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Oil prices plummet more than $6 amid economic

NEW YORK - Oil prices fell harder than they have in 17 years Tuesday, as fears... more

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French Court fines eBay over fake goods

A French court has ordered eBay to pay 40m euros (£31.6m; $63m) to luxury goods... more

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Karis is Super Filthy Gorgeous!!

Philips Shavers is receiving praise for its considerate, thoughtful ad for... more

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Wrigley sold (the company NOT the Ballpark)

Candy maker Mars Inc. says it's buying Wm. Wrigley Jr. Co., makers of Extra,... more

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New Listing Identifies Top 25 Amazing Cities for Eggheads

American cities have been ranked to create a list of the "smartest" cities... more

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The other oil shock: Vegetable oil prices soar

Rising prices for cooking oil in India are forcing residents of Mumbai to ration every... more

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PBS Dr. David Graham shows how FDA managers tried to silence him for indicating Vioxx unsafe.

Remember this horrifying story?
According to the link below it it hasn't changed.
Where is our outrage?
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FDA and Drug Approval Overview
Vioxx was one of the most widely used prescription drugs in the world and, for many, it may have been a killer. The Food and Drug Administration (FDA) is supposed to guarantee the safety of the medicines we take, but some say it may have disregarded warnings from its own scientists about this looming public health disaster. NOW's BAD MEDICINE explores the drug approval process and talks with FDA whistleblower, Dr. David Graham, who reveals how his FDA managers tried to silence him and quash evidence that indicated Vioxx was unsafe.
Approval Process

The drug approval process overseen by the FDA has been subject to complaints from many sides. In the 1990s it was criticized for being too slow ? keeping potentially life-saving drugs off the market and adding to development costs. The most recent controversies come from another perspective, questioning whether the process is too quick and relies too much on information from the pharmaceutical industry.

Approving prescriptions drugs is the job of FDA's Center for Drug Evaluation and Research (CDER). The process begins when a manufacturer has tested a new drug on animals and concluded three phases of testing on humans. The results from this process forms the basis of a "new drug application" (NDA), which the company submits to the CDER.

The NDA is then reviewed by CDER scientists who evaluate both the efficacy and safety of the drug and its risk/benefit ratio. The CDER reviewers may request more information from the developer and seek additional opinions from outside experts. CDER also checks the label information and investigates the manufacturing plant. The CDER director completes a final review and decides if the drug is ready for market. View an interactive graph of the process from CDER.

Some of the criticism Dr. Graham has leveled at the FDA process relates to what happens after a drug is approved. The FDA is also charged with monitoring drug safety of drugs on the market. The FDA tracks "adverse events" or negative "side effects" of drugs through the Office of Drug Safety, also a part of CDER. An adverse effect is a reaction which "results in death, disability, hospitalization, is life-threatening, causes a congenital anomaly, or requires treatment to prevent permanent damage."

Doctors and other healthcare personnel usually report these occurrences to the drug companies which are in turn required to notify the FDA of any serious incidents within 15 days of the original report. If a drug is new, the company must forward all reports quarterly for three years. After that time, all reports are filed annually. In addition, the FDA maintains a system of voluntary reports called MedWatch. Here, consumers and health care workers can submit reports which are then sent on to staff for evaluation.

In his November 2004 testimony before Congress, Dr. Graham suggested that the FDA is reluctant to admit that there are problems with drugs it has already approved. The FDA responded to Dr. Graham's testimony with a public rebuttal. In December 2004, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (JAMA) echoed some of Graham's criticism, publishing a series of papers which question the relationship of drug companies to the approval process. According to THE ECONOMIST, the makers of some of the drugs mentioned by Dr. Graham are feeling a financial effect. AstraZeneca's share price fell by 10%. Shares in GlaxoSmithKline fell by 6%. And as for Merck, the maker of Vioxx, traders have made a $40 billion reduction in the company's value. (Read Dr. Graham's testimony and the JAMA articles.)

Remember this horrifying story? According to the link below it it hasn't... more

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At HDDW we believe that Huntington's disease is treatable

There is exciting news in American Health care today!... more

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Revolutionary Waterless Car Cleaning System on BBC TV

Miracle Drywash is now used to clean all airside vehicles (e.g. luggage trucks) at... more

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Money Matters TV

Financial advice from James DiDio, CEO, Radnor Trust Co. and from David Ebner, Merrill... more

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Gender balance at the top = more profitability

"A new study by the giant consulting group McKinsey and Company found businesses... more

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Technology Boom in Israel

One of our intrepid VC2 producers is covering the growing tech industry in Israel. The... more

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AOL to Cut Global Work Force by 20%

AOL is cutting its global work force by an additional 2,000 jobs as it continues a... more

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Big Beer Merger

Coors and Miller are merging their U.S. and Puerto Rico operations (they make beer in... more

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FOXBusiness.com | going into business October 15th

Something else is GOING INTO business on OCT. 15th...

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Oil prices plummet more than $6 amid economic

French Court fines eBay over fake goods

Karis is Super Filthy Gorgeous!!

Wrigley sold (the company NOT the Ballpark)

New Listing Identifies Top 25 Amazing Cities for Eggheads

The other oil shock: Vegetable oil prices soar

PBS Dr. David Graham shows how FDA managers tried to silence him for indicating Vioxx unsafe.

At HDDW we believe that Huntington's disease is treatable

Revolutionary Waterless Car Cleaning System on BBC TV

Money Matters TV

Gender balance at the top = more profitability

Technology Boom in Israel

AOL to Cut Global Work Force by 20%

Big Beer Merger

FOXBusiness.com | going into business October 15th

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