Friday, May 21, 2010

Bravo Newsweek!?

There is hope out there in the form of a Newsweek article in the May 31 issue. The article is called "Desperately Seeking Cures" by Sharon Begley and Mary Carrmichael. In it the authors strike some of the key themes I have been discussing regarding how senseless the current medical research environment is and how difficult is is to translate science into real-world cures. I am thrilled to see that someone else actually recognizes these fatal flaws in our quest for terminal disease cures.

They describe the well known "Valley of Death" that exists in translating science into cures and how the current way of doing things has created it. Frustrated NIH investigators are exemplified that cannot find the resources to reduce their work to clinical proof of concept and the flawed patent system which makes it impossible to patent findings already published is also cited. The purpose of the NIH is to commercialize its research as is the purpose of patents. Both instruments of cures are not working. Mention is also made of the redundancy of medical research and its lack of coordination, both of which have been discussed on this blog.

One would think that the authors have read this blog but the point is that we are not alone in recognizing this fundamental problem. Where are the Cures? this is the rallying cry that must ignite the fundamental changes required to remedy this tremendous and costly crisis. We are not lone voices in the wilderness.

This blog is the precursor of a book that I have given the tentative title, "Where are the Cures". The book has been in the works for three years and is 80% complete. It details the full spectrum of systemic flaws that inhibit the curing of terminal diseases and more importantly proposes some solutions on how to accelerate the generation of real world cures. The Newsweek article is the first example of the use of the phrase, "Where are the Cures" and I am thrilled that someone else appreciates this problem. It has been a lonely three years and this article will hopefully facilitate the completion of the book.

Sunday, May 2, 2010

A New Cancer Drug; lots of heat but not much light

Last week the FDA finally approved Provenge, a late stage prostate cancer treatment based on a "new" mechanism that involves patient specific treatment. The company that developed the drug has some very happy shareholders and the treatment is an incremental advance. That's the good news. The bad news is that it is not a cure, it only extends survival by 3-4 months and it will cost $93,000 for a three dose treatment regimen. It is being called the first cancer vaccine but vaccines generally prevent diseases and are cures; this is clearly not that. Is this the best we can do after 60 years?

The thought leaders seem somewhat enthused by these modest results since they think it might lead to something better as research progresses. This is the same refrain academia always uses the grease the grant funding wheel that pays their salary. The mechanism involves mobilizing the patients own immune system and is therefore simply a variation on a theme that has been tried many times before. After 15 years of work on this treatment and hundreds of millions spent it seems a poor return on investment.

Provenge demonstrates just how anemic our effort to cure terminal diseases is. The FDA delayed approval of this drug for almost 5 years, it is an advance but a rather subtle one and it will be very expensive to the health care system. Yet the media is all over it with front page headlines. We need to stop this endless raising of hope based on incremental progress that is thrust on us by academia and the drug industry and demand that this issue of curing terminal diseases is resolved. Health care reform got done in less than a year, we must insist that our leaders reform the quest to cure terminal diseases with the same determination. The path to that end is the subject of the two previous posts and the purpose of this blog is to mobilize grass roots support for the resolution of this tragic problem that claims 2 million lives each year.

Thursday, March 25, 2010

In Search of a Strategy for Cures

In the past 75 years we have cured 4 diseases. None of these medical breakthroughs were expensive to accomplish. Virtually all of them occurred in spite of intense peer criticism and all of them involved the innovative use of existing, not new science. Most importantly, they were accomplished by maverick scientists following their own creative insights.

1- Alexander Fleming cured infectious diseases with his accidental discovery that something in molds killed bacteria. It took 20 years for him to motivate his peers and the drug companies before we finally had penicillin.
2- Salk cured polio with a simple vaccine that utilized a very low-tech heat killed virus. It cost him virtually nothing to make this finding. The Institute that was built to honor him has spent Billions of dollars since and has not cured one disease in its 50 year existence.
3- Leprosy was cured by an Israeli physician that used thalidomide (the drug that was banned for birth defects) on a leprosy patient. It emptied the Leper colonies.
4- Two Australian physicians fought the scientific community to prove that Peptic Ulcers were caused by bacteria and that simple antibiotics could cure them. Ulcer surgery is now very rare.

Organized science has not had anywhere near this success in spite of trillions of dollars spent during the same time frame. We still treat cancer the same as we did 50 years ago with drugs that are as bad as the disease. Alzheimer's disease remains untreatable and heart disease is still the major killer. These three terminal diseases are winning.

What is this telling us? First and most obvious is that we are doing something very wrong. Science has become a bureaucracy that has managed to escape any accountability for what it produces. We worship new technology for its own sake and have put all of our "Faith" in the elite "Thought Leaders" when we should be focusing on innovation and accountability.

We do not need to totally remake how we deliver health care (Obamacare) but we need to establish a system to cure the three terminal diseases that are both killing and bankrupting us. The current one has failed and in fact does not exist. This will solve rather than prolong the healthcare crisis.

Tuesday, March 23, 2010

The Real Healthcare Crisis

The National mandate for health care access is clear from the new health care bill. We are spending over a trillion dollars so less than 10% of our citizens can now have access to health care. I would submit that the much larger problem is our failure to cure the three major terminal diseases (cancer, Alzheimer's disease and heart disease). Just these three diseases cause almost 2 million deaths per year! That is more deaths than in all the wars of the 20th century! They also account for a major portion of our health care budget and threaten to destroy our economy.

Why is there no national mandate to save these 2 million lives per year? Why have we failed to cure these scourges in spite of massive expenditures over the past 50 years? Most importantly, is there a solution to this enormous tragedy?

Having spent the past 40 years in the drug discovery business as well as at the National Institutes of Health it has become abundantly clear to me that there is a simple reason why the terminal diseases remain the biggest killer in or society. Simply put, there is no coordinated strategy to find cures. We have trusted this task to academia and the drug companies, both of which have other agendas.

Academics are in it for the science and drug companies for the money. Science is what propels academic careers and the drug companies can make more money at less risk if they treat rather than cure disease. This is further exacerbated by an FDA that is not equipped for the job of dealing with terminal disease since its mission is simply to regulate and not collaborate and facilitate. All this must change.

By far the biggest impediment to removing the terminal disease threat is the fact the there is no national mandate or strategy to accomplish the mission. Imagine if we simply asked academia to get us to the Moon back in the 60s rather than take the Manhattan Project approach that we took with NASA. We would still be on the launch pad today. There is a long list of things that can be done to accelerate cures for the terminal diseases. The irony is that we can probably do this with no additional expense than we are already incurring and very likely with less.

The first step towards putting the fear of terminal disease behind us and truly solving our health care crisis is to generate the national will to develop a strategy and re-deploy our existing infrastructure to successfully attack the problem rather than just churn out random science and hope some of it will be relevant. The good news is that the talent and infrastructure already exist and no new funding is needed. I have put together a plan of attack that needs to be vetted by further discussion in the form of a soon to be completed book. The national will must however spring from the grass roots and flow to Washington in order for anything to happen.

This blog will hopefully start that process and generate a dialog that will produce action on this long overdue national tragedy.