Pat Sullivan Blog

A CFS Cure? - Update 10

When I saw Dr. Shoemaker four years ago he was just beginning to narrow in on the answer to fatigue related illness.  In virtually all of the 4,000+ patients he had seen there were a host of inflammatory, regulatory chemicals and hormones that were totally out of whack.  He was never taught at Duke Med school to even look for these markers but his research made him chase the rabbits where they led.  And the data he was getting contradicted much of what he was taught.  He told me then, "I had to learn when the data contradicts what I was taught,  the data is always right!"  That makes him more scientist than doctor.  And it makes him rare.  Most docs only believe what they were taught in med school.  Even new, well documented discoveries remain a mystery to them because they don't have time to read their own journals.  The only time most of them learn anything new is when a pharma rep takes them to Tahiti.  Sad but true most of the time.

At the time there were two little known hormones that were showing up as "dead low" in virtually all of his patients.  One was MSH, Melanocyte Stimulating Hormone.  The other was VIP, Vasoactive Intestinal Peptide.  Ritchie was excited but frustrated with this finding.  While he could measure them and see that they were low, he had no way of supplementing them.  Neither were FDA approved and thus not available to him to use.  They were available for researchers only for use in lab animals but not humans. Both are incredibly important and potent. MSH still is not available but VIP is available but only to docs who know about it and they are very few.

Shoemaker first got started chasing these rabbits 14 years ago when a group of about 25 of his patients suddenly all came down with the same cluster of symptoms.  They were very fatigued, had terrible diarrhea, headaches, achy joints and muscles, sensitivity to light, and had cognitive/memory issues and a host of other symptoms.  Ritchie was stumped.  They did not have the flu or anything else he could diagnose.  One lady had diarrhea so bad she was basically dying.  He tried every med he could.  Nothing stopped it.  Out of desperation, he thought of an old medication, Cholestyramine, used to lower cholesterol.  It had a side effect of terrible constipation.  He thought maybe this would help her.  It did.  When he saw her at her next follow she reported that not only did it stop her diarrhea it got rid of ALL her symptoms.  This totally perplexed Ritchie.  He saw absolutely no way this med could have stopped all her symptoms.  He gave the med to the rest of his sick patients.  They all got well.  Made no sense to him.

He called them all into his office where he tried to determine just what they all had in common.  After quite sometime, it was determined they all had only one thing in common.  Each had been in the Pokomoke river when there was a major bloom of an algae called pfiesteria.  Shoemaker learned that this algae produced a fat-soluble toxin that attacked the nervous system of fish and killed them.  This explained why cholestyramine helped each patient.  It bound to cholesterol in the bowel and prevented it from being reabsorbed. The toxin was bound to cholesterol. So the toxin was carried out of the system. 

But this did not explain everything.  These people were not the only people who had been in the river.  Why hadn't everyone gotten sick??   That question started Ritchie down every rabbit trail where it led him.  He learned that there was genetic component to CFS.  Virtually all the CFS patients he saw had a genotype where their immune system failed to recognize this type of toxin as a toxin.  So it did not remove the toxin.  About 25% of the population has one of the 12 or so subtypes of this major genotype.  He learned that the primary exposure to this type of toxin was mold.  Mold found in Sick Buildings and homes where water damage had taken place.  This is a very common occurrence.  The 12 genotypes represent a "spectrum" of extremely bad (the dreaded genotype) to somewhat bad.  Depending on your genotype you would either get really sick or only somewhat sick. Or you would not get sick at all if you did not have the genotype.

Basically, the toxin kicks off a strong immune response that starts an inflammation cascade that never gets turned off because the toxin is still there.  CFS and all other fatiguing illnesses are basically like getting the flu but the flu symptoms never leave.  The inflammation cascade wrecks havoc systemically.  It is like having a smoldering fire that is constantly starting brush fires all over the body.  Most docs go after the brush fires but are unaware of the underlying fire.  Put that out and all the brush fires go out.

When this fire continues for many years, damage to the body can and does happen.  The most serious of which is what happens to the brain. Particularly the hypothalamus.  It controls and regulates many functions in the body.  When it is not working, lots of things stop working well.  It is also where most of our VIP and MSH are made or are regulated.  In chronic conditions like CFS these are always "dead low".

While MSH cannot currently be replaced, there is a pharmaceautical company doing a LOT of work on it.  But VIP can and it helps put out the fire and even restores some of the functions of MSH. 

Chronic Fatigue Cure? - Update 9

Most people with chronic conditions like Chronic Fatigue Syndrome (I will use CFS as all inclusive for fatiguing illness), Fibromyalgiia , Post Lyme etc. try many different things to get well. I certainly did.  For 37 years I have been trying to figure out how to recover 100% of my health.  I have reached a place where most of the time I feel pretty good.  Not necessarily great but certainly highly functional.  When people learn that I was often very sick all the while I was building two software companies (ACT! and SalesLogix) they are shocked.  I learned how to be functional in spite of how I felt.  I remember a several week intense effort to raise money for SalesLogix where I was a basket case.  But somehow, I had learned how to separate how I felt with what I needed to do.  Often I would say, "how I feel is not me.  How I want to be is me."  I learned to play the role of health.  Only those closest to me knew I was sick.

