APSFA in Stroke Connections!

We made it into the American Stroke Association's Stroke Connection Magazine. The November/December 2006.

I call that a nice sized ad! :)

Roche Diagnostics Announces Nationwide Recall on Medical Device Used to Determine Blood Clotting Time

Roche Diagnostics Announces Nationwide Recall on Medical Device Used to Determine Blood Clotting Time

Contact:
Roche Diagnostics' Point-of-Care Technical Service Center 1-800-820-0995

FOR IMMEDIATE RELEASE -- October 19, 2006 -- Roche Diagnostics is notifying users of an important recall of all CoaguChek PT test strips currently in the market, due to a potential for a test strip defect that may cause falsely elevated test results. The company has identified the root cause and is instituting corrective action with highest priority. To date, the company has confirmed one incident and its internal investigation suggests that a small percentage of strips may be affected. To date, no deaths, illnesses or injuries have been reported due to this issue.

CoaguChek PT test strips are used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, also known as blood thinners. Blood thinners are used to treat patients with a potential for blood clots, for example, patients with heart valve replacements, certain types of heart disease or blood clots in their legs. Incorrect results may have serious or life threatening consequences because patients may be improperly treated.

Roche Diagnostics has determined the potential for a test strip defect when insufficient active ingredient (thromboplastin) is applied to the test strip, possibly causing falsely elevated results. As a result of the unpredictable positive bias, patient test results may be falsely elevated. This can result in an incorrect dose of anti-coagulant or unnecessary corrective measures to reduce the effect of circulating anti-coagulants. Both incorrect treatment choices could put patients at risk for blood clots.

Roche Diagnostics is notifying all home users of the CoaguChek PT test strip to immediately discontinue use of and discard the product as well as to consult with their health care provider to determine alternate testing methodologies and clinical implications. U.S. customers with questions or concerns should call Roche Diagnostics' Point-of-Care Technical Service at 1-800-820-0995.

Roche Diagnostics is notifying all health care professionals who use the CoaguChek PT test strip to institute 'duplicate testing' - or two strips on each patient - using different lot numbers to reduce the risk of bias. If health care professionals require another lot to enable duplicate testing, they are encouraged to call their medical supply distributor. For general questions, health care professionals should call the company's Point-of-Care Technical Service Center at 1-800-820-0995. These actions must remain in place until the issue has been resolved and health care professionals are supplied with unaffected replacement product.

Letters are being sent to customers, providers and physicians - including additional information regarding this voluntary action. Roche Diagnostics is working with its affiliates worldwide to coordinate appropriate activities. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Adverse Event Reporting program online http://www.fda.gov/medwatch/report.htm by phone 1-800-FDA-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from http://www.fda.gov/medwatch/getforms.htm by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax 1-800-FDA-0178. This action is being taken by Roche Diagnostics with the knowledge of the U.S. Food and Drug Administration.

http://www.fda.gov/Medwatch/safety/2006/safety06.htm#CoaguChek

http://www.fda.gov/oc/po/firmrecalls/roche10_06.html

Home INR Machines and Antiphospholipid Antibodies

Finally - someone has spoken up and said these machines do not work with us patients....that you are really playing Russian Roulette!

http://www.fvleiden.org/ask/94.html

Q."I bought a home Coaguchek® INR machine. My insurance company refused to pay for it, so I paid for it out of my own money, close to $ 2000. I have antiphospholipid antibodies and am on warfarin. Initially, I did many comparisons between the machine and hospital-testing INRs, before I and my doctor accepted the machine's numbers. Things were initially working fine. But recently I noticed that there was a discrepancy between my home INR machine (which read an INR of 7.8) and a hospital INR (which was 3.5). I ran all the controls for the machine (liquid and electronic) and they all ran fine. I called the company. They said their machine was fine. I bought a new box of test strips and the discrepancies were still there. I am done using the machine. I will deal with the hassle of going to the lab. At least I know those INR's are correct. I am really disgusted at what a waste of money the machine was."

A. Home INR machines do not give accurate readings in about 1/3 rd of patients with antiphospholipid antibodies who are on warfarin. This is not due to the machine malfunctioning, but likely due to antibodies interfering with the test method of the home INR machines

In one third of patients with antiphospholipid antibodies the INRs read by the home INR machines are unreliable: (a) they either read too high, compared to INRs tested in a laboratory from an i.v. stick (reference 2), or (b) the instruments flash up an error message (reference 1). This inaccuracy is likely caused by the presence of the antiphospholipid antibodies. Since antibody levels can fluctuate over time, the instrument may give accurate readings at times when the antibody levels are low, but inaccurate ones at times when the levels are higher. This is a phenomenon not unique to the Coaguchek® instrument, but is also seen with the ProTime® and the INRatio® instruments (reference 1,2). In patients who do not have antiphospholipid antibodies the home INR machines give reliable readings and are a good way to monitor warfarin therapy (ref. 3).

