In a series of experiments on seven terminally ill cancer patients, researchers at the University of Tübingen in southern Germany used antibodies to successfully reduce or eliminate active cancer cells. In some patients, the cancer quickly returned. In others the deadly disease disappeared, leading researchers to believe antibodies may hold a clue to defeating certain types of cancer.

Unusually, and perhaps uniquely, the university opted to build an antibody production facility rather than outsource production to a pharmaceutical company.

DW: Professor Salih, you and your team have a two-million-euro facility capable of creating antibodies for further trials on terminally ill cancer patients. What's stopping you from doing so?

Professor Helmut Salih: The medical product that you generate has to fulfill technical safety issues - to be clear of viruses or host cell DNA, or to be "stable," one of my favorites (laughs). So we have to check that a drug would be stable for six months at temperatures you see in the Congo. We are not in the Congo. And the patient's sitting in the hospital, waiting.

You're talking about the EU's medicine production guidelines, "Good Manufacturing Practice."

Prof. Dr. Helmut Salih

In general, GMP guidelines are necessary. If you develop a vaccine that's applied to healthy people - 80 million people in Germany - then safety is very important. But if you have a patient who's suffering from a life-threatening disease, and where we do not have any established therapy available, then I think that safety is not our most important concern. Efficacy is our concern.

An example: If you want to pour an antibody into a vial after production, you have to do this in a room where the particle density in the air is 1,000-fold lower - has to be 1,000-fold lower - than when you do an open-heart operation. I mean, we're treating patients with a life-threatening disease that will kill them soon. I think these [regulations] are over the top.

Fulfilling GMP criteria reduces the technical risk of the substance, [the risk of viruses]. But the actual risk is the biological risk. If you apply an antibody, and you get side effects, this is not precluded by GMP.

And this therapy would be limited exclusively to terminally ill cancer patients?

Yes, that's very important.

You're producing drugs, but you don't have GMP approval, so you can't use them. Now what?

My friends and coworkers have spent many years - five, six years now - producing antibodies. There are about 20 of us working on it. Nineteen are concerned with regulatory affairs. Only one is concerned with making the drug better. I think there's something wrong with that.

One possibility would be a change in the law [to] allow an extension for universities or academic institutions to treat terminally ill patients with novel drugs - drugs which, let's say, do not fully fulfill GMP guidelines. Of course, there need to be some standards. But not the full GMP program. Again, this is for terminally ill patients in an academic setting.

The other option would be intelligent finance systems, because there is no financing. If the law forces us to produce GMP, and we want to produce GMP at an academic setting, then we need adequate funding.

Can't pharmaceutical companies produce these drugs?

The reason drug development almost entirely lies in the hands of the pharmaceutical industry is pharmaceutical production. This is what we cannot do, because it's costly, and there's no funding for pharmaceutical production. Normal granting institutions do not fund production.

But I do not think we should leave drug development entirely to the pharmaceutical industry. Don't get me wrong: I'm grateful to them for the drugs they provide. There are very fruitful collaborations. But I think it must be possible to say that pharmaceutical companies - their decision-making on what is developed or not - is influenced by many factors other than scientific factors.

What would you say to people who think, well, of course the universities want to get in on this game. There are billions of dollars in cancer research profits to be had. Isn't there a real risk that universities would chase money instead of science?

Let me rephrase the question. There would be a risk, but then what would be a difference to the pharmaceutical industry? What would be worse than the pharmaceutical industry? The pharmaceutical industry, by all basic considerations, chases profits. They may have an interest in doing good for patients, and I trust that people are there who do this. But the general intention of a pharmaceutical company is profit. The university may start to chase profits as well. But they at least wouldn't be worse than the pharmaceutical industry, would they?

Professor Helmut Salih is a senior hematology and oncology physician who represents the University of Tübingen's GMP faculty. From 1999-2000 he worked at the BMS Pharmaceutical Research Institute's cancer research division in the United States.