Posts Tagged ‘FDA REMS’

Chronic pain- Recent Updates

2010-03-04

Hi everyone,

Recently, I’ve been having a difficult time with various illnesses  so I am a little behind on posting.  I have found multiple articles that may be helpful to those of you with chronic pain.

First let’s discuss slow breathing might help pain.  I first learned about this practice in prenatal classes prior to the birth of my first-born.  Imagine the scene on of Alien when Sigourney Weaver’s guts were being ripped apart by the alien.  Slow breathing did little to help 13 hours of Pitocin induced hard labor.

Fortunately, I have found tha slow breathing can be affective for chronic pain as well as anxiety attacks related to my FTD.  The author also mentions mindfulness exercises which I do incorporate with slow breathing.

Try to sit in a relaxed position.  Breathe slowly and concentrate on each breath and how it feels as it goes in and out .

Regarding mindfulness exercises, the mind is a wild horse and it takes awhile to “break it in.”  If you continue practicing mindfulness exercises which can be something as simple as repeating one syllable phrases over and over again, the results you will gain in helping to control your pain will be well worth the time.

The next article is Tattletale Pills Remind You to Take Your Medication.  Two topics are discussed.

Companies are using wireless technology to develop devices that monitor whether you take your pills.  One way people may be doing this in the future is swallowing a microchip about as thin as a few human hairs.

Over a two-year period, it became increasingly difficult for me to remember to take my medicines and take the correct dosage.  Fortunately, Selch has worked out a system that makes it easier to make sure I receive correct dosages at the correct times.  He bought a large square pillbox that has little boxes for each day of the week and boxes for morning, lunch, afternoon and bedtime.

He or my aide have to pour my meds which also include pouring  liquid pain medicine  into small plastic bottles for each time I need to take a dose.  Even though we have an organized system, someone still has to remind me to take my meds.

The author of the article writes about  a pill that, once ingested, wirelessly transmits information about side effects and how well it’s working. 

Information is sent it back in a readable form to a cell phone or e-mail account.

I wonder if it also tracks any information about side effects that may occur?  The author writes it might be available as soon as the end of 2011 but I imagine that it will be first  for the kind of medication that gets the most attention and research funding such as cardiac meds.  Still, if it works, it may be able to benefit those of us who take medication for chronic pain and FTD within the next five years.

The other invention discussed in the article is the GlowCap that helps people remember to take their medication.

If I was still taking my meds from a bottle,  I don’t think I would see the glowing orange light.  Also what “melody” are they talking about?  Have you ever seen the movei, “Little Shop Around the Corner?”  Jimmy Stewart plays the head clerk.  The manager bought a large amount of cigar or cigarette boxes that play a melody when the person opens the box.  No one wants to buy them and Margaret Sullivan ends up getting a job as a clerk in the store because she convinces a woman to buy the box by telling her that it is a candy box.  When you open the box to take a piece of candy, the melody plays so it reminds you not to eat too much chocolate.

The next article is New Extended Hydromorphone approved.  Hydromorphone is also known is Dilaudid which is one of the medications I take in liquid form for breakthrough pain.

Dilaudid, in past research, is known to be a short acting medication so an extended release version I think is definitely a plus for chronic pain sufferers because Dilaudid can be very affective in helping pain.  It works by making the person feel like the pain is not as bad as it is.

As Karen says, Exaglo is being released under the REMS program which we in the chronic pain have been welcoming like the plague.

The company that developed Exaglo is CombinatoRx, Incorporated (CRXX) which develops novel drug candidates with a focus on the treatment of pain and inflammation.

An article in Bioworld says Exalgo’s REMS  includes “safe-use tools” for prescribers, patients and pharmacists to ensure the “right patients” get the drug and at the appropriate dosages, he said.

Neuman noted that Exalgo’s REMS is less restrictive than the one Covidien initially had recommended to the FDA, which currently is working on developing a classwide opioid REMS.

As I have explained in previous articles, REMS for other specific long acting narcotics as they stand now are very restrictive and will certainly cause many physicians to stop prescribing these narcotics and many pharmacies to stop dispensing these narcotics.

