Cincinnati Children's Hospital Medical Research Scores Big Win: New Drug Quickly Approved, Shrinks Kids' Brain Tumors



Children's Hospital



CINCINNATI (TDB) -- Swiss pharmaceutical giant Novartis announced today in Europe the FDA granted accelerated approval for a new drug that shrinks brain tumors otherwise requiring surgery.  The drug was tested on 28 patients at Cincinnati Children's Hospital Medical Center and nearly a third had a reduction in the size of their tumors.  Doctors say the drug should fill an unmet medical need.  All of the patients were being treated for subpendymal giant cell astrocytoma, known to physicians as SEGA, an inherited disease related to a genetic disorder called tuberous sclerosis.  Tuberous sclerosis can cause severe mental retardation and seizures.  Novartis credited the breakthrough to Cincinnati Children's Hospital in an announcement from Basel today. Early approval came because the results in Cincinnati were so dramatic. Still, Novartis said more studies are taking place:

 
"The accelerated approval of Afinator [generic name everolimus} is based on an open-label, single-arm 28-patient study conducted by Cincinnati Children's Hospital Medical Center. The effectiveness of Afinator is based on an analysis of change in SEGA volume. A Phase III study is under way that compares Afinator to placebo to explore the clinical benefits of Affinator for patients with treatment associated with TS. 

"Prior to this FDA approval, the only treatment option for growing SEGAs, which primarily affect children and adolescents, was brain surgery. Tuberous sclerosis is a genetic disorder affecting approximately 25,000 to 40,000 people in the U.S. that may cause tumors to form in vital organs. SEGAs, benign brain tumors, occur in up to 20% of patients with TS."

Cincinnati Children's opened its clinic for tuberous sclerosis in the early 1990s and it now has a team of researchers battling the genetic disorder. Dr. David Neal Franz is the clinic director and you can learn more about him by clicking here.  Franz did not start out to become a physician.  He went to Earlham College in Richmond, Ind., and majored in history and literature.  That small liberal arts school set Dr. Franz on the path, though, that should help make life a little bit easier for many people on this planet.

FDA Finds 'Mad Cow' Risk At Ohio Ag Feed Plant

CLEVELAND (TDB) -- An Ohio plant that processes animal carcasses into protein used for cattle feed agreed to comply with Food and Drug Administration rules designed to lessen the risk of MAD COW DISEASE reaching American beef consumers. The plant, located in rural Holmes County, produces about 2 million pounds of protein meal per month. Some 90% is shipped outside Ohio, mostly to agricultural food brokers who sell to farmers and ranchers.

A federal lawsuit filed last week in Cleveland said poultry meal "that contains or may contain protein derived from mammalian tissues" was sold and did not contain proper cautionary statements. Scientists think protein from mammals can cause Mad Cow.

"These violations continued despite verbal and written reports from the FDA, as well as a formal warning letter in 2005 alerting defendants of the violations and demanding compliance. The warning letter stated that 'failure to promptly correct these violations may result in regulatory action, such as seizure and or/injunction, without further notice,'" said the lawsuit, which was handled by Joel D. Schwartz, a trial attorney with the Justice Department's office of consumer litigation in Washington.

The FDA has now obtained a permanent injunction. A consent decree filed in Cleveland federal court requires the company to follow the rules.

Mad Cow is a terrible disease, and an OUTBREAK could damage the U.S. beef industry, which is a major pillar of the farm and export economy. Worse, it would ruin lives, because there is no cure as a human victim's brain is destroyed. Mad Cow played havoc with Britain, and led to the U.S. to adopt rules governing how cattle feed is processed.

To prevent the outbreak and spread of Bovine Spongiform Encephalopathy (BSE), the formal scientific name for Mad Cow, the FDA promulgated regulations prohibiting the use of most mammalian protein in the manufacture of animal feeds given to farm animals such as cows, sheep and goats. Scientists believe there are forms of BSE that can pass from animals to people, and they cause progressive degeneration of the brain and central nervous system.

BSE is a fatal neurological disease in cattle. It has been linked to Creutzfeld-Jakob Disease, which also is usually fatal. Researchers believe that a variant of Creutzfeld-Jakob can be caused by eating meat from BSE-afflicted animals.

In its lawsuit against the Ohio meal processor, the government said the "regulation requires renderers that choose to produce both mammalian and non-mammalian protein products" take steps to ensure that there is no crossover or mixing. Poultry products are not considered a hazard for Mad Cow.