Ten Flu Prevention PSA Contest Finalists Chosen; Now the Public Votes for the Winner!

Help us select a winner! It's time for the public to vote for the best video in the HHS Flu Prevention Public Service Announcement (PSA) Contest. The producer of the winning video gets a $2,500 cash award, and the winning PSA will be broadcast on national television!

When HHS Secretary Kathleen Sebelius announced our contest asking people to help promote flu prevention, we had no idea what to expect. The response to the contest was amazing! Some 240 video PSAs were uploaded on YouTube!

All videos were reviewed for adherence to message and length criteria. More than 100 videos qualified for the next step: review by a panel of expert judges. Their review is complete, we are down to the final 10, and now it is your turn to select the best.

Keep in mind as you watch the PSAs that we need to reach as many people as we can. We are entering the fall flu season, and the 2009 H1N1 flu could impact all of us, so getting the message out on how we can best avoid the flu is critical. Think young and old; students and mothers;
and those most vulnerable -- then tell us which video delivers the flu prevention message best.

Voting starts on YouTube at 12:01 a.m. Eastern time, Saturday, Aug. 29, and runs through 11:59 p.m. Eastern time, Wednesday, Sept.16.

Information on the contest and how to vote is available at www.flu.gov.

You will find a wide range of seasonal and H1N1 (swine) flu information at www.flu.gov; we suggest you visit it often to get the latest information and guidance for home, school, business, faith-based organizations and so much more. Sign up for regular updates and let us know what your questions are.

Go online and vote; then stay tuned for the results!

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New National Poll Finds Americans Strongly Opposed to Cutting Medicare Payments for Nursing Home Care as a Means of Financing Health Care Reform

/PRNewswire/ -- As federal lawmakers continue to sound out constituents over the August recess on health care reform, and how best to finance a broad-based overhaul, a new Mellman Group (D) national survey (1000 Registered Voters, 8/21-24, +/- 3%) finds Americans, by significant margins, strongly oppose cutting Medicare-funded nursing home care over other funding options. Underscoring the unpopularity of cutting Medicare-financed nursing home care - now proposed by Congress - the data finds a full 66% of voters less likely to support their local member of Congress for reelection if they voted to cut seniors' Medicare-funded care to finance health care reform, believing that cutting such payments would reduce quality of care.

Says the new Mellman Group poll analysis:

"Voters overwhelmingly oppose cutting Medicare payments to nursing homes as a means of financing healthcare reform, expressing their distaste for this approach in several ways during our brief survey.

First, it is the least popular of the funding options being considered.

Second, cutting Medicare payments to nursing homes is far and away the least acceptable method of financing reform.

Finally, a large majority of voters would feel less favorable toward a Member of Congress who supported such an approach. Voters say they will take out their anger on Members who vote for such nursing home cuts at the ballot box. The reason is straightforward--most Americans believe that cutting such payments will reduce the quality of care seniors receive in nursing homes. While healthcare reform is important to many Americans, Medicare funds for nursing homes are considered off limits as a way to finance reform."

When asked "If Congress cut $32 billion in Medicare payments to nursing homes to care for seniors, do you think the quality of care seniors receive in nursing homes would get better, stay about the same or get worse?" the analysis indicates that, "Seniors are equally concerned, as 78% of those over 65 believe nursing home care will get worse because of such cuts and a majority believe care will get much worse (58%)."

The following are the poll questions and results:

1. Congress is now considering ways to pay for healthcare reform. Which one of the following do you think is the most acceptable way to pay for healthcare reform?

Cutting Medicare payments to nursing homes to care for seniors 3%
Raising taxes on people who make over $250,000 per year 45%

Requiring people to pay taxes on generous healthcare benefits they receive from their employers 6%

Taxing health insurance companies 14%
None 26%
Don't know 6%


2. And which one of the following do you think is the least acceptable way to pay for healthcare reform?

Cutting Medicare payments to nursing homes to care for seniors 49%
Raising taxes on people who make over $250,000 per year 8%

Requiring people to pay taxes on generous healthcare benefits they receive from their employers 14%

Taxing health insurance companies 9%
None 14%
Don't know 6%


3. If Congress cut $32 billion in Medicare payments to nursing homes to care for seniors, do you think the quality of care seniors receive in nursing homes would get better, stay about the same or get worse? [IF BETTER/WORSE ASK]. And is that much [BETTER/WORSE] or only somewhat [BETTER/WORSE]?

Much better 4% 7%
Somewhat better 3%
Stay about the same 11%
Somewhat worse 19%
Much worse 59% 78%
Don't know 4%


4. If your Member of Congress voted to fund healthcare reform in part by cutting $32 billion in Medicare payments to nursing homes to care for seniors would you be __more likely to vote to reelect them, __less likely to vote to reelect them or would it not make much difference to your vote? [IF MORE/ LESS LIKELY ASK:] Is that much [MORE/LESS] or somewhat [MORE/LESS] likely?

Much more likely 5% 7%
Somewhat more likely 2%
No difference 20%
Somewhat less likely 17%
Much less likely 49% 66%
Don't know 6%


"From the results of this objective, timely and highly significant national survey, it is abundantly clear the public, to its credit, harbors strong antipathy to slashing Medicare beneficiaries' nursing home benefits to finance any broader reform package," stated Bruce Yarwood, President and CEO of AHCA. "We strongly support the laudable objective of the Obama Administration and Congress to expand Americans' access to care, and help bring down health care costs. However, we will continue to warn both on Capitol Hill and at the local level how and why the $32 billion Medicare cuts now under consideration will not only harm seniors' ongoing access to quality nursing home care, but also jeopardize the jobs of the key frontline caregivers who make a significant difference in patients' care outcomes."

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Researchers Find High-Dose Therapy for Liver Disease Not Effective

/PRNewswire/ -- A national team of researchers led by scientists at Mayo Clinic has found that a common treatment for primary sclerosing cholangitis, a chronic liver disease, is not helpful for patients, according to a study published this month in the journal Hepatology.

Primary sclerosing cholangitis (PSC) is a disease of the bile ducts. In this case, the term "cholangitis" refers to inflammation of the bile ducts, while "sclerosing" describes the hardening and scarring of the bile ducts that result from chronic inflammation.

"Primary sclerosing cholangitis is a serious liver disease lacking an effective medical therapy," says Keith Lindor, M.D., Mayo Clinic gastroenterologist and the study's lead researcher. "Some studies have shown that the use of ursodeoxycholic acid, a naturally occurring bile acid, may be a potential solution for patients. Our research, however, showed long-term use of this treatment in high dosages is not suitable for patients."

In this six-year, multicenter trial, 150 patients were enrolled in the study to determine the effectiveness of ursodeoxycholic acid (UDCA) in treatment of PSC. Seventy-six patients were treated with higher doses (28 to 30 mg/kg/day) of UDCA and 74 patients were given a placebo. Serious adverse events were more common in the UDCA group than the placebo group, which prompted researchers to halt the study. UDCA has been thought to be a possible treatment solution for PSC patients, but this trial indicates that the drug, used at this higher dose, is not helpful.

"All of us were surprised that the higher doses of UDCA did not help; in fact, the risk of developing even more liver problems increased with the higher dosages," says Dr. Lindor. "While this was thought to be the best potential treatment for PSC, our study found that not to be the case."

Dr. Lindor says that patients who are currently on higher doses of UDCA should consult with their doctors. He also points out that these study findings highlight the need for more research to look into better treatment options for PSC.

PSC is a progressive disease that leads to liver damage and, eventually, liver failure. Liver transplant is the only known cure for PSC, but transplant is typically reserved for people with severe liver damage.

