Joseph F. Clark, Ph.D.

I was recently asked to write a 100 word memorial to be read at a memorial service to be held by the University of Cincinnati. The University has a very considerate tradition of having a memorial on the Tuesday after Memorial Day to honor all those in and associated with the University who have passed the previous year. A friend and colleague of mine died suddenly on Memorial Day weekend last year and the memorial service would coincidentally be on the one year anniversary of his death.

I’m honored and proud to have the opportunity to remember my friend in this way; but wow is it hard to put into a short paragraph what many of us felt when Bill died. I consider myself a writer and author and can type very quickly. The distinction between writer and author is a writer puts words down on paper or computer screen and an author publishes. I do both, so I thought this memorial might be a quick task. It was anything but quick and certainly not easy.

I needed to write for a general audience of people who knew and did not know Bill. It needed to be succinct at 100 words read aloud. But first and foremost it needed to pay an honest and heartfelt tribute to a departed friend. If the task was to do this in 1000 words, I would have no problem spewing out a verbal diarrhea of facts and anecdotes to cover all bases for everyone. But I needed to be focused. I started, stopped, deleted, cut, added and edited with feelings being expressed before sharing drafts with some colleagues. A few positive words of encouragement as well as edits and I believe, with help, I have come up with a fitting tribute.

“William L. Wurster came to us as a scientist and left as a friend. Bill had a rich and diverse personal history and a charitable side known to only a few select friends. His philanthropy was clever as only Bill could be and makes him missed throughout the world. As a regular at Sitwell’s in Clifton he was known as an eccentric artist creating paintings and sculptures. None of us knew the many facets of Bill’s life, which makes him all the more missed because we did not have the chance see his many sides. Nonetheless we are all richer for him having been in our lives. His absence leaves an unfillable void.”

I intentionally avoid this discussion of how or when I knew that being a scientist was right for me. The reason is because the answer, while truthful and kind of humorous, is not the stuff of learned scientific careers. In fact some might call it somewhat nefarious.

I was always interested in science, medicine biology and technology as a child. I remember receiving a microscope, chemistry set, electronics kits etc for gifts. These were always things I asked for. I would play with them and eventually broke the microscope trying to take it apart. Actually taking it apart was easy. Putting it back together never resulted in the same device. By many accounts I was regarded by most parents as a ‘good boy’ and not a trouble maker. I did however associate with some kids who were often, the subject of parental ire. On occasion when I was embroiled in the mischief of youth, I seemed to have a knack for talking my way out of a situation and avoid trouble. Let me explain. Say for example something turned up broken at home. With three kids, my parents would interrogate us to find out who was responsible for the damage. In this example, I with some other boys who came over to play did the damage. I would see and know the evidence that my parents had and would weave a story accounting for those observations while completely exonerating myself from any wrong doing. My brother and sister would often end up getting in trouble for my deeds after I had thoroughly lied to my parents.

While I am not proud of my exploits I did realize that I had a skill that was useful to a little boy, but hardly a career skill. I did however have aspirations in science and I learned about research including things like; hypothesis testing and research questions. It turns out that if you have a bunch of data or preliminary evidence; you can form a hypothesis and test it by asking a research question. The hypothesis is a statement that fits the currently known data. A scientist will use the information available to him or her to hypothesize that bacteria causes a disease. This is based on available facts showing bacteria are found in sick humans and an absence of bacteria in healthy people. The research question would be, ‘if I give the bacteria to a healthy person will they become sick?’ We all know the answer is yes bacteria, say e-coli, causes diarrhea but I came to realize that my apparent ability to make up alternate stories of the evidence my parents had was like forming a hypothesis for my parents by taking the events into account.

Outside of excuses to parents, I started to try to explain things based on circumstantial evidence I was acquiring. I remember telling my mother that cooking food didn’t just dry it out but changed the food. Curious as to how I came to this conclusion she asked me where that factoid came from. I proudly brought her to my room and showed her a cooked and dried hamburger that I had procured from a recent outdoor barbeque from the previous weekend – this was days ago – and an uncooked hamburger patty sitting in a corner of my closet. The cooked one was dry and hard like a hockey puck and the uncooked patty was a festering mush. Much to my chagrin my mother threw away my experiment.