That is the way it is with fatiguing illnesses.  Many people just learn to function anyway.  Others are simply too sick and they cannot do it.  But I have never talked with anyone who wanted to be the way they were.  Most were searching.  Their relatives and friends often would pass judgment on them.  "They are just lazy!"  I recently played golf with a VA Doctor who openly talked of his total disdain for Iraq soldiers "who were faking their illnesses (PTSD)".  I really wanted to punch him!!  Almost did.  When you feel really bad all the time, there is nothing else that you want except to get well.

I believe that time will prove that there is a single underlying dysfunction with most fatiguing illnesses that if corrected would cause virtually all the symptoms to disappear or at least bring a cohesive understanding on how to deal with those symptoms. 

I have said for many years that the main symptom of a CFS patient is they have seen MANY doctors.  Usually with no, to little help.  Mainstream and alternative docs basically have few answers.  There are nutritional supplements and some Rx meds that certainly can help.  I was helped a lot by a regimen of many supplements and a few meds, detox and exercise.  But none of these really fully the underlying problem. 

Think of the underlying problem like a smoldering fire,  The systemic symptoms are no more than brush fires that are continually kept alive by the real fire.  Doctors tend to focus on the brush fires.  They are not looking for an underlying basic problem.  Doctors don't have time to step back and look at the entire CLUSTER of symptoms always found with CFS, and ask what could be causing this wide ranging systemic illness?  Why do all these people have the same symptoms?

Well there is one doctor who for 14 years has searched and found some real answers.  I don't say that lightly.  And I have only recently begun to say it after knowing him and his work for 4 years.  And hope to help him prove more of this by funding a needed double blind, placebo controlled clinical study.  I hope it will prove conclusively that this entire cluster of symptoms is caused by a single underlying dysfunction.  Sounds simple!  It is, but it actually isn't. 

The fire that is lighting fires all over the body is caused by a very complex cascade of dysfunctions resulting in one basic problem.  It is confounded in that only about 25% of the population have a genotype that will be affected.  And even that is not simple.  There is one basic genotype with about 12 subtypes.  Those 12 make up a spectrum that determines just how badly you will be sick,  And getting sick depends on how much exposure you have to a very specific type of toxin made by a number of organisms.  The most common is mold.  The kind of mold you find in homes and building with water damage.  A dysfunctional immune response to mold toxin is the most common cause of fatiguing illness.

Four years ago, when I first went to see Dr. Ritchie Shoemaker MD, there was a news team in his office.  They were there doing a story trying to answer the question, "Why are people coming from all over the world, to see a Family Practice MD in Pokomoke Maryland?"  People were learning that he was discovering the cause of the fire.  He had not learned everything about it but he was closing in on it.  And he was able to help people partially with what he already knew.

When I recently saw Dr. Shoemaker in late May, I knew he had made tremendous progress, but I was not prepared for what he said to me.  "After 14 years of chasing every rabbit trail, and learning many things to help people, I have finally started to use a word I never really expected to use...CURE". 

Now you would have to know Shoemaker to understand how significant a statement that is.  He is a "by the book" doc, with a healthy skepticism.  He also suffers from this dysfunction.  In fact, he has the exact genotype as I do which puts us in the worst 3% on the spectrum of biotoxin illness.  It also means he and I are related!   More in the next post.

Brain Trauma - Damn Mold - Update 8

My next 7 sessions went well and I seemed to feel better after each.  More focused and calmer.  I was very impressed.  I was given graphs showing where I had been and where I was now.  It was very clear that my brainwave patterns had changed dramatically.  My left, right, front and back lobes all were much more in sync.  Where they had been separated from each other, they now were oscillating together. 

Lee showed me where I could still improve and would benefit from more training.  He explained that I probably had been "stuck" since my auto accident 35 years ago.  So it should not be a surprise that I would need more sessions.  They recommend that you wait 2-3 weeks before more sessions.  So 3 weeks later, I did 10 more sessions.  It was a paradox to me though.  While I mentally felt so much better, I had been experiencing other symptoms.   I had nausea, diarrhea, and sleep problems again.  It did not make sense.  I prayed and thought a lot about this.  My answer came out of the blue.

I consult with a number of start up businesses.  So I spend considerable time in different offices. While I was at one of those offices, one of their executives approached me and said, “Pat, you know a lot about health.  Why do I get a terrible cough, post nasal drip and stuffy every time I am in this building, and I am fine on weekends?  I asked a few questions and bingo, I had my answer.  This building had mold!!  It was the only thing that could explain his symptoms. His symptoms would leave after about 2 hours after him being out of the building.  While he was sensitive to mold, he had an immune system that recognized the mold toxin and eliminated it fairly quickly. Well, my immune system does not do that!

As I wrote extensively here, I am extremely sensitive to mold, I have a genotype where my immune system does NOT recognize the toxin.  The toxin is fat soluble.  It gets locked up in a cycle with cholesterol.   Cholesterol carries the toxin all over the body, particularly the brain.  It kicks off an inflammation cascade causing illness systemically.  The toxin is a potent neurotoxin.  Since the body considers cholesterol a very valuable chemical, it does not excrete much of it.  It recycles it constantly.  So the toxin has no way out.  And it becomes cumulative.

