Archive for the ‘FDA’ Category

Updates on Pain

2010-04-26

Hi Everyone,

I have had a lot going on and I wasn’t able to post last month but I am back and hope to write three posts this week.  Most of you don’t know I like to visit second life now and again, lately it has been again and again lol.  Right now, I am in a virtual world at a writer’s camp out site. Nothing like writing in the woods.  Today they are having an all day writer’s marathon.  I don’t think I will be able to stay for eight hours but I hope to use the time to get out these posts.  Anyone who is on Second Life, my avatar’s name is Eppie Shoreman.  Any of you who are on SL or plan to be on SL, there is a support group for chronic pain at “The Centering Place” on Second Life.  Contact me for details.

Now I am going to give you some updates on pain.  I’ve been meeting many people in the last few months who have other illnesses and also have developed chronic pain disorders.  Many of them are suffering greatly because their doctors do not know how to treat their pain.  I encourage all of them to see a pain management specialist.  Unfortunately, as many of us know, even seeing a specialist is no guarantee that your pain will be controlled.

There is some new information in the American Pain Foundation’s Spring Newsletter.  For those of you who are interested in Occupational Therapy there is an article written by an Occupational Therapist.

In “Health Decision Putting Your Best Foot Forward,” the author talks about challenging the decision that the doctor knows best.  Most of us who have chronic pain disorders have found ourselves in the difficult position, should I listen to this doctor and go quietly out of his or her office without adequate support for pain control or should I speak up for ourselves and try to get the medication and therapies I deserve?

Getting adequate pain relief unfortunately often  means seeing several doctors until you find one that will really listen to you and agree to be part of your team in helping you achieve good pain control.

I have found that bringing Selch to my appointments has been a really big help.  Having someone go with you to your doctor’s appointment who is knowledgable about your condition and is willing to stand up for your rights goes along way in helping you to find  health care professionals that will help you with your pain.

If you don’t have a friend or a relative who can fill this role, I suggest that you check out local pain support groups in your area and see if you can find someone in the group who is willing to be a “patient advocate” for you.  If you can’t find someone locally search for support services available in pain foundations and also visit different pain support groups on the Internet.  Post that you are in need of someone in your are to act as a “pain advocate” for you.  You may not find someone right away but I’ve found that when I am looking for support, persistance matters.  If you are in too much pain, ask a relative or friend to do this for you.

I cannot stress how important it is for anyone with a chronic pain disorder to get the help they need to achieve good pain control.  Any of you that have other ideas and experience to share regarding finding help for pain control, feel free to reply to this blog post.

Karen Richards writes some interesting articles on pain.  See “Growing Pains, a Predictor of Fibromyalgia,” She refers to an article in Reuters and talks about misconceptions about growing pains and how growing pains may be an early indicator of fibromyalgia.

Another very interesting article by Karen is “War on Drugs Has Ended – What Does This Mean for Pain Patients?” If you have read my blog, you know that I have posted more than once about the “War on Drugs.” Karen writes, ” In May 2009, nearly four decades later, Gil Kerlikowske, the new director of the White House Office of National Drug Control Policy (ONDCP), declared the war on drugs to be over.”  This guy must not be living on the same planet as those of us with chronic pain disorders.

Health care providers and even pain management specialists in growing numbers are refusing to give people who have chronic pain the narcotics they need to function day-to-day in their lives because of past DEA actions, pending regulations and the constant media exposure of the continuing War on Drugs.  Totemism regarding narcotics is still prevalent.  There are still so many people saying that we need to get rid of these evil narcotics that are destroying so many lives.  Eliminating prescription narcotics will do nothing to stop people from recreationally using narcotics.  They will just go to another readily available source to get their drugs.  Pain patients are left without adequate pain control.  When will the media and the government start caring about the millions of people in the world who are suffering from chronic pain?

About the ONDCP’s educational efforts regarding the needs of chronic pain patients, I am afraid it is too little too late.

The Pain Monitor from the APF has some interesting info for people with chronic pain. It has news information about different pain topics as well as resources for chronic pain patients.

These are some pain updates for April.  As always, I hope to be your faithful correspondent.

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.

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.

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.

American Values and Health Care Reform

2010-01-05

I just read an article about American Values and Health Care Reform and it inspired me to express my views about topics mentioned in this article.

The article is written by Thomas H. Murray, Ph.D.

