing exec Carl Worrell, was that Pharmacia would deliberately overpay Express Scripts to manage the Genotropin Bridge Program, a patient support program for sick children. In return, Express would place Celebrex in an advantageous position on its formulary, thus boosting its sales. Express has consistently declined to comment on the issue.

• The documents give a timeline for how the kickback plan occurred. In July 2000, Pharmacia picked “Company P” as the best bidder to run its “Bridge Program,” a Genotropin patient support program for sick children. Company P was both cheapest—“$20 million less expensive over the life of the 3 year Bridge Program contract than another bidder,” and “even if one ignored the ‘cost competitiveness’ criterion, Company P would still have prevailed because its quality of services was determined by Pharmacia to be highest.”

• But Company P was about to be screwed out of the Pharmacia contract, the government goes on to say: “Others within Pharmacia were working at cross purposes. In mid-July 2000, certain employees of Pharmacia were engaged in a dialogue with certain employees of Company Q, one of the largest and most influential pharmacy benefit managers or ‘PBMs’ in the country. In terms of influence, this PBM claimed through its contracts with a large number of health plans that it had tens of millions of American 'lives under management.'”

Needless to say, if you’re reading this blog and the phrase “lives under management” sounds familiar to you, please drop me a line at jedwards@brandweek.com. I’d love to know the identity of Company Q (although only Express Scripts’ name has been connected to this affair so far).

• “One week later, on July 20, 2000, a group of the PBM employees and Pharmacia employees met at Pharmacia’s Skokie, Illinois offices. At this meeting, the PBM employees reiterated their interest in seeing the Bridge Program contract awarded to the PBM’s subsidiary. Pharmacia informed them that their bid was $20 million more expensive than that of another bidder. The PBM employees again discussed assistance that the PBM could provide in generating sales of Pharmacia’s drug products, though this time with more specificity. In addition, a high level employee of the PBM provided the Pharmacia employees with a private tutorial on the PBM’s formulary bidding process.”

• Pharmacia later agreed to overpay for the Bridge Program by $12.3 million, the government says. But, “There were a number of different voices within Pharmacia which did not want to offer the Bridge Program contract to the subsidiary of Company Q, let alone at a cost of $12.3 million more than Company P’s bid. There were people who objected on the basis that Company P was a higher quality service provider (and significantly less costly). There were people who worried that the subsidiary of Company Q would be difficult to manage because the Bridge Program contract would pale in significance to the extra drug sales that could be generated by Company Q’s formulary decisions.”

• Then, “in an effort to assuage the Endocrine Care Business Unit’s concern that it would have to incur $12.3 million in excess costs over 3 years if Pharmacia awarded Company Q’s subsidiary the Bridge Program contract, Pharmacia promised the Endocrine Care Business Unit that another business unit within Pharmacia that expected to benefit from the improved formulary positioning and formulary ancillary benefits would reimburse the Endocrine Care Business Unit for these excess costs. This promise was made with the knowledge and approval of Pharmacia’s senior business executives.” This sounds similar to the scenario outlined here, low down in the story.

• “On or about August 1, 2000, Pharmacia retracted the award of the Bridge Program contract to Company P, despite believing that Company P’s bid price for the contract was millions of dollars lower, and that Company P’s ability to deliver quality service was higher, than the bid presented by Company Q’s subsidiary. Company P’s Vice-President asked the reason for Pharmacia’s about-face, and was told by a Pharmacia employee that Company P was losing out because Company Q (the PBM) had formularies and Company P did not. Instead, on or about August 1, 2000, Pharmacia offered the Bridge Program contract to Company Q’s subsidiary, at an inflated price of $12.3 million more than Company P”.

And that is how children with dwarfism—the main beneficiaries of the Genotropin treatments under the Bridge Program—were screwed out of top-notch care by Pharmacia as it pursued prime positioning for Celebrex et al.

What is interesting here is that the government is still declining to reveal the identities of many of the key players, including the companies, the “senior business executives” and the vice president from Company P who complained about the whole bum deal.