I asked more questions about that office and sure enough there had been numerous incidents of water damage in the past that had not been remediated.  A few times water had built up in the ceilings until it burst through the ceiling tiles.  With water damage like that, it is inevitable that mold would grow.  And as the weather warmed, the mold would bloom.  It was likely to be in the AC system as well.  I left the building and have not been back.  When I consult with them it is now over the phone. 

I immediately went on CSM, cholestyramine, which binds to cholesterol in the bowels and carries it out.  I felt worse for about 3 days but on the 4th day I turned a corner and began to feel really good.  Mold had been effecting me a lot and I had not recognize it. 

I talked with Lee about the mold and we decided to do a bit of an experiment.  He did another brain assessment in order to compare where I was now after clearing the toxin to where I was after 20 sessions.  I was way better but had not been able to "hold" some of the improvement to my brain patterns.  We then did 4 more sessions and it was clear that I was “holding” the changes better since the toxin was no longer present in my body.  I thought that was very cool and so did he. 

He was unaware of the issues with mold but now felt he had a new piece of useful info for people whose training simply did not seem to hold as well as it should.  Since about 25% of the population has a genotype that has problems clearing mold toxins, he knew he was running into that across the thousands of clients he and his affiliates worked with.  In fact, he said the clients with Chronic Fatigue and Fibromyalgia were the toughest ones to help. 

This also caused me to research afresh what Dr. Ritchie Shoemaker had been doing recently.  I made an appointment to go see him again.  More on that coming in the next post.

Brain Trauma - My Brain State Technologies Experience - Update 7

The first thing they do at Brain State Technologies is an assessment using the BST computer system.  They measure where you are.  How balanced or unbalanced the brain waves of your major lobes currently are?  The computer system then suggests protocols to be used in the ten sessions that typically are done when you become a client.  These protocols can be tweaked as they monitor the progress you make.  You also will be asked to fill out a subjective questionnaire regarding your health. While they ask about what you hope to accomplish in terms of your own physical and mental well being, their focus is to merely help the brain come back into a more balanced harmonious brain wave pattern. 

Brain State has worked with over 13,000 clients and have close to 200,000 sessions recorded in the database.  This is a huge database that grows everyday as they and their affiliates work with clients.  Because of the size of this database they have a very good idea what “normal” looks like.  They are also able to match specific brainwave patterns to certain pathologies.  They can tell that someone is depressed.  But they can also tell if that person is likely to hurt themselves or not.  They can see ADD, traumatic brain injury, anxiety states from the quick assessment they do.

When my assessment was done, Lee looked at the numbers without knowing anything from my questionnaire. He began to tell me what I felt and experienced.  Without knowing my past medical history basically could look at my brainwaves and see that I was likely experiencing certain health problems.  He asked me “when did you have an injury to your head?  Were you in an automobile accident?”  Keep in mind, I had not shared any of that with him.  He could simply “see” that in my patterns.  I was impressed to say the least. 

He  also said I did not sleep very well, struggled at times with anxiety and depression both of which were true.  He said my left and right side were VERY imbalanced and “not talking to each other at all.”  Same with my front and back.  He was concerned that I was taking some medications.  Occasionally medications can either slow and prevent the brain from changing very much.  But he said it likely would not matter a lot since during the assessment it was already clear that my brain was beginning to respond to the short “training” session they do in the assessment.

Ideally, they like to do your first 10 sessions over 5 days.  What they call an “intensive.”  My schedule would not allow that so I did my ten sessions over the next 2 weeks.  After the first one I felt a little “off”.   Something had definitely changed but it left me feeling a bit uncomfortable.  I shared that with Lee and he tweaked my next session a bit.  After the 2nd session I felt VERY much better.  Lee showed me where my brain waves had been 2 days earlier and where they were now.  The pattern looked totally different.

He explained the first session had shifted my autonomic nervous system which was stuck in a sympathetic dominant position , to a parasympathetic dominant position.  He explained that this was why I felt off.  The 2nd session they brought the sympathetic and parasympathetic pattern into balance.  Lee showed me the graphs and it was very interesting to see what they were talking about.  While I did not fully understand, it was clear in the first 2 sessions, my brainwaves had shifted dramatically.  In the next session, the two were brought essentially together.  And I could feel it!  I felt really good!

Here are pictures of my before and after brainwave patterns.  Download Pat_Sullivan-Session-1-15  More next post.

Brain Trauma - Brain State Technologies - Update 6

The more I learned about Brain State Technologies the more impressed I was.  The technical idea was fairly simple but the execution was very tough.  That is what you find with most software.  Simple idea, tough to pull off in a way that really works for lots of people.  BST basically analyzes the 4 major brainwaves, alpha, beta, delta, theta coming from the major lobes of the brains.  What Lee has found is anyone suffering from major, chronic health issues have waves that are unbalanced.  The left and right sides, the front and back lobes are all oscillating at widely different frequencies and are often not in sync with one another.   The waves can be much higher than they should be, or much lower. 