PSC most often affects people in their 30s to 50s. The average age at diagnosis is 40. However, the condition can arise in childhood. About 60 to 75 percent of people diagnosed with the disease are men. Approximately 70 percent of people with PSC have an associated disease such as inflammatory bowel disease, osteoporosis, gallbladder disease and bile duct cancer or cholangiocarcinoma. However, only 1 to 5 percent of people with inflammatory bowel disease have PSC.

Mayo Clinic's Division of Gastroenterology and Hepatology has been ranked #1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.

Other members of the Mayo Clinic research team include M. Edwyn Harrison, M.D.,Denise Harnois, D.O., Roberta Jorgensen, Jan Petz, Jill Keach, Julie Braaten, M.D., Ellen Miceli, Jeff Schmoll, Tanya Hoskin, Prabin Thapa and Felicity Enders, Ph.D. Other researchers include Kris Kowdley, M.D., and Jody Mooney, M.D., Virginia Mason Medical Center; Velimir Luketic, M.D., and Carol Sargeant, M.D., Virginia Commonwealth University School of Medicine; Timothy McCashland, M.D., and Tamara Bernard, M.D., University of Nebraska; and Alex Befeler, M.D., and Debra King, M.D., Saint Louis University.

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Immunization Rates Remain Stable at High Levels Among the Nation′s 19- Through 35-Month-Old Children

Childhood immunization rates in the United States remain stable at high levels, according to data from CDC′s 2008 National Immunization Survey (NIS) published in this week′s Morbidity and Mortality Weekly Report (MMWR).

“Vaccination is one of the most important things parents can do to protect their children′s health,” said Dr. Melinda Wharton, Deputy Director, National Center for Immunization and Respiratory Diseases. “Thanks to the hard work of doctors and nurses and other immunization providers and the commitment of parents, rates are still high, but we must all continue to work hard to reach those children who are not fully vaccinated.”

The 2008 NIS included children aged 19–35 months and born during January 2005–June 2007.

Among these children, coverage was 76.1 percent with the 4:3:1:3:3:1 series of vaccines, not a statistically significant difference from the 2007 estimate of 77.4 percent. The national goal for coverage with the 4:3:1:3:3:1 series is 80 percent.

Vaccines in the series are:

* Four or more doses of diphtheria, tetanus and pertussis vaccine (DTaP)
* Three or more doses of polio vaccine
* One or more doses of measles, mumps and rubella vaccine (MMR)
* Three or more doses of Haemophilus influenzae type b vaccine (Hib)
* Three or more doses of hepatitis B vaccine
* One or more doses of varicella (chickenpox) vaccine

For each vaccine in the series, the goal is 90 percent and this was met, except for four doses of DTaP vaccine, which was 84.6 percent.

The 2008 NIS data showed a small but statistically significant decrease nationally for coverage with the Hib vaccine. In 2007, coverage with three or more doses of Hib was 92.6 percent and in 2008 coverage was 90.9 percent. This decrease is likely due to a shortage of the vaccine that began in December 2007 and a temporary recommendation to defer the booster dose. At least 8 percent of the children in the survey were likely impacted by this recommendation. More vaccine became available this summer, and the booster dose is now being recommended again for children at age 12–15 months.

In 2008, coverage with three or more doses of doses of pneumococcal conjugate vaccine (PCV7) increased from 90.0 percent to 92.8 percent and coverage with four or more doses increased from 75.3 percent to 80.1 percent.

As in previous years, estimated vaccination coverage levels varied substantially among states and local areas. 4:3:1:3:3:1 state coverage ranged from 59.2 percent in Montana to 82.3 percent in Massachusetts. Coverage also varied among the 17 local areas surveyed, from 68.5 percent in Northern California to 80.9 percent Santa Clara County, Calif.

This is the first NIS report to include coverage for two or more doses of hepatitis A vaccine, which was 40.4 percent. This report also includes coverage among newborns with the first dose of the hepatitis B vaccine, which was 55.3 percent, an increase from 53.2 percent in 2007.

The proportion of children who had received no vaccine doses remained at 0.06 percent.

Among racial/ethnic groups, little variation in coverage was observed. Coverage for most vaccines remained lower for children living below poverty than children living at or above poverty. Sustaining high coverage levels and finding effective methods of reducing disparities across states/local areas and income groups remains a priority to fully protect children and limit the incidence of vaccine-preventable diseases in the United States.

The NIS is an ongoing random-digit dialed survey of households with children aged 19-35 months. It also includes a mail survey of the children′s vaccination providers to collect vaccination information. During 2008, 18,430 children with provider-reported vaccination records were included in this report.

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FDA Warns About Stolen Insulin

The U.S. Food and Drug Administration is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market.

Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

When the FDA first alerted the public to the theft in June, it reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about 2 percent of the total amount stolen has been recovered.

The FDA continues to aggressively investigate this matter and is asking for the public's help in reporting any information regarding these vials to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your health care provider because another insulin product may require adjustments in dosing.

3. Always look at your insulin carefully before using it. Levemir is a clear and colorless solution.

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GlaxoSmithKline Statement Confirming alli Safety

/PRNewswire/ -- The following is the GlaxoSmithKline statement in response to the FDA's Early Communication about the safety review of orlistat:

"GSK stands firmly behind the safety and efficacy of alli. Our primary priority is patient health, and we want people to know that there is no evidence that alli causes liver damage.

The FDA is reviewing data from suspected cases on liver injury associated with the use of orlistat/alli. Any routine assessment from a regulatory body does not mean that a risk or causal relationship exists.

alli is a 'non-systemically' acting medicine - it is minimally absorbed in the blood and works locally in the gastro-intestinal tract. There is therefore no obvious biological mechanism to suggest liver damage can occur with alli.

Liver changes can have many causes. People who are overweight and obese are predisposed to liver-related disorders.

The safety of consumers is of utmost importance to GSK. We continually monitor and evaluate reports of adverse effects associated with use of all of our products, including alli.

GSK regularly communicates with independent regulatory bodies and provides them with comprehensive safety data on our products. Orlistat, the active ingredient in alli, is the most-studied weight loss medicine, with safety established through 100 clinical studies involving more than 30 thousand patients."

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FDA Moves Forward on Implementation of Tobacco Law

The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC).

The Tobacco Products Scientific Advisory Committee is tasked with providing advice, information, and recommendations to the Commissioner of Food and Drugs on health and other issues relating to tobacco products. The committee will be asked to consider a variety of topics including:

*
o identifying the effects of the alteration of the nicotine yields from tobacco products;
o reporting on the impact of the use of menthol in cigarettes on the public health; and
o advising on an application for modified risk (use of descriptors such as “light”) tobacco product.

The TPSAC will consist of 12 members, including the Chair to be selected by the Commissioner of Food and Drugs, from among experts knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation or use of tobacco products. There will be nine voting and three non-voting members. Of the nine voting members, seven will be health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. One member will be an officer or employee of a state or local government or the federal government, and the final member will be a representative of the general public.

The three non-voting members will be identified with industry interests. These members will include one representative of the tobacco manufacturing industry, one representative of the tobacco growers, and one representative of the small business manufacturing industry.

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FDA Approves XYZAL(R) For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria

/PRNewswire/ -- UCB and sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved XYZAL (levocetirizine dihydrochloride) for children age six months and older for the relief of symptoms of perennial allergic rhinitis (indoor allergies) and chronic idiopathic urticaria (chronic hives) and for children age two years and older for symptoms of seasonal allergic rhinitis (outdoor allergies). Until now, XYZAL , a once-daily prescription antihistamine in both tablet and liquid formulations, has been used to treat symptoms of indoor and outdoor nasal allergies, as well as chronic idiopathic urticaria in patients age six years and older.