Personal Comment:
Because of the potential inaccuracies of home INR machines in patients with antiphospholipid antibodies, I prefer to see these patients not use home INR machines, but have their warfarin monitored with i.v. blood draws through an office or hospital laboratory. However, if a patient with antiphospholipid antibodies decides to use a home INR machine, I recommend that initially and every so often thereafter, such as every 6 months, the INR of the machine be compared to the INR obtained at a laboratory. If the machine gives unreliable readings, the patient should switch to i.v. stick INR measurements through a laboratory. Alternatively, the patient could correlate the INRs obtained with the home INR machine to the laboratory INR, and thus determine his/her unique therapeutic range with the machine. The patient could then continue using the machine.

References:

Perry SL, Samsa GP, Ortel TL: Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies. Thromb Haemost 2005 Dec;94(6):1196-202.
Moll S, Wobbleton DL, Misita CP, Bryant B, Malone R, Musty M: INR Determination by plasma-based methods versus point-of-care instruments in patients with antiphospholipid antibody syndrome on anticoagulants. Int Soc Thromb Haemost meeting; Sydney, Australia, Aug 2005. J Thromb Haemost. 2005 Aug;3(suppl 1);abstract.
Yang DT, Robetorye RS, Rodgers GM: Home prothrombin time monitoring: a literature analysis. Am J Hematol 2004;77:177-186.

Shopping for the APS Foundation of America, Inc.

http://www.apsfa.org/shopping.htm

We've discovered a great way to raise money for the APS Foundation of America, Inc. and it doesn't cost me any extra time or money.

All you do is start your online shopping at www.apsfa.org/shopping.htm and buy the gifts and things you need everyday at brand name retailers -- including Amazon.com, Dell, J.Crew, Martha Stewart, Gap, L.L. Bean, 1-800-FLOWERS.com, OfficeMax.com and more than 350 others. Just be sure to designate the APS Foundation of America, Inc. as your charity.

At no extra cost to you, up to 35% of every purchase you make automatically goes to the APS Foundation of America, Inc.!

So remember, if you're going to buy online, BuyFor Charity at: http://www.buyforcharity.com.

One more thing! Help others make a difference by sending this email to friends and family who are ready to make a change and support the APS Foundation of America, Inc. Just think... if everyone who shops online remembered to shop through BuyForCharity.com, what a huge difference we'd make for the all the charitable organizations that make our world a better place!

Do You Use a Home INR Machine??? We need your story!!

Do You Use a Home INR Machine??? We need your story!!

The APS Foundation of America, Inc. planning a "testimonial" page for people to turn to when deciding whether or not to buy/use the home INR machines (ex, Coagucheck, HemoSense, etc).

We're looking for positive and negative stories of the machine(s) that you have used. Please include your diagnosis and cost of the machine when all was said and done. We would like to use your first name and last initial and your State or Country.

Please email us at apsfa@apsfa.org for more information!

Need Flowers?

The APS Foundation of America, Inc. has partnered with flowerpetal.com to provide you a state-of-the-art shopping experience and unparalleled service for purchasing flowers and gifts online.

How does it work? flowerpetal.com, a Las Vegas-based e-commerce provider servicing the flower and gift industry, handles order processing, fulfillment and customer service, all backed by their 100% Satisfaction Guarantee. 12% of your purchases on this site (excluding tax) benefit our organization and its cause. You may also make an optional donation at the end of the purchase process.

SERONEGATIVE ANTIPHOSPHOLIPID ANTIBODY SYNDROME (SNAPS)…AND SNAPPING TO IT!!

By: Gale McCarty, MD, FACR, FACP “You don’t have the syndrome because your tests are low level or negative…” or “You have livedo, a heart valve problem, and thrombocytopenia, but these aren’t listed as criteria for diagnosis” are comments made frequently by healthcare providers from many specialties to patients with clinical features suggesting the Antiphospholipid Antibody Syndrome (APS).

http://www.apsfa.org/docs/APSFAVol2Summer2006.pdf

GoodSearch.com Fundraiser

What if APS Foundation of America - APSFA earned a penny every time you searched the Internet? Well, now we can!

GoodSearch.com is a new search engine that donates half its revenue, about a penny per search, to the charities its users designate. You use it just as you would any search engine, and it’s powered by Yahoo!, so you get great results. Just go to http://www.goodsearch.com/ and be sure to enter APS Foundation of America - APSFA as the charity you want to support. Just 500 of us searching four times a day will raise about $7300 in a year without anyone spending a dime! And, be sure to spread the word!

