Alta Charo, UMadison, Wisconsin

A look backward in time . . . the politics go all the way back to Roe V Wade in 1973, which led to special legislative rules involving fetuses, which led to same for embryos.

1980 - 1992 were years in which all science was suspended because there was no regulatory board to review proposals. The Reagan and Bush I administrations simply didn't have a review board. Simple solution.

During Clinton, we got a review board . . . and an advisory panel which took 9 months to come out with ethical guidelines, which were basically a plagiarized version of what already existed in the UK.

Then the Democrats were routed from the congress in 1994, and Clinton got very timid about this area. Embryo research was specifically mentioned in the Contract With America. The Dickey amendment was passed in 1995 and is still the law.

In 1998 when we first got stem cells to work on, we had to focus on lines because of that amendment.

In 2001 we had only funding for existing lines so that the gov't couldn't be somehow accused of enticing people to kill embryos.

The result is that we have no rules -- no funding from the feds means that there are no federal rules.

Instead we got state rules along with state funds. When states give you money they have to give you rules as well to say how you can spend it. So now we have a patchwork of funds and rules across the nation that was abandoned by its own federal government. There are also players from around the rest of the globe at work in our country.

So now we have to figure out what the rules are in which people will figure out how to collaborate. We can assume that whoever wins in Nov, we will have federal funds and that also means federal rules . . . but . . . federal law does not eliminate or necessarily override state rules . . . and it doesn't do anything at all to privately funded efforts.

How the hell are we going to come up with a coordinated set of rules . . .it will all be a legislative and bureaucratic slog. It will take a very long time. And the Dickey amendment will still be in force under the congress manages to do its thing.

We may see a dismal parade of scientists traipsing from agency to agency, trying to figure out under what rules they have to operate . . .

So, let's say the scientists somehow navigate that arena and then approach the FDA for permission to carry out their trials. In the 60's and 70's we loved the slowness of the FDA because it kept American women from taking thalidomide as they did in Canada and the UK. During the 80's and 90's there was pressure to hurry up and get things done a lot faster. Then about 5 or 6 years ago there was a slew of drugs subjected to intense intention from the public and the policy community . . . and the slowdown became the right way to go again.

So here we are with translational research in stem cell therapy. The FDA is in Mode Caution, not Mode Aggression. They want to know how confident we are that we're making safe decisions. How pure must your lines be? How many undifferentiated cells are in your transplants? Do we need medical records from the original donors of embryos from 9 years ago? Do we need to maintain immuno-suppressed animals for months and months and months to be sure that tumors are not forming? Will we be forced repeatedly to start over because our animals die of infections before our data is collected?

Okay, let's say that all that gets dealt with. Woo hoo, clinical trials. Uh oh. We now have a HUGE demand, lots of it from people who believe that their condition is going to kill them before they can get the drug. Think about thousands of people demanding to take part in clinical trials . . .ACT UP is the model.

There will somehow have to be access to treatments that have not been tested yet. They did that with the Aids patients -- but this is a biologic and not a drug. And biologics are much more complex and detaile--not to mention expensive- to manufacture than drugs . . . but we're going to have to figure out how to do it. The reason is that Americans are always ready to believe that the newest thing is the best.

But, let's say that all that gets dealt with. Woo hoo, new therapies. Uh oh. We now have the greatest new thing since sunlight in every headline, and that will mean a ton of people ready to buy it who HAVE NO healthcare. Big new struggle.

For 35 years the conversation about stem cell research has focused on the moral status of the embryo . . . let's get over it already.

For my money, the ethical issues are just beginning.

Great talk.