The FDA is Trying to Regulate Opioids - Why We Must Fight It!

by Heather Grace

Here's my letter to the FDA regarding their new attempt to control opioids, with their 'Risk Evaluation and Mitigation Strategies.' Visit the site and make your own comments NOW: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2009-N-0143. Deadline: June 30, 2009.

RE Docket No. FDA-2009-N-0143:

While I choose to have some faith in the FDA, and believe that they are attempting to help people by setting up these REMS, the idea is ill-conceived. To develop Risk Evaluation and Mitigation Strategies for certain opioid drugs assumes that the FDA has better knowledge about the patient than their treating physician does. I am sure when the people who drafted the REMS got together, it sounded like a good idea, but really, it is not that simple.

It is more than impractical--it is impossible to have the government control the dispensing of certain medications, and then truly make those medications available freely to those who need them.

Anyone who knows even a little about pain management understands how complex it is. Any pain patient, any good pain management physician will state unequivocally, there is no recipe for success in treating pain. There is no black and white diagnostic standard.

While some people suffer one short bout of chronic pain, lasting little over 90 days and then they get better, there are also many serious pain sufferers, with very serious diagnoses.

A doctor may have certain preferences about what he tries with a patient, and what she/he feels works well. After the first line treatment, she/he may try other options, other combinations, until a patient is stabilized and the pain is being effectively managed. As we all know, the ultimate goal is to get the patient back to some semblance of a normal life, where daily activities are possible, without excruciating pain limiting one to a bed-bound or couch-bound state.

Physicians are often limited by what a patient’s prescription plan will cover, so that, too, impacts what is prescribed. However, sometimes patients are faced with the issue of either getting proper pain management and going broke, paying out of pocket for things that aren’t covered, or accepting a lesser medication, that involves lesser pain relief.

There are already so many stumbling blocks for patients trying to find relief. I would hate to see the government further regulate the process, thus making it more difficult for people who are plagued by pain, and already have a very hard life.

There is a huge distinction between simple chronic pain and a diagnosis of Intractable Pain. Do you realize what Intractable Pain really means? Someone on the outside really doesn’t know what it looks like, or how it feels. It’s really impossible to understand the agony. If you have never experienced any sort of serious injury, count yourself lucky. Intractable Pain literally means pain that never goes away. Daily pain. Hourly pain. Minute-by-minute clock-watching, excruciating ‘will it ever end, dear God, please’ pain.

The official definition, according to IntractablePainDisease.com: "A severe, constant pain that is not curable by any known means and which causes a bed or house-bound state... Intractable Pain (IP) has four outstanding characteristics: (1) constant, (2) severe, (3) disabling, and (4) causes detectable biologic impacts on the body's blood pressure, pulse rate, hormone levels, and neurologic systems. It should be considered a serious catastrophic condition that, inadequately treated, leads to premature death. Some of its complications include dementia, osteoporosis, muscle wasting, obesity, and cardiovascular disease."

For people who live it, trust me, life is already plenty difficult. To make it any harder, would truly be an injustice. REMS would endanger the lives of anyone with IP or a similar diagnosis.

I urge the FDA to first, get a better understanding of what Intractable Pain and its related diagnoses, means to the people dealing with it. Meet with an expert, someone like Forest Tennant, M.D., Dr.PH, who can accurately lead you through IP and its challenges. I am confident that patients with severe chronic pain/IP are in good hands with physicians like Dr. Tennant. Why?

A physician with effective knowledge of pain management has many tools available, regarding assessment of one’s pain management. She/he can assess the patient’s overall affect, as well as their ability to function as they did prior to injury. The doctor may use simple in-office tests, such as blood pressure and pulse rates, their gait and speech, to gauge a patient’s current pain level. She/he may also rely on blood tests that show how well a patient metabolizes medication, thus further justifying a patient’s need for high-dose opioid therapy.

