NIH establishes Down syndrome patient registry

   (NIH) - 10-27-2012 - A new Down syndrome patient registry will facilitate contacts and information sharing among families, patients, researchers and parent groups. The National Institutes of Health has awarded a contract to PatientCrossroads to operate the registry. The company has created patient-centric registries for muscular dystrophy and many rare disorders.
   People with Down syndrome or their family members will be able to enter contact information and health history in an online, secure, confidential database. Registry participants will be able to customize their profile, update it online, and choose which information they would like to display, including reminders about their own medical care and general information about Down syndrome. They also will be able to compare their own medical information to that of other registrants in a confidential and anonymous manner.
   If a participant gives permission to be contacted, clinicians and researchers who are authorized to access the database will be able to contact these individuals to see if they are interested in participating in a research study.
   Ultimately, the registry will be able to link to biorepositories of tissue samples and other resources, with the goal of making it easier for patients to take part in clinical studies for new medications and other treatments for Down syndrome.
   The contract, which will support the creation of the registry through September 2013, received $300,000 in funding for its first year.
   "The new registry provides an important resource to individuals with Down syndrome and their families," said Yvonne T. Maddox, deputy director of the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which is funding the registry. "The registry links those seeking volunteers for their research studies with those who most stand to benefit from the research."
   Down syndrome most frequently results from an extra copy of chromosome 21 in the body’s cells. Infants with Down syndrome are likely to have certain physical characteristics, such as short stature and distinctive facial features, as well as health conditions like hearing loss, heart malformations, digestive problems, and vision disorders. Although Down syndrome most commonly results in mild to moderate intellectual disability, the condition occasionally involves severe intellectual disability. In addition, some individuals with Down syndrome age prematurely and may experience dementia, memory loss, or impaired judgment similar to that experienced by individuals with Alzheimer disease.
   "Down syndrome is complex," Maddox said. "A wide array of scientific expertise is required to address all its aspects in a comprehensive manner."
   Development of a patient registry was a leading recommendation in the 2007 NIH Down Syndrome Research Plan, which sets goals and objectives for the Down syndrome research field. Together with the Global Down Syndrome Foundation, the NICHD sponsored the Down syndrome National Conference on Patient Registries, Research Databases, and Biobanks to solicit the advice of a number of experts from the advocacy community, federal agencies, industry, and the clinical and research communities on how best to establish a Down syndrome registry.The plan for the registry was supported by the public-private Down Syndrome Consortium, which was established by the NIH in 2011 to foster the exchange of information on Down syndrome research, and to implement and update the Research Plan. Membership on the Consortium includes individuals with Down syndrome and family members, representatives from prominent Down syndrome and pediatric organizations, and members of the NIH Down Syndrome Working group, an internal NIH group that coordinates NIH-supported Down syndrome research.
   "We're grateful to those who provided us with the advice that allowed us to establish a national registry," Maddox said. "We are happy that this important step in furthering research on Down syndrome has been accomplished and hope that many families will take advantage of the opportunity to sign up as soon as the registry goes online."