"There are options for treating nasal allergies in young children, one of which is XYZAL . The availability of a liquid treatment with the established safety and efficacy of XYZAL provides caregivers a new treatment option that can help relieve nasal allergy symptoms in young patients once diagnosed by a physician," said Michael Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center; past president of the American College of Allergy, Asthma, and Immunology (ACAAI) and co-editor of the Atlas of Allergic Diseases.

Nasal allergies are currently the most common chronic condition found in children, with allergic rhinitis believed to affect as many as 40 percent of U.S. children. Recognizing the symptoms and increased hereditary risk are key elements to ensuring early diagnosis and proper management. A child with one parent living with allergies has a 48 percent chance of developing allergies, while a child with two parents living with allergies has a 70 percent chance of developing allergies.

XYZAL tablets received FDA approval on May 25, 2007 and XYZAL oral solution received FDA approval on February 19, 2008.

In September 2006, UCB and sanofi-aventis U.S. entered into an agreement to launch and co-market XYZAL in the U.S. UCB and sanofi-aventis U.S. have a long history in the nasal allergy treatment arena and are committed to advancing treatment for nasal allergy sufferers and helping meet unmet medical needs for patients with chronic nasal allergy symptoms.

About Allergic Conditions

Many people suffer from the symptoms associated with common allergic conditions. The immune system of nasal allergy sufferers overreacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Experts estimate indoor and outdoor nasal allergies affect as many as 40 million people in the U.S.

Seasonal allergic rhinitis (SAR), commonly referred to as "hay fever" or "outdoor allergies," is the most common form of allergic rhinitis. By definition, SAR includes nasal allergies to seasonal pollens like grass, trees, and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round" or "indoor allergies" and is characterized by allergic symptoms that last longer than four weeks. House dust mites, animal dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria (CIU) is most commonly known as "chronic hives of unknown origin" and is defined as the occurrence of daily, or almost daily, wheals and itching for at least six weeks with no obvious causes.

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FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat

The U.S. Food and Drug Administration announced yesterday that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.

The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.

Full text of the Early Communication about an Ongoing Safety Review can be found here. The Early Communication is a risk communication tool used by the FDA to inform the public about its ongoing safety reviews of drugs. The FDA will release its findings on orlistat as soon as the review is completed.

Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, fax, or phone.
-- Online
--Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

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HHS Secretary Announces $25.7 Million in Grants to Expand, Improve Health Center Services

Health and Human Services Secretary Kathleen Sebelius yesterday announced more than $25.7 million in grants to increase and improve health and support services at the nation's health centers.

“These grants could not be coming at a better time,” Secretary Sebelius said. “With more than 14.5 million Americans out of work, and 47 million without health insurance, the health centers are seeing more patients now than ever before.”

Overseen by the Health Resources and Services Administration (HRSA) at HHS, the Health Center system served more than 17 million medically underserved people in 2008, up from 10 million patients served in 2001. Since the economic downturn began, the health center patient population has grown by another one million people – a third of them children. By law, patients are accepted regardless of their ability to pay.

A total of 180 grants worth more than $21.9 million will give existing health centers the funds to add or increase mental health/substance abuse, enabling (i.e., outreach, transportation, case management services), oral health or pharmacy services. Additionally, 48 planning grants totaling more than $3.8 million will be distributed to organizations in hard hit areas that do not have health centers to help them develop new service delivery sites. New health center sites must meet federal requirements for governance, community involvement, quality of care and financial feasibility.

HRSA’s Health Center Program funds a national network of more than 1,100 community, migrant, homeless and public housing health center grantees. These organizations provide health care at more than 7,500 clinical sites, ranging from large medical facilities to mobile vans. In FY 2009, more than $2.1 billion was appropriated to support the Health Center Program.

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Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures

Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.

“Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”

Infantile spasms consist primarily of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms. Infants may have dozens of clusters and several hundred spasms per day. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.

Epilepsy is a neurological condition that produces disturbances in the normal electrical functions of the brain, causing people to have recurring seizures. Seizures happen when nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscle jerking, which may be repetitive, or lose consciousness.

Damage to vision is an important safety concern with the use of Sabril. The drug will have a boxed warning to alert health care professionals to this risk of a progressive loss of peripheral vision with potential decrease in visual acuity. The risk of vision damage may increase based on the dosage and duration of use, but even the lowest doses of Sabril can cause vision damage. Periodic vision testing is required for those taking Sabril. Because of the risk of permanent vision damage, the drug will be available only through a restricted distribution program.

Sabril was designated as an orphan drug by the FDA for use in treating infantile spasms. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. Orphan drug status provides the company with financial incentives to promote the development of a drug to treat a rare disease or condition.

Sabril is made by Lundbeck Inc. of, Deerfield, Ill.

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FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.

“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.

The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.

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FDA Proposes Mandatory Electronic Safety Reporting

The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format.

The agency issued two proposed rules today—one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting. Today’s rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review and archive.

“Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH). “Information obtained from these reports may be critical to future action that improves patient safety.”

Currently, CDRH receives most mandatory medical device adverse event reports on paper, which requires that reports are manually entered into the center’s adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. Not only is this step costly, but it hinders CDRH’s ability to review safety data quickly to uncover potential public health problems.

The proposed regulation for medical devices would require manufacturers, importers and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.

The electronic medical device reporting system, known as eMDR, provides a choice of two electronic options for reporting postmarket safety information. Small manufacturers with a limited number of reports may prefer an application known as eSub, which runs on free software available from the FDA. Large manufacturers, which can submit hundreds of reports per year, may prefer to use a batch submission protocol, based on a widely recognized informatics standard.

The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) currently receive adverse event reports on paper forms or electronically. Safety reporting data submitted on paper forms must be manually entered into the FDA’s Adverse Event Reporting System (AERS) before these data can be evaluated. Since 2000, CDER and CBER have allowed manufacturers (through a pilot program and FDA guidance) to submit adverse event reports electronically, which get quickly entered into AERS. This pilot program has enabled FDA staff to more rapidly review postmarketing safety data and identify emerging safety problems. Safety reports in electronic format can currently be submitted to the FDA either through the FDA’s Electronic Submission Gateway or on CD-ROM, digital tape, or floppy disk. International Conference on Harmonization (ICH) standards for data elements and technical specifications are used for these electronic submissions.

The proposed rule for drugs and biologics reporting would require manufacturers, packers and distributors to submit reports to the FDA in electronic format, which will eliminate manual processing of paper forms by both manufacturers and the FDA. Reports will be submitted to the FDA using either the ICH electronic standards or through an FDA safety reporting Web portal that is currently under development.

“Electronic reporting of serious and unexpected adverse experiences will reduce industry costs and encourage better communication with the FDA and other regulators,” said Gerald J. Dal Pan, M.D., director of CDER’s Office of Surveillance and Epidemiology.

The proposed rule for drugs and biologics reporting does not apply to safety reports filed under an investigational new drug application, annual reports that manufacturers submit to the FDA on approved drugs and biologics, biologic product deviation reports, reports of complications of blood transfusion and collection confirmed to be fatal, and certain reports on human cells, tissues and cellular and tissue-based products.

The proposed rule for medical devices does not apply to reports submitted on a voluntary basis.

