Piedmont Hospital Receives Grant for Equipment to Aid in Donor-Recipient Matching for Organ Transplantation

The Carlos and Marguerite Mason Trust recently announced a gift awarded to Piedmont Hospital to purchase a flow cytometer, a highly sophisticated piece of equipment used to help match organ transplant donors and recipients and improve transplantation outcomes.

Organ donors and recipients are both required to have human leukocyte antigen (HLA) testing before they can be added to the United Network of Organ Sharing (UNOS) waiting list. HLA testing determines histocompatibility – a condition in which the cells of one tissue can survive in the presence of cells of another tissue. It is critical that both the donor and the recipient share antigens for the transplanted organ to be accepted and remain functional.

“The Mason Trustees felt this investment in capital was appropriate to enable Piedmont to offer timely and effective care to organ transplantation patients,” said Alice Sheets, Carlos and Marguerite Mason Trust administrator. “The on-site technology also saves the hospital valuable healthcare dollars, which is a benefit to everyone."

This equipment is integral to Piedmont Hospital adding a 3,750-square-foot HLA laboratory. “Numerous benefits accompany the addition of the flow cytometer to our in-house lab,” said Noreen Carew, administrative director for Piedmont’s Transplant Services. “We no longer have to outsource HLA testing which helps significantly because our patients can be listed with UNOS, or matched with a donor, much quicker. Time is extremely valuable when it comes to organ transplantation.”

On-site HLA testing allows Piedmont to list its Status 7 patients (those who are temporarily unsuitable for transplant) on the UNOS wait list. Facilities with on-site HLA labs can test and list their Status 7 patients in a timely manner, considerably reducing their wait time for an organ.

“The flow cytometer measures histocompatibility using principles of light to generate very specific data from tiny particles and cells,” said Gabriella Henel, Ph.D., histocompatibility expert and director of Piedmont’s HLA Laboratory. “It employs many different lasers to detect and distinguish a number of different biological elements and provides a great deal of information about a patient's immunological state.”

Following transplantation, flow cytometry is used daily to monitor recipients’ immunological responses. If a patient starts to reject an organ, Dr. Henel and Piedmont Hospital’s transplantation experts can help determine the best treatment plan based on HLA antibody levels.

“The sooner the patient gets appropriate treatment for immunosuppression complications, the better chance the rejection can be reversed and the organ saved,” said Carew.

Piedmont Hospital’s Transplant Services program continues to expand and improve access to and the quality of transplant services throughout Georgia with the support of the Carlos and Marguerite Mason Trust.

Piedmont’s Transplantation Program

Piedmont’s Transplant Services program has grown dramatically since its first transplant in 1986. In the past 24 years, 2,220 (through December 2009) transplants have been performed, 204 of which occurred in 2009. Piedmont's extensive experience positions their program among the top 14 percent in the country. Outcome measurements, such as wait times to receive an organ, and graft and patient survival, remain among the best in the nation.

For instance, the median wait time for a kidney transplant at Piedmont is 27.6 months as compared to 36.3 months for the region and 43.2 months for the United States. One of the reasons Piedmont’s kidney transplant wait times are shorter than others is because of their focus on living kidney donation, including related, unrelated and paired donation. Paired exchanges enable incompatible living donor/recipient pairs to be cross-matched with other such pairs from across the country. Piedmont was the first program in Georgia to perform a paired exchange. Piedmont is also the only program in the state participating in two donor networks – the Southeast Consortium and the Paired Donation Network.
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FDA Approves Therapy to Treat Gaucher Disease

/PRNewswire/ -- The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. Without this enzyme, harmful amounts of a certain fatty substance (lipid) can build up in the liver, spleen, bones, bone marrow and nervous system, and can prevent cells and organs from working properly. About 1 in 50,000 to 1 in 100,000 people in the general population have Gaucher disease.

VPRIV provides long-term enzyme replacement therapy for Type 1 Gaucher disease, the most common form of the genetic disorder. It is an alternative to Cerezyme (imiglucerase), another enzyme replacement therapy. Cerezyme is currently in short supply.

"The approval of VPRIV will provide a safe and effective alternative treatment for patients with Gaucher disease," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "Patients who previously received Cerezyme as an enzyme replacement therapy for their Type 1 Gaucher disease can be safely switched to VPRIV."

The safety and effectiveness of VPRIV was assessed in three clinical studies involving 82 patients with Type 1 Gaucher disease ages 4 years and older. The studies included patients who switched to VPRIV after being treated with Cerezyme.

The most common adverse reactions to VPRIV are allergic reactions. Other observed adverse reactions with VPRIV are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time, a measure of clotting time.

VPRIV is manufactured by Shire Human Genetic Therapies Inc. of Cambridge, Mass.

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FDA Approves Pneumococcal Disease Vaccine with Broader Protection

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae. It also is approved for the prevention of otitis media caused by the seven serotypes shared with Prevnar. The bacterium can cause infections of the blood, middle ear, and the covering of the brain and spinal cord, as well as pneumonia.

“Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

The seven Streptococcus pneumoniae serotypes against which Prevnar is directed accounted for about 80 percent of IPD in young children in North America at the time that the vaccine was licensed. With the use of Prevnar, by 2007 the overall rate of IPD caused by these seven serotypes in children less than 5 years old was reduced by 99 percent. However, at that time, it was also shown that of the remaining invasive pneumococcal disease in this age group, 62 percent are caused by the six additional serotypes that will be included in Prevnar 13.

Safety was evaluated in 5,084 infants and young children who received Prevnar 13, compared with 2,760 who received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 were pain, redness and swelling at the injection site, irritability, decreased appetite and fever. These reactions were similar to what has been observed with Prevnar, which has a good safety record in the United States.

Vaccine effectiveness was assessed in a randomized U.S. multi-center immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were evaluated by several immunological measures. An evaluation of all these measures showed that Prevnar 13 induced antibodies that were comparable to those shown to be protective in Prevnar.

Post marketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety.

The vaccine is administered in a four-dose schedule given at 2, 4, 6 and 12-15 months of age. The vaccine is available in single-dose, pre-filled syringes.

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, Pa., a wholly owned subsidiary of Pfizer Inc.

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CDC's Advisory Committee on Immunization Practices (ACIP) Recommends Universal Annual Influenza Vaccination

A panel of immunization experts voted today (February 24, 2010) to expand the recommendation for annual influenza vaccination to include all people aged 6 months and older. The expanded recommendation is to take effect in the 2010 - 2011 influenza season. The new recommendation seeks to remove barriers to influenza immunization and signals the importance of preventing influenza across the entire population.

The Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC) on vaccine issues, voted on the new recommendation during its February 24, 2010 meeting in Atlanta. The vote took place against a backdrop of incremental increases in the numbers and groups of people recommended for influenza vaccination in years past, and lessons learned from the world's still ongoing first flu pandemic in 40 years.

Prior to today's vote, ACIP recommendations for seasonal influenza vaccination - which focused on vaccination of higher risk persons, children 6 months through 18 years of age and close contacts of higher risk persons - already applied to about 85 percent of the U.S. population.

Discussion at the ACIP meeting focused on the value of protecting all people 19 to 49 years of age, who have been hard hit by the 2009 H1N1 pandemic virus, which is likely to continue circulating into next season and beyond. Another reason cited in favor of a universal recommendation for vaccination is that many people in currently recommended "higher risk" groups are unaware of their risk factor or that they are recommended for vaccination. The ACIP discussion also recognized the practicality and value of issuing a simple and clear message regarding the importance of influenza vaccination in the hopes that this would remove impediments to vaccination and expand coverage. Finally, new data collected over the course of the 2009 H1N1 pandemic indicates that some people who do not currently have a specific recommendation for vaccination may also be at higher risk of serious flu-related complications, including those people who are obese, post-partum women and people in certain racial/ethnic groups.

More influenza vaccine doses will be required to vaccinate all adults. However, based on current projections, more licensed types and brands of seasonal influenza vaccines will be available in the 2010-11 influenza season than has ever been available before. Historically, uptake of seasonal influenza vaccine has been less than half of the number of persons with a specific recommendation for vaccination.

Annual influenza vaccination is a safe and preventive health action that benefits all age groups. However, certain people have a higher risk for influenza complications, including people aged 65 years and older, children younger than 6 months of age, pregnant women, and people of any age with certain chronic medical conditions. These people, their household and close contacts, and all health care personnel should continue to be a primary focus for vaccination efforts as providers and programs transition to routinely vaccinating all people 6 months of age and older.

The composition of the Northern Hemisphere's 2010-2011 seasonal influenza was announced at the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting yesterday in Bethesda, MD. Next season's vaccine will be trivalent (with three different vaccine viruses) and include an A/California/7/2009 (H1N1)-like virus, an A/Perth/16/2009 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus. The H1N1 virus recommended for inclusion in the 2010-2011 seasonal influenza vaccine is a pandemic 2009 H1N1 virus and is the same virus used in the 2009 H1N1 monovalent vaccine.

Recommendations of the ACIP become recommendations of CDC once they are accepted by the director of CDC and the Secretary of Health and Human Services and are published in the Morbidity and Mortality Weekly Report.
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GA Lyme Disease Association Announces New Website

The Georgia Lyme Disease Association is pleased to officially announce the publication of our new website: www.GeorgiaLymeDisease.org

In our first few weeks, our website had over 2,500 hits!

When it comes to tick-borne illnesses, our mission at the Georgia Lyme Disease Association is to urge citizens in Georgia and across the Southeast to take preventative measures seriously. We want folks to learn to recognize the early signs and symptoms of these often misunderstood, grossly underreported diseases. We encourage our medical providers to stay informed with the newly emerging tick-borne disease research data and medical treatment options and information. We also work to help patients and their family members by offering TBD education, monthly support group meetings, and online support.

We believe our citizens and healthcare providers will find our Lyme in the Southeast page of particular interest. It contains links to numerous southeastern scientific studies and news articles, confirming the dire need for more discussion and education about Lyme disease in the South. The article, “Lyme Disease in Georgia and the Southeast: A Twenty Year Review”, additionally cites 45 credible sources documenting our ongoing regional Lyme disease problem- a problem that has been ignored for far too long.

