FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder

The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals.

The approval is for ATryn, an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency. These patients are at high risk of blood clots during medical interventions, such as surgery, and before, during and after childbirth.

ATryn is a therapeutic protein derived from the milk of goats that have been genetically engineered by introducing a segment of DNA into their genes (called a recombinant DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that naturally occurs in healthy individual and helps to keep blood from clotting in the veins and arteries.

GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.

"This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high risk situations," said Jesse Goodman, M.D., M.P.H., CBER director.

Because hereditary AT deficiency occurs in a small population (approximately 1 in 5,000 people in the United States), the FDA granted ATryn an orphan drug designation. The orphan drug designation system encourages the development of medications for patients with a rare disease or condition.

The agency held an advisory committee meeting in January to seek the opinion of outside experts, who agreed that ATryn is safe and effective. CVM also briefed the committee about the animal drug components of the application.

Hereditary AT deficiency generally is first recognized and diagnosed in teenagers or young adults when they develop clots in their blood vessels, particularly during pregnancy, surgery, or prolonged bed rest.

CBER evaluated two studies that included 31 patients with hereditary AT deficiency who received ATryn to prevent thromboemboli (TE) before, during or after surgery or childbirth. All but one patient had a prior history of at least one TE, which are likely to recur in high-risk situations if left untreated. Only one of the 31 patients treated with ATryn developed a TE. The most common adverse reactions reported were hemorrhage and reactions at the infusion site. These reactions occurred in approximately five percent of patients.

As part of its review of the GE goat, CVM assessed the safety of the rDNA construct to the animals, including a full review of the construct and its stability in the genome of the goats over seven generations. No adverse outcomes were noted. CVM reviewed and concurred with the sponsor's plan to continue to monitor the construct and its expression for the lifetime of the approved product.

During its review, CVM determined that introduction of the rDNA construct did not cause any adverse outcomes to the health of the goats over seven generations. CVM also determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply. As part of the approval, CVM specified that these goats cannot be used for food or feed and validated a method suitable for identifying the rDNA construct in both animals and their products.

As required by the National Environmental Policy Act and its implementing regulations, CVM also determined that the GE goats do not cause any significant impact on the environment.

“We have looked carefully at seven generations of these GE goats; all of them are healthy and we haven't seen any adverse effects from the rDNA construct or its expression. I am pleased that this approval makes possible another source of an important human medication,” said Bernadette Dunham, D.V.M., Ph.D., CVM director.

A summary of the information on which the FDA made its approval decision for the rDNA construct in the goats, and CVM's guidance on the regulation of GE animals containing heritable rDNA constructs are available at http://www.fda.gov/cvm/GEAnimals.htm .

ATryn previously received approval from the European Medicines Agency for use in preventing clotting conditions during surgical procedures in patients with hereditary AT deficiency.

ATryn is manufactured by GTC Biotherapeutics, Inc., Framingham, Mass.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Approves First Ablation Catheters for the Treatment of Atrial Fibrillation

The U.S. Food and Drug Administration today approved the first ablation catheters for the treatment of atrial fibrillation (uncoordinated contractions of the upper heart chambers), one of the most common types of arrhythmias—or abnormal heart rhythms--affecting more than two million Americans.

The devices approved today, the NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav, can be used to create small, strategically placed scars in heart tissue to block irregular electrical waves that cause atrial fibrillation. The FDA previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia, but not atrial fibrillation.

Atrial fibrillation is usually treated with drugs, and in certain severe cases, with open heart surgery. Catheter ablation should be used only after drug treatment has failed to adequately control the symptoms of the condition.

“This approval provides physicians with another option for treating this common and potentially debilitating condition,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

While atrial fibrillation is a major risk factor related to stroke, there is no conclusive evidence that links the treatment of symptoms by ablation to a reduction in stroke. Therefore, the FDA agrees with the American College of Cardiology, the American Heart Association and the European Society of Cardiology, which recommend that patients at risk for stroke continue to take blood-thinning medications after ablation procedures for atrial fibrillation.

