Given the tremendous money, time, and resources spent on stem cell research, stem cell therapies should be all around us by now. They should already be available to physicians to treat patients with everything from heart disease, to stroke, to adult onset diabetes, to arthritis. However, just like the flying cars that seemed to populate the future of our youth, they haven’t materialized. Researchers often claim we don’t have enough research yet. Is this why?
A press release that turned into major media story this week may help explain the issue. This story relayed that scientists who examined 2,000 papers on “adult stem cells” find that the successes with these cells shouldn’t be allowed in anyway to take away from embryonic stem cell research funding. The researchers state that restricting one type of stem cell research (in this case embryonic) would harm the other type of stem cell research (in this case adult). While the connection seems a bit tenuous, what’s more interesting is that despite the huge amount of published papers on adult stem cells (ASCs) taken from patients (as of this writing 14,530 on mesenchymal stem cells and 67,720 on hematopoietic stem cells), the “adult stem cells” being discussed in this report are actually the much less studied IPS cells. I’ve blogged before on IPS cells (reprogrammed cells from a patient that are forced to become stem cells) which are a new stem cell type that while scientifically interesting seems to exist more to satisfy a business plan more than any real clinical need. Taking the religious issues out the embryonic stem cell (ESC) debate, the scientific landscape has changed dramatically when compared to just 15 years ago. At that time, it was assumed by many in the field that only ESCs could repair tissue and that ASCs may or may not be able to do the same. A decade later and after tens of thousands of publications, it’s clear that ASCs are capable of many of the feats of ESCs. So why didn’t the scientists review the ASC vs. ESC research? Why sound the alarm about money possibly being siphoned off from ESC research by IPS cell research? Where’s the discussion about the tremendous resources we’ve expended without yet a single ESC treatment? Good question.
I think this story highlights how many of our stem cell research programs have lost their focus on cures and instead are locked into a paper chase for grant dollars. An apt metaphor is a slot machine. The U.S. public pays dearly for medical research in terms of taxes and the highest drug prices on the planet, not to fund research minutia, but to fund cures. In this stem cell research slot machine, we all put our tax and drug coins at the top in hopes that we’ll see a big payoff in new cures. The public willingly plays this casino game so that their lives can be made better, not to produce basic science. To give you a sense of just how broken the stem cell research “slot machine” is at this point, as of this writing there are more than 152,000 research papers indexed in the U.S. national library of medicine under the search term “stem cells” without a single FDA approved cure. Even if we remove published research papers on Embryonic Stem Cells and IPS cells, that still leaves about 125,000 published research papers on ASCs. Since each of these papers uncovers some unique factoid about whatever is studied, we can use the number of papers as a rough metric of how much we know about a subject. To compare that number, there are only 12,477 papers investigating the use of the most commonly used antibiotic, Amoxicillin (52.3 million prescriptions in 2010). There are only 32,463 papers published on any type of low back surgery. Finally, there are much less than 10,000 under the common surgery “appendectomy”. Since these therapies can all be deadly in the wrong hands, why on earth do we need to know 4-12 times more about stem cells than we know about these common drugs and medical procedures? In addition, these comparisons vastly underestimate the research disparity when ASC research is compared to new drugs and procedures. Take for example the newly approved immunology drug Belimumab. How much in terms of publication volume is there on this drug? There are only 87 research papers listed. So in terms of the volume of published knowledge, there is approximately 143,000% more known about adult stem cells than this newly approved drug. How about new medical procedures? Robot prostatectomy is a new procedure to remove prostate cancer lesions using a robotic arm that assists the surgeon. The procedure is capable of reducing common complications such as lost sexual function because the robot is more accurate than a human. Surely, this new and exotic “space age” procedure that allows a robot to perform a delicate surgery must have tens of thousands of publications like ASCs? Nope. There are a paltry 729 papers listed in the National Library of Medicine, meaning we know 17,146% more about ASCs than this new procedure. To be fair, there is more human data published on this new drug and this new procedure, but that difference only highlights the problem. Why have we studied ASCs to death with animal models while we haven’t done the same for new drugs and procedures? Is there something special about stem cells that requires us to know more before they are commonly used in patients? I would submit that our need to know more is driven by business interests rather than humanitarianism.
