Mayo’s “Smart” Adult Stem Cells Repair Hearts

(BUSINESS WIRE)--Mayo Clinic investigators, with Belgian collaborators, have demonstrated that rationally “guided” human adult stem cells can effectively heal, repair and regenerate damaged heart tissue. The findings — called “landmark work” in an accompanying editorial — appear in today’s Journal of the American College of Cardiology.

Stem cells isolated from patients have normally a limited capacity to repair the heart. This innovative technology boosts the regenerative benefit by programming adult stem cells to acquire a cardiac-like profile. Primed by a cocktail of recombinant cardiogenic growth factors, mesenchymal stem cells (MSCs) harvested from the bone marrow of a cohort of patients with coronary artery disease showed “superior functional and structural benefit without adverse side effects” over a 1-year follow-up in a model of heart failure according to the study.

Significance of the Findings

“These findings provide proof-of-principle that “smart” adult stem cells have added benefit in repairing the heart, providing the foundation for further clinical evaluation,” says Andre Terzic, M.D., Ph.D., Mayo Clinic researcher and senior investigator of the study. “The successful use of guided “lineage specified” human stem cells is based on natural cardiogenic cues” adds Atta Behfar, M.D., Ph.D. first author of the study. The pre-clinical data reported in this seminal paper have cleared the way for safety and feasibility trials in humans, which were recently conducted in Europe.

In their editorial, Eduardo Marban, M.D., Ph.D., and Konstantinos Malliaras, M.D., of Cedars-Sinai Heart Institute, in Los Angeles describe the Mayo approach as a “boot camp” for stem cells and also write that the study “… provides the first convincing evidence that MSCs, at least in vitro, can in fact become functional cardiomyocytes (heart cells)...”

The long-term potential of the findings include development of an effective regenerative medicine therapy for patients with chronic heart failure.

How It Was Done

Researchers obtained bone marrow-derived stem cells from heart disease patients undergoing coronary bypass surgery. Testing of these stem cells revealed that cells from two of 11 individuals showed an unusual capacity for heart repair. These rare cells demonstrated upregulated genetic transcription factors that helped identify a molecular signature identifying highly regenerative stem cells. The cardiogenic cocktail was then used to induce this signature in non-reparative patient stem cells to program their capacity to repair the heart. Mouse models with heart failure, injected with these cells, demonstrated significant heart function recovery along with improved survival rate after a year, compared to those treated with unguided stem cells or saline.

Specifically, researchers found that the heart tissue healed more effectively; that human cardiac and vascular cells were found participating in the regeneration, repair and strengthening of heart structures within the area of injury; and that scars and vestiges of heart damage appeared to fade away.

Authors include Atta Behfar, M.D., Ph.D.; Satsuki Yamada, M.D., Ph.D.; Ruben Crespo-Diaz; Jonathan Nesbitt; Lois Rowe; Carmen Perez-Terzic, M.D., Ph.D.; Andre Terzic, M.D., Ph.D. of Mayo Clinic; Vinciane Gaussin, Ph.D. and Christian Homsy, M.D., Cardio3 Biosciences, Mont-Saint-Guibert, Belgium; and Jozef Bartunek, M.D., Cardiovascular Center, Aalst, Belgium.

The research was supported by the National Institutes of Health, the American Heart Association, the Marriott Heart Disease Research Program, Cardio 3 Biosciences, the Ted Nash Long Life Foundation, the Ralph Wilson Medical Research Foundation, the Mayo Clinic General Mills Clinician-Investigator Fellowship, and Mayo Clinic.

Mayo Clinic and Drs. Andre Terzic and Atta Behfar have a financial interest associated with technology related to this research program. In accordance with the Bayh-Dole Act, Mayo Clinic has licensed that technology to Cardio 3 Biosciences in exchange for equity. No royalties have accrued to date to the institution or the inventors.

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Reminding Healthcare Staff to Remove Catheters Reduces Infections by Half

/PRNewswire/ -- Urinary catheters are often left in place longer than needed, and new research shows that reminder systems that encourage hospital staff to remove catheters promptly can reduce the rate of catheter-associated urinary tract infections by 52 percent.

The review and meta-analysis was published July 30 in the journal, Clinical Infectious Diseases. The catheter-associated urinary tract infection (CAUTI) is the most common hospital acquired infection and was the first complication chosen for non-payment by Medicare, beginning in late 2008. Other insurers have now followed suit.

Lead author Jennifer Meddings, M.D., and her University of Michigan colleagues studied the effectiveness of reminder systems to decrease catheter use and reduce CAUTIs. They found that reminder systems that prompt hospital staff to assess and remove catheters on a routine basis reduced the rate of catheter-associated urinary tract infections by 52%.