REMEMBER, TICK-BORNE DISEASES ARE SERIOUS ILLNESSES!
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FDA Announces Possible Safety Concern for HIV Drug Combination

The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

When used together, the drugs may cause prolongation of the QT and PR intervals on an electrocardiogram. Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With torsades de pointes or with heart block, patients may experience lightheadedness, fainting, or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation.

Review of the data is ongoing. Preliminary findings suggest that some patients using Invirase and Norvir may be at an increased risk for heart abnormalities leading to irregular heart rhythms. For example, the risk for torsades de pointes may be increased in patients who are also using medications known to cause a heart disturbance called QT interval prolongation. The risk may also be increased in patients who have a history of QT interval prolongation.

Patients using Invirase should talk to their health care professional about any questions or concerns they have about Invirase. Patients and health care professionals should report any side effects from the use of Invirase to the FDA’s MedWatch program:
http://www.fda.gov/safety/MedWatch/default.htm1

Invirase is an antiretroviral medication that was first approved in 1995. Invirase is used in combination with Norvir and other antiretroviral medicines to treat HIV in adults. Invirase does not cure HIV infection, may not prevent you from developing HIV-related illnesses, and may not prevent you from spreading HIV to other people.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. FDA will communicate its findings to the public as soon as the review is complete.

Invirase is marketed by San Francisco-based Genentech, a subsidiary of the Roche Group. Norvir is marketed by Abbott Park, Ill.-based Abbott Laboratories.

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FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

Rituxan, an anti-cancer drug, is intended for patients with CLL who are beginning chemotherapy for the first time and for those who have not responded to other cancer drugs for CLL. Rituxan is administered with two other chemotherapy drugs, fludarabine and cyclophosphamide.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells--part of the body's immune system. Each year, about 16,000 people are diagnosed with and 4,400 die from CLL.

"Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA's commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases," said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

FDA approved Arzerra (ofatumumab) in October 2009 for patients whose cancer is no longer being controlled by other forms of chemotherapy and Treanda (bendamustine) in March 2008 for patients with CLL who had not received prior treatment.

Rituxan is a monoclonal antibody. It is manufactured through biotechnology methods rather than by the human body's own immune system. The drug binds to the surface of cancer cells, making it easier for the patient's immune system to attack the cancer cell as if it were a foreign pathogen.

The safety and effectiveness of Rituxan was evaluated in two studies that measured progression-free survival, defined as the time a patient in the study lived without the cancer progressing.

In one study of 817 patients who had not received any prior chemotherapy, progression-free survival was eight months longer for those receiving Rituxan plus chemotherapy than for those who received chemotherapy alone. In another study of 522 persons whose cancer had progressed following other chemotherapy drugs, progression-free survival was five months longer for those who received Rituxan plus chemotherapy.

The FDA analyzed the data on patients 70 years of age and older who had received Rituxan and found no evidence that adding the drug to chemotherapy benefitted elderly patients compared to receiving chemotherapy alone. However, there was also no evidence that Rituxan was harmful to elderly patients.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Some 59 percent of patients treated with Rituxan for CLL experienced an infusion reaction that resembled an allergic reaction (e.g., hives, low blood pressure, chills, fever, and nausea).

A decrease in infection-fighting, normal white blood cells was also commonly observed in patients enrolled in the Rituxan clinical trials.

Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth; progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal; and tumor lysis syndrome, which results from the death of a large number of tumor cells in a short period of time. When the tumor cells are killed by the drug, they release toxins into the bloodstream that can cause acute kidney injury and increase the levels of potassium and phosphate in the blood.

Rituxan is manufactured by San Francisco based-Genentech, a member of the Roche Group.

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FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The FDA will now require that the product labels reflect the following:

* The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
* LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
* LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
* Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

“The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone,” said Dianne Murphy, M.D., director of the FDA’s Office of Pediatric Therapeutics.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

“We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don’t adjust, we will determine the reasons and consider additional steps to support safe prescribing,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

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Cancer Wellness at Piedmont Fayette Hospital Presents “Get a Move On”

“Cooking with Herbs” Cooking Demonstration

Cancer Wellness at Piedmont Fayette Hospital (PFH) is promoting health and well-being for breast cancer survivors with a cooking demonstration titled “Cooking with Herbs” on Thursday, March 4, from 2:15 to 3:15 p.m. in the Piedmont Fayette Hospital Dining Conference Room. Registration is required by calling 404-425-7944.

Whether you will be planting them or buying them at the store, adding fresh herbs is a quick way to transform ordinary breast cancer fighting foods into extraordinary ones. Chef Hans Rueffert and dietitian Shayna Komar will educate you on simple ways to incorporate herbs into your every day meals.

“Cooking with Herbs” is part of the “Get a Move On” series – a combination of nutrition and exercise programs for breast cancer patients and survivors funded by a grant awarded to Piedmont Fayette Hospital from the Susan G. Komen for the Cure Greater Atlanta Affiliate.

