We invite you to our first Women’s Group (Ages 18 & older)
Thursday, February 16th from 7pm-9pm
Connect with other women who have bleeding disorders or are carriers, that live in the metropolitan area!!!
RSVP by Tuesday, February 14th
To ensure that refreshments are provided for you, please contact Annie: annhany@bestweb.net or 212-682-5510.
Topics and contents of discussion – health related or not – is presented for informational purposes only. The hemophilia association of new york (hany) does not engage in the practice of medicine, nor recommend specific treatments or drugs. You are urged to consult your physician or local treatment center before pursuing any course of treatment. Hany does not engage in the practice of law. Specific legal issues should be discussed with a qualified attorney.
Washington Days March 7 – March 9, 2012
The Hemophilia Association of New York is joining NHF for Washington Days on March 7 – March 9, 2012. If you would like to join us, please click on the link to register for Washington Days, click hereor go towww.hemophilia.org.
Washington Days participants are offered a discounted hotel rate of $179.00 per room (single or double) per night plus applicable taxes. This rate is available until February 1st. (After that date, you may have to pay a higher rate -- if a room is available). Information explaining how to go about reserving a hotel room under the NHF room block will be available on the "Thank You" page following submission of your completed registration form. (You can learn more about the hotel by visiting the Crystal Gateway Marriott Web site.)
If you are representing HANY in Washington D.C., please contact Annie at annhany@bestweb.net or 212-682-5510.
We will be reimbursing TRAVEL and HOTEL expenses. Please SAVE ALL RECEIPTS. All meals are your responsibility.
AGENDA:
Wednesday, March 7 4:30PM – Registration 6:00PM – Advocacy Training
Thursday, March 8 All Day – Meet with your Representatives
Friday, March 9 8:30AM – 12:00PM – NYS Advocacy Training
Albany Days March 18-19, 2012
This is your opportunity for you to learn about key legislative issues affecting the bleeding disorders community. It’s a chance for you to tell your stories to your elected representatives and staff members, helping them understand your needs and concerns. TRAVEL and HOTEL expenses will be covered by HANY. If you are interested in going to Albany, please contact Annie at annhany@bestweb.net or 212-682-5510.
AGENDA: Sunday, March 18 1:00PM – Registration 2:00PM – Advocacy Training Followed by Dinner Monday, March 19 All Day – Meet with your Representatives
Specific Issues and areas of concern:
S3865A CHP – non payment of factor in an outpatient setting.
S5849 Exchanges – ensuring that NY will have adequate coverage in their insurance exchanges scheduled to start coverage 2014.
Medicaid Redesign – currently factor is carved out of Medicaid Managed Care, but NYS Medicaid desires to have it covered under the Managed Care providers (not good for PHS or for profit providers).
Skilled Nursing Facility Access.
2012 DAY AT THE RACES Help Support Our Fight Against Hemophilia
Sunday, May 6, 2012 at 12:00 Noon in Belmont Racetrack, Queens, NY
Contact Kathy Hornreich at 917-868-6958
FDA Approves Baxter's ADVATE as the Only FVIII for Routine Prophylaxis in Both Adults and Children with Hemophilia A.
Thank you gentlemen for attending our men's group.
"Inhibitor Family Camp" Comprehensive Health Education Services Registration is currently open.
Comprehensive Health Education Services is pleased to present its’ 3rd Inhibitor Family Camp weekend to be held on April 13-15, 2012 at The Painted Turtle Camp in Lake Hughes, CA.
This program is designed for families with a child age 6-19with an active inhibitor. These children often report that they cannot participate in many of the activities offered at a traditional hemophilia camp due to the threat of injury. Or that if they do choose to participate, they may spend the rest of the week in a wheelchair watching from the sidelines. Inhibitor Family Camp provides these children and their families an opportunity to come together with their true peers in the hemophilia community because we believe that everyone deserves a camp to call their own.
Registration is currently open.
Space is limited so all registration materials must be completed in full by February 17, 2012. There is no cost to families associated with Inhibitor Family Camp. The program is generously supported by an educational grant from Novo Nordisk.
For additional information contact: Comprehensive Health Education Services at 877-749-2437
"Inhibitor Family Camp" is sponsored by Comprehensive Health Education Services. HANY provides this material for your general information only. HANY does not engage in the practice of medicine, nor does it advocate or recommend specific medical treatments. You should consult your physician or local treatment center before attending.
