NaBloPoMo, Day 25: Biologics

If you're one of my five regular readers, you know I spend a fair amount of time writing about health. Specifically, the plethora of health inequities due to our woeful lack of a cohesive national healthcare system, the anti-government, business kow-towing administration we've suffered through the last eight years with, and how misguided it is that we allow the healthcare of our citizens to be largely driven by a profit motive. This means I also write with some frequency about the pharmaceutical industry and the FDA.

Despite the number of hours I have clocked on the FDA website, I have never been very clear on what exactly the term biologics refers to. It was high time to get it. On the homepage of the FDA's Center for Biologics Evaluation and Research, the FDA breaks down biologics into seven groups:

Allergenics: the stuff used to test for and treat allergies.
Blood: FDA monitors the safety of the nation's blood supply.
Cellular and gene therapy: we'll get back to this
Devices: so many things like dialysis equipment, lab and testing equipment, pacemakers etc
Tissues: FDA does not oversee live organs, but things like getting an ACL from a cadaver. Stem cells, etc.
Vaccines: we all know what these are
Xenotransplantation: animal based stuff. Like if you got a pig heart valve. I think also the bovine bone gunk I had put in my jaw would be considered xenotransplantation.

This is a pretty sweeping list. But what we're really talking about when we talk about biologics is cellular and gene therapy. We've all heard of the bigger biologics because they present the most promising treatments for the most difficult diseases: Herceptin for breast cancer, Humira for rheumatoid arthiritis, and Epogen, used by cancer patients to boost red cell production decimated by chemotherapy, to name a few.

But how is a biologic different than a drug like aspirin? Why are biologics so forking expensive? When will they be available generically?

One of the Urban Farmers, who works for a company that produces biologics broke it down for me. Here it is, filtered through my highly unscientific mind: drugs are like making a cocktail--a jigger of this, a slug of that, pour over ice, slap on a garnish, done. Biologics are like raised bread. The ingredients are straightforward: yeast, sugar, water and flour but in order for these ingredients to become bread, stuff has to happen. But the right stuff won't happen if conditions are not just so: the water cannot be too hot or too cold or the yeast will not grow. In order to rise, the dough has to be kept at just the right temperature. It's ingredients plus a process. Make sense? Let's move on and don't mind that sound, it's just generations of scientists rolling over in their graves.

So! We now have an inkling of what a biologic is. Now I'm going to get all scientific on your asses by showing you this. The 23 atom aspirin on the left looks like it could be easily put together by a preschooler using Tinker Toys. The Epogen on the right ... not so much.

Back to our bread example: so even if you give me a shopping list, lend me your Kitchen Aid mixer and your lucky apron, I am unlikely to turn out a product exactly like yours. For a loaf of bread, whatevs. But if the slight differences in our results actually harmed me? This is the concern and the argument of companies like Genentech who openly admit that sometimes they can't even get their own product right, so delicate are some of these processes. And it must be mentioned, since this is always part of the equation when a patent is about to expire, that according to Wikipedia, breast cancer drug Herceptin brought Genentech $327 million in revenue for the fourth quarter of 2007 and would probably prefer to keep that stream of revenue flowing.

So we arrive at the concept of biosimilars, so named to allow for the fact that they can never be exactly the same as a proprietary biologic. There are significant barriers to getting biosimilars to people, as this abstract points to. Clearly this is the direction we need to go, so that all health care options are open to all people struggling with these devastating illnesses. There is a whole crapload of stuff out there about legislative efforts to get the ball rolling on biosimilars; I'm so exhausted that will need to be another post.