Familial Mediterranean Fever

A Melungeon connection to Familial Mediterranean Fever?

2011-09-20T09:59:00.000-07:00

Some people never give up trying to defeat a proven fact. A person who writes a blog on the Melungeons (Melungeons are a group of folks in the U.S. who we believe have a Mediterranean ancestry.) has written about Familial Mediterranean Fever, about which she knows nothing. See a response to this blog written by the "OTHERS" on FMF here and on my blog:

A Melungeon connection to Familial Mediterranean Fever?

It never fails to amaze me that some people would rather see friends and relatives die, than admit that there might even be a SLIGHT possibility of an inherited illness amongst them. Familial Mediterranean Fever can be a FATAL illness left untreated. Why would anyone suggest that a relative die? What is so scary to some people that they would write about something that they have not researched, and which they deny is even connected to them?

Years ago, N. Brent Kennedy, author of The Melungeons: The Resurrection of a Proud People, told me that IF Familial Mediterranean Fever turned out to be an Appalachian thing rather than a Melungeon 'thing,' then the importance factor of this FACT was raised.

As both a patient with FMF and a patient advocate for others with this disease, I can state that it appears this is so. Cases of Familial Mediterranean Fever are being found all over the United States and in particular amongst those families having roots in the Appalachian Mountain ranges.

I moderate two Familial Mediterranean Fever sites, a mailing list on yahoogroups,
http://health.groups.yahoo.com/group/fmf_support/messages

(subscribe - fmf_support-subscribe@yahoogroups.com )

I also moderate a website that is connected to the United States "rarediseases" organization. The rare diseases group is connected to a world-wide group of researchers and patients who are attempting to find solutions and cures for this at present incurable illness. It is written in 5 languages:
http://www.rarediseasecommunities.org/en/community/familial-mediterranean-fever

Also see NORD, National Organization for Rare Diseases
http://www.rarediseases.org/

I have researched this illness and corresponded with doctors and other researchers. It is data from these sources that allows me to recommend doctors practicing in various states and countries to patients searching for an answer to serious, life-threatening health issues and to encourage them to ask their doctors to do the research that would allow them to TRY colchicine.

Years ago, my own doctors told me that a TRIAL of colchicine given in a specific amount and for a limited time would not hurt me even if I did not have the illness. A POSITIVE response to colchicine is a POSITIVE diagnosis of Familial Mediterranean Fever. And colchicine is the ONLY medication that prevents this illness from being fatal.

A recent blog noted that: "Some people have been misinformed that having Familial Mediterranean Fever proves a Melungeon connection."

Nothing could be farther from the truth! Having Familial Mediterranean Fever proves that somewhere in your ancestry you have Mediterranean ancestry. Many of us who have a Melungeon connection in our family lines, do believe that the Melungeons have a Mediterranean connection. After all, the Melungeons themselves noted that they were 'Portyghee.' Portugal is a Mediterranean country and probably one of the most ethnically mixed countries in the world.

When a person writes about a medical problem, that person needs to have not only compassion, but accurate information. The person writing the blog has neither.

The blog mentioned noted that: "The most dangerous aspect of this dislusional thinking is that the advice to just TRY colchicine is very dangerous advice because colchicine is a very dangerous drug." How disingenuous!

Since colchicine requires a prescription from a doctor, that is, a licensed MD, a suggestion to TRY colchicine must pass a rigorous medical procedure before any such prescription can be given.

The statement from this blog that: "An ethical Dr. would only prescribe colchicine if the benefits outweighed the danger. Leave the prescribing to a licensed physician." would be funny, IF it were not so dangerous to the health of those of us who have suffered through dozens of doctor visits to dozens of different doctors over dozens of years arriving at several dozen different misdiagnoses in order to arrive at the correct diagnosis and receive a script for the life-saving product called COLCHICINE. One does not say, 'Doc, give me colchicine and get it.'

As with most drugs there are side effects to colchicine. Given the fact that Familial Mediterranean Fever can be a FATAL illness, weighing the benefits, LIFE against DEATH, seems to me to swing the scales in the direction of life.

I would hope that patients would choose life. Listening to tripe such as that written on the other blog can lead to death.
Nancy
Familial Mediterranean Fever blog - 'my story' w/ FMF, and LOTS of medical documentation, charts etc.
http://familialmediterraneanfever.blogspot.com/

Familial Mediterranean Fever- rarediseasescommunityhttp://www.rarediseasecommunities.org/en/community/familial-mediterranean-fever

2011-08-18T09:28:00.000-07:00

There is a LOT of information on Familial Mediterranean Fever on this blog. It begins with Nancy's PERSONAL EXPERIENCES with FMF and continues with descriptions of the disease, the symptoms of the disease, how it works and medical documentation from a variety of sources. I am not a doctor and I can not diagnose nor prescribe. I am a patient with FMF and a patient advocate. IF you need personal help you can reach me via e-mail at:
nmorri3924@aol.com

Here is my story with Familial Mediterranean Fever:

I think that by telling you my story with Familial Mediterranean Fever, it may help you see that this disease is easily mis-diagosed as everything under the sun. I am also including here an explanation of just HOW Familial Mediterranean Fever works:

Let me tell you about my experiences with Familial Mediterranean Fever. Please note that I am not a doctor, and I can neither diagnose nor prescribe. I wanted to be a doctor but in those days girls were not encouraged to do so. I followed the traditional wisdom but continued my interest in all things scientific throughout my life. I consider myself to be a genealogist with a scientific bent. I CAN tell you about my journey to better health and how I handled this.

Just about 10 years ago I was diagnosed, with a variant of Familial Mediterranean Fever. My DNA tests for this disease came back negative for all KNOWN versions of this gene mutation. At that time, I was tested for the 14 known genes As I understand it there are now over 170 mutations that can be tested for.

I think I will likely not do any re-testing. The doctors believe that I have a variation of the gene, which has not yet been found and for hundreds of years the symptoms and the response to colchicine treatment have diagnosed FMF. This is called CLINICAL DIAGNOSIS.

I have improved so much with that treatment . Dr. Chris Morris of Kingsport, TN, the doctor who first recognized this pattern among Melungeon descendants (and I consider myself to be a Melungeon descendant, says that a POSITIVE reaction to colchicine is a positive diagnosis of FMF for us. My own local doctor told me the same thing. (Melungeons are a fascinating group of people who are found in the southeastern United States particularly in NC/VA/KY/TN/WV. They are believed to have a Mediterranean ancestry.)

Familial Mediterranean Fever has many symptoms which do not quite fit together into a pattern that physicians can see, because in the United States it is thought to be very rare. I personally think it is not that rare.

I can remember attacks of high fever and pain in my lower right side occurring as early as 8 years of age when my doctor said I had appendicitis. My mother details attacks from infancy. I would have a high fever and I would have hallucinations/nightmares during the attacks. The doctor told her he thought that I had had a mild case of polio at one point, yet I had no polio after effects. I had these attacks periodically and in between I was a pretty normal child. Don't most children suffer with fevers of unknown origin from time to time?

As I grew older, the symptoms seemed to change, and I began to suffer with depression in Elementary school. Of course, it wasn't called that then, but I can recognize it now. The depression has continued all my life. In my 30s I began to experience worsening depression and the beginnings of fibromyalgia. By the time I was in my 40s, I was feeling a variety of symptoms, which were continuing to worsen and to remain with me for longer time periods in between periods of well being. I had had some physical accidents and some emotional traumas by that time and so my problems were blamed on that. By my late 40s, the well periods were few and far between. It got to the point that if I awakened and felt 'good' I thought something was wrong with me!

***
By this time, my doctors and many of my family thought that I was a hypochondriac because of the many and varied symptoms that I presented. I was told 'it is all in your head.' I was diagnosed previously and erroneously, it turns out, with fibromyalgia, (I had ALL the trigger points of fibro and my muscles ached so much at times that my mouth watered from the pain, like a popcorn hull between your teeth causes you to do. More on this symptom later.)

I was diagnosed by blood tests with rheumatoid arthritis. I had x-rays that showed osteo-arthritis. I suffered with chronic recurrent chemical depression, sleep apnea, sleep disorder with myoclonus, and Restless Leg Syndrome, colitis, spastic colon, gallbladder inflammation, appendicitis, possible kidney stones with their concurrent problems of vomiting and diarrhea, and so many other things that I can't even remember them. I had chronic respiratory problems, chest pains, sinus infections, allergies and asthma. I had thyroid problems that bounced up and down for years starting in my early teens.
***

FMF can affect the thyroid gland because this illness inflames the lining of all the body's organs. FMF also deposits a protein called amyloid and the thyroid can be involved in this. "Thyroid abnormalities were described in 19% of children with FMF and were more frequent among girls. A positive test for antithyroglobulin antibodies was found in several patients, but amyloid deposits were also found. Therefore careful examination for goiter, as well as measurement of serum thyroxine (T4), TSH, and antithyroid antibodies should be performed in all patients with FMF."

I had even looked into Chronic Fatigue Syndrome as a possible cause of my problems. All of these things didn't happen at once. As I said, as a child, I was pretty normal between attacks. Then I received the fibromyalgia diagnoses and lived with that for years, but the diagnoses kept being added and they grew worse as I grew older. Sound like I was a wreck? I was, but I am beginning to improve. It is like a miracle.

I came across the diagnosis of Familial Mediterranean Fever through my genealogical research. I think the number of descendants of these folks has been grossly under-estimated. Suffice it to say that I diagnosed myself, and took it to my doctor who had been treating me for 20 years. He laughed at me. Without a word, I got up from his examing table and walked out of his office. I never returned.

I went to 2 other doctors where the same thing happened before finding the doctor where I was finally diagnosed. I explained that I was looking for a diagnosis of FMF and held up my hand, saying "Don't laugh, let me continue." I asked for the medicine colchicine as a trial. Dr. Henshaw said, "Oh, that is a very rare disease and I don't think you have that," I asked him if colchicine would cause me any harm if I took it for thirty days. He said, "NO." and I told him I wanted a trial prescription. He wrote me one. Two hours after I took the first dose, I knew it was going to work.

At the point when I took the medicine, I could not rise from a seated position without pushing or pulling myself up with my hands. My hands, arms, and shoulders in particular were in constant pain, both in the muscles and the joints. I could not hold a coffee cup or a glass of water without using two hands, no thumbs to hold them. My thumbs and wrists were red, swollen and painful to the touch. I could not raise my right arm above my head to comb my hair or put on clothes and getting it behind me to hook my bra was out of the question.

