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Monday, August 1, 2011

Forced Choices, Part 5

This is Part 5 of a multi-part post.

This post is an attempt to explain how people can be forced to make financial decisions that are not beneficial, why Social Security is necessary, and why the system of medical insurance and private doctors in the United States needs to change.

There are SO many things wrong with what goes on in the U.S. Congress; it is hard to know what to talk about first.  I share the feelings of many Americans that the members of Congress are completely out of touch with the people they are supposed to represent. It seems that the majority of members either don't know, or don't care about the hardships most working and retired Americans face every day.  The policies they advocate are just plain bad for the average American, and only benefit the very rich and the biggest, richest corporations.

This post contains details of medical procedures, so if that is TMI, you may not want to read on.

Most of the major religions of the world talk about compassion for others in some way. Jesus is quoted as saying, “I am my brother’s keeper.” Almost all Christians agree the statement means that each person has a responsibility to help others.

Sikhs are often seen as warlike, but when you look at their core beliefs, as revealed by their ten gurus, compassion and charity are key principles.  My friend, Sean Toor, says that when a local Sikh Gurdwaras is following their beliefs correctly, there is a meal after each service, where all who are hungry may come and eat.  This is just one example of how Sikhs are called to practice compassion and charity.  If you look at the Sikh beliefs, as explained at,

you will see a very compassionate and progressive religion with much in common with Christianity.

These are just two examples, including a very large and a smaller religion, where believers are called on to care for other human beings with financial help, as well as emotional support and compassion.

The Dalai Lama said, "The practice of altruism is the authentic way to live as a human being, and it is not just for religious people. As human beings, our purpose is to live meaningful lives, to develop a warm heart. There is meaning in being everyone's friend. The real source of peace amongst our families, friends and neighbours is love and compassion."

I believe the expression of a need for human compassion by many religions, over thousands of years, is a foundation stone of any code of ethics or morality.  If that is true, then it is not only unethical, but also IMMORAL to profit from the misfortune or illness of another human.

The structure of medical care as a “For Profit Business” in the United States is ineffective and failing because by emphasizing profits, it automatically makes patient care, and care giver compassion, of secondary importance.  Being a “For Profit” enterprise opens medical care to all the abuses that greed and criminal minds can devise.  Medicare and Medicaid are great ideas, but in the “For Profit” model of care, they are subject to a multitude of abuses that put millions of dollars into the pockets of the unscrupulous and the criminals.

Setting up so-called “Health Insurance” as a “For Profit” business compounds the problems.  The policyholder is paying an insurance premium to protect themselves and their families from the financial ruin a major illness can cause.  The “Health Insurance” business, because they are in business to make a profit, is motivated to deny payment to the policyholder.  We see all kinds of devious ways Insurance Companies use to keep premiums and deny benefits.  Pre-existing condition exclusion is just one of those ways to steal from their policyholders and increase their profits.

As it exists today, the entire American Health Care System is not only ineffective, much too expensive, and subject to scams and theft; it is just plain IMMORAL.

Doctors should not be getting rich from treating human suffering.  There should not be an incentive for doctors to recommend unnecessary operations to increase their income.  Nurses and other care givers should not be overworked or underpaid by employers trying to make a profit and run the hospital or clinic like a business.

The Food and Drug Administration, FDA, is the U.S. agency that decides if treatment methods and prescription drugs are safe and effective. If criteria are met, the treatment or drug is described as FDA Approved.  If the FDA does not approve a treatment method, a doctor can’t perform it in the U.S., a U.S. hospital can’t offer it as an option, and an insurance company will not pay for it.  Again, we have a law that was enacted to protect the interests of the patient from quackery that has gone wrong.  Due to the “For Profit” structure of the American Healthcare System, FDA approval has become a source of abuse and probably bribery and other criminal activity.

When I was researching what method of treatment to choose for treating my Prostate Cancer, I looked carefully at the risk of side effects from each method of treatment.  ALL of the “Approved treatments” had significant risks of major, debilitating side effects.  Having to live the rest of my life wearing diapers was not an acceptable risk.  That is what led me to choose a treatment method that was not FDA approved.  I’ve talked about having to drive 3 hours to see my doctor.  The reason was, that I had to see a doctor who was willing to travel outside the U.S. to perform the procedure.  My doctor is a Board Certified Urologist who is licensed to practice in the U.S. and has performed thousands of FDA Approved Prostate Cancer treatment procedures.  The fact that he recommended HIFU above ALL FDA Approved treatments, combined with the results of my research, made the HIFU procedure the best choice for me.

