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Stephen L. DeFelice, MD


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The Patient Always
Gets Screwed


Promising Ovarian Cancer Therapy Blocked

Carnitine-Ovarian Cancer Promise and a Failed Attempt at a Clinical Study


When Was The Last Cure?


Translational Science - How Doctornauts Can Help


Senator Tom Harkin (D-IA) has been one of the leaders in Congress on Translational Science.


Doctornauts Barry Marshall and Lukas Wartman: Living Proof of the Urgent Need for the Doctornaut Act



View the Discussion Draft of the Doctornaut Act Prepared by Former Senator Bill Frist.




Dostoevsky, Jefferson and Franklin versus Regulatory Swarm

Stephen L. DeFelice, M.D.

July 23, 2012

Dostoevsky, Jefferson and Franklin versus Regulatory Swarm – Somebody Out There: Write a Book- Quickly!

When I was 19 years old I decided I wanted to become an existentialist psychiatrist- whatever that is or was. At that time, existentialism was taking academe and its students by storm, and I read heavily on the subject. I didn’t think much of Sartre and Camus-and still don’t- but one guy, who has been labeled an existential thinker, but I believe he would have no part of official existentialism, immensely impressed me. Fyodor Dostoevsky understood, and experienced, the depths of the mind like none other before or after him who have expressed themselves in public domain. I proceeded to read most of his works and learned a lot about a lot.

I believe it was in his novel, The Possessed, where he described the social dynamics of late 19thcentury Russia. Though he mentioned materialism as a warning sign, he was deeply concerned about the growing prevalence of nihilism when people themselves decided what was right and wrong and were free to do what they wanted. Observing the movement, he correctly predicted and warned of the oncoming of 20th century Russian communism with a single, visionary statement, “Boundless liberty leads to boundless tyranny!” He foresaw a tyrannical central government suppressing the people by various tools of oppression from instilling fear to making them chattels of the state.

I’m sure he was aware of the same concerns of the Founding Fathers of America.  Benjamin Franklin and Thomas Jefferson were keenly aware of the nature of government’s appetite to constantly push the buttons to obtain increased powers over its citizens which concern was reflected in the structure and language of the Constitution. But they, like Dostoevsky, feared the power of a concentrated government. Franklin and Jefferson were fearful of the return of a king like the one they rebelled against. Though it may be recorded somewhere, I wondered what they were thinking when there were rumblings of a push to crown George Washington the “King of the 13 Colonies” after the Revolution. He, like Julius Caesar (who rejected the offer three times and then supposedly fainted), refused the offer.

Like Dostoevsky’s Russia, we are living in an age of materialism and nihilism the latter characterized by changing sexual mores, the replacement of traditional family structure with multiple other types and  the diminishing impact of traditional religion on our individual behavior.

These three great men were not aware of a new type of pervasive state control the magnitude of which still escapes public awareness and scrutiny. No gulags, no concentration camps, no forced labor and no mysterious disappearance of citizens: They are regulations and regulators which are currently controlling much of your life and soon, if unchecked, mostly all of it. Historicallydictators, kings and all the rest, unlike regulators, generally didn’t extend their scrutiny into the smallest, multiple details of the daily life of its citizens. The intent of modern regulations is to do just that; to dictate the rules regarding people and organizations from small to large events. And, if something goes wrong on their part, it’s extremely difficult to correct the fault. It is faceless, elusive and difficult to defend oneself against its power. You cannot charge it with pointed bayonet for it is, in an operational sense, invisible.

Rather than cover broad samples of regulations, I’d like to describe a few personal samples ofRegulatory Swarm. The State of New Jersey sends out an annual letter to remind its car owners that it’s time to register your car including instructions on how to make payment. Well, one night after I left the local restaurant there was a ticket on my windshield. My registration had expired. I called the police station to explain that I had not received notice from the state, and they told me there’s nothing that they could do. I went to the Motor Vehicles Division, told my story and explained that it was the state’s fault that I hadn’t received the notification for registration. The clerk, expressionless, – no pity for me! –  said, “Well. This happens a lot. It’s not our problem, and you’ll have to contact the state and talk to someone there.” I asked her if she had the contact number for the office. She didn’t. I tried calling the state but gave up after an eternity of waiting. I paid the annual registration fee but didn’t realize that it was only good for six months, the time in which my normal registration would expire. After six months my neighbor told me that my registration had expired. Once more, I hadn’t received the state notice. I went to the Motor Vehicle Division again and had various types of personal identification with me but not one which was considered mandatory and, therefore, they couldn’t process my registration. I pleaded my case that it was obvious that I was I. But they stood firm and told me that, though it was obvious that I was I, they were not allowed to exercise their personal judgment and obligated to follow the regulations of the regulators. I reminded them that once more the state didn’t send the notice. The sympathetic clerk admitted that they’re still having the same problem. I return home for the required identification, returned to the office and once more paid the annual fee. In addition to the regulatory mismanagement, another lesson learned is how we are powerless against Regulatory Swarm. The only good news about this standard regulatory adventure is that I wasn’t ticketed the second time thanks to my neighbor.

