Endo Pharmaceuticals, Inc., and Qualitest, a generic drug manufacturing subsidiary, issued voluntary recalls of certain lots of oxycodone with acetaminophen (Endocet), hydrocodone with acetaminophen (generic Vicodin) and butalbital, acetaminophen and caffeine (generic Fioricet)  because some bottles may contain different strength tablets, resulting in individuals taking more than or less than the intended doses of active ingredients.

According to the Food and Drug Administration’s (FDA) safety alert:

Qualitest Pharmaceuticals issued a voluntary nationwide recall at the retail level for

• generic butalbital, acetaminophen and caffeine tablets USP, 50mg/325mg/40mg, and generic hydrocodone bitartrate and acetaminophen tablets, USP 7.5mg/500mg. One bottle of butalbital, acetaminophen and caffeine tablets was found incorrectly labeled with a hydrocodone bitartrate and acetaminophen tablets, USP 7.5mg/500mg, 1000 count label, printed with lot number C0590909B.

An accidental dosage of generic butalbital/acetaminophen/caffeine (Fioricet) could cause sedation, lightheadedness, dizziness, nausea, hypersensitivity, tremors, irritability and difficulty sleeping. Those who normally take generic hydrocodone bitartrate/acetaminophen (Vicodin) could experience withdrawal symptoms and worsening of pain due to missed doses of that opioid.

Endo Pharmaceuticals issued a voluntary nationwide consumer level recall for

• Endocet (oxycodone/acetaminophen) USP tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, lot numbers 402415NV and 402426NV. One bottle from each lot was found to contain a higher acetaminophen dose. This can be recognized by their larger size, and different shape and markings.

Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in people taking other acetaminophen-containing medications, people with liver dysfunction, or people who consume more than three alcoholic beverages a day.

If you are taking a generic version of Fioricet (butalbital products) or Vicodin (hydrocodone products) or the brand Endocet, please check your lot numbers immediately.

Lot numbers can be found on the side of the bottle. The medications look different from each other. The two Qualitest products are:

• The white, round-shaped tablet with "2355" debossed on one side is the butalbital/acetaminophen/caffeine tablets (generic form of Fioricet).
• The white with green specks, capsule-shaped tablet and debossed with "3594" on one side is the hydrocodone bitartrate/acetaminophen tablets (generic form of Vicodin).

The Endo brand formulations of oxycodone/acetaminophen (Endocet) are:

• Capsule-shaped 10 mg/325 mg tablets with an "E712" marking on one side and a "10/325" marking on the other.
• Oval-shaped 10 mg/650mg tablet with an "E797" marking on one side and "10" on the other.

Individuals who have these lots in their possession should:

• Stop using the product and contact the manufacturer for disposal and reimbursement information.
  • Qualitest at (800) 444-4011
  • Endo’s agent Stericycle at (866) 723-2681
• Notify the pharmacy where this medication was filled and report that you are in possession of an affected lot.
• Notify the health care provider who writes your pain medicine prescriptions and ask for guidance.
• Notify you insurance provider should a new prescription be written, so that it will be covered.
• Contact the FDA and report if you have had any adverse reactions described above or trouble receiving replacement medication by:
  • Online using FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm;
  • Regular mail by using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form;
  • Fax: (800) FDA-0178.

Consumers with questions may contact the manufacturers for more information.

NORD this week posted funding opportunities for 2011 through its Research Program. Funding is available this year for the study of Tarlov cysts via a Research Grant from the Tarlov Cyst Disease Foundation. The deadline for submission of abstracts and letters of intent is May 20, 2011. Questions may be directed to research@rarediseases.org. Read the RFPs.

Be a part of Tarlov Cyst Research NOW!
Please participate in the Patient Survey on the "Surveys & Research" page. The Foundation is  providing compiled data from the surveys to the Tarlov cyst researchers to whom funding has been provided.

http://www.time.com/time/specials/packages/completelist/0,29569,2053382,00.html

Then click on Health Special: Chronic Pain

King Pharmaceuticals Announces a Voluntary Recall of Embeda Extended Release Capsules

King Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer, voluntarily recalled all dosage forms of the extended release capsules of morphine sulfate with naltrexone hydrochloride (Embeda) from U.S. pharmaceutical wholesalers and retailers on March 10, 2011. This long-acting pain medication is used for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

The reason for the voluntary recall is that one of the pre-specified stability requirements was not met during routine testing. Available data currently suggests that requirement is not likely to cause adverse health consequences to individuals who are taking this pain reliever as prescribed by their health care provider. King reports that it will continue to monitor this issue. In the meantime this medication will not be available to the marketplace until the issue is resolved, which may take several months.

