Late last month, Johnson & Johnson’s Janssen subsidiary agreed to pay $181 million to resolve claims by 36 states and the District of Columbia for promoting the Risperdal and Invega antipsychotic drugs for unapproved uses [see here]. The settlement comes shortly before the health care giant is expected to pay as much as $2.2 billion over similar allegations by the Feds involving these and other drugs. But the deal with the states includes provisions that are more specific than the sort of restrictions that the Feds often impose on drug makers, such as agreeing not to misuse continuing medical education programs for marketing or awarding grants to doctors based on their prescribing habits. One provision in particular, however, restricts the ability of drug makers to use sales and marketing personnel to distribute peer reviewed reprints of journal articles that contain off-label information, which is a significant development. We spoke with Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, about the implications…
Arnold Friede was a witness in the J&J/Jannsen trial I attended last January – Allen Jone’s and Texas’ TMAP suit. Friede was a very compelling witness and seemed to have the clearest vision of the pharmaceutical companies’ illegal marketing techniques. In that suit, he testified about:
-
Promoting Risperdal as superior to other antipsychotics even when forbidden by the FDA and being warned for infractions
-
Continuing to deny Risperdal’s propensity to weight gain and glucose intolerance even when warned by the FDA
-
Promoting Risperdal off-label in children
Ed’s interview of Mr. Friede that follows the intro above is worth the read. The States are putting in restrictions that specifically restrict off-label promotion. If you recall, some of that Texas suit was about the ever expanding TMAP program, but it was also about the off-label promotion of drugs, particularly for kids. The same was true in the recent GSK suit about Paxil, the subject of Study 329 that I’ve been obsessed with for the last few weeks. The specific restrictions were encouraging, but beyond that – a variety of people are apparently becoming increasingly aware of what has gone on in drug promotion. When I retired in 2003, I was as dumb as most about all this stuff I write about now I’m ashamed to say. But now, the world seems to be waking up. These State attorneys not only know about but are specifically targeting a lot of the practices that lead to massive overprescription both on and off label. For example:
Pharmalot: Which provision are you referring to that’s especially important in the J&J settlement, though?Friede: The particular provision I refer to prohibits dissemination of reprints of off-label, peer reviewed articles by sales and marketing personnel unless the subject of the reprint is a use that the company has already submitted for approval to FDA via a supplemental new drug application. In other words, J&J/Janssen [JNJ] has agreed not to use sales or marketing personnel to disseminate any reprints, even if peer reviewed, about any off-label use unless they have already filed a supplemental application for that use…
There was a time when the reprints handed out by pharmaceutical representatives were legit. Of course the ones they gave out were the ones favorable to their products, but we all knew that. One would hardly expect to receive a reprint that was favorable to a GSK drug from a Jannsen rep. However, the article itself was legitimate. If it came from the Journal of the American Academy of Child and Adolescent Psychiatry, or was written by a respected academician, or came from a prestigious Department of Psychiatry or University – it might be worth looking at even if it came from a salesman. But in psychiatry, that all changed. And it happened in my medical lifetime. An article in Neuropsychopharmacology, the journal of the American College of Neuropsychopharmacology has an article about vagus nerve stimulation in the treatment of depression by the Chairman of Emory University’s Department of Psychiatry and other well placed colleagues. It turned out to be ghost-written and the authors were all stockholders or affiliated with the manufacturer of a device that is apparently as ineffective turned on as when it’s turned off.
Industry managed ghost-written articles began to appear in all of our major journals. In the Rothman Report from the Texas trial, we learned that Excerptia Medica was turning out so many of those pharma-funded articles that they had an author gap, articles that they hadn’t recruited enough KOLs to sign on for. So the reprints being handed out were likely written by the pharmaceutical company’s hired writers, but had all the trappings of a peer-reviewed journal article [because peer reviewed journals were publishing them]. And while it’s encouraging that they’re beginning to plug these loopholes that have been used for stealth advertising, the era hasn’t ended until the journals insist on the necessary filters to maintain their scientific integrity and journal editors are willing to retract articles that turn out to be deceitful. The bottom line? No more secrets…
I don’t mean to be picky, but paying $181 million to resolve claims by 36 states is chickenfeed compared to how much J&J might have been dinged by individual state lawsults.
As for the promise not to promote off-label uses — well, we’ve seen they’ve weaseled around this before.
No argument there [$$$]. And as for them being promise keepers, no false hopes there. What I like is that the States are on to their methods and reacting. PHARMA used to be left alone. Now they’re on the radar, and they’re a target. That’s got to be good. In the past, they were punished after the damage was done [if at all].
Risperdal reproached!
The ‘atypical’ antipsychotics-Risperdal,Zyprexa,Seroquel… are essentially reformulated 50 year old Thorazine at 10-20 x’s the price.Zyprexa was hailed as, ‘the most successful drug in the history of neuroscience’.
How can that be legitimate as the conditions the drugs are approved for are only 1% of the population?
Zyprexa especially was ‘pushed’ off-label and made Eli Lilly $67 billion to date.
–Daniel Haszard