Undaunted this curiosity to try to explain things helped me in science classes because it helped me deduce what the teachers were saying. The science had to make sense because all those things are related and seemed logical to me. In advanced science classes in college and graduate school I eschewed memorization and worked hard to make sense of the data the professors gave me. This helped me learn the material because it all became a story to me and not random facts.

I believe that I have succeeded, and continue to succeed, in science because science and medicine make sense to me. I try to see all the distinct observations and put them together to make a story. Much like the stories I told my parents. My experiments are more elegant than drying hamburger but the same curiosity is there. I do regret being a vessel causing my siblings to be blamed for things I did, but it did give me a skill that I have used for 20 years. I started as a liar; then a story teller and now tell stories and do research to prove those stories to the research community. So if your kid makes up a story and a lie to get out of trouble, congratulations you may have a budding scientist on your hands. Sorry mom and dad.

As most people who read my blog and My Ambulance Education, I am heavily committed to the education of all individuals at many levels of academia as well as science and medicine. Currently I am a Professor of Neurology in the University of Cincinnati. It has been my privilege to work and learn in the education systems of the USA, Paris France, and Oxford England. I have also traveled to multiple countries and institutes of higher education.

I am extremely happy to report that the state of the education system in the USA is sound and that our students are competitive. Indeed, I have found that the intelligence, tenacity and creativity of the students in Cincinnati are on par with the best students in Europe.

In my travels I have found that much is made of England’s dreaded ‘A level’ exams. While they are hard and stressful and are thought to put British high school students beyond the training of American high school students; they do not tell the whole story. An American high school student could not do well in the British A levels, but nor should they be expected to because that is not their goal. The British A level exams are typically 3 focused exams where the student has chosen to work towards them for the previous several years. Often taking no other classes except those related to A levels. The result is a highly trained and narrowly educated individual coming out of the British high school system.

A similar focus also occurs with the British college students where they do not have to take general electives or the so called core curriculum that Americans take. Almost all the college classes for a British student are within their major. Again the result is a highly trained individual lacking breadth of knowledge. If I wanted to hire a new graduate who was a science machine, I might hire a British over an American grad. But if I wanted out of the box THINKING, the American grad would be my choice.

In graduate school the American graduate student will get advanced classes focused on the field of study for that student. He or she will also have an opportunity to do independent research for their Ph.D. thesis. If there was a ‘gap’ in training between American and British students that didactic instruction is more than made up for in graduate school. But here is where the transition occurs that produces a highly trained scientist. The American trainee will have had an education based on breadth, depth and diversity. He or she will have had a chance to incorporate life experiences in their education and be prepared to face the world in a way that their often younger and spoon fed British counterparts will not. Please recall the old adage that discovery favors the prepared mind. I believe the diverse background of the American system better prepares young minds for scientific discovery.

In my opinion the American system is preparing our students of advanced education to be highly productive and capable individuals ready to face the job market and ready to work. I will always choose a new American Ph.D. student over a newly minted British Ph.D. any day.

Let me say up front, this may be the most contentious blog I’ve written. So, beware.

The definition of an orphan drug is that the market for said drug is less than 200,000 patients. This number of patients is considered to be not sufficient to be financially successful for drug companies to develop drugs. Orphan drug status means that one FDA designated company can develop and market specific drug targets for those patients. See; http://www.fda.gov/orphan/oda.htm for more information.

There are however lots of drugs that are still not being developed. I think we need a new definition of orphan drug to be able to get more useful drugs to the patients who need them. The solution may not be just increasing the size of the target market, but might be to extend the life of the drug. This could be achieved by increasing the length of time that a patent is valid. Alternatively the FDA could designate a drug an orphan drug to protect it for a longer period of time. They could choose to not allow copycat drugs to enter the market. One might argue that the copycat drugs are generics and the generics are just as good as the brand name but cheaper. Yes, that may be true for drugs already on the market. But what is happening is that companies chose not to take compounds to market because of the perceived risk of competition from generics.

I am not proposing a monopoly for any company or drug, and am in favor of a free market economy, but I am also in favor of providing opportunities to enhance the health of our nation. The current market is not treating the general population adequately and these suggestions can improve things.