Manufacturers submitting reports under either rule would be required to obtain an electronic certificate to use the FDA Electronic Submissions Gateway. Information on how to prepare and send postmarket safety reports for devices and for drugs and biologics is contained in draft guidance documents. Draft guidance for device reports is available today—draft guidance for drug and biological product reports has been available since June 2008.

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Improvements in Sexual and Reproductive Health of Teens and Young Adults

After a period of improvement, trends in the sexual and reproductive health of U.S. teens and young adults have flattened, or in some instances may be worsening, according to a new report from the Centers for Disease Control and Prevention.

CDC analyzed data from 2002-2007 from the National Vital Statistics System and numerous CDC reports and surveys including the Youth Risk Behavior Survey of high school students, the National Health and Nutrition Examination Survey (NHANES), the National Survey of Family Growth, the HIV/AIDS Reporting System, and the National Electronic Injury Surveillance System.

The data are reported in a Morbidity and Mortality Weekly Report Surveillance Summary, "Sexual and Reproductive Health of Persons Aged 10-24 Years - United States, 2002-2007." All the data are not new, but the goal of this report is to present data from multiple sources in order to summarize trends in the sexual and reproductive health of America's young people.

Findings include:
* There were approximately 745,000 pregnancies among U.S. females under age 20 in 2004.

* In 2006, the majority of new diagnoses of HIV infection among adolescents and young adults between the ages of 10 and 24 occurred among those aged 20-24 years and among males.

* About 1 million adolescents and young adults aged 10-24 years were reported to have chlamydia, gonorrhea, or syphilis in 2006. Nearly a quarter of females aged 15-19 years, and 45 percent of those aged 20-24 years, had a human papillomavirus (HPV) infection during 2003-2004.

* Approximately 100,000 females aged 10-24 years visited a hospital emergency department for a nonfatal sexual assault injury during 2004-2006.

Although the sexual risk behaviors and negative health outcomes tended to increase with age, the youngest age group - youth 10-14 years of age - were also affected:

* An estimated 16,000 pregnancies were reported among females in this age group in 2004.

* Approximately 17,000 young people in this age group were reported to have a sexually transmitted infection in 2006.

* During 2004-2006, 30,000 females in this age group visited a hospital emergency department because of a nonfatal sexual assault injury.

* Approximately one third of adolescents had not received instruction on methods of birth control before age 18.

"This report identifies a number of concerns regarding the sexual and reproductive health of our nation's young people. It is disheartening that after years of improvement with respect to teen pregnancy and sexually transmitted diseases, we now see signs that progress is stalling and many of these trends are going in the wrong direction," said Janet Collins, Ph.D., director of CDC's National Center for Chronic Disease Prevention and Health Promotion.

Among the signs that progress has halted in some areas:

* Teen birth rates increased in 2006 and 2007, following large declines from 1991-2005.

* Rates of AIDS cases among males aged 15-24 years increased during 1997-2006 (AIDS data reflects people with HIV who have already progressed to AIDS.)

* Syphilis cases among teens and young adults aged 15-19 and 20-24 years have increased in both males and females in recent years.

The report also identifies a number of racial/ethnic disparities.

Hispanic teens aged 15-19 are much more likely to become pregnant (132.8 births per 1,000 females) compared to their non-Hispanic black (128 per 1,000) and non-Hispanic white (45.2 per 1,000) peers. Additionally, rates of new HIV and AIDS diagnoses among young adults were highest among non-Hispanic black youth across all age groups.

"This report serves as a reminder that adolescents and young adults in this country continue to be impacted by STDs, including HIV," said Kevin Fenton, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. "It is imperative that all of us at the national and community level work together to ensure STD and HIV prevention programs are reaching young people, particularly in communities with the greatest burden of disease."

The full report is available at www.cdc.gov/mmwr.

(Note: this came out in July, but we missed it, thought you may have also... )

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HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information

New regulations requiring health care providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify individuals when their health information is breached were issued today by the U.S. Department of Health and Human
Services (HHS).

These "breach notification" regulations implement provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed as part of American Recovery and Reinvestment Act of 2009 (ARRA).

The regulations, developed by the HHS Office for Civil Rights (OCR), require health care providers and other HIPAA covered entities to promptly notify affected individuals of a breach, as well as the HHS Secretary and the media in cases where a breach affects more than 500
individuals. Breaches affecting fewer than 500 individuals will be reported to the HHS Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate.

"This new federal law ensures that covered entities and business associates are accountable to the Department and to individuals for proper safeguarding of the private information entrusted to their care. These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information," said Robinsue Frohboese, acting director and principal deputy director of OCR.

The regulations were developed after considering public comment received in response to an April 2009 request for information and after close consultation with the Federal Trade Commission (FTC), which has issued companion breach notification regulations that apply to vendors of personal health records and certain others not covered by HIPAA.

To determine when information is "unsecured" and notification is required by the HHS and FTC rules, HHS is also issuing in the same document as the regulations an update to its guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information. This guidance will be updated annually.

The HHS interim final regulations are effective 30 days after publication in the Federal Register and include a 60-day public comment period. For more information, visit the HHS Office for Civil Rights web site at http://www.hhs.gov/ocr/privacy/.

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Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply

The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, N.C. and Philadelphia.

A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and COMVAX, two of four vaccines licensed in the United States for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by Merck & Co. Inc. (Whitehouse Station, N.J.).

This shortage resulted in a recommendation by the U.S. Centers for Disease Control and Prevention to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from Dec. 18, 2007, through June 25, 2009.

Although current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.

“The FDA approved Hiberix under the agency’s accelerated approval pathway,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations.”

Before the availability of Hib vaccines, Hib disease was the leading cause of bacterial meningitis among children under 5 years old in the United States. Meningitis is an infection of the tissue covering the brain and spinal cord, which can lead to lasting brain damage and deafness. Hib disease can also cause pneumonia, severe swelling in the throat, infections of the blood, joints, bones, and tissue covering of the heart, as well as death. Hib disease is spread through the air by coughing and sneezing.

In 1992, the FDA disseminated rules regarding accelerated approval. The rules allow for earlier approval of treatments that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (including products that provide prophylaxis to those who would not otherwise be treated during a shortage). The use of such an approach can shorten the time required for product testing prior to receiving FDA approval. Accelerated approval is granted on the condition that clinical trials are continued during the post-approval marketing of the product to verify the anticipated clinical benefit.

Hiberix is used in nearly 100 countries. The FDA based its conclusion that Hiberix is safe and effective for use as a booster dose in certain children in the United States on data from seven clinical studies conducted in Europe, Latin America and Canada that involved more than 1,000 children.

As part of the approval, the manufacturer, GlaxoSmithKline, will conduct a post-market study in the United States to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared to a Hib vaccine already licensed in the United States. The study is intended to confirm the clinical benefit of booster immunization with Hiberix in accordance with the accelerated approval regulations, and to provide additional data on Hiberix for young infants.

The most common side effects seen in the studies following a booster dose of Hiberix included pain and redness at the injection site, fever, fussiness, loss of appetite and restlessness.

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Dental Hygiene Holds Second Annual White Coat Ceremony

The Clayton State University Department of Dental Hygiene held its second annual “White Coat” ceremony on Aug. 17 in the Harry S. Downs Center. A total of 55 junior and senior students took the dental hygiene oath.

“The Dental Hygiene program’s White Coat Ceremony is a great day of recognition for our current students. The day welcomes the junior students into the program and introduces them to the responsibilities associated with patient care while in the dental hygiene program. The ceremony also reminds the senior students of their responsibilities associated with patient care in the program and also promotes the principles of professionalism they will need to embrace in their future practice of dental hygiene,” says Dr. Susan Duley, head of the Department of Dental Hygiene.

