AstraZeneca Is ‘More Sensitive’ About Illegal Marketing
20 CommentsBy Ed Silverman // December 22nd, 2009 // 8:51 am
All those big fines are prompting some drugmakers to say they’ve found religion. For instance, Pfizer ceo Jeff Kindler recently gave a speech about corporate trust (watch it here). Now, AstraZeneca’s Dave Brennan confesses that his company is “more sensitive than we’ve ever been” about preventing illegal promotion of their drugs ever since it paid a $520 million to settle a US probe marketing of its Seroqeul schizophrenia med.
Off-label marketing has become “a much bigger issue in the last few years as a result of the government’s position on this,” he tells The Wall Street Journal. “If you go back ten years in this industry, this was not an issue. I mean, we trained our people not to promote off-label…so it’s always been sensitive. But now, it’s even more sensitive because we’re paying fines.” The fine, by the way, was $520 million. Last year, Seroquel generated $4.5 billion in revenue.
The drugmaker faces numerous lawsuits over its Seroquel marketing and documents released by plaintiffs attorneys allegedly showed AstraZeneca execs discussed broadening the market to include adolescents and patients with Parkinson’s and Alzheimer’s disease, and at medical meetings, in sales calls and with patient-advocacy groups, the Journal writes.
The goal of an AstraZeneca public-relations plan from 2001 was to “encourage and support…use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly.” It also said there needed to be “aggressive market penetration” among adolescents, the elderly and patients with bipolar disorder for Seroquel to outsell rival meds. The FDA didn’t approve the pill for bipolar disorder until 2006, the Journal reminds us.
In response, Brennan tells the Journal: “There were a wide variety of documents. Stuff that said we don’t promote off-label. Others that said different things. You know, that’s just the nature of how business runs over ten or twenty years. There’s millions of documents floating around. I don’t have any particular comment” on individual documents.
SteveM
The FDA has made it easy for AZ and the other Big Psycho-Pharma houses by expanding the indication profiles to include almost anything and everything.
Who needs to go off-label? AZ is pumping up the über-dirty drug Seroquel big time on TV right now as an adjunct for depression. Just following Abilify’s lead
BTW, Eli-Lilly is conducting an FDA sanctioned pediatric clinical trial for its rancid drug Cymbalta. Child psychiatrists will be brain bombing kids with that stuff in no time.
The fact is, with psycho-pharm, “off-label” means nothing because psychiatrists can back a diagnosis into a drug indication. Given drug dealing is all they do now, Big Psycho-Pharma has active physician collaboration even without the financial inducements. Because drugging by default has become normative.
Psychiatry is a mess…
Batman
They pay a big fine and they find “God”. Seems like the only way to get their attention.
Kinda sad.
harpy
Off-label marketing has become “a much bigger issue in the last few years as a result of the government’s position on this,” he tells The Wall Street Journal. “If you go back ten years in this industry, this was not an issue. I mean, we trained our people not to promote off-label…so it’s always been sensitive. But now, it’s even more sensitive because we’re paying fines.”
“Off-label marketing has always been illegal, but if you go back ten years in this industry, the law was not being enforced. I mean, we always knew it was illegal, but now the government has a big stick up its butt about following laws and shit so we’re paying attention.”
there, fixed that for ya.
Chris
> “we trained our people to not to promote off-label”
Lip service lives on.
For some companies, ‘more sensitive’ is just another way of saying that documents are ‘cleansed’ before being finalized and distributed, and employees are encouraged to watch what they put in writing. The underlying behavior doesn’t really change.
Justice in MI
Interesting comments. As usual, I especially hat tip Harpy.
While defenders of Pfizer in the recent big bust continue to insist that it was all about off-label, and that’s how Kindler summarized it in his Boston talk, the reality is that it was more: It was specifically promotion for indications that FDA had rejected, in significant part for safety reasons.
Conservative think-tankers emphasize “freedom of commercial speech.” But even that argument runs aground when companies violate explicit FDA rejections and–in DOJ’s phrase–”put public health at risk.”
Pinocchio
My guess is that the sensitivity is over getting caught.
Doc
Talk is cheap.
Anonymous
BTW AstraZeneca’s ‘bucket of money’ scandal with Mike Zubillaga occured during a Corporate Integrity Agreement. It is not uncommon for a reps sales forecast to exceed that generated by an FDA indication. In order to hit their numbers they are drawn into off-label marketing.
Drug reps should be considered PR people with a salary only. No bonus & they should be blinded to sales.
“Winter 2007: Zubillaga publishes newsletter in which he compares cancer docs offices to buckets of money and refers to selling “against” letrozole (Novartis’ Femara)—which would be a violation of the code of conduct controlled by the Zoldex CIA.”
http://www.brandweeknrx.com/2007/05/your_handy_az_b.html
Jack Friday
Believe me when I say there is A LOT more to come on this……
elmore
This just means they’re going to be sneakier. These guys are paid by how many drugs they sell. Selling more drugs means finding more sick people. That means, for psychotropics, diagnosing more people, especially sitting ducks like kids or old people. “Increased sensitivity” is a PR phrase. I’m waiting for one of them to say, “Wait, this is immoral.”
patrons99
Elmore,
You have expressed it perfectly…sickness sells…wellness doesn’t. It’s become a sickness industry. Healthcare reform? It’s not going to happen. The chairs just got rearranged, that’s all. Pharma and the fat cats (a whole array of parasites, e.g., insurance companies), will continue to gorge on the public. Don’t hold your breath, waiting for someone to say, “wait, this is immoral”. We are all “sitting ducks”. Drug safety and the public “health” have been savaged. It’s a disgrace.
