Biotech Mailbag Bonus: Elan Story Causes Stir
There is one thing that Davis and I do agree on, and he says it later in his research note: "We doubt very much the FDA would ever approve a drug like bapineuzumab that showed zero effect on the ADAS-Cog and did show an effect on NTB."
The data will speak for itself, soon.
Moving on, I received this note from Robb K.: "Take care of an AD [Alzheimer's] patient for a week and then write the article. Cognition is great if you are working and need to think, just being able to get around the house and find your shoes and wallet is the big part. Until you personally live it with someone that you love, you have no [expletive deleted] clue. I pray that you and all of the others of your generation never have to experience the soul-wrenching experience of watching someone you love have the mind slowly dissolve before your eyes."I sympathize with Robb greatly. I do have some personal familiarity with age-related senility and dementia, but nowhere close to the experience or heartbreak that's suggested in his letter. Alzheimer's is a truly devastating disease for the person afflicted and his families and caregivers. With that said, I'll make two points. First, don't get emotionally involved in your stock portfolio. These are investments, period. That requires a cool, objective detachment. Emotions cloud judgment, no matter how good the intentions. Second, I focused my story on the requirements to show cognitive improvement; what Robb talks about are functional measures -- stuff like getting dressed by yourself, or being able to brush your teeth or find your keys. The FDA wants to see improvements in both cognitive and functional measures before granting approval to any new Alzheimer's drug. It's not an either/or option for bapineuzumab. Harry Tracy of NI Research and the publisher of the NeuroInvestment newsletter chides me for being somewhat unfair to Elan and Wyeth over trying to come up with a better cognitive test. "The ADAS-cog is reviled by most dementia researchers that I know as a blunt instrument which misses potentially important aspects of neuropsychological function -- delayed verbal recall and executive functions being some of the most important omissions," he wrote. Tracy goes on to say, "The NTB's components are far more validated, where Elan and Wyeth are pioneering is in trying to develop a composite score from those pieces. Somebody had to eventually challenge the FDA's reliance on a substandard measure -- Elan and Wyeth may be self-serving, given [failed Alzheimer drug] AN-1792's history -- but there are a lot of companies rooting for the NTB... to become an accepted cognitive measure. I am too." (Tracy's newsletter has no position in Elan or Wyeth.) I respect Tracy's opinion a great deal, but I'd be more comfortable if Elan and Wyeth were not both trying to develop bapineuzumab and the cognitive test by which the drug will be judged. Isn't that a conflict of interest? Likewise, the FDA may very well agree with Elan and Wyeth that the NTB is a better test than ADAS-cog, but, as I detailed in my story, I wonder why the companies didn't secure a Special Protocol Assessment with the regulatory agency to lock that agreement into place. The lack of an SPA suggests, to me at least, that the FDA remains unconvinced about the validity or objectivity of the NTB. Let me end this special Mailbag with a reader who likes my story. Dan S. writes, "Awesome article. Incredibly well written." Thanks.
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