He says “Most thoughtful Americans would have something meaningful to say about the values we should choose for the foundation of our system of health care. And by focusing on these fundamental considerations, perhaps we can deepen and broaden the discussion of values and public policy.”

First he discusses “liberty,” which I agree should be a value and a right we have regarding health care reform.  He mentions that this  includes” the freedom to choose a physician and the freedom for physicians to choose their practice setting and patients.”  I would go further to say that physicians should have the freedom to practice medicine in the best way possible to assure quality of care.  So many physicians are constrained now by insurance companies and governmental regulations that affect the way they practice medicine.

Examples of this are physicians who feel  like they have to practice defensive medicine because they are worried about liability.  This has lead to some group physicians practices looking at each patient as whether they might be a liability to their practice.  I experienced the outcome of this practice myself.  I found a young female physician who promised she would stick by me as long as it took to find out what was wrong with me.

I came to a follow-up appointment to find that she had already discharged me from her care.  She told me that she did not know what I was doing there because she had made it clear to me on the last visit that I should go to Johns Hopkins and she was discharging me from care.  I was very ill and I burst into tears and told her I knew that had not happened.  She confided in me that she had presented my case in a weekly case discussion, hoping to get feedback from other more experienced doctors.  She was told to “get rid of me,” and that I was too much of a liability to the practice.

Others such as doctors who treat people with chronic pain are wrapped in bureaucratic tape due to previous actions by the DEA and REM’s instituted by the FDA for narcotics that take away the freedom to prescribe medications for the maximum benefit of the patient.  Any chronic pain patient can tell you about the infamous “pain contract” with doctors and the hoops we are forced to jump through to obtain our medicine.

Dr. Murray discusses, ” Under our current system, a young entrepreneur with a brilliant idea for a new business, a creative vision that can create jobs and wealth, can’t necessarily follow that vision: if this person has a job at a large firm that provides good health insurance and has a child or a spouse with a chronic illness, the aspiring entrepreneur’s freedom to pursue his or her dream is severely limited by the “job lock” imposed by our current patchwork of health insurance.”

I’ve had personal experience regarding this situation when I was younger.  My former husband was self-employed.  I  had a few opportunities to get in on the ground floor of a start up coding consultant companies that began to flourish in the late 80’s, but I couldn’t even consider it because I had pre-existing health conditions that would have made it impossible for us to buy individual health insurance at a reasonable price.

Mycurrent  husband and I have constantly had to worry about insurance coverage since I have become ill. Due to the contract nature of his work at times, the actual company he has worked for sometimes hasn’t provided insurance. There was a stretch of time in which we were paying over $2000 dollars a month just for prescriptions.

Despite the fact that I have a terminal illness, I still haven’t been able to qualify for disability.  I’m about to talk to another attorney  about the possibility but due to SSI’s policy of giving strong consideration for disability regarding evidence of disability in my medical records for the first three years after I became unemployed, I have not been able to qualify because  I was first disabled due to a complex regional pain syndrome and we saw many physicians until 2003 when it was fianlly diagnosed.  This is an example of governmental involvement in health care benefits.

Dr. Murray also discusses values such as  justice and fairness, responsibility, medical progress, privacy, and physician integrity.    Should every American be required to participate in health insurance?  I have a problem when lower middle class and middle class people are going to be forced to buy health care insurance when they are already being taxed for Medicare and Medicaid.  Where is the extra money for premiums supposed to come from?  Many families have at least one spouse who is out of work.  The poverty line is around $11,000.  There is no significant special funded provided in this bill for middle class families.

Dr. Murray writes, “What are our obligations to ensure that the resources devoted to health care will be used wisely? Will a universal health care system provide for appropriate utilization of services while ensuring quality of care of all patients.?”  If you look at most universal health care plans adopted by other countries, quality of care has suffered dramatically.  Patients have to wait months to see specialists or to have surgery.

Two years ago, I had a large deep venous thrombosis and was in the hospital for a month.  I read posts by people in the U.K.  and other countries that were still having complications from their DVT after two years.  Some of them were still waiting to have surgery.

Dr. Murray discusses The Emergency Medical Treatment Act  which requires that emergency rooms provide treatment without regard to ability to pay. Have we done enough with our health care system to provide for human decency when as Dr. Murray states, ” According to the Institute of Medicine,20,000 people a year die for want of health insurance. Thus, one of the key challenges of health care reform is to make certain that appropriate care is available to every member of our community when needed.”