Could it be that this probe isn’t over yet? What this space …

Download sent_memo_4_24_07.pdf

Sanofi Doing Pre-Launch Promotion for Acomplia (or Zimulti or Whatever It's Called This Week)

Sanofi has begun promoting Acomplia to doctors even though it is not yet approved by the FDA—kinda, sorta. What’s actually happening is that part of Sanofi’s diabetes sales force is briefing docs on “cardiometabolic risk, intra-abdominal adiposity and the endo-cannabinoid system.” (Those are posh med school words that mean “fat people.”)

According to a copy of a detail piece that a source kindly sent me (see download below), “increased activity of the endocannabinoid system has been shown to have an effect on: food intake, energy expenditure, and regulation of body weight.”

If only Sanofi had a drug that could regulate the endocannabinoid system. Sigh.

Oh, wait! It does! It’s called Acomplia! (Or maybe it’s called Zimulti?) Fancy that! What an amazing coincidence! According to this Sanofi press release, “Acomplia acts to decrease the overactivity of the endocannabinoid system”!

Of course, because Acomplia is not yet approved in the U.S. Sanofi sales reps aren’t allowed to mention the words “Acomplia,” “Zimulti” or “Rimonabant.” The drug goes before the FDA in June. Clearly, the Sanofites think they’ve got it right this time around, having been stalled at the FDA for some months.

The issues causing headaches for Sanofi right now: Whether the FDA will give them an indication for “obesity management,” (which likely won’t be reimbursed by insurance companies), “metabolic syndrome” (meaning a package of symptoms including intractable obesity that insurance companies would be likely to reimbuirse for), or Type 2 diabetes (which would definitely be covered).

Acomplia Report is predicting it will get obesity management only. Sanofi was expecting Acomplia to be a blockbuster, but such an unreimbursible indication would put a severe crimp on sales if  patients have to pay for it themselves.

Some thoughts on pre-approval promotions: The FDA clearly prohibits companies from touting a drug that is unapproved by the FDA. But it doesn’t prohibit them from discussing diseases and conditions generally, even if the only reason they’re talking about such a disease is that they have an upcoming pill for it.

From a layperson’s perspective, then, unbranded pre-approval promotions are identical to promoting “misbranded” (to use the FDA’s technical term) unapproved drugs, with the two exceptions that the promotion takes place before, rather than after, approval and that the name of the drug is not used. Seems like its walking on the legal line ... a technical difference is not the same as an ethical one ...

Such pre-approval detailing is common, a source tells me, and indicates that the company believes it is between 6 and 2 months from receiving an “approved” letter from the feds.

Perhaps Sanofi has developed some good answers regarding concerns that Acomplia makes its users depressed and anxious.

Download Acomplia1.PDF

Download acomplia2.PDF

AZ Chief Pledges Action on Bucket of Money Scandal ... or Does He?

According to the Independent today, AZ CEO Dave Brennan has promised to make heads roll if his internal investigators find any more nastiness in the Arimidex Bucket of Money business. But a close look at what Brennan was actually quoted as saying indicates ... er ... not very much.

While the lede of the Indie story says "AstraZeneca will discipline more of its US sales team if allegations of illegal marketing tactics are proven to be true, the drug company's chief executive promised," that's not exactly what Brennan is quoted as saying in the story.

In fact, the Indie doesnt't report what Brennan said until the very end of the story--a surefire indication that the reporter is trying to spin a very brief quote from Brennan into a major development. Here's what Brennan actually said:

[He said that misbehaviour within parts of a drug company's sales organisation was rare and] "relatively unpredictable", [and the important question was how a company dealt with it.]

OK, that's a truism, and doesn't tell us anything we didn't already know. He continues:

"There was an issue and we took action; if there is another issue, we will take more action. We have in place a very thorough and well-understood compliance programme in the US and across the entire business, with codes of conduct and operating principles and annual training, and I take all that very seriously."

The action here is presumably the firing of Mike Zubillaga. The promised action? It's prefaced with a Big If. That's an interesting "if" given that AZ's own training tapes appear to encourage exactly what Zubillaga was fired for encouraging—comparing Arimidex to Femara in violation of AZ's settlement with the OIG. Zubillaga sure didn't play the rep, the doc and the narrator on those tapes. (One of them was a woman!) Even if he ordered them made, he had help. So we'll see if Brennan's "if"  turns into action ...