The FDA based this approval on a clinical study of 167 patients at 19 medical centers in the United States, Brazil, Canada, the Czech Republic, and Italy. Data from the study showed the devices to be effective in eliminating symptomatic recurrence of atrial fibrillation episodes for one year in approximately 63 percent of treated patients versus 17 percent of the patients in the control group.

The catheters were the focus of an FDA Circulatory System Devices advisory panel on Nov. 20, 2008, when they received the panel’s unanimous recommendation for approval.

As a condition of approval, manufacturer BioSense Webster must establish a physician training program and conduct postmarket studies to collect data on these devices’ long-term safety and effectiveness (including incidence of stroke, mortality, cardiac arrest, major bleeding, and pulmonary vein stenosis), and the effect of physicians’ experience in operating the device on procedural safety.

Both catheters are manufactured by BioSense Webster of Diamond Bar, Calif.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

A Better Mesh: Researchers 'Tighten' Body's Protective Coating

A net with large holes won't catch small fish. Likewise, the microscopic fibers in the protective mucus coatings of the eyes, lungs, stomach or reproductive system naturally bundle together and allow the tiniest disease-causing bugs, allergens or pollutants to slip by. But Johns Hopkins researchers have discovered a way to chemically shrink the holes in the mucus layer's netting so that it will keep out more of the unwanted particles.

"The mucus layer is an outstanding barrier to most things, but not a perfect one for objects smaller than several hundred nanometers [about 1,000 times smaller than the width a human hair]. We still get sick far too often," says Samuel Lai, a chemical and biomolecular researcher in the Whiting School of Engineering and a member of the university's Institute for NanoBioTechnology (INBT).

"The question we asked was, Can we shrink the size of the holes in the human mucus barrier to help prevent its penetration by potentially harmful nano-size objects?" says Justin Hanes, principal investigator of the study and a professor of chemical and biomolecular engineering. Hanes also is director of therapeutics for the INBT.

The team showed that tiny strands in the mucus layer — the mucin fibers — naturally tend to bundle and bunch together, creating gaps large enough for pathogens and potentially dangerous pollutants to get in. But by adding a simple detergent to the mix, Lai and his colleagues partially disrupted the bundling of mucin fibers, a procedure that decreased the size of the holes in the mesh. Particles in the range of 200 nanometers in diameter that previously slipped through easily now became trapped in the more finely strung netting.

The findings were reported in the January 28 online edition of the journal Public Library of Science One. For this research, the team studied protective coatings taken from the female reproductive tract, conducting high- resolution microscopy experiments with particles as large as 1 micron and as small as 100 nanometers in size.

To shrink the holes in the network's mesh, the researchers used a detergent commonly found in many personal care products. Mucus treated with the detergent slowed nanoparticle movement dramatically, especially in the 200- 500 nanometer range, which was clearly demonstrated in videos enhanced by fluorescent imaging.

"We suspected the fibers are bundled together, making large holes in the mucus mesh, but this was the first time it was shown definitively," says Ying-Ying Wang, a doctoral student and National Science Foundation graduate fellowship recipient in biomedical engineering. "And we didn't know going into this study exactly how much we could shrink the holes, if at all. It was exciting to see particles the size of many potentially dangerous substances become completely trapped in mucus, since mucus-trapping typically leads to harmless removal from our bodies," Wang adds.

The team, which also includes Richard Cone, a biophysics professor and INBT-affiliated faculty member from the Krieger School of Arts and Sciences, and Denis Wirtz, professor of chemical and biomolecular engineering and INBT's associate director, envisions many potential applications for this concept.

"If there is an outbreak of influenza, for example, we imagine that doctors and nurses could inhale these agents in an aerosolized form and be protected against the virus for several hours," Lai says. "People who work where there are high levels of nanoparticles in the air, such as mine workers or builders, could use a product with these fiber debundling detergents to prevent dangerous exposure."

Since the mucus layer constantly clears from the body, any enhancement to its protective ability would be short-lived, adds Lai. For example, coatings clear from the lungs in as little as 30 minutes, while the mucus lining in the stomach and intestine takes several hours to renew. This study is only a start, Lai explains, and the technique has not yet been tested in humans. "The next step will be to try different substances, perhaps those paired to specific pathogens, and observe how these substances improve the performance of the mucus barrier," he says. In addition, microbe-killing agents could be combined with detergents to not only slow but destroy the trapped potential pathogens, he says. Animal studies are being planned.