Weight Loss, Type 2 Diabetes Risk Questioned

   (NIH) - 10/21/2012 - An intensive diet and exercise program resulting in weight loss does not reduce cardiovascular events such as heart attack and stroke in people with longstanding type 2 diabetes, according to a study supported by the National Institutes of Health.
   The Look AHEAD (Action for Health in Diabetes) study tested whether a lifestyle intervention resulting in weight loss would reduce rates of heart disease, stroke, and cardiovascular-related deaths in overweight and obese people with type 2 diabetes, a group at increased risk for these events.
   Researchers at 16 centers across the United States worked with 5,145 people, with half randomly assigned to receive an intensive lifestyle intervention and the other half to a general program of diabetes support and education. Both groups received routine medical care from their own health care providers.
   Although the intervention did not reduce cardiovascular events, Look AHEAD has shown other important health benefits of the lifestyle intervention, including decreasing sleep apnea, reducing the need for diabetes medications, helping to maintain physical mobility, and improving quality of life. Previous Look AHEAD findings are available at www.lookaheadtrial.org.
   "Look AHEAD found that people who are obese and have type 2 diabetes can lose weight and maintain their weight loss with a lifestyle intervention," said Dr. Rena Wing, chair of the Look AHEAD study and professor of psychiatry and human behavior at Brown University. "Although the study found weight loss had many positive health benefits for people with type 2 diabetes, the weight loss did not reduce the number of cardiovascular events."
   Data are currently being analyzed to fully understand the cardiovascular disease results. Investigators are preparing a report of the findings for a peer-reviewed publication.
   Few, if any, studies of this size and duration have had comparable success in achieving and maintaining weight loss. Participants in the intervention group lost an average of more than 8 percent of their initial body weight after one year of intervention. They maintained an average weight loss of nearly 5 percent at four years, an amount of weight loss that experts recommend to improve health. Participants in the diabetes support and education group lost about 1 percent of their initial weight after one and four years.
   In September, the NIH stopped the intervention arm, acting on the recommendation of the study’s data and safety monitoring board. The independent advisory board, charged with monitoring the study data and safety of participants, found that the intensive lifestyle did no harm but did not decrease occurrence of cardiovascular events, the primary study goal. At the time, participants had been in the intervention for up to 11 years.
   Because there was little chance of finding a difference in cardiovascular events between the groups with further intervention, the board recommended stopping the intensive lifestyle intervention, but encouraged the study to continue following all Look AHEAD participants to identify longer-term effects of the intervention.
  "The intervention group did not have fewer cardiovascular events than the group receiving general diabetes support and education, but one positive factor we saw was that both groups had a low number of cardiovascular events compared to previous studies of people with diabetes," said Dr. Mary Evans, director of Special Projects in Nutrition, Obesity, and Digestive Diseases within the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the study's primary sponsor.
   Type 2 diabetes — affecting nearly 24 million people in the United States alone — has increased in prevalence along with the country's epidemic of overweight and obesity. Cardiovascular diseases are the most common cause of death among people with type 2 diabetes. Look AHEAD is the first study to examine the long-term effects of a lifestyle intervention on major cardiovascular disease events and death in adults with type 2 diabetes.
   "Look AHEAD provides important, definitive information about the long-term health effects of weight loss in people with type 2 diabetes," NIDDK Director Dr. Griffin Rodgers said. "Beyond cardiovascular disease, this study and others have shown many other health benefits of weight loss through improved diet and increased physical activity. For example, for overweight and obese adults at high risk for diabetes, modest weight loss has been shown to prevent or delay developing type 2 diabetes."
   Participants were 45 to 76 years old when they enrolled in the study. Sixty percent of enrollees were women. More than 37 percent were from racial and ethnic minority groups. Researchers are now analyzing data to measure effects of the lifestyle intervention on subgroups, including racial and ethnic groups and people with a history of cardiovascular disease.
  Find more information about the Look AHEAD trial (NCT00017953), including a list of current publications, at www.lookaheadtrial.org. For a list of centers enrolling patients for diabetes or obesity trials, search for keywords "diabetes" or "obesity" at www.clinicaltrials.gov.
   Source: National Institutes of Health release.

Executives Sentenced for Roles in Conspiracies

   WASHINGTON – 10/18/2012 - Three former financial services executives were sentenced today in U.S. District Court for the Southern District of New York, for their participation in conspiracies related to bidding for contracts for the investment of municipal bond proceeds and other municipal finance contracts, the Department of Justice announced. The three former executives were convicted after a three week trial on May 11, 2012.
    Dominick P. Carollo, Steven E. Goldberg and Peter S. Grimm, all former executives of General Electric Co. (GE) affiliates, were sentenced by District Court Judge Harold Baer Jr. for their roles in the conspiracies. Carollo was sentenced to serve 36 months in prison and to pay a $50,000 criminal fine. Goldberg was sentenced to serve 48 months in prison and to pay a $90,000 criminal fine. Grimm was sentenced to serve 36 months in prison and to pay a $50,000 criminal fine.
    “By manipulating the competitive bidding process, the conspirators cheated cities and towns out of money for important public works projects,” said Scott D. Hammond, Deputy Assistant Attorney General for the Antitrust Division’s criminal enforcement program. “The division and its law enforcement partners remain committed to rooting out such corruption.”
    According to evidence presented at trial, while employed at GE affiliates, Carollo, Goldberg and Grimm participated in separate fraud conspiracies with various financial institutions and insurance companies and their representatives from as early as 1999 until 2006. These institutions and companies, or “providers,” offered a type of contract, known as an investment agreement, to state, county and local governments and agencies throughout the United States. The public entities were seeking to invest money from a variety of sources, primarily the proceeds of municipal bonds that they had issued to raise money for, among other things, public projects. Goldberg also participated in the conspiracies while employed at Financial Security Assurance Capital Management Services LLC.
   At trial, the Department of Justice asserted that Carollo, Goldberg, Grimm and their co-conspirators corrupted the bidding process for dozens of investment agreements to increase the number and profitability of investment agreements awarded to the provider companies where they were employed. Carollo, Goldberg and Grimm deprived the municipalities of competitive interest rates for the investment of tax-exempt bond proceeds that were to be used by municipalities for various public works projects, such as for building or repairing schools, hospitals and roads. Evidence at trial established that they cost municipalities around the country millions of dollars.
    “Today’s sentencing of Carollo, Goldberg and Grimm for their involvement manipulating a competitive bidding process of public contracts is the final step in a case that demonstrates the FBI’s commitment to investigate and prosecute those who illegally influence the financial markets for their own profit,” said Mary E. Galligan, Acting Assistant Special Agent Charge of the FBI in New York. “The co-conspirators scheme over many years deprived municipalities across the country of competitive interest rates on bonds, a yield that most cities would say they greatly need. The FBI will continue to work with our law enforcement partners to enforce the laws that protect our financial markets.”
    "The sentences handed down today send a clear message that crime motivated by outright greed will land you in jail,” said Richard Weber, Chief, Internal Revenue Service – Criminal Investigation (IRS-CI). “Quite simply, the defendants stole money from taxpayers and conspired to manipulate the competitive bidding system to benefit themselves instead of the towns and cities that needed this money for important public works projects. IRS Criminal Investigation is committed to working with our law enforcement partners to uncover this kind of corruption and secure justice for American taxpayers.”
    Carollo was found guilty on two counts of conspiracy to commit wire fraud and defraud the United States, Goldberg was found guilty on four counts of conspiracy to commit wire fraud and defraud the United States and Grimm was found guilty on three counts of conspiracy to commit wire fraud and defraud the United States.
    A total of 20 individuals have been charged as a result of the department’s ongoing municipal bonds investigation. Including today’s convictions, a total of 19 individuals have been convicted or pleaded guilty, and one awaits trial. Additionally, one company has pleaded guilty.
    The sentences announced today resulted from an ongoing investigation conducted by the Antitrust Division’s New York Office, the FBI and the IRS-CI. The division is coordinating its investigation with the U.S. Securities and Exchange Commission, the Office of the Comptroller of the Currency and the Federal Reserve Bank of New York.
    Today’s convictions are part of efforts underway by President Obama’s Financial Fraud Enforcement Task Force (FFETF) which was created in November 2009 to wage an aggressive, coordinated and proactive effort to investigate and prosecute financial crimes.
   Anyone with information concerning bid rigging and related offenses in any financial markets should contact the Antitrust Division’s New York Field Office at 212-335-8000, the FBI at 212-384-5000 or IRS-CI at 212-436-1761, or visit www.justice.gov/atr/contact/newcase.htm.
   Source: Financial Fraud Enforcement Task Force