I moaned and groaned as I came down the steps in the morning, turned sideways and taking one step at a time while holding on to the rail with my finger tips from underneath the railing. My brain was foggy; I could not think clearly, nor concentrate for longer than a few minutes. I had trouble doing simple arithmetic in order to balance a checkbook. No anti-inflammatories even touched my pain and three tablets of 800mgs each of ibuprofen did not even dull it. Only high-octane narcotics, which knocked me out completely, worked and then when I awoke, I had to deal with the hangover they caused on top of everything else, so I stopped taking them and waited to die.

MY life was miserable. I was very unhappy and I hurt so much at times that I was sure I could not stand it. Stress seemed to make it more intolerable. I was forced to take early disability retirement from a position that I loved because I could no longer tell my employer that I would be there every day and from the beginning to the end of the day. I was 58 years old at this time. Remember that you may not have all these symptoms if you are younger, but you can.

HOW FMF WORKS:

FMF works on the body's symptoms in a way that is best explained by the following:

In the course of day-to-day activities, people incur a lot of Micro-injuries; a muscle stretched a smidgen too far, bumping your hand on the table, and so on. Each time such an injury occurs, a substance called C5a is released. C5a is a chemotactic factor for neutrophils. A chemotactic factor is a substance that, basically, 'says', 'Come here and do this', to a cell.

Neutrophils are small white blood cells that are part of the normal non-specific immune system. They are the first cells to arrive at an injury, and have many, many functions, primarily as mediators of inflammation. They first cause the inflammation to occur; and then, when the need for inflammation is gone, they cause it to go away. They also act as scavengers, engulfing and digesting debris at the site of an injury.

They are pretty neat little cells; but, the important thing to remember is that, in the presence of C5a, they CAUSE inflammation; which, amongst other things, causes the release of more C5a. In 'normal' people, a protein called pyrin is made that INACTIVATES C5a. As long as pyrin is present, the neutrophils won't be called to the site of an injury. Now, for a micro-injury, in a healthy person, this is not a problem. The inflammatory response really isn't needed to control the site of the injury, and induce healing. In a larger injury, the amount of C5a produced overwhelms the pyrin, and the Neutrophils respond. This is a very neat feedback loop.

However in a person with FMF, the pyrin is either not present at all, or is present in less-effective forms or at lower levels. This is the reason that even very small injuries result in an inflammatory response by the neutrophils, which is inappropriate and which cause the release of more C5a, which calls more neutrophils . . . and so on. This response only stops when so many neutrophils are packed into the site of the injury that no more can get in.

This is CERTAINLY NOT a good thing. The reason that colchicine is an effective treatment for some people with FMF is that it reduces the speed and effectiveness of the neutrophil's response to C5a; thereby reducing the inflammatory response to injury. The downside of this treatment is that the neutrophils will also be sluggish in responding to a serious injury, which can compromise a person's whole immune system. I have found that my immune system had already been compromised. Before taking colchicine, it was take anti-biotics for two weeks, off of anti-biotics for two weeks and then on again. Since I started colchicine, I have had to take anti-biotics many less times than previously needed. I think this is an improvement. Understanding about FMF and its effect on my immune system allows me to better understand how to take care of myself and get the appropriate treatment.

Family Riddled with FMF needs DNA to find Middle Eastern Roots

2011-05-08T14:45:00.000-07:00

The article noted below says that FMF can occur without Middle Eastern roots. That is not exactly true. FMF can occur when one does not know that they do indeed have Middle Eastern roots and only DNA can tell you if you do. Our genealogies will only go so far back and that may not indicate the Mediterranean ancestry that many of us have. I feel that articles like this one below can lead folks astray and we need to encourage more definitive studies of ancestry before making such a statement. See:

Familial Mediterranean fever can occur without Middle Eastern roots
Body and Mind staff
Posted: 05/04/2011 12:10 AM

"The diagnosis took them, their two equally afflicted siblings and the doctors who diagnosed and treat them by surprise. FMF is found primarily among people of Middle Eastern descent — Sephardic Jews, Arabs, Turks, Armenians — and sometimes Greeks and Italians. The background of Zelonis and DeVore is Northern and Western European.

“But familial Mediterranean fever can occur in any ethnic group,” Sachs said. "

http://mobile.pennlive.com/advpenn/db_96632/contentdetail.htm;jsessionid=10B342D08B6C9067B870F90BB1DC3213?contentguid=K0ir2b8A&detailindex=1&pn=0&ps=5&full=true

For more information on Familial Mediterranean Fever please see:

Familial Mediterranean Fever blog - 'my story' w/ FMF, and LOTS of medical documentation, charts etc.
http://familialmediterraneanfever.blogspot.com/

FMF Support mailing list:
fmf_support-subscribe@yahoogroups.com

Familial Mediterranean Fever Community
http://www.rarediseasecommunities.org/en/community/familial-mediterranean-fever

Article on colchicine price on gout patients as well as FMF patients:

2011-03-30T19:18:00.000-07:00

What the following article fails to mention is the effect that having only one brand of colchicine has on patients who have Familial Mediterranean Fever. It seems that different brands do make a difference for different patients:

"A Giant Pain in the Wallet
How drug companies are making crucial, common drugs up to 100 times more expensive.
By Arthur AllenPosted Tuesday, March 29, 2011, at 7:09 AM ET

How did gout pills get so expensive?A drug called colchicine is all that keeps some 2 million American gout patients from suffering debilitating pain in their toes, elbows, wrists, and fingers. Doctors have prescribed the compound, derived from the seeds of the autumn crocus, for centuries. But patients who take colchicine woke up with a new symptom recently: a giant pain in the wallet."

http://www.slate.com/id/2289616/

Nancy

URLS for Familial Mediterranean Fever Research.

2011-02-28T20:40:00.000-08:00

A Variety of URLS for Familial Mediterranean Fever Research.

The following articles cover a wide variety of symptoms and signs of FMF and include diagnosing the illness as well as treatment. Some are more technical than others and some may be good for printing and taking to your doctors if necessary:

Shariz Medical Journal - This article has the DIAGRAM of SYMPTOMS that I have often used.
http://semj.sums.ac.ir/vol7/apr2006/fmf.htm

Jewish Genetic Diseases - FMF
http://www.mazornet.com/genetics/familial_mediterranean_fever.htm

Mayo Clinic -
Familial Mediterranean fever
http://www.mayoclinic.com/health/familial-mediterranean-fever/DS00766

GENETICS Home Reference - FMF

http://ghr.nlm.nih.gov/condition/familial-mediterranean-fever

Molecular Genetics in Clinical Practice
Familial Mediterranean Fever: The
Genetics of Inflammation - this article has the map of spread of FMF throughout the Mediterranean, by Dr. Daniel Kastner, chief researcher FMF at NIH and pretty technical but worth taking a look at:

http://www.prontodiagnostics.com/pdfs/hospital%20fmf.pdf

Genetic and Rare Diseases Info - FMF

http://rarediseases.info.nih.gov/GARD/QnASelected.aspx?diseaseID=6421

National Human Genome Research Institute

http://www.genome.gov/12510679

University of MD,
http://www.umm.edu/ency/article/000363.htm

Merck Manual - FMF
http://www.merckmanuals.com/professional/sec19/ch297/ch297b.html

An interview w/ Dr. Terry Getzug - I posted to this site a couple of times.....
http://www.jewishjournal.com/jewish_diseases/item/familial_mediterranean_fever_an_interview_with_terri_getzug_md_20100725/

Uncommon clinical pattern of FMF: protracted febrile myalgia syndrome - this is the "fibromyalgia" of FMF - many in the USA are being given this diagnosis.
http://www.springerlink.com/content/g86037681x5l1q87/

TEXTBOOK of Medicine
http://www.brown.edu/Administration/Emergency_Medicine/emr/pages/fmf.html

MEFV (NM_000243.1) sequence variants

http://fmf.igh.cnrs.fr/ISSAID/infevers/search.php?n=1

INFEVERS Home page:
The registry of Hereditary Auto-inflammatory Disorders Mutations
(includes other fever disorders)
http://fmf.igh.cnrs.fr/ISSAID/infevers/

Love and health in family ties,
Nancy

Wall St. Journal article on Colcrys

2010-04-13T10:34:00.000-07:00

•Wall Street Journal
•
•
•HEALTH INDUSTRY
•APRIL 12, 2010
An Old Gout Drug Gets New Life and a New Price, Riling Patients
•By JONATHAN D. ROCKOFF
A centuries-old drug used to treat excruciating gout pain had cost just pennies a tabletâ€”until last year. Now, the retail price has skyrocketed to more than $5 and some of the manufacturers have ceased production amid a battle over marketing rights.

The tale of how this common gout drug, colchicine, became the costlier branded drug Colcrys offers a window into the Byzantine world of drug pricing. The price rise is a consequence of a Food and Drug Administration effort to improve the safety of long-used but unapproved drugs, with a trade-off often made between drug affordability and safety.

In July 2009, a Philadelphia drug maker received FDA approval to exclusively market colchicine for gout attacks for three years. The company, URL Pharma Inc., was taking advantage of a push to bring medicines predating the FDA, like colchicine, under the agency's regulatory umbrella. The FDA offers exclusive marketing rights if a drug maker conducts clinical trials.

URL Pharma had commissioned studies that confirmed its colchicine product's safety and efficacy, while demonstrating it should be taken at a lower dose than typical and not used with certain other medicines. The company is marketing its drug as Colcrysâ€”and the retail cost averages $5 per pill, according to DestinationRx, a health-care data provider.

URL is also suing longtime manufacturers of unapproved colchicine, saying the companies are now illegally marketing their products. Some of the companies are fighting the lawsuits. Some themselves have raised pricesâ€”including one increase of just under a dollar per tablet to $1.17, according to DestinationRx. The higher price for Colcrys was first reported by Kaiser Health News.

There were 3.5 million prescriptions and $6.4 million in sales in 2008, according to the most recent data available from IMS Health, a drug-data firm.

"It's not a new product. It's been out for hundreds of years. To all of a sudden have to pay $125 or $150 a month, after it only cost $5 or $10 a month, is a real problem," said Stanley Cohen, a Dallas doctor who is the president of the American College of Rheumatology. He met with the FDA to express concern about the price increase.

The chief executive of URL Pharma, Richard Roberts, said that it priced Colcrys in line with other approved, branded drugs used to treat gout pain. To help patients afford Colcrys, Dr. Roberts said, the company is offering to pay a portion of co-pays, and it is providing a three-months' supply to low-income patients for $15.

Eileen Wood, vice president of pharmacy and health-quality programs at CDPHP, an insurer in New York state, said insurers will have to absorb much of the added expense. URL's contribution was "not any new therapeutic tool, not new science; they just added cost," she said.