People with pain can continue taking their current Embeda prescription as directed by their health care provider and should not suddenly stop taking the medication to avoid withdrawal symptoms. Signs of withdrawal are: 

withdrawal symptoms. Signs of withdrawal are: 

Individuals who have this medication in their possession should:

• Notify the health care provider who writes your pain medicine prescriptions before your current prescription runs out. Talk about options for new pain medications or treatments.
• Notify your insurance provider should a new prescription be written, so that it will be covered.
• Contact the pharmacy where this medication was filled and report that you are in possession of this recalled medication. Ask for directions if you wish to turn in your recalled supply.
• For any additional medical questions, please call the company at (800) 776-3637.
• Contact the U.S. Food and Drug Administration (FDA) and report any negative experiences. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Online: www.fda.gov/medwatch/report.htm

This is the third annual observance of Rare Disease Day U.S. This year’s theme is “Rare but Equal” which will highlight “Rare Diseases and Health Inequalities.” The growth of this campaign in just a few short years has been remarkable, but we look to everyone to continue that momentum to make this year’s celebration the most successful yet. Throughout the Rare Disease Day website, you will find many ways you can get involved. Big picture goals this year include:

• Creating a video encyclopedia of rare diseases
• Extensive media coverage
• Social networking blitz
• Creating a Rare Disease Physician Database
• Sharing patient stories, videos, photos, and blogs
• Joining hands with others worldwide

Rare Disease Day is sponsored by NORD, and they have launched The New Rarediseaseday.us Website.

What can you do as an individual to increase awareness about Tarlov cysts?

Share your story. Send your story or a video to share with NORD.

• Let the Newspapers & TV stations in your area know about Rare Disease Day and Tarlov cysts (call or write us for a press release)
• Contact your mayor, congressman, or governor and request a Proclamation for Rare Disease Day in your city or state
• Share it with your friends in your social network
• Join together with others in your state. Let us know if you are willing to have your name shared in the database of patients from your state for future networking

Alone we are “rare”; TOGETHER we are strong!

FDA issued a class I recall of Medtronic’s SynchroMed II and SynchroMed EL implantable infusion pumps and refills kits. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. These pumps and refill kits have been recalled because pocket fills - the unintended injection of drugs or fluids into the tissue under the skin at the pump pocket site - have occurred and may result in patient harm, serious injury, and/or death due to drug overdose or underdose.

Medtronic, which manufactures these pumps for the long-term infusion of pain, cancer treatment and anti-spasm medications, issued a “Urgent: Medical Device Correction” letter to health care providers on January 14, 2011. The letter reminded health care providers to check needle placement within the pump septum during the drug refill procedure —  the needle must be inserted through the refill septum until it has reached the needle stop in the pump reservoir. Health care providers should review the signs and symptoms of drug overdose, underdose, and withdrawal with their patients and caregivers at EVERY refill.

The manuals for these pump and refill kits do include warnings related to the potential for improper injection; however, Medtronic is currently updating the labeling for the SynchroMed II and EL pumps and associated refill kits with more information for avoiding pocket fills and managing patients as recommended in the January 2011 letter to health care professionals.

The recalled products were manufactured from June 1998 to January 2003 and distributed from April 1999 to January 2011. They are:

• SynchroMed II (Model No: 8637)
• SynchroMed EL (Model No: 8626 and 8627)
• Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566)

For individuals who have an implantable infusion pump, the manufacturer’s make and model number can be found on your medical device information card. If you are have either a SyndroMed II or EL implantable infusion pump model listed above, notify the health care provider who is managing your infusion care for further instructions.

• Contact the FDA and report if you have had any adverse reactions such as pain, swelling or redness at the injection/refill site after a recent pump reservoir refill; loss of pain or spasm control; or excessive sleepiness, difficulty breathing, nausea, vomiting or itching. Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm; by regular mail to 5600 Fishers Lane, Rockville, MD 20852-9787; or by fax to (800) FDA-0178.

Consumers with questions may contact Medtronic Patient Services at (800) 510-6735, Monday - Friday, 8 a.m. to 5 p.m., central time for more information.