What if a new indication of a drug about to go out of patent was discovered? The drug company would NOT try to develop the drug for a new treatment because it would cost time and money that would not be recouped. Further, scientists and physicians often do not want to do the years of research needed to get the drug approved for a new indication. So the treatment remains unused and is thereby orphaned.

Yes drug companies will make more money but more drugs for underrepresented diseases can be developed. In the example of a drug coming off patent, the company could be allowed appeal to the FDA to extend the orphan drug status of a previously developed drug and make it profitable for the company to do the development needed to get a new application for that drug. There are many cases where it looks like a drug might have a second application but it is not investigated by drug companies because the patent is dying.

Sub categories of such diseased such as wake up stroke or drugs targeted to be in ambulances or for disasters could be better developed. Drugs in ambulances can expire or go bad because of heat and cold cycles and that means they are not used or have drastically decreased profits. Disaster drugs often sit unused and therefore new ones may not be developed because of a weak market.

Numerous examples where drugs could be developed but companies choose to not go that route can be found. The federal government does not make drugs and cannot mandate a drug company to make and market a drug. Therefore companies need to have incentives to develop drugs for less profitable arenas.

Solutions to these problems do not need to cost the taxpayers’ money, but rather allow companies in these cases to be able to recoup their expenses with these drug development projects. Solutions could be:

1. Extend patent life.
2. Protect from or decrease costs of litigation.
3. If a new indication for a drug is discovered extend patent life for that drug. Especially for that indication. The FDA would need to approve generics for the old indication but forbid generics to be used for the new indication.
4. Restrict new drugs that unfairly compete for a period of time.
5. Optimize regulatory steps such as FDA required trials, reimbursement, or accelerate the process and allow longer periods of time for marketing.

I realize that I have not explained number 5 above. What I mean is that it takes the average drug 10 to 15 years to get to market. That is a huge expense and with a patent only being valid for 20 years the period of time that a drug can make money is very short. So if drugs can reach the market in 5 to 10 years, that is more than enough time to prove safe and effective and will increase the time where money can be made off that drug.

For anyone who is offended or concerned by all the discussion of profitability for drug companies please ask yourself one question. Who else is going to make and sell drugs? These are companies and this is a free market society. If you want more and better drugs than make it appealing for drug companies to get them to you. Pharmaceutical companies are not charities and charities are not manufacturers of drugs. But we have sadly legislated pharmaceutical companies out of business – almost. It takes one billion dollars to get a drug to market with only about 5 years of marketing for that drug to break even. What product makes $200,000,000 per year for the first five years after its launch? The answer is not much, but that is what is needed for a new FDA approved drug.

Our current system is broken and tainted. The result is helpful therapies are not being made, sold or developed to treat treatable diseases.

In the interest of full disclosure let me say that I am a Professor of Neurology at the University of Cincinnati. My research is into the causes, treatments and diagnosis of stroke and related neurologic emergencies. I am one of the founders of a very small biotech company that is working to make diagnostic devices for stroke patients. Recently, I wrote and published a book entitled, My Ambulance Education. A huge theme in the book is “helping people” and that theme is the desired endpoint of the blog above.

So here is some math that I find very humorous.

The NIH announced two months ago their challenge grants in support of the stimulus package, also known as ARRA. In the challenge grants it was announced that 200 grants would be awarded 1 million dollars each. That is the amount of the stimulus package for this program totaling $200,000,000.

Here is the humorous math. 20,000 grants were submitted. That means the odds of a grant being awarded is 1 in 100. That is kind of funny because the normal odds for NIH grants to be funded is 10 times better than that.

One might ask, what else could be worthy of a chuckle? Ok, some more math; in my case it takes hundreds of hours to write a grant. Let’s put a number of 3 weeks of work. The time to put together a grant is more than my time though as my employees work on the grants as well. So for each grant multiple person weeks are needed. Assuming that the cost in salaries to write and assemble one grant is; $5000.00 now multiply that by 20,000 grants. The result is $100,000,000 to write the grants. Where does that $100,000,000 come from? It does not come from the ARRA. It comes from discretionary funds in the institutions who are already strapped for cash. It is an investment hoping for a return. The cost of that investment is high because during that time, I ignored my students and teaching to focus on writing challenge grants to the ARRA. So there are financial and professional costs to writing grants like this.

