Joseph Calabrese, MD: So you might ask why has there been an increase in oversight with physicians and drug companies, and the answer to that is that drug companies understand that marketing to physicians has a remarkable and direct impact on sales,

and ethical norms haven’t been put in place, and for those that have, they’ve failed to deter unethical behavior on the part of physicians, sometimes because we don’t know what we’re doing, and we don’t know that it’s unethical, and sometimes it’s subtle, but it’s real.

Medicare and Medicaid have developed a huge interest in this because not only does the marketing of physicians increase sales, but it can, of drugs, but it can increase service utilization, device utilization, and that drives up costs, so they’re now - the office of the inspector general has a lot of resources to monitor this.

There are things that drug companies do that are helpful. This slide summarizes some of them, and these are the things that drug companies will target in meetings with physicians. Now in this most recent JAMA article, there are a lot of moderately provocative and some suggestions extremely provocative things. [Brennan et al. JAMA 2006;295(4);429-433]

That’s must reading, not because maybe everything is gonna happen that’s recommended, but because we need to think about and manage our own response to what’s being considered, so Brennan reports that there should be an alternative way for companies to interact with physicians, and that these objectives should be achieved in some other way.

In this article, there’s a discussion of gifting, and this article, I think for the first time, makes a definitive statement about zero tolerance for gifting, and it’s predicated on the assumption that when physicians receive things, even if it’s a pen, that it has an effect on prescription patterns, so I go around our suite once a week, or once every ten days, and just throw out things, and it’s amazing within seven days, the things that are there. Anything that has a drug company label on it . It’s like a fungus. It keeps coming back.

And I feel like an idiot doing this, because people think I’m cleaning or something, but I guess it is a way of cleaning, so literally, if you have all this stuff around your office, you look like a drug company, and pens don’t cost that much. We can buy pens and those little stickies, those don’t cost that much. Now joking aside, one thing that this article touches on is this issue of zero tolerance, and in particular, meals. So at lunchtime, we’ll have a program meeting, and historically we have had companies provide lunch during lunch, and it’s a program meeting, and for the first five or ten minutes, they talk about something new. Well, we probably should have stopped that a long time ago, but now it is a very clear statement, zero, nothing.

Audience: So have you stopped it?

Not yet. But here’s what I did. We had one of these last week, so I told everyone, “This is the last time.” You have to wean people off of a free lunch. So it’s coming down the pipe. Okay, so zero tolerance.

Sampling - this article is quite provocative in this particular area. The notion is that sampling provides not just medicines to patients, but access to physicians and it definitely does. I’ll have reps comes into my - if I make the mistake of - if I’m stupid enough to leave my door open, they’ll come by and they’ll stick their head in, and if everyone else is busy, they’ll ask me to sign for samples, and there is the recommendation that sampling to physicians be prohibited entirely. Entirely prohibited and replaced with a system of vouchers that distance the rep from the physician, and free samples really do induce physicians and patients to use medicines that are more expensive and not necessarily better, so I think this is gonna happen. I would welcome that for sure.

P&T committees, to be on a P&T [Pharmaceutical and Therapeutics] committee, and have done the research for the drug that’s being reviewed, that’s certainly a conflict of interest, but to be on a P&T committee, and have received funding from that company, but a drug being reviewed that’s for an illness entirely out of your area, that is also emerging as a potential conflict of interest as well, which to me is troublesome, because that basically means if you do a lot of treatment trials, you can’t review anything on a P&T committee. I’ve been on a P&T committee for 15 years.

Problems with CME [continuing medical eduation], this ought to be interesting to see how this shakes out. This is also has the potential of being extremely provocative. The first bullet is really important, so drug companies should not be permitted to provide support through a subsidiary agency to any ACCME accredited program. So right now, the way companies support is they have to go through a subsidiary CME certified agency and that kind of puts them at arm’s length. Well, that’s being reviewed here as not adequate, and what’s being recommended instead is that the manufacturers contribute to a central repository within the academic medical center. Well that’s fine if you’re in cardiology, or surgery or something, but if you’re in mental health, politically we don’t always get the resources that everyone else gets, so this will work, but I don’t know if it’ll work as well for us, so I’m a little worried about this, because I think politics is gonna have a negative impact on our access to this central repository.

