Thursday, June 23, 2011

A Nicotine Vaccine Just Might Cure Smoker’s Addiction




Peter Coleman, M.D. 

People love to smoke their cigarettes even though at the exact same time they hate the fact that they smoke.  They decide not to quit even though at the exact same time they would love to quit.  What a paradox this is!  In many ways cigarette smoking is one of the best models we have for the addiction process. It can help us understand the other, (more serious?) addictions we treat - Heroin, Oxycodone, Alcohol and Cocaine. 

Nicotine goes right to the pleasure center of the brain and activates the Dopamine pathways making us feel good and wanting us to keep smoking even when we know it is bad for us.  It can relieve negative feelings we don’t like including loneliness, fatigue, boredom, anger, and anxiety.  Intense cravings for cigarettes can be brought on by triggers in our environment.  Very soon after it is smoked the Nicotine goes to the brain and has all of these very powerful effects.

But what if there was a treatment that forever prevented the nicotine from getting into the brain.  What if there was a medical treatment that permanently would not allow nicotine to have any of these effects on the pleasure center or the other parts of the brain?  Such a treatment is being developed and is showing great promise!

An important thing to know about all drugs of abuse, including Nicotine, is that the molecule has to be small enough to get through the blood brain barrier.  If the molecule is too large it simply can’t get into the brain and so it can’t have any of its effects in the brain.

This is where vaccines come in.  Vaccines force the body’s immune system to make specific antibodies to attach to anything foreign that our body decides is dangerous.  So in order to cure drug addiction a great technique would be to get the immune system to make antibodies that would physically stick to a drug of abuse.  The resulting complex –the drug of abuse with the antibody attached - would be too large to cross the blood brain barrier.  The new complex would not be able to enter the brain.

This idea is not new.  In fact, some research done 40 years ago with morphine showed that rats could be induced into making antibodies against morphine.  These antibodies actually reduced the amount of morphine rats would use and when the same technique was applied in monkeys, similar studies showed the monkeys used less Heroin.

It is not very easy to induce animals to make antibodies to drugs of abuse because the molecules are small and generally not considered very “foreign” to the body.  So scientists have to combine the drug of abuse with something that the immune system considers to be dangerous, and then the immune system will make antibodies quite well.

When it comes to vaccines for cigarette smoking, scientists at three different companies are working to get a product that reliably forces the body to make antibodies in sufficient quantities to bind to Nicotine.  One of the vaccines that has made the most progress is called NicVax, made by Nabi Pharmaceuticals.  Recently I was at a conference where I was fortunate enough to hear a presentation from a company representative.  They have made amazing progress and are getting close to completing their final clinical trial before they submit for FDA approval.  NicVax has combined nicotine with a protein from bacteria called Pseudomonas.  Our bodies don’t like pseudomonas bacteria and our immune systems immediately react and make antibodies to both the pseudomonas component but also to the nicotine component.  These antibodies are then able to bind to nicotine if it is smoked and the nicotine cannot get into the brain.  There are no major side effects with this vaccine.


Results of testing in cigarette smokers are very promising. Patients given NicVax are able to make antibodies against nicotine.  It is necessary to give multiple doses of the vaccine in order to get high levels of antibodies and it can take up to 14 weeks to get these high levels.  The most recent reports indicate that, with a series of 6 shots, around 80% of patients in the trial are able to make high levels of antibodies.  The high antibody levels seem to last well over a year and it is likely that some of these antibodies will remain for life.  Some patients may require booster shots at some point.

The studies clearly show that patients with high levels of antibodies stop smoking fairly well.  Currently the results for these patients show that about 24% of them stop smoking completely for 12 months.  It is most likely this number will increase if patients take more booster shots.  What is most interesting in the studies is that the quitting rate keeps going up as the trial progresses – in contrast with most studies of other smoking cessation products where there is a steady decrease in success as some patients return to smoking.  With NicVax the number of quitters keeps increasing.  This makes sense when you think that with NicVax, patients have the antibodies that prevent them from enjoying cigarettes.  It seems likely that more and more of these patients will readily give up their cigarettes as they realize they are not getting much out of it.  Indeed, the studies show that even for the patients who keep smoking they are still partially successful. These NicVax patients who keep smoking find that their smoking goes down by about 50% as they realize they are not getting much out of it.