"We are also excited about the potential for reminder systems to have a cascade of benefits to patients beyond prevention of CAUTI, because reducing catheter use can improve patient comfort, reduce bloodstream infections, reduce need for antibiotics, improve patient mobility and decrease length-of-stay," says Meddings, a clinical lecturer in U-M's Department of Internal Medicine.

Urinary catheters are commonly placed to drain bladders in hospitalized patients. Unfortunately, catheters are often left in place longer than needed because doctors forget the catheter is still being used or do not routinely assess if it is still needed. Having a catheter increases the patient's risk for catheter-associated urinary tract infections, bloodstream infections, and other risks associated with decreased patient mobility when catheters are in place, such as life-threatening blood clots. But prior research by VA/U-M's Patient Safety Enhancement Program indicated that only 1 in 10 hospitals use reminders to prompt removal of urinary catheters.

In most hospitals, four steps are needed to remove a urinary catheter: 1. the physician recognizes it is there; 2. the physician recognizes it is unnecessary; 3. the physician writes an order for removal; and 4. A nurse removes the catheter according to the order. Catheter reminder systems function by bypassing several of these steps.

The reminders can take many forms, such as stickers placed on charts or on catheter bags that remind nurses or physicians to remove the catheter. Some hospitals, like U-M, have used computer-generated reminders that appear when someone logs into a patient's chart online. Stop orders also can be directed at physicians, in which a catheter is discontinued unless a physician directly renews it.

Meddings and her colleagues note that hospitals should consider "nurse-empowered" catheter stop orders, which empower nurses to remove urinary catheters based upon criteria, without requiring the nurse to request an order from physicians. The researchers also found no evidence that reminder systems would lead to catheters being removed too early, as catheters did not need to be replaced at higher rates.

"Because catheter reminders and stop orders are beneficial regardless of the technology used -- from verbal bedside reminders to computer-generated stop orders -- these interventions appear to be low-cost strategies that could be implemented in any health care system," according to Meddings and her co-authors: Mary A.M. Rogers, Ph.D., research assistant professor in U-M's Department of Internal Medicine; Michelle Macy, M.D., MSc of U-M's Departments of Emergency Medicine and Pediatrics; and Sanjay Saint, M.D., MPH, Associate Chief of Medicine at Ann Arbor VA Medical Center and Professor of Medicine, Department of Internal Medicine, Division of General Medicine.

In related work, Meddings, Saint and Larry McMahon, M.D., chief of U-M's Division of General Medicine, also recently studied the implementation of new Medicare policies to encourage hospitals to prevent CAUTI by no longer paying hospitals to treat hospital-acquired conditions such as CAUTI. In a study published in the June issue of Infection Control and Hospital Epidemiology, the U-M researchers studied the potential of the new policy to encourage CAUTI prevention by financially penalizing hospitals when patients develop these complications.

This work revealed that the Medicare policy's requirements for documentation of hospital-acquired CAUTI is a complicated 3-step process for a hospital to correctly document a hospital-acquired CAUTI in order to not get paid extra. If any of the details are incorrectly documented, the hospital will mistakenly be paid extra. The researchers found that although hospital-acquired CAUTI was a common condition, most cases were not correctly identified in payment requests to insurers because a specific code to identify a UTI as "catheter-associated" was very rarely used. Rare use of this catheter code was found similarly at the hospital, state and national level.

"The bottom line is we are hopeful that policies such as non-payment for hospital-acquired complications such as CAUTI may motivate hospitals to invest in preventive strategies such as catheter reminder systems," says Meddings. "Yet, the anticipated financial impact of non-payment for hospital-acquired CAUTI may not be large due to complex implementation details that may require more evaluation and changes in documentation of patient care before these types of policies have the expected financial impact."

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FDA Proposes Withdrawal of Low Blood Pressure Drug

/PRNewswire/ -- The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug's clinical benefit, for example, by showing that use of the drug improved a patient's ability to perform life activities.

Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

"We've worked continuously with the drug companies to obtain additional data showing the drug's clinical benefits to patients," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. "Since the companies have not been able to provide evidence to confirm the drug's benefit, the FDA is pursuing a withdrawal of the product."

The FDA today issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine. This is the first time the agency has issued such a notice for a drug approved under the FDA's accelerated approval regulations. Shire, the maker of the brand name drug, must respond to the FDA in writing within 15 days to request a hearing. If the company fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the FDA continues to believe that withdrawal of approval is warranted, approval of all midodrine products, including generic versions, will be withdrawn.

Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.

Under accelerated approval, a drug company may obtain approval of a drug used to treat a serious or life-threatening disease or condition based upon a surrogate endpoint. A surrogate endpoint is a clinical marker, such as a positive effect on blood pressure, believed to predict actual clinical benefits such as improved survival or decreased severity of the disease.

