Smaller Potential of the Personal

A writer at Forbes says that personalized medicine may not work for drug manufacturers.

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I think that the author

I think that the author raises good points, but the flip side is increased efficacy. Breast cancer is an illustrative example: discovery of biomarkers such as estrogen receptor (ER)-positive and Her2-positive tumors has revolutionized treatment. Yes, the markets for ER antagonists and Herceptin are smaller than the total breast cancer patient population, but if your tumor is positive for Her2, you know that your chances for survival are much improved with access to Herceptin -- and the incredibly high price of that drug reflects that market advantage. Further, if Herceptin had been tested for effectiveness in the general breast cancer patient population, the therapeutic effect would have been diluted so much that the drug may never have been brought to market (as only 20-30% of breast cancers are Her2-positive). Granted, we have no way of knowing the size of the patient population for as-yet undeveloped drugs, but patient stratification should increase relative effectiveness, and company profits. Whether this stratification can proceed all the way to an N of 1 remains to be seen, but the benefits of "personalized medicine" are many. Companies who cannot figure out how to make a profit in this new marketplace are simply at a competitive disadvantage.

The author of the original

The author of the original article (Henry Miller) raises good points. Could Pharma be racing towards eliminating swaths of their market with this new paradigm? Yes, in some cases. But, recall that many drugs have failed, due to safety or low efficacy over larger populations. As Dr. Miller points out, lower efficacy in larger populations can be fixed with appropriate biomarkers as predictors.

Here's my take: Ultimately, the value of drugs will be increased with more judicious and effective use--which is predicted by personalized medicine. Let's face it, doctors prescribe a cornucopia of drugs, many which may not be doing any real benefit, or actually causing harm. As dKovarik pointed out, the Her2 and ER positive treatments are justified in their higher prices. Thus, Pharma will win by selling a greater number of drugs to targeted patient classes; those who really stand to benefit the most from drug X, Y, or Z.

Still, I do think it's likely that margins may continue to creep lower without major blockbuster drugs. But don't just blame that on personalized medicine--I believe margins have already begun to decline in major Pharma for the last few years. The Generics may continue to predominate mass sales while small biotecs, and classic Pharmas will be the innovators.

Generics and new regulations

Generics and new regulations are pressuring classic Pharma. The companion diagnostics movement is creating powerful synergies between device makers and Pharma. I think this is great.

Don’t forget that some drugs that were scrapped will be resurrected due to the personal medicine trend. Some cancer drugs that were good for one use, prescribed off-label for other logical uses, could now be fully justified by solid clinical data at the forefront. Why have a doctor just guess at a treatment based on common off-label practices? Expert consensus without solid clinical data is often not that great.

Ultimately, the value of drugs will likely increase with this pers. med/ companion diag. movement. Isn't the evidence of some diminished value of prescription drugs in front of us? Is it really reasonable to take 5 - 20 medications per day for a reasonable healthy person?

Why not take fewer medicines that have dramatically better outcomes and are hugely more efficacious, so long as they are affordable?