A theory of quantum physics is that “anything that is observed will change.”  In a way, BST is feeding back to the brain what it looks like.  Like a mirror.  Allowing it to observe itself.  The brain responds to what it sees and tends to move to the more balanced state.   The real trick is that the software gradually “encourages” the brain to move to a more balanced, optimized state.  Amazingly, the brainwaves do move without any effort from the person being "trained."  While there are similarities, there is no standard "optimal" state.  Each person is different.  The software helps the brain find what is optimal for it.  And the changes tend to hold at optimal once there.

To be clear, this is not brainwashing or forcing the brain to do something it does not want.  The client is always fully conscious and aware.  Some protocols are done while meditating with eyes closed.  Some, eyes open with active visualization.   Even where a person is being trained that is resisting (say a child where a parent has brought them to be trained) the movement to a more optimal state occurs.  Just not quite as fast.  Children train very quickly as their brains are very plastic.  Us older folks may require more time.   BST is totally non-invasive.  All that goes into the brain via the ears, is "music like" sound.  There are NO subliminal sounds.  The system cannot hurt you.  Lee tried to run protocols on himself that would be the opposite of what would be good for him.  He found the brain would simply resist changing to a less optimal state.

As the brain moves to a more balanced state, powerful things can happen in the body often relieving long standing conditions.  It is believed the system also spurs the brain into building new neural networks around damaged areas as in the case of brain injuries.  It has been known for a very long time that the brain is actually quite plastic and can grow new connections, albeit slowly.  Lee’s theory is that trauma, in some people, can cause the brain to get into a “stuck” or survival position where it is basically doing everything it can to protect the individual from further damage.  When stuck many different negative pathologies can develop.

Lee was his first guinea pig. He would measure his brainwaves when he felt well and compare that to when he felt poorly.  Over time he began to learn what “optimal” looked like.  He gradually recovered from PTSD.  He also fully regained the use of his left arm.  Amazing that balancing the brain could heal an arm that was very damaged.  Lee then applied the technology to his son who was having great difficulty staying in school.  After training, his son made the dean’s list and graduated with honors.  He now works at BST.  They then used it on 8 of his sons buddies with great results. Then other friends and family.

About 4 years ago, BST began to use and sell the system commercially.  They work with clients locally in Scottsdale and sell the system to affiliates all over the world.  They currently have over 130 affiliates in over 14 countries.  The main system in Scottsdale is hooked up to all the affiliates and downloads all the data from every session.  This allows them to build a very large database so they can constantly improve their protocols and learn what protocols work best with different pathologies. They have data from well over 200,000 sessions from over 13,000 clients.  An assessment and 10 sessions costs between $1,200 and $2,500.  Each affiliate sets their own price.   Next post I will share my own experience.

 

Brain Trauma - New direction - Update 5

Right about the time I was fully settling into my new meds and enjoying the sense of being even more focused and less impulsive, I got a call from my local doc, He wanted to talk with me about something new.  I thought, “just what I need, something new!”  I had just gotten everything working really well and he wants to talk me about something new?  But since he was doing me a big favor prescribing my meds for an out of town doctor, I went in to talk with him.

He was happy the new meds were really helping me.  Then he asked a piercing question.  “Do you want to stay on the meds the rest of your life?”  I said, “well, I would rather not but as long as they were helping me I have pretty well settled the issue that I would likely be taking the meds the rest of my life.”  He asked, ”What if there was a way to heal the brain and get off some or all the meds?”  Well that was no brainer (pun intended.)  Of course I would prefer to be healed and be off all the meds if I could.  He then began to share with me something new he had encountered first hand. His wife had been helped tremendously from long time issues with anxiety and depression.  He said I needed to check out Brainstate Technologies.

The idea behind BrainState Technologies began about 9 years ago by a computer scientist named Lee Gerdes who was seeking a way to get well from the Post Traumatic Stress Disorder.  He had been assaulted in San Francisco by 4 teens with baseball bats.  He was hit in the head 4 times and in the arm once.  He had lost the use of the arm and experienced many symptoms from the brain trauma.  Insomnia, anger outbursts, difficulty paying attention, anxiety, depression, etc. 

He had been the chief scientist for a public software company during the Internet bubble.  Highly functional but with great effort and will power.  It took all his energy every day to do his job.  But he was very difficult to be around for his employees.  He could blow up at any time. Reminded me of me.

He tried every mainstream and alternative medicine modality out there with very little help.  .  He began to wonder if his computer and physics background could help him develop something that would help him. When the company he worked for was sold, he and 2 programmers began to work on what eventually became Brainstate Technologies.

After a few years work he hit upon a way to help himself.  He fully recovered from PTSD and fully recovered the use of his left arm.  All this from using a software program that optimized and balanced his brainwave patterns.  After successfully trying it on other willing guinea pigs in his family and other friends, he set about to commercialize the technology.  His goal was simply.  To help people!

Basically, BST is a very advanced type of neurofeedback that is truly a breakthrough in my opinion.   It reads brainwaves  from various areas of the brain in real time, and then processes them with sophisticated software algorithms.  It then plays those waves back to the brain through auditory signals, essentially mirroring to the brain what it looks like.  It then begins to encourage (tweak) the brain towards a more optimal and balanced pattern. And it works. 

