As enrollment in the Multikine study drags on for the next few years, I'd also watch out for any changes made to the study design or efforts to lower the number of patients enrolled. Stuff like that can be tracked easily at ClinicalTrials.gov.

Sticking with the obesity drug theme, Mark M. emails a question regarding Vivus ( VVUS):

"I appreciate your balanced and unemotional reporting of Qnexa and other weight-loss drugs as they attempt to gain FDA approval. Other than your articles, there seems to be a significant amount of bias in most of the reporting on weight-loss drug developments, maybe a reflection of positions held. In the case of Qnexa, I do not really understand how the FDA can question the safety of low-dose topiramate when they have already approved its use in other higher dose applications. Perhaps you can address this issue in a future article."

It's a great question. The thing to keep in mind is that the risk-benefit of any drug depends largely on the disease being treated and the patient population who will take the drug.

Let's start with an easy example. Cancer drugs, generally, cause significant side effects. That makes sense because a lot of chemotherapy drugs, for instance, are basically poison designed to kill tumor cells. Healthy cells are often collateral damage, too. Doctors, patients and the FDA are okay with the high toxicity of cancer drugs because they're used to treat patients with cancer, a fatal disease that is usually (not always) worse than whatever toxicity or side effects the treatment may cause.

If chemotherapy drugs were used to treat a less serious and non-fatal disease like psoriasis, the risk-benefit trade off would be unacceptable to everyone. Psoriasis can be a nasty disease, but patients aren't going to die from it. Moreover, psoriasis is a chronic disease, meaning patients require long-term treatment. If they stop taking whatever drug they're using to keep the psoriasis at bay, the disease will return. Again, chemo drugs would never be acceptable to treat psoriasis even if the efficacy was fantastic because the cumulative toxicity of long-term exposure would likely kill patients.

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