In Pain Topics.org, they outline the REM requirements for Exalgo.  They sound much like the REM plans for other narcotics.  I am concerned that even if a doctor agrees to enroll in the Alliance program and patients agree to enroll in the program that pharmacists will not enroll in the program.

Let me give you a personal example.

We have recently moved and Sech went to the local CVS to get my pain meds. filled.  We had no problem in obtaining the medication at the pharmacy in the previous state  where we lived . All CVS stores order from the same distributors.  Selch spent three weeks getting the run around from our new local CVS pharmacist before he finally agreed to order my medication.  When Selch brought the meds home, he opened the sack up to discover that the pharmacist had given me the Mylan Fentanyl patches although Selch had specifically ordered the Sandoz patches.  Mylan do not work as well for me.  I am not putting them down, to each his/her own and I bless what ever works for you.

The pharmacists said that Sandoz patches were not available.  CVS stores nationwide order from same distributor.  This does not compute.  If this is the attitude of pharmacists now will they be willing to enroll in this Alliance Program?

Notice in the Pain Topics commentary that” FDA Briefing Material for the meeting  provides no data indicating exceptional abuse liability for hydromorphone and  a clinical study conducted in only 9 subjects that found hydromorphone was no different in abuse potential than hydrocodone or oxycodone.”

Also, “hydromorphone products accounted for less than 1% of nonmedical use of all pharmaceuticals, less than 3% of such cases involving opioid agents, and it was implicated in less than 1% of all drug-related suicide attempts.”

I agree that data does not call for such a restrictive program for this new drug.  Lack of data has never stopped the feds from involving themselves in the practice of medicine and trying to persuade physicians not to prescribe narcotics.  Remember the  DEA practice ofraiding of doctor’s offices a few years ago?

The author of Pain Topics asks, “Will there eventually be separate REMS programs for every opioid analgesic, each with its own registration requirements and prescribing procedures?”

Unfortunately, I say yes there will be if they have their way about things.  I don’t know what drives the DEA and the FDA to practices that are and will keep more and more chronic pain patients from receiving their pain medications.

They consider those of us who need narcotics to have any quality of life an acceptable sacrifice for their stated agenda which is  to keep people from abusing prescribed pain medication.  Even their own studies and data do not show that there is significant abuse in people who take prescribed pain medication.

Taking pain medication away from people who need in it in hopes that it will keep people from abusing drugs(who are taking their relative’s and friend’s pain meds)  is not realistic.  When you cut off one source, people who abuse narcotics will just find another source for their habit. Despite the “War on Drugs,” narcotics are plentiful.  So what have they accomplished?

Are these agencies that naive or is this a power agenda?

I have no idea, but we as chronic pain patients need to tell everyone we know what is going onand  we or our loved ones who understand what is going on need to write our congressmen.  I understand that we are all victims.  We are victims of our illness and victims of the medical and governmental system.  But, the only way I  see that we can make a difference is if we ban together and tell anyone who might be able to help us in our cause for the right to have adequate pain relief.

There are some rays of hope in this darkness of denial such as the MayDay Pain Project.  John Stossel recently did a program about the plight of chronic pain patients, War on Pain.  It was on the Fox Business Channel so most of us were unable to see it.   To watch the program go here.

One of the physicians in the practice where I go for pain management is involved in the MayDay project.

Let’s all pray that someday soon this world will WAKE UP.  Until then, remember we are all brothers and sisters united by our souls.  Whether you believe it or not the thoughts that we think may affect our reality so try to think positive thoughts.  I’ll be thinking positive thoughts for all of you and know that you are always in my prayers.

Anti-depressants may not work

2010-02-02

I just read an article in Newsweek that says antidepressants may be no more effective than placebos. I have been on several antidepressants.  My relationship with antidepressants started when I was having moderate situational depression.  The doctor tried putting me on three or four antidepressants but none of them helped and I had the additional burden of side effects along with depression.

The only thing that helped my depression was getting out of the situation.  But, I have talked to many people who swear that antidepressants help them so I’ve always thought if they work for them and they suffer no side effects then I wish them the best of luck.

After I developed symptoms that could not be explained, physicians that I saw always pushed antidepressants.  They told me they weren’t saying that everything was in my head and that anti-depressants actually had been shown to help my symptoms.