Cancer Wellness at Piedmont Fayette Hospital is also offering Cancer WellFitTM, which is a safe, inviting exercise program to improve the physical health and quality of life for people with breast cancer. The program consists of one hour of group exercise two days per week plus one-on-one exercise consultations with a degreed exercise physiologist. The program is offered on Mondays and Wednesdays from 4 to 5 p.m. in the PFH Rehabilitation and Fitness Center in the Fayette Professional Center, directly across from the hospital. To register call 770-719-7290.

Individual nutrition consults are also available for patient’s pre-and post-breast cancer treatment to help them stay motivated, chart their progress and make adjustments to their diet and exercise plans as needed. To schedule an appointment, call 404-425-7944.

In addition, PFH would like to remind residents of the Look Good Feel Better program, a free, non-medical, brand-neutral, national public service program created to help individuals with cancer look good, improve their self-esteem, and manage their treatment and recovery with greater confidence. Classes are available for cancer patients on the first Monday of every month from 10 a.m. to noon in Conference Room A of the 1279 Building of Piedmont Fayette Hospital’s campus. The next class is Monday, March 1.

For more information please visit piedmontcancerconnection.org or fayettehospital.org.
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CDC: Latest Report on Nation's Health Shows Growing Medical Technology Use

Use of MRI and CT Scans Increasing Rapidly

The use of medical technology in the United States increased dramatically between 1996 and 2006, according to "Health, United States, 2009," the federal government's 33rd annual report to the President and Congress on the health of all Americans.

The report was prepared by the Centers for Disease Control and Prevention's National Center for Health Statistics from data gathered by state and federal health agencies and through ongoing national surveys.

This year's edition features a special section on medical technology, and finds that the rate of magnetic resonance imaging, known as MRI, and computed and positron emission tomography or CT/PET scans, ordered or provided, tripled between 1996 and 2007.

Highlights of the special section include:

* The rate of adults aged 45 and over discharged from the hospital after receiving at least one knee replacement procedure increased 70 percent from 1996 to 2006 (26.5 per 10,000 population in 1996 to 45.2 per 10,000 in 2006).

* From 1988-1994 to 2003-2006, use of antidiabetic drugs among adults aged 45 years and over increased about 50 percent, and the use of statin drugs to lower cholesterol among this age group increased almost tenfold.

* The number of new organ transplantations per 1 million people increased 31 percent for kidney transplants (43.7 per 1 million in 1997 vs. 57.2 in 2006) and 42 percent for liver transplants between 1997 and 2006 (15.6 per 1 million in 1997 vs. 22.2 in 2006).

The full report contains 150 data tables in addition to the special feature on medical technology. The tables cover the spectrum of health topics, serving as a comprehensive snapshot of the nation's health.

* Life expectancy at birth increased more for the black than for the white population between 1990 and 2007, thereby narrowing the gap in life expectancy between these two racial groups. Overall U.S. life expectancy in 2007 was 77.9 years.

* In 2007, 20 percent of U.S. adults were current cigarette smokers, a slight decrease from 21 percent in the previous three years. Men were more likely to be current cigarette smokers than women (22 percent vs. 17 percent).

* In 2005-2006, 30 percent of adults often or almost always had trouble sleeping in the past month.

* In 2007, 20 percent of adults 18 years and over had at least one emergency department visit in the past year, and 7 percent had two or more visits.

* The percentage of the population taking at least one prescription drug during the previous month increased from 38 percent in 1988-1994 to 47 percent in 2003-2006, and the percentage taking three or more prescription drugs increased from 11 percent to 21 percent.

The full report is available at http://www.cdc.gov/nchs/hus.htm.
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FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related Anemia

The U.S. Food and Drug Administration today approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy.

ESAs, which include epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen Inc. ESAs are forms of the human protein erythropoietin, which stimulates bone marrow to make red blood cells.

In April 2008, FDA required Amgen Inc. to establish this risk management program based on studies that found that ESAs caused tumors to grow faster and resulted in earlier deaths in some cancer patients.

Amgen’s risk management program, referred to as a REMS or Risk Evaluation and Mitigation Strategy, requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

In addition, the company’s APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program, which is part of the REMS, requires specific training and certification of health care professionals who administer chemotherapy to patients with cancer and counseling of their patients. It does not apply to patients being treated with an ESA for anemia due to other circumstances.

“Evaluation of Erythropoiesis-Stimulating Agents has been an ongoing and intensive process since 2004, involving a series of public meetings, labeling changes, and a required Medication Guide,” said Richard Pazdur, M.D., director of the Office of Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new risk management program will help ensure that patients and their health care professionals have fully considered the benefits and risks of using ESAs.”

Through the risk management program, Amgen must ensure that health care professionals who treat patients with cancer do the following:

* Register and maintain active enrollment in the ESA APPRISE program,
* Complete a special training module on how to use ESAs in patients with cancer, and
* Discuss the risks, benefits, and FDA-approved uses of ESAs with patients who have cancer before beginning a course of ESA treatment and document this discussion with a written acknowledgement from the patient.

Amgen is also required to oversee and monitor health care professionals and hospitals that use ESAs for patients with cancer to ensure that these caregivers are fully compliant with all aspects of the overall risk management program.

