FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis

The U.S. Food and Drug Administration today (March 4) announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning.

In patients with PAH, Letairis slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, Letairis is in a class of medications called endothelin receptor antagonists, which stop the action of endothelin, a substance that narrows blood vessels and prevents normal blood flow in those with PAH.

“We have concluded that monthly liver enzyme testing for patients taking Letairis, as previously noted in the boxed warning, is not necessary,” said Mary Ross Southworth, Pharm.D., deputy director for safety in the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Health care professionals should still continue to order liver enzyme tests when they consider it clinically indicated.”

Letairis was approved with a Risk Minimization Action Plan (RiskMAP) to manage liver damage and fetal malformation. The RiskMAP called for liver enzyme testing prior to treatment and monthly during treatment for all patients. It also required monthly pregnancy testing for women of childbearing potential because Letairis causes birth defects in animals, like other drugs in this class. The Letairis RiskMAP was converted to a Risk Evaluation and Mitigation Strategy in 2009.

The boxed warning on the risk of serious birth defects and the contraindication for use during pregnancy will remain in the labeling. Letairis will continue to be available only through a restricted distribution program called the Letairis Education and Access Program (LEAP). For women who can become pregnant, monthly pregnancy tests will still be required before Letairis is shipped.

The liver warnings were based on experience with other drugs in Letairis’ drug class, as well as a few observed instances of increased liver enzymes in people treated with Letairis. The FDA’s further evaluation has shown that rates of liver problems in Letairis-treated patients are consistent with rates within the general PAH population. In the controlled clinical trials, the rates of liver problems in Letairis-treated patients are similar to the rates in people receiving an inactive pill (placebo).

For a discussion of the FDA’s rationale and regulatory decisions regarding Letairis, refer to the Drug Safety Communication issued today.

People who take Letairis should not stop taking it without talking to their health care professional. Health care professionals should order and review tests for liver function as necessary based on the patient’s condition and history. Adverse events involving Letairis should be reported to the FDA MedWatch program1.

Letairis is made by Gilead Sciences Inc., Foster City, Calif.

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FDA Approves First Diagnostic Assay to Detect Both HIV Antigen and Antibodies

/USNewswire/ -- The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings.

HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. HIV damages a person's body by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year. Most recent CDC estimates are that there are about 56,000 new HIV infections in the United States each year. In addition, there are more than 1 million people living with HIV in the United States, according to CDC.

"The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "It provides for more sensitive detection of recent HIV infections compared with antibody tests alone."

The ARCHITECT HIV Ag/Ab Combo assay is not intended to be used for routine screening of blood donors. However, it is approved as a donor screening assay for HIV-1/HIV-2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical.

The ARCHITECT HIV Ag/Ab Combo assay will be used in clinical laboratories and in public health laboratories, and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously.

The ARCHITECT HIV Ag/Ab Combo assay is manufactured by Abbott Laboratories, Abbott Park, Illinois.

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A Better Genetic Test for Autism

/PRNewswire/ -- A large study from Children's Hospital Boston and the Boston-based Autism Consortium finds that a genetic test that samples the entire genome, known as chromosomal microarray analysis, has about three times the detection rate for genetic changes related to autism spectrum disorders (ASDs) than standard tests. Publishing in the April issue of Pediatrics (and online March 15), the authors urge that CMA become part of the first-line genetic work-up for ASDs.

Expectant parents who have family members with ASDs, as well as families who already have an affected child, often request genetic testing. However, there is still only limited knowledge about actual causative genes. The currently recommended tests (karyotyping to look for chromosomal abnormalities and testing for Fragile X, the single largest known genetic cause of ASDs) often come up negative. Chromosomal microarray analysis (CMA) is a genome-wide assay that examines the chromosomes for tiny, sub-microscopic deletions or duplications of DNA sequences, known as copy-number variants.