Drug companies that obtain approval under this program are required to conduct additional clinical trials after approval to confirm the drug's benefit. If those trials fail to confirm clinical benefit to patients, or if the companies do not pursue the required confirmatory trials with due diligence, the FDA can withdraw approval of the drug using expedited procedures.

According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.

The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options.

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FDA Approves ella(TM) Tablets for Prescription Emergency Contraception

/PRNewswire/ -- The U.S. Food and Drug Administration today approved ella(TM) (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.
An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.

According to the product's labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ella. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.

ella is manufactured by Paris-based Laboratoire HRA Pharma. ella will be distributed by Watson Pharma Inc., of Morristown, N.J.

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Technique to Preserve Fertility in Young Women May Be Unsafe for Patients With Leukemia

/PRNewswire/ -- Although the use of ovarian tissue cryopreservation and transplantation has lead to 13 live births in women with lymphoma or solid tumors, this method of fertility preservation may be unsafe for patients with leukemia, according to a recent study published online in Blood, the journal of the American Society of Hematology. The method involves removing and freezing ovarian tissue before the patient undergoes aggressive chemotherapy and radiotherapy, and then reimplanting the tissue once the cancer has been brought under control. One major concern with leukemia patients is the risk that their frozen-thawed ovarian tissue might harbor malignant cells that could induce a recurrence of the disease after reimplantation.

"Our study provides clear evidence that cancer cells in women with acute and chronic leukemias can contaminate the ovaries," said Marie-Madeleine Dolmans, MD, professor at the Universite Catholique de Louvain in Brussels and lead author of the study. "If this tissue is reimplanted in these women when they're ready to have children, there's a good possibility that the cancer will come back."

As most acute lymphoblastic leukemia (ALL) patients are diagnosed with the disease at a young age, consideration of the preservation of their fertility is especially important. In fact, according to the National Cancer Institute, 71 percent of those diagnosed with ALL are less than 35 years old, as are nearly 10 percent of those with chronic myelogenous leukemia (CML)(1). In 2010, it is estimated that 2,180 women will be diagnosed with ALL and 2,070 with CML(1).

As aggressive chemotherapy and radiotherapy are damaging to the reproductive organs, the researchers wanted to examine the safety of using ovarian tissue cryopreservation to safeguard the fertility of patients with leukemia. In this study, researchers examined the implications of the technique in 12 women with ALL, a fast-growing cancer of the white blood cells, and six women with CML, a slowly progressing bone marrow cancer. The 18 patients included in this study were between 2 and 31 years of age when their ovarian tissue was cryopreserved (from 1999 to 2008). The mean age of the patients with ALL was 14.5 years and 24.7 years for those with CML.

Although initial microscopic examination did not reveal any cancerous cells in the ovarian tissue samples collected from each patient, by using a technique called real-time quantitative polymerase chain reaction (RT-qPCR), the scientists found cancerous cells in the ovarian tissue of 70 percent of the ALL patients and 33 percent of the CML patients. For further analysis, the researchers engrafted the ovarian tissue samples into 18 healthy mice for an observational period of six months. In the mice who received tissue from CML patients, the grafts looked normal and did not appear to contain any cancerous cells. In contrast, four of the mice who received ovarian tissue from ALL patients developed tumors. Through use of RT-qPCR and the mouse model, the researchers demonstrated the viability and malignant potential of leukemic cells present in the frozen ovarian tissue, especially from ALL patients.

"Given our findings, further research is needed to develop safer options for fertility preservation in patients with acute and chronic leukemias," said Jacques Donnez, MD, professor at the Universite Catholique de Louvain in Brussels and co-author of the study.

"Leukemia patients can benefit from fertility preservation techniques," added Brandon Hayes-Lattin, MD, the Director of the Adolescent and Young Adult Center at the Knight Cancer Institute in Portland, Oregon. "But the strategies offered must be both effective and safe. Among its other strengths, this work emphasizes that molecular methods can be successfully applied to assessments of safety."

(1) National Cancer Institute. SEER Stat Fact Sheets. Available at: http://seer.cancer.gov/statfacts.

The American Society of Hematology is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology. ASH provides Blood: The Vital Connection, a credible online resource addressing bleeding and clotting disorders, anemia, and cancer. The official journal of ASH is Blood, the most cited peer-reviewed publication in the field, which is available weekly in print and online.

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Robots to Help Children With Autism

/PRNewswire/ -- Interbots, Inc., a high-tech spin-off company associated with the Carnegie Mellon University Entertainment Technology Center has teamed up with the Autism Center of Pittsburgh to provide innovative robot-based therapy for children with autism.

The program, "Character Therapy," through the use of the Interbot robot "Popchilla" will test the ability of children with autism with limited or no verbal skills.

According to Seema Patel, CEO and co-founder of Interbots, "We've had numerous individuals tell us our robots could be tremendous tools for Autism therapy. We're excited to be working with the Autism Center of Pittsburgh and the Sprout Foundation to take this first step. We're going to learn a lot from the next few months."

