BrandweekNRX

10 Reforms That Drug Advertising Needs Right Now

This will be my last post on this blog. As I walk off into the sunset to do this, someone new will take over for a while. I won’t spoil the surprise; check back tomorrow.

I’ve been writing about drug marketing for only three years, and blogging for less than that. But I’d still like to leave you all with some modest suggestions that would improve the promotion of drugs to consumers. I encourage your feedback and debate in the comments section below.

The BrandweekNRX DTC Reform Manifesto:

1. In TV ads for drugs, the FDA should ban disjointed imagery during side-effect warnings: One of the more compelling parts of the FDA’s review process was the presentation by Ruth Day of Duke University. She did a study showing that when drug ads listed benefits, the images on the screen matched the voiceover and moved slowly. But when side effects were listed, the images often became mis-matched to the voiceover and moved much faster or were more distracting. The result is that viewers find it more difficult to remember the side effects than the benefits. Once you know this, you’ll notice that this is a frequent aspect of drug advertising – as soon as they get to the bad stuff spots devolve into an avalanche of unrelated imagery.

2. Reminder ads should be illegal: Promoting a drug but not saying what it does or what its disadvantages could be? This helps neither the patient nor the doctor. The only health issue it promotes is drug companies’ bottom lines.

3. Product placement should be illegal, paid or unpaid: A product placement is essentially a sophisticated reminder ad (see above) and should be treated as such. When will the FDA wake up to this issue?

4. Drug company PR people should be properly trained to answer straight questions with straight answers: Here’s how the current kabuki show works: a reporter (or a blogger) calls up a drug company with legit questions about one its products. The pr person then asks for the questions to be submitted via email. The reporter submits a list of questions. The pr people ignore them. A day or so later (why does everything take more than 24 hours at drug companies? This isn’t the 19^th Century!) the pr person sends an email to the reporter containing a single statement that fails to address the list of questions that the company asked to see, and often doesn’t really address the issue at stake. If changing this means firing traditional PR staff and replacing them with medical science liaison staff trained in pr skills, then so be it. But for the official spokespersons of drug companies to be unable or unwilling to talk in detail about their products indicates either ignorance or incompetence or, just as bad, lack of transparency.

5. Pharma companies should be required by the SEC to break out their promotional costs: Currently, drug companies don’t have to say anything about how much they spend promoting drugs. They mix those numbers in with their selling, general and admin budget line. They do break out their R&D costs. But for some reason their promo costs remain a mystery. This is because marketing costs tend to be roughly double R&D costs. PhRMA frequently bleats that new drugs cost in excess of $800 million to develop. Give them the benefit of the doubt – but remember that such a drug will burn through $1.6 billion in ads, sales rep salaries and CME grants across its lifetime. Who ultimately pays for that? Consumers and taxpayers. Asking for transparency on this is not burdensome. Bristol Myers Squibb already does it in part (although I’d like to see something a little more detailed.)

6. FDA should require relevant head-to-head studies for second-to-market drugs: If companies want to launch a new brand, they currently have to prove to the FDA that the drug is both effective and safe. But they don’t necessarily have to provide data about the drug’s effectiveness or safety as compared to its key competitors in the market. Rather, new drug studies are often based on older, generic or less sophisticated drugs on the market. This is why doctors in crucial areas of practice – such as cancer – still lack evidence of whether Femara is more effective, and under what circumstances, than Arimidex. Neither AstraZeneca nor Novartis has dared to study both drugs against each other, even though they both treat the same thing. What does this have to do with advertising? Ads tend to be based on claims for the drug, but currently most DTC is laughably vague. “Take control of your life,” “Take action,” “Now you can do something about it,” and so on. If there were head-to-head studies on record with the FDA you’d soon see DTC advertising become a lot more specific about whose drugs are safer and whose are more effective. And we wouldn’t have fiascos such as this one, where doctors weren’t recommending certain cancer drugs because they weren’t being paid enough to administer them.

7. FDA-mandated transparency in Continuing Medical Education: Drug companies should have to report into a web-based form on the FDA’s web site the total amount of money they spend on CME, which companies they funded to provide it, and which categories they provided CME funding in, with each entry broken into dollars. Then, once a year, companies should have to file a PDF detailing every single CME payment they made to every single CME company, broken down by dollars, purpose, event and date. Medical education should no longer be like the Wizard of Oz sitting behind the curtain. Companies should have the right to educate doctors about anything they want, but there should be full transparency about it.