CMA offers about 100-fold greater resolution than standard karyotyping. However, since it is new, it is often considered a second-tier test. Depending on where a person lives, or what insurance they have, CMA may not be covered by health insurance. "Based on our findings, CMA should be considered as part of the initial clinical diagnostic evaluation of patients with ASDs," says Bai-Lin Wu, PhD, Director of Children's DNA Diagnostic Lab in the Department of Laboratory Medicine, which has offered CMA to families since 2006.

The research team, led by co-senior authors Wu (heading the Children's team), and David Miller, MD, PhD, of Children's Division of Genetics and Department of Laboratory Medicine (heading the Autism Consortium team), assessed the diagnostic value of CMA in the largest cohort to date - 933 patients with a clinical diagnosis of ASD (by DSM-IV-TR criteria) who received clinical genetic testing in 2006, 2007 and 2008.

Half were Children's patients who had their samples submitted to the hospital's DNA Diagnostic Laboratory, and the others were recruited through the Autism Consortium, a research and clinical collaboration of five Boston-area medical centers. Nearly half of the patients were diagnosed with autistic disorder, nearly half with PDD-NOS (pervasive developmental disorder - not otherwise specified) and about 3 percent with Asperger disorder. Ages ranged from 13 months to 22 years.

Testing included the two currently used tests (G-banded karyotype and fragile X), as well as CMA. When the researchers compared the tests' diagnostic yield, they found:

-- Karyotyping yielded abnormal results in 2.23 percent of patients
-- Fragile X testing was abnormal in 0.46 percent
-- CMA results were judged to be abnormal in 7.3 percent of patients when
the entire length of the chromosomes (the whole genome) was sampled.


Extrapolating from these results, the researchers estimate that without CMA, genetic diagnosis will be missed in at least 5 percent of ASD cases. CMA performed best in certain subgroups, such as girls with autistic disorder, and past studies indicate that it also has a higher yield in patients with intellectual disability (who constituted only 12 percent of this sample).

"CMA clearly detects more abnormalities than other genetic tests that have been the standard of care for many years," says Miller. "We're hoping this evidence will convince insurance companies to cover this testing universally."

In all, roughly 15 percent of people with autism have a known genetic cause. Establishing a clear genetic diagnosis helps families obtain early intervention and services for autism, and helps parents predict the possibility of having another child with autism.

In addition, by pinpointing bits of chromosomes that are deleted or duplicated, CMA can help researchers zero in on specific causative genes within that stretch of DNA. They can also begin to classify patients according to the type of deletion or duplication they have, and try to find specific treatment approaches for each sub-type of autism.

"Just in the last two years, a number of studies have revealed the clinical importance of ever smaller chromosome deletions and duplications found with advanced microarray technology," says Wu. "These new, highly-efficient tests can help in the evaluation or confirmation of autism spectrum disorders and other developmental disorders, leading to early diagnosis and intervention and a significantly improved developmental outcome."

Two known chromosome locations - on chromosome 16 (16p11.2) and chromosome 15 (15q13.2q13.3) accounted for 17 percent of abnormal CMA findings. Both chromosome abnormalities were initially linked with ASDs by Children's Hospital Boston and collaborators in The New England Journal of Medicine and the Journal of Medical Genetics, respectively, in 2008. Children's now offers specific tests targeting both of these "hot spots."

However, the researchers note that most copy-number changes were unique or identified in only a small number of patients, so their implications need further study. Many of them are presumed to be related to ASDs because they involve important genes, cover a large region of the chromosome, or because the child is the first person in that family to have the change.

"Some deletions and duplications are rare and specific to one individual or one family," says Miller. "Learning about them is going to be an evolving process. There won't be one single test that finds all genetic changes related to autism, until we completely understand the entire genome."

