Archive for the ‘REMS’ Category

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.

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Posted in Chronic Pain, consumer driven health care movemnet, DEA, FDA, FTD, governmental regulations, Health care issues, Medical System, Opioid therapy, Pain Management, Physicians, REMS, Treatment, WarOnDrugs | 1 Comment »

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.

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Posted in Chronic Pain, errors in medical treatment, FDA, Health care issues, Living with Illness, Medical System, Opioid therapy, Pain Management, pain management specialist, Physicians, REMS, Treatment | Leave a Comment »

Writing a comment to FDA about proposed REMS

2010-01-19

I received a response from a post I submitted on Chronic Pain Connection:

FDA REMS Proposal
Karen Lee Richards
Monday, January 18, 2010 at 09:55 PM

I would also encourage you and everyone concerned to write to the FDA.  They are taking comments from the public regarding these proposed REMS until Oct. 10, 2010.  Here’s a link to the FDA announcement.  Toward the bottom of the page of the FDA announcement is a link to their form if you’d like to submit it online and their address if you’d prefer to mail it.

Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs

This will take you to another page where it asks you to choose which document you want to reply to.

Choose FDA and choose public announcements.  There will be several items to choose from.  Select  Risk Evaluation and Mitigation Stategies for Certain Opioid Drugs and then you will be taken to a page where you can place a comment.

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Posted in Chronic Pain, consumer driven health care movemnet, FDA, governmental regulations, Health care issues, Medical System, Pain Management, Physicians, Politics, REMS, WarOnDrugs | 1 Comment »

Article on FDA REMS

2010-01-18

I just read an article titled ” When Elephants Dance , Ants take a Pounding”.

“On December 4, 2009, the U.S. Food and Drug Administration (FDA) called upon pharmaceutical company representatives to report on their progress in developing a REMS (Risk Evaluation and Mitigation Strategy) for extended-release or long-acting opioid analgesic products containing oxycodone, morphine, methadone, and other agents. Concerned about what are perceived as high rates of misuse, abuse, addiction, and overdose with these powerful pain relievers, this is the first time the FDA has demanded a REMS program for an entire class of drugs.”

Many of the drug companies manufacturing the above mentioned narcotics have formed a  Industry Working Group (IWG) to try to deal with the problems of drug abuse  while still trying to assure that people such as chronic pain sufferers will still be able to get the medication they need to function in their every day lives.

The FDA gave these IWG’s little information to form a base to construct a plan even though the IWG members have spent many hours putting together a plan. You can read in the article about the proposed phased in plan

As the article points out, the problems are not with the people who take the prescribed drug but it is a community problem.  No matter what the FDA regulates there is still going to be abuse of “prescription” drugs.  The FDA thinks by keeping doctors from prescribing narcotics with abuse potential that it will stop people who abuse prescription drugs.

Some of these drugs may still be available on the street because of prescription narcotics prescribed overseas.

It is obvious to any thinking person, that people who abuse drugs if they do not have prescription narcotics available will obtain drugs from the “street.”

Some FDA officials have admitted that it is their goal to get doctors to stop prescribing these narcotics period.  They obviously do not care about the thousands of people like me who need narcotics to make their pain manageable so they can live day to day.

These officials have also admitted that it is their plan to put all of us who are prescribed these narcotics into a register and ration the amount of narcotics we receive.

Why, why, why do they want to do this? They have to know that we who responsiblity take narcotics under a doctor’s supervision are not drug abusers.  Or do they?  Have they bought in to the totemism of the “evil’ narcotic so far  that they believe even legitimate narcotic use should be stamped out?

Is it to prove that they have done “something” to address the war on drugs so their funding will be continued?

I have seen so much violation of constitutional individual rights in the past few years, I’m starting to not recognize this country as America, Land of the Free.

What can we do? We can do what our founding fathers afforded us the right to do.  We need to spread the word about what is going on as much as possible and join the consumer movement for health care reform.

We can write to all our congressmen and women and tell them our stories.  Also we can vote people out of office who will not stand up for our constitutional rights.

Even though I have a terminal illness, I for one will not roll over and give up.  Fortunately, there are physician practices and other foundations with strong political backing who are prepared to fight these proposed changes.

I’ve already read so many sad stories about people being undermedicated due to physician fears of governmental retribution.  I understand their fears and concerns, but to stop giving people medication that they need to survive before any action has been taken against their practice is inexcusable.

The DEA did raid doctor’s offices but the numbers were few and most cases were settled out of court.  It was enough to send many doctors rushing away like herd animals.  They should look at what actually going on now, not what they fear may happen.  While they can help people who are in horrible pain they should remember their oath and not turn people away who are in agonizing pain.

I believe physicians should stand by their patients and face what is coming together.  I still see humanity in some physician’s practices and I am old enough to remember when caring for the patient was the primary focus of the physician.

We need strong minded compassionate people in the medical field.  This is another reason why I believe that the best model for health care reform in a consumer based movement.  We have a right to good quality of care.

I let myself for a minute imagine the post apocalyptic world for chronic pain patients that would exist if the FDA is allowed to intact their plans.

Thousands of  people who suffer from chronic pain and chronic illnesses will be having to make life and death decisions.  Such actions would force those of us who chose to live and carry on with their responsibilities to seek our narcotics from an illegal market who would be more than willing to welcome us into its clutches.

Those without money to pay for these narcotics might be forced to do things that actual junkies do not because we wanted to get high but to survive.

Is that what the government wants, to send thousands more consumers into the illegal drug market?

Hopefully, it won’t come to this.  As I said, I do see promising signs that physicians and organizations are joining force to keep this legislation from being acted upon.

If you want to read more information on guidelines that the FDA is using to define chronic pain and treatment of chronic pain with narcotics see  The National Clearinghouse Guidelines, Managing chronic non-terminal pain including prescribing controlled substances.

I also want to remind readers that I do have another blog that I am starting.  It is called The Professional Patient.

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Posted in Chronic Pain, consumer driven health care movemnet, Dying, FDA, governmental regulations, Health care issues, Medical System, Pain Management, pain management specialist, Physicians, Politics, REMS, Treatment, WarOnDrugs | 2 Comments »