Nancy Sparks Morrison, a retired schoolteacher who suffers from familial Mediterranean fever, an inflammatory disorder that's treated with colchicine, said she is buying colchicine from Canada because she can't afford Colcrys. Ms. Morrison said she plans to get help from URL Pharma to pay for Colcrys because the company has just expanded its assistance program. "I'm retired on Social Security, and I have a small pension," said Ms. Morrison, 71 years old, who lives outside Charleston, W.Va.

The price increase is an unintended consequence of the FDA's nearly four-year-old initiative to regulate unapproved drugs. These medicines were sold before the FDA was established, and therefore weren't required to undergo approval. After decades of use, the medicines are considered safe by doctors, but haven't been proven to satisfy the agency's standards. Colchicine's use has been traced back to the sixth century, according to the FDA.

Seventy drugs that were grandfathered have been approved since the FDA began its initiative, most notably pain reliever Vicodin, from Amneal Pharmaceuticals LLC, the FDA said.

The FDA had hoped a significant price increase wouldn't follow Colcrys's approval and regrets the increase, said Janet Woodcock, director of the agency's Center for Drug Evaluation and Research. Dr. Woodcock encouraged more competition, saying another company could seek approval for colchicine's regular use in gout, rather than the acute use that URL Pharma received approval for.

There had been no standard for dosage before FDA approval. Colchicine's excessive use can cause side-effects, such as severe diarrhea that is potentially fatal. The FDA said it receives reports of five deaths a year, on average, involving patients who took colchicine tablets.

"We took bad guidance, even guesswork, and made this evidence-based medicine," Dr. Roberts said.

Closely held URL Pharma, which is owned by a hedge fund, a private investor and employees, is a longtime seller of generic drugs, including colchicine. When the FDA launched its push, the company began searching for those with safety risks whose patients could benefit from clinical testing, Dr. Roberts said.

URL Pharma said its 17 clinical trials of colchicine involved a total of 988 patients. The trials showed that gout patients need take two tablets after an attack and one more an hour later, the FDA said. Trials also demonstrated side-effects from use with certain other medicines, including some antibiotics and antihypertensive medicines. Those are now flagged on the label of Colcrys.

After obtaining FDA approval of Colcrys, URL Pharma went to federal court to sue manufacturers of colchicine, including Excellium Pharmaceutical Inc., Vision Pharma LLC, Watson Pharmaceuticals Inc. and West-Ward Pharmaceutical Corp., saying they have been illegally marketing their colchicine products since Colcrys's approval. A fifth company, Qualitest Pharmaceuticals, settled and stopped production. The four companies are fighting the lawsuits.

"You have this product out for at least a hundred years and all of a sudden it's no good?" said Lou Dretchen, who oversees sales and marketing at Excellium of Fairfield, N.J. Mr. Dretchen said the small, closely held generic drug maker stopped colchicine production after URL Pharma sued. The other companies declined to comment.

Mon Apr 12, 2010 1:43 pm

--------------------------------------------------------------------------------

The High Price of FDA Approval

2009-12-29T17:58:00.000-08:00

The following post is here because of Kaiser Health's permission to post with credit from their site:

The High Price of FDA Approval

By Harris Meyer

Dec 29, 2009

Several months ago, Doris Webb was diagnosed with a rare disease called Familial Mediterranean Fever, a hereditary condition tied to her French ancestry that causes fevers, arthritis attacks and inflammation of the lining of the lungs and abdomen. Debilitating pain in her joints and bones was relieved by a prescription drug called colchicine.

Webb, of Morristown, Tenn., takes two to three tablets a day, paying $11 at Wal-Mart for a 90-day supply, according to her daughter Tina Martin, who also takes colchicine for FMF. The drug, which has long been used to treat gout, is cheap because, like thousands of prescription drugs, it pre-dates modern drug laws and has never been approved by the Food and Drug Administration.

Now, however, Webb, 66, who's on Medicare but can't afford the Part D drug benefit, her daughter says, faces a problem in getting her colchicine. In July, Philadelphia-based URL Pharma won FDA approval for a branded version called Colcrys, which sells for about $4.50 a tablet - nearly 50 times the price of the unapproved version. While the uninsured will be hit hardest by the cost increase, even insured patients, like Martin, will face higher costs. She says her copayment will rise from $10 to $35 for a 90-day supply.

The FDA found that Colcrys' drug interaction labeling and recommended dosing regimen make it safer than the unapproved forms of colchicine. The agency said it had received reports of 120 patient deaths from interactions of unapproved colchicine with other drugs. It granted URL Pharma and Colcrys three years exclusivity for treatment of gout - a recurrent arthritic inflammatory disease caused by uric acid buildup - and seven years for FMF under orphan drug rules.

But some rheumatologists and patients' groups charge that the FDA is letting URL Pharma overcharge the public for a drug that's no better or safer than the unapproved form. "If URL Pharma can show their medicine is superior, that's fine," said Dr. Chris Morris, a rheumatologist in Kingsport , Tenn. who has many FMF patients and gouty arthritis patients. "But I don't think they can. They're charging an outlandish amount for a medicine that's available for a fraction of the price."

There were about 3.5 million colchicine prescriptions filled in 2009, according to IMS Health. There are an estimated five million gout suffers in the U.S. and fewer than 200,000 FMF patients.

Colchicine is the latest unapproved drug targeted by the FDA under a 2006 initiative aimed at prodding drugmakers to go through the agency's lengthy and costly approval process. The agency already has removed a number of unapproved prescription products and ingredients from the market.

Recently, the American College of Rheumatology sent a letter to the FDA seeking a meeting to discuss how to keep colchicine affordable to patients. "We want to express our concern that a medicine used for centuries to treat gout and rare conditions, which costs pennies, will now cost patients quite a bit more," said Dr. Stanley Cohen, who is the Dallas-based president of the group, in an interview. "That doesn't make sense in the setting of health care reform."

Part of URL Pharma's business plan is to take advantage of the FDA's campaign against unapproved drugs.

"Four years ago we decided to join the FDA in this effort," said Dr. Richard Roberts, CEO of URL Pharma. "We are focusing on a few of the unapproved products where there are significant safety and medical issues, applying a lot of science and creativity to bring them into compliance and make them safer."

In 2005, the company won FDA approval for Qualaquin, a brand-name formulation of unapproved quinine sulfate, long used for treating malaria. The following year, after it sued to force unapproved quinine sulfate products off the market, the FDA halted sales of those drugs.

In its 2006 policy guide, the FDA estimated there are several thousand drugs being marketed without the agency's approval. Federal law required approval of new drugs for safety beginning in 1938, and for effectiveness in 1962. Many drugs currently on the market preceded those laws.

Unapproved products the FDA has forced off the market include codeine sulfate, carbinoxamine, ergotamine and trimethobenzamide hydrochloride suppositories.

The FDA is targeting unapproved drugs with potential safety risks or lack of evidence of effectiveness, as well as those being marketed fraudulently or competing with an approved drug. But the agency has also said it would consider whether halting sales would leave patients without good alternatives.

Cheap colchicine probably won't be on the market for long. URL Pharma is suing to force the unapproved products off the market. Whatever the outcome of that lawsuit, the FDA policy guide suggests the drug agency will give other colchicine makers a year from Colcrys' approval before moving to halt sales. FDA spokeswoman Karen Riley declined to comment on the agency's enforcement plans.

Nancy Sparks Morrison, 70-year-old resident of Cross Lanes, W.V. who operates a Web site for fellow FMF sufferers, says she and other patients already are having trouble finding cheap colchicine. Her pharmacist no longer can get her old brand, which cost about $10 a month, so she started ordering a Canadian-made version, which costs about $100 a month, through an online pharmacy.

"With Colcrys coming out, all the other makers have stopped production, and when supplies run out there will be no more generic colchicine," Morrison said. "Then Colcrys will be the only product and they can charge whatever they want. It's price gouging, there's absolutely no excuse."

Attempts to reach colchicine producers were unsuccessful.

Roberts argues that it's unfair to compare the price of Colcrys and unapproved colchicine. "The companies pushing out illegal products with no regard for safety issues didn't add value for patients and doctors that we've now created," he said. "We've revolutionized how colchicine can be used. We don't compare ourselves to illegal products."

He acknowledged that his company distributed an unapproved form of the drug until 2006 but decided several years ago to stop producing or distributing any non-FDA approved products.

Some experts say the higher price of Colcrys is a necessary tradeoff for greater public protection. "It costs a lot to come out with a new drug that meets the standards of safety and efficacy, and someone has to pay for that," said Dr. Tom Hazlet, an associate professor at the University of Washington School of Pharmacy.

URL Pharma is reaching out to calm the consternation over the price of its new product. It's offering a three-month supply of Colcrys for $15 to any U.S. patients with incomes under three times the poverty level. FMF patients with private insurance will qualify for coupons limiting their copayment to $25 per prescription. And Roberts said his company soon will announce a third assistance program for FMF patients who don't qualify for the other two, including Medicare beneficiaries who lack drug coverage.

But Tina Martin remains upset. "They've made the price astronomical," she said, "and it's not right."

© 2009. The Henry J. Kaiser Family Foundation

Colchicine and Colchrys - the PROBLEM

2009-09-18T16:24:00.000-07:00

I have a story to tell you and I am asking for your help. I believe that this goes well with President Obama's wish for health care improvement.

Let me start with a brief overview. I have an inherited illness called Familial Mediterranean Fever. (You can read more of this on this blog below this post.)

Doctors in the USA say it is a 'rare' illness. It is not. It has just been misdiagnosed as everything under the sun including any diagnosis that ends with 'itis,' because one of the major components of Familial Med. Fever is inflammation.

The medication for Fam. Med. Fever is colchicine given in 0.6mg twice to four times daily for life.

Colchicine is one of those old drugs - the doctors to the Pharaohs of Egypt gave it to them for their arthritic-like pains - and it has been grand-fathered in without FDA approval because of the common usage of it for treatment of gout and FMF as well as some newer uses for diseases like Behcet's Disease, recurrent chronic pericarditis, as well as for people with chronic constipation among other things.

Recently URL Pharma, Inc. has run tests on colchicine and the FDA because of these tests, has now given URL Pharma the sole rights of distribution for colchicine.

URL Pharma will be or is already, suing any other pharmacies who manufacture colchicine (generic) for infringement of their formulary and those companies are now ceasing production of colchicine or will stop shortly.