Though some are new, there are many ways to understand why patients need the medications they need. There are clear-cut tests to show how effective their medications are. Therefore, I do not see a need for government intervention.

The REMS states that it intends to ensure that the benefits of these drugs continue to outweigh certain risks. I believe there is a serious danger in trying to establish a need for medication within the concrete walls of an institution, instead of by the warm hands of the treating physician, where there is the full gambit of a patient’s history: their MRIs, CT scans, X-rays, blood work, physical examination, blood pressure and pulse rates.

Death by overdose is a rare occurrence. It is not something that happens frequently when a patient is being accurately monitored and treated by a responsible physician who truly knows their history, knows their pain, and understands the patient's prescribing needs. Only a knowledgeable pain doctor can truly mitigate the risks of these drugs, on a case-by-case basis.

To quote Dr. Forest Tennant, M.D., Dr.PH. in The Intractable Pain Patient's Handbook for Survival: “The biggest problem an Intractable Pain (IP) patient faces for survival is that a bona fide IP patient is a rarity among chronic pain patients... Control of IP requires the daily use of prescription medication. I estimate that one IP case occurs among about every thousand chronic pain patients. Due to IP's rarity, almost every doctor, insurance plan, hospital, or family member you encounter will initially assume you are just another, average, chronic pain patient who can get by with the standard firstline treatments such as exercise, positive mental attitude, acupuncture, massage, and non-prescription drugs. To survive, you will constantly have to fight this misconception, and you must educate most of the people you encounter.

“IP patients all require a custom-made, one-of-a-kind treatment plan. Most physicians and other medical personnel you encounter may be bewildered and even fearful of your treatment, because they may not have encountered another patient with your pain severity.”

Dr. Tennant’s handbook further cautions those with IP to understand that pain is their enemy: “Your IP is long-standing, constant, keeps you from sleeping, drives up your pulse rate and blood pressure, and alters your adrenal hormone levels. You must remember that your pain is your enemy. To cause it to worsen or flare for any reason may do further damage to nerves and other body tissues that are already permanently damaged.

“Your attitude about pain must change. Increased pain hurts you. When the pain flares, your pulse rate increases, and hormones stored in your adrenal gland flood your system causing further body deterioration, rusting, and aging.

“Therefore, you MUST do whatever it takes to suppress your pain and prevent flare-ups. You simply want to keep pain as far away and as controlled as possible. Never try to ‘work through it’ or ‘tough it out’ or believe that character and will power will solve your problem.”

Dr. Tennant has extensively studied Cardiac Adrenal Pain Syndrome – a serious threat to IP patients. Pain control is vital to survival, and to have uncontrolled pain creates a serious risk of damage to the heart, and even death. DEATH.

REMS is a serious threat to pain patients. Such regulation, ironically, could lead to death, due to uncontrolled pain. If the goal is to reduce deaths, then why on earth would you keep treatment from those who genuinely need it, for their very survival?

I hope you will understand, based on the many concerned citizens who have reached out to you, that the REMS program is not going to work. It wasn’t well-conceived or thought through. It may work for certain patients, but it would prove a huge detriment to those who suffer with conditions like Intractable Pain. I wish there was an easy answer. Believe me, it would make so many lives easier. But, because there is not a quick fix, the FDA should not further involve themselves in the treatment of patients, because they simply have no business trying to ‘protect’ people when they don’t fully understand the treatment of pain.

Like many others, I have done what I can to help the pain community. I have worked with many pain patients as well as pain management doctors. I offer products to help make lives easier.

Like many of those utilizing my site, I suffer with Intractable Pain. Unless you know someone with IP, or you treat patients with IP, you cannot possibly understand the difficulty in treating these patients and finding a regimen that will work for them. We already live much shorter lives than the rest of the world. Why make the time we have here any harder?

Please stop trying to regulate pain medication. It’s simply too complex for a government agency to control without seriously harming its citizens.

Most Sincerely,
Heather Grace
ThePainStore.com
& Intractable Pain ‘Survivor’