I gave them another go round.  Again, nothing but side effects.  So, I started refusing antidepressants.

Then, my doctor diagnosed me with complex regional pain syndrome.  He has a very scientific way of thinking and explained to me in a scientific manner why antidepressants work.  So once again I hopped on the horse.  This time my companion was Cymbalta.  For the first two weeks, I actually felt better.  I happened to be on vacation in No Where’s Ville, Pennsylvania when I had a severe anxiety reaction due to Cymbalta.  My physician advised that I immediately stopped taking it.

After that, I started doing some research of my own regarding side effects of antidepressants, reading some studies and reading  lots of testimony from other patients that  made me realize that antidepressants can have some major side effects, even suicidal ideation.

Since then, the only thing I have let my doctor prescribe in the anti-depressant category is Trazadone in a very small dose to help me sleep at bedtime.

I have been mostly focused on side effects of anti-depressants in recent years and haven’t paid that much attention as to whether they worked or not.  Many people said that they really work for them and who am I to judge?

I do remember reading a study that said the body adjusts quickly to change in serotonin levels.  I also read recently that serotonin levels are not the hallmark for depression that everyone has been thinking they are.

The article in Newsweek says that studies show that anti-depressants are no better than placebos.  I believe we all have the ability for self healing if we are able to have faith.  Perhaps there is something to the placebo effect and no one should be concerned or ashamed if it truly is a placebo effect.

I am  concerned  that when everyone starts reading this article , they might discount the placebo affect and perhaps not feel as well.  I suggest reading the writings of Edgar Cayce if you are open minded.  His abilities are an example of how the mind does have the power to heal.

I grew up in church where they told us that healing only came through Jesus.  Now I do believe that healing does come from God but the power to heal has been given to all of us.

Remember the passage in the Bible that said if you have the faith of a mustard seed you could move mountains.  I think so.

I once knew a man who had the “gift” of healing.  He knew this gift came from God and everyone has the potential ability to “heal.”  It is one of God’s gifts to humanity.

I cannot say whether antidepressants work for others or not.  In the article someone asked why would the FDA would approve antidepressants if they didn’t work?  The FDA has a huge political agenda and they are not always looking out for the best interest of the people.  See FDA REMS and the fact that they have blocked two new pain medications that might help chronic pain patients.

Please if you are on an anti-depressant, talk to your doctor before you decide to stop taking your medication.  If you get off antidepressants suddenly it can cause serious withdrawal symptoms that could be life threatening.

Opioid Treatment and the Chronic Pain Patient

2009-12-04

Today I read the following post

Long-Term Opioid Therapy – What Are the Effects?

Most people who need to take opioids on a long-term basis for chronic non-cancer pain are understandably concerned about what kind of effect it will have on them.  Many have mistakenly believed that opioids destroy both the body and the brain – and possibly even shorten lives.  Although pain management experts have long contended that opioid therapy is not dangerous when properly administered, until now there has been no actual research on long-term opioid use (10 years or more) to back them up.

Enter Forest Tennant, MD, who undertook a first-of-its-kind research study evaluating chronic pain patients who had been receiving opioid therapy for 10 to 35 years.  The results of his study should be extremely encouraging for patients who need long-term opioid therapy as well as their doctors, some of whom may have been hesitant about it.  Tennant concluded that the significant improvements in quality of life and physical functioning from opioid therapy are so positive they outweigh any negative complications, which can be easily managed.

Research Methods

Tennant’s study looked at 16 female and 8 male chronic pain patients between 30 and 79 years of age.  Their chronic pain conditions were:

Neuropathies and Arthropathies – 29.2%
Spinal Degeneration – 25%
Abdominal Adhesions or nNeuropathies – 20.8%
Fibromyalgia – 12.5%
Headache – 8.3%
Hip Necrosis –4.2%

The subjects had all been receiving continuous opioid therapy for 10 to 35 years.  All were taking a long-acting form of morphine, oxycodone, fentanyl or methadone and one or more short-acting opioids for breakthrough pain or pain flares.  They all also took additional medications such as muscle relaxants, sleep aids, hormone replacements and dietary supplements.