This work was funded by the National Institutes of Health and a graduate research fellowship from the National Science Foundation.

The study — Samuel K. Lai, Ying-Ying Wang, Richard Cone, Denis Wirtz and Justin Hanes; Altering Mucus Rheology to "Solidify" Human Mucus at the Nanoscale — can be viewed online at: www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone. 0004294.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

ETHEX Corporation Issues Voluntary Nationwide Recall

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now being expanded to the retail level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP). This additional level of recall is to further remove recalled products from the marketplace.

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Expanded Recall to Retail Level Includes the Following Products:

* Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)
* Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)
* Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)
* Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)
* Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)

Any retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch .

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

ETHEX Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP).

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to the Wholesale/Distributor Level:

Prescription Prenatal Vitamin Products:

Advanced NatalCare® Tablets
Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss Tablets
NatalCare PIC Tablets
NatalCare PIC Forte Tablets
NatalCare Plus Tablets
NatalCare Rx Tablets
NatalCare Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE Tablets
Prenatal MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets


Prescription Iron Supplement Products:

Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules

Any wholesaler inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Ther-Rx Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level

Ther-Rx Corporation, a subsidiary of KV Pharmaceutical Company is issuing a voluntary nationwide recall of prescription prenatal and iron supplement nutritionals as identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP).

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to the Wholesale Level:

Prescription Iron Supplement Products:

Chromagen® Caplet
Chromagen® FA Caplet
Chromagen® Forte Caplet
Encora® Capsule
Niferex® Gold Tablet
Niferex® 150 Forte Capsule
Repliva 21/7® Tablet

Prescription Prenatal Vitamin Products:

PreCare® Chewable Tablet
PreCare® Conceive Tablet
PreCare Premier® Tablet
PremesisRx® Tablet
PrimaCare® Capsule/Tablet
PrimaCare® Advantage™ Capsule/Tablet
PrimaCare® ONE Capsule

Any retail customer inquiries related to this action should be addressed to Ther-Rx Customer Service at 877-567-7676, or faxed to Ther-Rx Customer Service at (314) 646-3701, or e-mailed to info@ther-rx.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

Ther-Rx Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Issues Early Communication about a Safety Review of Xigris

The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection).

A recent study and an accompanying editorial published in the journal Critical Care Medicine reported an increased risk of serious bleeding events and death in patients with sepsis and baseline bleeding risk factors who received Xigris. The study, a retrospective review of medical records of 73 patients who were treated with Xigris, found that serious bleeding events occurred in seven of 20 patients (35 percent) who had a bleeding risk factor versus two of 53 (3.8 percent) of patients without any bleeding risk factors. More patients with baseline bleeding risk factors died (13 of 20, or 65 percent) compared with patients without any bleeding risk factors (13 of 53, or 24.5 percent). As noted by the authors, limitations of this study include the retrospective design (looking back at events that already have taken place) and small patient population.

Xigris is known to increase the risk of bleeding. The drug’s current prescribing information (labeling) includes a warning that describes bleeding as the most common serious adverse effect and lists a number of risk factors that should be carefully considered when deciding whether to use Xigris. The labeling contraindicates the use of Xigris in several clinical situations where bleeding could lead to significant adverse reactions or death.

The FDA is not recommending that prescribers stop administering this medication. Consumers and health care professionals should notify the FDA of any complaints or problems associated with this product. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Rheumatoid Arthritis Rising Among Women

After four decades on the decline, rheumatoid arthritis is on the upswing among women in the United States. That's the finding presented by Mayo Clinic investigators at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Francisco.

"This is a significant finding and an indicator that more research needs to be done to better understand the causes and treatment of this devastating disease," says Sherine Gabriel, M.D., Mayo Clinic rheumatologist and lead investigator on the study.

From 1955 to 1994, the incidence of rheumatoid arthritis had continually been on the decline. That apparently changed beginning in the mid-1990s. When Mayo researchers analyzed patient data from early 1995 to the start of 2005, they found that both the incidence and prevalence (percentage) of the condition were rising.