Former Pharma Marketing Director
It is not just about off label marketing. It is about putting in bogus clinical trials to prevent patients being accrued to competitive “real” clinical trials. It is about spending long hours on designing marketing strategy that subverts the truth, fear mongers, and attempts to place obstacles in front of physicians.
It is about buying their way into patient groups, and national organizations and manipulating the government and market to the detriment of patients.
It is about tampering with clinical trial data and making claims based on corrupted clinical trial data.
It is really about crimes against humanity; taking the most vulnerable of our society and using them as profit centers.
Now they are finding religion? We are in trouble. Religion is the last place they need to look to fix what they have worked so hard to break.
Ethics - they need to install and listen to an ethics committee that examines and questions the marketing department programs.
So pharma are you listening? Do not find religion, find a conscience! Or at least a good moral compass……
patrons99
Awesome…simply awesome. “It is really about crimes against humanity”…”find a conscience”. A wonderfully expressed view (from a former insider). I applaud you, sir! Unless someone like you comes forward, whistleblowers are just “whistling in the wind”.
elmore
To Former Pharma Marketing Director: Everything patrons99 says is true. Bravo, bravo. If only people like you were not “former” but actually running the show. Does anyone in government know or care enough to fix this? Or must it always be lawsuits because people got hurt?
Justice in MI
We’ve gone around this one before, but it will be a lot easier to “find a conscience” in a different incentive structure.
One of the most revealing documents to emerge in recent years was that one, via the WSJ, from an AZ manager wondering out loud whether or not to “bury” (his word) another study on Seroquel. Among the reasons not to–he felt they had a relatively good ethical reputation; if they did do it their competitors would “out” them; etc.
Among the reasons to bury–everyone else was.
Conscience?…”apres vous, Alphonse.”
Another former pharma marketing director
Everything the former marketing director states is true. Some companies are more guilty than others. The more “valuable” the patient ($$$), the more egregious. One of my fervent hopes was that “Health-Care Reform” would really focus on cleaning up the pharma and device industries. Doesn’t look like that is going to happen - an outcome of very, very strong lobbying and large amounts of cash.
Atlex
Former,
As a former marketing director myself and someone who chooses to stay in pharma (albeit in a different capacity), let me assure you that the vast majority of marketers (and everyone else) in pharma have a conscience and a strong moral compass. Just like every other industry (academics, priesthood, journalism, etc.), there are a few bad actors. My observation is that your vehement anti-pharma crusade probably has more to do with your own (perhaps guilty) conscience rather than an evangelical compunction to spread the gospel.
Atlex
Justice in MI
Atlex–To the degree I have any knowledge of this, I would agree with what you say on the level of individual people who work in the industry. Indeed, as I’ve said before, I believe moral compasses are proabably more reliable there than they are in the world I know, academia.
Nevertheless, it is difficult to imagine a statement like Kindler’s emerging from academia or even a different industry. Specifically this:
“Across society people believe that the rules meant to bring order to society instead are being manipulated to benefit the rule-makers. It has become so widespread that having questionable ethics is often seen as the norm. In fact, doing the right thing now seems quaint and old-fashioned when so many people seem to get away with doing the wrong thing.
People have had enough, and the backlash is real. Its fueling demands for more restrictions on businesses and on government…
Now sometimes this criticism is warranted; sometimes it’s not. But when the majority of people don’t trust you, they will find a way to force you to change. So this is where we are. And it’s up to us to earn back the trust that we’ve lost.
It will take a lot of time and energy, and it won’t happen overnight. But we have to start by letting people know that we hear them. This starts by acknowledging where we’ve gone wrong, showing that we’re making real changes…”
Obviously, this is not some blanket “wea culpa.” There are plenty of qualifications and generalizations beyond pharma. But is it your interpretation that, when Jeff Kindler refers to criticisms that are “warranted,” and “acknowledging where we’ve gone wrong,” he is referring only to acknowledging “a few bad actors”? Or do you think he means, and would you agree, that there are also systemic issues that need to be addressed?
Atlex
JiM,
I think you inferred more into Kindler’s statement than he meant to imply. He does acknowledge bad actions, not just by pharma, but by Big Business overall (remember the time and place of this speech). Importantly, he goes on to say, “Now sometimes this criticism is warranted; sometimes it’s not.” To me, the main takeaway from this speech is that bad actions have to be acknowledged and, the consequences of those actions (lost of trust), have to be dealt with. Are there systemic issues to be dealt with? I think Kindler would say, “yes” but with qualifications. The system makes it too easy for a small number of bad actors to have too great an impact.
As you can read, my previous statement was a reaction to continual complaints by some posters who always find fault in pharma.
Atlex
Justice in MI
Thanks for a useful response, Atlex. As you know, JK went through some specifics about no more “chotkes” to docs, transparency issues, need for a stronger FDA (unspecified beyond that), etc. Anyway, “the system makes it too easy” is just how I’d also say it–and also too tempting, given recently weaker FDA, blockbuster model, pressures re: market share, shareholders, etc..
So it really comes down to how small or large the number is of actors who do “bad” things, which will, in turn, depend on the situation. As I understand the DOJ reports, the Neurontin case, as decided in 2004, involved an extensive network at W-L, and would be fairly described as something approaching company-wide. The recent Pfizer cases (with roots in W-L and Pharmacia) may, indeed, be different.
Anyway, I do think of ethics-in-context, which is why I emphasis the latter when the former is raised by itself.