TOPIC: Child's Alleged 'Ecstasy Trip' Posted Online
This is a sickening story. Teenage girls laughing, poking and prodding a 5-6 year old girl whom someone obviously gave a hit of ecstasy (the date rape drug). The child's eyes continually roll back in her head (one of the signs of "X" intoxication). The teenagers get a huge kick out of the plight of the little girl -- all while traveling through city streets of what authorities believe is Houston, Texas. I almost cried as I watched the video -- at the lack of compassion for the child, at the fact that these teenage girls could derive fun from such a horrible thing and that there was likely an adult driving the minivan that carried this slut circus through town.
Here's the article and link to the video:

HOUSTON -- It's the video that's making the rounds on the internet (most likely on YouTube)
Investigators are trying to track down a little girl seen in a home video, and other teenage girls. The video shows a little girl riding without a safety seat on the floor of what appears to be a mini van in the Houston area. There are several teenage girls who claim the child may be on the drug ecstasy. The child's eyes are also seen rolling back in her head.
Investigators are seeking the public’s help in identifying her or any of the girls in the video. Jackson County sheriff's officials say they would like to do a welfare check on the child to determine if she's okay. Chief Deputy Curt Gabrysch says if you know who the child is, to please contact the Jackson County Sheriff's Department or your local police department.

Again, if you know anyone in the video, PLEASE contact law enforcement and give them the names. Someone needs to check on the welfare of the little girl -- and hold everyone involved responsible for the crimes they committed against her.

UPDATE: 7/11/07 - Teenage girls located, but claim there was no drug use. Um, they are lying -- so keep investigating and you'll find the truth.

TOPIC: Sweeping Changes Needed At US Food And Drug Administration

Source: MedicalNewsToday

Five current or former members of the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) called today for Congress to make sweeping changes to deal with a large number of longstanding problems at the agency.

"The current FDA system of regulating drug safety has serious limitations and is in need of changes," they say in Archives of Internal Medicine, released today. Since Congress is ultimately responsible, "it is up to Congress to take the steps necessary to reinvigorate the FDA's ability to assure the public that approved medical products are safe."

Curt D. Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine and the lead author, said the five decided to write the analysis after becoming discouraged by the FDA's inability to fix its own problems. "Congress has not provided adequate funding and authority to the FDA," he said.

• The group cites eight major problems impacting FDA performance, including:
• The system of initial approval of drugs often fails to detect serious adverse drug reactions.
• The same FDA center that approves drugs also has the responsibility of taking safety actions, creating a conflict-of-interest situation.
• The FDA is overly dependant on user fees from drug companies.
• The FDA is short on expertise in drug safety and public health.

"The key features of today's media stories about questionable drug safety are the same as with previous drug tragedies," Furberg said. "New drugs are introduced on the market with inadequate safety documentation; serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed. The only difference is the name of the culprit drug."

Furberg and his colleagues recommend that Congress make five changes:

• "Give the FDA more direct legal authority to pursue violations." The FDA's own report says that drug companies committed to 1,231 post-marketing safety studies that are incomplete; 797 were never started.
• "Authorize the adoption of a conditional drug-approval policy, at least for selected drugs."
• "Provide additional financial resources to support the safety operations."
• "Mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety."
• "Require broader representation of safety experts on FDA's advisory committees."

"Larger and longer clinical trials ought to be required for drugs that will be given for chronic conditions such as high blood pressure, diabetes and coronary heart disease," said Peter A. Gross, M.D., chairman of medicine at Hackensack University Medical Center and professor of medicine and public health at UMDNJ-New Jersey Medical School and a coauthor. "Trials should be required to have adequate numbers to assure the tested drugs are reasonably safe."

"Safety evaluation should be given the same priority as efficacy evaluation," the authors wrote, calling for the creation of a Center for Drug Safety within FDA "for continuous post-marketing surveillance and regulation." They say the center should be given adequate funding and staff to take advantage of the valuable data for safety monitoring already collected in private and public databases.

The conditional drug-approval policy could be modeled on programs in other countries for those drugs that have clear benefits but also have lingering safety concerns, requiring a re-review after two to three years. "A time-limited conditional approval status would place pressure on the sponsors to conduct and report post-marketing safety studies they commit to," said Furberg.

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