Is the era of Blockbuster pharmaceuticals over?

A blockbuster drug is define a drug that will make a $1 billion dollars or more for the company in a year. To do that, a drug will have to be a super drug for everyone, well sort of. But it will need to be able to treat the mass of the population who have that particular disease. Take Lipitor from Pfizer for example. If you have high cholesterol (dislipidemia, high LDL, high Triglycerides and low HDL) Lipitor will help you, period. There’s been a lot of talk while I was at the FDA and afterwards that the era of these big drugs are over. What else is there? Well, there’s specialized drugs that won’t treat the whole population but it will treat a special part of that population because of a certain genetic makeup.

Drugs designed to work just for you. After we’re broken the human genetic code a few years back, the time for personalized medicine isn’t too far away. There will be a time in the near future that we’ll carry around our genetic map in our wallets like our insurance card or our credit card, and the technology is being used now via DNA chip.

What this means is that the medication will be based upon your genetic makeup. Each of us reacts to certain drugs better than others (image a hand fitting into a glove, and a drug interacts with the receptors in your body a similar way).

For example, 25% of women who have breast cancer express a growth receptor called HER2. Breast cancer with this receptor expressed grow exceptionally fast compared to other types. Herceptin (trastuzumab), by Genentech, Inc, is a drug designed specifically to block the activity of the HER2 receptor. It does not work in people who don’t express the HER2 receptor, but it works exceptionally well in those people who does express it.

This type of thinking could be expanded to all disease types for the main reason that we all express different genes. And one day, we’ll be able to go to the doctor, hand them our gene chip and they’ll be able to give us the right drugs that’ll work for our bodies AND they would be able to predict future diseases we’ll get based upon our genetic code.