Source: January 13, 2011 Med Page Today

The FDA says makers of combination prescription medications can include no more than 325 mg of acetaminophen in each tablet or capsule.

The decision to restrict acetaminophen content was driven by the risk of liver toxicity from the products, which account for about 200 million prescriptions in the U.S. each year, the FDA said a press briefing.

To that end, manufacturers of Rx products containing acetaminophen - usually opioids like codeine, oxycodone, and hydrocodone - will be required to include a boxed warning on the risk of severe liver injury in product labeling.

A 2007 CDC study estimated that about 1,600 cases of acute liver failure occur each year, although the CDC did not provide information about the cause of those cases.

But another study attributed 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths each year over a nine-year period to acetaminophen-related overdoses.

"Overdoses from prescription products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States, many of which result in liver transplant or death," said Gerald Dal Pan, MD, director of the Office of Surveillance and Epidemiology in FDA's Center for Drug Evaluation and Research (CDER), on a conference call with reporters.

The FDA will also require labels to include a regular warning on the potential for allergic reactions, such as swelling of the face, mouth, and throat, difficulty breathing, itching, or rash.

The changes, which will be phased in over three years, will not affect over-the-counter medications that contain acetaminophen -- which already contain a warning about liver injury -- and is not expected to create a shortage of pain medication, said Sandra Kweder, MD, deputy director of the Office of New Drugs in CDER, on the call.

She added that combination acetaminophen products currently contain up to 750 mg of acetaminophen, but that products containing the lower doses of acetaminophen are effective at treating pain.

As the lower limit is implemented, Kweder said, patients need not stop taking combination pain medications containing acetaminophen but should seek direction from a healthcare professional.

"When taken as directed, acetaminophen is a very safe product," she said. "Our goal is to make it even safer."

The FDA noted that most cases of severe acetaminophen-related liver injury occur when patients take multiple products containing the drug, exceed the current maximum dose of 4,000 mg within a 24-hour period, or drink alcohol while using the products.

The action comes after an FDA advisory panel recommended the changes in June 2009.

Kweder said the FDA is still considering options for reducing the risk of liver injury from over-the-counter medications, which can contain a maximum of 500 mg of acetaminophen per dosage unit or 650 mg for extended-release products.

"Characteristics of Cognitive Functions in Patients with Chronic Spinal Pain" is running in the journal Neuroscience and Behavioral Physiology (2010 Dec 11) and was conducted by researchers at Department of Nervous Diseases, Therapeutic Faculty, I. M. Sechenov Moscow Medical Academy, Moscow, Russia,

 New research shows people who live with chronic spinal pain (for more than three months) experience difficulty with mental concentration and problems with remembering information.

Researchers placed a total of 64 patients with musculoskeletal pain syndromes in the lumbosacral area into two age groups: 30-50 years (41 patients) and 51-60 years (23 patients), according to an abstract published on www.pubmed.gov. The reference group consisted of 20 healthy volunteers comparable in terms of gender, age, and level of education. The patients underwent neurological, neuro-orthopedic, clinical-pathopsychological, and neuropsychological investigations, the abstract noted.

Among the results, according to the abstract:

• Complaints of difficulty with mental concentration were present in 17.3 percent of patients, and problems with remembering information in 20.2 percent of patients.
• As compared with healthy subjects, both groups of patients had significantly worse performance in tests assessing memory (delayed reproduction in the 12-word test), attention, mental flexibility and visuomotor coordination (the sequential number-letter combination test, digit symbol substitution test, and, in younger patients, the forward and backward number series repetition test).
• Cognitive functions in younger patients were affected by the sensory-discriminant (intensity) and affective-motivational (negative emotions, particularly anxiety) characteristics of pain.
• Cognitive functions in older patients were affected by the affective-motivational (anxiety, level of psychoemotional distress) and cognitive (level of catastrophization) components of pain.

The article is co-authored by Anne Louise Oaklander, M.D., Ph.D. Harvard/Mass. General, Donlin M. Long, M.D., Ph.D., and Richard North, M.D, Johns Hopkins and the Tarlov Cyst Disease Foundation President, Reta Honey Hiers, R.N.C.

We believe this article will increase awareness in the medical community about the diagnosis and treatment of Tarlov cysts by improved understanding of the pathology and symptomatology related to this medical condition.