What is the definition of appropriate care?  With the current health care system many people do not receive appropriate care.  The problem with Universal Health Care is that “appropriate care” only means that everyone has access to care.  This country already has a shortage of doctors and with the initiation of Universal Health Care many doctors will abandon ship.  This will leave physician assistants and nurse practitioners to provide for much of primary health care given to patients.  They will be overworked  and underpaid.  There will also be a shortage of people who want to work in a system where there are long lines of sick patients to take care of and low wages for their efforts.

Also, specialists will be more scarce and to try to save money, the healthcare system will prevent patients from seeing specialists as much as possible.

If you don’t believe me, read stories of chronically ill patients who have tried to receive good health care through HMO’s.  If you are a healthy person, HMO’s work wonderfully.  You only need to see a primary care physician and there is little out of cost expense for preventative medicine.  Chronically ill patients and patients who are seriously ill cost the system more money.

I use to review records for quality of care in HMO’s and I saw many cases of primary care physicians or usually a physician assistant or nurse practitioner putting off appointments for patients to get in to see a specialist.  Also, abnormal test results were often overlooked and not discovered until two or three visits later.  You will see with any program of universal health care that health care must be rationed so expense procedures and tests will often be delayed.

Dr Murray states, “But if everyone is to receive care when it is needed, fairness and responsibility also require that everyone participate in financing it. In its 1993 report, “Genetic Information and Health Insurance,”4 a task force of the Human Genome Project’s Ethical, Legal, and Social Issues Working Group proposed the concept of universal participation. Insurers who recoiled at the idea of universal access accepted universal participation as a legitimate goal. To them, universal access meant that healthy people could skate along without paying any premiums — until they got sick, at which point insurers would have a legal obligation to enroll them and pay their medical bills.”

Everyone can see the obvious problems that arise with that system.  Dr. Murray continues, ” Only people who expect to file insurance claims would voluntarily buy policies. A policy of universal participation eliminates adverse selection. And “universal participation” is a more accurate and inclusive term than “universal mandate,” which addresses only the individual’s obligation, not the national commitment to assuring that care will be available when and where it is needed.”

Len Nichols, director of the Health Policy Program at the New America Foundation, recently invoked the Old Testament in discussing stewardship. ” When food is more than sufficient to feed all, allowing some people to starve is indecent and represents a failure to live up to universal moral duties.Dr. Murray writes “To Nichols, the principle concerning the availability of food in Leviticus should be applied to health care today: just as the gleaners of Leviticus should not starve, so people in need of basic, effective health care should not be allowed to suffer and die. Stewardship requires us to be mindful of the basic needs of others and of the power and responsibility we have to use the resources in our control to meet those needs.”

He says “Stewardship therefore requires that we pay scrupulous attention to quality, efficiency, and cost-effectiveness — or value, to use the market’s sense of the term. The evidence that we do not get good value for our money — that our health outcomes fall far short of those in many other countries, that regional variations in expenses do not track variations in quality, that our hospitals too often fail to ensure consistent adherence to practices known to enhance quality (such as hand washing) — is overwhelming. Everyone entrusted with the leadership of our health care institutions and with the allocation of our health care dollars has an obligation to be a thoughtful steward of those scarce resources.”

Will the government be able to initiate such programs to ensure quality of care? As I have stated before, there was  a program the government initiated through the Health Care Financing Administration that contracted a company that I worked for to do “peer review” screening of Medicare, Medicaid patients  by reviewing their medical records for proper utilization of services, proper coding of diagnoses to insure accurate billing and most importantly screening for quality of care issues.

I pre-screened these records for physicians and then the physician would review the records with potential problems.  In many ways the program fell short. Within the 10 year period that records were reviewed, fewer and fewer records were selected due to budget constraints and pressure from lobbyists.  I believe the fact that the program  existed did improve over all utilization of services and quality of care in hospitals.  Unfortunately, the government abandoned the program.

Also, very few physicians or hospitals were actual sanctioned at the state level even though some major patterns of poor quality of care were found.  Also, results of these studies as well as any quality review that hospitals and physicians do within their hospitals and practices are “protected” from public viewing.