Through trauma of various kinds, the brain can get "stuck" in certain patterns in its effort to "protect" the person from further hurt or trauma.  Once stuck, the brain is very difficult to change using old technology.  Standard biofeedback and neurofeedback can help but can take hundreds of sessions.  Medicines can alter some functions and mask some symptoms but they usually cannot balance brainwave patterns.  In a matter of just a few sessions, Brainstate training can dramatically move the patterns to a more normal and balanced pattern.

There still remains a lot to prove for todays medical standards but studies are now underway with some major Universities to do just that.  Prove that optimizing brainwaves can alter things in the brain and body. 

I see it as Star Trek like medicine. I said in my book that I thought we would see more breakthroughs in medicine coming out of physics rather than biochemistry. The problem is that mainstream medicine is still very focused on biochemistry.  I am not saying that good can't or won't come out of biochemistry because it does and will.  I just believe that we will see major breakthroughs from areas other than biochemistry.  Brainstate is very promising in that regard.  More in my next post.

Say No to Nationalized Health Care

I am increasingly concerned about moving to Nationalized Health Care.  I understand why our government wants it, and the "fairness" and "equal access" arguments for it.  But I fear the inevitable and inadvertent drop in the quality of our health care. 

In every case I am aware of, the quality of health care for the majority suffers dramatically in pursuit of providing health care to those who cannot now afford it.  Do we have to make the majority suffer for the sake of the minority?  Can't we find a better way to help the minority? 

Recently I played golf with a friend who lives in Canada.  He was here with his wife at the Mayo Clinic for a followup after treatment of a rapidly advancing cancer.   He had been told by their doctor back in Canada that it was a good thing she had gone to the US because she would be dead had she received treatment in Canada.  The type of treatment she needed simply would not have been paid for by the Canadian Government.  Actually, not even available.

He also told the story of another friend who was told he needed an MRI to determine if he had a brain tumor.  When told by the Canadian Health System that it would be 12 weeks, he came to the US for an MRI.  He did have a brain tumor and needed surgery ASAP.  He went back to Canada with these results only to be told they could not work him in for another 15 weeks.  So back to the US he came to get the surgery.  Well he is alive and others are dead because health care in Canada is rationed because the government simply cannot afford to offer the high quality care that comes with freedom and competition.

Rudy Giuliani was right when he said, "If we have national health care, the Canadians won't have anywhere to go for health care." 

Much more could be said about how quality suffers for all wherever nationalized health care is the only option available in a country.  See here to see what I mean.

Following is an article from the WSJ outlining yet another reason for keeping government out of your and your doctor's choice for health care.  It is very troubling when regulators get involved and IMPOSE "consensus" medical opinion on the freedom of doctors to treat you how they have best learned.  

By JEROME GROOPMAN and PAMELA HARTZBAND

The Obama administration is working with Congress to mandate that all Medicare payments be tied to "quality metrics." But an analysis of this drive for better health care reveals a fundamental flaw in how quality is defined and metrics applied. In too many cases, the quality measures have been hastily adopted, only to be proven wrong and even potentially dangerous to patients.

Martin Kozlowski

Health-policy planners define quality as clinical practice that conforms to consensus guidelines written by experts. The guidelines present specific metrics for physicians to meet, thus "quality metrics." Since 2003, the federal government has piloted Medicare projects at more than 260 hospitals to reward physicians and institutions that meet quality metrics. The program is called "pay-for-performance." Many private insurers are following suit with similar incentive programs.

In Massachusetts, there are not only carrots but also sticks; physicians who fail to comply with quality guidelines from certain state-based insurers are publicly discredited and their patients required to pay up to three times as much out of pocket to see them. Unfortunately, many states are considering the Massachusetts model for their local insurance.

How did we get here? Initially, the quality improvement initiatives focused on patient safety and public-health measures. The hospital was seen as a large factory where systems needed to be standardized to prevent avoidable errors. A shocking degree of sloppiness existed with respect to hand washing, for example, and this largely has been remedied with implementation of standardized protocols. Similarly, the risk of infection when inserting an intravenous catheter has fallen sharply since doctors and nurses now abide by guidelines. Buoyed by these successes, governmental and private insurance regulators now have overreached. They've turned clinical guidelines for complex diseases into iron-clad rules, to deleterious effect.

One key quality measure in the ICU became the level of blood sugar in critically ill patients. Expert panels reviewed data on whether ICU patients should have insulin therapy adjusted to tightly control their blood sugar, keeping it within the normal range, or whether a more flexible approach, allowing some elevation of sugar, was permissible. Expert consensus endorsed tight control, and this approach was embedded in guidelines from the American Diabetes Association. The Joint Commission on Accreditation of Healthcare Organizations, which generates report cards on hospitals, and governmental and private insurers that pay for care, adopted as a suggested quality metric this tight control of blood sugar.

A colleague who works in an ICU in a medical center in our state told us how his care of the critically ill is closely monitored. If his patients have blood sugars that rise above the metric, he must attend what he calls "re-education sessions" where he is pointedly lectured on the need to adhere to the rule. If he does not strictly comply, his hospital will be downgraded on its quality rating and risks financial loss. His status on the faculty is also at risk should he be seen as delivering low-quality care.