The Journal of Pain publishes original articles related to all aspects of pain, including clinical and basic research,patient care, education, and health policy. The mission of the Journal is to improve the care of patients in pain. It is read by physicians, nurses, physical therapists, and other health care professionals working in fields related to pain and pain management. Articles selected for publication in the journal are most commonly reports of original clinical research.

A Tarlov cyst “poster” (a common type of visual, scientific presentation made at medical conferences) was presented at the 13th World Congress on Pain August 30 – Sept. 2, in Montreal. The title of the poster presentation is: Epidemiological Study of Tarlov Nerve-Root Cysts (TC) An Overlooked, Treatable Cause of Chronic Pain and Dysfunction

The poster was prepared by Anne Louise Oaklander, M.D. Ph.D., Priya Devan, research assistant to Anne Louise Oaklander, and Reta Honey Hiers, RNC, President of the Tarlov Cyst Disease Foundation. Thousands of physicians from more than 85 countries in the  world viewed this information and have a copy of it in the book prepared for attendees at this international conference. This is partly a compilation of Dr. Oaklander’s research, and includes patient surveys, in which many of you have participated . Thank you for your help and support in the research process through contribution of your information and donations. If you are a Tarlov cyst patient and have not yet participated in the Patient Survey, please do so today. It is located on the "Surveys & Research" page of the website.

Over the next several weeks, NORD will be distributing literature from its Member Organizations at the following major medical conferences to encourage timely diagnosis and raise awareness of rare diseases among physicians and other medical professionals: American Academy of Family Physicians, Denver, Sept. 30-Oct. 2; American Academy of Pediatrics, San Francisco, Oct. 2-5; American Society of Human Genetics, Washington DC, Nov. 3-5; American Public Health Association, Denver, Nov. 6-10.

Patients' Bill of Rights part of inaugural summit focusing on inadequate pain policies worldwide

MONTREAL, Sept. 3  2010 /PRNewswire/ -- Health care providers and researchers in the field of pain management are calling for governments worldwide to recognize the rights of people to the access of reasonable care for acute and chronic pain.

At the first annual International Pain Summit, delegates from 84 countries issued a declaration asserting that access to pain management is a fundamental human right. The Declaration of Montreal emphasizes that management of acute pain is inadequate for more than 50 percent of people in developed countries and 90 percent of people in developing countries, while chronic non-cancer pain, which can be triggered by surgery, injury or disease, occurs in at least one in five people worldwide.

As part of the 13th World Congress on Pain in Montreal, which took place August 29-September 2 2010, the International Pain Summit, hosted by the International Association for the Study of Pain (IASP), was created to call attention to inadequate knowledge of pain management techniques by most medical workers and the lack of national policies in both the developed and developing world regarding the seriousness of pain as a global health problem. The summit is the first global meeting about the crucial aspects of pain management, with a focus on advocacy and assistance for all countries to develop national pain strategies.

"The World Health Organization estimates that 5 billion people live in countries with low or no access to controlled medicines and have insufficient access to treatment for moderate to severe pain," said Michael Cousins, MD, chair of the Summit's steering committee and professor and director of the Pain Management Research Institute in Sydney. "With this declaration, it is our goal to ensure that countries have the knowledge and support to establish laws, policies and systems that will help those in pain receive fully adequate pain management assistance."

The summit delegates, as part of their declaration of basic rights, will also call for the assessment of pain to be included as the fifth vital sign, thereby ensuring that health care providers accurately recognize and assess all factors affecting a person's health at any one time.

In its "Declaration that Access to Pain Management is a Fundamental Human Right," delegates to the inaugural International Pain Summit will propose that all people:

1. Have a right to the access to pain management without discrimination.
2. Have a right to be both informed about how their pain can be assessed through the recording of a fifth vital sign, and informed about the possibilities for treatment.
3. Have a right to access an appropriate range of effective pain management strategies supported by policies and procedures appropriate for the particular setting of health care and the health professionals employing them.
4. Have a right to access appropriate medicines, including but not limited to opioids, and to access health professionals skilled in the use of such medicines.
5. Have a right to assessment and treatment by an appropriately educated and trained interdisciplinary team at all levels of care.
6. Have the right to a health policy framework that, in governing pain relief treatment in the social, economic and regulatory environment, is compassionate, empathetic and well-informed.
7. Have a right to access best-practice, non-medication methods of pain management (ranging from relaxation and physiotherapy methods to more complex cognitive behavioral treatment) and to specialist-performed interventional methods, depending upon resources of the country.
8. Have a right to be recognized as having a disease entity, requiring access to management akin to other chronic diseases.

