There is a real danger that this bill could be voted on in the Senate this week or next, and that the Senate language could be introduced in a House bill that they could already have consponsors lined up for which could cause a House bill to move rapidly.
If S. 3546 becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.
This dangerous bill fails to contain language whereby causality of an adverse reaction could be determined. There is far too much likelihood under it that safe dietary supplements would be unfairly blamed for adverse reactions that are actually being caused by Rx drugs.
The vitamin trade associations are all for it, but its a bad bill. They're for it because the large companies which politically dominate the trade associations can more easily handle the red tape costs of compliance than smaller companies. Consumers would be the ultimate losers as we'd have to pay for the increased costs of compliance.
See http://www.lef.org/featured-articles/consumer_alert_130906.htm where you can learn more and with one Mouse click you can send a form letter to your senators and congressman against this bad bill.
Fish oil could potentially save more lives than cardiac defibrillators, devices used to revive individuals whose hearts have stopped beating and to prevent and treat life-threatening heart arrhythmias, researchers estimate in a new report.
Past research has linked the omega-3 fatty acids found in oily fish to a lower risk of fatal heart rhythm disturbances. This latest study tried to estimate the potential public health impact of raising adults' omega-3 levels with fish oil supplements.
Using a computer-simulated community of 100,000 Americans and data from past medical studies, the researchers calculated that raising omega-3 levels would save 58 lives each year.
This amounts to a 6.4-percent total death reduction -- mostly by preventing sudden cardiac death in apparently people, according to the study authors, led by Dr. Thomas E. Kottke of the Heart Center at Regions Hospital in St. Paul, Minnesota.
Conversely, the researchers estimate that far fewer lives would be saved by defibrillators, devices that deliver a "shock" to restart the heart or to resolve ventricular fibrillation, an otherwise fatal heartbeat irregularity in which the heart quivers instead of contracting normally.
For example, the study found, even if automated external defibrillators (AEDs) were available in every home and public area, the devices would lower a community's annual death rate by less than 1 percent.
AEDs are portable devices that can be used by lay people to shock someone in cardiac arrest. They are frequently available in public places such as large stores or on airplanes. Though the devices do save lives, the researchers note that AEDs would make little difference in the overall rate of sudden cardiac death.
Kottke's team estimates that implantable defibrillators would lower the cardiac death rate by 3.3 percent, still not as much as the 6.6-percent lower death rate achieved by increasing the use of fish oil supplements.
Though the implantable devices are effective, the researchers point out that about half of adults who die suddenly from cardiac arrest have no warning signs beforehand -- and would, therefore, never be candidates for an implanted defibrillator.
The study, which is published in the American Journal of Preventive Medicine, has its limitations, as a computer simulation. Though the researchers based their estimates of fish oil benefits on two large studies, it's not yet clear that omega-3 fatty acids prevent sudden cardiac death in apparently healthy people.
Ongoing trials in Italy and England may help answer this question, Kottke and his colleagues note.
If fish oil is as effective against fatal heart arrhythmias as evidence suggests, the researchers conclude, it would have more widespread benefits than either AEDs or implanted defibrillators.
SOURCE: American Journal of Preventive Medicine, October 2006.
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