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Zelnorm for IBS

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In compliance with an US-FDA request, Novartis has suspended marketing and sales of its irritable bowel/constipation drug Zelnorm (tegaserod maleate) which was approved by the US-FDA in July 2002, after an analysis of its clinical database (involving 18,000 patients) showed a greater incidence of MI (myocardial infarction: heart attack), stroke, and unstable angina (chest pains) among patients taking the drug, stated in a MedScape report. Access www.novartis.com for more information.

It just never ceases to amaze me how the FDA is so reputable,* NOT *, but still approves drugs so the companies can make their billions, then after many people have heart attacks, strokes or even die, they finally look at the numbers of people affected in a negative way.

The FDA needs an overhaul, just like the healthcare system.

Hum...I wonder when the FDA will look at the numbers of seriously ill people and ones that die from implants ? ? I guess after millions of lips are implanted with the new saline lip implants with valves......cause aspergillis and pseudamonas and is transferred to their husbands..........as well as many of the women getting necrosis

and the implants destroying their faces. This is gonna be an added sad time.......

**************It's only a deal if it's where you want to go. Find your travel deal here. (http://information.travel.aol.com/deals?ncid=aoltrv00050000000047)

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Subj: Emailing: FDA Science & Mission at Risk - Report of the Subcommittee on Science & Technology - 2007.pdf

Toxic Alert From Toxic Discovery

FDA Science & Mission at Risk: Report of the Subcommittee on Science and Technology.

Prepared for the FDA Science Board and was released in Nov. 2007

----------------------

Here are just a few verbatim quotes from the attached 60-page report:

1. The FDA cannot fulfill its mission because its scientific bas has eroded and it scientific organizational structure is weak.

2. The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.

3. The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.

4. FDA does not have the capacity to ensure the safety of food for the nation.

5. The development of medical products based on "new science" cannot be adequately regulated by the FDA.

6. There is insufficient capacity in modeling risk assessment and analysis.

7. The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.

8. The FDA has substantial recruitment and retention challenges.

9. The FDA has an inadequate and ineffective program for scientist performance.

10. The FDA has not taken sufficient advantage of external and internal collaborations.

11. The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.

12. The FDA cannot provide the information infrastructure support to regulate products based on new science.

The report also found that the FDA "cannot even keep up with the advances in science".

---------

Attached provided to you by Toxic Discovery

www.toxicdiscovery.com >> In compliance with an US-FDA request, Novartis has suspended marketing and > sales of its irritable bowel/constipation drug Zelnorm (tegaserod maleate) which > was approved by the US-FDA in July 2002, after an analysis of its clinical > database (involving 18,000 patients) showed a greater incidence of MI > (myocardial infarction: heart attack), stroke, and unstable angina (chest pains) among > patients taking the drug, stated in a MedScape report. Access www.novartis.com > for more information.> > > It just never ceases to amaze me how the FDA is so reputable,* NOT *, but > still approves drugs so the companies can make their billions, then after many > people have heart attacks, strokes or even die, they finally look at the numbers > of people affected in a negative way. > > The FDA needs an overhaul, just like the healthcare system. > > Hum...I wonder when the FDA will look at the numbers of seriously ill people > and ones that die from implants ? ? I guess after millions of lips are > implanted with the new saline lip implants with valves......cause aspergillis and > pseudamonas and is transferred to their husbands..........as well as many of > the women getting necrosis> and the implants destroying their faces. This is gonna be an added sad > time.......> > > > **************> It's only a deal if it's where you want to go. Find your travel > deal here.> > (http://information.travel.aol.com/deals?ncid=aoltrv00050000000047)>

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