Additionally, the declaration proposes that:

1. Health care professionals have an obligation to offer a patient in pain the management that would be offered by a reasonably careful and competent health care professional.
2. Governments and all health care institutions establish laws, policies and systems that will help promote – not inhibit – access to pain management.

"This declaration signifies a historic day to advocates of pain management as well as those who suffer from chronic pain worldwide," said Dr. G.F. Gebhart, PhD, president of the IASP and professor and director of the Center for Pain Research at the University of Pittsburgh School of Medicine. "It is our hope that, with this declaration, all countries will begin to develop policies and regulations regarding widespread access to pain management regardless of gender, race, age and other factors."

The declaration was prepared with due regard to current general circumstances and modes of health care delivery in the developed and developing world. The IASP believes it is the responsibility of governments; those involved at every level of health care administration, as well as health professionals to update articles of its declaration as new frameworks for pain management are developed. However, failure to offer adequate pain management is a breach of a patient's human rights.

The FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction.

NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease. Some toxicity symptoms that may occur as side effects are: skin lesions, orange color to skin, and severe muscle weakness.

GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography.

The FDA recommends health care professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

Learn more

• Read the MedWatch safety alert.
• Read the FDA Drug Safety Communication.

WASHINGTON -- The FDA approved ketorolac tromethamine (Sprix), a short-term use, intranasal painkiller for moderate to moderately severe pain, for use in patients who require an analgesic at the opioid level.

The drug is an inhaled form of a non-narcotic, nonsteroidal anti-inflammatory injectable analgesic for use in ambulatory patients.

Drug approval was based on two phase III, placebo-controlled clinical trials of a combined 621 adult abdominal (n=300) and orthopedic (n=321) surgery patients.

Patients reported a statistically significant reduction in summed pain intensity difference over 48 hours following surgery in ketorolac tromethamine over placebo. The study also found patients required 26% to 36% less morphine than those prescribed placebo.

Ketorolac tromethamine, as a spray or injectable, should not be used for more than five days in a row.

The drug is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis, or those with high risks of bleeding. It is also contraindicated in patients with peptic ulcer disease or a history of gastrointestinal bleeding, patients requiring treatment for perioperative pain in coronary artery bypass graft surgery, those with advanced renal impairment, and those at risk for renal failure due to volume depletion.

The nasal spray should not be used with probenecid or pentoxifylline.

Side effects include mild nasal discomfort, new onset or worsening of hypertension, fluid retention, edema, oliguria, elevation of serum urea nitrogen and creatinine, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and rhinalgia.

The drug is manufactured by Roxro Pharma of Menlo Park, Calif

We are very excited and pleased to announce that Dr. Anne Louise Oaklander’s Tarlov cyst research will continue through December 2010! Dr. Oaklander is integrating compiled data from the Patient Surveys on the Foundation’s website into her research. If you have not yet participated in the survey, please do so and remind others to participate. This survey data is being used for Tarlov cyst research. You can be a part of Tarlov cyst research NOW!

2009 began with the implementation of the Foundation’s Tarlov research grant contract and ended with the incredible opportunity to provide a meeting at the NIH Office of Rare Disease Research in Washington, DC. This meeting was an extraordinary collaboration and communication between researchers and scientists, staff at the NIH National Institute of Neurological Disorders & Strokes (NINDS), Office or Rare Disease Research (ORDR), physicians who are knowledgeable about and have expertise in treating Tarlov cysts in the U.S., the recipient of the Foundation’s Tarlov cyst research grant, Anne Louise Oaklander, M.D., PhD., and Tarlov Cyst Disease Foundation leadership. The results of this meeting provided new beginnings in 2010 for future partnerships in Tarlov cyst research and education. As more plans are finalized, we look forward to updating you throughout this year and the next about exciting opportunities made possible by this meeting.

Primary outcome measures were apparently a moving target in many company-sponsored studies of gabapentin (Neurontin) for off-label uses such as neuropathic pain and bipolar disorder, researchers have suggested. Eight of 12 studies of gabapentin... full story http://www.medpagetoday.com/Neurology/PainManagement/tb/16952

Tarlov Cyst Research Information

Tarlov cyst researcher, Anne Louise Oaklander, M.D., PhD., has shared the following initial research project goals.