8. FDA-mandated transparency in grants and donations for non-profit groups: Again, as above, drug companies should have to properly report in detail who they funded, how much they funded and when they funded, on a single public web site. That will allow patients and doctors to more objectively evaluate the statements of various pressure groups on health issues. Ever wondered why Planned Parenthood was so gung-ho about hormonal contraception? Could it be because the Robert Wood Johnson Foundation, funded by J&J stock, is a major donator to its various affiliates? (Here’s just one of many.)

9. FDA mandated transparency for payments and gifts to doctors: The laws of Minnesota and Vermont, which require all drug company payments and gifts to individual doctors be recorded and made transparent, should be adopted nationally. The public has a legitimate interest in knowing whether doctors are speaking as objective experts or as paid sock puppets. So many doctors make it into media coverage because their expertise has been leavened by consultancy fees on the very issue they’re being asked to comment neutrally upon.

10. FDA mandated transparency in prescription-writing habits: Some doctors have gotten annoyed at the fact that sales reps can check scrip databases and find out how much of each drug they write. Reps often know more about doctors’ scrip habits than doctors do. The doctors are wrong on this issue. In just the same way that the public should be able to see which doctors are on pharma payrolls, there’s an obvious public interest in being able to see whether doctors prescription habits correlate with the payments they’ve received from drug companies.

Are Drug Companies Doing TV Product Placement?

For a couple of years I’ve followed the issue of drug brand product placement on TV. The Indianapolis Star today published a story that confirms (and indeed very kindly cites) my previous work (here and here) on this topic.

The gist: The number of drug brands being mentioned in TV scripts is on the increase, and has doubled.

The question is, Are drug companies making deliberate efforts to get their brand names mentioned (and thus courting the wrath of the FDA for irresponsible promotion)?

The answer is yes and no.

A small number of companies have made paid efforts to get their brands mentioned. Organon is one of the few companies that has come out of the closet about its relationship with the show Scrubs, which often features the Nuvaring logo on its props and in backgrounds.

But most companies deny that they do this.

Are they telling the truth?

Umm, again, yes and no.

In the times I’ve reported on this issue in the past, I noticed that there were plenty of product placement agencies who either had drug companies as clients or were in talks with drug companies. Why would a drug company hire a placement agency if it didn’t want to engage in placement?

And I also noticed that some drug companies forthrightly denied that they made payments to get their brands on TV … but declined to deny that if a show needs props or information they send the product right over. In other words, they get their placements for free.

The rationalization here is that if the company isn’t directly paying a TV producer or network to get a mention then it isn’t actually product placement. Of course, this is not how placement works – generally, clients pay agencies and agencies get the product on the show, usually by convincing the director or producer that they will save production costs by accepting realistic props for free. And on medical shows like Scrubs and ER, sometimes the writing staff just needs to know that they’re describing drugs accurately.

Plenty of scripted shout outs are, as Lilly claims in the Star article, happenstance. Prozac and Viagra are cultural clichés, those companies don’t need to pay writers to get mentions. In fact, if you look at the top 10 drugs listed by the Star, you’ll see that most of the brands fall under the “punchline” category – Vicodin, Botox, etc.

So, does that mean that the level of deliberate placement activity by companies is small? Could be. But I keep coming back to one thing: If companies aren’t engaging in this activity, why do the numbers keep on going up and up? Surely, if the TV biz was left to itself, the numbers would be flattish from year to year.

 

Pressure Groups Demand Disclosure for Pharma Donations

Today's good idea for the business comes from a group called Essential Action (lousy name, BTW). This coalition of pressure groups wants all pharma companies to disclose all the donations they make -- in the form of educational grants, etc -- to various charities, patient groups, and foundations.

Why?

Because, as everyone knows, these patient groups are allowed to say things about drugs that companies themselves are not. And patients often rely on these groups for objective information, not knowing that some of them have taken millions of dollars from drug companies with an interest in patients' prescriptions.

It's all about transparency. The more the better. No one is saying drug companies can't donate money to causes they're interested in. It's just that they shouldn't be able to hide those donations when their sock puppets are chatting about the amazing off-label uses of gabapentinvirogleevatronical-dopoid-3, or whatever.

