MedAdNews "Pharma Blogs: Week in Review"

I'm enjoying this weekly summary more and more . . .:




The aftershocks of the Zubillaga saga won't go away and may turn into even more powerful earthquakes. Right before Easter, AstraZeneca fired oncology regional sales manager Michael Zubillaga over an unapproved internal newsletter after his crass comments referring to doctors' offices as a "big bucket of money" hit the blogs and even the mainstream media. Then an anonymous group of AstraZeneca employees shared internal sales documents with blogger Dr. Peter Rost at Question Authority, alleging that AstraZeneca was engaged in illegal off-label marketing of the breast cancer drug Arimidex against Novartis' Femara. Specifically, the employees claimed that confidential training tapes used by AstraZeneca show reps how to raise doubts over the results of trials of Femara, and then switch back to discussing Arimidex's own positive trial data. Dr. Rost says he believes the tapes prove that AstraZeneca is operating illegally.

This prompted a request from California Democrat Rep. Peter Stark to the Office of the Inspector General to investigate FDA's oversight of pharmaceutical marketing to physicians.

The April 25 letter from Mr. Stark was not unexpected. At Pharmalot, Ed Silverman's sources told him earlier in April that the Congressman was curious and wanted to know more about the off-label allegations. In his letter, Mr. Stark says he is "concerned about industry greed leading to clinical decisions not based on sound medical science." He goes on to say, "If this is happening at one company, it's likely happening at most drug manufacturers."

According to the Congressional Quarterly, the request from Mr. Stark has stirred the Office of Inspector General (OIG) into looking into the allegations. Meanwhile, AstraZeneca says its own internal investigation into the anonymous allegations has yielded disciplinary action. Mr. Silverman says, "there were no details provided about the number of people involved, their employee rank, or the specific violations uncovered. So for the moment, there is no way to verify the extent to which the company has actually taken action."

As an aside, BrandweekNRx claims that the Zubillaga saga marks a turning point in the coverage of pharma. "The Bucket of Money scandal, with a few exceptions, has unfolded almost entirely on blogs," BrandweekNRx says. "It marks a real turning point in Big Pharma's relationship with the media, if only because these whistleblowers have turned to Rost rather than Alex Berenson at the Times. I mean, how many other Congressional inquiry demands have been based on blog coverage?"

AstraZeneca is not the only company dealing with allegations of illegal marketing based on the leak of internal sales documents from an anonymous employee. On Monday, Dr. Rost revealed that a whistleblower, whom he calls Jane Roe, claims that Pfizer used the HIV sales force to illegally promote the AIDS drug maraviroc before its approval. The allegations came after an FDA advisory committee voted unanimously to recommend the accelerated approval of maraviroc, a CCR5 inhibitor, for use along with other antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1. If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade. Discovered by Pfizer scientists in 1997, maraviroc works by blocking viral entry to human cells. Rather than fighting HIV inside white blood cells, it prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

Jane Roe claims that she and other representatives were given an unapproved slide set for maraviroc in 2006 and were asked to slip the slide set onto memory sticks and give them to doctors that the company trusted. Allegedly, the sales representatives were asked to promote an expanded access trial for maraviroc. The reps were allegedly used as liaisons to help medical affairs enroll new research sites and promote the trial.

In a thread on Cafe Pharma, Jane Roe allegedly speaks up about why she went to Dr. Rost to get the news out about her complaint. "I tried going to Pfizer, hired a lawyer, and called the OIG," she says. "I finally decided I wanted to do the right thing and going [to] Rost was my best option for getting out the truth. He does have a bias against Pfizer but I asked him and he agreed once he knew the story and saw the evidence. He was willing to do what everyone else was not. I am on my way out as it is just a matter of time before they put it all together. I know many will blame me for doing this just remember I didn't initiate the wrong I witnessed it and tried to tell Pfizer. Once I told them they iced me out and have made my life pretty stressful. I am looking at it now and thinking its kind of comical in [a] wierd [sic] way. I just wanted to do my job and be treated fairly and trust me if you ever complain that will not happen."