Humorously, the costs of the challenge grants do not end there. Believe it or not someone has to read those grants to make decisions on who gets the funding. Now this is very funny. On average it takes 8 hours of work to read and review one grant. The average reviewer will review 10 grants. That means that 90% of the reviewers will NOT read a grant that will be funded. Remember, only one in 100 grants will be funded. But again those reviewers will spend 80 hours of work, two normal work weeks, reviewing grants. I estimate that in time and effort it will cost $24,000,000 to review the 20,000 ARRA grants. Add that to the cost of writing the grants the total cost for writing and reviewing the challenge grants is $124,000,000 all spent to fund $200,000,000 of stimulus money. So the net infusion of dollars into the economy is; $76,000,000. Finally because not all the money will go to fund research only about $45,000,000 will be used by the people writing the grants.

One more bit of math. I submitted 5 challenge grants. That increased my odds of getting funded from 1 out of one hundred to 5%.

I do not however think for one second that the NIH has done anything wrong. I think that the federal government should not micromanage the agencies who are getting funding. Not when the DHHS and NIH have been highly successful and prudent with their spending.

The truth is this is not funny. But if I do not laugh about it, I’ll cry.

There are people who proclaim themselves as experts. But how does one become a perceived an expert? Having a lot of information on a subject does not make an expert. A text book has a lot of knowledge but that text book will not answer a question without someone looking in it and it needs an ‘expert’ to write it. So, writing on a subject sometimes becomes the touchstone of the expert.
In medicine and science experts often write and publish articles in journals. These articles are reviewed by other ‘experts’ before the journal publishes them. So their publication implies that ‘experts’ agree that the author is well versed in that subject.
For inventors the litmus test often used as a gauge is patents. A patent is issued by a government that says that other ‘experts’ have reviewed it and agree that it is new and important enough to have a patent issued. The invention even gets a birthday and a life span where it can be owned and used by the inventor.
What about books? Books are publications written by people who may be considered experts or self proclaimed experts. In the examples of journals or patents independent ‘experts’ have examined what is written and concluded that the author has demonstrated expertise. This so called peer review is rigorous but is distinctly lacking with many books that are published by so called experts. I have written several books, but for the sake of example, lets examine two of them. One book entitled, Creatine and Creatine Phosphate is a scientific text reviewed by my peers and considered a solid reference on the subject of creatine. I consider myself an expert on creatine and patents and other publications are added evidence for that claim. Another book I wrote is, My Ambulance Education. I worked on an ambulance and in the book conveyed how that impacted me personally and professionally. It is one person’s perspective, so I do not consider myself an expert on ambulances or educating ambulance personnel. The two books are linked, however, in that the ambulance work helped pay for me as I was in college learning about creatine.
I recently encountered a self describe expert, who will remain nameless. This person is in the medical field and has a degree. He claims hundreds of inventions and has published several books. But, when I closely examined the literature and credentials for this person he had no patents and no publications or texts that have undergone peer review. I found no experts who consider him an expert. I concluded he is not an expert in anything except self promotion.
If you ever encounter a self describe expert you can check their validity with some simple searches on the internet. Do not use google for this. Try: http://www.ncbi.nlm.nih.gov/sites/entrez for science and medicine and http://patft.uspto.gov/ for patents and inventions. They are both free. There you will find the real experts.

When I worked on the ambulance I was doing that to ‘help people’ and my goal in my career over 20 years later is still to ‘help people.’ On the ambulance and when I worked in the Emergency room I was helping people one person at a time. That was rewarding, frustrating and hard work, but well worth the time and energy. Now, I do research that has the potential to help people. I have also talked to congress and politicians and powerful physicians to develop strategies and technologies that should help people. However, I have gone from helping one person at a time to potentially helping millions. A lot like the dedicated people in emergency services there are equally dedicated research people working very hard to ‘help people’ on a grand scale. While it may take years, the results will be worth the wait because we will all benefit from the work of these dedicated and brilliant scientists and physicians.

The National Institutes of Health fund about 40,000 grants to do medical research. Of those funded projects only 14 have to do with medical research in the pre-hospital setting. This is just sad.

Over 50% of all medical emergencies that come to hospitals arrive via the ambulance. Paramedics, firefighters, EMTs, Police and a host of paramedically trained professionals can give quality care to patients in emergency situations when time is critical.