Credit where it's due: Lilly already does this.

So who are these groups that have signed on to this coalition?

Some of them are the usual big-mouth suspects:  the AIDS Healthcare Foundation, the American Medical Student Association, etc.

And then there are some unusual ones: the Albanian Consumers Association, The Finnish Consumers' Association, New View Campaign on Women's Sexual Problems, the Togolese Consumer Association.

The heads of the largest pharma companies will all be getting a letter urging them to follow Lilly's lead. Who knows, maybe on this issues the Christian Health Association of Malawi has got it right ...

 

Survey Says Drug Marketers Expect Ad Spigot to Remain on 'Full Blast'

Dendrite just published a survey of 134 respondents in the industry, on the state of pharma marketing. You can get the full report for yourself here.

The highlights, and some discussion:

Biggest challenge: 61% said regulations. But this was in April -- since then the Senate has backed off its threat to more tightly regulate DTC so that number is probably inflated.

Fear of consumer backlash to DTC fell from 44% to 31%. The industry appears to think that consumers are getting used to the ad bombardment.

To change consumer perceptions, 25% said Patient Assistance Programs were the way to go. Not at Lilly, presumably, which just abolished changed theirs earlier this year to make their numbers look better (see comments section).

No end in sight to DTC spend increases: a plurality expected ad spend to rise 5%.

Marketing mix: Some highly misleading graphics in the report show traditional adspend declining and web programs taking their place in the marketing mix. Not included in the graphic: the relative prices of these elements. You can get a really good web site, blog and search optimization program going for less than $1 million; but you generally need to spend tens of millions on TV. So decreased spend on TVin the overall mix doesn’t necessarily mean that “less” money is actually being spent on TV, especially in light of the above prediction of a 5% increases in DTC spend …

 

GSK'S Alli Blog: Currently the Most Interesting DTC Experiment Out There

Check out GSK’s new blog for its OTC weight loss drug Alli. Yes, it’s another corporate drug blog. But what’s different about this one is its tone and style, and the way it has been upfront about some of the negative side effects of the drug.

Here’s an example. This was posted by Steve Burton, the GSK vp on Alli:

“The rule of thumb is to limit your calories from fat to about 30% per meal, or about 15 grams of fat per meal.  I learned this the hard way when I ate a fish sandwich and french fries from a fast food drive-through WITH TARTAR SAUCE, and a soda.  Really smart, huh? Good thing I was close to home so I could change my clothes.*  But you know what? It hasn't happened since. Yes, I still see occasionally undigested fat floating in the toilet. But I'd rather have the fat flushed away when I go to the bathroom than have it wrap around my waist or clog my arteries.”

I can’t think of any other marketing vp who would talk about their product that way. The strategy on the Alli blog actually seems to be to play up that particular side effect, with lines such as:

“Toilet humor never seem to lose its appeal, whether you’re in kindergarten or on YouTube.”

“Caryn had one  ‘alli-oops’ episode after eating a chicken with crispy noodles appetizer, according to People. alli, she says in the article, ‘is forcing me to eat healthier. Yup, alli will punish cheaters if you don't stick to a low-fat diet.”

The blog is also punching back at media critics. This post responds to a BusinessWeek story that called Alli a lifestyle drug.

Another interesting part is that some of the posters are part of the Allifirst 400, a bunch of Alli consumers who’ve been picked by GSK to blog about the drug. It’s an interesting approach to consumer generated media.

GSK is even upfront about the fact that it’s a corporate blog, and that corporate blogs tend to have a high cheese factor. “I've spent my career writing business memos so my blogging may sound a little, er, corporate,” says Burton in the opening post.

It’s weirdly refreshing. GSK seems to have understood that by being honest about your product’s flaws – and this is a product with some major flaws – you inoculate yourself from criticism about them.

Viagra Campaign Suggests Pfizer No Longer Interested in Medicine

Pfizer's new ads for Viagra feature middle-aged men singing "Viva Viagra" to the tune of Viva Las Vegas, according to Bloomberg.  The new ad also features middle-aged men playing guitars and driving motorcycles and vintage cars. You can see the ad for yourself here. Interestingly, the online version carries no side effect warnings.