The cost of colchicine for me after insurance payment has run about $10.00 a month. The cost of Colchrys, the name of the new single ingredient (colchicine) script from URL Pharma for gout, FMF etc will, my pharmacist tells me, be approximately $300.00 per month.

Other sufferers of FMF who take 4 or more tablets per day, will see monthly bills of $800.00 or more.

I am a senior citizen on Medi-care and with AARP prescription services, so I receive limited benefits for drugs. I have limited disability income and a small pension.

Before I found the diagnosis of Familial Mediterranean Fever, I was for all intent and purposes bed-ridden. The pain I suffered never went away and it was excruciating. I believe I would now be dead without colchicine. It allows me to lead a near normal life for a person of my age. I am able to do housework and to enjoy my life. I am miserable thinking of what lies ahead of me should I be unable to afford this medication. I believe I will die without this medicine which I will be unable to afford.

You can read more information on Familial Mediterranean Fever by continuing to read below this post on this blog. There is LOTS of medical data on there as well.

I moderate a world-wide message board for people with Familial Mediterranean Fever. See:
http://health.groups.yahoo.com/group/fmf_support/messages

Nancy Sparks Morrison
5113 Lynwood Dr.
Charleston, WV 25313
1-304-776-5601
nmorri3924@aol.com

Familial Mediterranean Fever

2009-01-05T12:01:00.000-08:00

Familial Mediterranean Fever

Please feel free to copy and use any of the following information for your own or family's personal use.

I am NOT a doctor. I can not diagnose nor prescribe. I have Familial Mediterranean Fever. I was born with it and I self-diagnosed at age 56 after finding this illness among related peoples while doing my family genealogy. At the time I was for all intents and purposes BEDRIDDEN. I had NO IDEA I had any Mediterranean ancestry. DNA has since proven that I do. I will explain more fully as we go along in this blog:

FAMILIAL MEDITERRANEAN FEVER is a hereditary genetically restricted disease commonly found among Jews originating from North African countries, Armenians, Turks and Arabs. In the United States, it is considered a RARE disease. It is NOT. It is just being misdiagnosed as everything under the sun!

In this blog, I will describe what FMF does; what the symptoms are; how it works; how to treat it, as well as how to get your doctor to listen to you. There is also information here on the medication used to treat FMF, as well as medications that should not be used while on colchicine. Left untreated, FMF CAN be a FATAL disease.

Closely following the pattern of autosomal recessive inheritance (both parents must carry a recessive gene) , FMF is recognized by two independent manifestations:

1.) acute, short-lived painful, bouts of stomach pain, (may be followed by diarrhea); pleuritis, an inflammation of the lining of the body cavities, and/or some of its internal organs, which in its acute stage may produce, stabbing pain in the side or affected cavity, possible fever of 101-103 degrees, similar to gallbladder/kidney stone attacks/inflammation, and short, dry cough and body pain similar to arthritis and FIBROMYALGIA and

2.) nephropathic amyloidosis, which can lead to terminal renal failure even at a young age. (kidney disease) In half of the people this disease appears before age ten.

The gene for FMF is located on the short arm of chromosome 16, yet the exact nature of the disease remains unclear.

Foggy-headedness (inability to think clearly) may also be a part of the symptoms because of inflammation of the brain lining which causes the brain to swell.

Fatigue (severe) can also be a problem.

Infertility and pregnancy loss in women with FMF is much more common than it is in the general population. (The treatment for FMF can HELP infertile women bear children.)

The identification of FMF is based on

1. clinical findings; do you have the stated symptoms?

2. family history; do you have ancestry from any of the countries mentioned (or) has your family been located in the southeastern US, in particular, NC/VA/KY/TN/WV for generations?

3. physical examination; can you show the doctor where and how you hurt

4. laboratory results; more on what these lab results may show later in this blog.

Laboratory tests should be obtained when the patient is better as well as from patients experiencing attacks. If you are under 30 and/or the parent of a child with these symptoms, then the most usual description of the symptoms will likely fit you.

If you are over 30 and have been left untreated you may have already received dozens of different diagnoses or you likely will receive such.

No specific diagnostic test is available. There are are now over 170 specific gene mutations that cause FMF. The genes have been identified and this should lead to the development of a blood test to identify the disease in people. It is NOT necessary to have genetic testing done as a clinical diagnosis is considered adequate. More on getting genetic testing will be found later in this blog.

Amyloidosis can affect untreated FMF patients. This can be the FATAL part of this illness and there will be a broader discussion of this later in the blog. However, in its early stage, it can be recognized by protein in the urine.

The medicine colchicine which comes from a plant that grows in the Mediterranean and is also used to treat gout is effective in controlling this disease.

Colchicine treatment was first introduced in 1973 and in a dose of 1-2 mg/day on a continuous basis, has been found to prevent attacks in most patients and amyloidosis in all patients.

Colchicine treatment has been shown to be safe and entirely suitable for FMF patients.

Many FMF patients appear to be getting diagnoses of FIBROMYALGIA and CHRONIC FATIGUE SYNDROME.

CAUSE of FMF:

Familial Mediterranean Fever, long-mysterious, has now yielded up its secrets. The cause is a lack of pyrin, a neutrophil protein which slows down neutrophils (neutrophils are the white cells that come to the site of an injury to help heal the injury) when enough have reached an area (Hosp. Pract. 33: 131, April 15, 1998.) Too much of a good thing is not good.

Lacking pyrin, neutrophils mob body cavities every once in a while.

In addition to fever, patients may have

1. pleuritis, that is severe pain in the chest area which makes it hard to breathe deeply, feels as though your breast bone is broken.

2. arthritis, which may be in one or more joints and will usually skip from joint to joint rather than remain in one joint.

3. peritonitis, which is severe stomach area pain which may be mistaken for an acute appendix, or gall bladder attacks. Many patients have had multiple surgeries for such symptoms with negative findings.

4. a hot rash which can look like a baby's heat rash or a strep infection. This rash can be found on the ankles frequently but may be on any part of the body including the face, which leads many doctors to mis-diagnose LUPUS as the cause.

5. Many other symptoms which lead doctors to a misdiagnosis in the United States where many doctors hear only a mention of the disease name during their schooling.

Colchicine, famous for its ability to slow down neutrophils (as in acute gout), controls the attacks and prevents the dread complication of secondary amyloidosis. As you can imagine, FMF can mimic most diseases. "Don't miss it". http://www.pathguy.com/lectures/spleen.htmMolecular genetic diagnosis: Ann. Int. Med. 129: 539, 1998.

_____________________________

Nancy's PERSONAL EXPERIENCES with FMF.

I think that by telling you my story with Familial Mediterranean Fever, it may help you see that this disease is easily mis-diagosed as everything under the sun. I am also including here an explanation of just HOW Familial Mediterranean Fever works:

Let me tell you about my experiences with Familial Mediterranean Fever. Please note that I am not a doctor, and I can neither diagnose nor prescribe. I wanted to be a doctor but in those days girls were not encouraged to do so. I followed the traditional wisdom but continued my interest in all things scientific throughout my life. I consider myself to be a genealogist with a scientific bent. I CAN tell you about my journey to better health and how I handled this.

Just about 10 years ago I was diagnosed, with a variant of Familial Mediterranean Fever. My DNA tests for this disease came back negative for all KNOWN versions of this gene mutation. At that time, I was tested for the 14 known genes As I understand it there are now over 170 mutations that can be tested for.

I think I will likely not do any re-testing. The doctors believe that I have a variation of the gene, which has not yet been found and for hundreds of years the symptoms and the response to colchicine treatment have diagnosed FMF. This is called CLINICAL DIAGNOSIS.

I have improved so much with that treatment . Dr. Chris Morris of Kingsport, TN, the doctor who first recognized this pattern among Melungeon descendants (and I consider myself to be a Melungeon descendant, says that a POSITIVE reaction to colchicine is a positive diagnosis of FMF for us. My own local doctor told me the same thing. (Melungeons are a fascinating group of people who are found in the southeastern United States particularly in NC/VA/KY/TN/WV. They are believed to have a Mediterranean ancestry.)

Familial Mediterranean Fever has many symptoms which do not quite fit together into a pattern that physicians can see, because in the United States it is thought to be very rare. I personally think it is not that rare.

I can remember attacks of high fever and pain in my lower right side occurring as early as 8 years of age when my doctor said I had appendicitis. My mother details attacks from infancy. I would have a high fever and I would have hallucinations/nightmares during the attacks. The doctor told her he thought that I had had a mild case of polio at one point, yet I had no polio after effects. I had these attacks periodically and in between I was a pretty normal child. Don't most children suffer with fevers of unknown origin from time to time?

As I grew older, the symptoms seemed to change, and I began to suffer with depression in Elementary school. Of course, it wasn't called that then, but I can recognize it now. The depression has continued all my life. In my 30s I began to experience worsening depression and the beginnings of fibromyalgia. By the time I was in my 40s, I was feeling a variety of symptoms, which were continuing to worsen and to remain with me for longer time periods in between periods of well being. I had had some physical accidents and some emotional traumas by that time and so my problems were blamed on that. By my late 40s, the well periods were few and far between. It got to the point that if I awakened and felt 'good' I thought something was wrong with me!

***
By this time, my doctors and many of my family thought that I was a hypochondriac because of the many and varied symptoms that I presented. I was told 'it is all in your head.' I was diagnosed previously and erroneously, it turns out, with fibromyalgia, (I had ALL the trigger points of fibro and my muscles ached so much at times that my mouth watered from the pain, like a popcorn hull between your teeth causes you to do. More on this symptom later.)

I was diagnosed by blood tests with rheumatoid arthritis. I had x-rays that showed osteo-arthritis. I suffered with chronic recurrent chemical depression, sleep apnea, sleep disorder with myoclonus, and Restless Leg Syndrome, colitis, spastic colon, gallbladder inflammation, appendicitis, possible kidney stones with their concurrent problems of vomiting and diarrhea, and so many other things that I can't even remember them. I had chronic respiratory problems, chest pains, sinus infections, allergies and asthma. I had thyroid problems that bounced up and down for years starting in my early teens.
***

FMF can affect the thyroid gland because this illness inflames the lining of all the body's organs. FMF also deposits a protein called amyloid and the thyroid can be involved in this. "Thyroid abnormalities were described in 19% of children with FMF and were more frequent among girls. A positive test for antithyroglobulin antibodies was found in several patients, but amyloid deposits were also found. Therefore careful examination for goiter, as well as measurement of serum thyroxine (T4), TSH, and antithyroid antibodies should be performed in all patients with FMF."