The paper's co-first authors were Autism Consortium members Yiping Shen, PhD, of Children's Department of Laboratory Medicine and the Center for Human Genetic Research at Massachusetts General Hospital, and Kira Dies, ScM, LGC, of the Family Research Network of the Autism Consortium and Children's Multi-Disciplinary Tuberous Sclerosis Program. A number of specialists from Children's Departments of Neurology, Developmental Medicine and Clinical Genetics and physicians from other medical centers in greater Boston were also authors on the study. The research was supported by the Nancy Lurie Marks Family Foundation, the Simons Foundation, Autism Speaks and the National Institutes of Health.

Families interested in scheduling an appointment at Children's may call the Developmental Medicine Center (617-355-7025) or the Department of Neurology (617-355-2711).

Citation: Shen Y; et al. Clinical genetic testing for patients with autism spectrum disorders. Pediatrics 2010 Apr; 125(4):e1-e17. (Published online March 15)

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Medicare Expands List of Covered Preventive Services to Include HIV Screening Tests

The Centers for Medicare & Medicaid Services (CMS) today announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries
of any age who voluntarily request the service. The decision is effective immediately.

Under the recently passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS now has the flexibility of adding to Medicare's list of covered preventive services, if certain requirements are met. Prior to this law, Medicare could only cover additional preventive screening tests when Congress authorized it to do so.

"Today's decision marks an important milestone in the history of the Medicare program," said HHS Secretary Kathleen Sebelius. "Beginning with expanding coverage for HIV screening, we can now work proactively as a program to help keep Medicare beneficiaries healthy and take a more active role in evaluating the evidence for preventive services."

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law. Among other requirements, the new services must have been "strongly recommended" or "recommended" by the U.S. Preventive Services Task Force. For instance, the Task Force graded HIV screening as "strongly recommended" for certain groups. More information about the Task Force is available online at
http://www.ahrq.gov/clinic/uspstfix.htm.

"Every adult should know their HIV status," said Dr. Howard K. Koh, HHS assistant secretary for health. "This decision by Medicare should help promote screening and save lives."

CMS uses the national coverage determination (NCD) process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making its decisions and allows opportunity for the public to comment on CMS'
proposals.

"Medicare's coverage of HIV screening tests is an important step forward in protecting beneficiaries from the potentially devastating and life-threatening complications of HIV and Acquired immunodeficiency Syndrome (AIDS)," said CMS Acting Administrator Charlene Frizzera.

AIDS is diagnosed when an HIV-infected person's immune system becomes severely compromised or a person becomes ill with an HIV-related infection. Of the more than one million estimated to have the HIV infection, the Centers for Disease Control and Prevention has estimated that about a quarter of them do not realize they are infected. Without treatment, AIDS develops within 8 to 10 years. While there is presently no cure for HIV, screening can help identify infected patients so that they can receive medical treatment that could help delay the onset of AIDS for years.

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New Rules Protect Patients' Genetic Information

Individuals' genetic information will have greater protections through new regulations issued today by the U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury.

The interim final rule will help ensure that genetic information is not used adversely in determining health care coverage and will encourage more individuals to participate in genetic testing, which can help better identify and prevent certain illnesses.

"Echoing the late Senator Ted Kennedy, our efforts to protect Americans undergoing genetic testing from having the results of that testing used against them by their insurance companies is one of the 'first major new civil rights' of the new century," said HHS Secretary Kathleen Sebelius. "Consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases. Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies."

The interim final rule with request for comments and the notice of proposed rulemaking implement Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). Under GINA, and the interim final rule, group health plans and issuers in the group market cannot:
increase premiums for the group based on the results of one enrollee's genetic information; deny enrollment; impose pre-existing condition exclusions; or do other forms of underwriting based on genetic information. In the individual health insurance market, GINA prohibits issuers from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions.

Further, under GINA and the new interim final regulations, group health plans and health insurance issuers in both the group and individual markets cannot request, require or buy genetic information for underwriting purposes or prior to and in connection with enrollment.
Finally, plans and issuers are generally prohibited from asking individuals or family members to undergo a genetic test.