For years, Pfizer has been criticized by both the FDA and the  AIDS Healthcare Foundation for promoting Viagra as if it were a recreational drug and not a legitimate treatment for a medical condition. The foundation actually sued Pfizer, claiming its ads tacitly condoned use of Pfizer Viagra at parties and because of its resultant use by crystal meth addicts has helped spread AIDS. The suit was, predictably dismissed.

With the legal troubles out of the way, Pfizer now appears to have completely dropped the pretense that Viagra is anything other than a recreational party drug.  And, if the Bloomberg report is accurate, it has backed off its August 2005 promise to do more educational, unbranded advertising for medical conditions...

Novartis and Olagunju: A Case Study in Pharma PR and Media Failure

Last week, Peter Rost broke a nice scoop about how Novartis has alledgedly submitted false data to the FDA to support its application for Tasigna. That application -- by amazing coincidence! -- has now been delayed while Novartis provides more information from the FDA.

This comments thread on Ed Silverman's Pharmalot contains pretty much everything you need to know about blogs, pr, the media, pharma marketing and the future.

Lesson one, the scoop was broken on a blog, Peter Rost's, and not by the WSJ, the NYT, BusinessWeek, Forbes, Fortune or any of those guys. Arguably, Rost has broken more scoops on the drug biz this year  (AZ bucket of Money scandal, Pfizer Maraviroc scandal,  Pfizer India scandal, and now this one) than any single reporter at any of those publications. It used to be that the media's fear of blogs was offset by blogs' dependency on the media -- blogs were reduced to fact-checking or commenting on real reporting that was still done by the media. But now that is no longer true. Any of these stories would have made decent 'readers' at the WSJ, but instead that paper's coverage of them has been tepid at best and non-existent at worst.

Lesson two, Novartis -- and I can say this from experience, virtually every pharma company operating in the U.S. -- is not equipped to deal with the blog-based internet media. Look at this description, by Ed Silverman, of Novartis' pr resources:

"Novartis is a complicated beast - pr is run out of Basel, then there’s the New York corporate office and finally, there’s the pharma appartus in East Hanover, NJ. This makes it difficult for me to know where to turn, partly because Basel sometimes, I believe, viewed The Star-Ledger as local media. Pharmalot, however, is seen all over the place (and I noticed a great number of Basel readers over the past two days). So maybe now I’m on their radar."

None of the execs answering the phones in any of those three offices -- four if you count their outside pr counsel, Ruder Finn -- has the power to simply return a phone call and engage in a straight conversation with a reporter. They all have to consult with each other before delivering a canned answer itself creates more questions than answers.

Lesson three, in the old days, the news media didn't pay much attention to who delivered the message to them. If the comment came from a company spokesperson or the company's outside pr agency, it didn't make much difference to us. But for bloggers like Rost, the medium is the message and your pr people -- and lawyers, for that matter -- are now as much a part of the story as the story itself is. Check out Rost's blast of Ruder Finn here. This is not the first time Ruder Finn has managed to become the subject of coverage rather than a guider of coverage. See here, here, here and here.

It's not limited to Ruder Finn, of course. Robinson, Lerer & Montgomery managed to get themselves mentioned here and  here.

There are some signs that pharma is waking up to the new reality. J&J just got itself an interesting new blog and AZ at least returns bloggers' phonecalls.

But the bottom line is this: Until now, most of the thinking about blogs has been about how they will affect the media. But for pharma, and any other business segment for that matter, the more grave consequences will be for pr. Because Rost et al, unlike the Times and the Journal, just don't feel the need to cooperate with Novartis' four sets of pr folk before running with what they've got. And Rost's sources (and Ed's and Jack's and this guy and this guy and this guy) don't feel the need to wait for The Times and the WSJ to conclude that their info has reached whatever importance threshold they use as a benchmark before publishing -- and beating them -- on some great stories.

Big Pharma's Nigerian Nightmare

What was the deal yesterday with the drug business and things of Nigerian origin? Two stories yesterday both involved Nigerians with angry lawers accusing companies -- Novartis and Pfizer -- of misdeeds.

First,  Peter Rost broke a nice scoop on a former senior data analyst at Novartis who claims the company submitted flawed data to the FDA: Nigerian-native David Olagunju alleges in a suit that he was fired for "disclosing and refusing to participate in illegal and unethical activities regarding the testing and reporting of human drug study results concerning Tasigna (ANM), Novartis' new cancer drug."

