Halfway down the Danube

Rats

Today, I met a very nice American woman. She runs a drug testing company here in Romania.

Strictly speaking the company is based in the US. But it is very active here in Romania, and she is running their Romanian (and Bulgarian, and Serbian) drug testing programs. As in, giving experimental drugs to Romanians (and Bulgarians, and Serbs) to see what happens.

Yeah, it got my attention too. Here's how it works.

A big drug company (we'll call it BigDrug) has a new drug to test. Let's say it's a drug against... oh... blood infections. They contact this woman's company, which we'll call TestCo.

TestCo has developed a network of contacts all across Romania (Bulgaria, Serbia, etc.). They get in touch with hospitals and clinics, who agree to work with them on the testing.

Then: a Romanian comes into a clinic here in Bucharest. He diagnosed with a blood infection. Aha, says the clinic, blood infection; there's this new drug for that! They ask him if he would like to be part of the drug test.

If the patient says no, that's fine -- treatment proceeds in the normal Romanian manner. If he says yes, he gets a second choice: he can either take the experimental drug, or get the "best level of care". The "best level" means he gets treated as if he was in a Western hospital or clinic, with the best non-experimental drugs and treatment available there. TestCo pays for all this, although the ultimate payer is of course BigDrug.

Then the folks at the clinic monitor the outcome of the treatment -- whether with the experimental drug or the "best level" -- under TestCo's supervision.

When a sufficient number of people have taken the experimental drug, and been monitored, the results are collected and sent back to BigDrug. BigDrug is of course financing many other test runs in many other places; at the end, they have some statistically meaningful results suggesting whether the drug works or not.

Okay. So, why do this here?

1) It's cheaper. If the equipment is available (and it isn't always), low labor costs mean that it's less expensive to provide that "best level" of care. For a moderate fever, for instance, "best level" may mean just a clean bed in a quiet room, cold compresses, and a nurse checking you every hour or so. In the US or Germany, that might cost hundreds of dollars per day. Here, much less.

2) More patients. More in three ways. First, Eastern Europeans are less healthy than Westerners. So it's often easier to find people with blood infections (or whatever). Second, one legacy of socialism is a very centralized health care system. Except for rich people who can afford clinics, most folks end up going to a handful of big hospitals, where they're easy to locate. And third, health care here isn't as good as in the West. So people are more likely to be interested in participating in the tests -- whether to take the experimental drug, or to get the "best level" of care.

3) Competent clinicians. Africans (say) get sicker much more than Europeans. Why not test drugs there? Because in Africa, it would be much harder to find hospital and clinic workers who can properly explain the tests, inform the patients, and then keep careful and accurate records. Eastern Europe, on the other hand, has lots of good doctors, nurses and medical technicians. These people can observe carefully, record meticulously, follow protocols, and provide good results.

4) Not much competition (yet). TestCo might approach a hospital in France, say, only to find that they were already doing testing for a blood infection drug for some other company. (This actually happens more often then you think, because drug testing companies tend to cluster around certain hospitals and clinics). But nobody else is doing testing in Romania right now, although other testing companies are interested and will probably move in soon.

One obvious question: Is it clean? Are the patients really informed and free to choose, will they get the "best level" of care anyway, do the doctors really report back good data?

Well, TestCo follows EU and American protocols. (They have to, otherwise the test results wouldn't be accepted by the US Food and Drug Administration and/or the Europeans.) They say that everything they do is transparent and subject to oversight by both the Romanian and Western regulatory agencies. Their business depends on their product, after all, and their product is good data.

Let's say for now that this is true, and that corruption and corner-cutting plays little or no part in this. What should we think?

Ms. TestCo had no doubts. "This gives Romanians more choices," she says. "Nobody has to participate. But if they do, then they get access to Western level medical care, subsidized by the drug companies.

"In addition, the testing is pumping millions of dollars into the Romanian health care system. We pay the clinics top dollar for their data collection, and we also purchase supplies and equipment that stay with them after the studies are done. This is saving lives."

Perhaps. I got a different reaction from a Romanian colleague.

"They're here because we're poor and because our health care system is screwed. They do the tests, maybe we get a little money -- how nice. Then the drug company makes the drug and gets rich off of it. The drug company gets the money, Western patients get the drug, we get nothing.

"We're rats."

(Me? I don't have a clear opinion on this yet. Still thinking about it.)

Posted by douglas at March 11, 2004 05:58 PM