Here’s another personal story that should make one shake their head in despair. My daughter died suddenly and left no will. Her son was the sole heir. He had a death certificate and documentation to confirm the latter. We went to her bank with the documentation to find out how much money was in her checking account. We spoke to the manager and were told that she was prohibited by regulations to reveal the amount. We were then told in order to get an official release we had to go to the state court a distance away with the documentation. We drove to the court, located the proper office and were politely accommodated. We were given the legal papers for the release for the bank but there was one proviso. We were only permitted to withdraw up to $99. If the amount were greater we had to return to the court and obtain additional legal papers for the bank to release the remaining sum. I asked her the following question:

Question: “What is the reason behind the $99 rule?”

Answer: “I don’t know.”

Question: “What if there was $100 in my daughter’s account. Could we withdraw $99 and leave $1 remaining without having to come back to the court?”

Answer: “I don’t know. Nobody has ever asked that question before.”

Question: “Is there any way to find out?”

Answer: “I’m not sure who knows about these regulations.”

I decided to leave the court in a hurry in order to protect my brain and heart.

There was $94 in my daughter’s account, and I was relieved. You would think otherwise. After all, money is money, but I just couldn’t go back to that court. This was psychologically interesting and Dostoevsky would understand this. I feared that there was $110 in her account. This would force me to make a decision to return to the court and spend half a day in time and aggravation.  I did, however, finally come up with a creative solution to retrieve the $110 but it would violate a regulation and, in the regulatory swarm book, it would have been a crime.

Summing up the aggravation by incompetent regulators, bad regulations, a system lacking feasible remedies, waiting in lines and on the phone, forced overpayment of my registration fee, loss of time and acceleration of stress and cardiovascular disease- just over vehicle registration: The ticket costs me somewhere near  $100 and the registration process three days of  lost time. Regarding my daughter- do I need to further adumbrate? I work at home so I have some flexibility of time. I wondered, however, how a full-time worker could take the time off, even without pay, without some negative feedback from the boss further accelerating the oncoming of cardiovascular disease and also creating unnecessary tension at home with the family. Now these small regulation fiascos like this one happen millions of times a day in every walk of like.  We all have experienced and heard stories about regulatory overload. Get ready for many more!

On a larger scale, in my previous post, Carnitine and Doxorubicin: Potential Promise for the Treatment of Ovarian Cancer, I described how a single, high level FDA official by taking an independent regulatory action to the Orphan Drug Act led to a company, which had previously agreed to support a clinical study on a potential new therapy that I discovered for ovarian cancer, withdrew its support after the FDA action.  Just imagine my personal costs and time to support and gather all the information required for the FDA application that was rejected but would have been accepted except for the new regulation.   I then was told that it would be extremely difficult and costly to have the decision reversed.  And who pays the ultimate price of this Regulatory Swarm?  They are late stage ovarian cancer patients who have a certain rendezvous with death missing out on a potential new therapy. More than that! This new regulation will discourage other new potential therapies from entering clinical studies. Once more, patients pay the price?

Since President Obama took office regulations have skyrocketed in number, more than in any other administration. The Obamacare law contains about 2500 pages. Regulators are now frenetically writing regulations of each page in order to implement the law. Though we won’t know until the finished product is published, one sources estimated that 170,000 regulations will follow. And whatever the number, based on statistical probability algorithms, there definitely will be mass contradictions and confusion in the law where both individuals and organizations will be defenseless to resolve their problems without great effort, if at all.

The encouraging news is that there is certainly a cultural awareness of the ongoing tide ofRegulatory Swarm but little awareness of its impact on our freedom. Remember the Regulatory Swarm Equation: More laws and regulations = less freedom.

Of course there are other issues to be addressed. For example, regulations are mostly a hidden tax but not all the time. Just ask Supreme Court Chief Justice Roberts. Also, Internet has opened a new avenue on the attack on freedom and Regulatory Swarm will soon become a huge player in this world of vast open information. Also, let’s not forget we’ve entered the Age of Informers who are feeding the regulators. Combine all of these movements and unless there’s something I’m not seeing, we are, unawares, in a highly synergistic rapidly moving Regulatory Swarm phase not only where the state regulates its people from the “cradle to the grave” but as Joseph Stalin said, “From erection to resurrection!”

So where are the leaders? Can it be a presidential campaign issue? At this time, I doubt it. In any event, someone out there should write a brief, simple and persuasive book with representative examples to alert our country of the Regulatory Swarm and the need to draw lines. Also, I believe this is fertile territory for the blogosphere!