NIH Launches Clinical Studies Nationwide to Investigate Rare Diseases

FOR IMMEDIATE RELEASE

Friday, May 5, 2006
CONTACT:
Joyce McDonald orAnn Puderbaugh
301-435-0888

NIH Launches Clinical Studies Nationwide to Investigate Rare Diseases $71 Million Effort to Address Neglected ConditionsThe National Institutes of Health (NIH) announced today it is launching the first clinical studies of its Rare Diseases Clinical Research Network (RDCRN). More than 20 studies are expected to open in the next few months at about 50 sites across the United States and in several other countries including the United Kingdom, Japan, and Brazil.

Rare Diseases Studies Listed By City:http://www.ncrr.nih.gov/clinical/rdcrn_studylist.asp

Officially, a rare disease is defined as a disease or condition affecting fewer than 200,000 persons in the United States. About 6,000 such disorders have been identified, impacting an estimated 25 million Americans. Few drug companies conduct research into rare diseases since there is little chance to recoup the costs of developing treatments for such small, geographically dispersed populations.

“By studying the genetic component of these rare diseases, we hope to be able to better predict the course of the illnesses and provide more effective, personalized treatments for those afflicted,” said Elias A. Zerhouni, M.D., NIH Director. “Ultimately, this individualized approach, completely different from how we treat patients today, will allow us to prevent or to promptly treat the complications arising from these genetic disorders.”

The RDCRN has received five-year funding awards totaling $71 million and is coordinated primarily by two NIH components — the Office of Rare Diseases (ORD) and the National Center for Research Resources (NCRR). A central data and technology coordinating center and 10 research consortia will investigate a variety of diseases including Angelman, Rett, Prader-Willi syndromes; myelodysplastic syndrome and other bone marrow failure conditions; lymphangioleiomyomatosis (LAM), rare genetic disorders of the airways, and other rare lung diseases; episodic ataxia, Andersen-Tawil syndrome, and nondystrophic myotonias; several vasculitides; urea cycle disorders; antiphospholipid syndrome and other rare thrombotic diseases; rare pediatric liver diseases; and rare genetic steroid defects.

"Increased collaboration among researchers investigating rare diseases will not only lead to discoveries that will help prevent and treat these conditions, but may also produce medical advances that will benefit the population in general,” said Stephen Groft, Pharm.D., Director of NIH's Office of Rare Diseases.

The initiative includes interventional trials to test new therapies or drugs, as well as longitudinal or natural history studies that will provide information about the characteristics of rare diseases and their progression over time. Data collection standards have been established for the research projects and the data produced will be made publicly available with appropriate safeguards for patient confidentiality.

“This network was created to share the experience, approaches, and tools for the study of rare diseases and to train the next generation of investigators,” said Barbara M. Alving, M.D., NCRR’s Acting Director. “The adoption of standards and common data elements across diseases is groundbreaking, promotes cross-disease analysis, and provides a rich source of information to be mined by researchers around the world.”

Each consortium in the network includes active participation by the relevant patient advocacy groups. In addition, the Coalition of Patient Advocacy Groups (CPAG) was created to represent the more than 30 patient advocacy groups involved in the network. CPAG has been instrumental in outreach to the affected populations and gaining their input into the development of studies.

“In forming this coalition of rare disease groups, NIH has created a powerful vehicle for us to collaborate and communicate with one another that has already brought dividends,” said Patrick Cochran, CPAG Chair and founder of the Periodic Paralysis Association. “Not only have we been able to share information and learn from each other, by working together we have also secured additional support from foundations and corporations.”

The RDCRN is funded by the ORD; NCRR; National Heart, Lung and Blood Institute; National Institute of Child Health and Human Development; National Institute of Neurological Disorders and Stroke; National Institute of Arthritis and Musculoskeletal and Skin Diseases; and National Institute of Diabetes and Digestive and Kidney Diseases — all components of NIH — an agency of the Department of Health and Human Services. For more information about the RDCRN, please visit: http://www.ncrr.nih.gov/clinical/cr_rdcrn.asp.

NCRR provides laboratory scientists and clinical researchers with the environments and tools they need to understand, detect, treat, and prevent a wide range of diseases. This support enables discoveries that begin at a molecular and cellular level, move to animal-based studies, and then are translated to patient-oriented clinical research, resulting in cures and treatments for both common and rare diseases. NCRR connects researchers with one another and with patients and communities across the nation to harness the power of shared resources and research. For more information, visit http://www.ncrr.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

http://www.nih.gov/news/pr/may2006/ncrr-05.htm

The APS Foundation of America, Inc does work closely with the Rare Thrombotic Diseases Consortium which works with the Rare Diseases Clinical Research
Network.

http://rarediseasesnetwork.epi.usf.edu/
http://rarediseasesnetwork.epi.usf.edu/rtdc/learnmore/index.htm#aps
http://rarediseasesnetwork.epi.usf.edu/rtdc/takeaction/groups.htm

We will posting more information as it arrives on progress they are making and when the contact registry is ready to be launched.