"The premise behind the program is that children with autism are sometimes more likely to communicate with a non-human entity," said Cindy Waeltermann, Founder and Director of the Autism Centers of Pittsburgh. "When you have a child with autism, you use whatever interests them to gain access into their world. The idea is to bridge the gap between their word and ours.

Popchilla will be used in the first phase of the program with a trained therapist. Programmers and developers at Interbots have created an iPad application that will allow the therapist to direct sessions, which will eventually be transitioned to allow the child to control the robot through an iPad application to identify emotions.

According to Waeltermann, "By using Popchilla as an intermediary, we hope to increase the understanding of the child's internal feelings, thus reducing behavioral frustrations. If they are able to identify that they are 'angry' and what 'angry' means, it can significantly help them understand what they are feeling, reducing behavioral ramifications."

The program is funded by Spark. Spark is an initiative of The Sprout Fund catalyzing projects and programs that engage children ages birth to eight through the creative use of technology and media. Spark challenges individuals, organizations, and communities to generate inventive technology-based solutions to the issues and opportunities facing today's young child. Through its funding opportunities and extensive network of support, Spark is unleashing the innovative potential of Southwestern Pennsylvania and transforming our region into one of the best places on earth to be a kid.

"Our emphasis has always been making the use and control of our robots as simple and flexible as possible. You don't need to have a technical background to control our characters. You can control them with a variety of other familiar devices. So that opens a lot of interesting applications - like having a therapist or a parent use our robots as a tool to interact with children - even the possibility of kids using the robot to express themselves and explore emotions on their own," according to Sabrina Haskell, Interbots, Designer & Co-Founder.

The iPad application is currently in production and the program is slated to begin this fall.

"Nobody is more excited than the parents of the children with autism who have the potential to gain great strides from this program," said Cindy Waeltermann. "That's what this is all about -- thinking outside the box to reach these kids."

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Goldwater Institute Files Lawsuit Against Federal Health Care Bill

Legal challenge seeks to protect health care freedom and preserve constitutional checks and balances

The Goldwater Institute filed a lawsuit today to strike down the 2010 federal health care reforms as a fundamental attack on individual freedom and the rights guaranteed to all Americans by the U.S. Constitution.

The lawsuit filed in U.S. District Court in Phoenix is a private challenge to the health care bill championed by President Barack Obama. Arizona and 21 other states are pursuing public lawsuits against the federal law, based in large part on preserving their traditional authority to regulate health insurance. This new lawsuit, known as Coons v. Geithner, argues the federal health care bill exceeds the powers of Congress, violates individual rights, interferes with the authority of states, and violates the separation of powers by setting up a new bureaucracy without meaningful congressional oversight or judicial review.

“This lawsuit is our effort to bring down one of the most sweeping invasions of individual liberty and state sovereignty in American history,” said Clint Bolick, litigation director for the Goldwater Institute. “The federal health care bill is a sledgehammer to solve a problem that needs the precision of a scalpel. This is the most overbearing and intrusive way possible to try to address America’s rising health care costs.”

Nick Coons serves as the lead plaintiff in the lawsuit. A small business owner from Tempe, Mr. Coons pays for all of his medical care out of his own pocket and he wants to continue making his own health care decisions. Under the federal health care bill, Mr. Coons will face significant fines from the IRS if he doesn’t buy a health insurance plan that has been approved by the government by 2014.

“The government is making me spend money on something that I don’t want,” Mr. Coons said. “Is a stranger who works for the government in some other part of the country really going to know what I need? I am the best qualified to make these decisions for myself.”

The new federal law also violates Mr. Coons’ medical privacy by forcing him to disclose his medical records to an insurance company, and those records could be accessed by the federal government and others without his permission.

Mr. Coons has been joined as plaintiff in this case by U.S. Representatives Jeff Flake, Trent Franks, and John Shadegg, all of Arizona. The federal bill created a powerful board, called the Independent Payment Advisory Board, to assure cost containment. The board will have no meaningful oversight from Congress or the courts and can’t be repealed, except during a short time in 2017. This provision of the law violates the separation of powers doctrine essential to America’s system of government.

Other plaintiffs represented by the Goldwater Institute include Arizona state House Speaker Kirk Adams and 28 other Arizona legislators. Earlier this year, these lawmakers tried to resolve the state’s budget deficit in part by voting to reduce the state’s relatively generous benefits for people receiving health care through Medicaid. But the passage of the federal health care bill forced the Legislature to restore all benefits they had reduced or risk losing $7 billion in federal funding for the program. This federal coercion violates the First Amendment rights of these lawmakers to vote solely in the best interests of Arizona citizens.