ESAs are approved for the treatment of anemia that may occur as a result of kidney failure, from certain kinds of chemotherapy, from the drug AZT, which can be used for the treatment of HIV infection, and for the treatment of anemia among certain patients undergoing surgery.

Procrit, Epogen and Aranesp are manufactured by Thousand Oaks, Calif-based Amgen.

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MERIAL Receives Full License Approval for ONCEPT(TM) Canine Melanoma Vaccine

/PRNewswire/ -- Merial, a world-leading animal health company, has gained full-licensure from the U.S. Department of Agriculture for ONCEPT(TM) Canine Melanoma Vaccine, DNA. ONCEPT is a breakthrough vaccine indicated for aiding in extending survival of dogs with stage II or stage III oral canine melanoma, a common yet deadly form of cancer in dogs.

ONCEPT is the first and only USDA-approved, therapeutic vaccine for the treatment of cancer - in either animals or humans.

Traditionally, dogs with stage II or stage III malignant melanoma survive less than five to six months when treated with surgery alone.(1) Clinical studies of ONCEPT demonstrated significantly longer life spans even in dogs with stage II or stage III of oral melanoma. In fact, median survival time of dogs treated with ONCEPT could not be determined because more than 50 percent of the treated dogs were still living melanoma-free at the conclusion of the study or died of unrelated illness.(2)

Canine oral melanoma is a common type of cancer in dogs and is the most common malignant tumor of the dog's mouth. It can also be seen in the nail and footpad.(3) Canine melanoma may be seen in any breed and is a highly aggressive cancer that frequently spreads throughout the body, including the lymph nodes, liver, lungs and kidneys.(4) To date, the most common treatments for this form of cancer have been radiation and surgery to establish local tumor control. Canine oral melanoma, however, has a high propensity to metastasize to other parts of the body and is often resistant to chemotherapy.(2,3)

"Canine melanoma spreads readily, and, unfortunately, existing treatments have not succeeded in controlling the disease," said Dr. Bob Menardi, a veterinarian and spokesperson for Merial. "ONCEPT is a new adjunct treatment option for dogs that have been diagnosed with this often fatal disease."

The vaccine was developed through a partnership between Merial and Memorial Sloan-Kettering Cancer Center. While Memorial Sloan-Kettering was testing a human melanoma vaccine, they received an inquiry from Dr. Philip Bergman - who at the time was with Animal Medical Center, and currently with Brightheart Veterinary Center - seeking novel treatments for canine melanoma. The discussions resulted in clinical trials of the Memorial Sloan-Kettering melanoma vaccine, and subsequent parallel trials by Dr. Bergman and Memorial Sloan-Kettering refined the dosage and protocol to the current therapeutic regimen for dogs. Dr. Bergman completed the initial clinical work on ONCEPT at Animal Medical Center in New York.

"We're very excited about continuing research into this vaccine to explore the potential implications it has for humans. We hope this will result in improved cancer treatment for all," explained Jedd D. Wolchok, MD, PhD, a medical oncologist who specializes in immunotherapy on the Melanoma and Sarcoma Service at Memorial Sloan-Kettering and also Associate Director of the Ludwig Center for Cancer Immunotherapy.

The USDA issued a conditional U.S. Veterinary Biological Product License for ONCEPT in 2007. During the period of conditional licensure, ONCEPT was available to veterinary oncologists as Merial conducted additional research to further support the safety and efficacy of the vaccine.

The results of that research led to the full licensure of ONCEPT. Merial obtained licensing rights from Memorial Sloan-Kettering and Dr. Philip Bergman, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (NASDAQ:VICL) , completed the industrialization and regulatory requirements for full licensure. The vaccine will be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle.(5) The device was developed in conjunction with Bioject, Inc., a Portland-based drug delivery company (OTC Bulletin Board: BJCT).

"The Canine Transdermal Device makes administration of the vaccine easy and quick for oncologists and their patients, leaving one less worry for dog owners dealing with their pet's cancer treatment" said Dr. Richard Stout, executive vice president and chief medical officer of Bioject. "We are proud to work with Merial in bringing this breakthrough product to market."

"The approval of ONCEPT is a milestone in the cancer vaccine field and a significant advancement for our DNA delivery technology platform," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Therapeutic vaccines -- the holy grail of vaccinology -- are delivered after disease onset to impede disease progress for the patient's benefit. We believe this achievement is a major step toward the initial approvals of therapeutic vaccines for humans."

ONCEPT is available for use by specialists practicing veterinary oncology, so pet owners will want to ask their veterinarians about how best to access this treatment option.

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,700 people and operates in more than 150 countries worldwide. Its 2009 sales were $2.6 billion. Merial is the Animal Health subsidiary of sanofi-aventis. For more information, please see www.merial.com.

Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and work by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies. For more information about Bioject, visit www.bioject.com.

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. Additional information on Vical is available at www.vical.com.

(1) Bergman PJ, Wolchok JD. Of Mice and Men (and Dogs): development of a xenogeneic DNA vaccine program for canine malignant melanoma. Cancer Therapy 2008;6:817-826.

(2) Data on file at Merial. Study 05-171. 2009.

