Bapineuzumab: Speculation on Alzheimer's Drug

Contributed by: Dennis Fortier, President, Medical Care Corporation

Bapineuzumab is an Alzheimer's drug that is now in the final stage of FDA approval. We described the mechanism of Bapineuzumab in this earlier post.

No one can say with any degree of certainty if it will be approved or not, but as noted in an update provided by Fierce Biotech,  there has been an interesting development in the progress of the clinical trial.  The companies sponsoring the trial, Pfizer/Wyeth and J&J, amended the protocol last year to expand the study by several thousand research subjects.  This is a very costly move in terms of research investment and time required to conclude the study, and has led to much speculation as to why the trial was expanded.

A leading theory that makes lots of sense, is tied to the recently revised guidelines for diagnosing Alzheimer's disease.  Under the new guidelines, the presence of disease pathology can be recognized much earlier, when symptoms are much subtler, compared to the former standards.  This bodes well for more effective treatment.

However, the new guidelines also create a potential conundrum in terms of currently approved treatments.

The FDA has approved 4 drugs for treating Alzheimer's, but all of those approvals are based on the former definition of the disease, that requires a later stage of disease progression and more severe symptoms before the diagnosis can be made.  It is possible that the Bapineuzumab trial was initiated to demonstrate efficacy against the late stage disease that was defined in the old guidelines, but revised to demonstrate efficacy against an earlier stage of disease as defined in the revised guidelines.

Although the trial protocol was amended about a year before the new guidelines were released, a draft version of the revisions have been available and mounting industry consensus has been visible for quite some time.

If the drug works, and the trial sponsors can demonstrate that it works at very early stages of Alzheimer's, this could be a giant leap forward for the field.

The Case For Alzheimer's Research

Contributed by: Dennis Fortier, President, Medical Care Corporation

The case for funding Alzheimer's research, and for participating in such research,  is a compelling one.

You've all heard or read the numbers: more than 5 million Americans diagnosed, probably at least that many in early stages and not yest diagnosed, with all numbers approximately tripling by 2050.  Neither our health care system nor our society can absorb the looming impact of this epidemic.

In this excellent opinion piece posted at CNN, Dr. Ronald Petersen of the Mayo Clinic describes an approach to averting a national, disease-driven crisis.  I encourage you to click through and read it.

Larry King: Alzheimer's Special

Contributed by: Dennis Fortier, President, Medical Care Corporation

Many of you may have seen Larry King's CNN special last night on Alzheimer's disease.  It was a one-hour special report on the urgency of the challenge this disease poses for our aging population, for our health care system, and for our society.

Overall, I thought there was a fair amount of good information presented.  The expert testimonies from Dr. Ron Petersen at the Mayo Clinic and Dr. Jeffrey Cummings from the Cleveland Clinic were excellent and clearly characterized the nature and the magnitude of this epidemic.  Heartfelt stories from care givers brought a very personal face to the disease and provided an in depth look at the way this disease can affect an entire family.

Having said that, I also thought the show performed one major disservice to the public.  There was much dramatic emphasis on the fact that Larry King and Ron Reagan visited the Cleveland Clinic to be evaluated for early signs of Alzheimer's and Ron Reagan chose to forgo an evaluation based on his preference to remain "blissfully ignorant".

To be clear, everyone has the right to make such a decision and I don't begrudge Reagan his right to do so.  However, he couched his decision against the backdrop that "there is no cure" and implied that it is therefore better "not to know" about the early presence of disease process.  This is a myth we need to stop perpetrating and Larry King missed the opportunity to set the record straight.

While there is no cure for Alzheimer's disease, there is certainly treatment.  Importantly, some people respond remarkably well to treatment, adding years of independence to their lives.  Broadcasting the message that it is "better not to know", as King did last night,  may prevent some people from gathering the facts and making a more informed decision,based on the knowledge that early intervention and appropriate treatment could be significantly beneficial.