To overturn the federal health care bill, the Goldwater Institute’s Scharf-Norton Center for Constitutional Litigation is suing President Obama in his official capacity as head of the executive branch and Timothy Geithner, who as secretary of the Department of Treasury oversees the IRS and its task of fining individuals who don’t buy health insurance by 2014. The other two defendants are Secretary of Health and Human Services Kathleen Sebelius, whose department would implement the health care bill; and Attorney General Eric Holder, who oversees the Justice Department and other agencies set to enforce other provisions of the health care bill.

The Obama administration is expected to ask that this lawsuit be dismissed on the grounds that the federal bill won’t be fully implemented until 2014. But last month, U.S. District Judge Henry Hudson rejected that argument against the state of Virginia’s legal challenge to the federal health care bill. Judge Hudson said Virginia deserves its day in court because the bill “radically changes the landscape of health insurance coverage in America.”

The Goldwater Institute will host a telephone town hall about this lawsuit against the federal health care bill at 7:00 p.m. tonight, August 12, 2010. To join the town hall, call (888) 886-6603 and enter event ID number 15269.
Learn more about Coons v. Geithner here. The Goldwater Institute is a research and litigation organization whose work is made possible by the generosity of its supporters. To support this lawsuit call Katie Charles at (602) 462-5000 x 249.

Fluoride Could be Contributing to Early Puberty, Studies Show

/PRNewswire/ -- The medical and public health community is shocked by the news that young American girls are reaching puberty at ages as young as 7 years (1). However, according to Paul Connett, PhD, Director of the Fluoride Action Network, "If fluoride's dangers had not been taken off the scientific radar screen by the US Public Health Service when it prematurely endorsed fluoridation in 1950, maybe key warning signals would not have been ignored for over 50 years."

In 1956, it was reported, after one of the first fluoridation trials (1945-55) had been completed in Newburgh/Kingston NY, that young girls were starting to menstruate on average five months earlier in fluoridated Newburgh compared to non-fluoridated Kingston (2). This result was ignored and there was no follow-up research.

In 1997, Dr. Jennifer Luke in the UK, as part of her PhD thesis (3), reported that fluoride accumulates in the human pineal gland. The pineal gland produces the important hormone melatonin which acts like a biological clock. One of the processes it is thought to control is the onset of puberty. Luke published this work in 2001 but the result has been ignored and no fluoridating country has attempted to repeat her findings, something which would be easy to do if there was the will to do so.

Luke also found that animals exposed to fluoride had lowered melatonin levels and showed signs of reaching puberty earlier. Again this result has been ignored and no fluoridating government has attempted to repeat Luke's work.

Connett says, "We are not saying that exposure to fluoride is a definite cause of early puberty in girls, but not pursuing this possibility is bad for science, bad for medicine and bad for public health."

Simply put: if you don't look, you don't find. The medical community is being kept in the dark on the possibility that fluoride, a highly toxic substance, which is deliberately added to the drinking water of 184 million Americans daily, is causing a variety of harms from the subtle to the serious.

Connett says, "Apparently, it has become more important for the American Dental Association and the Centers for Disease Control and Prevention and other agencies of the US Department of Health and Human Services to protect this outdated, unethical, ineffective and the dangerous practice than it is to protect the health of the American people. Key research is not being done. Doctors are not being warned."

This and other tragic aspects of the US's peculiar obsession with fluoridation are to be documented in an upcoming book co-authored by Connett. The book, titled "The Case Against Fluoride: How Hazardous Waste Ended Up in Our Drinking Water and the Bad Science and Powerful Politics That Keep it There," will be published by Chelsea Green in early October of this year.

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FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

/PRNewswire/ -- The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk.

Aseptic meningitis has a number of causes including, but not limited to, viruses, toxic agents, some vaccines, autoimmune diseases, and certain medications, including Lamictal. Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck and sensitivity to light. Hospitalization may be required.

In suspected cases of meningitis, the underlying cause should be rapidly diagnosed so that treatment can be promptly initiated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.

"Aseptic meningitis is a rare but serious side effect of Lamictal use," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Patients that experience symptoms should consult their health care professional immediately."

The FDA became aware of the association between Lamictal and aseptic meningitis through routine adverse event monitoring and communications with the drug's manufacturer. Since the drug's approval in December 1994 through November 2009, there were 40 cases of aseptic meningitis identified in patients taking Lamictal. The symptoms were reported to occur within one to 42 days after starting Lamictal. Thirty-five of the 40 patients required hospitalization. In most cases, symptoms ended after Lamictal was discontinued. In 15 cases, symptoms, often more severe, returned when patients restarted the drug.

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CDC: Two-Thirds of Emergency Visits Occur During Non-Business Hours; Percentage of Non-Urgent Emergency Patients Drops To Less than 8 Percent

/PRNewswire/ -- A new report from the Centers for Disease Control and Prevention once again debunks the myth that emergency departments are crowded with non-urgent patients, a finding noted by the American College of Emergency Physicians (ACEP).