This business about funds for physician travel, I don’t think this is controversial. This is definitely going to happen. Drug companies interested in having faculty or fellows attend meetings should provide grants to the central office, at least a central office within the department. If it’s the central office within the hospital of the university I think we’ll be at some risk, since we don’t normally get as much access to resources, at least at our place, compared to the big departments, and then the notion is that this office should disperse the funds, and that trainees will no longer be dependent on industry largesse to be able to go a meeting.

Speakers’ bureaus and ghostwriting, this is a really important topic for folks who are investigators and the bottom line is that we should not be on any speakers’ bureaus. I think it’s okay to train speakers about a data set. I think we have an ethical obligation, if you generated that data, you gotta make sure people talk about it in a way that’s - it’s thoughtful, and scientifically balanced, so I think it’s important for us to be involved in the training of people on a data set, but to be on a speakers’ bureau yourself is no longer recommended for an academic.

Okay, so ghostwriting, this is an area of potential liability if you work with companies, because companies wanna be involved in the drafting of papers. Well, we got a huge problem if you let that happen, and I think the prudent thing to do when you’re working with a large company about a large, important data set is save every single revision of the manuscript, so that you have a record, an electronic record that documents your involvement in manuscript preparation, so that is - I think that’s helpful, but the bottom line is that you gotta write the article.

Currently drug companies have their own infrastructure that manages the data, but in the second reference at the end of this slide presentation, there’s a recommendation by JAMA that every company be asked to secure a second opinion on the data analysis of results, and we’ve been asked to do that already, so that’s coming, and I think that’s a wonderful idea, so every big data set now has gotta go to someone else, at least an outside statistician, if not a statistician unrelated to the trial, and do the same thing, or conduct the analysis from scratch. That’s a good question.

Okay, here’s another good topic, and this weighs in favor of what Husseini was talking about yesterday, and basically because the process of drug depends on input from us, consulting with, or accepting research support from industry should not be prohibited, and that greater transparency is necessary. So what about this business of consulting? Nowadays when you consult, there has to be a document that defines what you’re consulting on, what the deliverable is, so that makes it kind of annoying because in large, there are lots of pages, but the bottom line is that if you consult, there has to be a clear cut deliverables, so it’s not just pandering.

Academic medical centers should be able to accept grants for the general support of research, as long as the grants are not designated for use by a specific investigator. This one’s gonna really, really - I mean, if this actually happens, that would be very hard to manage. Consulting agreements and unconditional grants should be posted on a publicly available website, consulting agreements, that means I work with twelve or thirteen different companies. I think it actually helps if you work with more companies, because it shows that you’re committed to not just - not have all your eggs in one basket, you’re less likely to be biased, so I don’t know what’s going to happen here, but it’s just something to keep in mind.

Now, the office of the inspector general is a group of people I’ve never had any interactions with, and I want to keep it that way, because we all have a lot to lose. But you might wanna look at this website. (http://oig/hhs.gov/authorities/docs/03/05053FRCPGParmac.pdf).
This is the most rigorous document I find that addresses our vulnerability, because this is such a difficult area, so you look at these four points, and this is how they decide who to go after, okay? Number one, does it interfere with clinical decision making? Oh, well that’s kind of broad reaching, so is what’s being done, does it interfere with the clinical decision making?

Number two, does it have a marked effect on company sales? So if you’re involved in a drug, and the design of the study was methodologically sound, and it leads to regulatory approval, yeah, it’s gonna result in a lot of sales. Number three, does it increase cost of Medicare and Medicaid? Of course. Number four, does it raise concerns about patients’ safety or quality of care? You could see what the OIG uses is these broad reaching, and what they call statutory safe harbors, so if you address these issues you’re functioning within a statutory safe harbor.

I think that this is really hard to manage, and I think that the only way to navigate this morass of controversy is to be meticulously invested in scientific balance. If at the end of a presentation, someone is unduly pleased with what you’ve said, you probably weren’t balanced about the way you said it. No good drug is as good as people think, and no bad drug is as bad as people say, because how can you address this other stuff from the office of the - it just seems to me it’s not management, but it is thought provoking, so I thought I’d put it down.

At the very minimum, broad disclosure is necessary and this is an example of what I would call something that is very usable, so the first thing is to list whomever you’ve worked with, either a consulting relationship, or research funding, or honoraria. The second thing is to note that you don’t have an equity interest in any company. Anyone who’s doing trials should not have an equity interest in any company. That doesn’t include mutual funds, since you don’t control what a mutual fund invests in. As I mention number two, no speakers’ bureaus.