I had even looked into Chronic Fatigue Syndrome as a possible cause of my problems. All of these things didn't happen at once. As I said, as a child, I was pretty normal between attacks. Then I received the fibromyalgia diagnoses and lived with that for years, but the diagnoses kept being added and they grew worse as I grew older. Sound like I was a wreck? I was, but I am beginning to improve. It is like a miracle.

I came across the diagnosis of Familial Mediterranean Fever through my genealogical research. I think the number of descendants of these folks has been grossly under-estimated. Suffice it to say that I diagnosed myself, and took it to my doctor who had been treating me for 20 years. He laughed at me. Without a word, I got up from his examing table and walked out of his office. I never returned.

I went to 2 other doctors where the same thing happened before finding the doctor where I was finally diagnosed. I explained that I was looking for a diagnosis of FMF and held up my hand, saying "Don't laugh, let me continue." I asked for the medicine colchicine as a trial. Dr. Henshaw said, "Oh, that is a very rare disease and I don't think you have that," I asked him if colchicine would cause me any harm if I took it for thirty days. He said, "NO." and I told him I wanted a trial prescription. He wrote me one. Two hours after I took the first dose, I knew it was going to work.

At the point when I took the medicine, I could not rise from a seated position without pushing or pulling myself up with my hands. My hands, arms, and shoulders in particular were in constant pain, both in the muscles and the joints. I could not hold a coffee cup or a glass of water without using two hands, no thumbs to hold them. My thumbs and wrists were red, swollen and painful to the touch. I could not raise my right arm above my head to comb my hair or put on clothes and getting it behind me to hook my bra was out of the question.

I moaned and groaned as I came down the steps in the morning, turned sideways and taking one step at a time while holding on to the rail with my finger tips from underneath the railing. My brain was foggy; I could not think clearly, nor concentrate for longer than a few minutes. I had trouble doing simple arithmetic in order to balance a checkbook. No anti-inflammatories even touched my pain and three tablets of 800mgs each of ibuprofen did not even dull it. Only high-octane narcotics, which knocked me out completely, worked and then when I awoke, I had to deal with the hangover they caused on top of everything else, so I stopped taking them and waited to die.

MY life was miserable. I was very unhappy and I hurt so much at times that I was sure I could not stand it. Stress seemed to make it more intolerable. I was forced to take early disability retirement from a position that I loved because I could no longer tell my employer that I would be there every day and from the beginning to the end of the day. I was 58 years old at this time. Remember that you may not have all these symptoms if you are younger, but you can.

HOW FMF WORKS:

FMF works on the body's symptoms in a way that is best explained by the following:

In the course of day-to-day activities, people incur a lot of Micro-injuries; a muscle stretched a smidgen too far, bumping your hand on the table, and so on. Each time such an injury occurs, a substance called C5a is released. C5a is a chemotactic factor for neutrophils. A chemotactic factor is a substance that, basically, 'says', 'Come here and do this', to a cell.

Neutrophils are small white blood cells that are part of the normal non-specific immune system. They are the first cells to arrive at an injury, and have many, many functions, primarily as mediators of inflammation. They first cause the inflammation to occur; and then, when the need for inflammation is gone, they cause it to go away. They also act as scavengers, engulfing and digesting debris at the site of an injury.

They are pretty neat little cells; but, the important thing to remember is that, in the presence of C5a, they CAUSE inflammation; which, amongst other things, causes the release of more C5a. In 'normal' people, a protein called pyrin is made that INACTIVATES C5a. As long as pyrin is present, the neutrophils won't be called to the site of an injury. Now, for a micro-injury, in a healthy person, this is not a problem. The inflammatory response really isn't needed to control the site of the injury, and induce healing. In a larger injury, the amount of C5a produced overwhelms the pyrin, and the Neutrophils respond. This is a very neat feedback loop.

However in a person with FMF, the pyrin is either not present at all, or is present in less-effective forms or at lower levels. This is the reason that even very small injuries result in an inflammatory response by the neutrophils, which is inappropriate and which cause the release of more C5a, which calls more neutrophils . . . and so on. This response only stops when so many neutrophils are packed into the site of the injury that no more can get in.

This is CERTAINLY NOT a good thing. The reason that colchicine is an effective treatment for some people with FMF is that it reduces the speed and effectiveness of the neutrophil's response to C5a; thereby reducing the inflammatory response to injury. The downside of this treatment is that the neutrophils will also be sluggish in responding to a serious injury, which can compromise a person's whole immune system. I have found that my immune system had already been compromised. Before taking colchicine, it was take anti-biotics for two weeks, off of anti-biotics for two weeks and then on again. Since I started colchicine, I have had to take anti-biotics many less times than previously needed. I think this is an improvement. Understanding about FMF and its effect on my immune system allows me to better understand how to take care of myself and get the appropriate treatment.

Two researchers of FMF, Babior and Matzner (1997) suggested that the pathogenesis of FMF be as follows: Pyrin, or marenostrin, is postulated to activate the biosynthesis of a Chemotactic-factor inactivator, an enzyme that normally occurs in the serosal fluids. They suggested that a chemotactic factor (probably C5a; 113995) can be released by Sub clinical injury to the serosa during normal activities, but the amounts released are small enough that they are cleared by the inactivating enzyme before they can provoke an inflammatory reaction. In FMF the inactivating enzyme is absent, allowing the chemotactic factors to survive long enough to call in neutrophils, which then release a variety of products, including an enzyme that generates more C5a. The result is an upward spiral that culminates in a full-blown inflammatory reaction: an attack of FMF. Think of the cloud that comes with a nuclear explosion.

Picture the bottom of the column being encircled by C5a (the cause of pain) in an ever-widening spiral until it reaches the mushroom at the top of the cloud, which is the full blown FMF attack. If you have ever been told that you are overly sensitive to pain, here is the explanation. You are not overly sensitive. You have more pain because your body cannot relieve the pain the way those who are 'normal' can.

The medicine colchicine, which I started taking in 0.6mg daily doses, once daily and now take twice a day, and which the Merck Manual says can be taken in that amount 4 times a day, is made from a plant called the Autumn Crocus which grows in the Mediterranean.

***
It is not harmful taken in small doses for a short time even if you do NOT have the disease. It needs to be carefully monitored by your doctor through periodic twice-yearly blood tests, and is available only by prescription. New information, just in, reveals that doctors in Israel find that there is relevance between familial Mediterranean fever and fibromyalgia pain.

The newest information on FMF and 'FIBROMYAGLIA' comes from Medscape Medline article that I found while searching on the Internet. You need to give your doctor the following information: To find the article, go to http://www.medscape.com/.

You must register and then click on MEDLINE.

Type in Familial Mediterranean Fever connected to fibromyalgia. The first article to appear is the document you need to copy and take to your doctor along with the address above.

The article concludes that 'the detection of FM (fibromyalgia) and definition of tenderness thresholds is relevant to this disease (FMF,) since musculoskeletal complaints are common in this group of patients but not always explained by objective findings.' With this article you can ask your doctor for a trial of the medicine because the connection is there for him to see.

Familial Mediterranean Fever, long mysterious, has now yielded up its secrets. The cause is a lack of pyrin, a neutrophil protein, which slows down neutrophils when enough, have reached an area (Hosp. Pract. 33: 131, April 15, 1998.) Lacking pyrin, neutrophils mob body cavities every once in a while. In addition to fever, patients may have pleuritis, arthritis, peritonitis, and/or a hot rash (looks like a strep infection) on the ankles.

Colchicine, famous for its ability to slow down neutrophils (as in acute gout), controls the attacks and prevents the dread complication of secondary amyloidosis. As you can imagine, FMF can mimic most diseases. Don't miss it.
Molecular genetic diagnosis: Ann. Int. Med. 129: 539, 1998.

Comparison of Familial Mediterranean Fever/Fibromyalgia/Chronic Fatigue as well as diagnostic criteria and misdiagnoses given for FMF:

Let me say again, that I am not a doctor and I do NOT diagnose nor prescribe.

I have Familial Mediterranean Fever, I found it, and diagnosed myself. My doctor confirmed it.

My DNA proves that I have the ancestry to have this illness.

I have done a LOT of research on FMF and I am sharing with you what I have found. You can take this information to your doctor and feel free to share it with anyone who needs it. FMF has many symptoms, one of which, is that many of the muscles of your body are sore.

Drs can diagnose this as 'fibromyalgia.' Fibromyalgia is NOT a DISEASE. It is a SYNDROME which simply means a 'set of symptoms.' Being given a 'syndrome' as a diagnosis is a useless waste of time and money and may cause more injury to the patient. You might even die, if the CAUSE of your fibromyalgia is something like FMF. Someday, Fibro may indeed become a disease in and of its ownself. That time is not YET. Fibro may have hundreds of causes, but one of them is FMF.

The newest information on FMF and ‘fibromyalgia’ comes from Medscape Medline article that I found while searching on the internet. This study corroborates what I understood and had known intuitively, from the first time that I heard about Familial Mediterranean Fever and realized that this was what I had.

***
Fibromyalgia in familial Mediterranean fever.J Rheumatol 1994 Jul;21(7):1335-7 (ISSN: 0315-162X)
Langevitz P; Buskila D; Finkelstein R; Zaks N; Neuman L; Sukenik S; Smythe HA; Pras Heller Institute of Medical Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.

OBJECTIVE. To determine whether chronic lower body pain in a subpopulation of patients with familial Mediterranean fever (FMF) is due directly to the musculoskeletal manifestations of FMF or whether they are connected to mechanical problems in the low back and leg/foot or to other factors operative in fibromyalgia (FM).

METHODS. In 93 consecutive patients with FMF a point count of 14 tender points (TP) was conducted by thumb palpation. Tenderness thresholds were assessed in some of the TP and of control point sites by Chatillon dolorimeter.

RESULTS. In female patients with FMF dolorimeter thresholds of fibrositic and control point sites were significantly lower than in male patients with FMF (p < 0.004). Also patients with FMF with back pain and foot/leg pain are more tender than patients with FMF without this characteristic (p < 0.001).

CONCLUSION. The detection of FM and definition of tenderness thresholds is relevant to this disease, since musculoskeletal complaints are common in this group of patients but not always explained by objective findings. The symptoms of ‘fibromyalgia’ are a part of the problems of FMF.

From the source document, the study conducted by doctors from Israel concludes: “The detection of FM (fibromyalgia) and definition of tenderness thresholds is relevant to this disease, (FMF) since musculoskeletal complaints are common in this group of patients but not always explained by objective findings.”

*** IF you have been diagnosed with fibromyalgia, you need to eliminate as a cause, FMF and 3 other illnesses that can also cause 'fibro.'