New to APS?

Have you recently been diagnosed with Antiphospholipid Antibody Syndrome? Not sure where to start? The diagnosis itself can be a little bit overwhelming. We've compiled a list of tips for people who are newly diagnosed with APS from people who have APS.

These tips did NOT come from a Doctor or anyone in the medical profession.

http://www.apsfa.org/newlydx.htm

Related Publications

These are recommended reads on APS. We have also provided links to purchase the ones that are available at Amazon.com.

http://www.apsfa.org/publications.htm

The APS Foundation of America, Inc. does not endorse any of the above books. Most were recommended to us by other members.

Rare Diseases Clinical Research Network

http://www.rarediseasesnetwork.org/

The Rare Diseases Clinical Research Network was created to facilitate collaboration among experts in many different types of rare diseases. Our goal is to contribute to the research and treatment of rare diseases by working together to identify biomarkers for disease risk, disease severity and activity, and clinical outcome, while also encouraging development of new approaches to diagnosis, prevention, and treatment.

Antiphospholipid Syndrome Collaborative Registry (APSCORE)

http://www.apscore.org

The Antiphospholipid Syndrome Collaborative Registry (APSCORE), sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Center on Minority Health and Health Disparities (NCMHD). The purpose of this national registry is to collect and update clinical, demographic, and laboratory data on patients with Antiphospholipid Syndrome (APS), as well as patients with antiphospholipid antibodies who do not have other symptoms commonly associated with APS. The registry also serves as a repository of blood samples from those enrolled in the registry.

APS on Mystery Diagnosis!

Did you catch the segment about APS on Mystery Diagnosis?? The show was called "Falling through the cracks" and it aired on March 6th on the Discovery Health Channel. Check your local listings for the rerun!

Would you like to buy Lupus Wear?

There are a NUMBER of APS, Lupus, Thrombosis, & Factor V Leiden Awareness Items located at this CafePress store http://www.cafepress.com/apsfoundation

Looking for FVL Wear?

There are a NUMBER of APS, Lupus, Thrombosis, & Factor V Leiden Awareness Items located at this CafePress store http://www.cafepress.com/apsfoundation

Thrombosis Wear

There are a NUMBER of APS, Lupus, Thrombosis, & Factor V Leiden Awareness Items located at this CafePress store http://www.cafepress.com/apsfoundation

Other APS Gear

There are also some fun items located at http://www.cafepress.com/apsfoundation

Would you like to buy APS wear?

There are a NUMBER of APS, Lupus, Thrombosis, & Factor V Leiden Awareness Items located at this CafePress store http://www.cafepress.com/apsfoundation.

APS & Thrombophilia Support Groups

At the APS Friends & Support site, you read messages from others under headings interesting to you. You can start new messages or add comments to the string of messages that already exist. It can be found by going to http://www.apsforum.com.

A forum run by Heidi & Tina founders of the APS Foundation of America, Inc., a non profit organization.

This forum is an information source and a friendly support group for people who have Antiphospholipid Antibody Syndrome or for anyone who's lives are touched by it. It is sometimes referred to as APS, APLS, or APLA and is known as Hughes Syndrome or "Sticky Blood" in the UK. APS is an autoimmune clotting disorder that causes recurrent clotting events including premature stroke, repeated miscarriages, phlebitis, venous thrombosis and pulmonary thromboembolism.

If this disease touches your life in some way, please feel free to join in our discussions! :) We're glad to have you visit!

bloodclotting-disorders-thrombophilia-HughesSyndrome: http://health.groups.yahoo.com/group/bloodclotting-disorders-thrombophilia-HughesSyndrome/

Anti-Phospholipid_Antibody_Syndrome: http://health.groups.yahoo.com/group/Anti-Phospholipid_Antibody_Syndrome/

Antiphospholipid_Antibody: http://health.groups.yahoo.com/group/Antiphospholipid_Antibody/

AntiphospholipidAntibodySyndrome: http://health.groups.yahoo.com/group/AntiphospholipidAntibodySyndrome/

Brain Talk Communities: http://brain.hastypastry.net/forums/forumdisplay.php?f=267

APS-Syndrome: http://health.groups.yahoo.com/group/APS-Syndrome/

thrombosis: http://health.groups.yahoo.com/group/thrombosis/?yguid=123337734

APSgroup-USA: http://health.groups.yahoo.com/group/APSgroup-USA/

Antiphospholipid Antibody Syndrome Support: http://groups.msn.com/AntiphospholipidSyndromeSupport