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POPI s Sinskey Said Pharma World Should Embrace Druglettes

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At A Glance:

Name: Anthony Sinskey

Age: Early 60s

Title: Co-director of the Massachusetts Institute of Technology’s Program on the Pharmaceutical Industry

Background: Harvard School of Public Health, Post-Doctoral Fellow, 1968; MIT, Doctor of Science, 1966

People close to Anthony Sinskey, Co-director of the Massachusetts Institute of Technology’s Program on the Pharmaceutical Industry, say he knows what pharma is doing before the industry itself does. Which is why Sinskey isn’t surprised at the state of pharmacogenomics within big pharmas: ”We’ve come to expect” pharmas’ reaction when faced with potentially market-shifting technologies, he says.

Though the technology is here already, big pharma companies just don’t know how to integrate it and, worse, they tend to behave like lemmings, he says. Will this be a long-term dilemma for pharmacogenomics? SNPtech Reporter spoke with Sinskey recently.

What’s your take on pharmacogenomics? Do you think the future of pharma is tied to pharmacogenomics, or vice versa?

Well I think it’s going to be a very major component of the pharmaceutical portfolio or the pharmaceutical strategy of the future. You cannot deal without it. The science is driving it that way. …

Do you think as a result there are going to be haves and have-nots among biopharma?

I don’t know how one can survive without having a strategy to deal with the advances in pharmacogenomics. So if you don’t have one — if you’re dismissing it and don’t think it’s a viable business model— I pretty much think you’re heading for mediocrity, at best.

What do you think pharma companies’ biggest challenges will be once they’ve adopted pharmacogenomics technologies?

Well, converting [the technologies] into effective economic models. If we move into the “druglettes” era, how does the big pharmaceutical [company] manage that? The anomaly in the pharmaceutical industry in part is the blockbuster, right?

Everybody looks for the blockbuster, but in fact could you predict that Lipitor would be a blockbuster when they started? Probably not. So I think it’s the question of what will be the new business model.

What do you think it will be?

The powerful aspect of pharmacogenomics is diagnostic testing; when and how this diagnostic testing takes place will lead, hopefully, to more efficient strategies [for] prescribing a given treatment — especially in those complex drug areas like diabetes, the autoimmune diseases, and so forth. And then one will manage subsets of these populations [in] these complex disease areas. Then, what will be the economic model there?

I think the economic model will be effective because you will be more efficient.

You know, the ironic thing in the pharmaceutical industry is if a therapy doesn’t work you don’t get your money back. If we really knew what that cost is to health care, and how much it costs to treat non-responders, and we eliminate that problem with new pharmacogenomics technologies, will that then become an economically viable model?

Do you think from a pop-psychology perspective that this will demand a certain level of humility from the pharmaceutical industry, that they should concentrate on producing druglettes, as you call them, as opposed to blockbusters?

Yeah, I think in a way. Because a lot of the pharma business is driven by these big marketing groups. The real question is, ‘How does the pharmaceutical industry make it through this transition? All you have to do is look at the debate going on between Novartis and Roche.

Roche says ‘we can make it on our own because we have these strong pillars of diagnostics’ — which I actually believe — ‘and then we can find new strategies for drugs’. And then the guys from Novartis say ‘You haven’t proven you could do this, and I’m going to buy you and do it my way.’

Should pharmas invest more in new pharmacogenomics technologies, or should they sit tight and wait until these tools mature a bit, as some in the industry are saying?

The tools are there, and they are going to be developed with or without pharma, because the driver of this industry is the NIH anyway.

But the question pharma has to answer is how to integrate these technologies and business models. And I think that’s the challenging part; what are the new business models that will capture the benefits of pharmacogenomics?

Do you think the big pharma companies are under the influence of a sort of collective cold-feet syndrome, where they all fear to dive into new pharmacogenomics technologies too forcefully too soon?

The pharmaceutical companies either buy in, big time, or actually they’re very late. ... Recombinant DNA technology was available just as easily to the pharmaceutical companies as it was to Genentech. But their looking at it as a tool and not as a new business paradigm opportunity allowed the Genentechs and the Amgens to develop.

So that’s been the traditional thing among the pharmaceutical companies. It’s to be expected because one doesn’t know what the unknown will bring in terms of a business model. The pharmaceutical companies have major programs in pharmacogenomics and SNP analysis. But it’s not clear to me that they buy into a business model.

Now the people who will buy into the business model are going to be coming from the insurance companies — Kaiser and companies like that. I think the other thing is that we just don’t have enough data out there to say that there is an economic model.

Do you think the technology is still too nascent?

No, I think the technology is pretty clear. Integrating all the data from these technologies is one issue. And then the second thing is, how does that translate into channels to market? I don’t think there is a need for clarification on the business models for pharmacogenomics. The folks from IBM tell me the same thing — they pretty much know what’s going on and know how to handle all this data, but..[see] big storm clouds ahead about how to handle integrative personalized medicine strategies.

In your view, should the FDA play a greater role in urging pharmas to adopt these technologies, or should it sit on the sidelines and be more of a passive bystander which only moves to review final outcomes?

I think the FDA has an obligation to encompass new technologies for their evaluations. And I think the FDA will actually welcome new ways to analyze a patient population.

How would you grade the agency today on its performance with pharmacogenomics?

I think they’re going through a little bit of a transition phase right now, but I think the [FDA] is one of the greatest agencies in [the United States]. It does a very good job. You can criticize its rate, but it has a challenging job because it’s got to prove safety — a negative issue in a way.

What’s your opinion on the kinds of responsibilities physicians have when it comes to educating themselves about new personalized-medicine technologies?

There’s a question of talking about today’s clinical issues versus tomorrow’s and how do we make that transition. The key to effective medicine is whether the physicians will buy into giving diagnostic tests. If they don’t buy in, it doesn’t matter. They have to buy in, and that requires the training for them also.

Do you think it’s the responsibility of the pharmaceutical industry to educate them?

It’s a valuable component of it, but pharmaceutical companies can get caught in some conflicts here, so you need almost a neutral party — like the professional societies these physicians belong to.

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