Compared to the previous decade when approximately 36 women out of every 100,000 developed rheumatoid arthritis each year, the new study showed a jump to 54 women in the more recent decade. The incidence for men remained at about 29 per 100,000. Overall, the percentage of the entire population with the condition rose from 0.85 percent to 0.95 percent.

Researchers say it's not clear why this is happening, but an environmental factor may have a role in the shifting incidence and prevalence among women.

The study included 350 adult patients from Olmsted County, MN, whose average age was 56.5 years. The majority, 69 percent, were women.

The research was supported by Mayo Clinic and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Others on the research team were Cynthia Crowson; Hilal Maradit-Kremers, M.D.; and Terry Therneau, Ph.D.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---

Mayo Clinic Study Finds Younger Men With Erectile Dysfunction at Double Risk of Heart Disease

/PRNewswire-USNewswire/ -- Men who experience erectile dysfunction between the ages of 40 and 49 are twice as likely to develop heart disease than men without dysfunction, according to a new Mayo Clinic study.

Researchers also found that men with erectile dysfunction have an 80 percent higher risk of heart disease.

"The highest risk for coronary heart disease was in younger men," says researcher Jennifer St. Sauver, Ph.D. The study was published in the February 2009 issue of Mayo Clinic Proceedings. The results suggest that younger men and their doctors may need to consider erectile dysfunction a harbinger of future risk of coronary heart disease -- and take appropriate steps to prevent it, says Dr. St. Sauver.

"The importance of the study cannot be overstated," writes Martin Miner, M.D., in an editorial in the same issue of Mayo Clinic Proceedings. The results "raise the possibility of a 'window of curability,' in which progression of cardiac disease might be slowed or halted by medical intervention," writes Dr. Miner, who practices at the Men's Health Center, Miriam Hospital, Providence, R.I.

Erectile dysfunction is common, and prevalence increases with age. It affects 5 to 10 percent of men at age 40. By age 70, from 40 to 60 percent of men have the condition.

Dr. St. Sauver says researchers wanted to learn more about the connections between age, cardiovascular disease and erectile dysfunction. Two previous studies, both published in 2005, laid groundwork for the Mayo Clinic study. One found that erectile dysfunction predicted an increased risk of heart disease, but the erectile dysfunction of the study participants was not assessed with an externally validated questionnaire and cardiac events were not subjected to standardized review for diagnostic accuracy [Thompson et al, JAMA, 2005]. The second predicted that future cardiovascular disease would be higher in younger men with erectile dysfunction, but wasn't able to follow the men to determine if heart disease developed [Ponholzer et al, Eur Urol, 2005].

For the Mayo Clinic study, the investigators identified 1,402 men who lived in Olmsted County, Minn., in 1996 and did not have heart disease. Every two years for 10 years, these men were assessed for urological and sexual health.

Answers to questions from the Brief Male Sexual Function Inventory, a statistically validated questionnaire, were used to determine erectile dysfunction. The baseline prevalence of erectile dysfunction in study participants was: 2.4 percent in men aged 40-49; 5.6 percent in men aged 50-59; 17 percent in men aged 60-69 and 38.8 percent in men 70 years and older. Those initial data and the increasing incidence of erectile dysfunction over time were linked to data from a long-term study of heart disease in Olmsted County residents, led by Veronique Roger, M.D., Mayo Clinic cardiologist.

Over 10 years of follow-up, researchers found that men with erectile dysfunction were 80 percent more likely to develop coronary heart disease compared to men without erectile dysfunction. The highest risk of new heart disease was seen in the youngest study participants who had erectile dysfunction. In men 40 to 49 years old when the study began, the number of new cases in men with erectile dysfunction was more than 50-fold higher than in men without erectile dysfunction. Statistically, that's a cumulative incidence of 48.52 per 1,000 person years in those with erectile dysfunction compared to 0.94 per 1,000 person years in those without erectile dysfunction.

In men in their 50s, 60s and 70s, the total incidence of new cases of heart disease also was higher in those with erectile dysfunction. However, the differences were not as striking as those seen among the 40- to 49-year- olds.