Dr. Karl Haden, founder and president of the Academy for Academic Leadership, was the keynote speaker at the ceremony. Tianddria Walton (Newnan), president of the Student American Dental Hygienists’ Association at Clayton State, led in reciting the oath along with her fellow classmates.

Haden was also guest speaker for the first White Coat ceremony at Clayton State in fall 2008. For more than 15 years, Haden has consulted with colleges and associations in academic healthcare. Haden’s areas of expertise include leadership development, organizational change, ethics, team building, negotiation and conflict management, strategic planning, curriculum development, and the scholarship of teaching and learning.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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FDA Launches New Center for Tobacco Products

The U.S. Food and Drug Administration today launched its new Center for Tobacco Products in an historic effort to curb the hundreds of thousands of deaths caused by those products each year.

The Center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009. The FDA’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, and establishing and enforcing advertising and promotion restrictions.

Lawrence Deyton, M.D. M.S.P.H., an expert on veterans’ health issues, public health, tobacco use, and a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences, will serve as the Center’s first director.

“We are thrilled to announce Dr. Deyton’s appointment as director of the Center for Tobacco Products and look forward to him joining the agency,” said FDA Commissioner Margaret A. Hamburg, M.D. “He is the rare combination of public health expert, administrative leader, scientist, and clinician.”

Before coming to the FDA, Deyton was Chief Public Health and Environmental Hazards Officer for the U.S. Department of Veterans Affairs. His responsibilities there included oversight of the VA’s public health programs including tobacco use, the health of women veterans, the long-term health consequences of military service, and the VA’s emergency preparation and response. He was selected after a national search.

The FDA’s Center for Tobacco Products, located on the FDA’s White Oak Campus in Silver Spring, Md., will use the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.

To implement the program, the FDA will start with $5 million from the fiscal year 2009 budget to establish the necessary administrative functions for the Center. As set forth in the Family Smoking Prevention and Tobacco Control Act, funding for the Center and other activities related to the regulation of tobacco will come from user fees paid by manufacturers and importers of tobacco products.

According to the Centers for Disease Control and Prevention, cigarette smoking causes an estimated 438,000 deaths, or about 1 of every 5 deaths, each year. On average, adults who smoke cigarettes die 14 years earlier than nonsmokers.

“As many Americans know, freedom from tobacco dependence is the key to a healthy future,” said Assistant Secretary for Health Howard Koh, M.D., M.P.H. “Dr. Deyton’s public health and tobacco cessation experience will be invaluable as the Department of Health and Human Services and the Food and Drug Administration take on this challenge.”

One of Deyton’s priorities had been revitalization of the VA’s smoking and tobacco use cessation programs. Under his leadership, current smoking among veterans enrolled in the cessation program fell from 33 percent in 1999 to 22 percent in 2007. The VA health care system is the largest integrated provider of health care and medical services in the United States, with more than 1,400 sites serving nearly 6 million veterans in fiscal year 2008.

“I am eager for the challenge of leading the tobacco team at FDA,” said Deyton. “This is a tremendous opportunity for us at FDA to work hand-in-hand with the CDC, researchers at the National Institutes of Health, and public health leaders in the states to make progress in combating tobacco use – the leading cause of preventable death in the United States.”

In 2002, Deyton established the VA’s Public Health Strategic Health Care Group, which encompassed responsibilities for HIV, hepatitis C, tobacco use cessation, bioterrorism, and issues such as SARS, pandemic influenza, and other emerging public health threats. He became Chief Officer in January 2006 and since then has been successful in efforts to address the health needs of veterans.

Deyton has served for 11 years in leadership positions in the National Institute of Allergy and Infectious Diseases at NIH, six years in the Office of the Assistant Secretary for Health at HHS, and as a legislative aide with the House of Representatives Subcommittee on Health and the Environment in the 1970s.

He was a founder in 1978 of the Whitman Walker Clinic, a community based AIDS service organization in Washington, D.C. He is a graduate of Kansas University, the Harvard School of Public Health and the George Washington University School of Medicine. Deyton’s post-doctorate medical training was at the University of Southern California/Los Angeles County Medical Center. He is board certified in Internal Medicine and continues to care for patients on a regular basis.

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Federal Guidelines Encourage Employers to Plan Now for Upcoming Influenza Season

Recommendations Range from Encouraging Hand Washing to Allowing Some Employees to Stay Home

Department of Commerce (DOC) Secretary Gary Locke, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and Homeland Security (DHS) Secretary Janet Napolitano today announced new guidance for businesses to plan for and respond to the upcoming flu season.

The guidance, released by the Centers for Disease Control and Prevention (CDC), is designed to help employers prepare now for the impact of seasonal and 2009 H1N1 influenza could have this fall and winter on their employers and operations.

Employers' plans should address such points as encouraging employees with flu-like symptoms or illness to stay home, operating with reduced staffing, and possibly having employees who are at higher risk of serious medical complications from infection work from home, according
to the CDC guidance.

It is not known whether the 2009 H1N1 influenza virus will cause more illness or more severe illness in the coming months, but the CDC recommends that everyone be prepared for influenza. Because seasonal and 2009 H1N1 influenza pose serious health threats, employers should
work with employees to develop and implement plans that can reduce the spread of flu, and to encourage seasonal flu vaccination as well as H1N1 vaccination when that vaccine becomes available.

Secretary Locke suggested businesses set the right tone in the workplace. That means implementing common sense measures to reduce the risk of spreading the flu and encouraging workers who are sick to stay home.

"The President has mobilized the federal government to get America prepared," DOC Secretary Locke said. "But government can't do it alone. For this effort to be successful, we need the business community to do its part." Making the right decisions will not only improve public
health, it also has the potential to protect economic productivity: Employees who are sick and stay home will not spread the flu in the workplace.

"This new guidance will help our private sector partners continue to prepare for the upcoming flu season to keep our economy functioning and our critical infrastructure secure," said DHS Secretary Napolitano. "Ensuring business continuity is important to our cooperative efforts to
keep Americans safe."

There are many actions that can be taken to help reduce the spread of flu. The guidance notes the importance of using these actions, including regular and frequent hand washing and routine cleaning of commonly touched surfaces.

"One of the most important things that employers can do is to make sure their human resources and leave policies are flexible and follow public health guidance,'' said HHS Secretary Kathleen Sebelius. ``If employees are sick, they need to be encouraged to stay home. If people begin to
experience flu-like symptoms at work, they should be sent home and possibly encouraged to seek medical treatment. ''

Employers should review sick leave policies and ensure employees understand them, according to the guidance. Employers should try to make sick leave policies flexible for workers who may have to stay home with ill family members or if a child's school is closed, the CDC says.

Employers should consider offering vaccine against seasonal flu, and encourage employees to be vaccinated against seasonal and H1N1 flu, the guidance says.

Employers also might cancel non-essential face-to-face meetings and travel, and space employees farther apart, the report says. And employees who are at higher risk for flu complications might be allowed to work from home or stay home if the flu is severe, it says.

"Keeping our nation's workers safe is a top priority," said Deputy Secretary of Labor Seth Harris, who participated in the announcement. "Faced with a renewed H1N1 challenge during the coming flu season, we are developing tools that will help ensure America's workers stay
healthy and our businesses remain viable."

For more information, visit www.flu.gov.

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Life Expectancy at All Time High; Death Rates Reach New Low, New Report Shows

U.S. life expectancy reached nearly 78 years (77.9), and the age-adjusted death rate dropped to 760.3 deaths per 100,000 population, both records, according to the latest mortality statistics from the Centers for Disease Control and Prevention (CDC).