Cleaning Products Contain Known Carcinogen

   WASHINGTON, D.C. – (EWG) - 10/12/2012 – In a dramatic illustration of why it is essential that makers of cleaning products fully disclose their ingredients on product labels, the release of Environmental Working Group’s Guide to Healthy Cleaning has resulted in the revelation that more than half of a line of cleaners marketed to parents of babies contain an ingredient that releases formaldehyde, a known human carcinogen.
   The company is New York state-based BabyGanics, whose representative has described its products as “so safe that you can even drink them” in a video posted online. In the video uploaded by BabyTVcom on Feb. 13, 2008, he then drank from a bottle of a BabyGanics cleaner.
   EWG’s Guide to Healthy Cleaning, which gave more than 2,000 products grades of A-to-F based on the potential hazards of their ingredients and the completeness of their ingredient disclosures, gave “F” scores to a number of BabyGanics products because of poor disclosure. After the company contacted EWG and protested its grades, it agreed to post a full ingredient list on its website. This list, in turn, revealed that more than half of its products contain a preservative called HHT (Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine), which releases formaldehyde during product use. As a result, those products will continue to be graded “F” on the EWG guide until their formulations are changed.
   Executives of BabyGanics told EWG that the company is making plans to remove the preservative from its entire line.
   “Consumers should be wary of products that release formaldehyde because it is a carcinogen that experts believe is unsafe even in small amounts,” said Johanna Congleton, a senior scientist at EWG. “It would be hard to find anyone, especially parents, who believe it’s acceptable for products marketed as safe to use around babies to contain a substance known to release a known human carcinogen.”
   The BabyGanics revelation is a dramatic reminder that consumers cannot take companies’ labeling and marketing claims at face value.
   “As a mother of two young children, I am shocked that companies don’t have to tell consumers what’s in their cleaning products,” said Heather White, EWG’s chief of staff and general counsel. “So many families buy these products because they think they are safe, when in fact they contain chemicals that could pose serious dangers, including cancer. My advice to consumers is simple – don’t buy products labeled only with generic terms like ‘surfactants’ or ‘preservatives.’ Companies need to tell us exactly what’s in the products they’re selling. We have a right to know what chemicals we’re bringing into our homes in the products we buy. And EWG’s Guide to Healthy Cleaning was created to help consumers exercise that right.”
   The BabyGanics line is sold by national retailers such as Babies R Us and Bed, Bath & Beyond.
   EWG’s guide has highlighted how many cleaning products contain toxic chemicals and how difficult it is for even careful consumers to find out exactly what’s in them. Many companies use generic names like “surfactants” and “mineral salts” to describe some of their ingredients. Current federal law does not require disclosure of ingredients on the vast majority of cleaning products. EWG’s rating system and the information provided by the guide is challenging other companies to reevaluate what they put in their products and to detail that information on their product labels and on their web sites.
   EWG plans to do further research to evaluate more closely the use of toxic preservatives in household cleaning products.

The Arms Debate

Not All American's Have the Right to Bear Arms

Photo by Steve Rensberry (c) 2018