The rationale behind this practice is that physicians or hospitals would unfairly be targeted due to unavoidable mistakes and that if results were given to the public, doctors and allied health care personnel would be less likely to participate in quality review.

First of all, I think participation in quality review should be mandatory.  The patient is being provided a service.  Therefore they are the true customer and deserve to receive information regarding performance standards.  Too many doctors and hospitals mistakenly think that the insurance company is their customer because that is who pays them.

Physicians say that practicing medicine is different from any other service such as providing tax information, car repair, etc. but the fact that they do provide a service to their customer, the patient, should allow for patients to be given information about quality of services so they know who may be able to best serve them.

I don’t think physicians should be penalized for every mistake they make but as baby boomers are getting older, I believe they would demand the same kind of service that they have come to expect in other areas.

I think that it will take a long time to  enact universal health care.  The government is trying to plan it so the entire universal health care program is not actually enacted until after the election of 2012.  But, I think people are already being fed up  by governmenal interferance and will not welcome even by preliminary actions because the country is in such a difficult mess as it is.

Dr. Murray states, “The bill likely to emerge from Congress will probably do a better job of moving us toward universal participation than of ensuring proper stewardship of our health care resources.”    Perhaps, repitition of services can be eliminated.  That contributes in a major way to cost of health care.  “Proper stewradship of health care resources?  I seriously doubt that will happen with a federally governmentally run health care system for reasons I have explained above.  Also, consider all the bureaucracy that comes with governemental intervention, constitutional issues and the program being able to work with state laws regarding health care.

It will be a very interesting endevor.

Prescribed drugs versus generic equivalents

2009-12-31

All of us who have a chronic illness have been faced with the decision to have a medication filled as the doctor prescribed or buy a generic equivalent.  Many times when doctors write a prescription, they check a box that allows for a generic equivalent of the drug to be prescribed.  A generic equivalent of a drug is supposed to be the same drug made by a different manufacturer usually at a cheaper price.

But does the generic equivalent allows work exactly like the originally prescribed drug?

A recent article in the NY Times, “Not All Drugs Are the Same After All”, discusses this issue.

According to F.D.A. rules, the new generic version must “have the same active ingredient, strength and dosage form” as the brand name or reference product.

The article provides a good discussion about whether or not this means that the generic equivalent works the same way as the prescribed drug when used in treatment of a patient’s symptoms.

From my own experience, results using generic drugs have been mixed.  In recent years, most of my physicians have allowed for generic equivalents for the drugs they prescribe.

Some physicians may lean towards using the prescribed drug but they are assured by studies given to them by pharmaceutical representatives that the generic equivalent is safe and effective.  They don’t have time to stop and think that these studies are done by the manufacturers and it is in their best interest for the studies to show that generic equivalents are equal to the originally prescribed drugs.

Also, many insurance companies refuse to pay for the more expensive “brand name” drug. These factors give the doctors incentive to prescribe generic equivalents.

I first noticed that there might be a problem with taking a generic equivalent when I was prescribed Cipro by my doctor for a urinary tract infection.   At that time Cipro was expensive and I didn’t have prescription insurance so I opted for the generic equivalent.  I took the medication as prescribed but after 10 days I still had symptoms of a urinary tract infection.

I made a follow-up appointment to see the doctor.  He had ordered a urine culture and sensitivity which shows specific bacteria and which drugs are likely to be the most effective in treating the infection.  He scratched his head and told me that the Cipro should have worked.

He looked at my chart and saw that I had an allergy to sulfa drugs.  Antibiotics with sulfa are used often for treatment of urinary tract infections.

He told me that he couldn’t but me on sulfa and some of the other antibiotics that he might consider I had problems taking them in the past due to stomach trouble.  The doctor said Cipro should have been the target drug for me.

Then he asked me, did I take Cipro as prescribed or did I choose to take a generic equivalent.  I admitted that I had taken the generic equivalent in consideration of cost of the medicine.

He suggested I  “bite the bullet” and pay for the Cipro as prescribed.  He explained to me that generic equivalents do not always work as well as the original drug because the manufacturers are allowed some variations in the way they make the generic equivalent.

After taking the new prescription of Cipro for three days, my symptoms disappeared and I finished taking the medication as prescribed by the physician.

For the most part, generic equivalents have been satisfactory in treating my symptoms.