But this coercive approach was turned on its head last month when the New England Journal of Medicine published a randomized study, by the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group, of more than 6,000 critically ill patients in the ICU. Half of the patients received insulin to tightly maintain their sugar in the normal range, and the other half were on a more flexible protocol, allowing higher sugar levels. More patients died in the tightly regulated group than those cared for with the flexible protocol.

Similarly, maintaining normal blood sugar in ambulatory diabetics with vascular problems has been a key quality metric in assessing physician performance. Yet largely due to two extensive studies published in the June 2008 issue of the New England Journal of Medicine, this is now in serious doubt. Indeed, in one study of more than 10,000 ambulatory diabetics with cardiovascular diseases conducted by a group of Canadian and American researchers (the "ACCORD" study) so many diabetics died in the group where sugar was tightly regulated that the researchers discontinued the trial 17 months before its scheduled end.

And just last month, another clinical trial contradicted the expert consensus guidelines that patients with kidney failure on dialysis should be given statin drugs to prevent heart attack and stroke.

These and other recent examples show why rigid and punitive rules to broadly standardize care for all patients often break down. Human beings are not uniform in their biology. A disease with many effects on multiple organs, like diabetes, acts differently in different people. Medicine is an imperfect science, and its study is also imperfect. Information evolves and changes. Rather than rigidity, flexibility is appropriate in applying evidence from clinical trials. To that end, a good doctor exercises sound clinical judgment by consulting expert guidelines and assessing ongoing research, but then decides what is quality care for the individual patient. And what is best sometimes deviates from the norms.

Yet too often quality metrics coerce doctors into rigid and ill-advised procedures. Orwell could have written about how the word "quality" became zealously defined by regulators, and then redefined with each change in consensus guidelines. And Kafka could detail the recent experience of a pediatrician featured in Vital Signs, the member publication of the Massachusetts Medical Society. Out of the blue, according to the article, Dr. Ann T. Nutt received a letter in February from the Massachusetts Group Insurance Commission on Clinical Performance Improvement informing her that she was no longer ranked as Tier 1 but had fallen to Tier 3. (Massachusetts and some private insurers use a three-tier ranking system to incentivize high-quality care.) She contacted the regulators and insisted that she be given details to explain her fall in rating.

After much effort, she discovered that in 127 opportunities to comply with quality metrics, she had met the standards 115 times. But the regulators refused to provide the names of patients who allegedly had received low quality care, so she had no way to assess their judgment for herself. The pediatrician fought back and ultimately learned which guidelines she had failed to follow. Despite her cogent rebuttal, the regulator denied the appeal and the doctor is still ranked as Tier 3. She continues to battle the state.

Doubts about the relevance of quality metrics to clinical reality are even emerging from the federal pilot programs launched in 2003. An analysis of Medicare pay-for-performance for hip and knee replacement by orthopedic surgeons at 260 hospitals in 38 states published in the most recent March/April issue of Health Affairs showed that conforming to or deviating from expert quality metrics had no relationship to the actual complications or clinical outcomes of the patients. Similarly, a study led by UCLA researchers of over 5,000 patients at 91 hospitals published in 2007 in the Journal of the American Medical Association found that the application of most federal quality process measures did not change mortality from heart failure.

State pay-for-performance programs also provide disturbing data on the unintended consequences of coercive regulation. Another report in the most recent Health Affairs evaluating some 35,000 physicians caring for 6.2 million patients in California revealed that doctors dropped noncompliant patients, or refused to treat people with complicated illnesses involving many organs, since their outcomes would make their statistics look bad. And research by the Brigham and Women's Hospital published last month in the Journal of the American College of Cardiology indicates that report cards may be pushing Massachusetts cardiologists to deny lifesaving procedures on very sick heart patients out of fear of receiving a low grade if the outcome is poor.

Dr. David Sackett, a pioneer of "evidence-based medicine," where results from clinical trials rather than anecdotes are used to guide physician practice, famously said, "Half of what you'll learn in medical school will be shown to be either dead wrong or out of date within five years of your graduation; the trouble is that nobody can tell you which half -- so the most important thing to learn is how to learn on your own." Science depends upon such a sentiment, and honors the doubter and iconoclast who overturns false paradigms.

Before a surgeon begins an operation, he must stop and call a "time-out" to verify that he has all the correct information and instruments to safely proceed. We need a national time-out in the rush to mandate what policy makers term quality care to prevent doing more harm than good.

Dr. Groopman, a staff writer for the New Yorker, and Dr. Hartzband are on the staff of Beth Israel Deaconess Medical Center in Boston and on the faculty of Harvard Medical School

Brain Trauma - Interactions - Update 4

When we use meds and even natural supplements, interactions can occur. How meds and supplements are metabolized and eliminated from the body become very important.  The pathways that eliminate one med can block a pathway for either the absorption or excretion of another med.  That either increases or decreases the levels of the other med. 