Brennan continues:

"As for any particular situation at any particular point of time, I would say that the management responded by doing what they thought they ought to do."

Well, duh.

The article is interesting not because Brennan has said anything that wasn't known already, but because it demonstrates that the issue is on his radar. How long it stays there is another question entirely.

Sales Rep Details: They Work, Say 2 New Surveys

Amid all the blather about sales force ineffectiveness and laying off armies of reps, come two new studies in the Public Library of Science journal Medicine. The first analyzes interactions in which the rep tried to get the doctor to promote off-label: The study was based on call sheets obtained in the Neurontin litigation of yore. The second study is an anecdotal account of how reps see docs, and the subtle ways they use to persuade them to just write the damn scrip already.

Both have the same conclusion: details work, because docs believe they aren't being bribed, swayed and cajoled when, in fact, they are. (If they weren't, then reps wouldn't do what they do.)

Some highlights:

"After receiving the detail visit, 46% (50/108) of physicians reported the intention to increase their prescribing or recommending of gabapentin in the future."

The study was based on : "Market research forms that describe detail visits for gabapentin became available through litigation that alleged that gabapentin was promoted for “off-label” uses. Forms were available for 97 physicians reporting on 116 detail visits between 1995 and 1999."

In the second study:

"Reps ask for and remember details about a physician's family life, professional interests, and recreational pursuits. A photo on a desk presents an opportunity to inquire about family members and memorize whatever tidbits are offered (including names, birthdays, and interests); these are usually typed into a database after the encounter. Reps scour a doctor's office for objects—a tennis racquet, Russian novels, seventies rock music, fashion magazines, travel mementos, or cultural or religious symbols—that can be used to establish a personal connection with the doctor."

Keep reading until you get to the bit about the golf bags!

Drug Companies Express Increased Interest in Rx Product Placement

More agencies are coming out of the closet on the issue of doing product placement for pharmaceutical brands. I had a chat with Scott Tanenbaum, svp/director of client service of GSW, on the subject recently.

GSW handled the branded entertainment effort for Roche’s Tamiflu, which included a tie-in with the movie Happy Feet. The dancing penguins from the flick also appeared in Tamiflu ads.

But the drug itself was not named in the movie.

However, other drug companies have dipped their toes in the product placement water, including Dey Pharma for EpiPen; and Organon's Nuvaring and J&J's Remicade.

The moves are controversial because the FDA has never explicitly approved or disapproved of product placement for Rx brands. In my opinion, the FDA has made it pretty clear that it’s looking at major TV and print ads, and has neither the sophistication nor the resources to look at anything else. Thus, the FDA’s unofficial position is, “You might as well try this because we’re not looking at it.”

Tanenbaum thinks it is a matter of time before drug companies find a way to do product placements, especially on a show like House, where the script can get into enough detail to handle the fair balance risk/side-effect information.

My Q&A with Tanenbaum continues after the jump.

AZ Bucket of Money Training Tapes: Fantastically Boring!

As I type this I'm listening to the AZ training tapes that Peter Rost just posted (new readers start here). If confirmed, these tapes (here and here) seem to be yet another piece of evidence indicating that inside AZ there was a strategy of comparing Arimidex to Femera (letrozole), which would be against AZ's code of conduct and therefore its agreement with the federal government.

Two thoughts spring to mind:

When Rost first posted these, I was hoping they would be awesome wiretaps of villanous sales reps conspiring to screw Medicare for cancer money. But no, they are corporate role-playing tapes in which one bad actor pretends to be a drug rep and another bad actor pretends to be a doctor who prefers letrozole. Lo and behold, the rep manages to persuade the doctor to go back to Arimidex by the sheer Socratic power of her logic! The dialog in these tapes make the drug-rep-training scenes in Side Effects look like Casablanca.

More seriously, if the authenticity of the tapes is confirmed it means that it was more than just Mike Zubillaga at AZ involved in the Arimidex vs. Femara promotion, and that such a promotion was a more systematic corporate policy.

Again, it will be interesting to see how AZ and the OIG explain all this when they get done with their investigations.