Thought Leader: (Eco)systemic Change - Pharmaceutical Executive


Thought Leader: (Eco)systemic Change

Pharmaceutical Executive

Do they have the electronic piece down?

Not yet. But in the United States, the flow of information is going through many impasses and bottlenecks because there is no real system. It's an agglomerate of many small systems, which creates this huge interconnected network where the flow is impeded and not streamlined.

You mention better patient care, higher quality care. For companies that conduct clinical trials, is there a benefit to plugging into this network?

Certainly. The companies that manage clinical trials, like contract research organizations (CROs), are an integral part of the healthcare system because they are the intermediaries between the pharma industry and the clinical centers that actually do the testing of new drugs.

The CROs are managing this very difficult task with their professional know-how and experience. So they need to be integrated and linked by this new healthcare information network to play their role.

I think this is especially important in Phase IV trials, which involve monitoring much larger amounts of data. Without such an electronic network, performing tasks in a timely manner would be impossible.

For companies that are not already collecting Phase IV information this way, do you think they'll change?

The Phase IV data are not yet collected in this efficient way. But if this new healthcare information network is in place, they will get nearly real-time results. This will improve efficiency because companies will become aware, at an earlier point, of adverse reactions.

What's the first step companies can take toward collecting data that way?

All players in the healthcare arena have to make plans. How each player actually connects into this new network is primarily a task for their individual IT departments, to ensure that they have the right open standards for connectivity with the healthcare information network.

You think consumers can afford greater ownership of the healthcare system. Should consumers pay more for care?

I am convinced that the educated consumer can contribute to improving healthcare delivery by demanding quality. Quality and efficiency will be recognized by the consumer, which will result in the healthcare delivery system emphasizing quality over cost. And the provider should be competing to provide the best healthcare—not just compete on a level of service with the least cost.

There are obviously some wrong expectations by the public regarding the action of drugs. This may be partially due to DTC advertising, which leads to the idea that you swallow a pill and you're cured. But no drug is risk-free. And recently, we have seen litigation coming up, and now we have a crisis in the pharma industry due to adverse reactions. We know that therapeutic failures, drug toxicity, and drug interactions exist and have to be monitored.

In the near future, we will be able to deliver better therapies with drugs personalized to cohorts of patients that are much smaller than the ones for blockbuster drugs. But we have to look at genetically defined groups of patients, or even at individuals and their genetic makeup.

Are pharmaceutical developers and researchers buying into that idea?

Yes. It will be necessary to develop this personalized medicine era in conjunction with the diagnostic industry, to develop the tools—so-called genetic tips—to analyze the personal genetic makeup of the individual patients.

There are so-called polymorphisms that contribute to variations in human beings; these variations cause different drug responses and adverse reactions. We know that for an average drug, only between half and two-thirds of the patients react positively. And adverse drug reactions are estimated to cost just short of 180 billion dollars annually in this country. That's an enormous amount of money that can be saved. On the other hand, we will have higher costs for diagnostics and personalized medicine. But the shift will be to the benefit of the patient.

You're involved in so many different areas. What's taking up most of your time, and what's going to be the hardest to figure out?

I have one very interesting project in telepathology, working with the Massachusetts General Hospital Department of Pathology, where I previously served for eight years on staff. I am working with a laboratory in Rio de Janeiro—the Sergio Franco Laboratory—to transmit virtual images of pathology.


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