I believe Nicotine vaccines will play a powerful role in helping patients quit smoking.  If these vaccines can produce high enough levels of antibodies that last for a lifetime, we really can talk about a cure for smoking.  Once the vaccine has been given there will be no turning back.  I wonder if it will ever bring up an ethical question – should we be giving a treatment that permanently takes away patients option to change their minds. What if they ever want to return to smoking again?

Wednesday, June 22, 2011

Observing Grief

Chris Newcomb, M.Div.

I heard a very sad story yesterday while discussing aftercare plans with one of our detox patients.  This individual lost three family members on the same day, at the same time, and it was a murder-suicide!  That’s right; the patient’s father decided he couldn’t live any longer.  Not wanting to leave his wife behind to mourn his death, he decided to kill her first.  His sibling, an adult with the brain of a child, was also murdered so that he wouldn’t be a, “burden to anyone” or so the father reasoned.  Then to conclude this horrid series of events, the father took his own life.  To top it all off, this took place on a major holiday last year that is usually a time for celebration, joy, and family bonding.  In all seriousness, no wonder our patient was using drugs!  

I can’t tell you how horrible I felt for this person.  In their grief, they decided to use drugs.  The pain was, understandably, felt like it was too much to bear even for a sober individual.  Grief had come in like a typhoon and the only way, they thought, out was to medicate the awful feelings they were experiencing with opiates. 
 
A little over 24 hours ago, I faced a very tough decision in my life.  My cat, Delilah, whom I have had the pleasure of knowing the past 16 years, had gotten sick over the weekend.  She was vomiting and staying secluded in one of the upstairs bedrooms of our house.  My wife and I thought perhaps it was a stomach bug and she would recover very quickly.  We were in for a surprise. 

On Monday, two days ago as of this writing, we took Delilah to the vet.  It turned out that she had chronic renal failure (i.e. kidney failure).  From a pain level perspective, our vet said that a score of 80-100 points indicated ‘severe pain’.  Delilah’s score was 180.  She was most likely experiencing, at best, profound nausea and, at worst, excruciating pain.  We had a decision to make. 

Our topic for this month is Step 6 from the Big Book of Alcoholics Anonymous.  This step says that we “were entirely ready to have God remove all these defects of character.”  Defects of character lead an alcoholic or drug addict to use their substance of choice.  For example, a person with the defect of character of rage might decide to shoot heroin instead of dealing with the intense feelings of anger that are so uncomfortable to experience. 

There is a litany of possible character defects such as jealousy, resentment, success, failure, or lust to name a few.  I would like to highlight in this article how grief can be a character defect.  While it may seem harsh to say, even something as powerful, and often appropriate, as the emotion of grief can be a character defect that can cause great harm in our lives or the lives of those we care about.

The vet told us that we could take Delilah home and try a few different treatments to improve her quality of living.  The success rate long-term was roughly 10%.  Not a good number.  If we could afford it, he advised we could even do a kidney transplant for her.  We couldn’t afford it. 

The only other option was to put her down.  I was horrified.  She had been my best “animal friend”, so to speak, for 16 years, through college, graduate school, and ten years of my working life.  I couldn’t imagine her dying.  Sure, I knew she was getting older but she never really had any health problems up to this point.

I was inundated with questions:  Is this the right choice?  Can I go through with it?  What if I’m wrong and she can be healed?  Can I live with this choice?  How will I deal with the pain if she dies?

