US regulators have approved Merck & Co.'s new drug Cancidas (caspofungin acetate), the first of a new class of drugs designed to fight potentially deadly fungal infections.
The US Food and Drug Administration approved the drug for treatment of invasive aspergillosis in patients who do not to respond to or cannot tolerate other antifungal therapies.
Aspergillosis is a potentially fatal fungal infection, often seen in hospital patients, with about one-third of patients surviving only 3 months after becoming infected. Patients with compromised immune systems are particularly vulnerable to the deadly infection, such as those on chemotherapy, those infected with HIV and organ transplant patients.
An advisory panel to the agency unanimously recommended earlier this month that the FDA approve Cancidas, although there were questions about the drug's long-term efficacy.
Most panel members were concerned about the potential for bias in Merck's non-comparative study of Cancidas to treat aspergillosis, because the study used "historical controls" gleaned from medical histories of patients on standard therapy, rather than the classic randomized design using a control group.
"We're left with a lot of open questions," said panelist Dr. Jonathan Schapiro of Stanford University School of Medicine, who had argued that Merck should still conduct comparative studies.
He suggested, and panelists agreed, that further studies resolve questions such as Cancidas' long-term accumulation in tissues and its safety when used with the immune-suppressing drug cyclosporin.
New York Times January 30, 2001
Well folks, like most things in life there are some good aspects of this story and some bad. One can almost be guaranteed that Merck biased their FDA submission in favor of their approval. The lack of comparative studies may mean it is not much better than what is currently on the market.
The good news, however, is that this may actually be a wonderful anti-fungal agent. We really do not have many of them, only three oral ones, Diflucan, Sporanox and Nystatin. It is my understanding that all of these are fungal static drugs. That is, they don't actually kill the yeast. But Cancidas appears to actually be a fungicidal drug which kills it.
It may provide a helpful tool in the box we have to aid people who are suffering with yeast. The unfortunate problem is that this drug will be abused by physicians who do not understand that it is useless to treat yeast unless one looks at the diet, because the problem will return.
First of all it is impossible to kill all the yeast in your body unless you are dead. So the goal is to control it. If one does not use the diet to reduce the yeast and just takes the drugs, this is very similar to trying to stop your car with your brakes but forgetting to take your foot off the gas pedal.
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