"In older men, erectile dysfunction may be of less prognostic importance for development of future heart disease," says Dr. St. Sauver.

This study did not determine reasons for the increased risk of heart disease among men with erectile dysfunction. Some have theorized that erectile dysfunction and coronary artery disease may be different manifestations of the same underlying disease process. A buildup of plaque that can block arteries around the heart may plug the smaller penile arteries first, causing erectile dysfunction. Alternatively, arteries may lose elasticity over time, contributing to heart disease. This arterial stiffening may affect the smaller penile arteries first.

Other Mayo Clinic researchers were: Brant Inman, M.D.; Debra Jacobson; Michaela Mc Gree; Ajay Nehra, M.D.; Michael Lieber, M.D.; Dr. Roger; and Steven Jacobsen, M.D., Ph.D.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Oxendine Warns of Consequences of Proposed Health Insurance Tax

Insurance and Safety Fire Commissioner John W. Oxendine testified to legislators during his agency’s appropriations hearings that increasing the tax on health insurers and hospitals would lead to higher health insurance rates, more uninsured and could add to the financial hardships facing small hospitals already strapped for cash.

“I felt an obligation to inform the members of the House and Senate subcommittees that the proposal is more than just a 1.6 percent tax on health insurers and hospitals,” Oxendine said. “If passed, this measure will increase the cost of health insurance, and could force more Georgians into the ranks of the uninsured. In addition, the financial problems that hospitals are already facing will only be compounded.”

Oxendine’s remarks were in response to the Department of Community Health’s proposal to raise $317 million in revenue for fiscal year 2010 by imposing a new tax on health insurers and hospitals.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---

Hopkins Transplant Surgeons Remove Healthy Kidney Through Donor's Vagina

In what is believed to be a first-ever procedure, surgeons at Johns Hopkins have successfully removed a healthy donor kidney through a small incision in the back of the donor’s vagina.

“The kidney was successfully removed and transplanted into the donor’s niece, and both patients are doing fine,” says Robert Montgomery, M.D., Ph.D., chief of the transplant division at Johns Hopkins University School of Medicine who led the team that performed the historic operation.

The transvaginal donor kidney extraction, performed Jan. 29 on a 48-year-old woman from Lexington Park, Md., eliminated the need for a 5-to-6-inch abdominal incision and left only three pea-size scars on her abdomen, one of which is hidden in her navel.

Transvaginal kidney removals have been done previously to remove cancerous or nonfunctioning kidneys that endanger a patient’s health, but not for healthy kidney donation. Because transplant donor nephrectomies are the most common kidney removal surgery — 6,000 a year just in the United States — this approach could have a tremendous impact on people’s willingness to donate by offering more surgical options,” says Montgomery.

“Since the first laparoscopic donor nephrectomy was performed at Johns Hopkins in 1995, surgeons have been troubled by the need to make a relatively large incision in the patient’s abdomen after completing the nephrectomy to extract the donor kidney. “That incision is thought to significantly add to the patient’s pain, hospitalization and convalescence,” says Montgomery. “Removing the kidney through a natural opening should hasten the patient’s recovery and provide a better cosmetic result.”

Both laparoscopies and transvaginal operations are enabled by wandlike cameras and tools inserted through small incisions. In the transvaginal nephrectomy, two wandlike tools pass through small incisions in the abdomen and a third flexible tool housing a camera is placed in the navel.

Video images displayed on monitors guide surgeons’ movements. Once the kidney is cut from its attachments to the abdominal wall and arteries and veins are stapled shut, surgeons place the kidney in a plastic bag inserted through an incision in the vaginal wall and pull it out through the vaginal opening with a string attached to the bag.

Montgomery says the surgery took about three and a half hours, roughly the same as a traditional laparoscopic procedure.

The Jan. 29 operation is one of a family of new surgical procedures called natural orifice translumenal endoscopic surgeries (NOTES) that use a natural body opening to remove organs and tissue, according to Anthony Kalloo, M.D., the director of the Division of Gastroenterology at Johns Hopkins University School of Medicine and the pioneer of NOTES. The most common openings used are the mouth, anus and vagina.

