Spectrum Pharmaceuticals and Satraplatin

I typically avoid discussing the stocks I recommend and report on in my newsletter, but this is a rant against the FDA -- specifically the process by which the agency approves or fails to approve drugs for diseases with no treatment, such as advanced prostate cancer.

If you read this blog, and subscribe to my newsletter, you would note I am one of the few analysts who consistently defends the FDA -- but not this time and not on the issue of drugs for the terminally ill.

I believe the statistical fascists at the FDA need to add humanity to their slide rules for certain illnesses - and one of the worst illnesses is advanced prostate cancer. There is no real treatment (there is Taxotere which extends life for nine weeks for the patients willing to put up with its toxicity and side effects) and the men who get this disease die very hard

The drug under consideration is satraplatin, an oral form of a platinum chemotherapy, developed by Spectrum Pharmaceuticals (SPPI), and to be marketed by GPC Biotech and Pharmion. The trial results were a bit mixed, in part because the primary endpoint was not an endpoint previously recognized by the FDA, and, in part, because final survival data for patients will not be available until the end of the year. Frankly, this is all irrelevant! Men with advanced prostate cancer die a an agonizing death after following a terrible treatment regimen.

What's the big deal with approving a drug that may work on a subset of the patients -- the same argument I made here for Provenge from Dendreon (DNDN). These drugs have been shown NOT to harm people, and the trial data suggests satraplatin reduces the progression of the disease and the pain associated with the disease. The FDA should not have convened a panel, it should have just approved the damned drug.

The panel itself will be dominated by oncologists -- and don't kid yourself, they are not there for the betterment of humanity. They are their to represent one point of view -- their point of view.

Many oncologists are fanatical about their own treatment regiments and the doctors who participate in these kinds of panels are even more obsessed by the statistics and data about the drugs. They could give a damn if a subset of patients may benefit. If the treatment doesn't meet statistical goals, it doesn't matter if it's a treatment that's better than anything else out there.

Forget the futility of current treatment, forget that satraplatin is a pill and does not need to be infused like other chemotherapies -- vastly improving the treatment experience for the patient! Just stick with the numbers, the docs say -- the toll on the human beings afflicted doesn't count.
This obdurate attitude is palpable if you attend one of these meetings. I am not going to this one as the meeting on Provenge was enough for me for one year.

I would give satraplatin an even-money shot at getting a panel approval. That does not mean the FDA staff will go with the advisory panel decision if it's positive. After the Provenge debacle anything is possible.

And if it gets voted down, think about this -- the number of men who die every month from prostate cancer is about the same number of boys and girls we have lost in Iraq since the inception of the war (3600-plus). So if satraplatin extended life in a meaningful way for 8.6 percent of the victims of advanced prostate cancer, it would be the same as extending the life of all our soldiers who have died in Iraq.