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Minyan Mailbag - Targeted therapies


Targeted does as targeted is


Note: Our goal in Minyanville is to remove intimidation from the financial markets and encourage an interactive dialogue among the Minyanship. We share this next discussion with that very intent.

Professor Miller:

I read Sharon Begley's article in the
9/10/2004 Wall Street Journal on why "targeted" therapies don't work. This seemed to conflict with your "personalized" theory. Because if I have it right, a targeted and personalized drug would work. I'd be interested to read your comments about the article.


Minyan SL

Dear SL:

Ms. Begley makes a common error -- very common among journalists and distressingly common among oncologists -- that just because a targeted drug does not work in all patients, it is a failure.

It is not that targeted drugs lack efficacy, it is that they are used in an untargeted fashion which masks their effectiveness. Targeted use of targeted therapies will be the future of cancer treatment. Chemotherapy and irradiation will go the way of the leech -- useful in isolated situations, but not a widespread treatment modality.

Early in Herceptin's development, the drug was given to all breast cancer patients. It failed. When it was given to those 25% of breast cancer patients who tested positive for the target, it succeeded and has become an important drug for the treatment of breast cancer. A similar story is developing with Iressa.

The solution is not, as Ms. Begley implies, to give up on targeted therapies. Instead, doctors and industry must commit to qualify patients before dosing to make certain the patient has the particular marker. The term "targeted therapy" will then be something more than a Wall Street road show catch phrase.

A much larger number of targeted therapies need to be developed so doctors have an entire toolbox of therapies from which to choose. That will require the FDA to rethink the way it evaluates targeted therapies because a clinical and regulatory process of 10 years per drug means too many of our family members and friends will die from cancer before the toolbox is sufficiently filled.

Cancer is a devious foe, always shifting itself to survive. A large toolbox of targeted therapies is the only rational answer to beating this foe. When cancer shifts to become tolerant to one therapy, a genetic test of this "new" cancer tells the doctor which targeted therapy to select from his/her toolbox to beat it back again. Armed with such a toolbox, doctors can win Ms. Begley's "war between optimism and realism."

If you recall, one of the signposts in my recent article was that companies needed to start screening patients in advance for these targeted therapies to truly reach their potential. There is no reason -- save unreasonable barriers erected by the FDA -- that we cannot quickly generate targeted therapies for numerable targets. Perpetuating the myth that targeted therapies are ineffective certainly isn't helping.

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