Tarlov Cyst Research: Specific Goals

• Identify patients with Tarlov cysts utilizing large patient databases
• Compare identified TC patients to those of the population at large to identify demographics (gender, age, race) and medical co-morbidities associated with Tarlov cysts
• Test several hypotheses including gender association, parity, connective tissue disorders, history of back injury/trauma, and infection by viruses that damage spinal sensory ganglia
• Determine prevalence of all medical complaints and illnesses of TC patients and compare with an age and sex matched control cohort with normal lumbosacral imaging.
• Examine the disease history within the year prior to radiologic discovery of the Tarlov cysts
• Undertake an unbiased case-control study comparing patients with symptomatic Tarlov cysts and asymptomatic Tarlov cysts
• >Investigate whether specific radiological features of Tarlov cysts correlate with the symptoms present. (Outcome variables will comprise cyst location, maximum visualized diameter, absence or presence of free communication with cerebrospinal fluid (CSF) as determined from flow study or comparing T2 MRI signal in cyst fluid and CSF).
• Measure correlations between radiological variables and the presence of neurogenic bladder or bowel, chronic leg pain paresthesias, chronic pelvic or perineal pain, low back pain,(and sensory dermatomes
• Find radiological markers for increased risk of symptom development to assist in identifying patients who merit closer observation or those who should be considered for treatment of existing symptoms
• Determine if Tarlov cyst patients’ neuropathic pain is less recognized and treated than neuropathic pain associated with better recognized syndromes such as diabetic neuropathy or postherpetic neuralgia
• Identify cohorts of patients with chronic nerve pain and compare what proportion have had their pain treated by any measure
• Acquire preliminary information concerning efficacy of specific treatments

This February 28, 2009, thousands of patients, their families, medical professionals, researchers, educators and others will join in the observance of the first Rare Disease Day in the United States.

 Governors in Alabama, Connecticut, Florida, verdana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Hampshire, New York, Oklahoma, Oregon, Pennsylvania, South Carolina,South Dakota, Tennessee, Texas, Virginia and West Virginia issued Proclamations that February 28, 2009 is Rare Disease Day. This day is an opportunity to increase awareness about rare diseases and the difficulties encountered by those who are diagnosed with a rare disease.

 Rare Disease Day was observed for the first time February 29, 2008 in Europe and was a great success. This year, more than 100 rare disease organizations in the United States are partnering with the National Organization of Rare Disorders (NORD) and with the European Organization for Rare Diseases (EUORDIS) to improve awareness of rare diseases throughout the U.S. and Europe.

 In the U.S., a rare disease is defined as one that affects fewer than 200,000 Americans. Yet since there are nearly 7,000 such diseases, approximately 30 million Americans suffer from a rare disease, according to the National Institutes of Health (NIH).

 People with rare diseases experience certain challenges as a result of the fact that their diseases are so rare.  These include:

• Difficulty in obtaining a timely, accurate diagnosis
• Limited treatment options
• Difficulty in finding physicians or treatment centers with knowledge and expertise
• Treatments that are often more expensive than those for common diseases
  Reimbursement issues related to private insurance, Medicare and Medicaid
• A sense of isolation and hopelessness 

Rare diseases can affect the entire family of an individual patient. Caregivers often endure ongoing stress and isolation managing the medical and financial issues that arise.

 One example of a rare disease that most physicians and the public have never heard of is Tarlov cyst disease.  Tarlov cysts (TC) are also known as perineural/perineurial, or sacral nerve root cysts. They are spinal fluid filled cysts that form off the nerve root sheaths and can cause intense nerve pain, since the cyst walls contain spinal cord nerves. They are located most prevalently in the sacral section of the spine between the lumbar area and tailbone (coccyx). The most common symptoms that patients with Tarlov cysts experience are pain in the lower back and in the buttocks, legs and feet, weakness and/or cramping in legs and feet, abnormal sensations in the legs and feet (paresthesias), pain sitting or standing for even short periods of time, bowel and/or bladder dysfunction, headaches (due to the changes in the spinal fluid pressure), sciatica, and vaginal, scrotal, rectal, pelvic and abdominal pain. When a patient describes this group of symptoms, a lumbar-sacral scan should be ordered to rule out the presence of Tarlov cysts.