Medical research is a massive business that like any industry, protects it’s own interests. For example,U.S. medical research spending doubled leading up to the early part of this decade-from $37.1 billion in 1994 to $94.3 billion in 2003, while inflation during that time period would have only accounted for 24.2% of the increase. This makes medical research now well over a 100+ billion dollar industry. How do the sizes of other industries compare? Medical research as an industry dwarfs the 2.7 billion dollar alternative medicine industry, the 20 billion dollar dietary supplements industry, and the 4.7 billion dollar fitness industry. This medical research industry is also bigger than the predicted alternative or clean energy market (projected to be just 92 billion by 2013).
In summary, medical research is a huge 100+ billion dollar industry that we all fund. This industry is often made up of dedicated and hardworking scientists who do produce discoveries that can change lives and make society better. Some of these great discoveries have come in the world of stem cell research. However, to the public, their investment in this industry is a Vegas bet, best codified by a giant slot machine that will hopefully pay off in new treatments. The public simply doesn’t care about the 1,636th study on a unique piece of data about the WNT signaling pathway in stem cells (there are are 1635 as of today) unless that leads to a cure now. Because our stem cell research focus on scientific minutia is focused on securing new grant dollars rather than funding projects expected to lead to therapies, the process of translating stem cells to the bedside is broken. Instead of a rapid payoff in clinical treatments that follow a predictable timeline, we’re seeing a sizable industry that has learned how to get the public to place more of it’s hard earned coins in the machine. The media needs to start paying attention to the math and start asking why we need to know tens of thousands times more about stem cells before they can be used in patients when compared to other new drugs and procedures.
The solution? Switch the majority of NIH monies to clinical stem cell research rather than basic science research. While it’s always helpful to find out more about a topic, at some point you simply need to “fish or cut bait”. In addition, we have a broken regulatory system that’s trying to classify stem cell body parts the same as drugs and in the process, slowing down medical advances to a glacial pace. As a result. reapportioning NIH monies alone won’t fix the whole problem, to do that, we need regulations that make sense to patients and physicians. Our regulations need to respect physician practice of medicine rights, while promoting progress and rapid clinical translation of stem cells, rather than obstructing treatment through needless red tape.
Post-script: I recently learned while erroneously typing only the search word “knee” into the National Library Medicine PubMed system that we only have about 93,000 publications on this body part. I was shocked to learn that we have far fewer publications on the most injured and treated part of the musculoskeletal system than we have on “stem cells”.
After I posted this blog, writer Michael Crow wrote a similar editorial in the Boston Globe. I have posted it below:
A radical way to fix the nation’s medical-research establishment
June 19, 2011|By Michael M. Crow
The United States spends around $30 billion a year on the National Institutes of Health, an agency that has been called the “jewel in the crown of the federal government.” The NIH is by far the nation’s most important single funder of medical research — the scientific work that drives our university labs, our drug companies, and our major hospitals — and its budget amounts to an enormous bet that by advancing basic medical science, we can reap improvements in national health care.
In one arena, at least, that bet is paying off: America has become the unquestioned global leader in biomedical science. As it has, the NIH has also become critically important to states like Massachusetts, which reaped more than $2 billion in funding last year, fueling a high-tech economy of high-paying jobs.
But biomedical science is not the same thing as health, and in a very important sense, our investment in the NIH is not fully paying off. The agency’s own mission statement holds that its ultimate goal is applying knowledge to “enhance health, lengthen life, and reduce the burdens of illness and disability.” And on that count, America is doing less impressively. Among the large industrialized countries of the Organisation for Economic Co-operation and Development, the United States spends the most money on its health care both as a share of gross domestic product and per capita, according to a 2009 report — but our life expectancy ranked 24th of the 30 countries in the report. And on numerous other measures — including infant mortality, obesity, cancer survival rates, length of patient stays in hospital, the discrepancy between the care of high versus low income groups — the country fares middling to poor. Our global leadership in research, in other words, has not translated into leadership in health.
To tackle this problem, NIH director Francis Collins made news six months ago by announcing a new “translational research” institute dedicated specifically to converting laboratory findings into medicines and diagnostics that real patients will use. Its supporters hailed the idea as an important step; others in the research sector objected, worried about its impact on the current structure of an agency their work depends on for funding.
But in a larger sense, his proposal — which would create a 28th institute within the NIH bureaucracy — amounts to an admission that America’s medical research establishment is insufficiently focused on outcomes beyond science. For all the money America spends on medical science, its innovations aren’t really improving our health as much as we would hope.