Retailers Win on Pharma Bill
Despite a well-financed campaign by the pharmacy benefits management industry, Gov. Andrew Cuomo signed the controversial bill that bans health plans operating in New York from mandating that patients fill certain prescriptions by mail order. The measure was backed by New York's retail pharmacies but ran into heavy opposition from the PBM companies. A coalition that included the Medical Society of the State of New York promoted the bill (A-5502B) as pro-consumer because it gives plan members the option of getting their medications at either a pharmacy or by mail. It also means saving drugstore jobs. The PBMs charged that the ban would result in higher costs for health plans. A spokesman for PBM company Express Scripts said that the chapter amendments that will be added to the bill in January 2012 meant “the governor and Legislature clearly agreed with our position.” The governor signed the bill with the understanding that the chapter amendments will guarantee that retail pharmacies' reimbursement for a drug will not exceed that of mail-order suppliers. (From Crain's Health Pulse 12/14/11)
Hemophilia B Gene Therapy Breakthrough
Treatment for Blood Disease Is Gene Therapy Landmark
By Nicholas Wade New York Times
Medical researchers in Britain have successfully treated six patients suffering from the blood-clotting disease known as hemophilia B by injecting them with the correct form of a defective gene, a landmark achievement in the troubled field of gene therapy. Hemophilia B, which was carried by Queen Victoria and affected most of the royal houses of Europe, is the first well-known disease to appear treatable by gene therapy, a technique with a 20-year record of almost unbroken failure.
“I think this is a terrific advance for the field,” said Dr. Ronald G. Crystal, a gene therapist at Weill Cornell Medical College. “After all the hype in the early 1990s, I think the field is really coming back now.” Gene therapy has had minor success in very rare diseases but suffered a major setback in 1999 with the death of a patient in a clinical trial at the University of Pennsylvania. Another gene therapy trial treated an immune deficiency but caused some cancer in soem patients.
The general concept of gene therapy — replacing the defective gene in any genetic disease with the intact version — has long been alluring. But carrying it out in practice, usually by loading the replacement gene onto a virus that introduces it into human cells, has been a struggle. The immune system is all too effective at killing the viruses before the genes can take effect. The success with hemophilia B, reported online Saturday in The New England Journal of Medicine, embodies several minor improvements developed over many years by different groups of researchers. The delivery virus, carrying a good version of the human gene for the clotting agent known as Factor IX, was prepared by researchers at St. Jude Children's Research Hospital in Memphis. The patients had been recruited and treated with the virus in England by a team led by Dr. Amit C. Nathwani of University College London; researchers at the Children's Hospital of Philadelphia monitored their immune reactions.
Hemophilia B is caused by a defect in the gene for Factor IX. Fatal if untreated, the disease occurs almost only in men because the Factor IX gene lies on the X chromosome, of which men have only a single copy. Women who carry a defective gene on one X chromosome can compensate with the good copy on their other X chromosome, but they bequeath the defective copy to half their children. About one in 30,000 of newborn boys have the disease, with about 3,000 patients in the United States. Dr. Nathwani and his team reported that they treated the patients by infusing the delivery virus into their veins. The virus homes in on the cells of the liver, and the gene it carries then churns out correct copies of Factor IX. A single injection enabled the patients to produce small amounts of Factor IX, enough that four of the six could stop the usual treatment, injections of Factor IX concentrate prepared from donated blood. The other two patients continued to need concentrate, but less frequently.
Treating a patient with concentrate costs $300,000 a year, with a possible lifetime cost of $20 million, but the single required injection of the new delivery virus costs just $30,000, Dr. Katherine P. Ponder of the Washington University School of Medicine in St. Louis notes in her commentary in The New England Journal of Medicine, calling the trial “a landmark study.” The patients have continued to produce their own Factor IX for up to 22 months, said Dr. Edward G. D. Tuddenham, director of the Hemophilia Center at the Royal Free Hospital in London. One patient, a geologist, had a good response at first, but his level of Factor IX has declined to 1 percent of normal, the level at which the disease kicks in. “We attribute this to the fact that he had an inflammation, and although we treated it promptly, we should have been quicker off the mark,” Dr. Tuddenham said.
The patient cannot be injected again with the same virus because his immune system is now primed to attack it. “He’s very philosophic about it, but he’s a scientist, and his motivation is to help the science,” Dr. Tuddenham said. Twenty more patients will be treated to assess the best dose of the virus, the goal being the highest dose that does not set off an immune system attack, Dr. Tuddenham said. “We are pretty close to the sweet spot,” he said. If all goes well, a genetic treatment for hemophilia B “could be available for widespread use in a couple of years.”