"Today's genetic technologies yield data that are vital to helping Americans make personal, medical decisions. It is essential that we protect such information and ensure it is not misused by health plans or insurers," said Labor Secretary Hilda L. Solis. "The rules issued today protect individuals against the unwarranted use of information related to their personal health because no one should have to fear that disclosure of their medical data will put their job or health coverage at risk."

Additionally, HHS, through its Office for Civil Rights (OCR), issued a notice of proposed rulemaking with a 60-day comment period, to propose changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to prohibit health plans from using or disclosing genetic information for underwriting purposes.

The proposed rule published today modifies the HIPAA Privacy Rule pursuant to GINA Title I to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by covered health plans for eligibility determinations, premium computations, applications of any pre-existing condition exclusions, and any other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits. In combination with the new penalties for violations of the HIPAA Privacy Rule, as provided for by the American Recovery and Reinvestment Act of 2009, a use or disclosure of genetic information in violation of the HIPAA Privacy Rule could result in a fine of $100 to $50,000 or more for each violation.

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HIV Screening Tests Proposed to Be Added to Medicare's List of Covered Preventive Services

The Department of Health and Human Services (HHS) today announced a new proposal that would cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service.

"The President has set clear priorities for an improved national response to ending the HIV epidemic," said HHS Secretary Kathleen Sebelius. "Today's action by HHS' Centers for Medicare & Medicaid Services (CMS) sends a strong signal that this Administration takes prevention very seriously, especially when it comes to HIV and AIDS."

"While younger age groups account for most cases of HIV infection in the United States, the Centers for Disease Control and Prevention (CDC) estimates that in 2006, approximately 19 percent of all U.S. residents with AIDS were age 50 years or older when the disease was diagnosed, " she added. "Knowing about their HIV status can help patients live longer, fuller lives as well as avoid unintentional transmission of the virus to others."

CMS' efforts mark the first time that Medicare has proposed to expand its list of covered preventive services under a new authority established by Congress. The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) gave CMS the ability to consider whether
Medicare should cover "additional preventive services," if certain requirements are met.

Acquired immunodeficiency syndrome (AIDS) is diagnosed when an HIV-infected person's immune system becomes severely compromised or a person becomes ill with an HIV-related infection. Of the more than one million Americans estimated to have the HIV infection, the CDC has estimated that about a quarter of them do not realize they are infected. Without treatment, the HIV infection usually develops into AIDS within 8 to 10 years. While there is presently no cure for HIV, screening can help identify infected patients so that they can receive medical
treatment that could help delay the onset of AIDS for years.

"This proposal to cover HIV screening for our Medicare population has great potential in terms of saving lives and improving the quality of life for many seniors, as well as beneficiaries under age 65," said Acting CMS Administrator Charlene Frizzera.

The White House's top HIV/AIDS official saluted the move by HHS, calling it a critical step in helping HIV and AIDS patients to get the treatment they need.

"The President is committed to re-focusing national attention on the domestic HIV epidemic and salutes this decision as an important step in our overall strategy," said Jeffrey S. Crowley, the Director of the White House Office of National AIDS Policy. "We are working with agencies across the government to achieve the President's goals of reducing HIV incidence, getting all people living with HIV/AIDS into care and improving health outcomes, and reducing HIV-related health disparities. The actions taken by the HHS today are an important part of
our efforts."

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law, as long as they have been "strongly recommended" or "recommended" by the U.S. Preventive Services Task Force.. For
instance, the Task Force graded HIV screening as "strongly recommended." More information about the Task Force is available online at http://www.ahrq.gov/clinic.

CMS uses the national coverage determination process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making itsdecisions and allows opportunity for the public to comment on CMS'
proposals.