Herbals and even fruits like grapefruit can be very problematic.   Obviously, there can be side effects to anything we put in our body.  I experienced two problems.  First, I was accustomed to using a number of herbal supplements and found some were a problem  .  Second, the combination of Vyvanse and Pristiq raised my levels of noradrenalin too much.  This caused a slight tremor and sense of inner tension at times that was uncomfortable to me.  It wasn’t overwhelming.  It just was there and bothersome to me.

I had to gradually isolate and eliminate any of the herbals that caused me problems.  But it was not always easy to figure out if something was bothering me or not.  For instance,  I was taking a Vitamin C that also had high amounts of Quercitin in it.  I eventually learned it was the Quercitin that definitely caused problems.  I eventually learned that Milk Thistle, Curcumin, Pomegranate, Green Tea extract, Black Tea extracts and even bioflavonoids in typical Vitamin C caused problems.  It was very frustrating!! 

I spent time on forums where people discussed their experience with different meds.  It seemed EVERYBODY on the forums had all kinds of problems and often blamed the med.  Now the med may in fact, been bad for them, but in my experience if someone is taking meds, they often are also taking other supplements to try to help themselves get and feel well.   It made me think that many of the problems these people were experiencing were from other herbs and supplements they were taking.  It is very easy to confuse the two. 

Today most psych meds are prescribed by GPs (General Practitioners).  These docs get most of their info from the pharma reps and also don’t focus on the psych area so their experience is very limited.  Even psych docs get this stuff wrong.  My own psych doc got me into deep trouble in just 6 days by prescribing inappropriately.  It is a very frustrating area.  The brain is still mostly unexplored territory and extremely complex.  It seems rare to get it right the first time, the second time or ever.  Then complicate it when people are “self medicating” with other herbals and supplements and you can have a real mess on your hands very quickly.  I gradually worked out what additional supplements I could take and which ones I couldn’t. 

So then I had the noradrenalin problem to get fixed.  Dr. Parker and I tried a few different approaches.  Taking Pristiq at a different time.  Taking less Pristiq.  Taking it every other day.  Lowering the dose of Vyvanse.  None of these approaches worked.  I would still have the tremor/tension.  So he finally prescribed an old, very mild hypertension med called Tenex (guanaficine).  One of the things it does is mildly block the action of noradrenalin in the body.  So a very small dose of Tenex did the trick.  I learned that Tenex was fairly often used when a stimulant was used to treat ADD. 

I was glad I had a solution but it was beginning to bother me regarding the number of meds I was taking.   Especially since I was taking some meds to counteract what other meds did to me.  While there was no question I was functioning better, I did not like the feeling of needing to take so many meds.  However, I knew I would continue to choose better function over my dislike of the meds.   More in the next post.

Brain Trauma - A New Doc - Update 3

I have found things are usually not simple.  Read my book and you will get some idea of how complicated a web of chronic unwellness can be.  Well taking Vyvanse was that way too.  The goal is to find the right dose.  One that lasted about 12 hours.  30mgs lasted about 5 hours in me.  When I talked to my doc about this after my first dose he said to take 60 and then increase it more till it lasted 12 hours.  He even said I could take a dose early and one later.  So over the next 6 days I kept increasing the dose till I was taking 90mgs.  And I crashed.  Totally crashed. 

I felt totally depressed.  I wept for no reason at all twice.  I was a mess in less than a week!  I immediately stopped the med and felt better.  But I was so disappointed.  It was so promising the first two days, but then went straight downhill from there.  I was perplexed.  So I researched.  I read and read.  I found a few blogs by psych docs who used Vyvanse extensively and mostly specialized in treating ADD.

What I read made me mad.  I learned it was important to very slowly raise the dose over several  weeks until the right dose was found both for effectiveness and duration.  One website was particularly helpful.  www.corepsych.com .  Dr. Charles Parker, in Reston VA,  wrote a blog that resonated with so many things for me.  First off, he had run the Amen Clinic in Washington DC for 5 years and then went back into practice treating patients.  (Amen Clinic is basically a diagnostic service to other docs.)  One of the services he offered was giving 2nd opinions on SPECT scans.    So I set up a teleconference.  I sent him all my scans, reports and filled a host of new forms for his office.  I then had a 2 hour conference with him by phone.   It was VERY interesting.

First he agreed that I had been under-treated for very obvious issues and he was kind of upset about it.  He said they basically took the approach of trying to simply stabilize me from the ups and downs I had experienced for the past 35 years.  But they had ignored major findings and did not treat me.  He also said he felt that Amen had missed a significant finding that would explain why I responded so well to Vyvanse at first and then crashed.   He said he sees it all the time in his practice. 

Rarely does only one condition exist but rather there are usually “co-morbid”  conditions.  Typically, if all the issues are not dealt with, then one med can often either not work or cause other problems.  This is why it is not unusual for people on psych meds to struggle to find the right med or combination of meds that will actually work and help them to function at a higher level.

He said the condition that Amen did not mention was the fact my whiplash accident caused injury to both the front AND back of my brain.  The front was related to my ADD symptoms but the back was tied more to depression because the injury damaged the area where serotonin has more of an effect.  Dopamine effects the front and serotonin the back primarily (admittedly simplistic).  Truth is both are working throughout the brain but these are primary areas where they work.