High Intensity Focused Ultrasound, or HIFU, was first investigated at Indiana University, over 50 years ago.  When technology finally caught up and made the treatment practical, it was researchers in Europe, who developed the equipment.  HIFU was approved for use in Europe in 1997, and in Canada, in 2000.   It is in clinical trials in the U.S. but still has not been approved by the FDA.  The structure of the original clinical trials was flawed, because the ONLY treatment methods compared were the French HIFU machine, which is low power, and can only treat a prostate gland of 25 grams or less; and Cryogenic treatment, which causes impotence as an after effect in 100% of patients.  No one wanted to be in the control group, so those trials made little progress.  I talked to a doctor at Duke University who was participating in the trials, but because of the structure, you could not choose whether you were in the experimental or control group, so I did not sign up for the trial.  In addition, my prostate was between 85 and 100 grams when I was diagnosed, so the French machine was not an option.

My doctor is trained to use the Sonablate® 500 system, designed and manufactured by Focus Surgery, with headquarters in Indianapolis, Indiana.  This machine is capable of treating a prostate glad of up to 50 grams, and has better imaging resolution than the French machine, so the doctor can “see” the area being treated more clearly.  Clinical trials in the U.S. now include the Sonablate, but I don’t know the structure of the trials yet.  I will update this information when I’ve been able to research the details of the trials.

I was on hormone suppression therapy for about a year to get my prostate down to treatable size.  This is an FDA Approved therapy, and my health insurance did pay for some of the treatment.  When my prostate shrank below 50 grams, I had to choose whether to have the procedure in a hospital in Mexico, Canada, or The Bahamas.  Treatment in Canada is more expensive, so I chose The Bahamas, because I had always wanted to take a trip to the islands.  The cost of the procedure in 2008 was $25,000 plus the cost of my airfare and hotel.  Since the procedure was not FDA approved, I had to pay for all of it myself.  The treatment took 5 ½ hours.  I was asleep for the procedure, so there was no pain.  The clinic was clean and the nurses from England and Australia were very kind and thoughtful.  My doctor from the U.S. performed the procedure.  I was up, and walking around the Atlantis resort the next day.  There was no pain and only some minor discomfort from the supra-pubic catheter.

The urethra can experience some trauma from heat generated by the ultrasound beam cooking the cancer, so the catheter is placed through the abdominal wall and directly into the bladder.  That lets the urethra rest and heal.  Debris from the prostate collects in the bladder, and is removed by the catheter.  A week after treatment, I was scheduled to see my doctor in the U.S. to have the catheter removed.  During that week, I was supposed to start closing a valve on the catheter to get the bladder used to filling up and used to voiding normally.

The recovery process was going well until the balloon that holds the catheter tube in the bladder failed.  That obstructed the tube and prevented urine from flowing out of the bladder.  I was still having a lot of prostate debris in my bladder, and a large bit was obstructing the urethra, so I couldn’t empty my bladder normally.  In the middle of the night, the pain from the pressure of an over-full bladder became unbearable, and I had to go to the ER.

The doctor in the ER would not treat me, and called the on-call urologist to come in.  I had documentation on how I had been treated, and what should be done if there was a problem with the supra-pubic catheter to give to U.S. doctors, in case I was not able to see my doctor.  Because HIFU was not an FDA approved procedure, the urologist thought he had to take 45 minutes to lecture me on the folly of choosing that treatment.  He insulted my doctor, who is a past president of the state association of urologists and has impeccable credentials, and accused him of just doing HIFU for the money.  Finally, he put me to sleep and removed the failed supra-pubic catheter, but he did not follow the instructions in my documentation, and inserted a Foley catheter, which goes through the urethra, into the bladder.

I’ve already talked about how this complicated and prolonged my recovery, so I won’t repeat the story.

Why did I write about my personal experience with the effects of FDA approval?  To demonstrate that the process is broken, and denies American patents the best options for medical care.  Whether the cause is bureaucratic inertia, or lack of personnel to investigate new drugs, equipment, and procedures, the FDA is harming, instead of helping patients in many cases.  Sometimes it seems as if the right bribe has not crossed the right palm.  I’m not accusing anyone of anything improper, but it seems that if a procedure was approved in Europe in 1997, and in Canada in 2000, the FDA SHOULD have had ample time to study it.  Why is HIFU still not approved by the FDA in 2011?

To be continued …

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