The report, "Deaths: Preliminary Data for 2007," was issued today by CDC's National Center for Health Statistics. The data are based on nearly 90 percent of death certificates in the United States.

The 2007 increase in life expectancy - up from 77.7 in 2006 -- represents a continuation of a trend. Over a decade, life expectancy has increased 1.4 years from 76.5 years in 1997 to 77.9 in 2007.

Other findings:

* Record high life expectancy was recorded for both males and females (75.3 years and 80.4 years, respectively). While the gap between male and female life expectancy has narrowed since the peak gap of 7.8 years in 1979, the 5.1 year difference in 2007 is the same as in 2006.

* For the first time, life expectancy for black males reached 70 years.

* The U.S. mortality rate fell for the eighth straight year to an all-time low of 760.3 deaths per 100,000 population in 2007 -- 2.1 percent lower than the 2006 rate of 776.5. The 2007 mortality rate is half of what it was 60 years ago (1532 per 100,000 in 1947.)

* The preliminary number of deaths in the United States in 2007 was 2,423,995, a 2,269 decrease from the 2006 total.

* Heart disease and cancer, the two leading causes of death, accounted for nearly half (48.5 percent) of all deaths in 2007.

* Between 2006 and 2007, mortality rates declined significantly for eight of the 15 leading causes of death. Declines were observed for influenza and pneumonia (8.4 percent), homicide (6.5 percent), accidents (5 percent), heart disease (4.7 percent), stroke (4.6 percent), diabetes (3.9 percent), hypertension (2.7 percent), and cancer (1.8 percent).

* The death rate for the fourth leading cause of death, chronic lower respiratory diseases, increased by 1.7 percent. Preliminary death rates also increased for Parkinson's disease, chronic liver disease and cirrhosis, and Alzheimer's, but these gains are not statistically significant.

* There were an estimated 11,061 deaths from HIV/AIDS in 2007, and mortality rates from the disease declined 10 percent from 2006, the biggest one-year decline since 1998. HIV remains the sixth leading cause of death among 25-44 year-olds.

* The preliminary infant mortality rate for 2007 was 6.77 infant deaths per 1,000 live births, a 1.2 percent increase from the 2006 rate of 6.69, though not considered statistically significant. Birth defects were the leading cause of infant death in 2007, followed by disorders related to preterm birth and low birthweight. Sudden infant death syndrome (SIDS) was the third leading cause of infant death in the United States.

The full report is available at www.cdc.gov/nchs.
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Free Prostate Screening at North Fulton Regional Hospital

Tuesday, September 15 & Wednesday, September 16
5:15–7:30 p.m.

North Fulton Regional Hospital Outpatient Surgery (3000 Hospital Boulevard)
Glover Little, MD John Moseley, MD

The screening consists of a PSA blood test and a physical exam.Who should participate:
- Men age 50 or older with no prior history of prostate cancer
- Men age 40 or older with a family history of prostate cancer
- African-American men age 40 or older
- Men who have not been seen by a urologist or been tested for prostate cancer within the last 12 months
- Men who have not already been diagnosed with prostate cancer

Screenings are by appointment only, and space is limited. To schedule your FREE screening, call 770-751-2660.
www.northfultonregional.com
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The HRSA Genetics Collaboratives are Bringing Genetic and Newborn Screening Services to Local Communities Around the United States

/PRNewswire/ -- Overcoming the challenges of bringing quality and cutting edge genetic and newborn screening (NBS) services to local communities and to children and families with hereditary diseases is extremely complex. It requires coordinated, multifaceted and multidisciplinary efforts that are national, regional, and local and include public, private and not-for-profit partnerships. In order to meet these challenges, the Health Resources and Services Administration/Maternal and Child Health Bureau (HRSA/MCHB) awarded the American College of Medical Genetics (ACMG) a cooperative agreement in 2004 and later renewed it until 2012 to serve as the National Coordinating Center (NCC) for seven similarly-funded Regional Genetics Collaboratives known as the HRSA Genetics Collaboratives (http://www.nccrcg.org/).

These seven HRSA/MCHB-funded HRSA Genetics Collaboratives and their National Coordinating Center (NCC) are working to improve access to local genetic and newborn screening services, information, and resources for individuals and families with heritable disorders. A major component of the NCC/Genetics Collaboratives system involves using a variety of approaches to link primary care providers, geneticists and other specialist providers, and public health services into a comprehensive medical home that meets all the needs of individuals and families with heritable conditions. Activities at all levels engage consumers and families, with new opportunities for partnerships continually emerging.

"Hundreds of professionals including public health officials, newborn screening program staff members, primary care providers, physician geneticists, genetic counselors, consumer advocates, and families are active in the HRSA Genetics Collaboratives. The Collaboratives are bringing genetic discoveries into local communities in every state in the country and are working hard to improve local access to newborn screening and genetic services for everyone by addressing the unique needs of the community," says Judith Benkendorf, MS, CGC, a genetic counselor and Project Director of the NCC. "Each regional Genetics Collaborative has fostered a variety of approaches to building linkages between public health, genetics specialists, primary care/the Medical Home and families. Some of activities are even being replicated nationally. A benefit of the current coordinated system is that each HRSA Genetics Collaborative has access to national expertise, positioning it to be a 'go to' resource for information about genetic and newborn screening services," added pediatrician Tracy L. Trotter, MD, FAAP, Senior Partner, San Ramon Valley Primary Care.

The NCC also facilitates collaborations between the HRSA Genetics Collaboratives and national projects, using local communities to pilot materials and programs for policymakers, health professionals and families. Many national organizational partners contribute additional resources.

NCC initiatives include:
-- building national capacity in the use of telegenetics;
-- establishing a searchable national network of genetic service and
subspecialty providers experienced in the diagnosis and management of
infants with heritable disorders detected through NBS programs;
-- collecting and disseminating data that establish the value of genetic
services to payers and policymakers;
-- developing disaster preparedness strategies to ensure that NBS
programs and treatment of patients with metabolic conditions are not
interrupted in the case of an emergency;
-- developing and distributing of management guidelines and "just in
time" resources for providers caring for patients with heritable
disorders;
-- addressing the transition of patients with heritable conditions from
pediatric to adult care; and
-- developing resources for state policymakers.

National data collection efforts include tracking pilot NBS programs and establishing and maintaining a patient follow-up database useful in rare disease research. Maximizing collaboration between the genetic services, primary care, NBS and public health communities is critical to the success of each of these efforts and to the collective impact of the NCC and the Genetics Collaboratives.

The Seven Regional HRSA Genetics Collaboratives

Region 1: The New England Regional Genetics Collaborative (NEGC), with CT, MA, ME, NH, RI and VT (www.negenetics.org/)

Region 2: New York-Mid-Atlantic Consortium for Genetic and Newborn Screening Services, with DC, DE, MD, NJ, NY, PA, VA, and WV (www.wadsworth.org/newborn/nymac/)

Region 3: The Southeast NBS and Genetics Collaborative, with AL, FL, GA, LA, MI, NC, SC, TN, PR, and USVI (http://southeastgenetics.org/)

Region 4: The Region 4 Genetics Collaborative with IL, IN, KY, MI, MN, OH, WI (http://region4genetics.org/)

Region 5: The Heartland Regional Genetics and Newborn Screening Collaborative, with AR, IA, KS, MO, ND, NE, OK, and SD (www.heartlandcollaborative.org/)

Region 6: Mountain States Genetics Regional Collaborative Center, with AZ, CO, MT, NM, NV, TX, UT, and WY (www.msgrcc.org/)

Region 7: Western States Genetic Services Collaborative, with AK, CA, HI, OR, WA, and US Pacific Basin (www.westernstatesgenetics.org/)

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Flu-Like Illness Being Reported in Communities District-Wide

District 4 Public Health wants parents and employers to know that flu-like illness is being reported in communities within the 12 county Region. Because only a small portion of persons with respiratory illness are tested for novel H1N1, confirmed and probable case counts represent a significant underestimation of the true number of novel H1N1 flu cases. Because of the low testing rate, we should not use these as indicators of the presence of H1N1 in our community.