My wife and I talked and cried and cried and talked.  We realized that we really only had one choice and that was to put her down unfortunately.  I leaned over to the cage and told her that I would do anything I could to save her but we just didn’t have the money.  I told her that I loved her and she would never be forgotten and was always in my heart.  She let out a small whimper cry and turned around looking away from us.  We both understood her to be saying, “Goodbye, I can’t take this anymore.”  It was hard to watch.  And, I made the hardest decision I’ve ever had to make.  At 12:32pm on Monday, June 13, 2011 I made the awful choice to put my beloved cat Delilah to sleep.  Forever.  She now is buried in our backyard in between an azalea bush and a shed with impatiens flowers to mark the spot. 

Grief is never fun.  It is a deep, dark pain that blows through your soul.  It rips at the very edges of your sanity and turns your emotional center upside down.  I knew that the day would come when I would have to let Delilah go.  I had no idea how awful and difficult that would be.  I always hoped I would find her dead not that I would be the judge and jury setting up her execution.  While it was in spirit of an act of mercy, it surely didn’t feel that way. 

Now as time passes, I long to have her back.  I want to pet her.  I want to hear her purr.  I want to watch her play and chase toys around the house.  Those are now just memories.  So, what is there left for me to do now, you may ask?  Not let my grief become a character defect that hurts me or others.

So, why am I telling you this story?  There are two reasons.  First, writing this article is a way for me to honor my friendship with Delilah.  It is a way for me to acknowledge my pain without destroying myself.  I used to love to get drunk in high school.  I loved the feeling.  I could certainly use that feeling now, at least, over and against the angst I feel over my loss.  That would be a choice to use grief as a character defect.  I can’t make that choice today. 

Second, writing this article is a way for me to serve others by encouraging them to take stock of their relationships.   We never know how long the people, or pets, in our lives will be around.  Treasure them and spend time with them.  You’ll be glad you did when they’re gone.
 
My patient has a long road ahead.  It will take years of counseling, meetings, and tears for them to come to grips with not only the horrific events that happened to their relatives but also how they, for better or for worse, used their grief as a character defect and destroyed their life.  The good news is my patient decided to come to us for help to get their life back.  My patient has 100% support from The Coleman Institute!  

This month, please take a few moments to see what character defects you might have lurking in your life.  Be honest.  Take an honest inventory and see what they are, how they operate, and ask your higher power to shut them down by helping you choose safe and healthy alternative ways to deal with the pain life brings your way. 

Delilah was given her name because of a song, of the same name, by the rock band Queen.  I will end this article in her memory with a quote from that song for my furry, feline friend Delilah:
 
“Delilah, you're the apple of my eyes

Meow, Meow, Meow

Delilah - I love you”
 
 Delilah
(5/15/95 - 6/13/11) 

Wednesday, June 15, 2011

Buprenorphine Pain Patch



Peter R. Coleman, M.D.

Recently some drug reps from Purdue Pharma came to let us know about a new pain patch that has come on the market.  It is called Butrans and is available in three different strengths.  It contains the drug Buprenorphine.  The Buprenorphine is delivered in fairly low doses, but it is provided in a steady dose for a whole week.  It has been found that when the drug is delivered in this way over an extended time, it is not necessary to use very high doses.

Butrans has been studied in patients with moderate to severe chronic pain.  Usually patients have been switched from other opiate drugs and continued on the patch. The results have shown that about 60% of patients were able to switch to the patch. The studies lasted about 12 weeks.  There were two studies that did not show that the Butrans patch had any pain relieving value, but in one of the studies the other opiate it was compared to had no value either.

One of the advantages of a steady patch like this is that patient will get a steady dose of the medicine and be less likely to abuse it.  We see this with Fentanyl pain patches and it really is a big advantage when so many patients take more of their medicines than are prescribed.

There are a couple of negatives about this drug.  First, it is only strong enough to treat pain for patients who are on quite low doses of other opiates.  So, the very patients that we worry will abuse their medicines are not going to be able to take this patch.  Second, we don’t know if the pain relief that was seen in the short-term studies will last for months or years.  Third, we don’t know if there will be major problems with withdrawal when it is time to stop the patch.  The patch is also very expensive when compared to short-acting opiates like hydrocodone.

It is good to have another medicine we can use for pain patients. It will be interesting to see if it finds much of a use in clinical practice.