Since 2004, successful NOTES in humans have removed diseased gallbladders and appendixes through the mouth, and gallbladders, kidneys and appendixes through the vagina.

Recently, Kalloo says, some medical experts have called for more studies to compare the safety and effectiveness of NOTES against traditional laparoscopies, which also leave very small scars, have been in use for many years, and are proven to be safer and less painful for patients than older “open” abdominal procedures. He supports more studies.

But, he adds, “natural orifice translumenal endoscopic surgery is the final frontier to explore in making surgery scarless, less painful and for obese patients, much safer.” An organ donor, in particular, is most deserving of a scar-free, minimally invasive and pain-free procedure.”

Additional surgeons from Johns Hopkins University School of Medicine who participated in the procedure were Mohamad E. Allaf, M.D., assistant professor in the departments of Urology and Biomedical Engineering and director of minimally invasive and robotic surgery; Andy Singer, M.D., Ph.D., assistant professor in the Division of Transplant Surgery; and Wen Shen, M.D., M.P.H., assistant professor in the Department of Gynecology and Obstetrics.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Clayton State Honors Student Association Holding Blood Drive February 4

Clayton State University’s Honor Student Association will host a blood drive on Tuesday, Feb. 4, beginning at 9 a.m. and ending at 4 p.m. in the Ballroom of the Student Activities Center on the Clayton State University Campus.

“The Honor Student Association hosts two blood drives every fall and spring semester and at least one during the summer semester,” says the Honors Student Association’s Jodi-Ann Paragon-Singh says. “We have been doing this for at least 4 years now. The blood drives were actually started when a previous honors student, who volunteered at the Red Cross, was approached and asked to help set-up drives on campus.

“It is so important to donate to these drives. Currently there is no synthetic substitute for blood. So when there is an emergency and people require blood transfusions, the only source is from blood donors. There are nearly five million people who receive transfusions every day so giving blood means saving lives!”

Criteria needed in order to give blood include, being at least 17 years old and at least an eight week interval since your last blood donation. All of the eligibility requirements can be found on the Red Cross website, www.givelife.org. Any questions concerning eligibility can be addressed on the day of the drive.

“Every minute of every day, someone needs blood. That blood can only come from a volunteer donor, a person like you who makes the choice to donate. There is no substitute for your donation,” says Paragon-Singh. “Make a date to donate!”

For more information on the blood drive contact Paragon–Singh at jparagonsingh@student.clayton.edu.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---

Upcoming Screening for GPTV Documentary Features Clayton State Professor Catherine Deering

Clayton State University Professor of Psychology Dr. Catherine Deering appears in an upcoming documentary titled, “Post Traumatic Stress Disorder, The Invisible Wounds of War,” for Georgia Public Television (GPTV). A viewing of the documentary will be held at the Push Push Theater, Decatur, Ga., on Tuesday, Feb. 3 from 7:30 p.m. until 9:30 p.m. The screening is open to the public.

“I am very much looking forward to the screening. Having it in a public arena will allow for a dialogue about the issues. I hope that people will have a chance to express their views about the current war and to ask questions about post-traumatic stress disorder,” says Deering.

Deering has worked with combat veterans who have posttraumatic stress disorder (PTSD) for more than 18 years. She is also currently serving as a consulting psychologist at the Atlanta VA Medical Center and has worked there since finishing her pre-doctoral internship there in 1991.

Throughout her interview, Deering discussed the signs and symptoms of PTSD, the research regarding the most effective treatments, the impact of PTSD on the family of the veteran, and her opinions about what the public most needed to know about PTSD in combat veterans. She also discussed group psychotherapy, her specialty area.

“I am eager to see how the documentary producers balance the different perspectives of the combat veterans from different wars, the activists, and the clinicians. I hope that the documentary will educate the public and provide some hope for recovering from Post-traumatic Stress Disorder,” expresses Deering.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---

A Valentine’s Gift for the Heart from Your Heart

For those who are looking for a meaningful gift for Valentine’s Day, the Piedmont Heart Institute offers a gift for the heart that you can purchase online. The CT coronary calcium scan is a quick and painless method for the detection and risk assessment of coronary artery disease. For $125, your loved one will receive a CT scan of his/her heart with the Aquilion® ONE Dynamic Volume CT Scanner at Piedmont Hospital, the first CT scanner of its kind in Georgia. A report of the findings will be mailed to the patient or his/her personal physician.