"We are pleased to be able to propose an expansion to Medicare's portfolio of preventive services," said Barry M. Straube, M.D., CMS Chief Medical Officer and Director of the Agency's Office of Clinical Standards & Quality. "Before the MIPPA law, CMS had not been able to
expand preventive services without Congressional action. Now we can take more active steps to evaluate the evidence about which services are reasonable and necessary to help keep Medicare beneficiaries healthy."

CMS will accept public comments on the proposed decision through Oct. 9, 2009, and will issue a final coverage decision by Dec. 8, 2009.

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Cancer Community Alarmed at CMS Policy Lumping Life-Saving Cancer Therapy With Diagnostic Testing For Major Funding Cuts

/PRNewswire/ -- The following is being released by US Oncology:

Concerned members of the cancer community, including physicians, patient organizations and other care advocates, spoke out today in opposition to a proposed federal policy under consideration by the Centers for Medicare and Medicaid Services (CMS) that would lump life-saving radiation therapy in with diagnostic testing services in receiving major Medicare funding cuts. In support of their cause, a bipartisan letter led by Reps. Parker Griffith (D-AL), Sue Myrick (R-NC), Lois Capps (D-CA) and Mike Rogers (R-MI), was sent to Health and Human Services Secretary Kathleen Sebelius urging a reversal of this proposal.

"I am very alarmed at the prospect of these dangerous funding cuts being made to radiation therapy, which is a safe and effective treatment proven as a trusted tool in the fight against cancer," said Bernard W. Taylor, M.D., a radiation oncologist at Texas Oncology-Longview Cancer Center in Longview, Texas. "For vulnerable cancer patients like mine, this proposed policy would limit their access to vital radiation treatment through longer wait times and less time spent with their doctors. We must educate policymakers on the radical difference between life-saving, therapeutic radiation therapy and diagnostic testing, and the critical need to spare radiation therapy from these cuts."

At issue is a 19 percent funding cut in Medicare reimbursement to the radiation oncology specialty contained within the CY 2010 Physician Fee Schedule Proposed Rule, equating to cuts of up to 44 percent for certain codes critical to the provision of radiation therapy treatments. Of particular concern in the rule is a proposed policy that raises the utilization rate for medical equipment costing over one million dollars from 50 to 90 percent. The lawmakers and other experts in the industry warn that cuts of this size will result in the closing of many freestanding and community-based cancer centers, particularly in rural areas, harming patient access to care.

"As a radiation oncologist who practiced in the community setting, I am aware of how these severe cuts would limit access to life-saving radiation therapy for cancer patients," said Rep. Griffith. "I am proud to be working on healthcare reform to expand access to high quality, effective care for cancer patients and all Americans, and I look forward to working with both parties as well as the administration to find a solution that averts these cuts and protects patient access to care."

The Congressional letter submitted to Secretary Sebelius, signed by more than 60 Members of Congress, asked CMS to refrain from finalizing the proposed reductions in Medicare payment for radiation oncology services, and to refrain from applying a higher assumed equipment utilization rate to radiation oncology equipment. The letter states:

"We are writing you today to emphasize a clear distinction: Radiation therapy is not diagnostic imaging. . . The therapeutic use of radiation to treat cancer should not be the target of those concerned with volume growth in the area of diagnostic imaging."

The proposal to reduce rates for diagnostic imaging was made by the Medicare Payment Advisory Commission (MedPAC) in their March 2009 report. MedPAC has subsequently stated that it never intended to include radiation therapy in any Medicare reimbursement cuts and yet CMS proposed to extend the cuts to radiation oncology anyway.

According to the National Cancer Institute (NCI), radiation therapy has been found to be under-utilized, with a variety of barriers, including travel time to care, cited as standing between patients and treatment. Following a review of relevant literature, the Agency for Health Care Research and Quality (AHRQ) found evidence of disparities in radiation therapy use among older patients; women; and African Americans, with the exception of care provided in the Veterans' Administration system. In another study of more than 11,000 women in Florida who had undergone breast conserving surgery, the odds of receiving post-surgical radiation therapy decreased by 3 percent for every 5-mile increase in the distance to the nearest radiation therapy facility.

