Success! Or Is It?

Today's Wall Street Journal had an interesting front page story (subscription required) about the development of a new drug to control blood pressure. The main thrust of the story was how a small, creative firm succeeded on a project that Big Pharma had abandoned.

The story caught my eye for a couple of reasons. First, I was familiar with its contours from the research on my book. This new class of drugs for lowering blood pressure inhibits renin, an enzyme that starts the biological cascade that leads to higher blood pressure. The molecule that inhibits renin is complex and hard to make, which is why most companies abandoned research in this area in the 1980s. However, renin is very similar to an enzyme in the human immunodeficiency virus (which causes AIDS) called the protease. The scientists who worked on the industry's abandoned renin inhibitor programs became the lead scientists in the race to discover protease inhibitors.

Long way around to my point, which is: Why is Novartis now willing to bankroll the development of renin inhibitors? Does the world really need an eighth (or is it ninth?) class of medicines for controlling blood pressure?

The story suggested there will be one advantage for this drug (which will be a very expensive patented medicine for a field where most drugs have gone generic): it stays in the body at sufficient levels for over a day. And since most heart attacks occur between 5 a.m. and 8 a.m. when blood pressure spikes because the person's medications are wearing off, that will make this new drug very popular with prescribing physicians, the story informs us.

I immediately wondered: So, isn't there anything on the market already that stays in the body at sufficient levels for a full day? And if not, why hasn't the drug industry, after all these years of selling highly-profitable drugs for blood pressure control, not formulated one of its existing drugs (through time-release capsules, for instance) that would accomplish the medically necessary task?

I posed those questions to Dr. Steven Nissen of the Cleveland Clinic, outgoing president of the American College of Cardiology. Here's his reply:

24-hour blood pressure control is VERY important. Take a look at the VALUE trial where a long-acting agent (amlodipine) beat a short acting agent (valsartan). There are long-acting therapies that are either currently generic or going generic soon:

1. Amlodipine (50 hour half life!) - goes generic in 2007.
2. Hydrochlorothiazide – dirt cheap generic. Sustained effects when given once per day.
3. Lisinopril – generic ACE inhibitor with 20 hour half life.

So I can treat patients with three classes of long-acting anti-hypertensive agents for a dollar a day once amlodipine goes generic!

Thanks Steve. So, it turns out that this miraculous new drug is nothing more than another me-too. I can already see the commercials: "Did you know that early mornings are the most dangerous time for people with high blood pressure? Take long acting . . . "

Posted by gooznews at February 7, 2007 06:59 PM