"The percentage of non-urgent patients dropped to only 7.9 percent in 2007 [from 12.1 percent in 2006]," said Dr. Angela Gardner, president of ACEP. "The report also makes the excellent point that non-urgent does not imply unnecessary. As we have said repeatedly, our patients are in the ER because that's where they need to be.

There were approximately 222 visits to U.S. emergency departments every minute in 2007 (http://bit.ly/9B5kHJ) and the number of visits increased by 23 percent between 1997 and 2007, according to the report. Preliminary data for 2008 indicate that emergency visits will increase to a record high of more than 123 million (http://bit.ly/ak6oRx).

The report, "National Hospital Ambulatory Medical Care Survey: 2007 Emergency Department Summary" offers far more detail than the data brief released by the Centers for Disease Control and Prevention (CDC) in May. The U.S. Department of Health and Human Services, of which the CDC is a part, has indicated that this is the last fully detailed report of its kind to be issued about emergency department visits.

Dr. Gardner is urging the CDC to reconsider:

"It is essential to know what is happening in our emergency departments as we implement health care reform. This report is rich in data about who our patients are, how old they are and why they are seeking care in the ER. From a planning perspective, this information is invaluable. It would be a mistake for the CDC to discontinue tracking what is happening on the front lines of healthcare, the nation's emergency departments."

Babies under 12 months old had the highest visit rate at 88.5 visits per 100 infants. The second highest visit rate was by adults age 75 and older, with 62 visits per 100 people.

Approximately one-quarter of all visits were by patients insured by either Medicaid or the State Children's Health Insurance Program. The uninsured represented about 15 percent of all visits.

"Most doctors' offices are open for around 45 hours a week, as opposed to the 168 hours a week emergency departments are open," said Dr. Gardner. "That nearly two-thirds of emergency patients came to the ER between 5 p.m. and 8 a.m. during the week or on weekends highlights the unpredictable nature of health emergencies. When you are the one who has a sick child, the last thing you want is a 'closed' sign or after-hours message."

The report also notes that only 0.1 percent of patients die in the emergency department.

"We do an excellent job of stabilizing and treating our patients, but the persistent problems of overcrowding, ambulance diversion and boarding admitted patients in the ER are not going away," said Dr. Gardner. "We know from the Massachusetts experience that visits will continue to rise with health care reform. We also know that as Baby Boomers age, a tsunami of patients in need of emergency care is just around the corner. We need help and we need it now."

The report says the main issue contributing to overcrowding has been delays in moving the sickest patients to inpatient beds. Admitted patients have often been boarded in the emergency departments or hospital hallways for hours to days, resulting in overcrowding and diversion of incoming ambulances to other hospitals.

ACEP is a national medical specialty society representing emergency medicine. ACEP is committed to advancing emergency care through continuing education, research and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies.

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House, Senate Put Forth Legislation to Renew Funding, Bolster Nation's Bone Marrow and Umbilical Cord Program

/PRNewswire/ -- The National Marrow Donor Program® (NMDP) today applauded the introduction of the "Stem Cell Therapeutic and Research Reauthorization Act of 2010." Sens. Orrin Hatch (R-UT), Christopher Dodd (D-CT), Richard Burr (R-NC), Jack Reed (D-RI), John Ensign (R-NV), and Al Franken (D-MN) introduced the act in the U.S. Senate as S. 3751 on Thursday, Aug. 5. Last evening, Reps. C.W. Bill Young (R-FL) and Doris Matsui (D-CA) introduced the companion legislation, (H.R. 6081), in the House. This legislation seeks to reauthorize the C.W. Bill Young Cell Transplantation Program (National Program) and the National Cord Blood Inventory (NCBI). These programs must be reauthorized before the NCBI sunsets.

Last year 12,000 patients searched the national registry, publicly known as the Be The Match Registry®, for a marrow donor or umbilical cord blood unit. Congressional support of the National Program and the NCBI is critical to ensure all patients have access to transplant.

"I am pleased with the introduction of this legislation and continued bipartisan support," said Jeffrey W. Chell, M.D., chief executive officer of the NMDP. "The reauthorization will provide us with the opportunity to continue our efforts to increase the number of adult donors and umbilical cord blood units available through the National Program."

Since its inception in the mid-1980s, the NMDP has operated the National Program awarded via a competitive bid process administered by the Health Services Resources Administration (HSRA). Every day, the National Program helps thousands of patients with leukemia, certain lymphomas, and other life-threatening diseases find a matching donor or umbilical cord blood unit. For many of these patients, a transplant may be the best or only hope for a cure. To date, the NMDP has facilitated more than 40,000 transplants. This accomplishment would not have been possible without the ongoing, sustained support of Congress and its efforts to increase unrelated marrow and cord blood transplants in the United States.