We should be proactive and conduct ourselves as if this virus is already in our communities. Therefore, it is important for everyone to take steps to prevent contracting the flu and follow recommendations to prevent the further spread of illness.

Currently, the CDC is recommending that anyone with a flu-like illness stay at home for 24 hours after the last sign that fever is subsiding without the use of fever-reducing medicine. However, any ill persons who work in a health care setting are being asked to isolate themselves for up to seven days until feeling better.

“Public Health has been working closely with school systems and many other partners, some of these partners are also reporting incidents of flu-like illness,” said Michael Brackett, M.D., director of District 4 Health Services. “Novel H1N1 is confirmed in some parts of our District, so we are not surprised to see clusters popping up as schools reopen. This was predicted.”

The symptoms of novel H1N1 are similar to regular seasonal flu and include fever, lethargy, lack of appetite and coughing. Some infected people have also reported runny nose, sore throat, nausea, vomiting and diarrhea. Most people who get it recover at home in approximately a week, the same as with seasonal flu.

“There is no vaccine available yet to protect people from catching novel H1N1. Until a vaccine has been developed and proven safe, our best course of action is to take steps to prevent the spread of illness in our schools – not just novel H1N1 but any kind of virus,” said Brackett.
“Some of the medical recommendations will change as we learn more about this virus. These are everyday actions you and your children can take to stay healthy.”

• Do not send your child to school with a fever. Keep childrenwith flu-like illness at home so they don’t infect others.• Sick children should not return to school or participate in any activities putting them in contact with others until their fever has been gone for at least 24 hours without the use of fever-reducing medication.

• Cover your nose and mouth when you cough or sneeze (using your sleeve is good). If you use a tissue to cover coughs or sneezes, throw it in the trash after you use it. Teach your children to do the same.

• Avoid giving children aspirin and products that contain aspirin. Aspirin use with a virus has been associated with a rare medical problem called Reyes Syndrome.

• Wash your hands often with soap and water, especially after you cough or sneeze and before you eat. Alcohol-based hands cleaners are also effective if regular soap and water is not available. Be a good role model for your children.

• Avoid touching your eyes, nose or mouth. Germs spread that way.

• Try to avoid close contact with sick people.

• Have your family – including your children – vaccinated against regular seasonal flu.

People who develop severe illness should contact their local healthcare provider immediately. Most cases of novel H1N1 illness have been consistent with regular flu and should be treated similar to regular flu. People who have underlying at-risk medical conditions who develop flu-like symptoms or who think they were exposed but don’t have any symptoms should seek medical advice.

From what we know now, Public Health is NOT recommending schools close when novel H1N1 infections occur in students and/or faculty. However, we are working closely with Local, State and Federal Health experts and other partners to monitor the situation. Recommendations will change as the disease spreads and as we learn more about it or if the virus changes in severity.
For more information about novel H1N1, contact your local county health department or go online, www.cdc.gov or www.flu.gov.
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Mother's Immune System May Block Fetal Treatments for Blood Diseases

/PRNewswire/ -- Pediatric researchers have resolved an apparent contradiction in the field of prenatal cell transplantation -- a medical approach that holds future promise in correcting sickle cell disease and other serious congenital blood disorders. In a new study in animals, the researchers showed that the mother's immune response interferes with the offspring's earlier ability to tolerate transplanted donor cells.

The study team concludes that focusing on transplant techniques that avoid the maternal immune response may allow scientists to take advantage of fetal tolerance to achieve a long-sought goal of treating blood diseases prenatally.

While cautioning that much work must be done to understand how these animal findings apply to humans, the current findings are "surprising but reassuring," said study leader Alan W. Flake, M.D., of the Children's Center for Clinical Research at The Children's Hospital of Philadelphia.

The study appeared online August 3 in the Journal of Clinical Investigation.

For over 50 years, explained Flake, it has been a fundamental precept of immunology that a fetus tolerates foreign antigens in a window-of-opportunity period before its immune system fully develops the capacity to mount an immune response. Scientists assumed that by carefully introducing donor cells and stimulating a fetus to develop tolerance to those cells, one could set the stage for a later organ or cellular transplant that would not be rejected by a more mature immune system.

As prenatal diagnosis has continued to become available for a greater number of congenital diseases, scientists have considered the possibility of correcting blood disorders such as sickle cell disease or thalassemia. After first transplanting a small number of healthy cells in an early-stage fetus to establish tolerance, a second dose of transplanted cells later in gestation would proliferate, and treat the blood disorder before birth. Researchers use hematopoietic cells -- stem cells that that develop into blood cells -- in this technique, in utero hematopoietic cell transplantation (IUHCT).

However, over the years, Flake's team and other research groups found that IUHCT studies in animal models yielded inconsistent results, ranging from no tolerance to transplants to full tolerance and every degree of tolerance in between. Contrary to the concept of fetal tolerance, an immune barrier seemed to be acting against transplanted cells.

The current study, done in mice, solves the puzzle of an apparent immune barrier. Newborn mice (pups) that received cell transplants in utero were divided into two groups. Mice nursed by their biological mothers lost the transplanted donor cells, while mice nursed by foster mothers retained those donor cells.

The mothers whose fetuses received the donor cells transplants had developed antibodies against those cells, and subsequently transmitted those antibodies to their pups through breast milk. "Those antibodies in the breast milk triggered rejection of the transplanted blood cells in the pups," said Flake. "But in the absence of a maternal immune response, we confirmed that immune tolerance does occur in the early-gestation fetus 100 percent of the time."

Of course, mouse biology is not the same as human biology, and Flake added, "Mouse time is not the same as human time." Because mice have such a brief gestational period, the mother's immune response didn't develop until after the birth of her pups, and was therefore transferred by breastfeeding. In large animals and humans, said Flake, the more likely route of maternal-to-fetal transmission would be through the placenta late in pregnancy, and not through postnatal breastfeeding.

However, it remains an open question whether the mouse findings are applicable to larger mammals and especially to humans. Flake's study team is continuing their investigations in larger animal models.

Looking forward to techniques to avoid maternal immune reactions to prenatal cell transplants, Flake proposed two possibilities. One would be use the mother as a source of donor cells, which would not stimulate an unwanted immune response. Another strategy could involve inducing the generation of increased numbers of T regulatory cells; those cells normally act to prevent the fetus from inappropriately reacting against maternal cells.

The ultimate goal, said Flake, is to develop IUHCT as a prenatal treatment for any congenital blood disorder that may currently be treated with postnatal bone marrow transplants. That would include sickle cell disease, thalassemia, and some inherited immunodeficiency diseases. Currently such postnatal transplants are risky and relatively rare.

"Our current finding is not a clinical breakthrough," added Flake. "But it does offer new potential to the field of cellular transplantation."

Funds from the National Institutes of Health, the Ruth and Tristram C. Colket Jr. Chair of Pediatric Surgery at The Children's Hospital of Philadelphia and the Albert M. Greenfield Foundation supported this study.