 Tarlov cyst disease is often misdiagnosed/undiagnosed by the medical community, due to lack of education or understanding about the pathology of symptomatic Tarlov cysts, failure to order MRI of the sacrum, and because of the many other body systems that can be affected by the spinal cord nerves. Only a handful of physicians in the world are knowledgeable about and willing to treat Tarlov cysts. To learn more about Tarlov cyst disease, please visit the Tarlov Cyst Disease Foundation’s website at www.tarlovcystfoundation.org. The Foundation provided funding for Tarlov cyst research this year, and Anne Louise Oaklander, M.D., Ph.D., at Harvard Medical School and Massachusetts General Hospital in Boston, has received the initial research grant.

 Other important things to remember about rare diseases are:

• Many rare diseases are very serious, life altering or life-threatening.
• Most rare diseases have no effective treatment or cure.
• Since many rare diseases are genetic, about half of the people affected by rare diseases in the U.S. are children.
• Research on rare diseases often adds significantly to the general   understanding of more common diseases. 

The National Organization for Rare Disorders’ Medical Advisory Committee has announced that Anne Louise Oaklander, M.D., Ph.D will receive the Tarlov Cyst Disease Foundation’s grant for Tarlov cyst research.

Dr. Oaklander is an attending physician in Neurology and Neuropathology at the Massachusetts General Hospital and Associate Professor of Neurology at Harvard Medical School. She directs the Nerve Injury Unit, which she founded in 2002 at Massachusetts General Hospital, following her fellowships at Johns Hopkins. Dr. Oaklander works in the emerging field of nerve injury and neuropathic pain and is internationally recognized for her research, as profiled in Science and New Yorker magazines as well as in print and broadcast news media.

We are excited about Dr. Oaklander's research with the Foundation's grant and hope that her project will put us one step closer to improved diagnosis and treatment outcomes for Tarlov Cyst Disease. Dr. Oaklander’s publications should help educate the medical community and public alike about the diagnosis and treatment of Tarlov cysts.

Tarlov Cyst Disease Foundation Board of Directors

The Researcher Selection Process:

Requests for research proposals were sent out in March 2008. 

Initial Research Proposals were received in May  2008.

NORD's Medical Advisory Committee extended invitations for final proposals from the research grant applicants July 2008. 

Full Research proposals were received September 8, 2008.

Medical Advisory Committee  selected the researcher/grantee November 2008!

The Tarlov Cyst Disease Foundation has provided a grant for restricted Tarlov cyst research. The term “restricted,” means that the grant is exclusively for researching Tarlov cysts. The Tarlov Cyst Disease Foundation is working with the National Organization for Rare Disorders (NORD) to determine the researcher,  provide the grant and oversee the research process.

The process to determine the researcher/grantee began in March 2008 with NORD’s international request for proposals (RFP) and their existing database of researchers. The RFPs will be placed in medical and scientific journals and newsletters throughout the world. Individual mailings will be sent to academic researchers. Applicants may submit research proposals to NORD, no later than May 9 and apply for the grant the Foundation has provided. To read more about the research grant, visit the NORD website at : www.rarediseases.org/research/fp08/Tarlov_Cysts_2008_RFP.pdf .The NORD Medical Advisory Committee and the NORD Board of Directors will determine the final applicant, and the “grantee”/researcher will be announced on or around November 7, 2008. The grant is for a period of one year, and the researcher will submit the research results for publication to the scientific and medical community. The results of the research could be used to obtain further funding from NIH (National Institutes of Health) or other funding agencies.

Providing this restricted Tarlov cyst research grant was a long-term dream that the Tarlov Cyst Disease Foundation members and donors helped to make possible. This is a significant initial step in the process to have a researcher focus on Tarlov cysts. The Foundation will continue seeking grants and more funding for research and education in the future; this is just the beginning! 

If you wish to be part of the efforts provided by the Foundation, on behalf of all those around the world who live with the pain of symptomatic Tarlov cysts, contact the Foundation by writing to contactus@tarlovcystfoundation.org .You may also become a Foundation member or donor by visiting the “Join Us” page on this website.

We invite all Tarlov cyst patients to participate in the Patient Survey on the “Research & Survey” page of this website. These surveys will be provided to the grantee/researcher selected, so you will be part of the groundbreaking research that will provide solutions for the future!

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March 2008

Tarlov Cyst Disease Foundation Submits Congressional Grant Proposal Requesting Funding for Tarlov Cyst Research and Education

For the past two years, the Tarlov Cyst Disease Foundation has been working with the Honorable Congressman John J. Duncan, Jr.'s Tennessee and Washington offices to submit  proposals to congress for appropriation of funding for Tarlov cyst research and education. The proposals were submitted in March 2007 and March 2008. 