Where does it begin?
When I first learned about the Pfizer employee and AstraZeneca employees' allegations, they sounded hauntingly familiar to me because of an e-mail inquiry I received months ago. As editor of Med Ad News, marketing and advertising executives occasionally ask me for an opinion or advice on tracking down a bit of information. In this particular case, an advertising executive was doing research for a direction for a campaign that they were going to propose to a client. The executive asked me, "Is there a precedent for a brand doing competitive advertising that references the generic name of a product that is not approved in the U.S., but is branded and approved in other countries?"

Did this set off alarm bells in your head like it did in mine? In my reply to the executive, I stated that FDA would probably look askance at any materials developed on this concept as they would not offer U.S. physicians a true comparison - the competing drug referenced is not available in the United States and the doctors wouldn't have any clinical experience with it.

The executive agreed that the tactic would not fly with FDA and that it would probably not even get past the client's legal and regulatory departments. The agency was "just curious" if there was a precedent.

This may have been just an extreme case of brainstorming, but I do wonder if all the oxygen gets sucked out of the room by all the talking done during marketing sessions. I also wonder what kind of strategy the agency (who I will not name) went with for that particular client and brand (which was not named by the agency). And if this tactic was too extreme to go with, why look into it in the first place?

It seems to be human nature to push right up against firmly drawn lines, and if there is a gray area, to dance around in it. Logic seems to have nothing to do with it - like the person in the horror movie who has to check if the axe-wielding psychopath is still lurking just outside the door because they haven't heard him in five minutes.

BrandweekNRx sees another parallel between the AstraZeneca and Pfizer sales representatives' complaints. According to BrandweekNRx, the whistleblowers highlight an unresponsive OIG. In both instances, the whistleblowers claimed to go to OIG first and had not gotten any response, so they then went to Dr. Rost. "Clearly, the lesson here is that if the OIG could just respond to emails and faxes a little quicker - even just a note to say 'Thanks! We're on it! We'll get back to you as soon as we can!' - neither of these people would have gone anywhere near Rost," BrandweekNRx says.

Pink cupcakes
On the lighter side, there has been some note made of AstraZeneca's breast cancer drug marketing initiatives centered around Mother's Day. Dr. Rost posts AstraZeneca's directive to to sales representatives . The May and Mother's Day-centered initiative promotes MUMs (Mothers United for Mammograms), which AstraZeneca's Missy Moran of the Mid-Atlantic Sales Team says offers the company an opportunity to not only support breast cancer education, but "can also be leveraged to enhance our presence in key accounts . . . Utilize this campaign to gain access and enhance selling opportunities for Arimidex, Abraxane, and Faslodex with your key accounts." The idea is for sales representatives to set up tables in waiting rooms and other areas ("chemo areas can be successful") and distribute pink flowers, information in pink Arimidex bags ("They will also be highly visible throughout the entire office"), and pink-iced cupcakes ("Refreshments and food will help attract patients to the table.").

The bloggers writing about this gave the impression that they think this initiative is tacky. They're also all men. Quite frankly, if I were a breast cancer patient and some cheerful people are handing me flowers and cupcakes on my way out of chemo, I'd be very happy about that (and having had a breast cancer scare in the past, this is not a topic far from my mind at times). I'm also enough of a cynic to understand that the flowers and cupcakes are not being given out just to make me feel happy. I realize that other people might not think the same way, though, and might ask their doctor about treatment with Arimidex even if it's not right for them.

But I don't think this initiative is truly tacky. Truly tacky is the tale that I heard once of an initiative by a sales representative from a top 10 pharmaceutical company - I am leaving out the company name and the name of the drug to protect the innocent in this admittedly anecdotal tale. If the tale is true (it was passed on to me from someone at the University of Pennsylvania Center for Bioethics), then this beats pink cupcakes all out. It seems that the rep went into the doctor's office with a tarp, a beach backdrop, and a sunlamp. She spread sand on the tarp, stripped down to a bikini, and sunbathed. The sign on the backdrop read, "[Our SSRI] is like a day at the beach." Allegedly this was a hit with the doctor, and the rep's idea, published in the department newsletter, got her a nice cash bonus that month.

This incident happened during the early '90s, I was told. Sales behavior like this seems to have been curbed over the years, as scrutiny of pharma has become more intense. I don't expect to see a sunbathing rep in the waiting room anytime soon, but let's hope tacky doesn't make a comeback, and that more internal and external policing of marketing departments will fend off borderline unethical sales tactics.

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