He explained that dopamine and serotonin were sort of on a teeter totter with each other.  When one goes up, the other goes down. In my case, my teeter totter was broken in that BOTH dopamine and serotonin were both starting out low.  Raising dopamine drove serotonin even lower.  That is why I crashed into a weepy depression.  Vyvanse dramatically increased dopamine in my PFC.  But as it did so it lowered my serotonin even lower.  He said my initial response to Vyvanse told him that it was likely a good med for me, but we had to raise serotonin and  noradrenalin as well.  For this he recommended Pristiq.  

Pristiq is another very new med.  It is the son of Effexor.  Pristiq is a SNRI. It raises both serotonin and noradrenalin. Pristiq is an isolated metabolite of Effexor that appeared to be the most effective and active metabolite.   It was believed from studies that it was a much “cleaner” med than Effexor with  a lower side effect profile than Effexor and other SNRIs and SSRI’s.  

One major problem that working with Dr. Parker caused was the fact that he was in VA and I was AZ.  The rules would not allow him to be my official doctor unless I actually saw him in person.  Since it was quite an inconvenience for me to do this I took a different course.  I went back and visited an doc, an MD who I had worked with often in the past 12 years or so as he tried to help me unravel all my mysterious symptoms.  He was a good guy, a friend and often had been helpful to me.  I told him all the new stuff I had learned from Amen Clinic and Dr. Parker.  He was excited to learn I had uncovered a huge underlying cause of many of the issues we had struggled with over the years.  I asked him if he would work with me and Dr. Parker by prescribing the meds that Dr. Parker recommended.  He said that as long as he understood what we were trying to accomplish with each med he would be happy to do this. 

Now this is a bit unusual because most docs would never do this.  THEY are the experts and don’t need any other doc telling them what to do!  His involvement will become an important piece of this update as you will see later.

So within a few days I was on Pristiq and Vyvanse.  And I began to feel much better.  We very gradually worked the dose of Vyvanse up to where I could feel it’s effects for about 12 hours.  The effects quickly became much more subtle than my original reaction.  I simply could tell that I was far more focused and calm.  My thoughts did not go racing through my head.  I found out what it was like to have a working Executive Center.  I felt I could consider business options much more effectively.  I did not have my usual tendency to impulsively make a decision.  If something bothered me, I could simply think about it for awhile until settling on a direction.  And Vyvanse did not push me into depression because Pristiq was doing a great job raising the levels of other neurotransmitters.  I felt like my brain was hitting on most if not all cylinders again.  It felt great!  But there were still problems to solve.  More in the next post.

Brain Trauma - My brain works better - Update 2

The pre-frontal cortex is the executive center of the brain.  It is where problem solving, emotion and complex thought takes place.  Damage, or under functioning in the PFC is what most often causes  inattention, distractibility and impulsiveness.  It is the source of most ADD/ADHD.

The more I read the report from Amen the more it was obvious to me everyone simply had either missed or ignored this finding for some reason.  I have my suspicions but I won’t get into that.  But from the SPECT scan, it was very clear there was very little blood flow in my PFC.

So I went back to my doc and asked why nothing had ever been done about the main finding from Amen Clinic?  He said, “what do you mean?”  I showed him the report and he sort of just looked at it and said well that is interesting.  I had told him many months before that since my accident, many years ago,  I struggled with inattention, being easily distracted and very impulsive.  I also experienced times of explosive anger where I could go off in a near rage but then 30 seconds be totally fine.  Everyone else around me though would be a mess however! 

He said these were all classic symptoms of ADD/ADHD and damage to the PFC.  I asked why we had not done anything about this before?  He replied, “well you seemed to be responding well to the things we were doing and it did not occur to me to do anything more.”  I was not happy with him but what are you going to do?  I had been helped but now I realized I could probably be helped a whole lot more.

He said that we could find out really quickly if I could be helped by an ADD stimulant.  He said I would likely know in a few days if I could feel better.  So he wrote a Rx for Vyvanse.  Vyvanse is the son of Adderall.  A new med that cannot be abused like other amphetamines.  This is due to the fact that the Amphetamine is bound to Lysine and has to be metabolized to release the stimulant.  And the stimulant is only released gradually based on how fast you metabolize it.  The goal is to find a dose that lasts about 12 hours.

So the next morning I took the smallest dose, 30mg and went to work.  About 45 minutes later I went “WOW”.  An amazing quietness came over my brain.  My thoughts slowed in a way that I could not remember ever feeling.  My thoughts were not altered, they just came at me in a slower, more controled way.  My head was quiet!!  I had grown so accustomed to thoughts racing through my head that I thought it was normal!!  35 years of having a Traumatic Brain Injury (TBI) how did I know what normal was? I knew I had developed many compensatory skills to deal with the pace of my thoughts but now I did not need to work hard to pay attention or to stay calm.

Well, if this new brain speed was normal I wanted more of it!  I almost cried.  I felt so amazingly good.  It was not a euphoric feeling.  It was just a feeling of calm, quiet and control over what was going on in my head.  I knew I had hit on a new answer for my health.  More in the next post.