"We support using data to ensure that payment rates for medical procedure are appropriate," said Leonard Kalman, M.D., Chairman of US Oncology's Public Policy Steering Committee. "However, making cuts of this size to radiation therapy - a treatment modality that more than 1 million cancer patients rely upon each year for both curative intent and palliative treatment - without an expressed rationale backed by supporting data is unsound and frankly quite frightening. On behalf of our country's cancer patients, many of whom will rely on radiation therapy at some point in their illness, we must ensure that these cuts are not applied."

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Vaccinations of Volunteers Start in First H1N1 Clinical Trial

Emory University researchers began vaccinating volunteer participants Aug. 10 in the first of several planned clinical trials of a new H1N1 vaccine.

The clinical trials are being conducted by the eight Vaccine and Treatment Evaluation Units (VTEUs), supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

Emory began signing up several hundred interested volunteers about two weeks ago and has been screening the volunteers to make sure they fit certain criteria. Volunteers will receive their first vaccinations over the first week of the trial and will return several times over the course of nine weeks to receive additional vaccinations and blood tests.

The Emory clinical trial will evaluate the safety and immune response to an H1N1 vaccine and also help determine how the pandemic flu shot should be given along with the seasonal flu shot to make it most effective. Participants will receive two H1N1 vaccinations concurrent with, before, or after, the seasonal flu shot.

The trials are being conducted in a compressed timeframe because of the possible fall resurgence of pandemic H1N1 flu infections that may coincide with the circulation of seasonal flu strains in the Northern Hemisphere.

The trials are expected to gather critical information that will allow the NIH to quickly evaluate the new vaccines to determine whether they are safe and effective in inducing protective immune responses. The results will help determine how to begin a fall 2009 pandemic flu vaccination program.

The U. S. government declared the H1N1 outbreak a public health emergency in April and two months later, the World Health Organization classified the outbreak a pandemic, reflecting its widespread nature.

“We have had a tremendous response from volunteers wanting to participate in the clinical trials,” says Mark Mulligan, MD, principal investigator of the Emory VTEU and executive director of the Hope Clinic of the Emory Vaccine Center. “Hopefully this will make it much easier to have a vaccine available for the fall flu season. We are very appreciative of the efforts of our volunteers.”

This first adult clinical trial as well as subsequent pandemic vaccine clinical trials will be conducted at the Emory Vaccine Center’s Hope Clinic in nearby Decatur. Pediatric clinical trials will be initiated one week after the first adult trial and will be conducted at the Emory-Children’s Center on Emory University’s campus. Harry Keyserling, MD, and Paul Spearman, MD, co-directors of the Emory VTEU, lead the pediatric studies at Emory-Children’s Center.

The VTEUs were established in 1962 as a vital research component of the NIAID. The units conduct clinical trials for all infectious diseases other than HIV/AIDS. They have conducted hundreds of clinical studies over the past four decades. Emory was designated a VTEU site in 2007 and received a seven-year contract of approximately $23.7 million.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to combat pandemic influenza. Results are expected to be available weeks after the trials begin.

In addition to Emory, VTEU sites are Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Group Health Cooperative, Seattle; Saint Louis University, St. Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. They will be joined for these studies by Children’s Mercy Hospital in Kansas City and Duke University Medical Center.

For more information about the Emory flu clinical trials, call 877-424-HOPE (4673) for the adult and senior studies, or 404-727-4044 for the pediatric studies, or e-mail for further information about the upcoming trials.

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Swine Flu (H1N1) Infectivity to Increase Markedly and Lethality to Remain Low According to Latest Replikin* Peptide Genomic Data

/PRNewswire/ -- Amid all the speculation over what course the Swine Flu epidemic will take, Boston-based biotech firm Replikins Ltd. (www.replikins.com) last week analyzed the most recent peptide genomic sequence data available and determined that the infectivity of the H1N1 virus will increase markedly, while its lethality will remain relatively low for the immediate future.