When I first began to develop my complex regional pain syndrome, my primary care physician prescribed Percocet.  The pharmacy filled the prescription as Percocet.  I took it as prescribed and it did help to relieve my pain.

Because of ongoing pain problems, I was admitted to the hospital and was seen by a doctor who was a pain management specialist.  He ordered some injections of various medications and for the first time in a long time my pain was under control.

He suggested that I see him after I got out of the hospital.  Unfortunately, when I called to make an appointment, I was told that he did not have an opening for a new patient for three months.  They offered to make an appointment with a doctor who had just joined the practice.

He came in to see me and I talked to him about new medications the other doctor had suggested I might try.  He explained that he was hesitant to give me any narcotics for pain relief.  I asked him if could at least give me Percocet because it had helped decrease my pain in the past.  He said he would increase the dosage of Percocet, allow me a larger quantity and that should help my pain.

After I received my prescription at the pharmacy, I discovered that it was a generic equivalent. I didn’t think much about it because I had taken many generic equivalents.

After a few days of taking the medication, I did not obtain the same relief from pain that I had previously even though the dosage was higher and I was able to take the medication more frequently.  Also, the new medication made me sick to my stomach although the original Percocet had only made me feel slightly nauseated.

I called the doctor back a few times but he refused to give me anything else for pain.

I didn’t remain under the care of this physician for much longer.  I do think that the generic equivalent didn’t work as well as the original Percocet.

These problems I have had using generic equivalents have not stopped me from using them. For the higher priced medication that I take, if a generic equivalent is available, the insurance will refuse to pay for the prescribed “name” medication.

Using generic equivalents has usually not posed a problem for me.  There have been a few instances that a doctor wrote a letter to the insurance company because he or she insisted that I have the medication as prescribed.

When doctors do this, there is usually a good reason for it such as they have had past experience with less than optimal results for patients taking the generic form of the drug. Doctors do not like doing paperwork so for them to go out of their way to write a letter to an insurance company regarding non-payment for a certain prescription drug means that not receiving that medication is having an impact on the patient’s recovery from symptoms.

For the past two years, I have had a continuing problem with my Fentanyl medication because my insurance company refuses to pay for the expensive Duragesic brand name.

The problem is not with the Fentanyl itself but with the adhesive in the patch.  Pharmacies usually offer at least of couple of generic brands for Fentanyl.  The Mylan patch is a smaller patch that contains Fentanyl. The Fentanyl is not distributed in a clear pouch like the Duragesic brand.  It is coated in the Mylan patches.

Some patients prefer Mylan patches because they are smaller and because of the way the Fentanyl is distributed in layers of the patch, the patch can be cut so the user under a doctor’s supervision is able to cut the patch down to a smaller dose.  This gives people who are trying to reduce the amount of Fentanyl they are taking the advantage of decreasing the dosage in smaller steps than are provided for with the regular strength of patches.  For instance someone who is taking 75 mcg. patch and needs to reduce their dosage with the Mylan patch they do not have to go all the way down to the next available lower dosage patch which is 50 mcg.  They can cut the patch under supervision from their doctor to a lower dosage that is higher than 50 mcg.

I have never been in the position to need to lower my dosage.  I was given the Mylan patch by a pharmacy twice because that was the only brand they had in stock and in the hospital once because it was the only brand they had in stock.  I did not like the Mylan patches.

I wear the patches on my back and the patches did not stick as well nor did they provide the amount of Fentanyl delivery to my system that I was accustomed to.

For many years I have used the Sandoz generic Fentanyl patch without any problems. It is similar to the Duragesic patch with the clear pouch.

A little over a year ago, Sandoz changed something regarding the adhesive for the patch.  After that, I started having trouble with itching, redness and irritation at the patch site.

I tried wearing the patches in different locations but due to fat stores because of recent weight gain, the Fentanyl was being stored in the fat and was not being delivered at the same rate to my blood stream.  I had increased pain and withdrawal symptoms.

So my husband has had to become aggressive about making sure ever bit of adhesive is removed from my skin after taking off a patch and we have had to change the placement of my patches more to the side.

Some may consider this only a small inconvenience but any inconvenience causes more stress which as you know leads to more pain and other problems in someone with a chronic illness.

I hope this post has provided some issues for you to think about when you choose whether or not to use a generic equivalent that may help you in receiving optimal care for your condition.  Always consult your doctor before you make any decision on changing medication.