Study Results

Almost all of the patients (22 of 24) said their pain had permanently decreased over time.  And the vast majority (20 of 24) felt their opioids still provided the same relief as when they started treatment.  All of the patients  reported one or more functions or activities they can do now that they couldn’t do prior to beginning opioid therapy (i.e., get out of bed everyday, take walks, shop or visit friends).

Several new medical conditions developed in the group over the 10+ year period, such as hormone abnormalities, weight gain, tooth decay, tachycardia, hypertension, osteoporosis, hyperlipidemia, and diabetes.  There was no clear way to determine whether these conditions were caused by the pain, the opioid therapy, the natural aging process, or were just inherent in the patients; however, all of the conditions could easily be medically managed.

All but one of the males in the study experienced lowered serum testosterone, a known complication of opioid therapy, which can be controlled by hormone replacement therapy.

Notably, there were no neurologic complications including dementia, hyperalgesia, tremor or seizures.  Nor were there any liver, kidney, or gastrointestinal complications, except for minor constipation.
Conclusions

Rather than causing serious health problems, Tennant suggests that because of the decrease in pain, opioids may actually allow or even promote neurologic healing.  He goes on to suppose that opioid therapy may prevent a number of medical complications of pain and also may prevent early death due to the over-stimulation of the pituitary-adrenal-axis or possibly electrical stimulation produced by damaged nerves.  Tennant acknowledges that this is a small study and states that much additional study is needed to determine cause and effect of medical conditions in opioid-maintained patients.

Finally, Tennant concludes, “Even though the number of patients evaluated here is relatively small, the great improvement in their quality of life and physical functioning is so positive and the complications of the therapy so easily managed that long-term opioid therapy should continue to be provided and evaluated.”  End of article


I wish this information was more readily available to patients who are considering pursuing opiate treatment for their pain as well as to provide correct information about narcotics to the general public.  Physicians are using many different types of medications to treat chronic pain disorders and some of them have shown promise in treating chronic pain.  What many people don’t realize is that many of these other medications have more side effects and medication interactions than narcotics.

Opiates are still a main stay of treatment for chronic pain patients and there are good reasons for this.  Although opiates have become a totum of evil due to a  massive media push claiming that opiates  by their very existence have caused a rise in prescription drug abuse.  Opiates of themselves are not evil and it is more of a reflection of the culture, change in family dynamics etc. that are the cause for a “rise” in drug abuse involving prescription narcotics.  This phenoma is not because of sudden lax rules in prescribing narcotics by physicians or not the fact that narcotic prescriptions are on the rise.

When I think about when I was growing up in the 70’s, doctors were more lax about prescribing narcotics then and narcotics were available.  There is a rise of availability of narcotics strictly due to their illegal status because the illegal drug business is profitable.  Perhaps because of the constant portrayal of street drugs as “evil” more people have taken to “abusing” prescription pain medication because it seems more socially acceptable and the product received in deemed to be safer.  Narcotics are not harmful to patients who take them as prescribed under a doctor’s supervision. There has been no study that proves that long-term narcotic use is harmful to the patient’s internal organs.  Studies actually show more damage to patient organs from continuation of chronic pain.  New studies involving chronic pain show that it is different from acute pain and the result of continuing chronic pain can have a devastating effect on the mental and physical well-being of a person.

The truth is that thousands of people suffer from chronic pain and bad media press, increased governmental regulation and shift of  the War on Drugs to prescription medication  has made it more difficult for patients who suffer from chronic pain to receive the treatment they need to deal with their illness.

Insulin is not with held from diabetics and so in the same way opiates should not be with held from patients who suffer from chronic pain.

Because narcotics have received such a bad rap, it is hard for people who do not have chronic pain or are an advocate for a loved one or person that has chronic pain to understand that receiving narcotics under a doctor’s supervision does not equal drug abuse.  Any person who has chronic pain and takes narcotics will eventually become physically dependent on the medication.  It may surprise people to know that many other drugs cause dependency such as anti depressants.  That is why doctors are careful to wean their patients off of anti depressants.  If you do not believe that withdrawal occurs for these patients, then talk to a few people who have been on a certain antidepressant for a long time and went off of the medication cold turkey.

