New FDA Scrutiny on Pain Medications

Thank you for bringing this issue to our attention, Dr. Rowe.  I am very concerned by this new initiative of the FDA and fear that this will be one more example of non-medical professionals putting up barriers to the effective treatment of chronic pain.

 I hope you will read my Share Post on this topic, FDA and Pain Management, in which I go into more detail on these issues.

The American Pain Foundation has been a leader in this area and I applaud the Foundation's efforts to include people living with pain in advocating for the Pain Care Policy Act. I urge everyone to to to the Foundation's web site and see how you might be able to participate.

In several studies that have been done to see if chronic pain patients get addicted using strong pain medications to control their pain.  In all of these studies the percent of patients becoming addicted is very small and they usually are people who have a tendency to addiction.  Now with the FDA saying that they require doctor's to be licienced to perscribe each of these medications, we chronic pain patients will have an even harder time trying to get a doctor to even treat us. 

I am one patient who has had adverse reactions to the very drugs that the FDA has approved.  Once such drug, the first drug the FDA approved for Fibro, Lyrica, I gained 85 lbs in 2 months. I am now a diabetic, have liver problems and may have to have an operation on my stomach all due to Lyrica.  Why don't they address the other medications problems instead of our much needed pain medications?  If I could sue, the drug company, the doctor who gave me that medication and the FDA for approving it, I would.

Karen L Simon a woman, wife, mother and grandmother. I have trauma induced Fibromyalgia from an on the job injury to my upper spine and have never had any addiction's problems.  I was on oxyCotin for over a year and stopped taking the medication all at once and did not have any withdrawal symptoms.

I am a 59 y.o. woman with chronic pain due to severe DDD,Fibromyalgia,osteoarthritis with osteopenia and scoliosis. I also have a history of mutiple medical issues requiring surgery beginning with a Total Hysterectomy at age 28. I did become addicted to Opoids. Mainly because some of the physcians I saw just handed me prescriptions for them instead of looking for the cause of my pain. To complicate matters further, I have Major depression. That began with my 1st hospitalization for Postpartum depression at age 24. Something I did not know because no one else picked it up was that the pain meds increased the depression and put me in a vicious cycle of depression. Finally in July of 2007 and after a near fatal overdose I found my Miracle. I was refered by a friend to a wonderful addicionologist. I have not felt this good in ages. However the down side is the meds I take cost over $500.00 a month. One of them is Suboxone for which there is no generic. The doctor has to has a special certification to prescribe it. I am fortunate to have found him and that he is close to home as there are only about 150 doctors in the country that are certified to give it. This is exactically what you are talking about. If this would be the requirement for each drug used to manage pain it isn't hard to see where the story leads. Patients could end up having to see a litany of doctors for the correct meds. I do not believe this is the best way to handle this.

As I said yesterday, the problem with opiods on the street are NOT from doctors. Granted there are just a small group of them who sell scripts, but they are few and far between AND they get caught sooner or later.

I suffer from 8 herniated discs, a compression fracture, numerous impinged nerves and canals and a stenosis. My doctor put me, eventually, on 100 mcg's of fentanyl which worked very well for me, but she had one patient die after eating it and combining it with Heroin so she called me and said she was discontinuing all patches for all patients. She was concerned that the FDA would give her a hard time for continuing to prescribe after a death, even though I was taking exactly as directed.  Kneejerk reaction at best, and definately overkill but I do understand the squeeze the government is putting on doctors and it's risking their licenses. To me, this is unfair as hell to all concerned.

My own experience with 3 young adults is that most of the pills on the street are coming from Mexican or overseas online pharmacies who sell by the hundreds, discretely, without prescription. What I think would serve our governing of illegal use of opiods is not to put more pressure on the doctors who already underprescribe due to fear of losing their license, but by putting that effort into stopping the illegal border crossing of these pills and patches.  Listen, my kids have seen dealers in their teens who have ziplock bags (the gallon size) with literally hundreds of Oxycontins , Percocets, vicodins, etc., even morphine patches. This is where we need to concentrate our energies and our funds, but that is my opinion of course.