The company's quantitative analysis of the most recent sequence data available on PubMed, a standard scientific repository for published papers, showed an increase of 46% in the Replikin Count* over the past five months. This points to a marked increase in infectivity in humans. At the same time, while the total number of replikins has gone up significantly, their composition appears to have changed in a way that makes them more closely resemble their counterparts in earlier pandemics.

The firm, which had predicted a year ago the likelihood of the current H1N1 outbreak, used its proprietary FluForecast(TM) software program to make these determinations. "The dual differentiation of these properties may provide advance warning of the future course of H1N1," noted Samuel Bogoch MD PhD, chairman and founder of Replikins Ltd. "Our understanding of the protein chemistry of rapid replication enables us to develop synthetic vaccines specifically tailored to destroy or restrict replication of the targeted virus strains prior to an outbreak."

Earlier this month, Replikins announced that it had succeeded in synthesizing the first H1N1 influenza vaccine, which is now ready for testing. It used the same approach to produce a peptide H5N1 (avian flu) vaccine that successfully blocked low path H5N1. It has not previously been possible to correlate virus structures with a virus outbreak or cessation of outbreak, let alone to predict six to 12 months ahead of the outbreak or its cessation. In 2001, Drs. Samuel and Elenore Bogoch first demonstrated this correlation retrospectively for whole-organism replikin counts in outbreaks and pandemics of the common influenza strains over the past century.

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Public Health Laboratories To Assume Primary Responsibility for Confirmatory Testing of Swine Flu

/PRNewswire / -- Approximately sixty-five state and local public health laboratories around the United States will assume primary responsibility for confirmatory testing of Human Influenza A H1N1 of Swine Origin, or "Swine Flu," within the next week. Previously, all swine flu specimens had to be sent to CDC laboratories in Atlanta for final confirmatory testing, which identifies specimens to the strain level.

The rRT-PCR swine flu panel diagnostic test kits are being shipped this week from the Centers for Disease Control and Prevention (CDC), which developed the assay. Public health laboratories are slated to begin testing late next week following on-site validation of the test.

Deployment of the test was made possible via an emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on April 27 in response to a request from CDC.

"Testing will now proceed more rapidly, because we will have sites around the country that can fully characterize the virus, rather than only one at CDC in Atlanta," said Frances Pouch Downes, DrPH, APHL president, and director, Michigan Public Health Laboratory, Michigan Department of Community Health. "Public health labs are receiving considerable attention in connection with the deployment of the swine flu test, but this is really business as usual for us. We're there in the community, ready to protect the public's health as the situation warrants."

Each year state and local public health laboratories conduct routine surveillance to monitor circulating strains of influenza. Their findings are used to develop the influenza vaccine for the following season and to control the spread of the disease in the current year. Additionally, public health laboratories subtype influenza specimens received from clinical and hospital labs. Test results support decisions regarding patient treatment and measures to control the spread of disease.

Yet even though influenza surveillance and diagnostics are routine functions at public health laboratories, this year's outbreak poses particular challenges. "Lab folks are resilient, but even they have limits in how long they can manage to do more with less," said APHL Executive Director Scott Becker. "The economic downturn has really taken a toll on state and local health departments. I am seriously concerned about staff burnout if this outbreak continues more than a couple of months."

Results of a first quarter 2009 APHL survey indicate that the public health laboratory workforce, which numbers only 6500 nationwide, has been reduced by at least 500. These reductions apply to administrative and IT support as well as to laboratory staff. Survey results also show deep cuts to laboratory budgets -- sometimes requiring the elimination of entire public health programs, mandatory furloughs and reductions in funding for essential equipment and supplies. More cuts and staff reductions are anticipated in coming months based on initial responses to APHL's second quarter survey on the impact of the economic downturn.

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