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Thursday, September 21, 2006

Cargo Cults Red Flag

Ever wonder how so many drugs fail their big trials? It begins with the scientific foundation that goes into the development of a drug. This "foundation" is the softest and most manipulated area of corporate science. Generally you will find higher paid PhD scientists who work in cubicles bullying low paid white lab coat wearing individuals around. When you move a drug further along you run into tougher customers. Human trials for example can be hard to work around. No one wants to flat out fabricate the data. There are tricks to work around less than stellar data. If that fails you make up an excuse such as a placebo response being unexpected. But how honest people with no stake in the outcome of a drug company predict what will fail and what might just make it?

I am going to predict a failure. The company name is Medivation, Inc. and they have a drug to treat Alzheimer's disease. The first red flag is of course a Biotech company pursueing Alzheimers disease. You have a patient population that has just lost their mind. The only way to tell if your drug is helping them is to invent some endpoints that you think are important. You certainly won't be able to ask the patient if they're feeling better. Medivation today is announcing that they have successfully demonstrated efficacy in not one but all five efficacy endpoints they went after. What are the endpoints?

The primary endpoint was the Alzheimer's Disease Assessment Scale-cognition (ADAS) The key secondary efficacy endpoint, the Clinical Global Impression of Change (CGIC). Dimebon-treated patients also achieved statistically significant improvement (p less than 0.01) compared with placebo patients on all three of the other secondary efficacy endpoints - the Activities of Daily Living, the Neuropsychiatric Inventory and the Mini Mental State Examination.

It's curious that they did so well. Were they really double blinded? Has no one else come this close? Is there a positive control to compare this drug to? There certainly has been no shortage of corporate R&D projects on the disease. Have we finally seen something to throw millions of dollars at or do we throw that kind of money around with little provocation?

If you're going to lie you should throw in some failure. It looks better that way. Now I'm not saying that Medivation is lying. They do however employ some unusual measurements which have worked out in their favor. The measurements were taken in support of a Phase 2 clinical study of 183 patients with mild to moderate Alzheimer's disease conducted at 11 sites in Russia. Russia?

A Dr. Hung explains that, ""The Phase 2 data that we are announcing today are an important step in validating Medivation's business model. We secured our first equity financing less than two years ago, and to date have used less than $20 million in funding our operations. With that investment of time and cash, we have not only generated positive results in a large Phase 2 Alzheimer's disease trial, but also initiated new development programs in Huntington's disease and hormone-refractory prostate cancer, both of which are scheduled to enter the clinic in the next three quarters. We also remain committed to finding new technologies to reach our targeted portfolio of four to six programs."

It's not so much that they've developed an effective treatment for Alzheimers, but that they have validated a business model. They most assuredly saved money by using Russian doctors and their patients in their clinical trials. Could this indicate a cheapness in the research? Again, were these truly double blind tests? Based on my biases against Russians and Biotechnology I'm going to say that this is all bullshit. It's a non-scientific hunch but I think I spot a Cargo Cult. Not only are they successfully treating Alzheimers but they are also taking on Huntingtons and prostrate cancer. That's too much science for the money. Cargo Cult!


CL Psych said...

Hmmm. Just wandered onto your blog and I'm liking what I see so far. Great post regarding "Medivation."

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