The proposed legislation demonstrates the continued federal commitment to these programs and recognizes the importance of providing patients and physicians with a single point of access to marrow and cord blood units that can be used for transplant. It also addresses the importance of building a diverse registry of marrow donors and cord blood units. Additionally, the legislation includes modifications necessary to continue the successful work of these programs.

The NMDP applauds the hard work and dedication of Congress to produce a bipartisan and fiscally responsible bill that will assist the NMDP in advancing its life-saving mission. The NMDP looks forward to working with Congress, and its network partners in the transplant community including, physicians, cord blood banks, donors, patients, and their families, to gain additional support for continued success of cellular transplantation.

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Salix Announces FDA Acceptance for Filing and Priority Review Designation For XIFAXAN550 sNDA For the Treatment of Non-Constipation Irritable Bowel Syndrome

(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company’s efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. Non-constipation irritable bowel syndrome (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M).

“We are pleased with the FDA’s acceptance of the sNDA for XIFAXAN550 and their decision to grant Priority Review for our application”

A Priority Review classification is granted to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this classification, the FDA has issued an action date of December 7, 2010 under the Prescription Drug User Fee Act (PDUFA).

“We are pleased with the FDA’s acceptance of the sNDA for XIFAXAN550 and their decision to grant Priority Review for our application,” said Bill Forbes, Pharm.D., Executive Vice President and Chief Development Officer, Salix Pharmaceuticals. “This review classification signals that the FDA considers that XIFAXAN550 may have the potential to provide a significant advance in the treatment of non-constipation irritable bowel syndrome. We believe the availability of XIFAXAN550 has the potential to change the treatment paradigm for Non-C IBS. Today’s news marks a milestone for Salix, XIFAXAN550 and patients suffering from this widespread condition.”

About Irritable Bowel Syndrome (IBS) and Non-Constipation Irritable Bowel Syndrome (Non-C IBS)

IBS affects approximately 15 percent of or, potentially, over 30 million adults in the United States and is among one of the most common, chronic conditions. IBS includes altered bowel habits with bloating, abdominal pain and discomfort. Non-constipation irritable bowel syndrome (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M). Among other contributors, recent science has shown that alterations in gut flora/bacteria have been identified as a potentially important contributor to the pathophysiology of IBS. The Company now estimates the U.S. commercial opportunity represented by the non-constipation IBS market to be approximately $7 billion in peak year.

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Governor Celebrates First Day of Classes at New MCG/UGA Medical Partnership

Forty aspiring physicians began their education in Athens Monday as part of the inaugural class of the Medical College of Georgia/University of Georgia Medical Partnership.

“This was a pretty clear decision for me when you look at the per capita number of doctors in Georgia,” said Governor Sonny Perdue, who gave the keynote address at a dedication ceremony to mark the historic partnership. “The fact is that we were importing medical talent not only from around the nation, but from around the world, to serve our citizens in Georgia. And while we love that people like to come to our state, we felt like we need to grow more of our own.”

The inaugural class of the four-year medical education program consists of 40 MCG students who will study basic science and clinical skills in a program that mirrors the curriculum of the Augusta campus. Like other speakers at the dedication ceremony, University System of Georgia Chancellor Errol B. Davis, Jr. praised Governor Perdue and the General Assembly for supporting the expansion of public medical education in Georgia.

“It’s important to note that they did this in the midst of this economic downturn,” Davis said. “Their commitment to expanding medical education and providing more doctors for the people of the state has not wavered.”

MCG President Dr. Ricardo Azziz and UGA President Michael F. Adams both emphasized how the partnership leverages the strengths of the state’s only public medical school and its largest and most comprehensive research university.

“Only through collaboration will we succeed in addressing the growing health needs of our state, our nation, and our world,” Azziz said. “Only through collaboration will we generate the cutting edge discoveries that will transform the way we care for our people.”

“It has taken a lot of people coming together to make this possible,” Adams said. “The development of a health sciences campus and the admission of the first class of medical students have been among the most important developments, I believe, in my time here at the university.”

MCG/UGA Medical Partnership student Justin Brooten of Atlanta addressed the audience at the dedication ceremony on behalf of students. He noted that members of the inaugural class have studied in numerous fields, including biology, languages, economics and psychology, and have wide-ranging medical interests as well.

“One word which characterizes our shared pursuit,” he said, “is passion – a passion to learn, a passion to care, and a passion to contribute.”

He added that the partnership will increase opportunities for students to engage in interdisciplinary studies and that the smaller class sizes in Athens will facilitate student/faculty interaction.

The partnership is part of an overall plan to increase the MCG School of Medicine's class size from 190 to 300 students by 2020 to help meet the need for physicians in a state that ranks in the top 10 both in population and population growth, according to the U.S. Census Bureau.