These other three are:
1. Chiari Syndrome,

2. Hemochromatosis,

3. Wilson's Syndrome.

There may be hundreds of causes of fibromyalgia pain, but these 4 are prominent and should be ELIMINATED before accepting a non-specific diagnosis of fibromyalgia. Doctors will tell you that fibromyalgia will NOT kill you, YET 3 of these 4 illnesses CAN be DEADLY if left untreated.
Posted by Nancy at 12:58 PM 0 comments
A COMPARISON OF FIBROMYALGIA, CFIDS, AND FAMILIAL MEDITERRANEAN FEVER

The following list compares symptoms given for fibromyalgia and chronic fatigue syndrome with the symptoms that I and others have had with Familial Mediterranean Fever. The fibromyalgia symptoms and the Chronic Fatigue Symptoms were taken from the Internet sites of both groups. I have taken the symptoms of FMF from the paper on the disease, sent to me from the National Organization of Rare Diseases. The other symptoms, which I suffered from my variation of FMF, are easily explainable secondary symptoms of the primary ones.

I believe that the symptoms of FMF are erroneously diagnosed in many patients because I believe the heredity behind the disease is unknown by many people and is much more prevalent than previously thought. I also believe that the original mutations for FMF have mutated beyond what has already been found and is not being recognized as the same disease. The fact that over 170 genes have been found over the last 10 or so years, proves this point.

*** I have talked with people who were diagnosed with fibromyalgia, chronic fatigue syndrome, rheumatoid arthritis, MD, MS, scleroderma, anklyosing spondolitis, lupus, Lyme Disease and any number of different maladies including KIDNEY problems and recurring flu, when what they actually had was a variant of FMF or one of the mutations of this illness.

All the muscle pain, trigger spots and muscle soreness of my `diagnosed,' fibromyalgia are GONE since I have been treated with colchicine! EXCEPT when I have some sort of infection. Then these spots will hurt again, but taking an anti-biotic to cure the infection stops the hurting as well.

In the following chart, I am not saying that fibromyalgia or any of the other illnesses actually are FMF. I have only recently found the study that says that fibromyalgia is ONE of the symptoms of FMF. There may be many causes of fibromyalgia. What I am saying is that this inherited illness is not well know in America and therefore this illness is frequently being misdiagnosed.

The stomach pain in my case has been mis-diagnosed as inflammation of the gallbladder, colitis, appendicitis, etc and usually had vomiting and diarrhea as well. Everyone has a cough from time to time, and flu-like symptoms.

SYMPTOMS

1. Fatigue Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

2. Widespread
Pain Fibromyalgia/Familial Mediterranean Fever

3. Joint Pain Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

4. Fever Chronic Fatigue/Familial Mediterranean Fever

5. Headache Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

6. Sleep
Disturbance Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

7. Morning
Stiffness Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

8. Depression Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

9. Anxiety Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

10. Sore throat Chronic Fatigue/Familial Mediterranean Fever ?

11.Chills/
Nightsweats Fibromyalgia ?/Chronic Fatigue/Familial Mediterranean Fever

12. Swollen
Lymph nodes Chronic Fatigue/Familial Mediterranean Fever

13. Skin rash Chronic Fatigue/Familial Mediterranean Fever

14. Muscle
Weakness Chronic Fatigue/Familial Mediterranean Fever

15. Confusion/
Disorientation Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

16. Difficulty
Concentrating Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

17. Memory Loss Fibromyalgia/Chronic Fatigue/Familial Mediterranean Fever

18. Inability
to exercise Fibromyalgia ?/Chronic Fatigue/Familial Mediterranean Fever

19. Reduced
Sex drive Fibromyalgia ?/Chronic Fatigue/Familial Mediterranean Fever

20. Dizziness/
Lightheadness Fibromyalgia ?/Chronic Fatigue/Familial Mediterranean Fever

21.Irritibility Fibromyalgia ?/Chronic Fatigue/Familial Mediterranean Fever

22. Personality
Changes Fibromyalgia/Chronic Fatigue/Familial Mediterranean

23. Mood swings Fibromyalgia ?/Chronic Fatigue/Familial Mediterranean Fever

24. Possibly
Inherited Fibromyalgia/Chronic Fatigue ?/Familial Mediterranean Fever

25. Acute, short-
lived, painful
bouts of stomach
pain (may be
followed by
diarrhea) Familial Mediterranean Fever

26. Pleuritis,
inflammation
of the lining of
the body cavities,
which in acute
stage may produce
stabbing pain in the
side. Familial Mediterranean Fever

27. Short dry cough Familial Mediterranean Fever

28. nephropathic
amyloidosis which
can lead to kidney
failure Familial Mediterranean Fever

29. Infertility and
pregnancy loss
more common Familial Mediterranean Fever

CRITERIA FOR DIAGNOSIS OF FMF

I received the following from a doctor who diagnosis FMF patients. The following is his criteria for diagnosis of this illness:

Major Criteria:
Typical attacks (3+ of same type; temps 100 degrees, lasting 12-72 hours INCLUDING)

1.Peritonitis
2.Pleuritis or percarditis
3.Arthritis (typically hip, knee, ankle)
4.Fever

Minor Criteria:
Incomplete attacks with variation on severity; duration, temperature), involving 1 or more sites:

1.Abdomen
2.Chest
3.Joints (multiple, lower back, upper ext.)
4.Exertional leg pain
5.Favorable response to colchicine

Supportive Criteria:

1.Family history of FMF
2.Appropriate Ethnic origins
3.Age <20 years at disease onset
4.Episodic proteninuria/hematuria
5. Unproductive laparotamy or normal appendix removal
6. Consanguity of parents (Cousins?)

Features of the Attacks:

1. Acute short-lived painful bouts of stomach pain (may be followed by Diarrhea) and frequently misdiagnosed as appendicitis, kidney, gallbladder problems. Place your hand, fingers spread where your appendix is located.)

2. Pleuritis, inflammation of the lining of the body cavities, which in the acute stage may produce stabbing pain in the right side or of the chest(mine started there and spread throughout my stomach or I had problems with chest pain, breast bone pain.)

3.. A short dry cough

4. Muscle and joint pain frequently misdiagnosed as fibromyalgia

5. osteo OR rheumatoid arthritis (During a crisis of FMF, the RA Factor rises just as it does with Rheumatoid Arthritis.)

6.. Nephropathic amyloidosis (can lead to kidney failure)

7. Infertility and pregnancy loss more common.

8. Attack may be SEVERE, requiring bed rest.

9. Spontaneous remissions

10. Symptom-free intervals at least in youth

11.Transient, inflammatory response, with one or more abnormal labe test:

WBC;
ESR;
SERUM AMYLOID A;
FIBRINOGEN

FMF Diagnosis Requirements:
You must exhibit -

ONE + Major Criteria - OR
TWO Minor Criteria – OR
ONE Minor Criteria plus 5 supportive criteria - OR
ONE Minor, plus 4 of the following:
Family History of FMF
Appropriate ethnic origin
Age under 20 at onset
Severe attacks
Spontaneous remissions

These are the most important symptoms that you must stress to your doctor if you are to get this diagnosis and IF you have any or all of them. The other symptoms that are in this chart are the secondary symptoms that I sufferedwith this illness. Print out the following questionnaire and answer it.

The following is a list of symptoms associated with Familial Mediterranean Fever.

Please take a few minutes to read through the list and then go back and place a check mark in the yes or no columns for each symptom you feel that you have either NOW or had in the PAST.

Write a brief description below each symptom you have marked, including WHEN you experienced the particular symptom and its DURATION.

Please take this list with you when you see your physician to ensure that you don't forget to mention any of the symptoms you have been experiencing. Make two copies of this so that you can give one to your doctor after you have talked to him about these things, and still have a copy for yourself. Start copying the questionnaire from this point.

GENERAL QUESTIONS ABOUT YOUR HEALTH:Your doctor needs to know this information about you.
A. Are you working?
1. Are you now working? YES ___ NO ___
2. If not, could you work all day, five days a week, year round? YES ___ NO___
3. Did problems with your health stop you from working? YES ___ NO ___
4. When did you stop working if so? month, ____day, ____ year___

B. Activities of Daily Living: Consider a month to be 30 days.
1. How many good days a month do you have when you feel well and complete all living and home care activities? Number of days ____

2. How many fair days do you have a month where you can function, but have serious difficulty doing so, and fail to complete some living and home care activities? Number of days_____

3. How many bad days do you have where you function poorly or not at all and fail to complete most living and home care activities. Number of days ____

FAMILIAL MEDITERRANEAN FEVER SYMPTOMS QUESTIONNAIRE(FMF)

SYMPTOMS:

1.My symptoms have been recurring periodically for many years.___yes ___no These symptoms are growing worse and I have been given MANY different diagnoses.___yes ___no

2. I have had periodic, recurrent fevers of 101-103 degrees. ___yes ___no (Think about the flu and cold symptoms you may have suffered. Could ithave been something else?)

3. I have had chills and/or night sweats. ___yes ___no

4. I have had acute, short painful bouts of stomach pain over the years going as far back as childhood.. ___yes ___no (See # 5)

5. I have been diagnosed with:
Appendicitis ___yes ___no
Kidney stones ___yes ___no
Gall stones ___yes ___no___
Ulcers ___yes ___no
Other, describe

___yes ___no

Were any of the above diagnoses proven true? ___yes ___no(Please list which ones, noting any surgeries you have had for theseproblems.)

6. I have been treated for kidney problems (inflammation, infections,stones,etc.) ____yes ___no
I have been diagnosed with Nephropathic amyloidosis (can lead tokidney failure) ___yes ___no ___ don't know

7. I have had stabbing pains in my chest cavity or breast bone area which were NOT connected to heart problems. ___yes ___no (See number 8)

8.I have been diagnosed with:
Bronchitis ___yes ___no
Asthma ___yes ___no
Pneumonia ___yes ___no
Pleurisy ___yes ___no
Collapsed lung ___yes ___no
Costochronditis _____ yes ____no
Relapsing Polychondritis ______yes ________no

Where any of these found to be actual problems? ___yes ___no (Pleaselist which ones.)

9. I frequently/periodically have unexplained swollen lymph nodes? ___yes___no

10. I have or have had a short dry cough. ___yes ___no Duration:_________

11. I have or have had skin rashes periodically. ___yes ___no Number ofyears: _______ Do you or any members of your family suffer with VITILIGO or loss of pigmentation (skin coloring?)___yes __no

12. I have suffered with depression ___yes ___no
Age at onset ofsymptoms: ______
Number of years duration: _________
If you have taken antidepressants, please list which ones.