(3) Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine 2006;24:4582-4585.

(4) Liao JCF, et al. Vaccination with human tyrosinase DNA induces antibody responses in dogs with advanced melanoma. Cancer Immunity 2006;6:8-17.

(5) ONCEPT product label.

ONCEPT(TM) is a trademark of Merial.

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Dr. Nicole Sroka Hosting Open House at New Office Location

Nicole Sroka, M.D. will host an open house on Tuesday, Feb. 16, from 5:30 to 7:30 p.m. at her new office location on the Piedmont Fayette Hospital (PFH) campus at 1279 Hwy 54 W, Suite 210, Fayetteville, GA 30214. Community members are invited to stop by the new location for a tour and some light appetizers.

Dr. Sroka is part of the Piedmont Breast Surgical Specialists and was the first fellowship-trained breast surgeon on staff at Piedmont Fayette Hospital.

Prior to joining Piedmont Fayette Hospital, Dr. Sroka completed a breast surgical oncology fellowship at Memorial Sloan Kettering Cancer Center (MSK) in New York City. She rotated at PFH for five years prior to her fellowship as part of her residency training in Georgia, where she also practiced at Atlanta Medical Center. Dr. Sroka grew up in Wisconsin, received a bachelor’s degree in molecular biology from the University of Wisconsin in Madison, Wis., and received her medical degree from the University of Wisconsin Medical School.

Dr. Sroka is a member of the Society of Surgical Oncology, American Society of Clinical Oncology, Southeast Surgical Oncology and the American Medical Association. She has also previously received the Gold Medal awarded for Outstanding Resident Submission from the Southeastern Surgical Society.

Dr. Sroka’s office hours are Monday through Wednesday from 8:30 a.m. to 4 p.m. and on Fridays from 8:30 to 11 a.m. To schedule an appointment, please call 770-719-5710. For more information visit piedmontphysicians.org.
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FDA Approves New Indication for Crestor

On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it.

The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

Specifically, this includes men 50 years of age and older and women 60 years of age and older who have an elevated amount of a substance known as high sensitivity C-reactive protein in their blood and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of high-density lipoprotein or HDL cholesterol, the so-called “good cholesterol.”

This new indication does not support the use of Crestor in individuals who have an elevated high sensitivity C-reactive protein but no traditional cardiovascular risk factors.

Crestor is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. High amounts of low-density lipoprotein or LDL cholesterol, the so-called “bad cholesterol,” is a known risk factor for heart attacks, strokes, and heart disease.

“This expanded indication for Crestor will provide health care providers with a new therapeutic option to help appropriately-identified people lower their risk for a cardiac event,” said Eric Colman M.D., deputy director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

The new indication was based on results from a study called the JUPITER trial, which compared 8,901 patients who received Crestor for two years to the same number of patients who received a placebo. Patients who took Crestor experienced fewer cardiac events, including heart attacks and strokes, and underwent fewer procedures such as coronary angioplasty or coronary artery bypass surgery to treat or revascularize their arteries.

High sensitivity C-reactive protein is a nonspecific indicator of inflammation, which is associated with the buildup of cholesterol and other fatty material in the coronary arteries.

Crestor is already approved for use in combination with diet and exercise to lower LDL cholesterol and a related substance known as triglycerides in patients with a high amount of these substances in their blood. The medication is also approved to slow the progression of atherosclerosis – a thickening of the artery wall due to the buildup of cholesterol and other fatty materials.

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Cancer Wellness at Piedmont’s Programs and Services for February

Comprehensive Complimentary Services Offered to Anyone Affected by Cancer

Cancer Wellness at Piedmont offers comprehensive services and programs for anyone affected by cancer at any phase in his or her journey. All programs take place at Cancer Wellness at Piedmont, located in the Piedmont Hospital Cancer Center at Piedmont West Medical Office Park, 1800 Howell Mill Road, Suite 700, Atlanta, GA 30318. For more information please visit piedmontcancer.org or, to make a reservation for one of the classes listed below, call 404-425-7944, and please indicate which classes you plan to attend.

Classes offered every month include: Cancer Wellfit©, Gentle Yoga, Art Therapy, Guided Imagery and Relaxation for Optimal Health, Mindfulness Training 101 & 201, Breast Cancer Support, Gynecological Cancer Support, and A Guy’s Group.

Some special events for February:

Opening and Balancing the Heart Chakra: Self-Love, Self-Compassion, Self-Forgiveness – Explore paths to open and balance the heart chakra by joining Dr. Jody Iodice, Ph.D., and Angela Buttimer, registered yoga teacher, as they help you examine and reflect on the psychological emotional, physical and spiritual implications of the heart chakra through writing and dialogue. Wednesday, Feb. 17, from 10 a.m. to 1 p.m. (light lunch provided)

Humor and Psychoneuroimmunology (PNI) – PNI is the field of scientific study which explores how feelings, emotions and thoughts affect our immune and neuroendocrine systems. Come join Dennis Buttimer and Dr. Jody Iodice for good laughs and learn how humor affects both your immune system and general health. Cancer isn’t funny, but humor can really help. Friday, Feb. 19, from 10 a.m. to 1 p.m. (light lunch provided)

Comfort Foods – Comfort foods don’t always have to be bad for you. There are many healthy and delicious options. Join the Spice Girls and Cancer Wellness dietician Shayna Komar who will provide essential information and answer any questions. Wednesday, Feb. 24, from noon to 2 p.m.