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Clayton State Preparing Students and Faculty for Possible Swine Flu Outbreak

Clayton State University’s University Health Services is encouraging the Clayton State faculty and students to be prepared for flu season.

In an all-campus email communication, Dr. Julia Spinolo, director of University Health Services and assistant professor of Nursing, had a very basic message for the faculty…

“If a student has flu like symptoms (a fever of 100.5 or greater, sore throat, runny nose, and cough) please tell them to stay home!”

Spinolo also encourages faculty members to send students who appear to be ill to University Health Services (UHS) and to plan ahead.

“Develop a plan for notification of illness. Inform your students how you wish to be notified if they have the flu. Develop a contingency plan for how you will handle the continuation of instruction should you be ill and are unable to attend or conduct class for up to two weeks,” she said. “Review your attendance policies, penalties, and make up procedures for students work. Please consider that we WANT students to stay home if they are sick, so please be lenient regarding students missing class for illness.

“Consider needed changes in your syllabus and your attendance policies. Schedule make up days for tests and project/paper due dates. Consider alternative on line assignments that do not require class attendance as an option.”

Spinolo also reminds faculty about some of the basic prevention techniques, including using hand sanitizer and proper cough technique (coughing in the inner elbow instead of hands).

A similar message will be going out to the student body early next week, in conjunction with the start of fall semester classes.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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Healing Pain Through the Art of Quilting

Patchwork of Hope Network (TM) Visits Atlanta to Raise Awareness of After-Shingles Pain

A local quilting group has joined a national initiative to help raise awareness of after-shingles pain, or postherpetic neuralgia (PHN), a particularly painful and debilitating disease. The group will be hosting an educational seminar in the area and invite members of the community to share their stories and reveal their quilting skills. Attendees will help by contributing to a patchwork quilt that is a handmade memorial and testimonial to those who suffer, and a reminder that they are a member of a community and do not have to face after-shingles pain alone.

Approximately 1 million Americans will suffer from shingles each year, and one in five of those people may develop PHN. PHN results from nerve damage caused by the shingles virus. For some PHN patients, a gentle breeze or a slight change in temperature can cause excruciating pain.

Together the National Council on Aging (NCOA) and the National Pain Foundation (NPF) are spreading the word about PHN through the Patchwork of Hope Network (P.H.N.) program. This often debilitating condition can affect not only those suffering, but their family and friends as well.

The campaign includes several live events throughout the year where attendees will hear presentations about PHN symptoms and potential treatment options, meet others affected by PHN and have an opportunity to create individual quilt squares to tell their story about how PHN has affected their lives.

Local physician Anthony Grasso, M.D., a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will discuss shingles and after-shingles pain and ways to cope. Additionally, a local PHN patient will share her personal experience with PHN and John Sebby, of the NPF, will discuss resources for dealing with PHN.

WHEN: Wednesday, August 19
10 a.m. to 12 noon

WHERE: Lou Walker Senior Center
2538 Panola Road
Lithonia, GA 30058
(770) 322-2900

About National Pain Foundation

The National Pain Foundation (NPF), a non-profit organization, is the premier provider of information, education and support to people with chronic pain. Materials are provided for both patients and medical professionals interested in the field of chronic pain. The NPF aims to empower people in pain by educating them about their condition, providing information about the options available for managing their pain, teaching them to take a more active role in their treatment plan and helping them to connect with others who also are on this journey. For more information, visit www.nationalpainfoundation.org.

About National Council on Aging

The National Council on Aging (NCOA) is a non-profit service and advocacy organization headquartered in Washington, DC. NCOA is a national voice for older Americans - especially those who are vulnerable and disadvantaged - and the community organizations that serve them. It brings together non-profit organizations, businesses and government to develop creative solutions that improve the lives of all older adults. NCOA works with thousands of organizations across the country to help seniors find jobs and benefits improve their health, live independently and remain active in their communities. For more information, visit www.ncoa.org.
REFERENCES

Harpaz R, Ortega-Sanchez IR and Seward JF. Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report. 2008; 57(05): 1-30. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm. Accessed February 20, 2009.

Shingles Vaccine: What You Need to Know. Department of Health and Human Services: Centers for Disease Control. Available at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-shingles.pdf. Accessed February 15, 2009.

Cure PHN: Your Questions Answered. VZV Research Foundation, Inc. 2004: 1-6. Available at: http://www.vzvfoundation.org/publicdownloads/PHN_Brochure_Feb2004.pdf. Accessed February 9, 2009.

Galer BS. Advances in the Treatment of Postherpetic Neuralgia: The Topical Lidocaine Patch. Today’s Therapeutic Trends. 2000; 1-20.
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FDA Issues Public Health Notification on Glucose Monitoring Technology

The U.S. Food and Drug Administration (FDA) today advised health care practitioners and patients against using certain glucose monitoring technology that employs a specific test strip when the patients are also receiving therapeutic products containing non-glucose sugars.

Non-glucose sugars contained in some therapeutic products such as peritoneal dialysis solutions and certain immunoglobulins can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis.

In a Public Health Notification and an accompanying Advice for Patients, the FDA listed the manufacturers and brands of glucose test strips that contain glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ)—the chemical that reacts with the non-glucose sugars (maltose, galactose and xylose) contained in some therapeutic products that produce a falsely high test result,

Most GDH-PQQ devices are used in health care facilities, which should instead use a laboratory assay to measure a patient's glucose if the patient is also receiving an interfering product. The FDA also makes recommendations to minimize the risk of potential shortages of these products until health care facilities can obtain non-GDH-PQQ strips and meters.

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8/12/09 Statement from the American College of Surgeons Regarding Recent Comments from President Obama

The American College of Surgeons is deeply disturbed over the uninformed public comments President Obama continues to make about the high-quality care provided by surgeons in the United States. When the President makes statements that are incorrect or not based in fact, we think he does a disservice to the American people at a time when they want clear, understandable facts about health care reform. We want to set the record straight.

Yesterday during a town hall meeting, President Obama got his facts completely wrong. He stated that a surgeon gets paid $50,000 for a leg amputation when, in fact, Medicare pays a surgeon between $740 and $1,140 for a leg amputation. This payment also includes the evaluation of the patient on the day of the operation plus patient follow-up care that is provided for 90 days after the operation. Private insurers pay some variation of the Medicare reimbursement for this service.

Three weeks ago, the President suggested that a surgeon’s decision to remove a child’s tonsils is based on the desire to make a lot of money. That remark was ill-informed and dangerous, and we were dismayed by this characterization of the work surgeons do. Surgeons make decisions about recommending operations based on what’s right for the patient.

We agree with the President that the best thing for patients with diabetes is to manage the disease proactively to avoid the bad consequences that can occur, including blindness, stroke, and amputation. But as is the case for a person who has been treated for cancer and still needs to have a tumor removed, or a person who is in a terrible car crash and needs access to a trauma surgeon, there are times when even a perfectly managed diabetic patient needs a surgeon. The President’s remarks are truly alarming and run the risk of damaging the all-important trust between surgeons and their patients.

We assume that the President made these mistakes unintentionally, but we would urge him to have his facts correct before making another inflammatory and incorrect statement about surgeons and surgical care.

About the American College of Surgeons

The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and to improve the care of the surgical patient. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 74,000 members and is the largest organization of surgeons in the world.

Web site: www.facs.org
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FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder

The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”

The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.

Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

Saphris is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients.

The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia) and drowsiness (somnolence).

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.

Saphris is manufactured by Schering-Plough, Kenilworth, N.J.

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