13. I have had problems with infertility and/or pregnancy loss. ___yes ___no

14. I have had severe muscle and joint pain for many years. ____yes ___no
How many years? ____
My pain seems to move from joint to joint.____yes ___no (See number 15.)

15. I have been diagnosed with:
Osteoarthritis ___yes ___no
Rheumatoid arthritis ___yes ___no
Fibromyalgia ___yes ___no
Chronic fatigue syndrome ___yes ___no
Costochronditis _____yes _____no
Lupus ____yes ______no
MS ____yes _____no
MD _____yes ____no
Relapsing Polychondritis ____yes ____ no

Any other fairly rare disease _____yes _____no
Name the illness ___________________________

Normal pain medicines (aspirin, ibuprofen) and other anti-inflammatories do NOT help my pain or just slightly dull it. ____yes _____no

16. I have morning stiffness. ___yes ___no

17. I have muscle weakness, for example getting up out of a chair or bed.__yes ___no

18. I have suffered from anxiety. ___yes ___no
Number of years: ________
Please list any medications that you have taken for this.

19. I have suffered with confusion or disorientation. ___yes ___no

20. At times I have difficulty concentrating. ___yes ___no

21. At times I have experienced dizziness/light headedness. ___yes ___no

22. At times I suffer from memory loss, such as not remembering a word you are sure you know, or forgetting the name of a relative or close friend.___yes ___no

(4)23. I have SEVERE fatigue. ___yes ___no
Give several examples of when, where and how you have fatigue. (Do you need assistance with household chores? What kind and how often? What happens when you try to do things you used to do?)

24. I have headaches. ___yes ___no
Frequency: _____________ (Please listwhether these are tension headaches, sinus, migraine or cluster in yourdescription.)

25. I have mood swings and/or am irritable. ___yes __no

26. I do not sleep well nor do I feel refreshed upon arising. ___yes ___no
Have you been to a sleep clinic? ___yes ___no
When?___________
What was the diagnosis?

27. I am absolutely unable to exercise. ___yes ___no (This means you areNOT ABLE to exercise, not that you just don't like to or can't find the time to exercise.)
What happens to you if you try to exercise?
Can you clean your house regularly or do you require assistance?

28. I have a reduced sex drive. ___yes ___no

29. I know that I have ancestry from the Mediterranean areas such as Spain, Portugal, Italy, Greece, Turkey, or Jewish or Arab ancestry, or Moorish ancestry. Or any other ancestry from around the Mediterranean. ____yes ___no

30. I know that I have Melungeon ancestry from the areas aroundNC/VA/KY/TN/WV. ___yes ___no List common surnames that you believe have a Melungeon ancestry if is known.
Posted by Nancy at 12:55 PM 0 comments
COLCHICINE Usage:

I am not a doctor and I do not diagnose nor prescribe. I am a genealogist with a scientific bent and this information comes from my own experiences with colchicine use as well as the research I have done.

Please see your doctor for more information. My doctor told me that a 30-day trial of colchicine taken in the amount indicated would not hurt me EVEN if I did not have this illness and I would know shortly whether or not it would help.

I knew within a couple of hours of taking the first dose that it WAS going to help. By the end of the month, I was improving a lot, continuing thereafter, and after the first year, my life became near normal. Familial Mediterranean Fever is CYCLICAL, but the medication reduces the length and strength of what I have come to call the periodic crises. My crises now come about every 4 months, last for 2 to 3 days and are less severe than previously but it took a couple of years to get here. I can continue with my life during most of them.

Colchicine is a very old drug, which has been used to treat joint pain since the 6th century A.C. It is an alkaloid found in the crocuslike plant Colchicum Automnale. The alkaloid extracted from the bulb of the meadow saffron ( a flower) or Colchicum was used in ancient times. Today, it is produced by a chemical (synthetic) method. Colchicine was originally used for the treatment of gout. It has been used for centuries (approximately 2000 years) as an anti-inflammatory agent in the treatment of gouty arthritis.

Its APPROVED indications are: Treatment of acute attacks of gouty arthritis. Prevention of acute gout attacks Management of familial Mediterranean fever (FMF) Colchicine is considered "mankind's" oldest and most powerful anti-inflammatory medication. The use of colchicine can be traced to the ancient Egyptian physicians who successfully treated the arthritic problems of their Pharaohs with it.

More recently, the use of colchicine has expanded to include many OFF-LABEL indications. Some of these off-label uses are now considered to be standard but others are still INVESTIGATIONAL. These include the use of colchicine for treatment of such illnesses as primary biliary cirrhosis (PBC), alcohol-induced cirrhosis, scleroderma, sarcoidosis, amyloidosis, and Behcet's syndrome, Multiple Sclerosis,

(see: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=313499&dopt=Abstract)

and many more. Colchicine has also healed patients who suffered from back trouble due to disk problems which is commonly called Anklyosing Spondalitis. It is also being used for Pericarditis, and Sarcoid arthritis.

It will be interesting to see what use will be made of colchicine for the people who have Alzheimer's Disease and for whom amyloidosis is being found in the brain. Other uses include stopping the progression of neurological disability caused by multiple sclerosis, and among those seeing success most recently are treatment for Idiopathic Pulmonary Disease. Because it has a mitotic action, it inhibits rapidly proliferating cells and has been used in cancer therapy and as an immunosuppresant. Inflammatory dermatoses or systemic diseases with prominent skin manifestations are also among the illnesses for which doctors are trying colchicine and with some success.

A thirty-day trial of colchicine at 0.6mgs twice daily will let you know whether or not this medication will help you. My doctor says that taken in this amount and for this time period, it will not hurt you.

***
You should follow these precautions when taking colchicine however:

STORE THIS MEDICINE at room temperature in a tightly closed container, away from heat and light.

COLCHICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

AVOID DRINKING GRAPEFRUIT JUICE while taking this medicine. Use of alcohol while you are taking this medicine may increase stomach problems. Do not drink alcohol unless your doctor approves.

START TAKING A HIGH POTENCY MULTIPLE VITAMIN AND MINERAL SUPPLEMENT EACH DAY. More on this below.

The LEAST serious side effects of colchicine include loss of appetite, hair loss, skin rash, unusual bleeding, and weakness. I had loss of appetite, which was just fine with me, as I needed to lose weight. (I have now lost a total of 100 pounds.) My hair is thinner, but thinning hair for women seems to run in my family.) I know of no one who had any of these others.

THE FOLLOWING MEDICATIONS:
clarithromycin,
cimetidine,
ketoconazole,
erythromycin,
diltiazem,
as well as grapefruit will cause a decrease in Colchicine metabolism and increase the level of colchicine in your blood.

The medications
rifampin,
phenobarbital,
phenytoin, etc)

will raise Colchicine metabolism and clearance and lower Colchicine blood level.

Check for any of the medications when using colchicine and let your doctor know.

Narcotics such as codeine, morphine, and meperidine (Demerol) and sedatives such as phenobarbital, butabarbital (Butisol), amobarbital (Amytal), alprazolam (Xanax), and lorazepam (Ativan) may interact with colchicine but my information does NOT say how they will interact.

Colchicine does not penetrate brain tissue, heart muscle, or skeletal muscle. The main side effects of colchicine are abdominal pain, nausea, vomiting, increased motility, & diarrhea. The following information will keep this from happening:

***
IMPORTANT INFORMATION: Colchicine needs to be started slowly because among other things colchicine is being used for the elderly and nursing home patients who have 'severe' constipation. It is NOT a laxative but increases the motility of the intestinal tract so that food moves along more rapidly. You KNOW that if they are giving it to the elderly, it is considered to be a generally safe drug although I am not minimizing the serious side effects that this drug can have. As with any drug, weighing the benefits against the problems is required by both patients and doctors.. RULES for taking colchicine:

1. NEVER take colchicine on an empty stomach. Always eat a little something, take the pill and then eat some more.

2. NEVER take colchicine with milk. And if at all possible do not use any diary products for 3 days before beginning colchicine use and somewhat limit dairy products thereafter, if stomach/intestinal problems occur. More on this below.

The normal dose of colchicine for FMF is 0.6mgs twice daily. That is one 0.6mg tablet in the morning and one 0.6mg tablet in the evening with dinner or at bedtime with food. However starting at this level may have intestinal side effects so it is always best to start by taking:

ONE 0.6 MG TABLET OF COLCHICINE and dissolving it in one quart of water. Put some flavoring or sugar in to cover taste if you don't like the taste. It is not good, but not that unpleasant I think. Drink ONE 8 oz. glass of this each day for 4 days.

Dissolve a second tablet in one quart of water and drink TWO 8 oz.glasses a day for 2 days remembering to eat both BEFORE and AFTER the medication.

Repeat for another 2 days.

If at any time diarrhea occurs STOP taking the colchicine, and take something for diarrhea like Immodium AD from the drugstore, and once the diarrhea is under control, start OVER w/ one tab/one quart of water and follow the above regimen.

If everything goes ok, then start taking one whole tablet of colchicine with one glass of liquid and as noted with food every morning. After taking one tab a day for a week, increase to 1 and 1/2 tab, (use a pill cutter to cut the pill) and take the one tab in the morning and the half tab at night.

Then after a week take 2 tabs each day. Some folks have had to do this 3 or 4 times in order for their stomachs to heal enough that they can manage. Other folks seem to tolerate the medication well with no problems.
Posted by Nancy at 12:53 PM 0 comments
Friday, December 5, 2008
Familial Mediterranean Fever
INTERACTIONS OF DRUGS/HERBALS WITH COLCHICINE

In researching, I recently ran into some interesting information on Interactions of drugs/herbals with colchicine and the effect that colchicine can have on the absorption of various nutrients our bodies need for health. In most cases adding a high potency vitamin and mineral will take care of this and avoiding a few things will probably help as well. Please read the information below and check it with your doctor.

Remember now that I am not a doctor and I do not diagnose nor prescribe so you should always check with your doctor before changing any medication.:Interactions of colchicine with:

nutrient affected by drug: Beta-Carotene

• mechanism: Colchicine has been linked to impaired absorption of these nutrients.(Robinson C, Weigly E. 1984, 46-54.)

• nutritional support: Individuals taking colchicine would most likely benefit from taking a high-potency multivitamin/mineral supplement to compensate for these interactions.

nutrient affected by drug: Vitamin B12

• mechanism: Colchicine interferes with vitamin B12 metabolism by reducing intrinsic-factor-B12 receptors.