If this legal action goes through it will only send legitimate pain patients to the streets. Like back room abortion clinics and speak-easies during prohibition it will cause a booming new market for racketeers.  It is totally insane and incredibly counter productive.  May the originators of such ridiculous ideas be struck down with acute and chronic framinal stenosis

I agree with you! It is very easy for someone to set in judgement when they don't suffer everyday! It would be impossible for me to function with my pain medication! I understand that there is abuse but a lot of that is some DR'S. that will give medication to anybody that can pay a office call! does the FDA understand that there are mikkion's of people that would have no qaility of life at all with out their medication's!Thank you very much for letting me voice my comment! Kenneth Scott

To remove or severly restrict a pain medication that helps people with there pain, that is taken legitimately and as directed, is folly when it is done to prevent addicts  from acquiring them to stop their misuse, and their sale on the street. This will not prevent addicts from acquiring their fixes, but will prevent a lot of legitimate users to suffer a lot of pain. Read the labels or follow your Physician's prescription orders. Safe and effective WHEN USED AS DIRECTED!!

I am just plain sick and tired of the government interfereing with our ability to receive pro-active help for our pain.  So many doctors today absolutely refuse to prescribe any kind of narcotic pain med due to the harassment so many of them receive from the government.

I am all in favour of additional training for doctors in treating chronic and acute pain. But I am not in favour of making pain patients feel as if they are street junkies trying to con their doctors into writing prescriptions for a fix.  For too many years I was so often made to feel subhuman because I suffered from chronic pain, that it almost drove me to the point of suicide. Thankfully, for the past several years I have been in the hands of an excellent pain management specialist who has been able to keep my pain at a reasonable level, and never once made me feel guilty of suspect for requiring this kind of assistance.

Keep the government out of our doctor's offices.

i understand some things about the FDA because i;ve dealt with them in a former job in the healthcare area. But i agree with everyone, now that i am a pain patient, because it has been difficult to get meds. My pcp won't presrcibe them , so i have to go to a pain specialist.

i am always afraid that the special certification will then lead to very specific protocals for pain med prescribing according to a condition, rather than looking at a pt as a real person.

i think they (the FDA) should concentrate on the big picture- what things are getting into our food sources, and childrens toys, etc. And- let Drs treat the sick and not dwell on our med use, but be fair and listen to the patients needs!

thank you,

gale sweet,RN

Then the F.D.A should take a better look at these medications before they okay them to be perscribed to we the people rather(ginnie pigs). Maybe their JOBS would not be so very TOUGH!!!! All this is about are the ignorant people who do abuse and misuse these type of meds, but what about the HONEST ones who REALLY NEED them for HEALTH PROBLEMS. Now yet again we have to suffer for those other peoples actions!!! What kind of country is AMERICA becoming??? Next they will be telling us how we have to spend OUR OWN HARD EARNED MONEY!!!! You F.D.A. needs to sit back down and come up with a better way,or your gone to be the next president BUSH who the WORLD will shun at due to the WAR they will cause for the innocent people who REALLY need this type of med... my words to the F.D.A go after the SCUMBAGS that are KILLING us from filth in our FOOD!!! (CONTAMINATION)!!

Then the F.D.A should take a better look at these medications before they okay them to be perscribed to we the people rather(ginnie pigs). Maybe their JOBS would not be so very TOUGH!!!! All this is about are the ignorant people who do abuse and misuse these type of meds, but what about the HONEST ones who REALLY NEED them for HEALTH PROBLEMS. Now yet again we have to suffer for those other peoples actions!!! What kind of country is AMERICA becoming??? Next they will be telling us how we have to spend OUR OWN HARD EARNED MONEY!!!! You F.D.A. needs to sit back down and come up with a better way,or your gone to be the next president BUSH who the WORLD will shun at due to the WAR they will cause for the innocent people who REALLY need this type of med... my words to the F.D.A go after the SCUMBAGS that are KILLING us from filth in our FOOD!!! (CONTAMINATION)!!,germ warfare?? look at the people we have lost due to the f.d.a not going after the other countries where our clothes, toys ect.. come from, but thats not even a slight cocern to them. Look at the deaths from the irrigation so they say with the food HERE IN AMERICA, where was the F.D.A. at during the inspection of all these things??? Our DOCTORS have it hard enough with their malpratice insurance, LEAVE OUR DOCTORS ALONE!!!

It is very unfortunate that there are those in our society that are obtaining the very medications that we as cronic pain suffers need to function and live our daily lives to keep food on our tables and a roof over our heads.  I have seen people come into the pharmacy I go to with a precription for the very med I take and seem to be in no pain at all...It infuriates me that there is a shortage of the meds I need because of those individuals who sell them to those who get high from them.  Just makes my life miserable and those of who really need the medication.  Just my thoughts!!

