Tearing down the walls

August 1, 2005

I always worry when people make logical arguments. They usually begin with the phrase “The next logical step is…” Usually, their arguments are spot on and so, so logical. The problem is that real life is anything but logical. This brings us to personalized healthcare.

I always worry when people make logical arguments. They usually begin with the phrase "The next logical step is..." Usually, their arguments are spot on and so, so logical. The problem is that real life is anything but logical. This brings us to personalized healthcare.

If ever anything was logical, it is personalized medicine. Today we draw hope from cure rates in the teens for "intractable" forms of cancer and search for drugs to slow the effects of degenerative diseases. What better way to solve these problems than to find them early and prevent their physical effects?

While that sounds good, developing these technologies is going to be difficult. Unfortunately, finding them will be only half the battle. The regulatory machinery currently in place to govern the commercialization of medicine in the U.S., namely the FDA, is geared for diagnosis and treatment, not prevention. A protocol that links in vivo diagnostics and preventive technologies, either medications or physical intervention, is going to go over like a lead balloon. None of the protocols for review are going to fit.

You only have to think back a few years to the regulatory debacle that was full-field digital mammography for a glimpse of what is waiting for products designed to fit this new age of medicine. Worried that digital imaging would reveal more abnormalities, leading to more biopsies, the FDA made manufacturers "prove" that their new digital equipment was no better than film mammography.

If this serves as a precedent, personalized medicine is doomed before it can start. So what do we do? We start looking for shared interests among academia, mainstream practitioners, and, especially, equipment vendors.

The developers of tomorrow's technologies have to start thinking today about how they will win FDA approval. They need to look down the road and define classes of technologies and determine how they might be applied. Then, as they evolve these technologies, they must begin planning clinical trials in which they can all participate, so as to share the costs of clinical R&D and mitigate what will almost certainly be a very expensive venture.

With these data in hand, they will have to work with the FDA to evolve the regulatory process under which product submissions can be evaluated. Most challenging of all, they must provide the training necessary for reviewers to interpret the data. This will be tough, as no federal regulator is going to agree to be trained by the companies they are hired to regulate. Academia will have to get involved as a go-between. And the expanding involvement of the medical community can't stop there.

Evaluating medical products aimed at prevention may require monitoring tens of thousands of patients over many years. The process may be more cumbersome even than the evaluation of vaccines, as this new paradigm requires that a diagnostic be proven effective and then a preventive be shown to keep the disease away - ideally - forever. Academia will play a key role, but at some point, the mainstream medical community will have to get involved.

The mechanism for doing all these things is already coming into place. The vendors of imaging equipment have long cooperated through cross-licensing agreements and even, on occasion, the cross supply of components. Working together to support the development of a class of products is just an extension of this good business sense.

Similarly, vendors depend on luminaries to guide the development of today's technology, sometimes putting engineering teams onsite to tweak prototype equipment. Luminaries often sit on advisory committees for the FDA, thereby providing a bridge to government for information from manufacturers to cross.

Finally, there is the part of the community that tends to the needs of the public. The rising interest in and adoption of IT systems will pave the way for their participation.

What's needed now is vision and the will by vendors to drive this process, to assess the stumbling blocks in the way of preventive medicine and begin tearing them down before tomorrow's technologies run into them.

Logical arguments about the inevitability of preventive medicine will not be enough.