Machiavellian principals clearly state the earlier something can be identified and treated the better the likelihood of successful treatment. Ambulance personal are the people with the first opportunity to start treatments. So why are we NOT doing substantial research to treat patients in the ambulance? I do not know the answer to that question. But I do know ways to change that situation. First we need to tell the politicians that our tax dollars need to benefit this area of society. Call, email and write letters to your federal, state and local agencies to support medical research focused in improving care in the ambulance. Only community action will change this situation.

There are also barriers to improving care in the ambulance. These need to be addressed by grassroots actions. Some physicians are hesitant to have ambulance personal ‘diagnose’ and treat some conditions in the ambulance. This may be a quality of care concern or a medical legal issue. Either way the best avenue to address this concern is with evidenced based medicine, which means to do the research studies to prove what can and can’t be done in the ambulance. This is an educational issue as well as a research issue that can be best answered with the help of the NIH and some solid research projects.

Finally when time is critical such as in an ambulance action has ramifications and this causes concern for law suits. Everyone is concerned that if a person has something done to them in an ambulance some ambulance chasing lawyer will sue everyone. Lawyers are costing lives in the ambulance and hospital arenas because no one will diagnose, treat or take any action because of law suit risk. That is just sad. We need to limit the extent to which medical legal issues dictate research, development, diagnosis and treatment of medical emergencies in the ambulance.

I think President Obama needs to present a state of the sciences in address; like the state of the union. Yes, of course, I’m biased in this subject, but times are desperate. I work in a university hospital and train physicians and scientists at the cutting edge of technology. What we do is discover new ways to diagnose brain disorders and new was to treat them etc. But we cannot find the students to engage in doing this work or to train for the future. The average age of the nation’s scientists is increasing. We are going to lose a generation of scientists because new people are not learning from experienced scientists.

Why are the bright young students shying away from science and technology? Well, because they are smart. Teaching science in high schools and colleges pays very poorly. Plus because of dwindling enrollment those programs are being cut. Moreover, many types of research are seen as socially unacceptable. Medical research to save lives, may involve animal research and that is perceived as cruel. Scientists are called vivisectionists and targeted by animal rights groups with bombs and smear campaigns. Other technologies are sometimes associated with environmental accidents or global warming. Who wants to be associated with such negative connotations?

Research funding has dried up. Less than 1 out of every 10 grants submitted to the National Institutes of Health get’s funded. “Researcher” as a career title is a misnomer because almost all one’s time is spent writing grants. Ask the average Nobel Prize winner in chemistry if they did their prize winning experiments and many will say no it was a student or technician they supervised.

The average scientific researcher will spend 10 or more years learning laboratory skills. Some of these skills can be exceedingly technical. But in today’s research environment many of those so called ‘successful’ scientists will abandon those skills and write grants and papers often without adequately training the next generation in those skills. New students see senior scientists locked in offices writing grant after grant followed by paper etc and choose another discipline.

So we need to keep science in the lab and off the grant administrators table. This can only be done by a paradigm shift in society. We need to remember that the future of a creative and productive society is with scientists and technologists and that these people are trying to improve society. Second, we need to ensure that scientists can do science. This means that administrators and paperwork that prevents a researcher from his or her research needs to be drastically cut if not eliminated. This is not a problem that needs a trillion dollar fix. This needs intelligent minds to find some simple solutions. In the short term and long run it will save society money and bring great advances in our future. Mr. Obama, do not throw money at this problem capriciously, improve the process and image of science and research in our nation.

I went to college for nine years to obtain a bachelors, masters and Ph.D. I am very proud of those accomplishments and completely embrace the moniker geek. I love doing cutting edge research and teaching the next generation of ‘geeks.’ The problem is that with that education I did not learn how to market or promote myself or my research. Self promotion is becoming more and more important in science because the federal system of peer review by its nature means that new and outside the box thinking cannot be supported. If you are the first with an idea, your peers will not be familiar with that concept and new things are shunned as being too risky. Innovation now seems to be more of a contest to see who is the first person to try to use a diabetes medicine to treat heart attack. That means research is not to discover things but to test the discoveries of others. Creativity and innovation as well as simple scientific curiosity are being lost.

The culture of discovery is rapidly vanishing. That is just sad.