Guess what? Novartis recently announced that its Tasigna approval application was being delayed by the FDA. (Ed Silverman at Pharmalot carries a different take here.)

Second, the WSJ reported Nigerian lawyers withdrew their case against Pfizer in favor of what they claim will be a refiled case with stronger evidence in the Nigerian meningitis flap. Briefly, the Nigerian government has accused Pfizer of using a meningitis outbreak to test Trovan, an experimental drug, on 100 children.  11 kids died as a result, the Nigerians claim. Pfizer denies the claim.

The meningitis case is interesting in a "Life Imitates Art" type of way. Movie fans will remember that it sounds a lot like the premise of The Constant Gardener. I mention this because the drug industry at one time had an informal whispering campaign to discredit the movie. GSK vp Mike Pucci  used the movie as an example of how pop culture had turned against the industry in his talks at pharma conferences, in which he urged the biz to get its shit together and make a stronger case to the public.

More interestingly, the industry-friendly DrugWonks once excoriated the movie as a bunch of improbable  lies.  DrugWonks is technically correct: The movie takes place in Kenya, but the Pfizer suit is about Nigeria; the disease in the movie is  tuberculosis, but the disease in Nigeria is meningitis; a bunch of people are killed by the drug in the movie, but only 11 are killed in Nigeria... so that's lots of differences!

Wyeth Courts PR Disaster in Attempted Hotel Eviction

How aggressive and petty are lawyers who represent big drug companies? There's a delightful item on Ed Silverman's Pharmalot today that provides a snapshot on that issue:

"A funny thing happened on the way to the courthouse last week in New Brunswick, NJ. A large number of Wyeth lawyers and their opponents, who were representing a woman suing the drugmaker over its hormone replacement therapy, were staying in the same hotel. But then the lawyers for the plaintiff, Ellen Deutsch, were suddenly asked to leave their handful of rooms."

The plaintiffs' lawyers said the hotel told them that Wyeth wanted them out -- and as Wyeth had paid for about 40 rooms for its lawyers and staff, they were using their leverage.

Wyeth denied it:

“The hotel booking for these trials is done by a travel logistics firm. Without our knowledge, this firm took it upon themselves to ask the hotel to move the plaintiff’s team when they found out they were staying at the same hotel as our lawyers. Wyeth did NOT know they were doing this, nor did we authorize it. When our lawyers found out, they immediately put a stop to it and apologized to the plaintiff’s lawyers. This was a case of an overzealous vendor - nothing more.”

Regular readers may recognize this statement as yet another version of the Cephalon defense (ie, it wasn't us wot did it, it was someone else).

And Ed wisely notes:

"A Wyeth spokesman didn’t provide any info about the ‘travel logistics firm,’ how it suddenly learned that both teams of lawyers were staying at the same hotel, why such a move was made on the eve of the trial, or what, if any action was taken by the drugmaker against this mysterious firm."

Med Students Express Ambivalence to Reps, DTC

In a new survey by Epocrates, the makers of handheld electronic medical info devices for doctors, med students expressed ambivalence toward drug reps, Big Pharma, and DTC.

Some highlights:

When asked, 'What is your opinion of the pharmaceutical industry?' the results were:
54% neutral
28% negative
17% positive

Do you think schools should limit access of pharma reps to students?
Yes 42%
No 47%

What are the potentially negative effects of DTC?
Misinformed patients 66%
Patients self diagnosing 66%
Undermining the physician 27%

Do disease awareness campaigns lead to early disease detection?
87% agreed

My take: med students are evenly split as to the benefits and evils of sample case carriers and their employers.  That's interesting as more and more med schools are shutting their doors to reps -- in other words, their older more experienced teachers have decided they don't like reps.

As for DTC, these results seem to show that students don't like branded DTC but do like unbranded disease awareness. Don't leap to any conclusions though -- the questions on that part of the study were designed to elicit only criticism of DTC and only praise for disease awareness efforts.

We're still waiting on the results to the counterpart questions: "What are the potentially positive effects of DTC?" and "Do disease awareness campaigns that are actually thinly veiled ads for new branded products lead to early disease detection?"