According to statistics from the National Heart, Lung and Blood Institute, 50 percent of men and 64 percent of women who died suddenly from coronary heart disease had no previous symptoms of the disease. While many people think they would know if they were at risk, it’s best to be checked so you enjoy time together with loved ones for years to come.

“The CT coronary calcium scan is a non-invasive way of obtaining information about the presence, location and extent of calcified plaque in the coronary arteries, which is a sign of coronary artery disease,” according to Szilard Voros, M.D., chief of prevention, wellness and women’s heart disease at the Piedmont Heart Institute. “Because calcium is a marker of disease, the findings are given a calcium score, and the amount of calcium detected is a very helpful predictive tool.”

Piedmont’s Aquilion® ONE from Toshiba America Medical Systems, Inc., can reduce diagnosis time from hours and days to a matter of minutes. Toshiba’s Aquilion ONE dynamic volume CT system builds one 3D image of an entire organ in a single rotation by using 320, half-millimeter, detector rows so physicians can see everything inside the organ. Physicians provide one comprehensive exam that reduces cost and radiation exposure by eliminating multiple tests; and access to complete, accurate information to diagnose and treat patients faster.

Piedmont Heart Health Advantage, a predictive and preventive service of the Piedmont Heart Institute, also offers cardiovascular consultations and advanced lipid testing that includes genetic markers.

To purchase a gift for the heart from the heart, visit piedmontheart.org. For more information, call Piedmont Heart Health Advantage at 404-605-5222.

A free, online, risk evaluation also is available at piedmontheart.org. Click on HEARTawareTM to take a seven-minute risk evaluation that may save your life. Once the assessment is completed, each participant is provided with a customized confidential report that explains his/her specific risk factors for heart disease, as well as recommendations for lifestyle modifications to reduce those risks.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---

Study Finds Broad Access to Parenting Support Lowers Risk of Child Maltreatment

When parents have access to proven parenting information and support designed to address problems all families face—from tantrums to encouraging good behavior—key measures of child maltreatment fall, according to a study released in the Jan. 26 online edition of the journal Prevention Science.

The study, which was funded by the Centers for Disease Control and Prevention (CDC), found lower rates of confirmed abuse cases, child out–of–home placements, and hospitalizations and emergency room visits for child injuries in counties where parenting support was implemented.

“Previous studies have shown reductions in children′s social, emotional and behavioral problems,” said Ron Prinz, Ph.D., at the University of South Carolina, the study′s lead investigator. “This is the first large–scale study to show that by providing all families, not just families in crisis, with access to parenting information and support, we can reduce the rates of child maltreatment in whole communities.”

Using a multi–level system of parenting support called the Triple P—Positive Parenting Program, nine study counties in South Carolina implemented a wide range of support mechanisms for parents including local media, brief public seminars, and parent consultation by specially trained providers in clinics, schools, churches, and community centers.

Researchers estimate the results of this study could translate annually into 688 fewer cases of child maltreatment, 240 fewer out–of–home placements, and 60 fewer children with injuries requiring hospitalization or emergency room treatment for every 100,000 children under age 8.

“Engaging parents is an important step in our ongoing efforts to prevent child maltreatment and promote safe, stable, nurturing, relationships for children in all communities,” said Rodney Hammond, Ph.D., director of the CDC′s Division of Violence Prevention. Child maltreatment harms people and society, contributing to costly long–term health problems ranging from heart disease and obesity to depression and anxiety, making this type of prevention study critical.”

For more information on the Triple P – Positive Parenting Program, visit www.triplep.net. For information on CDC′s prevention research in child maltreatment, visit www.cdc.gov/injury. For a copy of the study, visit

http://www.springerlink.com/content/a737l8k76218j7k2/?p=587ecf68cf6745058cb3e636889cdf70π=0.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page