In a trial in 2006, a patient injected with a corrective gene produced his own Factor IX but only for 10 weeks. The designer of that treatment, Dr. Katherine A. High of Children’s Hospital of Philadelphia, said the new therapy had worked because the delivery virus had been made more efficient and because the research team had treated the patients with steroids to suppress immune system attacks on the virus. “I think it’s incredibly exciting, and I say that even though these people are my competitors,” she said. Dr. High is listed as a co-author of the report because her laboratory helped monitor the patients and provided proof for regulators that the virus would not insert its human gene into the patients’ sperm and make the change hereditary. A serious problem with other delivery viruses is that they insert themselves randomly into chromosomes, sometimes disrupting a gene. The virus used by Dr. Nathwani’s team, known as adeno-associated virus-8, generally stays outside the chromosomes, so it should not present this problem. Still, patients will need to be monitored for liver cancer, a small possibility that has been observed in mice.
“I don’t think it’s a showstopper, but it’s a critical safety issue that has to be assessed,” Dr. High said. Patients have little or no immunity to the adeno-associated virus, which infects rhesus monkeys. The virus has a propensity for making liver cells its target, which is good for the therapy because these cells are the natural producers of Factor IX. However, liver cells do not live forever and slowly replenish themselves, possibly limiting how long the therapy will last.
About 80 percent of hemophilia cases are of the type known as hemophilia A, which is caused by defects in a different blood-clotting agent, Factor VIII. Researchers have focused on hemophilia B, in part, because the Factor IX gene is much smaller and easier to work with.
HEALTH-RELATED MATERIAL IN THIS NEWSLETTER IS PRESENTED FOR INFORMATIONAL PURPOSES ONLY. THE HEMOPHILIA ASSOCIATION OF NEW YORK (HANY) DOES NOT ENGAGE IN THE PRACTICE OF MEDICINE, NOR RECOMMEND SPECIFIC TREATMENTS OR DRUGS. YOU ARE URGED TO CONSULT YOUR PHYSICIAN OR LOCAL TREATMENT CENTER BEFORE PURSUING ANY COURSE OF TREATMENT. HANY DOES NOT ENGAGE IN THE PRACTICE OF LAW. SPECIFIC LEGAL ISSUES SHOULD BE DISCUSSED WITH A QUALIFIED ATTORNEY.
We'll have our first Women's Group in 2012!!! We'll keep you posted.
Topics and contents of discussion – health related or not – is presented for informational purposes only. The hemophilia association of new york (hany) does not engage in the practice of medicine, nor recommend specific treatments or drugs. You are urged to consult your physician or local treatment center before pursuing any course of treatment. Hany does not engage in the practice of law. Specific legal issues should be discussed with a qualified attorney.
We have a new, easy & safe way for you to make a donation to us. Remember that your credit card bill will indicate "NYcharities.org" not our name because your donation is being processed by them.
Thanks to all the men that were able to attend the group on November 17th. It was a very good informative session about health insurance. If you have any question about this, don't hesitate to call us!!!
Baxter Healthcare Corporation has sent a notice of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with RECOMBINATE [Antihemophilic Factor (Recombinant)]. The Sterile Water for Injection label indicates that the shelf life is longer than what was actually approved by the FDA.
Please continue to use the RECOMBINATE product as labeled on the kit. There is no impact to the safety or efficacy of Recombinate if the Sterile Water for Injection diluent is used before the expiration date of the RECOMBINATE.
The following are the NDC and Lot numbers of the Sterile Water for Injection vials:
NDC Number | Lot Number | Size | Expiration Date ========================================== 0944284210 | TRA11802AC | 10 mL | 01-23-2014 0944284410 | TRA11810AC | 10 mL | 03-22-2014 0944284410 | TRA11803AC | 10 mL | 01-25-2014 0944284410 | TRA11803AD | 10 mL | 01-25-2014 0944284410 | TRA11810AA | 10 mL | 03-22-2014 0944284510 | TRA11805AA | 10 mL | 02-01-2014 0944284510 | TRA11805AB | 10 mL | 02-01-2014 0944284510 | TRA11805AC | 10 mL | 02-01-2014 0944284510 | TRA11819AA | 10 mL | 06-20-2014 0944284310 | TRA11808AC | 10 mL | 02-23-2014 0944284310 | TRA11816AA | 10 mL | 05-18-2014 0944284310 | TRB11820AA | 10 mL | 07-14-2014 0944284310 | TRA11806AC | 10 mL | 02-07-2014
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership. You must sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. To enroll in the PNS, please call (888) UPDATE-U or go online at www.patientnotificationsystem.org
HANY provides this material for your general information only. HANY does not engage in the practice of medicine, nor does it advocate or recommend specific medical treatments. You should consult your physician or local treatment center before pursuing any course of treatment.