Chemo Chic – Join Rudi Caruthers in this interactive empowerment class for women undergoing chemotherapy and radiation. The class is sponsored by the Georgia Cancer Foundation and a support person is welcome to attend. Thursday, Feb. 25, from 1 to 3 p.m.

For more information and a full list of classes please visit piedmontcancer.org.
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HPV Vaccine Shows Promising Results in Genital Diseases in Young Women

A five-year, multi-site international study has shown that human papillomavirus (HPV) vaccinations given to adolescents and young women decrease the number of abnormal Pap smears, biopsies and cases of genital warts, researchers report in the final analysis of a study published online Feb. 5, 2010, in the Journal of the National Cancer Institute.

Since some of these genital abnormalities are identified as precursors to cancer, it is anticipated that these findings will eventually translate into lower rates of cervical, vulvar and vaginal cancers.

HPV is one of the most common sexually transmitted infections. Although most infections will clear up without intervention, some infections with low-risk HPV (types 6 and 11) can cause genital warts and abnormal cervical cells, while high-risk types of HPV (types 16 and 18) can progress to cancers of the cervix, vulva or vagina.

“Cervical cancer is the second leading cause of cancer death in women worldwide, right behind breast cancer in women,” says Kevin Ault, MD, associate professor in the Department of Gynecology and Obstetrics, Emory University School of Medicine, and a co-investigator on this study. “This vaccine has been shown to reduce the number of biopsies and painful treatments in women, while also reducing cancer risks in a woman’s life.”

The researchers studied 17, 622 women aged 15 to 26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the vaccine targeting HPV types 6, 11, 16 and 18 (known as a quadrivalent vaccine). Women in one group were uninfected with HPV (negative to 14 HPV types), while another group had a mixed population of HPV-exposed and -unexposed women (intention to treat group). All women underwent cervicovaginal sampling and Pap testing.

In the group that was uninfected with HPV, vaccination was up to 100 percent effective in reducing the risk of HPV 16/18-related high-grade cervical, vulvar and vaginal lesions and of HPV 6/11-related genital warts. In the mixed group, vaccination was statistically significant in reducing the risk of any high-grade cervical, vulvar and vaginal lesions, genital warts, Pap abnormalities and cervical therapy, irrespective of HPV type.

“The HPV vaccine is specifically designed to prevent cancer in its earliest stages,” says Ault. “Researchers were aware of the tight link between HPV and cancer, which helped in the development of this vaccine.”

Ault continues, “Many of the treatments for HPV today can cause problems later in life for pregnant women, which can lead to premature delivery of their babies. We hope getting this vaccine during a woman’s younger years will prevent those complications, as well.”

The U.S. Food and Drug Administration approved the preventative vaccine, known as Gardasil, in 2006 for use in females nine to 26 years of age. To date, there is no vaccine specifically designed to treat HPV, once infected.

With this data now complete, the researchers are looking at the possibility of second-generation vaccinations for more types of HPV not covered by the quadrivalent vaccine.

During the study, Ault received consultancy and advisory board fees from Merck and Co., Inc. (the maker of Gardasil), and has previously received funding through his prior institution to conduct HPV vaccine studies for GlaxoSmithKline. He currently is receiving funding from Merck and Co. on another HPV vaccine trial.
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Low Production of Serotonin in the Brainstem a Likely Cause for SIDS

/PRNewswire/ -- Taking the next step in more than 20 years of research, researchers at Children's Hospital Boston have linked sudden infant death syndrome (SIDS) with low production of serotonin in the brainstem, based on a comparison of brainstem samples from infants dying of SIDS compared to brainstems of infants dying from other, known causes.

The findings, published in the Feb. 3 issue of The Journal of the American Medical Association, may give a concrete approach to identifying babies at risk for SIDS, the leading cause of death for infants between 1 and 12 months old in the United States.

In the brainstem, serotonin helps regulate some of the body's involuntary actions, such as breathing, heart rate and blood pressure during sleep. The researchers, led by Children's neuropathologist Hannah Kinney, MD, believe that a low serotonin level impairs the function of the brainstem circuits that regulate these activities, putting a baby at risk for sudden death from stresses such as rebreathing carbon dioxide when sleeping in the face down position.

The future goal of this work is to devise a test to identify infants with a serotonin brainstem defect early, and to develop preventive treatments that would correct the serotonin deficiency.

In 2006, Kinney and colleagues showed that SIDS is associated with abnormalities in the number of cells and receptors related to serotonin in the brainstem, but it wasn't clear whether SIDS may be caused by overproduction or underproduction of the chemical.

In the new study, the team measured the levels of serotonin and tryptophan hydroxylase, the enzyme that helps make serotonin, in 35 infants dying from SIDS and two control groups (5 infants dying acutely from other causes, and 5 hospitalized infants with chronic hypoxia-ischemia (insufficient oxygen supply to tissues). Tissue samples from the brainstem were obtained from autopsies and provided by research partners at the San Diego County Medical Examiner's Office in California.

