The Poverty of Drug Development and the FDA

by Michael Shulman
BiotechBlitz



One of the great things and hosting a blog is the discipline it forces on you, not just to write, and read posts, but to stay fresh and keep reading even when lunch, sleep or a baseball game beckon. Vacation will soon be upon me – two weeks at the beach, a serious beach, not too many people or commercial establishments – and it is at that time I take a look at some “deep” research, at topics and magazine articles and papers about technology and molecules and dancing mice, not trying to make another discovery, but trying to find the market segment where the next great discovery is bound to happen.

And, in honor of the slowdown I enjoy the week before I leave, and also to avoid doing other things, like writing one of my two newsletters, I started a bit early this year. And what I have discovered it is not good – there is a real poverty of “almost there” research and product development in all the great areas of life sciences, and disease prevention and treatment, except cancer. And, even in cancer, it is mostly about incremental treatments a smidge better than what is on the market – that is the way to get an FDA approval, isn’t it? – and a complete lack of a bold vision for curing cancer.

It would be easy to blame companies on this lack, but the real answer lies with Francis Bacon – Elizabethan spy, philosopher, statistician (such as it was back then), the man who gave us our current rules of scientific discovery and evidence – and the FDA. I cannot criticize Bacon, since a response is highly unlikely, but the FDA seems fair game. If you think I am being too obtuse or showing off, check him out at http://en.wikipedia.org/wiki/Francis_Bacon and start reading better books – put down those picture book biographies of Pamela Anderson and The Governator – although both are living testimony to the growth in the cosmetic medicine market.

Where was I? Oh, if you read all the postings in this blog – please, don’t do it without stimulants – and my newsletters – I am typically a defender of the FDA. Or, let’s say I was. More and more, however, terrible leadership, terrible decisions and the increasing poverty of truly creative drug development is putting me off and making me realize one of the growing problems in our health care systems is the FDA. Fewer drug approvals, more approvable letters (known as kiss of death letters), no leadership, too many statistically driven questions, too little concern for patients. And an approval process with an outright pernicious impact on creativity.

Everything is about the increment – there are too few companies pursuing cures for diabetes, cures for Alzheimer’s Disease, cures for cancer. It is too hard – better to go after a target that is more manageable. If a colorectal cancer treatment extends life five and a half months, let’s see if we can develop one that extends life eight months. If this new diabetes drug reduces blood glucose a certain level, well let’s come up with a treatment that reduces it the same amount with less doing and side effects. If the FDA has approved several drugs that barely work in putting off Alzheimer’s symptoms for six months to a year, maybe we can do 10% better.

This “investing to the increment” involves hundreds of billions of dollars to make marginally better solutions to problems. Meanwhile, we are light years away from curing diabetes, curing Alzheimer’s, curing any one of a number of forms of cancer. The whole rage is treatment – the practical approach – the business like approach – because the rewards are easier to obtain and greater with incremental investment. This is not just Big Pharma, it is mot life sciences companies. Even worse, bold, new biotechs with hot technology are increasingly being bought out by dinosaur Big Pharma companies who then superimpose this investing in the increment approach to their product development.

There are some solutions:

1) Extended patent protection for more powerful or more successful treatments that cure diseases
2) A faster regulatory path for drugs for the terminally ill or for previously untreatable diseases
3) Bonuses – and I mean big ones – for treatments that radically reduce the cost of a disease to Medicare and Medicaid.

I don’t see the current administration doing anything with the FDA except asking them to approve some form of abstinence pill – how about Ambien? – and the current head of the FDA has no vision or political clout inside or outside the agency. Maybe after Mark McClellan earns enough money as a consultant and speaker to pay for his kids; education he can come back and run the FDA and I can start writing about stocks again.

On that note – if you want to see a bold, creative company, incredibly risky, check out Transition Therapeutics (TTH.TO) my freebie for the month, maybe the quarter, for all you cheapskates who only consume free information




BiotechBlitz is a regular contributor to BioHealth Investor
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