The Foundation had the assistance of the National Organization for Rare Disorders (NORD), the National Institutes of Health (NIH), The University of Tennessee Brain & Spine Institute and other individuals to create and support the proposal and the Foundation. The Labor, Health and Human Services, and Education Sub-Committee received, reviewed, and approved the initial proposal at the end of summer 2007.  It was sent to the Appropriations Committee for their final approval, and if approved, for inclusion in the 2008 Congressional budget, after passing the full vote of Congress. The results of the 2009 Fiscal year proposal will not be announced until late 2009.

 The Labor, Health and Human Services, and Education Sub-Committee membership represents 13 states with 17 members. Constituents, who have Tarlov cysts and who live in those states, contacted the committee members with the assistance of the Foundation. These Tarlov cyst patients are a part of the Foundation's Congressional Proposal committee, working closely with the Foundation's Board of Directors, to share important information about the proposal and Tarlov cyst disease, and to request their Congressional representatives' support of the proposal.

Tarlov Cyst Disease Foundation Hosts International Teleconference with Baxter International, Inc. and Physicians Who Treat Tarlov Cyst Patients

An incredible meeting of physicians to discuss treatments for patients with Tarlov cysts occurred in the spring  of 2007.The Foundation arranged the meeting with Baxter International representatives from the Medical Affairs and Bio-Surgery Science divisions, in an unprecedented opportunity to discuss the use of the product Tisseel/Tissucol in surgical procedures, and in the procedure for aspiration and fibrin glue injection. The Tarlov Cyst Disease Foundation's President moderated the teleconference. Physicians who participated were from France, Italy and across the United States from the east coast to the west coast. This initial communication provided an opportunity for the physicians to share their treatment procedures for Tarlov cysts, and discuss possibilities for the future. There was a collegial harmony during the teleconference as they discussed their desire to share information with each other and to continue collaboration in the future. The teleconference was very beneficial as a communication between the company that manufactures Tisseel/Tissucol and the physicians who are using it to treat Tarlov cysts. The ultimate beneficiaries of this Teleconference are Tarlov cyst patients internationally.

Key summary points from the Teleconference:

• There was consensus among the neurosurgeons, interventional neuroradiologist, neurologist, orthopedic surgeon, and pain management specialist that changes in cerebrospinal fluid (CSF) pressure are a critical factor in the cause of Tarlov cysts and in the treatment.
  It was discussed that a possible treatment consideration should be made, regarding a combination of aspiration and fibrin glue injection procedure and a shunt placement, to prevent future cyst development due to increase in CSF pressure. This was discussed due to new cyst development or refilling of cyst, that has occurred after surgery and aspiration and fibrin glue injection procedures.
  The physicians were in agreement to share their data from patient treatments and outcomes in order to provide a scientific research analysis in the future. The Foundation will facilitate this project with a research company.

• Baxter International representatives made the following key points regarding the physiology of the product Tisseel/Tissucol:
  * The FDA and Baxter recommends that Tisseel/Tissucol not be used more frequently than every 12 months in the same patient, due to the increasing possibility of an allergic reaction to the product. Tisseel has been used for 28 years in surgical procedures for heart, pancreas, liver and other organ surgeries as a tissue sealant.
  * Tisseel is a biodegradable product that is physiologically designed to absorb in 7-14 days. Baxter International, Inc. has not tested the use of Tisseel in closed cavities such as inside a cyst, nor in a closed cavity containing cerebrospinal fluid.
  * Tisseel, a tissue sealant product, physiologically reaches 70% of its clot forming potential in 3 minutes, and it reaches its full potential in 2 hours.
  * There is nothing in the physiology of Tisseel that would be affected by the patient taking Non-Steroidal Anti-Inflammatory Drugs (NSAID), before or after the procedure using Tisseel.

Fostering communication and collaboration within the medical community is one of the Tarlov Cyst Disease Foundation's specific purposes and objectives. We believe the teleconference is a beginning of improved understanding between physicians willing to share their experiences. It is the Tarlov Cyst Disease Foundation's plan to provide a mechanism for future research endeavors with clinical investigators, industries that provide pharmaceutical products and devices, academic research centers, and others interested in scientific data collection related to Tarlov cyst patients and their treatments and outcomes.