“There are counties in Georgia that don’t have any physicians at all, and those shortages need to be addressed,” said Dr. Douglas Miller, dean of the MCG School of Medicine and MCG senior vice president for health affairs. “A public university and a partnership such as this is ideally positioned to lead a response to health care disparities.”

The students will be educated in the Interim Medical Partnership Building, a historic building that was originally constructed in 1857 as the Athens Cotton and Wool Factory and has since been renovated to provide a state-of-the-art learning environment. In 2012, the partnership is scheduled to move to a 58-acre campus in Athens currently occupied by the Navy Supply Corps School. The new campus will be known as the UGA Health Sciences Campus and will house the UGA College of Public Health and other health-related programs.

“UGA will become a much stronger research university with the inclusion of medical education,” said UGA Senior Vice President for Academic Affairs and Provost Jere Morehead, “and today’s dedication of the interim medical partnership building is precursor of greater things that will come in improving health care for the people of Georgia.”

The first graduates of the partnership will graduate in 2014 and can begin practicing, depending on the chosen specialty, in 2017 after completion of postgraduate education. By 2020, the partnership is expected to educate 60 students per year in Athens, for a total of 240 students for the four-year program. In addition to helping educate more physicians, the MCG/UGA Medical Partnership opens up new possibilities for collaborative research into diseases that disproportionately affect Georgians, such as diabetes, obesity and stroke. “We have been given the opportunity to influence the health of the state of Georgia,” Campus Dean Dr. Barbara Schuster said. “May we have the strength and presence of mind to seize this unique opportunity.”
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'Improving Access to Clinical Trials Act' Passes U.S. Senate in Victory for CF Advocates

/PRNewswire/ -- The U.S. Senate last night passed the "Improving Access to Clinical Trials Act" (I-ACT), a bipartisan piece of legislation championed by the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

The legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public healthcare benefits.

"We are one step closer to breaking down a serious barrier to participation in clinical trials, which one day could deliver a cure for cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This legislation represents an important opportunity for people with CF to take part in groundbreaking research that was previously out of their reach. We are elated that this bill has been approved by the Senate."

The legislation was introduced by Senator Ron Wyden, D-Ore., with Senators Chris Dodd, D-Conn., James Inhofe, R-Okla., Richard Shelby, R-Ala., Dick Durbin, D-Ill. as original co-sponsors and an additional 14 co-sponsors also signed on.

Current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it makes them ineligible to receive government medical benefits. This penalty has stopped significant numbers of people with rare diseases from participating in clinical studies.

Following Senate approval, the bill now awaits consideration by the U.S. House of Representatives. Reps. Edward Markey, D-Mass., and Cliff Stearns, R-Fla., are leading the effort to pass the bill in the House. The legislation, HR 2866, is co-sponsored by 135 members.

Passage of this legislation is particularly important for people with CF, a rare genetic disease that affects 30,000 people in the United States. A limited patient population makes it challenging to find enough people to participate in research studies evaluating the effectiveness of promising new drugs.

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Study on Fructose and Pancreatic Cancer Generates Premature and Potentially Misleading Conclusions

/PRNewswire/ -- A study published in the August issue of Cancer Research (1) has resulted in several premature and potentially misleading conclusions when it comes to fructose and its effect on pancreatic tumor cells. Unfortunately, the media covering this story, and even the authors, have been too quick to extrapolate the results of laboratory research on pure fructose to real-world conditions, which is not appropriate or helpful to consumers.

The main contribution of this paper is to demonstrate that cancer cells utilize fructose as an alternate substrate to glucose for fueling growth. Cancer cells are well known for having multiple mechanisms to escape the body's normal controls, which makes controlled laboratory studies poor models for generating meaningful results.

This study does not look at the way fructose is actually consumed by humans, as it was conducted in a laboratory, not inside the human body. The study also narrowly compared pure fructose to pure glucose, neither of which is consumed in isolation in the human diet. Humans consume a wide array of foods that contain both fructose and glucose in combination along with many other sugars and nutrients. Most notably, both sugar (sucrose) and high fructose corn syrup contain roughly 50 percent glucose and 50 percent fructose.

The study's authors inaccurately state that high fructose corn syrup is the most significant source of fructose in the diet, whereas in the United States more fructose is still consumed from sugar than from high fructose corn syrup. Indeed, worldwide, humans consume nine times as much sucrose as they do high fructose corn syrup. Fructose is a natural, simple sugar also commonly found in fruits, vegetables, table sugar, maple syrup, and honey.

The causes of pancreatic cancer are poorly understood. To blame one component of the diet is highly speculative based on one, small study done in a Petri dish.

People should seek the advice of physicians, rather than rely on any one study, to make important decisions on medical treatment for a serious disease such as cancer.

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