• nutritional support: B12 supplementation would be judicious prophylactically and administration is indicated when any deficiency is detected. A generous and wholly safe dosage of 10-25 mcg per day of vitamin B12 would compensate for the adverse effects of taking colchicine. Periods testing of serum levels would be appropriate for monitoring vitamin B12 status. THIS is of UTMOST importance, since colchicine usage can cause neuropathy of fingers, toes if not used WITH B12.

nutrient affected by drug: Magnesium

• mechanism: Colchicine has been linked to impaired absorption of Magnesium.(Roe DA. 1985, 159-160.)

• nutritional support: Individuals taking colchicine would most likely benefit from taking a high-potency multivitamin/mineral supplement to compensate for these interactions.

nutrient affected by drug: Potassium

• mechanism: Colchicine has been linked to impaired absorption of Potassium.(Roe DA. 1985, 159-160.)

• nutritional support: Individuals taking colchicine would most likely benefit from taking a high-potency multivitamin/mineral supplement to compensate for these interactions.

nutrient affected by drug: Sodium

• mechanism: Colchicine has been linked to impaired absorption of Sodium.(Roe DA. 1985, 159-160.)

• nutritional support: Individuals taking colchicine would most likely benefit from taking a high-potency multivitamin/mineral supplement to compensate for these interactions.

nutrient affected by drug: Dietary Fat

• research: A variety of studies indicate that colchicine interferes with the intracellular phase of fat absorption.(Arreaza-Plaza CA, et al. Biochim Biophys Acta 1976 May 27;431(2):297-302; Roe DA. 1985, 159-160; Pavelka M, Gangl A. Gastroenterology. 1983 Mar;84(3):544-555; Pavelka M, Gangl A. Verh Anat Ges. 1978;(72):687-689; Race TF, et al. Am J Med Sci 1970 Jan;259(1):32-41; Glickman RM, et al. Gastroenterology 1976 Mar;70(3):347-352; Miura S. Nippon Shokakibyo Gakkai Zasshi. 1980 Apr;77(4):572-82.)

(MY NOTE: Now this I think is VERY interesting since I have lost 100 lbs since beginning colchicine treatment. I would think then that anyone who is thin and does not need to lose weight would want to add additional fat to his or her diets. Doesn't THAT sound wonderful? :-)

nutrient affected by drug: Lactose

• mechanism: Colchicine has been linked to impaired absorption of lactose. In studies of patients with familial Mediterranean fever (FMF) Fradkin et al found that colchicine induces significant lactose malabsorption in FMF patients and concluded that this interaction was at least partially responsible for the gastrointestinal side effects of the drug.(Roe DA. 1985, 159-160; Werbach, MR. 1997, 223-224; Race TF, et al. Am J Med Sci 1970 Jan;259(1):32-41; Fradkin A, et al. Isr J Med Sci. 1995 Oct;31(10):616-620.)

(MY NOTE: since some of us are already lactose intolerant, this certainly makes sense. I am personally going to note any increase in intestinal distress w/ additional milk etc to my diet. Also some herbals are linked to problems with colchicine absorption so they are best avoided. See below.)

Note that you should ALWAYS ask your doctor about any herbal you are taking :

herbs affecting drug performance: Salicylate-containing Herbs such as Betula lenta (Sweet Birch bark), Cimicifuga racemosa (Black Cohosh rhizome), Filipendula ulmaria (Meadowsweet flower), Gaultheria procumbens (Wintergreen leaves), Populus canadensis (Poplar bark and/or buds), and Salix spp. (Willow bark)

• mechanism: Herbs high in salicylates (aspirin-like compounds) can precipitate herbal alkaloids and impair absorption of colchicine.(Brinker, F. J Naturopathic Med 1997;7(2):14-20; Brinker F. 96, 99-100, 1999.)

• herbal concerns: Herbs high in salicylates should not be taken with colchicine.

(MY NOTE: I wonder then if we should be taking aspirin along w/ colchicine. )

herbs affecting drug performance: Herbs containing Tannins such as Camellia sinensis (Green Tea and Black Tea), Arctostaphylos uva-ursi (Uva ursi), Juglans nigra (Black Walnut), Rubus idaeus (Red raspberry), Quercus spp. (Oak), and Hamamelis virginiana (Witch Hazel)

• mechanism: Herbs high which yield tannins when extracted by hot water can precipitate alkaloids which can impair absorption of colchicine. Tannins will not precipitate low concentrations of alkaloidal salts in the presence of many gums present in plants such as Acacia, Agar, Aloe, Flax, Guar, Irish moss, Locust bean, Marshmallow root, Okra fruit, pectin powder, Psyllium seed husks and Slippery Elm bark.(Brinker F. J Naturopathic Med 1997;7(2):14-20; Brinker F. 99-101, 1999.)

• herbal concerns: Herbs high in tannins should not be taken with colchicine.

(MY NOTE: Stop drinking tea.)

For more information see: What's really in the supplement you're taking? Find out now http://www.lifetimetv.com/health/features/supplements07-12-00.html

Again, let me note that I am not a doctor and I do not diagnose nor prescribe. The information given in these pages is for educational use only.

Here are some urls on Familial Mediterranean Fever which your doctor may be interested in. Either copy these materials and give them to him/her or give him/her the urls. There are now over 170 mutations to genes that have been found that CAUSE FMF and there may be many more out there still left to find. This illness mimics so many things!!

Tell your doctor that while you know he may not believe Familial Mediterranean Fever is what is causing your problems, you HAVE the ancestry from which it is possible to inherit it. ----

DON'T TELL your doctor that you are NOT sure about your connections or you will be setting yourself up for a definite NO when you ask for a trial of the medication.

Tell him that you have cousins who have BEEN DIAGNOSED with this illness who are now healing. You are not lying. Over 600 people in the last few years, some of them cousins to you, have taken colchicine and are now healing. The medication colchicine will NOT hurt you taken in the amount needed to control this illness according to my doctor, EVEN if you do NOT have this disease. You can tell him this from your cousin NANCY who has this illness. :-)

URLS for Doctors

First I want you to go to a website where you will have to register. http://thelancet.com/ - This is the DOCTOR's JOURNAL that ALL doctors USE!!! It is FREE but in order to search you have to fill out the registration form. They want to know what field you are in. I believe there is a field called RESEARCH or something like that. FILL That one in. You are doing RESEARCH. :-) Once you get the registration screen name and password, you can search for anything medical. In the search engine put Familial Mediterranean Fever. A LOT will come up. The peice you are looking for is:

Familial Mediterranean fever Eldad Ben-Chetrit, Micha Levy [PDF ] Volume 351 Issue 9103 Page 659

Click on the TEXT connection for this peice and it will come up. PRINT the whole thing out then go back and click on those diagrams (MAP of spread of FMF and the other one showing HOW FMF works.) Enlarge those by clicking on them and print them out too.

Sephardi DisordersFamilial Mediterranean Fever http://www.jewishgeneticscenter.org/what/sephardi/familial.asp

Print out the peices from the following urls. Staple each by itself and include it in what you are sending to the doctor.NORD - National Organization for Rare Disorders, Inc. http://www.rarediseases.org/search/rdbdetail_abstract.html?disname=Mediterranean%20Fever,%20Familial

Gale Encyclopedia of Medicine: Familial Mediterranean fever http://www.findarticles.com/cf_dls/g2601/0005/2601000525/p1/article.jhtml

eMedicine - Mediterranean Fever, Familial : Article by John Meyerhoff, MD http://www.emedicine.com/MED/topic1410.htm

QJMed -- Abstracts: Grateau et al. 93 (4): 223 http://qjmed.oupjournals.org/cgi/content/abstract/93/4/223

Familial Mediterranean Fever2 http://www.thedoctorsdoctor.com/diseases/familialmedfever.htm

FMF index http://www.med.gazi.edu.tr/journal/1998_2_89_91.html

Familial Mediterranean Fever and Related Disorders: Genetics and Disease CharacteristicsThis study is currently recruiting patients. You have to pay for your transportation to Bethesda, and your room and meals while there, approximately two nights, but ALL tests, labs, doctors exams are FREE, paid for by our taxes

http://www.clinicaltrials.gov/ct/show/NCT00001373?order=1

Contact info: Beverly Barham – 1-888-996-4267

Please call for information on being included in this study rather than applying over the website.
____________

There is also an active support group for those who believe that they have Familial Mediterranean Fever. Please go to yahoogroups.com and search for the fmf_support group. Please feel free to join us on this list.
____________
FMF Patients: Other diagnoses given/suspected - these are ACTUAL diagnoses given to patients later identified as having FMF.

Sprain/strain/injury

Fibromyalgia

Chronic Fatigue Syndrome

Polymyalgia rheumatica

Polychondritis

Manic-depressive disorder

Depression

Chronic recurrent chemical depression

Lyme Disease

Reiter's

Ankylosing Spondylitis

Rheumatoid Arthritis

Scarlet Fever

Rheumatic Fever

Colitis

Sepsis

Anxiety Disorder

Malingering

Sciatica

Glandular Fever

Osteo-arthritis.

Sleep apnea

Sleep disorder with myoclonus

Restless Leg Syndrome

spastic colon

gallbladder inflammation

possible kidney stones with their concurrent problems of vomiting and diarrhea

chronic respiratory problems

allergies

asthma

thyroid problems that bounced up and down

Lupus

Somatoform Disorder

Migraines

Hypochondria

Pituitary tumor

Chronic Staph infections

Chronic kidney infections

Chronic Bronchitis

Diabetes

See some of my other urls noted below. If I can be of further help to anyone, please feel free to e-mail me at:
nmorri3924@aol.com

The MELUNGEON HEALTH EDUCATION AND SUPPORT NETWORK:
http://www.melungeonhealth.org/

Melungeon Printed Resources:http://melungeonhealth.org/resources.html

ONE HUNDRED and SIXTY-NINE Melungeon and associated websites:http://melungeonhealth.org/websites.html

A Melungeon mailing list that is family friendly -to join go to: http://groups.google.com/group/melungeons?ht+en

Definition of Melungeons:
http://www.geocities.com/mikenassau/definition.htmAlso includes several urls.

Melungeon Information and Common Surname List:
http://sparksgenealogy.com/melungeons.html

Diagrams of physical characteristics
http://melungeonhealth.org/info.html

Fibromyalgia in YOUR family? Inherited? Maybe!!
Causes of Fibromyalgia, Nancy, Fibromyalgia http://www.holisticonline.com/Remedies/CFS/fib_causes_nancy.htm

MelungeonDNA info
http://www.geocities.com/bourbonstreet/inn/1024/DNAannouce.html

Sparks Genealogy:
http://sparksgenealogy.net/
(Select: Index/Nancy's Corner/The Melungeon Connection)
(Select: Index/The Melungeon Media Release)