Compared with controls, the serotonin levels in the lower brainstem were 26 percent lower in the SIDS cases compared to controls, while the tryptophan hydroxylase levels were 22 percent lower. Levels of binding to serotonin receptors were also lower by more than 50 percent. The consistency and correlation of these findings with each other reinforce the idea that SIDS in the majority of cases is a disorder of serotonin the brainstem, the researchers say.

"The baby looks normal during the day; there's nothing that would tell you that baby is going to die of SIDS that night," says Kinney, who has studied SIDS for more than 20 years. "There's something about sleep that unmasks the defect, which we believe is in serotonin circuits: the baby experiences some kind of stress during sleep, such as rebreathing carbon dioxide in the face-down position or increased temperature from over-bundling, that cannot be compensated for by the defective brainstem circuits, and the baby then goes on to die."

In a normal baby rebreathing carbon dioxide, serotonin pathways in the brainstem would stir the baby awake long enough to turn its head, allowing it to breathe fresh air, Kinney adds. A baby with low serotonin levels in the brainstem may never stir.

SIDS has puzzled doctors and families for decades, but once the medical community recognized that a baby's position while sleeping affects the risk for SIDS, national awareness campaigns sprouted to persuade parents to place babies to sleep on their backs. However, such campaigns haven't completely solved the problem, prompting ongoing research to find a biological component to SIDS.

While this study provides strong evidence for a biological cause of SIDS, it also shows that other risk factors, such as sleeping on one's stomach, can aggravate the risk. Of the SIDS infants in the current study, 95 percent died with at least one risk factor, and 88 percent died with at least two.

The next step in this research is to find out what causes abnormally low serotonin levels in the first place. Genetic variations may be partly responsible, says neuroscientist David Paterson, PhD, in Kinney's lab, a contributing author of the paper. Kinney's lab is searching for such variations.

In the meantime, parents should remove unnecessary SIDS risk factors, Kinney says. During pregnancy, there is no safe level of alcohol a mother can drink and no safe level of smoking, both firsthand and secondhand. Until 12 months of age, babies should sleep on their backs in a crib with a firm mattress, and without toys, soft pillows, excessive blanketing or excessive clothing.

This study was supported by funds from the First Candle/SIDS Alliance, CJ Martin Overseas Fellowship, the CJ Murphy Foundation for Solving the Puzzle of SIDS, CJ Foundation for SIDS, the National Institute of Child Health and Development, and the Developmental Disabilities Research Center at Children's Hospital Boston.

Citation: Jhodie R. Duncan, PhD, David S. Paterson, PhD, Jill M. Hoffman, BS, David J. Mokler, PhD, Natalia S. Borenstein, MS, Richard A. Belliveau, BA, Henry F. Krous, MD, Elisabeth A. Haas, BA, Christina Stanley, MD, Eugene E. Nattie, MD, Felicia L. Trachtenberg, PhD, Hannah C. Kinney, MD. Brainstem serotonergic deficiency in Sudden Infant Death Syndrome. JAMA Feb. 3, 2010, Vol. 303, No. 5.

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FDA Approves Xiaflex for Debilitating Hand Condition

The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.

Dupuytren's contracture affects the connective tissue found beneath the skin in the palm of the hand. Too much collagen can build up, forming thick, rope-like cords of tissue that can prevent the fingers from being able to relax and straighten normally. The disorder is most common in Caucasians and in men over age 50.

Xiaflex is a biologic drug made from the protein product of a living organism. It works by breaking down the excessive buildup of collagen in the hand.

"Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients. Since there are no other non-surgical alternatives for Dupuytren’s contracture, Xiaflex will be an important advance in the management of this disabling condition," said Bob Rappaport, M.D., director, Division of Anesthesiology, Analgesia, and Rheumatology of the FDA’s Center for Drug Evaluation and Research.

Xiaflex is injected directly into the collagen cord of the hand and should be administered only by a health care professional experienced with injections of the hand, because tendon ruptures may occur.

The most common adverse reactions in patients treated with Xiaflex were fluid build up, swelling, bleeding, and pain in the injected area. Although no serious allergic reactions have been observed, such a response would not be unexpected because this foreign protein could prompt an immune system reaction.

In one 66-patient study, 44 percent of those injected with Xiaflex were treated successfully, compared to 5 percent for patients who received a placebo. In a separate 306-patient study, 64 percent of patients given Xiaflex were treated successfully, compared to only 7 percent of patients receiving the placebo.

Xiaflex is manufactured by Auxilium Pharmaceuticals Inc., a specialty biopharmaceutical company based in Malvern, Penn.

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FDA Announces Safety Risk Associated with HIV Drug

The U.S. Food and Drug Administration announced on January 29 that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine).

Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA’s Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.

Non-cirrhotic portal hypertension occurs when blood flow in the portal vein – a major vein in the liver – slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding.

The Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.

The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people.

Videx/Videx EC is marketed by Princeton, N.J.-based Bristol-Myers Squibb.

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