It's time to step up and let your voice be heard. The super committee is less than a week away to present their final plan to Congress to ensure both Medicaid and the Affordable Care Act are protected in the final deficit reduction package.
Take two minutes to call your members of Congress toll free today.
1. Call 1-888-876-6242 and ask the Capitol Hill Switchboard operator to be connected to one of your members of Congress.
2. Tell the staff member that you are calling to urge the member to reject any cuts to Medicaid as the super committee considers how to reduce the nation's deficit.
At NHF 63rd Annual Meeting with Linda, Joan, Annie, Ellen & Marta.
Thanks to the parents that were able to attend the NY Presbyterian Support Group for Parents on October 27th
Medical Advisory #414
Warning About Use of Non-Sterile Alcohol Wipes
In January 2011, NHF issued a Medical Advisory (#412) about a recall of non-sterile alcohol wipes produced by one company, Triad. In April, the FDA forced this company to close. Now, additional infections have occurred in patients using non-sterile alcohol wipes manufactured by another company, Pacific Disposables International (PDI). This company has also been required by the FDA to recall their products. Both of these companies package their products under their own label and under other companies’ labels.
At this time, it appears prudent to recommend that all individuals who have alcohol wipes or other prep pads/swabs in their home examine the individual packages to see if they contain the word “Sterile.” This includes wipes that are packaged with factor or other IV preparation kits. If the word “sterile” does not appear on the package, there is no way to determine if they are in fact sterile or not. Therefore, individuals should discontinue use of any wipes that do not state “sterile” and request replacement with sterile wipes from their clotting factor distributor.
Nurses should also check their supply of alcohol wipes to ensure that they are only using sterile wipes. This is particularly important for patients with indwelling venous access devices (catheters or ports) and for patients with compromised immune systems, but should be standard of care for all patients.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. (October 26, 2011)
CHAPTERS: Please distribute this information to your membership. You must sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. To enroll in the PNS, please call (888) UPDATE-U or go online at www.patientnotificationsystem.org
HANY provides this material for your general information only. HANY does not engage in the practice of medicine, nor does it advocate or recommend specific medical treatments. You should consult your physician or local treatment center before pursuing any course of treatment.
On October 17, 2011, the New York Blood Center presented HANY with a check for $2,000.Thank you to all those who generously donated their “Red Cell and Platelet Advantage” points to the Hemophilia Association of New York. These people not only donate their blood cells to others, but have chosen to donate their Thank You gift to us.
For more information on this program go to: www.mydonoradvantage.com/choose.
From the New York Blood Center: Beth Shaz, MD, Vice President and Chief Medical Officer and Harvey Schaffler, Executive Director Donor Marketing;
From the Hemophilia Association of New York: Edward Rogoff, Board President and Linda Mugford, Executive Director.
Fall Family Retreat
Thanks to everyone who joined us in our first Family Retreat. Check for updates for the 2012 camp invite.
The following information pertains to anyone who receives healthcare benefits from New York State Medicaid or Family Health Plus.
If you are covered by one of these programs, you should have received a letter by now from the New York State Department of Health (NYS DOH), which highlighted changes in Medicaid pharmacy services beginning October 1, 2011. Please be aware that these changes do not affect hemophilia clotting factor therapies. You can continue to receive your factor from your current specialty pharmacy provider (i.e., Hemophilia Treatment Center 340B program or other specialty pharmacy or home care company). These will continue to be covered as a Medicaid fee-for-service benefit. New York State is considering making changes to the way Medicaid and FHP cover factor in the future, but as of now factor is exempt from these changes.
Please note this does not replace previous advisories from the NYS DOH requiring you to select a Medicaid Managed Care (MMC) plan for your basic health care coverage. The MMC plan you chose will provide coverage for all Medicaid benefits except factor products. Examples of some of the services that will be covered by the MMC plan are preventive health and dental services, hospital inpatient and outpatient services, laboratory and x-ray services, and other prescriptions drugs.
If you have any questions, you may contact the New York State Department of Health Medicaid Helpline at 866-976-3526. You can also contact your Hemophilia Treatment Center or the Hemophilia Association of New York at 212-682-5510.
Back-to-school preparation is better done before the first day of school. But if you haven’t done so you are still in time to tell the school about your child’s bleeding disorder.