Drug dependency does not equal addiction.  Addiction requires a psychological craving for the drug and most people who take opioids as prescribed do not develop a psychological dependence.  Many doctors have confused a patient’s request for a higher level of pain medication as drug seeking behavior when it is actually a sign that the patient’s pain is not under control.

The War On Drugs for all its good intentions has not reduced the amount of illegal drug traffic.  It has created many jobs for people in law enforcement, courts and the prison system.  But, the government still has the same problem that they had when they tried to prohibit alcohol.  People want to be able to use these substances as they do alcohol and nothing the government can do will decrease that desire. I am not saying that making all drug use legal will solve all problems regarding drug abuse.  I do not know if that would be possible in our society.  By criminalizing drug use  criminal industries will naturally look to drugs as a way to obtain profit just as they did when there was a prohibition on alcohol.

For the War on Drugs to work, people would have to change their minds about the way they feel about their personal right to use what substances they desire in their daily life.  The media wants everyone to believe that if the government did not “control” drug use that there would be a massive apocalyptic  like wave of drugged out zombies who would destroy everything near and dear to the law-abiding citizen’s heart.  The problem with this is that there just isn’t any proof that this would be so.

I’ve seen recent so called documentaries about the plight of opium addicted women and children flooding the plains of the U.S. as pioneers progressed towards unclaimed country in the 19th and early 20th century.  Yes people did become physically addicted to opium and cocaine.  Also, snake oil salesmen sold products to people that could harm or even kill them.  It was the original intent of the FDA to protect people from falling prey to these snake oil salesmen. The truth is when almost anyone who likes to do genealogy  searches for information about ancestors such as Great Uncle Grover or Great Grandmother Pearl, they usually find brief accounts of  people struggling to survive on the farm or ranch mixed with amusing anecdotes.  Rarely, does anyone find personal accounts recalling tales of long-suffering drug addiction and family interventions among the common folks.

Those heart breaking accounts of families being torn apart by drug abuse and painful intervention are recent occurrences are certainly real ,but they  have been mined by the media to feed the habit of the general population for reality based television.

I’m not saying that substance abuse isn’t a problem.  I am saying that things shouldn’t have gotten  to the point that the government has become so involved the Drug War that regulations and red tape are surrounding chronic pain patients and their doctors, causing doctors to practice defensive medicine and keep many chronic pain patients from having a decent quality of life.

How has it happened that there is much more government interference in the way that physicians practice medicine in regard to prescribing narcotics?  The DEA, not having much success in winning the War on Drugs, in my opinion  has switched to softer targets.  Because when it comes down to it in any law enforcement situation be it convictions by the district attorney or tickets written by the police, numbers count.  High numbers of convictions or in the case of the DEA, documentation that they are making a difference in decreasing the business of “illegal drug use”  means success and more funding.

The following is a policy statement issued by the DEA regarding the wonderful ways they are changing regulations to protect against drug abuse of prescription pain medications and how their new regulations actually make it easier for the doctor to prescribe schedule II narcotics to the patient.  Also, they mention according to their statistics they really haven’t reprimanded very many doctors and so their impact of pursuing doctor’s in their medical practices is small.  It is explained at the following site http://www.justice.gov/dea/speeches/s090606.html.

Many physicians and advisors in the health care industry are concerned these acts by the DEA may only be window dressing in light of  tougher regulations  proposed by the FDA.

The real story is that new FDA regulations include the possibility of requiring doctors and allied health personnel to take special training classes for each scheduled narcotic  they provide that is on the government’s list.  See http://updates.pain-topics.org/2009/10/dea-opioid-rems-intimidating-future.html regarding the possible future and scope of this training.   News about further requirements from the FDA on this matter are supposed to be published today, December 4, 2009.  I have also read in various blogs that the DEA has a future proposal in which they would take the list of patients who receive schedule II narcotics and ration the amount of medication that they may receive.  The very thought horrifies me.

Now I will talk about doctors doing “business as usual” with the DEA.  The DEA since the 90’s has taken the bold step of raiding doctor’s offices where they suspect illegal drug trafficking. There were some actual “pill mills” but those were disposed of quickly and easily. It is true that the DEA has not raided “many” physician’s offices but they took pains to raid doctor’s offices in a way to make an example to other physicians.  They first selected small and rural physician practices in which physicians prescribed “a more than average” amount of pain medications.  I am not just talking about time released scheduled narcotics but narcotics such as Lortab and Percocet as well.