3/6/09

Here is another prime example of where the government does not

need to be involved!!! Drs should be able to prescribe opioid pain meds

for their chronic pain patients without all these extra barriers put

into place.

As it is, there are far too many pain patients suffering

needlessly b/c Drs fear persecution and prosecution from

different govt entities.

People need to understand that chronic UNCONTROLLED

INTRACTABLE PAIN is DEADLY!

It puts stresses on the body, via the heart, blood pressure

and the immune system.

It puts stress on the patient and those who live with

the CP ( chronic pain ) patient.

CP patients have a RIGHT to live as comfortably

as possible, and if this means by having to take

pain medications to lower their pain levels,

then so be it.

Chronic pain patients do not become addicted

to pain meds.

And chronic pain patients are not going to be

diverting their prescriptions to other persons, b/c

they need their meds to help lower their pain levels.

CP patients have no interest in diverting or sharing their

RX's with other people.

The FDA is on the wrong track here totally with

this new REM program.

And it is once again the chronic pain patients

who will pay the price, with their lives !!!!

I am a twenty-three year old pain sufferer, with DDS, and Piriformis Syndrome. It is already hard enough for me, as a young person, to get anywhere close to the medication that I need for my pain. The last thing needed is another fiery hoop to jump through in the form of finding a doctor with the right combination of licenses to heal you, ridiculous. America has a problem with drug abuse, that can't be questioned. But for me to feel scrutinized for having bad genes and needing these drugs is a terrible feeling. Please keep the people who need these drugs in mind, we are in serious pain and need the help.

Having had major head/brain/neck surgery due to a Chiari Malformation, I can say that without the current regiment of narcotic pain meds I take in a day, I would not be functional under any circumstances.

That being said, this article smacks of the 'new day of Socialized medicine ala the Obama adgenda'.

Government of any sort needs to butt-out and leave the practice of medicine where it belongs---in the hands of capable scientist and medical practitioners.

Screw the FDA.  It is in no way protecting and/or serving chronic pain patients who require opiate medication.  Check the reputable studies.  The addiction rate is still 3%, the same as addiction rates to any substance in the general population.  Despite all the manufactured horror stories, this statistic has remained stable.

For decades the FDA has been underfunded and impotent. An FDA employee, whose job it was to answer questions such as these, told me that factories in foreign countries, including India and China, that manufacture generic drugs are inspected at best every 18 months.  They are also notified well in advance of the date of the inspection.

If the FDA has a little extra cash now, they should be using it to make sure that all genetic drugs are safe.  They should also make sure that all studies on new drugs use appropriate methodologies, statistically meaningful samples and do not hide or minimize side effects and adverse reactions.  Also, of course, the FDA should immediately stop using doctors who take money from pharmaceutical companies as evaluators and advisors.

However, those things would be much too dificult to do and would upset the cronyism, patronage, corruption and general incompetence that have become the norm at the FDA.  So once again pain patients, a vulnerable and easy target group, have become a way for a government agency, unwilling to do it's mandated job, to score lots of favorable press coverage. 

The FDA needs a major personnel and policy overhaul to properly serve the American public.

The facist DEA needs to be permanently abolished. The Controlled Substance Act  

Screw the FDA.  It is in no way protecting and/or serving chronic pain patients who require opiate medication.  Check the reputable studies.  The addiction rate is still 3%, the same as addiction rates to any substance in the general population.  Despite all the manufactured horror stories, this statistic has remained stable.

For decades the FDA has been underfunded and impotent. An FDA employee, whose job it was to answer questions such as these, told me that factories in foreign countries, including India and China, that manufacture generic drugs were inspected, at best, every 18 months due to lack of funding.  They were also notified well in advance of the date of the inspections.

If the FDA has a little extra cash now, they should be using it to make sure that all genetic drugs are safe.  They should also make sure that all studies on new drugs use appropriate methodologies, statistically meaningful samples and do not hide or minimize side effects and adverse reactions.  Of course, the FDA should also immediately stop using doctors who take money from pharmaceutical companies as allegedly unbiased evaluators and advisors.

However, those things would be much too dificult to do and would upset the cronyism, patronage, corruption and general incompetence that have become the norm at the FDA.  So once again pain patients, a vulnerable and easy target group, have become a way for a government agency, unwilling to do it's mandated job, to score lots of favorable press coverage. 

The FDA needs a major personnel and policy overhaul to properly serve the American public.

The facist DEA needs to be permanently abolished. The Controlled Substance Act needs to be repealed.

If these things are done we will all be safer and healthier.

tabt