Michael Fossel Michael is President of Telocyte

April 26, 2016

The Tempo of Alzheimer’s

Hardly a day goes by, and never an entire week, without my seeing yet another article, often a cover article, that suggests we will soon cure Alzheimer’s disease. If articles were anything to go by, then the increasing tempo of those articles, to say nothing of the increases in both research and funding, would suggest we will soon solve the problem. But, publicity, laboratories, and money are not the same as actual clinical results. In fact, the issue is never the amount of resources, but where you aim those resources. If we wish to cure Alzheimer’s, then we need to put some honest intellectual effort into understanding Alzheimer’s. Until then, publicity, laboratories, and funding are only a reflection of wishful thinking. No one ever cured a disease by injecting money into the patient, let alone making them swallow a laboratory, or listen to publicity.

Yet oddly enough, publicity is often perceived as a goal in itself. I see biotech companies who strive to get themselves mentioned on the news, as though that would create success. But whether are on the cover of Time magazine or mentioned in this week’s edition of The Scientist, news stories are never equivalent to a cure for Alzheimer’s or anything else. In fact, I suspect there is often an inverse correlation: the more your drug or your biotech company is mentioned in the media, the less likely it is to get through FDA trials, let alone improve patient care. Just a suspicion, but founded on frequent observations over the past two decades or more.

Some of us want to find a cure, and never mind the kudos.

Other people just want the kudos.

The fact that we hear about another potential “drug that may cure Alzheimer’s disease” on an approximately weekly basis, underscores not only the frantic need for a cure, but the fact that none of the alleged cures actually work. As we say in medicine, when you have dozens of professed cures for a disease, you can be pretty sure that none of them actually do a damn thing. The more strident the claims for “the cure” the more you should suspect an absence of data. When there is a cure and when it works, it will be a single intervention and you’ll know it works because, guess what, it will actually work.

I regret that the media gets caught up in the inflated claims, but it speaks to the public’s hunger to believe. One of these days, it won’t be a claim and it won’t be inflated, it will simply be the facts. When we finally have the facts, it will be because we have shown we can cure Alzheimer’s disease and it will be Telocyte on the cover, but only after we cure Alzheimer’s.

 

April 12, 2016

Rational Behavior

We waste stunning amounts of money and effort on comprehensively ineffective trials.

As a recent article points out, in the past 15 years, there have been 123 Alzheimer drug failures and, while four medicines have been approved, none of them affect the progress of the disease. Symptomatic therapy at best, we have no medications – none – that have any effect on the disease or on its mortality. A quick look at clinicaltrials.gov lists almost 1,500 interventional trials aimed at treating Alzheimer’s disease, yet once again there is no evidence that any of these trials has resulted (or will result) in an intervention that changes the outcome of Alzheimer’s disease.

Federal funding for Alzheimer’s is estimated at almost half a billion dollars and some have estimated that Eli Lilly’s potential treatment for Alzheimer’s, solanezumab, may end up costing the company one billion dollars to achieve approval of that drug alone, even though there is no evidence that it actually prevents or cures the disease. The most optimistic interpretation of the statistical data of thousands of patients over many years, would be stretching it to suggest it might possibly delay cognitive decline and death by 2-3 months over an eight year period from diagnosis to death. Even that wishful thought is doubtful and scarcely any consolation to those enduring an extra handful of weeks in a skilled care nursing home (or having to pay for it).

No matter what the current target of choice – beta amyloid, tau proteins, inflammation, or any other target-du-jour – none of these targets have ever been shown to offer a glimmer of hope. Despite the history of repeated and consistent failure, we continue to spend (and vote to spend) money on these same drug targets. We eagerly bash our empty heads against the same solid brick wall, naively hoping that one day we fill find that the wall will be made of air (like the air in our brains, which leads to our irrational behavior). The apocryphal observation pertains: the definition of insanity is doing the same thing over and over and expecting a different result. We waste money and effort on ineffective and expensive trials aimed at targets that we know are futile.

The irony – and the tragedy – is that we can both prevent and cure Alzheimer’s disease, both effectively and inexpensively if we understand the actual pathology and target the underlying causes. We could do, effectively and inexpensively, what big pharma has failed to do ineffectively and expensively. What big pharma can’t do for one billion dollars, Telocyte can do for 0.5% of that figure, simply by aiming at the right target.

We need rationality, insight, and just enough funding to prove it can be done.

April 6, 2016

The Rabbits of Research, The Frogs of Alzheimer’s

 

Perspective often shrinks personal problems.

Late Sunday night, I received a cry for help from a woman whose mother has Alzheimer’s disease: she asked me to meet her family and offer professional advice. Their concern was not only her medications, but the ability of her physician, the stress on the family, and the patient’s own medical and psychological problems. Not surprisingly for someone with Alzheimer’s, the patient not only had paranoia, depression, panic episodes, and confusion, but the heart-rending loss of memory and reasoning that really lie at the heart of Alzheimer’s – if Alzheimer’s can be said to have a heart, which is a stunning oxymoron for such a horrifying disease.

We each have our own problems and – such is human nature – we get wrapped up in those personal problems, losing sight of greater issues. I had been thinking about a dozen issues that play into any biotech effort: potential investors, vendor specifications for plasmids, approaching the FDA for pre-IND meetings, conference calls with our IP attorneys, details of our preclinical research, and whether or not one of our scientific advisory board members had time to define a sequence for us. Amazing how large these – and many more – issues loomed in my life, then suddenly became so much smaller and less important when I heard from someone whose loved one has Alzheimer’s. It’s true that the only lasting way that my colleagues and I can help her – and hundreds of thousands of others – is to complete the research and offer a cure, but there is much more to helping than curing. Sometimes, it’s simply a matter of small acts of compassion, such as finding a referral to someone who can help with day-to-day problems, even if they can’t cure the deeper problem itself. And sometimes, of course, it’s simply a matter of understanding how unimportant our own problems are, in perspective.

Two thousand five hundred years ago, a story teller described the panic of a group of frightened rabbits who, in turn, suddenly surprise a group of frightened frogs, whose panic sends them into the pond. Aesop was right about human life: there will always be rabbits, there will always be frogs. No matter how much the “rabbits” of research need our attention and our hard work, the “frogs” of Alzheimer’s patients must always have our care and our compassion.

And, perhaps quite soon, we will change those frogs into healthy humans, whose fear becomes a thing of the past.

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