A family practice doctor in a rural community may look like he or she is prescribing “more” narcotics but actually he or she is seeing the same patients more often over a life time so if the doctor had several elderly patients with chronic pain conditions, it would appear he or she was prescribing more narcotics than the average physician.

The tactics of the DEA actually would appear silly in their draconian nature if the results of their actions were not so sad.  They have targeted certain physician practices as described above.  They are already provided with lists of patients who have narcotic prescriptions filled, as well as what pharmacy the prescriptions were filled,  by what physician and when the prescriptions were filled.  With this information, they were able to do routine background checks on patients as well as find patterns of any patient who had narcotics filled at different pharmacies, by different doctors within a certain period of time.

Any patients of the doctor’s practice that the feds intended to review who  had a history of drug related violations or had patterns indicating “doctor shopping” for narcotics were contacted by the feds.  The feds threatened prosecution of various drug offenses and offered “deals” to these patients if they would “rat” on their physicians.  Ratting met anything from simple statements that the doctors provided them a prescription for narcotics to confessions that the doctor had actually known about their drug history and “drug shopping” activities an chose to ignore it when giving them a narcotic prescription.

A doctor can be very prudent in his practice and still not know about a patient’s drug history, recreational drug abuse or “doctor shopping” involving other doctors because they only know what patients are willing to tell them.  Most doctors if they suspect a history of drug abuse or “doctor shopping” will take appropriate measures in dealing with these type of patient.  There is no reason to think that any prudent businessman wouldn’t do so and especially doctors who have taken an oath to practice medicine.   Yes, the primary focus of many doctors has leaned towards  financial advancement.  With Medicare fraud, regulations by insurance companies and new Joint Commission requirements, doctors are not going to risk their practice by prescribing narcotics to people who they know would abuse them.

After the DEA obtained information about certain patients and “confessions”, they would approce the doctors with the evidence and ask them if they would prefer to settle out of court or face a public jury trial.

Most doctor’s settled out of court and were given reprimands.  Those brave courageous doctors who chose to fight the good fight and bring their case to court found themselves confronted with over eager district attorneys who were willing to prosecute to the fullest extent of the law and beyond.  Most of these doctors lost their medical practices and their licenses.  Many chronic pain patients who lived in small communities were stranded without a way to obtain more pain medication.  Other doctors in the area were certainly not going to run the risk of their fellow fallen physician.

Word soon spread to other physicians across the country.  This caused a wide spread panic among physicians.  Some general practitioners and even pain specialists decided to get out of the business of prescribing opioids.  Other pain management doctors consulted their lawyers and started enforcing strict guidelines for their patients to follow if the patient wanted to continue opioid treatment.  The first things to arrive were physician patient pain contracts.  Patients had to sign lengthy documents in which they promised to be willing to undergo random drug testing, not to engage in any recreational drug use, to inform the doctor if they received any pain medications by any other physicians.  Any means all pain medicines down to a lortab given to you by your dentist after a dental procedure.

These rules were up to interpretations by the doctor.  Some doctors did as a paper exercise but some doctors used the pain contract to engage on some kind of power trip.  I don’t know if they were seduced by power or extremely paranoid but I have read multiple cases of patients being discharged because they did not inform the physician before they took a pain pill prescribed to them by their dentists and when they mentioned it off handedly to the nurse during the next appointment, they were discharged from the doctor’s care.  Once, I waited four hours in the doctor’s waiting room for a urine drug screen test.  The receptionist kept telling me to be a good patient and sit down.  Finally, I was discovered by a nurse as they were locking up for the day.

If a patient is discharged by a pain management physician for any reason, it is definitely a black mark on their record and it makes it more difficult for a patient to find another pain management physicians because the pm doctors do not want to take on the liability of someone who has been discharged from care.

New regulations to be enforced by the DEA  and FDA provide more red tape to gag the physician from providing proper opiate treatment to their chronic pain patients.  For information regarding requirements regarding classes that physicians must take see the following http://www.dhss.mo.gov/BNDD/BNDDnewsletter.pdf.