It’s important to contact the principal, school nurse and your child’s teachers (including gym instructors) to explain to them about the bleeding disorder your child has.
Make sure the school has your contact information up-to-date to get in touch with you in case of an emergency. Also provide them the contact information of your child’s doctor.
Your child should be able to participate in all of his classes, including physical education. However, if frequent bleeds happen during gym class, your doctor or the physical therapist at the HTC can work with the school to arrange a modified exercise program.
HANY can provide you with free pamphlets for the school, to explain hemophilia. Call us for copies at 212-682-5510. Your hemophilia treatment center is also available as a resource for starting the school year right.
It’s important to keep communication open between home and the school.
♦♦ Emergency Preparedness ♦♦
The National Hemophilia Foundation (NHF) has prepared a document called: At a Glance! Key Steps for Individual/Family Preparedness in an Emergency, click here to read it, which helps family members follow simple steps to prepare in case of an unexpected emergency.
If you are a residents of New York City, you can receive emergency notifications from the city's website by clicking here to registeror by calling 311. All other residents should contact their local government office to find out the emergency plans in your area.
CAMP SESSIONS ARE CLOSED
We will keep you posted for 2012 camp sessions at any of the three specialty camps nearest to our area. All three camps provide on-site medical care and supervision.
Hole in the Wall Double H Ranch Camp High Hopes Ashford, CT. Lake Luzerne, NY. Brantingham, NY.
Remember...
It is very important for you to register with the Patient Notification System (PNS) to inform you when a blood product is withdrawn or recalled.
Click here to get more information and to register at their website.
Medical Advisory #413
Baxter Voluntarily Recalls One Lot of Recombinate
Baxter BioScience has announced that it is voluntarily recalling one lot of Recombinate Antihemophilic Factor (Recombinant). Baxter states that this recall is being taken as a precautionary measure after a retrospective review of its manufacturing process revealed a breach in aseptic processing. This lot did meet all in-process and final container specifications, which include sterility and pyrogenicity. There have been no adverse events reported regarding use of this lot of Recombinate to date. This action is being taken with the knowledge of the U.S. Food and Drug Administration (FDA). (July 28, 2011)
Recalled Lot:
Lot Number - TRA09834AB AHF IU/vial - 1060 Expiration Date 1-28-2012
If you have any of this product in your possession, please contact Baxter Customer Service at: 1-800-423-2090 for instructions on how to return the product and obtain a replacement.
You must sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. To enroll in the PNS, please call (888) UPDATE-U or go online at www.patientnotificationsystem.org
HANY provides this material for your general information only. HANY does not engage in the practice of medicine, nor does it advocate or recommend specific medical treatments. You should consult your physician or local treatment center before pursuing any course of treatment.
New York: Tell Your State Legislators to Support Coverage for Outpatient Clotting Factor Products
Earlier this year Representative Kellner and Senator Robach introduced legislation, A6039A and S3865-A, on behalf of the New York State Hemophilia Advocacy Coalition. Passage of these pieces of legislation would allow the Child Health Plus (CHP) and Family Health Plus (FHP) programs to begin providing coverage for outpatient blood clotting factor products for children and adults with hemophilia and other bleeding disorders.
These public health insurance programs were designed to provide a way for low-income New Yorkers to access quality health care. In fact, New York is the only state not providing coverage for outpatient clotting factor products under the Children’s Health Insurance Program (CHIP). Passage of A06039A and S3865-A will rectify this unfair practice, ensuring that CHP and FHP eligible individuals are able to access necessary treatment.
We urgently need your help to get the bills passed before the legislative session ends. A06039A is currently before the Assembly Ways and Means committee. S3865-A is before the Senate Finance committee.
Please contact your State senator and representative TODAY and ask them to urge the Chairs of the respective committees above to put A06039A and S3865-A up for a vote.
On June 9th, we got together to honored Mr. Harrington's retirement at the Princeton Club. We thank you, Thom, for your 30+ years of your devoted work with the Association. Thanks to everyone who was able to join us in this celebration.
The Hemophilia Association of New York welcomes Linda E. Mugford as our new Executive Director.Ms. Mugford holds degrees in Business Administration and Organizational Management, and has 25 years experience in not-for-profit and health-related careers.
As former manager of Comprehensive Hemophilia Services of New York Blood Services, Ms. Mugford not only brings knowledge of the issues facing those with bleeding disorders, but has a track record of action, working with both consumers and health care providers, and as an advocate for affordable access to medical treatment.
