At A Glance
Name: Roy Bullingham
Title: Healthcare consultant for Sicetnon
Background: PhD in chemistry from the University of Cambridge, UK; and MD from the University of London at Guy’s King’s College Hospital and the Hammersmith Hospital. He was a vice president for clinical pharmacology at Pharmacia until the company was acquired by Pfizer in April. He was laid off from Pfizer in June.
Roy Bullingham, a former pharmacology executive at Pharmacia, knows a thing or two about big pharma’s pharmacogenomics needs and anxieties. To him the biggest issues are more external — and therefore, he says, “perceived” — than internal. In short, he said, the issues slowing down pharmacogenomics technologies is not so much a lack of funds or knowledge as it is a surfeit of uncertainty.
SNPtech Reporter caught up with Bullingham following a presentation he gave at an IBC personalized medicine conference in London a couple of weeks ago.
What do you feel are some of the biggest commercial and regulatory barriers — as you call them — to the adoption of pharmacogenomics in the United States and Europe?
The biggest commercial barrier is probably who pays, because it’s not at all clear — and I come from industry — but if you just stand above it all, it’s not at all clear who would pay for this. I’ll tell you, somebody will pay for this if there was some value, so they can see the value. Well, that’s the problem for pharma, because it sees the value in selling more drugs. And to them, this looks like something that will sell less drugs. Until somebody breaks that barrier and shows a way forward — for example, either you can sell less drugs but charge more for them — it isn’t clear how that will work.
At what stage do you think that pharmas and payors will be comfortable enough so that this will pick up steam. Will there be 10 Herceptins on the market, or 20 or 30?
I don’t know, but I think Herceptin is a small product for a small indication. It just so happens that it’s an indication that is very serious. So, I think that right now in industry, when you have a very serious indication but not applicable to everybody in that situation, I think we do now actually think seriously about pharmacogenomics. But, of course, [since] the industry’s focus on blockbusters is still very strong, and the industry is not seriously thinking about small groups with serious indications; it’s seeking antihistamines for runny noses or [the analgesic] Celebrex, because those are the ones that generally go out and make more than $2 billion.
In terms of the payor, how will the distinct systems in the United States — dominated by private insurers — and Europe, which favors publicly funded health care, play in either slowing down or speeding up pharmacogenomics?
I think the private payor system actually will be more amenable to this, in the US, because from the perspective [of] the private payor … they can see themselves saving money because they will not prescribe an expensive drug to somebody in whom it will not work, or in whom there will be safety issues; they can see the money that will be saved immediately. Especially for the more expensive drugs, and for the longer type of indication, I think there is an opportunity there with the private payor because you can go and show them that money will be saved.
The only fly in that ointment is that if you don’t have an alternate therapy, then that argument will ultimately fail. …
Now when you get into Europe, it’s much more complicated because the health system really wants to save money. But they get into the problem of who will administer this. I don’t think there will be [the] same paying problem so much, but in a way they very much regard the health-care system in Europe as the pot — you know, there’s so much money in it, so if we spend money on this, and we can’t spend money on that, and we have to cut costs. …
So going along with a new expensive therapy, essentially the question for the European authority might be ‘Where are we going to reduce the costs?’ They can say ‘We’re going to save money here,’ but you won’t save any money unless the alternative therapy is cheaper; so it can become a money game where you move money around inside a fixed amount, which becomes a different strategy.
In theory, in the US, if it’s good enough, then somebody will find the money to pay for it. There isn’t the same market in Europe, where the governments decide.
I don’t get the sense that pharma’s opinion of pharmacogenomics technologies is a major cause in what some see as a delay in the industry’s adoption of the tools. It sounds like pharmas know the technologies are out there, and that they’re likely viable, but they nevertheless are holding back from investing too much money in them until more of the downstream issues — for example, regulatory issues — are settled.
That’s more or less right. I don’t think most large pharma companies regard the regulatory authorities as a barrier; they will go and talk to them about how [pharmacogenomics tools] are going to be [used]. So it’s more the strategic aspects of this that are problematic at the moment.
There are a lot of external barriers [like payor and regulatory issues]. If it was just internal barriers [like lack of funding] within pharma then I think there will be a lot of sitting down and jawing, and eventually something would be done about it, and you’d get strategies inside the pharma companies that would address those issues.
But, there’s a lot of external barriers, and that means — as far as companies are concerned — a lot of unknowns. … [These kinds of barriers] are perceived barriers, but also, to be blunt and commercial, [they’re] also going to want to spend money on something that benefits this company and not another company.
That’s an interesting point. There’s this argument that pharma companies are leery of pharmacogenomics because they feel that making drugs for smaller patient cohorts means that the balance of a one-time larger cohort would go to competitors. You had mentioned this in your talk in London, but isn’t this argument a two-way street?
Yes, it is. I’m not painting pharma as black and evil. What it’s struggling with is how this [pharmacogenomics] can be made to work. I do think that pharma also thinks that the way that we’re doing things now — with blockbuster drugs and all the rest of it — nobody believes that that is anything that can continue for … more than 20 or 30 years.